TTA’s Blooming Spring 5: Hinge Health’s IPO, 23andMe bought by Regeneron, sans Lemonaid, WeightWatchers’ future, debuts of Smarter Technologies and Fuze Health, VA EHR update, more!

May 23, 2025 | by

 

23 May 2025

The major news this week was the Hinge Health IPO, the first for digital health in two years–but the downside was that it was at a lower valuation. Denouements abounded with most 23andMe genetic assets bought by Regeneron, without a drink of Lemonaid. WeightWatchers’ time may have passed, new heads for Calibrate and Oak Street, and two more ‘arranged marriages’, Smarter Technologies and Fuze Health. An update on the VA EHRM in the budget. Masimo’s recovering, as is Ted of Strata-gee. 

Remember our soldiers, sailors, airmen, and Marines who have passed on this Memorial Day. Our Monday newsletter will be on Tuesday.

News roundup 22 May: an inflight ‘save’ and AliveCor’s KardiaMobile, rolling out the VA/Oracle EHR in ‘waves’, Fuze Health formed from LetsGetChecked/Truepill, hacking and ransomware 92% of PHI data breaches (A renaming of a 2024 ‘arranged marriage’–can it be saved?)

News roundup: Hinge Health public @$32/share, lower valuation. Is WeightWatchers game over? Calibrate replaces CEO, new prez for Oak Street, NMC gets ‘Smarter’ rolling up 3 portfolio companies, another splash of investor ‘cold water’ (The first health tech IPO in 2 years and ‘smushing’ when they can’t)

Update: Masimo’s website status and an analysis of the Sound United sale (Getting up and running post-attack, but what happened?)

23andMe sold to Regeneron for $256M in court-supervised bankruptcy, sans Lemonaid. And is it worth it? (We come up with a number, it’s likely)

From last week: UnitedHealth Group changed out CEOs suddenly. The new one is a surprising ‘blast from the profitable past’ but that didn’t stop Mr. Market from taking the stock down down down. Another blast involves Elizabeth Holmes’ partner Billy Evans fronting a diagnostic testing- in-a-box startup.”Surprise, surprise!” No surprise that Holmes lost her appeal of an appeal–nor Omada Health filing for an IPO. Unfortunately, our investigator on all things Masimo met his own surprise walking on a sunny day–fortunately, Ted’s on the mend. More about BCIs with Apple integration, a chronic pain management startup, Parkinson’s data, two good raises, and what payers pay to keep their execs safe.

Short takes: Synchron BCI integrates with Apple devices, Shields Health partners with Duke on specialty pharmacy, raises for Cohere Health, Olio (More BCI action with Apple getting into it)

Theranos’ revenge? Holmes’ partner Billy Evans founds a startup for diagnostic testing, denies it is ‘Theranos 2.0’; Holmes loses Federal rehearing appeal. (Is Holmes advising long distance? Letters from a Texas Jail?)

News roundup: Omada Health files for IPO, UPMC-Redesign partner on chronic pain management, OK and PA AGs warn 23andMe users to delete data, Verily to build Parkinson’s dataset, what payers paid for exec security (Omada follows Hinge. But the last is surprising–between a lot and a little)

This just in: UnitedHealth Group CEO Andrew Witty steps down immediately, replaced by former CEO Stephen Hemsley (updated 15 May) (UHG may change out CEOs, but continues to be hammered by Mr. Market)

Best wishes to Strata-gee’s Ted Green on a fast recovery! (Ted, our ace Masimo investigator, was put rather suddenly in a bad place…use your eyes when you drive!)

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News roundup 22 May: an inflight ‘save’ and AliveCor’s KardiaMobile, rolling out the VA/Oracle EHR in ‘waves’, Fuze Health formed from LetsGetChecked/Truepill, hacking and ransomware 92% of PHI data breaches

May 23, 2025 | by

Leading our news with a short, heartwarming story.

A passenger on a 29 April KLM flight from Uganda to Amsterdam experienced, three hours in, heart attack symptoms and extreme pain. The Dutch passenger’s luck was that a group of passengers were medical volunteers with Cura from the World, a Oklahoma-based group returning from a medical mission to Uganda. Dr. TJ Trad, the founder/CEO and an invasive cardiologist, created an aid station for the passenger where his legs could be raised and his vitals monitored with the assistance of a nurse. The lucky part was that the team had most of its equipment aboard, including a 12-lead ECG to confirm his cardiac status, plus five medications used for emergency treatment. He was stabilized, but the interesting part was that Dr. Trad used his personal AliveCor KardiaMobile to monitor the patient for arrhythmia, the later and high emergency stage. Dr. Trad was carrying it because a year earlier, he had experienced his own heart attack that canceled out his last medical mission trip and used it to monitor himself. With the patient under monitoring and medications, the KLM flight did not have to divert to Tunisia and it landed at Amsterdam Schiphol three hours later. At the hospital, the Dutch patient was examined over 12 hours and eventually discharged, as he was not diagnosed with a heart attack, stroke or pulmonary embolism, according to the passenger’s wife speaking with CNN. Dr. Trad was able to catch his connecting flight home. From an aviation perspective, it underscores the need for medical training and an emergency kit for monitoring this type of incident. Hat tip to Dave Albert, MD, founder and chief medical officer of AliveCor.

