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Virtual Care Regulatory Round-Up: Telehealth & Digital Care ‘State-of-Play’ by Nathaniel Lacktman

BY JESS DaMASSA, WTF HEALTH

Just as HHS extends the Covid-19 public health emergency waivers until July, we kick-off a brand-new monthly interview series about the state-of-play for all things telehealth and digital care policy and reimbursement. Called the WTF Health Virtual Care Regulatory Round-up, we’re partnering with our friends at Wheel to feature health policy experts, lobbyists, health plan folks, and other virtual care experts and insiders who can keep us updated on the changing regulations and what they will mean to those health tech co’s whose businesses rely on virtual care.

Attorney-to-the-stars-of-telehealth, Nathaniel Lacktman, who chairs the Telemedicine & Digital Health Industry Team at Foley & Lardner and is a Board member of the American Telemedicine Association (ATA), kicks the series off for us with an update on those public health waivers and how he is coaching health tech businesses in preparing for the inevitable transition of care that will come when they come to an end.

What will happen to patients who live across state lines from their virtual care providers? What business decisions need to be made to avoid abandoning patients and maintaining continuity of care? Nate’s not bullish on a federal national license, but there are some cases where cross-state patient-provider relationships can continue to exist – they just might not work for everyone’s business model.

And, on the subject of telehealth business models, Nate gives us his take on where he thinks reimbursement will be headed, how policy around virtual prescribing will be impacted post-pandemic (particularly around controlled substances), and whether or not Medicare’s originating site requirement will be put back in place. We also get Nate’s perspective on which virtual care business models seem to be working best among health tech startups and what legal risk those more ‘reckless’ players might be creating for the rest of the field without even realizing it. Great education on virtual care and what’s happening in the space RIGHT NOW. Watch!

Special thanks to our series sponsor, Wheel – the health tech company powering the virtual care industry. Wheel provides companies with everything they need to launch and scale virtual care services — including the regulatory infrastructure to deliver high quality and compliant care. Learn more at wheel.com.

Matthew’s health care tidbits: Digital Health is dead (well, not quite)

Each week I’ve been adding a brief tidbits section to the THCB Reader, our weekly newsletter that summarizes the best of THCB that week (Sign up here!). Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

For today’s health care tidbits, the elephant in the room has truely come home to roost, and now it’s landed on the phone wire, it’s close to breaking it. OK, I have stretched that metaphor to death but you’ll get my point. Writing on THCB earlier this month Jeff Goldsmith and Eric Larsen picked up on something I’ve been saying for a while –the fall in valuation of publicly traded digital health companies will have a knock effect on private companies

It took a while–those public companies stock prices started falling from their heights 14 months ago–but in the last month the venture capital scene has gone quiet. The days of sub $20m ARR companies getting mutli-hundred million dollar valuations are over for now. They will be back at some point in the future, as that’s how Silicon Valley has always worked, but it’ll be a while and in the meantime everyone is going to have to figure out what to do in the new world.

The “What to do?” question is getting harder as the data starts to come in, and it’s getting ugly. On the one hand the two fastest growing digital health companies ever have both had their comeuppance. Livongo was a tremendous exit for its investors and ended up trading at 20 times future revenue before it got acquired by Teladoc for $18bn mostly in stock. This quarter Teladoc wrote off much of its investment in Livongo and the whole company is now only worth $5bn. Clearly those “synergies” between telehealth and chronic care management didn’t work. The other rocket ship was Cerebral, which went from nothing in Jan 2020 to by Jan 2022 having over 100,000 patients and thousands of providers on its system as it raised over $300m from Softbank et al. Its aggressive & expensive customer acquisition costs, with its controversial controlled medication prescribing patterns, brought it way too much controversy. Its young CEO is gone, and it’ll be a slow climb back with bankruptcy and collapse the likeliest of outcomes.

But the part of digital health that’s trying to replace the incumbents is not the only place showing ugliness. The technologies and services being rolled out are often not working. Exhibit A is a randomized controlled trial conducted a Univ of Pennsylvania. One set of heart patients was set up with connected blood pressure cuffs, a pillbox that tracked their Rx adherence and lots of coaching help. The others were sent home with the proverbial leaflet and told to call if they had problems. You’d assume many more deaths and hospital readmissions in the second group. You’d be wrong. There were no differences.

