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ProceedingsNational Summit on State Regulation of Health Professionals in the 21st Century
Sandra Greenberg: This session will examine policy issues and key questions associated with scopes of practice: who decides, and how are those decisions made. To address the issue we have four speakers coming from various perspectives. To begin, I'd like to introduce our first speaker, Dr. James Winn, who is Executive Vice President of the Federation of State Medical Boards of the United States, Inc., a national organization comprised of medical licensing and disciplinary boards in the United States, the District of Columbia, Guam, Puerto Rico and the Virgin Islands. Dr. Winn is a charter fellow of the American Academy of Family Physicians and a former diplomate of the American Board of Family Practice. He has served as a member of the National Board of Medical Examiners, the Texas State Board of Medical Examiners and the Quality Assurance Committee of the Texas Medical Foundation. He is also a former member of the Council on Graduate Medical Education's work group on international medical graduates. Currently, Dr. Winn sits on the Executive Committee of the National Practitioner Databank as well as the Composite Committee and the Budget Committee of the United States Medical Licensing Examination.
James Winn: I think one of the things that we want to do today is to visit a little bit about some of the issues surrounding the scope of practice. The moderator has asked that we provide some thought provoking and perhaps provocative comments and I'm certain that everyone here will not totally agree with what I have to say. But perhaps it will be fodder for our discussion later this morning.
Now I think that we all agree that health care in the United States today is being reengineered and that probably the reengineering is mainly attributable to economic factors driven by a managed care environment. The way we deliver patient care is being transformed. There are increasing pressures to cut health costs by looking to alternative practice models and alternatives to what traditionally has been the practice and sometimes a very costly way of practicing. Because of all of these factors you're going to see an increased push to expand the medical scope of practice of non-physicians. You can also expect to see continued so called turf battles where physicians and non-physicians go head to head about who can, in fact, deliver health care and in what area, as well as turf battles between medical specialties which perhaps have been around since medical specialties were first created. Now as regulators it is our mandate to provide public protection. Our concern sh ould be that patients receive care from providers that have actually met a minimum level of competence demonstrating that they can, in fact, deliver health care services safely. The public is not going to be well served by competition among caregivers and in order to prevent a fragmentation of our health care delivery system we must actually work towards a complementary system of disciplines that will meet the future health care needs of our society.
Medical practice acts define the regulation of the practice of medicine. I thought I would spend a little bit of time talking about how medicine is regulated because almost all of the other health professions have derived their practice acts from the medical model. Medical boards are the granddaddy of all licensing authorities for health professions. Most of the medical boards in this country have either been in existence over 100 years or are approaching 100 years of active regulation. Now the medical practice act is the statutory authority by which the medical board acts. And the medical practice act can, in fact, cover selected non-physician providers such as physician assistants. As I mentioned, all licensed providers generally are covered by some type of similar practice act although many of these are not quite as comprehensive as the medical practice act.
The licensure of physicians in the United States actually began in colonial days with the first laws that required a licensing examination for physicians and that law appeared as early as the mid-1700s. Since 1956 the Federation has maintained and promoted a model practice act called The Essentials of a Modern Medical Practice Act. That document has been revised at least seven times and is currently undergoing a comprehensive revision. That promotes to medical licensing authorities the ideal guide of a medical practice act. Common elements in these acts include a definition of the practice of medicine, how the Medical Board should be composed and, in fact, today we recommend that there are a significant number of public members of Medical Boards. With only a few exceptions Medical Boards in this country have adopted that regulation and do include public members. It also would set up the requirements for receiving a medical license, the definition of what prof essional conduct is and how the board can enforce the medical practice act and discipline physicians. It also requires compulsory reporting and investigations. Now this can be somewhat controversial but the Federation supports the responsibility of physicians as well as other health care providers to alert the medical boards to problem physicians. The other elements include requirements for registration and re-registration, impaired physicians treatment, the funding of the medical board, how fees are collected and distributed, and regulation of non-physicians such as physicians' assistants. I think it's important to remember that medical licensure exists to protect the public. It assures a minimum standard of competency. It sets up the educational requirements, training requirements, examination requirements and I like to point out that at least for medicine there are three critical points that go together to form the basis for medical licensure. I call this the triad of medical licen sure and it's a fact that an individual has attended and successfully completed a course of study in an approved medical school. That person must also then complete a required amount of postgraduate training and pass a rigorous examination to validate the training and educational experiences.
Licensure cannot be accomplished simply by passing an examination. It is impossible to devise an examination that would adequately evaluate the total medical school experience or the training experience. It is important to remember that the medical practice acts do set out what these minimum requirements should be. It is important to note that medical regulation is not designed to limit manpower or to address manpower issues. The primary mandate is to assure that the applicants for licensure have achieved a minimum standard based upon the appropriate education examination and training requirements. And that by demonstrating that they are deemed to be able to safely deliver health care.
Well, let's talk a little bit about the philosophy of professional licensure based upon the fact that it's a privilege and not a natural right. Consumers should be protected through licensure. That's the entire basis for this. By insuring minimum qualifications have been met and the scopes of practices have been defined, the public can be assured that practitioners offer only those services for which they've been adequately trained and have been determined to be competent in. So we must look at how minimum standards are established. What are the tasks involved in certain professions? What is the cognitive and practical knowledge that's critical to the practice? What are the consequences of a lack of knowledge and skills? And I would submit to you we have to assess what level of risk society would tolerate by allowing an individual to do certain tasks that may or may not be traditionally within their scope of practice.