VA now dubbing the rollout of the Oracle Cerner EHR as a ‘wave’ strategy. Dr. Neil Evans, the acting executive program director of VA’s Electronic Health Record Modernization Integration (EHRM) Office elaborated on the ‘wave’ in an interview with GovCIO Media & Research. Each rollout will be clustered in sites that routinely work together and where patients flow for care from one location to another. For instance, the planned 2026 rollout previously announced in December 2024 will be in four Michigan locations: VA Battle Creek Medical Center, VA Detroit Healthcare System, VA Ann Arbor Healthcare System, and VA Saginaw Healthcare System. The nine additional sites in 2026, except for Alaska standing alone, are similarly clustered [TTA 4 April]. The new news? FTA:

  • The White House’s proposed discretionary budget for FY 2026 calls for an increase of nearly $2.2 billion in funding for the EHR program as a “top priority effort.”
  • The proposed budget also plans to streamline much of the agency’s over 1000 IT systems, which it claims are “decades old” and “duplicative.”
  • It pauses procurement of new systems and directs the U.S. Department of Government Efficiency Service (DOGE) to conduct a full review of the agency’s IT systems alongside the VA.
  • Other government agencies are going through the same process: National Oceanic and Atmospheric Administration (NOAA), Defense Department (MHS), and the Coast Guard also are modernizing their EHRs. VA is learning from them as well as the private sector, according to Dr. Evans.

The ‘wave’ needs to work. Veterans Affairs Secretary Doug Collins outlined VA plans at two House appropriations hearings last week on the 2026 and 2027 VA budgets. The total for the EHRM is $3.5 billion in FY 2026 (Federal budgets start in October; the total budget has been dubbed the ‘Big Beautiful Budget’) and is needed for additional rollouts in FY 2027. But given the failures at the six existing implementations and the continuing fixes and patches, in a process that seems like it started in 1900 (actually 2018), one can understand the consternation of Veterans Affairs committee member Rep. Greg Murphy (R-NC): “I’m still dumbfounded at the billions and billions and billions of dollars that have been poured into an EHR that should have never been done in the first place. It’s not a system that should be used for the largest healthcare system in the country.” Healthcare Dive

Fuze Health launches–phase 2 of a merged LetsGetChecked and Truepill ‘arranged marriage’. The merger of the two last October with digital/mail order pharmacy Truepill operating as a subsidiary of at-home diagnostics via testing kits LetsGetChecked was a $525 million deal that we classified as a ‘smush’ when it was announced last August. Both were heavily invested in by Optum and torching  through cash. While $525 million was the purchase value in the headline, only $25 million was in cash and the rest of the financing didn’t add up to the total. The Phase 2 of this entity, Fuze Health, now has a third partner, prescription deliverer Alto, and a new name, Fuze Health. No acquisition amount is mentioned for Alto, which has a total funding of $62.4 million through a June 2021 Series B plus equity crowdfunding (March 2024!) and no financing from Optum (Crunchbase). The only Fuze management mentioned in the release are Alicia Boler Davis, Alto’s CEO, and Paul Greenall, Fuze chief development officer. Their website links back to the four individual companies.

In 2022, LetsGetChecked acquired Veritas Genetics, now prominently featured as part of Fuze. Also in 2022, Truepill fell under DEA scrutiny with a ‘show cause’ action after being a fulfillment pharmacy for Cerebral and Done Health in their Schedule II controlled substance violations. This was settled in November 2023 with multiple requirements including continuing heightened compliance (DEA release). Fuze Health promotes itself as “a technology-powered home health screening, genomics and pharmacy services provider committed to transforming patient experiences and enabling its healthcare partners – including care providers, health plans, employers and life sciences companies – to excel in an outcomes-focused system.” No mention of investors or backing, as is typical in these announcements.  Now go forth and make money. Hat tip to HIStalk 5/23/25 

