 Good morning and welcome to the Vermont House Human Services Committee today is Wednesday, March 23rd. And this morning we are continuing our discussion and receiving testimony on age 728 and acts relating to opioid overdose response services. And the focus really of today is to get an idea of what are the barriers, if any, on access to MAT, especially as it relates to pre pre authorization. And our first witness we're going to hear from three people, three professionals, medical professionals who are working very closely in this, starting with Dr. cluster, followed by Dr. And ending with Jacqueline Bray who was a nurse practitioner at safe recovery. Thank you, Dr. cluster for taking the time. Absolutely. Thank you. I guess by way of introduction. I'm Nels cluster, and I am the medical director at the hub in Brattleboro, as well as that serenity house which is a residential treatment center in Wallingford. And then I work with a multi provider, large spoke severe to health in in Bennington. And again, you know, thank you for the opportunity as well. The reason why I reached out to Dame Whitman was I was concerned about some sections of age 728 as related to prior authorizations and do the Norfolk formulation choices, and higher dosage limits and I was concerned that those changes might be unnecessary, if not harmful. I'm hoping that I can build on the previous testimony from doctors, the colonists and Lord, and hopefully not repeating what they've already talked about. But the pharmacology one on one is where I wanted to start because of the mistaken idea that the absence of naloxone makes the mono product preferred over the combination. It's the, it's the opposite because the effectiveness of both these products is the same from a clinical sense, you know, as far as the work they do around treating opiate withdrawal and cravings. And the lock zone is actually added in there to hinder misuse and the negative consequences that come from misuse. And to help understand that I want to introduce the concepts of bioavailability and intrinsic activity and receptor affinity. So I'm really hoping that you've got the handout that I sent to Julie last night because that was certainly help. So, you know, course suboxone is combination of buprenorphine and naloxone and bioavailability basically means how much the medication gets into your system to do the work it's supposed to do. And when you take this medication appropriately, which is, you know, sublingually or under the tongue, then about 50% of the buprenorphine is bioavailable it's there to do what it's supposed to do. And the rest of it is metabolized and lost from having effect. When you take the medication sublingually naloxone is negligible absorption and really is not present to do with naloxone tends to do. If, however, and this is a general rule of thumb, if you are to inject this medication, then the buprenorphine is 100% bioavailable as is naloxone being 100% bioavailable. Now in this second table, there's an inverse relationship to how strongly these medications adhere to the opioid receptors and how much they activate or turn on the system. So starting with, you know, opioids, these are we have a call full strength opioids, the ones that most of us are probably familiar with morphine oxycodone percocet delotted heroin fentanyl methadone. And because of the strength of these the activity they have at the receptor, there's no limit to what they can do pain relief. But conversely, then there's also the risk of overdosing because one of the potential side effects, especially as doses get higher is that opioids can suppress respiration they can stop the brain's drive to breathe. The buprenorphine is also a strong medication is very effective for treating opioid use disorder. It's also useful for treating pain as well up to certain level. It has what's called it's really considered maybe a 50% opioid. It has ceiling effects or limits to as effectiveness. So some people with opioid use disorder will require stronger medication and the buprenorphine, but also it means that we don't have the concern that overdosing that is really quite rare with the buprenorphine. The opium component has no strength at the opioid receptor. So we call an antagonist. And you could understand this to be a cousin of Narcan. It fits into the opioid receptor, and it blocks any other opioids from having a chance to occupy the receptors. So my patients can affect this. I use the image of the game of King of the Hill, and if you were consider the game of King of the Hill to occupy opioid receptors out of all three of these classes of vacations, the deluxe and Narcan are always going to win the game of King of the Hill, wins the game over buprenorphine or the other opioids. So buprenorphine having a stronger receptor affinity is going to win the game of King of the Hill against the other opioids, which is what makes it helpful for treatment for abuse disorder is that you no longer to get to reinforcing effects would get high from the other opioids. Now in the case of the the mono versus a combination product. If you inject the combination product, as I mentioned, the naloxone is there to do its work it's 100% bio available. It's going to win the game of King of the Hill. And what that means that it's going to do a lot dislodge the buprenorphine, or inhibit the buprenorphine from getting the receptors, or also dislodge other opioids from the receptors. And what that does is going to cause a rapid and severe withdrawal, because your receptors been filled with opioids that have a stronger signaling effect and all of a sudden you're getting no signaling effect whatsoever. And that is why it is there to discourage misuse because if you inject it you get the serious because precipitate withdrawal and a lesson to take your medication appropriately. And if you were to inject the mono product, as you can see you go from a 50% bioavailability to 100% bioavailability, which in essence means you're getting double the effects from the buprenorphine. And over time this could actually lead to more severe opioid use disorder as your tolerance and increases from using more and more. Then so from that individual level, then I wanted to comment on the public health aspect of this. This is a survey on drug use, it's a federal study been around for a long time. And what we see from this is about a quarter of people misuse or buprenorphine. And we say misuse that of course includes injecting it into taking it in a proper fashion, but also includes diversion as well. And we know that misuse of these medications is much more common early in treatments the risks are higher than. And from experience to we know that misuse is much higher with the mono product is the combination product. Another study then again close to home discern from the National Institute of Drug Abuse. This is a study across Northern New England, Maine, New Hampshire, Vermont, looking at intravenous drug use and hepatitis C virus, and the participants, 85% of the participants in that study reported they use buprenorphine to get high. And so we know a couple of one that you know over prescribing as well can contribute to diversion, selling your medication, because in essence, what I don't need for myself I sell to make some money. And we know as well as was mentioned on Monday, that diversion then contribute to new cases of opioid use disorder, more people getting used to using these medications. And that seems to be especially more common with the younger people who have buprenorphine as a first opioid. I think that kind of the concrete examples or bring this all together is to look at pregnant women. We used to recommend a mono product for pregnant women. There was the thought that even though it's a negligible full amount of naloxone that we were concerned about having adverse effects on the fetus. Over time, what has happened is it's been determined there is no adverse effect for naloxone again probably because it had a negligible absorption by the subliminal route. And so now the combination products recommended for pregnant women as well, which is a particularly vulnerable population. And this is for a couple of reasons both individual benefits as well as public health benefits. One of the reasons this is disruptive to go from the combo to the mono during pregnancy and then back onto the combo after pregnancy disruptive and a lot of women are in comfortable with that. As I mentioned, there's you know, feel safety there's no harm to the fetus with this, but also as the aspect maternal safety. I'm quite sad that there's a high level of coercion