TTA returns: government shutdown effects, favored nations deal, funding overview, Veradigm still treading water, 23andMe bought back, and more!

October 3, 2025 | by

 

 

 

 

3 October 2025

Hello, Editor Donna is back, trying to catch up after a long and unanticipated leave that is not quite finished. We look at the effects of the US government ‘shutdown’ (not much except in telehealth), Pfizer’s ‘favored nations’ deal on drug prices (moving power away from the PBMs) and multiple big deals. We’re also gobsmacked that Veradigm still can’t get its reports together and Wojcicki bought back 23andMe. Sadly, one of our telehealth pioneers, John Boden, has also passed. More next week.

Editor Donna is back. Here’s the catchup.

From our last Alert: 

No, this shouldn’t happen to you–an unwanted hiatus for Editor Donna (an oops and a break that could have been worse)

Congratulations to James Batchelor MBE (Well Deserved!)

And a read with even more relevance now: Should free-falling UnitedHealth Group be broken up? Or break itself up to survive, before it becomes another GE? (updated) (Not a rant, more a ‘get going’ to avoid disaster!)

* * *
Advertise on Telehealth and Telecare Aware
Support not only a publication but also a well-informed international community.

Contact Editor Donna for more information.

Help Spread the News

Please tell your colleagues about this free news service and, if you have relevant information to share with the rest of the world, please let me know!

Donna Cusano, Editor In Chief
donna.cusano@telecareaware.com

Telehealth & Telecare Aware – covering news on latest developments in telecare, telehealth and eHealth, worldwide.

Editor Donna is back. Here’s the catchup.

October 3, 2025 | by

A summer hiatus that’s turning out to be a bit longer than expected. Recuperating from a broken left arm and resuming a mostly “normal life” including some vacation has taken appreciably more time than your Editor thought when last posting in late June. (In fact, where the heck did June go?) Getting back into the issues surrounding healthcare technology and healthcare in general has also taken awhile. So this article will be a mix of ‘this and that’ of tying off some stories that were hot in June. Starting with the current drama…

The US Federal Government shutdown and telehealth. It was uniquely constructed to not affect vital citizen services such as Social Security, Medicare, Medicaid, and even access to our national parks–and to be laid at the feet of one party, not the one in control. Life is going on as the shutdown continues. It may end tomorrow with a congressional resolution (CR) kicking the can down the road for a few weeks, it may end in November with the same.

Most affected from our perspective: Medicare telehealth flexibilities extended from the pandemic now revert to pre-pandemic rules, except for practices under the CMS Medicare Shared Savings Program (MSSP), practices in the end-stage renal disease (ESRD) program, and mental health. Audio-only reimbursement is terminated as is telehealth beyond the rural health program. Health and Human Services (HHS) has furloughed 41% of employees, over 32,000, though the short-term effect is expected to be minimal.

Continuing: programs such as Medicare, Medicaid, OIG’s Health Care Fraud and Abuse-related activities, parts of other agencies such as NIH direct medical, the Indian Health Service (IHS), FDA medical device and drug reviews, emergency preparedness, and other mandatory services. FierceHealthcare, Healthcare Dive   ATA Action is advocating for immediate restoration of Medicare’s telehealth flexibilities, in place since 2020, and the Acute Hospital Care at Home program. One hopes that Senator Schumer and Representative Hakeem Jeffries take note.

Such a deal? Under the shutdown wire, the Administration’s ‘most favored nation’ deal with Pfizer benefits state Medicaid programs and consumers who go on Pfizer’s website and buy drugs direct. In return, Pfizer gets a three-year relief from tariffs on their drugs from the Section 232 probe into the effects of pharmaceutical imports on national security. Details beyond this are scant, but the industry’s lobbying group, PhRMA, has been pressing for allowing drugmakers to sell DTC, bypassing insurers and pharmacy benefit managers (PBM). For commercial and individual insurance, the effect is nil for now. Healthcare Dive unpacks it.

Big deals continue. This week, VC giant General Catalyst, of which this Editor took a very dim view back in February, closed its $515 million acquisition of Summa Health, a non-profit integrated healthcare system based in Akron, Ohio. The acquisition through its HATco subsidiary was announced in January, but had to be boosted by $30 million and meet additional conditions to pass muster with Ohio’s attorney general. How acquiring one regional system advances their goal of “health assurance”, defined as “a more affordable, accessible and proactive system of care”, is To Be Determined. FierceHealthcare

Evolent Health is exiting the ACO business, selling it to competitor Privia Health for $100 million. The sale adds Evolent Care Partners’ more than 120,000 lives in MSSP, as well as commercial programs and Medicare Advantage. Privia now adds more states and their covered lives will total 1.5 million when the sale closes in Q4. The Medicare ACO business continues to contract to a few players; value-based care and Federally subsidized incentives in MSSP and ACO REACH turned not to be all that.  Healthcare Dive

There’s a rundown of other acquisitions and sales rounded up in HISTalk 1 October, indicating a certain liveliness in the market: specialty care coordinator Switchboard acquiring Conduce Health (undisclosed amount), Sunstone Partners taking a majority stake in healthcare cybersecurity/compliance firm Clearwater, AI voice agent developer Assist Health tagging a $76 million Series B round, and others.

In amazement….

  • Veradigm still can’t get itself current with its financial filings and submit itself for Nasdaq relisting as of this week. Revenue is still flat, they repurchased $180 million in convertible notes, and got itself a new CEO, Donald Trigg, in what has been a revolving door position. The last interim CEO ankled in April.  Veradigm release   Insult to injury: a data breach in July (announced to customers 22 September). This affected at least 70,000 patients in Texas and South Carolina, plus customers in California. HIPAA Journal
  • 23andMe was sold back for $305 million to its co-founder and CEO, Anne Wojcicki. She set up an entity, TTAM Research Institute, a non-profit public benefit corporation (PBC), to buy the company for $305 million. Unlike Regeneron’s $256 million bid, Wojcicki’s TTAM is acquiring Lemonaid along with the main Personal Genome Services and Research Services businesses. TTAM is a clever acronym of the spelled-out 23andMe. The Bankruptcy Court of Missouri approved the sale on 7 July and it closed on 14 July, after no further bids from Regeneron. Interestingly, none of the articles mention Wojcicki’s backers. 23andMe release, CNBC, HIPAA Journal.

To this Editor, selling a company back to the CEO who had full financial control over the company but augured a $6 billion valued company into Chapter 11–nosediving after bad investments, a major data breach and turmoil around its data and privacy–is beyond absurdity. I’m surprised that the bankruptcy judge even permitted it given the history, but she legitimately bested Regeneron’s offer by $50 million. It also included the nearly-finished Lemonaid. Supposedly all business is now ongoing. It’s her risk, her money, as noted in our last article on 3 June. And now her responsibility to make a go of it.

And a sad goodbye. Longtime Readers will remember John Boden, one of the pioneers (2001) of healthcare tech care management software for supporting older adults and a national expert in eldercare through his ElderIssues firm. He frequently commented on Steve’s and my articles, along with many insightful and funny emails. He was also a former Marine pilot (VMA-6, Vietnam) who wrote about his experiences in ‘Klondike Playboy’. John “Went West” on 4 December last year after a few years of retirement. Editor Steve discovered this during my hiatus. Our sympathies to his wife, children, extended family, and his VMA-6 shipmates. Legacy obituary

Thank you for your patience! My articles will be ramping up slowly as therapy continues. I’ll also be catching some additional vacation after next week. 

TTA’s Blooming Spring 3: Masimo’s cyberattack takes it down, WW’s Chapter 11, Neuralink’s ALS success, UHG’s 1K bet on AI apps, NIH/CMS autism data project, a look at payer earnings, more!

May 9, 2025 | by

9 May 2025

This week’s drama was all about Masimo, developing literally as this Editor was writing. Their website outage was revealed to be from a cyberattack that took down nearly all their systems. Not good for a monitoring/tech company. But their good news was that they sold Sound United to Samsung–2/3rds off. The others deserving of more attention are Neuralink’s successful BCI implant in an ALS subject and UHG’s 1,000 app bet on AI. Not so dramatic: WeightWatchers’ prepackaged, quick bankruptcy, the NIH/CMS autism data project, and Amedisys divesting to salvage their UHG sale. 

Short takes: HHS forms NIH/CMS autism data project; Oscar Health beats Street w/Q1 $275M net; Centene’s $1.3B earnings; UHG has class action suit on earnings, 1K AI apps in production; Cedars-Sinai and Redesign Health partner on development; FDA, Lilly, Novo Nordisk win vs. compounders (Big step forward for autism research)

News roundup: WeightWatchers in 45-day prepackaged Ch. 11, Neuralink BCI successful in ALS subject, telehealth VR reduced TMD pain–study, AliveCor maxes up KardiaMobile 6L, TytoCare-Allina Health partnership, UHG-Amedisys divest some more (WW losing runway, a Neuralink win, Amedisys divesting to save their two-year-old UHG deal)

Breaking–Masimo Mystery SOLVED–cyberattack, website down for days, new websites up–and where’s the public explanations? Sound United sold. (Another cleanup on Aisle 10–the Sound United albatross flys off)

From last week: Cherry blossoms are starting to fall, much like Teladoc’s revenue for Q1 in our lead story. Can their acquisition of a small virtual mental health provider with insurance coverage help turn around BetterHelp? And what about their main business? Novo Nordisk would rather partner than fight with teleprescribers Hims & Hers, Ro, and LifeMD for GLP-1 Wegovy–will this be a trend? Commure adds to its ‘house that Jack built’ tech stack with a HealthTap partnership. And Masimo’s latest episode of its ongoing soap opera is that its former CEO (and major shareholder) is claiming ownership of shares as part of his severance–but they haven’t been granted and very much in dispute. (Irony alert: they’ve increased in value since his departure!)

