News roundup: Precision’s $102M raise, more on BCI; Withings clears BPM Pro 2; Nebraska 1st state to sue Change/UHG, related insider trading update; VA Oracle go-lives may resume; ATA intros CODE; ClearDATA HITRUST certified

One more funding. A competitor of Elon Musk’s Neuralink, Precision Neuroscience. closed their Series C at $102 million. This round was led by General Equity Holdings, with participation from firms including B Capital; Duquesne Family Office, the investment firm of Stanley F. Druckenmiller; and Steadview Capital, bringing their total funding to $155 million. The total brings them according to their release as one of the best-funded brain-computer interface (BCI) company after Neuralink, whose funding is unknown. The funding will be used to advance its clinical research and expedite development of its cutting-edge brain implant. 

Precision is the developer of the Layer 7 Cortical Interface to treat motor paralysis. At the time of their last funding in January 2023, this Editor noted that their difference was to treat neurological illnesses and events such as stroke, traumatic brain injury, and dementia. Their focus remains largely there: severe spinal cord injury, stroke, ALS. So far, the investigational device has been tested its device in 27 patients through research partnerships and was designated by FDA as a Breakthrough Device.

More on BCI in this must-read article by Timmy Broderick for STAT. The upcoming issues around BCI now center around the engagement of CMS (Centers for Medicare and Medicaid Studies) for coding, coverage, and payment for devices after the investigational stage; privacy issues about neural data; and continued support after implantation. This last one is acute as these companies are young. There has already been the example of Second Sight’s bankruptcy, leaving subjects stranded with useless retinal devices in their eyes. BCI to this Editor will develop through 2025–and be a major focus of investment by 2026-2027.

Withings gains FDA clearance, intros BPM Pro 2. A professional-level product for hypertension and chronic heart failure (CHF) targeted to care teams to connect with their patients, the FDA clearance covers blood pressure and pulse rate measurement in adults with arm circumferences of 9 to 17 inches (22 cm to 42 cm) or 16 to 20 inches (40 to 52 cm). What is really interesting about the connected (Wi-Fi, cellular, BT) device is that care teams can program the device through the Patient Insights feature for the patient to interact with the device in real time. Through a small screen, it asks questions that help to track the patient’s condition, reinforce medication adherence, and assess their satisfaction. It also has a Retake Measure feature to retake a reading if results exceed predetermined thresholds and increases accuracy. Withings plans to upgrade the device to take a 1-lead ECG to detect atrial fibrillation; this is a separate clearance and expected to become available in 2025. The device is not yet CE Marked. Withings was named a CES 2025 Innovation Awards Honoree in the Digital Health category. (Photo, Withings website) Release, Mobihealthnews, MedCityNews

UHG’s Mound of Misery multiplies with Nebraska’s Change Healthcare lawsuit, plus separate but related insider trading. 

  • Nebraska became the first state to sue UnitedHealth Group, Optum, and Change Healthcare over those affected by the late February ALPHV/BlackCat hack of Change’s systems. In Nebraska alone, it affected 575,000 individuals. (It is actually hard to find someone who was not affected by the hacking of the leading exchange for major claims clearing and payments.) Nebraska’s attorney general Mike Hilgers is suing because of the company’s carelessness in handling data and, even worse, in its slow notification of those affected. Our Readers will recall that Change/UHG initially tried to push off notification on healthcare providers. When HHS threw the ball back to Change [TTA 5 June], notices didn’t go out until August-September. The charges in state law center on consumer law: financial data protection and consumer protection statutes, deceptive trade practices, and Federal standards on privacy (HIPAA, and HIT protection. The lawsuit was filed by the AG in the District Court of Lancaster County, Nebraska. Nebraska Examiner
  • The Change acquisition and later problems were possibly the catalyst for stock sales by senior/C-level UHG executives, including UnitedHealthcare CEO Brian Thompson. The $300 million Hollywood (Florida) Firefighters Pension Fund initiated a class action lawsuit alleging that the sales were made while the Department of Justice (DOJ) was considering an anti-trust action against UHG that would revisit the so-called ‘firewall’ between it and Change.  The complaint specifically mentions that UHG executives were aware of it as early as October 2023. The Wall Street Journal revealed the investigation on 27 February 2024–the same time as the Change breach was revealed, cracking the stock almost immediately. Executives including Thompson ($15 million), UHG CEO Andrew Witty, and board chairman Stephen Hemsley ($102 million) were named. The class action covers the period for stock purchased between 14 March 2022 and 27 February 2024. UHG has until 1 March 2025 to answer the complaint. Healthcare Finance News  (This is likely to affect the settlement of the Thompson estate–Ed.)