What is the necessary education and training for that particular profession? How is the best method to examine the cognitive and clinical skills that the person has? And how are outcomes to be measured? Standards for physicians have been established, as I said, for a long time. However, many health care professions are still developing and appropriate education and training standards are also being developed. In The Wall Street Journal yesterday many of you may have noticed a little blurb talking about nurse practitioners. And this little blurb reported that nurse practitioners have increased by 16 percent in 1998 over 1997. But I was intrigued by a quote from Mary Mundinger who is Dean of the School of Nursing at Columbia University. Her quote is "Nurses and doctors are indistinguishable in being able to competently diagnose and manage the kinds of problems patients present in their first visit." Well, that's a pretty broad reaching statement and, if true, s uggests that at least physicians are being terribly over trained and that maybe medical school is not essential. I think what it does point out to me, though, is that there's a terrible need for appropriate data that will validate or not validate these types of assertions. And I think that you can go from nurse practitioners to pharmacy technicians and suggest that pharmacy technicians can, in fact, supplant pharmacists in almost every situation. As a physician who practiced for over 20 years I can tell you that the first visit of a patient is extremely critical. And being able to competently handle that and to assess what needs to be done and do that or to obtain additional examinations or consultations is sometimes a very laborious and exacting task. Now certainly nurses may be able to identify the problem and, in many cases, take care of that problem. But I think to suggest that they are equal to physicians in those abilities is going to require some additional data.
Licensure versus privileging. Licensure actually differs from privileging and I think it's important to talk a little bit about this because this really gets down to some of the issues about scope of practice. For physicians, licensure assumes a minimum level of competence. A medical license is issued for physicians to assure consumers that that individual has obtained a level of competence for the general undifferentiated medical practice. The Medical Board's responsibility is to determine qualifications and fitness for the practice of medicine. Now privileging is actually the responsibility of the profession. Certification by medical specialty boards indicates that diplomates have obtained expertise in a particular specialty. This is based on requirements over and above those requirements for licensure based upon the training received and the education received for that specialty. Hospitals and health care facilities are actually responsible for defining the privi leges and granting the privileges for physicians and other non-physicians and allied health care professionals based upon a review of their training experience, available resources, patient needs, as well as their licensure.
As we talk about modification and expansion of scopes of practices I think it's important to bring up the issue of accountability. The public demands and will continue to demand increased accountability from its health care practitioners. Patients are concerned about cost, accessibility, quality and appropriateness of services rendered, as well as the outcome of those services. State licensing boards provide public accountability through the process of licensure and enforcement and as regulators they are not influenced by economic or other social pressures. At least they should not be influenced by those pressures. Boards have the legislative duty to receive and process consumer complaints and take disciplinary actions when appropriate, regardless of any resulting hardship economically to that licensee. The issue of public protection should always be foremost. What about competing scopes of practices? As mentioned earlier, there are issues between physicians. For in stance, should family doctors be doing Cesarean sections? Or should that solely be reserved for obstetricians? Now, quite honestly, those battles between physicians and different specialties really should not be an issue for regulators unless the public safety is somehow compromised. And since all of these physicians hold a medical license for the general undifferentiated practice of medicine they are accountable for the services they provide. If an individual seeks to provide an expanded scope of services over and above their training, they have to be prepared to defend themselves to the Medical Board in case there is some type of problem or complaint.
But competing scopes of practices between physicians and non-physician clinicians is somewhat more troublesome. The number of non-physician clinicians is growing rather dramatically. There's a projected 70 percent increase in the supply of non-physician clinicians between 1995 and by the year 2005. Moving from approximately 230,000 existing in 1995 to an anticipated 385,000 non-physician clinicians by the year 2005. These include nurse practitioners, physician assistants, certified nurse midwives, chiropractors, acupuncturists, naturopaths, optometrists, podiatrists, certified nurse anesthetists and so forth. When we have expanding scopes of practice there is obviously a shift in accountability. And what regulatory board is the most effective? Who will be ultimately responsible for the patient's care? The issue of who's in charge actually becomes more complex. Physicians have traditionally been held responsible for patient care, particularly from the tort liability standpoint.
As expanding scopes of practice occur, they will shift accountability to other licensing boards. At this point I think it's unclear whether these regulatory boards are equipped to evaluate complaints and issues of quality care in these new practice areas. If a board is designed to evaluate, for instance, a pharmacist and whether they're qualified to provide pharmacy services, can that board, in fact, determine effectively whether somebody has acted appropriately if the pharmacist has now been granted an expanded scope of practice that includes some medical acts? Also, there has to be some recognition of where regulatory boards are in the disciplinary area. For instance, there is at least four to five times the number of nurses in this country as there are physicians. Yet the actions against nurses are only half of what they are for physicians.
There needs to be coordination among regulatory boards and we need to have these outcome studies to know what safely can be done. In Texas they have a Health Professions Council. This is basically a group of regulatory boards that send representatives and talk about some of these issues. It doesn't provide any statutory authority to change things. It cannot make formal policy but simply makes recommendations and has been effective in working out some of these issues. Well, we want to promote uniform standards. I think it's important to preserve state-based regulation. I think it's important to have the dialogue between the disciplines and we should facilitate evaluation of contingent competency. We want to maintain a repository of core credentials. The Federation has done this via the establishment of a Federation credential verification service. And it's important to recognize the public's need for enhanced access to information about practitioners.
