[Senate Hearing 107-818] [From the U.S. Government Publishing Office] S. Hrg. 107-818 DISEASE MANAGEMENT AND COORDINATING CARE: WHAT ROLE CAN THEY PLAN IN IMPROVING THE QUALITY OF LIFE FOR MEDICARE'S MOST VULNERABLE? ======================================================================= HEARING before the SPECIAL COMMITTEE ON AGING UNITED STATES SENATE ONE HUNDRED SEVENTH CONGRESS SECOND SESSION __________ WASHINGTON, DC __________ SEPTEMBER 19, 2002 __________ Serial No. 107-36 Printed for the use of the Special Committee on Aging ----------- 83-477 U.S. GOVERNMENT PRINTING OFFICE WASHINGTON : 2002 ____________________________________________________________________________ For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpr.gov Phone: toll free (866) 512-1800; (202) 512�091800 Fax: (202) 512�092250 Mail: Stop SSOP, Washington, DC 20402�090001 SPECIAL COMMITTEE ON AGING JOHN B. BREAUX, Louisiana, Chairman HARRY REID, Nevada LARRY CRAIG, Idaho, Ranking Member HERB KOHL, Wisconsin CONRAD BURNS, Montana JAMES M. JEFFORDS, Vermont RICHARD SHELBY, Alabama RUSSELL D. FEINGOLD, Wisconsin RICK SANTORUM, Pennsylvania RON WYDEN, Oregon SUSAN COLLINS, Maine BLANCHE L. LINCOLN, Arkansas MIKE ENZI, Wyoming EVAN BAYH, Indiana TIM HUTCHINSON, Arkansas THOMAS R. CARPER, Delaware JOHN ENSIGN, Nevada DEBBIE STABENOW, Michigan CHUCK HAGEL, Nebraska JEAN CARNAHAN, Missouri GORDON SMITH, Oregon Michelle Easton, Staff Director Lupe Wissel, Ranking Member Staff Director (ii) ? C O N T E N T S ---------- Page Statement of Senator Larry E. Craig.............................. 1 Panel I Dan L. Crippen, Ph.D., Director, Congressional Budget Office, Washington, DC................................................. 2 Ruben King-Shaw, Jr., Deputy Administrator and Chief Operating Officer, Centers for Medicare and Medicaid Services, Washington, DC................................................. 29 Panel II Sister Anthony Marie Greving, Director, Area Agency on Aging, Pocatello, ID.................................................. 46 John Rusche, M.D., Senior Vice President and Chief Medical Officer, Regence BlueShield of Idaho, Lewiston, ID............. 53 Alan Wright, M.D., Senior Vice President and Chief Science Officer, Centers for Health Improvement, AdvancePCS, Hunt Valley, MD..................................................... 65 Matthew A. Michela, Senior Vice President, American Healthways, Nashville, TN.................................................. 75 APPENDIX Testimony by American Dietetic Association....................... 91 Statement of Richard M. Wexler, Medical Care Development Inc./ME Cares, Augusta, ME............................................. 93 (iii) DISEASE MANAGEMENT AND COORDINATING CARE: WHAT ROLE CAN THEY PLAY IN IMPROVING THE QUALITY OF LIFE FOR MEDICARE'S MOST VULNERABLE ---------- THURSDAY, SEPTEMBER 19, 2002 U.S. Senate, Special Committee on Aging, Washington, DC. The committee met, pursuant to notice, at 9:31 a.m., in room SD-628, Dirksen Senate Office Building, Hon. Larry E. Craig (ranking member of the committee) presiding. Present: Senator Craig. STATEMENT OF SENATOR LARRY E. CRAIG Senator Craig. Good morning, everyone. The Senate Special Committee on Aging will convene. Thank you all very much for joining us this morning to discuss the topic of disease management and care coordination. A very special thanks to Chairman Breaux who allowed me to facilitate this hearing and to chair it. He will be here in a few moments. I think he just called in tied up in downtown traffic and was there earlier for another engagement, so he will be joining us in a few moments. He is as interested in this topic as am I. Disease management is an emerging technology with the potential to improve patient quality of life and may reduce health care costs. Disease management can best be described as a coordinated and proactive approach to managing care for patients with chronic illnesses. Chronic illness is common among Americans on Medicare, and I would like to call attention to some charts that now have been turned in my direction. The yellow bar chart--why do we not spin that around. I have got a copy of it here at