And my talk is on medical-legal issues in emergency radiology. And the objectives of this are, first an introduction, why should I be concerned? We'll talk about malpractice in emergency radiology and why emergency radiology is unique. We'll talk about malpractice law and the standard of care, basically an overview of the legal requirements. We'll talk about communications issues, and then we'll talk about a number of tips you can use to mitigate risk. So initially, malpractice and why should I be concerned? We're not perfect and mistakes are inevitable. I'll start out with a number of statistics. First the ABR in 2017 noted that an estimated 30% of abnormal radiographic findings are missed and about 5% of radiological interpretations rendered by radiologists in daily practice contain errors. An article in the New England Journal of Medicine in 2011 noted that 90% of radiologists will have been sued at least once during their career by the age of 65. An article in JACR in 2016 noted that radiology is the eighth most likely specialty to be implicated in a medical malpractice claim. In an article in Radiographics in 2018, the authors noted that at least 5% of adults seeking outpatient care experience diagnostic errors, which contribute to nearly 10% of deaths annually and up to 17% of adverse hospital events. So now why is emergency radiology unique? We work in very high volume. There's rapid pace and turnaround time both in terms of requirements because of the patient injuries as well as agreements with emergency clinicians. The patients tend to have higher acuity. We do a lot of work after hours, which creates a lot of problems in terms of resources. And then emergency radiology spans multiple subspecialties and in essence we're the jack of all trades and master of none. And there is no generic emergency radiology practice and you'll see variation in scope of services, particularly some places do some modalities and not others. Variation in training. There are emergency and trauma fellowships, but not everybody working in emergency radiology has them. Variability in terms of staffing with some places having full-time emergency radiology attendings, others with variations of call from other radiology subsections and teleradiology. Patient acuity can be arranged with some places having dedicated separate trauma sections as well as the fact that various facilities are different level of trauma level. And then in terms of follow-up and potential loss to follow-up. So given these differences, is an emergency radiologist at greater risk of being sued? And the answer is probably. A recent JACR article found that the ED accounted for a disproportionate number of liability claims against radiologists. And the authors noted that the odds of a claim arising from an ED examination were nearly four-fold higher. And then the authors hypothesized a number of the same things I listed as to why emergency radiology is unique, as to why increased liability might stem, ranging from call schedules whereby subspecialists were interpreting things outside of their normal scope, a wider range of pathology involved in emergency radiology, the rapid pace, and the unusual coverage hours. So in order to navigate these risks, the basic awareness of medical malpractice law is important. And you need to practice cognizant of the risks but not paralyzed by them. So we'll do a quick overview of medical malpractice here. To successfully establish a medical malpractice claim, a plaintiff must prove four key elements. That there is a duty, breach of that duty, causation, and harm or damages. So the duty must be a doctor-patient relationship. When a physician-patient relationship is established, the physician owes a legal duty to practice within the accepted standards of care for that specialty. And as radiologists, you can owe a duty to a patient even if you never even see them, as long as they're a patient of the radiology department where you work. Once they arrive in the department for a study, you as the radiologist have a physician-patient relationship. Next, there has to be a breach, and that occurs when a physician does not meet the accepted standards of care. And so the standard of care is the degree of care which a reasonably prudent radiologist would exercise under the same or similar circumstances. And not meeting the standard of care is strong indicia of malpractice. So we're always asking ourselves, what would the reasonably prudent radiologist have done or not done in this situation? And to a large extent, the standard of care is going to be determined in the courtroom setting based on expert testimony as to what the standard of care in that situation is. The standard of care can also arise from clinical practice guidelines, regulations, and institutions' rules, all of which could be admitted during litigation to assist the court or the jury as a learned treatise or other exception under the federal rules of evidence, as well as being relied on by expert witnesses as the basis for their testimony. Now practice parameters issued by ACR and other organizations always say by their terms that they're not the standard of care, but they actually can be used as evidence of the standard. Next, you need to have causation. A plaintiff needs to prove that the radiologist's negligence was the cause of the damages. In other words, the harm would not have occurred if the standard of care was met. And finally, you have damages. The patient has to show that he or she was actually harmed as a result of the physician's actions. And damages can be direct, as in injury, or indirect, things like pain and suffering, emotional distress, loss of consortium, other nebulous injuries. And then the plaintiff has the burden of proof, which means they need to present enough evidence to support the claim by a preponderance of the evidence. And by preponderance