Sandy Greenberg: Lucinda Maine, our next speaker, serves as Senior Vice President for the Professional and Public Affairs with the American Pharmaceutical Association, the national professional society of pharmacists. Her division works towards pharmaceutical care system development and key practice policy and scientific areas. Advocacy of the emerging role of pharmacists in all practice settings as a drug therapy manager and as a primary care resource are essential to her responsibilities. This also includes attention to state and federal regulatory affairs. Dr. Maine is a pharmacy graduate of Auburn University. She received her Doctorate in the Kellogg Pharmaceutical Clinical Scientist Program at the University of Minnesota.
Lucinda Maine: I want to share with you what I characterize as a case study of scope of practice changes in two dimensions. I would really like to have you think about the fact that scope of practice changes don't occur just in a single and advanced practice dimension. And pharmacy really is very much at the vortex, if you will, of resolving two diverging scope of practice issues. And I'll speak to the first one in the context of what's happening to the traditional practice of pharmacy. The practice that most of you can relate to and think about is the context of filling the traditional prescription order written by physicians and increasingly a host of other people. Pharmacy has just begun to realize that it is difficult in an era of managed care to keep up with the two point four billion units of production that are the retail delivered prescription units of today. Somewhere between 65 percent and 95 percent of those are adjudicated by third party programs. And there is no question that those numbers are escalating rapidly, expected to be upwards of four billion of those units, up from two point four to four billion just in the first half of 2000 to 2010.
And there's no question that the boards of pharmacy and the profession are struggling simply with the questions associated with how do you regulate the safe, accurate, efficient, patient sensitive drug distribution model? That is, unfortunately, not radically changed over about 150 years. We still get the vast majority of our information on that same four by five piece of information written in sometimes legible handwriting. But there's lots of things happening today as well. The electronic transmission of prescriptions which we strongly recognize as a value added in terms of making the system safer and more efficient. Add to that the continued growth of mail order and just before I went to sleep last night CNN ran yet another segment on my now favorite topic, the online pharmacy. Drugstore.com, planetRX.com and whomever else.com. And we're trying to figure out, as a professional practice association, what those mean.
Add to that also the fact that we have this delegated authority and if pharmacists, , are going to begin to take on some very important drug therapy management roles in an advanced model of practice, to whom do we delegate the patient sensitive, efficient, accurate drug distribution system? Well, increasingly to pharmacy technicians. But there are state laws across the country right now that don't acknowledge that there's a category of personnel known as pharmacy technicians to whom the pharmacist must delegate an increasing amount of the technical, non-judgmental responsibilities of processing prescriptions. In addition to the technicians as personnel, you have technology. I was asked yesterday who actually oversees those automated dispensing machines that are increasingly appearing in long-term care institutions or on the floors of hospital pharmacies. Where there may or may not be a department of pharmacy. That department of pharmacy in some states, in a hospital , isn't even under the jurisdiction of the Board of Pharmacy. So there are enormous questions with respect to simply regulating the changing traditional scope of pharmacy practice. But that's not nearly as interesting as the emerging scope of practice changes. Very much in the dynamic that Dr. Winn mentioned about pharmacists assuming new roles in the care of patients. Central to that is the role that medications play in the amelioration, cure and prevention of acute, chronic and preventable illnesses.
I thought that I would mention three examples for which evidence is accumulating that if pharmacists do these things well then the public is better served or is well served. The first I would mention is in the context of immunization authority. As a country we struggle with third world, in some cases, immunization rates of children. But, more importantly, of adults. And that's really where pharmacists have focused the lion's share of their attention with respect to immunizations for a host of very valid reasons. Right now and it's rapidly increasing, there are 27 states where pharmacists have the legal authority to actually administer the immunization and other medicines. But, for the most part, pharmacists focus their efforts on flu, pneumonia, increasingly hepatitis, diphtheria, the adult immunizations that are either occurring on an annual basis or need to occur over an extended number of years. There are some really good reasons for that. The equivalent of the A merican population walks across the threshold of a pharmacy on a weekly basis, according to some figures. I'm not sure if that's evidence based or not. But we like to use it. We do know, however, that using a five digit zip code analysis of the distribution of pharmacists in relationship to other primary care providers, pharmacists are, in fact, more present in more rural and frontier zip codes than other primary care providers. And they're more co-present with physicians than any of the other primary care provider groups. And so it makes a compelling argument, in some cases, at least we think, for asking pharmacists to take on some roles that may have not traditionally been theirs if access is an issue that we need to deal with.
An interesting and very recently emerging application of pharmacist advanced practice role is in the area of emergency contraception. And I really credit the State of Washington as being a pioneer not only in collaborative practice. Pharmacists in Washington have had collaborative practice authority in their state practice act for 20 years. They have used it very well and they've accumulated an excellent body of evidence that when people are appropriately trained and there's an excellent standard of practice that is negotiated in an interdisciplinary context that the public can be very well served. They have, you might be surprised to learn, in the context of this emergency contraception activity, earned the endorsement of the state medical association for the role that pharmacists have contributed in this area of women's health. And the third area of advancing practice that I would draw attention to is chronic disease management, areas such as hypercholesterol, pat ient management, diabetes, and asthma. It is in that context that collaborative practice authorities now exist in 24 states (after the completion of the current legislative cycle). Minnesota is probably the last state to have earned collaborative practice authority and these authorities look quite different from one state to the other. There's some predominant models certainly but each state is different and that reflects the politics and the practice and the aspirations of pharmacists and other providers in each of those states.
