Archive of Lia's Media

Joe Moore: Hello everybody. Welcome back to Psychedelics Today. Joe Moore here coming at you from Breckenridge, Colorado. Today on the show we have Lia Mix. Lia is a very influential person in the psychedelic space, founded a lot of really important organizations in psychedelia and is an LMFT with some really interesting big insurance company experience.

So I hope you all learn a bunch from this one. There's a lot of conversation about unity and what are we actually trying to do here with some of these different projects that are underway and how can we come together to make meaningful change before things get really concretized in a framework that we don't necessarily love.

I think that's it for the intro. Thank you all for tuning in. Thank you to Lia for coming over and doing this one in person, and I hope we can do more with Lia in the future. Alright, everybody, have a beautiful rest of your day. Enjoy this episode and see you on the other side.

All right, here we are, Psychedelics Today, recording on June 16th, 2024 with Lia Mix. How are you?

Lia Mix: I am so well, Joe. I'm really happy to be here with you.

Joe Moore: Good. This is really great. And we get to do it in my living room, which is wonderful.

Lia Mix: It is, it is a wonderful living room.

Joe Moore: Thanks. I had almost nothing to do with it, so that's great.

Alright, so today we're gonna talk about you. We're gonna talk about the recent FDA advisory committee (AdComm) meeting. We're gonna talk about the future of psychedelics in medicine, how we might be able to unify to bring psychedelics into their best fruition in the medical field. Let's first talk about you, you're a therapist.

Lia Mix: am. I'm a family therapist by training and I spent the first half of my career primarily in community mental health. So homeless populations, chronically mentally ill. That's a lot of foster care. And then after about, I did 12 years of direct service. I actually navigated to working in the system itself.

I really could see family therapies based on systems theory. And I'm a systems thinker. That is definitely how my mind works and was fascinated with how the system, the healthcare system legal system, all these different interacting systems, but primarily the healthcare system was holding a lot of the suffering in place that I was trying to treat clinically.

So my choice was to actually jump in and work inside the system itself. And I'm happy to tell you a little bit about that.

Joe Moore: Let's go a little bit further into that. So when you say that it makes me think Washington, DC or like state level organizations, but how did that play out for you?

Lia Mix: What that looked like is working 15 plus years in the commercial health insurance industry and I developed an expertise in actually bringing new behavioral health, clinical specialties, helping them come into the healthcare system and then to be covered by health insurance.

It was a very unique experience and I'm super grateful for it because you get to really look at all of these. You get to look at how the machine works and then really use it actually to help people have more access to care. So doing that at scale and impacting directly 20 million covered lives and indirectly, eventually impacting the entire commercial market of 250 million.

There's a lot that goes into that. Everything from helping code claim systems developing medical policy, building provider networks, all the way up to crafting legislation. A lot of these healthcare plans are regulated at the state level. And so you wanna make sure that the legislation is properly aligned for there to be access.

Joe Moore: Just really, if you could do a really quick overview. I think you mentioned something about autism coverage in some, can you do a high level on that for us?

Lia Mix: Yeah, sure. So that is something that I'm incredibly proud of. And of course I was working with many people in what I share, but the treatment for autism, the most evidence backed treatment for autism is called Applied Behavior Analysis.

And when I started working in the. Health insurance industry, there was almost no coverage for this treatment. Now the issue with that is that it's extremely expensive. It's about 40 to $80,000 per year per child for an average of six or seven years. So it's like what family can afford that? And at the same time, you need to catch developmental windows so that a person will be more functional in their life.

So you have this huge moral conundrum. These children who have autism, if they can benefit from, it's called a BA, they need to get it as soon as possible. And so moving the needle on, going from almo, almost no coverage for applied behavior analysis. And within five years we were able to accomplish almost complete coverage in the commercial markets.

And of course, that was a combination of working for one of the largest. Insurance carriers and then seeing how the market dynamics actually can work to push coverage into the market. So you can get, for example, one of the things we saw is executives in the tech industry moving from one co, one company who wasn't covering applied behavior analysis for their child to a different company so that they could have that coverage.

And that started the self-funded groups. So the Googles of the world who pay for their own healthcare benefits. That started a rush actually to cover these treatments. That's one of multiple types of market effects that you can induce to get coverage moving when needed.

Joe Moore: So that price tag that you mentioned.

Should give people in the psychedelic space a lot of hope. I hope you all heard that story. So I assume you had some interactions with a bunch of people in government at that point then, right? You mentioned that earlier. So you started developing a few relationships at that point?

Lia Mix: When I was working inside of the insurance industry, the primary interface with the government was through our lobbyists, that's how it's done.

And as I've gone on to work with the Federal Government, Department of Health and Human Services (HHS) and so forth that came subsequently. And after I came into psychedelics and I'll tell you, I knew nothing about psychedelics until they found me. And that was in 2014.

Joe Moore: Let's talk about that.

They didn't like just sneak into your house, right? What happened?

Lia Mix: It was a side door. Yeah. And what happened is I was so fortunate to have a experience of having MDMA assisted therapy and I had been trying to treat longstanding childhood trauma for decades at that point. Tried all of the things and then I was seeing somebody.

Long story short, the experience was one session of MDMA assisted therapy was a liberation from what would be called C-PTSD. And when we hear stories of vets coming back. From war, and they have serious PTSD and then they're liberated from it. It is a very distinct experience. So my PTSD was developed over the course of my childhood, and we know from like the work of Dan Siegel at Stanford, that when a child is exposed to violence, while their nervous system is developing it affects brain development.

It affects nervous system development, right? And so I was living with all of that, those symptoms. I had this session with MDMA assisted therapy and I finally feel like I can relax. I finally feel like I, the experience was, I knew it. This is me, thank God. And it was a liberation. Now, at that time, I was already helping to bring other behavioral health treatments into the healthcare system and get insurance coverage. So my experience was this collision of my personal growth path and my career path because everyone who can benefit from MDMA assisted the from psychedelic therapies should have safe, affordable access to them.

That's what I do for a living. So the way that I experienced it, 'cause I didn't know anything about psychedelics, it was like hippies dancing around in tie dye somewhere. There's nothing wrong with that, but I don't know how we go from that to insurance coverage for psychedelics, right? So I just entered into a prayer and I'm still in that prayer today, and the prayer is how can I be in service?

Joe Moore: Was this the bridge that kind of brought you to the CIIS program, or did you find some people that suggested you come to that program?

Lia Mix: So what happened is there, there started to be an unfolding of events that I really felt were not fully, I wasn't fully orchestrating them. I decided that the first thing that I would do related to psychedelics, my very first thing was I would go to this book talk by someone named Al Abate at this Women's Visionary Congress in Santa Cruz.

My plan was to just quietly sit in the audience. Yeah. I have no idea what I'm getting myself into here. And it was amazing. I met Ann Harrison, Annie Oak, I met Bia and her parents.

I met Maria Manini, who's an elder in the field. And I met. Janis Phelps. How I met Janice Phelps is as I'm quietly sitting in the audience before this thing begins, Janis Phelps stands up and she says, if there are any therapists in the audience, I just wanna let you know that we are starting at CIIS, the first training program above ground training program for psychedelic therapists.

Please come and talk to me if you're interested in this program. And I just looked up at the universe and I said, okay, you're just gonna spoonfeed it to me like that. So I spoke with Janis that evening and I told her what I did, and she asked if I would come do the program and I did which was my first experience of a psychedelic community.

This the first year of the CIIS program. And what was really interesting about this, Joe, is. That if you've never experienced a psychedelic community and you step into one, you'd notice that it's different. There's something different here. And what I came to understand was that what was different is that there's a few degrees, greater psychological safety in psychedelic communities, people's nervous systems are more regulated.

So your nervous system is registering less threat. Right? This is my understanding of it's taken me a few years to under to figure that out, but that's definitely what it was. And I just knew that I wanted more of that in the world. That is what we need. When we can regulate our nervous systems better, we'll have more access to our prefrontal cortex, our creativity, our ability to.

Collaborate and to solve problems together. It's really where we're trying to get. So I was so blessed in that first year to develop incredible mentorship. Amy Emerson was my mentor. I met Bob Jesse and many other recognizable names in the field that that year. And it, one of the things that I noticed as I sat in the classroom and there was all of, the science and the spirit and all of this being woven together, was, there was no discussion about how we were gonna bring this into the healthcare system.

And that was concerning. And also I started to talk about it. Did and started to that the first year, I just started to try to educate the field about what needed to be done to bring psychedelics into the healthcare system. To launch a new clinical specialty into the healthcare system is no easy task.

You have to set up a multiple different nonprofit entities so that the field can be recognized by the incumbent system and be covered by health insurance. The FDA is just the beginning and we do wanna get into talking a little bit about what just happened at the FDA, but I'll just finish by saying a little story.

In order to do this really well, you have to set up things like a professional certification board that's nationally accredited, right? You've heard of board certified MDs. You need that for your own field. You have, that's a consumer protection entity. You have to set up a professional association that sets standards, ethics rules clinical practice guidelines, et cetera, deals with medical malpractice insurance.

