CVS works their plan in Oak Street Health buy talks, Carbon Health $100M investment + clinic pilot; VillageMD-Summit finalizes (updated)

January 11, 2023 | by

CVS, Walgreens, Amazon, Walmart all chasing the same type of companies to expand their service continuum. During their Q2 2022 earnings call, CVS Health announced that they were determined to enhance their services in three categories: primary care, provider enablement, and home health. And CVS’ CEO Karen Lynch was pretty blunt about it: “We can’t be in the primary care without M&A” (sic). So CVS’ latest moves should come as no surprise.

Oak Street Health: CVS is in talks with this value-based care primary care provider for primarily older adults in Medicare and Medicare Advantage plans. With 100 offices nationally, it’s not too small, not too large to combine with other operations. As a public company traded on the NYSE but puttering along in the $13-$22 per share range since the fall from a high of $30 in August, the news of CVS’ interest has boosted them above $28 and a market cap of just under $7 billion. Although Oak Street has previously maintained that they have no interest in a sale, it has never been profitable and is on track to lose $200 million this year. That is not a good look for CVS but they are working a strategy. Previously, CVS walked away from primary care group Cano Health [TTA 21 Oct 22]. Bloomberg News (paywalled) reported that CVS could pay $10 billion which would be over $40 a share. Healthcare Dive, Reuters

Carbon Health: CVS leads their Series D with a $100 million investment plus piloting Carbon Health operations in primary and urgent care clinics in their retail stores. However, the deal came at a price. Last week, prior to the investment announcement, Carbon announced that it would wind down lines of business in public health, remote patient monitoring, hardware, and chronic care programs, cutting 200 jobs in addition to a June cut of 250, at the time about 8% of their workforce. Carbon will now concentrate on their clinic core business. 100 are presently located across Arizona, Nevada, Colorado, Kansas, Florida, Massachusetts, and California (San Francisco, Bay Area, and San Jose).

In the last two years, Carbon raised $350 million and grew by acquiring four clinic chains. It diversified by buying Steady Health (chronic care management in diabetes) and Alertive Health (remote patient management)–both businesses they are departing. Reportedly last month they bought Inofab Health, an Istanbul-based digital health platform for patients with asthma, chronic obstructive pulmonary disorder, and cystic fibrosis. Crunchbase, FierceHealthcare, Mobihealthnews, SF BizJournal,

CVS is still working its Signify Health acquisition past the Department of Justice (DOJ) and the Federal Trade Commission (FTC). It went into a Second Request for information in late October under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR), which adds 30 days to the review timetable after the Second Request has been complied with. There is some competitive overlap between CVS and Signify in home health management and accountable care organization (ACO) operations, and some divestitures may be necessary. A closing in Q1 as planned seems optimistic. Acquiring Oak Street may complicate matters since their clinics operate as a Direct Contracting Entity (DCE, now ACO REACH). This present administration is not friendly towards healthcare consolidation of any type, especially with entities participating in Federal programs. (See UHG’s acquisition of Change Healthcare, with court approval being appealed by DOJ.) Reaching (so to speak) deep into CMS programs could be a red flag.

Walgreens’ VillageMD finalized their Summit Health acquisition for $8.9 billion yesterday (9 Jan) (updated). Now with 680 provider locations in 26 markets and 20,000 employees, the group adds to VillageMD’s primary care practices specialty practices in neurology, chiropractic, cardiology, orthopedics, and dermatology plus 150 City MD urgent care locations. 200 VillageMD locations are already adjacent to Walgreens locations. Walgreens Boots Alliance (WBA) and Evernorth, the health services business of Cigna, were the two investors. WBA raised full-year sales guidance from $133.5 billion to $137.5 billion. The current chair and former chief executive officer of Summit Health, Jeffrey Le Benger, MD, will be the interim president until VillageMD finds a permanent president reporting to VillageMD CEO Tim Barry. Release, RevCycleIntelligence, Forbes  At this point, Walgreens hasn’t moved forward with the rumored acquisition of ACO management services organization Evolent Health [TTA 1 Oct 22], which would be far more complex. 

Amazon is still awaiting Federal approval for One Medical as well as in multiple states (Oregon only the first; expect scrutiny). It is also closing Amazon Care and opening asynchronous non-face-to-face telehealth service Amazon Clinic.  Walmart continues on an internal strategy of opening Walmart Health clinics in underserved areas. Earlier in 2022, they announced the opening of more health ‘superstores’ in Florida, having established 20 in Arkansas, Illinois, and Georgia starting in 2019. Walmart’s approach to retailing health services and products, since getting serious about it in 2018, has wavered with multiple changes of strategy and executive departures [TTA 22 Nov 22]

Theranos trial updates: Holmes’ freedom on appeal bid opposed; Balwani files appeal to conviction

January 10, 2023 | by

Lost between the holiday and Happy New Year merriment were two year-end court filings by legal teams for Theranos’ Elizabeth Holmes and Ramesh ‘Sunny’ Balwani, who hope to stay free for at least part of 2023.

Elizabeth Holmes: In a joint filing on 30 December, Federal prosecutors and Holmes’ defense requested a hearing by Judge Edward Davila of the District Court on Holmes’ request to remain free on bail until her appeal in the Ninth Circuit Court of Appeals is resolved. In the filing, the prosecutors agreed to file their objections to her freedom by 19 January. Holmes’ defense had filed her three-page appeal on 3 December with 10 reasons why there should be a new trial. The full legal brief is due on 3 March. Both prosecution and defense had requested that the hearing by Judge Davila take place on 17 March.

Holmes was convicted on four counts of defrauding investors, with her sentence of 11 years and three months taking place on 18 November 2022. She remains free on bail until 27 April, her surrender date. The US Bureau of Prisons has not made public where she will spend her sentence. There is also a question of restitution of $121 million yet to be decided in court. SiliconValley.com

Sunny Balwani: His appeal was filed on 20 December, on the two-week deadline after sentencing, also in the Ninth Circuit Court of Appeals. Unlike Holmes, Balwani was convicted on 12 counts, including two counts of patient fraud. The appeal reportedly will be on the grounds of Judge Davila’s rulings and decisions adverse to Balwani during the case. Other possible factors: the weakest counts are the two on patient fraud where testimony and proof were indirect–Balwani had little to do with patients–and that he left in 2016 before the collapse. His sentence was 12.9 years (155 months). Like Holmes, his restitution is yet to be decided. Balwani is currently free on bail, with his surrender date 15 March. No motion to remain free on bail while the appeal is in progress has been disclosed, nor the Federal prison location decision. Yahoo!Finance

For those craving a recap of l’affaire Theranos and perhaps to reflect on it, Yahoo!Finance has produced an hour-long video documentary, ‘Culture of Hype’, on Theranos as a product of Silicon Valley culture. It was produced before their convictions and sentencings. It ends with discussion of how the multiple conflicts between an admittedly naïve founder vision, transparency, and the need to finance said vision in multiple iterations in any startup or early stage company can lead to borderline executive behavior and company collapse. (And yes, your Editor has seen it happen firsthand.) Was Elizabeth Holmes a victim, a sociopath, or something in between? She will have time to contemplate it, as this Editor continues to maintain that her chances of reversing her conviction and going free are as small as that nanotainer she is modeling above.