on was was a high level of coercion on pregnant women who were prescribed the mono product course by their partners and my peers who recognize they had this more, you know, highly valued medication. Because you just had an adverse effect on on their wellness and public health benefits, of course, with the combination is less diverted. So less of those problems, and also lower health care costs as well because you know with the mono product and the version. There's increased injection as well because that typically the main purpose of seeking mono product. And with less injection of course we get less infections less abscesses less bacterial infections, less cases of hepatitis and HIV. We've got very, I mean really the nation as far as availability of the MOUD medications for opioid use disorder, which is also known as MAT medication assisted therapy. Only one site in the state has a waiting list and that's simply because of workforce issues when having counselors. There are two for these completely telehealth organizations lacking critical oversight there they're not doing drug screens they can't do medication counts, and they don't do the physical exams which are really important for determining appropriate dosage so you know feeling that that makes the in person hub and spokes definitely preferred treatment setting over those. And then to kind of tie up specifically out the prior authorization process. We have medical directors agree that some sort of oversight is necessary and that is a role played by prior authorizations. The vast majority of these medications do not require prior authorization. If you take more than a dozen of doses or 16 milligrams or less, having medications of 24 milligrams are ineffective, you're getting more make. If you take more than 24 milligrams you're taking more medication and you're not getting more benefits not getting more effect. And so anyone it prescribes over that amount is misinformed either about the ceiling effects or the diversion risk. Additionally, starting the medication is very important and no quantity limits on the two milligram film her tablets which will be start with the induction process or building up and starting the medication. The average processing time again is 30 minutes for prior authorizations almost immediate response. Additionally, removing the prior authorization could actually moves from Montenegro between 17 to $35 million. The reason being that to be increased use of the formulation sublacate, which costs 10 to 15 times the amount of the buprenorphine and also loss in rebates that we get from the companies to manufacture the suboxone and the combination product. So I'll stop there and say thank you for the time and leave myself open to questions. Thank you. Thank you very much. Dr and thank you for taking time out from your testimony to me of your of your doctoring to provide us with testimony. And it's really clear that you are and I that the way the hub and spokes program works there is a very close tie to diva and that's that's helpful. I have a question because I'm a social worker I'm not a doctor. Who does the prior authorization. Do you call. Do you write something or is. Does the physician do that does the person at the front desk or is there a case manager who does the what what is what is it. Yeah, I do not personally do the prior authorizations that's probably your office in your office who does it. Yeah, so with the blueprint we have nurse case managers. And that to or we even have receptionist who can do this. Usually we prepopulated the form with a lot of repetitive information and we fill in the specifics about that. And it gets faxed off and we get the response from there. Okay, so this is, I'm very familiar as a social worker with pre populated forms but what are the questions and how many is it one page. And is it, what do I need to what information do I need to have for the pre to fill out this pre authorization. Okay, so it is it's a it's a one page form. And it's going to have the name of the patient is mother identifying information, as well as the name of the physician who is asking for the prior authorization. And essentially about was to ascertain that this has been used for opiate use disorder and not some other purpose, and that you've had discussions with the patient about, you know, side effects appropriate use of the medication. And then, right down the reasons why this higher dose or this different formulation is clinically indicated. Thank you. If you don't fill it out is the nurse case manager in the room. How does she know, or he know the answers to why you think, as the physician it needs to be different and what you have done. How does that communication work. I will give those specifics, either in person or electronic health records have you know texting fast capability, but also it's important I include that in my progress note. So in case that needs to be sent along or definitely it's there for the, the nursery case manager to be able to find the appropriate if the requested information to complete the form. So, so if I've come into your office and I have opioid use disorder and you've been treating me or whatever and I'm going to need a higher than. I'm going to need a higher dosage or something that's your assessment. I live in suburbia. They're like seven pharmacies within five minutes of doctors offices. You tell me, I've got one, and I say, okay, I'm going to the pharmacy and I will be in the pharmacy within 15 minutes. Will the pharmacy even have yet the pre authorization from you. They would a couple of things here. It often takes some time. I wouldn't go for my office in 15 minutes to get the authorization of course we're talking about somebody's been on the medication for a while anyway. But typically we do hear something back again the average is 30 minutes definitely by the next day will have had decision which is most often an approval. Additionally, if that is not been completed yet is pharmacies have the opportunity to do an override, meaning to fill the prescription that I've written for that higher dosage without having the prior authorization so we have that question then, while we in case we don't get the prior authorization right away. The patient is not left kind of sitting in the pharmacy waiting and waiting and waiting they can actually get that higher dose. I was pleased I did I did a little informal research this weekend and talk to three pharmacists in the Burlington area and I was pleased to know that they all were aware of the pride of this three day Medicaid emergency. One never would do it, no matter what. And they all said that the patient needed to know that there was this three day that they could ask that. So it was not something that that the pharmacy would offer. When you know, as a, did you know that you know didn't come in. But that's, we did hear it sounds like you may have talked with or reviewed our prior testimony from Dr snow. No, what was Lord, Dr Lord. Where did I get snow. I'm sorry, Dr Lord, who in the in those few occasions where you might need the mono dosage. He said, now what was basically it was moving mountains. He said it would take an act of Congress to get pre authorization. And that's how he described it. And so I'm wondering if you, how you see the prior authorization of the mono as different from that. And how to how to make it less an active Congress. Yeah, and I think to me that there needs to be this kind of barrier to the mono product, given all the negative effects of it that I've mentioned there, because most patients do not have serious reactions to the combined product. And there should be a process around this. I mean the vast majority are done are well suited to taking the films, if not the films and you never go to the tablets. I mean with any medication of course an extreme reaction is a possibility, and it's relatively rare. So I just I personally do not find myself advocating for the mono product. And so for those cases where I actually have a documented medical reaction to it, which is really relatively rare and in the case that I have that there's never any issue getting the approval. It's just not an act of Congress if I have the right information in place. So thank you so you just died. This is helpful. You disagree with Dr Lord, I appreciate that. Yeah, he might be more open to the mono product than I am, and therefore has different experience with it. Thank you madam chair, and thank you Dr cluster for being here. I just want to start by making you aware in case if you weren't that as our draft sits today. I'm looking for a