That's the club that everybody, everyone belongs to. That builds consensus and leverages collective bargaining power in the incumbent system. So those two things are essential for a new clinical practice. And we started, I started to talk about these things and just did that for a while. And everyone seemed to think that it was very important and it sounded good, but nothing was happening.

And I remember one day going to a mentor of mine and saying. These things really need, I know that these things need to be done if we're gonna bring this into the medical system and if we're gonna get insurance coverage, and am I being asked to do these things because it's not happening.

I'm trying to explain to people what needs to happen. And he just looked at me and he said, sorry, kiddo. And I cried about it, and then I rolled up my sleeves and got to work. My work in the field has included helping to launch with, in steering committees, right? This is not me doing these things.

This is a collaborative effort with the field, which it must be. So launching what is now the Board of Psychedelic Medicines and Therapies, BPMT, which is the certification board. APPA the American Psychedelic Practitioners Association, and Enthea, which was at the time a nonprofit insurance company to help sell, set the market conditions for psychedelic therapy to be covered.

And what happened was after we launched coverage for psychedelic therapy with Dr. Bronner, I was approached by the Department of Health and Human Services, and that's when I set up my current firm Delphi.

Joe Moore: That's great. So BPMT, that would be the group doing certification, like board certified X, Y, Z.

So you would be board certified. Physician in this, or psychiatrist in this, and therapists in this. So it would cover like therapists and psychiatrists or others as well?

Lia Mix: Yeah, that's such a great question. So how we designed it was for there to be, it was incredibly intentionally designed. There is intended to be a license track and a non-licensed track, or what in the healthcare system would be called a technician track.

So the board would decide what are the criteria to sit for the exam, and people who have different types of licensure could sit for the license track. And then when you have a technician track, what's really great about that is you can diversify the types of practitioners who are working in the field.

So it'll be much more likely, for example, that an African American participant or patient would. We have access to an African American practitioner sitting in the room with them, and we know from the work of Monica WilLias and so forth, that is very possible that culturally reflective care could be a clinical safety issue.

And so if you are a BIPOC person, it would probably be preferable to be able to have access to someone who is reflective of your background or any person's background, right? We need to serve the community and the population that is very diverse. And so when you able to do that, and you have other fields where that license track and then having a technician track that is accepted in the medical system and it is reimbursed by insurance.

What's really nice is if you have a board like this that's setting the exam. That's ensuring people have a certain degree of skillfulness, we have to demonstrate that, right? This is a consumer protection entity. Someone can make a complaint to that certification board against a practitioner who has that certification.

And also, very importantly, payers, healthcare payers. So on the commercial and government side, the United's Aetna's Medicare, Medicaid can actually look to that certification to build their networks. They can say, ah, these people have the appropriate training. Now we have a unified standard, and we can identify who is competent to carry this work by that credential.

You can even have scenarios, and we, this did happen with a BA, where that credential is written into state law. As this is the credential that a person needs in order to practice and be reimbursed and so forth. And what's really wonderful about that is it is the field itself that is designing that criteria.

It's not a regulatory body that really doesn't know about psychedelics, doesn't understand the nuances of psychedelic harms, potential harms and benefits, right? Can't necessarily evolve the way that we will need to evolve. As soon as we start to understand more things like what Matt Bagget was talking about the other day, we need a lot more research about what different types of therapies work well with psychedelic therapy.

What doesn't work well. All of that needs to be. Brought background into a kaizen process where we're continually improving the field. And we also need to ensure, I'm speaking specifically about the certification board, that there is the highest degree of ethics that's being upheld. There's the highest degree of competency and if in someone is in violation of that, you have a board entity that understands how to evaluate that state licensure boards currently have, would have no idea how to properly assess if someone was actually harmed or how they were harmed in a psychedelic therapy experience.

Of the things that are underway that need to be accomplished in order to do things like assuage the Advisory committee of the FDA, I think we really wanna talk about that for a minute and what everyone is not talking about.

So you and I have had this conversation, Joe, that the thing that folks are not talking about that was operating in the room on June 4th during the FDA advisory committee is fear. Fear was operating in that room.

Joe Moore: Let's talk about what the meeting was first. Great. So what was the advisory committee meeting?

Lia Mix: the advisory committee meeting is a process and I'm not an expert in FDA regulatory process. So to listen to the Matt Baggott piece, if you want some technical details on what was going on there.

It's a very normal process for the FDA to gather a collection of basically representatives of stakeholders in public health, right?

To learn about a new therapy and to weigh in on. Safety and effective and efficacy. So this was, this is what was happening on June 4th and it's, it a very important meeting. The FDA tends to vote with the advisory committee 70 to 80% of the time. So they need to take this very seriously. One of the things that we really need to understand is that you have a bunch of representatives from different stakeholder groups in the healthcare system and so forth, learning about MDMA therapy, really probably close to, they're really new to the process.

They're very new to the therapy and they're hearing, they're looking at the data, they're hearing about the data and so forth, and then they are hearing stories of people being harmed and psychedelic therapy. Now being hurt. When we are vulnerable, psychedelics put people into a vulnerable state that is understood.

Being hurt when we're vulnerable is a primordial fear. That is a deep fear. And so they heard a lot about how people have been harmed, and what they didn't hear was the field of practitioners showing up and saying, we've got this. We understand the harms. We understand how to help prevent them, how to identify them, and how to appropriately address them if they do happen.

We have organized ourselves into bodies that are normal, bodies that are recognized in the healthcare system, that provide consumer protection, that provide ethical oversight, that provide standards of care, that provide clinical practice guidelines. That cooperate with the incumbent systems. With the a MA, with the a PA, with the state licensure boards, with the payers, these structures are in place. We've got it. We understand the people who are expressing concern should be expressing concern. I think what's very important for the field to understand and the public to understand is that the advisory committee, this is a kind of a cakewalk compared to medical policy boards for any of the payers, their attorneys, their underwriters.

This is the beginning of the scrutiny and what they're asking us to do is step up and to reassure them. It is our job to reassure the public and the regulatory bodies and the stakeholders involved that we have this. We understand it and we're gonna come together. We're gonna organize and we're gonna provide these consumer protections.

So what we saw is a lot of talk about the things that could be talked about. Oh, the double blind thing. A lot of things that are not even, they're non-issue. They've actually been already resolved, but they were talking about those things because they couldn't talk about the main thing that was scary.

There was one of the advisory committee members who put it very elegantly and she said something like, the therapy is the greatest strength and the greatest liability. And that is the crux of the matter. So the question now is, how are we gonna come together as a field and show up in a suit and tie seriously saying.

We as the field of practitioners, understand, we know this. We've got this, and we will handle it. Just like every other area of medicine, medical malpractice is an issue in every other area of medicine. This is no different. And so we are organizing ourselves in the way that every other area of medicine organizes itself in order to deal with these issues, which are particularly complex and nuanced with psychedelics.

And we've been working on this for many years, and we can do it. So one of the things that I think, has become a liability, we notice with this, these, this term that's being used a therapy cult.

A therapy cult.

Joe Moore: We've done some good work on cults on the show, by the way. There's some really great research on cults.

I think the guy's name was Matthew Reky, created like a scale where you could actually measure just how culty is it. And he uses a more technical term called high demand groups which I think helps inform how we want to think about cults.

Lia Mix: To your point, Joe, that's exactly right. So let's look at what a cult actually is. So a cult is an organization, right? That has a figurehead that is like making up the rules, right? And everybody is under the control, infallible. You can't question, you get asked to leave all of that, right?

Now, if we are looking at. Psychedelic therapy and MDMA therapy as like MAPS, under MAPS' control, and Lykos' control, right? With a particular figurehead. That's where this cult thing starts to come into play. A very different view is this is the drug developer who is moving MDMA through the FDA, and you have a fully developed field of practice of practitioners that are external, that are independent practitioner governed, practitioner led organizations that are not under MAPS yolk, that are not under Lykos yolk, or Compass, or any of the other drug developers.

They are independent bodies that can be influenced by their members. That can be influenced by public, right? Th this is the opposite of the occult. This is ethics. Standards of practice. Standards of care being held in a plurality. Of entities that are building consensus about what safe and efficacious treatment or effective treatment looks like with psychedelic therapy.

So now you move away. This isn't healthcare, isn't that an organization that's controlling all of this? No, this is a new clinical specialty that's being governed and managed by organizations of practitioners, as is normal in the healthcare system and their relationship with regulatory bodies.

So that use of that word, which, we hear it coming up again and again, I think is indicative of the issue. I don't believe that maps is a therapy cult or that lycos is a therapy cult or anything of that nature. But when you are an outsider looking in and what you're hearing are these harms happened, whether this stuff is true or not, that doesn't matter.

What matters is that there is a norm, normal bodies that are set up to actually evaluate that there will be harms. We all know there will be harms in psychedelic therapy. I tend to believe that the benefits will vastly outweigh the harms. Absolutely. That does not mean that we can avoid or we dealing with the harms actually, when the harms are raised and they have a proper body to go to, they have a professional association.

They have a certification board. They have places where those. Harms that have been experienced can be expressed. We can learn. We can all learn and grow from that. There's no reason for any of that to be suppressed. It needs to be explored. And the person who's had the experience needs to be cared for and the practitioner involved, needs to be cared for in.