I would contrast the experience in Minnesota with the experience of our colleagues in Pennsylvania. Pennsylvania does not have, after three or four or 100 years of seeking it, a collaborative practice provision in their state pharmacy practice act. What did they do differently? Minnesota went initially and got the act of the profession of pharmacy together. They had a task force comprised of people from the state association, state pharmacy association, the retail federation, the hospital association, the college of pharmacy, the board of pharmacy and they sat down and they said, "What do we aspire to do? And who does that influence?" The next cycle went out to that sphere of influence and they sat down with medicine and nursing and, hopefully, the regulatory authorities in each of those contexts, before they approached the legislative officials who might carry a bill through discussion and action. It was only after they had secured an agreement through some comprom ise, didn't get everything they initially said they wanted to have, but they achieved their ultimate objective. They took it to the legislature and though the whole process occurred in approximately two years, the passage of new practice act occurred in a single session. And in a single busy session with the new governor there to oversee it.
Pennsylvania, in contrast, also started three or four or five years ago and they originally thought that they had pharmacists acting together. But that has subsequently dissipated. They had a tremendously difficult time, probably because they didn't approach it very well, in negotiating a relationship with medicine. And pharmacy has a very interesting influence as we begin to address issues of state practice authority from our colleagues in the pharmaceutical industry. And I think that the important lesson learned across many states is that the industry is often the agitator to bring forces opposing changes in pharmacy scope of practice to the attention of other colleague professions. They're often the people that come to medicine and say, "Have you heard what those pharmacy folks want to do?" Why do they do that? Well, I really try to figure that out myself, accepting there's kind of a love/hate relationship between the producers of medicine and the people who are central to the supply chain and that's because those people in the supply chain have been so effective in many cases in implementing things like generic and therapeutic interchange consistent with state law and managed care practice. So the industry inserts itself in the politics of practice discussions in a way that I hope most people in this audience would think was not exactly within their scope and authority to do. But that's the reality of what we've learned. One other interesting example that I don't believe has even actually been introduced in North Carolina yet. is that their state pharmacy association is approaching their collaborative practice authority via a change in the Medical Practice Act. And, obviously, they're doing that in a collaborative venture with the people who are closest to the control of that Practice Act. And that answers I think some of the issues, or at least they're attempting to answer some of the issues, that Dr. Winn addressed in terms of under whose authority does this expanded practice ultimately rest.
As we've gone through the changes in the various states and at the national level, the sensitivities of medicine and nursing and other disciplines and the industry have become acutely obvious to us. And the fact is that we must initiate the dialogue, not in the legislative and not in the regulatory context necessarily, but as colleagues sitting down with an interest of our patients at the local level at the heart of our discussions. I think that pharmacy is a little bit vulnerable, not withstanding the fact that there are a number of good examples of practice standards, but I would say right now that we lack as a profession a universally recognized set of standards of practice that are embraced and agreed to by all of the significant players. That's a practice standard that relates to the traditional practice of pharmacy and practice standards related to the advance practice of pharmacy.
Again, there are good examples of practice settings specific standards but I don't think we've yet achieved an across-the-board understanding of the various roles of pharmacy. I think the other thing that influences the dynamic of pharmacists changing scopes of practice again, is a corporate influence that is somewhat unique to the profession of pharmacy given the retail and business persona that we have had for so long and continue with. On the one hand, we are blessed with having 55,000 units of retail pharmacies. Almost every place patients can access a well trained, licensed and regulated health care provider who has as its social object something that they hold dear, a prescription medicine. But at the same time people recognize that we are for profit businesses in many cases and are motivated as for profit business people in many cases. And there's a question mark about what's really driving any of our changes in scope of practice with respect to the business motivations. It's also widely recognized that managed care has taken all of the money out of dispensing prescriptions. I don't even think physicians want to do that anymore. And so what do pharmacists look to for their future to keep those 55,000 health care facilities viable out there in the marketplace?
I'll close with just a couple comments about the role that a national initiative could play. I draw your attention to the fact that NABP, our National Association of Boards of Pharmacy does, in fact, maintain a model practice act that I hope is useful to the various states. I characterize it as a unidisciplinary model practice act. I'm not sure the extent to which they engaged any other disciplines in a discussion about their reaction to what we set forth. It's a very progressive practice act, acknowledging the various roles that I've mentioned here. I think about the need for rational health policy which I'm not sure we have at the national level. I think in some cases we've achieved it at the state and local level to a much more significant extent. I live in Washington, D.C. which my husband characterizes as 36 square miles of illusion surrounded by reality. And I know from seven years of experience at the National Professional Society of Pharmacists that when we try to engage our colleague profession organizations we have a difficult time achieving consensus about changing roles and expanding roles in safeguarding the public health. Because I think we fail to do the most important things: to bring the evidence that does exist into play in a convincing way. But I would maintain that as strongly as I believe that we need research to underpin our discussions, that that is hard, hard research to do. It's timely and it's expensive, and as somebody characterized for me one time, if we did the ultimate, randomized control clinical trial of pharmacist services the FDA would ask us for a second study. Because that's their standard of evidence. And I'm convinced that the Congressional Budget Office and everybody else in the world would ask for the same thing.
