The last news roundup for 2019: ACA mandate unconstitutional, more $ for health research, PartnersHealthcare rebrands, Hackensack Meridian pays ransom, breaches>heart attack deaths, telepsychiatry merger, more

December 19, 2019 | by

Well, it’s happy trails for 2019, until we meet again in 2020, paraphrasing a well-known Roy Rogers tune (Roy was a movie and TV cowboy singer in the US; his eponymous roast beef sandwich chain was an advertising client for one of this Editor’s first jobs). So we’ll round up the news as we and I trust most of our Readers will be off for most of the next two weeks to be observing the holidays with family, friends, de-stressing, defrosting, or attempting to catch up on work while it’s quiet before January Madness hits. It’s hard to believe that This Year of Grace is almost over.

Breaking News: In a somewhat split decision, the Fifth Circuit Court of Appeals ruled Wednesday evening that the (Un) Affordable Care Act’s (ACA)’s individual insurance mandate, compelling everyone to signup Or Else, is unconstitutional. Congress zeroed out the mandate charge in 2018’s tax law. A decision regarding severability of the mandate from the ACA law has been remanded to the District Court. FierceHealthcare, Healthcare Dive

Also here in the US, we have both an impeachment of a President (a House action which will fail utterly in the Senate, and regarded by ordinary folks as a political annoyance) and a Federal budget running out on Friday that hardly anyone notices because it’s been extended since October by two continuing resolutions (CRs). The new budget that has to be signed by President Trump on Friday is, according to this POLITICO report today, chock full of health research dollars for NIH, the All Of Us genomics initiative directed by Eric Dishman, the Patient-Centered Outcomes Research Institute, or PCORI. and more. There’s some coal dust in the stocking for the national patient identifier initiative. Separately, CMS’ Blue Button 2.0 is offline due to a bug.

PartnersHealthCare rebranding, investing $100 million. Now called Mass General Brigham to better align with its parents (Massachusetts General Hospital and Brigham and Women’s Hospital, the Boston Globe reported that MGB will be spending $100 million for the first 18 months of a digital health initiative to improve the patient experience and the efficiency of care. Much will be around patient convenience, for example the ability to book appointments online, communicate with care providers via video and text, and providing online access to their medical records through OpenNotes. Efficiency initiatives will be focused on analytics and AI to manage patient flow and track revenue. The strategic plan and rebranding is promoted as a five-year project. Partners has been a pioneer in the field, with other large health systems following such as Novant Health (NC) and Mount Sinai (NY) with innovative partnerships and investments. FierceHealthcare

Hackermania in Hackensack continues. TTA reported last week that local New Jersey media identified Hackensack Meridian Health had been the victim of a ransomware attack starting on 5 December. The health system confirmed on Friday that it was a ransomware attack and they paid an undisclosed sum covered by insurance. The attack forced them back to paper records in all 17 of their hospitals, so with the insurance–and against law enforcement advice–they decided to pay up. Asbury Park Press, Healthcare IT News,Health IT Securitywhich also mentions the November attack on Oahu (Hawaii) Cancer Center. International hacker and ransomware attacks on vulnerable healthcare organizations are the subject of these year-end roundups: CISOMag, Becker’s Hospital Review.

Cyberbreaches increase fatal heart attacks? A Vanderbilt University study has also traced an uptick in patient mortality after heart attack to delayed care due to breaches. A survey of 3,000 Medicare-certified hospitals, about 10 percent of which had experienced a data breach, led to 36 additional deaths per 10,000 heart attacks. Krebs On Security blog

Short takes: the Sutter Health-Aetna partnership is adding home visits via Heal and telemedicine via 98point6 in Sutter’s Northern California area….Medtronic snapped up eating behavioral health startup Klue to reinforce a hybrid closed loop system to simplify diabetes management….Telepsychiatry is still niche, but InSight Telepsychiatry and Regroup Telehealth, two of the larger companies in the field, agreed to combine to be the single largest with a few hundred centers. Both American Well and Teladoc are encroaching on this area. 

