VA renews Oracle Cerner EHR contract, but with multiple caveats, metrics, and annual renegotiations

VA finally gets tough with Oracle Cerner–when things are not peachy at the latter. The Oracle Cerner EHR contract with the Department of Veterans Affairs (VA) was renewed with 28 key performance metrics attached to monetary credits. Instead of another five-year term, there are five one-year terms that allow VA to revisit the contract annually. It was not a ringing vote of confidence in the relationship, with good reason, as the EHR implementation has ground embarrassingly to a halt over five years with only five deployments in VA medical centers, of 166 centers plus their medical clinics [TTA 26 Apr, 18 Mar].

The renegotiated contract holds Oracle accountable in four key areas, according to a VA update document obtained by Bloomberg Government:

  1. Reliability: Minimizing outages (time when the system crashes completely), incidents (time when one component of the system isn’t working), and interruptions (time when the system is operating slowly) of the system.
  2. Responsiveness: Quickly and reliably resolving help tickets and clinician requests.
  3. Interoperability with other health care systems: Ensuring that VA can quickly and reliably access patient health records from private sector hospitals when necessary, so we can provide informed, world-class care to those we serve.
  4. Interoperability with other applications: Ensuring that the EHR system interfaces with VA’s website, mobile app, and other critical applications, so Veterans have a seamless and integrated health care experience.

With 28 performance metrics that if not met will result in Oracle paying a monetary credit to the VA, there’s a big monetary incentive for Oracle. For instance, in the VA update document, they claim that Oracle would have paid approximately a 30-fold increase in credits for the system outages, which is only one of the metrics. “The amended contract lays the groundwork for VA and Oracle Cerner to resolve the EHR issues identified by the “assess and address period” and optimize EHR configuration for future sites.” Becker’s, Healthcare IT News

The contract negotiations were a hot button in recent weeks for both the House and Senate veterans’ committees, with multiple bills proposed and hearings. The 9 May hearing by the House Subcommittee on Technology Modernization Oversight (Committee on Veterans’ Affairs) was no love-fest, with chair Matt Rosendale (R-MT) once again concluding that the best thing for the VA would be, as he proposed in his bill H.R. 608, to cut Oracle loose and start over. VA obviously did not agree, being between a rock and a hard place, but this hearing put Oracle’s Mike Sicilia on the hot seat about the EHR’s pharmacy software to support the VA’s role as both prescriber and prescription filler–which he previously committed to having fixed by this past April. Carol Harris, Director, Information Technology and Cybersecurity, Government Accountability Office (GAO), responding to Rep. Rosendale’s questions, described a system that is not fully functioning and puts veterans at risk with failings by both Oracle and VA. In the current state, VA users are extremely dissatisfied. The present workarounds and ad hoc processes outside of the system are not sustainable and are set to fail. She also pointed out that VA needs to set goals for what constitutes user satisfaction with clear and objective measures before future deployments. VA must take a leadership role in change management beyond what Oracle does in the deployment. Hearing on YouTube (2.01:50) Witnesses and support documents

The added scrutiny comes at a bad time for Oracle Health with turmoil reportedly festering within the Cerner acquisition. Oracle has laid off 3,000 workers, pausing raises and promotions. Don Johnson, who once was a successor to CEO Larry Ellison, departed from leading Oracle Health and AI. Reportedly, Dr. David Feinberg who briefly headed Cerner prior to the sale, is now a ‘ceremonial’ chairman of Oracle Health. Cerner’s signature buildings in Kansas City are being sold and emptied. If Mr. Ellison wants to transform healthcare, he needs to start at home, rebuilding Cerner-Oracle Health rather than decimating it, and fixing VA as Job #1. Business Insider

Additional recent coverage: 28 April, 20 April, 19 April, 31 March

Breaking & updated–Time’s Up! Ninth Circuit Court to Elizabeth Holmes: proceed to Federal prison. District Court: surrender 30 May, pay $452M in restitution with Sunny.

Breaking/Updated. With the bail pending appeal denied, it was back to Judge Davila and the US District Court to determine a new surrender date to a Federal penitentiary. That date is now 30 May. The Ninth Circuit Court of Appeals ruled Tuesday that Elizabeth Holmes’ appeal did not meet the standard for a further delay of her sentence–that it raised a substantial question of law or fact–and that her motion for bail pending appeal was denied. The ruling by the three-judge panel was brief and is here (PDF) with the pertinent text below:

Appellant’s motion for bail pending appeal (Docket Entry Nos. 36-38) is
denied. Appellant has not shown that: (1) the appeal raises a “substantial question”
of law or fact that is “fairly debatable,” and (2) if that question is decided in
appellant’s favor, the likely outcome is reversal, an order for a new trial on all
counts resulting in imprisonment, a sentence that includes no term of
imprisonment, or a sentence with a term of imprisonment less than time served
plus the expected duration of the appeal process. {USC and Hardy references snipped}

The existing briefing schedule remains in effect.

The appeal remains ongoing. The Ninth Circuit could require a new trial or a fresh sentence, but Holmes will be in prison serving time while the appeals court reviews it. Her chances of receiving any changes as a result of this appeal can be characterized as slim to none.

The defense requested self-surrender on 30 May (2 weeks) and Judge Davila granted it two hours later today (Wednesday). That motion is here with Judge Davila’s order is here. The judge had recommended the Federal Prison Camp (FPC) at Bryan, Texas, but a final assignment confirmation is to be confirmed by the Bureau of Prisons (BOP).  Mercury News

Also Tuesday, Judge Davila set the full amount of restitution to those defrauded by Theranos as $452 million. Both she and Sunny Balwani will be jointly liable for the restitution amount. It is higher than the $381 million the judge used for sentencing purposes [TTA 9 March] but this Editor notes that the AP stated that it is joint. There is an additional $25 million in promissory notes signed by Holmes which are part of a civil action [TTA 25 March]. How this restitution breaks out will require an examination of that restitution decision.

One wonders if Liz or Elizabeth (pictured above) will be the woman serving and paying off this amount, if one believes the incredible tale by Holmes in the New York Times two weeks ago. It’s a lot of bag lunches. Mercury News 

Monday roundup: Envision files Ch. 11, who’s to blame for Meta Pixel abuse?, CVS Health to shut clinical trials unit, Amino Health scoops $80M, DocGo flat but optimistic, Owlet way down in revenue

What was envisioned last week came to pass for Envision Healthcare on Sunday. The hospital and physician staffing company filed for Chapter 11 reorganization five years after it was taken private by investment company KKR. At the time of that massive buyout, the value of the company was pegged at $10 billion. Things started to go south for Envision after 2020 with the pandemic drying up patient volumes for two years, with the added factors of regulations kicking in on ‘no surprise’ billing, inflation, staffing shortages, and major fights with health plans around out-of-network inflated charges plus a huge claims dispute with UnitedHealthcare [TTA 12 May]. Ironically, Envision won the main dispute with UHG; that $91 million won in arbitration in an insider’s view would have staved off the bankruptcy this year.

