We wish you a Merry Christmas and a Happier 2021!

Editor Emeritus Steve and Editor Donna wish all our Readers a Merry Christmas and a Happy New Year, no matter how (much or little) you (can) celebrate it. Take a break, have a Kit Kat or something indulgent like a bottle of Pol Roger.

We hope you like this little angel and candle from 1906. (Our angel would have known Pol Roger, which dates back to 1849, but not Kit Kat.)

No matter what, we will be bidding goodbye to 2020, which has resembled a cross between Medieval Times and the Spanish Inquisition without the entertainment value.

Unless something earth-shattering happens (and one can never rule that out), TTA will be back on the week of 4 January.

4 min 40 seconds of holiday cheer: Liverpool FC visits Alder Hey Children’s Hospital

The pandemic put paid, unfortunately, to the annual visit of the Liverpool Football Club (the Reds) to Alder Hey Children’s Hospital in West Derby. The virtual visits were made possible thanks to a telemedicine robot, an innovative piece of equipment funded by the Alder Hey Children’s Charity.

The short article and video clip of the virtual visit by the first team does speak for itself.

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.

Developing a medical, healthcare, or life sciences product? Here’s a R&D resource.

Your Editor, as part of her reactivated marketing consulting work, speaks with various companies across the (primarily US) healthcare spectrum. Earlier this week, I was introduced to the work of MIDI Product Development, a research and development consultancy since 1972 for medical, life sciences, and healthcare products. Their proprietary DevelopmentDNA™ innovation and design control approach to product development performs for the client the research, design, and engineering, taking into account technical/IP, regulatory compliance (FDA Class I, II, III), manufacturing, and human usability requirements. Their products are diverse in, for instance, imaging, tabletop units, ‘lab on a chip’, LASIK surgical systems, MRI, and PET scanners. In this time of pandemic, they have developed a Rapid SARS-CoV-2 Device/Disposable, a Disinfection Fogging Device to combat HAIs (Hospital Acquired Infections) and COVID-19 in hospitals and beyond healthcare environments, and a UVC-LED System to combat HAIs from spreading room-to-room via foot traffic.

In speaking with Gregory Montalbano, one of the two principals with his brother Chris, they are interested in working with diverse health technology companies, including home healthcare. The company is located near New York City in Smithtown, Long Island, and, unlike many consultancies that rent out labs, they have their own 15,000 square foot facility. MIDI has worked with companies in the UK, Europe, the Middle East, and Asia/Pacific. Their website is linked above including their contact information. We’d be pleased if you mention that you read about them in TTA. Or contact Editor Donna in confidence.

News roundup: Milken Institute’s telehealth brief with ATA push on Congress, GoodRx confirms 62% are CoronaDepressed, Johns Hopkins’ COVID mortality risk study and calculators

The hot US health tech issue is retaining, consolidating, and adding to the gains that telehealth and remote patient monitoring (RPM) made during the pandemic. The influential Milken Institute (formally the Milken Institute Center for the Future of Aging, Center for Public Health, and FasterCures) has published a short white paper on how best to increase access to telehealth services and support innovation as part of that aim. Their five core recommendations are: 

  1. Permanently lift Medicare location restrictions on telehealth to ensure that older adults can receive a variety of services in their homes and communities, regardless of where they live. (This was also recommended by the Taskforce on Telehealth Policy (TTP) [TTA 18 Sep] which was jointly formed by the ATA, NCQA, and the Alliance for Connected Care.)
  2. Meet the growing need for behavioral health care by addressing barriers to remote care and expanding the availability of telebehavioral  health services.
  3. Increase equitable access to telehealth services through digital technology, literacy programs, and broadband coverage.
  4. Support development and implementation of innovative telehealth and mobile health technology for prevention, well-being, clinical care, and research.
  5. Develop and document clear data sharing standards to support transitions of care across acute, post-acute, and long-term care settings, including care provided in the home and in residential care facilities. 

