TTA Snow Edition: Raises/SPACs pile up for Sharecare, Owlet, Zocdoc, Modern Health; airborne COVID detector passes test; RPM for clinical trials; Theranos and VA EHR updates

Weekly Alert

 

 

The snow won’t stop across the US, and neither do the big raises and SPACs this week. The spotlight’s on behavioral health, patient data storage–and Owlet’s baby monitoring sock. Can COVID be detected in the air?–looks like it. More ‘normal business’–a partnership for renal monitoring, care management, and Current Health’s RPM for clinical trials. Plus an update on VA’s Cerner EHR rollout and the Theranos trial.

GAO tells VA to postpone Cerner EHR implementation–but VA will be continuing (Typical government push-me-pull-you)
Deal and news roundup, 17-18 Feb: Sharecare goes SPAC for hefty $3.9 bn valuation; Humana Care Support pilots; AliveCor, AstraZeneca partner on renal, cardiac; Current Health RPM in clinical trials
The Theranos Story, ch. 70: the lab director turns Federal evidence (And nothing to do with Silicon Valley Lifestyles)
Airborne SARS-CoV-2 detection device for indoor use successfully tested (Useful for other bacteria and viruses too)
Funding roundup, 16 Feb: virtual mental health gains two (more) unicorns, Zocdoc’s fresh $150M, Owlet’s $325M SPAC (The eyeblinking raises and public offerings go on)

Only one truly dizzy deal — Signify Health — this week for a change. NHS apps try to get a handle on the pandemic and triage patients. Two US ‘neoinsurers’ raise big money, but one’s seeing the SEC and DOJ. 

News and deal roundup: Signify Health’s $564M IPO, RapidSOS’ $85M Series C, Poland’s Telemedico raise, Livongo’s Zane Burke to Bardavon
NHS touts COVID-19 Test and Trace app; Livi’s MJog notifies users of vaccine jab info (Trying to turn the corner)
Lasting effects of the pandemic lockdown on health and wealth (More Bad News)
‘Neoinsurer’ Oscar Health goes for $100 million IPO; Clover Health’s big SPAC under SEC microscope (A tale of two insurers, one a potential scandal)
NHS digital triaging app eConsult closes £7 million funding round (Deals spreading in UK)

The Dizzy Deals keep on coming with 23andMe going SPAC-y with Richard Branson for $3.5bn. HIMSS goes ‘hybrid’ for Singapore–but Las Vegas F2F is a ‘maybe’. Telehealth usage soared dizzily but unevenly during the early pandemic. Not so dizzily in the UK, B-Secur ECG algorithms get FDA clearance and Scotland’s Project Liberty advances. 

Belfast’s B-Secur obtains FDA 510(k) clearance for HeartKey ECG/EKG algorithm library (Plug and play?)
23andMe will go the SPAC route with Virgin Group in a $3.5 bn valuation (Ka-Ching!)
The shape of telemedicine during the first half-year of the pandemic: significant but wildly uneven usage (Income and speciality differences)
Short takes, 4 Feb: HIMSS 21 Global/APAC go ‘hybrid’; ATA announcements including virtual ATA2021; Hillrom acquires EarlySense monitoring tech
Communicare247 advances in Scotland’s Project Liberty social care with Stage 2 funding (Smarter homes for independent living)
Bluestream Health telehealth partners with Impresiv Health management consultants (Adding telehealth to client services)

Our third all-new Alert for 2021 has a bumper crop of 10 Dizzying Deals and equally dizzy debates about telehealth parity and coverage. And just as in the movies, Crime Does Not Pay (except in long prison sentences) for ‘telemedicine’ fraudsters being convicted as part of the $4.5 billion ‘takedown’.

Crime Does Not Pay–especially when defrauding Medicare of nearly $1 billion (Latest convictions in October’s National Health Care Fraud Takedown)
Telehealth parity, coverage, access debated in New Hampshire, South Dakota; CMS issues corrections to RPM in 2021 Medicare PFS rules (Will reimbursement advances stick?)
Funding, acquisition news roundup, round 2: Lyra Health’s $187M Series E, DarioHealth-Upright, GetWellNetwork-Docent Health, Hillrom-BardyDx (updated)
Funding news roundup: Philips buys Capsule, Hims’ SPAC + Privia partnership, Signify Health’s $100M IPO; closed funding for K Health, Aledade, Conversa Health

From Deals to COVID (only two scoops) to once again, Theranos and questions on Silicon Valley Startup Ethical Norms. The promise and peril of telehealth, especially in developing countries. Oddly, not much out of virtual editions of CES and JPM.

Comings, goings, and more: YouTube goes healthy, COVID vax distribution and EMA hack, IPO/M&A roundup, Japan’s health tech startups highlighted at CES
2021 predictions: telehealth law and if at all possible, stay away from FDA (US) (From law firm Foley; the wise advice on FDA is from Bradley Merrill Thompson)
COVID-19 and telehealth–promise or peril? And the perils of digital health in conflict countries and India. (JISfTeH’s latest edition)
The Theranos Story, ch. 69: Elizabeth Holmes ‘faked it till she made it’–like other Silicon Valley startups? (Updated) (Lifestyles of the Rich, Famous, and Busted)

Our first postings for 2021 focus on digital health’s funding Boom Town, also confirming that utilization gains made during the worst of 2020 are sticking. Haven, the three-headed hydra that was going to slay the ‘hungry tapeworm’, is closing. But never fear–CES and JPM are next week, with plenty of news to be expected.