So digital health needs to see if it can produce services companies that move the needle on costs and outcomes. The advantage is that they are eventually competing with hospital systems whose DNA doesn’t allow them the ability to let them cross the chasm to the new world. The bad news is that those systems have huge reserves which they can use to subsidize their old world activities.

I’m hoping digital health’s impact in the next 2 years will be as big as it was in the past 2, It’s by no means dead or over, but I am pessimistic.

What Do You Mean, “Innovation”?

BY KIM BELLARD

One of my favorite movies is The Princess Bride. Among the many great quotes is one from Inigo Montoya, who becomes frustrated when the evil Vizzini keeps using “inconceivable” to describe events that were clearly actually taking place. “You keep using that word,” Inigo finally says. “I do not think it means what you think it means.”

So it is for most of us with the word “innovation” – especially in healthcare.

What started thinking me about this is an opinion piece by Alex Amouyel: Innovation Doesn’t Mean What You Think It Does.  Ms. Amouyel is the Executive Director of Solve, an MIT initiative whose mission is “to drive innovation to solve world challenges.” It sees itself as “a marketplace for social impact innovation.”    

In her article, Ms. Amouyel notes that traditional definitions of innovation focus on the use of novelty to create wealth. She doesn’t dispute that view, as long as “wealth” includes the less traditional “community wealth,” which includes “broadly shared economic prosperity, racial equity, and ecological sustainability.” I suspect that innovators like Jeff Bezos or Elon Musk don’t ascribe to that view of innovation.

Ms. Amouyel’s view is: “For me, innovation is about solving problems. And if innovation is about solving problems, what problems you are solving and who is setting about solving them is key.” She notes the multiplicity and difficulty of both global and community-level problems that we face, and urges: “Most urgently, we should zero in on problems that affect the most underserved among us.”

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The Sovereignty Network will help patients make money out of your health data

By HAMISH MACDONALD 

Being a patient has always meant being at the bottom of a trickle-down pyramid in healthcare. Late to get information, our test results, our data, and as for earning the money that our healthcare data is worth – that is something the healthcare industry does without our permission or dues. We are left right out of that.

But what if we made clinical data tools available on your device, so that you could build the most valuable set of healthcare data that exists about you anywhere? What if you owned that particular data set as your personal asset? Well, we think that researchers are going to want access to it – and pay you for that access.

Not only that, how valuable would it be to have the most complete and accurate healthcare data set available about you under your ownership and control? How can you expect a doctor or yourself to reach the best conclusion with incomplete information about your health?!? Frustration, confusion, anxiety and poor health outcomes are often the result.

How The Sovereignty Network empowers you to build your own healthcare data set

Building the most valuable data set about you, for you, is what we have done at The Sovereignty Network. We elevate you as a patient to be a Data Owner. There are 4 easy steps to becoming a Data Owner and earning what your data is worth – and having a complete and accurate set of your healthcare data on hand for your peace of mind.

  1. We have clinically coded simple to answer FHIR and SNOMED CT questionnaires that cover the entire spectrum of your health. We call it “DCPLEG”. By filling out questionnaires in your personally owned and secure profile that represent your Demographic, Clinical, Psychosocial, Lifestyle, Environmental and Genomic data you paint a complete 360 degree view of your health.
  • Where Clinical data sets are also available, such as in the US via the newly implemented Patient API rule, you can also add your clinical data from your healthcare providers. The spread of the FHIR data interoperability standard around the world makes this increasingly feasible to accomplish.
  • Data Researchers are able to sit at their desktop and specify the precise criteria that they are looking for (anonymized, of course) using the same clinical codes that you and others have already filled out in your health profile above. E.g. Age, sex, condition(s), medication(s), procedures, deeper demographic information, environmental, lifestyle, psychosocial markers, etc. Through partners even individual base pairs within a whole genome can be specified. Through the Sovereignty Network they can then make you an offer that you can’t refuse, as it were. If you agree to the offer, only then can they make contact with you with their survey they invite you to complete.
  • We have invented a new class of work we call the “Data Coach” that works rather like the synaptic fluid between joints but here between the Data Researcher and you as the Data Owner. A Data Coach is a vetted healthcare professional / healthcare data expert who verifies on your behalf the specific criteria needed by the Data Researcher. If a Researcher is willing to pay you, say, $100 to fill out a 20-minute survey because you fit their desired set of criteria, you are probably willing to pay some fraction of that to qualified Data Coaches to verify the criteria. (And once verified, criteria likely don’t need to be verified for another Data Researcher).