The consensus is that CMS’ 2021 Physician Fee Schedule post-pandemic (public health emergency=PHE) does not do nearly enough in that it returns–of legal necessity–to the status quo ante geographic restrictions, though it devised a temporary Category 3 to store over 50 telehealth billing codes [TTA 3 Dec]. The American Telemedicine Association (ATA) was joined by multiple organizations on Monday in pressing Congressional leaders to extend national telehealth ‘flexibilities’ as part of the $1.4 trillion omnibus spending deal that is needed to avoid a government shutdown on Friday (yes, this Friday) at midnight. The organizations joining the ATA on the letter to Congress are the Alliance for Connected Care, College of Healthcare Information Management Executives, Connected Health Initiative, eHealth Initiative, Health Innovation Alliance, HIMSS, and PCHAlliance. ATA release.

We are shocked, shocked that CoronaDepression worsens in those already suffering. Prescription discounter GoodRx analyzed prescription fill trends for anxiety and depression meds and found that they reached an all-time high in 2020–9.5 percent higher than the previous high in 2016. It peaked in April as the pandemic was underway, and possibly reflected some stockpiling.

Of their sample of 1,042 individuals diagnosed with anxiety and depression prior to the pandemic:

  • 22 percent responded that their symptoms were “much worse”
  • 40 percent said they were “worse”
  • 28 percent stated that symptoms were the “same”
  • a surprising 10 percent said symptoms were “better” or “much better” 

One of the main factors in that 62 percent reporting worse/much worse was the length of quarantine. “Those who reported quarantining due to COVID-19 were far more likely to report “worse” or “much worse” symptoms compared to those who did not quarantine. Over 70% of those who reported quarantining for more than one week said their depression and/or anxiety symptoms were “worse” or “much worse.” Loss of job and income, plus COVID-related events affecting friends and family, were also key in worsening symptoms. Many also had difficulty reaching their doctors/therapists and renewing medication. The study was conducted 1-10 November. GoodRx study

More depressing news (sic) of mental health challenges to older adults in the Isolation Age: The Future of Remote Care Technology, Lockdown Loneliness feared more than COVID, and the PLOS One study.

But cheer up and carry on, your COVID mortality risk may not be as bad as you think. A team of researchers at the Johns Hopkins Bloomberg School of Public Health created a COVID mortality risk calculator, based on algorithms calculating factors such as age, gender, sociodemographic factors, location, and a variety of different health conditions. Risk scores are grouped into five categories from lower than average/close to average to high.  While primarily for public health authorities to prioritize populations for vaccination, uninfected individuals can use it to determine their personal risk of future infection and complications after infection. It’s easy to use and your results may surprise you. There is also an interactive US map of the risk level of major cities, counties, and states. The study is published in a paper that appears in the journal Nature Medicine.  Johns Hopkins release, risk calculator

AI-powered contact tracing as part of an ‘application ecosystem’ for COVID-19 information and vaccination

Following up with Avaya UK on October’s Perspectives on COVID-19 contact tracing and the use of AI to automate virtual agents for initial contact, they have released details on their contact tracing application that integrates with current Avaya software or into a company’s call center system. Based on their materials, it automates the initial contact with the individual using natural language text to a smartphone or tablet messaging app, web chat, or email. AI in the contact tracing app helps to screen the response and directs it to the correct agent. Augmentation tools provide real-time prompts and suggestions during a live call with the individual. Notifications can also be automated and also individual follow up can be made via text message. Additional features are detailed on their web page and in the contact tracing overview (PDF). Having heard horror stories from friends who have been subject to contact tracing and follow up apps in the wake of COVID-19 contacts and diagnoses, a great annoyance was daily live phone calls with agents repeatedly asking the same information and making the same assistance offers. Text messages would have been far more acceptable and directive.

Contact tracing is a part of their OneCloud Communications Platform as a Service (CPaaS) which enables organizations to design their own applications and workflows with a platform that supports SMS, MMS, voice, messaging, transcriptions, and digital channels. With vaccination now front and center, for provider organizations, OneCloud can be used to build systems for COVID-19 vaccination information access, recruiting staff, and administering the process. Additional details are in their OneCloud CPaaS overview.

This week, OneCloud for healthcare was awarded Frost & Sullivan’s Competitive Strategy Leadership Award. Release.

Hat tip to Mary Burtt of AxiCom UK

Amazon’s feint into large employer telehealth; HealthLake dives into structured health data analytics

Much ado about…..? Amazon is reportedly making an effort to lure large employers into its Amazon Care telehealth and in-person care platform. Amazon Care is a health benefit presently offered to Amazon employees, with telehealth nationally and in-person for Seattle area residents.  

