That was great. Our next speaker is Daniel Blaney-Cohen, who's not an M.D. and is going to tell us how to keep ourselves out of trouble. Thank you. I'm not an M.D. I'm not going to tell you how to keep yourself out of trouble, but I will talk about many of the ways that you can possibly get into trouble. I will try to, I'm with the American Medical Association, I'm one of the lawyers in our State Advocacy and State Legislative Affairs unit. The staff lead for the Amazopioid Task Force, of which I'm an AANS, and the Congress is a part of. I don't think they are here today, but Dr. Jennifer Sweet and Katie Urico, who I'm guessing most of you probably know, have been wonderful for the ... just the mouse ... for that. That's why the title is there, but I am going to focus on the legal implications of opioid policy and the clinician. If I look down, I just want to make sure that I stay on time. One of the things that I will not discuss ... I will not discuss sea snails, but sea snails sound awesome, and I am going to use sea snails in all of my future presentations. One of the things that I also want to emphasize ... let's see, how do we move forward? There we go. I want to focus on a couple of things, and I'm going to bounce back and forth between them, because as we heard, there is ... Dr. Follett noted, there's a lot of intersections and overlap and bypasses and all of that. This is going to be no different, but I want to talk about the data, and you're going to see some of the same slides, but I'm going to approach it a little bit differently. Like you, but in different ways, lawyers like evidence. I like evidence. I like policy makers to use evidence. Wouldn't we all? And I all will talk about the chaos in the legal policy landscape, and also, it was great to hear Dr. Follett talk about optimism. I'm optimistic primarily because of what's happening here. It's pretty close. I, walking through the exhibit hall, understood absolutely nothing, but knew that you did, and so when you have medical professionals ... I've worked for the AMA for about 20 years. I love representing physicians on the legal and policy front, so it's truly a pleasure to be here and to provide, hopefully, some helpful information. We saw this slide before, but I want to talk about it a little bit differently. Death expectancy is going down, but I want to talk about how this slide is affecting the state policy landscape, and sort of what you saw in the 2014, 2015, 2016 state legislative sessions in the last couple of years in the federal landscape is a massive increase in new policy, massive state legislative increases, literally hundreds of new laws. I'm not joking. I'm going to exaggerate at points during this presentation. I'm prone to exaggerate when it suits my purposes. Remember, I'm a lawyer. I'll try to identify and be transparent about when I'm exaggerating, and so you actually know that. We call that puffery because we don't like to say we exaggerate, but I want to talk about how this is playing out. Some of the things that you've probably seen about, there are about 400 individual suits going on against pharmaceutical manufacturers that have been consolidated in the Northern District of Ohio. We'll see how that's going to play out. May 10th, just next week, there's going to be a settlement conference. We'll see there are more than 40 state attorneys general who have asked for information from pharmaceutical manufacturers and distributors. AGs like to get information, and they get unhappy when they don't get it, so expect to see more legal action there. There are criminal cases against some of your colleagues across the country, and pharmacists and pharmacies expect that to continue, primarily because there are some things like an opioid task force from our current attorney general, and there are assistant U.S. attorneys in, I think, about 40 different states that have been designated as parts of those task forces, and one of the things that 48 state attorneys general are doing is sharing information with the Department of Justice, including information from the Prescription Drug Monitoring Program in your state. I'll talk about PDMPs a little bit more, the legal and policy implications about them, but keep in mind that the information, as PDMPs get better, and this is a crazy contradiction, right? As PDMPs get better, they provide you with more helpful information about the controlled prescribing history of your patients, but as they get better, how much are law enforcement actually accessing them? And this is really confusing to me, because I read the statutes. The statutes generally have strong protections against law enforcement, you know, going fishing. Sorry about that. And they can't go just generally looking for anything, but in this current environment, we're extremely concerned. We're talking to all of our state medical societies about the concern of fishing expeditions. I don't have time to go into other legal cases, but there are a couple of legal cases in California and in the Ninth Circuit in Oregon. See, I can't say sea snails are half the words that were said today, but I can say Ninth Circuit, and it sounds impressive, or maybe not, but keep in mind that there are legal cases that transcend the country and that give law enforcement pretty significant access to prescription drug mounting programs. These are big deals. So