More gimlety views on CVS-Oak Street Health, Amazon-One Medical acquisitions

March 2, 2023 | by

Perhaps this Editor is not that much of an Outlier in thinking that these deals don’t beat, say, sliced bread. Oak Street Health (OSH) disclosed its financials in an SEC 10-K filed on Tuesday. One must wonder what CVS is seeing in the company other than bulking up its primary care profile. Their loss grew to $510 million from 2021’s $415 million. While OSH grew impressively in 2022 with a 51% increase in revenue to $2.2 billion, driven by 40 new centers ending with a total of 169 facilities in 21 states, expenses grew exponentially for the new patients: medical claims expenses grew 48%, cost of care went up 49%, and sales and marketing up 38%. Scalable, so they claim; profitable, not till 2025 at earliest.

Other problems were revealed in the 10-K. OSH has substantial business from other payers, which may not be pleased that CVS owns a small payer called Aetna, though has pledged to keep OSH payer-neutral. OSH leases or licenses most of its care centers from Humana. That payer also accounted for 32% of its 2022 capitated revenue. Centene’s plans and HealthSpring made up an additional 23%. Other, more routine concerns are regulatory review, attrition of physicians and clinician staff, and last but not least, breakup fees ($500 million if CVS walks away, $300 million if it’s OSH). When you add these to other factors as outlined in our earlier article, such as the Medicare Advantage and high-need populations, CVS is cutting off a hefty slice of loaf, especially considering that the more complex Signify Health buy is due to close this quarter. Earlier opinions on the buy [TTA 16 Feb], Healthcare Dive

Now to Amazon and One Medical. This Editor received her invitation to buy a One Medical membership earlier this week (left). Countering this Editor’s analysis from last week, which maintains that Amazon is already under a broad antitrust microscope viewed by the Federal Trade Commission (FTC) and the Department of Justice (DOJ), Healthcare Dive counters, quite logically and in the view of their experts, that if either agency was going to object, they would have done so before the closing, and the grounds were likely too novel. The article concedes that the FTC could take action further down the road, for instance if Amazon violates HIPAA or consumer privacy with ad trackers. Instead, the focus is on objections by consumer groups, Amazon leveraging health data, privacy violations, and a general consumer unease around Amazon dealing with their health issues.

  • Consumer protection group Public Citizen urged regulators to block the deal in a letter to regulatory groups after it was announced last summer. For instance, it could bundle One Medical and Prime membership (a no-brainer). By tying the two together, Amazon could gain consent for using patient data from health records. Amazon could also serve ads for products related to medical conditions without that access (that old Pixel/ad tracker business again). These concerns are publicly shared by two FTC commissioners.
  • “Analysts said that data acquisition was likely a big driving factor for the deal. After linking One Medical’s data with that from its other products and services, Amazon can analyze petabytes of healthcare data in the cloud and use the findings to better manage the health of One Medical’s Medicare population, build new products and pinpoint people with rare diseases to solicit participation in clinical trials, according to (market research firm) Forrester’s (Natalie) Schibell.” [Editor] That would, of course, require patient consent. 
  • Forrester noted that the consumer unease around Amazon in healthcare is substantial. 34% of surveyed adults weren’t at all comfortable with Amazon for healthcare needs with an additional 17% only somewhat more comfortable (tier 2). Trust levels are low, and it would take only one or two incidents, such as a security breach or HIPAA violations, to destroy it. This Editor would add that if One Medical practices were not managed impeccably, that would go viral among individual and corporate members, in a way that Amazon Care did not.

Mid-week roundup: another hurdle for Oracle Cerner VA delay, Walmart builds out clinic infrastructure, Cerebral round 3 layoff of 15%, Evolent Health’s 9% layoff, Quil Health age-in-place tech shuts

March 1, 2023 | by

Oracle Cerner EHR rollout faces yet another hurdle. The Department of  Veterans Affairs (VA) announced that the next go-live, Ann Arbor (Michigan) Healthcare System, originally scheduled for completion by July 2023, would be delayed until much later this year or even early 2024.  It turns out that a key reason for the delay is that Ann Arbor is a VA research center, and there are major concerns that the EHR changeover won’t blend well with their medical research. VA Under Secretary for Health Dr. Shereef Elnahal told FedScoop during a media roundtable that “…there are many VA medical centers that are heavy with clinical research because of their academic affiliations, and so those centers will need this research functionality. It’s not just an issue with the Ann Arbor Hospital.” In the article, Dr. Elnahal also lamented that the VA health system running on two separate EHRs, VistA and Oracle Cerner, presented additional risks to security. Also FedHealthIT   Hat tip to HISTalk 24 Feb

Walmart’s 32 clinics are building out their infrastructure. Working with their Epic EHR, all the clinics are now operating on the Horizon Cloud on Azure platform paired with VMware cloud infrastructure and digital workspace technology services. A blog published by VMware interviewing BreAnne Buehl, director of life sciences solutions for VMware, and David Rhew, MD, global chief medical officer at Microsoft, details the ambitions of Walmart to move beyond ‘minute clinic’ to broader primary care and chronic disease management, into proactive predictive analytics. Becker’s Hospital Review, VMWare

And on the less cheerful side:

  • Beleaguered telemental health/ADHD provider/prescriber Cerebral announced another 15% layoff, cutting 285 people. It is its third layoff in one year, following a 20% cut last October.  Cerebral is also closing its medication-assisted treatment (MAT) program for opioid use disorder (OUD). A Cerebral spokesperson said the decisions were made to reorganize the company to “refocus on the most important service offerings for our patients.” Another reason for the MAT program closing is the pending renewal of requiring in-person visits for certain mental health medications. For instance, the Drug Enforcement Agency (DEA) is proposing that buprenorphine can be prescribed via telehealth for treating OUD for 30 days but then an in-person exam would be required.  Last year, Cerebral faced still-unresolved DOJ and FTC actions on their telehealth prescribing of ADHD and other controlled Schedule 2 medications, from deceptive advertising (FTC) to overprescribing (DOJ) [TTA 18 Nov 22]. Topping this off are dueling lawsuits with former CEO Kyle Robertson [TTA 30 Nov 22]. Cerebral at the end of 2021 was valued at $4.8 billion by Softbank and other investors, but no one wants to talk about its worth today.  Reuters, Layoffs Tracker, Behavioral Health Business
  • Payer/provider management services organization Evolent Health quietly laid off 460 positions in its Chicago operations, about 9% of their 5,100 person staff, starting in December 2022 into last month.  Their Q4 net loss doubled to $11.25 million on $382 million in revenue, doubling 2021’s $5.65 million loss, though full year 2022 closed with a final loss of $19 million, about half of 2021. The company projects Q1 revenue of $420 million to $440 million, with 2023 revenue of $1.92 billion to $1.96 billion with a shift of emphasis to specialty care, bolstered by its closed acquisition in January of Magellan Specialty Health from Centene. Layoffs Tracker, Washington Business Journal
  • Quil Health shut down operations, with employees departing 10 February and executives 24 February. The Philadelphia-based Comcast-Independence Blue Cross joint venture was founded in 2018 to support older adults and caregivers in ‘aging-in-place’ alert and monitoring technology. The sole report in HISTalk states that the website is offline plus their CEO Carina Edwards updated her LinkedIn profile for Quil with a February 2023 end date and changed the company description to past tense, pushing up her board positions. Their Facebook page is still live but no posts after 16 January after announcing their joining the AARP AgeTechCollaborative. In 2019, this Editor wrote that they were developing pre- and post-care support through TV (!) with Comcast working on an ambient sensor-based device to monitor basic vital signs and fall detection, which launched in 2020 as Quil Assure. To this Editor, it sounded like a home version of QuietCare circa 2009 with multiple sensors and diagnostics. 

Should your healthcare organization become a public benefit corporation (PBC)?

February 24, 2023 | by

Is it this year’s ‘IT’ social trend–or a way to return companies to their purpose? Public benefit corporations (PBCs) are finding a foothold within healthcare and digital health organizations. Developed in 2010, the PBC form is a for-profit corporation that is structured to pursue a social mission and recognized in that structure to create a long-term public good or benefit by providing services and generating revenue. It can be publicly traded (though relatively rare). 36 states, including the ever-popular Delaware, and the District of Columbia permit PBCs to be formed. In terms of corporate accountability, achieving their stated social mission or purpose must work alongside maximizing value for shareholders. Otherwise, they are structured like standard for-profit corporations. 

Examples of healthcare PBCs are Aledade (practice management services in value-based care models which just acquired Curia in VBC analytics), Mark Cuban Cost Plus Drugs, Osmind (behavioral EHR), and startup Crescendo Health (health data). Other well-known PBCs are Lemonade (insurance), Veeva (cloud software for life sciences), Patagonia (clothing), Ben & Jerry’s (unusually within Unilever), and Coursera (online learning). Companies like Veeva have converted from traditional publicly traded corporations to PBC.

Would this form be right for your company? From what this Editor has read (see below) if the company is truly purpose-driven from the top and the bottom. A PBC company’s board of directors is required to balance its mission/purpose with the financial interests of shareholders and investors. A mission focus can be attractive to both. It also orients management on the long term versus living and dying by quarter-to-quarter performance. Part of this can be environmental, social, and governance (ESG) criteria. For many companies in healthcare that are oriented to service and to benefit health (beyond the loose ‘transformation’) but must generate profitable revenue, a PBC can differentiate your company from competitors that are standard corporations that answer to VCs and PEs. 

Intertwined with this is the B Corporation (B Corp) certification, granted by a third-party organization called B Lab. It is not necessary to be a PBC to have it but it helps the ‘look’. Like most third-party certifications, it’s a high and distracting bar, requiring assessments and changes in corporate governance, and has to be renewed every three years. (This Editor worked for an internationally known travel organization starting with an ‘A’ before healthcare that attempted to achieve the Malcolm Baldrige Quality Award after high scores with J.D. Power. That effort served to distract everyone for an entire year from real business. And then we missed! And then we got bought–and moved!)   FierceHealthcare, Kiplinger’s, US News, 

News roundup: UHG closes $5.4B LHC deal, Teladoc’s record $13.7B ’22 loss, Olive AI divesting UM, Cigna exec can’t join CVS, VA anti-suicide program awards, Equiva-Infiniti ACP initiative, Newel Health’s Parkinson’s device

February 23, 2023 | by

UnitedHealth Group added more home care to its Optum unit with the close of the LHC Group deal on 22 February. Final cost was $5.4 billion or $170 per share of the now-delisted Nasdaq company. The acquisition was announced in March and survived two reviews: a request from the Federal Trade Commission (FTC) for additional information which held up the close past the original December date and a shareholder suit on ‘material nondisclosure’ in the SEC filing. FTC requested information on worker pay and ‘vertical harm’ on market competition, but did not proceed with further action prior to the closing. LHC Group serves 960 locations in 37 states, with 30,000 employees and revenue of $2.2 billion last year. The original announcement indicated that the Louisiana-based management team will be coming over to Optum Health and co-founders Keith and Ginger Myers will personally invest $10 million in UHG following the acquisition close. Interestingly, as of today (Thursday noon ET), neither company has announced the closing on their websites. Home Health News, FierceHealthcare  For those into value-based care, as previously noted, Optum is acquiring via LHC Imperium Health, a good-sized ACO, population health, and management services company. It’s another fit as Optum is a major physician group owner, many of whom are also in ACOs, and made LHC even more attractive. According to their website, Imperium now manages 16 ACOs and is in partnership with a large ACO group. 

Unsurprisingly, Teladoc notched a record loss for 2022– $13.7 billion on revenue of $2.4 billion. This included the Q1 2022 $6.6 billion write-off of the Livongo acquisition. On the investor call, company executives scaled down 2023 revenue forecasts to $2.55-$2.68 billion, which is about 9% growth. Teladoc remains at about 80 million members. The company’s ‘balanced growth’ plan to move toward profitability has already resulted in January’s announcement of 6% of staff being laid off and a reduced geographic footprint, presumably including real estate and leases. Healthcare Dive, HISTalk 2/24/23 which also cross-references the MedCityNews Livongo ‘lemon’ interview

Olive AI continues to shrink and juggle, with today’s announcement of their putting their utilization management service line up for sale. Earlier, they announced divesting their population health and 340B service lines to a sister company. The UM line buyer would take on the accounts and the 100-person staff. Olive AI is an automator of routine health system administration tasks such as these. Their pivot will be in automating revenue cycle management for health systems. Last week, Olive announced the release of 215 employees, about 35% of its remaining staff, in addition to its July layoff of 450 employees, then about 33% of staff. If this Editor’s calculations are correct, Olive is down to about 900 or less. Becker’s  Original report in Axios is paywalled, but indicates problems with the software’s efficacy, multiple executive departures, and a previous asset sale.