Hacking and ransomware now constitute 92% of healthcare data breaches. Once upon a time, when this Editor reported on what were then unusual data breaches, the more common causes were insider theft, unauthorized access/disclosure, and improper disposal or loss. They have nearly vanished as the ‘business of breaches’ has settled down and internal security has approved. A cross-sectional study published as a research letter in JAMA Network surveyed breaches from 2009 to 2024 using HHS’s Office of Civil Rights (HHS-OCR) reporting. Of 566 incidents in 2024, 457 were “IT incidents” and 61 were tagged as ransomware, totaling 92%. Despite the massive Change Healthcare breach, ransomware breaches fell to 11%.  Considering patient records, there were 170 million breached in 2024 and hacking/IT incidents accounted for 91% of the total. Of 732 million records affected from 2010 to 2024, hacking or IT incidents and ransomware (considered as a subset) accounted for 88% (643 million) and 39% (285 million) of incidents. Since 2020, ransomware has affected more than half of all patients annually, reaching 69% in 2024–again, the effect of Change Healthcare. Also Healthcare Dive

Industry news short takes: fundings for Qure.AI, Centivo, Rippl, Surescripts; M&A closings for GE Healthcare-Intelligent Ultrasound, LetsGetChecked-Truepill. And is Hinge Health going public soon?

October 3, 2024 | by

The waning days of summer wrapped with a few moderate-sized fundings:

India’s Qure.AI scored a $65 million Series D, bringing their total funding to $125 million. Leading the raise: Lightspeed and 360 ONE Asset, followed by Merck Global Health Innovation Fund, Kae Capital, Novo Holdings, Health Quad, and TeamFund. Qure.AI uses AI to analyze radiology images and ultrasound scans, against billions of clinical image datasets. It currently is used in over 90 countries and 3,100 locations including NHS Trusts. While headquartered in India, Qure.AI has international HQs in NYC, London, and Dubai. The fresh funding will be used to expand its US presence, invest in foundational AI models, and interestingly, acquire medtech companies. Another emphasis of the company is to expand skilled radiology to locations which are resource-constrained, such as healthcare facilities in developing nations or in global rural areas. It is also being used in clinical trials by Johnson & Johnson, Astra Zeneca, and Viatris. MedCityNews 

Centivo added $75 million in equity and debt financing, bringing their total funding to $226.4 million. Centivo provides a primary-care centered health plan directly to employers in all 50 states by partnering with local health systems and direct contracts with ACOs in 18 markets. Centivo replaces traditional health plan and broker relationships. What they offer to employers is an advanced primary care centered model through Centivo Care, an in-house virtual primary care practice. They claimed as of 2023 results of 71% reduction in member out-of-pocket costs compared to commercial plans offered to employers, saving employers 15% or more, and increasing utilization of primary and specialty care. Whether this will “fix America’s broken healthcare model” (a meme we’ve heard many times before) is debatable, but the siren song of reduced healthcare costs for employers is evidently attractive to a raft of funders. It attracted new strategic investors Cone Health Ventures and MemorialCare Innovation Fund, plus existing financial investors including B Capital, Cox Enterprises, F-Prime Capital, Ingleside Investors, and Morgan Health (a division of JPMorgan Chase). Debt financing was provided by Trinity Capital and ongoing banking partner, JPMorgan Chase.  Release, Mobihealthnews, MedCityNews

It’s a $23 million Series A for Rippl to advance virtual on-demand dementia and senior-focused behavioral care. The new funding will be used to expand the company’s geographic footprint, currently Washington, Texas, Illinois, and Missouri, to California, Florida, and Arizona. The company’s key partners are the Alzheimer’s Association, Medicare Advantage Plans, ACOs and other payors and payviders. Rippl is also a participant in the Centers for Medicare & Medicaid Services’ (CMS) eight-year alternative payment model, the Guiding an Improved Dementia Experience Model (GUIDE Model). It started in July with 390 healthcare providers. The Series A was led by Tina Hoang-To, Kin Ventures Founding General Partner, with participation from Rippl’s seed investors ARCH Venture Partners, General Catalyst, GV (Google Ventures), F-Prime, Mass General Brigham Ventures, and 1843 Capital. JSL Health also joined the round. Release 

E-prescriber Surescripts now has a majority investment from private equity TPG Capital. The investment amount was not disclosed and regulatory approval is pending. Its current ownership is 50% by the National Community Pharmacies Association and the National Association of Chain Drug Stores, with the other half Express Scripts and CVS Caremark. It was not disclosed how the ownership shares would be adjusted among the five entities, as CEO Frank Harvey said that all will remain. Surescripts brought in Triple Tree to explore a sale back in April. This Editor noted then that Surescripts has about 95% of the e-prescribing market, enabling it to obfuscate their real business in the vagueness of “health intelligence sharing”. Certainly the PBM owners can use the cash, if cash they’ll get. Release, FierceHealthcare 

Closing M&A deals kick off the fall:

On Tuesday, GE Healthcare closed their $51 million purchase of Intelligent Ultrasound’s clinical AI business [TTA 25 July]. Intelligent already partnered with GEHC on its ScanNav Assist AI technology to power its SonoLystlive and SonoLyst X/IR for GEHC’s Voluson Expert and Voluson Signature ultrasound devices, plus the Voluson Swift. GEHC plans to incorporate Intelligent’s solutions across its ultrasound portfolio through improving workflows and enhancing ease of use for clinicians and patients. MassDevice

And the Optum-arranged ‘marriage’ of LetsGetChecked and Truepill wasted no time in closing on Tuesday. Truepill, a digital/mail order pharmacy, will operate as a subsidiary of LetsGetChecked, an at-home diagnostic with testing kits. Earlier reports indicated that Truepill would be the surviving entity.  Both companies have substantial investments from Optum Ventures and have been losing money for years. Truepill was caught up in the Cerebral and Done Health Schedule II as a fulfillment pharmacy for both and fell under DEA scrutiny with a ‘show cause’ action. TTA extensively analyzed the structure of the “$525 million” acquisition by LGC and the Optum role in it at the time of the announcement TTA 22 August. Interestingly, the closing announcement does not reiterate the acquisition cost. Release, Mobihealthnews

Will virtual MSK provider Hinge Health go public soon? Blake Madden in his Hospitalogy blog 1 October confirms that Morgan Stanley has been hired to run the long-rumored IPO process. Undoubtedly, their management is looking at Sword Health’s nifty recent raise and $3 billion valuation. Investors have been pushing for an exit for some time. In April, the last time that Hinge was on the TTA radar, it had cut 10% of its 1,700 employees yet at that time was rumored to be considering an IPO. Hinge’s last raise was an October 2021 $400 million Series E led by Tiger Global and Coatue Management for a total funding of $826.1 million over 10 raises (Crunchbase). At that time, their valuation was a bubbly $6.2 billion, which despite $400 million in cash reserves (as of April) and its popular niche, in today’s market would be drastically revised downward. Stay tuned….

US telehealth controlled substances prescribing waiver may expire at year’s end; DEA may further restrict

September 13, 2024 | by

Current waivers end 31 December without DEA, Congressional action. The Drug Enforcement Administration (DEA) apparently through inaction, will allow the current virtual prescribing flexibilities impacting Schedule II and higher drugs to expire at the end of year. These waivers which removed the in-person examination requirement under the Ryan-Haight Act were instituted during the Covid pandemic and extended twice [TTA 11 Oct 23, 11 May 23] with a final expiration of 31 December 2024.

Reportedly, the DEA is not only wishing to reinstate the status quo ante, but also reportedly wants to institute additional restrictions. However, any draft rule that would reimpose or changes restrictions has not been put out for the public comment period, review, and final rule implementation which typically takes anywhere from 60 to 120 days, well past year’s end. Last year, when a draft rule was released for comment, nearly 40,000 comments were received.

At the time of the 2023 extension that kicked this particular can down the road into the end of a presidential election year, DEA had stated that they would use 2024 to finalize telemedicine prescribing rules, but no action has been taken. Since then, the Department of Justice has filed multiple charges of Medicare and Medicaid fraud and illegal distribution of controlled substances against seven Done Global employees [TTA 3 July and prior], with investigations pending on practices by provider Cerebral and pharmacy Truepill. 

Under the aegis of the American Telemedicine Association (ATA), a coalition of 330+ organizations have again written as of Tuesday 10 September to the current administration and both houses of Congress to 1) extend the waivers for two years, as part of the end of the Federal fiscal year (starting 1 Oct) package, and 2) use the time for DEA to “to fulfill its congressional mandate to establish a special registration pathway that balances access to medically necessary care with appropriate enforcement.” The rationale centers on the lack of time, but strongly around the availability of psychiatrists throughout most of the US–there are none in half of US counties especially in rural areas. (The average MD psychiatrist is well over 50, nearing retirement, and not well reimbursed for his or her time–which is why med school grads in heavy debt don’t gravitate to the specialty.) What is not stated is that many if not most telepsychiatry providers do not have models that will support in-person evaluations as required without waivers.

There are no public actions or responses either by Congress or by the DEA as of today (13 September).