KKR will apparently lose its $3.5 billion equity in the company as $8 billion in debt restructuring takes place. What’s before the court is that the Envision staffing operation will be separated from the AmSurg surgical clinics. Senior lenders will have their debt rearranged into equity into one or the other company. Junior lenders, bondholders, and KKR will receive zero, or as we say locally, bupkis. It’s envisioned (sic) that the restructuring will take about three to four months.  Financial Times, Envision release

The hospitals, that’s who! If you believe Meta, it’s the hospitals that abused those poor Pixels, making them do things against their wishes to tattle all sorts of PHI and PII to Big Bad Meta which sends patients all those Nasty Intrusive Ads. Meta is being sued by parties from the ACLU to patients in class action lawsuits on how the Pixel was used on hospital patient portals and scheduling websites. Meta’s argument is that the health systems’ developers could but did not control how the ad trackers were used and that “Meta did not implement or configure” the Pixels used on the health systems’ websites. In fact, Meta claims that they have filtering tools that screen out sensitive data and that would alert the developer. “It’s ultimately the developer, not Meta, that controls the code on its own website and chooses what information to send,” according to the May 5 filing in that busy US District Court of Northern California.

This could influence outcomes in the multitude of lawsuits being filed against health systems like Kaiser Permanente, UCSF Health, and LCMC Health in New Orleans plus Willis-Knighton Health in northwest Louisiana (Healthcare Dive). If the District Court finds that Meta, and possibly other ad trackers such as those from Google, Twitter, or Bing were not inherently liable for personal health data violations that monetized PHI, then the health systems are 100% on the hook for the data breaches (or ‘wiretapping’ in a creative use of terminology). It also makes the potential paydays possibly less lucrative–in the eyes of this Editor, as Meta and Google have far deeper pockets than any ol’ health system. SC Media, Paubox   The Meta Pixel backstory here

CVS Health to shut its clinical trials unit by December 2024. CVS, like Walgreens and Walmart, jumped into the clinical trials business during the Covid-19 pandemic, seeing a need in the market with pharmaceutical companies and a ready-made, 100 million deep diverse base of patients among their pharmacy users. CVS cited to Healthcare Dive that the shutdown was to better concentrate on core business. Current active trials on the website include narcolepsy, rheumatoid arthritis, and kidney health. No disclosure as to profitability but CVS has a lot to digest with new buys Signify Health and Oak Street Health.

Amino Health’s $80 million funding is a bright spot in this sideways spring. With a digital guidance model that works with employers and health plans to help 1.6 million members navigate their care, their new funding will be used for technology scaling. Equity and debt financing were led by Transformation Capital, which will be joining the Amino board, and Oxford Finance LLC. Amino is being boosted by the Federal Transparency in Coverage (TIC) Rule which makes pricing disclosure a key part of plan navigation. Amino originally started with a direct-to-consumer model but shifted to enterprise, including brokers and third-party administrators. Amino’s total raise is now $125 million (Crunchbase). Mobihealthnews, Amino release

DocGo’s two services, mobile health and medical transport, essentially swapped revenue this quarter in a better-than-average picture. Their mobile health services area in Q1 fell 19% to $72.9 million from $90.1 million in Q1 2022, while transportation services grew 44% to $40.1 million from $27.8 million in Q1 2022. This added to total revenue of $113 million with a net loss of $3.9 million. Their 2023 revenue guidance remains at $500-$510 million with adjusted EBITDA guidance of $45-$50 million. 

What’s promising here is that it’s a SPAC that didn’t crack like practically every other. DocGo pointed out in their release that they have a backlog of $205 million in total contract value over approximately three years and they have doubled their RFPs. Their patient target for 2023 is 50,000. Share price today on Nasdaq ticked up to $8.77. Considering their high last year of $11.08, they are not doing badly in this time at all. Mobihealthnews .We last saw DocGo providing mobile clinics in a Tennessee pilot with Dollar General [TTA 24 Jan] which now is tied in with the state of Tennessee, plus a pilot in NY and NJ with Redirect Health. They provide services in 26 states and the UK.  

This Editor is trying to be as cheerful as the baby at left about baby sock/monitor Owlet, which has had a rough ride in the past two years. Their revenue dropped to $10.7 million in Q1 2023 versus $12 million in Q4 2022 and $21.5 million in Q1 2022. Owlet ended 2021 with a nastygram from the FDA that pulled their original Smart Sock off the market [TTA 4 Dec 2021] but rebounded early in 2022 with the Dream Sock and Dream Duo [TTA 16 Feb 2022] that avoided the claims that sent them into 510(k) Marketing Neverland.  Still, they were delisted by the NYSE in December 2022. On the positive side, Owlet wound up 2022 with $69.2 million in revenue and a good-sized private placement of $30 million in February [TTA 18 Mar]. It has submitted to FDA for two products, including the steep de novo climb on an enhancement to the Dream Sock. Now a much smaller company than it was last year, they have reduced operational expenses to $15.1 million from $24.1 million in Q4 2022 to get to breakeven by end of this year and to be relisted on the NYSE in the future. Having followed them since the early ‘telehealth for the bassinet set’ days of 2012-2013, this Editor wishes them bonne chance. Owlet release, Mobihealthnews

Week-end roundup: Cano Health’s $60M loss and divesting, Oscar Health exits CA, UCSF Meta Pixel lawsuit narrows, Syneos goes private for $7.1B, Envision nears Ch. 11, Australia’s A$429M EHR modernization funded

Cano Health’s Q1 was not a cheerful one, what with a board fight, the Cano 3 resigning and nailing a long list of grievances to the door, and a new chairman of the board, Sol Trujillo, who specializes in turnarounds. The results bore out the Cano 3’s concerns, with a $60.6 million net loss versus 2022’s barely-there $100,000. Revenue increased 23% to $866.9 million but per member per month (PMPM) revenue fell 13%, driven by a higher proportion of non-Medicare members but partially offset by membership growth: 388,667 including 207,420 Medicare capitated members, an increase of 44% and 29% year-over-year. Adjusted EBITDA was only $5 million, compared to $29.2 million in Q1 2022. What’s being divested to improve cash flow are the proverbial ‘non-core assets’ which are outside of Medicare Advantage–a complaint of the Cano 3 who noted things like family self-dealing and a murky relationship with a Miami claims recovery outfit. Cano also raised 2023 forecasts for membership and total revenue, but no mention of growth in medical centers. Cano earnings release, Healthcare Dive, Digital Health Business

In other slimming-down news, Oscar Health will exit its exchange plans within Covered California at the end of the year. While they have 35,000 members, their medical loss ratios (MLR) are over 100% versus the desired 80%. (MLR, a key metric in exchange plans, is defined as the proportion of total paid medical service claims and all quality improvement activities together, then dividing that number by the total premium revenue minus all allowable deductions. New CEO Mark Bertolini says they will return when Oscar reshapes their product offerings and strategy. This Editor hears a heavy boot drop. Healthcare Dive

