Dick Merritt
Group Director
Forum for State Health Policy Leadership
National Conference of State Legislatures
Carolyn Clancy, MD
Acting Director
Agency for Healthcare Research and Quality
United States Department of Health and Human Services
We're going to continue our journey through the labyrinth of federal health agencies this morning. Yesterday our journey took us on stops to the Centers for Disease Control, to the Substance Abuse and Mental Health Services Administration and then finally the great visit from the new direction for the National Cancer Institute at NIH. Today we'll be visited by the agency for Health Care Research and Quality and by the Centers for Medicare and Medicaid Services. I do regret to tell you however that we will not be hearing from the Secretary of the Department this afternoon. He has had to cancel out on us and that's unfortunate. I do not know at this point if he'll be sending someone in his place but Secretary Thompson unfortunately will not be with us this afternoon. Tom Scully however, the administrator of CMS will be with us at lunchtime and I encourage everyone to be there. I know that will be quite interesting.
We begin this morning with presentations from the Agency for Health Care Research and Quality. This is an agency that may not be quite as visible as some that we visited by but it does incredibly important work. We've had very good relationships with the agency over the years. We're most known to them really through their user liaison program, which is a wonderful program. I know that several of you have participated in that program. We have a great relationship with Chris Williams over here who has been very helpful to us through the years.
I'm going to introduce the Acting Director of the agency now. Dr. Carolyn Clancy is a clinical researcher and practicing internist and is currently serving as the Acting Director of the Agency for Health Care Research and Quality. She's been at AHRQ since 1990 and until recently was the agency's director of the Center for Outcomes and Effectiveness Research.
Following Carolyn there will be brief presentations from three senior researchers at the agency. These will Dr. Helen Burstin, Dr. Gregg Meyer and Dr. Lisa Simpson. We've got a very tight time frame this morning and I'm going to be the taskmaster. I've asked each of those individuals to speak for only about 15 minutes so we can allow 10 or 15 minutes following their presentations for questions and then we'll probably have some time at the end hopefully for a little more dialogue. With that we're going to begin the program.
Good morning and thank you very much. It would be hard for me to tell you how excited we are by this opportunity so thanks very much for including us. The title of this presentation is AHRQ or ARC, We're Here to Help. I'm going to provide a brief overview of what the agency is about and then I will be followed by Gregg Meyer who directs our Centers for Quality Improvement and Patient Safety whose going to take to you about the states role in improving patient safety. He will be followed by Helen Burstin who directs the Center for Primary Care Research and has been leading the agency's efforts in making sure that the health care system is part of the response to a potential or actual bio-terrorist event. Then Dr. Lisa Simpson who will be joining us a little later and is the Deputy Director for the Agency and a pediatrician will be talking about research that we support relevant to Medicaid and the SCHIP programs.
The mission statement of the agency is to support, conduct and disseminate research that improves access to care and the outcomes, quality, cost and utilization of health care services. This sort of sounds like we are here to meet all of your needs. The research that we sponsor we hope provides better information to improve health care decision making. So, in essence, if you were to ask us what's our strategic plan, we support and conduct research to support improvement in health outcomes. In other words; what works, either clinically or from a policy perspective. We support research to strengthen quality measurement and improvements and also research that identifies strategies to improve access to care and foster appropriate use of services and reduce unnecessary expenditures without actually doing harm.
This is sort of like a New Yorker's view of the universe, just to give you a sense, because I wanted to spend a couple of minutes since I know you are touring the labyrinth of federal programs to explain where we fit in the bigger picture. On the top part of this slide what you see is bio-medical research which focuses on such questions as what can work to cure or prevent disease and on the bottom half is Health Services research which focuses on how do we use that information most appropriately in typical practice settings and in the communities where people live. The reason I say it's like the New Yorker slide, those of you who are familiar with that famous New Yorker cover where the country drops off just west of the Hudson River. In terms of resources this isn't exactly drawn to scale.
Again, just to emphasize where we fit in. NIH focuses on basic bio-medical bench research and efficacy clinical trials; what can work under ideal conditions. The Center for Disease Control who you heard from yesterday focuses very much on the public health system and community based interventions. We focus on the effectiveness of health care services and the health care delivery system. So our work is patient centered and not disease specific because many patients unfortunately enough have more than one condition, so you actually have to treat the entire patient.
