Tunstall Healthcare (UK) and Group Holdings’ 2019 year end reports filed: highlights

October 8, 2020 | by

With all the changes at Tunstall Healthcare Group [TTA 2 Sep, 10 Apr], their Companies House filings due 30 September for the 2019 fiscal year might tell us more about their status prior to the entry of their new funders Barings, M&G, and a possible third investor. Tunstall files three main reports: one for Tunstall Healthcare (UK) Limited, for Tunstall Healthcare Group Limited, and Tunstall Group Holdings Limited, the holding company. The UK unit and Tunstall Group Holdings filed by the 30 September deadline; the Healthcare Group has not filed as of today.

Tunstall UK’s report is in PDF here. Revenue in the UK crested the £100 million level, up over £3 million from 2018. Of this, the core UK revenue amounted to £68.2 million, up 0.8%, with the remainder export trade with other Tunstall companies. Operating profit was, before adjustment for EBITDA, £27.4 million, adjusted to £16.8 million, down from 2018’s £19.4 million.

  • The report also notes revenue growth for Connected Care Managed Services and Group Living Services. 2019 was challenging for Group Living Installations and Digital Health with continued declines, though the report adds some optimism for 2020 due to cloud-based services, for customers to use their own devices, and–of course–to COVID-19 and remote monitoring’s rise in most areas.
  • COVID-19 rears its gloomy head here even though outside the report period. On page 5 is an assessment of the company as a ‘going concern’; even factoring in a gloomy second late 2020 COVID lockdown scenario, the directors believe that the company will continue to operate and comply with its covenants. On page 6 under ‘events after the financial period’ is a further explanation of this.
  • Finally, the new financing is referred to on page 7. Tunstall Group Holdings has been purchased by a Jersey-based group. It was restructured to reduce its existing debt and establish a new available loan facility of over €20 million.

Tunstall Group Holdings’ (TGH) report is in PDF here. Their global revenue amounted to £216.7 million with an operating profit of £47.9 million before adjustment for EBITDA, £19.5 million adjusted. Both were reduced from 2018. The consolidated income statement, as in 2018, shows a consolidated loss of £71.1 million, reduced by £15 million from 2018. An additional note on the restructuring is the forgiveness of the balance of £531 million owed to the financing arm TGH Acquisitions Limited (page 11).

  • The Americas sale is detailed on page 85. It is easy to see why the unit was sold, as in 2018 it had an operating loss of £4.3 million on £31 million in revenue. Factoring in asset disposal and other parts of discontinued operations, it’s fortunate it’s a one-time only event.

Jersey-based organizations, of course, enjoy far more favorable taxation structures. This Editor’s limited understanding of UK filings is that the Group will have to file with the Jersey Companies Registrar, but the UK group will have to file with Companies House as operating in the UK. If any Reader can clarify this, please comment below.

Charterhouse now finally lists Tunstall as one of their ‘realised’ exits. A long and unprofitable road from 2008 to 2020.

Hat tip on the reports to a Reader in the UK industry who wishes to remain anonymous.

DOJ ‘takedown’ charges 86 defendants with $4.5 bn in fraudulent telemedicine claims in largest ever action

October 2, 2020 | by

We unpack the 2020 National Health Care Fraud and Opioid Takedown. Closing out September was the largest simultaneous group of Department of Justice (DOJ) and Federal agency coordinated actions concerning fraudulent medical claims. The indictments charged 345 defendants, including 100 medical professionals, across 51 federal districts, for submitting fraudulent claims against Medicare and private insurance programs totaling over $6 bn.

The vast bulk–$4.5 bn–of the fraudulent claims were classified as ‘telemedicine’ and were perpetrated by more than 86 criminal defendants in 19 judicial districts. The remainder of the charges rounding to the $6 bn were for substance abuse treatment and opioid distribution fraud: more than $845 million connected to substance abuse treatment facilities, or “sober homes,” and more than $806 million connected to other health care fraud and illegal opioid distribution schemes across the country. 

These ‘telemedicine’ claims included unnecessary durable medical equipment (DME), genetic or diagnostic testing, and prescription drugs. The typical scam worked like this:

  • Telemedicine company executives paid doctors and nurse practitioners to order unnecessary durable medical equipment, genetic and other diagnostic testing, and medications, often for pain, for patients
  • The patient for whom it was ordered had either no contact with the doctor or nurse practitioner or only a brief telephonic conversation. The person may not have been a patient of the practice.
  • DME companies, genetic testing laboratories, and pharmacies then purchased those orders in exchange for illegal kickbacks and bribes, then submitted false and fraudulent claims to Medicare, state Medicaid, and private insurers which are Medicare Advantage plan sponsors

Most of the Federal charges in the indictments here cite Federal anti-kickback statutes in both criminal and civil law.

