National Summit on State Regulation of Health Professionals in the 21st Century

Welcome and Keynote: Overview of Changes

Linda Siderius: Good morning. I would like to welcome all of you to this Summit on the Regulation of Health Professionals in the 21st Century. I acknowledge and really admire the diversity of participants that we have at this conference. There is a wide array of organizations and people who are here today with amazing amounts of expertise and knowledge in the area of regulation of healthcare professionals. I notice there are some people from the "old guard" if you will of regulation of healthcare, as well as many new faces, and I hope that we will draw on all of the ideas that each of you bring to the table. We will turn now to comments by our panel this morning. Before we do that, I just want to encourage all of you that this is a time, as a conference to "think outside the box," to be creative, to be challenging and to be controversial. It is a "no holds barred" conference where I hope lots of ideas will come to the table. I hope we will foster that creativity. We have a lot of speakers who have a lot of information to give to us. I hope you will ask questions and have a frank and open discussion about where we want to see regulation of healthcare in the 21st century. Our first speaker this morning is Dr. Troyen Brennan. Dr. Brennan received an MA in Philosophy and Politics at Oxford University, a MD and MPH was earned at Yale's School of Medicine and a JD from Yale Law School. He is a professor in Law and Public Health at the Harvard School of Public Health. In addition, he is the Professor of Medicine at the Harvard Medical School. He is a physician at, and the President of, the Brigham and Women's Hospital and Organization. Dr. Brennan is also a member of the Pew Health Professions Commission.

Dr. Troyen Brennan: (click here for overheads from Dr. Brennan's presentation) There are a number of people who are speaking at the conference who have been associated with us on the Pew Health Commission and that is the capacity in which I am here today as well. I do not want to go over the Pew Health Commission report in detail. Instead what I want to do is to provide perhaps a little bit of context. This presentation will be a little bit about our task force on work force regulation and as I said there will be a number of other people speaking today and tomorrow about these issues.

Our commission went back over the old information from the previous task force and deliberated very seriously on the regulatory issues especially around quality of care. The result is we issued a report, Strengthening Consumer Protection, a little of which I will go over today, and in addition putting that into some context. Our report's purpose was basically to try to engender legislation and debate about these sorts of issues, so we intended it to be a resource tool for legislatures and we wanted to outline what we thought basic reforms would be. The key areas we looked at, and we will come back to these, are the relationship of boards and the governance of boards, the scopes of practice that those boards look after, and issues of continuing competence. Those are the three areas of focus for us: board and governance structure, scopes of practice and continuing competence.

I wanted to try to outline a little bit of why we were interested in those things but in order to do that I want to take a step back and put us into some context so we can understand why it is these regulatory issues are so important today. As a Professor at the Law School and the School of Public Health at Harvard, I have to lecture about healthcare reform and I like to break it down into fairly easy aspects for the students and I think it is also helpful for those of us who are much more sophisticated about healthcare issues, to go back to basics as well.

When you think about it, any kind of healthcare system really only has three structures. There is a financing structure, there is a delivery structure and then a series of intermediaries between those two. There is somebody who is gaining a dollar from the individual patient and then there is a group of people being paid those dollars to deliver healthcare service and then there is a series of intermediaries in between those people. It is important to keep in mind that there are only three structures of healthcare.

When we are doing healthcare reform there are really only two strategies that we pursue at least in this country. They are basically a market strategy and a bureaucratically regulatory strategy. Bureaucratic has negative overtones but when a political economist thinks about bureaucracies they think about it as a very rational approach to changing behavior. When I say bureaucratic regulation it has no overtones of bureaucracy but rather it is just an approach. Either we regulate people to prescriptive rules or we let the market take hold and people in pursuit of profit end up making the decisions.

Finally, in healthcare reform, there are really only three goals. This is an important part to keep in mind because any one set of reforms is going to be oriented towards one goal or one structure of healthcare and it is going to have one strategy. The goals that we have in healthcare are: let's get access for everybody, let's get higher quality care for everyone and let's try to provide as high a quality as possible. In addition, cost containment. So, we want to reduce costs, improve quality and increase access. Now, unless you are a very firm believer in continuous quality improvement, do you think it is going to be difficult to reach all three of those goals at the same time? These goals are going to tend to be in competition with one another.

Using those basic structures, strategies and goals, you can come up with a method for categorizing almost any kind of healthcare reform that is introduced. For instance, if your goal is cost control, and you are taking a bureaucratic regulatory approach, you can apply that to either the level of financing or the level of delivery as we do. We are very interested in cost control today and we are going to continue to be interested in cost control for what I expect is the professional lives of most of the people in this room.

After the break of the baby boom, somewhere around 2030 or 2035, things are going to change a little bit, but pure demographics are going to drive us over the course of the next 20-25 years into a situation where we have to impress cost control because of the aging of the population. As well, constant introduction of new and expensive technology drives up cost; so cost is the major concern today and it will continue to be a major concern. At the financing level, if you want to control cost, you can put in price control for volume and performance standards. Some of you might have recognized that as the way Medicare Part A pays hospitals - basically has cost controls through a regulatory approach, to the prospective payment system. We set the price that we are going to pay individual hospitals. You can dial that down to regulation so that all the teaching hospitals today are complaining about the Balanced Budget Act. Well, that is at the regulatory approach that is bound to dollars that are coming in through the financing system. At the level of delivery, you can reduce costs by a number of approaches - technology would be a good one. Certificate of need was always treated as a way to reduce healthcare costs at the level of delivery by setting forth rules about who could build what kind of new technology or new hospital beds.

We could continue to go through this, but I just want to emphasize a couple more points. If we want the market, as opposed to a regulatory approach to undertake cost control, we can do that at the level of financing through tax reform, or we can do it at the level of delivery, through managed care. Today in healthcare, markets are emphasized. Like it or not, although there is a bit of a sort of bureaucratic push back against managed care today, managed care is a way that we are reducing cost and it does reduce cost at the level of delivery by creating incentives for physicians to reduce the amount of care provided for individual patients. And it is the market that we are pushing in healthcare today.