We wish our Readers a Festive Holiday Season, whether you celebrate the week of Hanukkah, Christmas, Kwanzaa, or

another holiday. Rest, reflect, and our best wishes for a happy, healthy New Year. We will be off except for perhaps an occasional article until after 2 January.

 

Babylon Health to enter US market with two large strategic partners: report

December 19, 2019 | by

An apparently exclusive report in Mobihealthnews confirms the recent speculation that Babylon Health is entering the US market starting next month with its smartphone-based chat and triage service. Kurt Blasena, Babylon’s senior managing director of commercial strategy and revenue growth, said at the October Digital Health Innovation Summit in Boston that there are two current partners and a projected additional one to three more in 2020. The hints were that they were two “very large” strategic partners and one implementation will be for the state Medicaid market. The partners were not named, which leads this Editor to guess that the Medicaid implementation hasn’t been cleared with its state yet.

Babylon is experienced at international rollouts but not the US market. According to Mr. Blasena, they been busy localizing the service for the US by adapting the chatbot’s natural language processing system and hiring US-based staff. Part of the US difference is negotiating through how local healthcare is delivered, plus the thicket (this Editor is being kind) of Federal, state, and local regulations.

Right now their US operations are in a Prospect Heights, Brooklyn NYC apartment and in a WeWork in Austin, Texas. Mr. Blasena, according to his LinkedIn profile, is resident in San Diego.

Babylon Health has abundant cash on hand from a $550 million August Series C led by the Saudi Arabia Investment fund along with previous investors Kinnevik AB and Vostok plus new investor Munich Re. The stated intent was to expand into the US and other international markets in addition to presently being in Rwanda and Canada. Release  Stay tuned….

Calling all pitchers! Join us at Baker Botts on 5th February for a great evening

December 18, 2019 | by

Baker Botts (UK) LLP, in association with the Digital Health & Care Alliance and Ascendant Corporate Finance, invites you to join them for the DHACA/HTF fourth annual pitch event on Wednesday 5 February 2020 at their London office close to Bank tube station. The evening will feature a number of healthtech/medtech sector companies presenting their business for five minutes each, followed by two minutes of Q&A from the audience and panel of funders. Prizes will be awarded by Baker Botts Partner, Neil Foster, to the most fundable company and best presentation (as voted on by the panel and audience). Attendance is free.

Stuart McKnight, Managing Director of Ascendant Corporate Finance, will be the keynote speaker and will discuss key venture investment trends in the digital health and medtech sectors including highlighting the biggest deals and the most active investors.

We are particularly keen to have the best companies pitching so if your company would like an opportunity to pitch at this event, please download a copy of the pitch form by clicking here and return it as soon as possible it to Abigail Brookes at abigail.brookes@bakerbotts.com and definitely by Friday 10 January 2020. This event is also a great opportunity to meet and network with like-minded people, organisations and investors.

In order to qualify to pitch, you should be a private company within the healthtech or medtech sector, seeking funding within the next year. Successful applicants will be informed no later than w/c 13 January 2020.

Finally just to add that the Digital Health and Care Alliance is also running our next DHACA Day at Baker Botts on 18th March – you can book here, now. The agenda is in active development so keep checking.

Appello acquires Medvivo Careline telecare in second major move this year (UK)

December 17, 2019 | by

Appello announced another major acquisition to close out the year. Effective 5 December, they have acquired the home monitoring business of Medvivo, Medvivo Careline Ltd. Careline provides telecare alarm monitoring, ‘comfort calls’, and out-of-hours call monitoring services to at-home and at-risk customers. The company was formerly known as Magna Careline. Terms were not disclosed.

The Medvivo Careline acquisition increases Appello’s monitoring customers by about 20 percent to approximately 250,000. Appello’s earlier acquisition this year was of RedAssure Independent Living from Worthing Homes [TTA 17 Oct]. Appello is the UK’s largest telecare monitoring service.

Medvivo, in its statement, took some pains to position the sale as enabling the company to focus on their now core business of integrated urgent care services across Bath and NE Somerset, Swindon and Wiltshire. It demonstrates that the UK health tech area continues to consolidate, notably in the monitoring area.