Yes, Virginia–non-competes ARE enforceable. So Amy Bricker, Cigna’s former head of pharmacy benefits unit Express Scripts, found out when she tried to join CVS as a senior executive as chief product officer for its consumer area, not Caremark which is a direct competitor. She had signed a two-year non-compete/non-disclosure barring her from any employment with any direct competitor. Cigna apparently imposes non-competes on only their most senior executives, a total of 16. This is a temporary restraining order from the US District Court for the Eastern District of Missouri to bar her from joining the company, duration unknown. Cigna had to post a $250,000 bond for possible future damages. FTC (again) is attempting to ban non-compete use both in future and retroactively. Restraining order, Healthcare Finance News, Healthcare Dive

Some blue side up news: 

  • Mission Daybreak Grand Challenge awarded by the VA. 10 companies were awarded $20 million to pursue digital health approaches to prevent veteran suicide as part of a 10-year VA initiative. The first-place winners were Stop Soldier Suicide and Televeda, awarded $3 million each. Healthcare IT News has additional details on all the finalists.
  • Digital health is leveraging an existing $14.2 billion FCC initiative called the Affordable Connectivity Program (ACP). Two companies, Equiva Health, a digital patient engagement and health relationship management solution provider, is partnering with internet provider Infiniti Mobile to create Equiva ACP Connect. The product configures tablets and mobile devices for care management and patient education distributed by hospitals, nursing homes, insurers, and other healthcare organizations. Release
  • Newel Health has received a grant from the Michael J. Fox Foundation to further development for Soturi, a digital therapeutic solution for Parkinson’s disease management. Soturi utilizes data collected from a wearable sensor, using an algorithm-based decision-making method, for personalized treatment. The project will be presented at the SINdem conference in Bressanone, Italy on 24th February. Release (PharmaPhorum)

Breaking: Amazon closes One Medical $3.9B buy, despite loose ends–and is the Antitrust Bear being poked?

February 23, 2023 | by

The Big Deal closes, but loose ends and larger issues remain. Today’s news of Amazon closing its purchase of the One Medical primary care group is being received in the press, especially the healthcare press, enthusiastically. This Editor cannot blame her counterparts, as since last year there’s not been much in the way of good news, compared to 2020-21’s bubble bath. Her bet as of a couple of weeks ago was that the deal would not go through due to Amazon’s financial losses in 2022 and/or that the FTC would further hold it up, both of which I was wrong, wrong, wrong on. (Cue the fresh egg on the face.)

Wiping off said egg, here is what Amazon is buying and their first marketing move. (Information on size and more from the 1 Life 2022 year end 10-K):

  • Amazon acquired 1Life Healthcare Inc. for $3.9 billion, or $18 per share in cash.
  • The practices are primarily branded as One Medical, closing out 2022 with 836,000 members and 220 medical offices in 27 markets
  • It is a value-based primary care model with direct consumer enrollment and third-party sponsorship across commercially insured and Medicare populations. Their Net Promoter Score (NPS) is an extremely high 90. (NPS is a proprietary research metric that indicates customer loyalty and satisfaction.)
  • They also have at-risk members from the $2.1 billion Iora Medical acquisition in seven states, in Medicare Advantage (MA) and Medicare shared savings value-based care (VBC) arrangements [TTA 27 July 22].
  • One Medical has contracts with over 9,000 companies, establishing Amazon at long last in the desirable corporate market.
  • One Medical also provides a 24/7 telehealth service exclusively to employees of enterprise customers where there are no clinics.
  • Amazon will be offering a discounted individual membership of $144 versus $199 for the first year, without an Amazon Prime subscription.

The Federal Trade Commission (FTC), which had additional questions about the buy as part of a Second Request in the Hart-Scott-Rodino Act reporting process, did not act in time to prevent the closing. Nor did the SEC or DOJ. This is CEO Andy Jassy’s first Big Deal at Amazon and certainly, the champagne and kvelling are flowing at HQ plus One Medical’s investors and shareholders for a successful exit. But should Amazon be looking over their shoulder? 

What are the open issues? Is a large, hungry Bear called Antitrust being poked, or lying in wait for its prey?

  • The FTC has the right to probe into the transaction despite the closing and a deadline passing for antitrust review. In FierceHealthcare and STAT, FTC spokesman Douglas Farrar is quoted as telling the WSJ (paywalled) in a statement that “The FTC’s investigation of Amazon’s acquisition of One Medical continues. The commission will continue to look at possible harms to competition created by this merger as well as possible harms to consumers that may result from Amazon’s control and use of sensitive consumer health information held by One Medical.”
  • As previously reported here, only in December did the FTC send out subpoenas to current and former One Medical current and former customers as part of its investigation. That’s late to stop a buy–unless FTC had something else larger in mind.
  • Early February reports in Bloomberg and the WSJ indicated that this may be part of a larger FTC action in developing a wide-ranging antitrust lawsuit against Amazon on multiple anticompetitive business practices. Their chair, Lina Khan, is highly critical of Amazon’s business practices. Amazon’s buy of iRobot, maker of Roomba, which at $1.7 billion was a comparative snack, is still not closed and has received a lot of negative attention for possible misuse of consumer information. 
  • Sidebar: This FTC is ‘feeling its oats’ on antitrust. GoodRx found itself making history as FTC’s first culprit of the 2009 Health Breach Notification Rule, used to prosecute companies for misuse of consumer health information. This was for their past use of Meta Pixel, discontinued 2019, to send information to third-party advertisers. One Medical is a HIPAA-covered entity which puts it at a far higher risk level. 
  • The Department of Justice (DOJ) has not publicly moved to approve or disapprove–yet. 
  • The change of ownership has not been reported as passing muster by regulators in multiple states. Example: Oregon approved it, but with multiple stipulations [TTA 6 Jan]–and there are only five One Medical clinics in Oregon. States like New York, Massachusetts, Connecticut, and California are not exactly pushovers for approval, with California alone having two approval entities.
  • Congress is increasingly feisty on data privacy–consumer health information and its misuse in telehealth [TTA 9 Feb]. 

