News roundup: Kaiser/Best Buy Lively partners; Teladoc’s mental telehealth, Livongo execs depart; approved apps make comeback in US, DE; United Airlines tests COVID CommonPass for international flying

Kaiser Permanente is adding to its existing partnership with Best Buy Health. The joint program will develop remote patient-monitoring tools for older adults centered on Lively Mobile Plus. By pressing a button on the phone, users can connect with individuals trained to triage emergency and nonemergency situations, from car trouble, home lockouts, or medical emergency. Kaiser Permanente has rolled it out to their Medicare members as part of its Medicare Affinity Program for independent living at home. In 2019, the Kaiser system piloted Lively Mobile Plus after Best Buy’s acquisition of GreatCall. Becker’s Hospital Review 6 October and 22 October. Photo from Best Buy via Kaiser on Twitter, @aboutKP.

Teladoc launches mental telehealth to Canadian employers. Four Livongo C-levels will depart after closing. The Teladoc Mental Health Care program is available to employees of Canadian companies and provides access to psychiatrists, psychologists, and therapists via phone, web or mobile app. It is in addition to Teladoc’s Mental Health Navigator and disability products in Canada. Press release, Becker’s Hospital Review  Becker’s has also been keeping a close eye on Teladoc’s SEC filings. The letter, filed 15 October, stated that Livongo CEO Zane Burke, President Jennifer Schneider, MD, CFO Lee Shapiro (widely conceded as the merger engineer), and SVP of business development Steve Schwartz will leave the company after the closing. Livongo’s Executive Chair Glen Tullman will keep his seat on the combined company’s board of directors. Look for more changes that won’t make Livongo employees happy. Our previous Skeptical Takes on the merger here.

Approved Apps Revive! The American Telemedicine Association (ATA) announced a new partnership with the UK’s ORCHA–the Organisation for the Review of Care and Health Apps–to develop an approval procedure for health apps. Announced at the virtual HLTH conference, the objective is to create a review process to vet safe and effective health apps out of various app stores. ORCHA’s automated, intelligent review engine can assess thousands of apps against more than 300 measures in order for a healthcare organization to build and manage a health app program. Both are trying to solve the same problem faced by Happtique and IMS Health (now IQVIA) in those long-ago days of 2014. ATA release, Healthcare IT News 

For Readers with long memories, iMedical Apps is still with us and their team is still reviewing health apps both personal and professional. They’ve extended their reach to reviewing apps to prescribe with iPrescribeApps.

Meanwhile, in Germany, the Digital Healthcare Act (DVG) now finally permits doctors to officially prescribe apps to patients. The Federal Institute for Drugs and Medical Devices (BfArM) certified Kalmeda for tinnitus and Velibra, a therapy program for anxiety disorders as Germany’s first two insured health apps. Germany also is kick-starting prescribed health apps through fast-tracking medical apps that are CE-marked as Class 1 and 2a low-risk medical devices. Healthcare IT News

United Airlines is testing an app-based ‘health pass’ to speed safer global travel. CommonPass, created by the Commons Project Foundation and the World Economic Forum to enable travelers to securely share their COVID-19 test status, taken 72 hours before flight, across borders. The app will also facilitate a health declaration that may be required by the destination country and generates a quick response (QR) code scannable by airline staff and border officials. UAL’s London-Newark test follows on a test with Cathay Pacific between Hong Kong and Singapore. FierceHealthcare, MarketWatch

Weekend reading: contact tracing in assisted living/LTC facilities via sensor-based ADL technology raises ethical issues

Contact tracing for COVID-19 is still ‘not quite there’ in many countries, especially those countries like the UK which had created centralized models and were slow to move to the decentralized systems based on Apple and Google’s APIs, the (Gapple? AppGoo?) Exposure Notification system now in use in Ireland and Germany. For the most vulnerable in assisted living, who aren’t using smartphones that ping adjacency to other smartphones and are moving around most of the time within the residence, other approaches have been developed. Already in place in many communities are sensor-based trackers for activities of daily living (ADLs) for both safety and predictive health analytics, as well as provide conveniences such as apartment entry for residents.