Sometimes that's going to involve some kind of punitive action. And then of course, there's the whole other layer of what we wanna be sure that the FDA's hearing is about. Post-market surveillance. You have entity of the state of Colorado Rocky Mountain Poison and Drug Services. This is a 60-year-old entity that does post-market surveillance for drugs, and they are very dedicated to tooling their systems for the nuances of psychedelics and they just published an article in Nature Mental Health, which starts to outline some of how they're thinking about it and they're taking on expertise from the field, but they sit outside of the field. This is the entity that the FDA and the regulatory bodies, the authoritative bodies, will be able to trust that the data collection, if it is put in place, the data collection and the analysis of the adverse events and the benefits of psychedelics are being assessed within an appropriate analytic structure, right?

A data analytics structure. So that post-market surveillance piece also could have been something. I think that these are more commercialization types of concerns, but they are coming up sooner. Because of the therapy component. Yeah.

Joe Moore: One thing we didn't really get into is that, that amazing line you had, like therapy being both really amazing here in this context and also like really problematic.

And I think one of the issues is just, 'cause we didn't name it here, the FDA doesn't have any oversight on psychotherapy. And I think that was perplexing for them to have to say I don't know what you guys are doing. This looks amazing, the data's great, but what's going on here? What do you think the FDA was, thinking of this psychotherapy component?

Lia Mix: Yeah. First I wanna clarify that line is inspired by a member of the advisory committee, right? And so someone who is representing a. That the public looking at this for the first time, right? The FDA has been looking at this and working very closely with maps and lycos for many years.

So they might have a different per perspective on it. So I think that FDA has been, we've seen in the guidance that they've given about here's how to structure the therapy. They appear to be quite on board with therapy being a component and also understanding that they can't regulate that.

But if I were in their shoes, very hopeful that the guidance that they're giving will lend to safety as this moves into the healthcare system.

Joe Moore: I just wonder how firm, so you've. Now you're not really an expert in this aspect. So like this whole FDA project, I always wonder how firm the decision is.

But at, but as you said, this is just the beginning. We have so much more to go through before we know really what this looks like in practice in prescribe ability and things like that. Would you say that's a fair representation? Like you, you were saying earlier, we still have so much more left to do before we're seeing this deployed at scale and affordable rates.

Lia Mix: Yeah. Getting this through the FDA is the essential hurdle, but it really is the beginning of access, right? Which is, that's where we're all trying to get to. If people do not have access, safe, affordable access to these therapies at scale, like what are we doing? So I remember when, now when you brought up about the FDA not regulating therapy, I wanted to give you, I.

And imagine this. Sure. So on the timeline that we're on, we saw what we got. We got a advisory committee that was very fearful, not sure about the data, feel fearful about this, right? You saw the vote and it was really quite negative. Now, that was the timeline where you really didn't have anyone showing up to say, we understand that these harms happen.

We understand how they happen. We understand how to help as the practitioners, how to help prevent them, identify them, address them. So there's no counter to that. On another timeline, what happened in that advisory committee meeting was you had. Nicole Buchanan, tenured African American professor, executive director of the BPMT, the certification board standing up and saying, we have set up a certification board to ensure public safety.

This is a consumer protection entity. We will achieve national accreditation. That is the gold standard for professional certification boards. There are hundreds of these, and we will make sure that people who have this certification understand ethics, they're properly identified and that there's a mechanism for these complaints to be dealt with properly.

He would've had Lynn Marie Morkey of the Psychedelic Medicine Association, md, jd. This is the woman who goes to the A MA. She goes to the A, she goes to their conventions and represents psychedelics, right? She's the interface of psychedelics facing out into the incumbent system, helping medical professionals who aren't necessarily psychedelic practitioners understand this would've already been known.

We would've already that the advisory committee would've said, okay, clinical practice guidelines are on the way. We have PPGs professional practice guidelines, which is a lower level of evidence. We have those underway, right? Alright, you guys are on top of it. This is exactly what we need to see. You would've had leaders for a professional association that is member governed like the A MA.

Like the A PA, ethics Codes Standards for the training programs, accreditation standards. Right. Again, CPGs, PPGs underway, and the thousands of practitioners in this association saying, we will take responsibility. You'd have Andrew Penn open nurses, we are with them. We've got this right. We are working with our community of nurses.

We understand these things. We are coordinating this all together. And then the real kicker is you would have Britt Rollins of the national psychedelic Association saying, we're really focused on what's happening at the state level, but we understand there needs to be a unified code of ethics for any practitioner of psychedelic therapy.

There is gonna be the interface between medical. Treatment, right? The medicalization healthcare and what's happening at the state, therapeutic use, people are gonna flow back and forth between those things. We understand that and we are setting standards for how that happens. And that any practitioner, if they're working with psychedelics with the patient understands consent, understands where to take a complaint.

The practitioner understands what's in their scope, what's out, how to send somebody to another practitioner if something comes up that's out of their scope. This is all normal healthcare and we have all of these things very close to being in place, but we're not quite there yet. And right now is the moment to really double down on coming together as a field and making things these things happen.

Unifying as a field, creating coordination across these organizations and being able to reassure. The public and the regulatory bodies that we can do it

Joe Moore: right. I could see the news cycle going so much better for, team psychedelic medicine if that kind of stuff was in place. And yeah it's certainly tragic.

It wasn't there.

Lia Mix: We could put that spin on it or we could say it's still there to do we still have this to do and now it is becoming more and more clear that this is ours to do. Do we want a world where. Existing bodies like the A MA and the A PA who really don't understand psychedelics or state licensure boards who don't understand psychedelics, decide that, okay, now they have to do something about it, or are we going to take responsibility?

And I think now is really the time. Now, what I wanna say about this is when I say we take responsibility, I do mean all of us. And part of taking responsibility in my experience means also recognizing our own shadow that we are bringing into this work. And that is true regardless of the role that we are playing.

If we are an administrative person, if we are a clinical person, right? If we are a funder, if we touch this work in any way, there is a strong potential that our shadow will show up. That is what we are being asked to resolve.

Joe Moore: Let's talk about what is the shadow.

Lia Mix: Sure. As we know, MDMA therapy was really brought forward by, of course, Sasha and Ann Shulgin.

And Ann Shulgin's contribution was about shadow. So these are the aspects of, I'll just talk about on the personal level, the aspects of ourselves that are hidden from us, but they're often simply rooted in fear, right? The ways that we operate that we're trying to navigate around fear.

And in doing so. We are having unintended impact, often unintended impact on other people. Now there, there are certainly people who are straight up malicious and that is also a form of shadow. It's not really what I'm, the field needs to absolutely be prepared for that and be prepared to address that.

But how it occurs to most people, even people who outwardly appear to be engaged in ic, malicious acts, is internally people believe that they're doing the right thing. And that's what's tricky about shadow, right? And we see this operating inside of psychedelic therapy in the therapy room, and we see this operating in every other aspect of the field, just like it's operating out in society.

So what we are being asked, I believe is. To be able to manage shadow, and that is a must be a collective effort. Our own shadow is hidden from us. And I'll use myself as an example. So we have all kinds of folks coming into this work. People who are at, everybody has shadow by the way, that is a part of, the human setup.

And we have people coming into this field at various places and their healing process and so forth. And certainly I was one of these people, and part of my shadow, my experience is that when you come to work inside of psychedelics it's not oh, it's gonna be kumbaya and everything's gonna be like easy and gravy.

No. Actually the opposite. You are gonna be given probably some of the things that are your greatest fears, right? And. You could be very hurt, right? Things could happen that could feel very hurtful, and your own way of dealing with fear will emerge. One of my ways of dealing with fear based on my conditioning, is to shut down, is to stop speaking.

And so in encountering things, in working in this field, that really scared me. I stopped speaking and that's why, as Joe, like this is the first time that I've done a podcast because I, even though I was focused on, trying to prepare the field, I just couldn't, I couldn't raise my voice.

I couldn't lift up my voice. And that is part of my shadow, because the fear is still there, right? Even if you're shut down and you're not speaking, where does that fear go? What happens with that fear? I've been so lucky to be doing some really deep work, and I've discovered something very interesting about the nature of human suffering, nature of human healing.

What I've discovered for myself is that when we are hurt, especially as adults, when we encounter things that hurt us, often those harms are actually laying down in the well worn ruts of the harms that we have experienced in the past, right? It's scarring old wounds, right? And so if we take radical responsibility that it's me, I am having these experiences, these are my experiences.

To contend with, what am I going to do with them? What am I going to learn with them? How am I going to show up? How can I show up differently? My, I am so very grateful and blessed to be able to say that the discovery that I have made in my life is that when we decide that we are going to heal, that healing that happens can be so deep and so complete, that we are actually more healed and more whole than if we had not gone through those difficult things.

And so I'm telling you today that although I'm reporting, I've experienced things that have hurt me deeply working in this field, that I am also more healed and more whole than I would've been if I wouldn't have gone through them.

Joe Moore: Yeah. It's powerful. Thank you. But

Lia Mix: I, the only appropriate response for me at this point, for all of those, the experiences that I have had and the people who seemingly, had some involvement, is gratitude.