The nationwide charges were executed by an alphabet soup of agencies at the Federal level:

  • Enforcement actions were by the Criminal Division, Fraud Section’s Health Care Fraud Unit, in conjunction with its Health Care Fraud and Appalachian Regional Prescription Opioid (ARPO) Strike Force program, and its core partners, the US Attorneys’ Offices, Department of Health and Human Services Office of Inspector General (HHS-OIG), the FBI, and the Drug Enforcement Agency (DEA)
  • Prosecution is by Health Care Fraud and ARPO Strike Force teams from the DOJ’s Criminal Division’s Fraud Section, 43 US Attorneys’ Offices nationwide, and agents from HHS-OIG, FBI, DEA, and other various Federal and state law enforcement agencies. 

Unpacking the actions which reveal some dizzying schemes, some of the more interesting individual cases against fraudulent ‘telemedicine’ in the 2020 National Health Care Fraud and Opioid Takedown took place in Florida and Illinois:

  • Middle District of Florida: a telemarketing operation collected the personal information of Medicare beneficiaries, purchased doctor’s orders for orthotic braces, and then submitted more than $25 million in claims to Medicare
  • Southern District of Florida: three telemedicine executives and three owners of durable medical equipment companies were charged and pled guilty in connection with more than $175 million in fraud loss
    • Editor’s note: none of the principals of QuivvyTech have been identified by this Editor in the ‘Takedown’ indictments and corresponding information documents listed for the Southern District. Humana’s civil suit against QuivvyTech is here [TTA 27 August]. 
  • Northern District of Illinois: seven defendants were charged with defrauding insurance programs of more than $205 million. One is a very busy doctor who, according to the indictment, was the top prescriber in the United States for multiple genetic testing billing codes. He worked for more than 10 telemedicine companies, was licensed in 17 states, and allegedly paid five of his friends and relatives to sign telemedicine orders in his name for medically unnecessary genetic testing and durable medical equipment. “In total, the scheme allegedly resulted in $145 million in false and fraudulent claims billed to Medicare and approximately $54.6 million paid by Medicare for claims associated with this doctor’s name.” 
  • Your Editor cannot resist the twist that ‘telemedicine’ fraud took in her home state of New Jersey. Two cases involving telemarketing, senior health fairs, and door-to-door sales (!) of genetic testing, including genetic cancer screening, had a total fraud value of nearly $1bn. A multi-jurisdictional case involving the District of New Jersey, the Middle District of Florida, and the Southern District of California also involved the ordering of orthotic braces signed off by ‘telemedicine’ doctors who didn’t speak or only briefly spoke to Medicare beneficiaries/members. $871 million purchased a great deal of real estate, personal luxury items, and nightlife events for the two owners of the DME companies involved, who incidentally entered guilty pleas.

A biotech extra. In the list of multi-jurisdictional actions is a scheme to mislead investors, manipulate a biotechnology company’s stock price, and defraud payers for COVID-19 and allergy testing. The company named in the complaint is Arrayit Corporation, a publicly-traded company (OTC) located in Sunnyvale, California. This was jointly prosecuted by the National Rapid Response Strike Force, the Market Integrity and Major Fraud Unit of DOJ’s Fraud Section, and the US Attorney’s Office for the Northern District of California. The separate Securities and Exchange Commission (SEC) charges on the veracity of their COVID-19 test is here. For those with a speculative bent, the current value of the stock is zero.

DOJ press release. Also FierceHealthcare’s overview.

Editor’s note: ‘Telemedicine’ has been placed in quotes to differentiate these scams from legitimate provider-patient telemedicine video/audio consults or telephonic medical visits which may involve patient diagnosis and prescribing. These are now more frequently called telehealth. The differentiation is already well understood by our professional Readers and is made for the benefit of our non-professional Readers who may view this article on Twitter and LinkedIn feeds, or via Google search. 

COVID-19’s negative impact on clinical trials–can remote patient monitoring and telehealth companies help?

September 30, 2020 | by

We’ve previously noted the interest of large drug clinical trials companies in remote patient monitoring–example the acquisition of the much-passed-along Care Innovations by PRA Health Sciences [TTA 8 Apr]. Logically, these clinical trials have been hampered by the COVID-19 pandemic, affecting recruitment, data sharing, preservation of data, and how trials can be conducted.

