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

February 9, 2023 | by

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

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

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

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

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

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

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

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

February 9, 2023 | by

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

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

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

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

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

Amazon gets all tangled up on their $3.9B One Medical buy as FTC widens antitrust scrutiny

February 7, 2023 | by

Amazon’s ride towards being the #1 threat to healthcare hits an oncoming train. A report in stock analysis newsletter Seeking Alpha, picked up from other sources (the subscription Dealreporter), states that the Federal Trade Commission (FTC) hired outside economists to scrutinize Amazon’s $3.9 billion purchase of provider network One Medical (1 Life Healthcare). In a little-noticed action in early December, FTC also sent out subpoenas to current and former One Medical current and former customers as part of its investigation.

Both the Wall Street Journal and Bloomberg (paywalled) are reporting that this appears to be part of a larger FTC action in developing a wide-ranging antitrust lawsuit against Amazon on multiple anticompetitive business practices. In a recent example, FTC held up Amazon’s acquisition of iRobot (Roomba) during the summer, and in September, requested information from 1 Life and Amazon above and beyond the usual required Hart-Scott-Rodino Act (HSR) reports reviewed by the FTC and DOJ [TTA 15 Sept 2022]. This examination has been going on for some years, across two administrations, but may come to fruition as early as this spring. The main investigation is around Amazon favoring its own products, how it treats outside sellers on its platform, and copycatting the products of outside sellers. It may also cover Amazon Prime bundling practices. Prime also plays into its healthcare strategy. FierceHealthcare

Another factor: the highly profitable growth of Amazon Web Services (AWS) has taken a nosedive along with the cloud market, killing Amazon’s growth and value, according to Seeking Alpha’s analysis (may be paywalled). Amazon is also closing or pausing already built-out food stores–Fresh supermarkets and Go convenience shops–ending a long-term commitment to developing them.

When all of these factors are combined with Amazon’s 18,000 layoffs and huge 2022 net loss of $2.7 billion, it’s hard to believe that Amazon now has enough blue sky fisc to make the huge investment and long-term commitment that a largely new and cash-intensive business, delivering healthcare through real live providers in offices, will require. Amazon’s current health business is either transactional virtual retail (Pharmacy and the new non-face-to-face Amazon Clinic for virtual medical referrals) or hardware+subscription (Halo)–areas that Amazon knows well. But managing an entirely new and complex area that provides expensive and regulated provider services?

This Editor will go out on a wintry limb and predict that Amazon, facing FTC and state anticompetitive actions plus plenty of shareholder profit pressure , will cancel the deal with One Medical–leaving One Medical on another limb.

Week-end roundup: more House actions on telehealth benefits, VA EHR; Oracle exec moves to FDA digital health; Angle Health raises $58M; layoffs at Akili, Innovaccer, Athenahealth, Mindstrong

February 4, 2023 | by

Has the House in this 118th Congress acquired a propensity for taking fast action? It seems that under the new Speaker, the House on both sides, though divided, is energized and responding to changes that would benefit worker health–and perhaps find a way out of the VA Tower of Trouble that would ultimately benefit veteran care.

The first is a short (four page) bipartisan bill still in draft, the Telehealth Benefit Expansion for Workers Act, that would amend current law in the Public Health Service Act, the Employee Retirement Income and Security Act of 1974, and the Internal Revenue Code of 1986 to allow employers to provide telehealth to employees as excepted benefits. This allows employers to finance an additional benefit not covered under their primary health plan. Examples of excepted benefits are vision and dental plans. Sponsors of the bill are Rep. Suzan DelBene (D-WA) as lead and co-sponsors  Tim Walberg (D-MI), Angie Craig (D-MN), Ron Estes (R-KS), Mikie Sherrill (D-NJ), and Rick Allen (R-GA). This builds upon the Medicare and other plan reimbursement expansions contained in the omnibus budget plan passed in the 117th Congress that extended telehealth in high-deductible health plans with health savings accounts (HSAs). At this point, the bill is not numbered, submitted, or on Congress.gov. HealthcareITNews

Not addressed in this bill or any other is whether the extensions will cover hospital-at-home remote patient monitoring (RPM) that was permitted under waivers during the Public Health Emergency (PHE). With its scheduled 11 May end, the Connected Health Initiative (CHI) believes that CMS will not allow remote monitoring to continue in hospital-at-home programs, under current reimbursement and devices. CHI had sent Congress at the end of January a list of their priorities and they’ve received a hearing, but no action has been taken yet. Healthcare Finance

The second is a House bill that would support solving the issues around the VA implementation of the Oracle Cerner EHR without returning to VistA. This is being proposed by Democrats on the House Veterans’ Affairs Committee. According to FedScoop, which broke the story, this is being worked on as an alternative to Rep. Matt Rosendale’s H.R. 608 which would pull the plug on Oracle Cerner and revert back to VistA [TTA 1 Feb]. Exactly how this bill would solve Oracle Health’s issues with Cerner Millenium and support VA in continuing that EHR implementation after June is not specified. FedScoop’s source told them that “the proposal may have a wider scope than prior attempts at legislative oversight and could involve a complete rethink of how other IT projects are conducted within the agency. This proposal is focused at a higher level than just one program.” The lack of specificity in this broad brush is not precisely reassuring, but a bipartisan ‘game on’ by both parties on Veterans Affairs, perhaps a ‘good cop/bad cop’ treatment, could be an effective ‘nowhere to hide’ approach with Oracle. Becker’s