report back to basically review current processes as they relate to prior authorization I think that you provided a lot of clinical information to us today and we've heard a lot of different perspectives on what clinicians and doctors are trying to use the best path for their patients but I did just want to make you aware that we are looking for a report back and I think that one of the things that I wanted to bring to your attention some of the considerations that we're having as prior authorization. I don't know exactly what the doses or what's the medications but whether or not prior authorization is helping in this sense is that, you know we received that, you know, of the 3000 prior authorizations, plus that took place last year. The 5% were approved, and the 5% that were denied were basically because of Medicaid being a secondary payer. So the question is, is that if it's not. If there's such a large amount of these prior authorizations happening. If it's not necessarily changing somebody's treatment. What is the purpose of this path, especially when looking at a lot of research that's been published related to Medicare that removing prior authorization increased uptake and treatment and decreased things like emergency room visits related to substance use I think that there's a couple of articles in the Journal of American Medical Association that we saw that says that while health plans use prior authorization to encourage appropriate medication use and then contain spending, they can also reduce the probability that a patient receives prescribed medications and lead to worse outcomes. I also have an article here and I'm just wondering if these are the sorts of things that were taken into consideration is the Journal of managed care and specialty pharmacy says that health insurance decisions may have unintended consequences on patient and payer outcomes, despite lower drug utilization and pharmacy cost savings. Therefore, careful evaluation of restrictions before policy implementation and continued reevaluation after implementation is warranted. So, while I respect a lot of the clinical judgments that you're making and that we see that different clinicians have different perspective different comfortability levels. I just want to reiterate that what we're really looking at is is prior authorization, helping people in their treatment path or is it an additional barrier that may ultimately be bridging people from receiving treatment and putting a lot of time on to providers for what costs other than other than controlling costs between payers, which may be important. And so I actually what I would like to ask as well is that one thing that I don't think you mentioned Dr. Closter is that you mentioned to me prior is that you're on the clinical utilization review board. And I'm wondering if these are some of the considerations that you've taken into account. As you create recommendations. Yeah, you know absolutely on the clinical utilization review board or curb as we refer to it. So prior authorization process and the sort of, you know, necessity or lack of necessity of it often comes up. And again, as you were saying, you know, in many cases, you know, most physicians are responsible and you find that if you're requiring prior authorizations and you're proving 100% of them, then really what is the point of doing those. I think in the case of a lot of I don't know if any of the research is specific to prior authorizations around opiate disorder. Typically we're talking about a lot of ranges of medications and treatment choices in those regards. It is for MIT. It is for MIT specifically tried to interrupt. Okay, yeah. I think what Representative Whitman is trying to, to perhaps ascertain is that we really appreciate or he really appreciates we all do have your information and, and as you, as you are aware, we have heard some supporting this and some, some, and some physicians and provide medical providers having a different perspective. And so, we're back to the, let's explore, let's be curious. And so setting up and so that's part of what he is getting at that that's, we have heard and we're not the body to decide for what is best medical practice, but we can ask the respective groups to be curious and to look at the multitude of experiences because I mean I will say for me I was surprised to hear that several of the private insurers do not have this. As they testified to us and so I'm going. Okay, then if the issue you know what is the difference, what is the difference and if the difference bottom line is the 17 to 35 million, then that's a different order of policy choice. So, we're not asking anyone today to, to make that decision, but to help inform us as what will be the kinds of questions to ask in this report back. Yeah, but I think to that mean one of my concerns is that there are a lot more providers in the moud world these days, and they're great number of them who are not following clinical practice, the best practices. And for that reason I think prior authorization might be useful to continue. Thank you. Thank you for that we have a question from representative Rosenquist. Thank you. Thank you, Dr. cluster. I was a little confused as to what's the length of time like a pre authorization. Is that good for just a one prescription or is it good for a period of time. Yeah, I said those are typically good for at least one year. One year. So you just have to get free authorization once a year. Right. That's right. Let me double check on that because for a lot of medications with the continued use of prescription is not required. But I do believe though for the super northern prior authorizations that we do wind up completing those once a year. Okay. Thank you. We have a couple of questions then I am very aware of your time and of the time of the two other medical professionals. So we've got a question from a question from representative small and then the final question from representative Whitman. No, I'm good. Oh, you're good. I get the final questions. I'll do to them. Thank you, Dr. cluster for being here with us this morning to build on representative Rosenquist question. If there was a change in dosage for the patient. Would that require a new prior authorization. If it's a 16 milligrams or lower no. If it's above the 16 milligrams yes. And there's a difference if you're in a hub versus a spoke if you're in a hub at the threshold of 16 milligrams and in the spoke I believe it is 24 or sorry I put the other way around. 24. Okay. And I just really understanding that physicians are approaching this very differently and hearing your approach with the mono buprenorphine product, I, I would just like to know what what that process would look like if you were to prescribe a mono buprenorphine. What steps would a patient have to go through in order to say, prove that the mono buprenorphine product was best for them. Well, so first of all, in worst case scenario, let's say what they were in the office for induction and had a serious reaction to it. You know, epinephrine boom and a story we go to the mono product, you know, then that relatively rare event. Otherwise is typically hearing reports that you know I have a rash or you know I have swelling, in which case then we have the committee office and we witness and document these things and then to go to bat to get the mono product or do a different product But in a way I mean, again, it's an unpalatable aspect of doing this work, but quite often it's a seeing as believing process. So, just, just to clarify, a patient would have to be prescribed the suboxone, and you would have to witness the serious reaction to then be able to prescribe a mono buprenorphine product. Right that would be the process for someone who is a naive to these medications. Otherwise, you know there might be a track record in which case before we start prescribing we can gather information from the previous prescribers about what they've documented as far as reactions to these products. And that sounds a lot like the med watch form is that is that still the form that that you would be using for that or is it just a similar process. It would just the med watch form was better case he's requiring that in October of 2020. And I'm talking about just sort of doing my diligence as I shall always do if somebody's transferring to a program or has left the program is coming to me. I want to know what happened before it's part of the history gathering so that we can put together a plan that will match their needs. Absolutely thank you Dr cluster. Thank you. Thank you so much. I won't ask us