After receiving generic IV ketamine or branded drug nasal spray Spravato, patients are monitored for two hours. Nurse practitioner Denise Hosier performs a blood pressure check for a patient who’s received Spravato at the Mental Health Center of Denver, where she is director of adult integrated care and nursing services.
Should the ketamine clinics sprouting up across the country be more heavily regulated?
Modern Healthcare's Senior Hospital Operations Reporter Alex Kacik and former Safety & Quality Reporter Lisa Gillespie talk about ketamine in this Beyond the Byline podcast.
Subscribe to Beyond the Byline
Subscribe to Modern Healthcare
Follow us on Twitter
Music Credit: Coffee by Cambo
Alex Kacik: Physicians are experimenting with nontraditional ways to treat issues like depression and anxiety. The psychoactive drug ketamine has been approved by the FDA as an anesthetic, but it is increasingly being used as an off label drug for depression and chronic diseases. Should the ketamine clinics sprouting up across the country be more heavily regulated? Welcome to Modern Healthcare's Beyond the Byline where we offer a behind the scenes look into our reporting. I'm Alex Kacik, senior operations reporter. Our former Safety and Quality Reporter Lisa Gillespie is joining me today to talk about ketamine. Thanks for joining me, Lisa.
Lisa Gillespie: Sure thing, Alex.
Alex Kacik: All right, Lisa,
Lisa Gillespie: Tell us more about how you got into this story and what you learned about the history of ketamine use in healthcare and what the recent trends are.
Alex Kacik: Yeah, so I was turned on to this story from an editor. If you do a Google search of ketamine and the city that you're living in, there are pages upon pages upon pages of providers that you can find that are touting the drug for a range of uses. And I just thought that was fascinating. And the more I learned about how clinics also operate, outside of sort of the usual regulations that kind of oversee the practice of medicine. It was super fascinating to me, which is kind of why I chose to dig into ketamine that was initially approved in the 1970s by the Food and Drug Administration as an anesthetic. And so the doctor traditionally who have had the most experience with the drug are anesthesiologist, in those settings that use the drug at pretty high doses, probably in the early 2000s, as physiologists decided that, you know, they could open up their own like little private clinics and offer this to patients at much lower doses. For things like treatment, resistant depression, but also, you know, some chronic diseases and whatnot. And I think that was kind of because there's been emerging research for some years now about how ketamine can be helpful. And these clinics have exploded in recent years, like past 5-10 years. So really interesting story. And obviously, the COVID 19 pandemic has exacerbated mental healthcare access issues.
Alex, I know that you have done some reporting about the frequency and severity of mental health cases over the past two years, is that right?
Alex Kacik: Yeah, yep. So the backdrop behind all this is that it's been hard to find the mental healthcare long before the pandemic, whether it was insurers like narrow networks, low reimbursement rates, just a lack of in the number of psychiatrists, you know, per capita across the U.S. and I saw one stat, I think, from the AMA a few years data now, but no, fewer than half the counties have a psychiatrist in them across the U.S. So, you know, as more people were trying to cope with the trauma that's occurred over the past two years, you know, the pandemic has brought these issues to the forefront. And you know, they're losing loved ones, income and isolating, and loss of routine. And this is just making these episodes more acute and more frequent. So people are disproportionately going into emergency rooms, which is never the best situation for someone in a mental health crisis. And then, you know, child and adolescent mental health issues, and suicide rates are going way up, unfortunately, you know, total health, mental health claims for children 13 to 18, doubled from, you know, mid-2019 to mid-2020, according to some data from Fair Health. And then, you know, for close to 18 million adults experienced delays or cancellation of appointments over the past year or so, and nearly 5 million went without unnecessary care. That's according to data from the National Alliance on Mental Illness.
You've had these systemic issues associated with mental healthcare. And, you know, it's interesting to see and you know, these other opportunities and treatment interventions come into the fray, and whether they can alleviate some of that burden. But what did you find out about, you know, the studies that have come out about ketamine efficacy and whether it works when it comes to treating certain mental health issues? I understand, you know, depression is one of them.