Digital Health as Boom Town: 2020’s dizzying funding rounded up by Mercom Capital, StartUp Health (Funding fiddles merrily while COVID burns)
Telehealth claims rose 3,060 percent to October, settling in to over 5 percent of all claims–led by mental health (US) (Telehealth utilization sticks–but so is CoronaDepression)
New Year’s Deal and Event Roundup: Optum-Change Healthcare, Walgreens-Amerisource Bergen, December’s deal potpourri, CES and JPM (No sign of deal cooldown, and big events go virtual)
Haven finds no haven in healthcare, will close in February (Where lack of focus and an embarassment of egos will get you)

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Telehealth & Telecare Aware: covering the news on latest developments in telecare, telehealth, telemedicine and health tech, worldwide–thoughtfully and from the view of fellow professionals

Thanks for asking for update emails. Please tell your colleagues about this news service and, if you have relevant information to share with the rest of the world, please let me know.

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

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Deal and news roundup, 17-18 Feb: Sharecare goes SPAC for hefty $3.9 bn valuation; Humana Care Support pilots; AliveCor, AstraZeneca partner on renal, cardiac; Current Health RPM in clinical trials

Sharecare, a free/paid app platform that enables users to consolidate all their health and wellness data in one location and use proprietary health management tools, is going the SPAC route with Falcon Capital Acquisition Corp. It will trade on NASDAQ under SHCR. Initial enterprise value is expected to be $3.9 bn with approximately $400 million in growth capital. Closing is expected to be in Q2 of this year.

Founded in 2010 by celebrity doctor Mehmet Oz, MD (now on the board and not in active management) and WebMD founder Jeff Arnold, the current CEO, Sharecare will also have an undisclosed investment by strategic partners Anthem and Digital Alpha. Anthem is looking at the AI value plus consumer engagement and personalized care. Helping to fund both the public equity and cash position is a fully committed private investment in public equity (PIPE) of $425 million at $10.00 per share which is below market value. Falcon Capital will retain about 20 percent of the company. Mr. Arnold will join the board and be retained as CEO. After the closing, Sharecare and Falcon will donate about $4 million in stock to Sharecare’s charitable foundation.

Sharecare sells the platform to enterprises such as providers, employers, health plans, government organizations, and communities, as well as individuals on their free apps. Release, FierceHealthcare, Becker’s

Rival health plan Humana is also adding to its care management tools with a pilot of the Humana Care Support program. The platform creates an integrated, personalized experience for members, including a multi-disciplinary care team and SDOH integration. The pilot targets select groups of Medicare Advantage members in Kentucky, Pennsylvania, and West Virginia with multiple chronic conditions, complex congestive heart failure, and diabetes, with multi-disciplinary care teams. Humana Care Pilot is built on Salesforce’s Health Cloud platform for viewing the patient’s medical history and integrating clinician workflows. Its analytics are powered by Microsoft’s Azure and Power BI. The goal is lowering costs and improving outcomes for this high-cost group of patients. If successful, the program will roll out to other markets this year. Humana release, FierceHealthcare

AliveCor, the developer of the KardiaMobile mobile ECG/EKG, and AstraZeneca are partnering on research for new disease management solutions in cardiovascular, renal, and metabolism (CVRM) therapeutic areas. This will use AliveCor’s monitoring system for blood potassium. The Kardia-K AI platform uses ECG/EKG neural network analysis to measure a patient’s potassium levels without a patient blood draw. Hyperkalemia (elevated blood potassium) is linked to renal issues and kidney disease as well as cardiac issues. Kardia-K received Breakthrough Device Designation status from the FDA to screen for elevated levels of blood potassium in September 2018, and was validated in a study with Mayo Clinic published in 2019. Release, Mobihealthnews

Current Health, a monitoring and care management RPM system for enterprise-level health organizations, announced its “Community” initiative to build diverse longitudinal datasets for decentralized clinical trials. Their platform is FDA-cleared and used at scale in phase III and phase IV drug trials by major pharmaceutical organizations for remote endpoint collection and for virtual trial delivery. Monitoring is performed through wearables and sent to the electronic data capture (EDC) vendor for the clinical research organization (CRO). Current Health is using Community for its own COVID-19 study to predict hospitalizations and inform clinical treatment. The study is recruiting US participants diagnosed with the virus in the last 48 hours. Current has locations in Edinburgh, London, Boston, and San Francisco according to their website. Mobihealthnews

Airborne SARS-CoV-2 detection device for indoor use successfully tested

Smiths Detection, a UK-headquartered developer of threat detection and security screening technology, announced this week the success of the BioFlash Biological Identifier in detecting the virus that causes COVID-19 disease in an airborne state. This was proven in testing conducted by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Maryland.

The SARS-CoV-2 CANARY biosensor used in the BioFlash device detected and identified the presence of low levels of aerosolized, live SARS-CoV-2 in a Biosafety Level 3 containment area. The CANARY technology is a cell-based biosensor. Using proprietary aerosol-collection techniques, the Identifier can provide rapid, sensitive, and specific identification of biological-threat agents including viruses, toxins, and bacteria.

According to the release: 

  • USAMRIID’s test confirmed detection down to an estimated 6,000 airborne infectious particles of the SARS-CoV-2 virus within a controlled environment
  • 6,000 particles compares favorably to as many as one million particles emitted in a single sneeze by an infected person 
  • The test results also pick up the COVID virus without cross-reactivity with influenza and Middle East Respiratory Syndrome (MERS)

Additional testing is underway to reinforce the data on effectiveness and determine strategies for use in indoor settings. No mention is made of projected cost or anticipated release, but it is encouraging news for those of us who want to be back in the Great Indoors, in offices, and traveling. Photo courtesy of Smiths/FTI Consulting.