VA confirms that additional Oracle EHR implementations may go live in 2025, after 18 months of dead stop. The Oracle Cerner EHR is reportedly ‘running better’ at the current six sites where it is operating: five VA only (including 20 community clinics and about 100 support sites), and the sixth at Lovell jointly with the Military Health System (MHS). The restart of EHR Modernization (EHRM) was confirmed earlier during budget hearings by Kurt DelBene, assistant secretary for information and technology and chief information officer. Crash and lag downtimes are reduced by half and incident tickets by 60% since the last updates in August.  Timing remains indefinite for 2025 (FY ends 30 September 2025) but current VA Secretary Denis McDonough confirmed that primarily VA staff will continue to work on it under the Trump Administration. “The overwhelming majority of VA professionals who work on EHRM will be working on EHRM on January 21st, just as they were on January 19th,” McDonough said at an 11 December press conference. Federal News Network

Short takes:

  • The American Telemedicine Association (ATA) launched its new ATA Center of Digital Excellence (CODE) last week. CODE is constructed as an alliance with leading health systems for the development and implementation of digital health best practices that prioritize patient-centered care, equitable access, and improved clinical and operational outcomes. Tools span enhancement of workflows and patient engagement to improve healthcare accessibility. ATA release
  • ClearDATA’s CyberHealth platform and cloud managed services have earned Certified status by HITRUST for information security. ClearDATA provides healthcare specific managed cloud security, compliance and operations solutions. HITRUST, the Health Information Trust Alliance, is a non-profit that sets standards for data organizations through the HITRUST CSF framework. Release

News roundup: Omada Health files S-1 for IPO in 2025–and a look at 2024 healthcare IPOs, Philips debuts new smart baby monitor, ActiveAlert launches in UK, ATA Nexus 2025 calls for speakers, abstracts

Omada Health plans exit into the public markets. Omada, which has virtual health diabetes and hypertension management programs, reportedly filed an S-1 with the Securities and Exchange Commission (SEC), according to a Business Insider source. The IPO may be planned for 2025. Omada has been on a hot streak lately, inking deals with Amazon for their health condition programs, adding GLP-1 management, plus accreditation from NCQA and URAC.

Unlike the bare shelves of 2023, 2024 has racked up a few healthcare and digital health IPOs. Waystar’s IPO landed in June and closed today at $26.80, above its $21.50 opening price. This is for a decidedly unglamorous but revenue-generating part of healthcare–RCM and payments management. Tempus AI, in the far glammier AI in precision medicine sector, also IPO’d in June at $37, and after some initial summer sag recovered to $48.96 today. But June also saw yet another formerly hot healthcare tech company, Sharecare, go private after three years of a cracked SPAC. It was bought at 13% of its peak valuation. [TTA 26 June] Another supersonically sad summer story was Tel Aviv-HQ’d Nuvo, which developed and markets a digital pregnancy monitoring system. It went public on Nasdaq via a SPAC on 1 May–then filed for Chapter 11 reorganization by 22 August. Has this finally, finally put paid to SPACs? Bloomberg News, The Middle Market

Virtual MSK provider Hinge Health reportedly is testing the IPO market, having hired Morgan Stanley to start the process. [TTA 3 Oct]

Omada investors since 2011 have poured $525 million into the company over 11 rounds, ending with a debt financing in January 2023. There are 33 investors, including eight lead investors such as Fidelity, Cigna, and Andreessen Horowitz. Crunchbase

If one is to believe the analyst and investor quotes in this Business Insider article, once we get past 2024 and into Q1 2025, the ‘clogged pipe’ of waiting IPOs will roar back into the market like a hungry beast. Aside from wincing at the heckuva mixed metaphor, this Editor tends to be a lot more sanguine about next year. She believes that there are a lot of hungry investors waiting, all right–to offload years of risk to the public and other investors and recoup some if not all of their investment money. Mr. Market may, or may not, feel the same. Hat tip to HIStalk 4 October

On a lighter note, Philips is introducing its most advanced monitoring system to date, the AI-assisted Avent Premium Connected Baby Monitor. The system includes a camera/mic, ‘parent unit’, and app. The camera/mic tracks the baby’s chest motions in sleep and breathing without a wearable. It also has Cry Detection + Translation, which uses AI-assisted and machine learning to interpret baby’s cries. Parents can set up notifications via the parent unit or the app to better understand if baby is tired, gassy, hungry, uncomfortable, or irritated. Release, Mobihealthnews

At the other end of the age spectrum, the Taking Care personal alarm (PERS) company in the UK is introducing ActiveAlert. It adds an AI-assisted twist to personal assistance by triggering a wellbeing check-in call when it detects changes in the frequency, timing, or nature of alarm calls. Their models use 30 years of alarm call data. If there is a change, families are notified. According to their release (PDF), the patterns of alarm call usage can be used to take a more proactive approach to elder care in alerting for concerns or red flags to families before emergency scenarios arise. 