This just in: Teladoc acquires UpLift for $30M, bolstering struggling BetterHelp telemental health; Q1 revenue down 3% (Can this telemental health be saved with one acquisition?)

News roundup: Hims, Ro, LifeMD and Novo Nordisk partner on Wegovy prescribing (updated); Commure partners with HealthTap for virtual care after hours; WebMD Ignite adds texting to member health ed; hellocare.ai raises $47M for virtual nursing  (When you can’t beat ’em in weight loss meds, join ’em. With a side of Commure’s interesting M.O. on acquisitions.)

Masimo updates: former CEO Kiani claims 13.2% ownership, and a review of the new management’s style (updated) (The soap opera continues)

Holding this over: The weekend read: why SPACs came, went, and failed in digital health–the Halle Tecco analysis/memorial service; why OpenAI is going to be a bad, bad business (Grab the cuppa and lunch for a good read and podcast. Updated–Also Tecco’s blog post on why she quit being an angel investor.) 

* * *
Advertise on Telehealth and Telecare Aware
Support not only a publication but also a well-informed international community.

Contact Editor Donna for more information.

Help Spread the News

Please tell your colleagues about this free news service and, if you have relevant information to share with the rest of the world, please let me know!

Donna Cusano, Editor In Chief
donna.cusano@telecareaware.com

Telehealth & Telecare Aware – covering news on latest developments in telecare, telehealth and eHealth, worldwide.

Short takes: HHS forms NIH/CMS autism data project; Oscar Health beats Street w/Q1 $275M net; Centene’s $1.3B earnings; UHG has class action suit on earnings, 1K AI apps in production; Cedars-Sinai and Redesign Health partner on development; FDA, Lilly, Novo Nordisk win vs. compounders

May 8, 2025 | by

NIH, CMS to create autism data platform to enable research. The National Institutes of Health (NIH) and the Centers for Medicare & Medicaid Services (CMS), both under Health & Human Services (HHS), are partnering to enable NIH to build a real-world data platform. The purpose is to advance research around the root causes of autism spectrum disorder (ASD) that now affects 1 in 31 US children, according to HHS. The data gathered include claims data, electronic medical records, and consumer wearables focused on Medicare and Medicaid enrollees with a diagnosis of ASD. The first step establishes a data use agreement under CMS’ Research Data Disclosure Program.

Researchers will focus on autism diagnosis trends over time, health outcomes from specific medical and behavioral interventions, access to care and disparities by demographics and geography, plus the economic burden on families and healthcare systems.

The pilot program, intended to be a model for other conditions, will create a secure tech-enabled mechanism to enhance data sharing with timely, privacy and security compliant data exchange.  HHS release, FierceHealthcare

Payers, other than UnitedHealth, had an upbeat Q1.

  • Oscar Health, the feisty provider of ACA exchange individual and small group plans, notched a Q1 net income of $275 million with adjusted EBITDA of $329 million on revenue of $3 billion, up 42% from Q1 2024. Membership exceeded 2 million, up 41% from prior year. The ever-feisty CEO Mark Bertolini (center) railed on the earnings call against a shortened Federal enrollment period cutting off at 15 December versus January, as well as other enrollment changes. Oscar release, FierceHealthcare
  • Centene Corporation, one of the main rivals to UnitedHealth Group and a significant player in Medicaid state plans, had a decent Q1 turnaround with $1.3 billion in earnings and a  17% jump in premium and service revenues to $42.5 billion from $36.3 billion in Q1 2024. Their current membership versus Q1 prior year was down about 500,000 with the losses in Medicaid and traditional Medicare. They also increased their 2025 premium and service revenues guidance range by $6.0 billion to a range of $164.0 billion to $166.0 billion due to ACA exchange plans and Medicare Advantage (MA) revenue forecast performance. However, it’s projected by analysts that Centene will exit the Medicare Advantage market after this year in Alabama, Massachusetts, New Hampshire, New Mexico, Rhode Island and Vermont–about 3% of MA membership. CEO Sarah London criticized proposed cuts to Medicaid. Centene release, HealthcareFinance
  • UnitedHealth Group, after an anemic Q1 financial report driven by increased utilization and rising costs, cut its 2025 earnings per share (EPS) guidance by 12% to between $26 and $26.50 (Healthcare Dive). This just in: a shareholder group filed in Federal Court in the Southern District of New York on violations of securities laws affecting share price. It centers on the 2025 financial guidance provided prior to Brian Thompson’s assassination and how group CEO Andrew Witty did not account for: 1) the impact of that act but doubled down on the EPS forecast, 2) the increased scrutiny around the company for denials of claims even prior to the act, and 3) the general ill will generated as more information reached the general public. The affected group are those shareholders purchasing UHG stock between 3 December 2024 and 16 April 2025. Healthcare Dive, SDNY filing
  • Meanwhile, UHG has doubled down on AI development, totaling over 1,000 apps. According to a report in the Wall Street Journal, the company has these apps in production in their health delivery and pharmacy units, transcribing conversations from clinician visits, summarizing data, helping process claims, powering customer-facing chatbots, and in engineering to write software. According to chief digital and technology officer Sandeep Dadlani, half of the apps use generative AI and the remainder a more “traditional” form, without explanation of “traditional”. According to Dadlani in the article, “AI has a role to play in the claims evaluation process, but it will never be allowed to deny a claim”. Software, not necessarily AI powered but usually rules-based or using algorithms, ‘auto adjudicate’ 90% of UHG claims. UHG was sued in Federal Court as far back as 2023 in using an AI-powered application to evaluate and deny claims.

Redesign Health gets freshened up with a Cedars-Sinai partnership. Redesign Health is a combination funder and company builder which has launched over 60 healthcare-related companies, some clear successes such as Calibrate (weight loss) and Jasper Health (cancer care navigation), with others on the development curve such as Vault Health and Uptiv Health. They announced a partnership with the Cedars-Sinai health system in Los Angeles to add their clinical expertise and innovative research. Other strategic value additions through the new partnership are tapping into funding support, access to clinical environments within Cedars-Sinai’s network, and their dataset for validation of technologies and design. Redesign release

And in the pharma compounders versus Big Pharma war, the former have lost two battles. The compounder’s trade group, the Outsourcing Facilities Association (OFA), had separate lawsuits filed in Texas to force the FDA to reclassify both tirzepatide and semaglutide as still in shortage, which would permit compounding pharmacies to produce weight loss drugs with these active ingredients. The Texas judge found yesterday (7 May) for both FDA and Eli Lilly, the producer of Zepbound, that tirzepatide was no longer in shortage, which closed the door on the OFA. At the end of April, the same Federal judge ruled against the continued compounding of semaglutide, the active drug in Novo Nordisk’s Wegovy and Ozempic [TTA 27 Feb]. 22 May is the end date for the large compounding pharmacies for semaglutide, while smaller state-based compounders must cease immediately. Biospace 8 May, 25 April  Novo Nordisk’s new partnerships for Wegovy-based weight loss prescribing: TTA 1 May, 8 May

News roundup: 9 additional VA centers named for Oracle 2026 EHR rollout; ATA Action acquiring, expanding with DTA; Dr. Oz to lead CMS while HHS cuts; DOJ seeks death penalty for Mangione

April 4, 2025 | by

VA moving forward with the 2026 Oracle Cerner rollout of (lucky?) 13 centers. In March, the Department of Veterans Affairs (VA) announced that the EHR Modernization (EHRM) for 2026 would be expanded to a total of 13 sites, adding nine to the four in Michigan announced in December. True to form, ‘later this year’ was less than one month later, yesterday. The additional nine are in Ohio (4), Indiana (3), Kentucky (1), and Alaska (1): 

Cincinnati VAMC-Fort Thomas (Fort Thomas, KY)
Chillicothe VAMC (Chillicothe, OH)
Cincinnati VAMC (Cincinnati, OH)
Dayton VAMC (Dayton, OH)
Louis Stokes Cleveland VAMC (Cleveland, OH)
Fort Wayne VAMC (Fort Wayne, IN)
Marion VAMC (Marion, IN)
Richard L. Roudebush VAMC (Indianapolis, IN)
Alaska VA Healthcare System (Anchorage, AK)