of the evidence, this is different than the criminal standard beyond a reasonable doubt. Preponderance of the evidence just means more likely than not. And so for the defendant radiologist to win, the scale needs to be tipped to less likely. And so the plaintiff loses their case if he or she is unable to prove any of the four elements I mentioned, a duty, a breach of standard of care, causation, or damages. So if I meet the standard of care and make no errors and dutifully and accurately record my findings in my report, am I good? The answer is no. You still need to adequately communicate the findings. And liability for communication tends to be troubling to people in radiology, as you may have acted with exceptional skill and made a great call or catch, and it's all in your report as clear as day. And you end up being liable for what many view as tantamount to clinical or administrative follow-through. But I would argue the failure to communicate is like fumbling on the one-yard line. You've already done all the heavy lifting, but then you haven't picked up the phone to complete the issue. And courts have echoed this and have noted that the communication of a diagnosis so that it may be beneficially utilized may be altogether as important as the diagnosis itself. Now, the ACR issued practice parameters on communication of diagnostic imaging findings most recently revised in 2020, and they differentiate between routine reporting, which are things that can be communicated through the usual channels established by the hospital or facility, and non-routine communications, whereby the radiologist should expedite delivery of findings in a manner that reasonably ensures timely receipt. So these non-routine communications are the ones that create issues. So what are they? They are findings that suggest the need of immediate or urgent intervention, findings discrepant with a proceeding or preliminary interpretation where the discrepancy is of healthcare significance, meaning if you're doing a secondary read from an outside institution and you're going to make a different finding, you have to pick up the phone and make a call. And then findings where you're reasonably believed to be seriously adverse to the patient's health and may not require immediate attention, but if not acted upon, may worsen over time and adversely impact the patient's outcome, in other words, things that are likely cancers. Communication has to be timely. It has to be to a physician or healthcare provider responsible for treatment decisions or his or her designee. Or if they can't be contacted, you're allowed to contact the patient directly. And it needs to be documented, including the time, the method of communication, and the name of the person with whom the communication was made. Now telephone and in-person communication have been specifically referenced as appropriate in the ACR parameters as well as by courts. Other forms of communication have to be in compliance with HIPAA and should guarantee receipt of communication. And as such, things like texting, faxes, voicemail, email might not be acceptable. So at this point, do that at your own risk. At any rate, whatever form of communication you end up using has to be closed loop. You can't just send information out into the void and not hear back from the other side. So essentially, we have to practice under the assumption that the ordering clinician is never going to read our report and that anything we need them to know, we have to actually tell them in their ear. And studies have suggested that up to 15% of clinicians actually don't read reports. So we'll do a quick aside here, turnaround time and the pace of the ED. Is there such a thing as moving too fast? And is the pace of the ED a setup for failure? In a recent 2019 article, Doctors Lawrence Miroff and Leonard Berlin argued that there's no credible relationship between speed of diagnostic image interpretation and accuracy. Their point was that it was more radiologist dependent and some people actually can read faster than others without any issues. But there is some worrisome precedent. There is a case in Florida, Burstein v. West Boca Medical Center, where in 2015, a 64-year-old man on Coumadin fell and hit his head on a file cabinet. He was brought by paramedics to the local ED where he received a non-contrast head CT. And the radiologist read the head CT as negative and the patient was discharged 15 minutes later. And then upon getting home, the patient's condition worsened. He was brought to a different hospital and a subsequent CT showed massive endocranial hemorrhage and the patient died the next day. A wrongful death lawsuit was filed by the family and the plaintiff's attorney subpoenaed the time log and record of every key stroke the radiologist, that first radiologist made during the evaluation of the patient's case. And it revealed that the radiologist spent only six minutes and 26 seconds reviewing the 691-image study, which the lawyers emphasized was just half a second per image. And the defendant's hospital and radiologists ended up settling for $2 million. Now because this was settled, we never get to learn what weight the jury might place on a radiologist's speed. But it is food for thought. There may be, fast may be too fast. So given that mistakes are inevitable, is there anything I can do to limit liability for malpractice? The risk of mistake will never be eliminated, but it can be minimized and managed. And in a previous article, I argued that you can abide by the five C's, compassion, competence, care, communication, and clarity, with compassion being empathy and respect both to patients and in front of a jury, competence, stay within the limits of your own expertise and get help when you need it, care, particularly in terms of proofreading your reports, as well as having systems to prevent losses to follow