Oracle’s loss, FDA’s gain. Troy Tazbaz, formerly Oracle’s senior VP heading up their cloud transformation efforts, joined FDA as Director of their Center of Digital Health Excellence. In that capacity, he will be in charge of technology evaluation, policy development and strategic partnerships for safe healthcare use of digital technologies that advance public health. Certainly he is tanned, rested, and ready: Mr. Tazbaz  left Oracle last September and used part of that time to achieve a dream of bicycling from Chesapeake Bay in Maryland to San Francisco Bay over 58 days. FierceHealthcare

Employer insurer Angle Health raised a $58 million Series A. Lead was Portage Ventures, along with PruVen Capital, Wing Venture Capital, SixThirty Ventures, Mighty Capital, and several others. Angle’s angle is to act as a fully digital, full-stack insurance carrier that delivers comprehensive healthcare benefits tailored to startups and technology companies on one platform. Their baseline telehealth offering covers primary care, urgent care and behavioral health, outsourced to Included Health. They bundle this with administrative services and care navigation, and use the First Health and Cigna PPO networks according to their website. Angle recently expanded from Utah into Arizona, Georgia, Indiana, Ohio, Missouri, and South Carolina. Release, FierceHealthcare

Unfortunately, layoffs continue in and out of healthcare as funding and usage go south:

  • Akili Interactive in January cut 30% of staff, or 46 people. Akili has developed cognitive therapies for ADHD and other mental illness, including EndeavorRx, a prescription treatment delivered through a video game. Non-ADHD therapies have been put on hold. They announced going public via a SPAC in January 2022 via a merger with Social Capital Suvretta Holdings Corp. I which closed last August at over $14, and are currently trading at $1.92. Mobihealthnews
  • Innovaccer, a health data analytics company, later in January laid off 15%, or 245 people, in the US and India, to concentrate on their ‘core portfolio’. This is their second layoff round;  90 people or 8% went in September. This was quite a turnaround to their sunny-side up 2021, where they raised Series D and E rounds totaling $255 million backed by Tiger Global, Whale Rock, Mubadala Group, and Microsoft M12, achieving a unicorn valuation over $3 billion.  Mobihealthnews, Inc42.com
  • Athenahealth yesterday released 178, or 3% of its staff, two months after going private. They pointed to overhiring, a sluggish recovery in doctor visits, and inflation. They plan to release or move to less expensive office space in their current cities of Watertown, MA and Austin, TX. Boston Globe
  • In yet another sign that virtual mental health’s boom is deflating sharply, Silicon Valley-based Mindstrong is essentially shutting down. Almost all of its C-suite including the CEO and CFO are gone plus an additional 128 jobs including therapists. It is closing its headquarters and is ceasing patient services as of 10 March, yet is still recruiting on its website. Employees are departing between 24 March and 15 April, when presumably the last one out the door will turn out the lights.  Mindstrong raised over $160 million since 2014 including a $100 million Series C in 2020. Behavioral Health Business

News roundup: GoodRx pays $1.5M to FTC on Meta Pixel use, ATA concerns on Covid PHE end, defending Livongo sale to Teladoc, Philips lays off 18K, Amazon health layoffs–and big ’22 loss, Ireland HSE digital head quits, Matt Hancock assaulted on Tube

February 3, 2023 | by

Rounding up the week–and it’s not over. 

Prescription discounter GoodRx settled with the FTC for $1.5 million for the unauthorized sharing of user health data with Facebook, Google, Criteo, and other advertising sites. GoodRx used the Meta Pixel and other Javascript trackers in software development kits (SDK) for sharing user data with third-party advertisers. They would then be capable of serving personalized health and medication-specific ads to GoodRx users. This differs from the earlier Meta Pixel incidents which involved hospitals using the tracker on their website appointment schedulers and patient portals which exposed personal health information (PHI) under HIPAA regulations. GoodRx is not a covered entity, thus does not fall under HIPAA violations of PHI.

For the first time, the Federal Trade Commission (FTC) used the Health Breach Notification Rule, created in 2009, in charging GoodRx in a Federal court with misuse of consumer health information. The action was taken in US District Court for the Northern District of California, which has yet to approve the FTC order and the settlement.

