Week’s end roundup: Theranica clears, Pixel Watch fall alert, Veradigm delays, Walmart adding 40+ clinics by 2024, Bright Health’s dim future, Ontrak founder charged with insider trading

March 3, 2023 | by

Theranica received FDA 510(k) clearance for its Nerivio device for migraine prevention in patients 12 and older. Theranica’s devices are based on a pain inhibition mechanism known as Conditioned Pain Modulation (CPM) where someone who suffers pain has a dysfunctional response to harmless stimuli. According to their product information, Nerivio wraps around the upper arm and uses non-painful remote electrical modulation (REN) to activate peripheral nerves to modulate pain. In addition to the device, the app allows users to customize their migraine treatments, receive reminders for preventive treatments, track patterns, and share migraine data with their doctor, as well as a guided relaxation routine. Theranica is based in Israel and New Jersey. Release, Mobihealthnews

Google’s Pixel Watch added fall detection to capabilities. It uses the motion sensors already in the watch and machine learning to detect a hard fall. If the wearer hasn’t moved within 30 seconds, it will vibrate, sound an alarm and display an on-screen notification that can be called off by pressing ‘I’m OK’ (left) or ‘I need help’. If the former, the alarms escalate until an automated call to 911 is made. The user has to activate the feature and Google claimes that the ML will help it avoid false positives. A very useful feature for older people, lone workers, and runners/walkers, but at the price point of $350 at Best Buy or $11/month via AT&T or Verizon, perhaps not all that attractive to cost-conscious users.    Engadget, Google blog post, Mobihealthnews

And in the Delays Must Be Catching Department, Veradigm, the former Allscripts, is delaying its Q4 and FY 2022 reporting due to a software flaw that affected its revenue reporting. Originally 1 March, the new date is yet to be determined, but they anticipate a reduction of $20 million dollars against what was previously reported from Q3 2021 into estimates for Q4 2022. Not exactly confidence-making for a company in the data management/software business. Coincidentally, the company which bought then-Allscripts’ large hospital/practice EHRs, now called Altera, Canadian giant Constellation Software, is also delaying its Q4/FY 2022 reporting, in this instance due to the Altera acquisition [TTA 15 Feb]. Veradigm’s release gives you the more complicated explanation.

Walmart Health’s Big Announcement is that it will be doubling the number of its Health Centers from the current 32 to over 75. By Q1 2024, Walmart’s plan is to open 28 new locations in the following metros: Dallas (10), Houston (8), Phoenix (6) and Kansas City MO (4). Missouri and Arizona are new states. All these will include the Epic EHR and the infrastructure improvements previewed earlier this week [TTA 1 Mar]. Release

Insurtech Bright Health may have a dim future. 18 months ago, Bright Health seemed to be the most promising insurtech out there, with a healthy Medicare Advantage plan base, family and individual plans, substantial growth, acquisitions of Zipnosis (‘white label’ telehealth triage for health systems) and development of the NeueHealth value-based care provider management network. Bright Health had a buttoned-up management team from UnitedHealth Group, investment groups, Target, CVS, and the Advisory Board. They raised $2.4 billion from prestige investors, including Cigna Ventures and Bessemer, went public on the NYSE in June 2021, and added $925 million in two post-IPO raises in December 2021 and October 2022 (Crunchbase). Fellow insurtechs Oscar and Clover struggled through their own financial and management challenges after an IPO and SPAC respectively. Oscar was sued last year by shareholders for misleading information; Clover lost $558 million in 2021, but reduced to $338.8 million in 2022 and promising a path to profitability. Healthcare Finance. 

Bright Health now appears to be a broken-bulb-filament away from default and bankruptcy. They ended 2021 with a $1.2 billion loss which is not unusual with companies of this type (see above). Bright exited individual and family plans in six states plus cut back MA expansion plans, also not atypical. Healthcare Finance This didn’t appear to help. By last December, their stock declined to below $1 triggering a notice of delisting from the NYSE if it’s not above $1 by May. The stock continues to trade below $0.50. They reported a 2022 loss of $1.4 billion, $0.2 billion up from 2021, on increased revenue. This week, it’s been reported they have told investors that they are facing credit insolvency, having run through $350 million in revolving credit, violated a liquidity covenant, and need $300 million to cover it by end of April. Further analysis in FierceHealthcare and on an interesting LinkedIn post by Ari Gottlieb, ‘Pay for Failure’.