I'm grateful.

Joe Moore: Yeah. Yeah. It seems like a lot of us are going through the pressure cooker conveyor belt lately, and I've been thinking about it and sitting with it, and I think it is, it's hard to have that perspective, but it's this is for forming the diamond like later, that we need to show up as

Lia Mix: Right and really holding each other through that process.

When we see someone that we care about in pain, in fear. How can we hold them so that they can do that really deep work so that they can heal in a new way. It's I'm not gonna pronounce this exactly right, but it's like the Japanese art of, I think it's called Zi, and this is where shattered pottery is reassembled using gold.

Joe Moore: So pretty,

Lia Mix: it's stunningly beautiful. And so when you come back together, when you have these things that shatter you and you're held in love and you're held in such a way that you can face the fear and really look it in the eye and start to evolve and grow into the next version of yourself, what comes out on the other side is so beautiful.

And very importantly probably in. Can be a higher contribution to other people. And to, if you're working in this field and to bringing these medicines forward. Yeah,

Joe Moore: absolutely. There's so much here and spot on about radical self responsibility one, the core tenants of the Burning Man Festival, if we're allowed to call it a festival.

Anyway, did you have mentioned Mr. Dalio earlier? Did you have a line from him that you wanted to share?

Lia Mix: Oh, it just relates I, he is, I could quote Ray LIO all day. I think it was just to one that I came across recently, which was, the past is valuable in so much as what we can learn from it, right?

So we can get wallowing around in the past and blaming people and all of that kind of a thing. But is that really useful? So looking your question or your statement of, was that tragic that we didn't show up right it with our suit and tie and saying, we've got this, was that tragic that we didn't show up to the FD in that way?

I don't really look at it that way. I say, okay, what's in the past? In the past and what can we learn from that now so that we can move forward together better, more swiftly and I think this conversation about shadow is really important.

Joe Moore: Yeah. I think that's why it's really helpful to be in community with people, not to just be out hiding, especially if you're doing this psychedelic work.

It's so essential. There's like a positive spin on shadow that sometimes we do, coming from Carl Jung's work ITO Cohen, who's a Jungian psychologist we work with sometimes he's great. Yeah. He talks about golden shadow, and that's a yian concept. It's like the positive sides of shadow that we don't always get so great.

Just there's more, there's so much material out there on shadow. Everybody just wanna make sure are curious and dig into that whole concept more

Lia Mix: so there's something bubbling up. Actually it's a little bit of a different note. It's, but it is on this theme of posthumus analysis, right?

Postmortem, I guess say analysis. When I look back at the evolution of. These projects for the field. And I believe that there are some that I am not specifically naming. So anyone who's involved with those projects, the Psychedelic pharmacist Association is another one. And there, there are others.

So I want to really, there's so many, there's so many. Yeah. So I just wanna say I know that. And if you are involved in an organization of practitioners or otherwise helping the field to, to organize itself and to set these standards good. Anya keep going. I think one of the things that I've looked at is how these initiatives have been financially supported.

And they have been to some degree. And also I think that I. When I look at things like how legislation is supported and how much time and effort and money is put into legislation, that goes nowhere or that is part of an iterative process, right? Okay, that didn't work. Now we're gonna go back and try it again.

We need to keep going. We need to keep trying, right? That is the same mentality that we need to bring to building the field for the healthcare system, right? We've gotta keep going. Yes, it's gonna be an iterative process. Yes, it's gonna be messy, and we need to have a continual strong flow of support. That is not with the expectation of that this is gonna go perfectly.

It is with the expectation of we, we are going to keep trying. We're going to support in every way possible. The people who are giving their. Time and energy to do this for the field, right? It's a massive undertaking. We are going to protect them. We are going to care for them. We are going to help them carry it forward.

And when things get messy, we're gonna create a container that will carry out, rupture and repair in the way that we need to see this happen. For psychedelic healthcare in general, we have to be the example. We have to be actually doing these things and creating what we want to see in the world, what we wanna see change in terms of how we take care of each other inside of these organizations.

And it's gonna be hard, and it's gonna be messy, and it's gonna be expensive. Yes. It's just like moving the needle on drug policy reform, right? So if there is a good use. Of funds to help MDMA come through the FDA, come into the healthcare system and actually be accessible, and then all of the other psychedelic medicines and therapies to follow.

Setting up these structures and making sure that they are given everything that they need in order to succeed is an extremely important use of funding right at this juncture. If we really want this. And it is also the way, it's a very interesting thing in psychedelics that if we ensure that everyone who can benefit has safe, affordable access to it.

And the psychedelic tide. The rising psychedelic tide floats all boats, right? Investors get their return, people become more healthy. It's a win-win all around. So this is how we do that. If we are gonna meet the incumbent healthcare system where it's at, and we're going to reassure the stakeholders that we, that psychedelic healthcare is viable and safe,

Joe Moore: and it's worth the initial, gigantic investment.

And there's these long tail of beneficial things that can happen, like we were talking about earlier, less ER visits, I think better health outcomes generally. When we look at a bigger pool of people, I think we're just gonna see longer lifespans and less healthcare required overall.

Lia Mix: Yeah. When you start to cure.

Mental illness, the benefits to society are enormous. Enormous. It's really interesting. We were talking about this a little bit earlier too, so there, the way that the incentives of the healthcare system are currently structured, there's a pretty like cause and effect stream whereby those who put in a lot of money for drug development, the bulk of the financial benefit flows directly back to them, right?

A huge portion of that. Now, when you actually cure a disease, what you can have is a financial benefit that still flows back yes, to the drug. Developer for sure, but then some of that value is more diffused into society more broadly, right? So yeah, less ER visits, less medical expenditures on all different types of illnesses, right?

People who have a mental health condition are four times at four times more medical spend than someone who doesn't less child abuse, less substance abuse, less domestic violence, fewer children in the foster care system, right? People being more productive, more creative, more engaged, and more fun. I think this is gonna be a lot more fun if we can have these therapies available and people I feel a lot more fun than before when I was trapped inside of PTSD, which is a certain kind of, it does feel like a certain kind of imprisonment.

At least that was my experience, and I think others folks would resonate with that. So when we say the phrase our liberation is bound together with others, for me, I can feel that viscerally. And I am also, I also carry a lot of urgency because my brother has severe PTSD from the similar things that I experienced.

And he is a highly intelligent, wonderful, beautiful, sweet person who has all of these symptoms and for like millions and millions of people, he will not be able to access MDMA assisted therapy until it is legal, but it, that will be his choice. And so I feel. I am, when we think about the people who can benefit from this, I feel very close to this, very close to home, quite literally.

And so if there's anyone out there who is listening to this, who has a family member, or they themselves are waiting for this to be legal so that one of their family members or themselves can have the relief of this therapy, I wanna just tell you I'm with you. I very much understand that. And I'm committed to doing everything in my power to help ensure that everyone can have safe, affordable, access,

Joe Moore: big mission and a lot of work.

Lia Mix: It's a, we, it's, but there's so many of us, Joe. Yeah. There's so many of us with good minds and hearts. And there's a tremendous amount of financial capacity if we're focused on what is essential right now. What is critical right now. For some reason I feel really called to mention, um, Sandor Iron Rope, who is a Lakota person who you introduced me to recently.

And the issue of indigenous reciprocity may seem like it doesn't belong here, but I believe that it does. For example, when we designed the certification board as having the technician track, what that can also mean is that people who are coming from indigenous backgrounds would be more likely to be able to work in the field too.

So you could have someone coming from an indigenous background sitting in the same room as someone who's coming from a Western medicine background who are carrying this work together. And I really feel that we. How is the what, right? Like how we solve for these things. We can take these things into consideration as we go.

We're gonna have a much better world in an, hopefully a more expeditious manner if we're focused on doing the right thing, right? And weaving that into the structures that can interface with the incumbent bodies.

Joe Moore: I love that. As we're working towards wrapping up, anything else you wanna try to include that we may have overlooked?

Lia Mix: I just wanna say how grateful I am to you, Joe. You have been carrying this mantle much longer than I have, and I've been working now in the field since 2016. I would say I look across at you in this living room. And I can't imagine the journey that you have been on to help these medicines reach people to help prevent people from being incarcerated or having access to these medicines.

All the things that you have committed your life, your precious life too. I feel just a tremend gratitude to you and to Psychedelics Today and to all of those who have been working in the field, especially our elders who've been carrying this at great cost to themselves for decades and decades. I think that is really where I'd like to land it.

And of course a shout out to Rick, Lykos, MAPS and everyone who's working in different forms of drug development. Also bringing this at the state level and through religious use. We really do need a full spectrum of access to this work, which I believe in very much just very grateful to be a part of this movement and to be able to contribute in the ways that I do.

Joe Moore: Amazing.

And there you have it, Lia Mix. I hope y'all like that one. I certainly had a great time and learned a ton and tend to agree full on with this one. It's really learned a lot and I think we can all learn a lot from Lia's experience here. How can we help the most people here in the best ways?

And let's really, get together and talk about that and think about that and try to get a little bit more unity here in the space. Alright, I think that's it for now. Thanks for tuning into psychedelics today. We will see you on the next episode. This is Joe Moore signing off. Bye-Bye.