Planning ahead to 2025, the American Telemedicine Association will be returning south–to New Orleans. ATA Nexus–Redefining Care Delivery will be 3-5 May at the New Orleans Convention Center. Deadline is 1 November for speakers and general content proposals, as well as research abstracts for oral and poster presentations. Information for applications is here. The form for requesting the sponsorship and exhibit prospectus is here. Release

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

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

ATA requests expediting of revised proposed rule on controlled substance telehealth prescribing; announces Nexus 2024 meeting 5-7 May

ATA and 200 organizations request from DEA a revised proposed rule on controlled substance teleprescribing–stat. The American Telemedicine Association (ATA), in a 2 April letter (PDF link) with over 200 signatories, requests that the DEA quickly issue a revised proposed rule for industry comment.

Last October, the Drug Enforcement Administration (DEA) and Health and Human Services (HHS) extended for the second time pandemic flexibilities for prescribing controlled substances through 2024. The proposed rule issued in May had 38,000 comments, which overwhelmed DEA and HHS. The two agencies were unable to come up with a revised proposed rule by end of year and punted to 2024. The final rule is scheduled to be issued by this fall.

The 2 April letter advocates continuing many of the pandemic flexibilities due to care shortages and disruptions to patient care. If DEA were to create a special registration process for telehealth prescribers as many have proposed, transitioning and training would be needed to minimize disruptions in care to providers and patients in time for the new rule to take effect in 2025.

The controversy is around permitting and regulating the prescribing of controlled substances through telehealth. The pandemic rules suspended the Ryan-Haight Act restrictions that required in-person evaluations/visits prior to prescribing. Legally, that cannot continue. The extension of pandemic flexibilities permitted 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. ATA release   HealthcareDive 4 April

ATA is also resuming an in-person spring conference, Nexus 2024, 5-7 May, at the Phoenix Convention Center in Arizona. It will have 300 speakers on 30+ topics. The meeting is being pitched to primarily care delivery and provider organizations. An overview of the conference is in the ATA release. More content information here (PDF link). Online registration (attendee and exhibitor) or email AmericanTelemedicine@​xpressreg.net

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

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

Thursday roundup: Kaiser-Geisinger won’t close till ’24, Validic buys Trapollo, Veradigm’s ’22 financials delayed again, ORA telehealth’s $10M Series A, ATA adds 3 to board

Some more reveals on the Kaiser Permanente/Risant Health/Geisinger Health deal. Perhaps the most significant one in Kaiser’s quarterly financial statements was that the closing with Geisinger is projected to be sometime in 2024, subject to the usual regulatory approvals. As announced in April, Geisinger will be the founding system of a new non-profit group, Risant Health, that will bring together a targeted five to six non-profit community health systems. Financial disclosures were also made that were centered on the timing of substantial investments and commitments:

  • Kaiser’s financial commitments to Risant will be made in the five years following closing. The $5 billion previously announced is the upper end of the support. Confusingly, Kaiser is also committing to a minimum investment of $400 million over five years inclusive of funds generated by Risant Health. 
  • Risant’s support and investment into Geisinger will end earlier, in 2028, but in that time will make an investment of a minimum of $2 billion to support Geisinger’s hospital, technology, and strategic development. It will be inclusive of funds generated by both Risant and Geisinger.
  • Risant will also make available to Geisinger no less than $100 million” through 2028 to support expansions of Geisinger’s health plan and care delivery services into bordering Pennsylvania communities.
  • Risant will also make available to Geisinger funds for research and education for 10 years after the 2024 closing

Kaiser’s Q1 was far better than its money-losing ($4.5 billion) 2022, with $1.2 billion in net income. Geisinger has not yet reported Q1, but it had a $842 million net loss in 2022.  FierceHealthcare

Digital health/personalized care company Validic is buying Trapollo, a similar connected care company. Both have platforms facilitating chronic care patient management via remote care and EHR integration. The acquisition price and workforce transitions were not disclosed. Trapollo’s former owner, Cox Communications, will become a shareholder in Validic. Trapollo senior VP/general manager Steve Nester will have the same title at Validic. It will remain at the Validic HQ in Durham, NC, with Trapollo’s former distribution center remaining in Sterling, VA. This continues the trend of consolidation of businesses in similar or complementary services. Release