GoodRx responded to the charges in their release that they stopped using pixel trackers in 2019 to protect user privacy. The trackers transmitted no PHI but primarily IP addresses and web page URL information. GoodRx maintains that this is a “novel application” of the Health Breach rule. But they settled with the FTC to avoid ‘the time and expense of protracted litigation’ on privacy issues they’ve already updated. HISTalk, The Markup, FierceHealthcare  TTA’s Meta Pixel articles

The good news for most of us is that the Public Health Emergency for Covid-19 will be ending 11 May. Not such good news, according to ATA and ATA Action, for mental health patients. While the omnibus budget passed at the end of the 117th Congress last year extended many telehealth provisions for two years [TTA 4 Jan], it did not extend the remote prescribing of controlled substances as part of the Ryan Haight Act. They are urging the Drug Enforcement Administration to release its rules for special registration for telemedicine as a first step. Release

With Teladoc’s $6.6 billion writeoff of the costs of acquiring Livongo in Q1 2022 [TTA 4 May 22], did Teladoc pick up an $18 Billion Bunch of Lemons in Livongo? Or did Teladoc mess up the expensive buy? You have to hand it to MedCityNews’ Arundhati Parmar for asking that burning question of Zane Burke, who was Livongo’s CEO at the time and the engineer of the sale, now CEO of Quantum Health. Not surprisingly, he said that “When we left the business, it was a freaking good business”, had just turned a big funding, was EBITDA positive, and wasn’t seeking a buyer. The massive difference was in the cultures, a ‘chasm’ that wasn’t bridged. One indicator: none of the top 16 Livongo executives stayed with Teladoc–and they were not required to as a condition of the sale. Teladoc considered it a ‘roll up’. 

This Editor was skeptical about it from the start–see TTA analyses 6 August and 11 August, as it happened in 2020. And while many smart observers were enthusiastic, others were not–the synergies (forgive me) they saw and the bottom line boosts were not there as predicted. In retrospect, which is always 20/20, it’s now proven to be a terrible buy. Teladoc has rebooted Livongo as of last month. More than the writeoff cost for Teladoc, it cost the industry, and affected lives.  It’s an important read in today’s situation.

Philips will be laying off 6,000 globally over the next two years, in addition to 4,000 booted this past October. Reasons why are the 2021 recall of Respironics ventilators, BiPAP machines, and CPAP machines because of the potential health risks of deteriorating polyester-based polyurethane (PE-PUR) foam, supply-chain challenges, lower sales in China, and the fallout from the Russia-Ukraine war. Their new focus will be on R&D and fewer ‘more impactful’ projects. Dataquest India, Mobihealthnews

Amazon’s layoffs of 18,000–and huge 2022 loss–also affected their developing healthcare areas. The shutdown of Amazon Care affected 159 jobs. But surprisingly, growth areas that had just rolled out new programs also lost staff. Amazon Pharmacy, which just rolled out RxPass, a $5 per month medication prescription service, laid off some of its program managers, risk compliance managers, and billing managers. Employees working on Halo health and fitness trackers were also laid off.  Becker’s Hospital Review  Yet many health executives see Amazon as the #1 threat to health systems’ core business. In a survey by Health Tech Nerds (sic), these execs predicted that Amazon might buy Color, Walgreens, and Smile Digital Health–in addition to a health plan! At this point, their One Medical buy is under scrutiny by both the DOJ and FTC [TTA 15 Sept 22] and on 2 February they reported a $2.7 billion net loss for 2022, the first since 2014 (The Verge) so those predictions on aggressive healthcare moves might be very blue side up.  Becker’s Hospital Review

In Ireland, Prof. Martin Curley, who headed digital innovation for the Health Services Executive (HSE), resigned in an unusual fashion. On LinkedIn announcing his resignation effective immediately, he said he has “called off this particular ascent on Everest”. In the post, he expressed frustration with supply chain and funding blockages, but later interviewed by the Irish Times cited poor IT infrastructure creating patient adverse outcomes, even death–and that senior administrators blocked new technology solutions. He is now a visiting professor at the University of Bath and a professor of innovation at Maynooth University. Irish Times 16 Jan, 25 Jan

And former Health Secretary Matt Hancock cannot catch a break. First, he was suspended from the Conservative Party in November, having decided that traveling to Australia for several weeks to appear in a reality show was more important–while he was Conservative Whip and Commons was still sitting. Now as an independent representing West Suffolk, in December he announced he will not stand for re-election next year. The insult upon injury was being assaulted last month by a 61-year-old man on the London Underground, following Mr. Hancock through Westminster station and onto a train, and earlier by the same man on Parliament Street. The Lancashire man was arrested. Lately quite in the BBC News.

Killnet racks up 22 more healthcare cybervictims and data thefts; whitepaper on best defense practices

February 3, 2023 | by

Ransomware attacks keep rolling through healthcare organizations. The latest tally just for Killnet, the rogue group of pro-Russian hacktivists, is up to 22 hospitals from Los Angeles to Egg Harbor, NJ. Becker’s HealthIT on Tuesday reported on 17 listed by BetterCyber on 31 January with another six yesterday. (BetterCyber’s Twitter feed subtracted Dartmouth Health Cheshire Medical Center from the victim list yesterday, thus 22.) Most affected are regional and community hospitals.

According to SC Media’s report on an HHS Cybersecurity Coordination Center (HC3) Alert, health and personal data were ‘exfiltrated’ onto the Killnet list. Quite oddly, and this Editor is sure it’s just a coincidence, the HC3 analyst note linked is offline; on a search to cross-check the link, the HHS pages show up in index form. Also Becker’s HealthIT 1 Feb 

The attacks were DDoS (distributed denial of service), described by HC3 as “thousands of connection requests and packets to be sent to the target server or website per minute, slowing down or even stopping vulnerable systems.” This ties up IT and slows down services such as websites or information portals. The danger in DDoS attacks, as noted in previous coverage [TTA 22 Dec 22] is that DDoS can be cover for other cybercrimes or information gathering in preparation for same. 