About 300 Amazon employees use it, which is low given their employee size and after 15 months. Since internal takeup has to date been limited, this Editor observes that Amazon may be testing the scaleup waters by inviting other companies in. These reports indicate that online real estate marketplace Zillow was approached but has moved no further with it. Companies would be charged a per member per month fee plus a ‘technology fee’. 

For those interested in telehealth’s positioning among US employers, the Credit Suisse report by Jailendra Singh’s team makes important points on where both Teladoc and Amwell stand with employers and health plans–and it’s not promising for Amazon:

  • Telehealth has been adopted by 90 percent of employers, but it’s a fraction of benefit spending for them
  • What’s important to employers is not the cost of the program, but employee engagement, the potential volume of medical cost savings, and management of chronic conditions
  • Telehealth vendors are increasingly ‘carved into’ contracted health plans
  • Between direct employer contracts and health plans, Teladoc is settled into this segment, and diversified into medical systems with new acquisitions InTouch Health and chronic care management with Livongo. Amwell is situated in the white-label provider market with health systems and health plans, with few employer contracts. 

 AMZN Making a Push in Telehealth For Large Employers: Appears to Be More Noise than Substance

A better-positioned initiative for healthcare providers that Amazon just announced is HealthLake, which is a HIPAA-eligible AWS cloud service for storing and analyzing structured and unstructured data at petabyte scale. The ‘lake’ is the data lake in the cloud. It copies health data in the Fast Healthcare Interoperability Resources (FHIR) format, and analyzes unstructured data uses specialized machine learning models, like natural language processing, to automatically extract meaningful medical information. Current users, according to their website, are Cerner, Konica Minolta, and Orion Health. Hat tip to HISTalk.

Who are the top tech influencers in UK, Germany, and France? Tyto PR compiles a ‘Tech 500 Power List’.

A snack for the weekend. The close of this Year Like No Other (which to this Editor feels like Unfinished Business) brings the usual year-end lists and predictions for 2021, which we all hope will be a better year. UK/EU PR agency, Tyto PR (not to be confused with telehealth/RPM company Tyto Care and with no business relationship), has prepared the former, covering 500 tech influencers in the UK, Germany, and France. While the list is general tech, there’s some representation of health tech and influencers, especially political and academic. The main page lists the top 50 in UK, with pages in German and French for their respective top 50 lists.

#1 on the UK list is Matt Hancock, who needs no introduction to our UK Readers. #3 is Liz Aschall-Payne, CEO of ORCHA (Organisation for the Review of Care and Health Apps), which reviews and rates medical and health apps, and on whose LinkedIn feed this Editor viewed it. In October, we noted their partnership with the US’ American Telemedicine Association (ATA) on the app rating problem. On all the lists, there are a lot of politicians and professors, by their own admission, attributed to COVID-19. The list main site, for your review.

Weekend Must Read: The Future of Remote Care Technology and Older Adults 2020

Laurie Orlov, founder of Aging and Health Technology Watch and well-known industry analyst/advocate in health and aging-related technologies, has released her latest report, The Future of Remote Care Technology and Older Adults 2020 (PDF, free download). Recently, Laurie and I had an opportunity to catch up and review her findings.

This Editor immediately went to the ‘bleed lead’ which was:

COVID-19 HARMED THE WELLBEING OF OLDER ADULTS
Gap in technology access widened into connection chasm

The University of Michigan study from June (cited above and elsewhere in the report) illustrates the change in social isolation for those aged 50 to 80, with numbers that were slightly high to begin with in 2018. Isolation rocketed to 56 percent, putting a Klieg light on mental health that we’ve seen continued in the recent ‘lockdown loneliness’ PLOS One and SECOM studies. The reasons why will be no surprise, as they’re true for nearly all: a screeching halt to in-person experiences, severing in-person connections with family and friends, closing the doors of senior living and nursing homes to visitors (still closed in many states!), breaking healthcare contacts with providers, and losing timely diagnosis of health conditions, new and ongoing.

Most of the report documents the consequences: how telehealth rose, then fell (Epic and Commonwealth Fund last reports), how the experience wasn’t entirely satisfactory and held multiple structural limitations (e.g. tech, vision, hearing, dexterity) for the 50-80 age group (nor providers in obtaining a physical sense of the patient)–a POV you won’t see in mainstream healthcare/tech media nor the funding markets–and how technologies scrambled to fill the gaps (with plenty of examples).