up, communication, as we mentioned, needs to be timely, appropriate, and documented, and then clarity, document your findings and use hedging sparingly. And this is the article I had in AJR in 2019. In it, I also did a number of tips for avoiding malpractice. I'll give 10 of them here. First, stick to search patterns and know your blind spots, and watch out for edge-of-the-image findings, the first and last slice of imaging can often be an issue, and keep a running mental list of prior errors and recheck those areas you've missed before, because lightning can strike the same place twice, and you will make the same errors if you're not cognizant that that's your blind spot. Number two, use differential diagnosis as a way to be certain without being overconfident. And disclaimers and limitations are not per se legally protective, but they may be useful to explain an inability to answer a clinical query. Next, recommend appropriate follow-up studies, even non-radiology ones. Follow-up studies are your friend, and it gives you a second bite at the apple in terms of not missing something. Use simple, clear language and avoid jargon. Your report may be read by a patient or even a jury, and this is especially true now that electronic radiology reports are being sent directly to patients under the 21st Century Cures Act final rules. As mentioned before, proofread your reports, that shows care, and a jury may be more likely to consider that if you're sloppy in your report, you may be careless in other aspects of your diagnosis, and be especially careful when using templates. If you don't read them, sometimes they contain language that is in error. And review every image and sequence of the study, including the scout film. You're legally responsible for having looked at all of them. And be careful when reviewing cases outside of your area of expertise, and obtain consult liberally. If you're working at night and have an opportunity to run a difficult case by a subspecialist in the morning, that's always helpful and will look diligent to a jury. And bear in mind that there are legal consequences to guessing and winging it. Document all discussion with clinicians, including date and time. You're building a record that you act diligently and follow the standard of care. And your report will be Exhibit 1 in any subsequent lawsuit, and keep that in mind. Note that a second set of eyes is often beneficial. If that's not possible, consider taking a break and revisiting a difficult case. And avoid things like satisfaction of search, biases, and anchoring based on context or prevalence. And be cognizant of the fact that the clinician's indication for the study that they give you is sometimes wrong, or one they select out of convenience or laziness. And thank you for your attention. I guess we'll take questions at the end. And here are my references. And thank you. All right. So we're going to be talking about government enforcement very quickly. This is like a several hour talk, condensed into 17 minutes. But I'll start by saying this. MedMal could be very scary, I know. But when you're investigated by the government, you probably wish it was a MedMal suit. This is what I've been calling when I talk and talk to my clients and at conferences like this. I call it the new MedMal. And the reason I call it the new MedMal is because government investigations really are becoming a routine part of being a physician and working in the health care field. You heard that 90% of radiologists, by the time they're 65, will get sued in a MedMal case. And unfortunately, those numbers are also increasing when it comes to those who will be investigated for potential health care fraud. So let's talk about that a little bit. This might be a little hard to see, and I apologize, but I'll tell you what it says. So this is a list of, by fiscal year, the government's total recovery in False Claims Act cases against health care providers. We don't have time to go into a lot of what the False Claims Act is. But 100,000 foot level, it's a civil enforcement statute that the government uses to investigate and prosecute civilly allegations of health care fraud. And we'll talk about some examples here in a few minutes. Every single year, the government gets billions, billions with a B, dollars from health care providers under the False Claims Act. You will see that the lowest recovery since 2009 was last year. And we all think that's because COVID affected most of last year. But that low number was a total, and I'll highlight it here, of $1.85 billion. That was the lowest in 10 years. You can see that many years before that were in excess of $2 billion. There was an excess of $3 billion there. So this is huge dollars. And this is just from health care providers in one year alone. The reason the False Claims Act, one of the reasons it's so powerful is because it has whistleblower provisions, what we call QUITAM provisions. Or if you're at Yale or Harvard, QUITAM. But I went to UGA, go Dawgs, so I don't pronounce the Latin like they might. But the QUITAM provisions are whistleblower provisions that allows anyone that works at doctor's office, hospital, whatever, laboratory, pharmacy, to file a whistleblower suit. And that individual, if that suit is successful, gets between 15% and 30% of the government's eventual recovery. So in 2020 fiscal year alone, if you look at that very bottom right number, you'll see $261 million. That's the amount of money that went to the whistleblowers and their attorneys. Of course, I don't represent whistleblowers. I represent physicians. But $261 million in one year alone. And then if you go all the way to the left, this number is perhaps even more scary. If you look down that column that says new matters QUITAM, you'll see the number 456. That means that last year in 2020, 456 new whistleblower matters were filed against health