How can a healthcare organization ‘keep calm’ and lessen the impact of cyberattack, as it’s ‘not if, but when?’ A whitepaper by Cynerio,  focuses on microsegmentation, a network security technique that logically divides the data center into distinct security segments down to the individual workload/workflow level, and then defines security controls. (In marketing, market profiling down to buyer personas is similar.) The paper looks at how organizations should focus on four areas: visibility, risk mitigation, real-time defense, and regulatory compliance, then work through multiple considerations. Happily, the whitepaper (no registration required) is mostly understandable to those outside of IT. It also provides three case studies and checklists. Cynerio is a NYC-based healthcare-focused cybersecurity management company that helps hospitals to manage risk and secure their IoT, IoMT, and unmanaged IT and mobile devices.

Pull the plug on Oracle Cerner in the VA! Two House Representatives urge return to VistA, send bill to Veterans’ Affairs committee

February 1, 2023 | by

Hold your hand up if this comes as a complete surprise. A Congressman who was the top Republican on a subcommittee overseeing technology at the Department of Veterans Affairs (VA) has evidently had quite enough of the Oracle Cerner problems in implementing Cerner Millenium. Rep. Matt Rosendale of Montana has introduced H.R.608, titled “To terminate the Electronic Health Record Modernization Program of the Department of Veterans Affairs”. It would pull the plug on Oracle within 180 days, dissolve the VA Electronic Health Record Modernization Integration Office, and restore VistA/CPRS. In other words, back to the drawing board.

It was co-sponsored by Rep. Mike Bost of Illinois who is the chairman of the House Committee on Veterans’ Affairs, where the bill was referred on 27 January. Rep. Rosendale is now the chair of the House Veterans Affairs Subcommittee on Technology Modernization. 

This follows on last week’s two-day slowdown of both the VA and MHS Genesis systems, last summer’s Congressional hearings with the roasting that Oracle Health’s head Mike Sicilia and VA heads received over the OIG report on the ‘unknown queue’ that created 149 adverse events, and October’s delay in further Oracle Cerner rollouts in the VA from January 2023 to June.

While the likelihood that the bill would pass both House and Senate, and be signed into law, is low, H.R. 608 is one very heavy and clever cudgel for getting Oracle–and the VA staff involved with the conversion–to Pay Attention! Fix The Problems! There’s also leverage far beyond the VA EHR. Oracle has multiple Federal contracts which could be jeopardized or defunded. Stay tuned to further developments in VA’s Tower of Trouble and Oracle’s Mound of (Acquired) Misery.  Hat tip to HISTalk for the heads up, actually obtaining a screenshot of part of the bill which has not yet been posted on Congress.gov.  FCW.

Rounding out week: Oracle Health engineering head departs; Hive ransomware KO’d by DOJ; Google sued by DOJ on antitrust, lays off another 12,000; Pearl and Precision Neuro raise, Enabled Healthcare ADAPT grant

January 28, 2023 | by

Oracle Health engineering executive VP Don Johnson ankles after six months. Mr. Johnson, who was a nine-year veteran of Oracle, came up through the cloud infrastructure area starting in 2014, after a previous stint from 2005 at Amazon Web Services. He led product strategy, engineering, and operations before shifting over to Oracle Health. Oracle’s Cerner acquisition has been one Tower of Trouble, a Mound of Misery, even before it closed last June. Being barked at by Congress and the GAO over the VA and MHS, plus eroding relationships with health systems over EHR problems, and with the pressure from the tip-top to fix it fast and get on with the transformation of healthcare, could lead one to consider a long trip to a Remote Pacific Island. The Register. Hat tip to HISTalk.

In one for our side, the Department of Justice (DOJ) announced that the international ransomware network known as the Hive was shut down. Its servers in Los Angeles and darknet sites were seized. The DOJ continues to pursue charges against Hive members. The Hive ransomware was used in attacks on an estimated 1,300 companies worldwide since June 2021, yielding about $100 million in ransom payments. Hospital systems attacked were numerous, including Memorial Hermann Health System in Houston and a Louisiana health system.   DOJ release 26 Jan, Healthcare IT News, HealthITSecurity

The problems at Google continue with a DOJ civil antitrust lawsuit released earlier this week accusing Google of monopolizing multiple digital advertising technology products. For those of us in marketing who came up with a choice of multiple search engines and ad technologies, Google’s monopoly of the “ad tech stack” that website publishers depend on to sell ads and that advertisers rely on to buy ads is very real, and very expensive. You live and die by Google algorithms on your search ranking, both natural search and optimization. In other words, you deal with Google or nobody. So the DOJ lawsuit, joined by eight states, is, in this Editor’s view, overdue. Few are drawing a line between this antitrust suit and the layoffs of 12,000 Google staff (6%) last week plus the cutbacks at Verily, but this Editor will. DOJ release, CNBC