NHS touts COVID-19 Test and Trace app; Livi’s MJog notifies users of vaccine jab info

The NHS Test and Trace app, launched in September in England and Wales, released its first report on notifications this week. 1.7 million app users have been advised to isolate due to close contact (not defined) with a person then found to test positive for the virus. The app notifies the user of the positive contact as quickly as 15 minutes after a user inputs a positive test result. Over 3.1 million test results have been entered into the app across England and Wales, of which 825,388 were positive. The testing combines both those booked through the app and manually entered there. 

The NHS’ analysis suggests (their term) that the contact tracing has prevented approximately 600,000 cases. Test and Trace incorporates a symptom checker that has been used over 1.4 million times.

As well as contact tracing and booking a test the app allows users to check their symptoms via the symptom checker. Coronavirus symptoms have been reported into the app over 1.4 million times in England and Wales since 24 September.

For a contact tracer, it’s been extremely successful with a download count of 21.63 million. It’s estimated that 56 percent of the eligible population aged 16+ with a smartphone has downloaded the app. It was 2020’s second most downloaded free iPhone app in the App Store in 2020. Gov.UK Department of Health and Social Care release, Mobihealthnews

Seeking info on your vaccine jab? Livi is supporting the NHS through its MJog app, notifying users of vaccination messages including vaccination eligibility, the latest information about vaccines, and whether or not users can phone their GP. Since the December rollout, 25 million vaccination text messages have been sent to NHS patients. The MJog platform saw a 220 percent increase in messages sent during the same period the prior year. The app in addition sent out five million appointment reminders. Livi acquired patient notification app MJog, a patient messaging service for the NHS during the past 12 years, last October. Mobihealthnews.

COVID-19 and telehealth–promise or peril? And the perils of digital health in conflict countries and India.

The Journal of the International Society for Telemedicine and eHealth (JISfTeH) has published its latest issue today (13 Jan). JISfTeH is one of the few journals which shine a bright spot on digital health in developing countries. This month concentrates on conflict countries and COVID in India: 

  • Scaling Up Digital Health In Conflict Countries discusses the lack of any form of digital health and coordination in Afghanistan, Somalia, Sudan, and, with some exception, Nigeria. It compounds the extreme lack of healthcare services–for instance, 23 percent of Afghanis have poor access to healthcare, resulting in a high mortality rate. It can change. Rwanda, once synonymous with war, has one of the best healthcare systems in Africa due to the use of digital health services. India is using digital health in combating the TB explosion of 300,000 cases in one year. The exception in Nigeria is the liftoff of 54Gene, a genomic studies company in the world’s most genetically-diverse continent, which has secured $4.5 million in seed funding.
  • Speaking of India, telehealth has been kickstarted there due to COVID-19. The Indian Government is prioritizing the use of telehealth in the population and both public and private institutions have rolled out initiatives. India’s challenges are how patients pay for it (70% of healthcare expenses out of pocket) and how it reaches the two-thirds of population in rural areas where there is inadequate telecom and broadband for services. The irony, of course, is that India is a huge exporter of software and telecom services to the world. COVID-19 As A Catalyst for Telehealth Growth In India: Some Insights.

The editorial by Richard E. Scott of Canada and Prof. Maurice Mars of South Africa, COVID-19 and eHealth: A Promise or Peril Paradox?, cautions on the floodgates opening for telehealth in COVID’s wake. Spontaneous telehealth, where “healthcare providers themselves saw the value of an eHealth solution and implemented it independently and without traditional steps or approval” is quite separate from evidence- and needs-based telehealth. There is a lot of pressure at the national level, by the WHO, and by vendors to ‘make hay while the sun shines’. “Enthusiasm must be tempered with thoughtful guidance” on multiple and quite variable factors.

News roundup, lockdown edition: Oscar Health’s $140M raise, IPO filing; Centene’s Diameter Health investment; Abbott’s telehealth-guided COVID antigen test

Before we break for the Christmas and New Year’s festive season, though most of us are partially or fully locked down for travel and get-togethers, binge-watching the telly for comfort, a few items of interest–we’ll keep it short:

An Oscar Health Double Header. Not only did this relatively new payer in the individual, small group, and Medicare Advantage markets gain a $140 million funding round last week, adding to a $225 million raise in June (Fierce Healthcare), but they quietly filed their S-1 registration with the US Securities and Exchange Commission (SEC) to go public on Monday (Healthcare Dive, Oscar release). Since their founding in 2012, the company has raised $1.6 bn in 10 rounds. The fresh funding will go towards 19 new markets and four new states in 2021, adding to their current 18 states and 211 counties. 

Speaking of payers getting into other lines of business, Centene Corporation, which has Medicare plans with different brands in all 50 states, seems to be moving in a different direction with some recent acquisitions and investments. Centene was the lead investor in an $18 million Series B round for Diameter Health, an enterprise data interoperability developer. Optum Ventures, LRVHealth, Connecticut Innovations, and Activate Venture Partners also participated. Fierce Healthcare Centene recently finalized their acquisition of Apixio (AI-assisted clinical data mining of unstructured data) [TTA 14 Nov] and is acquiring Pantherx, a specialty pharmacy focused on orphan medications and rare diseases, to blend into their Envolve Pharmacy Solutions unit. It does appear that Centene is moving into the UnitedHealthcare/Optum model of dividing services and innovations which can be sold to third parties (Optum) from their health plan and pharmacy businesses (UHC), which may be less profitable in the next few years.

An antigen test for COVID-19 with a telehealth spin is Abbott Pharmaceuticals’ BinaxNOW 15-minute antigen test. It is the first at home, telehealth guided test to get an FDA emergency use authorization (EUA). The Ag Card Home Test requires a prescription and used telehealth to guide users through the sample self-collection process, then to help them read and understand their results. MedTech Dive  It was followed up this week by Quidel’s EUA for a dipstick-style collection with a reading in minutes, similar to that of a pregnancy test, but is only cleared for healthcare settings for now. MedTech Dive

Above: Rockefeller Center, 2011. This year’s tree was mangy and the decorations leading to the plaza scarce.