care providers. That number is actually up from the previous two years. So this is huge business. It's huge money for everyone. It's huge money for the government. It's huge money for the whistleblowers, for the plaintiff's lawyers, and I'll be honest, for me as well, defending these things. And believe it or not, there is legislation now in Congress where there's bipartisan legislation where they are trying to strengthen the False Claims Act. For some reason, they don't think it's strong enough. I would totally disagree with that. But this ain't going anywhere anytime soon. So what are the priorities? There's various False Claims Act cases can take various shapes and forms. In June of this year, the guy in charge of False Claims Act enforcement, the DOJ, gave some of the top priorities. Opioid enforcement is one of the top priorities, has been for several years, will continue to be. Receipt of COVID relief funds. If you're a physician or work at a physician's office, hospital, whatever, you probably received COVID relief funds. Might be PPP loans, might be the provider relief fund under the CARES Act. Probably both. And even though when the provider relief fund came out, the secretary of HHS said, oh, these are no-strings-attached grants. And then literally for the next four months, all she did is release the strings that were attached. They're not no-strings-attached grants. There are many strings. And if you received the money, you didn't have to sign a contract or look at the strings and agree to them. You agree to the terms and conditions of the COVID relief funds by accepting it and not returning it. And you have, whether you know it or not, paperwork requirements, reporting requirements if you received over $150,000. There are certain things you can do with the money and certain things you can't do with the money. And the government's going to start auditing that. They've already started criminal investigations related to just folks that got PPP funds for companies that were non-existent. But for those of you who got legitimate provider relief funds, you didn't ask for it. It was just automatically deposited into your account. They're going to start auditing to make sure you follow the rules. So it might be a good idea to figure out what those rules are. Senior citizen abuse, EHR misuse. These are things like over-utilizing templates on electronic health record systems, things of that nature. You all were, well, for those that work at health systems, you might not have had to pay for it, but physicians were required to spend a ton of money subsidized by the government to convert to EHR, you know, however long, seven, eight, nine years ago. And EHR has some great things that come with it. We talked a little bit in your talk about it. But if you over-rely on some of the functionality like templates, copy and pasting, things of that nature, you can get in trouble. Let's move on. Some other areas of focus, telehealth fraud. Okay. And this comes in kind of two pieces. There's just the straight up fraudulent telehealth schemes that the government typically prosecutes criminally. I'm handling several of them. This is typically where a physician signs a contract with a telehealth company and gets paid for logging onto the telehealth system and approving orders. A lot of time those orders are back braces, genetic testing, things of that nature. And the physician logs onto the system, clicks some buttons, looks through the notes, approves it, and then gets paid for it. That the government considers is fraud. They consider that fraud because most of the time, the physician's not actually seeing the patient, usually not even talking to the patient, and maybe approving items and services that are not medically necessary. I know no one at this conference would do that. So let's move on to what might affect you more, which is just your everyday use of telehealth technology, which expanded significantly during the COVID pandemic. The government loosened a lot of the regulations. It was a literal lifesaver for so many people. But there are still requirements for telehealth. Every state has its own requirements. CMS has requirements for Medicare use of telehealth, billing telehealth to Medicare, all the Medicaid programs, all the private payers, et cetera. And we'll see here in a minute that CMS has already said they are going to start auditing physicians regarding their use of telehealth services. The Stark Law and the Anti-Kickback Statute. One of my classes I teach is law school classes, all semester talks about the Stark Law and Anti-Kickback Statute. And I'm going to pretty much summarize that in 30 seconds here. The Stark Law and the Anti-Kickback Statute, another 100,000-foot level review, governs relationships between you all as physicians or other health care providers and entities like hospitals, laboratories, pharmacies, nursing homes, device manufacturers, pharmaceutical companies, et cetera, et cetera, et cetera. If you are employed by an entity, even if you're just an employed hospital doc, if you work for a physician group, if you have a contract with a nursing home, whatever it is, an imaging center, you're the medical director of the imaging center, this triggers the Stark Law and the Anti-Kickback Statute. And there are, essentially what it says is if you get money from an entity to which you refer patients, there could be an issue, unless one of various exceptions apply. And it would take me longer than an hour to talk about all the various exceptions, but there are exceptions. An example is bona fide employment exception. If you're an employee of a hospital, as long as you're getting paid fair market value compensation, which is why your CEOs always push back on you. You know, I love you all, I represent doctors, but every doctor thinks they're the best doctor in the world, and they're the ones