Lia Mix: It is wonderful to be with you all today for this really important conversation and it is especially fabulous to be with you, Heidi and Charlie for this conversation. We have been having this conversation. I've had this conversation with each of you over the years, but never together.

And so this is fantastic because you're both carrying so much wisdom about insurance coverage and I know that this conversation is gonna be really valuable for this audience. And it's gonna be a fun conversation. We're not stuffy insurance people. We're fun insurance people. So we're gonna have a great time.

The first thing that we wanted to do is give you guys just a little bit of foundational information about the landscape. The payer landscape and the healthcare delivery landscape that will give you something to work from. We have these things in our heads, but we think that this is just essential information to get started.

So first of all, whenever you're having a conversation about policy, especially around psychedelics, you wanna know which access wedge you're in. Are you talking about religious use? Are you talking about legalization or decrim? What's happening at the state level or are you talking about medicalization?

So this conversation is squarely in the medicalization access wedge. Now when we look at the payer landscape. This is what we see. You can see a little over half are commercial plans. These are largely employer sponsored plans. The self-funded groups are wealthy companies that are paying cash for their medical claims, the Googles of the world, and they pay the large carriers to administer those benefits for them. Now, the fully insured plans, which also includes the in individual plans, those are the ones that the health insurance carriers, the insurance companies, they carry risk for those themselves. And so you can affect those by getting the carriers to cover them.

You can also affect those legislatively at the state level. On the government side, of course, you have Medicare, Medicaid. VA and Tricare, and they have their own decision making processes. So this looks pretty manageable, right? We can do this. When you look a little bit closer, it actually looks like this.

And what you're seeing here are individual. Each of these wedges are individual buckets of people who are covered by different policies, different decision makers, different motivations, different buckets of money. And each of these wedges is often working with different information when they're making coverage decisions.

So they don't, and the real kicker is they don't actually share information. Very well with one another. So this is actually a substantial task that we have in front of us and why these conversations are so important.

Charles Gross: One comment on the self-funded and fully insured on the commercial side. So we're in the commercial insurance world. Lia did a great job of explaining self-funded, which is the companies. Bear the medical risk for the costs of the claims, and the insurance company manages the benefit.

The fully insured, the insurance company bears the risk for medical expenses and manages the claims. Now, most large carriers, the vast majority of covered lives in the commercial book of business are in the self-funded accounts. So most large United's, Elance is Aetna's of the world.

Their commercial book of business is mostly the management of the benefit and not managing the medical costs, the vast majority of the revenue for the commercial carrier. So for an Elance, Elancer, United in the commercial book of business, back to that fragmented pie you saw.

The vast majority of the revenues for a United or an Elance on their commercial book of business are generated by the fully insured book. For example, when I was at Elance, I need to mention I'm retired from Elance/Anthem. But when I was there on our commercial covered lives, we probably had 12 or 13 million self-funded, and four to 6 million of fully insured.

And the revenue was almost the reverse of that, where most of the revenue came from our fully insured. So that's an important consideration as we'll talk further this afternoon.

Lia Mix: Great. Thank you so much, Charlie. That really is an important consideration and that'll become apparent as we talk about how coverage decisions are made.

This we wanted to offer you, oh, just a quick understanding of the healthcare delivery system, so you can think of these as separate channels. Or pillars or silos of the healthcare delivery system. So each of these have practitioners who have specific types of training and licensure, different types of services that are rendered in these different channels of care.

And sometimes they intersect, right? And they work well. Pharmacy and medical work frequently, very closely together, but often they are quite siloed. So there's not, the information sharing across these things can be a little bit challenging. And inside of the commercial health insurance companies, each of these represents an entirely separate division of the company.

With different decision makers, and that goes all the way up. So when you have therapies that would include, let's say behavioral health and pharmacy, you have a bunch of different decision makers with different motivations and so forth who have to make those decisions together. So it adds to the complexity.

Okay, because we know that you remembered most of that, but you might forget a couple of things. Here's a QR code and you can use this to go to a landing page. It has all the slides that we presented plus the resources that are referenced or likely gonna be referenced during our talk today.

Let's give folks a minute to take that. Great. Okay. And Charlie discussion about insurance coverage at its core is a discussion about health equity. Who is gonna have access to these transformative therapies under what conditions? So it's not just about if it's covered.

When, who, how. All of those play into this question of who has access, and this is an incredibly important conversation. Yeah. And none of us have a crystal ball when it comes to psychedelic therapies. So I just wanna do some level setting that. We're gonna have a conversation here, but we don't know.

And there is no one who knows exactly how this is gonna roll out. It could roll out in a lot of different ways. So what we've decided is that the best thing to do is talk about how coverage decisions are typically made, and then let's look at what's different about psychedelic therapies and kind of some things that we might be able to anticipate with what we see so far, such as with the new CPT codes and so forth.

Charlie, we're gonna, we're gonna start with you. Please. If you could just illuminate inside of the black box for us of commercial health insurance, how are coverage decisions for pharmacy and new therapies typically covered? What's a normal process?

Charles Gross: Great question. And I'm looking out at this postprandial crowd here, and I can see the glucose levels are plummeting.

We're just in the crash. So I want to do something a little different. So I'm gonna ask. For everybody who had, and I'm gonna talk about Elance 'cause that's what I'm most familiar with. There are parallels with other insurers and I could talk to you about those offline. Who has heard of Elance? I'm gonna ask you to stand up.

I know this. If you've heard of Elance or Anthem, lemme say Anthem. Stand up. Okay? Okay. We raise some people raise their hand, they're really crashing. Okay. No. Remain standing. Remain standing. Remain standing. This is interesting. So it's only two thirds of the audience. Okay? Those who have heard of Carolon remain standing.

If you haven't heard of Carolon, sit down. Wow. Did you guys see what just happened? We have maybe 12 people left standing. Those of you remaining standing, who can explain,

who can explain the connection between Anthem and Carol on sit down, guess what happens to me? No, I'm not gonna say. You can explain it. The people standing, I think so. I'm gonna call on you better Be careful. Who can explain. Who can explain, I think So you think that's right. Who can explain how behavioral health within Caroline is managed?

Both commercially and for Medicaid and for Medicare, I dunno, commercially. So you have to sit down. That's it. You I only bring that up. For two reasons. One, it's interesting to see that two thirds of you knew about the health insurer, but less than, I don't know, 10 people, 12 people knew what Caroline is.

Caroline is critically important as you think about how we're gonna get this reimbursed. Carol how many people, show of hands, I'm gonna ask you this. Have heard of Optum? Everybody's heard of Optum. Caroline is Ance Optum. Okay. How many people have heard of ever north? Much fewer. So ever north is, I gotta get this right.

Who's ever north is Cigna. Thank you. Thank you. My point is, there really is no such thing as an insurance company, right? There are multiple versions of an insurance companies, depending on a whole bunch of different things. I think it was that famous health insurance exec, DW Wincott, who said, there's no such thing as a baby.

Do you guys know him? Yes. Yay. From Wincott. Okay, maybe not. Anyway, he was a famous pediatrician psychoanalyst who said, there really isn't a baby. There's a baby. And he was writing in the late forties, a baby and a mother, or a baby, and a caregiving system. And he said, you can't just look at a baby in isolation.

So you can't look at an insurance company in isolation. It's about the product. And that makes all the difference in terms of how you're gonna get things covered. Companies all differ. By line of business. So there's a segment in Ance for commercial, there's a segment for Medicaid, there's a segment for Medicare.

Each of them has a p and l owner, a profit and loss owner who is ultimately responsible for the profitability of that group. Caron and Optum as well, and ever North as well, is a wholly owned subsidiary. Of the respective insurance companies who manages the behavioral health benefit for the company.

In essence, the health insurer ance contracts with Caron, the subsidiary to manage the behavioral health business. So when Lia showed you that slide before with pharmacy and wellness, and behavioral health and medical, most of those functions are contracted out. To Caron, who then has a suite of companies that provides those with certain exemptions.

So when you're talking to care managers at a United or a an ance, you're really talking to a Caron or an Optum, and those are the ones who are also making both coverage decisions and benefit decisions. And most importantly, pharmacy at Ance is managed as a wholly owned division within Caron. So the pharmacy decisions, what gets on and off the formulary is a carolon decision.

And I think the same is toward Optum, although I'm not a hundred percent sure. So you need to, as you think about coverage decisions, be thinking about who do I need to talk to within what I previously thought of as a united, or I previously thought of as an ance. But there you need to find the line of business and who's responsible for what within that line of business.

I think your prompt to me was what are the standard processes by which decisions are made benefit coverage determinations? The, that's a long-winded answer to get to. There are no standard processes because it all depends on the book of business that you're talking about. Maybe I'll stop there.

Is that I could go, but

Lia Mix: yeah, I Great. You'll have another crack at it in just a second. Heidi, same question to you. Thank you so much, Charlie, that was illuminating and Heidi we're gonna take it to you. Same question. What could you say would be a normal kind of standard process for new coverage decisions on the Medicare Medicaid side.