want to keep in mind that as these are going up, the pressure, the legal implications of this, the pressure on the federal government, the pressure on state legislators, literally hundreds of new laws, that's not an exaggeration, have been enacted. How are those going to be enforced? That remains an open question. Some of those laws being enacted have to do with prescribing limits. Prescribing limits, they range all across the board, and this is sort of an old chart. Florida is one of the latest to introduce prescribing limits, as has Arizona. Why should there be a three-day limit in one state and a seven-day limit in another state? I don't know. I challenge anyone in this room to tell me why is three better than seven, or maybe neither really is better, and exceptions. How is a pharmacist at that pharmacy counter supposed to know? For those of you who do neurological surgery, that is the first time for a patient who has an acute interventional surgery. How are they supposed to know at the pharmacy counter? Does your prescription say that? It says post-op pain. Okay. It says post-op pain. How many people write post-op pain on your scripts? All right. There's one. Not me. It's one of those things. So what happens? What are the legal implications? Well, one of the things that happens, as you are probably aware, is that patients are denied medication. They're denied that pain relief. Why is that happening? CVS, Walgreens, a number of other distributors and pharmacies have settled for many millions of dollars with the DEA for bad practices. If you like to read DEA administrative actions, I swear to God, if anybody remembers CSI, they read CSI episodes. There's bad activity that happened in the past, and those are the reasons for those settlements. But pharmacies, they don't want to pay out millions of dollars. That doesn't help them. So they're going to enact policies that have specific restrictions. Here are some of the restrictions that are playing out in state law. Guidelines. We talked about guidelines a little bit. I would suggest that the guidelines that you should be following are the ones that you're learning about today. You heard about a lot of different options for pain care today. That's kind of cool. That's the clinic, that's the type of education that the AMA says, meaningful and relevant. That's what we talk to state legislators about. That's meaningful and relevant education. But everybody here, this is that slide that Dr. Pollack said, everybody's going crossways. I watched a movie the other day, it's a really bad movie, but it had one of those junkyard car crashes. And I wish I'd already submitted my slides, but I think I might put that in next time. How are you supposed to practice medicine in an environment where who are you supposed to listen to? And we haven't seen it yet. And again, I don't want to scare people or provide answers to it, because you're providing the best care you can to the patient that's before you. But when you have bodies like the CDC, and we can say whether we like or dislike or have other thoughts about what a seven-day guideline is or what a 90 morphine equivalent threshold is and how beneficial it is and what the strength of evidence is, the CDC is one of those things that is becoming a standard of care. And where do standards of care show up? Well, they show up in civil suits. They show up in criminal suits. They show up in medical professional licensing investigations. I'm not saying it's going to happen to you, but that's where it shows up. A friend and colleague of mine who's an oncologist, officially, she's listed as an internist, but specialty, went up specializing in oncology. She was sent an investigational letter from her state medical board because she was an opioid prescribing outlier. She's an oncologist, but the medical board has her as an internist. So compared to other internists, she's an outlier. She's an oncologist. Thankfully, it did not require hiring a lawyer. It did not require a formal investigation, but it was almost there. In the addiction medicine field, I just recently learned this, buprenorphine, if you try to calculate the MME of buprenorphine when it's used for the treatment of substance use disorder, it gets kind of wacky. It's really high. But there are addiction medicine physicians who have had to hire lawyers because they are the subject of a formal investigation from the state medical board. They don't see pain patients. They don't prescribe buprenorphine for the treatment of pain. But the PDMP tagged them as an outlier because the MME was really high. Those are legal implications of some of these policies. The AMA Opioid Task Force recommendation, the Opioid Task Force convened in 2014. The AMA board saw lots of activity going on around the country and thought, you know, we really need to try to work as one in organized medicine, just as there's organized neurosurgery. AANS and CNS were one of the original members. There are 28 organizations, state and specialty societies, American Osteopathic Association and the American Dental Association. I don't know about you guys, but when you get 28 doctors in a room, how easy is it to come up with and agree with the same things? Not the same as politicians. It's challenging, right? And remember, I'm a lawyer. I like to ask questions that we already know the answers to, or at least that I think I know the answers to. But anyway, this wasn't difficult for the medical societies and the physician representatives for those medical societies to come to agreement with. This was back in 2014. These recommendations were issued in 2015. And as a result of this, you know, organized medicine started to speak a little bit more clearly with one voice. Some of the implications of this, some of the downstream effects of this have been, these aren't really surprising anymore. 