News roundup: Cera hits £89.5M revenues, Alcove Carephone in new elder housing, Everlywell home test kits raise $179M; FDA clears Lucira’s all-in-one COVID test kit, Apple Watch new ECG feature

Farringdon, London-based Cera announced a high point in its revenues of £89.5 million ($120 million) since their 2016 launch. While it is primarily a home care company d/b/a-ing under Cera Care (and seeks to hire an additional 5,000 staff, mostly professional carers), we noted back in March their £52 million ($70 million) raise and the launch of SmartCare, a sensor-based analytics platform that uses machine learning and data analytics in real-time on behaviors to personalize care and detect health risks with a reported 93 percent accuracy. Cera also has a proprietary app to connect families with Cera on visits and progress. Unfortunately the Cera website is singularly uninformative on company news and SmartCare. Mobihealthnews

Alcove is partnering with Cornell Court in Saffron Waldon, Essex, an extra-care community developed and run by L&Q Living, to fit out apartments with their in-residence Carephone tablet. Having the access to the tablet, residents can easily initiate a group video call with family members, as well as attend virtual care and therapy sessions and activities including bingo and exercise classes. There is also access to a ‘virtual concierge’. The combination of onsite services and the Carephone access helps with resident independence. All helpful as the UK remains on a non-virtual lockdown in most places and Christmas looks distinctly un-festive this year, especially for older adults. Local Authority Building & Maintenance (LABM) Online.

COVID-19 has certainly been a boom of a boon for at-home testing companies.

  • Everlywell just raised a hefty Series D of $179 million. They market and process over 30 FDA-cleared kits, including (of course) symptomatic COVID-19 (SARS-CoV-2, lower nasal swab) with a follow up from the lab in 24-48 hours via their app coupled with a telehealth consult. Other kits include thyroid, indoor/outdoor and food allergies, and hepatitis C, at prices ranging from $49 to a comprehensive food sensitivity test at $259. Prediction: Everlywell and similar companies will be 2021’s 23andMe/Ancestry.com.  Fierce Biotech
  • An equally intriguing ‘home run’? FDA cleared the first ‘all-in-one’ home test for COVID-19 under an EUA (Emergency Use Authorization). The Lucira Health molecular test from a nasal swab sample is completed by a battery-powered handheld unit that includes all the reagents needed to process the test. The unit then shows the result with a green light for positive or negative. Average time: 2 minutes. Molecular tests are more sensitive and accurate than the current quick tests of antigens. Go-to-market of the single-use test kit is expected early spring 2021, at a cost of $50. The by-prescription test can also be performed in point of care settings. The company will be filing early next year to have as an option prescription via telehealth. Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale participated in the trials and will be first on distribution. Fierce Biotech, Lucira press release, FDA release

Remember when any burp from Apple was Major News, breathlessly awaited? Now ho-hum. FDA cleared the latest update of the Apple Watch’s ECG monitoring. Now the feature enables heart rate detection up to 150 beats per minute and adds a classification category called A-Fib with high heart rate. The Apple Watch has been used in some studies to monitor for atrial fibrillation. No release date is set for the watch. However, AliveCor is suing Apple on patent infringement of three patents, from the Apple Watch Series 4 and later devices, so stand by. Mobilhealthnews

CMS expands telehealth, RPM in 2021 Physician Fee Schedule, creates post-pandemic temporary category (updated)

On 1 December, the Center for Medicare & Medicaid Services (CMS) announced its all-important 2021 Physician Fee Schedule (PFS), which sets out the fees and rules for physicians providing services to Medicare fee-for-service beneficiaries and generally serves as a guideline to commercial payers. If one only reads the release headline, one would assume that the national telehealth payment expansion that was approved when the public health emergency (PHE) was declared in March would be largely retained permanently in the 2021 PFS after the earnestly desired end of the PHE, extended to 20 January 2021,

Interpreting CMS-speak is always a task, and so it is here. Your Editor will do her best to unpack it. 

Paragraph 5 is the sobering note for the telehealth ‘bulls’. Telehealth expansion, on a permanent basis, applies to Rural Health, Federally Qualified Health Centers (FQHC), and certain Medicare program models (e.g. two-sided Medicare Shared Savings Program ACOs, ESRD, Episode Payment models, and Medicare Advantage), and with a limited number of new codes. From the release:

“This final rule delivers on the President’s recent Executive Order on Improving Rural Health and Telehealth Access by adding more than 60 services to the Medicare telehealth list that will continue to be covered beyond the end of the PHE….These additions allow beneficiaries in rural areas who are in a medical facility (like a nursing home) to continue to have access to telehealth services such as certain types of emergency department visits, therapy services, and critical care services.”

The release then goes on to explain the kicker: “Medicare does not have the statutory authority to pay for telehealth to beneficiaries outside of rural areas or, with certain exceptions, allow beneficiaries to receive telehealth in their home.” (Editor’s emphases) 

What seems like a pullback in the PFS is a reversion to status quo ante in geographic and model restrictions, which can’t be changed except by Congress. What CMS can do is expand, and create, new Categories for covered codes.

