History and Elimination of the DATA Waiver with Stuart Gitlow, MD, MPH, MBA Partner, CMO at Limitless Ventures- GP LLC Past President of American Society of Addiction Medicine
Dr. Stuart Gitlow, a physician with 30 years of addiction medicine experience, shares the benefits of buprenorphine treatment he has observed in his own practice. He takes us through the fascinating history of the DATA Waiver (X-Waiver) and how the elimination of the requirement will impact care and prescribing. I really enjoyed this conversation and I think you will as well.
Transcript:
Terri
Welcome back. My guest today is Dr. Stuart Gitlow. He is a partner and the chief medical officer at limitless ventures, as well as a past president of the American society of addiction medicine. Most of you know by now that the DEA has eliminated the data waiver program. In today’s interview, we are going to talk about the history of that waiver and what it means now that it is no longer required. So first, I will start by welcoming Dr. Gitlow and asking him to share a little bit about the work that he is doing with Limitless ventures.
Stuart
Hi, folks. So Limitless ventures is a company that invests in new companies, startup companies that are working in the healthcare space specifically focused on mental health and addiction. So I’ve been doing that for the past two or three years now, but largely have a private practice of addiction medicine and psychiatry that I’ve been running for about 30 years.
Terri
Okay, all right. So you have a lot of experience with addiction medicine, to say the least. Yes. Okay. All right. Fantastic. Now let’s talk about the history of the data waiver, or “X Waiver”, as some know it as. Teach us about how that all came about.
Stuart
Well, first, let’s start out by saying that never in the history of American medicine have physicians ever been limited in terms of the number of patients that they’re allowed to treat. It really wouldn’t make a lot of sense. Imagine if you suddenly came down with lung cancer and went to see an oncologist, and he said, oh, no, I’m sorry. I’m at my limit. I can’t see any more patients with lung cancer. I could see you if you had pancreatic cancer, but not lung cancer. That would be very strange, very odd, and the public would immediately rebel. So it’s a little odd that we ever had a law that prevented addiction specialists from seeing more than a certain number of patients with a specific addictive disease. Let’s talk about how that came about. Back in the early 90s, when buprenorphine began to be studied with respect to its potential for treating patients with opioid use disorder, the only primary treatment available was methadone.
Methadone had to be provided in specific opioid treatment programs. The reason for that was twofold. One was to make sure that they were getting appropriate specialty care. And the second was to keep opioid addicts from going to your backyard medical practice. People didn’t want addicts going to the same practice where they were being seen, and so it ended up being a segregated group that could only receive first line treatment at a specific place where no one else was being seen and where they were able to get the care that they needed. All of a sudden, buprenorphine becomes available. It looks as though it’s going to be just as good a treatment, if not better than methadone, and there was a push for it to become available at all physician offices as any other prescription medication would have been. It would end segregation and it would end the monopoly that opioid treatment programs had on the treatment of patients with opioid use disorder.
For that reason, there was pushback politically from both of those parties, the public as a whole who didn’t want addicts to be seen in their favorite doctor’s office, and opioid treatment programs that didn’t want to lose their control of the entire population. And so came about a rule that sort of met in the middle. And what it did was it prevented doctors from treating initially more than 30 patients with opioid use disorder with buprenorphine in their office. Eventually that was lifted to 100, and eventually again, it was lifted to 275. But realize that an average private practice psychiatrist would have 700, 800 patients that they see on a regular basis, because we don’t see every patient every week. We don’t even see every patient every month. But if you figure, what’s the caseload of patients that we might see regularly with some degree of frequency over the course of a year, it’s about 700 or 800. And so 30, 100, 275, whatever it is, it’s a fraction of what we are actually able to see just on a regular basis.
So we looked at it as being something that was never called for, was only pushed for politically. And now, finally, that entire thing that’s been with us for 20 odd years is no longer present. Now we can finally see as many patients within our own limitations as we can. And given the extent of the epidemic, there’s certainly a demand right now. What we need to make sure of is that enough physicians are going to make themselves available to help treat this illness as they do diabetes, hypertension, and any of a number of other chronic lifelong health care disorders.