2015, this was just when groups like the National Governance Association, so many state task forces started to come up with their own recommendation. State legislators started to get really involved. So one of the things this allowed us to do, and it really had huge effects and huge positive effects on state medical societies, it allowed state medical societies to have a common point of reference. And we continue to do this. On the site there, and we update it about every six months, we're in the process of updating now, we take recommendations on the education that like AANS and CNS provides to you. We know that physicians go to a lot of different places to get education and resources. So we want to promote those resources. There are about 300 or so resources now there from organized medicine, and we're going to continue to do that, continue to promote the education that's meaningful and relevant to you. When you have continuing medical education mandates, again, we want it to be meaningful and relevant. A new one-hour CME mandate in a state, or two hours or three hours, it's not going to do much. But you may have to satisfy that as a political legal compromise. Some of the data, PD&P queries, have gone up, and I'll be transparent here. I've been criticized by people because apparently the Y-axises or axes aren't quite fair. So I'll be transparent. I don't necessarily want them to be fair. I want to emphasize what physicians have done. Notice two things about this. One, there's massive increase in PD&P queries. There are decreases now, we're under 200 million in terms of dispensed opioid analgesics, which is about back to 2006 levels, still high, but there's been a significant decrease. What has this meant? What are the clinical implications of this? What are you going to do as physicians if you see a PD&P report and that patient is on multiple opioid prescriptions from multiple prescribers? What are you going to do? I know it's a case-by-case basis. But consider when you provide care to that patient, and let's say it's a massive back surgery or a minor back surgery, but there's pain. You guys sometimes do painful things to people, in a good way, obviously, I know that. But you do painful things to people, they need pain relief. A sea snail might not help everybody. So that was funny, I know, thank you. But what's going to happen? What's now that third opioid prescriber for that patient? What does that mean? What are the legal implications of that? What are the clinical implications if you tell that patient, I can't prescribe opioids for you? Are you going to have your PA do it, maybe? Who normally prescribes post-op for you? These are some of the legal implications, I don't know how they're going to turn out. But people are watching. I'm not a conspiracy theorist. But with all of this data, this data isn't being captured for nothing. MME, one of the things here that I want you to pay attention to, MME is decreasing across the country. But I would suggest that clinically and policy-wise, this is not a great picture. Why is there such massive discrepancy in MME across the country, and even within states? I don't know the answer to that. Policymakers don't know the answer to that. Public health officials don't know the answer to this. Yet they're enacting policies and creating new legal doctrine based on the fact that there are opioids being prescribed. Instead of this, what we are trying to do is work with public health officials, encourage them, work with epidemiologists, work with policymakers to understand why is this happening and what can we do, not to create one single standard of care, but to improve care, to as physicians that were speaking previously were talking about, improving those non-opioid and non-pharmacologic alternatives. Talk more about that in just a second. Chronic pain patients, the opioid crackdown is hurting. This is a guy who, he said he feels like a criminal every time he has to go back to his doctor, feels even worse when he has to go to the pharmacy counter, and gets interrogated. Literally gets interrogated. We hear many stories like this over and over. What do you do in that situation? Patient first comes to you, they have pain, they're not a surgery candidate, but they still have pain. Are you going to prescribe opioids to that patient? What are you going to prescribe to that? Or let's say that you have a patient, a long-term patient, that they've been stable. Let's say it's like 200, 300 MME, 10 years, and they've never experienced, there's no indication that they're diverting their medication, no indication of any problems. Two, three hundreds a lot. Are you going to taper that patient? Consensually, non-consensually, are you going to refer that patient to someone else? These are the questions that are happening. What are the legal implications when a physician's office is shut down for whatever reason? Let's say that