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The Mental Health ‘Formulary of the Future’? Otsuka’s Work in DTx, Psychedelics, & More

By JESSICA DaMASSA, WTF HEALTH

Otsuka Pharmaceuticals is expanding its mental health formulary – looking beyond traditional medications to psychedelics, and to the “intersection of technology and psychiatry” with digital therapeutics currently in clinical trials for Major Depressive Disorder. Kabir Nath, Senior Managing Director of Otsuka’s Global Pharmaceutical Business, lets us in on the thinking behind these bold moves, why the pharma co is even innovating to expand the spectrum of treatments available for mental illness in the first place, and how soon these new therapies will reach patients.

“Follow the science” is a key undercurrent of this conversation, particularly as we talk through Otsuka’s investments in psychedelic medicine start-ups Compass Pathways and, more recently, Mindset. Kabir says the body of clinical evidence for these therapies is building and we get his prediction on when they might become more mainstream and readily available.

We also get his take on digital therapeutics (DTx) and the work Otsuka is doing with Click Therapeutics in Major Depressive Disorder. Their clinical trial, done in partnership with Verily, is the first-ever fully remote clinical trial conducted in this space, and the hope is that it not only generates evidence to support the emerging DTx category, but that it also sets a precedent for a new, tech-enabled way to run clinical trials.

This is just the beginning. There’s lots more on the innovations changing pharma and the future of mental health care in this one. Watch now!

British Doctor Suspended for falsely claiming she was “promised” a laptop. WTF!

BY SAURABH JHA

If forced to choose Britain’s two biggest contributions to civilizations, I’d pick the Magna Carta and the vaguely instructional “fuck off.” If permitted a third, I’d choose “managerialism.” Brits are good at telling others what to do. Managerialism is how the Brits once ruled India. Buoyed by the colonial experience, British managers felt they could rule doctors. 

The new Viceroy, the manager-in-chief, is the General Medical Council (GMC). The GMC is a physician watchdog, funded by doctors, which works for the public good and is answerable to…well, I’ll get to that later. Their relevance rose exponentially when the psychopathic Dr. Harold Shipman, a charming, clinically adept, general practitioner, killed over two hundred patients. Never again, said the managers. They promised to keep the public safe from dodgy doctors with aspirations of Jack the Ripper and Sweeney Todd.

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Russ Johannesson, CEO, Glooko

Russ Johannesson has been CEO of Glooko since 2018. In that time the diabetes data platform has expanded internationally, made a couple of acquisitions, and added support for digital therapeutics and distributed clinical trials. He brought me up to date with the latest–Matthew Holt

THCB Gang Episode 93, Thursday May 26 1pm PT, 4pm ET

Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday May 26 were medical historian Mike Magee (@drmikemagee); Suntra Modern Recovery CEO JL Neptune (@JeanLucNeptune); and fierce patient activist Casey Quinlan (@MightyCasey). Plenty of conversation about guns as a public health crisis, and also much about data use, data reidentification and controversy there.

You can see the video below live (and later archived) & if you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels.

#HealthTechDeals Episode 31| Homethrive, Greater Good, Parallel Learning, Cayaba Care, Miga Health

You know what Jess just realized? We haven’t heard my opinion on Cerebral! Scandal! Firings! Intrigue! Legal Issues! Risk! Skyrocketing! Dying! Cerebral offers quite some food for thought. Check out the episode for my opinion on this incredibly fast-brewing story as well as more multi-million deals: Homethrive raises $20 million; Greater Good raises $10 million; Parallel Learning raises $20 million; Cayaba Care raises $12 million; Miga Health raises $12 million.

-Matthew Holt

Defanging HIPAA: How Your De-identified Data Was Re-identified For Profit.

BY MIKE MAGEE, M.D.

Arthur Sackler continues to demonstrate just how wealthy one can become by advantaging patients and their diseases.

He’s been dead since 1987, but his ghost continues to access your personal health data, pushes medical consumption and over-utilization, and expands profits exponentially for data abusers well beyond his wildest dreams. Back in 1954, he and his friend and secret business partner, Bill Frohlich, were the first to realize that individual health data could be a goldmine. That relationship would still be a secret had it not been exposed in a messy family inheritance feud unleashed by his third wife after Sackler’s death.

That company, IMS Health, was taken public and listed on the NYSE on April 4, 2014, transferring $1.3 billion in stock. I’ll come back to that in a moment. But in the early years, the pair realized that the data they were collecting would multiply in value if it could be correlated with a second data set. That dataset was the AMA’s Physician Masterfile which tracked the identity and location of all physicians in America from the time they entered medical school. 

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Will Boeglin demos TimeDoc Health

Will Boeglin is CEO of TimeDoc Health. It’s one of a new breed of companies supplying the capability for physician groups and health systems (including FQHCs) to deliver CCM (chronic care management) and RPM (remote patient monitoring). Both of those services are now reimbursed by Medicare, and some private plans, but rolling them out and tracking all that activity–not to mention accounting and billing for it–is non-trivial for practices. That is where TimeDoc comes in. Will started the company as part of a med-school project and just raised $48m to really get it going. He showed me how it worked, and gave an extensive and interesting demo–Matthew Holt

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.

I Want to Believe

BY KIM BELLARD

I know, I should be writing about hot topics like monkeypox or the baby formula shortage, but, c’mon, Congress held hearings last week about UFOs – the first in 50 years!  I mean, I followed Project Blue Book in the 1970’s, watched “The X-Files” in the 1990’s, and have seen UFO videos on YouTube.  If Congress is starting to take UFO’s seriously, how could I not?  

And for those of you who don’t see any possible connection to healthcare (except for those unpleasant alien probes…), let me put it to you this way: by 2050, is it more likely that:

  • We’ll know what UFOs actually are;
  • We’ll have fundamentally reformed the U.S. healthcare system.

I thought so.

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CVS Health’s Head of Enterprise Virtual Health Weighs-in: ‘What’s Next’ for Telehealth at CVS, Aetna

BY JESS DaMASSA, WTF HEALTH

What are the BIG questions a BIG healthcare company like CVS Health is trying to answer when it comes to virtual care and creating the healthcare business model of the future? I’ve got Dr. Creagh Milford, CVS Health’s Head of Enterprise Virtual Health, who’s purview covers both CVS Pharmacy (9,000+ stores including 1,100 Minute Clinics) and Aetna, which provides health insurance to 39 million people.

Creagh’s big concern right now: how to weave together existing care models with virtual so 1) the consumer has a single front door and 2) the provider workforce – which includes everyone from pharmacists to primary care docs and beyond – is coordinated and working together. As you’ll hear, there’s a lot of thinking about “pivot points,” or where the patient and provider meet in the virtual-and-in-person ecosystem. The goal is to make those interactions easy and seamless – for both patient and provider alike – and we get into the strategic thinking, clinical operations, and tech underpinnings that are evolving to make those transitions possible.

Long-term, Creagh believes that healthcare consumers have “voted with their fingertips” and that virtual care is here to stay, but as part of a hybrid model in which questions about quality and cost are still being worked out. Will incentives ultimately realign to make virtual care more enticing across the healthcare system? What types of technology will be next to augment the hundreds of thousands of virtual visits a year coming out of Minute Clinic, or happening as part of an Aetna plan benefit? Here’s how one of the biggest healthcare companies in the country is driving virtual care forward. Watch now!

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