Our focus is both on the content of clinical services and the environment in which those services are provided. And very importantly we have a unique roll in focusing on cost effectiveness. What are the tradeoffs between quality, outcomes, access and cost? If you think about health care expenditures going up, which is something you probably think about every waking moment and perhaps even in your sleep recently, these tradeoffs are going to be increasingly important. Again, effectiveness research focuses on actual daily practice, not the ideal situation of a clinical trial.
So just to give you an example of how this might work for diabetes, the NIH would be supporting research to develop and test interventions to cure or prevent disease. The CDC might be focusing very broadly on health behaviors, testing community interventions, broad programs to increase exercise and improve diet and so forth. AHRQ would be developing evidence to help clinicians and patients select the best interventions and evaluate quality improvement efforts.
So this is our little map for what we do internally. You can see on the left hand side of this slide are the three over-arching areas that we focus on and on the top very importantly are the decision makers. Clinical decision makers include clinicians, patients and their families. Health system decision makers are sort of a heterogeneous group that include people who lead managed care plans; people who lead hospital systems or individual hospitals and so forth and then public policy decision makers obviously include all of you and federal policy makers.
So I wanted to give you some examples of some of the research that we've recently supported. This was published in the New England Journal of Medicine a couple of weeks ago and asked the question does practice make perfect. The investigator actually looked at patients in the Medicare program and tried to figure out, demonstrate the relationship between the volume of procedures done at a hospital and the outcomes for the patients in terms of mortality. What you see here on the slide is for surgery to address cancer of the esophagus or cancer of the pancreas, clearly patients treated at low volume hospitals, were much more likely to experience mortality in the next 30 days than those treated at high volume hospitals. For those who aren't so clinically inclined, let me just tell you these are both very complicated procedures. Now we're not saying what to do with this information. Our role is to generate the evidence, policy makers and our customers need to figure out what's the best strategy here in terms of what are the implications of this for the programs that you're running.
We have a national survey which is based on our consumer assessment of health plans and we recently published some results detailing selected aspects of Americans experiences with health care services in the year 2000. So you see on the left hand side of the slide the percentage of Americans over the age of 18 who received urgent medical care as soon as they wanted based on ethnicity. What you can see is that Hispanics reported significantly worse experiences than Blacks or Whites.
The purpose of this survey, it enables us to actually obtain patients reported experiences with care based on the best survey techniques available and also trying to report those results in a way that's meaningful to those. About 100 million patients in America have access to the results from the Consumer Assessment of Health Plan Survey.
Another study looked at the use of drugs to treat ADHD and depression in youth and this is actually simply just reporting on the use of different trends of drugs. It's not actually saying what's appropriate or not but what you can see is that the selective seratonin reuptake inhibitors, you may know them by such names as Prozac and Zoloft and related drugs are way up just in the years between 1995 and 1999 and if you're trying to think about how you might get a handle on the cost of drugs for the Medicaid program for example, this is interesting information. It shows you where some of the likely targets of opportunity might be.
Very recently, and Dr. Burstin will be talking much more about this; we actually launched a website with the help of investigators from the University of Alabama. This helps clinicians who see patients in the emergency department, radiologists, pathologists, and infectious disease specialists, both physicians and nurses learn about bio-terrorist agents and actually get continuing education credit for doing so and it's now going to be expanded to primary care clinicians.
So this is all fun stuff and I hope I've made this sound relatively interesting and we have a lot of fact sheets for you to read more about what we do and we would be happy to download extensively for you anytime. But the real critical point and the reason we're so excited to be here today is it's been very clear since the agency was established in 1989 that the expectation is not just that we're going to support neat or interesting research, but that we will support research that will lead to improvements in care. So when John Eisenberg, our former director, first testified before the House Appropriations Committee, he was asked how do you know the research has an effect on people. And he started to talk about publications and prestigious journals at which point Rep. Porter who was then the Chair of that Subcommittee said no, that's not quite what I had in mind. I want to know how do you know it affects people's lives. And that's become something of a touchstone for us at the agency and where we see potential partnerships with you and our research as being very important.