Terri
Right, so interesting. So that compromise was to keep things at the clinics, but also not have so many of those types of patients coming into my doctor’s office where I might be sitting in a full waiting area with those types of people. Right?
Stuart
Exactly.
Terri
Yeah.
Stuart
I ran for many years, I ran the community mental health center in Nantucket. We saw a widespread general psychiatry population. Major depression, generalized anxiety disorder, schizophrenia, all comers, and we would see patients with addictive disease. When buprenorphine became available, we started to see patients for opiate use disorder. They started to come in and ask for that medication because they’d never been able to get treatment from us before other than counseling. With the medication available, nantucket suddenly had a nosedive of the number of opioid overdoses they usually have from seven to ten overdoses per year. During the time that we prescribed buprenorphine there, the number fell to zero. And so we did a great job of treating the folks with opioid use disorder. The problem was that the patients who came to the clinic didn’t like sitting with those individuals in the waiting room. So they asked us would we see them at a different time or in a different place, could they be scheduled at another time?
So they weren’t coming. They were very forthright in saying, I don’t want to come in at the same time as the people who are opiate addicts. My family will see them. They’ll think maybe I’m one of them. There were all kinds of different stigma that arose around it. And so we ended up in a position where we would root them in through a different door into the facility. They would wait in a different waiting room. It was awful, but it was the only thing that we could do at the time to keep all the patients happy.
Terri
That’s interesting. Maybe this is just my ignorance, but I don’t know that. I mean, how do you know that what the person sitting next to you in the waiting room with you is struggling with? I mean, unless they’re in some sort of active withdrawal or something and it’s just clear that what’s going on.
Stuart
I think to an extent that the stereotype of an opioid addict, a thin, gaunt individual who looks as though he’s lived an extra 20 years of his life beyond his age, it doesn’t fall far from the mark. And just as a group, these individuals can sometimes act out a little bit, particularly early in their treatment. So they would stand out. And it took time for us to work through that with them when counseling, but it was something that the patients noticed.
Terri
Interesting. Okay, well, what we certainly hear a lot about is with the pushing everybody to those methadone clinics where they could get it, if that’s where they need to go, then that becomes a neighborhood problem. Right. I don’t think the community certainly wasn’t involved in all of the political machinations that were going on. But I don’t think many people want to live in a community where there’s a methadone clinic and there’s people hanging out.
Stuart
No, in fact, and there’s a lot of confusion about that. I’ve been involved in several city council meetings in Massachusetts over the past couple of years where a buprenorphine program was trying to be opened. But it was going to be a public one. So there was a public hearing and the people who spoke out against it, the populace of those townships I won’t mention the towns, but they basically said, I don’t want this long line of IV drug abusers out the door every morning. Who knows what mayhem will be caused. And that was the argument. And some towns agreed to have the program open and some towns didn’t, thinking an office based practice of opioid use disorder treatment would be just like a methadone center. And methadone center had a bad left, a bad taste on their mouth for whatever reason. But there’s a lot of stigma, there’s a lot of misunderstanding.
And to some extent, the way some of these programs run plays into that misunderstanding the methadone programs with the long lines out the door in early hours of the morning, that is what happens. And so the issues that some of the townspeople raised were legitimate ones.
Terri
Yeah, well, you have your own mini antidotal study once you started prescribing out of your office and how people then, okay, hey, I want you to treat me, and your overdose rates went down in that area right? It does work, patient safety?
Stuart
Yeah, the treatment works beautifully and the patients respond well. In my own office, the average patient that I had seen when I was doing a buprenorphine practice was seven years that they were coming in every month or however often they needed to come in, but steady, without dropping out, without relapsing, and generally speaking, doing very well over long periods of time on the medication. So it really works wonderfully.