And if there weren’t enough proof that the High Wide and Handsome Days Are Over, the Department of Justice (DOJ) indicted CEO Terren Peizer of Ontrak, a telemental health provider, with insider trading using Rule 10b5-1 trading plans. This rule was actually set up by the SEC to allow insiders to safely trade their shares by setting up a predetermined plan that specifies in advance the share price, amount, and transaction date, plus certifying that they are not aware of non-public information that can influence the price. The last is the rub. DOJ alleges that during mid-year 2021, Peizer was aware that the largest Ontrak customer, Cigna, was at high risk of departing on the heels of Aetna, and sold his stock. If convicted, Peizer may be facing up to 45 years in Club Fed plus disgorgement of funds. Ontrak trades on Nasdaq, today at about $0.60. FierceHealthcare

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

February 15, 2023 | by

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

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

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

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

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

Weekend news and deals roundup: Allscripts closes sale of hospital EHRs, closing out CEO; DEA scrutiny of Cerebral’s ADHD telehealth prescribing; more telehealth fraud; Noom lays off; fundings; and why healthcare AI is only ML

May 6, 2022 | by

That was fast. Allscripts closed its $700 million March sale of its hospital and large physician practice EHRs to Constellation Software Inc. through N. Harris Group. The Allscripts EHRs in the transaction are Sunrise, Paragon, Allscripts TouchWorks, Allscripts Opal, and dbMotion. They reported their Q1 results today. According to HISTalk earlier this week, CEO Paul Black will be stepping down, with President Rick Poulton stepping in immediately. Update–this was confirmed on their investor call Thursday and the transition is effective immediately. No reasons given, but there were no effusive farewells.  Healthcare Dive

A damper on telemental health? Online mental health provider Cerebral, which provides talk therapy, audio/video telehealth, and prescriptions for anxiety, depression, insomnia, ADHD, and other conditions, is finding itself under scrutiny. This week, its main mail fulfillment pharmacy partner, Truepill, stopped filling prescriptions for Adderall, Ritalin, Vyvanse, and other controlled Schedule 2 pharmaceuticals. Cerebral is redirecting current patients with these prescriptions to local pharmacies and as of 9 May, will not prescribe them to new ADHD patients.

Based on reports, the Drug Enforcement Agency (DEA) is looking at Cerebral in particular as part of a wider scrutiny of telehealth providers and pharmacies filling telehealth-generated prescriptions due to allegations of overprescribing. It also didn’t help that a former VP of product and engineering plus whistleblower claims in a wrongful dismissal lawsuit that Cerebral execs wanted to prescribe ADHD drugs to 100% of diagnosed patients as a retention strategy. Bloomberg Law. Unfortunately, Insider is paywalled but you may be able to see a report in the Wall Street Journal. Becker’s Hospital Review, FierceHealthcare

Also troubling telehealth is recurrent fraud, waste, and abuse cases involving Medicare and Medicaid. Back in 2020 the National Healthcare Fraud Takedown took down over 80 defendants in telemedicine fraud [TTA 2 Oct 20, 30 Jan 21]. The Eastern District of NY based in Brooklyn has indicted another physician, an orthopedic surgeon, in a $10 million fraud involving durable medical equipment (DME). In exchange for kickbacks from several telemedicine companies, he allegedly prescribed without examination and with only a cursory telephone conversation DME such as orthotic braces. DOJ release

Some fundings and a sale of note–and a big layoff at a well-known digital health leader:

  • Blue Spark Technologies, an RPM company with a patented Class II real-time, disposable, continuous monitoring body temperature patch good for 72 hours, TempTraq, raised a $40 million intellectual property-based debt solution (??) to fund growth led by GT Investment Partners (“Ghost Tree Partners”) with support from Aon plc (NYSE: AON)  Release
  • Specialty EHR Netsmart acquired TheraOffice, a practice management platform for physical therapy and rehabilitation practices which will be added to its existing CareFabric platform. Neither terms nor management transitions were disclosed in the release.
  • ‘White label’ telehealth/virtual health provider Bluestream Health is implementing its systems in Mankato Clinic, with 13 facilities across southern Minnesota. It’s a rarity–physician-owned and led–and in business since 1916. This also fits into a new telehealth trend–providers working with ‘white label’ telehealth companies and not with the Big 5. Release
  • Ubiquitously advertised (in US) weight-loss app Noom is laying off a substantial number of employees–180 coaches plus 315 more employees. Reportedly they are pivoting away from on-demand text chat to scheduled sessions that don’t require so many people. While profitable in 2020 ($400 million) and with Series F funding of over $500 million in 2021, it’s come under criticism that while its pitch heavily features easy behavioral change achieved through cognitive behavioral therapy (CBT), their real core of weight loss is severe calorie restriction. Engadget
  • Element5, an administrative software provider for post-acute facilities, raised a $30 million Series B from Insight Partners. They claim that their software is AI and RPA (robotic process automation) based. Release, Mobihealthnews

And speaking of the AI pitch in healthcare, a VC named Aike Ho explains why she doesn’t invest in healthcare AI companies because there’s no such thing in healthcare–it’s just machine learning. On that, Ms. Ho and your Editor agree. She also makes the point that the market they address is ancillary and not core services, plus they have difficulty clinching the sale because they don’t relate well to achieving or can’t prove at this stage improved clinical outcomes. Ms. Ho’s looooong series of Tweets is succinctly summarized over at HISTalk (scroll down halfway).