Lisa Gillespie: Yeah, so there is research with which, it's sort of debated about how robust it is, which is its own issue. So there is research, the most robust is for treatment resistant depression, and like major depressive disorder.
Janssen Pharmaceuticals, patented a...so they isolated molecule that is, in ketamine, the drug and they patented that molecule and it's they call it spravato. And the FDA doesn't have a mechanism exactly to like regulate how it's being provided. And they also can't really, totally crack down on how it's being marketed either. And so, you know, there are websites with providers touting it for like PTSD or postpartum depression, all these things that don't necessarily have research behind them. And so it's super controversial. There are large academic medical centers, like Yale, Mass General that have programs and, you know, I interviewed the doctors that run those programs. And, you know, they really believe in what they're doing. And they do research and they say this works. And then I also talked to people were like drug overall, like drug safety experts, you know, there's a Center at Johns Hopkins that looks at drug safety overall. And they say that these trials like aren't or like, the research just isn't robust as it should be, and especially compared to other drugs, you know, that treat similar conditions. So, there's a fair amount of like this gap and research. And so that's sort of one of the issues.
On the other hand, you have patients that are really suicidal, and, you know, have maybe made attempts, other drugs have not worked for them. This is sort of a last resort. But that also brings up the issue. You know, it seems like a lot of these clinics are run by anesthesiologist, who like, you know, I don't there's not like concrete data about the number of those clinics that have mental healthcare, you know, mental health training. So you know, there's this question of like, anesthesiologist, if they're delivering care solely without mental health person there as well, like you're treating patients with severe suicidal ideation, maybe attempts, whatnot, ketamine doesn't work for everybody, just like every drug doesn't work for everybody. And so you have so many where this, this fails, like, you probably need somebody around to that it's gonna like counsel your patient to, you know, not lose hope and whatnot.
So, I also looked into the hallucinogen psilocybin, which is also known by some as magic mushrooms. Right now, there are some clinical trials that are going on to test out uses for things like PTSD and depression.
And Alex, I know you've talked to some providers who are going through this process, what have you learned about it?
Alex Kacik: So I talked with a doctor in Maryland as part of Adventus Health Aquilino Cancer Center, and they pair psilocybin in psychotherapy to help cancer patients cope with their disease because you know, how heavy some of these term potentially terminal illnesses can be. So it was an interesting awareness, it's sprouting up, it's integrating, you know, some of this mental healthcare or new types of interventions with, you know, go big with major diagnoses or traumatic injuries. So the center it screens, each of its patients for mental distress, and then it offers a psilocybin clinic clinical trial that seeks to alleviate trauma and depression. And they have like meditation classes, one-on-one counseling, group therapy and community based support services seems to be kind of the next iteration of mental health integration here.
But you know, some of the obstacles obviously, like everywhere, like staffing is a major issue and finding, you know, the right type of help to scale these programs or even keep the ones that are existing afloat. And then insurers only pay for some mental health therapy. And it's if they do, it's typically a low amount. The director at the cancer center told me that there's an under appreciation for the amount of stress cancer brings and how that impacts a patient's life reimbursement seems to be structured around medication and procedures rather than around holistic care.
You mentioned Mass General and some others, big health systems are starting their own ketamine clinics. How does the regular regulation come into picture here? And how are they assessing kind of the market and that sector given you know, the relatively ambiguous or lack of regulation there?
Lisa Gillespie: So there are some larger academic medical centers, mainly academic medical centers, I didn't find like a private hospital system or like a nonprofit hospital system that is doing this there might be I just didn't find it. But yeah, so there's no regulation. There is a trade association although I reached out to them and they didn't get back to me so I don't know how vigorous they are. But I, you know, I don't know if it opens up to like liability per say, but definitely, you know, there's like a need like Mass General, Dr. Christina Cushing, there's told me that every time you know, they start turning a profit, she invested back in hiring more staff, expanding the space to get more patients, you know, word of mouth travels quickly. So it's like kind of this supply and demand issue. And, you know, they have a long waitlist. And in the meantime, you know, if patients are on the waitlist, and they really need care, they end up going to a private clinic, in terms of like, the legality, I mean, it's perfectly legal, I won't, you know, it would be up to states to regulate this, like, in the same way that states crackdown on opioids, for instance. But in my research, I didn't find any states that have done that, you know, it might be that there's, you know, maybe there isn't there are safety issues, like I don't, you know, that's kind of like the question. And when you go into, you know, look at like patient accounts, like I went on to Reddit, and, you know, we're trying was trying to, like, get a sense of how this works for patients, right. It seems like there's a lot of positivity out there. But like the other limiting thing about ketamine, though, is that it's mostly private pay. I mean, there's some insurers who will pay for it, it's kind of one off spravato, there's a bit of more coverage, that the cost of the drug is like, relatively cheap, but then you have to, you know, like, there's the facility costs, there's the cost of having the doctor there, like the nurses to make sure that you're, you know, pulse doesn't go way down during or way up during administration.