The Careline website has already been cut over to Appello here. Appello release.

Outcome Health founders Shah, Agarwal plead not guilty in Federal court

December 17, 2019 | by

As expected, the co-founders of in-office health information/advertising firm Outcome Health today (Monday) pleaded not guilty in the Northern District of Illinois Federal Court in Chicago. Of a total of 26 counts in the Federal indictment, Rishi Shah, the company’s former CEO, has been charged with six counts of mail fraud, 12 counts of wire fraud and two counts each of bank fraud and money laundering. Shradha Agarwal, the former president, has a somewhat lighter charge count of six counts of mail fraud, nine counts of wire fraud and two counts of bank fraud. Both were released on bond: $20 million for Mr. Shah, $10 million for Ms. Agarwal. Crain’s Chicago Business, may require free registration.

The charges relate to deception layered around company performance as detailed in our 3 December article–overstatement of advertising placement and delivery, manipulating third-party data on patient engagement on Outcome’s tablets, and fraudulently stating results to auditors. This was used to leverage nearly half a billion of a total $1 bn raise by major firms such as Goldman Sachs, Alphabet, and the Pritzker fund.

Last week, we covered the pleas of Ashik Desai, former EVP of business operations/chief growth officer (guilty) and Brad Purdy, former COO/CFO (not guilty). Mr. Desai, interrupted from his graduate studies at Wharton, is cooperating with the prosecutors; Mr. Purdy is blaming Mr. Desai.

A podcasted discussion on Crain’s Daily Gist has expressed the opinion that some in tech and healthcare, especially in Chicago, believe the list of charges and heavy penalties are ‘unusual’ and ‘extreme’ for a startup, considering that the revelations started four years ago, the accused stepped down two years ago. and restitution has been made to the defrauded companies. Moreover, the business and the model was not far fetched or pie-in-sky–it was a reasonable model, according to report John Pletz. The company continues in business, albeit scaled down. Mr. Pletz believes that the outcome of Outcome Health will be far more due diligence on investors’ part (accentuated by the WeWork/Softbank crash in the same car) on startups. “Failure is expected–fraud is not.” The resolution of the charges will also be far in the future, perhaps years, due to this being an extraordinarily complicated case. There will be further hearings in January, but do expect it to drag on. A mini-surprise in his commentary was stating that the analysts may turn their plea to guilty. 

News roundup: Proteus may be no-teous, DOJ leads on Google-Fitbit, HHS’ mud fight, Leeds leading in health tech, malware miseries, comings and goings

December 12, 2019 | by

Proteus stumbles hard, cuts back. The original ‘tattle-tale pill’ company, Proteus Digital Health, plans to lay off 292 people in the San Francisco Bay Area and to permanently close its three Redwood City and Hayward locations, starting 18 January, according to notices sent to California state and local offices, including the state employment development department. It is unclear where Proteus will be located after the closures.

This followed after Proteus failed to launch a twelfth funding round of $100 million. According to reports, they furloughed most of their employees for two weeks in November and are reorganizing. This is after a substantial number of investors have put in about $487M in funding through a Series H (Crunchbase), including a game-changing investment by Novartis dating back to 2010.  Proteus achieved unicorn status about three years ago, but its high-priced pill tracking technology with a pill sensor tracked by a skin-worn monitor reporting into a smartphone has a built-in limited market to expensive medication. Otsuka Pharmaceutical in 2017 partnered with Proteus for an FDA-cleared digital medicine system called Abilify MyCite that basically put an off-patent behavioral drug back into a more expensive tracking methodology. But Proteus remains a great idea on tracking compliance in search of a real market, and may not have much of a future. San Jose Mercury News, CNBC

But ingestible detectable pills are still being tested. On Monday, as Proteus’ bad news broke, eTectRx announced its FDA clearance of the ID-Cap System and its testing at Brigham and Women’s Hospital and Fenway Health, focusing on HIV medication when used for treatment and prevention. Release, HISTalk

Department of Justice taking the lead on scrutinizing Google’s Fitbit acquisition. The Federal Trade Commission also sought jurisdiction over the transaction. According to the New York Post, “both agencies are concerned that a Google-owned Fitbit would give the search giant an even bigger window into people’s private data, including sensitive health information, sources said. Under the Hart-Scott-Rodino Act, all large mergers must file proposals with both the DOJ and the FTC, but only one antitrust agency reviews the merger.”