Turning your data set into licensable income – or donating it to causes you support

Because you and only you own the copy of your healthcare data that you have built – your record, or specific parts of it, is now licensable.

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#HealthTechDeals Episode 29 | Osmind; Turquoise Health; Mahmee; Simplifed

In this episode of #healthTechDeals Jess DaMassa is hoping Matthew Holt disappears, possibly on Elon Musk’s rocket to Mars. Matthew just wants him to buy Chelsea FC. And then there’s actual funding deals for Osmind ($40m), Turquoise Health ($20), Mahmee ($9) & Simplifed which got $6m despite having Matthew help!

The Licensing Walls Come Tumbling Down

BY KIM BELLARD

Abortion rights continue to be one of the most heated issues in American politics, super-fueled by last week’s leak of a draft Supreme Court opinion that would overturn 1973’s Roe v. Wade and return the issue to the states to decide. 

I’ll leave it to others more qualified than me – women, for example — to weigh in on abortion itself, but I want to talk about how abortion pills are going to force changes to our healthcare system that many may not be ready for.

Although the stereotype of abortions is a procedure done by a physician in an office/clinic, the majority of abortions in the U.S. are now done through the use of abortion pills.  It is a two step process, and the two medications must be prescribed by a physician. Until last December, women were required to see a physician in person, but the FDA permanently lifted those requirements, following a temporary waiver during the pandemic. The pills are considered both highly effective and safe.  There are startups, like Hey Jane and Just the Pill, that specialize in them.

Not surprisingly, since the leak searches for “abortion pills” have hit all-time highs.

The states that have been passing various abortion bans have not ignored the loophole that abortion pills represent. There are a variety of restrictions that have been enacted, such as requiring in-person visits to outright banning use of telehealth for them. In those states, some women have opted to travel out of state to do the telehealth visit and/or to receive the pills via the mail. 

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The Reckoning: What Happens to Digital Health After COVID?

By JEFF GOLDSMITH and ERIC LARSEN

It has been a rough year so far for digital health. After an astonishing $45 billion poured into new digital health companies in 2020 and 2021, and an early 2021 peak in market valuations of publicly-traded digital health providers, valuations and multiples have collapsed. Once high-flying Teladoc, which traded at an eye-watering 42x revenues and commanded a $45 billion market capitalization, is now trading around 2.7X at about $5.7 billion. AmWell, the next largest telehealth player, has seen its stock drop more 90% from its high.

Nor is the evaporation in market value is confined to just a few highly visible incumbents. The 29 healthtech companies to go public (either via IPO or SPAC) in 2021 were collectively trading 45% lower than their opening day price by the end of the year, according to STAT. Among the privately held firms, re-valuation of digital health is getting underway. Bearish market signals portend a sharp correction in digital health, characterized by brutal price competition, widening (and less tolerated) operating losses, layoffs, and ultimately, widespread consolidation. 

However, there is also major pushback from the ‘demand side’ of the digital health equation. With the explosion of digital health players, potential customers are confused and frustrated. There is a fundamental disconnect between the exuberant (and as yet largely unsubstantiated) promises of digital health startups and the needs of the four ‘phenotypes’ of health care customers. How digital health firms respond to those customers’ needs will ultimately determine the shape and size of the digital health market.

Why is the Digital Health Market Correcting?

Let’s start with the supply side. It is not difficult to identify the source of the digital health boom: hyper liquidity in the market fueled by expansive COVID-related fiscal and monetary policy. In the heat of COVID, Congress enacted three enormous stimulus/relief packages in eighteen months. The Federal Reserve also turned deeply dovish, keeping interest rates near zero and embracing epic quantitative easing – pumping $120 billion a month into the economy and expanding its balance sheet by more than $6 trillion. Much of this newly printed cash found its way into the coffers of private investors. Private equity, growth equity, and venture capital collectively raised $733 billion in new capital across 2021.  Globally, private equity firms alone invested $151 billion in healthcare in 2021.