  • CMS expanded Category 1 which is the basic list of telehealth covered codes (CPTs and HCPCS). If you are in a rural area or a covered model, the expansion is real but limited: the number of new codes in Category 1 is nine codes of the 60 stated in the release. 60 is also far less than the 144 service codes added since the start of the PHE.
  • The remaining telehealth codes of the 60 quoted are in a new, temporary Category 3, which will extend through the calendar year the PHE ends–which is, as of today, 31 December 2021. (If the PHE goes into 2022, unless the rule is changed, 31 December 2022.)
    • Category 3 includes over 50 telehealth service codes for the PHE that are not in Category 1–thus the count of 60 the CMS press release trumpeted. 
    • What is not spelled out in CMS’ press release or public Fact Sheet is if statutory geographic (rural) and model restrictions will apply to this category after the PHE ends. Given the above, this Editor’s interpretation is that statutory restrictions will apply unless there’s a Federal change.
  • The Fact Sheet also clarifies certain frequency limitations, who can deliver telehealth services in a practice, telephone-only interactions with a new HCPCS code, and direct practitioner supervision.  Fact Sheet–Final Policy, Payment, and Quality Provisions Changes

For remote patient monitoring (remote physiologic monitoring) services which were modified during the PHE, there are important clarifications and two finalizations of modifications to RPM services made during the PHE, also in the Fact Sheet. 

The exception to the above is apparently the Medicare Diabetes Prevention Program (MDPP). Virtual delivery of certain services, such as educational classes which shifted from in-person to virtual and weight measurement, will not continue past the end of the PHE. CMS MDPP release. Also mHealth Intelligence.

What this all really means. CMS has Kicked The Telehealth Can Down The Road for 2021. They have retained many of the changes that the pandemic forced, but the geographic and model restrictions remain. But practices have made serious procedural modifications to incorporate remote and telephonic visits. Many patients in the Medicare age group are still self-isolating to a significant degree, and depending on the path of COVID-19 (and the flu) have good reason to limit in-office visits. This year’s use of telehealth in this group, according to CMS, was astounding: between mid-March and mid-October 2020, over 24.5 million out of 63 million beneficiaries received at least one of those 144 Medicare telemedicine services. What remains unclear is if Category 3, after the PHS, could continue to apply nationally through Congressional action, as there are several bills before this soon-to-close Congress.

Certainly this, plus post-COVID usage, will influence the 2022 PFS and perhaps stimulate Congress to allow CMS to permit payment for telehealth services nationally.

Editor’s note: References in addition to above are Center for Connected Health Policy’s Telehealth and Medicare page, the proposed CY 21 PFS Fact Sheet (PDF), and COVID-19 Telehealth Coverage Policies. Hat tip to former colleague Madeline Short, COO of Wilems Resource Group.

Update 3 December: The American Telemedicine Association published its comments on 2 December, agreeing with CMS Administrator Seema Verma’s comments on making telehealth permanent outside of geography, itemizing the present bills languishing in Congress, and also lamenting the short shrift that the final rule gave to remote patient monitoring. Also, Healthcare IT News includes additional comments from ATA chief Ann Mond Johnson. Some states like Texas and Wisconsin are pushing for updated parity rules applying to state-regulated plans, which would include commercial plans and Medicaid. Hat tip to reader Paul Costello for the heads-up.

News roundup: Pfizer’s COVID-19 vaccine on horizon, CVS’ new CEO, Vodafone UK 5G health survey, Centene acquires Apixio AI, Doro’s 24/7 Response

As infection rates continue to rise, Pfizer’s and German partner BioNTech SE’s COVID-19 vaccine was the top of the news this undecided post-US election week. It was found to be “more than 90 percent effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis” of the Phase 3 clinical study. They exceeded their evaluable case count (total was 94). Protection was achieved 28 days after the initiation of the 2-dose vaccination. Pfizer release. Chain and independent pharmacies have already signed on for distribution at no cost to patients, covering about 60 percent of pharmacies through the US, Puerto Rico, and the USVI. It’s expected that FDA approval will be by end of year with availability early next year. HHS release. Work on 10 other vaccines goes on. The NHS is lining up for distribution with Health Secretary Matt Hancock promising that they’ll be ready from December as coronavirus diagnoses and deaths climb up from summer levels. BBC News

CVS’ CEO Larry Merlo announces 1 Feb 2021 retirement, Aetna head Karen Lynch to take the helm. Ms. Lynch will also join the board of directors. Mr. Merlo will depart after the shareholder meeting and serve as a strategic adviser until 31 May, which is typical of CEO phased departures. He leaves CVS in excellent shape having conducted during his 10-year tenure the acquisition of Aetna in 2018 and the growth of CVS to almost 10,000 store locations, initiating 1,500 HealthHUBs, and over $199 bn in earnings through Q3 this year. Ms. Lynch joined Aetna in 2012 from Magellan Health Services, a specialty/behavioral managed health company, and Cigna. She hit a home run with vitalizing Aetna’s Medicare Advantage business to 2.5 million members from under 1 million in 2013 and became Aetna’s president in 2015. Mark Bertolini, Aetna’s CEO during the merger in 2018 (but not Federally approved till September 2019), lost his spot on the board in an apparent spat/downsizing last February.  FierceHealthcare, Healthcare Dive, Fortune

Vodafone UK’s new survey on 5G and Internet of Things (IoT) devices in UK health and social care has been issued. A key finding is the comfort level of some telehealth consults well past 50 percent, and over 60 percent in the 18-34 and 35-54 age groups. There is 60-70+ agreement with Government investment in digital technology to ‘future proof the UK healthcare sector’ and to pay for care homes’ high-quality broadband and mobile. More in Vodafone’s study here.