ATA press release, Biden Administration letter, House letter, Senate Leadership letter, Healthcare Dive

ATA Action, ATA’s trade organization and advocacy arm, has also formed a political action committee (PAC), ATA Action PAC. Its stated purpose is to support incumbent Federal candidates including Congressmembers who support their goals in virtual care policy. Candidates on the Federal or state levels will not receive support.  Release

Truepill to be acquired by LetsGetChecked for $525 million

August 22, 2024 | by

When is $525 million not $525 million?  Ireland’s LetsGetChecked and California-based Truepill have two things in common: backed by Optum and burning through cash. The deal went under the Labor Day wire:

  • How the buy is structured: $25 million in cash, another $200 million in possible earnouts tied to revenue milestones, and $150 million via a convertible note offering to finance the deal….which doesn’t add up to $525 million.
  • While LetsGetChecked is technically is doing the buying, it is creating a merger NewCo to unify both businesses. Truepill will be the surviving trade name as it has the slightly healthier business.
  • This creates a digital pharmacy to market and fulfill LetsGetChecked’s at-home testing kits.
  • Most of Truepill’s senior management, including their CEO, Paul Greenall, will remain. Greenall also received a $7.25 million forgivable loan. (The reason why is unstated, but these loans usually cover stock option purchases.)

No closing date nor required regulatory reviews are disclosed.

According to Axios, both businesses are in the red. “Truepill lost $15 million on $64 million in revenue for the first four months of this year (increased revenue run rate), while LCG lost $32 million on $39 million in revenue over the first five months of 2024 (declining revenue run rate)”. Truepill was valued in 2021 at $1.6 billion and had acquired $370 million in VC funding. 

As projected at the beginning of the year, health tech M&A are either tuck-ins or throwing in together to survive. Truepill had been shopped since March but received only one other offer. During the Cerebral and more recently developing Done Schedule II drug prescribing scandal in mid-2022, Truepill, as a mail-order pharmacy for both, found itself in the middle of it and under DEA scrutiny with a ‘show cause’ action. LetsGetChecked was also deeply underwater and not looking like it was surfacing. With the NewCo, it seems like an Optum Ventures-engineered ‘shotgun wedding’.  TTA 19 June,  19 Dec 2022

Done CEO, president arrested, charged with $100M fraud on Adderall distribution in first Federal case on telemedicine prescribing (updated)

June 19, 2024 | by | 1 Comment

Done effectively done at the C-level, but not done in business yet. Last Thursday, Ruthia He, the founder/CEO, and David Brody, listed as the clinical president of Done Global (Done), were arrested in California on a Federal indictment filed in the US District Court for the Northern District of California. They are charged with providing easy online teleprescription access to Adderall and other Schedule II stimulants through patients paying a monthly subscription fee and skirted the normal restrictions provided in the Controlled Substances Act (CSA) and other regulations. By providing easy access and raising subscription fees, He and Brody are charged with generating over $100 million in revenue by arranging for the prescription of over 40 million pills from 2020 into 2023, during the pandemic when the Ryan Haight requirements were temporarily suspended by the DEA. 

Given the multiple counts of conspiracy to distribute controlled substances and distribution of controlled substances, the charges may earn them a maximum 20 years in Federal prison. One would also expect a clawback of payments made by subscribers, health plans, and Federal programs. The latter two, according to the DOJ release, amount to $14 million alone.

The Done indictment is the first Federal prosecution of criminal drug distribution related to telemedicine prescribing by a digital health company. In the 2020-2023 period, Done was a seed stage company, cited in the indictment as misrepresenting its size. Its current backers are Craft Ventures, F7 Ventures, and Offline Ventures but no additional rounds are listed on Crunchbase or other sources. He was a former product designer at Facebook and she was involved as an investor in or founder of various startups before Done according to her LinkedIn profile. David Brody, MD, is a psychiatrist listed as the chief medical officer of Connectix Health and as a self-employed consultant in Collaboration Care, with no reference to a position at Done. 

According to the Department of Justice release, He and Brody:

  • Targeted drug-seeking users through social media buys in the tens of millions of dollars.
  • Intentionally structured the Done platform to facilitate access to Adderall and other stimulants. This is evident from their current website which emphasizes ADHD. 
  • Instructed Done prescribers to prescribe Adderall and other stimulants even if the Done member did not qualify or they were not medically necessary. They also mandated that initial encounters would be under 30 minutes. 
  • He put into place a monthly auto-refill function for subscribers without further check-ins.
  • Discouraged Done prescribers from follow-up care. The compensation structure for prescribers solely paid on the number of patients receiving prescriptions–not for medical visits, telemedicine consults, or time spent after the initial consult.  
  • Conspired to defraud pharmacies, Medicare, Medicaid, and commercial insurers by dispensing Adderall and other stimulants to Done members, who also continued to pay subscription fees.

Further, “He and Brody allegedly persisted in the conspiracy even after being made aware that material was posted on online social networks about how to use Done to obtain easy access to Adderall and other stimulants, and that Done members had overdosed and died.” 