Now, we do not only try to gain cost control. For instance, some people would say we can use the market to improve quality of care, but this is the argument that goes as follows - some people who like small cars do not want to pay much for them. My wife drives a Volkswagen, and it is not a very safe car, but she likes the way it handles and she is not overly concerned about safety. My sister, on the other hand, drives a Volvo - she is very concerned about safety and wants to pay more. People who are market advocates say the same thing, if you want to promote quality and healthcare do not get into all these bureaucratic rules and regulations, offer people different products and let them purchase how much quality they want. It is a completely different approach than a bureaucratic approach to quality, and a bureaucratic approach would have much more to do at the level of financing and a level of delivery.

Most of what we will talk about today would be a bureaucratic approach to improve the quality of care, at the level of delivery. We are not going to talk about Section 1983, action or national health boards, those were old reforms that were left from the Clinton Administration's Health Plan, but state databanks and state oversight licenser authority is bureaucratic regulation at the level of delivery. So, it is important for us to keep that in context, because the strains of other reforms that are going on in the healthcare system, those oriented towards cost control, and the strains of other strategies, for instance, the market, as well as the strains that are associated with a regular inter level of finance rather than at the level of delivery, will create the context for and the pressures on those regulations that we might undertake in quality regulation.

This is a way you can stack these things up, the level of financing, the intermediary, the level of delivery and quality cost and access, market and bureaucracy, and you can characterize any healthcare system that you would like according to this structure. For instance, in Great Britain, they always relied on a bureaucratic approach. They had a bureaucratic approach to financing, so they had broad taxes and a global budget and universal coverage. That is how they went about access, cost and quality. Then, they ran that through the National Health Services group, their intermediary, and then they delivered everything to a National Health Service. They undertook rationing, which is a very bureaucratic approach to reducing costs, and they had physician commitment as commitment to quality.

You can see that there are not a lot of other lines coming down here. Almost no orientation towards the market, whatsoever. It is just helpful to illustrate the British system under the changes that the Thatcher government put into place, that the present Labor government has now taken down. They moved to a different intermediary, the fund holder, which is basically the mechanism by which they undertook managed care. It gives you the sense that in addition to their traditional focus on the NHS and the bureaucratic approach, they also undertook at least some financing to fund holders which were basically risk takers who then had to manage care in order to make money.

So, you can put both very bureaucratic and very market driven approaches together, in the same organization of a healthcare system. That is how the United States looks today. See, we like to complicate things and it gets ever more complicated every day. But, you should realize that here, what we are talking about today, would be over here at the level of delivery, a bureaucratic approach to improving the quality of care. That is going against the tide of the market and we are coming out of six to eight years, actually we can go back as far as 1982, with the Reagan Administration's overall reduction in funding for regulatory programs oriented towards healthcare, to see that we are into 17 years now of emphasis on the market approach, and in particular managed care.

The other thing that is important to note is that we are much more oriented towards cost reduction than we have been to quality. That is the context in which we will be discussing issues today and it leaves me with about five minutes to talk a little bit more about where we stood in the Pew Commission. Professional regulation and consumer protection is important but it feels a little isolated and uncoordinated. Well, it is the least renowned in some ways of a bureaucratic or regulatory approach overall in the healthcare system. In that market-driven system, are we positioned in professional regulation to undertake a renaissance of interest in a regulatory approach? Public government versus private market. That is the key issue that we have to face. Do we develop regulation that integrates with the market or do we try to plan against the market approach? Questions have been raised by people who are interested in the continuous quality of improvement, as to whether we should be licensing institutions instead of individuals. Is the focus on the individual and policing the individual wrong? Don Berwick and I had a book we wrote two years ago suggesting that perhaps it was wrong if we were going to successfully integrate notices of continuous quality improvement into quality regulations. An issue that will come up repeatedly from people who are presenting about the Pew Health Commission Report is the relationship between state control and national control. How much federal control do we impose? In a health law textbook that I wrote with Clark Havighurst and Jim Blumstein, the major point is the amount of increase in federal oversight of healthcare that has occurred really since 1972. Nineteen seventy-two to 1975 you have the first anti-trust cases Goldfarb vs. Virginia State Bar that opens up professional, federal anti-trust oversight. You have the passage of the Employment Retirement Income Security Act (ERISA) and you have the passage of the HMO Act. Three very different bits of legislation and court decision making that have basically changed the federal prominence in healthcare.

Now, the current issues for regulatory boards and governance - and I do not think that these need to be repeated either, from our point of view - limited public participation, limited information available to the public. Little policy coordination amongst the individual boards, and yet should not there be some new role for protecting consumers in a new healthcare era? Those of you who are students of the history of healthcare know that most of the professional license boards grew out of the state medical societies on the physician side and have remained in the control of, in most circumstances, the professions themselves. That has been something that we have been concerned about.

I will not go through all these recommendations in detail. I would like to pick out a couple of them. On the regulatory boards and governance side, and I know David Swankin will be talking more about this, we have advocated a national policy advisory board to develop scopes of practice in continuing competence standards. This is a major recommendation of ours, to do not only with boards and governors but also scopes of practice and competence standards. I said those are the three areas that we focused on in our deliberation.

We have a series of other recommendations about regulatory boards and governance that David will go into. Perhaps one that led to the greatest debate amongst our commission (and you should realize our commission was never all on the same page to start with). This was an area of some controversy, increasing individual board accountability by increasing public non-professional membership to at least one-third. A number of the commission thought it was better to have more than half of the board be public members to increase public oversight and accountability.

Most of our commissioners were not people who were seen in the regulatory process or the history of oversight of the profession. In looking in lieu of the issues they felt that this was an important point, as was our recommendation of five in that regard, which is that they simply need to provide resources necessary to staff boards. Again, this is an ongoing and very serious problem because otherwise these boards cannot reach these responsibilities in an expeditious and efficient fashion.

David Swankin will talk about Congress' role as we see it and also about recent regulatory activity. On the professional practice authority we thought the most important and continuing issue to be tension amongst the profession and increasing turf battles. There have been some very difficult turf battles, but I would say that they have not really been shooting wars in the way that they will become in the future, because if cost control is going to be the major issue then what everyone is going to see is overall dialing down to resources that are available. Something we have not been used to in healthcare.