As we noted in July, a number of ADL and location trackers have repurposed themselves into highly accurate contact tracers since they retain the history of resident and staff movement. Profiled are CarePredict (ADLs), ZulaFly (location tracking), and CenTrak (location tracking). Residents in many facilities with these systems are early adopters of contact tracing, even if they don’t know it.

While the article is detailed and fairly laudatory about how these systems can assist residents and staff in arresting the spread of COVID-19 which has ripped through nursing homes and senior living, it then diverges into other issues, some worth considering even if some of the verbiage is over the top:

  • These location monitoring systems haven’t been used for infectious disease outbreaks before, but the article admits that the pandemic has presented extraordinary circumstances
  • Use of these systems cannot substitute for effective infection control: staff and resident handwashing, mask wearing, and staff PPE. (Something like wearing a used mask and not washing your hands for the rest of us)
  • These systems are dependent on facility-wide internet/Wi-Fi. Many LTCPAC facilities do not have it, thus creating a digital divide in care even in residences proven to have high-quality care.
  • Resident rights and privacy. Residents apparently have only limited choices in using these technologies, even if they are restricted to their rooms. Not all see the need for monitoring technology for their safety and intrusive ‘alarms’ that bring in staff. There is a real issue around older adults’ autonomy and privacy rights which tends to be forgotten in the balance of privacy and safety, with prediction of illness based on behavior a step further.

Interviewed for this article, Laurie Orlov of Aging in Place Technology Watch, believes “It’s pretty darn useful if you’re in independent living, and you decide to go for a walk. If it’s night, and there’s ice, having a full detection capability that knows where you are is really useful. I think with fall detection, and anything that can help when you’re alone, the benefits exceed the cost of the privacy — assuming that you’re with it enough to opt in.”  Senior Sensors (The Verge)  (Disclosure: Editor Donna consulted for CarePredict in 2017-18)

A counterpoint to this article is also by Laurie Orlov and published on her website, reviewing the future of remote care technology and older adults in 2020. It’s a preview of a to-be-released later this year report.

Alcuris appointed as supplier to Spark DPS (UK)

Alcuris, an assistive technology company based in Loughborough (Leicestershire) announced this week that they have been appointed to the Spark Dynamic Procurement System (DPS) (scroll down page) provided by Crown Commercial Services (CCS).

A DPS permits buyers to access framework agreements that meet common purchasing requirements across the UK government. The Spark DPS is for emerging, innovative technologies and

  • Allows customers access to proven new technology innovations which are useful for solving public sector problems
  • Quality and price can be assessed based on individual customer’s requirement
  • A dynamic filtering system, giving customers flexibility based on requirements
  • Fully compliant with UK and EU regulations.

Suppliers on Spark must demonstrate that they can provide at least one new or innovative technology for one or both of ‘Radical’ and ‘Disruptive’ Innovation. Alcuris submitted its Next Generation Telecare Memo service under the Disruptive Innovation category. The Memo Hub service was entered into TechForce 19 as an Activities of Daily Living (ADL) monitoring system with results here [TTA 6 August]. For more information on the Spark Innovation Marketplace and how it works for buyers, there is a webinar on 18 November (information and registration here). Alcuris press release. Hat tip to Adrian Scaife of Alcuris

Propel@YH digital health accelerator announces 2020 cohort of 10 companies

Propel@YH, commissioned by the Yorkshire & Humber AHSN (Academic Health Science Networks) digital health accelerator, last week announced its 10-company 2020 cohort, to start on 26 October. They are:

  • Co-Opts ltd; a smart speaker for automated recording, transcription and summarisation of therapy sessions
  • CyberLiver Ltd; remote monitoring of at-risk cirrhosis patients using wearables and an app
  • I.M.M.E; a VR experience created to support Williams syndrome, supporting isolation, rehab mobility and mental health
  • Liria Digital Health; a technological solution addressing the health and wellbeing of perimenopausal, menopausal, and postmenopausal people
  • My Food 24; an online food diary system which automates the diet tracking and analysis process
  • SeeAI; a platform that supports early fracture diagnosis through x-ray images 
  • Ufonia Ltd; an AI-enabled accessible clinical assistant called Dora that can conduct an intelligent clinical conversation via a regular voice telephone call
  • Vastmindz; an AI face analysis app to measure real-time heart and respiration rates, oxygen saturation, stress level, blood pressure and atrial fibrillation risk
  • Warner Patch; a non-invasive, wearable wireless (using 2G network) sensor that predicts tissue health disease evolution using AI for clinicians to give preventive care, improve patient outcome and save care costs
  • Written Medicine; a pharmacy label and discharge summary translation system, that works across 11 different languages

Propel@YH is designed to attract international digital health companies to the Yorkshire/Leeds area. The AHSN is one of 15 innovation centers acting as the innovation arm of NHS England. Partners in the program include Nexus (University of Leeds’ academic research and tech development community), Barclays Eagle Labs (business incubation/networking/investment), Hill Dickinson (legal and strategic advice), and Leeds City Council. 

Neville Young, Director of Enterprise and Innovation for the Yorkshire & Humber AHSN, said: “This is the second time we’ve been able to offer this great opportunity for innovative digital and data-driven health companies and we were truly blown away by the innovation and talent presented by this year’s shortlist. Our panel had a tough choice choosing our finalists from this year’s entries but we think the mix of businesses and applications we will be working with this year really will play a part in supporting the NHS and healthcare providers throughout the pandemic and the ‘new normal’ ways of working.”  YHAHSN press release

UK highlights: Doro acquires Connexus Careline, Tunstall warns on winter isolation and disconnected care, Buddi seeks Sales Account Manager

Doro continues its acquisition streak in the UK, acquiring the assets of Connexus Careline from Connexus Housing Group. Connexus currently provides services to local authorities, housing associations, the private sector, and charities, with about 25,000 telecare connections in the UK. Terms and timing were not disclosed. Based on the August count, this brings Doro in at over 250,000 UK connections. Doro’s acquisitions have been ElderCare UK [TTA 11 Aug], Invicta Telecare, parent of Centra Pulse and Connect [TTA 19 Sept 19], and Welbeing [7 June 18], Press release (PDF).

So many open questions… What are their future plans for integrating all these individual systems and different technologies? What will Doro UK represent in the market, now that they are second in the UK?

Tunstall Healthcare UK is also reminding local governments, health and social care leaders that winter is approaching, and now is the time to set up remote patient monitoring to connect to care the most vulnerable in cold weather, a factor magnified by their isolation during the continuing pandemic. Tunstall features several solutions in RPM which are mentioned in the release.

Editor’s note: this type of seasonal release was a staple for QuietCare when I was in marketing for our activity/temperature monitoring of those living at home alone. We also included a proprietary study made during winter (and later summer) among our client base. 1) It’s surprising that more RPM and telecare companies don’t take this approach, especially now, but 2) Tunstall could have made an even greater case for itself with some quantitative research stats.

Buddi is seeking a Sales Account Manager position to join their Health Sales Team based in the southern half of England. The particulars are here (PDF) including application and contact information. Thank you Fiona Carmichael of Buddi for reaching out to us! (If you have a position to fill, our listings are complementary.)

Teladoc sues Amwell on patent infringement–again

This week’s Big News in the Telehealth Wars was Teladoc suing their chief rival Amwell (the former American Well) for patent infringement. These relate largely to telemedicine carts and robotic technology patents acquired by Teladoc via InTouch Health, which was finalized in July. InTouch Health’s value in the neighborhood of $1bn, when all was factored in, was reinforced by its over 130 patents and pending applications.

Notices were sent by Teladoc in mid-September for compliance by 18 September. It was mentioned by Amwell as meritless in filings with the Securities & Exchange Commission but apparently did not make a dent in their through-the-roof IPO raise of $742 million on 16 September. Their share price remains steady at over a $10 per share increase from the IPO price.