Veradigm, the former Allscripts, 2022 financials continue to be in a tangle. As previously reported [TTA 3 Mar], Veradigm delayed its Q4 and FY 2022 reporting due to a software flaw that affected its revenue reporting going back to 2021. On 22 March, this expanded to their extending their year-end audit and 10-K filing because of “internal control deficiencies related to revenue recognition.” In a recent SEC filing, they stated that they may be able to file their 10-K by 14 June, but cannot guarantee it. The revenue impact may be as high as $40 million and affect their 2021 closing. HIStalk 5/17/23

Singapore’s ORA Telehealth just scored the region’s largest Series A raise–US$10 million. It was co-led by TNB Aura and Antler with participation from Gobi Partners, Kairous Capital, and GMA Ventures for a total funding to date above US$17 million. ORA is unique in that it’s a vertically integrated platform that markets to a young customer base (average age: 38) on three platforms: Modules (676 different formulations of prescription skincare), OVA (women’s health), and andSons (men’s health).

The American Telemedicine Association (ATA) welcomed three additions to its board this week:

  • Marc Adelson, JD, Teladoc Health’s deputy chief legal and global chief compliance officer. Prior to joining Teladoc in 2011, he was  co-founder and executive legal director of the Institute for Patient Safety & Quality in Virtual Care, the first federally qualified patient safety organization (PSO) focused on virtual care.
  • Kavita Patel, MD, MS, a practicing primary care physician at Mary’s Center, a Federally Qualified Health Center in Washington DC and Maryland. She is also a venture partner at New Enterprise Associates, an NBC/CNBC/MSNBC contributor, and was formerly director of policy for the Office of Intergovernmental Affairs and Public Engagement in the Obama administration
  • Sarah Pletcher, MD, MHCDS, system vice president and executive medical director for strategic innovation at Houston Methodist, and responsible for advancing a wide range of virtual and other innovative care models and solutions.

Mid-week roundup: CVS-Oak Street closes, DEA extends controlled substance telehealth waiver, Bright Health selling CA MA plans, Talkspace, Teladoc turnarounds? (updated)

CVS closed its $10.6 billion deal for Oak Street Health, well before the anticipated end of 2023. It picks up 169 primary care offices in 21 states–and an unprofitable operation that clocked a loss last year of $510 million without much of a change till 2025. The quick closing was likely spurred by both the Department of Justice (DOJ) and the Federal Trade Commission (FTC) letting their antitrust challenge period expire at the end of March with nary a whimper. DOJ and FTC, the latter which has been remarkably ‘pixelated’ of late on privacy issues with GoodRx and Teladoc’s BetterHelp, evidently passed on ‘egg on the face’ and let the ovoid land squarely on Elizabeth Warren’s Senate desk. She had asked FTC to ‘carefully scrutinize’ the deal. Shareholders received a tidy $39 per share. OSH will remain a multi-payer practice and now-former CEO Mike Pykosz will lead the company under CVS’ new healthcare delivery arm. This follows on CVS’ closing of Signify Health [TTA 30 March].  CVS release, FierceHealthcare Our prior gimlety coverage of CVS/OSH: 16 Feb, 2 March, Unlike OSH, CVS had a strong Q1 with $2.1 billion in profit, slightly down from 2022’s $2.4 billion, and an 11% boost in revenue. FierceHealthcare

DEA in-person prescribing requirements on Schedule II and higher controlled substances postponed indefinitely. The proposed rule would have added back in-person requirements for telehealth prescribing of controlled substances after the official end of the Public Health Emergency and its in-person waivers on 11 May. On 25 April, the DEA filed a draft temporary rule with the Office of Management and Budget for the extension. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires that Schedule II medications and narcotics (including Adderall and Ritalin) require an in-person prescription, while Schedule III or higher medications, including buprenorphine, Ambien, Valium, Xanax and ketamine can be prescribed for 30 days via telehealth but would require an in-person visit before a refill. The DEA was deluged with 38,000 comments and advocacy pressure from ATA. The change has also thrown a wrench in the works of online mental health companies which prescribe many of these drugs. FierceHealthcare  Updated–The ATA has weighed in favorably about the DEA postponement. Kyle Zebley, executive director of ATA Action, stated in their release that “Our hope is that the DEA will use the time of an extension to be responsive to the concerns of telehealth advocates, patients, and the American people to create rules that ensure access to clinical care that is not inappropriately restricted.”