Will this be ‘buy now, regret later’, a lá Teladoc’s expensive acquisition of Livongo, or Babylon Health going public with a SPAC? Is this a clever trap laid for Amazon?

  • Amazon is already under a Federal and state microscope on data privacy. Information crossing over from One Medical to their ecommerce operations such as Pharmacy and Prime will just add to the picture. 
  • Accepting Medicare/Medicare Advantage increases scrutiny on quality metrics and billing, to name only two areas. At-risk patients in Medicare and other VBC models, especially Medicare Shared Savings Program (MSSP) fall under CMS scrutiny. Amazon may take a look at that and spin-off/sell off the former Iora Health practices/patients.
  • Amazon has failed in healthcare previously, as a partner in the misbegotten Haven and in its own Amazon Care ‘home delivery’/telehealth model selling to companies, now closed. Its asynchronous virtual care service, Amazon Clinic, is too new to judge its success. 
  • Office-based, brick-and-mortar healthcare provided by doctors, nurses, and allied health professionals is an entirely new area for Amazon. Will they be satisfied with their new masters–and new metrics? It is also expensive. One Medical has never been profitable and did not project breakeven for years. (If one asks how this is different than CVS acquiring Oak Street Health, or Walgreens acquiring VillageMD and Summit Health, CVS and Walgreens have experience for decades in multiple aspects of providing healthcare–profitably and in compliance.)
  • One wonders how heavy of a hand Amazon will place on One Medical’s operations. How their management, doctors, and other professionals will feel after a year or two of Amazon ownership is anyone’s guess. This Editor doubts they will remain in place or silent if unhappy.
  • Selling to enterprises–and account retention–is a vastly different relationship-building process and buyer journey than 1:many consumer transactions. One Medical made a go of it with 9,000 companies and enrolling employees at about a 40% rate, so they did something right. By contrast, Amazon failed to sell Amazon Care well to companies. Humility and service, for starters, are required.
  • Last but certainly not least, is how Amazon will deal with regulation and compliance at multiple levels.

Expect that the FTC and DOJ will not be done with Amazon any time soon in what looks like a wider antitrust pursuit that may take some time, which they have. Amazon has tens of millions in government business (AWS) at stake and shareholders expecting a reversal of losses. Pro tip to Amazon: run One Medical as a separate operation with minimal integration and no information sharing until past this. And then some.  Healthcare Dive, Becker’s

Theranos’ Balwani seeks to remain free during appeal, argues he owes nothing in restitution (updated for Holmes appeal)

February 22, 2023 | by

12.9 year Federal sentence set to begin 15 March. On Friday 17 February, Ramesh ‘Sunny’ Balwani, former Theranos president/COO, his defense attorneys, and the prosecution were in Judge Edward Davila’s Federal District courtroom to argue that Balwani should remain free during appeal, and–surprisingly–should owe nothing in restitution to investors.

Balwani is scheduled to report is scheduled to report to the minimum security Federal prison at Lompoc, California to begin his 155-month sentence on 15 March. During the hearing, Judge Davila did not issue a decision on Balwani’s freedom through appeal, nor about restitution. In play are the parallel sentences and appeals of Balwani’s boss and lover, Elizabeth Holmes, with her delay of surrender based on appeals being filed and restitution being decided in the same court.

Balwani’s defense is taking a different tack than Holmes’ defense regarding restitution. His attorney, Amy Walsh, presented that the company was still valuable at the time of Balwani’s dismissal in May 2016. Theranos still had $350 million in cash and intellectual property worth $100 million. Judge Davila seemed skeptical of that:  “Are you saying his conduct was completely divorced from Theranos’ demise?” The prosecution is seeking a far higher restitution–$900 million–than the $120 million Judge Davila estimated at the time of Balwani’s sentencing.

Elizabeth Holmes is also seeking to remain free while appealing her 11.25 year sentence in the Ninth Circuit Court of Appeals, with filings in December and January [TTA 24 Jan, 10 Jan] with Balwani’s filings on a similar timetable. Her defense team also filed for a new trial [TTA 15 Jan] based on purported errors by Judge Davila during her trial. Her restitution hearing on the $121 million Judge Davila has estimated during her sentencing is now scheduled for 17 March. As with Balwani, the prosecution is seeking a far higher restitution–$804 million.

Holmes’ surrender date is scheduled for 27 April to the Federal prison in Bryan, Texas–a change by the Federal Bureau of Prisons from Dublin, California, as rumored in November [TTA 30 Nov]. The women-only minimum security Bryan facility is considered in the Federal system to be ‘heaven’ compared to the Dublin satellite camp, though the latter is only about an hour from her home, partner Billy Evans, and her soon-to-be two children. The selection is important because Federal inmates serve in general 85% of their sentence.

Updated  Holmes’ second child has been born, according to a court filing on Thursday. Her defense continues to press for postponing her surrender during the appeals process. Defense and prosecution continue to wrangle on Holmes’ flight risk, based on the never-taken January 2022 Mexico trip and one-way ticket, now on the basis that she has never directly denied that she intended to flee nor explained her lack of a return ticket [TTA 24 Jan].  Mercury News

Balwani’s defense also maintains that government misconduct during the trial makes success for appeal likely, that he is not a flight risk based on his behavior since 2018, and has no history of violence. The clock is ticking down on both Balwani and Holmes. AP

Breaking: AliveCor wins presidential review on ITC Final Determination on Apple patent infringement

February 22, 2023 | by

Enforcement held for PTAB appeal decision. As anticipated after the International Trade Commission (ITC) decision, finding that Apple Watches infringed three AliveCor patents on ECG readings [TTA 3 Jan], the Final Determination issued 22 December 2022 has passed the 60-day mandatory presidential review and is now in effect.