Amwell’s infringing products, according to reports on the lawsuit filed in the US District Court for the District of Delaware, encompass their Carepoints line of digital scope, stethoscope, and four different types of telemedicine carts, including the Horus HD Digital Scope System and the Thinklabs One Digital Stethoscope. There are nine contested patents. Teladoc is asking for treble damages plus court fees. Amwell has already stated that this type of business for them is in single digits–5 percent of revenue in 2019.

Both Amwell and Teladoc have been down this road before in 2015 and 2016. Teladoc also started it then, with Amwell countersuing–and losing in June 2016, with additional patent challenges filed by Teladoc with the USPTO. This record doesn’t bode well for Amwell, but even though IP fights tend to generate nasty headlines and drain resources, what is contested is a fraction of their business. Curiously, to this Editor’s knowledge, there is no record of InTouch Health, prior to their acquisition, challenging Amwell on these systems. Healthcare Dive, Healthcare IT News, Fierce Healthcare, WSJ (paywalled)

The Theranos Story, ch. 67: the Holmes/Balwani indictments stay, Holmes’ defense strategy fails

What Elizabeth Holmes needs is Perry Mason and a good scriptwriter from the 1960s. On Tuesday, Judge Edward Davila hit the ‘REJECT’ button on Holmes and ‘Sunny’ Balwani’s six motions since August to have the July indictments by a grand jury–a second indictment of 14 July, then a third and operative charging document of 28 July, dismissed. In a single compact, well-reasoned order, all six motions were denied for both cases:

  1. Pre-indictment delay. The first indictment was made in June 2018. The findings were that the delays were due to defense motions which were agreed to by the government and the judge, then the pandemic which suspended all in-person court proceedings and then became remote. The separate trial dates were moved to October 2020 and then at defense requests due to preparation and witness travel, moved to March 2021. 
  2. Statute of limitations on the fraud counts from investors. Even the definition of investor was narrowly defined here as securities purchasers. However, the broader interpretation, for example business partners such as Safeway [TTA 8 Oct] and board members, are also included as investors. 
  3. The indictments did not provide fair notice of the charges. Fair notice was found. Again, investors include business partners and even their board members who had promissory or convertible notes.
  4. Duplicity of the multiple counts was not found.
  5. Failure to omit doctors as victims of the Theranos scheme; doctors were omitted after the first indictment. The judge did find some lapses in prosecution language.
  6. All the dismissal requests for the first indictment applied to the later two.

It seems as if the defense, particularly Holmes’, threw a lot at the wall to lessen charges against their clients, and none of it stuck. One wonders how Holmes (who did marry a wealthy man) but particularly Balwani, are affording all this legal churn.

Unless there are publicly released findings on Holmes’ mental defect defense, alleging her inability to discern right from wrong (a/k/a insanity defense lite, Twinkie Defense II, High Anxiety) [TTA 18 Sept], hold off on popcorn purchases till next spring. San Jose Mercury News (which incorrectly reverses the analogy, sorry), Wall Street Journal, and the Register (UK), which helpfully provides a PDF of the court order.

Digital health investment smashes the ceiling: $9.4 bn invested through 3rd Q

$9.4 bn is a whole lot of bubbly! To no one’s surprise in the industry, kick-started by telehealth, Rock Health’s tracking of US digital health company investment through 3rd Q smashed through 2018’s full-year high point ($8.2 bn) with a cannonball of a total. Adding $4.0 bn to first half’s $5.4 bn, it represents 311 deals and is 27 percent above last year’s oddly fading-in-the-stretch $7.4 bn [TTA 7 Feb]. Rock Health projects the year total to be about $12 million and 400 deals. 