The four locations in Michigan are VA Battle Creek Medical Center, VA Detroit Healthcare System, VA Ann Arbor Healthcare System, and VA Saginaw Healthcare System. This is almost two years after all installations replacing the venerable VistA were halted in April 2023, with the priority to fix the five troubled current deployments and the 2024 MHS joint installation at Lovell FHCC. This series is termed ‘market based’ with the locations relatively close to each other for greater efficiency, versus the earlier far-flung centers. In addition, “VA will adopt a standard baseline of products, workflows and integrations aligned with subject-matter-expert recommendations.” VA release, HealthcareDive

ATA Action acquires Digital Therapeutics Alliance (DTA), launches Advancing Digital Health Coalition. The advocacy arm of the American Telemedicine Association (ATA) will be combining with the DTA, a 501(c)(6) non-profit trade association with a mission of advancing digital therapeutics globally. The new organization will continue to take policy roles in advancing telehealth, ATA Action’s focus, but expanding into policies governing digital health tools in diagnostics, remote patient monitoring, and AI, leveraging DTA’s established relationships at the FDA and international regulatory agencies. Kyle Zebley will remain executive director of ATA Action. Andy Molnar, CEO of DTA, will transition to head of digital health at ATA Action. ATA Action is also launching the Advancing Digital Health Coalition, a membership non-profit which will extend the work of the DTA into advocacy for innovative digital health technologies transforming patient care, including digital therapeutics, prescription drug use related software (PDURS), and remote monitoring devices. Timeframe was not disclosed. ATA-DTA release, Advancing Digital Health Coalition release, FierceHealthcare, Healthcare IT News

Over at the Feds, Dr. Mehmet Oz was confirmed today (Thursday) by the US Senate to head the Centers for Medicare and Medicaid Services (CMS). The vote was 53 to 43.  Former TV personality and PA Senate candidate Dr. Oz, a cardiac surgeon, graduated from the University of Pennsylvania, earning both an MD and an MBA from Wharton. He became a professor at the Columbia University – Vagelos College until 2022. The now-whitehaired Dr. Oz will be CMS Administrator over a downsizing organization, which will be 300 staff lighter and with a Congress that needs to find billions in savings. Within Health and Human Services (HHS), Secretary Robert F. Kennedy Jr. has presided over 10,000 in packaged out layoffs, with another 10,000 laid off this week for an ultimate 25% downsizing across all agencies to 62,000. Reports indicate confusion, which is sadly typical of mass layoffs for organizations of size. HealthcareDive, MedTech Dive 27 Mar, MedTechDive 3 April, HealthcareITNews

The US Department of Justice (DOJ) will seek the death penalty against Luigi Mangione. The Federal murder charges brought in December have been increased by Attorney General Pam Bondi. She has directed Acting US Attorney for the Southern District of New York, Matthew Podolsky, to seek the death penalty for this murder as an act of political violence, premeditated and threatening the public. Currently, the Federal government has a moratorium on executions which she has committed to reviving. The accused murderer of Brian Thompson, CEO of UnitedHealthcare, is currently incarcerated at Brooklyn’s Metropolitan Detention Center, facing first-degree murder as an act of terrorism charges brought by New York State. He and his attorney are requesting that Mangione have access to a laptop for reviewing case documents, an unprecedented privilege. Mangione also faces charges in Pennsylvania on gun and false identification charges from his flight from NYC. The DOJ will be waiting some time for Mangione, as the New York charges have precedence. New York has not yet set a trial date, which is certain to be a circus given his fan girls.  DOJ release, FierceHealthcare, NY Post

News roundup 21 Feb: UHG offers buyouts to 30K before layoffs (updated); more inside the Transcarent-Accolade deal; Hims acquires NJ testing company; layoffs bite inside HHS; in fundings, Vitalchat gains $6M, Frontera seeds at $32M, Harrison.ai $112M (AU), Abridge’s $250M

February 21, 2025 | by

UnitedHealth Group ends an annus horribilis with more horribilis. UHG offered early this week 30,000 employees their “Voluntary Resignation Severance Program” or VSRP. If the employee accepts between 24 February and 3 March, the program offers anywhere from 7 to 30 weeks severance, based upon tenure and salary grade; they’ll receive their termination date on 17 March with all released by 1 May, as of now. A wrinkle: their managers must approve of their taking the package, which could set up a situation of being released later involuntarily. UHG has 420,000 employees and oddly, is still posting available positions but they may be ‘ghost’.

Reports have been compiled by employees posting largely anonymously across social media and websites such as Reddit, Facebook, LinkedIn, TikTok, and TheLayoff.com. The buyout offer, according to reports, is concentrated in the benefits operations area. According to CNBC’s sources, benefits oversees multiple subdivisions that help manage customer service, claims, enrollment, customers’ insurance benefits, and more. As is typical with voluntary severance offers, the whip is that if employees do not take the VSRP, those laid off later will receive a reduced package.  There is no information about additional benefits, such as 401(k) and incentive vesting, or healthcare benefits–the last ironic for a healthcare company.

On social media, the betting is that UHG is only the first payer to institute layoffs, with the decline in Medicare Advantage payouts and reductions in ACA subsidies. Other factors: AI (per the last earnings call, they are replacing many customer service functions with AI programs) and offshoring. This is not going to be a great year for any payer, if you work for one, and their suppliers/partners. HealthPayerSpecialist (hat tip to Mansur Shaheen via LinkedIn), FierceHealthcare, PYMNTS.com, Minneapolis Star-Tribune   A followup article by Mr. Shaheen with UHG interviewing employees and accessing company information is here. Another reason why is that UHG’s attrition rate, for various reasons including company response to the Brian Thompson murder and their higher pay rates, was much lower than forecast.

Updates on the Transcarent deal for Accolade. Contained in the latter’s SEC Schedule 14A, an announcement of a stockholder meeting (virtual) and preliminary proxy statement, are more tidbits in the runup to the deal with Transcarent:

  • Transcarent’s merger sub was formed on 3 January, indicating this deal has been on the table for some time
  • In April 2024, Accolade was considering acquiring a strategic company (unnamed). That company rejected the offer and instead offered to buy Accolade by May. Later that month into August, a special committee and outside advisors considered competing purchase offers, well over 16.
  • Transcarent’s original offer was made at end of July, was unsolicited, and an August proposal was rejected. A second proposal was rejected in September based on financing.
  • In October, after business reverses, Transcarent submitted another bid for shares at $7.25 and was delayed by the special committee 
  • Between that date and year’s end, the other proposals faded away for a variety of reasons.
  • Transcarent’s final offer was $7.03 per share and accepted in January.

Regarding transitioning incentives in the deal, expected to close in Q2:

  • It can be terminated by 7 October. If Accolade terminates it, the payment to Transcarent is $19.8 million. If Transcarent terminates, the fee to Accolade is $29,950,000
  • Top management (Rajeev Singh, Stephen Barnes, Robert Cavanaugh, and Richard Eskew) shares will accelerate in vesting. Some top management such as CEO Singh will enjoy retention bonuses.
  • It describes treatment of employee benefits such as restricted and performance stock units (RSU, PSU) being converted to cash and that other benefits for continuing employees will be cut over for a year.

Also Endpoints News

Hims & Hers buys a testing lab in NJ.  The acquisition of Sigmund NJ LLC, also known as Trybe Labs, in Kearny NJ will support at-home blood draws and more complete and affordable whole-body testing. The acquisition was self-financed and not disclosed. Hims, a telehealth prescriber for GLP-1, ED, hair loss, migraines, and anti-depressants, in the release pointed out that the Trybe Labs buy will enable them to serve high-impact clinical categories including low testosterone, perimenopausal, and menopausal support for patients and providers. Through using a blood lancet, they will test for hormone levels, cardiac risk, stress markers, cholesterol, liver function, thyroid function, and prostate health. Mobihealthnews, Endpoints News

Layoffs within HHS are extensive–and as of a court action today, going through. Most of those eliminated by DOGE (Department of Government Efficiency) are probationary hires–in their first year–and some in year two. Those released at HHS include 1,300 at the Centers for Disease Control and the National Institute of Health (unknown but expected to be upwards of 600). Those released will have a month’s severance but will end work on Friday 14 February. Some probationary NIH employees will be retained. Cuts include CDC and other HHS contract workers and include dozens at the Vaccine Research Center housed at NIH. The current acting principal deputy director, Nirav Shah, will be departing on 28 February as will Renee Wegrzyn, the appointed head of Advanced Research Projects Agency for Health (ARPA-H), which performs biomedical research in conjunction with the private sector established in 2022 by the last administration. Ironically, reviewers of Elon Musk’s Neuralink project and other brain-computer interface companies were among the 20 fired at FDA’s Office of Neurological and Physical Medicine Devices.