So they're all these costs that are wrapped up into it. And so like, it can be, you know, $500 bucks for a single infusion for a day. And so the people that are receiving this treatment like are not, you know, like, they're probably not on Medicaid, like, they're probably not low income, these are people with means that can get this care for the most part. So it is still sort of limited.
And I was really interested, because I saw that you also had interviewed someone from Mass General and Boston, you had talked to the executive director of their ED there. And I was curious about what you found out about the frequency of mental health visits that they'd been seeing.
Alex Kacik: Yeah, so like many emergency departments, you know, Mass General has been overwhelmed with the number of patients coming in both pediatric and adult. And they've been, they have this like separate unit that's kind of adjoined near their ED that is like private rooms for mental health patients in crisis. They don't need like the inpatient care, they need a place to stay that's safe and no surveillance. So they just expanded that from six private rooms to 20. But during some of the peak days, I mean, you still have like 40 or 50 people coming through the ED who need you know, mental healthcare.
So but you know, around, I think their median is around 15. So they're hoping this will take some of the stress off of their emergency department itself. And, you know, the director told me, they are in a new unfortunate frontier of many psychiatric patients seeking care at hospitals and the volume is way up. And you know, the ED is never an ideal setting. I talked with the CEO at a Pennsylvania based health system who said that the ER in Chester County one day a couple of weeks ago was more than half full with behavioral health patients. So just to contextualize just the number of patients coming in, and it seems pretty ubiquitous. But you know, in that area, he was mentioning just the the whole system of care for mental health patients has kind of eroded around it. So there's been a hollowing out of residential care facilities, those have changed ownership, some of them have been pared down or closed. And that's further increased the burden on the hospitals in the area.
So Lisa, what's your long term outlook here? Could potentially ketamine clinics alleviate some of that burden on the broader healthcare system? I think you've already run into some limitations, but I guess what's your outlook here in terms of the popularity and you know, whether there'll be scaled and, you know, none of the regulatory front as well?
Lisa Gillespie: I think this is still sort of early days. It's kind of, you know, it's like the wild wild west almost here in the U.S. And so I think, for Ketamine to be offered as a mental health treatment widely like, you know, your large health system opening a unit, I think, probably will take way more research and quite frankly, until insurers see enough evidence, seen how long that can take. I don't think that the payment issue will be a hurdle.
There are definitely programs in the U.S. that train mental health therapists and psychiatrists and whatnot on delivering Ketamine for sure, but it's still sort of like this niche area. And I think like, you know, any generic drug that's used off label, it just has a ways to go if it is going to be taken up.. I think that, you know, psychedelics that are going through clinical trials right now might have a bigger, might have like more promise just because they're going the traditional route. And as we know, you know, insurers and health systems are, you know, traditionally more comfortable with drugs that go that route. So, for better or for worse.
Alex Kacik: Alright, Lisa. Hey, thank you so much for taking the time and sharing your reporting with us.
Lisa Gillespie: Sure. The pleasure.
Alex Kacik: All right. Thank you all for listening. And if you'd like to subscribe and support our work, there's a link in the show notes. You can subscribe to Beyond the Byline on Spotify, Apple podcasts or wherever you listen to your podcast. You can stay connected with our work by following Lisa and I at Modern Healthcare on Twitter and LinkedIn. We appreciate your support.
Send us a letter
Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.