  • Average deal size topped $30.2 million, 150 percent greater than the $19.7 million average in 2019.
  • Driving this total were “mega deals” of $100 million or more, accounting for 41 percent of all deals (compared with 30 percent for year 2019). Even with the inclusion of fitness companies that this Editor does not consider true health tech, such as Zwift (interactive fitness entertainment), ClassPass (online fitness), and Tonal (more online fitness), the 20+ remaining companies indicate a concentration of Big Capital into Big Deals. The Big Deals concentrate in three sectors: on-demand virtual care delivery, R&D process enablement, and fitness/wellness.
  • Not surprisingly, telehealth and telemedicine are soaring: $1.6 bn in funding compared to $662 million same period 2019
  • Also pointing to concentration: 64 percent of this year’s investors have previously made investments in digital health, which exceeds any prior year. Institutional venture firms have the largest share of transactions (62 percent), with corporate venture capital accounting for 15 percent of transactions.
  • Given COVID and election year craziness, IPO action has moved right along and matched 2019’s six. Accolade and GoHealth in July; Amwell, Outset Medical, and GoodRx in September. Hims Inc. is merging with a blank-check company as SOC Telemed did in August. MDLive may be going public in early 2021.
  • What is down so far this year is merger and acquisition activity. Through September, there are only 63 acquisitions, which will likely trail by year’s end 2019’s 113. Teladoc is the 9,000 Elephant in M&A, with InTouch Health closing in August ($1 bn final due to the stock value soaring) and Livongo at $18.5 bn dwarfs the remainder. Optum-AbleTo has been reported in ‘advanced talks’ but there’s no confirmation of closing; it was reported to be at $470 million. 

Note: Rock Health only counts US deals in excess of $2 million, so international activity by companies like Doro are not included.

Also Mobihealthews.

The Theranos Story, ch. 66: Walgreens and Safeway aren’t investors, they’re business partners!

The difference is not hair-splitting in the defense effort to have charges tossed. In Federal District Court on Tuesday (6 October) in San Jose, Elizabeth Holmes’ defense made the case to Judge Edward Davila on dismissing some of the prosecution’s charges against her. As petitioned in late August, the defense maintains that two of the entities, Walgreens Boots and Safeway (a Western regional supermarket chain), were unfairly classified as investors versus ‘business partners’. As investors, the prosecution could charge Holmes with fraud crimes with a longer statute of limitations. If they were to be classified as business partners and ‘transactions’, while there were crimes committed, the statute of limitations has expired.

The prosecution’s rebuttal is that Walgreens and Safeway could be considered as both investors and partners. The defense response was that the government took too much time to file the charges and failed to get the proper consent, which may be the hair that splits the ability of the prosecution to use these charges.

Let’s look back at both companies’ involvement with Theranos

  • Walgreens reportedly invested over $140 million in Theranos. This consisted of direct funding (a $40 million loan convertible into equity), and an “innovation fund’ designed to fund the rollout of Theranos Wellness Centers in Walgreens US locations starting in 2013. Walgreens filed suit against Theranos in November 2016 to recoup that investment based on breach of contract, after civil lawsuits were filed against them jointly, halted development, and settled for $25 to 30 million in late July 2017 when Theranos assets were dwindling to barely breathing status [TTA 3 Aug 17]. More details on their Partnership from Hell are recapped here from the 2016 lawsuit.
  • Safeway’s involvement as the exclusive supermarket partner was planned to be even more extensive. Their 2012 deal was $350 million for building 800 clinic locations in Safeway stores. This was dropped in November 2015 [TTA 20 Nov 15], around the same time as Walgreens halted the expansion of the Theranos Centers. According to reports at the time, Safeway had already built out the 800 locations, later repurposing them for flu shots and similar. Direct investment was estimated at $10 million (WSJ). Safeway settled with Theranos for $30 million in June 2017. 

The publicly available history shows that both funded Theranos directly in addition to being business partners. Both took substantial additional risk investments from building out facilities to showcase Theranos’ services for their customers. Both settled civilly for amounts far below the fair recoupment of their investment.

While this sounds like legal nitpicking, the defense strategy, in this Editor’s layperson’s calculation, is to erode the number of charges against Holmes and their seriousness so that her inevitable sentence becomes lighter. Another move in this vein is the mental defect defense [TTA 18 Sept] alleging Holmes’ psychic inability to discern right from wrong in her business dealings. Start with something over the top like ‘insanity defense lite’, and then chip away at the rest of the charges. Fox Business, Mercury News

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

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

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?

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

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

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 Careand 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

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

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.