that deserve to be in the 99th percentile of compensation. And the CEOs and the CFOs of your health system says, doc, you are the best, but we can't do that. They're actually probably telling you the truth, because if they did do that, you might wind up having to pay it all back to me and the government when there's an investigation. Just one of a million examples here, in August of this year, a Michigan health system agreed to pay $2.8 million to resolve False Claims Act allegations that it submitted claims for certain medically unnecessary services. You know, this was a typo here. There's another, there is another settlement in August of 2021, and I copied and pasted the wrong thing, where the allegations were that the hospital system overpaid when acquiring a physician group. So anytime a physician group is acquired, which of course happens all the time, and then typically what happens is those physicians remain on staff and become employed physicians, both of those transactions have to meet certain requirements and be consistent with fair market value. So the money they pay you to buy your practice has to be consistent with fair market value, and then your compensation has to be consistent with fair market value. And I could, this is the one thing, if you remember anything, remember this. If part of the way that they're calculating the purchase price or your compensation is how much you could potentially refer to the hospital. So if they say, well, Dr. Jones can refer a lot of patients, you know, and this might not be as applicable with a lot of radiologists, but if that's part of the equation, then there's potentially an issue under the Stark and Anti-Kickback Statute. Improper billing. In August of this year, Texas Hospital agreed to pay more than 3 million to resolve false claims at KETAM, whistleblower suit, alleging improper use of modifiers like 25, 59, and XU. Improper use of modifiers is a big thing. It's low hanging fruit, pretty easy to prove, and can lead to big cases. And of course, medical necessity. Everything that you bill for to a federal healthcare program has to be medically necessary. Now, you guys went to school for 100 years to become doctors, and the reviewers at Medicare went to high school, maybe, if you're lucky. And they are going to tell you what's medically necessary and what's not. And unfortunately, oftentimes they can. So an example here, same month, August of this year, Illinois Hospital agrees to pay $2.8 million to resolve allegations that it violated the False Claims Act by submitting claims for medically unnecessary cardiac catheterization procedures performed by an affiliate physician. And this was the result of a self-disclosure. So the hospital actually self-disclosed that they thought there was a problem, still had to pay $2.8 million. So what's next? Unfortunately, I think we, fortunately for me, I'll be honest, unfortunately probably for everyone else in this room, I think we will see an increase in government enforcement across the board. We're now, what, almost a year into the new administration, but we have seen in this new administration an increase in government enforcement in the healthcare space particularly, an increase in individual liability. So what the DOJ has said is, if there's an issue, let's say you work at a hospital and there's an issue and they come investigate and they determine the hospital owes them $10 million, let's say, they're not gonna close that case. They're instructed not to close that case until they have determined which individuals are liable and gone after those individuals. CARES Act enforcement, we'll talk about that. We already talked about that. Telehealth, telemedicine, I'll spend a minute on that. And then I'll also spend a minute on speaker programs. So in January of this year, the OIG updated its work plan, saying that, as we discussed, they were gonna audit Medicare Part B telehealth services used during the COVID pandemic in two phases. And the second phase is what I'll focus on. You could read about the first phase there. Audits including additional audits to make sure that certain requirements are met, like distant and originating site location requirements, virtual check-ins, et cetera, et cetera. Again, while the requirements have been loosened, there are still requirements and you have to follow those requirements and the audits unfortunately are coming. All right, last thing we'll talk about are speaker programs. I actually have a case right now with a radiologist. It's an interventional radiologist. I don't know if there are any interventional radiologists here. I won't obviously use any names, but this particular physician had a contract with a large device manufacturer that made a certain product used in some of the procedures that he performed. So he entered into a contract with them saying, we'll pay you money to go educate both the public and other physicians, primary care physicians mainly, on this product. You use it a lot, you believe in it, you believe it's a lifesaver, and so we'll pay you to go out and educate. Very common. I'm not gonna ask for a show of hands, but I'm sure that there are folks in this room who have or had those contracts. Well, in November of last year, the OIG released a fraud alert saying that they're very concerned about these types of arrangements and noted that over $2 billion had been paid in just three years to healthcare providers from drug and device companies. They said that the OIG is skeptical about the educational value of such programs, which honestly is a ridiculous statement, I think, but that's what they said. And when the OIG is concerned about something, we all have to make sure that we're concerned about it as well. And they provided a non-exhaustive list of suspect characteristics, and you're gonna recognize some of these because essentially some of these are