Historically we have been used to eight to ten percent annual inflation because there have always been enough resources to go around. The last three years that inflation has come down three to five percent and some places even lower than that. Now, this year in hospitals we are seeing a deflation in the amount of money coming through Medicare. One of those things that health economists told us could not happen. As that occurs, these turf battles are going to get more and more difficult and we really feel there is a need to start to begin to police these through practice authority changes.

Again, we have looked at a national role, at least a national policy advisory committee, which would help develop standard and a more uniform scope of practice. Again, keep in mind, in developing these scopes of practices are going to happen in some ways to be cause and effect, and a lot of people in healthcare are going to be pushing the market and free choice and trying to decide how we are going to provide reasonable regulatory oversight while allowing that choice and those market driven decisions. We think that the state should use the national model and implement scopes of practice that are uniform for the profession. This will come into the set of issues I know will be discussed later as well about how uniform those scopes of practice are and how much we can begin to break down barriers between practice and various states, especially as more and more pressure is being put on us to, as one would say, nationalize standards of care.

I know that we are going to talk about the regulatory activity. Bruce is here from Colorado about their legislation, the mental health professions, so I will not go into detail on that. It is a very interesting area. Finally, we have been concerned about continuing competence, continuing education not being sufficient. We think that the policies are inconsistent across professions and states and cannot be tolerated any longer. So we need to get both public and private sectors more involved in oversight and with regard to continuing competence, we think that healthcare professionals must be able to demonstrate their competence on an ongoing basis throughout their careers. Not doing it simply is shirking our responsibility to assure quality of care.

Linda Siderius: Thank you Dr. Brennan we will take questions after everyone has had a chance to make comments up here at the head table.

Robert Oshel: Thank you. It is a pleasure to be here today and talk about these important issues and to represent Dr. Vincent Rogers, the Associate Administrator, who unfortunately was called away because of budget issues and had planned to be here, but when budget calls, you have to go. Anyway as I said, we are pleased to be here and to help support the summit because we think these issues are important to not only be discussed but also action needs to be taken on the issues that we are talking about here today. The overall mission of HRSA, the Health Resources and Services Administration, is to assure access to healthcare and services for all Americans. The Bureau of Health Professions within HRSA serves this mission assuring access to healthcare, through its program to foster a diverse, competent and appropriately distributed workforce. In other words, get the right people with the right skills in the right places at the right time.

As we all know, there have been rapid changes in the healthcare environment. The changes are in terms of a number of things. One would be the rapid change in technology with potential to change the role of healthcare practitioners. There has been change in the role of the professional and para professional personnel. For example, there are practitioners, physicians assistants, nurse assistants. All of these emerging professionals are demanding an increasing autonomy and increasingly they are gaining further autonomy in various jurisdictions. There have also been changes in the locus of service delivery and the way service is delivered, such as telemedicine, for example. There have been changes in provision in the ways that the provision of healthcare is organized. For example, managed care. All of that of course affects the role of healthcare providers. There has been increasing consumer activism not only towards the healthcare system in general but increasingly consumers take a more activist role in how their own healthcare is provided. There have been changes in the distribution and supply of healthcare practitioners. There have been changes in medical education and training and of course, changes in how healthcare is financed. And of course there have been changes in the perceived federal and state roles in the delivery and regulation of the healthcare professions as the healthcare environment changes.

Well, that is an awful lot of change occurring over a relatively short period of time and we expect that these changes will continue. As these seemingly ever more rapid changes impact access to healthcare, both in terms of the quantity of services and the quality of services available, changes will obviously take place in the way that the healthcare professions are regulated. The current compelling matter within the health services industry seems to be that market forces and market populism not only drive these changes, but that market forces and market populism provide the appropriate responses to these changes. For example, with the failure of national health insurance, the market, largely in terms of increasing reliance on managed care, was left to assure the availability and access of services to those who need the service. As we all know, the rise of managed care has not solved all these problems in terms of cost, quality and availability. This of course is not to say that national health insurance would have solved these problems or would not have introduced another set of problems, but what we can say with assurance is that the current market driven system causes consternation and discord among policy makers who are concerned about access to healthcare services, the quality of services, and the knowledge, skills and the ability of various practitioners to deliver the services.

The mantra of market forces among decision makers in the private sector especially, but also among decision makers in the public sector, is increasingly exerting its influence and leading to questions concerning what the appropriate federal role is, if there is an appropriate federal role, in the makeup of the healthcare workforce and its regulation. You need to look at its distribution of the workforce, the workforce's flexibility and mobility, not only geographically but also in terms of how services are provided. And then lastly, in terms of the required skills and competencies, including recommendations or requirements as to what types of practitioners should have the skills and in what settings they should be allowed to practice. All of these issues have importance for access to healthcare returning to the mission of HRSA and the Bureau of Health Professions and its mission to reinforce the role of HRSA. When we speak of a federal role, or the appropriateness of a federal role in general terms, not just in terms of healthcare services, it can generally be said that there is a compelling federal obligation in the assurance and the provision or the protection of a good or service when the other entities charged with this obligation fail to fulfill their role.

With harms or potential harms and inequities or potential inequities have accrued one or more segments of the population, or the population as a whole for that matter. In other words, the federal government steps in or is mandated by the public to step in when the private sector and other levels of government fail to protect the public's perceived interest. An example of this is the federal legislation that was ultimately seen as needed to assure access and accommodations and services and goods, including healthcare services, for people with disabilities. Looking only at healthcare services, not only were there disparities and inequities among the states, but also among health professionals among themselves, who fail to see an obligation to assure access to care for people such as those with HIV. Hence, the need in 1990 for the Americans with Disabilities Act. Similarly, the Bureau of Health Profession's program, the National Practitioner Databank, grew out of a realization that the state medical and dental licensing boards were not adequately protecting the public throughout the nation, by ensuring that practitioners, records of malpractice payments, licenser of clinical privileges, adverse acts and so forth were made known to relevant licensing and credentialing authorities when practitioners moved from state to state, or sometimes even from hospital to hospital or HMO to HMO within the state. So, the federal government recognized the need, Congress recognized the need, and legislation was passed which set up a system to ensure that credentials and information was made uniformly available throughout the country.