It's very, very clear that we're facing incredible challenges in this country in terms of the kind of quality of care that is being provided. What you see here is a sort of graphic depiction of the gap or the chasm between the high quality care that could be provided on the right hand side, labeled "excellent quality" and on the left hand side what most people are actually getting. We have a lot of work to do and we need to work together.
So how can we help the states? We can support research to improve or inform policy decisions. For example, how can drug prices be reduced without unanticipated consequences? We supported a study some years ago showing that a drug cap for Medicaid beneficiaries sounded like a really good idea, and if you only looked at the pharmaceutical piece of the pie it actually did save money in the short run. It has the unanticipated consequences of waiting to increase nursing home admissions, hospital admissions and significant worsening of health status for some of those individuals. We can provide information from current studies and try to make that available to you as rapidly as possible. Where we need help from you is actually letting us know are we addressing the right questions and are we making the information available in a way that's timely and also useful.
We have products that we can provide. One example that's being used, by a lot of states for their hospitals, are some quality indicators. This is software that you can use with hospital discharge data to flag potential quality problems and of course as Dick Merritt mentioned earlier, we have our user liaison program which is a series of seminars and workshops for state and local policy makers.
This slide just describes the quality indicators I mentioned a few moments ago. Some of these won't be available until this summer. This is easy to use software; we're also investing in the technical assistance, so you may want to consider this as you're thinking about quality of care in the hospitals in your state.
Very exciting areas coming up for us in the next year, for the first time ever we're going to have an annual report on the quality of care in this country. I'm sure most of you in your daily work here about quality of care and often it's probably linked to the phrase along the lines of "going to hell in a hand basket" to we're having quality problems, the reality is we don't have a national benchmark and this report is going to provide that and we're very excited about that.
We're also going to be providing a report on disparities in health care, which again we think will be a very important opportunity. These reports as you could imagine will be tightly linked, since it's hard to think about reducing disparities in health care without thinking about that as an important part of the overall quality challenge that we're facing.
So, where do we need feedback from you? What questions or issues are most important now and in the near future; by near future I mean over the next 3 to 5 years and how can we make our products more useful. We truly are here to help and very much want to hear from you. So with that I'm going to stop.
QUESTION: My name is (Sen.) Pat Thibaudeau and I'm from the state of Washington and I'm wondering, have you looked at research on drug classes or just individual drugs?
In general we have tried to focus our research efforts on classes of drugs for a variety of reasons. But we have a new Centers of Excellence program called the CERT, the Centers for Education and Research on Therapeutics. We don't have one in Washington State yet, although we're hoping that we can expand that program in the future. The purpose of these centers is to promote the appropriate and safe use of pharmacological agents as well as biologics and devices. But by enlarge those investigators focus on classes of drugs.
QUESTION: I'm (Rep.) Elliot Naishtat from Texas and I'm curious; have you come up with a procedure and approach to doing the first annual survey of quality of care in this country?
Yes, I will start this and Dr. Meyer may want to jump in here as well. We're very excited about this opportunity because we have leading economic indicators and different approaches to getting that and yet we have never had any sort of approach to look at quality of care. We will be looking at clinical process measures of quality as well as patient perceptions of quality of care across a broad array of conditions. It's important to note that while the agency is leading this, we are working very closely with other parts of the department and have been very much informed by advice from the Institute of Medicine which advised us to array the measures along six important dimensions of care; effectiveness, safety, timeliness, patient centeredness, equity and efficiency. We see the first report; it's going to be produced at an annual basis as literally that, the first report. They're going to be areas where we wish we had more information but we think that's also a function of the report as well to say here's what we know and that will of course prompt and stimulate many questions about well, why aren't you reporting on this kind of condition or for this kind of population. In some cases that's going to be because we don't have data or we don't have good evidence about what's effective and that's clearly where we need to do more work. Does that help? [Yes]
QUESTION: I think you mentioned something about getting into the cost or value. Will someone else be talking a bit more about how you get into this the whole value issues?