every speaker program you've ever been to. For example, alcohol is available, and that concern is heightened when the alcohol is free. Okay, that meal of exceeding modest value, whatever that means, but if you have a meal exceeding modest value and free alcohol, according to the OIG, you are part of a problematic speaker program. Also, the program is held in locations not conducive to education, like restaurants. And essentially every speaker program I've ever heard of is at a restaurant with free alcohol and a nice meal. So according to the OIG, these are all very problematic arrangements. And the problem is these arrangements could be considered to be violative of the anti-kickback statute. So the suit I am defending now, which we're hoping we'll be able to get thrown out on the motion to dismiss, but we'll see, but the suit I'm defending now had some of these elements in it, but it was a great program. It was a radiologist that was going and educating primary care physicians on something they knew nothing about and saving people's lives, and yet here we are. All right, so finally, how do you avoid this? There's really no foolproof way. Like I said, it's somewhat not a matter of if, but when you might fall under an order or an investigation, unfortunately. But probably the number one thing you can do is create a compliance program. If you work for a big health system, you probably already have one or a big practice group. If you work for a small practice group, have your own physician group, make sure you have a compliance program. The OIG and the DOJ recognize that smaller entities are not gonna have as much money to spend on compliance as bigger entities, and at least they're gonna tell you that's okay as long as you tailor it to what you need. And I won't read all of these, but these are the seven elements of an effective compliance program, and make sure that you incorporate all of these elements into your compliance program. So I went a minute and a half over, but I did give like five hours worth of information in 19 minutes, so I will be around later for any questions. Thank you. Okay, so an error, a preventable harmful event has occurred, and it's time to say you're sorry, or think about it. What are some of the system's considerations? So we'll talk about the basic rationale for transparent and compassionate communication with patients and families after harmful events and errors. We'll look at the current legal environment around that, and then we'll describe what is now considered to be the optimal institutional and systems processes to facilitate the communication. So the rationale has been well articulated for a very, very long time. It's pretty well understood. You know, from a basic ethical standpoint, when there is a preventable adverse event, which is harmful, in which there's been systems flaws or personal responsibility, it's the right thing to do to explain the issue to the patients, to empower them to make the best decisions they can based on their own autonomous preferences and based on the best information they can get. And to withhold any kind of information from them that is pertinent and relevant to their care and decision-making going forward is really runs up against the best standards of informed consent. We also know that patients and families suffer very significant distrust in the setting of these adverse events. And that can really be very detrimental to their health-seeking behaviors in the future, can really erode their faith in our care. And saying sorry to them or making apologies and the honest communication will help kind of restore that trust, so important to the patient-physician relationship. We also know that patients and families experience very significant emotional harms in the setting of harmful adverse events and preventable adverse events in particular. And we know there's data to suggest that when the apologies are made and when the disclosures are made, that the emotional harms, the long-term anxiety, the long-term depression, and even the PTSD will be improved if there's effective disclosures and apologies made. The same is true for the physicians or the nurses or other providers involved who experience significant emotional distress in the setting of these events. And the ability to come to some kind of resolution, to be able to talk to the families openly and freely it has felt some degree of ability to enhance resilience and well-being in the practitioners who are involved in these. It has also felt that the systems where the issues can be discussed freely and openly and with patients and families are those which are able to talk about them in a more healthy way within their systems to put together processes that will mitigate the likelihood of these events occurring in the future. Finally, there's a strong sense that the tort system as we've grown up with it, the deny and defend kind of system where you deny any event has occurred and if it comes to light that it has, you defend it rigorously is deeply, deeply unhealthy and flawed. It undermines collegiality, it undermines good communication within the work environment, it undermines communication with the patients and families and it prevents the patient and families from getting the information they need at the time they get it and it prevents them from getting the compensation that they need to take care of their healthcare needs at the time. And there's also been a theory that it's the flawed communication and the perceived or real lack of transparency and not negligence itself that brings most patients to bring lawsuits. And so with that in mind, there are a lot of, there've been over time a proliferation of apology laws in the various states. There are now 39 states that have apology laws on the books. The problem with these apology laws is that they're highly, well, one problem with them is that