Similarly, one can justify a federal role or involvement in the health professions and services delivery and distribution and health workforce competency when the entities and agencies charged with these responsibilities, which society regards as having these responsibilities, again fail to meet expectations or fulfill the public's trust. For example, Dr. Peter Wiernick in his recent article, "The War on Healthcare Professionals and Healthcare Delivery" in Cancer Investigation blasts government involvement for several pages in this article. He said "whatever proposal is adopted [to fix the system]," he says, "it must result in the greatest degree of governmental disengagement from the day to day running of the healthcare system if the plan is to succeed in reducing costs to individuals, and at the same time, maximize provider and beneficiary satisfaction." He goes on to say, "just as the government's track record for running insurance plans, Medicare and Medicaid, is less than satisfactory, so is its record in running hospitals." And he sites the Veterans Administration. He goes on to say that, "governmental solutions for the healthcare system will only increase administrative costs" and he cites thousands of bureaucrats employed to formulate regulations in instances which the cost of complying with regulations reportedly outweigh the benefits by factor of 20 to one or more. Well, what solutions does he propose for the problems in the healthcare industry? Surprise! What he proposes is a stronger federal role. "Current health insurance might be made more affordable for those who can not afford it now," he says, "if health insurance premiums were regulated by a federal agency rather than by state agency." He proposes that the federal government pay for all professional school tuition for every medical nursing and physician assistant student in the country in exchange for two years of mandatory national service at a location that the federal government determines they ought to be practicing. And he calls for full federal government funding of all medical research which presumably entails control of what kind of research gets done.

I can assure you that those of us in the Department of Health and Human Services are not looking for a larger federal role in the regulation of healthcare profession. But, we know that a stronger federal role may be thrust upon us. That is one reason why we believe that the report of the Pew Commission Task Force on Workforce Regulation and the issues it has raised are so important and why we wanted to help support this national summit. The federal government does not claim to have the solutions for the issues raised by the task force. We neither endorse nor oppose any of the recommendations made by the task force, but we believe it is vital that these issues be addressed and the solutions be found which best meet the needs of the public. Those are the consumer needs as well as the needs of the healthcare professionals and the healthcare industry. Currently, those solutions must be found and adopted at the state level. If they are not, inevitably there will be calls for further federal involvement perhaps because the states are not perceived by the public as adequately protecting the public interest, or maybe even perhaps because the state governments themselves have come to believe a stronger federal role is required.

The report of the Pew Commission's Task Force on Healthcare and Workforce Regulation Strengthening Consumer Protection: Priorities for Healthcare Workforce Regulation delineates three areas for starting to determine that new directions are needed to assure access to care: quality of care; appropriate distribution of health professionals - employment of the right people with the right skills while minimizing costs. Now, this may mean breaking with traditions sanctioned and promulgated by law and regulations in most of the states. Regulations and traditions concerning services delivery, introduction of technological innovation, overlapping competencies and skills among various job descriptions in the health professions. The three issues singled out, as we heard already, work regulatory boards and government structures, scope of practice authority, and continuing competence requirements. We believe that it is vital that each of these issues be dealt with in an optimum way to protect consumers. Doing this will ultimately best serve the professionals themselves and the healthcare industry as well as healthcare consumers.

Now, the federal government is not prepared at this time to recommend any policy remotely resembling a national licensing initiative that would supplant the authority of states. Given the major ongoing changes in the healthcare environment I mentioned earlier, perhaps it is time to consider some of the following: one would be national consensus of standards for regulations and licensing health professionals that would be uniform across the states, to maximize flexibility and choice of practice location. Two, national consensus of standards for competencies which could be in the form of recommendations for quality assurance as opposed to mandates. In other words, shall-should versus shall. Thirdly, national uniformity and scope of practice for emerging clinicians' categories to reduce overlap of skills and competition for reimbursement. Fourth, national uniformity and appropriateness of care within scopes of practice, to reduce deskilling of competencies within practice settings which compromise quality of care. Fifth, national consensus standards for competencies within disciplines to promote and assure uniform quality of services throughout the nation. Lastly, national consensus recommendations for consumer, non-professional representation on regulatory and licensing boards, to maximize consumer interest and public understanding. All of these issues need to considered.

Perhaps, we also need to explore the establishment of a National Advisory Council on Health Professions and Regulation. Comparable to other national advisory councils, this would advise the Secretary of Health and Human Services, advise the Congress on regulatory and licensing issues of national concern and interest. This clearly is a first step towards an expanded federal role. Perhaps, even national licensing but we are certainly not there yet. You and your actions will help to determine whether we ever go there. Therefore, keeping with the summit's theme from dialog to action, I urge you during the next two days to conduct vigorous, spirited discussion to determine the best policies for protecting the public in terms of changing regulatory board and governance structure, scopes of practice and continuing competence. Then, after the two days of dialogue after the summit is completed, I would urge you to go back to your states and take effective action to work toward adoption at the state level, and maybe even at the national level, if that is what is perceived to be needed, at the policies you have determined are best. From dialog to action. Without the action, to make needed changes, the dialog from these two days will have little utility. Thank you.

Ms. Siderius: Thank you Dr. Oshel. Our last keynote speaker is Senator Hollinger who has been a Maryland State Senator since 1987. She is a graduate of the Mount Sinai School of Nursing in New York and she was a member of the House of Delegates in the Maryland General Assembly from 1979 until 1986. She has served as the Chair of both the Women's Network and the Health Committee of the National Conference of State Legislatures. She has served as President of the Women Legislators of the Maryland General Assembly. Currently, Senator Hollinger serves as the Vice Chair of the Senate Economic and Environmental Affairs Committee, and Chairman of that Committee's Health Sub Committee. In 1995 she was appointed Senate Chair of the Joint Committee on Healthcare Delivery and Financing. Some of her legislative accomplishments focus on issues related to health, health occupations, mental health, healthcare cost containment, long-term care, bioethics, education, the environment and child welfare issues. In the past years, her bill to establish patient care advisory committees in all hospitals in Maryland became the first law of its kind in this country. Recently she sponsored and saw passed into law the patient access bill, legislation to revamp the State's method of handling Medicaid patients, and a bill that will increase much needed organ and tissue donations for needy recipients. Senator Hollinger.