Healthcare payer Centene Corporation is acquiring healthcare analytics company Apixio. Apixio’s AI platform analyzes large amounts of unstructured patient data in physician notes and medical charts. It then creates algorithms to extract high-quality insights to support payers’ and providers’ administrative activities. Acquisition cost is not disclosed and close is expected by end of year. It will be an ‘operationally independent entity’ in an Enterprise group, but complement other in-house technologies such as Interpreta. A bit of catch up here as larger plans Anthem, UnitedHealth/Optum, and Humana all have either substantial in-house AI analytics or have contracted with outside vendors (e.g. Microsoft) for this capability. Release. (Disclosure: This Editor was formerly with Centene, via their WellCare Health Plans acquisition)

Doro Mobile UK and Ireland is introducing ‘Response by Doro’, a touch button service to summon help if needed. The alert button is on the back of the phone versus on the screen, which differs it from most mobile systems. The standard level connects to family and friends, with the Response Premium level connecting to a 24/7 service. For BT Mobile and EE mobile customers with a Doro mobile phone, their first month’s access to Response Premium is free. Release (PDF)

Discovering ways to non-invasively early detect COVID-19 from heart rate, sleep, or a cough sound, even among the asymptomatic

Heart rate, sleep quality, daily movement–cough sound frequency? Several studies in the US and UK are attempting to turn up ways to early diagnose mildly symptomatic, asymptomatic, or even pre-symptomatic COVID-19 cases, without the PCR swab or a blood test.

The more obvious of the two comes out of the Scripps Research Translational Institute. The DETECT study started in March (!) with 30,500 participants sending in data in the first six weeks of the study on heart rate, sleep quality, and daily movement. This information was then matched with self-reported symptoms and diagnostic tests taken if any. In this way, new infections and outbreaks could be detected at an earlier stage.  The study is attempting to confirm if changes in those metrics in an individual’s pattern can identify those even at a pre-symptomatic or asymptomatic stage. 3,811 reported symptoms, 54 reported testing positive, and 279 negative for COVID-19. The numbers seem small, but the analysis carries out that the combination of sensor and symptom data performed better in discriminating between positive and negative individuals than symptom reporting alone. The symptom data were taken from Fitbits and any device connected through Apple HealthKit or Google Fit data aggregators, then reported on the research app MyDataHelps. FierceBiotech, Nature Medicine (study)

Also using vital signs, back in August, Fitbit released early data on a 100,000+ study where changes in heart rate and breathing could detect about half of diagnosed cases at least one day to a week before diagnosis. Symptomatic cases were 1,100 in this sample. Heart rate and breathing were detected to become more frequent in the symptomatic, with the variability in time between each heartbeat dropping, resulting in a more steady pulse. The preferred tracking was at night during rest. However, there was a 30 percent false positive rate on the algorithm used, which is extremely high. FierceBiotech Related to this work, Fitbit was selected at the end of October by the US Army Medical Research and Development Command (USAMRDC) to receive nearly $2.5 million from the US Department of Defense through a Medical Technology Enterprise Consortium (MTEC) award to advance a wearable diagnostic capability for the early detection of a COVID-19 infection. Fitbit will be working with Northwell Health’s Feinstein Institutes for Medical Research to validate their early detection algorithm. Business Wire

And what about that ‘Covid Cough’? MIT is researching that this cough is different than other coughs, like from cold or allergy. Their research found that there’s a difference in the sound of an asymptomatic individual’s cough–and that sound frequency difference could not be heard by human ears. (Dog ears perhaps?) MIT researchers created “the largest audio COVID-19 cough balanced dataset reported to date with 5,320 subjects” out of 70,000 cough samples. The algorithm performed well. “When validated with subjects diagnosed using an official test, the model achieves COVID-19 sensitivity of 98.5% with a specificity of 94.2% (AUC: 0.97). For asymptomatic subjects it achieves sensitivity of 100% with a specificity of 83.2%.” This sure sounds like an AI screening tool that is inexpensive and convenient to use with multiple populations even daily. IEEE-EMB  BBC News reports that similar studies are taking place at Cambridge University, Carnegie Mellon University, and UK health start-up Novoic. The Cambridge study used a combination of breath and cough sounds and had an 80 percent success rate in identifying positive coronavirus cases from their base of 30,000 recordings.

All of these will be useful, but still need to be validated–and that takes time, for which this Editor thinks is short as this virus, like others, will eventually 1) mutate out or 2) be effectively treated as we do with normal flus. But down the road, these will serve as a template for new ways for early screening or even diagnosis of other respiratory diseases.

Perspectives: How Advanced Communications Technology Has Created A ‘New Normal’ In Healthcare

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today, we have a contribution from Dave O’Shaughnessy, Avaya’s Healthcare Leader for EMEA and APAC, with a brief discussion of how AI and advanced communications technology can help healthcare in the long term. (It’s hard to say ‘a post-COVID world as France and Germany are experiencing second round lockdowns, and UK may not be far behind.) Interested contributors should contact Editor Donna. (We like pictures and graphs too)

Across industries, we see working patterns being transformed to create the ‘new normal’ as a result of COVID-19 and our reactions to the pandemic. The healthcare sector has been no different. The pandemic and its restrictions have brought a great number of new challenges to healthcare systems. And as has been the case across so many other sectors, communications technology has stepped in to plug the gaps caused by the pandemic.

The good news is that, not only have communications solutions successfully plugged the gaps, but they’ve also provided a blueprint for the future of healthcare. As we’ve found in other industries, we’ve actually seen the intelligent adoption of this technology lead to better experiences for patients, and better outcomes for providers, than were present before.

The most important (and immediate) area where this is most obvious is in contact tracing – tracking the physical, interpersonal interactions of those who have tested positive for COVID-19. This helps identify people who may need to be quarantined more quickly, therefore reducing the spread of the virus.