The penalty in the bond assessed against Apple–$2 per watch–applies to Apple Watches with the ECG feature imported or sold during the presidential review period. It is the first Limited Exclusion Order (LEO) with a cease and desist order against Apple. However, the penalty cannot be enforced until AliveCor’s appeal of the US Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) ruling is decided. PTAB’s ruling in early December 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 as unpatentable: 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.

The PTAB appeal is in progress. AliveCor also has a separate action against Apple through its Federal antitrust case in the Northern District of California. That will not go to trial until early 2024. AliveCor has about 170 patents, but the loss of any patents is important to a company’s IP and ultimately, funding. It’s also a clear signal to innovative companies that a David can win against a Goliath. AliveCor release

ATA 2023 Annual Conference 4-6 March–a special deal for our Readers

February 18, 2023 | by

The American Telemedicine Association (ATA) annual conference and expo is only two weeks away–4-6 March in San Antonio, Texas. ATA2023 is the only US event solely focused on telehealth and virtual care, with three full session days, an interactive exhibit floor, two receptions, a research track, and more. More information is available here.  This Editor will also note that average temperatures in San Antonio at this time of year will be warm without Texas stickiness–in the high 70s F°–so if you are looking to defrost, Go Texas! 

Registration link is here. But as a media partner of ATA (see above), our Readers are eligible for a discount of $250. On registration, enter this code: ATA23TAW250. If you attend, love to hear your feedback!

Short takes: Avaya’s Ch. 11; Aetna sells India telehealth; fundings for IncludeHealth, Senniors, Thatch, Previa, MDI; layoffs at Collective Health, Vicarious, Olive AI

February 17, 2023 | by

Avaya files second Chapter 11 reorganization in six years. The company, which provides virtual care and collaboration tools (and has contributed to our Perspectives series), is restructuring with a financing of $780 million. This was anticipated from August-September last year when they announced accounting problems with their cloud subscription revenue, resulting in substantial layoffs, $250 million in cost cuts, a CEO change, and a continuing crash in the stock value which was close to 99%. In December, they announced a likely delisting from the NYSE. Major creditors include Microsoft, Wistron Corp., and SHI International. Current customers will continue to be served. Upon completion of the restructuring process in a projected 60 to 90 days, Avaya will reduce its total debt by more than 75%, from nearly $3.4 billion to about $800 million. CRN 14 Feb, CRN 7 Sep 22, Yahoo Finance    Hat tip to HISTalk

Aetna’s subsidiary Indian Health Organisation (IHO) is selling its telehealth business to MediBuddy. Transaction cost was not disclosed. Bangalore-based MediBuddy is buying what is currently called vHealth by Aetna and will be rebranded over the next six months to MediBuddy vHealth, to be integrated with its other services. vHealth is a subscription-based primary healthcare service that offers telehealth consultations, an extensive outpatient network, pharmacy, diagnostics, dental services, delivery of medicines, blood tests, and other home healthcare products across 38 Indian cities. IHO employees will continue with MediBuddy. Last February, MediBuddy scored a $125 million Series C funding, led by Quadria Capital and Lightrock India.  Press release (Hospitals Management India), Mobihealthnews

A few early-state digital health fundings rounded up by Mobihealthnews:

  • Ohio-based digital musculoskeletal (MSK) health care and training company IncludeHealth raised $11 million in a funding round led by CincyTech with participation from Tamarind Hill and other investors. The fresh funds will be used to expand the MSK-OS remote care platform. Ray Shealy joined as COO and Grant Koster joins the board of directors. Also Finsmes 
  • Madrid, Spain-based Senniors raised $5.6 million in seed funding. Senniors provides home care services including therapy, mental healthcare, and nutrition counseling for older people and others who need support. The seed round was led by SixThirty with Sevenzonic, KIMPA, Zubi Capital and Invertidos.
  • Thatch, a health benefits startup, raised over $6 million in total funding across pre-seed and seed rounds from 16z and GV, with participation from Lux Capital, Quiet Capital, Not Boring Capital and BrightEdge. It includes a tech-enabled Health Savings Account, a Thatch debit card for all healthcare expenses, and on-demand access to experts who can resolve billing issues via text. Release
  • Previa Medical, based in Lyon, France, raised €2.1 million for its AI-based predictive medical device to alert providers to early signs of sepsis and raised $2.2 million in seed funding. It included participation from Kreaxi, M2care, Veymont Participations, Hopla Memory, CCI Capital Croissance, Holding Seraip, Bpifrance and BNP Paribas, with equity and debt financing from Banque Populaire AURA. SEPSI-SCORE analyzes patient risk factors for sepsis in real time through patient records drawn from hospital software to alert providers up to 48 hours before symptoms develop. Finsmes
  • And one more: $20 million in Series A funding to healthcare analytics company MDI Health. MDI uses AI in pharmacology to prevent negative outcomes in chronic polypharmacy patients and at-risk populations. Mobihealthnews

While layoffs in healthcare have slowed down somewhat, they do continue: 

  • San Mateo-based Collective Health, a benefits administration software provider for enterprises, laid off 54 of an estimated 500-1,000 employees. LinkedIn corporate posting
  • Vicarious Surgical, a robotic surgical developer which has received funding from Bill Gates and BD, is planning to reduce its workforce by 14% to conserve cash. Ironically, they are making a 510(k) submission for a robotic system to compete against giant Intuitive Surgical’s da Vinci. Med tech has tightened up substantially with giants like Baxter whacking 3,000 jobs (5%) in its global workforce and Abbott releasing temporary workers hired to produce COVID-19 test kits in Maine. Medtech Dive
  • Olive AI, which automates routine administrative healthcare processes such as revenue cycle management, laid off an additional 215 employees last week, about 35% of its remaining staff, due to account losses. In July, 450 employees or about 33% of staff were released. Axios

A Valentine’s Day tribute to Dame Esther Rantzen

February 17, 2023 | by

This is a lovely tribute to a Dame–Dame Esther Rantzen. Our UK Readers will know her from her TV journalism work, as presenter of That’s Life! on BBC TV for 21 years, and who was instrumental in the founding and popularization of both ChildLine and The Silver Line older adult helplines. She is also a supporter of Alertacall Ltd., noted when the company was awarded the Queen’s Award For Enterprise: Innovation [TTA 12 May 22]. 