Amazon-One Medical gains conditional OK in Oregon–a preview of coming scrutiny?

January 6, 2023 | by

Amazon has approval for the $3.9 billion One Medical acquisition from the Oregon Health Authority (OHA)–but with conditions.  OHA’s task is to review transactions such as these in how they affect patient cost, access, quality, and equity. OHA’s key comments were positive on cost and access, equivocal on quality, and expressed concern on equity (28 December PDF here):

Cost: “…the transaction will not meaningfully change Amazon and One Medical’s market share for primary care services in Oregon. Commercial insurance payment rates for One Medical are negotiated through the partnership with Providence [Health & Services].” In the Conclusions, they noted that “Amazon, with its advanced supply chain and purchasing power, may generate efficiencies and savings for One Medical, though any savings would not necessarily be passed to consumers.

Access: The few One Medical clinics were found to be in urban areas where there is good access to healthcare. “The entities have also stated that they plan to expand One Medical’s network of clinics, which may provide additional access to services.”

Quality: “OHA has limited insight into quality for One Medical locations, since its [five] Portland clinics opened in 2020 and 2021 and One Medical does not participate in some programs that require regular quality reporting.” However, they noted that “Amazon’s business model also has the potential to impact quality.”

Equity: concern on “One Medical siphoning off commercially insured patients with higher payment rates from clinics that serve more Medicaid and Medicare-covered patients.”

Conditions for approval are in reporting on these areas. Amazon is to report on the services it provides and the quality of care, plus any governance or organizational changes, every six months for five years after the acquisition closes. OHA then must perform follow-up analyses on the impact of the transaction on the commitments Amazon makes on cost, access, and quality of care. 

One Medical’s limited Oregon footprint proved to be helpful to Amazon in gaining OHA approval–but may be a Preview of Coming Difficulties. One Medical operates in 29 markets including NYC, Los Angeles, Boston, and Atlanta, with 815,000 members and 8,000 company clients. States like New York, Massachusetts, Connecticut, and California are not exactly pushovers for approval, with California alone having two approval entities. Then there are the Feds. Back in September, Amazon disclosed the Federal Trade Commission (FTC) was scrutinizing the acquisition, with no resolution announced yet. One Medical also owns Iora Health, which has a full-risk value-based care model for patients in Medicare Advantage (MA) and Medicare shared savings across seven states–HHS and CMS territory. Two more shoes yet to drop: the SEC and the Department of Justice (DOJ). DOJ of late casts a gimlet eye on any healthcare merger–just ask UnitedHealth Group and Change Healthcare, which they are still fighting.

This Editor will stand by last year’s prediction: Iora will be sold either before or immediately after closing. The higher cost/higher care needs Medicare market doesn’t fit with Amazon’s monetization model. It is less profitable and requires advanced risk management, a skill set that Amazon doesn’t have and likely doesn’t want. MA and MSSP (Medicare Shared Savings Program) routinely face regular Federal scrutiny, which Amazon doesn’t do well either. Amazon can use the cash; it is facing major league bad press with its planned layoff of 18,000 workers, about 6% of its 300,000-person corporate staff. One wonders if many of its shareholders (other than Jeff Bezos) approve of this massive investment in a relatively small provider organization.  Reuters 

Mobihealthnews, FierceHealthcare

Telehealth extensions signed into US law with Federal FY 2023 omnibus bill

January 4, 2023 | by

Jammed into the final moments of the now-ended 117th Congress before Christmas was the passage of the FY2023 ‘omnibus’ $1.7 trillion Federal budget bill. This bill did at least several good things for those of us concerned with US telehealth, as it extended provisions for Medicare reimbursement that become guidelines for commercial health plans and help to cement telehealth as a permanent part of health care delivery. There is also a tax provision that affects high-deductible health plans. 

Their passage is important as the Covid-19 Public Health Emergency (PHE) is set to expire on 11 January and no movement has been publicly discerned for its renewal. In the fall, the Department of Health and Human Services (HHS) notified US state governors that there would be at least a 60-day notice before the PHE ends. It is unknown whether this notice has been given.

To summarize the two-year extensions that go to the end of 2024:

  • Expanding originating and geographic site to include anywhere the patient is located, including the patient’s home
  • Expanding eligible practitioners qualified to furnish telehealth services, including occupational therapists, physical therapists, speech-language pathologists, and audiologists
  • Extending the ability for federally qualified health centers (FQHCs) and rural health clinics (RHCs) to furnish telehealth services
  • Delaying the in-person requirement for mental health services furnished through telehealth, including the in-person requirements for FQHCs and RHCs
  • Extending coverage and payment for audio-only telehealth services
  • Extending the Acute Hospital Care at Home (AHCAH) initiative, pioneered by Johns Hopkins two decades ago. It also requires the HHS Secretary to publish a report comparing AHCAH programs with traditional inpatient care delivery. 
  • Extending the ability to use telehealth services to meet the face-to-face recertification requirement for hospice care
  • Extending high deductible health plan (HDHP) safe harbor exceptions for telehealth services in high-deductible health plans.

The final bill did not extend the Ryan Haight in-person waiver for the remote prescription of controlled substances. As mentioned in our earlier article, this is a wise move in this Editor’s view given the abuse of this waiver by certain telehealth organizations. ATA/ATA ACTION release.

The HHS Secretary will be required to submit a report to Congress on the utilization of the above services. The interim report is due in October 2024 and the final report in April 2026, according to the American Hospital Association. Affecting hospitals and practices in the bill:

  • It delayed the statutory Pay-As-You-Go (PAYGO) Medicare 4% sequester for two years, preventing the $38 billion in Medicare cuts that otherwise would have taken effect in January.
  • Partial relief from a 4.5% reduction in physician reimbursement rates starting on 1 January. The legislation reduced the cut to 2% for 2023 and around 3% for 2024.

HealthcareFinance

Other features of this bill having an effect on healthcare and telehealth (from Infrastructure Report Card):

  • $455 million for the expansion of broadband service, including $348 million for the ReConnect program, a series of grants administered by the US Department of Agriculture for the construction, improvement, or acquisition of facilities and equipment needed to provide broadband service in eligible rural areas. This could help rural areas and hospitals in provider-patient and provider-to-provider consults.
  • $1.65 billion for the National Institute of Standards and Technology (NIST), an increase of $424 million, or 34%, above the FY 2022 enacted level. Specific funding is allocated for the measurement labs and research at $953 million, a $103 million or 12% increase above the FY 2022 enacted level. The goal is to spur research advances in cutting-edge fields like carbon dioxide removal, artificial intelligence, quantum information science, and cybersecurity.