Lawsuits of health systems on Meta Pixel being used to send private patient information to Facebook and other third-party advertisers are now rolling through the courts. The class action against University of California San Francisco (UCSF) Health just got a little narrower. Judge William Horrick of the US District Court for the Northern District of California granted defendant UCSF Health’s motion to dismiss several plaintiff claims. As a public entity, UCSF argued that the “unjust enrichment” claims were invalid. ‘Jane Doe’s’ lawyers representing the class of patients have a deadline of 30 May to amend the breach-of-contract claim. Health systems caught up in the ad pixel mess should follow this closely, though Becker’s seems to be the only news coverage. Our coverage of Meta Pixel

And in other healthcare news from two ends of the spectrum:

  • Biopharma contract research organization (CRO) Syneos Health will be going private in a $7.1 billion deal.  Elliott Investment Management, Patient Square Capital, and Veritas Capital are leading the cash buyout for $43.00 per share, a tidy 24% premium to the 13 February closing price, which is a somewhat unusual delay but apparently due to heavy media speculation around it. Syneos was formed in the merger of two large CROs, InVentiv Health and INC Research, and as a public company has been on the share price roller coaster, though the category is considered to be highly attractive for investment to improve the odds of biopharma success.  The deal is expected to close in the second half of the year. Syneos release, Healthcare Dive
  • Healthcare staffing company Envision Healthcare envisions filing a Chapter 11 bankruptcy soon, according to a Wall Street Journal report. They are carrying about $7 billion in outstanding debt, ongoing and costly legal spats with UnitedHealthcare, and has had difficulty finding physicians and nurses that are contracted to augment hospital staff. Conflicts with payers center around out-of-network billing charges which are far above the customary and the ‘no surprises’ patient protection billing law that took effect this year. Investor KKR owns the company and reportedly has already written it down. Their EBITDA cracked from $1 billion in 2020 to about $250 million in 2022. FierceHealthcare, Healthcare Dive

And Down Under, the modernization of Australia’s health system EHR, estimated to cost A$429 million over two years, is now funded in the 2023-4 budget. The My Health Record (MHR) modernization will improve data sharing across service settings, sharing of pathology and diagnostic imaging information, and increase usage of MHR by allied health professionals. The budget also includes substantial fresh funding to the Australian Digital Health Agency (ADHA)–over A$325 million over four years and an ongoing A$80 million–and A$5.7 billion to Australia’s national Medicare program including strengthening primary care and urgent care. IT News (Australia)

Babylon Health ‘Take Private Proposal’ includes London High Court administration request

An added fillip to Babylon Health’s going private under a ‘Take Private Proposal’ is the inclusion of administration in the UK. This was revealed in their 8-K (001-40952) filed on Wednesday with the Securities and Exchange Commission (SEC). It states that the Framework Implementation Agreement ‘contemplates’ that part of the Take Private Proposal will involve the appointment of administrators, the British form of the US Chapter 11 reorganization procedure. Specifically, the Babylon Holdings Limited board will request that administrators be appointed by the High Court in London. These administrators will then supervise the transfer of assets from Babylon Holdings Limited to Babylon Group Holdings Limited and then their sale to the ‘NewCo’ formed after the reorganization by AlbaCore Capital as the Go-Forward Business. Any assets or subsidiaries not transferred will be dissolved along with Babylon Holdings Limited. 

This was not disclosed in the press release or the earnings announcements. Our article yesterday.

The pertinent paragraphs (the last two above ‘Forward Looking Statements’) also reinforce that ordinary Class A shareholders and holders of other equity instruments receive nothing. With the shares on the NYSE trading at $1.19 (1pm EDT 11 May), they are almost there.

One wonders if the NHS and private users of Babylon Health’s apps are aware of this development buried in an 8-K filed in the US.

Hat tip to Ari Gottlieb of A2 Strategy via LinkedIn, who read the 8-K, noticed this in his posting (recommended reading), and has had watch on Babylon for some time.

Mid-week roundup: DEA extends telehealth prescribing waiver to November; telehealth usage continues to erode; NextGen EHR hacked, 1M records breached

The answer: 11 November. The question: how long was the Drug Enforcement Administration (DEA) planning to extend their telehealth waiver of in-person prescribing requirements on Schedule II and higher controlled substances?  Both the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued the “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications”rule on 9 May before the Public Health Emergency (PHE) expired on 11 May. It’s a six-month reprieve for the beleaguered telemental health providers/prescribers and their patients–and sure to be hotly debated over the next few months as a final rule must replace the temporary extension rule and the Ryan-Haight Act isn’t going away. DEA release, TTA 4 May

FAIR Health’s tracking of telehealth medical claims has languished in the Fives–as in 5%–since last year. February is the latest month of tracking and it declined from 5.9% in January to 5.5% in February. Again, the vast majority of claims are for mental health codes (66.7%) far ahead of diagnosis #2, acute respiratory diseases and infections, where Covid-19 once resided. However, the latter accounted for 25.6% of asynchronous (store and forward) telehealth diagnoses. A new metric on the report is audio-only telehealth, which is only slightly more popular in rural versus urban areas. The greatest difference from the national norm is in the West, where February telehealth claims were 7.6%. Monthly national summary, FAIR Health main page for monthly and regional summaries.

NextGen’s EHR/practice management system hacked, 1.05 million patient records breached. Information stolen included patient name, dates of birth, addresses, and Social Security numbers. This was revealed in a filing with the Maine attorney general’s office since it included over 4,000 Maine residents. The hack of the NextGen Office system took place between 29 March and 14 April 2023. It’s been a bad year for NextGen’s IT and security teams, as it also experienced a short-term ransomware attack in January by AlphV/BlackCat. (The two couldn’t be related…could they?) No word yet on class action lawsuits or Federal penalties.  TechCrunch

Week-end roundup: Is ChatGPT *really* more empathetic than real doctors? Amwell’s $400M loss, Avaya emerges from Ch. 11, Centene sells Apixio, more on Bright Health’s MA sale, layoffs at Brightline, Cue Health, Healthy.io

Gimlet EyeA Gimlety Short Take (not generated by ChatGPT). This Editor has observed developments around AI tool ChatGPT with double vision–one view, as an amazing tool with huge potential for healthcare support, and the other as with huge potential for fakery and fraud. (If “The Woz” Steve Wozniak can say that AI can misuse data and trick humans, Tesla’s AI-powered Autopilot can kill you, plus quit Google over AI, it should give you pause.)

The latest healthcare ‘rave’ about ChatGPT is a study published 28 April in JAMA Network that pulled 195 questions and answers from Reddit’s r/AskDocs, a social media forum where members ask medical questions and real healthcare professionals answer them. The study authors then submitted the same questions to ChatGPT and evaluated the answers on subjective measures such as “better”, “quality”, and “empathy”. Of course, the ChatGPT 3.5 answers were rated more highly–78%–than the answers from human health care professionals who answer these mostly ‘should I see a doctor?’ questions. HIStalk noted that forum volunteers might be a little short in answering the questions. Another point was that “they did not assess ChatGPT’s responses for accuracy. The “which response is better” evaluation is subjective.” The prospective patients on the forum were also not asked how they felt about the AI-generated answers. Their analysis of the study’s shortcomings is short and to the point. Another view on compassion in communication as dependent on context and relationships was debated in Kellogg Insight, the publication of the Kellogg School of Management at Northwestern University, in Healthcare IT News.