James Batchelor, their founder and CEO, penned a lovely post on his personal blog to her:

A brief excerpt:

In her association with Alertacall, just as with Childline, The Silver Line, and the around 50 other charities she is involved with, Esther is genuinely invested in trying to change the world for the better.

Esther is the real deal.

Her celebrity may be what catches your attention but it is the fact she works so hard for causes she truly cares about which has made me, and so many others, admire her over the years. I will repeat it again, she is the real deal.

He also lauds her ability to galvanize action through her appearances and communications, listening and leading through example.

If she wants something to happen, Esther will also commit to it entirely. What’s more she will make sure you are committed to it with an equal tenacity, hold you to account and ensure you follow through on your promises. 

James notes many other ways Dame Esther has made the world a better place. Please comment below! A “love letter” to Dame Esther Rantzen

Is CVS’ Oak Street Health deal genius? Or a waste of time and $10B?

February 16, 2023 | by

A sample of the split opinion. In the buccaneering between CVS and Walgreens, plus Walmart and Amazon, to add primary care, CVS definitely buckled the swash with three deals: Signify Health (being questioned by DOJ and FTC) [TTA 21 Oct 22 latest], a $100 million investment in Carbon Health [TTA 11 Jan], and Oak Street Health [TTA 9 Feb]. These are in line with their strategy of acquiring companies to expand their capabilities in primary care, provider enablement, and home health. The wisdom of the first–primary care–is being questioned by a few in healthcare. 

The basic argument is that primary care is money-losing, ‘unless you have significant ancillary revenue and downstream referral income’ according to Randy Davis, vice president and CIO of CGH Medical Center, based in Sterling, Illinois. Oak Street’s Medicare Advantage business is also money-losing because of its dependence on increasing severity scores (risk adjustment) and is generally an ‘uphill battle’. This Editor will add that as previously noted–and lauded in CVS’ release–Oak Street is notable for serving underserved patient populations–50 percent of Oak Street Health’s patients have a housing, food, or isolation risk factor. That equates to greater expenses that may or may not be reimbursable. Oak Street certainly has proven the money-losing part, forecasting a loss of $200 million for 2023 and not projecting a profit until 2025. Mr. Davis was blunt, calling it a deal that made no sense and “CVS better have a plan they implement in 18 months or they’ll get slaughtered.”

Another rap on the deal is that it is not big enough. Given the size of Oak Street at about 169 offices and the national figure is quoted as 600,000 ambulatory sites, it’s tiny. However, what isn’t considered is Aetna’s existing relationships with primary care physicians through ACOs formed as joint arrangements, and if Signify Health goes through, the Signify/Caravan ACOs. In fact, this may be a factor in the DOJ/FTC consideration of antitrust.

Others see opportunity in integrating primary care into CVS’ retail locations (Carbon Health) and serving historically underserved communities–much the same tack that Walgreens is taking with VillageMD (acquiring Summit Health) and Walmart with Walmart Health clinics. Becker’s Hospital Review

And as to Amazon, this Editor’s prediction is that Amazon will strike its Jolly Roger and sail away from the One Medical buy.

Mid-week news roundup: Parsa admits Babylon SPAC was ‘big mistake’, FTC’s strategy on GoodRx action, Oracle signs Accenture for VA training, Constellation delays ’22 reports, Emirates Health launches Care.ai and Digital Twin

February 15, 2023 | by

Regrets? Babylon has a few. A short but surprising interview in Mobihealthnews by Ali Parsa will give Readers an idea of the bubbly mindset of 2020-21 and the crises that followed for some companies. Babylon had 400% growth, then felt it had to go public via a SPAC in October 2021. It cost them a lot, including losing US shareholders, yet being listed on the NYSE. Parsa admitted “But in hindsight, that was a very big mistake. There’s no question.” While their revenue has continued to climb, on target to hit over $1 billion this year as of January, the cracked SPAC (opening at $272, today at $11.50) has forced Babylon to reorganize, selling non-core businesses like the Meritage IPA, reorganizing as a foreign private issuer to a domestic, and planning a reverse share split. These were announced last fall to avoid an NYSE delisting when the shares fell below $1 [TTA 13 Oct 22].  It also is leading them to shed Medicaid business and target commercial payers, such as Centene’s Ambetter. There’s a hint at the end of the article of some tech changes to promote continuous vital signs monitoring. You have to give Mr. Parsa credit for not papering over his errors.

FTC’s moves against GoodRx a preview of coming courtroom attractions–and collections? The start of February marked the first time that the Federal Trade Commission used the never-used-before Health Breach Notification Rule (HBNR), enacted in 2009, to elicit a penalty. With GoodRx choosing to settle for $1.5 million rather than fight [TTA 3 Feb], the FTC has now demonstrated a willingness to use Federal action against other online health companies sharing user data with third parties and monetization of that data. An attorney quoted in the Healthcare Dive article analyzing the ramifications: “This is the FTC trying to signal all these apps and other startup companies that are collecting a lot of sensitive data that we have a mechanism for enforcing data privacy rules against you.” Seven charges against GoodRx were around deceptive representations and unfair practices, with the HNBR the eighth layer of cake icing. According to another attorney quoted, the FTC is expanding the definition of breach into data that is shared or distributed “without the consent or authorization of the person whose data it is.” It seems like HBNR are yet more initials to be dreaded by digital health businesses that aren’t covered entities and stay well outside HIPAA privacy laws. 

Oracle Cerner getting help in digging through the Mound of Misery around their VA EHR implementation. FedScoop reported today (14 Feb) on Oracle’s signing of Accenture to improve clinician training on the Cerner Millenium system. Oracle EVP Ken Glueck confirmed that “We signed a contract with Accenture probably a month ago. So they are part and parcel of the training procedure for the continued rollouts when they resume in June of 2023.” They also confirmed that it was within the current ‘budget envelope’. Not surprisingly, Accenture is part of the Leidos Partnership for Defense Health that is implementing the Department of Defense’s considerably further along and relatively less troubled version of the Cerner EHR, MHS Genesis.