they're highly variable. I'm gonna take this off so I can get some oxygen. They're highly variable. There are partial apology law states and 34 of the 39 are partial apology law states where the laws will protect any statements that are made expressing sympathy, condolence and commiseration. There are only five full apology law states which protect statements of apology and admissions of fault and it's felt that these more full apology laws, these, excuse me, more full apologies where there's expressions of direct responsibility and direct apologies for that personal responsibility are somehow more effective in helping with the malpractice liability and leading to less likelihood of lawsuits. That's the theory at least. But it turns out that there is now emerging data that the state apology laws are not as effective as we would like to have thought they would be. This is a Medscape article that just came out a couple of weeks ago that has been making the rounds. Basically, there's data showing that the state apology laws have not only failed to reduce the malpractice claims but also actually have led to an increase in the rate of liability claims and this could have a chilling effect on physicians apologizing despite the laws intended otherwise. The data has come out and it's compelling and the actual academic articles from the legal literature, the empirical evidence demonstrates that apology laws not only fail to have their intended effect but have a perverse effect on malpractice liability risk. There are some things that are still not known. There's some data constraints with what was analyzed. There may be some missing claims. It has been felt that we really don't know what the effect of full or partial apology laws is although it turns out that in the latest article that full apology laws actually may have even worse outcomes than partial apology laws say. So this was kind of interesting and unfortunate. We don't know whether the apology laws have led to more apologies. We don't know what percentage of them are poorly executed apologies. We don't know as more of these events come to light to patients whether more of them are, whether that's deterring them from suing versus knowing about it and going ahead and suing. So we just don't know. But what really, this is kind of not new news. The real message here is sorry in these situations where there are preventable adverse events that are harmful in which there has been a personal or a systems issue. Sorry is not enough and particularly it's not gonna be enough in situations where the patients and families, and we know this happens frequently, suffer significant monetary or financial setbacks. That is if you are, say you're sorry but there's still a need, they've still suffered substantial financial setbacks, it's not gonna be enough just to say you're sorry. You're gonna need to figure out how to give them some remuneration. So the solution though that has been put forward is not to kind of disband the laws but to change them and to emphasize what are called apology and disclosure programs, make the communication, make the apologies in the context of these kind of system-wide and enterprise-wide systems that have been put together to facilitate the communication. And so the experts who are talking about the flaws in the apology laws are saying that they need to be, that the apologies are best done through these disclosure and apology programs. So let's focus on that now. So what are these? These are systems-wide coordinated processes that facilitate in which there is a prompt identification of the medical injuries, there is an early event reporting, timely and compassionate disclosure and explanations, apologies made when appropriate, that is when there has been a preventable, harmful, adverse event in which there's been a serious systems flaw and or individual responsibility and offers of compensation, which is a very complex topic, but basically it's, has there been, is the practice outside of the standard of care? And these are systems that, in these systems that have these programs, they will aggressively defend the cases when without merit, but they'll make the offers of compensation when they are merited. They engage the patients in the discussions of the quality and safety issues and incorporate those lessons into their improvement programs. And the systems entail a multi-step, multi-stakeholder process, as you can imagine, where it's not just the individual clinician going in and saying, I'm sorry, but it really involves a very significant multi-step process. So the outcome of these is the most well-described one, programs have been around now for quite some time. And there's been, most of these are single payer university systems, although there is a private practice, there is a private practice liability insurer on the West Coast that is helping its private practice member systems implement these programs. And the outcome of these apology and these communication resolution programs is there have been, as of yet, no reports of a negative financial impact. And in fact, some have reported substantial favorable outcomes in terms of the liability malpractice profile of the University of Michigan, most notably in it described its experience in which after 10 years of this program, fewer claims, fewer lawsuits, lower time to resolution, lower cost rates, lower patient compensation, and transaction expenses. And it's worth noting that the University of Michigan is in a partial apology law state. There have been some institutions that have reported systems improvements. But it is notable that these are, for the most part, large self-insured healthcare organizations, and it may be much harder for smaller independent private practices to implement. And as I described, the processes that need to be put into place in the following slides, you'll see why