Amwell posted a disappointing and sizable $398.5 million net loss in Q1. This was over five times larger than the Q1 2022 loss of $70.3 million and Q4 2022’s $61.6 million. The loss was due to a noncash goodwill impairment charge related to a lasting decline in the company’s share price. Current versus prior year Q1 revenue remained flat at $64 million, $15 million lower than Q4 2022 due to a decline in professional services revenue. Visits were 1.7 million visits in Q1, with 36% through the new platform Converge. Guidance for the year remains at $275-$285 million with an adjusted EBITDA loss between $150-$160 million. Mobihealthnews This contrasts with rival Teladoc’s optimistic forecast released last week, though remaining in the loss column [TTA 4 May]. 

Avaya emerged from Chapter 11 on Monday. According to the release, the company has financially restructured and now has $650 million in liquidity and a net leverage ratio of less than 1x. This was a lightning-fast bankruptcy and reorganization, usually referred to as ‘pre-packaged’, as it was announced in February with the company emerging from it in 60 to 90 days. Avaya provides virtual care and collaboration tools (and has contributed to our Perspectives series). 

Another restructuring continues at Centene. Their latest sale is Apixio, a healthcare analytics platform for value-based care. The buyer is private equity investor New Mountain Capital. New Mountain has $37 billion in assets under management. Centene acquired Apixio in December 2020 in the last full year of CEO Michael Neidorff’s leadership. Since 2022, Centene has been selling off many of their more recent acquisitions such as two specialty pharmacy divisions, its Spanish and Central European businesses, and Magellan Specialty Health. Transaction cost and management transitions were not disclosed. Based on the wording of the release, Centene will continue as an Apixio customer as well as other health plans. Given the profile of the 10 largest health plans, which includes Centene, and their diversification, Centene’s divestments coupled with the involvement of activist investor Politan Capital Management have led to speculation.

Another take on Bright Health’s projected divestiture of its California Medicare Advantage health plans is from analyst Ari Gottlieb on LinkedIn. If Bright sells the MA plans for what they paid for them–$500 million–according to Mr. Gottlieb they can pay off their outstanding JP Morgan credit facility as well as negative capital levels in many of the states where they had plans and are now defending lawsuits. It still leaves them $925 million in debt.

Unfortunately, we close with yet another round of layoffs.

  • Covid-19 test kit/home diagnostics Cue Health will be surplusing about 26% of its current workforce, or 325 employees. Most will be in the San Diego manufacturing plants. This is on top of 170 employees released last summer. The current value of the Nasdaq-traded company is estimated at $105 million, down from $3 billion at their 2021 IPO. Current share price is $0.68. HIStalk, San Diego Business Journal.
  • Another telemental health company is shrinking–Brightline–reducing their current workforce by another 20%. This affects corporate staff and is in addition to the 20% let go last November. Brightline’s focus is on mental health for children and teens, and has investment to date of $212 million. Becker’s 
  • Healthy.io, which offers in-home urinalysis and wound care, plus a new app for kidney care, laid off 70 staff while enjoying a fresh Series D raise of $50 million from Schusterman Family Investments.  Becker’s

Mid-week roundup: CVS-Oak Street closes, DEA extends controlled substance telehealth waiver, Bright Health selling CA MA plans, Talkspace, Teladoc turnarounds? (updated)

CVS closed its $10.6 billion deal for Oak Street Health, well before the anticipated end of 2023. It picks up 169 primary care offices in 21 states–and an unprofitable operation that clocked a loss last year of $510 million without much of a change till 2025. The quick closing was likely spurred by both the Department of Justice (DOJ) and the Federal Trade Commission (FTC) letting their antitrust challenge period expire at the end of March with nary a whimper. DOJ and FTC, the latter which has been remarkably ‘pixelated’ of late on privacy issues with GoodRx and Teladoc’s BetterHelp, evidently passed on ‘egg on the face’ and let the ovoid land squarely on Elizabeth Warren’s Senate desk. She had asked FTC to ‘carefully scrutinize’ the deal. Shareholders received a tidy $39 per share. OSH will remain a multi-payer practice and now-former CEO Mike Pykosz will lead the company under CVS’ new healthcare delivery arm. This follows on CVS’ closing of Signify Health [TTA 30 March].  CVS release, FierceHealthcare Our prior gimlety coverage of CVS/OSH: 16 Feb, 2 March, Unlike OSH, CVS had a strong Q1 with $2.1 billion in profit, slightly down from 2022’s $2.4 billion, and an 11% boost in revenue. FierceHealthcare

DEA in-person prescribing requirements on Schedule II and higher controlled substances postponed indefinitely. The proposed rule would have added back in-person requirements for telehealth prescribing of controlled substances after the official end of the Public Health Emergency and its in-person waivers on 11 May. On 25 April, the DEA filed a draft temporary rule with the Office of Management and Budget for the extension. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires that Schedule II medications and narcotics (including Adderall and Ritalin) require an in-person prescription, while Schedule III or higher medications, including buprenorphine, Ambien, Valium, Xanax and ketamine can be prescribed for 30 days via telehealth but would require an in-person visit before a refill. The DEA was deluged with 38,000 comments and advocacy pressure from ATA. The change has also thrown a wrench in the works of online mental health companies which prescribe many of these drugs. FierceHealthcare  Updated–The ATA has weighed in favorably about the DEA postponement. Kyle Zebley, executive director of ATA Action, stated in their release that “Our hope is that the DEA will use the time of an extension to be responsive to the concerns of telehealth advocates, patients, and the American people to create rules that ensure access to clinical care that is not inappropriately restricted.”

Bright Health put its California Medicare Advantage plans up for sale. The company, staring down at bankruptcy [TTA 7 Apr, 20 Apr] does not yet have a buyer for the MA plans. When they are sold, it will be Bright’s exit as a health insurer, as it has exited MA plans in Florida and exchange plans everywhere else–in a flurry of state investigations ranging from Tennessee to Texas. Bright plans to focus on its provider arm, NeueHealth. Healthcare Dive

Talkspace narrowed its loss, increased revenue. The telemental health provider narrowed its Q1 net loss to $8.8 million compared to 2022’s $18.3 million in Q4 2022 and $20.4 million in Q1. Revenue increased to $33.3 million versus last year’s Q1 of $30.2 million. Their source of business has shifted to B2B with a 71% increase, a sharp departure from their formerly dominant consumer segment which has declined 40%.  Their 2023 forecast revenue is $130-135 million. It is still facing a Nasdaq delisting as trading below $1.00 per share and a class action lawsuit on subscription renewals. Mobihealthnews