Terri
And what it does is it gives you a chance to work with them in terms of therapy right. Because it’s not just pop the pill and everything is great. I’m assuming they need to deal with their traumas and whatever it is that contributed to them having a substance use disorder in the first place.
Stuart
It’s a mixture. It is a mixture. It’s like diabetes or hypertension, right? If I work with a diabetic patient and I give them insulin for their diabetes, if I do nothing else, their morbidity has dropped dramatically, their mortality rate drops dramatically. Now I can add more and I can certainly work with them on their diet and their exercise program and how they feel and their other health comorbidities all the other issues. Same thing with hypertension lose weight, exercise better, quit smoking, all of the things that you need to do but if you do nothing more than take this anti hypertensive, you’re still going a long way. So when we have folks with opioid use disorder and we’re treating them with buprenorphine, that’s the major intervention. That’s the intervention that will result in a dramatic drop in morbidity and mortality. We can add more, we can certainly do counseling for the patients who want it.
What we found was that the majority of patients were not particularly interested in it. They wanted to get on with their life. They didn’t feel that they needed it or they felt that their twelve step program was sufficient. So there’s a variety of things but what we used to do was simply schedule those who wanted to have therapy or long periods of time discussing whatever it was that was of interest. We’d schedule them on a different day so that we could have longer periods in which to talk with them.
Terri
Yeah, that makes sense. A lot of America just wants a pill to pop and that’s it. They just fix me, don’t make me change anything and work hard and be introspective in any way. So that does make sense, but you’re right, it is the first major step, and it goes a long way to saving a life. So whether you combine it or not, you’ve already made a big difference. So I think it’s safe to say that you feel the elimination of the waiver is a good thing.
Stuart
I think it’s wonderful. Now the question comes as to whether or not physicians will actually begin to embrace the concept, because the concept is simple. About ten to 15% of the American public has addictive disease. Some percentage of them are dealing with opioids. The average primary care physician is seeing a significant number of patients from this population on a regular basis, and yet, typically, they’re not prescribing buprenorphine at all. So the question is, will they? Now, they can now they’ll have their DEA certificate, which they undoubtedly already have. They don’t need anything additional. Now they can begin to treat this population, which generally wants just the medication just the same as they get their antihypertensive and their statin and their metformin. It’s the exact same type of approach. So any physician could do this. The question is, will they? And it’ll be very interesting to see how that turns out.
Terri
Yeah. Do you have any words of wisdom for them? I mean, clearly if they have a patient that comes in, as you described, that looks pretty obvious that they have a substance use disorder going on, then that should be a fairly easy conversation, I would think. I’m more used to seeing those healthcare professionals where you aren’t identifying them from any physical attributes. They look just like us. You’re very surprised. So for a primary care physician, do you have any suggestions for how they could reach those that maybe would naturally fly under the radar but need some help?
Stuart
Certainly what you can do is first make sure your patients are aware that there is a medication that will be helpful for them. We found and again, I’m an addiction psychiatrist, but we never did outreach. I never had commercials on TV. I never had ads. I didn’t have a website. People came to us because they wanted treatment for this illness. So it’s something which people will, if they know you’re a doctor, who will treat it. They’ll come and they’ll ask. That’s one certainly looking for track marks, doing a urine drug test from time to see if a person is using a drug that they haven’t been prescribed, looking at the prescription monitoring program database to see if a person is being prescribed multiple opiates for multiple physicians. All of those things are hints. But I often find that one of the best ways to get the answer to the question is to simply say, what was your response the first time you ever got an opiate that way?
