Welcome back. In today's session, we address the major topic of health care quality and health care quality control and the way the law intervenes to make sure that patient care meets a certain standard. In this area like many others, legal policy intervenes with medicine at different stages of the medical process. So there's multiple legal devices that apply to the practice of medicine that seek to achieve a basic quality standard. In a few sessions, we'll get to the major one of medical malpractice and the rules about standard of care. Today, we'll talk about licensure and accreditation, which is more of an upfront gate keeping regime intended to assure that before doctors or nurses or pharmacists ever start practicing that they've achieved a certain standard. This question about how the law regulates medical quality quickly becomes one of when does the law intervene to regulate medical quality. So if a certain activity can cause harm, we might seek to intervene before, during or after that activity to make sure it's done right. The simplistic example that I've alluded to before is driving a car, where before the fact we've all got to get licenses. While we're driving, there's a certain degree of monitoring from police officers or red-light cameras. Then after the fact, if we cause an accident or driving while intoxicated, the law might intervene well, after the problem occurs but yet impose consequences on us based on how we behaved at the time we were driving. So the same temporal analogy applies to health care and the way that law and policy attempts to intervene to ensure medical quality. We regulate doctors before the fact through licensure. We monitor their behavior during the actual procedures or diagnosis. Less so from the government's perspective in health care. But often through private institutions, through checklists, through standards. We try to make sure that in the moment they're doing the right thing. Then after the fact if something goes wrong and if there's evidence that a standard was breached, we intervene with consequences through things like the medical malpractice system. So whether it's before, during or after the important point is all of these safety regulations work only if they're helping the actual practice of medicine become safety. So as you learn about these and as you critique them, be it licensure, be it medical malpractice, ask yourself, how well is this legal intervention really doing to get what we want out of it? Namely, better medical care. So licensure is a very old idea, it predates the United States. We can find evidence way back into the middle ages or before that of government entities saying, if you're going to do this very special thing, practice medicine, practice surgery, you need a government license to do so, so you need a certain kind of education. You need to pass a certain kind of exam. Certainly, licensure has varied through history. In the early United States, pretty much as soon as the government was formed, over 200 years ago, each state government started to pass laws saying who could be a physician in their state. Today, we have laws of course that apply to nursing licensure, dental licensure, pharmacists licensure. So pretty much every slice of the medical profession today has its own set of licensure laws. One historical artifact though that's still really important in the United States, is that within our federal system, these are still state laws. So there's variation between the states. There's also the ability for providers to move from one state to another in ways that as I'll allude to in a few minutes, can sometimes be problematic. But this is still a creature of state law. I'll allude to a couple other areas that have become somewhat more nationalized. But licensure laws are still state laws in the United States, and that's very important for the way they operate. So not only is this a creature of state law but it's really then every state when they pass a licensure law, turns around and delegates the standard setting, the operation, the procedures to a medical board of licensure, and they call them different things. But in every state, it's essentially a government board that's staffed by doctors or nurses or pharmacists, sometimes a few patient representatives, but it's essentially the profession regulating the profession. So consider that as well when you ask whether licensure is rigorous enough, whether it's doing what we want of it. It really is a field of self-regulation and has been for some time. So the other issue of course with licensure, let's talk about what it's trying to achieve and some of the limitations of it. It's clearly trying to achieve a baseline level of competence, and thereby serve health and safety and medical quality goals, setting basic uniform standards for education, for knowledge before somebody can enter the medical profession, and that's kind of it's best-case aspirationally. It makes the field harder to enter. So the standards should be higher. We're not letting just anybody into practice medicine or to practice nursing or other healthcare professions. So we think that that achieves a quality bump as well. It also helps define in ways that can be problematic going forward. It also helps curve up the practice of medicine by eliciting what physicians, and defining who physicians are and what they do in contradistinction to what nurses do, in contradistinction to what physicians assistants do. So there's a field specification that starts with the licensure determination which is subject of heated debate right now. Some people think that those delineations are too dramatic and actually hurt the efficient practice of medicine. Other problems with the licensure regime. I think the most inherent problem is that it is an upfront standard-setting. Somebody has to achieve this before they start their career. So that's good, at the start of their career. What happens years in, decades in, when maybe the best practices have changed, maybe their skills have diversified, how do we ensure ongoing quality of care from a given individual provider? Well, we don't get much help from the licensure regime. We're going to have to look to other legal interventions like the medical malpractice standard there. So that's an inherent limitation to any upfront licensure regime is, where is the recurring quality control going to come from? Now, some states have institutionalized continuing medical education requirements which attempt to get at this, but really no state imposes a rigorous re-examination that's anything like the original examination. That's true of medical care, that's true of driving as well, and it's just a problem with upfront licensure regimes. The other problem in the health care context does come from the fact that this is still a creature of 50 different states. Sometimes a provider can run a foul of a licensure board. They've behaved so badly in a given state that they receive professional sanction after hearing with the medical board. They can pick up and move to another state which may license them without full awareness of their conduct in the original state. This is a well known problem with state-by-state licensure. It's something that I think state boards are more cognizant of and in a world of data transparency are somewhat more able today to weed out than they were a decade or two ago. But it remains a problem when you have multiple licensing entities as opposed to a single national entity like many other countries do around the world. So this is the way licensure will continue for individual physicians. Let me talk about a few wrinkles here. One thing that is national is a private standard setting credentialing called Board Certification, which many of you are familiar with and maybe you possess board certification in certain specialties. Importantly, these are national certification entities. They're not technically government boards at all, although sometimes they act symbiotically with government regulation of health care. These are private entities that the board of a certain specialty which are national entities. So that's a uniform standard of certification that many individual providers access. It is different from licensure and operates from a legal perspective different from licensure. Likewise, another field that's becoming more nationalized in a world of real concern about opioid, addiction, and controlled substance use and abuse is physicians who prescribe medications that are scheduled on the federal controlled substances act. A certain types of pain killers and opioids would be exhibited here. Those physicians are regulated by the national government as well as by their own state governments. So there's enough of a concern about how these substances are distributed, and there's a federal statute called the Controlled Substances Act which gives the Federal Health and Human Services Department and the Federal Attorney General power to regulate and enforce physicians directly. So that's another exception where regulation in that area practices more national. Let me talk a bit about hospitals, which likewise, are subject to the same regime of state-by-state licensure but also have a big federal overlay to this. So in every state, there are licensure requirements for hospitals, for insurance companies, for HMOs, and these come with very rigorous requirements and frankly more so than with individual physicians come with ongoing certification and registration requirements as well. This has been spurred by federal law. So a lot of the federal funding, be it for hospital construction under the Hill-Burton Act and related statutes as well as federal reimbursement under programs like Medicare and Medicaid, require hospitals to have all the appropriate state licensure. They even often, many of these federal statutes, also require a private certification, now called the Joint Commission, formerly called the Joint Commission on Accreditation of hospitals. That's a private national organization that does site inspections and quality control checks on hospitals. In order to receive certain private and public insurance funds, hospitals have to be accredited under that private organization as well. So what we see in the realm of hospitals is that somewhat more complex mix of state law and national federal statutes as well as private-national agencies like the Joint Commission involved. But really throughout this topic of licensure, what we have is a regime that operates most stringently, most substantively at the beginning of a person's career. That's all well and good. But as we've seen, there's some limitations about licensure and protecting patient safety as a physician goes through his or her career. For that, we're going to need other legal interventions to make sure that the quality of care, in the moment, meets a certain standard. That leads us to our next topic, which is medical malpractice.