Teladoc also waxed positive, ‘beating the Street’ with Q1 revenue growth of 11% to $629 million. This was powered as expected by BetterHelp, Teladoc’s direct-to-consumer mental health business. Their revenue grew to $279 million, a 21% increase. Teladoc’s enterprise business also had a 5% boost to almost $350 million. Their weight loss business is expected to be another net positive income generator, but not affecting results until 2024 as it won’t be introduced until Q3 [TTA 21 April]. The road to profitability will be a long one, as losses this quarter were $69.2 million, but compared to last year’s $6.7 billion writedown of Livongo, it’s positively smooth. Healthcare Dive

Short takes: Amazon dims to black Halo wearable line, eVisit acquires Bluestream Health, Moving Health Home launches to lobby Congress, government

Amazon shuttering Halo health and fitness product line and services. On Wednesday, Amazon emailed Halo users that the line (View, Band, and brand new Rise sleep tracker) and services, including apps, will be switched off on 31 July. Users will be able to download or delete health and other data. Subscriptions will be refunded as well as all purchases made in the last 12 months. Remaining staff in the Halo unit will be laid off. This was not unanticipated given that Amazon cut jobs at Halo back in February as part of their mass layoff of 18,000 then and another 9,000 last month. Amazon is being quite ruthless in reacting to its 2022 loss and changing up its bets in healthcare to buying F2F care, like One Medical–as the Federal Trade Commission cleans its sights to hunt big game [TTA 23 Feb, 23 March] and the Department of Justice lurks in the wings, despite the sale closing. Engadget, Amazon notice, The Verge, Becker’s

Virtual care platform eVisit acquires virtual care platform Bluestream Health. Bluestream adds ‘white labeled’ telehealth as a customized “front door” for health systems along with virtual care workflow and LanguageLine translation to eVisit’s capabilities in automating patient care management for large health systems. eVisit picks up Bluestream’s 50,000 providers and 500 health systems to add to its 100 healthcare delivery organizations, 2,000 sites of care, and access by over 275,000 clinicians.  Acquisition cost and leadership/workforce transition are not disclosed. eVisit is based in Phoenix while Bluestream is HQ’d in NYC. This Editor first met with founder Brian Yarnell about 2015 or possibly earlier, when the company was operating out of two offices in shared workspace. Release, eVisit Bluestream acquisition page. FierceHealthcare

A new industry organization launches to lobby Congress and government for home health. Moving Health Home announced in March that it was forming to unify healthcare organizations to advocate for home health and to make the home a reimbursable site of care from insurers and Medicare. This spans prevention such as fall risk assessment and nutrition as well as direct care in the home including hospital at home. Members include Amazon, Hackensack Meridian Health, DaVita, Signify Health, Dispatch Health, and many others from the clinical, vendor, and provider areas. It’s headed by Krista Drobac, who has been for some time an activist in the connected health and health policy areas. Earlier this month, they announced that there will be a House bill, Expanding Care in the Home Act (ECHA) which is similar to prior bills both in the House and Senate.

Mid-week roundup: Kaiser Permanente to buy Geisinger, setup separate system; GoodRx co-CEOs step down; strong earnings for Centene, Humana; Clover Health stock woes, settles $22M lawsuit

Today’s big news was that Kaiser Permanente will be acquiring Geisinger Health. Technically, the acquisition is being made by Risant Health, a separate non-profit organization founded by the Kaiser Foundation Hospitals that will acquire other non-profit community health systems. Acquisition costs and a timetable for the transaction were not disclosed and will be subject to the usual state and Federal regulatory review and requirements.

Geisinger will be the founding system of Risant Health, a non-profit that will be headquartered in the Washington, D.C. area. Its current president, Jaewon Ryu, MD, JD, will become CEO when the acquisition closes. Risant’s purpose will be to advance value-based care by acquiring and connecting other multi-payer, multi-provider, community-based health systems in areas such as care model design, pharmacy, consumer digital engagement, health plan product development, and purchasing. 

Kaiser Permanente is a giant integrated care system with 12.6 million members based in California. It operates in eight states (California, Colorado, Georgia, Hawaii, Maryland, Oregon, Virginia, and Washington) and the District of Columbia. Geisinger Health is Pennsylvania-based, has 10 hospital campuses, its own health plan that covers more than 500,000 members, and the Geisinger College of Health Sciences with schools of medicine, nursing, and graduate education. Geisinger was also a pioneer in incorporating telehealth and remote patient monitoring into its healthcare system. The benefit to Geisinger joining Risant is that as the lead system, it will help to shape their operational model. Reportedly, Kaiser will spend $5 billion and acquire five to six health systems over the next five years. The health systems will retain their names and operational areas.

On the face of it, this seems to be a novel solution to both health systems’ challenges. Both have had operating losses and net losses in recent years and difficulty expanding out of their geographic areas. Kaiser has a tightly integrated health plan and service model that is location-dependent. Geisinger has been squeezed in Pennsylvania by UPMC and Penn Medicine along with other community systems. In 2020, it ended its effort to expand into southern New Jersey via a merger with AtlantiCare. However, this current administration and state regulators have not favored health system mergers, which has seemingly been anticipated by Kaiser in forming the Risant Health organization. Healthcare Dive, FierceHealthcare, Kaiser/Geisinger/Risant release

GoodRx names Scott Wagner as interim chief executive officer. Current co-CEOs and founders Doug Hirsch and Trevor Bezdek will be stepping down but staying with the company as chief mission officer and chairman respectively. Wagner was formerly CEO of GoDaddy and is a board member of other digital and advertising businesses. In February, GoodRx was the first ‘victim’ of the newly aggressive Federal Trade Commission policies on Meta Pixel and other ad trackers collecting user health-related data and sharing for revenue with Facebook, Google, Criteo, and other advertising sites. The FTC used the Health Breach Notification Rule, created in 2009, to GoodRx in a Federal court with misuse of consumer health information. Even though GoodRx is not a HIPAA-covered entity and they ended the practice in 2019, they settled with the FTC for $1.5 million. But the likely reason for the CEO change is that the company is still unprofitable. It ended 2022 with a net loss of $32.81 million and laid off 16% of staff last September. Mobihealthnews, FierceHealthcare

It’s earnings report season for payers. The news has been good for some, not for others. 