Senator Hollinger: Thank you. Good morning. It is a pleasure to be here this morning. As you can tell from my bio, I have had 21 years of serving in the legislature, serving on the committee that handles all the turf battles. I was six feet tall when I started in the legislature, and you may think there are no turf battles going on, but I have never been through a year in Annapolis without turf battles. I will start out by walking you through some of those battles at least just from this year. In case you think we do not do anything, this is our health occupation's code for Maryland. Everything you ever wanted to know about the health occupation is right in here, except for the newest thing that you would like to do for your profession that is still waiting to get into this code. We have in Maryland 19 major boards. Most have two consumer members, except for the Board of Physician Quality Assurance which is a 15 member board and has three consumers. When we checked with our Board of Nursing, which is of course our most competent board, we found that they have trouble getting their consumers to participate. Very often when you ask consumers if they would like to serve on a board of physical therapy, or a board of social work or nursing, or physicians or acupuncture, the first thing that they will tell you is, well, that is not exactly the board I was interested in serving on, my background is in this... People like to serve on things that they are familiar with and very often they feel that they are not competent to make decisions within that profession. So, naturally, when they serve as consumers, even when they go to the meetings and they serve on all the committees that the board set up, they do not always feel like they have the highest level of competence to make certain decisions. So, it is easier on paper to talk about consumer participation than sometimes it is in reality.

Now, what did we do this year? Well, one of the things we did this year was a bill that I sponsored for the last three years that has had a very interesting history. It is a bill that would make medical directors of HMO's accountable to the State Board of Physician Quality Assurance. Every physician in the State of Maryland can be disciplined by the state board except for one, the one that heads up the HMO. The one that makes the bottom line decision on who gets what healthcare. The one that controls the cost, and the quality, and the standard of care, and the prescription that you are prescribing, and the tests that you would like to refer to, that is the only physician in the State of Maryland that cannot be disciplined by the board.

The insurance commissioner has the power in Maryland to say you cannot be certified or licensed as a medical director anymore in Maryland, but they have to scale 25 people in their decision-making which they say is not medical - they contract - and still they can not be disciplined in Maryland. They just may not be able to be a medical director anymore. So, tomorrow they can go out and take care of your mother and that is perfectly all right. I wonder who killed these bills. Well, the first year it passed the Senate and then the HMO's figured out what the bills said. They killed it in the House. The second year in the Senate, it got past the second reading, (the committee report - they tried to kill it for the committee report) it needed 24 votes and got 27. When it came up for a third reading, the final vote in the Senate, 48 hours later, you would have thought the HMO's had gone out on the street and hired everybody that is just being put from welfare to work. They had nothing else to do. From Wednesday to Friday we went from 27 votes to 22.

This year, more people in Maryland have had problems. What happened? It passed the Senate with 29 votes. People who had resisted for a few years, and thought, I guess things are really bad and they are not improving on their own, maybe we need to do something. In the House, after it passed the Senate, in the House the leadership was afraid to call it up for a vote so it is still in a drawer somewhere. If you happen to be in the Maryland legislature and you want to walk around the building, see if you can find that bill. There is no vote in the House attached to it.

That is one battle. Was that turf? It was turf between quality of care and quality of cost, or managed cost. I do not call it managed care anymore - it is managed cost. It was a battle that had to do with the board but really was related to the quality of service. It was not a turf battle amongst the profession. All of the professional groups supported it. All of them. Because they were all impacted by the medical director. We had a bill this year on physician assistants - on prescriptive authority. This bill has been around our legislature for years and years. We finally got it through this year. There was a bill for nurse practitioners that would designate them as primary care providers. Of course, again, that has to do with quality of care and who gets served versus the insurance companies (who did not want them to have that designation to some extent) but mostly the physicians who did not want them to have that designation. Massage Therapists. A few years ago when they were trying to get their bill through, maybe five or six years ago when it first started, they were giving executive massages at lunch to the legislators. And I resisted that because as Chair of the subcommittee I did not want to be lured in by being massaged too heavily. However, the day of the hearing, with five minutes to hearing time they caught me going into the Senate office building - forced me, I was kidnapped - to go and have an executive massage and they made a mistake of putting my jaw out. So, for about five years or three years or two years or whatever it was - they did not have my support. But, quite frankly, my mind is always open and now that my mouth is opened, I was able to look at it in a little bit more objective way. This year they were able to get certification and a new designation as registered massage practitioners.

Now, within each profession there are different levels of who gets what kind of a name. In this instance, we had certified massage practitioners that have much more to do with the delivery of healthcare. Then, there is another level of the people that work in the sport's facilities and do not necessarily - they are more recreational without working in massage parlors which is what the vocal sub divisions were interested in - getting rid of those people in the massage parlors. Then, we had a bill that passed this year, that goes a little bit towards what we are talking about-we are state number three in the country that has passed legislation setting up an interstate compact for mutual license recognition of nurses, because nurses again are traveling all over the country. On our Board of Physician Quality Assurance on the consumer side we have established a Web site with the name, address, area of concentration, graduate school, date of degree, profiles of physicians, other links to appropriate Web sites such as the AMA or the HMO's if you want to check where they can practice and at what network. We are doing an awful lot through the computer to the electronic transfer of information to try and bring more consumer friendly information to the public.

Another bill that has had quite a dueling battle is the desire of nurse psychotherapists to be able to prescribe. Some mental health providers are feeling very threatened - psychiatrists, psychologists, social workers, particularly, the psychiatrists because the one thing that the HMO's left them with is the ability to prescribe. So, now the psychiatrists have turned basically into pill pushers and they do not want another one of the mental health providers to be able to have that prescriptive ability. That turf battle will continue.