HHS employs more than 80,000 people across multiple agencies and has a budget of $1.8 trillion. NIH alone has 20,000 people and has a $47 billion annual budget. STAT, Mobihealthnews

Funding highlights include a stunning seed round:

  • Vitalchat, a provider of in-patient virtual nursing and procedural telehealth, closed a $6 million Series A round. Investors were led by Green Harvest Capital Industries (GHC Industries). Two of their principals will join the Vitalchat board: Ankit Patel, GHC’s CEO, and Saagar Parikh, co-founder/principal. The new funds will be used for product innovation, market expansion, and deeper AI integration into clinical workflows for its AI-assisted virtual sitters. Release
  • Frontera Health’s seed round of $32 million was a return to 2020’s Big Raises. It was co-led by Lux Capital and Lightspeed Venture Partners, with Bison Ventures, Menlo Ventures, and Inspired Capital participating. Frontera specializes in autism services, including virtual autism diagnosis and assessments, as well as in-home and center-based ABA therapy. It uses what they call ‘digital phenotyping’ to analyze interactions and behaviors, providing real-time cognitive reasoning and objective data points for clinical assessments. Behavioral Health Business noted substantial raises by other companies such as Anna Health and Prosper Health, along with private equity (PE) investments.  Release, Mobihealthnews
  • Down Under, Harrison.ai’s Series C totaled $112 million in a Series C funding. It was led by Aware Super, ECP, and Horizons Ventures. It provides medical imaging diagnostic support in radiology and pathology, including workflow solutions. Harrison is opening a US headquarters in Boston to expand their US business. It already has clients in APAC, EMEA, UK, and US, where it has 12 FDA clearances. One of their CT brain algorithms has FDA Breakthrough Device Designation and Medicare reimbursement through the New Technology Add-on Payment (NTAP).   Release, Mobihealthnews
  • Abridge raised an old-school level $250 million Series D investment. This was co-led by Elad Gil and IVP, with a long list of participants including Bessemer Venture Partners, California Health Care Foundation, CapitalG, CVS Health Ventures, K. Ventures, Lightspeed Venture Partners, NVentures (NVIDIA’s venture capital arm), Redpoint Ventures, Spark Capital, and SV Angel. Abridge’s platform converts patient/clinician conversations into structured clinical notes in real time using (guess) generative AI. Funding will be used to further develop AI capabilities and commercial growth to support broader applications. It claims 100 of the largest and most complex healthcare systems in the US, from rural systems to children’s hospitals, leading academic systems, and nationally recognized cancer centers, Release

News roundup 2: RFK Jr. confirmed as HHS Secretary, new MAHA commission formed; Amwell narrows loss by 68%; HEALWELL (CA) nears close of Orion Health (NZ) buy; Summer Health buys Caraway; Spectrum.Life (IE) plans to double users; 2025 NY Digital Health 100 announced

February 14, 2025 | by

Robert F. Kennedy, Jr. was confirmed this morning as US Health and Human Services (HHS) Secretary. The Senate vote was fairly standard for President Trump’s appointees, along party lines (with one exception) in a 52-48 vote. Secretary Kennedy survived bare-knuckle committee hearings (and a family ‘diss’ from cousins) to put into place measures to Make America Healthy Again (MAHA) as promised during the 2024 presidential campaign. Today’s presidential Executive Order also makes Secretary Kennedy the leader of the MAHA Committee, which, according to a White House statement will be “tasked with investigating and addressing the root causes of America’s escalating health crisis, with an initial focus on childhood chronic diseases.” such as autism and fatty liver disease, plus adult asthma and the causes of the low US life expectancy.  The EO’s four policy directives focus on reversing chronic disease through:

  1. transparency on health data to “avoid conflicts of interest in all federally funded health research
  2. prioritizing “gold-standard research on why Americans are getting sick” in all federally-funded health research
  3. working with farmers to ensure food is healthy as well as affordable
  4. expanding health coverage and treatment options “for beneficial lifestyle changes and disease prevention.”

The timeframe is short: 100 days to produce an initial assessment, and 180 days to produce a strategy to improve child health. All this and learn HHS too. Next up in hearings: Mehmet Oz, MD as CMS Administrator, expected to face far less flak.  FoxNewsDigital

Amwell straining to get weller, financially. Still in the red but improving by about 68%, Amwell’s full year 2024 net loss was $212.6 million on $254 million in revenue versus 2023’s net loss of $679.2 million, which included a non-cash goodwill impairment charges of $436.5 million. Taking away the one-time charge though, the loss improvement was $31 million.

Q4 had a strong 36% improvement in subscription revenue versus prior year, driven by the implementation of a 22-month joint contract with technology firm Leidos to digitize the Military Health System (MHS). However, this contract expires in July and given cost-cutting in Washington, is not assured of renewal. Leidos is already in negotiation with the Department of Defense for a three-year extension. In cost reduction, Amwell reduced R&D expenses by 29% and looks at further cuts for 2025 of 10%.

For 2025, Amwell forecasts revenue in the range of $250 to $260 million, including the previously announced divestiture of Amwell
Psychiatric Care, about $30 million) with adjusted EBITDA loss between $55 to $45 million. Positive cash flow is not forecast until 2026. But Amwell’s share price, in such a hole that the NYSE threatened delisting a year ago, has bounced from below $8 in January to closing at $11.73 today (13 February).  Amwell 2024 financial report, Healthcare Dive

HEALWELL AI one step closer to closing its purchase of Orion Health. HEALWELL needed consent from New Zealand’s Overseas Investment Office of New Zealand (OIO) to proceed with the purchase announced in December [TTA 19 Dec 2024]. HEALWELL is an artificial intelligence company focused on preventative care through the early identification and detection of disease while Orion’s products–Orchestral, Amadeus, and Virtuoso–are data exchange, patient record, and analytics platforms that benefit clinicians and patients. The complex buy totaled NZ$200 million/CA$165 million (US$115 million) for 100% of Orion’s private shares. CA$86 million will be paid in cash and the balance will be paid in HEALWELL stock plus CA$20.5 million in a 3-year performance-based arrangement. The companies are now on track to complete the sale by 1 April. Newsfile release

Summer Health buys Caraway. Summer is a text service that connects parents with pediatricians for urgent care through texting and converts doctor’s and clinical notes into lay language via generative AI. Caraway served a different market–Generation Z women between 18-29 for mental and reproductive health. What they did share was one investor: the powerful 7Wire Ventures. Was this another Shotgun Merger? While Caraway enjoyed an initial funding of over $10 million plus $16 million during the 2023 slump, apparently it had ceased business in December and took its website offline. How Summer positions it is that it now can serve children, teens, and young adults. In addition to its 50-state DTC direct pay service, it will pick up Caraway’s insurance contracts. There are no references to purchase price or workforce transitions. Other than the release, there’s no reference to Caraway services on the Summer website. Summer had a Series A raise of $11 million last April.    Summer release, Behavioral Health Business  Hat tip to Mario Aguilar of STAT Health Tech’s newsletter.

Following up on Ireland’s Spectrum.Life.  They ended their 2024 serving 1.5 million users and project 3 million in 2025 in Ireland and the UK. Spectrum.Life now has 300 employees in Dublin and Manchester delivering digital health, mental health, and wellbeing for employers and employees in the workplace, insurers, and educators. Last year it was listed as #41st in Deloitte Ireland’s 2024 Technology Fast 50 Awards. Release.

And a bit closer to the Editor’s home is the latest New York Digital Health 100. Named by Digital Health New York (DHNY) and in its sixth year (oh, the changes!), the list has 48 new startups (which is illustrative of the churn in the NY digital health scene) these 100 companies raised about $4 billion, with over half going to biotech (26%), care delivery (24%), and mental health (13%) companies. A download of the full report and lists is available at the above link.

Government updates: GAO scores HHS on cybersecurity issues; patient issues largely omitted from EHR notes in VA study

November 20, 2024 | by

The Government Accountability Office (GAO) latest report remains critical of HHS’ leadership on cybersecurity issues. Using the immense Change Healthcare data breach as a glaring example, GAO’s latest report released 13 November outlines HHS’s continued ‘challenges’ in ensuring that, among Federal agencies, it takes the lead in strengthening cybersecurity in the healthcare sector. For instance, HHS coordinates with the Cybersecurity and Infrastructure Security Agency (CISA), which is the national coordinating agency for critical infrastructure security and resilience. Where HHS comes up short (again) against GAO prior reports and recommendations is:

  • Weakness in tracking how healthcare organizations are effectively mitigating ransomware 
  • Not yet assessing how healthcare organizations are adopting the ransomware-specific practices outlined in the NIST (National Institute of Standards and Technology) cybersecurity framework centered on identifying, detect, protect, respond, and recover.
  • Inability to document the effectiveness of support HHS provides to healthcare organizations, such as guidance documents, training, job aids, and threat briefings to help the sector manage ransomware risks.   
  • Not conducting a comprehensive sector-wide cybersecurity risk assessment addressing IoT (Internet of Things) and OT (operational technology) devices and systems common in healthcare.
  • Using their Administration for Strategic Preparedness and Response (ASPR) to fully and consistently monitor its working groups supporting the healthcare sector on progress against goals, responsibilities, and on their collaboration.
  • The Centers for Medicare and Medicaid Services (CMS) has had requirements since 2020 with parameters that conflicted with those established by other federal agencies that share data with states, such as the Social Security Administration.
  • CMS has policies to assess states’ cybersecurity but does not coordinate with other federal agencies on the assessments.