The bill was signed into law by the president on vacation in St. Croix, USVI. Given the bumpy start of the 118th Congress today, these are at least not up for grabs.

Split decision! ITC rules that Apple violated AliveCor patents; enforcement held for PTAB appeal

January 3, 2023 | by

David v. Goliath slugfest continues. The International Trade Commission (ITC) confirmed its Initial Determination [TTA 28 June] that Apple Watches infringed AliveCor patents on ECG readings. This Final Determination counters the US Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) December ruling that found not only in favor of Apple’s patents but also invalidating AliveCor’s three patents in question [TTA 8 Dec].  

The ITC’s findings come under a 60-day presidential review from 22 December. The penalty on Apple comes under a Limited Exclusion Order (LEO), a cease and desist order. It sets a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during this review period. However, enforcement of the ruling will be delayed until the review of AliveCor’s appeal of the PTAB ruling wends its way through that process in the Northern District of California, which is expected to take place in early 2024, a year from now.

A running dispute since 2020. Once upon a time, AliveCor and Apple worked together to give ECG functionality to the Apple Watch. This ended after the Apple Watch 4 incorporated ECG readings. This resulted in court actions related to patents starting in early 2021 [TTA 29 Apr 21, 9 July 21]. Apple is now up to the Watch 8, incorporating more and more cardiac and health monitoring features. AliveCor has also moved on with financing with a GE Healthcare-backed Series F this past August, the KardiaMobile 6L, and the KardiaMobile Card. As of today, it has over 170 patents.

As this Editor remarked in December, going after a rival’s patents is an often necessary but risky business that can backfire. Right now, David has moved Goliath to a draw now, with further matchups this year into next. AliveCor release, Mobihealthnews      Hat tip to Dr. Dave Albert, founder and Reader.

News roundup: DDoS attacks may be ‘smokescreen’, DEA slams Truepill with ‘show cause’, telehealth claims stabilize at 5.4%, Epic squashes patent troll, Cerner meeting exits KC, MedOrbis, Kahun partner on AI intake

December 22, 2022 | by

Readers won’t get out of 2022 without one last cybercrime…article. DDoS attacks–distributed denial of service–escalated worldwide with Russia’s invasion of Ukraine in February. (Ukraine and military aid is a hot topic this week with President Zelenskyy’s visit to the US and Congress speech.) Xavier Bellekens, CEO of Lupovis, a cybersecurity company and a cyberpsychologist (!), postulates that DDoS attacks, as nasty as they are, may be a smokescreen for far more nefarious and damaging attacks. While IT goes into crisis mode over the DDoS, other attacks and information gathering on systems preparing for future attacks are taking place. Russian cyber groups focus on large organizations and move down the line into the most vulnerable, using both manual and automated approaches. Worth reading given the vulnerability and IT short staffing in healthcare organizations. Cybernews

The fallout from Cerebral and Schedule 2 telehealth misprescribing expands. The Drug Enforcement Agency (DEA) issued a ‘Show Cause’ to online pharmacy Truepill for inappropriate filling of ADHD Schedule 2 medications, including Adderall. A ‘Show Cause’ order is an administrative action to determine whether a DEA Certificate of Registration should be revoked, which could put Truepill out of business. The red flag for the DEA: 60% of  Truepill’s prescriptions–72,000–filled between September 2020 and September 2022 were for controlled substances, including generic Adderall. Truepill was Cerebral’s primary mail order provider, though they also used CVS and Walmart. The company stopped filling Cerebral’s ADHD prescriptions in May 2022.

In the order, the DEA cites that “Truepill dispensed controlled substances pursuant to prescriptions that were not issued for a legitimate medical purpose in the usual course of professional practice. An investigation into Truepill’s operations revealed that the pharmacy filled prescriptions that were: unlawful by exceeding the 90-day supply limits; and/or written by prescribers who did not possess the proper state licensing.”

The company stated in an emailed statement that they were fully cooperating with the investigation. If it does move to a hearing, Truepill’s chances of a successful defense are statistically low.

Truepill also fills prescriptions for Hims & Hers, GoodRx and Mark Cuban Cost Plus Drug Company. It was valued in its 2021 funding round at $1.6 billion. Companies in telemental health and prescribing of Schedule 2 ADHD medications, such as Cerebral and Done Health, are under enhanced scrutiny over their business practices [TTA 1 June]. Mobihealthnews, DEA press release, HISTalk, Digital Health Business & Technology

Telehealth medical claims stabilize. FAIR Health’s latest reports for August and September report that the percent of medical claims coded as telehealth are back up to 5.4%. June and July dropped slightly to 5.2% and 5.3% respectively. Also steady are that the vast majority of claims are for mental health services. In September, they were 66% of diagnoses far ahead of ‘acute respiratory diseases and infections’ at 3.1%. In procedure codes, psychotherapy accounts for over 43%.

A patent troll Epically bites the dust. Back in the early to mid-2010s [TTA’s index here], patent trolls (technically non-practicing entities which have no active business) presented a significant threat to early and growth-stage health tech companies. One, MMR Global (which apparently no longer exists), was notorious for buying up EHR and PHR-related patents and then filing patent infringement lawsuits against both small and large healthcare organizations with similar patents–and their users–that were generally monetarily settled. But NPEs are still active. One in south Florida, Decapolis Systems, used the same techniques as MMR Global had, suing in this case multiple Epic customers for patent infringement. Epic not only defended its customers but also sued Decapolis in the US District Court, Southern District of Florida. The court found that both Decapolis patents were invalid, ending what Epic termed ‘vexatious patent litigation’. Decapolis had successfully sued 24 other entities, including other EHRs, which settled. Owned by an inventor, this company will have to find another line of honest business. Epic release, Thomson Coburg

Oracle’s message to Kansas City: no more Cerner meetings for you. And maybe more. Cerner’s site for its annual customer/partner conference since 2007 has been in Kansas City, attracting about 14,000 visitors. Not only will it be integrated into Oracle CloudWorld in Las Vegas, 18-21 September, it’s been retitled Oracle Health with no mention of Cerner. The loss to local KC business is substantial–estimated to be in the $18 million range. While it’s logical to integrate it into the massive CloudWorld conference, it’s also another message to KC after Oracle’s sudden real estate downsizing that Cerner’s presence there will shrink…and shrink..as it’s absorbed into Oracle Health, and further confirmation that the Cerner name is gradually being sunsetted. KansasCity.com, HISTalk

A new (to this Editor) specialty care telehealth company, MediOrbis, is partnering with Kahun for an AI-enabled digital intake tool. This is a chatbot capable of conducting an initial medical assessment. Based on the patient’s answers and Kahun’s database of about 30 million evidence-based medical knowledge insights, it provides a summary for the physician before the telehealth visit and highlights areas of concern. Mobihealthnews  MediOrbis also has partnered with remote care/engagement Independa to add its capabilities to Independa’s HealthHub on their LG TVs.