Helping government and healthcare organizations across the world with their contact tracing efforts, what we’ve found is that the most effective contact tracing efforts make use of artificial intelligence and automation. After all, the effort involves mountains of meticulous information gathering and analysis—all required to meet standards set by global health and government agencies. Acting upon that data manually just isn’t feasible, given the immediate needs at hand.

Therefore, the best systems employ AI virtual agents for initial patient contact, as well as for the simple data collection interactions – only falling back to live agents when the interaction becomes more complex. AI is also employed to deliver cloud-based, proactive notifications to automatically reach out to individuals or groups with optional response tracking, text interaction, and auto-forms to capture critical information.

Patients benefit from a smoother experience while providing the tracing information required, while healthcare providers and governments are able to collect more information with the resources they have.

Even without these focused AI technologies, however, our customers are putting their advanced contact centers to good use in combating the pandemic. In Saudi Arabia, for instance, one medical facility adopted a multi-experience approach, making it easy for patients to get the COVID-19-related information they need through a wide range of communications channels. This provided demonstrated results for improved knowledge on coronavirus safety measures in the community.

Going forward, we see tremendous use cases for extending this technology to make it easier for patients to directly engage with their doctors through asynchronous messaging. Such capabilities are of particular interest to mental health providers, who have found themselves unable to conduct in-person therapy sessions in the face of increased demand.

All of these solutions were implemented because of specific, pandemic-related challenges. But once the pandemic subsides, they’ll continue providing value, making it easier for patients to consume healthcare services, while delivering increased efficiency for providers.

Hat tip to Mary Burtt of AxiCom UK

News roundup: Kaiser/Best Buy Lively partners; Teladoc’s mental telehealth, Livongo execs depart; approved apps make comeback in US, DE; United Airlines tests COVID CommonPass for international flying

Kaiser Permanente is adding to its existing partnership with Best Buy Health. The joint program will develop remote patient-monitoring tools for older adults centered on Lively Mobile Plus. By pressing a button on the phone, users can connect with individuals trained to triage emergency and nonemergency situations, from car trouble, home lockouts, or medical emergency. Kaiser Permanente has rolled it out to their Medicare members as part of its Medicare Affinity Program for independent living at home. In 2019, the Kaiser system piloted Lively Mobile Plus after Best Buy’s acquisition of GreatCall. Becker’s Hospital Review 6 October and 22 October. Photo from Best Buy via Kaiser on Twitter, @aboutKP.

Teladoc launches mental telehealth to Canadian employers. Four Livongo C-levels will depart after closing. The Teladoc Mental Health Care program is available to employees of Canadian companies and provides access to psychiatrists, psychologists, and therapists via phone, web or mobile app. It is in addition to Teladoc’s Mental Health Navigator and disability products in Canada. Press release, Becker’s Hospital Review  Becker’s has also been keeping a close eye on Teladoc’s SEC filings. The letter, filed 15 October, stated that Livongo CEO Zane Burke, President Jennifer Schneider, MD, CFO Lee Shapiro (widely conceded as the merger engineer), and SVP of business development Steve Schwartz will leave the company after the closing. Livongo’s Executive Chair Glen Tullman will keep his seat on the combined company’s board of directors. Look for more changes that won’t make Livongo employees happy. Our previous Skeptical Takes on the merger here.

Approved Apps Revive! The American Telemedicine Association (ATA) announced a new partnership with the UK’s ORCHA–the Organisation for the Review of Care and Health Apps–to develop an approval procedure for health apps. Announced at the virtual HLTH conference, the objective is to create a review process to vet safe and effective health apps out of various app stores. ORCHA’s automated, intelligent review engine can assess thousands of apps against more than 300 measures in order for a healthcare organization to build and manage a health app program. Both are trying to solve the same problem faced by Happtique and IMS Health (now IQVIA) in those long-ago days of 2014. ATA release, Healthcare IT News 

For Readers with long memories, iMedical Apps is still with us and their team is still reviewing health apps both personal and professional. They’ve extended their reach to reviewing apps to prescribe with iPrescribeApps.

Meanwhile, in Germany, the Digital Healthcare Act (DVG) now finally permits doctors to officially prescribe apps to patients. The Federal Institute for Drugs and Medical Devices (BfArM) certified Kalmeda for tinnitus and Velibra, a therapy program for anxiety disorders as Germany’s first two insured health apps. Germany also is kick-starting prescribed health apps through fast-tracking medical apps that are CE-marked as Class 1 and 2a low-risk medical devices. Healthcare IT News

United Airlines is testing an app-based ‘health pass’ to speed safer global travel. CommonPass, created by the Commons Project Foundation and the World Economic Forum to enable travelers to securely share their COVID-19 test status, taken 72 hours before flight, across borders. The app will also facilitate a health declaration that may be required by the destination country and generates a quick response (QR) code scannable by airline staff and border officials. UAL’s London-Newark test follows on a test with Cathay Pacific between Hong Kong and Singapore. FierceHealthcare, MarketWatch

The book of ‘Thank and Praise’ with a selection of their 1,000 messages (UK)

James McLoughlin of the UK organization Thank and Praise has reached out once again to this Editor with an update on their social thanking of the ‘unsung heroes’ in healthcare during the depths of the COVID-19 pandemic. TAP has compiled a free e-book of a selection (64 pages) of their over 1,000 messages–print and video (page 65)–posted on their thanking walls. The messages thank healthcare workers, teachers, shop workers, church staff, food deliverers, social workers, homeless outreach, and many others who helped others. The illustrations were contributed by children and young adults. The book is also being sent to the organizations mentioned in the book. Reach out to James if TAP can help your organization. Our previous coverage: TTA 10 Apr, 12 June   Press release

Nanowear’s ‘smart clothing’ in NY/NJ hospital trials to monitor patients for early-stage COVID. Is it the Year of the Sensor?