Funding raises in seed, Series A and B are the most common–two of note in Series B this past week:

  • Pearl Health raised a $75 million Series B of $55 million in equity capital and an anticipated $20 million in a line of credit. The round was led by Andreessen Horowitz’s Growth Fund and Viking Global Investors. Pearl is a developer of services and software for independent providers to enable them to better participate in value-based care through consolidating healthcare data and then using that information to create personalized patient care plans.  Release, MedCityNews 
  • Precision Neuroscience raised $41 million, also in a Series B.  Precision is another brain-computer interface technology like Synchron [TTA 17 Dec 22], in this case focused on treatment of neurological illnesses and events such as stroke, traumatic brain injury, and dementia. Leading the round is Forepont Capital Partners. Mobihealthnews 

In even earlier-stage companies, grants from accelerators are still present and are significant. Enabled Healthcare is a startup that has received a grant of $50,000 from Village Capital’s ADAPT program, It is one of four receiving an equity-free, peer-selected grant. ADAPT, funded by MetLife Foundation, supports innovation and development of solutions for key issues related to climate change, healthcare and wellness, and economic mobility. Enabled was selected from over 130 startups. Enabled combines in-person and virtual monitoring approaches to better coordinate care for those with complex needs on Medicare and Medicaid, and will go live in March. Release 

Mid-week news roundup: CVS Health Virtual Primary Care launches, VA’s two-day Oracle Cerner EHR slowdown, and microsampling blood + wearables for multiple tests

January 27, 2023 | by

CVS Health finally has Virtual Primary Care up and running. First announced by CVS last May, Virtual Primary Care provides primary care, 24/7 on-demand care, and scheduled mental health services to Aetna members nationwide enrolled in eligible fully-insured and self-insured commercial health plans. Members in VPC can schedule urgent care, 24/7 on-demand care (that may vary by plan), an in-office primary care visit, Minute Clinic visits, and expanded virtual mental health services. Amwell announced that it would be the provider in August on their Q2 2022 earnings call. The release mentions that board-certified physicians and nurse practitioners will be delivering primary care services through physician-led care teams and coordinating with CVS pharmacists. This applies to virtual mental health services as well. (One trusts that this in-network approach will avoid the problems they experienced with Cerebral and Done Health on their prescribed ADHD drugs.) Health records, lab results, and medications are shareable via the patient CVS Health Dashboard. At this point, there is no mention of further rollouts to other plans. Becker’s.

Somebody threw sand in the Oracle Cerner EHR gears at the VA–and it started at MHS. A report from the Spokane Spokesman-Review seems to be the only report out there (other than HISTalk picking it up) on the two-day slowdown in the Oracle Cerner Millenium EHR rolled out at the VA and the Department of Defense’s Military Health System (MHS Genesis) that covers active duty. On Monday and Tuesday, there was a “major slowdown” that did not abate until Tuesday afternoon.  It affected more than half of all MHS providers, as well as VA clinics and hospitals in Washington, Idaho, Oregon, and Ohio. Mann-Grandstaff clinicians reported problems to the Spokesman, which contacted the VA. Their press secretary Terrence Hayes confirmed that changes made to the system by the DOD, which shares a database with the VA, “had the unintended consequence of interrupting services that provide connectivity to the network.” The system slowed down from screen to screen, requiring clinicians to work extra time to make all entries, and was not resolved until configuration changes were made. This is another incident adding to a Very Large Dogpile, including interoperability between VA and MHS versions, 498 outages between September 2020 and June 2022, plus two veteran deaths.

And maybe Stanford, forever associated with Theranos, is trying to get its reputation back–in running multiple blood tests on microsamples. A new paper published in Nature Biomedical Engineering by a group of 17 researchers led by Stanford Medicine determined that valid tests could be run on a microsample (10 μl) of blood that could be drawn from a finger prick at home to test for thousands of metabolites, lipids, cytokines, and proteins. This testing would be paired with data captured from wearables. They tested reactions to food (Ensure shake) and the effects of physical activity on blood with wearables monitoring heart rate and step count, plus a continuous glucose monitor (CGM) to profile individual physiological status, including cortisol. Unlike Theranos, it’s not done in a ‘lab in a box’ in a supermarket trying to duplicate (fake?) existing diagnostic tests, and it employs mass spectrometry molecule-sorting technology in a lab. Becker’s.

Healthcare cyberattack latest: NextGen EHR ransomwared by AlphV/BlackCat, back to normal – 93% of healthcare orgs had 1-5 ransomware incidents

January 25, 2023 | by

Cyberattacks on healthcare continue their drip-drip-drip. The latest is on an EHR/practice management platform used by small to enterprise-sized specialty practices, NextGen Healthcare. The hacker group associated with the AlphV/BlackCat ransomware moved into the system on 17 January. For a short time, they reportedly exhibited NextGen information on their extortion site but later took it down. NextGen reported a short-term disruption to operations. A NextGen spokesperson stated that “We immediately contained the threat, secured our network, and have returned to normal operations,” the spokesperson said. “Our forensic review is ongoing and, to date, we have not uncovered any evidence of access to or exfiltration of client data. The privacy and security of our client information is of the utmost importance to us.”  NextGen has also stated to this Editor that no patient data was affected.