Heidi Allen: Awesome. I feel like I should lead you through calisthenics before if he has you stand up. I really need to like, because, public health insurance is very complicated. And Lia already gave this caveat starting out, but I think it's worth saying, I consider myself an expert in the US healthcare system, and specifically I am an expert on the Medicaid program.

But you don't have to go very deep before I'm confused. It's so complicated and there's so many unknowns of the way that this is gonna roll out, that I feel like what I'm offering today is expert guessing, and I hope it's only slightly better than non-expert guessing. It's really, you could probably do a regression to see, how much more accurate we turn out to be than, a monkey.

But, I don't know. Okay. So Medicaid is America's health insurance for low income people. And it's a partnership between the federal government and states. So both of them put money into the program and that means that they both have a lot of say about what is offered through the program. Some important thing, one important consideration is that all Medicaid programs, except for one state, has a constitutional requirement that they balance their budget every year.

The Medicaid program is a huge part of every state's budget, and it competes with things like education and roads and libraries and child protective services and everything else the state does. So anytime you have innovations that come into Medicaid that are gonna raise costs, you have trade-offs that the state has to make.

The federal government doesn't have that same constraint. They can go into deficit spending, which they. Often do, but the Medicaid programs cannot. So that's a real pressure point to think about when you think about psychedelics coming into Medicaid. They have a highly vulnerable population with a high burden of mental health disease and they have a lot of people who would be eligible for these therapies.

And if they're very expensive, the Medicaid program is gonna wanna look at them carefully. However. This is true of both Medicare and Medicaid. There's federal statutes that say what kind of what kind of treatments can be carved out and which kind cannot. And mental health is a protected category.

So there's a lot of, many of you have been probably following the weight loss drugs. Medicare has a carve out for weight loss drugs. So the Medicare program has not been covering any of the GLP one drugs. But this isn't the case. With mental health. So basically, if an efficacious treatment gets past the FDA, there is an obligation, I think, for both the Medicare and the Medicaid program to pay for it.

But sticking with Medicaid for a moment, there's gonna be a lot of challenges for implementing that. And there's places in the implementation where access breaks down. And I think that one of my concerns for the Medicaid program is that you could end up having coverage. Without care, and we're gonna go into some of those challenges that they face over time.

But basically when new innovations come out in Medicaid in mental health, there is, I think, an assumption that they will pay for it Now. Medicare is a federally run program, and it's a federally financed program. And so they don't, and they don't have the budget considerations. They do have solvency, which you hear about a lot in the media.

Like the Medicare program has to stay solvent for people who are aging into it in the future. But it's a big program. It's a well-funded program and they have a commission, the Medicaid the Medicare Payment and Access Commission. Or MedPAC that makes a lot of coverage decisions for them. I think that when new treatments come out that haven't been well studied for the Medicare population, they have a lever that they can engage, which allows them to say, we're not gonna cover this until there, there's more evidence.

That it benefits people age 65 and older, or people with work limiting conditions. So I think that in the case of psychedelics, it very well could hit a trigger, particularly MDMA, which skewed young in the clinical trials. I think that there's very much the possibility that they could use their federal decision making power and say, we would like to see more research with older people before we cover this.

So they would cover it. Under the condition of research. So it's a limited coverage, whereas Medicaid will probably if if whoever the manufacturer, Lycos SA, whoever's, whoever is working with the molecule, if they participate in the Medicaid drug rebate program, Medicaid doesn't actually have that same lever.

They can't say, we're not gonna cover it. So they're gonna engage other tools to try to protect the cost that it might have on the program. Great. Oh, thank you, Heidi.

Charles Gross: Pick up on that on the commercial side. And Heidi, your comment just reminded me of this or resonated with me. mpac, was that the name of the Medicare?

Heidi Allen: There's MedPAC for Medicare and Macpac, which I'm a commissioner on for Medicaid.

Charles Gross: Okay. So I think it's PAC for Medicare. In the commercial world, the equi, roughly the equivalent of that are the pharmacy and therapeutic committee of the respective insurance companies. So they make decisions about what goes on the formulary based on the evidence and also new therapeutics.

So one takeaway for all of you as you're considering your interface and the industry as it's considering its interface to get these covered from a commercial perspective is to understand more deeply. The p and t committee structure at respective health insurers. And in terms of that long sale cycle, you need 18 to 24 months to figure out who's on those committees.

How can you engage with them, how can you educate them? I know there were some great comments, I think by Graham and Bennett this morning about free education courses. I think it would be great if the industry could say, we're gonna make a. Focused concerted effort to educate the health insurance industry about and I know efforts are underway.

I don't want but to a focused effort to educate key decision makers on t and t committees about this interface. And I think it was Bennett's point, don't talk to the same people you usually talk to because you're talk, you're preaching to the choir basically in many instances. You need to get outside.

Your focus may be and think about broader folks within the payer commercial structure.

Lia Mix: Great, thank you both. I'm just gonna make a quick comment and then we're gonna move into coverage for PAT. So in terms of market conditions that can accelerate coverage adoption across different decision makers, carriers, government bodies.

On the commercial side, you do see market effects where if one carrier or certain companies start to cover a certain benefit. That starts to set up a market condition where that's gonna be desirable. And so if you get United, for example, covering it, the other carriers will look at it. If you get Google looking at covering something, then Apple's gonna look at it too.

Those kinds of effects are very real. And can work to, to the benefit of something being covered. And then my understanding from learning from you, Heidi, is that there is a similar effect with Medicaid programs where they can actually learn from one another. So if coverage happens in one state.

There are committee processes and so forth for some states where other Medicare programs can learn how to implement that coverage in another state. So there's some good things that can actually happen across these different decision makers and programs. And we would love to see that happen, of course, for psychedelic assisted therapy.

However, there, there's some real challenges and so I'd love to hear, Heidi, I'm gonna throw this back to you first. W from a payer perspective, a government payer perspective, what are some of the things that are different about psychedelic assisted therapy and some of the things that they would be taking into consideration with coverage?

Heidi Allen: I think that one consideration is the vulnerability, the population they serve. So there will probably be concerns, making sure that it's an efficacious, safe treatment. I think that, the other, big elephant, that I mentioned before is that it, if it's expensive, it's gonna have a budgetary impact.

And so I think that states, because they have to cover mental health benefits, because they can't, there's, they don't have as much picking and choosing as maybe, the private market. They will have to engage tools like utilization Review. Medical necessity, requirements, prior auth, failure of other treatments in order to coverage cost, or, basically to, to stay budget neutral.

I think one of the other big challenges that they have is that you can't force mental health providers into your network. They have to wanna work with you. And particularly the Medicaid program is budget constrained. And so they're a low, they're the lowest payer often when you compare them to Medicare or private insurance.

And so I think a big challenge that they will have are finding qualified psychedelic practitioners who contract with them in order to provide these services. So that's what I mean by coverage without care. It can be a covered benefit, but if you can't find anybody, if no clinics are participating in the Medicaid program, if no individual practitioners are enrolled in Medicaid managed care plans, then and there's something that insurance companies use called network adequacy, and that means that you have to demonstrate that you have providers to treat the needs of your population, but it's not disaggregated by types of coverage.

Or types of providers. So for example, network adequacy for mental health will be divided by adult providers. Pediatric providers, the number of providers in a geographic area. It's not the number of psychedelic assisted therapy practitioners in a general area. That's not how they, so you could demonstrate that you have network adequacy for mental health and not have any psychedelic assisted therapy practitioners in your network.

And states are gonna have to be in the Medicaid program. States are gonna have to be convinced that this is really important for their population and that. That, they will have to do the work engaging with managed care organizations to identify providers and get them in network.

Yeah. Otherwise, again, it'll be covered. But when you try to find somebody who will provide it for you, there won't be anybody to do it.

Lia Mix: So Heidi, this is a really important point and Charlie wanna follow up with you. So what's, what Heidi is talking about is when Medicaid has this coverage without care.

So yes, it's covered, but we don't actually have anybody in the Medicaid network or Medicare network to provide the service. Now, Charlie is that the same on the commercial side? Can you have that dynamic where there's coverage without actually access to care?

Charles Gross: That's my old friend Henry here. Can you hear me?

My microphone's been, yes, we're good. Okay. Yes, it's a challenge. The phrase for it is ghost networks, where you have a directory with polar providers either who are no longer taking patients or are selectively taking patients depending on the funding source and the adequacy of the funding.

So the same applies certainly in the commercial space. And I think it begs the larger question that we'll chat about, which is who's going to credential. The providers are providers gonna ask for specialty credentialing? And then how are payers going to interface with that specialty credentialing system?

I think it was interesting to note that I just saw a piece earlier this week, I think, where Compass is contracting with a New Jersey provider, Meridian Health, to explore how. Their treatment. Thank you.

Thank you. How their treatment of their compound for major depression will get delivered. So the notion that maybe, compass and Meridian three years from now will be able to turn, for example, to a Horizon's Blue Cross Blue Shield and say, we've got the compound. And oh by the way, horizons, you don't need to worry.

We've got the delivery system, we've got credential certified providers that can deliver the care in a quality way that we're gonna oversee, potentially would make the path towards an acceptance by a large payer that much easier. So I think that's gonna be an interesting, not that, 3D years from now that.