TMF Futures: Keeping Data Alive has just been published by Arkivum, a University of Southampton (UK) spin-out which specializes in the digital preservation of valuable data for the life sciences industry and global scientific institutions through the Arkivum Trust. This initial survey was conducted in July 2020 by Arkivum, Phlexglobal, the Ethical Medicines Industry Group (EMIG), and Survey Goo. The 206 senior representatives surveyed all have responsibility for/knowledge of clinical trials, with senior and director-level positions in general and senior management; regulatory; quality assurance; clinical; operations.

TMF refers to the trial master file that is required by FDA and EMA. Paper TMFs have largely converted to electronic form (eTMF). Life science organizations have also largely transferred data to eClinical applications. Despite that, the survey found that 45% of clinical research organizations (CROs) struggle to manage, locate and report data, while 50% are unable to convert documents from multiple software applications in order to make them usable. 

Topline findings of the survey:

  • 74% of respondents say that COVID-19 will continue to compromise their ability to deliver on clinical trial objectives for the next six to 12 months;
  • 70% say that COVID-19 has triggered a change in the way clinical trials will be conducted;
  • Interoperability between eClinical applications used in trials remains a major challenge – for example, 39% of all respondents and 50% of contract research organizations are unable to convert documents from multiple eClinical applications;
  • Current archiving of clinical trial data is not always fit for purpose – for example, 65% of compliance, legal, and regulatory professionals describe their ability to access data as ‘extremely inadequate’ or ‘very inadequate’.

Of interest to our Readers is page 11 of the survey, which found that 56% of respondents believe that there will be increased remote patient monitoring in post-COVID clinical trials, and that 22% believe that new technology will be developed to shorten clinical trial duration and reduce cost. In addition, recruitment has to come from more diverse areas and to mitigate the difficulty of finding people to be in clinical trials.

For telehealth developers, providers, and software developers who have the systems, data, and access to patients/users, clinical trials and CROs may be a strong future market. We may also have profitable insights into interoperability and data sharing.

To obtain a free copy of the survey, fill out the short form here. Arkivum press release. Hat tip to Penny Lukats of SENSO Communications (UK).

Doro adds Spain’s Victrix SocSan to its growing brand portfolio for £1.28 million plus shares

September 30, 2020 | by

Sweden’s Doro has a new addition to its portfolio, and it’s an interesting one. Victrix SocSan, headquartered in Madrid, coordinates health and social care primarily through data analysis blending different health and social care sources “to provide low-cost yet highly effective proactive interventions for chronic disease management, elder care, and wellbeing.” It concentrates on care workflow and information exchange, according to their website. Unlike previous Doro acquisitions such as ElderCare UK [TTA 11 Aug], Invicta Telecare, parent of Centra Pulse and Connect [TTA 19 Sept 19], and Welbeing [7 June 18], it’s about the technology and not the territory or system. “A strong technical platform and knowledge is an important component in our strategy. The Victrix Care Platform gives us new opportunities to develop and offer coordinated and proactive care services, both in individual and assisted living, ” according to Doro Group President and CEO Carl-Johan Zetterberg Boudrie. 

The acquisition cost is modest compared to some of the US blockbuster deals we’ve seen lately. Cash upfront is SEK 14.8 million (UK£1.28 million, US$1.65 million, €1.41 million). The 232,744 shares in Doro AB closed today at SEK47.50 which is about SEK11.05 million (UK£956 thousand, US$1.2 million, €1.1 million). There are other payouts noted in the press release. Their results will be consolidated into Doro’s from 30 September. According to the release, the Victrix team will be joining Doro. Their CEO and founder, Joe Killen, is a familiar figure in the UK from his nearly 20 years at Tunstall Spain and Southern Europe. Hat tip to one of our UK Readers who wishes to stay anonymous.

News roundup: Amwell’s socko IPO raises $742M, Walmart and the Clinic Wars, Taskforce on Telehealth Policy report released, Israel’s Essence releases fall detection sensor system

September 18, 2020 | by

Telehealth bullishness shows no sign of diminishing. On Wednesday, Amwell‘s (the former American Well) IPO stunned markets by not only debuting at $18 per share (a price only large investors received) but also opening at $25.51 on the NYSE (AMWL) and floating more than 41 million shares for a raise of $742 million. If underwriters exercise all their options, the raise could exceed $850 million. Only last week, the SEC filing projected a sale of 35 million shares at $14 to $16 a share. Back in August, the raise was estimated to be only about $100 million. (One could consider this a prime example of ‘sandbagging’.) Friday closed at $23.02 in a week where Mr. Market had a lot of IPOs and hammered traditional tech stocks. As reported earlier, Amwell is backed by Google via a private placement and also Teva Pharmaceutical.