Coal from stockings being thrown about at HHS. According to POLITICO and the New York Times, the disagreements between Seema Verma, the head of the Centers for Medicare and Medicaid Services (CMS), and the Cabinet-level Secretary of Health and Human Services (HHS), Alex Azar, have boiled over, enough to have to be settled by the President’s acting chief of staff, Mick Mulvaney. According to the Times, both President Trump and VP Mike Pence have told them to find a way to work together. Both are administration appointees, but President Trump has not been reluctant to cut a mis-performing or overly contrary appointee loose. The latest salvo from those obviously not on Ms. Verma’s side was the revelation that she requested compensation for jewelry stolen on a business trip, contrary to government policy of course. She was compensated for other items which is standard. (Isn’t that what homeowners’ insurance is for? And what sensible person actually travels with valuable jewelry?) Under Ms. Verma, CMS has been quite progressive in developing new business models in Medicare fee-for-service, moving providers to two-sided risk, and innovating in both Medicare and Medicaid. It will either be settled, or one or both will be gone. Pass the popcorn.

Leeds picks up another health tech company. Mindwave Ventures is opening an office there, as well as appointing Dr Victoria Betton and Dr Janak Gunatilleke to the roles of chief innovation officer and chief operating officer. Mindwave develops technologies around digital products and services in healthcare and health research. Leeds reportedly is home to over 250 health tech companies and holds an annual Leeds Digital Festival in the spring [TTA 11 April].

Ransomware attack hits Hackensack Meridian. Systems were down for about a week. While this large New Jersey health system hasn’t admitted it, sources told the Asbury Park Press that it was ransomware. And if it’s not ransomware, its Emotet and Trickbot. Read ZDNet and be very apprehensive for 2020, indeed, as apparently healthcare is just one big target.

Comings and Goings: There may be some end of year bombshells, but after last week’s big news about John Halamka, it’s been fairly quiet. Paul Walker, whom this Editor knew at New York eHealth Collaborative, has joined CommonWell Health Alliance as executive director. Mr. Walker was most recently Philips Interoperability Solutions’ vice president of strategy and business development. CommonWell’s goal is improving healthcare interoperability and its services are used by more than 15,000 care provider sites nationwide. Blog release, Healthcare Innovation ….Dr. Jacqueline Shreibati, the chief medical officer for AliveCor, is joining Google Health in the health research area. Mum’s the word when it comes to Fitbit (see above). CNBC ….Peter Knight has pleaded guilty to falsifying educational credentials to gain his position as chief information and digital office at Oxford University Hospitals NHS Foundation Trust. He held that position from August 2016 until September 2018. BBC News

“There were practices going on there that were wrong”: Outcome Health’s Desai pleads guilty, cooperates with DOJ.

December 12, 2019 | by

Perhaps the smartest move, under really, truly bad circumstances. Ashik Desai, the former executive vice president of business operations/chief growth officer of point-of-care health information/advertising company Outcome Health, ‘copped a plea’ this past Monday to felony wire fraud charges. According to the Chicago Tribune, Assistant US Attorney Matthew Madden told Judge Thomas M. Durkin of the Northern District of Illinois Federal Court in Chicago that Mr. Desai is cooperating with the investigation. “When I was at Outcome Health, there were practices going on there that were wrong,” Mr. Desai said, understatedly, during his court appearance Monday. “I participated in those practices that ended up defrauding Outcome’s customers.”

According to the article and other sources (WTTW), Mr. Desai is only 26; he started at Outcome as an intern when it was still Context Media and departed in 2017. With continued cooperation, the prosecution is recommending only 10 years in prison, half of what a conviction might bring at the statutory maximum of 20 years. He was released on bond and surrendered his passport.