And I would also ask the question what comes first - good changes in practice or regulation? We changed our practice act 10 years ago. But practice hasn't changed profoundly to follow up on that. So I think practice probably has to precede changes in regulation except at the point which my colleague, David Swankin, mentioned to me yesterday. There are some real public health issues involved, public protection issues. And my last comment is that all of this has to be driven by our goal. And our goal is to improve patient care. And I think central to pharmacists changing practice is the acknowledgment which we have made as a profession that medicines are not managed very well in our modern medical care system. In part that's because 35 years ago when the predominant financing and organizational mechanisms for health care were designed, Medicare and Medicaid at the public level, patients got their care in hospitals. They got it and they went home and you didn't have the preponderance of long-term patient management issues of chronic disease. You didn't have an armament of incredibly powerful and increasingly expensive d rugs to bring into that war. And I don't believe that their models of practice have caught up. That really needs to be the focus of our scope of practice discussions in pharmacy and with medicine and with other disciplines that are involved in the medication use process. I think we need to create a philosophy of best use of available personnel but, quite frankly, I don't know how you regulate that. Because that best use will very much relate to the local phenomenon of who is available and what are the needs of the community. Because health care is, after all, local.
I think that some national dialogue, maybe between the regulatory authorities could be beneficial to helping create some uniform understanding of what's in the best interest of patients. But I hate to picture inviting APHA and AMA and all of the other As to that discussion because we probably couldn't agree. But I would hate the regulatory authorities if they didn't invite us. Maybe if they asked us to send some of our best patient care providers to the discussion, people who were invested deeply in the team approach to quality patient care, then a productive dialogue would, in fact, ensue.
Sandra Greenberg: Our third speaker is Dr. Rob Alder. Rob has a Master's degree in medical science and a Ph.D. in epidemiology. He also has graduate level training in financial management and governance in health care. Until 1997 he was the chief epidemiologist for the City of London, Ontario, with a faculty appointment at the University of Western Ontario. Dr. Alder has researched and published on issues including disease surveillance and health services planning. He has served as a consultant and lead editor on health services reviews in Malaysia, India, the Sudan and the Northwest Territories of Canada. Currently, he is Chair and CEO of the Health Professions Regulatory Advisory Council of the Ontario Ministry of Health.
Dr. Rob Alder: I want to talk to you about determining health profession scopes of practice in Ontario. And I really have two components to this and that is who decides and how. Well, who decides is the Minister of Health. He or she is the, from the point of view of the health sector, government. The Minister of Health is a member of the Cabinet and the Cabinet is headed by the Premier and the Premier would be your Governor counterpart. So the decision about changes in scopes of practice and who gets regulated and who gets deregulated is a decision of the Minister of Health. It requires legislative changes and therefore, obviously, it takes government officials to do that.
The body that I head up, the Health Professions Regulatory Advisory Council (HPRAC), advises the Minister on these decisions. So the Minister decides and HPRAC, our body, advises. The legislation is one entire piece of legislation called the Regulated Health Professions Act, which set up the organizational structure and the operational functioning of the regulatory system. That sets the framework under which each of the professions, there are actually 23 regulated health professions in Ontario, regulated by 21 colleges. There are two colleges that regulate more than one profession. For example, audiology and speech language pathology are regulated by one college. In addition to the RHPA framework each of the individual professions has a profession specific act. And that profession specific act spells out essentially, among other things, the scope of practice. It indicates, for example, the title that is protected. It has a statement on the general scope of the profe ssion. And it also indicates the acts, the actual controlled acts, that profession is authorized to undertake.
In our legislation, the Regulated Health Professions Act, we have a list of some 13 controlled acts. They are, for example, communicating a diagnosis, performing a procedure below the dermis, setting or casting a fracture, moving joints of the spine beyond the usual range, administering a substance by injection and so on. There are 13 controlled acts and each profession will have one or more of those controlled acts authorized. They will be authorized to administer one or more of those controlled acts. Now there are some professions that, in fact, have no controlled acts. But they are still regulated under the Regulated Health Professions Act. For example, dieticians have no controlled acts. But, nevertheless, they are regulated under the Regulated Health Professions Act. So in total we have in this system 22 pieces of legislation. The intent of this design is to facilitate changes in scope of practice or changes in which professions are regulated. So if a professio n wanted to increase or change their scope of practice then one simply has to open that specific act. Not the whole system, not the whole Regulated Health Professions Act, just that act is opened and the scope changed. If you want to introduce a new profession, you drop in another act. But the framework still applies. If you want to take out a deregulated profession you take one off but the framework still applies. So it's designed so as to accommodate changes in scope of practice because if you open the whole piece of legislation, the whole framework, then there will be somebody out there that says, "By the way, while you're opening the act, we'd like to have a change over in this little corner, over in this one." We just want to look at that specific profession and the scope of practice in that particular act.
The system is administered by the Minister. In fact, the Minister has powers here that essentially can require the colleges, the governing boards, to do anything that in the Minister's view is important for fulfilling the public interest intent, of the legislation. And that tested about 10 years ago when the government of the day was negotiating with the Ontario Medical Association about fee structures under the Ontario Health Insurance Program. And, as I recall, the physicians were saying, "Well, fine. We'll opt out." The government said, "Wait. You're not going to opt out. That's against the Canada Health Act, against the whole concept of universal availability and things of this sort." So the government approached the College of Physicians and Surgeons and said, "You will stop opting out. You will stop opting out." And, indeed, they stopped opting out. So that demonstrated or tested the system, the power of the Minister, and showed that, indeed, that power is the re.