NextGen is used by about 2,500 practices in the US, UK, India, and Canada, including over 20 specialties.

The group behind AlphV/BlackCat ransomware has an infamous history. Reputedly, the gang has been kicking around since 2012 and was the same group of charmers that attacked the Colonial Pipeline in 2021, using the Darkside ransomware in May 2021 that dried out gas stations across the US East Coast. Their next ransomware edition, BlackMatter, targeted agriculture during fall 2021. Healthcare IT News, The Record/Recorded Future News

More severe attacks affecting 93% of healthcare organizations. While NextGen contained the attack quickly, both the Censinet/Ponemon Institute and Fortified Health Security’s 2023 Horizon Report tracked 2022 healthcare data breaches and concluded that while the number of incidents didn’t change much, their severity ramped up. More according to SC Media in these reports: 

  • Over a dozen of the biggest incidents in 2022 each impacted well over 1 million records
  • Nearly half of the respondents experienced a ransomware attack in the last two years
  • 93% faced between one to five ransomware-related incidents
  • Outages lasted upwards of 35 days

The common ground with NextGen is danger to patient safety, because electronic record damage can translate quickly into unavailable patient care.

Updated PharmaCare Services, a pharmacy management company based in Texas, is listed as a victim on BlackCat’s extortion site. They were exhibited with NextGen and remained when NextGen’s listing was challenged and then taken down. PharmaCare is staying mum on any ransomware disruptions, according to GovInfoSecurity.

One ray of hope is improved medical device security, included in the ‘omnibus’ budget package approved in late 2022. FDA will be required to enforce new standards for premarket device submissions. One is a software bill of materials, adequate evidence to demonstrate the product can be updated and patched, and a description of security testing and controls. This was before Congress in the Protecting and Transforming Cyber Health Care (PATCH) Act which didn’t go far, but elements of which found their way into the omnibus. A needed change for medical devices and long expected by manufacturers. SC Media

Using wearables to monitor biomarkers related to neuropsychiatric symptoms post-traumatic event

January 25, 2023 | by

Tracking biomarkers related to post-traumatic outcomes via a wrist-worn wearable. A January study published in JAMA Psychiatry (full text) monitored 2,021 participants who experienced traumatic stress exposure, mainly from car accidents but also physical assault, sexual assault, serious falls, and a mass casualty incident. 

The Advancing Understanding of Recovery After Trauma (AURORA) study examined adverse posttraumatic neuropsychiatric outcomes after traumatic stress exposure, especially among socioeconomically disadvantaged patients. Qualifying patients used the (Alphabet) Verily Life Sciences’ Study Watch for a minimum of 21 hours a day over the eight-week tracking period, starting with screening and qualification in the emergency department (ED). 

  • Participants used smartphones to complete a rotating battery of questionnaires consisting of 10 common adverse post-traumatic neuropsychiatric sequelae (APNS) symptom domains: pain, depressive symptoms, sleep discontinuity, nightmares, somatic symptoms, difficulty with concentration, thinking, or fatigue, avoidance of trauma reminders, trauma reexperiencing, anxiety, and hyperarousal.
  • Using the wearable’s accelerometer feature, it monitored eight significant biomarkers for pain, sleep, and anxiety. A reduction in 24-hour activity variance was associated with greater pain severity. Six others were associated with rest-activity measures indicative of changes in pain over time and one with repeated sleep-wake disruption indicative of changes in pain, sleep, and anxiety.

Depending on the data plus self-reporting on the questionnaires, the patient could be recovering or worsening post-event. The study concluded that “wrist-wearable device biomarkers may have utility as screening tools for pain, sleep, and anxiety symptom outcomes after trauma exposure in high-risk populations.” This Editor notes that over time, wearable monitoring was coupled with plentiful subjective information.

The group was selected from an initial 19,019 patient pool drawn from 27 emergency departments. 3,040 patients met the study criteria including being within 72 hours of the trauma, aged 18 to 65 years, and were able to speak and read English. They also provided informed consent and completed baseline assessments for a final completion group of 2,021. Most of the participants were female, half of the study were African American, 34% were white and 11% were Hispanic. Nearly 80% of the study did not have a college degree, while 64% earned $35,000 per year or less. The study was headed by a team at the University of North Carolina at Chapel Hill.  Also Mobihealthnews

Theranos Holmes trial updates: did she book a one-way flight to Mexico last year, or were the prosecutors reckless and wrong?

January 24, 2023 | by

The latest skirmish between prosecution and defense. Did Elizabeth Holmes book a flight to Mexico with the intent to flee–or not? According to the prosecution last week, Holmes in December 2021 had booked a one-way ticket to Mexico that was scheduled for the end of January 2022. The departure date was after her conviction in early January that year [TTA 4 Jan 22]. Moreover, the prosecution claims that now revealed fiancé Billy Evans flew not only to Mexico but also to South Africa, and was out of the country for weeks.