GAO’s latest report recommended that:

  • HHS, in coordination with CISA and sector entities, determines the sector’s adoption of leading cybersecurity practices that help reduce ransomware risk.
  • HHS, in coordination with CISA and sector entities, develops evaluation procedures to measure the effectiveness of its support in helping to reduce ransomware risk.
  • HHS includes IoT and OT devices as part of the risk assessments of the sector’s cyber environment.
  • ASPR takes action to fully and consistently demonstrate leading collaboration practices .
  • CMS 1) solicits input from relevant federal agencies on revisions to its security policy to ensure consistency across cybersecurity requirements for state agencies. 2) revises its assessment policies to maximize coordination with other federal agencies.

Highlights and full report 

EHR notes also come up short when it comes to issues brought up by patients–and include information outside the clinician-patient transcript. This observational study from the Regenstrief Institute by two Indiana University medical researchers at the VA found multiple discrepancies in EHR notes that are supposed to recap the actual conversation between patient and clinician during a primary care appointment versus the actual transcript. It took place at four primary care clinics at a midwestern Veterans Affairs (VA) Medical Center and one associated VA community-based outpatient clinic, all using the current VistA EHR. Video and audio recordings were used to create transcripts that were compared with the EHR notes.

The discrepancies were bi-directional. According to the study, “fewer than half of issues that patients initiated in discussion were included in notes, and nearly half of notes referred to information or observations that could not be verified.” There was also a difference in recording by who brought it up. For instance, psychosocial issues were common in patient-clinician discussions. “The researchers found that when the clinician initiated discussion about these issues, 92 percent of notes in the EHR included them, but when the patient initiated discussion, only 45 percent did.”

There were also gaps in quality that were questioned in the study:

  • 8% of notes lacked an assessment and plan. Were some assessments truly incomplete, and some important plans actually skipped?
  • 18% of notes were missing follow-up plans. Were some follow-up plans never arranged?
  • 26% lacked reports of diagnostic test results. Were such results simply absent or unimportant, or were important findings unavailable, difficult to access, or overlooked?

“We recognize that certain variations in EHR documentation stem from authors’ preferences or styles about how to organize or structure notes. At the same time, notes should not lack critical elements.” Reasons for omissions could include “lack of recognition of the significance of a problem by clinicians, forgetfulness while writing notes, insufficient time to complete records accurately and thoroughly; belief that the issue had already been addressed; or prioritization of other concerns.”

Both Drs. Michael Weiner and Richard Frankel are researchers in various aspects of health information technology to improve patient outcomes and doctor-patient communication. They are affiliated with the US Department of Veterans Affairs Health Services Research and Development Center for Health Information and Communication, as well as professors of medicine at Indiana University’s medical school. Regenstrief Institute article 12 Nov, BMC Primary Care published study 18 July 2024

HHS reorganizing ONC, ASTP in tech funding, talent bid; FDA’s Digital Health Advisory Committee named; GAO scores progress on VA Telehealth Access Program

August 8, 2024 | by

Time to make lemonade? The US Department of Health and Human Services (HHS), in the midst of technical challenges such as AI and cybersecurity, has turned its weary eyes to a reorganization of a function that goes back two decades to the GW Bush administration. Technology has been under the purview of the Office of the National Coordinator (ONC) for Health Information Technology (HIT), currently Micky Tripathi, within HHS–but not entirely. The HHS solution is to rename ONC-HIT as the Office of the Assistant Secretary for Technology Policy, or ASTP, and to add in IT functions distributed to other offices within HHS. 

  • Not unexpectedly, HHS will hire three new technical experts: a chief technology officer (vacant for several years), a chief AI officer (currently held by Tripathi). and a chief data officer.
  • The new ASTP will also absorb the IT functions within HHS’ Assistant Secretary for Administration (ASA).
  • Another shift is being made to the HHS 405(d) Program, a partnership between the health sector and the federal government to align healthcare  cybersecurity practices. That moves from ASA to the Administration for Strategic Preparedness and Response (ASPR).

With this, ASTP hopes for more funding. Since the early 2000s, their budget has remained stagnant at $50-65 million, not including ‘paste ons’ for initiatives such as HITECH and 21st Century Cures. Healthcare Dive, Fierce Healthcare

Another alphabet committee formed to advise the Food and Drug Administration (FDA). The Digital Health Advisory Committee (DHAC) has been named to advise FDA on topics such as AI/ML, virtual reality, wearables, digital therapeutics, and remote patient monitoring (RPM). The chair will be Ami Bhatt, MD, chief innovation officer of the American College of Cardiology. A full list of the committee is in FierceHealthcare and the DHAC industry representative pool is here.

The Government Accountability Office (GAO) has more than a few reservations about the Veterans Health Administration’s Telehealth Access Program. The VA has had in place since 2019 a distributed telehealth program to enable veterans without internet access at home to obtain clinical telehealth services at outside locations. The Accessing Telehealth at Local Area Stations (ATLAS) pilot program works with private organizations, such as veterans service organizations, to provide locations where veterans can connect with VA clinicians for video consults. The problem is that 14 of 24 ATLAS sites active at the time had no veteran visits in Federal FY 2022 and 2023. Of the active 10, reports were favorable but not measurable. Where GAO scores VA is that the program lacked performance goals and related measures. VA going forward will implement goals and measures based on leading good practices and assess the effectiveness and efficiency of the ATLAS program on an ongoing basis. GAO report.

News roundup: Change responsible for data breach notices; 37% of healthcare orgs have no cybersec contingency plan; health execs scared by Ascension breach; CVS continues betting on health services; Plenful’s $17M Series A

June 5, 2024 | by

HHS agrees with providers that the data breach notification is on Change Healthcare, not them. Health and Human Services’ Office for Civil Rights (OCR) moved quickly to formally change the FAQs that kicked off the 100+ provider letter [TTA 23 May]. Now “Covered entities affected by the Change Healthcare breach may delegate to Change Healthcare the tasks of providing the required HIPAA breach notifications on their behalf.” “Covered entities” in this case refers to the providers. Only one entity–Change or the provider–“needs to complete breach notifications to affected individuals, HHS, and where applicable the media.” Providers must contact Change Healthcare for the delegation. 

Chad Golder, general counsel and secretary at the American Hospital Association (AHA) said in their statement, “As we explained then, not only is there legal authority for UnitedHealth Group to make these notifications, but requiring hospitals to make their own notifications would confuse patients and impose unnecessary costs on providers, particularly when they have already suffered so greatly from this attack.” HHS notice, Healthcare Dive

Meanwhile, UHG still does not know the extent of the breach which started in late February. Knowing the extent of the breach is needed to start notifications. It has not formally notified HHS of the breach long past the 60-day mandated window (see #3 in the HHS FAQs). This may create an ‘unreasonable delay’ (see #6). Not all Change systems are back up either–see the Optum Solutions page that has plenty of red Xs.

Only 63% of healthcare organizations have a cybersecurity response plan in place, leaving 37% without a plan. This is based on a survey of 296 IT/data security/management executive respondents working at healthcare organizations in the US performed by Software Advice, an advisory and consulting firm. Other findings:

  • Nearly 1 in 3 have had a data breach in the last three years
  • 42% of practices have experienced a ransomware attack, and of those, 48% say the attack impacted customer data
  • 34% failed to recover data after the ransomware attack
  • 55% of medical practices allow access to more data than employees need to do their job which makes them more vulnerable to attacks
  • While 41% of data breaches are attributable to malicious hacking, another 39% are due to malware, 37% are due to social engineering and phishing scams, 36% are due to software vulnerabilities, and 30% are due to employee error.

It would have been helpful if Software Advice in its report had broken down the type of practices surveyed. Healthcare Dive

Meanwhile, healthcare executives were ‘scared’ by the Ascension Health breach, as they should have been. Katie Adams’ piece in MedCityNews explores reactions from five different C-suite hospital executives about the recent attack on Ascension. The IT and data officers are from MD Anderson, Yale New Haven Health, CommonSpirit Health, Allegheny Health Network, and UPMC. The overall take was that threats are more common than ever, bad actors are abundant and getting better (using tools that can make amateurs into pretty good “bad actors” via “LLM products and have them help you build ransomware code.”), managing weaknesses in third-party vendors that live in the cloud is a Herculean task, phishing, and the need for ‘government’ to be involved. 