Bright Health put its California Medicare Advantage plans up for sale. The company, staring down at bankruptcy [TTA 7 Apr, 20 Apr] does not yet have a buyer for the MA plans. When they are sold, it will be Bright’s exit as a health insurer, as it has exited MA plans in Florida and exchange plans everywhere else–in a flurry of state investigations ranging from Tennessee to Texas. Bright plans to focus on its provider arm, NeueHealth. Healthcare Dive

Talkspace narrowed its loss, increased revenue. The telemental health provider narrowed its Q1 net loss to $8.8 million compared to 2022’s $18.3 million in Q4 2022 and $20.4 million in Q1. Revenue increased to $33.3 million versus last year’s Q1 of $30.2 million. Their source of business has shifted to B2B with a 71% increase, a sharp departure from their formerly dominant consumer segment which has declined 40%.  Their 2023 forecast revenue is $130-135 million. It is still facing a Nasdaq delisting as trading below $1.00 per share and a class action lawsuit on subscription renewals. Mobihealthnews

Teladoc also waxed positive, ‘beating the Street’ with Q1 revenue growth of 11% to $629 million. This was powered as expected by BetterHelp, Teladoc’s direct-to-consumer mental health business. Their revenue grew to $279 million, a 21% increase. Teladoc’s enterprise business also had a 5% boost to almost $350 million. Their weight loss business is expected to be another net positive income generator, but not affecting results until 2024 as it won’t be introduced until Q3 [TTA 21 April]. The road to profitability will be a long one, as losses this quarter were $69.2 million, but compared to last year’s $6.7 billion writedown of Livongo, it’s positively smooth. Healthcare Dive

News from ATA 2023: debate over DEA in-person prescribing requirement, winners of Telehealth Innovators Challenge, 2024 board chair announced

The American Telemedicine Association’s annual conference, ATA2023, which wrapped two weekends ago, had some major debates, awards, and some board changes.

Special ‘listening’ session on DEA’s proposed changes on telemedicine prescribing of controlled substances. This would resume the in-person visit requirement for Schedule III-V non-narcotic controlled medications. A 30-day limit on a prescription would be permitted for a telehealth remote visit and prescription, but an in-person visit would be required during that period or thereafter before any renewal. The DEA proposed rule issued 24 February (draft here) includes allowing care to be delivered uninterrupted for 180 days after the end of the public health emergency (PHE) ending 11 May, but then requires an in-person physician visit. ATA opposes this new requirement for patients who were prescribed these medications solely during telehealth during the PHE (release 25 Feb). Public comment on the proposed rule is open for 30 days (27 March). A representative of the DEA was in the audience for the Monday 6 March discussion moderated by Kyle Zebley, ATA’s senior vice president of public policy. Other telehealth measures were extended for two years in last year’s passage of the 2023 Federal budget bill [TTA 4 Jan]. Healthcare Finance

Winners were announced for ATA’s Telehealth Innovators Challenge. The four categories and winners were:

Femtech and Women’s Health Winner: SimpliFed. SimpliFed is a virtual breastfeeding and baby feeding provider network that improves access to professional lactation support.

In-patient Care Solutions Winner: Great Speech. Great Speech provides speech therapy through a network of 200+ therapists and adds artificial intelligence (AI) technology and proprietary algorithms.

The Patient Experience: Clearstep Health. Clearstep guides healthcare consumers to the best next steps for care based on their symptoms, insurance, location and preferences via a virtual triage system set up for providers. 

Tools That Deliver Care: Strados Labs. The Strados Cardiopulmonary Platform, using the RESP Biosensor, captures wheezing, coughing, and other lung sounds plus respiratory dynamics, then to a clinician portal supported by machine learning algorithms.

SimpliFed also won the overall Judges’ Choice Award. Oshi Health, a virtual-first gastrointestinal care clinic integrating evidence-based medical care and behavioral health support into a convenient, high-touch, data-driven care model, received the overall People’s Choice Award. Release

Sree Chaguturu, MD, has been named Chair-elect of ATA’s Board of Directors for a two-year term starting May 2024. Dr. Chaguturu is executive vice president and chief medical officer, CVS Health. He has served on the ATA Board of Directors since December 2020. He will follow Kristi Henderson, DNP, CEO, MedExpress and senior vice president of the Center for Digital Health and Innovation for Optum Health, who is now Immediate Past Chair. Release

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

ATA organizes Telehealth Awareness Week this week

The American Telemedicine Association has, without a lot of advance fanfare, put together Telehealth Awareness Week this week from Monday 18 through Saturday 24. The purpose of the week is to showcase the many ways virtual care improves access to quality healthcare services for all individuals, including members of rural and underserved communities.