Telehealth two-year extensions included in US Federal ‘omnibus’ budget bill

December 22, 2022 | by

Expanded telehealth access extended for two years. The ‘omnibus’ fiscal 2023 spending bill before Congress Thursday contains extensions for four areas of improved national telehealth access developed during the COVID-19 Public Health Emergency (PHE) starting in January 2020. Because they apply to Medicare and high-deductible health plans (HDHP), they become guidelines for commercial health plans and help to cement telehealth as a permanent part of health care delivery.

The two-year extensions include:

  • Retained expanded reimbursable access to telehealth for Medicare beneficiaries put into place during the PHE
  • A two-year delay in implementing the Medicare telemental health in-person requirement
  • Extension of safe harbor provisions to offer telehealth as part of HDHPs with Health Savings Accounts (HSAs)
  • Extension of the Acute Hospital Care at Home Program. This waiver permits some emergency department and inpatient hospital patients to be treated from their homes. 

At this time, the PHE is set to expire on 11 January 2023. It has been extended every 90 days since January 2020 and may be extended again. The bill did not extend the Ryan Haight in-person waiver for the remote prescription of controlled substances, a wise move in this Editor’s view given the abuse of this waiver by certain telehealth organizations. It does request the Drug Enforcement Agency (DEA) to promulgate final regulations specifying the circumstances in which a Special Registration for telemedicine may be issued for controlled substances, and the procedure for obtaining the registration.

Another wise move on Congress’ part in this monster 4,000+ page, $1.7 trillion spending bill is to further prohibit the creation of a national patient ID for healthcare that supposedly would facilitate EHR interoperability. 

The bill is supposed to come before a lame-duck Congress at the eleventh hour before their Christmas leave on Thursday. Some opposition has coalesced due to wasteful earmarks covering pet projects that are included in the (unread by most representatives) bill and the fact that a new Congress with a change of party control in the House will be seated in January. However, for those of us in the US telehealth business, these inclusions are not controversial nor wasteful, and if the omnibus bill fails for some reason, will likely be included in any short-term extensions which are typical in keeping the government running. ATA release, POLITICO Future Pulse

Few specialty telehealth visits require in-person follow up within 90 days: Epic Research study 2020-2022

December 21, 2022 | by

35 million visits make the case that virtual visits can stand alone, even in medical specialties–but how much was the pandemic a factor? Epic Research, a public benefit corporation owned by Epic Systems Corporation, analyzed telehealth consults over 26 months in a dual team study. The study found that most patients did not require an in-person follow-up appointment in that specialty within 90 days. The dual team study (two teams working independently) reviewed US EHR data collected from 1 March 2020 through 31 May 2022.

There was an extremely wide spread by specialty both in the number of visits and in-person follow-up within the three-month window. 

Looking at the study findings:

  • The lowest in-person follow-up percentage was in genetics at 4%, followed by nutrition at 10%; the highest–unsurprisingly–was obstetrics at 92%.
  • Far and away, the specialty with the greatest number of telehealth visits, over 4.3 million, was mental health and psychiatry. Their in-person follow-up was 15% of that number. That ‘cadence of care’ cited in the study report could be in part due to state medical regulations and insurance guidelines requiring in-person review, especially when prescribing Schedule 2 (those with a high possibility of abuse and dependence) or even Schedule 4 drugs.
  • Other specialties falling below 25% of in-person follow-up were endocrinology and neurology (both with 1 million telehealth visits), plus diabetes services, nephrology, pulmonology, medication management, gastroenterology, rheumatology, and addiction.
  • Cardiology and surgery, with both at 1.4 million telehealth visits, surprisingly had follow-up percentages around 43%
  • Above 50% in follow-up are geriatrics and fertility, both of which require more in-person examination. Geriatrics also covers a broad range of chronic condition care management in patients.

In looking at the numbers, this Editor will point to three situational factors unique to the pandemic period and its aftermath that may skew these findings on in-person follow-up visits to a lower range: 

  1. Most medical offices in the US closed from the start of the pandemic (about March 2020) and did not reopen until mid-year. Many health specialty practices and psychiatric clinics did not reopen for in-person visits until the fall or even later.
  2. Online mental health consults took off like a rocket–and are coming back to earth with greater scrutiny of prescribed Schedule 2 drugs (see Cerebral Health, Talkspace, et al.)
  3. Continuing patient apprehension on in-person visits into this year
  4. The continuing of public health emergency (PHE) compensation for telehealth visits into 2022 both in Medicare and private insurance

A flaw in the article is that these points are not considered in influencing in-person visits in the future.

10 reasons for a new trial? Elizabeth Holmes’ legal team files appeal, delay in prison start (updated)

December 15, 2022 | by

Elizabeth Holmes and her legal team continue their campaign to keep her out of Federal prison. On 2 December, on the deadline from two weeks of sentencing but just made public, her three-page appeal was filed with the US Court of Appeals for the Ninth Circuit.  She has until 3 March to file legal briefs in the 9th Circuit Court of Appeals in California. In addition, her legal team has requested from Judge Edward Davila that she remain free until her appeal is concluded due to not being a flight risk, citing close family ties and pregnancy. Holmes was scheduled to report to Federal prison (still to be determined by the US Bureau of Prisons) on 27 April 2023.

The 10 reasons for a new trial are not fully enumerated in the SiliconValley.com article, but include purported errors by Judge Davila during the trial. These include allowing the jury to hear about regulatory action against Theranos and the company’s voiding of all test results from its Edison lab machines. The filing argues that those events took place after she made any “relevant” statements to investors. Another reason was the sudden visit by former lab director and key prosecution witness Dr. Adam Rosendorff to her home [TTA 26 Oct, 20 Oct]. Dr. Rosendorff reaffirmed in the court hearing that he testified truthfully and honestly, the visit took place during a moment of distress, and that he continued to believe that Holmes needed to pay her debt to society. 

Legal experts mostly agree that Holmes presents little to no flight risk, as she is known everywhere, and is no threat to her community. Where they are split on whether she will remain free during the full process of the appeal, which could be a year or even more. Appeals have low rates of success at the Federal level. To these observers, Judge Davila has been scrupulous–‘bent over backwards’–to be fair to both prosecution and defense during the trial. He has already heard and rejected defense arguments for new trials and acquittals. He did not permit the prosecution to run wild or overcharge either. The decision of another jury on COO Sunny Balwani on all 12 counts, the same as Holmes, also conducted by Judge Davila, may very well factor into an appeal to the judges, unfavorably for the defense. One wild card factor is that the jury convicted her on but four out of 11 counts (acquitting or deadlocking on the rest; Count 9 was dropped due to a prosecution error). The jury for her trial proved 1) difficult to select and 2) difficult to retain, going through three alternates of the five.