Take our Board of Dental Examiners. The only board in the State of Maryland that has to be disbanded and reconstituted because of the fights and the dynamics that were going on within the boards between the dentists and the hygienists. You do not want to know about that one. Getting anything done was like pulling teeth. We now have a new board and the fights are a little bit less but guaranteed the battles are still there within the board. I have just started a Maryland Patient Advocacy Group. It is starting with consumers. We want a grass roots network across the states, quite frankly to lobby and be the voice of the public, whether it is on a licensing issue or whether it is on any other quality of care issue. Mostly what they are lobbying for are reforms and managed care in our state so that there is a higher level of care.

The Board of Physician Quality Assurance puts out brochures to inform the consumers 1) what they do, 2) how they handle complaints, 3) what you need to know when you choose a doctor, 4) when is sexual contact between a doctor and a patient part of the medical treatment? We have legislated in that area. When we legislate in a lot of these areas, part of what we legislate is putting out consumer information. And we have just passed legislation that talks about what happens when there is sexual abuse within a professional setting by a professional in the State of Maryland. We are setting standards in that area. We are responding to something that we thought was a problem. We have in our health department a sub division that puts out an HMO report card every year. It is important to us that consumers understand what they should be getting.

This year, as a shock to me, because the House killed my medical record bill again, which was also a dental records bill - there were two of them - they finally decided, let us shut her up for a year. They said how about if we put in the health department (since the insurance commissioner handles appeals and grievances) an HMO Quality Assurance Medical Director? Will that make you happy? And let us put some real teeth in this. Like a big fat $250,000 dollar fine. Well, it is great and it will help with quality of care but the only one that penalizes is the HMO. It does not penalize the medical director making the decisions, so again it is very nice, but I will be back again next year and they will not be happy to see me.

Now, when you talk about turf, Maryland has Johns Hopkins University. Johns Hopkins Hospital Eye Clinic is known all over the world and it took Maryland all of this time - 20 or 15 years - to pass the Eye Drop Bill. Last state in the country? Why? I just explained why. Because it was stepping geographically on the turf educationally. What happens in states where there are no professional schools? How many optometry schools are there around the country? There are not that many. But, in the states that have optometry schools, you will probably will find, if you look at this history of that very hard fought piece of legislation over the years in every state, that the first state to pass the law, were the states that had optometry schools. And so the last state to pass the law was the state that had the Wilmer Eye Clinic.

There is another thing that happens geographically, namely what the needs of that individual state are. Last week I was at a national conference in Washington and everybody again was talking about managed care and I was sitting next to a legislator from South Dakota who said Maryland is one of the highest penetrated managed care state. How about South Dakota? Because it is a rural state they are not dealing with the same problems we are, they are trying to find people to go into rural areas and practice. Maybe they are one of the first states that are letting nurse practitioners and physician assistants do everything because they will take anybody that will go and take care of people. So, the geography of the state has an awful lot to do with scope of practice. If there is a glut of a certain professionals as there would be, going back again to the eyedrop bill, in a state where there is an optometry school, there is probably a glut of optometrists versus ophthalmologists. Depending on the geography of that state has an awful lot to do with what kind of legislation gets through and what the needs of that state are.

If you look at what happens in Congress where a lot of this has to happen, the least populated states have the least representation, so the needs they might have in that state may be the last to be the national standard because the more populated states with the larger amount of professionals will fight it and they will have to vote in Congress to fight it. The other thing that happens is the evolution, particularly with the new professions. The acupuncturists in Maryland started out years ago under the Physicians Quality Assurance Board. A few years ago, they got their own board. Complementary medicine and alternative health care are finding new ways and they have new popularity and as the public demand is changing, we are licensing more people and giving them their own boards. That is having an impact. Most of our boards already have continuing education. I know on my nursing license I have to validate how many hours I have worked in the past two years, in order to keep my license. I have to validate what my experience has been.

Telemedicine is another piece of legislation that I understood. I put the bill in. The Board of Physician Quality Assurance had one goal for telemedicine, the Medical Association had another, and they had a battle within the profession. The bill passed the Senate got to the House, the House did not understand what we were talking about at all and quite frankly, it is confusing. Whether you give full licenses - whether you give it just for exempt consultations where it is the second physician involved. There are a lot of confusing issues there. What happens if you have to pay the licenser fee in every state? You may not want to practice anywhere. This, I think, would be a good avenue to use for a national standard. I do because it really does involve every state and I think this would be one natural place to start. But states do fear when the federal government supersedes us.

Those of us who serve in state legislatures are a little bit concerned about the federal government taking over anything. We do like the idea of national standards from a standpoint and most of our laws will say that in order to become registered or certified that you need to pass your national exam. In other words, do not make up something for Maryland to make it easy. But, we want you to pass a licensing a licensing exam with national standards. We dictate what the education should be. We dictate how far along - often we dictate how many hours of practice before you even get that title. I think in that area it is appropriate. But, I think scope of practice has a lot to do with the turf battles of the state and the geography because we do not want to hold back the states that are willing to move forward in some of these areas.

Ms. Siderius: Thank you Senator Hollinger. We have about 15 minutes for questions.

Audience: Good morning, committee. I am Fred Shiel, Chief Inspector for the Louisiana Board of Pharmacy. Senator Hollinger, you mentioned that a physician's assistant was granted expanded prescriptive authority. Did it also give him a right to dispense?

Senator Hollinger: No. I am trying to remember how the bill read this year. I do not think so. I think that they have the right to prescribe. I think most of our legislation in Maryland, the only dispensing privileges are in emergencies and that type of thing but not to dispense in any other way.

Fred Shiel: In your Board of Pharmacy, you mentioned some restriction there. What is the makeup of your Board of Pharmacy in numbers, other than pharmacists?

Senator Hollinger: The Board of Pharmacy has eight professionals, six pharmacists, and two consumers.

Fred Shiel: There is something that the Board is faced with right now. We actually have 17 members on the Board, 16 of which are practicing pharmacists and the elderly consumer representatives by mandate of the state. As of tomorrow and possibly one day next week, they are going to rule by the ethics board whether a pharmacist on a board that licenses the pharmacists and permits the practice site can actually be a fair consumer representative for that profession.