  • Centene reported year-over-year gains, with Q1 revenue of $38.9 billion versus prior year $37.2 billion. Q1 profitability also gained at $1.1 billion versus prior year $849 million, which missed Wall Street projections. Their outlook was scaled back due to Medicaid redeterminations, 2024 Medicare bids and investments. They also attributed the increased profitability through the strategic sale of Magellan Rx and internal reorganizations. Fierce Healthcare
  • Humana’s Q1 was also profitable and met Wall Street analyst expectations with earnings of $1.24 billion, or $9.87 a share (adjusted to $9.38/share), up from prior year $930 million, or $7.29 a share. This reflects investments in their Medicare Advantage business. Humana is projecting an aggressive target of a 17% membership increase, reversing from last year’s losses.  Fierce Healthcare
  • Clover Health’s Nasdaq notice, settles $22 million in SPAC class action lawsuit. Nasdaq notified Clover on 20 April that since their stock traded below $1.00 for 30 days, they have 180 days to 17 October to regain compliance with the Minimum Bid Price Requirement. This was disclosed in Clover’s SEC 8-K filing last week. There are other ways to maintain a listing (e.g. transferring to Nasdaq Capital Markets) but the anemic share price (closing today at $0.73, a drop of over 90% from the SPAC high) shows no signs of reviving. On Monday, Clover announced a $22 million settlement in a class action lawsuit filed in Tennessee around the company’s January 2021 SPAC. The following month, Hindenburg Research published that Clover did not disclose a Department of Justice (DOJ) investigation in 2020, claiming it was ‘non-material’ [TTA 9 Feb 2021]. The share price fell off the roof and kicked off multiple similar class action suits which are proceeding in New York and Delaware. Release

Breaking: Elizabeth Holmes’ surrender stayed by 9th Circuit Court of Appeals

This just in. As expected, Elizabeth Holmes will not be surrendering to Federal prison tomorrow, 27 April. Her defense filed yesterday for an emergency stay in the Ninth Circuit Court of Appeals. The court granted it on 25 April, yesterday. Since she was free on bail at the time of the filing, this emergency stay keeps it in effect until her motion for continued bail pending appeal is ruled on.

The PDF of the two-page notice is here.

While the surrender will be stayed based on the court’s rules, if the court follows the similar circumstances of Sunny Balwani’s stay and appeal, Holmes will have perhaps a month more freedom on bail before a further extension of bail is rejected. The main 100+ page appeal based on prosecutorial misrepresentations and actions by Judge Edward Davila in the presentation of evidence, plus oversentencing. will be reviewed by the court [TTA 19 April], which may take about a year. Neither the extension of bail or the appeal are given much chance of success.

Now what happens? The Daily Mail revealed that she and Billy Evans are living in an oceanfront San Diego rental, with their two children William and newborn Invicta, born on 9 February in San Diego. The residence is supposedly priced at $9 million. They have departed the rental in Silicon Valley and moved to Mr. Evans’ sunnier home town where the family will remain. Evans and his parents are readying a $3 million townhouse. They will be caring for the two children while the inevitable long trip to Bryan, TX–if Bryan will be the Federal facility–happens. To be updated.

Weekend recap from HIMSS23: Glen Tullman’s 5 predictions, HIStalk’s random four-day walk, Oracle Cerner integration ‘going great’, Seema Verma to Oracle, Caregility’s debuts three enhancements

From the reports on HIMSS23, it seemed almost–normal. Companies were there, attendance was back to near pre-pandemic levels, a normal exhibit hall, and while it was Chicago complete with snow flurries, and there were differences–no aisle carpet in the exhibit hall ‘for the environment’, suits were a rarity, Cerner disappeared into Oracle Health, and the industry was through a cycle of boom then bust–it was almost Old Times. 

So what’s next? Filling that hunger for a future view was Glen Tullman, late of Allscripts and Livongo, now 7wireVentures founder and CEO of Transcarent. His five predictions were:

  1. Consumers are in charge. They have an array of options unless in an emergency. The industry must build a new and different relationship with them
  2. AI will inform the experience. Eliminate paperwork, simplify documentation, analytics to optimize staffing levels, improve use of real-time data in care.
  3. Care will happen in 60 seconds. Quick and convenient response to care has to be the norm, especially for chronic conditions. Without this, three undesirables will happen: avoidance of care, wait until their condition is so serious that their healthcare costs become much higher, or wind up in the emergency department.
  4. Health systems will be the hub…maybe. They can own the consumer health experience. But health systems will need to change their payment model. 
  5. At risk is no risk. Health systems must “lead the way” to value-based care, care quality, and what appropriate care plans should look like.

Interestingly, payers aren’t mentioned in this model–and they see themselves as the hub, not health systems, through their acquisitions are providers and home health. MedCityNews

HIStalk’s random HIMSS23 walk. Perhaps the best ‘you are there’ take on HIMSS23 was published over four days by HIStalk, including Dr. Jayne’s commentary. They need no commentary from your Editor, including surviving Chicago’s weather, the distances, the no-aisle carpet exhibit hall, long lines for coffee, and local dining delights including wet beef and tavern pizza (avoid deep dish). Pro tips: if you’re an exhibitor, book meetings in advance to assure your ROI, and nothing beats F2F–true of both HIMSS and ViVE, booths were packed.  They were there so you and I didn’t have to be. Where do you think HIMSS24 will be?

Monday: Mr. HIStalk, Dr. Jayne

Tuesday: Mr. HIStalk, Dr. Jayne

Wednesday: Mr. HIStalk, Dr. Jayne

Thursday: Mr. HIStalk, Dr. Jayne  (see in Mr. H’s comments about how Microsoft has quietly taken the lead in health tech with Azure, Nuance, and now generative AI. Watch out Larry Ellison.) 

Healthcare Dive interviewed David Feinberg, now chairman of Oracle Health. According to him, everything is going great with the Cerner integration. “The integration has been pretty smooth” and they are well on their way to creating “a cloud-enabled health platform that brings all kinds of information together to make individuals and communities healthier around the world” and in building an EHR-agnostic health records database to link thousands of separate hospital databases. No mention of the troubled VA EHR implementation. (Ahem)

Announced during HIMSS as an exclusive to Healthcare Dive, Seema Verma, formerly Centers for Medicare and Medicaid Services (CMS) administrator during the Trump administration, is joining Oracle Life Sciences, the company’s clinical trials business, as senior VP and general manager. She has spent the last two years as senior adviser to private equity firms TPG and Cressey, and serving on the board of directors for health tech companies Lumeris, Monogram, Wellsky, and Lifestance.

And to this Editor, Caregility, a cloud-based virtual care and telehealth platform that connects virtual visits, clinical consultations, tele-ICU, remote patient monitoring, and point-of-care observation in hospitals, announced that they have a new portfolio of AI-enhanced hybrid care solutions built on best-in-KLAS (non-EMR) Caregility Cloud. According to the release, “A computer vision application analyzes live video streams of patients and their environment to detect movement and changes that could lead to adverse events such as falls or self-harm. A contactless monitoring system continuously captures patient vital signs, detecting variations in heart rate, breathing patterns, and movement that could be indicative of physiological events like awakening from sleep or an induced coma. An ambient clinical intelligence algorithm generates documentation from live clinician and patient conversations for the patient’s electronic health record.”

Insurtechs in the widening gyre: Bright Health sued for claims non-payment, fined $1M by Colorado; Clover Health lays off 10%, outsources operations

When the centre cannot hold, more revelations are at hand.