Still pending are monetary damages. Updated: checking Judge Davila’s calendar, this will take place after January as his calendar is filled.

It does look like Holmes may enjoy freedom through 2023–but her chances of reversing her conviction and going free are as small as that nanotainer she is modeling. FoxNews, Ars Technica

Mid-week roundup: Wisconsin’s Marshfield Clinic zeros out telehealth staff; Komodo Health lays off 9%; epharmacy Medly’s Ch. 11, PharmEasy layoffs; OneStudyTeam releases 25%

December 15, 2022 | by

Year-end brings reckonings and reorganizations….and may leave you feeling like Pepper.

Marshfield Clinic, located in rural north central Wisconsin, eliminated its 18-person telehealth department on 1 December. It is not clear from reports whether telehealth is being eliminated (HISTalk) or whether this is being maintained by current IT staff. This follows news of ongoing financial difficulties in this network of 12 community and rural hospitals and 65 clinics. In August, they renegotiated some loans in the wake of losing $25 million that month–and their CFO departed. The health system is also in the throes of replacing a 30-year-old homegrown EHR with Cerner. Like most rural hospital systems, Marshfield has been keelhauled between increasing wage and supply costs plus the ending of CARES Act subsidies. It has had ongoing merger discussions with Minnesota’s Essentia Health. WSAW-TV 7 (Wausau WI)

Recently fast-growing Komodo Health is laying off 9%, or 78, staff.  The layoffs were positioned as a ‘restructuring’ to remaining employees. Interestingly, Komodo has about 40 positions recently posted and listed as open on LinkedIn, not including its CFO who is departing at end of this year.

Komodo is reportedly planning to IPO in 2023. In early November, it completed a structured equity infusion of $200 million from Coatue and Dragoneer. Reportedly, Komodo’s annual recurring revenue is $150 million but is not yet profitable. Last March in its Series E, it was valued at a rich $3.3 billion. 

Komodo is in the complex analytics business of creating data maps out of de-identified patient data. From this, they create software applications that reveal patient behaviors, can guide treatment, highlight care gaps, and, in their words, ‘reduce the global burden of disease’. Like mapping patient health journeys, everyone agrees it is valuable, but then debates on how to apply it. Is it the whole truth and nothing but? Or are my patients different? Whether strapped health systems and health plans see that Komodo’s applications are necessary, given their in-house data, with the knock-on cost of integrating it into their systems, is entirely another question that influences Komodo’s growth. TechCrunch, FierceHealthcare, Mobihealthnews  

Two epharmacy operations have run into significant financial difficulties.

  • Brooklyn’s Medly filed for Chapter 11 bankruptcy reorganization on 9 December, closing 20 stores. A scrappy upstart founded in 2017 that grew from a storefront in Brooklyn to over 20 physical locations in New York, New Jersey, and Philadelphia plus four same-day prescription delivery centers, they went through a cash crunch in August that derailed their filling prescriptions for close to one month. Precipitating this was their purchase of Boulder-based integrative pharmacy Pharmaca in late 2021 to add 21 locations in 20 markets across nine states, first-half losses of $35 million, and failure to obtain over the summer a $100 million loan. Medly owes about $121 million plus $47 million in trade debt, unpaid salaries, and other unsecured debt. A bidder, MedPharmaca Holdings Inc., will have an opening bid of $18.5 million at a bankruptcy auction for almost all of Medly’s assets, including the Pharmaca stores.

A complication–employees are also suing the company in a class action lawsuit for mass layoffs. 1,100 of 1,900 employees were not given up to 90 days written notice, as required by Federal and NY State Worker Adjustment and Retraining (WARN) Acts. WARN act notices were posted after the layoffs, according to the lawsuit. Employees also lost salary, commissions, bonuses, accrued holiday pay, and 401(k) contributions. Oddly, their website lists about 20 open positions, but this Editor is sure that is due to the website manager also being laid off.  FierceHealthcare, Boulder Daily Camera, Digital Health Business

  • Nearly 8,000 miles away, PharmEasy of Mumbai, India has laid off an undisclosed number of people in a second round of layoffs, primarily in product technology, quality analytics, and support verticals. Their problems, reported in India’s Inc42, center on mounting losses, a funding crunch, and a shelved IPO. India’s Business Standard reported that the layoffs will go into the hundreds. PharmEasy is an online store covering most of India that delivers everything from medications and lab tests to doctor referrals and Dettol. 

And last in this (depressing) roundup is Boston’s OneStudyTeam’s 25% layoff of 160 employees with the usual “restructure our team going into 2023” and “streamline operations” statements, despite being used by 70% of biopharma companies.  OneStudyTeam has a clinical trial workflow platform that enrolls and manages patients. As part of clinical trials holding company Reify Health, it is a sister company to Care Access, a decentralized research organization (DRO). In April, Reify added $220 million in Series E funding for $479.6 million in total, increasing its valuation to $4.8 billion. Mobihealthnews, Crunchbase

AliveCor loses Patent Office ruling with Apple; three patents invalidated

December 8, 2022 | by

Apple prevails in the patent infringement suit by AliveCor–and got three AliveCor heart monitoring patents invalidated as ‘unpatentable’. In the duel of patent infringement claims dating back to May 2021 between AliveCor and Apple, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) not only ruled that Apple did not infringe on AliveCor’s patents, but also threw out the AliveCor patents that were the basis for the infringement. AliveCor had sued Apple for patent infringement on their ECG technology in three US patents: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”) in their Apple Watches 4, 5, and 6. [TTA 29 Apr 21, 9 July 21] 

The term ‘unpatentable’ is used when the PTAB deems the patent, even when granted in the past, too obvious or too general. When the PTAB finds that, they throw out the patent and it is no longer valid.

Apple of course crowed that they developed their own patents fully on their own, and not from the time when AliveCor’s ECG monitoring was incorporated into earlier Apple Watches. Apple is up to the Series 8. AliveCor has already announced it will appeal and await the pending ruling from the International Trade Commission (ITC) to block the import of Apple Watches. The ITC’s initial determination in June was positive [TTA 28 June] and AliveCor of course is ‘cautiously optimistic’ on the Final Determination due in a few days (12 December). With the PTAB’s finding, it is far less likely that the ITC will impose an import block when AliveCor’s patents have been invalidated.  9to5Mac, Mobihealthnews

AliveCor has moved forward with its KardiaMobile series, including a credit card-sized device (left), and has enjoyed substantial investment, with an August Series F (amount undisclosed) round led by GE Healthcare. 