Events both virtual and local are listed here including two later events:  ISfTeH’s Global Connections for Sustainable Telehealth, 6-7 November, in-person in San Jose [TTA 12 Aug], and Forefront 2022: Provider-to-Provider Telemedicine Summit, held virtually on 12 October. The Week’s 53 endorsing and founding partners are also supported by 71 Congressional Policy Champions. ATA release (PDF) 

Week-end news roundup: Fitbit revives with 3 new watches, Sena Health hospital-at-home, SteadyMD surveys telehealth clinicians, 9.4% fewer adult dental visits in England, save the date for ATA 2023

Fitbit’s three new wearables–will they revive the brand? Fitbit, now owned by Google, announced the debut of two new smartwatches and one fitness tracker, available now for preorder and shipping in September. Will buyers find them more attractive than their predecessors? From left to right:

Fitbit Inspire 3 upgrades from the predecessor with a color display and similar $99.95 price. Monitors for irregular heartbeat, reminders to move, wakey-wakey alarm, apps, and more.

Fitbit Versa 4 is a thin, light fitness smartwatch with sleep, SpO2 monitoring, GPS, irregular heartbeat, stress, pay hands free, Amazon Alexa, and connects to your smartphone. Four colors, will set you back $229.95.

Fitbit Sense 2 is chunkier with more information and tracking on health and stress than Versa 4 for a higher price at $299.95.

Readers can weigh in on whether these will be attractive, as the Fitbit brand has, over the past two years, almost vanished from the fitness smartwatch consciousness. GearPatrol, Mobihealthnews

New entrant in the developing hospital-to-home service provision area Sena Health is partnering with southern New Jersey’s Salem Medical Center to deliver Salem’s hospital-to-home program. Sena’s capabilities with Salem include up to 23 hospital-level services at home and 24/7 care coordinators. To qualify, patients must have been seen in the ER and evaluated on certain criteria. When cared for at home, they receive two in-person nursing visits daily and can connect with a dedicated clinical team if needed. Hospital-to-home is being trialed all over the country and is considered to be ‘hot’, but at this point is not all that widespread. HealthcareITNews

SteadyMD conducted a survey among a group of potential workers for their telehealth care team, among 1,700 clinicians: doctors (35%), nurse practitioners (52%), and therapists (12%). Some interesting findings such as:

  • Experienced (10 years +) doctors and therapists are most interested in telehealth practice, with nurse-practitioners (NPs) less so
  • Flexible schedules and working from home are the main attractions
  • Night shifts are attractive to 86% of therapists. Doctors and therapists average about 60%. But the latter two are far more interested in weekend work–not the therapists.
  • Telehealth as a full time delivery of care goes between 50 and 69% for each. Clinicians want more hours if the arrangement is part-time.

SteadyMD is a telehealth infrastructure provider that works with healthcare organizations, labs and diagnostics companies in 50 US states.

Something that can’t be delivered by telehealth except for diagnosis is your annual dental visit and treatments, and it’s down 9.5% in England, based on a report published by NHS Digital. The tracking of NHS adult dental visits covers the 24 months prior to June 2022 compared to the 24 months prior to June 2021. When compared to the 24 months up to June 2019, the reduction is 25.3%. Since dental practices closed except for emergency care due to Covid in March of 2020, there is an overlap in the numbers. They do indicate that dental treatments have not recovered in volume from before the pandemic. One good sign is that child dental treatment has strongly rebounded, up 42.1% in the 12 months prior to June 2022 versus up to June 2021, but still down over 20% compared to the 12 months prior to June 2019. Regional data is included in the NHS Digital report (link above).

The American Telemedicine Association announced its 2023 ATA annual conference will be in San Antonio, 5-7 March 2023. More information on “From Now What? to How To! The Vision and Realities of Telehealth Adoption” already is up on their website here.