The colleges themselves are autonomous corporate bodies without capital share. Their funding is by and large predominantly from the fee structure. They are directed as a board of directors, in a sense, by the college council that has professional members elected by the profession itself and public members appointed by the government. In all cases the proportion of public members varies by profession as spelled out in the profession specific act. But in all cases the professionals will have the majority. My understanding is most colleges have close to 50 percent public members in Ontario. The colleges have a regulatory function, not a policy function. Their function is in registration and complaints and disciplines, incapacity, quality assurance, patient relations programs, setting standards of practice and clinical guidelines. They have latitude to set regulation under their profession specific act but that regulation is approved by the government. They can pass byl aws for their activity. The decisions of the complaints committee or registrations committee in the councils can be appealed to the Health Professions Appeal and Review Board. This is a tribunal body. And then decisions of that board can be appealed to the court. So that's an appeal mechanism that is in the system. The Health Professions Regulatory Advisory Council is funded by the ministry. It operates with a specific budget and must concur with or comply with administrative policy or administrative guidelines of the ministry. But it is at arms-length and I'll get into that a little bit more in a moment. It's responsible for advising the Minister on which professions should be regulated, which currently unregulated professions should be regulated, which currently regulated professions should be deregulated and changes in scope of practice. Currently, we have a statutory mandate to evaluate the effectiveness of the complaints and disciplines process as it relates to sexual misconduct, the quality assurance and the patient relation programs of each of the 21 colleges in the system. Also it will advise the Minister on anything to do with health regulation that the Minister refers to it. And one of the big referrals we're working on right now is a review of the system. This system has been in place for five years. We are now undertaking a review of the entire system, looking at the effectiveness of the system in terms of holding professions accountable, of protecting from harm, enhancing quality of care, at efficiency in the system, at the flexibility and indeed the fairness in the system. So all of that will be part of the review. So, in a sense HPRAC is somewhat like the National Policy Advisory Group that the Pew Commission recommended. Except at this point this is specific to Ontario. In a sense, it's also like the state level oversight body. To a limited extent, we have a statutory obligation to evaluate these various programs of the colleges.
The system generally works. It has been a bit of a rocky road but nevertheless these evaluations have been proceeding and, by and large, proceeding quite well. Let's focus in a bit more on HPRAC itself and its organization. The Council at HPRAC reports to the Minister through the Chair. I end up briefing the Minister three to four times a year and also am in contact with the Minister's office on a fairly regular basis. We interact in terms of the wording of referrals to us prior to referrals and things of that sort. The Council has quite a substantial budget for bringing in consultants, specifically to the evaluations, and we also bring in project specific consultants on various specific projects. The Chief Operating Officer manages the lineup of policy advisers or policy analysts that are in the council. These are appointed people, Ministry people, public service individuals. The members are appointed by the government and compensated by honoraria. There are criter ia for the appointments to the Council one of which is that the member is not a member of a college or a college council. So it's a neutral body. And this is important for the fact finding alternative dispute resolution that we undertake. The members must not be public servants. It's an arm's length from the Ministry so we can carry out our deliberations in a process that we define. A third criteria is premium education so we have high level thinkers, diverse, relevant experience and you can see that we have an epidemiologist health institutions administrator, health economist, consumer affairs specialist, political scientist. Northern Social Services and bioethics is also represented.
In identifying these individuals we also look for a track record of wisdom and lateral thinking and ability to withstand lobbying groups. The previous Chair, in fact, was invited to a dinner by one member of one of the groups pushing for regulation of traditional Chinese medicine. And her picture ended up subsequently in a newsletter and that group was arguing that they were on the inside with the body that advises the Minister and therefore likely to get some favors. So we've very sensitive as to how we are approached and interact with stakeholders in the process.
I've talked about the who. Let me move to the how. We established principles and criteria for the regulation of professions and these are established by HPRAC, identified in the legislation, communicated so all the stakeholders know that these are the principles and criteria by which we make decisions. And we use these as a substantive framework for the fact-finding role that HPRAC carries out on behalf of the Minister. Let me get into the public interest principles. These are actually legislative objectives that you can find stated explicitly or implicitly in the clauses of the legislation. There would be protection from harm, a high quality of care, accountability of professions, accessibility. So in the case where optometrists are seeking expansion of scope of practice to include prescription of therapeutic pharmaceutical agents, HPRAC would develop questions around this. For example, what is the risk of harm that would be associated with optometrists having that particular expansion in scope of practice? What would be the impact on the quality of care offered to the public? And those questions then are put out to all the colleges, all the professional associations. Indeed, we have a mailing list of 1,100 that deals with patient advocacy groups. And all of the responses to those questions are shared among participants in the process. And everyone gets to comment on the other person's position. Ultimately, we're trying to find information here. The same kind of approach is used when we look at determining new professions that want to be regulated. We look at the relevance of the profession to the Minister of Health. Are they dedicated to promoting, maintaining, establishing health? We look at the risk of harm, sufficiency of supervision. Paramedics, for example, are well supervised by physicians currently in Ontario. So maybe they wouldn't fare very well on that particular criteria. We look at alternative regulatory mechanisms. Also in that co ntext we look at other jurisdictions. Staff are very much involved in looking at the regulation of other jurisdictions. We look very closely at evidence of effectiveness and at literature, both mechanistic and empirical evidence of effectiveness in certain treatment and diagnostic modalities that are included in the profession. We look at the educational requirements and the body of knowledge. How do they teach their body of knowledge and their standards of practice? We look at leadership's ability to favor the public interest over the profession's interest, likelihood of compliance, size, willingness to commit. These are criteria that we use in this process. The process starts with a profession requesting to the Minister that they be regulated under the Regulated Health Professions Act. The Minister refers that request to HPRAC who in turn provides the applicant with the request for information package and they provide a written response to the nine criteria I just outlined. HPRAC wo uld then notify the public through public advertising, the media, that this application is in place. It provides all interested participants with the applicant's information or their completed request for information. Written submissions from all participants are analyzed by HPRAC. We identify outstanding issues, move to public hearings and then there is an opportunity for the applicant to rebut any other association's comments. We identify outstanding issues that we'd like people to debate and dialogue. In the end the staff are also doing literature searches and searching the internet and things of this sort. Ultimately, we bring together a body of evidence that we as a council use or take under advisement in putting together recommendations to the Minister.