Patent invalidation is a danger in any patent infringement lawsuit. In 2015, Bosch Healthcare, which had bought HealthHero, an early RPM platform marketed as Health Buddy, and ViTelNet, was a serial patent challenger. They went after Philips, Viterion (while owned by Bayer), both to a draw, and won against a slew of barely-out-of-the-cradle companies forgotten by nearly all of us such as Alere Health, MedApps, Waldo Health, and Express MD Solutions. Then they sued Cardiocom in 2012 with the same expectation. Except that a year later, Cardiocom was acquired by Medtronic. Deep-pocketed Medtronic fought back hard–and by 2015, the PTAB invalidated most of Bosch’s key patents. Bosch withdrew from the US market abruptly in 2015. TTA 19 June 2015, 7 September 2015 primarily about the ongoing Teladoc-Amwell dustups

Given their funding and device development, AliveCor will likely not face Bosch’s fate, but such invalidations have consequences yet to be determined and litigated. 

Who’s buying, selling, funding wrapup: athenahealth IPO deux?, NextGen EHR buys reseller TSI for $68M, Cloudwave buys Sensato; fundings for Lumen, UpStream, Aide Health

December 3, 2022 | by

athenahealth may go public a second time. This was teased by CEO Bob Segert in the Boston Globe (paywalled) earlier this week. He claimed in the article that since the company went private in 2019, they have added nearly 2,000 clients each year of the past three and that revenues are in the billions. Healthcare IT News recaps some of their moves from going from public to private and downsizing to today. Their other news is that they have instituted a clinical advisory board of 30 members (!) to provide feedback and guidance on clinical features and direction to athenahealth’s product team. One hopes that the sharper members advise a change in the first letter of their name from the oh-so-twee lowercase to an uppercase ‘A’. 

NextGen Healthcare, an EHR/EMR and revenue cycle management software provider for medical/dental practices, is acquiring reseller partner TSI Healthcare. The agreement is for $68 million in cash upfront, with a contingent consideration of up to $22 million in cash if TSI meets certain goals by March 2025. TSI has been a NextGen reseller for 16 years. The acquisition will enable NextGen to expand in key specialties including rheumatology, pulmonology, and cardiology. No mention is made of management or staff transition, nor of SEC review as NextGen is a publicly traded company on Nasdaq. Hat tip to HISTalk 2 Dec. Release, BusinessJournals Triangle

Massachusetts-based Cloudwave is acquiring Sensato Cybersecurity to increase cybersecurity capabilities. Cloudwave provides cloud services hosting with cybersecurity capabilities exclusively to healthcare organizations. Sensato adds cybersecurity-as-a-service (CaaS) to manage security needs, determine where security gaps are, and threat intelligence. Transaction price and details were not disclosed, but Sensato’s founder John Gomez will join CloudWave as chief security and engineering officer. Healthcare IT News  Cybersecurity continues to be top-of-mind for healthcare organizations. The latest Big Data Breach at CommonSpirit Health system hospitals got even worse, with the third-party breach of an undisclosed number of patient records at their Franciscan Health hospitals in September and October. This followed the ransomware attack on other CommonSpirit system hospitals’ EHRs in October. Healthcare IT News

As we near the end of the year, funding is wrapping up with a flurry in some surprising areas such as optimizing metabolism and care coordination for chronic conditions, reducing burden on primary care practices/GPs. One is for an early-stage company in the UK for the latter.

  • Lumen’s $62 million Series B was led by Pitango Venture Capital with Hanwha Group and Resolute Ventures.   Lumen measures metabolism via a handheld, breathalyzer-like device equipped with a CO2 sensor that analyzes whether the body is burning fats or carbs for fuel which can promote weight loss, energy for fitness, and sleep. With that data, the app delivers to users personalized meal plans and nutrition along with when to eat. The new funding will be used to expand these nutrition and lifestyle coaching services. The device is sold direct to consumers, with the app services sold on a SaaS basis: three yearly plans with a range of services from $249 to (on sale) $349.  Mobihealthnews, MedCityNews
  • Another Series B raise of $140 million went to UpStream, for total funding of $185 million. UpStream is in the decidedly unsexy area of care coordination, workflow, and financial platform technology for groups of advanced primary care practices enrolled in value-based full-risk care models, most of which are centered around Medicare and Medicare Advantage. They also deploy pharmacist-led care teams into primary care practices. Their platform and services are free to the practice, with a risk-sharing agreement that pays UpStream through savings (upside risk) but also holds them accountable if savings are below the benchmark (downside risk). Practices are paid on quality during the performance year versus having to wait for CMS to pay in Q3-4 of the following year. This is an MSO (management services organization) ‘in a box’ versus organizing ACOs that is mainly technology-based, a new wrinkle for this Editor who used to be in marketing this area. MedCityNews, Mobihealthnews
  • Aide Health is a clinician-to-patient platform for better management of chronic conditions now bolstered with £1 million in pre-seed funding. Founded by Ian Wharton, CEO, and Brian Snyder, COO, the platform measures physical, mental, and social wellbeing markers for more proactive care. Aide is piloting with the NHS for asthma or Type 2 diabetes with a cohort aged 18 to 75.  Funding was led by Hambro Perks through its EIS fund, with participation from Fuel Ventures, 1818 Ventures, and APX. BusinessCloud (UK)

“Big Story” update: where Elizabeth Holmes will spend 11 years, Cerebral sues former CEO Robertson, Amwell buying Talkspace?

November 30, 2022 | by | 1 Comment

Where will Elizabeth Holmes serve her sentence, whatever it is? A story that got lost in the Thanksgiving shuffle was Bloomberg News’ (paywalled) report that Judge Edward Davila recommended that she be remanded to a minimum security Federal women’s prison in Bryan, Texas, outside of Houston. What has previously been mentioned in the press and by legal commentators is that she would likely serve her time in a northern California minimum security prison about an hour from her present home, the Federal Correctional Institution in Dublin, California. According to commentators, the larger Bryan facility may be better than Dublin, which is a satellite camp. Bryan  “…compared to other places in the prison system, this place is heaven. If you have to go it’s a good place to go,” Alan Ellis, a criminal defense lawyer, told Bloomberg. The final say will be made by the Federal Bureau of Prisons. The selection is important because Federal inmates typically serve a minimum of 85% of their time, unlike time served in state prisons. Gizmodo reports on Bloomberg’s reveal

Holmes’ reporting to prison is scheduled for 27 April 2023. Her appeal to the Ninth Circuit Court of Appeals must be filed within two weeks of sentencing, which by this Editor’s calendar is 2 December but may be later due to the holiday. Holmes may be permitted to stay out of custody pending appeal if it extends beyond the surrender date if the judge permits. 

Editor’s commentary: One wonders whether Holmes’ appeal will be successful. One factor is what Judge Davila acknowledged: “What is the pathology of fraud? Is it the inability to accept responsibility?” Even in her personal statement during the sentencing, there is evasion. Holmes did admit some sorrow about patients and investors relating to her own failings (back to her again), but sorrow is not responsibility. Moreover, Holmes did not refer to making amends for that sorrow created by the Fraud That Was Theranos. Her defense continues to blame others, like Sunny Balwani, former president and live-in. Even the 130 character letters, many from others who knew her only briefly, blamed others including Balwani, almost tracking to the defense’s talking points. The case proved conspiracy with Balwani, who will likely be sentenced on 7 December for what is expected to be something close to the full 20 years as convicted on all 12 counts.