it's possible that private practices will be more challenged in trying to implement these sort of programs. So, first of all, you need strong institutional leadership and articulation of this as a priority, that honesty and transparency after harm is integral to the clinical mission. It's not merely a claims management mechanism, but rather it's to enhance the patient and provider experiences. Remember, we talked about the provider's resiliency and well-being being enhanced by the communication, as well, of course, the patient's significant emotional setbacks that are enhanced when there's good communication around these. Enhancing patient safety, putting together processes to mitigate the likelihood of such events in the future requires transparency, requires healthy communication, and that means healthy communication with patients and families, as well as internally. And it's for improved peer learning, and sometimes it can lower the liability and defense costs. So that's the basic message, kind of that has to be articulated from the leadership front. And then in terms of the specific processes, there needs to be, or there ought to be an organizational gap or readiness analysis, meaning the C-suite is ready to do it. Are the quality and safety folks ready to do it? Are the risk managers ready to do it? Is the Office of General Counsel ready to do it? Are the parties who are the most important stakeholders clinically within the hospital all aligned to put together and implement these programs? A strong, robust event reporting system is essential to these so that the events can be adjudicated in a systematic, responsible way so that the analysis can be brought to the patients and families in a straightforward and comprehensible way. And then some sense of the human factors issues that are entailed, that is a recognition, a cultural recognition within the institution that when these events occur, it's more often than not a interplay of human behavior, interacting with systems and interacting with technology to create sort of like the hole in the Swiss cheese that ultimately leads to the outcomes. And then finally, kind of the establishment of a just culture, which understands how this is not just a human flaw issue, but it's also the systems and technology interplaying with the human behavior and understanding that and being able to discuss it in a way that does not create shame or blame, but rather uses it for a robust learning opportunity to prevent the issues from happening again and to facilitate the communication amongst the providers and with the family. So it entails a lot, entails intensive educational programming and now there are consultants and consultants organizations that will help with this. There ought to be a strong relationship between the hospital risk managers and liability insurer reps. And one can imagine that in private practices where there were multiple different insurers may have very different takes on how they want to approach things. It might be a more unwieldy situation than in a university system, say where there's one provider, one insurer at making the decisions. Establishment of formal decision protocols, meaning an event occurs, who do you talk to and what's the flow of communication in the first 24 hours? What do you say to the patient immediately? What do you then do? What kind of process occurs over the next few weeks? And what is then, how is the communication then brought forward to the patient and family? Who needs to be involved in the chain of communication within the institution? Helping that provider, that interventionalist in the middle of the night when there's an adverse event, helping them figure out exactly who they need to call and having that flow sheet available and then full-time project managers. So a lot to put it together. The systems who do this ought to also put together robust support systems for the patients and families, for their emotional needs, as well as for their financial needs and for any questions they may have. You don't want to just go in and talk to a patient and give them some devastating piece of information without having important supports available to them. Similarly, you want some supports for the providers. If you're going to ask providers to go in on these very difficult and challenging conversations, you need to have some degree of, you have to have emotional support available for them within the institution or resources that you can tie them to outside of the institution, professionally and by their peers as well. Also providing for the clinicians who you're asking to go into these robust communication training and then provision of a cohort of individuals within the institution who can be called upon on a 24-7 basis when the adverse events occur, who you as the clinician can call and who will take you through the process and help coach you through what needs to be said, what should be said at any given time and what shouldn't be said. So those are the basic processes that are required. The communication itself is just one piece that is extraordinarily important, but in order to do it effectively, it has to be bolstered by a very robust systems-wide process. That is kind of what is being considered now that it's kind of understood that the apology laws themselves are not sufficient and saying you're sorry in and of itself may not be sufficient. The good news is that there's a lot of support systems available now. There's a lot of groups and organizations that are now working with large organizations to help them put together the processes necessary for the communication. So that is, that's my 17 minutes. Thank you very much for your attention.

emergency radiology

medical-legal challenges

malpractice suits

missed diagnoses

communication failures

standard of care

healthcare fraud

telehealth scrutiny

compliance programs