Done was singled out in June of 2022 when Cerebral was facing Federal investigation and a grand jury subpoena, actions that continue today but haven’t proceeded to an indictment. At that time, Truepill (also under DEA scrutiny on Schedule II, TTA 22 Dec 2022), CVS, and Walmart Health refused to fill prescriptions by both Cerebral and Done. With Cerebral facing investigation, Done wasn’t far behind. By September 2022, according to The Wall Street Journal, Done was being investigated by the Drug Enforcement Agency (DEA). The Verge

He and Brody are charged with reacting to that investigation by obstructing justice: deleting documents and other communications, encrypting their messages versus using company email, and failing to produce documents to a Federal grand jury.

Despite Cerebral’s far higher profile and volume, even with an ongoing investigation not only on prescribing but also on ad trackers [TTA 9 Feb 2023], the prosecution of Done’s head executives on criminal drug distribution charges is the first brought by the Justice Department against a digital health company for violations related to the CSA and drug prescribing regulations plus fraud.

In this Editor’s view, the relaxation of teleprescribing Schedule II drugs for three years invited abuse. Done may be the first, but it won’t be the last. See the prediction 8 July 2022 made by a former state ADA that both the Feds and states won’t stop at prescribing but will go on to telehealth billing (scroll to last item).

Done has not made any statements directly to press to date, save a short statement on their website:

Done Global strongly disagrees with the criminal charges filed last week against our founder, Ruthia He, and Dr. David Brody, which are based on events that principally occurred between February 2020 and January 2023. Since our founding, Done Global has worked to make mental health care accessible for tens of thousands of Americans trapped in a spiraling national crisis. Done Global will continue to operate – and do everything in our power to ensure that tens of thousands Americans that rely on us do not lose access to their mental health care. At the same time, we will continue to support our clinicians as they exercise independent clinical judgment, practice evidence-based medicine, and provide best-in-class health care.

Update: This statement has been expanded since our original article. Notably, the company declares that “Done is fully aligned with the Drug Enforcement Administration and the Department of Justice on eliminating drug abuse in America” and that they have protocols in place to prevent abuse. Done is also committed to continuing normal operations. Full text is here. David Brody is still listed as clinical president on the medical team page. Ruthia He is not listed on the website at all nor are other company leaders. Press releases posted on the site end in 2022.

Mobihealthnews and Fierce Healthcare essentially recap the DOJ release. The Verge includes the text of the 22-page indictment at the end of their article. 

Editor’s Note: On 30 May, TTA included a Perspectives article on collaborative care authored by Sussan Nwogwugwu, DNP, PMHNP, Clinical Leader at Done. This contributed article was non-promotional and primarily about alleviating clinician burnout. It briefly mentions technology in telehealth with one mention of ADHD as an example.

News roundup: DDoS attacks may be ‘smokescreen’, DEA slams Truepill with ‘show cause’, telehealth claims stabilize at 5.4%, Epic squashes patent troll, Cerner meeting exits KC, MedOrbis, Kahun partner on AI intake

December 22, 2022 | by

Readers won’t get out of 2022 without one last cybercrime…article. DDoS attacks–distributed denial of service–escalated worldwide with Russia’s invasion of Ukraine in February. (Ukraine and military aid is a hot topic this week with President Zelenskyy’s visit to the US and Congress speech.) Xavier Bellekens, CEO of Lupovis, a cybersecurity company and a cyberpsychologist (!), postulates that DDoS attacks, as nasty as they are, may be a smokescreen for far more nefarious and damaging attacks. While IT goes into crisis mode over the DDoS, other attacks and information gathering on systems preparing for future attacks are taking place. Russian cyber groups focus on large organizations and move down the line into the most vulnerable, using both manual and automated approaches. Worth reading given the vulnerability and IT short staffing in healthcare organizations. Cybernews

The fallout from Cerebral and Schedule 2 telehealth misprescribing expands. The Drug Enforcement Agency (DEA) issued a ‘Show Cause’ to online pharmacy Truepill for inappropriate filling of ADHD Schedule 2 medications, including Adderall. A ‘Show Cause’ order is an administrative action to determine whether a DEA Certificate of Registration should be revoked, which could put Truepill out of business. The red flag for the DEA: 60% of  Truepill’s prescriptions–72,000–filled between September 2020 and September 2022 were for controlled substances, including generic Adderall. Truepill was Cerebral’s primary mail order provider, though they also used CVS and Walmart. The company stopped filling Cerebral’s ADHD prescriptions in May 2022.

In the order, the DEA cites that “Truepill dispensed controlled substances pursuant to prescriptions that were not issued for a legitimate medical purpose in the usual course of professional practice. An investigation into Truepill’s operations revealed that the pharmacy filled prescriptions that were: unlawful by exceeding the 90-day supply limits; and/or written by prescribers who did not possess the proper state licensing.”

The company stated in an emailed statement that they were fully cooperating with the investigation. If it does move to a hearing, Truepill’s chances of a successful defense are statistically low.