I’m not asking about their use, their behavior, their background, or anything stigmatizing. I’m simply asking what was their response? And a general patient might say, oh, I’ve never had an opiate. I don’t think anybody’s ever prescribed one to me. Okay, that’s all I need to know. Some patients will say, oh, I had it. It made me nauseated, I was very uncomfortable, and I hoped I would never have so much pain that I needed to take one again. That would be the bulk of people, but about 15, 20% of people will say, oh, that was one of the great experiences of my life. I hated the pain, but the opiate gave me this feeling of warmth and it enveloped me. And I said, right, so that’s the person where I’m going to be worried and I’ll ask some more questions. So there are ways of getting into it with a patient without putting them on guard or on edge.
Certainly you can ask about their family history. Most people won’t feel stigmatized if you say, did any of your parents or siblings have difficulty with addictive disease? They’re happy to answer that question because it doesn’t, they think, say anything else. And so again, you’re trying to get at the heart of the matter and you’re approaching it in a way that the patient feels comfortable, and that’s always key.
Terri
Okay, yeah, that makes perfect sense. So for physicians that never did have that X Waiver, I’m thinking that reasons that they didn’t is, one, they just didn’t want to go through the process, or didn’t want to be told that they had to go through the process, didn’t want to outwardly invite a bunch of those kinds of people into their practice. Is there also an element of intimidation of how to prescribe it and use it? Is it quite simple and really is not complicated in any way, or it really is simple?
Stuart
It’s a drug which has a ceiling effect, meaning above a certain dose doesn’t tend to do very much, and below a certain dose tends not to work very well. 16 milligram is the label amount. In other words, the FDA label the approval amount. 16 milligrams is the target dose, and anywhere from eight to 24 milligrams is usually right for people, but the vast majority respond well to 16 milligrams. It’s very unusual to have a person go into sudden withdrawal if they’re given the drug. Usually it can be tapered up or started at 16, but either way, the medication usually works nicely with few side effects, without any significant associated risk factors, a person is able to return to work. They don’t have the withdrawal or the craving from other drugs. And like Prozac for instance, which generally works at 20 milligrams, you don’t have to really give it a lot of thought beyond that and works quite nicely.
And again, like with major depression, can you do counseling? Of course. And we’ve known for years that about 70% of people with major depression respond well to Prozac, and about 75% respond well to Prozac plus counseling. With Buprenorphine, the numbers are comparable it’s something where the medication by itself at 16 milligrams, will meet the needs of the vast majority of individuals with opioid use disorder.
Terri
Okay. All right. Fantastic. Have you seen anything currently in the short term, or do you anticipate anything long term that will be some struggles associated with the elimination of the waiver?
Stuart
The biggest question for me is the degree to which the various branches of government see eye to eye on the question. Let’s say that suddenly tomorrow every doctor begins treating all the people with opioid use disorder, because we’ve found that barely 10% of the public that has opioid use disorder is getting prescribed first line medication for it. So we could see we won’t, but we could see a roughly tenfold increase in the prescriptions for buprenorphine, and that would not be unreasonable. Now, some percentage of the prescriptions that are written will be diverted. In other words, some patient might decide, I need a few extra dollars, I’m going to sell these on the street, or I’m going to give some to my spouse, or I’m going to leave it out where my kids might happen to use it, right? I mean, any of those things could happen.
As a result, law enforcement might observe an increase in the number of problems associated with buprenorphine. They might see it in a raid of a drug dealer or something along those lines and say, oh my, this came from a doctor who was prescribing it. There’s where the problem is. And that’s the scary part, because we could be in a situation where you’d find that doctors are told not to prescribe it because a small percentage of it is ending up on the street even though you’re helping thousands and thousands of people with opioid use disorder. Another issue might be some confusion. The Department of justice filed an indictment against Rite Aid a week or so ago. In the indictment, one of the things that they raised was what they call a red flag about doctors prescribing. One of the red flags was a prescription for patients receiving a controlled substance for more than twelve consecutive weeks.