all to get an MD degree after your testimony but it's been really very very helpful and hold on representative McFawn I had said that the last question was from as you have a question. It's quick. I had said that we were finished. Here I realize that I do not have a question. What I would like to do from now on when a doctor comes in here and tells us stuff that we don't try to convince that doctor of something else. And the other thing is that I'm sure you have the right to ask as many questions as you want. And I respect that but you took up a lot of time and you have done it on this bill and and then to put a clamp on other people that want to ask questions. I realize the other doctors are waiting but let's let's be a little bit fear. Most of these questions are being asked by the same people. So that's all I have to say. I do not have a question. Thank you. Okay. Thank you. Thank you represent McFawn and appreciate your comments. I don't believe that there were other questions from the people who did not ask them today. But thank you. And again thank you. Dr. Hussner I appreciate the time and I hope you don't mind my teasing you about us getting an MD degree. No, I was hoping to do sort of you know med school one on one here as well so I appreciate I take that as a compliment. Yes, yes. And I particularly like the fact that you provided us with what I would call the cliff notes that are on our so that we can refer them. So thank you. Thank you very much. And if you thank you as well. I appreciate the opportunity today. Thank you. And committee. Dr. Conger if you would please come and you get to sit in the witness seat right here. Welcome. Welcome. Thank you and a committee. I also believe that Dr. Conger has posted as some written remarks that are on our web page as well, but I won't start by asking you to make your remarks. And then we'll probably ask you lots of questions. Um, try to get our arms around this. So first, it's, as you well know, there are basically two camps with respect to the prior authorization issue, and the issue particularly of whether mono people in orphaned or people in orphaned with naloxone should be restricted. I would only mention in passing a reference to Dr. Judge Katanji Jackson Brown, who talked about the fact that all of us have hidden biases. And I think that that's an important thing to understand even though we are professionals and we act professional. We often bring with us hidden biases about how people behave when they have an opioid use disorder. And in my experience that is a very important consideration. It's so my primary goal in treating people as you're going to discover I am not against prescribing monobu, but my primary goal in treating people is to keep them in treatment and to make sure they don't die. I've had one person die in the last seven years. And I feel very badly about that. I'm willing to accept the fact that I don't control behaviors outside of my office which represents a very limited part of the time that a person is on this planet. And I'm willing to accept the fact that the way in which I recommend they take medications doesn't necessarily happen. So that's my bias. I've been in Vermont for 45 years, and for the last seven years, I've been a waivered position to prescribe even working products. I have treated about 230 patients, 80% of them are still in treatment after an average of six years and I think it's very important to understand that if somebody goes to a given practitioner, to get the medication that person feels they need, they're going to do what all of us do. They're going to go somewhere else. And so my goal is to avoid that to try and keep them in treatment with me. And that may mean that I have to change the kind of prescription that is not necessarily based on medical science, excuse me. Refer, before going, I'm not going to go into pharmacology, I'm going to refer to a physician by the name of Ivan Pavlov. I don't know how many of you are familiar with him. He did research several hundred years ago and in Russia about behaviors. Okay, and is it with dogs? This is, okay. Yes, the bottom line. So think about Pavlov when you think about the way people react to medication. If somebody thinks that the medication they're going to take will make them sick, that person is not going to take it and it doesn't matter what the bioavailability is and what the pharma dynamics are. That's probably the fact of seeing that medication. And remember, you have to put it in your mouth and keep it there for five minutes. And if you think it's going to make you sick, it will. And so people, yeah, sorry. I apologize. I have to make a technical announcement because we are on YouTube and some people are having problems with the YouTube broadcast. They can't hear us, but they can't see us. And if they would like to see us, if they go on their internet and go on the legislative webpage to the Human Services Committee. Is it documents? Under documents for today, Wednesday, under Julie Tucker's name is the link. So you should be able to click there and get it. And so, again, if you're having trouble seeing it, please go to our committee webpage. And under Wednesday today, click on Julie Tucker's name and you will be able to get the video. I apologize. As part as open meeting, we need to make sure that folks can see this. Sorry to interrupt. No problem. People that are around me all the time. So I would mention. So you have some perspective on my practice. About 45% of my patients have required a prior authorization for their treatment. I have never been denied. My main is a nuisance that serves no clinical purpose, but it's one that I'm accustomed to and I'm able to get through without much difficulty. I'm concerned solely about the stress that places on the people I serve when the prior authorization doesn't come through as expeditiously as you asked about not address that more specifically with respect to the three types of prior authorization. Maybe I should discuss that now. This is the dose limitation, which means that I am restricted to 16 milligrams dr cluster can prescribe 24 milligrams. The, all of us take have the same training in the prescription of the open orphan. And if I went to practice in a hub, I would be able to prescribe 24 milligrams it makes no clinical sense to have this separation of powers and 24 milligrams is an FDA approved dose. I think that the prior authorization should be lifted to 24 milligrams for all positions, regardless. The DEA does a very good job of monitoring whether or not position practices are appropriate. I don't think prior authorization prevents that. The problem I have is that it's much easier to request a prior authorization in advance. I always tell my patients, if you think you need to change the dose, call me patients all have my cell phone, and we'll talk about it and I can put in the prior authorization the day ahead of time so that's planning, and it's a mild nuisance and we can always it's never died, because the reason I asked for it is because the current dose is not effective in maintaining them in treatment and that to me is the key goal. About 28% of my patients are on model view. All of those patients basically have been willing in the past to buy it on the street at a higher price, because when they see or think about the people in our final product it makes them sick. They have documented reactions but most of them have reactions that are conditioned behavior, and they just refuse to take it so what's going to happen I one patient, for example, who had not even asked me about a prior authorization, and she kept trying to take the people off an eloxone product. It made her sick. And she continued to use opiates. And we had final discussion. Well it turned out she was swallowing it. I think you may have heard from some of the testimony. If you swallow a subliminal tablet you get no effect. But that was the only way she could avoid feeling sick, which he had that thing in her mouth for five minutes. That's just one example of the kind of problem that occurs. When you tell someone, you can't have that product that someone else had. So, I generally speaking will approve a request for mono view in a person who is otherwise stable treatment, accepting that it is more likely that those drugs are misused and people are thinking but both were misused. In fact, there are plenty of medications misused which do not require prior authorization. Opiates and opioids do not require prior authorization, stimulants do not require prior authorization. And in fact, fentanyl and heroin don't even require prescriptions. So