Senator Hollinger: Usually what we do and the way our law reads here is that they shall be licensed pharmacists with five actively engaged in practicing and two are consumer members, but more and more in our licensing statute, we have designated differences of who serves within the same profession so that we do not get everybody from the same place so we get people - some in education, some are in hospital settings, some are in pharmacy settings and that type of thing.

Audience: Hello my name is Rob Alder, I am Chair of the Health of the Health Professions Regulatory Advisory Council in Ontario. A two part question. First, one specifically to Dr. Brennan. That one is in the recommendation of the Pew Commission regarding the National Policy Advisory Council. You speak about research and development that should be done, research and develop scopes of practice. I am wondering if you could characterize the scope of that research that you have in mind. Is it primary research? Secondary research? To what extent would you see an agency like that being involved in primary research?

Troy Brennan: Well, I think that they would have to do some primary research. The basic question surrounding the scopes of practice battles is that one profession is going to be able to do it safely and the other profession is not going to be able to do it safely. So, if they are not oriented towards primary data collection, then I do not think they are going to accomplish their tasks. Fortunately, the health services research is a field that has really bloomed over the course of the last 15-20 years and there are a number of different kinds of measures of quality today that are available to us that were not available previously so there is a whole host of outcomes that we could look at. Some of this research tends to be expensive, some of it tends to take place just on administrative databases and is not too expensive. But, the fact that we make most of these decisions completely in the absence of any evidence is rather ridiculous. It all then becomes sort of political and lobbyists working in the state legislature, and that does not seem to be a good way to be making decisions about these kinds of matters.

Robert Alder: My second question actually gets yourself and Senator Hollinger to interact. Dr. Brennan, you mentioned of course that the national policy body ought to focus on research among other things. Senator Hollinger you mentioned that in many cases, scopes of practice are defined by things that are really beyond research, for example, the geography of a state or whether or not it has an optometry college in the state. Dr. Brennan, what do you think, your research, that is your platform, how is that influenced by geography, the presence of a certain college, and Senator Hollinger, your perspective on integrating research in the decision making.

Dr. Brennan: I may have misheard the Senator, but I did not think she was saying that just because there is an optometry college located somewhere that is the way regulation should take place. I believe what she was saying is that it is just a matter of circumstance and power - you have an optometry college in one place, you will have a fairly well informed legislature of optometry. You have Wilma Eye Clinic in Maryland - they have been a powerful force in terms of orienting the state legislature toward ophthalmologists. I did not hear anything that the Senator said disagreeing with our contention that some factual reasonable evidence about how well the optometrists as opposed to the ophthalmologists perform in certain scopes of practice would be anything but helpful to the state legislature.

Senator Hollinger: Right. The research is important and I will tell you that when we do a bill the first thing we ask is, what is happening in other states? What are the outcomes? How many complaints to a board that have already gone that extra step. In order for any emerging profession or expanded scope of practice to pass, we expect people to come in if we are not the first state (usually we are not) but we expect the people who want the change to come in and give us some facts. Now, this year, just to show you how smart we are getting, the Maryland Senate, half of us, were put into a pilot program to start doing all of our work on the floor and then committee on laptop. A little knowledge is dangerous because we can now get into the middle of any liar's battle on the floor of the senate or liar's battle in the committee room when testimony is being given, and pull up the facts, and what is happening in other states and what is in the paper, and what is in the books and what is anywhere, and call people on it. I did it a lot. It is fun. I had one lobbyist run around from where he was testifying to ask me where I got my information and I gave him Web site. So, this could be a new day in politics and the research and the information to us is important. People who serve on my committee do take this pretty seriously, except remember, the legislature is made up really of consumers. Most of us are not health professionals. The only nurse in the Senate and up into this year when they just elected a physician, so up into this year I was the only health professional other than a retired optometrist that served in the Senate. Everybody else out there is truly a consumer.

Robert Oshel: I would like to comment on the research issue as well, that is what my prime role is at the Bureau. There is research and then there is research. The legislatures need to be a little more aware that some of the information that they get that reports to be research might not be as definitive as perhaps it should be. We can always tell when the state legislatures are in session because we get calls from the various professional associations and states that want their scope of practice changed for information comparing malpractice rates, for instance of physicians in anesthesia, to the malpractice rates of nurse anesthetists for example. We can give them the number and we tell them there are all sorts of reasons why those rates might be different from state to state or profession to profession but have very little to do with the competence of the people in those professions. Physicians have deep pockets. Nurse anesthetists do not, for instance. State laws from state to state vary in terms of how easy it is to bring in malpractice and how easy it is to have a payment made. So, sure we can give them rates and they will quote those rates back to the legislatures whether or not they really mean what they report to mean is something else again. People doing the research and people receiving the results of the research have to be very careful of what they are getting.

Senator Hollinger: One of the things that a is a famous quote from our state legislatures is, "figures lie and liars figure." We do need to have credible sources of information and I do think that is really important.

Dr. Brennan: I would like to make one more point on that an aphorism amongst researchers is that the main outcome of any research project is the need for more research. I have found that the staffers and state legislatures to be very savvy about issues, understanding for instance the need not to compare Michigan nurse anesthetists to Indiana anesthesiologists and also do reasonable severity adjustments because nurse anesthetists might get the easier cases and the anesthesiologists the more difficult cases and those kinds of things. But, I think overall, our goal has to be to provide more factual basis for these kinds of scopes of practice debates. And I think we all agree on that.

Audience: My name is Becky Nichols I am a staff member with the Texas Board of Medical Examiners and I have two questions, one for Dr. Brennan. A couple of your slides mentioned tort reform or malpractice reform and I would like for you to expand on that and how you see that that might impact on the healthcare industry. My second question is for Dr. Oshel regarding the National Practitioner Databank. It has now been in existence for nine years, what impact has it had on the healthcare industry so far?