The defense in its filing countered that Evans booked the flight in late December 2021 under her name. She had hoped to be acquitted and then free to attend a wedding of close friends in Puerto Vallarta in late January 2022. In the defense filing, “Once the verdict was issued, Ms. Holmes did not intend to make the trip.” She would also be unable, as any trip would require court approval, her passport was expired, and as is customary, in the possession of the District Court.

According to the defense, Evans visited Mexico for four days, returning to California across the Tijuana toll bridge with a credit card receipt. The Cape Town, South Africa flight was weeks later–20 February 2022 departing San Francisco via Newark, returning 4 March via United and in economy class.

Why are the travel plans being made public by the prosecution now? Why is Evans being pulled into it? Holmes has been convicted for a year, sentenced, and is currently appealing. The prosecution knew much earlier about Holmes’ booked-but-untaken flight to Mexico and asked the defense about them via email. When told, prosecutor Jeff Schenk thanked defense lawyer Lance Wade. “I suspected there was an explanation, and I look forward to receiving additional information tomorrow.” The next day from Schenk, “Thank you again for the background information, confirmation, and for addressing this situation quickly. I do not believe there is need for us to discuss this further.” 

The timing is interesting because the prosecution filing objecting to Holmes’ freedom on bail while on appeal had to be filed by 19 January for a hearing by Judge Edward Davila on 17 March [TTA 10 Jan]. Was this one ‘see, see?’ objection? Will there be more? Mercury News

Note: New York Air (737-300 above) is remembered fondly by your Editor as she was this airline’s ad manager for 3 1/2 years in her Life Before Telehealth. It ceased operations in early 1987, merged into Continental Airlines in an ill-starred event called ‘The Big Bang’. (No, we didn’t fly to Mexico — neither will Elizabeth Holmes for the next decade.)

CVS, Walgreens, Walmart….Dollar General health clinics?

January 24, 2023 | by

Can Dollar Tree and Family Dollar be far behind? A possible new entrant to the onsite clinic wars may be Dollar General in piloting DocGo clinic vans in three Tennessee stores. DG Wellbeing will be providing urgent, preventative, and chronic care at three locations, two days a week each, with two in Clarksville and one in Cumberland Furnace, from 10am to 8pm based on current FAQs. DocGo vans will be located adjacent to the stores, in the parking lot. Appointments and walk-ins, Medicaid, Medicare, TRICARE, some commercial insurances, and cash are accepted.

Certain lab tests plus blood work are done either onsite or sent out. Medical staff on the van can write prescriptions. Some referrals (e.g. imaging) are done while other referrals are not available.

As to their strategy, you have to hand it to Dollar General. They get some good press from this. They are starting small in working through the details, outsourcing the healthcare part, and seeing if there’s sufficient demand to 1) expand and if promising 2) model the customer demographics–what we marketers call customer personas. If it doesn’t work, no Theranos-sized holes in their budgets–it’ll be GoneGone to DocGo.

Dollar General started to make moves into health about two years ago by noting the scarcity of health products in rural and underserved areas. They started to add more healthcare products (what they know about) on their shelves as part of the initial phase of the DG Wellbeing initiative and appointed a chief medical officer, Dr. Albert Wu. Currently, Wellbeing is in 3,200 stores (of 18,000+) with up to of 400 items per store. This past July, DG created a healthcare advisory panel including Dr. Patrick Carroll, chief medical officer of Vida Health; Dr. Katy Lanz, chief strategy and product officer at Personal Care Medical Associates and former chief clinical officer at Aspire Health; Dr. Von Nguyen, clinical lead of public and population health at Google; and Dr. Yolanda Hill, a board-certified physician in pediatrics and adolescent medicine. On Dollar General’s third quarter earnings call last December, CEO Jeff Owen noted the expansion of stores and the test of the DocGo vans to expand their services into rural health. Watch out Walmart, CVS, and Walgreens! Healthcare Dive, Forbes, Mobihealthnews

Their healthcare provider, DocGo, last week announced a partnership with Redirect Health, a platform offering directed to enterprises that provides on-demand, urgent mobile care to businesses in New Jersey and New York. DocGo SPAC’d on Nasdaq in 2021 and, unlike other SPACs, hasn’t cracked. Other than one wobbly point last year, it’s generally held its share price within a dollar or two of its initial offering range, which in this past year has to be considered good news.

Industry org news: ISfTeH International Conference call for presentations, new leaders for ATA Policy Council

January 19, 2023 | by

The International Society for Telehealth and e-Health (ISfTeH) is holding its International Conference in Winnipeg, Manitoba, Canada this year, 31 May to 2 June. It is being organized in collaboration with the University of Manitoba’s College of Rehabilitation Sciences and with support from Tourism Winnipeg. If you are interested in submitting a presentation proposal, go online to https://easychair.org/cfp/ISFTEH2023, or contact the Conference Chair, Dr. Amine Choukou (amine.choukou@umanitoba.ca). Abstracts are due on 3 February and full presentations by 17 February. Go to their main website (link above) for a link to the conference website (to come). ISfTeH is one of the oldest organizations in telehealth–a 25-year-old global federation of 45 national professional organizations in the field of telemedicine and eHealth, plus institutional, corporate, and individual members in over 35 countries worldwide.  Hat tip to Frederic Lievens of ISfTeH.