Smaller and lower profile than Teladoc, Amwell provides services for 55 health plans, 36,000 employers, and in 150 of the nation’s largest health systems, with an estimated 80 million covered lives. Like Teladoc, Amwell has yet to be profitable, with 2019 losses of $88 million and $52 million in 2018. FierceHealthcare, Marketwatch. Meanwhile, the Teladoc acquisition of Livongo has gone quiet, as is usual.

The Clinic Wars continue. Another front in the consumer health wars (and repurposing retail) is more, bigger, better clinics onsite. CVS drew first blood early this year with the expansion of MinuteClinics into fuller-service HealthHUBs, with a goal of 1,500 by end of 2021. Walgreens flanked them with 500 to 700 Village Medical full-service offices [TTA 9 July]. In this context, the expansion of Walmart Health locations looks limp, with their goal of 22 locations in Georgia, Florida, Arkansas, and Chicago metro by end of 2021. Another concern is with scale and modularizing the Walmart Health locations’ construction via constructor BLOX,  One wonders with recently reported layoffs of 1,000 at corporate and the replacement of industry innovation veteran Sean Slovenski with Lori Flees, whether there’s some radical rethinking of their clinic business investment as not mass but targeted to underserved areas that avoid CVS and Walgreens. FierceHealthcare, Walmart blog  CVS also announced the doubling of their drive-thru COVID-19 testing sites to 4,000 by mid-October. FierceHealthcare

More Weekend Reading. Here in the US, the Taskforce on Telehealth Policy, a joint effort between the National Committee for Quality Assurance (NCQA), the Alliance for Connected Care, and the American Telemedicine Association, has issued a report that focuses on maintaining quality care, fitting telehealth into value-based care models, enforcing HIPAA for patient privacy, and ensuring widespread and equitable access to broadband and technology. The involvement of the NCQA is a major step forward in advancing policy in this area. Press release/summary, Report page, Powerpoint slides, and webinar recording  Hat tip to Gina Cella for the ATA.

New entrant in passive fall detection. Israel’s Essence SmartCare is launching MDsense, a multi-dimensional fall detection solution for the residential market. It is sensor-based, using wall mounted intelligent sensors rather than wearable devices that statistically are not worn about half of the time and have their own well-documented performance concerns. The release also mentions it can differentiate between multiple persons and pets, which this veteran of QuietCare would like to see. MDSense is part of Essence’s Care@Home system which uses AI and machine learning to continuously collect actionable data to respond to fall events and manage care better towards improved outcomes.

Public Policy Projects, Tunstall UK release joint TECS study finding growth during pandemic, recommendations

September 18, 2020 | by

Weekend reading. Public Policy Projects and Tunstall Healthcare UK & Ireland have released a joint study finding, unsurprisingly but encouragingly, that the usage of technology-enabled care services (TECS) has accelerated during the COVID-19 pandemic. The nine-part, 62-page study electronically available here examines TECS through case studies in England, Scotland, and Wales as well as in France, Sweden, and especially Spain. There is a worthwhile examination of the types of TECS currently existing, a look back at the Whole System Demonstrator (WSD), barriers to adoption, and recommendations for policy going forward. ECHAlliance/Tunstall release.

Tunstall UK also won the ‘Leading Innovators in Assisted Living Technology 2020’ award at the Healthcare & Pharmaceutical Awards 2020, and the ‘Best Non-Clinical Equipment, Product or Service Supplier’ for their nurse call system, Tunstall Carecom, in the Care Home Awards 2020. ECHAlliance release

The Theranos Story, ch. 65: Elizabeth Holmes’ “mental disease or defect” defense revealed

September 18, 2020 | by

Going the ‘Twinkie Defense’ one better? While this Editor was enjoying a much-needed break from the Insanity of the World, hurtling across the wires was the revelation that Elizabeth Holmes’ pricey defense attorneys have prepared a defense for her that includes evidence “relating to a mental disease or defect or any other mental condition of the defendant bearing on the issue of guilt.” Interpreted, her mental state may have affected her intent and judgment in her business dealings. 

According to the filing, the defense is introducing testimony from Mindy Mechanic, Ph.D., a clinical psychologist and professor at California State University at Fullerton. According to her bio, her “work focuses on the psychosocial consequences of violence, trauma, and victimization with an emphasis on violence against women and other forms of interpersonal violence. Her work has addressed the mental health consequences of violence, such as Post-Traumatic Stress Disorder and depression as well as other important physical and social health outcomes.” 