physician, and there are physicians who have been arrested, and let's be honest, there are some people who, rather than practice medicine, they decided to deal drugs from their office. When that physician office is shut down, there have been literally hundreds, and in some cases several hundred, patients who need care. Not in a few weeks, but care like the next day. How are communities equipped to go ahead and handle those patients? These are the questions that we're asking. Quick snapshot into the life of 100 pain medicine physicians. The American Board of Pain Medicine did a quick little survey and asked, what is happening when you try to provide non-opioid pain medication? You can read what's happening here. The types of things that they were having trouble accessing because of prior auth and other utilization management techniques are the same things we heard about earlier today, and probably things that you heard about throughout this conference. An anesthesiology friend of mine who's a pain medicine specialist, he put a patient on a trial period for a spinal cord stimulator, and it worked. She was able to get off of all opioids. She was able to take walks with her husband, take care of her kids. That was the trial period. No problem with prior authorization for the trial period. But the specialty benefit pharmacy company or specialty benefit management company said, no, we cannot approve a permanent implant. Can't do it because it's not medically efficacious. So we're going through, we're literally trying to help with the specific health payer and the specialty PBM to break through that kind of red tape. But what are you going to do legally? Let's say that you know that opioids are not good for your patient. What if the non-opioid alternative is not available? What are you going to do? Are you going to continue to prescribe to your patient something that might result in harms at a level that might result in harms? Or if the patient is stable, continue to prescribe to somebody who you know you might be tagged as an outlier. But I like to be optimistic. It's a beautiful day outside. Why can we be optimistic? There are a couple of things here from neurosurgery, from JAMA surgery defining the optimal length of opioid pain medication. They found that depending on the type of surgery, whether it was like a gallbladder or hernia or some kind of musculoskeletal problem, the range was probably somewhere between like three and 14 days. But you know what? And here's the kind of the cool thing. It depended on what that actual patient needed. So nobody agrees that like a 30-day prescription just in case is necessary. I think that that probably happens. I think it's probably more myth than reality, and we have some data to back that up. But these are the things that have reasons for optimism, is that physicians across the country literally are implementing practices in their practices to improve pain care and to improve treatment for substance use disorders. Nobody had to tell physicians to do this. Nobody had to tell, there's one of our board members who's a plastic surgeon, they did a little trial period within their own surgical practice for rhinoplasty. And they figured out, yeah, we were prescribing too much. Let's bring it back down. And they published it. That's what physicians are doing. They're looking at their own data. And they're taking action. That's pretty exciting. There's obviously a lot more work to do on the public policy front. There is a lot more work to do. We talked about the National Pain Strategy, and HHS just named a physician and other representatives to the Interagency Pain something, something council. There's like three more letters or something. They love acronyms. They don't mean anything. But that's helpful. We've been waiting for a couple of years for that. And HHS just named the people for that. I want to leave you with a couple of things. The evidence and the research, as you and your practices have that evidence and research, share it with your colleagues. Continue to come to things like this to share it, because that's where physicians learn. But also, and this is where we can help, when there are barriers, when you experience those barriers, share that with the AANS staff. Share that with the AMA. You know, I'm always happy to hear, I talk to physicians all the time about barriers. I love to hear, and take this the right way, I love to hear physicians complaining. I know probably nobody in here ever does that. But I would imagine that you experience a prior authorization or some kind of UM hurdle at some point in time during your practice day or during the week. And if you don't, tell me that too, because I'd love to know who you're contracted with so we can tell every other physician in the country, only contact with those payers and going to those PBMs. Without those kinds of stories, without that information about the barriers that you have, we can't do our job on the legal or policy front. And finally, you know, I can't stress enough that the continued partnership with organized neurosurgery and with all of organized medicine, that ultimately is what makes us much, much stronger. So again, I'm happy to talk with anybody, I'd be happy to answer your questions. Thank you.

opioid policy

legal implications

clinicians

opioid crisis

prescription drug monitoring programs

physician education