EHR watchers last year also noted the $700 million sale of EHR pioneer Allscripts (now Veradigm) five hospital and large physician practice EHRs to Constellation Software, integrated into their N. Harris Group [TTA 6 May 22] and now called Altera. Constellation has delayed reporting its Q4 and FY2022 results, usually released about this time, to a date to be determined, because of the Altera acquisition. Release Constellation, a Canadian company, trades on the Toronto Stock Exchange at an eye-watering share price of C $2,405 and a capitalization of C$49 billion.

Swinging over to the UAE, Emirates Health Services at Arab Health 2023 launched both the Care.ai and Digital Twin services for its facilities across the region. Care.ai is an Orlando-based company. For EHS, this will create an AI-enabled automation system that will update and analyze patient data and and assist doctors in diagnosing patients using computer vision. Digital Twin is an energy management system developed in partnership with Schneider Electric and Microsoft using Azure. At Al Qassimi Hospital, it cut consumption by up to 30% and reduced breakdowns and maintenance work by up to 20% .EHS release  Hat tip to HISTalk 

Digital technology falling (even) short(er) in NHS nursing: QNI report (UK)

February 9, 2023 | by | 2 Comments

When health tech ‘magic’–isn’t. Roy Lilley and his several times per week newsletter (NHSManagers.net, subscribe here) are really must reads for our UK readers dealing with the foibles of the NHS and NHS Digital. Billions have been poured into digitization of records and equipping district (community) nurses with laptops and access to apps that connect them to patient information. All of which is apparently, a flop for the money spent. 

The Queen’s Nursing Institute (QNI) has published a study, Nursing in the Digital Age 2023, via its data gathering and analytics area, the International Community Nursing Observatory (ICNO). It obviously should be microscope-read by NHS Digital, but also by US developers (and in other countries) with clinical users. (Oracle Cerner, Epic, and 00’s of EHRs and workflow apps–take notice).

Mr. Lilley outlines the level of failure here–from his article: 

  • 5 yrs ago; 32.7% reported problems with lack of compatibility between different computer systems… in 2022 the figure had risen to 43.1%.
  • 5 yrs ago; around 85% of respondents reported issues with mobile connectivity… in 2022 this figure was around 87%.
  • 5 yrs ago; 29.5% reported problems with device battery life… in 2022 the figure was almost 53%.

The overall take of the QNI study is that nurses are highly digitally literate and embrace technology at scale, but in practice, the apps and the hardware have become impediments as the workload increases. For non-UK readers, district nurses travel a lot, often working from home–akin to home care or rural nurses in the US. Points from their executive summary:

  • Hardware–battery life, weight of laptop, old laptops, ergonomics not only from weight but also when working in cars. Safety and confidentiality issues lead many nurses to take the work home, leading to delays.
  • Software–connectivity, authentication, multiple platforms, little integration, repetition of data entry, and poor connectivity and software design leading to interrupted workflows.
  • Some scheduling tools cause workload issues, such as over-allocation of work, unmanageable workloads and loss of personal autonomy.
  • Systems design–impersonal, designed to act as a barrier to interacting with patients.
  • Duplicative workload–repetition with dual entry on paper and into platforms because of poor connectivity and software design
  • The use of electronic health records (EHR) and similar platforms was mixed in terms of productivity gains and work capture. 

Another issue: “Moving technology-enabled care (remote monitoring) to the community appears to have shifted work from the hospital to the community”, meaning an increased workload on nurses where specialists or non-nursing staff could do this. 

Mr. Lilley summarizes as a service what both the hardware and software should be accomplishing:

Just ten simple things:

  1. Who is the patient,
  2. where have they come from.
  3. See their record, have they been sick before and…
  4. What we did we do?
  5. Anything in their history that’s a red flag?
  6. What do we do to fix them up this time and…
  7. Record how we did it.
  8. Figure out what worked,
  9. What did it cost and…
  10. Do we want to do it again.

Both Mr. Lilley’s newsletter and the study (PDF) are must reads wherever you live. Especially if you are a software designer.

No wonder nurses are single-day rolling striking!

(He also has an interesting take on ChatGPT, AI for copywriting and reporting, which we will take on next week….) Hat tip to Editor Emeritus Steve.

Ad tracker action heats up: Congress questions DTC telehealth companies on sensitive patient health data sent to advertisers

February 9, 2023 | by

It looks like telemental and addiction counseling telehealth sites are routinely sending patient information to media ad platforms–Google, Facebook (Meta), TikTok, Microsoft, Snapchat, Bing, Pinterest, and Twitter–to serve ads back to patients. Four Senators sent letters this week to three telehealth companies treating patients: Monument (alcohol addiction), Workit Health (opioid and alcohol), and Cerebral (ADHD and other mental health). The letters questioned the use of ad trackers (pixels) such as Meta Pixel that collect information from telehealth sites and then use the information to send users targeted ads based on that information. Except that this is not about curtains or shoes, but medical treatment. 

Kicking this off was The Markup/STAT study in December, examining 50 telehealth websites.

  • 49 of 50 websites shared user/patient tracking data to advertising platforms. This captured data as routine as URLs and IPs, and as extensive as name, email, phone, questionnaire answers, when users created accounts, and cart behavior, such as a prescription medication or treatment plan.
  • 35 were found by the study to have trackers sending individually identifying information to at least one media platform that included names, email addresses, and phone numbers
  • 25 had at least one tracker that indicated when users added prescription drugs and other items to their cart or when they checked out with a subscription for a treatment plan
  • 13 had at least one tracker that collected patients’ answers to medical questions

Ad trackers then send that information to platforms, which then serve targeted ads back to the telehealth companies’ users and patients. For the telehealth companies, the data is monetized. Because ads are served, there is a revenue stream back to the telehealth companies. 

From the senators’ letter: “This data is extremely personal, and it can be used to target advertisements for services that may be unnecessary or potentially harmful physically, psychologically, or emotionally.” Markup/STAT

Users may well assume that because the telehealth companies eventually connect them to a provider covered by HIPAA, or sends them a prescription from a provider, such as migraine treatment, that their data is protected along the entire journey. That assumption has now been demonstrated to be incorrect. This included major, heavily advertised DTC providers such as Lemonaid, Keeps, Hims & Hers, Talkspace, and Roman (Ro). Many of them are now examining their pixel policies.

The December article linked above has all 50 companies and what information they found was sent to ad platforms. The only website that did not was Amazon Clinic–brand new and of course not wanting to share their information outside of Amazon.