The defense attempted to introduce this evidence without further examination by the Federal prosecution. Unfortunately, US District Judge Edward Davila did not agree. Ms. Holmes will be examined by two experts for the prosecution: Daniel Martell, Ph.D., a forensic neuropsychologist for the forensic litigation consulting firm Park Dietz & Associates, and University of California San Francisco psychiatrist Renee Binder, MD. Over the objections of the defense, the examination will be videotaped. The trial will commence with jury selection on 9 March 2021 [TTA 27 Aug].

Most of our Readers who care about this will be wondering, after they’ve picked themselves off the floor laughing at the above notion, that any person with a mental defect of this type could have fooled the savviest Sand Road VCs, Stanford/Hoover Institution luminaries, an admiral, a Marine general later Secretary of Defense, and Rupert Murdoch for years, to the tune of nearly $1 bn. That they should be gulled and fooled is disturbing enough. What is equally disturbing is the desperation of the defense to attempt an ‘insanity defense lite’ that sources and justifies Ms. Holmes’ inability to discern right from wrong.

This then proceeds to exactly what was the ‘interpersonal violence’ or post-traumatic stress that caused her judgment to warp quite this way. Was it her upbringing, which apparently was a bit upper-middle-class flaky–the ‘it’s not High Anxiety, it’s parents!’ reason? Was it a head trauma (the Howard Hughes defense), drugs, or surgery gone wrong? Did Sunny get Blue (in more than one way) on her? Stock up on the popcorn–la scandale Theranos has just gotten even more interesting. CBS Bay Area, Bloomberg News, Forbes, MedCityNews

A historical footnote. The term ‘Twinkie Defense’ came into usage in 1978 during the defense of the murderer of San Francisco mayor George Moscone and the better-known supervisor Harvey Milk. While not used per se by the defense team, the testimony of a psychiatrist for the defense that the murderer excessively consumed junk food, including Twinkies, as an indicator of depression and a sign of diminished capacity was hyped by the press as the ‘Twinkie Defense’. The term has passed into the vernacular. Ironically, both trials are occurring in the Bay Area.  Hat tip to The Crime Report.

The book of ‘Thank and Praise’ with a selection of their 1,000 messages (UK)

September 18, 2020 | by

James McLoughlin of the UK organization Thank and Praise has reached out once again to this Editor with an update on their social thanking of the ‘unsung heroes’ in healthcare during the depths of the COVID-19 pandemic. TAP has compiled a free e-book of a selection (64 pages) of their over 1,000 messages–print and video (page 65)–posted on their thanking walls. The messages thank healthcare workers, teachers, shop workers, church staff, food deliverers, social workers, homeless outreach, and many others who helped others. The illustrations were contributed by children and young adults. The book is also being sent to the organizations mentioned in the book. Reach out to James if TAP can help your organization. Our previous coverage: TTA 10 Apr, 12 June   Press release

Tunstall funding by M&G, Barings passes European Commission ‘concentration’ review

September 2, 2020 | by

The European Commission, in a brief filing on EUR-Lex, has stated their ‘non-opposition’ to the ‘concentration’ in Tunstall Group Holdings’ additional funding obtained by M&G Investment Management and Baring Asset Management via share purchase. Tunstall announced this funding in April [TTA 10 April] and filed with the European Commission on 3 June (prior notification).

The definition of ‘concentration’ in the EU is the legal combination of two or more firms by merger or acquisition. The prior notification from the Commission considers that this concentration may fall within the scope of the Merger Regulations but reserved a decision on this.

Charterhouse Capital Partners, the prior controlling investor, is not mentioned in the prior notification. Revealed in the notification is that Baring is actually controlled by MassMutual in the US, a surprise to this Editor. Hat tip to a Reader in the UK industry who wishes to remain anonymous.

Anthem-Cigna merger lawsuit finally wraps with ‘No damages for you! Or you!’

September 2, 2020 | by

Not with a bang, but a whimper and a large bill. The long, drawn-out (May 2017!) lawsuit and countersuit in Delaware Chancery Court between payers Anthem and Cigna ended with the decision by Vice Chancellor J. Travis Laster to refuse to award damages to either party in the litigation.