That contract will still be in place, but I think it's an interesting thing to think about.

Lia Mix: Yeah. So a unified credential can streamline the pathway for networks to be built. And who is deciding what those credentials are, what the training standards are. That's a really important consideration for the field.

I think that we'd be remiss we're running low on time, so I am gonna bring up this point. We, there is. Evidence, some evidence that with psychedelic assisted therapy, culturally adequate care actually means culturally reflective care. This is of course the work of Monica Williams and others in the field that indicate that it's a possibly a clinical safety issue for a person of color or a different background.

L-G-B-T-Q. To be able to have a practitioner who reflects their culture and their background in the room with them. And so I wonder how, if it is, turns out that it is actually a clinical safety issue, how this might play into the coverage decisions, if at all.

Heidi Allen: I don't think that coverage decisions work that way.

I don't think that probably they've done the analysis to show. That racial concordance or sexual orientation concordance or any of these, the evidence-based just isn't there yet. 'cause the clinical trials have been so small. But I think that it is a very important conversation to be thinking, and this is an important conversation for the Medicaid program too, because it's a diverse program.

It's a minority majority program. So it's really critical to be thinking about training a diverse workforce, which is why, I'm at the school of social work at Columbia University and we are partnering with schools of nursing and other schools of social work to get social workers and nurses as prepared to go into this field because they are a more diverse.

Population then psychiatrists or psychologists. And so there's a lot of, I think, what I've learned working in health policy over the years is there's so many levers to equity or inequity. There's levers at every step of the process. And one of the things anytime I get in front of an audience to really encourage us to do is to, instead of thinking about how to scale up.

How do we have the most psychedelic assisted therapy possible? Scaling big. What if we change the question to how do we ensure that the people who need these treatments the most are the first in line to receive them?

I found my people, that if you ask that question, it changes the conversation every time. It really it makes us start to think about every time we enter a place where there's a lever for access, how do we prioritize and think about what that lever means in terms of. Access and equity, and I think the example of provider certification training is a really good one because if you think of health policy as a three legged stool where you have access, you have affordability, and you have quality, I.

As you make adjustments in one area, you affect the other area. So if we could go all out on quality, we could say that every practitioner needs 150 hours of dedicated education and psychedelic assisted therapy. They need to take an exam and be certified by a board. They need to participate in a professional association and go through, CEUs every year.

Those are all really important quality measures, but when you invest that much money in your practice. You have to get it back somewhere, right? Like you, if you've taken a $15,000 training program and you pay a licensing fee and every, you have to charge more. And as you charge more, insurance companies will put more in place to try to decrease those costs.

And you, it may determine who you're able to see and who you're not able to see, and then you have access go down. So we can't just, we have to be enthusiastic about quality. But we have to recognize that every time we add to the cost of affordability, we are probably decreasing access. And so not to throw any of those things out, but to recognize that we're constantly making those trade offs and to make it in a very thoughtful, deliberate, strategic way.

Lia Mix: Yeah. Great. So just before we came on stage, actually, we were having conversation about the new CPT codes and how one of them actually allows. For a non-licensed provider to be reimbursed by insurance. And why that's important to this conversation is because you can have people from more diverse backgrounds possibly entering the field, who are then being overseen by nurses, by social workers and so forth.

So the way that those CPT codes are structured, the temporary codes that at least seems to be positive in terms of having a more diverse. Workforce and achieving some level of quality. I think the other piece of around quality that we wanna keep in mind too is about post-market surveillance, and this means.

The analysis that will be done as to what the outcomes are, like, what the person's training was, who the provider's training and background and what the outcomes they're having that'll play out over a number of years and could impact coverage decisions. As that analysis is done we have about six minutes left and I'd love to.

Jump to some audience questions. Yeah. There are some very good ones here. This is the big one. If MDMA is legalized through the FDA, how long do you think it will take afterwards for major payers to cover it?

No. Crystal balls, no. No predictions, but.

Charles Gross: It's interesting 'cause I was thinking about this obviously for the past couple of days as I thought about this conference. I think it it's gonna take a while. It's not gonna be instantaneous, but I don't think it's, I think it could be a year.

And lemme explain a little bit of the reasoning behind that. Again, it has to go through the p and t committee this commercial, we'll talk Medicare, medicaid in just a moment. But I think you're gonna need to go through the p and t committee. They're gonna look at evidence. I chuckled. We'll talk about it later.

I think I may be the only person in the world who still gets a paper newspaper, but this is the post from the end of April, front page below the fold. FDA bid on ecstasy shows it's hard to test psychedelics. Okay so this is, the, and this is, this is the post. This is what everybody in Capitol Hill looks at.

At least they look at the first page. I don't think they actually read it. But that's out there. And the insurers are also seeing this kind of information. So they're gonna, the p and t committee is gonna chew on this stuff, and the industry is gonna need to respond in a thoughtful, deliberate way.

I know our work is underway, but that's gonna be that, that is going to take a bit of time to move that through. And even once it's covered there, there's no guarantee that the, then you're gonna need to contract on an individual company level. Uh, there's no guar that, and that's a process, right?

And that's something that's gonna take some time. One, one piece that I think is connected to that is as an industry, it would make sense to think and get back to that in self-insured versus fully insured division within the commercial book of business, where most of the revenue comes from fully insured, but the vast majority of the membership in a commercial insurer is from.

Self-insured companies, those companies potentially are some of your greatest allies in getting insurance companies to provide the coverage. Your lobbying with them I think becomes a key piece of the strategy in terms of rapidly moving towards, coverage within a commercial book for this once FDA approval is granted.

Lia Mix: Great. And because it relates the recent ICER report that came out, Charlie, that was a little bit hard to hear news. That was a little bit hard to hear. And we wonder how do the payers, the commercial payers use that kind of report in their decisions?

Charles Gross: It'll become part of the discussion in those p and t committees and just, the. On the commercial side, arguably true also in Medicaid and Medicare for the private insurers. But let's just talk commercial. The decision makers are not the medical directors. If I said to you, if I could get you five minutes to do an elevator pitch to the chief executive officer of the company, the chief medical director for the entire company the CFO of the company or the president of.

The commercial division, who would you take your time with? cer we could argue about who it should be, but it certainly should not be the chief medical officer because they're already convinced. You go out and talk to the chief medical officers, they've read the clinical literature, they've seen the papers, so they're already fully on board.

You're gonna have to impress the underwriters on the fully insured book of visits, and you're gonna have to impress the account management guys on the non fully insured book of business, the a SO business, they need to feel like, gee, if I don't cover this, Verizon is gonna leave ance. Right?

They need to, so that, that's a pressure point that I think you guys should think about. How do you leverage that?

Heidi Allen: On the public side, I think the pressure point are your elective representatives and that includes state government, so the governor's office, the state legislature. I will say that in my real life, I.

Live and breathe, Medicare and Medicaid policy. And I don't hear any conversations like zero. I have not heard of peep. Those, my world, the psychedelics and my world of that have not intersected yet. So I think that there's a lot of work to be done to educate them. So I think that there will be a delay as they go, what psychedelics?

But they are public programs and. They are influenced by policy makers, and so making the case to people who then influence those public programs is actually super highly effective. One of the things that you know, I'm curious about is how the adult supervised youth models will impact insurance coverage, because it's interesting that, you can go to Oregon and you can do a psilocybin.

Session without a diagnosis, without a provider, without any intersection, with a, with the medical system. And if I were an insurer, I'd be like, why would I pay for this? You can, you know this, you could go and get it outside. So I'm curious how they will see those efforts. Because it's it's an example of where the public is ahead of the research and the policy and they're pushing things faster than the processes by which they make their way through the FDA and into the healthcare system. But, now you have this parallel path and I'm really curious how the two will intersect or influence each other.

Lia Mix: Great. We just have a couple more seconds and so I'm gonna ask a last question. This is a yes or no.

Heidi Allen: Okay.

Lia Mix: I love it's structured that way you guys are gonna answer how you're gonna answer. So you personally, if you had a family member who needed MDMA or psilocybin assisted therapy, would you personally send your family member to a provider who had not themselves?

Consumed that substance

Charles Gross: there We have it. The audience has spoken. Yes.

Heidi Allen: I'm gonna say 'cause I'm teaching students and I cannot tell students that they need to use these substances particularly, there's not a control, a legal way for them to do that. Yes. Because not everybody can take these substances, it is counter-indicated for a lot of people, and it would be dangerous for them to do that.

And to say that they can't be an effective therapist I don't think is true. Now, do I think that there's benefit from having your own experiences? Absolutely. But in the, there's also harm if you've done, so I think that there's it's just my answer is yes. I would send a family member.

Charles Gross: That wasn't a yes or no answer.

Heidi Allen: That was a yes answer. I noticed the answer was yes,

Charles Gross: I'm gonna do the same. I would say, I would send a family member to somebody who was well-trained and well credentialed to provide care. Now I say that, and I was thinking about this earlier when some of the earlier speakers, I'm probably in the vast majority of people in the room who hasn't taken a mind altering substance.