Well many of you may have noticed, I guess I'd say the last part of the 1990's when overall expenditures were relatively flat, having public conversations about cost effectiveness wasn't incredibly polite, right? Because we were worried that the bean counters had gone too far and were therefore impairing quality of care and most of the policy action was focused on quality. We have an internal group focused on trying to develop strategies to figure out how can we make cost effectiveness more useful to states. For example, we've been having conversations with the people from Oregon as they're using cost effectiveness to try to figure out how do they incorporate drugs into a formulary. We'd be happy to have more conversations with you. We don't have a formal approach just yet. One of the challenges about cost effectiveness in using that for decision-making has been trying to make the techniques which can be incredibly helpful, easy to use. But those two don't always go hand in hand and that's going to be a big focus of our efforts.
QUESTION: How do you, or do you function at the state level. Do you have projects, clinical projects going on around the country or do our health departments actually have people financed by grants from your agency or is it really a technical support where people are getting on line, professionals are getting on line to just access the information that you publish.
The short answer to that question is yes. Most of our research grants do go to academic institutions, which are not uniformly distributed across the country. We do try to supplement the fact of that uneven distribution with a lot of serious efforts of technical assistance. So the quality indicators, for example, we're going to have a contractor that will help people actually navigate the software if they're having problems, etc, and we do take a great deal of pride in our website and our user liaison program. We're more than open to suggestions about how to do that. Chris Williams, who directs our Office of Health Care Information and her staff, actually worked very closely with the state of Texas to try to take a product, a series of products, that we have developed called "Put Prevention Into Practice", which is kind of the next step in here's what we need to do in clinical prevention; here are some tools to help you do it and the feedback they got from the state was that they actually needed a little more help in trying to make this concrete for people. How do I know I've improved? How do I measure this? And they put together a lovely product. So we're more than open to that kind of suggestion.
QUESTION: Rep. Phyllis Heineman, South Dakota. Expanding on what you were talking about cost effectiveness and you'd also mentioned you had done a study as far as limiting medications, numbers of medications, have you done anything on the preferred drug list that so many of the states are looking at and seeing if that is cost effective and if it's also in terms of health outcomes has there been any research on that kind of fairly new development?
I'm not familiar with preferred drug lists. Can you tell me more about that?
Well basically what a lot of the private insurers are doing where you're trying to limit, you're kind of stepping up therapy rather than just paying it. You're trying to decide which drugs within each therapeutic class, not really closing a formulary but setting up preferred lists.
We have not addressed that issue specifically. We have some evidence reports that have looked at the use of drugs for specific conditions. For example, there's an evidence report that summarizes what we know about drugs for depression, which is obviously going to be a big category and compares the newer agents with the older ones and in some cases generates more questions about what we need to know. There's been a great deal of interest in studying the effects of formularies; does it have an impact? And we've published a number of studies looking at the effect of using different strategies to limit costs at the level of the individual patient, triple tier cost sharing and that kind of thing. But we have not specifically looked at formularies. But again, if you could sort of give us a sense of what are some of the specific questions we'd be happy to see if we could interest a researcher in doing that.
QUESTION: John McDonnough from Brandeis. Right now dozens of states and private payers are all going through a similar exercise deciding which drugs are going to go into which categories for the tiered approach and the preferred pricing approach. Doesn't it make sense to have a national institute of some sort that is really doing that work as opposed to every state reinventing the wheel and is there any conversation or dialogue going on at the federal level about trying to create some entity like that.
I think it's fair to say, not yet. There was a study done by the Institute of Medicine last year looking at how the VA's formulary works and what are some of the challenges in having a central structure that defines what ought to be in a formulary and how that breaks down in terms of local implementation, or not, and how much. So there were some implications there about how much flexibility there should be at the local level and so forth. The role of this agency, if there were such an effort, would be to support the development of evidence needed to support the choices. We would not be in the position of deciding or setting the criteria for what ought to be in that formulary or what are the top conditions. So certainly we'd expect to be a vital part of the action if such a move were made but so far I have not heard serious discussions about that.
QUESTION: Sen. Maggie Tinsman from Iowa. We have a very senior citizen state and we're not just talking about one drug. People come in with a sack of drugs that they are taking. Many, even medical professions doesn't know what drug counteracts with another drug, all these kinds of problems. Since we have the highest number of hundred year olds in proportion to our population in the U.S. we have a lot of drugs. So my question is are you or is it possible are you looking at as people get older they add drugs to their lives, how are they going to decide what drugs to keep in; what drugs to take out and what are we doing about just drugging ourselves as we get older with all these multiple drugs.