The tables are turned by Cerebral on co-founder/former CEO Kyle Robertson. Only a week or so ago, Robertson (through his attorneys) reportedly sent a letter to Cerebral management demanding access to documents detailing “possible breaches of fiduciary duty, mismanagement and other violations of law.” [TTA 18 Nov] Now Cerebral is suing Robertson for his default on a $49.8 million loan taken this past January to buy 1.06 million shares of common stock in the company. According to the filing in New York Supreme Court, he is personally liable for $25.4 million, plus interest and attorney’s fees. After his dismissal 18 May, he had six months to repay the loan or direct Cerebral to repurchase or cancel the shares. According to the lawsuit, “Robertson repeatedly asserted that he would not repay the loan.” The troubled company laid off 400 or more in October and is now valued at a fraction of last year’s $4.8 billion valuation.  Stay tuned. HealthcareDive, Mobihealthnews

A cracked SPAC may get itself sold. Talkspace, which has had a year of challenges since its SPAC, apparently is in talks to be acquired by Amwell. According to Calcalist, an Israeli business publication, Amwell is in advanced talks to acquire it for $1.50 per share, or about $200 million. This is quite a comedown from when Talkspace was valued in January 2021 at $1.4 billion. It executed its SPAC in June [TTA 25 June 2021] and hit Nasdaq at $8.90 per share. Today it closed at $0.88, so Amwell’s offer would be close to double. It would also remove another problem. Nasdaq notified Talkspace on 18 November that they were on the verge of delisting their stock, as it was trading for over 30 consecutive business days at under $1.00 per share.

The ‘advanced’ term is interesting because this past June, reports indicated that Talkspace rejected overtures by Amwell and Mindpath. The amount bandied about at that time was $500 million and a sale was expected during the summer. (What a difference six months of economic uncertainty makes.) 

In November 2021, founders Roni and Oren Frank stepped down and their COO resigned shortly thereafter on a conduct-related allegation. Shareholders started to sue starting then. YTD results have also been dismal, with losses of $61 million on revenues of $89 million.

Talkspace would bolster Amwell’s mental health capabilities in telepsychiatry with a DTC and enterprise product. If the company hung on to most of their $184 million in cash reported in June (of the SPAC’s $250 million), for Amwell it also would be a deal that almost pays for itself. HealthcareDive, FierceHealthcare

Mid-week news briefs: House members’ ‘grave concerns’ on two deaths tied to Oracle Cerner VA rollout; care.ai’s $27M funding; Clear Arch’s new mobile RPM platform; digital health investment in rough times

November 23, 2022 | by

A pre-Thanksgiving news roundup in this short week.

More miseries for Oracle Cerner’s VA rollout. This week, three House members sent a letter to the Department of Veterans Affairs (VA). After a 2 September visit to the Chalmers P. Wylie VA Ambulatory Care Center in Columbus, Ohio and interviewing the staff, they determined that the Cerner Millenium EHR as currently in use possibly led to the deaths of two veteran patients. The deaths were due to 1) hypoxia after an antibiotic ordered for mail delivery was never tracked nor received, leading to a decline in the patient’s condition; and 2) alcohol withdrawal symptoms after a patient’s missed appointment was lost in the EHR and not rescheduled, leading to his decline and death several months later. The three Representatives are asking Denis McDonough, the Department secretary, for answers on the processes and problems that led to this, and more. They are Mike Bost, R-Ill., Mike Carey, R-Ohio, and Troy Balderson, R-Ohio. Becker’s

care.ai, a system that uses sensor-based AI for care facilities, secured $27 million in venture funding from Crescent Cove Advisors. care.ai’s sensors and their Smart Care Facility Platform are currently used in 1,500 facilities in the US to automate, monitor, and streamline clinical and operational workflows in hospitals, skilled nursing facilities, and assisted living facilities. care.ai plans to use the funding from Crescent Cove Advisors to build on their ongoing operations and deliver ambient intelligence to healthcare. Release, Mobihealthnews

Clear Arch Health is introducing a new RPM mobile app, Clear Arch Mobile, as an alternative to its current tablet-based system. It connects via Bluetooth to devices and is based on the LifeStream Clinical Monitoring Dashboard by enhancing security (with two-factor authentication) and simplifying the collection and transmission of patient data for clinician assessment and intervention, as needed. LifeStream was acquired by Clear Arch earlier this year with their buy of Life Care Solutions. Clear Arch is a division of MobileHelp. Both were acquired by Advocate Aurora Enterprises in April. Release (PDF)

How to cope with the transition from easy funding to showing investors that they are squeezing every dime? That was the topic of a roundtable of investors at HLTH last week. One major problem was that the 2020-21 influx of capital boosted valuations to unrealistic and unsustainable levels, leading to unrealistic expectations for growth and moving into businesses that weren’t core. The advice was bracing from investor luminaries such as Glen Tullman of 7Wire Ventures/Transcarent, Emily Melton of Threshold Ventures, Andrew Adams of Oak HC/FT; and Krishna Yeshwant of Google Ventures.

  • Don’t focus on valuation. Focus on how much capital your enterprise needs to the next phase of inflection, minimize dilution, and set yourself up for the next up round.
  • Refocus and reprioritize, making the most of cash resources on hand
  • Have a plan to get to profitability, not just growth
  • Even more depressing news: the downturn is expected to continue through 2023 into 2024 — make cash last into 2025

Growth areas in healthcare they identified will be familiar: mental health, senior care and primary care –one is not, the Medicaid space. Mobihealthnews

Breaking–The Theranos denouement: Elizabeth Holmes sentenced to 11.25 years with an investor loss of ~$121 million

November 18, 2022 | by

Elizabeth Holmes received her sentence today by Judge Edward Davila of the US District Court of Northern California, in an over four-hour court proceeding.

The sentencing was based on Federal guidelines for four counts of a Class C (non-violent) felony, as well as the recommendations of probation officers. Your Editor watched this in real time from the NBC Bay Area feed and reporter Scott Budman’s Twitter feed from the courtroom (cameras are excluded). This started at 10am PT with last arguments made by prosecution and defense and victim statements. The actual reading of the sentence in his summation by Judge Davila took a little more than 20 minutes, delivered in a silent courtroom, concluding after 2pm PT.