Cigna, which was seeking nearly $15 bn from Anthem, seemed to receive the worst of his judgment. In his decision (PDF), VC Laster stated that Cigna was unable to prove that Anthem breached the Efforts Covenants and in fact, Cigna sought to derail the deal by pulling back on integration efforts, thus itself breaching the covenants. Thus, Cigna was not entitled to the $1.85 bn breakup fee or additional damages. Anthem proved that they sought to complete the merger and Cigna did not, thus seeking $20 bn in damages. In counterpoint, Cigna was able to prove that the deal would have been blocked regardless of their actions to demo the deal.

VC Laster’s conclusion, “In this corporate soap opera, the members of executive teams at Anthem and Cigna played themselves. Their battle for power spanned multiple acts….Each party must bear the losses it suffered as a result of their star-crossed venture.” The testimony revealed the deep divisions and battle lines between both companies during the merger preliminaries, until the Federal courts and DOJ put paid to it.

Yet the denouement of this Merger Made In Hell may not be fini. Anthem said in a statement to Fierce Healthcare that it feels “this decision is in the best interests of Anthem and our stakeholders.” But a Cigna spokesperson said they are not finished and considering a potential appeal. “We are pleased that the Court agreed with us that Cigna did not cause the merger to fail. We continue to strongly believe in the merits of our case, and we are evaluating our options with respect to appeal.” Certainly not the peaceful-in-public parting after the Federal denial of their merger by Aetna (acquired by CVS) and Humana (still in play).

The chief beneficiaries of this three-year drama? The law firms listed on page 1 of the opinion. Also Wall Street Journal (paywalled in part).

As practices reopen, telemedicine visits continue to plunge from 69% to 21%: Epic (US)

September 2, 2020 | by

The extreme high tide has receded–but still way up than before the pandemic.  The Epic Health Research Network (yes, that Epic EHR), updated its earlier study through 8 May [TTA 22 July] to compare in-office to telehealth visits through 12 July. The trend that EHRN spotted (as well as Commonwealth Fund/Phreesia/Harvard) continued with telemedicine visits declining as practices reopened. As of mid-July, telehealth visits, as a  percentage of national ambulatory visits, declined to 21.2 percent compared to 78.8 percent in-office. 

The new EHRN study used a broader sampling than previously. They surveyed healthcare providers of data: 37 healthcare organizations representing 203 hospitals and 3,513 clinics in 50 states. The decline in telehealth visits noted in early May continued, with May finishing with a national 50/50 split.

But in context, telehealth visits immediately before the COVID-19 pandemic were a whopping .01 percent. 

Regionally, the Northeast leads in July telehealth visits with 25 percent. The South has the least adoption of telehealth with only 13 percent. In terms of total office visits, neither the South nor West have rebounded to pre-pandemic levels, whereas the Northeast and Midwest have.

The key to the future of the telehealth bubble bath is if telehealth usage versus in-person stabilizes for several months. But there’s another factor which has come about through higher telehealth usage. Noted in our July article was speculation on the reasons why the sudden decline, other than practices reopening, most of which pointed to practice training, reimbursement, and older/sicker patients falling into the smartphone/digital divide. The STAT article has statements from telehealth providers which are quite bubbly and quotable, with the CEO of MDLive stating that new bookings are up 300 percent and mental health hasn’t declined. But a problem now surfacing is providing patients with the right care at the right time–and fitting it into the office schedule. What visits can best be handled as telehealth and which require an in-person visit? This Editor recalls that Zipnosis, a white-labeled telehealth system we haven’t heard from in a while, incorporated for health system applications a triage intake which would direct the patient to the right level of care. Can this be rolled out in a similar way to the practice level?

Is the NHS ready to adopt telemedicine through and through–and is telemedicine ready?

August 27, 2020 | by

This analysis by Dominic Tyer in Pharmaphorum discusses the rapid adoption of telehealth during the COVID pandemic, both telephonic and online, to keep people in touch with their doctors. Health Secretary Matt Hancock quantified the changes wrought as “I’ve lost count of the number of times someone said to me: ‘what would have taken months took minutes’.” The article goes on to quote him as saying that COVID-19 has “catalysed deep structural shifts in healthcare that were already underway”, citing as examples data-driven decision-making, working as a system, and telemedicine. In fact, to Secretary Hancock, “From now on, all consultations should be teleconsultations unless there’s a clinical reason not to.”

For all the advances, Mr. Tyer points out flaws such as safeguarding sensitive health issues, particularly for young people, use by rare disease patients and those with a genetic condition, and reaching the 10 percent of the population who do not use the internet. All of these are significant. He concludes that “in the UK there’s clearly the political will and healthcare backing for wider use of telemedicine by the NHS, despite some, as-yet not entirely resolved, technological and safety issues.”