This Editor notes that the rush for providers into generative AI, given this environment, is perhaps premature. Yet here they go; researchers from Mount Sinai’s Icahn School of Medicine used structured data, such as vital signs, and unstructured data, such as nurse triage notes, to develop models predicting hospital admissions using ChatGPT-4. It supposedly can learn from fewer examples than other machine-learning models currently used and use data from traditional models. Becker’s

Ascension is slowly coming back, now projecting that all their locations will have their EHRs restored by the week of 14 June. Currently, only Florida, Alabama and Austin are up and running. Ascension Rx retail, home delivery and specialty pharmacy sites are now open as well. They will have some ‘splainin’ to do to HHS OCR. Ascension update site

CVS is confident in the future of its retail health despite their struggles with Minute Clinics and Oak Street.  Despite the struggle of retail health clinics at other providers such as Walgreens/VillageMD and the shutdown of Walmart Health, Sree Chaguturu, MD, CVS Health’s executive vice president and chief medical officer, expressed complete confidence at a recent industry conclave, thINc360 – The Healthcare Innovation Congress. This is despite the closures of dozens of Minute Clinics in Southern California and New England [TTA 31 May] out of their 1,100 total plus that CVS seeking an investment partner for Oak Street [TTA 29 May]. Dr. Chaguturu returned time and again to the 10,000-odd CVS Pharmacy locations and their leverage within communities, leaning very hard on the 5 million people coming in daily and the ‘opportunity for their pharmacists to engage’. As a CVS customer at a small location, those busy pharmacists aren’t engaging with me unless I have a script to fill or need an OTC decongestant that’s on the state signoff list due to an ingredient. In fact, CVS locations have rather few people nowadays, including behind checkout counters. Then again, it was a meeting speech. FierceHealthcare

Concluding on a brighter note, Plenful’s Series A came in at a tidy $17 million. Plenful developed and markets an AI-assisted workflow-automation platform for pharmacy and healthcare operations, claiming that it automates over 95% of the work for disparate administrative workflows. Features include 340B audit, document processing, contracted rates optimization and inventory planning, and pharmacy cycle revenue and reporting. Founded in 2021, the company has already lined up some impressive clients. Lead investor TQ Ventures was joined by Mitchell Rales (cofounder and chairman of Danaher), Susa Ventures, Waterline Ventures, and Bessemer Partners, the lead for last September’s $9 million seed funding for a total of $26 million. Crunchbase, Mobihealthnews

Midweek news roundup: Optum exiting telehealth, laying off; Advocate Health selling MobileHelp; VA notifying 15M veterans re Change PHI breach, Oracle moving to Nashville–maybe? (updated)

May 1, 2024 | by

Optum Virtual Care closing, staff layoffs in progress. Optum Everycare CEO Jennifer Phalen on an 18 April internal conference call announced that the unit would close. According to sources, some employees would have layoff dates in July. No further details were available on other layoffs or plans for integrating Virtual Care’s capabilities into other Optum units, except for generalities. “We are com­mit­ted to pro­vid­ing pa­tients with a ro­bust net­work of providers for vir­tu­al ur­gent, pri­ma­ry and spe­cial­ty care op­tions,” and “We con­tin­u­al­ly re­view the ca­pa­bil­i­ties and ser­vices we of­fer to meet the grow­ing and evolv­ing needs of our busi­ness­es and the peo­ple we serve.” a spokesper­son for Unit­ed­Health said to End­points, a biopharma publication from the University of Kansas which broke the story.

For Optum, this is the second shoe drop about layoffs and closures in less than two weeks. Reports from social media and layoff-specific boards indicated that thousands were being laid off, from their plans to urgent care and providers [TTA 23 Apr]. These were not confirmed by Optum nor by UnitedHealth Group. It’s not known if this unit’s closure was included in the total. 

The larger picture is that it is symptomatic of the sudden growth, then equally sudden consolidation, of general telehealth. Optum opened the unit in April 2021 as the pandemic entered year 2. Utilizing existing capabilities, UHG claimed it facilitated more than 33 million telehealth visits in 2020, up from 1.2 million in 2019. The number looks sky high but in that time of practices closing it was a free-for-all in telehealth–and ‘facilitating’ is a nebulous catchword that could mean a practice using Facetime, telephones, or an EHR/population health platform module. Commercial claims for telehealth have remained at 4 to 5% since (FAIR Health, Jan 2024). Even during the pandemic’s first year, telehealth claims hit a peak of 13 percent in April 2020 that dropped fast to 6% by August 2020. Well over 60% are for behavioral telehealth claims.

A leading indicator: Last June, Optum Everycare’s CEO from their 2021 start, Kristi Henderson, a former Optum SVP for digital transformation, departed to become CEO of Confluent Health, a national network of occupational and physical therapy clinics. It was about as far away as one could get from telehealth, digital transformation, and Amazon Care, her former employer that expired in 2022.

Apparently, UHG and Optum see no further need for a virtual care specialty unit, instead integrating it into plans and other Optum services. According to MedCityNews, industry analysts aren’t surprised. Both Amwell and Teladoc have had well-known struggles. The latest: Walmart, after investing millions into their unit that included full clinics and a virtual care service, also made news on 30 April that it is closing both. Also greatly on UHG’s mind: cleanup after the Change debacle, making Mr. Market happy, and the looming antitrust action by DOJ. Becker’s, Healthcare IT News, 

In another sign that healthcare investors are selling off ancillary businesses, Advocate Health is selling PERS provider MobileHelp. It “no longer fit the strategic priorities of Advocate Health” according to their 22 April audit report (see document pages 10 and 13) and was authorized last December.

Advocate, through its investment arm Advocate Aurora Enterprises, acquired both MobileHelp, one of the earliest mobile PERS, and sister company Clear Arch Health, a remote patient monitoring provider, in April 2022. Cost was not disclosed at that time but later was reported to be $290.7 million. The plan at the time was to combine both MobileHelp and Clear Arch with a senior care/home health provider earlier acquired by Advocate for $187 million, Senior Helpers. That company was sold in March to Chicago-based private equity firm Waud Capital Partners for an undisclosed amount. The MobileHelp sale is expected to close later this year. Buyer and price are not disclosed. The expected loss on the MobileHelp sale was figured into FY 2023 as part of an asset impairment write-down of $150 million, which Advocate said was “related to the expected loss on the sale of MobileHelp.” The PERS and RPM business is a largely consolidated ‘cash cow’ type of business that (Editor’s prediction) will be snapped up by another player like Connect America, Alert One, or a smaller player like ModivCare. Milwaukee Business Journal, Becker’s, Crain’s Chicago Business (requires subscription)

VA admits that some veterans may be affected by Change Healthcare data breach, PII/PHI disclosure. While Department of Veterans Affairs Secretary Denis McDonough at this time believes that “there’s no confirmation yet” that veteran data was exposed, the scope of the Change Healthcare breach has led VA to formally alert via email 15 million veterans and their families of the possibility. The email also included information “about the two years of free credit monitoring and identity theft protection” that Change Healthcare is offering to those affected by the attack. The VA maintains that the attack resulted in only a temporary delay in filling 40,000 prescriptions but did not cause “any adverse impact on patient care or outcomes,” according to a department spokesman. NextGov/FCW 26 April, 23 April 

In related news, HHS as of 19 April had not received any notification from Change Healthcare nor UHG. They are required to file a breach report as providers and also as covered entities. They have 60 days from the breach occurrence on 21 February to report, which is coming right up. Becker’s

If Larry said it, it must be true…assemble the moving boxes. At an Oracle conference in Nashville last week, Oracle chairman Larry Ellison said to Bill Frist of investment firm Frist Cressey Ventures that he planned to move the company to that city as “It’s the center of the industry we’re most concerned about, which is the healthcare industry.” It’s their second public Larry and Billy meetup in the last few months, the last in November at the Frist Cressey Ventures Forum where Ellison had previously touted Nashville. Ellison is investing in and building a 70-acre, $1.35 billion campus on Nashville’s riverfront. Oracle is currently HQ’d in Austin, Texas having moved in 2020 from Redwood City, California but with extensive facilities remaining in the state. Texas and Tennessee have one thing in common–a superior business climate. Both are long on lifestyle, though Austin is not as temperate (read, hot) as Nashville. What Nashville has that Austin doesn’t is being a healthcare hub. At least in Ellison’s view, healthcare is where it’s at and so is Nashville. So as long as he’s running Oracle from his manse on Lanai, Oracle does what Larry says. Healthcare Dive, Healthcare IT News, The Tennessean

More fun facts about Larry Ellison and Nashville: David Ellison, his son, is founder of Skydance Media, a major Hollywood production company (Mission: Impossible and others) and negotiating a zillion-dollar merger with Paramount Pictures. David’s wife is a singer trying to make it in Music City and they have a home there. Kind of like the age-old trend of moving the HQ near where the CEO’s living. On moving the HQ to Nashville from Austin, this would affect perhaps 2,500 workers based there currently. Most of Oracle’s workers are dispersed and work remotely. 6,400 of former Cerner-ites are still in Missouri and 7,000 remain in California. Big hat tip to HIStalk—scroll down and see more about Larry and Billy’s talk, which also covered cybersecurity, the NHS (which uses Cerner), and automating hospitals and the hospital-payer interface.

Is BlackCat/ALPHV faking its own ‘death’? (updated) HHS and CMS come to Change affected providers’ assistance with ‘flexibilities’

March 7, 2024 | by

BlackCat/ALPHV blames the FBI for another ‘shutdown’ and exits, stage left. BlackCat put up a copy of the shutdown screen (left) that appeared on their old leak website back in December [TTA 22 Dec 23] on their new leak website, claiming that law enforcement shut them down. This was not confirmed by the FBI either way, but Europol and the NCA confirmed to Bleeping Computer that they had no recent activity involving BlackCat. The other tell was that the source code on both screens was different–it was served up on another server.

On a Russian hacker forum called Ramp, BlackCat/ALPHV claimed that they “decided to completely close the project” and “we can officially declare that the feds screwed us over. The source code will be sold, the deal is already being negotiated”. The source code is reportedly up for sale for $5 million.

