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

February 3, 2023 | by

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

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

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

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

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

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

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

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

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

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

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

Telehealth waivers take critical step in extending to 2024 in House bill now passed

August 3, 2022 | by | 2 Comments

In a 406-12 vote last week, the US House of Representatives passed HR 4040, the Advancing Telehealth Beyond COVID–19 Act of 2021. The bill, which now goes to the Senate after the August recess, extends key Medicare telehealth waiver provisions to the end of 2024.

The key provisions extended are:

  • Permitting Federally Qualified Health Centers (FQHCs) and rural health clinics to serve as the distant site (i.e., the location of the health care practitioner)
  • Medicare beneficiaries to receive telehealth services at any site, regardless of type or location
  • Any type of practitioner to furnish telehealth services, subject to approval by the Centers for Medicare & Medicaid Services
  • Audio-only evaluation and management and behavioral health services
  • Delay of in-person requirements for behavioral health telehealth
  • Use of telehealth to satisfy Medicare face-to-face telehealth requirements for hospice care

The current emergency telehealth extension expires five months after the end of the Covid-19 public health emergency (PHE). As of today, that ends in October 2022. For any further extensions or permanent changes, the Centers for Medicare and Medicaid Services (CMS) is required to seek them from Congressional legislation. FierceHealthcare, ATA releases 25 July, 27 July 

Home-based remote monitoring for Covid reduced hospitalizations, hospital length of stay: JAMA study

July 15, 2022 | by

Activation of remote patient monitoring (RPM) in this study is associated with lower hospitalization, intensive care use, and if hospitalized, length of stay. Conducted by Froedtert & Medical College of Wisconsin Health Network with Covid-19 positive ambulatory patients who accepted RPM in the home (N=9,378), the study’s purpose was to evaluate the implementation of a large-scale daily RPM program for patients who were managing symptoms from home. They compared those who activated their RPM (N=5,364, 57%) versus those who did not (N=4,014, 43%). The mean age was 46 and 58% were women.

  • 878 patients  (16.4%) had at least one RPM alert
  • 2.4% (128) of the activated patients were hospitalized, compared to 3.9% (158) of inactivated patients

A weighted regression analysis, adjusted for demographics, comorbidities, and time period, compared RPM-activated to the tracked but inactivated patients:

  • Lower odds of hospitalization (odds ratio, 0.68; 95% CI, 0.54-0.86; P = .001)
  • Greater time between test and hospitalization for RPM-activated patients 6.67 [3.21] days vs 5.24 [3.03] days)
  • Shorter length of stay (4.44 [4.43] days vs 7.14 [8.63] days)
  • Less intensive care use (15 patients [0.3%] vs 44 patients [1.1%])

The study excluded patients younger than 18 years, those with asymptomatic tests (because these were often scheduled before procedures or other planned admissions), patients who were admitted within 24 hours of a positive test, and those who already had internal PCPs to reduce the chance of missing hospitalizations. The RPM provider was GetWellNetwork using the GetWellLoop monitored by a centralized team of Froedtert & Medical College of Wisconsin nurses. Patients used the web or a mobile app to record their symptoms, temperatures, and pulse oximetry readings. Hospitalization Outcomes Among Patients With COVID-19 Undergoing Remote Monitoring (abstract and downloadable PDF)

Short takes: Now J&J splits up, a Color(ful) $100M, Cue Health goes DTC, Amwell’s busy Q3, Teladoc’s Investor Day 19 Nov

November 12, 2021 | by

Breaking up seems to be the thing this month. Now Johnson & Johnson is spinning off its consumer brands into a separately traded public company, retaining the pharmaceutical and medical device businesses. The consumer business includes such J&J global signature products such as Band-Aids, Neutrogena, Q-tips, Baby Powder and Shampoo, and the Listerine line of products. It’s expected to take 18 to 24 months. The pharma/med device business will retain the J&J brands, sub-brands like Janssen, and development in AI and robotics. The consumer products divisions will have to hunt around for a new one. Outgoing CEO Alex Gorsky must be heaving a sigh of relief and dreaming of a long vacation, as he won’t have to shepherd this one– incoming CEO Joaquin Duato starts in January. Pharma/med device is much larger, with $77 billion in revenue. Consumer accounts for $15 billion, with four products alone accounting for $1 billion each. The reason behind it, of course, are the talc lawsuits around Baby Powder and Shower to Shower which have been adroitly hived off, but continue. CNBC, Reuters