At some point in my youth, I was the guy in the seventies when my friends were tripping. I was the guide. So I was that kinda guy and then I went into mental health for obvious reasons. So I don't wanna say, I don't wanna say people shouldn't take it, but I think I agree with you. There are people who could be well-trained who don't necessarily have to have partaken.

That's a middle. Is that a middle? Yeah, that's a middle. Okay.

Lia Mix: And I think it's fair for you guys are easy on me. You're not even making me answer the question. I think it's fair for me to answer the question and my answer would be that if there was a choice, I would choose a professional who had themselves had the experience.

If there was a choice for my family members.

I am so grateful to you both. I'm so grateful to this audience. Thank you all for wonderful, your incredible listening and up and down and all the things you did and we hope this was a great helpful conversation for you. And thanks to everyone here for what you are doing, what you are doing for this movement.

Lia Mix: Thanks everyone for being here. I know there's a lot of other places that you could be. Appreciate it. First a disclaimer. I am speaking for myself. I am not speaking for or suggesting that I have knowledge of the intentions of the US government. How do we use our power to create global equitable access to psychedelic healing?

This address is an intentional act of love, of peace, and of faith that there is such thing as collective wisdom, a nodal network of intelligence that transcends space time. I am speaking to that collective and to the hearts of the nodes that beat in this room. When I was a kid, we'd ask my mom every year what she wanted for her birthday, and the answer was always gonna be the same.

But we'd ask her anyway, mom, what do you want for your birthday? And the answer came, world peace. I was like, thanks mom. So my name is Lia Mix. My professional work has brought health insurance coverage for new behavioral health treatments to tens of millions, directly and indirectly to hundreds of millions of people.

My work in the field of psychedelics over the last eight years has been to help establish the core infrastructure for psychedelic assisted therapy to be implemented into the US healthcare system and to be covered by health insurance. And now I collaborate with leadership in the psychedelic ecosystem.

And the Department of Health and Human Services relative to the spectrum of potential access to psychedelics in the domains of medicalization, legalization and religious use. I have found working in service to the medicines to be most humbling. I've experienced highs and lows from being quoted in the New York Times after launching health insurance coverage.

For psychedelic assisted therapy with Dr. Bronner to being asked to leave my own company. I've been through ruptures and repair on the path of personal evolution and service to this work. I've sat at the feet of my elder mentors and laughed joyfully and wept. I'm in surrender to this work. I see the inner and outer work of wholeness.

And liberation as one and the same. So I am here in all my humanness and I know my role, but more importantly, I am convinced that the answer to achieving global equitable access to psychedelic healing is going to take all of us because a part of the answer. Lives in each one of us, and it is catalyzed in the relationships between us.

Let us take a moment to experience this using our full body wisdom. So I invite you to close your eyes. Lower your eyes, yes, this is a policy. Talk. Close your eyes and now presence yourself in your body. Sense into your body. Now, imagine a world in which everyone you know, everyone they know, every living, living human being has safe, affordable access to psychedelics and psychedelic healing.

Notice how that feels in your body.

That feeling is our guide. That is our knowing. That is our how.

When you are ready, return your vision to this room.

You see my friends, the realization of global equitable access to psychedelic healing lives within us. So how do we realize it into the world around us? We start by remembering that the how is the what, that what we create will be a reflection of the process by which we create it. The qualities that we bring to the act of creation will be imbued into the creation itself.

And Dr. Groff reminds us that psychedelics are non-specific amplifiers. So what will we choose to amplify? Now is the moment to decide, and now is always the moment to decide. We just passed the summer solstice. This event and also the great Ann Shulgin remind us that to truly appreciate the light, which may guide and illuminate our path forward, we must also appreciate and look with great interest into shadow.

We have failed in the past to shepherd psychedelics to the many. You may ask any of the elders with wrinkled skin walking through these halls, the consequences of those failures. Some of these failures may be attributed to the amplification of a message of othering, of rejecting, of being against the system and the people in it, an amplification of exclusion, distrust, and fear.

The modern psychedelic movement has learned to work harmoniously with the systems and more recently to passionately embrace diversity, equity, and inclusion as essential to the vision of global healing. Inequality can be understood as an imbalance of power that affects who is valued and who is included.

If we believe that our outer world reflects our inner world. Then we look to bring awareness to the parts of ourselves that are oppressed, that are shamed, that are exiled, and we are curious about the ways in which our lack of wholeness disempowers us, distorts our authentic sense of self and our use of power.

The nature of the human condition in a pragmatic function of a young ego is to suppress. Through shame and denial, those aspects of ourselves, which are deemed disadvantageous to our survival in our family systems or in our society. But as we become self-aware and heal in the context of healthy relationships, we must reclaim those parts of ourselves if we wish to become whole again.

This wholeness allows us to step into our authentic power. We then experience and amplify a greater sense of safety and coherence for ourselves and for those around us. In more integrated and coherent states, we are more effective collaborators and co-creators. Creative synergies and efficiencies can be gained exponentially, but where we are in balanced.

Where our inner power dynamics are characterized by oppression, fear, or shame, consciously or unconsciously, this will show up in our relationships and what we create. Undoubtedly, our relationships hold the greatest opportunity to accelerate our own growth and their trajectory towards global equitable access to psychedelics.

Simply put our attitudes and behaviors towards one another can replicate fear-based modes of oppression, which cause inequities, or they can heal fear and create equity and balance. If we are mindful, there are telltale signs of fear operating on our relationships. blaming, shaming, rejecting, and labeling others as bad, and in essence, creating exiles.

In our external world, this is often a reflection of our inner world, perceived threat and lack of safety. If we're aware of social power differentials in our relationships and interactions, we may come to appreciate. How our response or non-response can reinforce existing inequities and imbalances of power.

So if we're in the socially or situationally defined higher status position, our task is to be more tolerant, to be more generous, to be more open, to create space, to create a container for the other, to receive the other, and to fill that container. With appreciation and respect to not make an effort towards this, at least starting with awareness, is to reinforce the imbalanced power dynamic.

And if we are in the socially or the situationally defined lower status position, our work is to be courageous and to authentically be self-expressed and to look for space that may be created. And to fill it with appreciation and respect to not do this is to reinforce the imbalanced power dynamic in every interaction regardless of status.

All of our work is to be aware of our nervous systems and the energy that arises and our thoughts that create story about other and self. We will not create justice with injustice. We will not create love with fear, and the choice is ours. And what is truly amazing about the psychedelic ecosystem is that we have the opportunity to develop and practice with safe community containers, using advanced tools to heal and to hold one another to create.

And to celebrate together. If you need any evidence of this in action, it's all around us at this conference. What we feel in this container is not months or years, but decades of intentional cultivation of safe community. What we feel here is an expression of the goodness and the path of peace that those whom we revere here embody.

And to which the majority actively inspire Aspire, it is one expression of a less fearful, more loving world that our hearts know is possible. A co-creation that grounds progress outwards in inner and interpersonal harmony and integrity. This con is a teaching that we are all participating in and an invitation to consider amplifying what we are experiencing here.

I thi I share these thoughts with you with some urgency because we're on the precipice of a potential surgeons in the resourcing of access to psychedelics. In November of last year, an article was published in the Journal of Neuropharmacology, identifying the need for the federal government to view psychedelics through a public health lens as a response to the mental health crisis.

This article was co-authored by Health and Human Services personnel and psychedelic researchers. Historically, there are many examples of the US government taking the lead to create a global sea change in response to public health. E epidemics When the US makes policy and budgetary changes other countries soon follow.

We saw this with Covid and perhaps more relevantly with HIV, just to name two. So currently the Gro Global Annual Mortality rate for all causes of death related to mental illness is 8 million. That is just 2 million less than the global annual mortality rate for cancer, with research showing robust and durable clinical efficacy.

And national surveys showing the use of psychedelics rising significantly, as well as the tidal wave of state and federal legislation. There's a potential perfect storm of rare, nonpartisan, political will and an identified need for a public health response from the government to the mental health crisis and the rise in use in psychedelics.

By the aforementioned journal article and activities such as having HHS representatives both present here and presenting here at this conference, the US government is signaling perhaps that it will look to the expertise of the psychedelic ecosystem to understand what type of response is needed. We would be wise to anticipate that they will be looking to us to help decide what to value, prioritize, and fund.

And if and when that happens, what will we choose to use our power to amplify? Will we be centered in a place of wholeness and equity? Or will we be amplifying the symptoms of separation and inequality such as greed, dominance, control, and prejudice? We can imagine the testing of our metal that this would be so my friends, the time is upon us and now is the time to decide what we will amplify.

Let us do our work. Let us become more whole, using the blessings of our tools wisely. Let us move through, rupture and repair skillfully with the safe arms of healthy communities around us. Let us intentionally choose leaders and mentors who embody balance, wisdom, integrity. Especially in their use of power.

And I believe if we do, if we are clear channels for that which we wish to see in the world, perhaps we may have a chance to amplify through collaboration with our federal government, a world superpower, a more equitable, peaceful, safe, and loving realization of global access to psychedelic healing. In short, we will transform the world only by transforming ourselves.

The time is now. We have the tools, we have the knowledge. Let's do it. Thank you so much.