The American Telemedicine Association (ATA) announced new leadership joining their ATA Policy Council. Mary Griskewicz, MS, FHIMSS, director of federal policy, Cigna, joins the Policy Council as chair, along with Alyssa Keefe, system senior vice president, public policy and advocacy, CommonSpirit Health; Leslie Krigstein, vice president, government affairs, Transcarent; and Sarah-Lloyd Stevenson, MPH, senior manager, Amazon. Current chair Mark Hayes, senior vice president, Federal policy and advocacy, Ascension, remains on the Policy Council as immediate past chair. Readers should note the new mix of organizations. The ATA Policy Council makes final determinations on policy positions taken by the ATA and ATA Action, the ATA’s affiliated trade organization. Reminder–ATA 2023 is 4-6 March. Release

UKTelehealthcare launches TECS consultancy in partnership with TECS Advisory

January 19, 2023 | by

UKTelehealthcare is partnering with TECS Advisory, one of the UK’s leading sector-specific advisory businesses, to create a Technology Enabled Care consultancy arm. The closure of the analog phone network is coming in 2025–only two years away–and many phone providers are already transitioning their systems. While UKTelehealthcare has been staging meetings and trainings for members (calendar and resources here), this consultancy can now offer a wider and more specific level of support.

Gerry Allmark, UKTelehealthcare’s Managing Director, said: “We are very happy to be working in partnership with TECS Advisory to deliver a range of consultancy services to our members and the wider TECS industry to support them in developing and growing their businesses.”

The scope of these services include: 

  • Strategic analysis
  • Evaluating services and technologies
  • Sales and marketing
  • Implementing new technologies and systems
  • Business plans
  • Improvement plans
  • Cultural change programmes
  • Bid writing/management – Specifications
  • Options appraisals
  • Mergers & acquisitions

More information on this development to serve telehealth in the UK, for clients ranging from NHS and Local Authority Housing, Health and Social Care Commissioners and Providers, Housing Associations, Residential Care Providers, and more, is on the news section of their website here. Hat tip to Gerry Allmark

Interesting pickups from JPM on CVS, Talkspace, Veradigm backs Holmusk, ‘misunderstood’ Babylon Health; six takeaways

January 19, 2023 | by

Out of a decidedly soggy JPMorgan healthcare conference that concentrated mainly on pharma and biotech, there was some news in the downtrodden health tech and related areas. Selected from FierceHealthcare’s Heather Landi’s take:

CVS Health’s open checkbook for the right companies in primary care, provider enablement, and home health was a throwback to the palmy days of 2020-21. A big announcement at JPM was their investment in in-home kidney care and end-stage renal disease management provider Monogram Health. Their Series C raise of $375 million was lead-funded by CVS Health, Cigna Ventures, Humana, Memorial Hermann Health System, and SCAN.  Release, Mobihealthnews This added up to a busy January for CVS with leading Carbon Health‘s $100 million series D [TTA 11 Jan] and $25 million for Array Behavioral Care [TTA 12 Jan].

Talkspace, the cracked telemental health SPAC most recently rumored to be in buy talks with Amwell, touted their “defined, very significant path to profitability within a short period of time.” New CEO Jon Cohen, MD, a surgeon and veteran healthcare exec, touted the strength of the telemental health model, the effectiveness of their asynchronous messaging therapy for depression and anxiety,  and their market change from consumer to employers and health plans. Talkspace has some distance to go, quickly, with a loss through Q3 2022 of $61 million on revenues of $89 million and a share price today of $0.74, which means eventual delisting from Nasdaq. Is a quick buy in their future?

Veradigm, still settling in on their new corporate name, has its own bet on behavioral health data on the analytics side, with a lead investment in Holmusk‘s $45 million Series B. Holmusk will pull in de-identified patient data from Veradigm to their NeuroBlu Database.  Release

And on to Babylon Health, where Ali Parsa must feel like Eric Burdon of the 1960s blues group The Animals in the depth of being ‘misunderstood’. Dr. Parsa promises a path to breakeven by end of 2024.  Babylon’s revenue is on target to hit over $1 billion. They operate in over 15 countries with well over 5 million transactions. But their SPAC cracked too from a high of $272 per share after listing in October 2021 to today’s price just above $11, leaving a lot of investors in the lurch. Even though Q3 revenue increased by $288.9 million versus $74.5 million in 2021, an increase of $214.4 million or 3.9x, and the Q3 loss correspondingly widened to $89.9 million, the loss was significantly lower as a percentage of revenue. They are also converting from a foreign private issuer to a domestic, planning a reverse share split, and selling non-core businesses like the Meritage IPA [TTA 22 Nov 22] It’ll either be more correctly understood by Mr. Market or…be bought?

Arundhati Parmar in MedCityNews had a tart take on the proceedings, leading with the convergence of therapeutics with devices and data, Primary Care-Primary Care-Primary Care, billion-dollar bolt-on acquisitions that may be good for biopharma (but not necessarily so in health tech where integration is leading), and innovative therapies that don’t save but actually cost mo’ money. All of which is no surprise to our Readers. And why is there a JPM every year? Healthcare insanity may be catching.