The multiple and most serious charges in the indictment are for the two founders, Rishi Shah and Shradha Agarwal, both of Chicago, and Brad Purdy, their former COO and CFO, all in their early 30s. These are criminal charges of fraud relating to their capital raises of about $1 bn during 2011 into 2017, deceiving their investors, lenders, and their own auditors for profit and misrepresenting to advertisers their delivery performance.

On Monday 9 December, Mr. Purdy pleaded not guilty to six counts each of mail fraud and wire fraud, two counts of bank fraud and one count of making false statements to a financial institution. His counsel, not unexpectedly but amusingly for those of us who are experienced in the corporate pecking order and what exactly a CFO is responsible for, stated: “Ashik Desai and several of his underlings committed a massive fraud. The evidence will show Brad Purdy was not part of that fraud,” he said. “Evidence is going to show Ashik Desai repeatedly lied to Brad and others to conceal his fraud from people like Brad.” Mr. Purdy also was released on bond and surrendered his passport.

Two of those underlings, Kathryn Choi and Oliver Han, pleaded not guilty on Thursday 5 December to their respective charges of wire fraud. They face five years maximum if convicted. In this Editor’s opinion, they were indicted to bring forth additional information to buttress the major charges on Mr. Desai and the three top executives. As ‘small fry’ with at most a little profit sharing, they are sideshows–easy to pressure. They may truly spill the beans if they and their counsel sense that things are going badly–if they have any more beans to spill. 

Mr. Shah and Ms. Agarwal are scheduled to appear in court next Monday, 16 December. They have previously stated that they will plead not guilty (FiercePharma). Flight risk is undoubtedly a concern for the prosecution regarding Ms. Agarwal. According to this Refinery29  interview from 2017, Ms. Agarwal is an Indian citizen and, while a long-time legal resident, not a naturalized American. Mr. Shah was born in the US. This cautionary Tale of the Unicorn, told in the Chicago Way, warns us all to be careful of what we see, are asked to do, sign on to–and sign off on.

News roundup: Philips allies with Humana for pop health, Dexcom’s outage outrage, Halamka ankles Lahey for Mayo, Google and NHS Wales changes, Agfa’s health sale, Victrix/WhatsApp, more

December 5, 2019 | by

Insurer Humana is identifying high-acuity and chronic CHF Medicare Advantage members and deploying two support programs utilizing Philips PERS and remote patient monitoring (RPM) systems. The first program identifies at-risk older people with chronic conditions and offering them Philips Lifeline with AutoAlert, Lifeline’s fall detection technology, and their CareSage predictive analytics. Philips Lifeline is already offered in select Humana Medicare Advantage plans. The second is a pilot with telehealth RPM to monitor a select group of CHF patients. This will use a Philips interactive tablet and connected measurement devices for care teams to actively monitor congestive heart failure patients. The rationale in the press release is centered on population health management, quality of care, and positively influencing patient outcomes, with “more efficient resource utilization” a/k/a lowering cost of care. Philips release.

Health tech is great, when it works–and Dexcom found out how serious it can get when it doesn’t. Dexcom, a continuous glucose monitoring system, experienced a server outage over the US Thanksgiving holiday weekend into Monday. It knocked out its updates in the Follow feature, frequently used by parents to monitor Type 1 diabetic children, and those with artificial pancreas devices that adjust insulin based on monitored BG levels. Dexcom was not only blasted by users on the server outage, which they attributed to ‘overload’, but also on its communications of the problem to users which depended on Facebook postings and not on real-time direct contacts or messaging. It was a ‘big surprise’ to their CEO, who also dismissed the possibility of a data breach, which seems a bit premature. Both Google and Microsoft provide cloud and tech services to Dexcom. CNBC 12/2, 12/3