the idea that you can prevent misuse by restricting the use of prescription product to me is fallacious. The, the biggest issue with prior authorization is the one that can't be done in advance. And that is the person who needs the annual renewal. And the way that person so a patient goes to the pharmacy, they have a prescription for me. It's got several refills on it. They go to pick up their refill the pharmacy then sends in the request to cover my meds to prior authorization. And it's denied because the prior authorization annual expiration date was yesterday. It's four o'clock in the afternoon. It may be a Sunday. So what is the patient going to do now if they belong to an ordinary practice they're going to have to call the practice to get a prior authorization submitted. They may or may not be able to get in touch with someone they can always get in touch with me. But I can't always get the prior authorization request in right away. So then the renewal has to be submitted that same one page for it is always approved. It's approved. It's approved quickly. But that's not the, that's not the crucial delay, the crucial delay is and then the pharmacist has to resubmit the application to the pharmacy. So the chance that that's all going to happen on the same day is low, unless the person has to come in let's say at eight o'clock in the morning on a weekday. And that's never when it happens. If a drug has been approved for use, there's no clinical reason that it should be renewed every year. I think that is, if I could only get rid of one of the prior authorizations that would be it because all the others I can anticipate in advance, and they're always approved. The process is not really very difficult. It's the one page form is Dr. cluster indicated. I put down my reasons for requesting it and it's always approved. So when you're doing that in advance, it's not a big nuisance, but it's always approved. So it doesn't really change anything. It helps me establish a better clinical relationship with the patient. And the key as I say is that my patients have stayed in treatment for many years. Very few of them have wound up using opiates. The most common misuse for people who are being treated for overuse disorder are not opiates. Okay. So I think that's the main benzodiazepines because even if they are using as some other form or even if they're sharing it or selling it, they're still using it and that to me is the key. In fact, there was a study in Sweden that showed that 80% of people on buprenorphine shared their medications, but it wasn't only buprenorphine it was penicillin. It was an anti anxiety medicine was a stomach medicine. I'm not going to ask around the table, but everybody does this. We are all our own pharmacologists, we are all our own doctors, once we're out of the office. So the illusion that we are somehow controlling behavior by prior authorization is simply that. And that's the reason that I find it to be undesirable as I say if I can only do one thing will be get rid of the annual renewal. Because if at least then, I can plan this in advance. I know how to do this I know what I need to write down, and it's approved it Dr cluster is correct and being concerned that maybe people aren't following clinical guidelines, but that has nothing to do with prior approval. That's really a management issue for the drug enforcement administration, and maybe for medical review boards to look at doctors practices or respect is worth practicing. The prior authorization is not addressed that what they look at as a one page piece of paper. They don't know what I'm actually doing they don't know what I've said is true. So it just doesn't solve the problem. I'll leave my speech at that and then answer any questions. Thank you. Thank you very much. Let me ask representative McFawn, do you have any questions. I can't hear you. Yes, Madam Chair, I do. I have one question. Thank you very much for that information doctor. My question is this how many of your patients. What percentage of your patients. Use more than 16 milligrams. 27% I'm sorry sir. 27%. Thank you. Thank you. I'm wondering if you treat any patients who are on private insurance. I'm wondering if you treat any patients who are on private insurance and are not. Yes, yes. I mean, I work at the committee health center in Burlington. The overwhelming majority of my patients either have no insurance, in which case ironically, they go to our pharmacy and they pay $30 a month for their people in orphaned mono product, which is cheaper. But I do have some patients with private insurance. They're much easier. They don't I don't read. They don't usually Medicare requires some prior authorizations, their preferred drug is different from Medicaid, which is big nuisance. Somebody switches from Medicaid to Medicare and all of a sudden, I don't know if you're familiar with the names, when they were getting suboxone now they have to get a subsoil. And they don't like it tastes different. People who've started on subsoil like it better because it tastes better, but they're not used to it. So you have to go through a few hoops to judge that, but with blue cross blue shield or MVP prior organization is not usually required, regardless of the product. Thank you. And so if you pay cash, there's no prior authorization. That's correct. I have some, I have some patients who initially said I'd rather pay cash for my, for my mono view, then wait for the prior authorization I said it shouldn't take that long but if you want I'll give you a prescription for a few days until we get it covered. Okay, I'm sorry. Yeah, again on the annual pre authorization. So let's say we did away with that. Okay. And a patient comes to the pharmacist and lays down the prescription how long is that prescription good for. Is it renewed? There are restrictions on the amount of renewals you can do on controlled substances which vary by the substance and I don't have any objection with those. For example, if you prescribe a full opiate, like oxycodone, you cannot have a prescription. If you prescribe, you may not, I'm sorry, you may not have a renewal. Okay, those are not or if you prescribe a stimulant. If you prescribe a metamine or a vivance, any of those drugs, you cannot, you cannot have a renewal. With buprenorphine products, you can have up to three refills. You can have depending upon the dose, you can either get a two week supply or a four week supply. I wish that that were eliminated but that's not the biggest issue. So I will patients who are unstable maybe getting I have some people who in the beginning maybe getting two or three days at a time and I want to speak to them or see them. Maybe a week or two weeks but somebody is doing very well. We'll get a four week prescription with two refills so a total of three months. So that's the longest period of time that I would renew a prescription a stable patient be three months. If it's going to be if they're limited to a two week prescription it's two months. That would be the potential danger of getting rid of the annual free authorization because somebody could continue to get the drug. No, the limit on the, there's no prior authorization for how many refills a person's allowed. Okay, so the number of refills I put on the prescription is unaffected by prior authorization. I can put in up to three refills on any product. It's going to be affected. And obviously, it doesn't come up for for a product that, well, it doesn't go for a product that doesn't require. It doesn't have refills on it. But that's just for the patient convenience. You have a clarifying question from Matt then so when you do a prior off, you get approval and you can keep doing refills under that prior off for one year. And at the end of that year you have to go through the process again and what you were saying earlier than is that unfortunately when you have to wait until it's out before you can do the prior. You have to a matter of fact, I am because of this issue, which is a big problem. And as I told you I have a large number of patients who require for other issues I keep a separate database. And I put down when the prior authorization is due, and I check it, and I try and anticipate if I know several days in advance, then I can do that and it's not a problem. I'm not going to do that now that's, I don't think I should have to do that. I do it because it saves a lot of aggravation on the part of my patients there's no extra work for me because prior authorization renewal just says, please renew the medicines. I don't put any justification, they say okay. So, let's say