As to the $22 million, BlackCat/ALPHV never admitted it was paid by Optum/Change (nor is Optum confirming), but the affiliate called “notchy” which didn’t get paid [TTA 5 Mar] shared (to Bleeping Computer) that “a cryptocurrency payment address that recorded only one incoming transfer of 350 bitcoins (about $23 million) from a wallet that appears to have been used specifically for this transaction on March 2nd.” That wallet distributed (seven) equal payments of $3.3 million in bitcoin to other wallets.

(Update) Speaking of “notchy”, let’s not forget that this affiliate claims to have 4 TB of PHI/PII data from Change that could be sold or leaked. Since they never got paid by BlackCat/ALPHV, it’s safe to assume that information will be up, so to speak, for grabs.

When it all adds up–the fake FBI ‘raid’, shutting down servers, the signoff on Tox of “GG’ (good game?), the cutting off of affiliates (which also confirmed this to DataBreaches.net–and may or may not have been paid)–it resembles an exit scam.

(Update) Another excellent summary about ALPHV in Krebs On Security also updates LockBit, which was seized in an international takedown in February, and about governmental entities they ransomwared.  To be continued….

The lobbying of HHS by Congress, the American Hospital Association, and UHG to help out providers has produced some results. On 5 March, Health and Human Services (HHS) issued a statement that summarized various ‘flexibilities’ and workarounds to aid providers who cannot access systems or have to resort to alternatives to ensure continuity of services to patients. These will be administered through the Center for Medicare & Medicaid Services (CMS) and range from prior authorization, advance funding, and claims processing for Medicare. From the statement:

  • Medicare providers needing to change clearinghouses that they use for claims processing during these outages should contact their Medicare Administrative Contractor (MAC) to request a new electronic data interchange (EDI) enrollment for the switch.
  • CMS will issue guidance to Medicare Advantage (MA) organizations and Part D sponsors encouraging them to remove or relax prior authorization, other utilization management, and timely filing requirements during these system outages.
  • CMS is also encouraging MA plans to offer advance funding to providers most affected by this cyberattack.
  • CMS strongly encourages Medicaid and CHIP managed care plans to adopt the same strategies
  • If Medicare providers are having trouble filing claims or other necessary notices or other submissions, they should contact their MAC for details on exceptions, waivers, or extensions, or contact CMS regarding quality reporting programs. CMS has contacted all of the MACs to make sure they are prepared to accept paper claims from providers who need to file them.

Many payers are also making funds available while systems are offline. Hospitals may also face “significant cash flow problems from the unusual circumstances impacting hospitals’ operations, and – during outages arising from this event – facilities may submit accelerated payment requests to their respective servicing MACs for individual consideration.”

The statement closes with a reminder of HHS’ December concept paper on cybersecurity strategy for healthcare. DataBreaches.net (full statement), Becker’s

(Update) More on how this is affecting patient care focusing on cancer treatment, from the point of view of a Community Oncology Alliance spokesman. In addition, how consolidation is making healthcare more vulnerable to cybercriminals, and comments on UHG and Federal processes and payment offers to date. HealthcareITNews.

And DDoS attacks and questionable downtimes are now common.

Editor’s Update 11 Mar: The DataBreaches.net website had a major DDoS attack on 7 March and was down for two days thru 8 March. It is now fully up and running with our links working.

Multiple US Government websites went down Thursday evening 7 March based on news reports: Department of Homeland Security (DHS), Customs and Border Protection (CBP), Immigration & Customs Enforcement (ICE), Citizenship and Immigration Services (USCIS), US Secret Service and Federal Emergency Management Agency (FEMA). The timing based on the State of the Union address to Congress is, well, interesting. Daily Express   Later reports announced restoration later in evening. Cyberincidents are not exactly unknown on government websites.

Short takes: Humana’s big MA loss (updated); Medicare telemental care bill back in Senate; HHS releases cybersecurity performance goals; Texas Healthcare Challenge hackathon 23-24 February

January 26, 2024 | by

Humana apparently surprised Wall Street with their Q4 losses, driven by escalating Medicare Advantage (MA) costs.  While revenues ($26.5 billion) for MA’s second largest plan provider were up from prior year’s $24 billion, MA expenses drove an adjusted Q4 loss of $361 million under the insurance segment. From Humana’s earnings statement: “The sector is navigating significant regulatory changes while also absorbing unprecedented increases in medical cost trends. We believe the elevated MA medical costs are an industry dynamic, not specific to Humana, and that they may persist for an extended period or, in some cases, permanently reset the baseline.” On the earnings call, their CFO cited increased inpatient costs, especially for short stays, and more spending in outpatient surgeries and supplemental benefits–trends that Humana expects to continue into 2024 and even into 2025. Home health under CenterWell were tidily profitable and growing. Perhaps MA’s sector problems were the reasons why Cigna, selling off their MA plans, backed out of their acquisition/merger? Q4 press release, management remarks, Becker’s, Healthcare Dive

Updated Humana announced the appointment of a President of Enterprise Growth, David Dintenfass, to spearhead customer growth and retention. His background is not healthcare but Fidelity Emerging Growth Markets, with previous stints at Procter & Gamble and Bank of America. This assumes that the cost problem can be grown out of. Expect more departures and arrivals to roil Humana, as their current CEO moves to a planned retirement transition later this year and has already laid off staff in January.  Healthcare Dive

A bipartisan Senate bill proposes to continue coverage of virtual-only telemental health for Medicare beneficiaries. The ‘Telemental Health Care Access Act of 2023″ is sponsored by four Senators: Bill Cassidy, R-La., Tina Smith, D-Minn., John Thune, R-S.D., and Ben Cardin, D-Md. and is designed to make permanent the pandemic waiver of in-person requirements that expires at the end of 2024. The senators cited rural health and overall access to mental healthcare. Mental health remains the leading claim line for telehealth. Healthcare Dive, draft bill

The Department of Health and Human Services (HHS) published voluntary cybersecurity performance goals for healthcare and public health organizations. These fit within the HHS 405(d) Program and Health Sector Coordinating Council Cybersecurity Working Group’s Healthcare Industry Cybersecurity Practices as well as the NIST Cybersecurity Framework and the Cybersecurity and Infrastructure Security Agency’s National Cybersecurity Strategy. (Whew!) The two voluminous sets of goals, Essential and Enhanced, directly address common attack vectors against U.S. domestic hospitals as identified in the 2023 Hospital Cyber Resiliency Landscape Analysis. As noted earlier this week, there were 116 million patient records exposed in 2023 data breaches, doubling that in 2022.

HHS means well, but this is another ‘blood out of a rock’ situation. Health IT departments all over the US, from providers to payers, have had or are facing layoffs in the ongoing clash of business versus technology, which won’t cease because HHS would like it to. HealthcareDive, HealthcareITNews, 

The Texas Healthcare Challenge Hackathon is back! After three years dark, this year’s edition will be held this year 23-24 February in Dallas. Sponsored by the Health Wildcatters, a Dallas-based accelerator in the DFW area, it is open to just about anyone who can apply–you don’t have to code or hack. Friday kicks off with “problem pitching,” where participants form teams around identified issues, with Saturday starting with morning motivation and intensive team hacking, moving to participants developing viable solutions, assessing market potential, creating functional business models, and addressing risks with mentor support from industry experts. The day culminates in team presentations, with judges awarding cash and in-kind prizes to winning solutions. Learn more and apply here (application form is under the numbers, click on “Hackathon Sign-Up”). Sponsorship is the second button.

News roundup: ONC recommends ‘nutrition labeling’ for healthcare AI apps but Google moves forward; CVS’ health services rebranding as Healthspire (updated); Clover Health repots out of ACO REACH

December 6, 2023 | by

Straining toward a model for AI app information? The latest grope by Federal regulators towards the “trustworthy use of artificial intelligence”, as the American Telemedicine Association terms it, is a labeling system that has been likened to ‘nutrition labeling’. This near-incomprehensible analogy to food labeling was proposed back in April by the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC), now headed by Micky Tripathi, Ph.D. This disclosure would consist of how the app was trained, how it performs, how it should be used, and how it shouldn’t, which does not sound onerous at all. The disclosures are designed to forestall issues around performance and bias that have previously appeared, such as Epic’s AI system designed to predict sepsis risk and an algorithm designed to flag patients needing assistance with complex treatment regimens. 