We do have the evaluations of the complaints and disciplines process, quality assurance and patient relations programs of each of the colleges. So that's looking at the effectiveness of each college's programs. And we also are undertaking a review of the entire system on these particular points. In the end, what we will do through these evaluations in this review is essentially hold the system accountable. We can identify weaknesses in the system and ultimately make recommendations to the Minister for improvement or strengthening of the system. So, in summary, who does it? It's the Health Professions Regulatory Advisory Council, that advises the Minister who makes the decision on changes in scope of practice and determining regulation. How do we do it? We have principles and criteria that we establish. We communicate and use as a substantive framework through which we do fact-finding as, by the way, recommended by the Pew Commission. And then the evaluations essenti ally look at the system as a whole and identify areas for improvement. That review is currently underway or about to get underway and we anticipate wrapping up the review and all the evaluations at the end of next year, the end of year 2000. And at that point we can maybe come back and tell you whether the system that seems to be very close to what the Pew Commission recommends, is working in Ontario.
Sandra Greenberg: Our final speaker for this session is Barbara Safriet. She's been an Associate Dean and Lecturer in Law at Yale Law School since 1988. Prior to that she was Professor of Law for 12 years at Lewis and Clark Law School in Portland, Oregon where she taught administrative, constitutional and health law. She currently teaches a seminar on the topic, "The Regulation of Health Care Providers" at the Yale Law School. Barbara earned a Bachelor's of Arts degree in economics from Goucher College and her Juris Doctorate degree at the University of Maryland School of Law and a Master's of Law degree from Yale. Her journal articles include "Health Care Dollars and Regulatory Sense," "The Role of Advanced Practice Nursing," and "Impediments to Progress in Health Care Workforce Policy, License and Practice Law." Ms. Safriet has lectured extensively on the issues of health care professionals' licensure and regulation and health care workforce problems. She s erved as a member of the Pew Health Professions Commission and on the Taskforce on Healthcare Workforce Regulation which was responsible for the document Strengthening Consumer Protection
Barbara Safriet: We thought it would be best if I went last because as a member of the Pew Commission and specifically, this task force, I think the comments that you've heard this morning and the different perspectives presented really in some ways reflect what the Pew Commission and the task force specifically started with. Which is looking at profession specific issues and problems and examples. Looking at regulatory structures both in this country at the state level, federal level, and also in other countries. Trying to extract guiding principles from all of that and rather than saying this is the way to do something, rather to say these are the issues. These are the principles. Here are some options from which to choose as you go about trying to deal with what we all thought was a very significant problem.
It is not debatable really that there is a need for some rationalization of our legal apparatus that sets out scope of practice for all kinds of health care providers. It may be driven in part by financial implications. But let me assure you that issues about scope of practice have been with us since at least the late 60s and early 70s and many a lawyer has made quite a fine living arguing about whether or not the ankle is part of the foot or the body. Because if it's a part of the foot legally a podiatrist could deal with it. If it's not a part of the foot then the podiatrist couldn't do it. This argument has gone on in every state for years and years and years. Similarly, questions of can only dentists make dentures? When I was in Oregon this was a huge issue and millions, seemingly, of dollars were spent on whether denturists make dentures. This was not driven by the new focus on health care financing. This was 15 years ago.
There are arguments in every state on whether or not an optometrist can prescribe drugs and administer drops. I'm not a health care provider of any kind, by the way, so don't look for technical expertise from me. But on whether or not optometrists can prescribe drops for very common, well-known, well-identified eye problems. Fights between optometrists, intriguingly, not ophthalmologists, but all physicians. Since any physician by law can prescribe those same drops. Whether they're competent or not is a different question, but by law and that's what we're talking about here, is legal scope of practice. So these issues long predate the current fussing and bothering over financing. Rather they strike at the heart of the issue of who is authorized and who is able. The real issue and it led to the forming of this whole task force, at least the question of scope of practice, is we have an increasing disjunction between legal authority and clinical ability. The law says w ho is allowed, but it has not kept up very well with the question of who is able. The source of the problem goes back to the turn of the century with the creation of the medical practice acts and their total usurpation of the field of medicine and defined medicine as all things health. In fact, medical practice acts speak only to disease, deformity, defects. They don't speak to health. But let's put that quibble aside. Let me read you a medical practice act which I shouldn't have to do for this body, but I do it every time I speak on this issue. And I used the Medical Practice Act more often than the Constitution. Here's the definition of the practice of medicine: "A person is practicing medicine if he does one or more of the following: offers or undertakes to diagnose, cure, advise or prescribe for any human disease, ailment, injury, infirmity, deformity, pain or condition, physical or mental, real or imaginary, by any means or instrumentality." That is only sub one. Sub two "adminis ters or prescribes drugs or medicinal preparations to be used by any other person" and sub three "severs or penetrates the tissues of human beings." That sets the stage for the scope of practice issues. Yes, it is about money ultimately. But the stage was set 100 years ago with these all encompassing medical practice acts which staked out the whole field and said this is medicine, only physicians can do it.