Will the UK revert to ‘underuse’, as the US has rolled back as well as practices have reopened? (What is ‘underuse’ defined as anyway?) Will these issues be resolved or ignored in a push forward for telehealth? And teleconsultations as a norm, with in-person an exception, is perhaps at this time, and in improving health outcomes, an overreach? Hat tips to Roy Lilley of the nhsManagers.net newsletter and Steve Hards

News roundup: CVS cashing out notes, catching up with ISfTeH, India’s Stasis Labs RPM enters US, Propeller inhaler with Novartis Japan, Cerner gets going with VA

August 27, 2020 | by

CVS Health is pricing out a tender offer for some notes. If you are holding one of a potpourri of notes with due dates of 2023 and 2025 from CVS, the company is making a cash tender offer, meaning they are cashing these notes out. This is usually done as part of rearranging financing, especially appropriate in the wake of the Aetna acquisition. The details are here in their release of 12 August. The collective value for both note years is approximately $3 bn each. An update is here on Seeking Alpha.

We have been remiss in not maintaining our following the Swiss-based International Society for Telemedicine and eHealth (ISfTeH) so we will direct your attention to their August update which features the effect of COVID on teledermatology, women’s health, teleurology, and news on members and developers. Their Journal, still edited by Professor Maurice Mars of South Africa, has published once this year in January.

India’s Stasis Labs, developer of a remote patient monitoring (RPM) platform utilizing a smartphone, vital signs devices, a bedside monitor connected into a platform, is entering the US market. It monitors six vital signs in a single monitor: heart rate, blood oxygen, electrocardiogram, respiratory rate, blood pressure, and temperature. Awarded a 510(k) clearance in April, Stasis, out of the Cedars-Sinai Accelerator program, has had a limited deployment at Texas-based emergency-care provider Hospitality Health ER and California-based Glendale Surgical Center and Orthopedic Surgery Specialists. It has also deployed to 50 cities in India. Mobihealthnews

Smartphone-connected inhaler sensor company Propeller Health has inked a deal with Novartis in Japan. Patients prescribed Novartis’ drugs for uncontrolled asthma, the Enerzair or Atectura Breezhaler, can now enroll in Propeller’s digital-management program. Data about their inhaler use will be transmitted from the sensor on the inhaler to Propeller’s smartphone app. The app also pings users with reminders and usage data. Propeller was acquired last year for a stunning $225 million by ResMed. Propeller this past May gained 510(k) FDA clearance for a sensor/app for use with AstraZeneca’s Symbicort inhaler.

Cerner’s EHR implementation with the US Department of Veterans Affairs finally took a step forward after many delays with the launch last Friday of a new scheduling system at the VA Central Ohio Healthcare System in Columbus, Ohio. Cerner migrated the information of some 60,000 veterans in preparation. The full EHR at the Mann-Grandstaff VA Medical Center in Spokane, Washington, originally scheduled for March, will go live this fall. Healthcare Dive

QuivvyTech: a ‘telehealth’ company, sued by Humana in telemarketing scheme (US)

August 27, 2020 | by

It was inevitable–the first alleged fraud and lawsuit involving a ‘telehealth’ company. The interestingly named QuivvyTech, which has styled itself as a telehealth company with “virtual care in general medicine, mental health, and complex care”, has been sued by insurance giant Humana. The grounds are that QuivvyTech telemarketers cold-called Humana members, who are generally members of Medicare plans, asked them about common ailments, and claimed they were working with Humana. They then recorded information that was sent to QuivvyTech physicians who would prescribe the members pricey and unnecessary creams (content undisclosed) fulfilled by co-conspirator pharmacies with QuivvyTech. The physicians listed in the suit electronically signed prescriptions for the members without reviewing patient history or having a prior relationship with the patient.

Humana not only is alleging harm in the payer-member relationship, but also lost millions in fraudulent claim payments for visits and medications. 

The lawsuit by Humana seeks treble damages, plus interest and fees, from QuivvyTech. It was filed in the US Southern District of Florida as many of the scammed members lived in Florida. QuivvyTech is based in Boca Raton.

Defendants in the suit include Frank Michelin, associated with QuivvyTech; Reliable Medical Supplies and Reliable Document Solutions, a telemedicine company with about 200 physicians; and physicians Jeffrey Mahon, MD, Elie Hercule, MD, Samuel Teniola, MD, Louis Mojicar, MD, Ananda De Silva, MD, and Jeffrey Stern, MD.

One wonders where QuivvyTech obtained Humana members’ phone numbers and information. 