This follows on the FTC’s still to be approved by a Federal court, but apparently successful $1.5 million action against med discounter GoodRx using the never-used-before Health Breach Notification Rule, enacted in 2009 [TTA 3 Feb]. 

Why this is significant: first, the FTC action using an old rule, followed by the senators targeting three prominent (and in Cerebral’s case, beleaguered) telehealth companies, and the red meat documentation provided by The Markup/STAT study provide grounds for endless follow-up by not only Congress, but also private and public (DOJ) litigation. Stay tuned.

Chronic traumatic encephalopathy (CTE) found in over 90% of deceased NFL player brains: BU study

February 9, 2023 | by

A topic TTA extensively covered from 2012 up to end of 2017 was long term brain damage created by repeated concussive, and likely sub-concussive, head impacts, culminating in chronic traumatic encephalopathy (CTE) which can only be diagnosed after death. Your Editor was privileged to attend presentations by researchers from Boston University (BU) and Ludwig-Maximilians-Universität München (LMU) in 2013 at NYC’s German Center for Research and Innovation and by BU’s Robert Stern, MD, at NYC’s MedTech in 2014 (indexed here).

In time for the Big Game known as the Super Bowl is the timely release by the Boston University CTE Center of their latest findings, and it will give anyone who plays contact sports caution. 

Out of 376 former National Football League (NFL) players studied, 345 were confirmed to have died with CTE–91.7%. The norm is around 0.6%, and the lone person with it was a former college football player (2018 study by BU of 164 brains of men and women donated to the Framingham Heart Study). CTE is characterized by misfolded tau protein that is unique and unlike changes observed from aging, Alzheimer’s disease, or any other brain disease.

Ironically, former players of teams in this Sunday’s Super Bowl LVII between the Philadelphia Eagles and Kansas City Chiefs were included in this study–former Eagles quarterback Rick Arrington, who played three seasons for the Eagles from 1970-73, and former Chiefs defensive tackle Ed Lothamer, who played for them in the very first Super Bowl and was a member of their winning team in Super Bowl IV.

The CTE Center cautions that the 91% quoted in the study should not be interpreted as a current/past player number, as the brain bank samples are subject to selection bias. The families donate the brains because their loved ones had the personality changes and debility in their final years, often in middle age and younger, that characterize CTE. 

In the past five years, CTE has been increasingly recognized as a risk in contact sports and in repeated concussion. According to the release, “In October 2022, the National Institutes of Neurological Disorders and Stroke (NINDS), a branch of the National Institutes of Health (NIH), updated their position on what causes CTE: “CTE is a delayed neurodegenerative disorder that was initially identified in postmortem brains and, research-to-date suggests, is caused in part by repeated traumatic brain injuries.” Research is ongoing on whether sub-concussive head trauma, easy to overlook, may be a contributing or causative factor.

There are also five active CTE Center clinical studies designed to learn how to diagnose and treat CTE. Project S.A.V.E. (Study of Axonal and Vascular Effects) is actively recruiting 50+ adults who  played 5+ years of a contact sport, including American football, ice hockey, soccer, lacrosse, boxing, full contact martial arts, rugby and wrestling. BU CTE Center release.  The Daily Mail has a surprisingly  comprehensive article on the BU research, relatively young former players who killed themselves and others who turned out to have CTE, and (in this Editor’s opinion) the NFL’s limited efforts in providing for research funding, changing play/practice, and for league awareness. 

CVS opens the checkbook, does the Oak Street Health deal for a generous $10.6B

February 9, 2023 | by

Staying on strategy, CVS buys provider group Oak Street Health. First rumored in mid-January, CVS Health and Oak Street finalized their deal today. The $10.6 billion purchase price of the NYSE traded company rewards shareholders with a $39 per share purchase price. 45% of the shareholders are composed of Newlight Partners LP and General Atlantic LLC plus certain members of the Oak Street Health Board of Directors. They have agreed to vote the shares they own in favor of the transaction (with a whew! at exiting). It is expected to close this year subject to the usual Department of Justice antitrust, Federal Trade Commission (FTC), and state-level review.

The $39 per share price was a tick lower than the January speculation that the price would be over $40 per share. $39 is not bad; at close of last week OSH was trading at $26.80, a far cry from its 2021 share prices in the $50-60 range. Today’s price closed at just above $35.  It has 169 offices and 600 providers across 21 states, making it a manageable size for CVS. OSH is headquartered in Chicago. Their CEO Mike Pykosz will continue to lead OSH, which will become part of CVS’ new Health Care Delivery organization and will be payer agnostic.  Oak Street is notable for serving underserved patient populations–50 percent of Oak Street Health’s patients have a housing, food or isolation risk factor.  

CVS Health’s long term plan, announced at recent earnings calls, is to add services in three categories: primary care, provider enablement, and home health. They are not hurting for profit or financing, closing out 2022 with $4.2 billion profit which certainly is a shining star in the depressed healthcare sky. CVS projects more than $500 million in synergy potential at the 2026 goal which is over 300 centers by 2026. But there will be losses first: 2023 loss about $200 million and not turning the profit corner till 2025 at earliest. An attractive point for CVS is  Canopy, their proprietary technology that determines the appropriate type and level of care for each OSH patient–and care integrates nicely into CVS Health’s community, home and digital offerings, as they say.

Will DOJ allow it without divestment? This administration has already taken a fairly hard tack on antitrust, trying (and failing, though appealing) to block UHG-Change Healthcare. Already the CVS-OSH tie-up has been opposed by an antitrust think tank, the American Economic Liberties Project. Oak Street adds primary care practices to those already under Aetna, many of which are in Federal ACO programs. Signify Health also has Medicare ACO practice groups, including the Caravan ACOs bought late last year. The Signify buy is already under a rolling DOJ and FTC review that has been moving slowly since last October. Signify’s other strength is diversification into home health, CVS’ third target area.

CVS’ investment in Carbon Health ($100 million Series D investment into primary and urgent care clinics in Western states) may be considered as Carbon will be piloting clinics in CVS retail locations. Release, Mobihealthnews, Healthcare Dive, Becker’s (including a breakdown of CVS’ 2022 financials), FierceHealthcare