Well first of all, let me congratulate Iowa. That's quite an achievement to have the most 100 year olds. We haven't focused questions or don't have studies to focus on the question that broadly. We have in some instances supported studies that look at very specific agents. For example there was a study in the state of Tennessee that looked at the use of specific types of arthritis drugs. A lot of older people, majority of older women report having problems with arthritis. So drugs like Motrin, Advil and so forth are extremely common. Unfortunately they also come with side effects and it turns out that Tylenol is just as effective for pain relief for most of those patients. So the purpose of this study was to try to see if you could develop strategies to persuade clinicians to use Tylenol more often than these other drugs.
Interestingly, in a nursing home, the investigator did two studies. One was in a series of nursing homes and one was an ambulatory practices and in the nursing home this was dramatically successful. In ambulatory care it was less so. A modest improvement, that is change in practice, but at a cost of extra visits which underscored for us just how difficult it's going to be to implement and sustain dramatic improvements in ambulatory care just because there's so much chaos at the level of the practice. But that's more the type of approach we take, more than the broad what are drugs doing to us. It's an issue that we're very, very much aware of.
We also sponsored a study that was done by agency staff looking at the rate of inappropriate prescribing in the elderly and up to 1 in 5 older people are actually getting a drug that's inappropriate and this is a very serious attempt to define and be very careful about what we mean by inappropriate. So we realize and it's a very crucial part of our patient safety efforts that we've got a lot of work to do in terms of improvement, because you're right, as an internist I see lots of older patients and you always know you're at an internist's office because everyone's sitting outside with a big sack.
QUESTION: I'm surprised about your response on formularies since at least where I live every hospital, every insurance plan, the state sort of has one but of course the pharmaceutical manufacturers hate formularies but at any rate I'm surprised that you haven't taken a look at that and then some are closed formularies, these are _____ institutions, not state run institutions?
It certainly hasn't been for lack of interest. The issue has been in some cases lack of access to the information needed to do the study. And in other cases it's been the fact that you're right, all of the organizations have formularies but they're all slightly different. So it's actually been pretty challenging to figure out how decisions are made at the level of any formulary.
My colleagues and I did a study last year trying to find out how did managed care plans handle new drugs and we chose four. Two of them are new agents for people with very severe arthritis; one was viagra and one was zyban to help people quit smoking. Interestingly every plan said that they were more likely to approve the arthritis drugs than the other two. Of interest to me, more plans were likely to approve viagra than zyban. I'll leave it to your imagination what that is about but we know very, very little about how the decisions are made. Where we think some of our greatest role may be is making sure that the people making those decisions have the right tools to be able to evaluate the submissions that are being made and the requests made upon them. So there is an effort right now among a group of pharmacists to try to develop a standardized submission form so that when people who are on these committees are looking at information about cost effectiveness they'll receive it in a standard fashion and we're hoping to fund a study to evaluate that approach.
QUESTION: Do you work with the FDA?
Yes, our Centers of Excellent Program is a program that was originally established under the authority of the FDA and was moved to the agency because it was thought that a non-regulatory approach might be more helpful here. That is to say to give people information based on the best evidence to make good decisions. But we work very closely with them.
QUESTION: Iowa may have the most 100 year olds but I believe Hawaii has the greatest average life expectancy and we just passed a long term care plan, a universal plan for our citizens which is going to be implemented in about 2 years. Most of the models that we look at in terms of long term care are based on medical studies and I think what we're looking for are more interdisciplinary types of research including social models and try to develop the best type of comprehensive plan available and this is what we need to come up with in a couple of years. I was just wondering if your agency or if you know of any other study that looks at the types of comprehensive care, including social and health models.
I believe that we have some studies that look at those issues. Part of the problem, you probably know far better than I do, is when you say long term care, you're talking about a very broad array of services from post acute care settings, to nursing homes, to home based care and people transitioning across these. I think it's been a challenge to try to get research that looks at episodes of care where people cross these settings and looks at the other supports that come in but it is an area of great interest to us and the really good news for you is that Chris Williams is here who reminds us 3 times a week about the importance of long term care. So I would encourage you to follow up with her in terms of what specifically we have funded. Thank you.
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