let's take the, if I have a medicine that requires prior authorization let's say no on 20 milligrams of buprenorphine, buprenorphine naloxone. When I submit the prior approval renewal, I just say request renewal of current prior authorization, and I don't have to put the reasons in again, they don't say well is it time to lower the dose, you want to change the product they just approve it and it takes what half an hour, but it has to get to them, that's the problem. It has to go from there to back to. And then the pharmacy and then you know there's this other step. So, I don't know if any of you have ever been to a pharmacy. But these days it's not a pleasant experience and if someone said, you know some pharmacists you can do an override but some say I'm not going to do that. And some of them have a really unpleasant relationship this is, you know, our patients have a big problem with trust, and pharmacies are not often the place where that is enhanced, shall we say. So, once it's been approved the pharmacy that has to resubmit the application. And they have to be around when it comes back. If they have a line of people waiting to get things done. So that half hour window is almost meaningless in terms of the total delay in the process. I can totally relate. I've seen that happen in the pharmacy to someone who was young in front of me. Yeah, yeah, amazing how differently they're true. And of course this is not restricted, the prioritization problem is not restricted to the opiate use disorder treatment medicines. But it's it can be a nuisance for anyone who thinks that they have a legitimate refill and it turns out oops. But the pharmacist is for some obscure reason. Let's say you are being treated with a prioritization drug or rheumatoid arthritis which is very expensive. The pharmacists are much more willing to give out a three day override on that they are for people in our case I just mystifies me. Thank you so much for being here today I think what I've heard a lot through your testimony is is the care for your patients and trying to make this a seamless process even though it seems to be overly complicated in some areas. I've had it in a in a different light. I would love to know I don't know if you prescribe opioids, but what the process is on Medicaid, if we're in the opposite direction and someone is experiencing pain are there prior authorizations for opiates. Not most of it depends upon the dose. For example, oxycodone hydro morphone diluted even methadone does not require a prior authorization unless you get above. I'm not sure because I don't use it very much but let's say, I know to 40 milligrams does not require prioritization. So, a single prescription for a full opioid does not require prior authorization by a large. Now, some of them may be an exception to that. Some of that is related to cost, but fentanyl is perhaps the one exception. That's usually a really required that they use some other opioid before that. The irony is that if people who died of overdoses with fentanyl, they've all used some other opioid before that also. But generally speaking, no. I think it's true for stimulus. You don't require prior authorization for that. I'm concerned to hear that it's easier to prescribe the prescriptions that are causing these long term issues, rather than the treatment there is a certain iron to that I should also mention. In order to prescribe the appropriate provider has to take a course. It's a very good course. In order to prescribe a full opiate the prescriber doesn't have to do that. We need to have any special training to prescribe the drugs for which we need to provide the treatment with buprenorphic. And that's that was the big problem that occurred. 20 years ago, if you want to know more details on that you should read my book. Which is available at Bear Pond. Thank you. You just review again you said there were three types of prior authorization one of them being the annual renewal. Right. And what were the other two, the other two are a dose between 16 and 24 milligrams. And the prescription of mono view, as opposed to people are vanilla, which are quite a bit testimony. I find it. I don't find that to be clinically useful. I mean, it's a bit of a nuisance it doesn't bother me much because I know what I need to write and I only only do that when I think it's a good idea and it's always approved. And that's always ahead of time so that one is not although it's is the one that is bruises the most anxiety among patients is the easiest one to forestall. I should say. Exactly. Yeah, and it's not it's really it's not an act of Congress, I mean it's takes me about five minutes. I have my letter already written just put the name on it. Thank you. Dr, we have. We have been persuaded or we have come to in terms of where we are and in part of this discussion to realize that we are not at a place where working with the administration. Wayne, I mean you were here when the different as you said the different camps or the different perspectives on this. So we are going to be asking for information or a report back. So what would be the questions that you think we should be that that would help help us. Okay, so let's take the three categories. The first one which I think, in many respects is the easiest is why should a practitioner have a different restriction on the dose of you can argue based on where that person is practicing, rather than a person's experience. Now, the feds for example, limit the number of patients you can treat based on your number years of experience, but they don't have any limit on the dose. So, I would ask, why am I restricted to 16 milligrams a doctor closer to 24. So that addresses the first issue. The third one, the second issue is why an annual renewal is needed for chronic medication. The same could be true if somebody's taking a very expensive medicine for diabetes. It's a chronic treatment of a chronic disease or hypertension there are medicines that are very expensive and require prior ruble. The annual renewal of a chronic medicine that is not expected to change doesn't make any sense to me. So you say why, why is that necessary. And then the third one is the prior authorization for people in our canal oxone which is the most controversial. You've heard my bias on it you've heard Dr clusters bias on it. So I had to pick one thing to change over the annual renewal. And the second one would be the 16 to 24 that's going to cover a lot of ground. I'm willing to go through jump through the hoops, but the problem is it's pointless, because it always gets approved I mean even now, I think 81% in the last year of the prior authorizations for people in our canal oxone were approved in that legislative report. So it's, it always gets proved. It seems to me it's creating an unnecessary bureaucracy that doesn't really solve any purpose. And I would say, if most of them are proved what's the point. Better understand the third one you talked about which claims the most troublesome one, apparently, and that's when somebody is moving from the locks on to the view, right. Correct. Is that correct. That's correct. The combination medicine, they're getting off that and going to the view. Anytime that happens, they need a prior author. That's correct. Even if there was a prior author, I mean Daniel authorizations. Well, if they were. If they had a prior, if they had a prior authorization for some, you know, let's say for 18 milligrams, then it would be a new prior authorization to change the product. If they had a prior authorization, sometimes what happens is a person is on Buprenorphine. In fact, in prison, everybody gets subutex. It's mono mono sorry Buprenorphine products, it's cheaper for the prisons, it were it dissolves more rapidly. And if I won't go into the details of how easy it is to misuse things in prison, but that's what they prescribe. So I have patients who were on Suboxone or incarcerated, they were switched to mono view, and they get out. And they're given one day prescription, sometimes. And now they come to me, and they want to get back their medication. And the fact that they were getting it in prison didn't require prior authorization so I have to submit that, or they may have taken it in the past, but if they have if it's if the prior authorization has expired, it's more than a year. Then it has to be no regardless, but just has to be done. Thank you. You might bring someone in from the Department of Corrections and ask them how they made that decision about model view. And that's what their concerns were. Thank you. I want to I'm looking around the table