Now, of course, buprenorphine is a controlled substance, right. Patients getting it will typically get it lifelong. And so that’s more than twelve weeks. Well, if Rite Aid starts to say, oh, the Department of justice is right, and there’s Dr. Gitlow, he’s written this prescription for a patient for buprenorphine for more than twelve weeks, we better do something about that. Well, that could put a lot of doctors in hot water who don’t belong there. And that sort of misunderstanding as to is this drug supposed to be used like other controlled substances and they’re all different. The degree to which one uses any controlled substance depends on the illness.
Terri
Yeah. Know your indications. Yeah. Hopefully that doesn’t get in the way. What about in terms of, I’m assuming, like, you can see more patients now, and so I’m guessing, I mean, not see more patients, but you can prescribe to more patients, and so I’m assuming you’ve started doing that as the need arises. Do you have any issues with until more people come on board and start prescribing? Are you seeing people coming to you that normally should go to see somebody else that’s a little bit closer to their residence, and you start getting into that pharmacist looking at a prescription and like, why did you just cross the county line to come get your prescription filled by Dr. Gitlow?
Stuart
Right. I think a lot changed during the pandemic. Certainly our office practice modalities changed a lot during the pandemic, and it will be very interesting to see what happens there. Almost all our patients decided at the beginning of the pandemic to be seen virtually by telemedicine, and as the pandemic wound down, they didn’t show any interest in returning in person. And yet it’s interesting because some of the laws that allowed us to practice across state lines during the pandemic don’t allow us to anymore. And so we said to those patients, well, you’d have to actually come in the office because you’re in this state and we’re in that state. And some of them decided to be seen locally if they could, or virtually, I think, by another doctor licensed in their state. But there’s also been a transition where the DEA has now proposed that patients being seen for buprenorphine treatment can be seen virtually the first time get a 30 day prescription, but then would have to be seen in person at least once before getting a continued prescription from the same doctor.
During the pandemic, the patient didn’t have to be seen in person at all prior to the pandemic. They couldn’t get any prescription without having been seen initially. So there’s been this back and forth pendulum, and doctors aren’t sure what the rules are, and the patients aren’t sure what the rules are, and the rules keep changing. So it’s been a little bit difficult to keep one’s eye on the regs to make sure that we, the doctors, aren’t making a mistake and for the patients to ensure that they’re still getting continuity of care.
Terri
Interesting. It would be nice if somebody could actually study the situation and determine, did we learn some things from changing the rules during the pandemic because were forced to, that actually we should just keep going with we did.
Stuart
My understanding is that during the pandemic itself, care was perceived as improved by the patient population and there was no increase in morbidity associated with their not having been seen in person. Initially it worked, and now there’s a good deal of pushback from the treatment community about these new regulations which seem to tend back toward what they used to be saying, hey, that’s not necessary. We’ve shown it not to be necessary.
Terri
Yeah, it’d be nice if we could have actually learned something from having to go through all of that makes it better on the other side, but maybe that’s too much to hope for. All right, well, this was fascinating. I was not aware of the history and certainly not aware, although I should have known that there were political issues that impacted it, because I think there are political issues that impact more than we realize for those that are not involved in the decisions. And, of course, what we’re looking at on the other side, that hopefully more and more physicians will become comfortable and become willing to do this and prescribe it for their primary care patients and maybe less opioid prescribing.
Stuart
I hope so. I mean, it’s wonderful seeing this population get better. And I can’t tell you how many of them will call me on their anniversary of their sobriety, even years after they’re no longer in treatment with me. And they’ll call me and say, thank you so much for helping me through and helping me get to where I am. And they’ll tell me about their kids and their job and their spouse. The stories are wonderful to hear. And as with any disease, there are some patients that we can’t get through to, but the vast majority of people respond well to treatment, and we’ve always found that people really do well when they get good continuity of care.
Terri
Yeah, that’s fantastic. Well, thank you for all of your doing all that you are doing for that group of patients. And it’s a much needed sector of work, and so I, for one, appreciate all that you’re doing for them.
Stuart
Thank thanks very much. It’s been a pleasure being here with you.
Terri
You too. Thank you, Dr. Gitlow