Weekend short takes: ATA, APA call for permanent in-person evaluation waiver, mental healthtech raised $5.5B in 2021, Allscripts sells hospital/large physician EHRs to Harris Group for $700M, Cognizant-Microsoft extends telehealth-RPM

72 groups asking for permanent telehealth in-person evaluation waiver prior to prescribing controlled substances. The American Telemedicine Association (ATA), ATA Action, and the American Psychiatric Association (APA) plus 69 other healthcare groups have written the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) to make the temporary waiver of in-person patient evaluation prior to prescribing controlled substances permanent, and to remove restrictions on patient location. The rationale is to increase access to care, specifically for mental health and substance use disorder treatment. Currently, under the soon-to-be ending COVID-19 public health emergency (PHE), mental health providers can prescribe controlled substances remotely through a telemedicine consult. The letter points out that studies confirm efficacy, clinician and dispensing would remain under current restrictions, and that DEA and HHS can work together to prevent drug diversion. Other signatories include Babylon Health, Teladoc, Zipnosis, One Medical, and Northwell Health. ATA release, ATA/APA letter.

Mental healthtech’s banner 2021 totaled $5.5 billion across 324 international deals. Industry researcher CB Insights found that:

  • Investment was up 139% versus 2020
  • Exits were also up 87% (43 versus 23). Of the 43, there were 35 M&As, five SPACs and three IPOs.
  • US companies dominated in mental health, raising $4.5 billion; EU $651 million, and Asia $289 million
  • Mega-rounds ($100 million+) totaled 15, all US and in Q4, versus four in 2020.

State of Mental Health Tech 2021 Report free download available on the CB Insights page. Mobihealthnews

Allscripts is unloading its declining hospital and large physician practice EHRs to Ottawa-based Harris Group for $700 million in a cash plus contingent deal. The Allscripts EHRs in the transaction are Sunrise, Paragon, Allscripts TouchWorks, Allscripts Opal, and dbMotion. Although the unit generated gross revenue of $928 million in 2021, its revenue was expected to decline 3-4% and EBITDA to shrink 10-15% in 2022. Allscripts is retaining Veradigm, which is growing 6-7% annually, and stated that expected after-tax proceeds of $600 million will be used for share repurchase and potential M&A related to Veradigm. Harris Group acquires and manages computer systems companies in North America, Europe, Asia, and Australia covering four sectors: public, private, healthcare, and utilities. It is owned by Toronto-based Constellation Software. HISTalk reports on the Allscripts investor call, Constellation release

Cognizant announced a collaboration with Microsoft Cloud for Healthcare to extend telehealth and remote patient monitoring (RPM) capabilities for their offerings combining remote patient monitoring and virtual health, utilizing connected devices such as smartwatches, blood pressure monitors, and glucose meters to collect and communicate patient health data to providers. Cognizant release

Friday short takes: Uber Health taps geriatrician CMO (updated), Sensyne Health completes £11M financing as part of formal sale, ATA + ECHAlliance ally, add GHCP Summit, Reimagine Care home-centered cancer care lands $25M

Uber Health’s first-ever chief medical officer is an unusual choice–a geriatrician. Michael Cantor, MD, JD is a board-certified geriatrician. According to his LinkedIn profile, he had previously been a CMO at insurtech Bright Health and CareCentrix. From the release, his expertise is in designing clinical programs for older adults and vulnerable populations for the most pressing gaps in care–and how technology can address them. Uber’s focus is in mobility–patient transportation and deliveries as part of social determinants of health (SDOH). They report 71% gross bookings growth for the business unit from Q4 2020 to Q4 2021. Release, Healthcare Dive

An update on Dr. Cantor: his CMO position at Uber Health is part-time, according to his LinkedIn profile. He will be continuing at Intuition Robotics as their CMO, having started with them in May 2021 (release). Intuition developed the ElliQ robot companion and is extending it to healthcare for older adults. Hat tip to Laurie Orlov for the info.

Some dismaying news from Oxford is that Sensyne Health, a clinical AI company for life sciences companies that analyzes data from US and UK health system EHRs, is having financial difficulties that have caused them to enter a Formal Sale Process (FSP). The £11.35 million will keep them solvent and not force a stop to their trading on the London Stock Exchange, and the FSP process will organize their outstanding debt until a purchaser can be found. Sensyne was founded by former UK science minister Lord Paul Drayson, and only last May inked two deals with the Colorado Center for Personalized Medicine (CCPM) and St. Luke’s University Health Network (PA/NJ) to expand its dataset. Sensyne release, Healthcare IT News

The American Telemedicine Association (ATA) announced that they will collaborate with Belfast-based ECHAlliance (European Connected Health Alliance) in the Global Health Connector Partnership (GHCP). The GHCP includes HLTH, The Digital Health Society, Health Parliament, the Commonwealth Centre for Digital Health, and Africa Health Business. The Global Health Connector Partnership Summit will convene at ATA2022, 1-3 May, in Boston. Release