Population health and genomics is more Color(ful) than ever, with the company’s $100 million Series E topping off last year’s $167 million Series D for a total of $497 million since 2014 (Crunchbase). Valuation of the company is now at $4.6 billion. Color’s platform is targeted primarily to the public sector–health agencies, research institutions, employer organizations, health systems, and others for custom-built software that can integrate patient information and genomics with lab results and education.  It previously teamed up with the National Institutes of Health for the ‘All of Us’ project collecting research data from a broad scope of the US population. Mobihealthnews

San Diego-based Cue Health, which up to now was known for a molecular COVID-19 at-home test, is expanding its direct to consumer market with a virtual health platform featuring their COVID-19 test (on FDA EUA, CE marked) starting on 15 November. It’s expanding ‘on cue’ with a membership offering, Cue+, with 24/7 online medical consults, e-prescriptions, what they term CDC-compliant test results for travel through in-app video proctoring, and same-day delivery of their products. Membership starts at $49.99 per month for the lowest level plan, escalating to $89.99/month for supervised COVID-19 testing. To make this work requires a Cue Reader that costs $249 along with testing packs priced at $225 for three. Cue also has in development testing for other factors–where it started prior to the annus horriblis of 2020. Not for those on a tight budget, but if you need it…. Cue release, Mobihealthnews

Amwell’s busy Q3 in visits reflected the uptick in the ‘delta’ variant of COVID-19, but was disappointing on the earnings side as urgent care brings in less revenue than behavioral health or specialty care. Amwell’s year-to-year revenue was down less than 1% to $62.2 million, but the decrease is forcing a revision in 2021 full year forecasted revenue. The Converge platform [TTA 29 April] has reached 4,000 providers and 43 enterprise clients which was far more than forecasted. Newly acquired SilverCloud and Conversa Health [TTA 29 July] are integrated into Converge and already cross-selling. Amwell, however, remains in the red with a quarterly net loss of $50.9 million. Healthcare Dive  

The Telehealth Wars continue to see-saw, with Teladoc’s Investor Day on Thursday 19 Nov next week. According to Seeking Alpha, a stock analysis site, “Bank of America is cautious on TDOC ahead of the event, citing questions about the near-term margin trajectory and competition. Shares of Teladoc rose 22% in the three weeks following its last investor day.”

US telehealth usage increases slightly in August, reversing months of decline

November 4, 2021 | by

A permanent or temporary lift for telehealth claims? FAIR Health, which is the non-profit that analyzes healthcare costs and health insurance information, has been tracking telehealth claims monthly since January 2020. This Editor has previously noted the peaks coming during the height of the pandemic (April 2020, 13%) and the rapid deflation after then to settling down during the summer to about 5%. In August, claim volume increased to 4.3% from 4.2% in July. It’s 2.4% mathematically, but still a decline from May’s 5%.

Of all telehealth claims, COVID-19 reappeared in the list of top five telehealth diagnoses nationally in August 2021 at 2%, the first time it had done so since January 2021. The vast number of claims–58.8%–were for mental health conditions, a slight change from July’s 60.7%, and decreased across every region. Also increased: acute respiratory diseases and infections, rising from 3.5% to 4.2%.

The largest increase in telehealth claims occurred in the Southern states, rising from 3.1% percent of medical claim lines in July to 3.5% in August. 

FAIR Health’s monthly tracker includes claims from the private (commercial) insurance population, including Medicare Advantage, and excluding Medicare fee-for-service and Medicaid. FAIR Health release, Becker’s Hospital Review

Share your story about healthcare inequities and community effects during the Time of Pandemic (deadline: 14 May)

May 12, 2021 | by

Do you have a story to share about how COVID-19 has impacted your community–or you or someone you know personally? Healthline.com, a leading US consumer healthcare information website, is seeking stories about how communities that have been impacted by inequities in healthcare have experienced COVID-19. Since many of our Readers are in organizations or businesses that support these communities–such as older adults, the disabled, the rural, in underfunded areas, and/or those who live without access to the internet–you may have a personal story about it. Were you able to overcome it?

Healthline has confirmed to this Editor that stories about communities outside the US are welcome.

Visit or share the following link to submit your story by 14 May. https://transform.healthline.com/submit

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

February 18, 2021 | by

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

February 18, 2021 | by

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

February 13, 2021 | by

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.

January 14, 2021 | by

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

December 23, 2020 | by

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

December 10, 2020 | by

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)

December 3, 2020 | by

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

November 14, 2020 | by

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

November 6, 2020 | by

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

October 30, 2020 | by

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