Bright Health, facing insolvency and a violation of a liquidity covenant by the end of this month, is now facing a lawsuit by health system SSM Health in the US District Court for the Western District of Oklahoma. At issue: payment of $13.1 million for 2,541 unpaid claims incurred for services SSM provided to Bright Health members between 1 January 2020 and 7 February 2023. This three-year plus timespan is not a simple glitch. SSM alleges in the suit that it provided $15.6 million worth of services in total to Bright Health plan members across facilities in three regions. In Oklahoma, SSM Health’s base, Bright exited Oklahoma’s Affordable Care Act exchange in December 2022 while under investigation by regulators. SSM has no contract with Bright to discount services in return for access to Bright’s network so charges the ‘rack rate’. The lawsuit docket is listed here though PACER is restricted access. FierceHealthcare

Bright Health is also under serious challenge at the state level. It was fined $1 million by the Colorado Division of Insurance (DOI) for violations during 2021-22. According to the DOI release, the complaints and violations centered on four areas: 1) failure to pay provider claims according to Colorado law; 2) failure to communicate with their members; 3) inability to accurately process consumer payments and accounts; 4) untimely processing of claims for physical and behavioral health coverage. $500,000 must be paid now, with the remainder held for specific improvement and compliance with metrics. Department of Regulatory Agencies (DORA) release  Bright is also under investigation in Tennessee, Texas, and Florida; it is under regulatory supervision in Florida and Tennessee with Texas considering receivership. Bright Health shares today closed at $0.164 and is on the verge of being delisted from the NYSE. Our recent coverage here.

New Jersey’s Clover Health, while not near the extremis that Bright is in, is cutting and outsourcing its way to profitability. Announced on Monday was a ‘corporate restructuring’ cut of 10% or 66 employees, based on public estimates of 656 (Pitchbook). Simultaneously, Clover’s CEO, Andrew Toy, announced outsourcing of core Medicare Advantage health plan operations to UST HealthProof in a move to increase operational efficiencies and reduce administrative costs. Both the layoffs and the UST implementation are expected to incur a 2023 first-half charge of $7-9 million, shifting to a $30 million savings beginning in 2024. Both moves were predictable as the company posted an $84 million loss in Q4 2022, a slight narrowing over prior year. Clover release, FierceHealthcare    Clover shares on Nasdaq were also below the delisting threshold at $0.80. Also industry analyst Ari Gottlieb on its overdue-ness on LinkedIn.

VA, GAO push back against proposed House overhaul measures

Today’s House Veterans’ Affairs Subcommittee on Oversight and Investigations meeting didn’t bode well for House bills demanding reform or restart. The Democrat-backed bill, dubbed the Manage VA Act, and the second Republican bill, Terminate VA’s EHRM Program (there is also a third, proposed by Republicans, the Electronic Health Record Modernization Improvement Act) were criticized by both VA and GAO representatives at the meeting.

The Manage VA Act proposes the creation of a VA undersecretary for management, who would serve as the Chief Management Officer (CMO). This would not only be for the Oracle Cerner EHR Modernization (EHRM) but also consolidate and standardize acquisition and IT functions across VA. VA and GAO criticized the new position as duplicative of the current VA structure and would run into obstacles similar to a CMO effort within the Department of Defense (DOD), such as lack of clarity and conflict with the CIO plus lack of funding for cross-functional teams and initiatives proposed by the CMO. To FedScoop, Shelby Oakley of the GAO representative expressed a dim view of how the VA has been handling things. “There needs to be much more discipline in the VA’s EHRM approach right now and it’s not clear that the CMO position would change that.” 

The Terminate VA EHRM Program bill, not unexpectedly, was derided as impractical and impossible. Fact: VistA is 40 years old and previous upgrade attempts have failed. Yet a VA deputy CIO just a month ago at an industry meeting, the Association for Federal IRM (AFFIRM), admitted that VistA is being moved to the cloud and being ‘containerized.’ Another VA software executive said it may be needed for another 10 years. You have to wonder if the House or Senate VA committees even know this and appreciate what it really is saying. 

Theranos’ Holmes files appeal seeking to overturn ‘unjust’ conviction, ‘excessive’ sentence (updated)

With the clock ticking down on her freedom, the Holmes defense appeals. Elizabeth Holmes’ last-ditch appeal was filed on Monday in the Ninth Circuit US Court of Appeals. The defense filing claims that her conviction was ‘unjust’ and should be thrown out on multiple grounds, based on prosecutorial misrepresentations and actions by Judge Edward Davila in the presentation of evidence.

  • Holmes did not falsely represent the Theranos blood lab technology to investors–that ‘highly credentialed Theranos scientists told Holmes in real time the technology worked’ and that ‘Outsiders who reviewed the technology said that it worked’.

What the jury heard was that the company’s lab machines could only perform a few tests and even in those, had significant accuracy problems. Yet Holmes claimed in her testimony that the labs could perform multiple tests with high accuracy. She admitted falsifying documents with pharmaceutical company logos (Merck/Schering-Plough, Pfizer) on internal reports to add credence to these claims, which was documented in other testimony, notably from a former Schering-Plough employee. 

  • Judge Davila ‘flouted the Federal Rules of Evidence’ by allowing certain testimony to be heard and excluding other testimony, such as from Sunny Balwani during his pre-trial testimony that he was responsible for the fraudulent financial projections.

The appeal claims that the jury heard testimony from a supposed layman who was actually an expert witness, a federal regulator’s report on Theranos that was ‘unfairly prejudicial’ (CMS closing the lab in July 2016?), and that Theranos voided test results from its labs [see TTA 19 May 2016], confusing the jury in that it was an admission that the Theranos Edison labs didn’t work. Excluding Balwani’s testimony on the Theranos financials and projections given to investors was labeled abuse of judicial discretion.

“These errors—together with the exclusion of prior testimony from Holmes’ co-defendant taking sole responsibility for the company’s financial model—produced an unjust conviction,” the appeal reads.

The problem with this part of the appeal is that all these ‘misrepresentations’ were factual. Holmes as CEO was well acquainted with both the faulty labs and the financials. With that CEO title comes a sign that The Buck Stops Here.  

Plan B–the ‘excessive’ prison sentence. If the appeals court does not throw out the conviction, the appeal turns to over-sentencing. Returning to Judge Davila, he used the wrong legal standard about the number of victims and the amount of investor losses, using a “preponderance of evidence” standard instead of “clear and convincing”. The sentence was also excessive for a woman whom “unlike other white-collar defendants–neither sought nor gained any profit from the purported loss and was trying to improve patient health.” To this Editor’s recollection, Judge Davila bent over nearly backward to exclude from the trial the prosecutorial desire to highlight Holmes’ fame and high flying lifestyle, including expenses for air, hotel, and clothing.

The Ninth Circuit Court of Appeals will need to get eye prescriptions updated, since there are 10,000 pages of trial transcripts and 16,000 pages from other court records to review. This review may take months, a year–or more–and has only a small chance of success. Mercury News (may be paywalled)    Updated. The full appellant filing of 132 pages is located here.