and on video. On the screen, does anyone have any further questions for Dr. Conjure. If everyone's done with their questions, I have some final comment. Okay. I'm checking and making sure. No more questions. I just make a statement. Okay. And I'm not opposed. I'm very open to considering things, but if 81% of prior authorizations are approved, that is the majority, but that still means one in five. It's not approved. Correct. I'd like to, you know, know why. Because I don't have that information. I know you know, but I can tell you one thing. I would guess, I mean, occasionally a, I've noticed, you know, who, who makes a decision about the prior authorization. It's basically that person being a judge. It may affect what that person ever breakfast. I don't know their mood. I've noticed that sometimes my initial request will be denied. And I submit further information as a fruit. So it would be if you really want to know about that 19%. You would want to know how many were ultimately approved for some of them that simply denied and then reapplied. And it's possible that those people who submit requests, didn't bother to put in a documentation necessary, which is what I would suspect it's, you know, if your, if your view is that it's a nuisance and you're a provider unfortunately, you may just not care. And if you don't care, you say, okay, I'll submit the prior organization, but I don't really care if it gets approved or not. I just don't put enough reason. I mean, the reason I usually put in is that this person's at risk for stopping treatment or for resuming opioids and invariably that's approved. They don't want that to happen. We don't, none of us wanted to have a patient. Thank you. And we have, Dr, we have another comment. And this is not at all this. Truly, I just wanted first of all to thank you for how, how you have your own system so you can know the prior approval ahead of time. I mean, there's just so many things that you said today that was a learning experience for me as well as just a caring experience. But I also wanted to say that I love how you started explaining about your bias and I always, my husband is a physician and he always starts every speech with his bias and I'm saying why Why do you do that? No one cares. You explained it perfectly. And in an example that made a lot of sense and I can see now why physicians often do that. And then the other part was the path flow. That's another thing that he quotes all the time. And then finally, your tie. I love that you work. You know, it's just perfect for them building and I This is the first time I've worn a tie in three years. Told me I had to wear a tie. Always do what she says. Tell her we noticed. It'll be on YouTube. Unfortunately, I don't know how much they see you. I know. I spent two years at the CDC, which influenced substantially my recognition of the issue of selection bias at all kinds of biases. Does your husband have an epidemiological training. He has some but he's also in an administrative. It's unfortunate that most of us. Who purport to be scientists don't recognize that issue, but also that's a subject for another year. Thank you so much. Thank you. My pleasure. You guys are doing good work. And now we have Jacqueline Bray who was a nurse practitioner from safe recovery. Jackie, welcome. Good morning, everybody. Thank you for having me. Can you hear me? Okay. We can. Okay. Yeah, so thank you for having me this morning. I'm a nurse practitioner currently working as if you've been working for Striper with in Howard Center. So I work at the low barrier. Program in Burlington at the club safe recovery. And then I also practice and see patients out of an office in St. And so I'm going to be referencing some notes reading, reading some things just apologize for looking back and forth. But basically, you know, in my experience, the prior authorization process required. Is creating some unnecessary roadblocks that prevent patients from receiving the care that they deserve. And I have been finding myself. Tailoring my prescribing practices to what my patients can access the easiest and quickest and this often doesn't align with what is a best practice or the best plan or even what is evidence based. And so the first part I wanted to speak to was in regards to the PAs required for prescribing doses greater than 16 milligrams. And this, you know, kind of the thought of what an optimal or adequate dose of the box on it for someone is first based on some older data that are that were kind of created based on studies of looking at people who were mainly using heroin. And this idea that the opiate receptors are mostly blocked at 16 milligrams and anything above that is not having an effect is a little outdated. For example, you know, one of the guidelines that's out there is if you have a patient coming in reporting that they're using about 10 bags of heroin a day, an optimal dose that's recommended for them would be the 16 milligrams. Generally, right now, most patients are not using just heroin, the drug supply is contaminated with fentanyl, which is much more potent and stronger than heroin and so it makes sense that potentially we're seeing people who need increased doses of the box. In general, the response to treatment varies widely among patients just like with any medication, you have different responses based on somebody's metabolism and other lifestyle factors. And so we should really be titrating someone's dose based on the clinical response and the restrictions that the TA places may impede providers ability to do this. And furthermore, one of the most important pieces is is the barrier that this creates for their patients and so much of the population that I serve are homeless they have limited or no access to transportation. And so typically they rely on one ride to bring them to the office to the visit, and that same ride takes them to the pharmacy directly after their appointment to pick up the medication. Often patients are telling me they don't have time to wait for the paperwork to be approved if it's, you know, even if it's a half an hour, that's a half an hour that their ride isn't willing to wait. So they may make the decision to delay increasing the dose until the next visit. And if this is the case. It increases the risk that they may use illicit substances because their dose is inadequate and subsequently be at higher risk for overdose. In regards to the med watch form. Again, medication adherence is vital to a person's success in a mat treatment program that the medication is not going to work as a patient is not going to take it. You know, yes, there are the risk of diversion is out there but as you know I think we've heard that is something that we can't necessarily always control and the reason that the street value is so high for beef and orcine is because it is not as available or readily accessible. And unfortunately there are some adverse effects that patients experience from the combo product beyond sort of what would be acceptable for another medication as a side effect. And that makes the medication intolerable and patients ultimately don't appear to the medication regimen. So for all, I won't say all but from most other meds, you will be able to go into your provider's office and say, look I've been taking this formulation it's making me really nauseous it's not going away I've tried other remedies and supportive care and the nausea is just not worth it to me I'm not going to take the medication and as a provider we would be able to be able to document that and the clinical record and switch to a formulation. That's not the case with the mono view. First, most of the time, patients have to demonstrate pretty much a life threatening severe reaction to the medication, and which requires them to come into the office and take a medication that we know they may have an adverse, adverse reaction to. Which is not something that I think is, you know, necessarily humane to ask a patient to continue taking a medication that they, they need, but puts them at other health risks. They have had patients drop out of treatment, because they have found that they can more easily access the mono product off of the street. And that is, again, easier and more rapid than waiting for waiting to go through that whole med watch process. Coming into treatment, which is, you know, one of the time that most people are, are, you know, one of their most vulnerable states. And anecdotally, again, as Dr. Congress said, not a lot of this is always based on science and the data, but anecdotally, most patients find that the transition from