QuivvyTech is still recruiting for physicians on job boards such as ZipRecruiter and StaffPhysicians.com. Becker’s Hospital Review, Healthcare Finance, Fierce Healthcare

The Theranos Story, ch. 64: Holmes’ trial moved to March 2021

August 27, 2020 | by

What a difference two years makes. Once the subject of breathless headlines and breaking news, the latest news on the trials of Elizabeth Holmes and Ramesh ‘Sunny’ Balwani in la scandale Theranos earned hardly any notice in the healthcare press. Only this Editor’s search for an update found information that the Federal court trials, due to the pandemic and corresponding difficulty with trial preparation and jury selection, have been moved to 2021. Pretrial hearings for both have been moved to October and December.

So not to further punish our Readers who are dreaming of mountain lakes and ocean beaches, your Editor, a/k/a Glutton for Punishment, has summarized the Court’s next steps. 

  • The Holmes and Balwani trials have been severed–legalspeak for separated
  • Holmes will go first starting on 9 March 2021 with jury selection in the Federal Court, San Jose, Judge Edward J. Davila presiding. Balwani’s trial will not start until Holmes’ trial is concluded.
  • The next court hearings for Holmes will be 6 October (pretrial motion), 2 December (status), and 16 February 2021 (status)
  • Balwani will have a status hearing on 8 December

In early August, the Department of Justice (DOJ) prosecutor added a 12th fraud charge to Holmes’ list, relating to a patient’s blood test. A grand jury was empaneled in June during the midpoint of the pandemic, leading to Holmes’ legal team attempting to obtain 21 broad categories of documents on the jury selection. Their intent is to overturn the indictment as improper.

No need to stock up on popcorn till a month before Easter 2021, but it will be munch-worthy as rumored witnesses will be ‘faces’ such as General James Mattis (ret.), former board member and customer; Henry Kissinger; and Rupert Murdoch. This Editor’s bet is that these aged titans will not appear, with the exception of the youngest, General Mattis. More likely to be called to appear, in this Editor’s view, are executives from Walgreens who did the deal with Theranos, the last-ditch investors at Fortress Investment Group, major investors such as Partner Fund Management, and early unrepentant backer Tim Draper of Silicon Valley VC Draper Fisher Jurvetson.

The Federal charges are summarized in TTA 13 May]The full sturm und drang by chapter are here.

CNBC, US Department of Justice, Northern District of California published notice  The 14 June indictment (15 pages)

Amwell plans $100 million IPO, plus $100 million from Google as a kickoff

August 26, 2020 | by

As expected [TTA 6 Aug], Amwell on Monday filed S-1 forms with the US Securities and Exchange Commission (SEC) registering them for an IPO to raise about $100 million. The number and amount of shares on the New York Stock Exchange, under ticker symbol AMWL, were not disclosed. Interestingly, and somewhat unexpectedly, Google’s cloud business is taking a private placement of $100 million in shares equal to the IPO price, to be executed on the IPO closing.

The partnership will mean that Amwell’s cloud services on Amazon Web Services (AWS) will be moving to Google Cloud. Amwell will also move some video performance capabilities to that platform, and will also cooperate on technology plus build out a dedicated sales effort to expand Amwell’s footprint in the sector.

Amwell’s telehealth business, like Teladoc’s, skyrocketed during the worst of the pandemic shutdown. According to the CNBC article on the IPO, Amwell told them in May that it’s seen a 1,000 percent increase in visits due to coronavirus and closer to 3,000 – 4,000 percent in some places (which without further data is meaningless). The IPO filing stated that revenue was up 77 percent January-June 2020 versus same period 2019, from $69 million to $122 million. Profits are not following, however. Its net loss nearly tripled over the same period, growing from $41 million in the first six months of 2019 to $111 million in the first half of this year. Seeking Alpha has the operating loss at a slightly higher $113.58 million.

This past May, Amwell also raised $194 million in a second Series C [TTA 23 May]. Their financing to date is over $700 million.

Amwell states that it provides telehealth solutions for over 2,000 hospitals and 55 health plan partners with over 36,000 employers, covering over 80 million lives, a higher metric than members. This is in comparison with Teladoc which claims 51.5 million members, 50 health plans, 70 global insurers, and 12,000 clients in 175 countries. Amwell is having to compete with a larger suite of services that a Teladoc-Livongo combination will eventually offer. Amwell’s by-contrast modest IPO and private placement corresponds to their relative size, but a contrarian would also look at Teladoc’s huge expenditures for InTouch Health ($1bn) and Livongo ($18.5bn) and rightly be concerned about their runway to ROI and profitability.