So when other professions, quite able professions, sought to have legal recognition of their ability to do this they did what? They bumped up against the total usurpation of the universe of health and illness which was included by law in the Medical Practice Act. That's why we have the turf battles, the legal battles, each and every day because when clinical psychologists, podiatrist, acupuncturists, advanced practice nurses, Physician Assistants, you name it, try to have legal recognition of their practice, of their ability, they have to go to the legislature and usually subsequent to that an administrative agency to carve out from that which is deemed to be the practice of medicine. That's the history of this.
The resulting laws are overly inclusive for physicians' scope of practice. It is totally undifferentiated and universal. Let me be the first to say that there are many constraints so that physicians don't practice beyond the scope of their ability most of the time, in fact, the vast majority of the time they don't. But it's not the law that constrains them. It is their professional ethics. It is their training. It is the credentialing system. It is the institutional credentialing system. But it is not the Medical Practice Act or the Board of Medicine that keeps them from doing that. You can't practice beyond the scope of your authority as a physician. It is impossible. You can practice beyond the scope of your ability and most physicians don't. But you see, most other kinds of health professions don't either. Their problem is not ability, their problem is authority. They have too little legal authority because law always drags behind developments. It's quite static. And you have under-inclusiveness for most every other kind of health professional and I refuse to call them non-physicians. They're not non-physicians. I'm a non-physician. What has that told you? Nothing. They're chiropractors. They're podiatrists. They're advanced practice nurses. They're clinical psychologists. But by having physicians and non-physicians, you're once again stating the norm as the physician as the provider of all care and making all the "non-physicians" other. That is culturally wrong. It is epistemologically wrong. And it is legally wrong. You want to be provocative? That's the point right there.
Now let me just tell you one final legal problem that comes out of all of this. Putting aside the millions of dollars that have been spent throughout this country in the last 25 years fighting over these battles of not who is able but who is authorized. It's a real catch 22 for any other kind of health care provider other than physicians. Because their scope of practice is this big and if you're trying to argue we want to expand the legal recognition of our proven abilities, if I were a regulator what would I say? I'd say how can you can tell me you're competent to do this? My job here is to protect the public. Well, the system we have now forces groups, at least in the main, to stand up and say, "We've been practicing beyond the scope of our authority quite safely. Here's the documentation. Here's the documentation to say 'I've acted in an illegal manner.'" As you might imagine, people aren't jumping at this chance. And that is intrinsic to our licensing scheme for all kinds of health care providers other than physicians.
If you have a constrained scope of practice defined in law, how do you go about having a proof that you're capable of doing it? Without standing up and saying, "I'm a felon." Well, there are a lot of ways. What we try to do in this was recognize that that is at the nub of this legal issue on scope of practice. We tried to give in the Pew Report some alternatives, including demonstration projects and pilot projects, to say yes, go ahead, practice beyond the scope of your, at the moment, static legal authority. Under controlled circumstances with lots of data gathering and safety devices built in. Should be the norm. But that's an alternative. Another alternative we tried to come up with is using Alternative Dispute Resolution to referee these turf disputes. I can't tell you how many legislative sessions I've been in and rulemaking proceedings where typically physician groups would say "they cannot do that." And a legislator or an administrator would say, "Well, why n ot?" And they'd say, "Because we do that. That is medicine. If they want to be doctors let them go to medical school." Well, that's not the issue. I would hope most people who want to be doctors do go to medical school. I would hope that most people who want to become certified nurse midwives go to those schools. And there is a recognition now, quite well demonstrated, that functional capabilities are extremely overlapping but our scopes of practice embedded in the law tend to be mutually exclusive. That's the nub of the legal issue here. And I think the reality is we need to have more uniformity. That's why we proposed at least one alternative of having a national body to gather information and data and share it to all the states on practice abilities, clinical abilities, demonstration projects and the rest, leaving it to the states. But there should be more uniformity. There shouldn't, as a logical or even intuitive matter, be wide variation in what a person as a member of a license d profession's competence is to treat physical and mental conditions of people. Diabetes is not different in New Mexico, I would hope, than it is in Arizona. Yet in one state some nurse practitioners can treat on their own and prescribe, in another state they can't. The same circumstance. This doesn't make a whole lot of sense. And the worst thing possible is it forces a diversion of very precious resources. Highly trained health care professionals who have to spend their time fighting in the legislature, fighting in the administrative agencies about having a legal cloth put around their demonstrated competencies. They have to spend hours and weeks and months doing that as opposed to dealing with the patients that they trained to serve.
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