illicit substances to a maintenance therapy is a little bit easier with the mono product. And so, whether that's a placebo effect or not is something that they're more willing to do. And so I, you know, the safe recovery program is embedded in a syringe service program so I often see patients who are regularly accessing a syringe exchange. They want to start treatment, but have shared that they are a little ambivalent or will be more ready to engage if they could more easily start with the mono product. The fear of precipitated withdrawal with the suboxone is a deterrent. And again, whether that is perceived by the patients are actually real, I think it's, you know, perspective here is what matters. And just, you know, in another piece, kind of to bounce off of Dr. Congress that the fact that people are prescribed the mono product and whether incarcerated. We also know that when they're released from incarceration, that is a very high risk time for someone to return to use. And because of that absence from use, they're at much higher risk for overdose. And so by in transitioning to a medication, a different medication can be destabilizing. And so the fact that they're required to do that, again, just add to that risk. So in closing, I just, you know, some may argue that the PAs are approved quickly and within a few hours. However, from my experience, the patients that I serve are really in survival mode. They're living their lives minute to minute, sometimes, you know, just to stay alive. And to approve paperwork is too long for some to wait, and exponentially increases their chance of either not engaging in treatment to begin with, dropping out of a treatment program, or resorting to more rapidly accessible street substances, which ultimately increases their risk for overdose and death. Thank you. And thank you for the job that you do. The three of you who are testified today are I think really practicing in a very difficult and challenging area, especially now. So thank you for that. Question, yes. Jackie, thank you for being here this morning. I just want to ask you the same question that we finished with Dr. Cunger on and if you were looking at being in our role, what would be the questions that we would need additional answers for as we look to the Drug Utilization Board to assist us with further information. I'm hoping to improve outcomes for people. Yeah, I think this may be kind of a one of the more challenging questions to answer but I think if, you know, overall looking at what is driving the utility of the prior authorization process and how, how much of our stigma bias in regards to looking at behaviors and engagement and response and treatment for those who individuals who misuse substances is playing a role here. Because again, you know, like I said, any other any other medication, this process isn't there. And I think the prescribed, but it's also not to say that prescribers can't continue to have clinical discussion and limiting doses or having other preventative ways to create diversion, to prevent diversion. So how is this prior authorization process really? What is the, what is the underlying purpose of it that we can't achieve in other ways in that, in the clinical setting? Thank you. I am looking around the room and I am looking on screen for, represent Rosenquist. On the primary reason would appear going from the combo drugs to the human treatment, it would seem that the trying to control cost is the primary reason that that exists to appear like to me. And yet we've heard from others that the majority of those are ultimately approved. Anyway, what would it, would there be an increase in the movement to the product you think if there was a prior authorization? I don't actually, just because I think it, you know, from the DEA perspective and regulatory boards, you know, buprenorphine is still seen as more easily divertible. And for that reason, I think as a prescriber, I would, you know, still do my due diligence to make sure that I'm prescribing the medication because that's the one that's, you know, really indicated in the one that the person is going to adhere to taking. And that would still be cautious, but would still have those kind of that baseline of, you know, that's not, that's not going to be the one that I start with necessarily. I think the rule of thumb and the general practice guidelines or that Suboxone is the preferred medication and that it would be independent practitioner, making sure that they're doing their due diligence to make sure that if they are prescribing the medication for the correct reason. Thank you. Thank you. Thank you, Jackie. I'm again going to represent Whitman. Yeah, thank you Madam Chair, and thank you Jackie for being here today and for all the work that you do. I just wanted to follow up on one comment that you made. You said that you have had patients that have dropped out of treatment due to some of the barriers and that it may be more easily accessible. On the street, and we haven't had the opportunity to hear directly from people who have engaged in treatment I was wondering if you could just provide some of the perspectives that you believe. You know that I've led you to believe this some of the things that you've heard from patients. Yeah, of course, so they're, you know, I think they're as someone who prescribed this medication the pharmacology of kind of the Noxium component and component and the absorption can be confusing. And so I think that exists in the in the community as well. And so, again, whether there are a lot of patients who have that perception that starting on the mono product or buprenorphine is going to make the transition a little bit easier. I thought that because the box zone has no lock zone in it it will cause them to have precipitated withdrawal. Again, this is not thought to be the case as no lock zone isn't always absorbed systemically but there are again, I think some people who may absorb more of it than others and are at higher risk for that precipitated withdrawal. And we know in the hub setting that when someone is transitioning from methadone to suboxone, they do a bridge of buprenorphine. So basically, somebody has to titrate down their methadone, and then they go a few days without any medication, then they start the mono product, and then they switch to suboxone. So, and I have patients who have that experience as well. And with the pregnant people, it used to be recommended that people who were pregnant were automatically switch to the buprenorphine. And so there is, because of those practices that we have that have been out there and we still are continuing, there remains this idea in the community that the buprenorphine is the more favorable product in terms of side effects and transitioning to maintenance therapy of being like a smoother process. And so when patients are coming, thinking about coming into treatment, or are in treatment and have had a episode where they return to use and are looking to get back on medication. If they're not able to easily access the mono product, they have said, well, I'm going to do this on my own on the street with the buprenorphine, and then maybe I'll come back to you for treatment, but I'm not going to do the med watch form and wait for all the paperwork to go through. Most often when people present for treatment, they're ready to start that day and we need to be able to optimize that moment and meet them where they're at. Thank you. Thank you. Again, I want to do a check around the room and on the screen. Are there any final comments or questions? Thank you. Thank you very much Jackie for taking your time and again for adding your voice and what your experience to our discussion as we try to figure out what policies to do. So thank you. Yeah, thank you for having me and hearing my, hearing my perspective and thank you for all the work that you do. I'm going to take a pause, a break until 1045. And when we come back at 1045, we will be talking about what we've heard in terms of the amendment that Dan is proposing related to getting information. So we iterate, taken by the Appropriations Committee, and, and we agreed have withdrawn, you know, the first four, the first four parts of those parts of the original bill that related to doing away with preauthorization, and we said we are going towards going to a getting a more information perspective. And so we're going to talk about that. And I understand that someone from Diva will be able to join us maybe at 11. But they've gotten copies of any sort of random thoughts we've had in writing. So they know where we're going.