Nanowear, a NYC-based developer of cloth-based nanosensors and monitoring systems, has entered a clinical trial collaboration with two major NY/NJ-area hospital systems to test for vital signs which may be predictive of an advancing case of COVID-19. 

The goal of the investigative teams at Hackensack Meridian Health, the largest health system in north and central New Jersey with 17 hospitals plus 500 patient care sites, and Maimonides Medical Center of Brooklyn, affiliated with Northwell Health, is to determine and assess patients for early signs of the ‘cytokine storm’ in the heart and lungs which indicates inflammation within the circulatory system, often leading to severe complications and death in COVID patients. The clinical trial will monitor patients with confirmed or suspected COVID-19. The release is not specific as to whether the garment will be issued to patients monitored solely in the hospital or inclusive of patients still at home.

Nanowear’s SimpleSENSE adjustable undergarment continuously captures key physiological signs related to the onset of COVID–real-time ECG, systolic and diastolic blood pressure, blood flow hemodynamics, respiration, lung volume and fluid, and temperature. The vital signs are then transmitted via a mobile app to a physician portal for monitoring and interpretation.  

The garment test is also significant as it is a contactless monitoring system–highly applicable to contagious diseases.

Last July, SimpleSENSE launched in a heart failure management clinical trial with Penn State Hershey Medical Center in Pennsylvania and Hackensack Meridian. The patented cloth-based nanotechnology sensors can capture up to 120 million data points per patient per day. The HF management trial was designed to validate and provide a pathway to clear its own diagnostic algorithm generated from the garment. The SimpleSENSE device and mobile platform have been submitted to FDA for Class II 510(k) clearance.  Also mHealth Intelligence.

This may be the Year of the Sensor. Human contact is out, remote monitoring is in. Earlier this week, we covered Philips integrating BioIntelliSense‘s BioSticker into its RPM systems. During 2018-2019, we profiled Doncaster UK-based MediBioSense, which uses the VitalPatch from VitalConnect. They recently announced that an enhanced VitalPatch suitable for seven-day use and body temperature sensing received CE Class IIa medical certification as well as FDA clearance. We last covered them when MBS adopted the Blue Cedar app security system in 2018, but based on their website press section, much has happened since in extending their sensor-based technologies. This Editor will try to catch up with Simon Beniston of MBS.

Can technology speed the return to office post-COVID? Is contaminated office air conditioning a COVID culprit?

Most offices in the US are still not open or only ‘essential personnel’. As this Editor noted on 19 May, a number of companies, including startups, are focusing on working with employers on return-to-work strategies. There are a raft of approaches including on-site clinics, temperature screening checkpoints, and check-in/reporting apps from Verily (Alphabet) and Fitbit’s Ready to Work. These screeners generally monitor for self-reported symptoms, but some will advise and track you to testing if you demonstrate risk, such as UnitedHealth Group and Microsoft’s ‘ProtectWell’ with a closed loop of testing recommendations that are reported to the employer. Collective Go from Collective Health goes a bit further in emphasizing up-front (molecular [PCR]) testing and continuous employee monitoring into their protocols for, apparently, every worker. OneMedical, which works with 7,000 employers, adds to their on-site management and testing additional contact tracing. FierceHealthcare

Maybe it’s in the air-conditioned air you breathe? Office building air circulation may be a culprit in the spike in Florida, Arizona, and Texas cases. The uptick in cases in Southern states where the contagion rates were initially fairly light may be due to the mostly recirculated air in office air conditioning systems. Most modern buildings don’t have windows which open. Older buildings have their own problems like mold from leaky systems and ‘soot’ (from air pollution and when people used to smoke in offices, remember when?). Newer LEED buildings are so ‘tight’ and energy efficient that air tends to be stagnant. Few buildings have good ratios of air exchange with the outside plus use HEPA filtration throughout the HVAC system. The total picture is that any virus can make its way through offices–six feet of distancing, masks, sanitization, no cafeterias, and acrylic panel separators be d****d.  (Contrast your average office building with modern commercial aircraft where about 50 percent of air is recirculated at any one time, there’s a total change about every three minutes, and HEPA filters are used! AskThePilot, a great site for all things airline)

A return-to-work readiness strategy suggested here by a Harvard Medical epidemiologist whose main area is TB spread are germicidal UV lights high in the room to catch the viruses that go up, then down. UV light for sanitization and disinfection is a technology used for several years to disinfect patient care areas (PurpleSun is one). Far-UVC, versus near-UVC, and potential uses are outlined in this Nature article from February 2018Harvard Gazette

FCC approves 70 more COVID-19 telehealth funding applications for an additional $32 million

The US Federal Communications Commission (FCC) today (1 July) approved 70 additional applications for funding telehealth during the COVID-19 pandemic. This funding covers both urban and rural providers, from large health systems to local community health centers. The funds for this thirteenth group totals $31.63 million of the $189.27 million in total funds awarded. To date, the FCC’s COVID-19 Telehealth Program, authorized by the CARES Act, has approved 514 funding applications in 46 states plus Washington, D.C. Equipment covered includes telehealth, computers, smartphones, tablets, remote patient monitoring equipment, and software.

A small sample of this group of healthcare organizations:

  •  Avera Health, South Dakota
  • Barnabas Health in NJ for remote patient monitoring equipment
  • Boston Children’s Hospital
  • Greater Philadelphia Health Action
  • Lehigh Valley Health Network in Allentown PA
  • Montefiore Medical Center in the Bronx, NY
  • Ryan Health in Manhattan
  • University of Alabama at Birmingham Hospital
  • UPMC in Harrisburg PA

FCC release. Full list of Telehealth Program recipients here.