The decision:

  • Prison sentence: 11.25 years (11 years, three months), to be followed by three years of supervised release. Holmes will be required to self-surrender on 27 April 2023. This is likely after her delivery date. This was less than the 15 years requested by the prosecution (in turn less than the 20 years maximum), more than the nine years recommended to the judge by the probation officers (what is called a downward deviation), but entirely based on the sentencing manual. Judge Davila obviously did not believe that he could justify that downward deviation.
  • The investor loss. Judge Davila estimated the total loss by 10 investors at $384 million, not $804 million. A ‘reasonable total loss’ is only $121 million. This winnowing down is a big win for Holmes. While she will never be able to pay it, below $500 million it takes down her possible sentencing, according to NBC’s legal commentator, former prosecutor Dean Johnson. The total and final amount will be settled at a later date at a restitution hearing.

Scott Budman’s tweets included the jousting between both prosecution and defense on multiple points.

There were victim impact statements directed to Holmes, which include the father of whistleblower Tyler Shultz, Alex Shultz, whose grandfather was investor, board member, and enabler George Shultz. “There’s a lot of talk about Sunny and Elizabeth. From my family’s perspective, Elizabeth is their Sunny Balwani. She took advantage of my family.” Theranos lawyers burst into their home (average for the bare-knucks tactics of one David Boies) with no chance for Tyler to defend himself. It also pitted the senior generation (now departed) versus son and grandson, ripping apart the family.

A cancer patient testified; the judge gently said he read her letter.

Holmes presented her own statement as the last word. “I am devastated by my failings. I have felt deep pain for what people went through, because I failed them. To investors, patients, I am sorry.”

Judge Davila’s formal sentencing of Holmes was well under 30 minutes. A judge’s summation must primarily justify the sentencing. It is where he speaks at length. It must detail his logic, discretion, reasoning, and thought process based on the information presented at trial and by precedent. The quotes are from Scott Budman’s play-by-play tweets:

“This case is troubling on so many levels. What went wrong? This is sad because Ms. Holmes is brilliant.”
“Failure is normal. But failure by fraud is not OK.”
“We know by the texts with Mr. Balwani that there was conspiracy.”
“What is the pathology of fraud? Is it the inability to accept responsibility? Perhaps that [is] the cautionary tale to come from this case.”

This Editor will reflect on this, with more information, next week. Will there be a genuine Silicon Valley impact in the middle of a downturn or has this all been factored in? There is the implosion of bitcoin/crypto FTX in the headlines–2022’s equivalent of the early 1930s’ fall of Swedish Match/Ivar Krueger and Ivan Boesky’s stock fraud of the Big ’80s.

Certainly there will be appeals by the defense and by the Feds. A defense appeal, for instance, may lengthen the time before she will serve her sentence.

Sunny Balwani’s attorneys will not be having a Palm Springs Weekend, either, now knowing the thought process of Judge Davila. 

With deep appreciation to the NBC Bay Area team coverage, the analysis by Dean Johnson, and warmly to Scott Budman.

The Theranos denouement: ‘Humble, hardworking’ Elizabeth Holmes sentencing Friday; prosecution and defense paint different pictures (updated)

November 17, 2022 | by

Elizabeth Holmes finally faces the music and perhaps the mercy of Judge Edward Davila on Friday, 10 am PT. Convicted on four felony counts of 11 and defrauding investors of over $144 million, the prosecution has called for Holmes to go to Federal prison for 15 years of the maximum 20, plus three years of supervised release. Restitution of $804 million would go to investors plus a fine of $250,000 for each charge. In US Attorney Stephanie Hinds’ 46-page pre-sentencing memo to Judge Davila, the prosecution states that she was blinded by ambition. “She repeatedly chose lies, hype and the prospect of billions of dollars over patient safety and fair dealing with investors. Elizabeth Holmes’ crimes were not failing, they were lying—lying in the most serious context, where everyone needed her to tell the truth.” They called her crimes “extraordinarily serious, among the most substantial white collar offenses Silicon Valley or any other district has seen.” and that her actions damaged the trust and integrity that is needed for Silicon Valley investors to trust companies to fund ideas before profits are seen. The cut: “She stands before the Court remorseless. She accepts no responsibility. Quite the opposite, she insists she is the victim.”

In all fairness, her defense has relentlessly painted Holmes as exactly that, from young, naive, battered, psychologically and sexually abused Trilby to Sunny Balwani’s Svengali. Their argument in their 82-page sentencing memo argues for mitigation to the point of no sentence at all, or a minimal sentence of no more than 18 months in home confinement plus her continuing service work. Supporting her character as a ‘humble, hardworking, and compassionate woman who deeply wants to give what she can to the world” and not motivated by greed or personal gain were character testimony letters from Billy Evans, her partner, as one would expect, but also from some unexpected places: the Senator from this Editor’s home state of New Jersey, Cory Booker, who knew her starting in 2012, and a former EPA head, William Reilly, who worked with Holmes’s father back in the George H.W. Bush administration. Their memo cited 130 letters.

Also revealed by the defense: Holmes is not only the mother of a year-old son but also pregnant. Evans’ letter contains another heartbreaking fact. Her beloved ‘wolf’ of a husky dog, Balto, was tragically killed by a mountain lion while she and Evans were living in seclusion in a rural area. While they lived in San Francisco, according to him, they were harassed by reporters, ordinary people, and threatening letters, so they hit the road for at least 6 months living in a camper.

Holmes’ ability to pay $804 million to the likes of Safeway and Walgreens seems to be a bit of a reach, as Holmes never cashed out of Theranos stock–at its peak valued at  $4.5 billion–is unemployed with no prospects, and is widely assumed to be, as they say, flat broke as are her parents. As to her sentence, what is widely expected is a multi-year sentence. If that happens, the defense will request that she remains free on bail (a motion for stay) while the filing to the Federal Appeals Court is made, a process that can take a year or more from filing to a decision. 

Judge Davila’s record has been to take in all the circumstances and to be measured in sentencing. After several years, he is intimately familiar with Theranos to the likely point of dreaming about it at night. Factors he may consider in sentencing, start of her term, where it will be served, restitution and fines: lack of flight risk, Holmes’ young child, and her current condition both physical and financial. Savvy court watchers have noted that if Federal law enforcement is in the courtroom, Holmes may initially be taken to prison and held, then freed on bail pending appeal. The jury convicted her on only four out of 11 counts (and threw out the 12th), but it remains that the prosecution proved and the jury decided that she was fully capable of engineering fraud, not once but several times, leaving Balwani’s Mesmerizing Influences aside.

Balwani’s own sentencing on 12 charges, with the same maximum of 20 years in Federal prison, is scheduled for 7 December, Pearl Harbor Day, at 10 am PT.

The Mercury News articles, while thorough, are paywalled: 11 November (defense memo), 11 November (Billy Evans letter), 14 November (prosecution filing). FierceBiotech, MedCityNews

The US Attorney, Northern District of California summary: U.S. v. Elizabeth Holmes, et al.  District Court documents here.

NBC Bay Area will cover the sentencing live here at 10 am PT, 1 pm ET, 6 pm GMT.