Truepill also fills prescriptions for Hims & Hers, GoodRx and Mark Cuban Cost Plus Drug Company. It was valued in its 2021 funding round at $1.6 billion. Companies in telemental health and prescribing of Schedule 2 ADHD medications, such as Cerebral and Done Health, are under enhanced scrutiny over their business practices [TTA 1 June]. Mobihealthnews, DEA press release, HISTalk, Digital Health Business & Technology

Telehealth medical claims stabilize. FAIR Health’s latest reports for August and September report that the percent of medical claims coded as telehealth are back up to 5.4%. June and July dropped slightly to 5.2% and 5.3% respectively. Also steady are that the vast majority of claims are for mental health services. In September, they were 66% of diagnoses far ahead of ‘acute respiratory diseases and infections’ at 3.1%. In procedure codes, psychotherapy accounts for over 43%.

A patent troll Epically bites the dust. Back in the early to mid-2010s [TTA’s index here], patent trolls (technically non-practicing entities which have no active business) presented a significant threat to early and growth-stage health tech companies. One, MMR Global (which apparently no longer exists), was notorious for buying up EHR and PHR-related patents and then filing patent infringement lawsuits against both small and large healthcare organizations with similar patents–and their users–that were generally monetarily settled. But NPEs are still active. One in south Florida, Decapolis Systems, used the same techniques as MMR Global had, suing in this case multiple Epic customers for patent infringement. Epic not only defended its customers but also sued Decapolis in the US District Court, Southern District of Florida. The court found that both Decapolis patents were invalid, ending what Epic termed ‘vexatious patent litigation’. Decapolis had successfully sued 24 other entities, including other EHRs, which settled. Owned by an inventor, this company will have to find another line of honest business. Epic release, Thomson Coburg

Oracle’s message to Kansas City: no more Cerner meetings for you. And maybe more. Cerner’s site for its annual customer/partner conference since 2007 has been in Kansas City, attracting about 14,000 visitors. Not only will it be integrated into Oracle CloudWorld in Las Vegas, 18-21 September, it’s been retitled Oracle Health with no mention of Cerner. The loss to local KC business is substantial–estimated to be in the $18 million range. While it’s logical to integrate it into the massive CloudWorld conference, it’s also another message to KC after Oracle’s sudden real estate downsizing that Cerner’s presence there will shrink…and shrink..as it’s absorbed into Oracle Health, and further confirmation that the Cerner name is gradually being sunsetted. KansasCity.com, HISTalk

A new (to this Editor) specialty care telehealth company, MediOrbis, is partnering with Kahun for an AI-enabled digital intake tool. This is a chatbot capable of conducting an initial medical assessment. Based on the patient’s answers and Kahun’s database of about 30 million evidence-based medical knowledge insights, it provides a summary for the physician before the telehealth visit and highlights areas of concern. Mobihealthnews  MediOrbis also has partnered with remote care/engagement Independa to add its capabilities to Independa’s HealthHub on their LG TVs.

Weekend short takes: May telehealth claims up to 5.4%; three health plan breaches, one at its law firm–affecting over 400,000 patients; layoffs hit Calm, Truepill (updated)

August 12, 2022 | by

FAIR Health’s telehealth claims took two bumps up in both April and May. In April, telehealth medical claims moved slightly upward to 4.9% from March’s 4.6%, but May increased 10% to 5.4%, a percentage not seen since May 2021. Mental health conditions still make up the vast bulk of claims at 62.8%, but 3.6% of telehealth claims involve COVID-19 diagnoses, with 3.2% of claims for respiratory diseases and infections. This is attributed to a regional increase in the Southern and Western states of the latest variants of COVID-19. FAIR Health monthly tracker main page

Priority Health, a Michigan-based nonprofit health plan company, was breached through its law firm Warner Norcross & Judd (WNJ). The October 2021 breach at WNJ wasn’t reported to Priority Health until 6 June. The unauthorized party potentially accessed first and last names, pharmacy and claim information, drug names, and prescription dates from certain prescriptions filled in 2012. 120,000 members were affected. What the information was doing at the plan’s law firm was not disclosed. Priority Health is Michigan’s second-largest plan with over one million members.

In other breaches, Texas-based Behavioral Health Group (BHG), had a data incident that affected 197,507 individuals. The unauthorized party had potentially removed certain files and folders from portions of its network on 5 December 2021.  The files include names, Social Security numbers, driver’s license numbers, financial account information, biometrics, medication information, medical record numbers, dates of service, passports, payment card information, and health insurance information. However, the information accessed doesn’t appear to have been misused.

First Choice Community Healthcare in Albuquerque, New Mexico, also had a data security incident that involved 101,541 patients. The PHI in the 27 March breach included names, Social Security numbers, patient ID numbers, medications, dates of service, diagnosis and treatment information, birth dates, health insurance information, medical record numbers, patient account numbers, and provider information. Again, there appears to be no misuse to date. HealthITSecurity

More health tech companies lay off staff.