Dr. Brennan: Well, I have been talking about tort reform and I have a particular axe to grind around enterprise liability and no faults. I have been talking about that for the last 10 years and we did a series of large studies showing that the malpractice system really does not work at all. All that empirical research and all that talking, I think that I have convinced about two people of my view and both of them work for me. I do not think it would be good for me to speak on tort reform except in so far as I would say there will be very little tort reform at least for the near future because we are in a very stable situation. The medical malpractice insurers and relatively wealthy having reserved at levels in the late 80's and the early 90's if there is going to continue to be a tort crisis which did not materialize. They are not interested in change. Plaintiff attorneys, a very stable population in most large metropolitan areas, know how to bring a case and they know what to expect. Same thing with the defense attorneys - they do not want any change. When you have a stable insurance system, it is not possible to get significant reform.

The only reform that we are seeing is ongoing continued tort reform which is really a euphemism for decreasing the ability of injured individuals to bring suits. That may change if we begin moving in a direction of a very heavy punitive damage laid in suits against managed care organizations - that could change the dynamics. But, without some significant change like that, there is going to be really not much tort reform. Once tort reform starts to happen it affects the crowd that is interested in physician disciplines, because in most states when we did heavy tort reform back in the mid-1980's and again in the early 1990's, the state constitutions required there was a quid pro quo, if you are going to decrease the rights of individuals to sue, you had to strengthen overall in the discipline and area activities. So, a lot of states got new responsibilities for the disciplinary boards as a result of tort reform. Unfortunately, most of those new responsibilities were never funded adequately so in my own state of Massachusetts for instance, we had a wonderful law that passed in 1986, never fully funded, and as a result, our disciplinary board continues to fall down on the table for the physicians. So, if there is a significant change in suits as a result of suits against managed care organizations, and we will see that over the course of the next three or four years, that could change the dynamics. That could lead to some changes in tort reform, which will in turn will lead to changes in the way in which we go about professional discipline.

Robert Oshel: A question about the impact of the databank is an important one and we are very interested in it. In fact, we are right now in the pretext stage of a national survey to do just that- find out what the impact of the databank has been. We are continuously looking at this, in fact, we have done a number of studies and surveys about the impact of the databank almost since the databank opened back in 1990. We had the office Inspector General for HHS conduct a couple of studies in the early 1990's and another one in the mid-1990's that looked specifically at the impact of the databank on decision making. One thing they found was that when they published the first study about 1992-93, about 42 percent of the time we sent back a matched survey, a matched response to a query. This contained new information that the questioner, that would be a hospital, or a HMO or another healthcare entity authorized to get the information, had not learned from the practitioner.

The second time they did the study about two years later, they found that that was down to about 24 percent. So, I propose what impact, and there has been a tremendous increase in the ability of practitioners to remember. But, a little more seriously, the found most recently, that in about two percent of the cases of a hospital receiving information back from the databank, that a practitioner had reported a malpractice payment or an adverse license action, or a clinical privileges action, or even a professional society membership action. About two percent of the time, the hospitals decision was different than it would have been in the absence of that information. Same thing is true about three percent of the time, when a HMO got in it a report back from the databank containing adverse information.

That does not sound like much, but we think it is fairly significant when you consider that we are not supposed to be providing new information not otherwise known to the hospital, to the HMO's. That everything we provide is asked for on the application, and is received from other sources or at least it is supposed to be on applications, it is supposed to be from other sources. What we are doing is serving as a backstop to make sure that the information that is supposed to be provided is provided, and that the people who need it, do get it. In that sense, we are clearly having an impact, that two or three percent of the decisions we think are making a difference in the professionalism and the safety of care provided patients.

Audience: I am B. R. Gordon with the Association of Optometry Boards and I enjoyed the Senator's presentation but since it has come up a couple of times I want to correct one major misconception. Having a major optometry school in the state is a major drawback to getting legislation. The four states that have the largest optometry schools in the country were among the last six to get therapeutic legislation that you referred to. In fact, they are state schools, they are private schools that are non-profit, so as in effect they are very ineffectual in lobbying so, certainly we have good friends in Maryland and they had difficulty politically passing their bill, but I think it is important to set the record straight, that in fact, having a school is a dramatic disadvantage in that case.

Senator Hollinger: Now that you reminded me, I think one of the battles that was used is that even Pennsylvania with the school has not passed it yet.

B. R. Gordon: Pennsylvania, Illinois, California, New York, were four of the last six to pass because if you have a very large optometry school you also have an even larger medical in the state.

Audience: This is not really a question I hope that the committee will indulge me while I make a comment. My name is Ben Shimberg I am with the Chauncey Group International. With the lost sight of one of the historical footnotes I would like to bring attention to the group, that a very interesting experiment was conducted in the state of California a number of years ago, that I still think has a lot of merit, even though it seems not to be at the moment. In the 70's California passed an experimental health practices act which dealt with this issue of scopes of practice in a very intelligent way of expanding scopes of practice. If a group comes in, for instance nursing comes in and say we would like to have prescription authority or something like that, certain circumstances, a doctor could stand up in a legislature and say, bad idea. The issue goes no further. From the minute a professional group comes in with a plan in which they would explain how the group would conduct the education training, how safeguards would be put in place and what kind of records would be kept if you allowed it was giving the group a temporary exemption from the existing scope of practice. It allowed them to do something which would otherwise be illegal for them to do. Then, they could conduct the experiment for maybe two or three years and keep track of how many misadventures they had and then they could go back to the legislature with data, saying that we had three events and explain that we can or can not do this safely. I thought it was one of the best ways of overcoming the strong power that doctors in legislatures can prevent expansion of scopes of practice. I have not been tracking legislation as as I did many years ago but Dave Swankin tells me he has checked it lately and there is nothing happening, and apparently the health department which previously administered the law, either has lost interest in it, or support ordered opposition. It is a good idea and I think it should not be a lost item.

Senator Hollinger: I think it is an interesting proposal and we do it in some ways when all of boards have to go through sunset where they are examined and they are professionals and they are disciplined and everything else is examined and they do consumer surveys and all kinds of things. Sometimes we will give a new power and put a two year sunset on it or three year, or five year. Right now I think we are at 10 or 15 years for the majority of the boards so when we do something new very often or we ask for reports to come back, so it is not a bad idea and in some instances it is not much different than what we are doing.

Ben Shimberg: Thank you Senator, it is good to know that it is still alive.

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