Telehealth Ignition

The spark to ignite the digital health explosion came from the surprise growth in telehealth visits in the spring of 2020. In the wake of the spring 2020 lockdown and freeze on elective hospital care that accompanied the COVID public health emergency, telehealth visits went from less than 1% of total Medicare Part B patient visits in 2019 to nearly 13% during the spring of 2020 (and nearly 38% of all behavioral health visits), according to an analysis by DHHS’s ASPE. Private insurers saw 50-70% of behavioral health visits turn virtual.

This surge was not caused by a spontaneous surge of consumer activism but rather by hospital systems desperate to remain in touch with existing patients during the spring COVID lockdown. These systems saw plummeting visit volumes not only due to service closures but to patient reluctance to visit hospital ERs and outpatient clinics crowded with contagious COVID patients. Larger systems with extensive IT infrastructure were able to stand up far more robust telehealth offerings than smaller systems. As Bob Wachter, Chair of Medicine at University of California at San Francisco said, “We made 20 years’ worth of progress in twenty days.”

The sudden multi-thousand percent rise in telehealth volumes led to breathless estimates of future growth in telehealth volumes and revenues. In July 2020, McKinsey estimated a total addressable market (TAM) of $250 billion for telehealth services — this from a business with a revenue base McKinsey itself estimated at $3 billion in 2019-2020, and $5.5 billion in 2020-2021. This risible TAM estimate assumed that 24% of all physician and outpatient visits (a 1.8 billion visit “universe”) and 25% of Emergency Department visits would be addressed through telehealth alternatives.

However, more than 90% of telehealth visits during the spring of 2020 were with physicians patients already knew, not random, anonymous physicians signed on to cover telehealth services by vendors. And 47% of those visits were one-time users, according to a recent Trilliant analysis. Visit volume growth was also materially aided by Congressional approval of temporary Medicare coverage for telehealth visits as part of the COVID Public Health Emergency declaration. 

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#HealthTechDeals Episode 27: Levels, Waltz Health, Safety Wing & Implicity

In this episode of #HealthTechDeals, Jess is enjoying Cinqo de Mayo in an Addams Family-themed hotel where she is playing “the mummy” introducing health tech companies coming back from the dead. There’s gossip about Amazon’s pharmacy operation over supplying insulin, and there’s deals for Levels ($38m) in CGM analysis, Waltz Health ($35m) in pharmacy search, Safety Wing ($25m) for health insurance for nomads & Implicity ($23m) doing cardiac implantable monitoring in France.

#HealthTechDeals Episode 26: Hello Heart, Concert Health, Vivian Health, Curebase, Mendel.ai & Blue Spark

It’s the May the 4th be with you day! In Episode 26 of #HealthTechDeals, Jessica is huddling in Boston after the American Telehealth Association conference, and has Star Wars-related trivia. There’s gossip there, there’s more gossip about Cerebral & its ADHD med strategy. Meanwhile a lot of copy cats in deals today with Hello Heart ($70m) for hypertension, Concert Health ($40m) for mental health, Vivian Health ($60m) for nurse staffing, Curebase ($40m) for DCTs, Mendel.ai ($40m) for NLP & Blue Spark ($40m) for RPM — all joining very crowded markets.

ONC Explainer: Micky Tripathi Deep-Dive on Info Blocking, API standardization & TEFCA

By JESS DaMASSA, WTF HEALTH

Micky Tripathi the National Coordinator for Health Information Technology at HHS says this year will be a “transformative” year for Health IT as the decade-long, $40 billion dollar effort to lay an electronic foundation for healthcare delivery heads to the next level. Why is this year THE YEAR when it comes to the digital exchange of health information? Where is federal health IT strategy headed in order to provide the standards and policies health tech co’s need to be able to kick up the pace of innovation?

We get into a SWEEPING chat about the technology and business implications of all the work coming out of ONC, including implementation of those new information blocking regulations, goals for API standardization, and TEFCA (Trusted Exchange Framework & Common Agreement). Micky not only gives the background on the regulations and policies, but also provides some analysis on what they actually mean for those health technology companies trying to do business in-and-around a more digital healthcare ecosystem.

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