To this Editor, who is not a lawyer nor plays one on TV, the effort to throw out the conviction is absurd. The prosecution piled high the fraud evidence to support each count. It was not difficult as there were a lot of investors. In the run-up to the trials, Judge Davila was meticulous and even-handed with both prosecution and defense. He was conservative in all aspects, from conduct during the trial to preventing over-aggressiveness by both sides in witness questioning to reining in the ‘Sunny as Svengali’ defense tack. Aside from this trial (but outside the appeal), there are other Theranos fraud cases at the Federal and state levels where awards were made to plaintiffs when the company still had money (see below; also Walgreens settled, see our Ch. 44). The appeals court might seriously consider the sentence issues. On the face of it, she was convicted of but four counts versus Balwani’s 12, yet is receiving very nearly the same length of sentence; however, these four counts were the heaviest (Ch. 16).  Though Judge Davila strictly considered the Federal sentencing guidelines and steered a middle course of 11.25 years between the 15 years (of 20 maximum) recommended by the prosecution and the nine years recommended by the probation officers, to be served concurrently, the appeals court may see an error, somewhere around losses–but it is unlikely, and even if there are errors, they may make no difference.

But to this Editor, one testimony says it all about the fraud. It was from Brian Grossman, then and now chief investment officer and CIO of PFM Health Sciences, a San Francisco firm that manages billions in public and private funds for early-stage healthcare investment. It is particularly damning. The firm invested $96 million based on the projections, the claims that it was a miniaturized lab capable of replacing thousands of feet of lab space into a box (the ‘steak’), of four-hour turnaround on lab results in retail, one hour in hospitals, and that a Stanford researcher of some prestige vetted it. From our article:

While Balwani nixed Grossman speaking with Walgreens and UnitedHealth, Channing Robertson of Stanford, who helped Holmes start Theranos, vetted their labs as extremely advanced technology–one with which competitors would spend years catching up–for a serious investor, sauce, potato, vegetables, and trimmings on that sizzling steak.

Unlike the picture the defense is painting of Balwani controlling Holmes, Grossman took care to note that Holmes, not Balwani, did most of the talking at the time. While he found the company highly secretive, he, unfortunately, discounted it. So in went PFM’s $96 million in February 2014, which included $2.2 million from a designated ‘friends and family fund’ which had investments from low-income people.

Three years later, PFM also won its own fraud case against Theranos, settling its lawsuit for about half–an estimated $40-50 million….The timing was good–it was while the company still had some money to claw back. 

Holmes is scheduled to surrender herself to the US Bureau of Prisons (BOP) on 27 April, less than two weeks from now. She will not be able to remain free while this appeal is pending, unless the defense files with the Ninth Circuit Court for a delay (expected) and the court agrees to stay the surrender for some time. A similar appeal was denied for Sunny Balwani, who surrendered on 20 April, a month later than his original date, to Terminal Island and will be held there indefinitely. Another major issue for the Balwani defense and being appealed is his assignment to the scandal-plagued Atlanta Federal Penitentiary. Judge Davila recommended that Holmes serve her sentence at Bryan, Texas, but the BOP has not confirmed that.

Still pending are the restitutions to be made by both Holmes and Balwani, separately, neither of whom have the $381 million (Judge Davila’s calculation for Holmes) or the $878 million that the prosecution has tallied. TTA 22 March

This Editor would like to give a hat tip with flourishes and trumpets to the moderator of the r/Theranos Reddit sub forum, mattshwink, and poster OldSchoolCSci, for clarification on many legal points of my analysis.  

VA pulls out the stick in contract renegotiation with Oracle Cerner, slams brakes on further EHRM rollouts–and is this trouble? (updated)

VA puts away the carrot, pulls out the stick with Oracle Cerner on the VA EHR modernization. Last Friday’s report in the Wall Street Journal (paywalled) confirms that the Department of Veterans Affairs (VA) is actively renegotiating its contract with Oracle at what is now the five-year mark. Until an agreement is reached, VA is pausing the rollout, which according to previous reports has been largely paused anyway due to multiple critical problems in the slow rollout to date. The WSJ report is cited in Becker’s.

Reports in March during Senate VA committee hearings indicated that the $16 billion contract was due for renegotiation anyway by 17 May. Typically, VA vendor contracts are for five years and the original contract was signed in 2017 with Cerner. VA’s contracting officer, Michael Parrish, testified in those Senate hearings that he will push for a more favorable contract [TTA 18 March].

The Oracle Cerner Millenium EHR was to replace the crusty, still working but not interoperable VistA EHR. The Department of Defense had already contracted with Cerner and Leidos to develop an EHR for the Military Health System (MHS), Genesis, replacing AHLTA. That has largely been completed in a smaller system, though not without its glitches. Billions had been spent in multiple multi-year efforts to make the two existing systems interoperable, for instance to cover records of service members transitioning from active service to reserve or veteran status and for military retirees.

Oracle closed its $28.4 billion acquisition of Cerner last June to much fanfare, but has not had a pleasant moment with the VA or Congress since. During 2021-22, failures of the Oracle Cerner system included hundreds of outages, the ‘unknown queue’ creating at least 150 instances of harm (including one averted suicide) at one VA health system (Mann-Grandstaff), four veteran deaths, training program troubles, more in a GAO Inspector General audit, and the VA’s EHRM Sprint Team itself identifying 14 main and multiple sub-issues in safety and medical research integration in the EHR Modernization Sprint Report (PDF) released on 10 March delving deeply into the initial implementations. 

In 2023, there have been three Senate and three House bills proposed with mandates ranging from ‘hold rollout till issues fixed’ to ‘pull the plug and start over’. The VA had two resignations tied to the EHRM failures, VA deputy secretary Donald Remy and EHRM director Terry Adirim, MD. Implementations were delayed at Michigan’s Ann Arbor (including medical research, TTA 1 Mar) and Saginaw (this month) systems to later this year or even 2024. None of this has been cheap. The Senate VA Committee hearings in March revealed that the VA has paid Oracle Cerner $4.4 billion on the contract so far, with a refund of $325,000 paid as compensation for ‘incomplete technology and poor training’. Obligations through the contract are at least $9.4 billion. The new system has been implemented to date in five VA medical centers out of 171. [TTA 18 Mar]

Updated. Another five-hour outage of both VA and DOD-MHS systems occurred on Monday 17 April. Affected systems included PowerChart, RevCycle, and other applications with latency issues and freezing. This may have been a result of transitioning to a larger database over the weekend. Today (Wednesday 19 April), the House Veterans’ Affairs Subcommittee on Oversight and Investigations will hold hearings on the proposals contained in the two House bills.  FedScoop

If Oracle really wants to transform healthcare, it can start with the VA as Job #1. Or give the keys to Epic. The VA is between the proverbial rock and a hard place. VA has to end VistA even though the old system is still being upgraded during the transition. Terminating the deal with Oracle and reverting five health systems would be perilous, if even possible. But the stakes for Oracle are even higher. Let’s start with billions in Federal contracts in other parts of government systems outside of healthcare. To get into healthcare EHRs, Oracle bought a Pandora’s Box with Cerner. The stakes are not only for our veterans but also to salvage its credibility in healthcare versus Epic–and with its lenders who financed the heavily leveraged Cerner acquisition plus $90 billion in debt load [TTA 10 Nov 22].