  • Calm, one of those incessantly advertised (in US) meditation apps, is discharging 20% (90) staffers, at least 12 in marketing, according to a report in the Wall Street Journal (may be paywalled). From this Editor’s LinkedIn post in response to early reports:
    • Calm was strategically ‘off’ in spending. They overspent on direct to consumer–expensive TV spots on major networks and sponsorships, paid social and search. If you wanted Calm’s full features, you paid for them. Expensive meditation apps are merely a “nice to have” and there are a bunch of free ones available. 
    • There’s also too much app overlap and mistargeting out there. Calm was trying to sell the app to businesses as a benefit (ROTFL) but was hedging its bets with buying Ripple, which designs apps for care coordination and condition management (another crowded area).
    • Another sign–new sole CEO named this summer. Now sole CEO David Ko came from Ripple and the two Calm founders moved over to co-chair roles.
    • This is a company that raised well north of $200 million to become a $2 billion unicorn as early as 2019, another sign of too much cash, too soon, and VCs/equity investors following the fad. ‘Mindfulness’ became a fad as early as 2018.
  • Truepill is up to its third layoff–33% or 175 staff, including all UK staff plus much of the product and data teams.  Their cutbacks relate to multiple failures, the first in betting on ADHD controlled substances, the second in blowing through vast amounts of funding but unable to obtain more (a Series D of $142 million but unable to float a Series E). Truepill’s ADHD med bet fell apart with its relationship with Cerebral, now under Federal investigation [TTA 16 June]. As early as May, Truepill, Cerebral’s primary mail order provider, had stopped filling their prescriptions for Schedule 2 medications [TTA 1 June]. This follows on a June layoff of 15% or 150 people. Truepill had also expanded into telehealth and diagnostics, two areas which will only be lightly supported going forward. TechCrunch

DOJ investigates telemental Cerebral on over-prescribing of controlled medications

May 10, 2022 | by

DOJ dropped an anvil on Cerebral’s head Friday night. Last week’s reports on the Drug Enforcement Agency (DEA) investigation of telemental health provider Cerebral were confirmed on Friday with the official notification that the US Attorney’s Office for the Eastern District of New York had subpoenaed the company as part of their investigation into possible violations of the Controlled Substances Act. According to the Wall Street Journal, the subpoena was issued to Cerebral Medical Group, the corporation it uses to contract with clinicians and provide healthcare services. The company is fully cooperating with the investigation by the Department of Justice, which includes turning over records pertaining to their prescribing of controlled substances such as Adderall and Xanax. This has been reported by FierceHealthcare which is citing (paywalled) Insider.

Last week, Cerebral announced that it would stop prescribing controlled substance prescriptions for new ADHD patients as of 9 May. However, they would continue prescribing controlled substances for other mental health conditions, according to a memo from their chief medical officer to their clinician network.

Cerebral’s Saturday statement in response to the subpoena maintains (from FierceHealthcare):

“To be clear, at this time, no regulatory or law enforcement authority has accused Cerebral of violating any law”

and

“Cerebral has dedicated significant time, energy, and resources to ensuring that its policies and procedures regarding the prescription of controlled substances and other medications both are medically appropriate and comply with all applicable state and federal law,” the statement also said. “As a responsible company, Cerebral is continuously improving its systems and practices. The foundation of this company is built on evidence-based, ethical, and compliant practices so that our patients can receive the highest quality of care and achieve the best clinical outcomes.”

The company has done well with the increased demand for mental health services provided via telehealth including remote evaluating and prescribing. In December, their $300 million Series C raise boosted their valuation past $4.8 billion.

Darkening this rosy picture is, as TTA noted last week, that a former VP of product and engineering, Matthew Truebe, has sued Cerebral for wrongful dismissal. According to him, the company put growth before patient safety, including overprescribing medications for ADHD. Other reports indicate that the DEA interviewed other former Cerebral nurse practitioners who felt pressured to prescribe ADHD medication after a short video call. The Verge

Cerebral has also gained notoriety for dodgy advertising claims pertaining to ADHD and other conditions. In January, advertising on TikTok and Instagram was pulled for claims that obesity is “five times more prevalent” among adults with ADHD, and stated that getting treatment for the mental health disorder could help patients “stop overeating.” These followed inquiries by Forbes and NBC News. Also pulled was their Facebook advertising around prescribing Type 2 diabetes medications, GLP-1 agonists, as a “wonder drug” for weight loss. 

Will this put a damper on the burgeoning area of telemental health and remote prescribing? Stay tuned. Also Becker’s. 

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

May 6, 2022 | by

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

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

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

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

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

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

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