But moving on to the future, which is the aim of this report, there are many gaps which need to be closed that are bigger than Teladongo:

  • synchronous and asynchronous telehealth–the latter primarily remote patient monitoring (RPM)
  • adoption of voice tech
  • broadband and device access, including training and management
  • governmental policy at all levels from Federal to local, including payer reimbursement

The last section of the report (page 18 to end) takes a look at where innovations could take remote care, where expectations are now, and where the opportunities are in connecting older adults. On page 22, there is a checklist for care providers and what they must consider in managing remote care. The summary of the future on page 23 wraps it all nicely.

The Future of Remote Care Technology and Older Adults 2020 (PDF, free download)

 

Lockdown Loneliness feared more than COVID-19 by nearly 1 in 6 over-65 Britons: study

Even with Margaret Keenan, 91, being the first person outside of the Pfizer clinical trial to receive a COVID-19 jab (that’s a vaccination to us Yanks) at Coventry Hospital on V-day 8 December, the Lockdown Blues will continue to play for the foreseeable future, right through the holidays and festive season. Last month this Editor noted a multi-country PLOS One study that pegged UK self-reported loneliness at 27 percent in the survey (March-April) period. 49 to 70 percent of respondents reported feeling isolated. Overall, “Being younger, female, having lower socioeconomic status, a pre-existing mental health condition, and living alone increased the odds of being lonely.” The survey was conducted via social media, so many of the findings detailed the effects among a younger group of adults.

28 percent of older Britons also believe that lockdown and enforced isolation have affected their mental health. A new study from SECOM CareTech that concentrated on older adults confirms even more depressing (sic) mental health findings in the older age group. Of their survey group of 500 people in the UK aged 65 and over (infographic at left):

  • Nearly 1 in 6 were more afraid of loneliness than COVID-19–and this is a group at high risk, with over 50 percent with one or multiple chronic conditions. A sample verbatim quoted: “I get depressed being in the house all the time, but I am too frightened to take the risk of going out even for a walk.”
  • Over half are worried about spending Christmas without their family. Another verbatim: “I seem to have nothing to look forward to now and the prospect of Christmas looks grim.”
  • 28 percent confirmed that COVID-19 had affected their mental health–of those, more than a quarter indicated that loneliness or not being able to see their family was a contributing factor.
  • 39 percent also reported that they had trouble sleeping. Verbatim: “I’ve had sleepless nights since the Covid-19 pandemic & lockdown… I’m constantly worried with the whole situation.”

What to do? Neil Fitzwalter, the care technology manager at SECOM CareTech, said, “More needs to be done to help those in long-term lockdown. That’s why we will be calling each of our CareTech customers on Christmas Day to wish them a Merry Christmas and make sure they’re okay.” Those on the monitoring teams will also be ‘signposting’ customers in the event they are experiencing a mental health crisis.

 

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

Global deals roundup: bubbly Butterfly blank check, Imprivata-FairWarning, Virta Health, OTV, WithMe Health, Perfood, Sofía

Christmas is definitely bubbly in the global tub, in the year-end rush to finalize those Big Deals and Corral That Cash.

‘Blank check’ acquisitions accelerate. The latest digital health SPAC (special purpose acquisition company) is hand-held ultrasound developer Butterfly Network with Longview Acquisition Corp. Longview, a SPAC sponsored by Glenview Capital Management, LLC, brings the listing on the NYSE, Butterfly brings the name and the tech. The deal is valued at $1.5 billion and is expected to have an estimated $584 million in cash after closing expected in Q1 next year. The combined company will trade under BFLY. Existing investors remain and will convert to common stock shareholders. Founder Dr. Jonathan Rothberg will be chairman and largest controlling shareholder. The company’s product is the Butterfly iQ+ hand-held ultrasound probe and mobile software. priced at $1,999 plus a ‘membership cost’ of a standard $99/year. Release This follows on last week’s three-way SPAC with GigCapital2 Inc., UpHealth Holdings, and Cloudbreak Health LLC [TTA 26 Nov].