An optional proposed disclosure around how the app was trained and tested would be important to healthcare organizations but potentially problematic to developers. There are quite a few caveats expressed by Silicon Valley investors around hurting startups and even giants like Epic through over-disclosure of proprietary information, enabling reverse engineering and poaching of intellectual property. Everyone likes transparency, trust, safety, and efficacy, but the conundrum is to disclose what is needed for proper and cautious use without providing an entreé to IP. Wall Street Journal, Becker’s, ATA release and AI principles 

Google, predictably, damns the torpedoes, full speed ahead with healthcare AI. And intends to write the rules. They’ve deployed AI tools already with Mayo Clinic and HCA Healthcare–Mayo for medical records and research papers, HCA for clinical notes. EHR Meditech is using Google’s AI for clinical documentation and to summarize patient histories. Bayer is also working with Google. Their products include a licensed algorithm for breast and lung cancer detection, a tool for diagnosing diabetic retinopathy, and a question-answering bot. Google makes no secret that they plan to influence Federal efforts at setting standards by hiring lobbyists, most of whom are out of the Food and Drug Administration (FDA), and playing a large role in industry groups such as the Coalition for Health AI (CHAI).  If you believe that Google, Microsoft, Amazon (playing catchup), or other healthcare service companies like UnitedHealth Group’s Optum will twiddle their thumbs and wait for the Feds to set standards and (good grief) enforce disclosure on AI tools, this Editor has several lovely bridges for sale. POLITICO, Becker’s

CVS Health grouping health services and multi-payer assets under CVS Healthspire. Monday’s announcement at the Forbes Healthcare Summit will roll up new $20 billion acquisitions Oak Street Health and Signify Health along with 1,100 MinuteClinics, the CVS Caremark pharmacy benefit manager (PBM), CVS Specialty, and its new Cordavis operation that works with pharmaceutical companies to bring to market  biosimilars. The rebranding, a clever melding of ‘health’ and ‘inspire’, will start this month into 2024. It’s not revealed whether the current names will be sunsetted for CVS Healthspire, or whether they will keep their established brand names. The parallels are with Evernorth (Cigna), Optum (UnitedHealth Group), and Carelon (Elevance, the former Anthem) in creating a vertically integrated healthcare company. At Investor Day, CVS Pharmacy announced a cost-plus arrangement for retail prescriptions built on the cost of the drug, a set markup, and a fee that reflects the care and value of pharmacy services–clearly in competition with Mark Cuban CostPlus.  Forbes, FierceHealthcare, CVS release, Investor Day release  

Clover Health exits the advanced value-based primary care program, ACO REACH. Clover’s exit at the end of the 2023 performance year after two years disbands their practice arrangements for CMS’ advanced original Medicare shared savings program, formerly Direct Contracting, and provision of beneficiary services after completing their required wrapups and reporting. It is part of their recent moves to become profitable, focusing on their Medicare Advantage business and Clover Assistant management. They outsourced their Medicare Advantage plan administration to UST HealthProof for a savings of $30 million and laid off 10% of staff as part of restructuring. A 2021 SPAC on Nasdaq debuting above $16 that survived investigations by the SEC and DOJ now has shares trading currently under the $1.00 minimum for listing. Clover also finally settled seven shareholder lawsuits over its non-disclosure of the DOJ investigation at the time of the SPAC. Cleaning house is all part of living to fight another day, like other ‘insurtechs’ such as Oscar Health. Clover release, FierceHealthcare  Also: Looking back at insurtechs and their ‘disruption’,  Insurtechs in the widening gyre

This ‘n’ that: HHS settles *2017* ransomware breach, Carbon Health lays off 114 in restructuring, why oh why VC General Catalyst wants a $3B health system, when Larry Met Billy, a lexicon of workplace terms

November 2, 2023 | by

It only took five years to levy a $100,000 fine. Doctors’ Management Services, a Massachusetts-based medical management company, had a ransomware attack back in 2017 that exposed 206,695 individuals to personal health information violations. The Health and Human Services (HHS) Office for Civil Rights (OCR), which is charged with actually enforcing penalties and remedies for data breaches, decided that Doctors’ management hadn’t done quite enough to protect their patients. The cyberattack was identified in December 2018, but Doctors’ didn’t report the breach to OCR until April 2019. Their network had been infected with GandCrab ransomware. After determining various protection failures, HHS put them on a three-year corrective plan to protect their data and collected the $100,000 fine, their very first. But still, nearly four years later? And with breaches, ransomware, and hacking going on every day?  Healthcare Dive

Another Covid unicorn comes down with a bang. Carbon Health, a 13-state network of primary care clinics along with virtual care in areas such as mental health, says ‘bye’ to 114 or 5% of its staff. It grew and got funded big during Covid as it set up testing and vaccine initiatives, achieving a valuation of $3 billion. In 2021, Covid accounted for 60% of their revenue, but as it waned in 2022, so did their revenue by 23%. To date, their funding has been over $622 million, with $100 million in January in a Series D funded by CVS Health Ventures. This isn’t their first big layoff–200 staffers said goodbye in January as well as 250 in mid-2022 which was about 8%. Becker’s

General Catalyst’s newest venture into Health Transformation Land, HATco, The Health Assurance Transformation Corporation, is in the market for a health system in the “$1 billion to $3 billion” range. Not too small to not have an impact in their communities, and large enough to have capabilities around value-based care plus a track record of excellence. This is to create their ‘blueprint’ for healthcare transformation. Interested parties should contact CEO Marc Harrison, MD. Their other plans to get there were announced at HLTH. As to why…General Catalyst has had a lot of experience with companies, and perhaps they feel they have a Better Way to Get There. Becker’s, TTA 10 Oct.

Of Note…The second wealthiest executive in healthcare, Oracle’s Larry Ellison, wasn’t too busy to hang out with the third wealthiest on Forbes’ list, former senator and HCA honcho Bill Frist, in Nashville at the inaugural Frist Cressey Ventures Forum. Ellison is also investing in a 70-acre, $1.35 billion campus on Nashville’s riverfront. It’s always nice to make nice with the neighbors, especially when they have major holdings in a large health corporation. Becker’s

To wrap up This ‘N’ That, Becker’s has a useful article that will keep you au courant on those workplace terms you see on places like LinkedIn. ‘Quiet quitting’, so popular in 2021-2, has had its day with layoffs leading to real ‘quitting’, leaving behind ‘grumpy stayers’ who try to get away with ‘Bare Minimum Mondays’. ‘Coffee badging’ was a new one on your Editor. The rest are catchy phrases for things as old as time in the workplace.

Short takes: follow up on Cano Health’s survival moves, eMed transitioning Babylon Health UK but Babyl Rwanda shuts, DEA extends telehealth prescribing for controlled substances thru 2024

October 11, 2023 | by

Cano Health takes the reverse stock split option to stay solvent. In Cano’s latest telenovela episode, a familiar stratagem for companies to drive up a dangerously low share price is to reverse stock split, usually in a large ratio. Cano is facing delisting on the NYSE as its shares traded, as of 11 September, below the $1 minimum for 30 days. [TTA 29 Sept]  Shareholders are being asked to approve a 1 for 60 ratio with the board having the right to adjust it down to 1-for-5 and up to 1-for-100, for both Class A and B common stock. At the current share price of $0.21, a new share’s value would be $12.60. No meeting date has been set, though the press release bluntly states that 30% shareholder ITC Rumba, LLC and the 20% held by current and former members of management and the board intend to vote in favor of it, achieving the necessary simple majority. 1:60 does sound last-ditch, reminiscent of Babylon Health’s late 2022 moves in a 1 for 25 exchange, before attempting to go private–and we know how that turned out. Release

eMed transitioning Babylon Health services in the UK. A check on Babylon Health’s UK website provides FAQs for current users. It leads with promises to expand digital-first primary care services on this registration page for visits, and to develop a chronic care management service starting with medical weight management using Wegovy. The FAQs also state there will be no disruptions to GP at Hand. There is a rebranding (left/above) that sunsets the Babylon name but retains the stylized heart. 

Babyl Rwanda‘s separate website and the eMed pages for Babyl Rwanda are still up, but a local report from 24 September states that the company has ceased operations in Rwanda. As of August, the government was scrambling to find buyers and to maintain operations to 2.4 million Rwandans. “According to Julien Mahoro Niyingabira, the Rwanda Health Communication Centre (RHCC) Division Manager, the Ministry of Health is in discussions with Babyl Rwanda to ensure continuity of services despite the closure of Babylon Health.” How that will be possible without a buyer to pay employees and maintain the operation is debatable. The New Times (Rwanda)

As for the US, the Babylon Health US site also remains up and intact with a small disclaimer at the top that US services are no longer available and to contact your health plan. It is the same as on our last visit on 14 September. It is odd to see, after another month, that no one has disabled the US services or corporate pages such as Investors. This is possibly because the architecture for the US pages are off the UK site (the tab at top has the eMed logo) and nobody is in the US operation to take down the pages. The US operation, in Chapter 7 bankruptcy liquidation, is now in the tender hands of the US bankruptcy courts, where filings, documentation, and processes move slowly indeed with no further public news.

And when you can’t decide, extend. The Drug Enforcement Administration (DEA) and Health and Human Services (HHS) once again are extending Covid-time flexibilities for prescribing controlled substances through 2024.  After 38,000 comments on the proposed changes to rules after the last extension in May, DEA and HHS punted again on reimposing Ryan-Haight Act restrictions that would require in-person evaluations/visits prior to prescribing. This allows clinicians to prescribe Schedule II–V controlled medications via audio-video telemedicine encounters, including Schedule III–V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid use disorder. Final rules will be timed for Fall 2024. Another year’s breathing room for  6 Oct DEA announcement, Federal Register 10 October “Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications”, Healthcare Dive