A New Paradigm is on the Horizon
We're on the cusp of a new paradigm...but only if we can get reimbursement
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Second, two notes from the Beckley Ecosystem:
Beckley Academy’s March cohorts of Relational Psychedelic-Assisted Therapy are open for applications. To help decide if our course is right for you, join us for a free 3-part webinar series. These webinars are an opportunity to meet our faculty and explore PAT through our educational lenses: ecological systems, decolonization, and trauma-informed care.
Our friends at Homecoming Health are looking for an experienced full-stack software engineer to help build out the world’s first practice management platform for the holistic healthcare space. Interested candidates may want to hear my conversation with Homecoming CEO Yuriy Blokhin on The Trip Report Podcast.
A New Paradigm is on the Horizon
When the weekly CBS news show 60 Minutes does a story on an emerging trend or technology, it is usually a sign that it has reached an inflection point and the mainstream is ready to consider it.
In 1993, 60 Minutes aired a segment titled “You’ve Got Mail,” which explored the growing popularity of email and its potential to revolutionize communication.
In 2018, the show aired a segment titled “CRISPR: The gene-editing tool revolutionizing biomedical research.” (The market for CRISPR gene editing therapies market is estimated to be worth $35 million in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 129%).
In October 2019, Anderson Cooper spoke with Roland Griffiths, Matthew Johnson, and others in the program’s first segment about psychedelics. Again, the timing was prescient as, just a few months later, the Overton Window officially opened for investment, and the formation of dozens (hundreds?) of companies began in earnest.
Last Sunday, 60 Minutes aired a segment on Transcranial Focused Ultrasound (tFUS), a non-invasive neurostimulation technique that scientists, investors, and enthusiasts have been chirping about for a few years.
tFUS is a non-invasive form of neurostimulation that uses ultrasound waves to target tissue deep within the brain. Unlike traditional ultrasound, tFUS focuses these waves to a precise point, allowing for targeted treatment without surgical intervention. This technology has potential applications in treating various neurological disorders, including Parkinson’s disease, Alzheimer’s, and other neurological and psychiatric conditions.
The procedure involves passing ultrasound waves through the skull to reach specific brain regions to modulate neural activity.
The 60 Minutes segment focused on the application for Alzheimer’s disease and the other on addiction with miraculous stories of recovery and improvement after only a single session—an unimaginable outcome with today’s treatment approaches.
However, what I found most intriguing about this novel approach to neurological and neuropsychiatric conditions is how much it has in common with psychedelic therapies, as both:
have “been around” for a very long time.
are radical departures from current treatment paradigms
leverage the brain’s inherent plasticity
require sophisticated clinical infrastructure and therapeutic support
are non-invasive “procedures” that will require some form of risk mitigation strategies (mandated or otherwise)
Finally, both are in development for a wide range of neurological and psychiatric conditions and applications, as well as spiritual transcendence.
For more in-depth coverage of tFUS, I recommend Sarah Constantin’s newsletter, Rough Diamonds, and, specifically, her vast library of tFUS research studies.
For our purposes, I want to explore matters of infrastructure and care delivery as both psychedelics and neuromodulation technologies require us to think entirely differently about how to deliver treatment compared to current approaches.
Care Delivery Innovation
Back in 2020, we speculated that psychedelic drug developers would have to not only prove the safety and efficacy of these compounds through FDA-sanctioned clinical trials but also that the unique properties of the psychedelic experience would require innovation in care delivery.
Unlike most prescription medications, psychedelic therapeutics will not be available for pickup at your local Walgreens or CVS.
Instead, the first phase of psychedelic medicine would look more like surgical workflows whereby patients prepare for and undergo a several-hour-long procedure under the watchful eye of trained, licensed, and credentialed providers and then recover and go home with subsequent follow-ups for integration.
Thus, the incumbent field that is poised to adopt psychedelic therapies is the relatively new field of Interventional Psychiatry.
From an April 2021 article in Psychiatric News about Interventional Psychiatry:
“Psychiatric interventionists utilize neurotechnologies to modulate and apply brain stimulation techniques to modulate dysfunctional brain circuitry that underlies psychiatric disorders. Interventionists utilize a number of therapeutics that are administered according to a structured protocol and require monitoring in a clinical setting. In the last 10 years, the number of treatments that interventionists use has vastly expanded, and more and more general psychiatrists are adopting these therapies into their regular practice.”
(tFUS is perhaps the latest and, by some accounts, the most exciting approach to neurostimulation.)
Recent news from Compass Pathways confirms this prediction as the company announced a partnership with Greenbrook TMS, a nationwide chain of clinics across the US that provide Transcranial Magnetic Stimulation (TMS), an FDA-cleared treatment for depression.
From the press release:
“…they have entered into a three-year research collaboration agreement to explore delivery models for investigational COMP360 psilocybin treatment ("COMP360") upon regulatory approval by the U.S. Food and Drug Administration (“FDA”). The collaboration will research and investigate models for the delivery of scalable, commercial COMP360 within healthcare systems, assuming FDA approval. The initial phase of the collaboration will comprise research into the delivery of COMP360 at treatment centers across the United States, such as through Greenbrook TMS’s current network of treatment centers, working with their patient populations, which include people suffering with treatment-resistant depression (TRD) and other mental health conditions.”
Care Delivery Innovation, Care Delivery Reimbursement
Finally, new paradigm treatments like psychedelics and tFUS will only be as impactful as they are sustainable businesses.
Right now, in the US, both medical and non-medical mental health providers (like psychologists, therapists, and counselors) are leaving the health insurance system.
In a recent piece from Boston-based psychiatrist Andrew Popper in STAT News, he noted why:
“Finally, I realized that from the insurer’s perspective, the numbers mattered more than the care: The insurer was getting paid from the premiums of my patient, and from the premiums of prospective patients, all while denying me payment for my work and preventing me from doing additional work. This is the business model — customers pay for the right to be deprived of the product they’re purchasing. I decided I would stop spending portions of my days fighting that model, and instead I’d follow most other solo practitioner psychiatrists who do not take insurance.”
This would be the death knell of innovative—and urgently needed—treatments like tFUS and psychedelic medicine.
Unless something changes in the the American healthcare system, we might as well write off any chance that these treatments reach the people that need them the most.
Fortunately, results of preliminary cost-effectiveness research makes the case that innovative treatments may end up saving payors.
Let’s hope a future installment on 60 Minutes is about the broad adoption of—an reimbursement for—innovative treatments that are desperately needed.
The new paradigm is reality.