Data security is hot too. Imprivata, which specializes in digital identity management for healthcare organizations to secure workflows and IT systems, just picked up the FairWarning Technologies insider threat prevention, patient privacy, and data security platform. FairWarning has worked with leading US health systems such as Mount Sinai Health System (NYC), Memorial Hermann (Houston), plus in the UK NHS Lothian and NHS Homerton. Not surprisingly as both companies are in the business of privacy, terms of the deal, timing, and leadership team were not disclosed. Healthcare IT News, Imprivata release.

Virta Health gained a healthy Series D with a $65 million raise, led by Sequoia Capital Global Equities. Virta now has a total funding of $231 million and now has joined the unicorns with a valuation of $1.1 bn. Virta’s treatment using remote patient coaching and carbohydrate dietary restriction reverses Type 2 diabetes, reducing A1C and eliminating the patient’s requirement for diabetes medications. Bloomberg, Virta release

Israel’s Olive Tree Ventures has rebranded itself as OTV and announced the closing of a $170 million fund with a total value of $170M. It is Israel’s first and only primarily digital health venture capital fund. Joining the company is a new Head of Asia Pacific, Jose Antonio Urrutia Rivas, for planned expansion into that market. Release

WithMe Health, an app-based personalized medication guidance company, raised $20 million in a Series B funding led by OMERS Ventures with existing investor Oak HC/FT and new investors Section 32, Shulman Ventures, and MTS Ventures. Release

In Germany, digital therapeutics startup Perfood GmbH raised a €5 million ($5.9 million) Series A to launch its first prescription therapeutics next year. Boehringer Ingelheim Venture Fund led the round, with UV-Cap and investiere. Their personalized nutrition products based on DNA sequencing and gut microbiomes are prescribed as alternatives or add-ons to conventional medications. Their first product available for prescription (in Germany only) will be sinCephalea for treating episodic migraine. MillionFriends is their weight management program based on coaching, gut microbiome analysis, and nutrition management. Mobihealthnews

And in Latin America, Sofía, a Mexico City-based telemedicine and insurance startup, gained a $19 million Series A funding, led by Index Ventures with Calvary Ventures, Kaszek Ventures, and Ribbit Capital. Started by three friends at the Instituto Tecnológico Autónomo de México (ITAM), the company launched with a COVID-19 related telemedicine service, grew quickly to 10,000 users, then moved into insurance, using a core group of 100 physicians in the D.F. in 70 different specialist areas. TechCrunch

Walgreens and VillageMD kickstarting the ‘Go Big’ strategy of over 500 co-located primary care offices

Va-room! Back in July, Walgreens Boots Alliance and VillageMD announced a Really Big Deal that involved 500 to 700 co-located full-service Village Medical primary care offices in more than 30 markets over the next three to five years, along with a billion-dollar investment by Walgreens in VillageMD over the next three years. This week, they announced the opening of the first 40 “Village Medical at Walgreens”, in addition to the 5 pilot offices in Houston, by the end of summer 2021. The first openings will be in Phoenix starting in two weeks, with the remaining flight of offices in Houston, El Paso, and Austin, Texas, plus Orlando, Florida.

The coordination of the Village Medical office with Walgreens pharmacy and in-store services is apparent in the announcement, with much made of coordination among them in influencing patient medication adherence (right dose at the right time), health outcomes, and lowering the cost of care. Many of the clinics will be in traditionally underserved areas with high rates of medical disparities and multiple chronic conditions. In the July announcement, they pledged that over 50 percent would be located in HHS-designated Health Professional Shortage Areas and Medically Underserved Areas/Populations. Release.

For Walgreens Boots, it confirms that they aren’t wavering from their ‘go big or go home’ strategy, clearly targeted to revitalize their retail locations and pharmacy in higher potential markets. Since then, Amazon has opened up Pharmacy in addition to PillPack, CVS is integrating SDOH into pharmacy as a trial, and Walmart Health continues to waver with a limping expansion of 22 clinics in four states. Walgreens picked a very strong partner in VillageMD and Village Medical, which now have more than 2,800 physicians across nine markets, cover approximately 600,000 lives, and manage $4 billion in total medical spend in value-based contracts. They also haven’t slacked in their own efforts. Only last month, they acquired Complete Care Medicine in Phoenix, opening 17 clinics there by summer 2021, along with announcing 10 new offices in Atlanta. VillageMD is also featuring 24/7 telehealth and virtual care in its offices. 

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.