Nashville-based Reimagine Care completed a $25 million capital raise led by Santé Ventures, Martin Ventures, and LRVHealth. Reimagine is a provider of home-centered cancer care for oncology practices and providers. The funding will be leveraged to further develop and commercialize the company’s first-of-its kind technology-enabled services in the Access Care Platform, launch their virtual care center, and expand the patient care team. Home-centered treatment reduces costs and increases patient convenience.  Release

American Telemedicine Association sets up ATA Action for policy advocacy

The American Telemedicine Association (ATA), which has been known for its advocacy of telemedicine and telehealth since 1993 (!), is doubling down with setting up a separate “affiliated trade organization”, ATA Action, for policy advocacy. This is centered on making permanent pandemic-expanded telehealth access for Americans, state and federal telehealth coverage, and appropriate payment policies. ATA Action will be led by Kyle Zebley, ATA vice president, public policy, as executive director. There is a long list of ‘founding members’ and ‘Advocacy Council Members’ listed in the ATA release.

Key policy advocacy is centering on nine major points, including: 

  • Removing the in-person telemental health requirement
  • Increased broadband access
  • Coverage through federal programs such as Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs), the Indian Health Service, TRICARE, and the Veterans Health Administration
  • Telehealth across state lines while maintaining state authority to regulate the clinical practice
  • Remove regulatory roadblocks to decentralized clinical trials
  • Align Medicare coverage of remote patient monitoring with how it is practiced

ATA is also confirming that their 2022 annual meeting will be in-person at the Boston Convention & Exhibition Center 1-3 May. Information and registration are here.

News & deal roundup: Oak Street adds telespecialty RubiconMD, ATA plumps for wider telehealth access, yet claims fall to 4%, West Suffolk NHS adds Zivver mail/file security, Northwell’s $100M for AI–and miss industry shows yet?

Primary care network Oak Street Health acquired virtual specialty telehealth provider RubiconMD for $130 million. Oak Street is a 19-state network of physicians in care centers who specialize in Medicare patients. RubiconMD has 230 specialists who provide doctor-to-doctor teleconsults (eConsults) in 120 specialties, with an emphasis on cardiology, nephrology, and pulmonology, which is a strong fit for Oak Street. RubiconMD also has separate offerings for specialty care panels and behavioral health. The $130 million includes up to $60 million in cash or cash/stock, subject to achievement of defined performance milestones. Management transitions were not disclosed. Release, FierceHealthcare

The American Telemedicine Association wants to preserve wider telehealth access into 2022–even if the public health emergency (PHE) for Covid has to be extended. Although the Medicare Physician Fee Schedule proposed by CMS for 2022 includes areas of wider telehealth access and reimbursement (temporary access under Schedule 3 added in 2021) into 2023 regardless of the PHE, Congressional action is required to permanently expand telehealth beyond the existing programs mostly for rural areas. If necessary, ATA is advocating that Health & Human Services (HHS) extend the PHE through 2022 so that telehealth access and reimbursement are preserved. ATA releaseFierceHealthcare

While this Editor can understand ATA’s frustration and the sincerity of its aims, it distorts the emergency meaning of a PHE that is just about nonexistent except for mandates. And telehealth claims, even with current access, have sunk down to a tick above 4%, 60% of which are mental health codes (FAIR Health July national data). Too many providers, too little demand? 

The West Suffolk NHS Foundation Trust (WSFT) has selected Zivver UK to secure its mail and file transfer systems, as it migrates from NHS Mail to Microsoft 365. It includes encrypted email to patients as a core requirement meeting NHS digital standards, and ease of use for both sender and recipient in MS Outlook. 4,800 staff at WSFT, which covers 280,000 people who live in West Suffolk. Release. Hat tip to HISTalk for this and the next two stories.

Northwell Health backs AI health startups via joint venture with Aegis Ventures with $100 million stake. The JV between the two New York-based companies “will ideate, launch, and scale AI-driven companies to address healthcare’s most challenging quality, equity, and cost problems” with stakeholders across Northwell’s extremely large system. According to the release, “Northwell has a track record of success in AI research, including the development of a landmark algorithm that predicts patients’ overnight stability to reduce the need to wake them for vital sign checks.” Nice to know that a health system appreciates patient sleep. 

And finally–miss the grip and grin of a F2F industry trade show and presentations? Your Editor, who was once a habitué of meetings from Boston to Florida, does. Really! Virtual conferences, once fun, are now tedious. So enjoy this walk through of HLTH21 by Ben Rooks, the Investor Man, at the Boston Seaport (a great venue, though not precisely central), right down to the barbers, puppy rescue, disco ball, and juice shots. Courtesy of HISTalk