Comings and goings: HIT pioneer, strategist, and general guru John Halamka is following the AI Star, leaving Boston’s Beth Israel Lahey Health to head up a machine learning/AI initiative at the Mayo Clinic in Minneapolis. Mayo this fall announced a 10-year high-level partnership with Google Cloud to store patient data and analysis. Modern Healthcare  According to the Healthcare IT News article, he’ll be returning on weekends to the Bay State to his 250-acre working farm….Also moving on to Google Health is Facebook’s Hema Budaraju, a product management director. Business Insider has annoyingly hid the news behind its paywall, leading to speculation in Mobihealthnews that she will be engaged in Google’s “social and environmental impact” efforts as she was at FB…And speaking of Google, founders Larry Page and Sergey Brin are stepping down at long last from active management. Google CEO Sundar Pichai will now be running Google and its corporate parent, Alphabet. See their letter on the GoogleBlog.…DigitalHealth reports on changes at the NHS Wales Informatics Service. Helen Thomas is now interim director as NWIS director Andrew Griffiths is departing this month. NWIS is also transitioning to a new Special Health Authority….Agfa’s Healthcare Information Solutions and Integrated Care, plus their imaging division, are definitely going to Italy’s Dedalus Holdings S.p.A. for €975 million. It awaits approval from various authorities, their employee groups, and the usual closing conditions. Release, DigitalHealth.

UK healthcare analytics company Victrix Socsan has signed a licensing agreement last month with WhatsApp. Victrix will use Whats App for communications with beneficiaries as part of their furnishing proactive preventive care services and provide secure information. Release.

SEC, DOJ charges Outcome Health founders Shah and Agarwal, others, with $487 million fraud, 26 counts of indictment (updated)

December 3, 2019 | by

All the points of information here. While we here in the US were enjoying our Thanksgiving feasts of turkey, steak, lobster, and lasagna, Outcome Health founders former Chief Executive Rishi Shah, former President Shradha Agarwal, and former executives Brad Purdy (COO/CFO), and Executive VP Ashik Desai, were being served a vastly different dish on 25 November. Underreported in the run-up to the holiday were two major legal actions against these individuals:

  • SEC charges of $487 million in investor fraud by “misrepresent(ing) the company’s business successes while raising hundreds of millions of dollars from unsuspecting investors”, billing clients (primarily pharmaceutical companies) for ads that never ran in medical offices, and manipulating third-party studies to make the company’s ad delivery look more effective than it actually was to create the impression of meteoric growth. The falsification trail was such that even they had trouble matching up their claims versus actual in their ‘selling of futures’.
  • 26 counts from a Department of Justice grand jury indictment on criminal charges of fraud relating to their capital raises of about $1 bn during 2011 into 2017 and their business practices. The indictment alleges deception of their investors, lenders, and their own auditors for profit and misrepresenting to advertisers their delivery of actual advertising in doctors’ offices which they may or may not have had, in extreme and additional detail to the SEC complaint. Arraignments for the defendants started on Tuesday 3 Dec.

Two young analysts, Kathryn Choi and Oliver Han, reported to Mr. Desai and are being charged with wire fraud. They are alleged to have created statements to deceive company auditors and providing advertisers with false patient engagement metrics on Outcome Health’s tablets. Both were hired in 2014 and placed on leave in late 2017. This action is highly unusual in reaching down to this level and naming two young subordinates.

One-time unicorn Outcome Health is, of course, still in business, selling advertising and educational materials at point-of-care, having settled with the SEC in October for $70 million in advertiser make-goods [TTA 31 Oct]. It also restructured/recapitalized in May by selling a majority stake to private equity firm Littlejohn & Co. In coming down to earth, the posturing of the executives should be less than two years ago, when Outcome was going to build its own Chicago office building–but this early October article from FiercePharma hardly moderates the healthcare change-agent hype for what is really POC advertising to inform and mostly distract patients who wait…and wait.

Additional information:

In this Editor’s view, once both SEC and DOJ are double-teamed on an indictment, avoiding Club Fed will be extremely difficult for the four main executives. (One assumes their US passports have been confiscated.) There is a huge amount of financial fraud leading to losses by some powerful companies. Even when losses are small, the Feds get their man most of the time. This Editor had a view of this at a distance, as the CEO of a company where she formerly worked was convicted of financial fraud in an enterprise formed after that company. He and his accomplice are serving five years in a Federal prison. Not even Elizabeth Holmes is facing the full fury of both Federal agencies, and she’s facing only nine counts in her indictment.