the desk so we can show it to the audience. The yellow bar chart shows several diseases with a high prevalence among America's seniors. Two of the chronic diseases shown are found in over half of Medicare beneficiaries. Even more striking is the fact that almost half of Medicare beneficiaries have three or more chronic conditions. The pie chart shows that 47 percent of those on Medicare have three or more chronic conditions. These citizens are especially vulnerable to medical complications. They also have high medical costs paid out of their own pocket and by Medicare. Unnecessary hospitalizations are one of the costly consequences that disease management programs are designed to prevent. These unnecessary hospitalizations are often a result of cross-drug interaction, poor medication compliance, deviation with treatment plans, and a lack of patient self- management skills. Lack of coordination and fragmented monitoring of seniors with chronic health conditions can also contribute to unnecessary health spending. Our population is aging. As the baby boom generation begins to retire, the share of chronically ill seniors is expected to increase. Future Medicare costs are certain to reflect both increased numbers of seniors as well as extraordinary medical inflation. Evidence-based disease management is a promising technology for helping to reduce avoidable spending and improve the quality of life for Medicare's most vulnerable in the near and the long term. We are here today to learn more about the opportunity that disease management presents. We hope to learn about the challenges faced in moving these techniques into the Medicare population. We also hope to learn about the breadth of disease management programs and lessons learned from models already underway in the non-Medicare marketplace. Today's hearing will consist of two panels. The first panel that is before us now, we are pleased to have and to welcome Dr. Dan Crippen, Director of the Congressional Budget Office, and Mr. Ruben King-Shaw, Jr., the Deputy Administrator and Chief Operating Officer at the Center for Medicare and Medicaid. The second panel of experts includes Sister Anthony Marie Greving, Director of Pocatello, Idaho Area Agency on Aging; Dr. John Rusche, Senior Vice President and Chief Medical Officer, Regence BlueShield of Idaho, headquartered in Lewiston; and Dr. Alan Wright, Senior Vice President and Chief Science Officer, Center for Health Improvement, AdvancePCS, in Fort Hunt, MD; and Matthew Michela, Senior Vice President for American Healthways in Nashville, TN. Well, ladies and gentlemen, to all of you welcome. As I have said, this is an area that I believe Congress must explore, as we move toward Medicare reform and a prescription drug program for our most needy, and to do both with two thoughts in mind, providing better health care to our seniors and controlling costs through more effective management. With that, let me welcome our first panel of witnesses, and Dan, we will let you start. Thank you. STATEMENT OF DAN L. CRIPPEN, PH.D., DIRECTOR, CONGRESSIONAL BUDGET OFFICE, WASHINGTON, DC Mr. Crippen. Mr. Chairman, thank you. I really appreciate the opportunity to be here today. This is an important topic, not only to me, but perhaps more saliently to my kids and my grandkids. We all thank you for holding this hearing. I hope to make three points. One, Medicare is a program in need of reform. Hopefully, that point will not take a lot of convincing. Two, there is a part of the Medicare population that, as you said, Senator, is fairly expensive. The question is, are they the same people each year--or who are these people? There is a concentration of expenditures within the Medicare population that invites further examination. Third, disease management, or case management, as is more probably the case with this population, has great potential, we expect, to reform the delivery of Medicare services. We think, however, that it is not yet proven that it will provide significant cost savings in this program. But that is not because we think it does not. We just simply do not have enough evidence yet. I have, I am sure, imposed this first chart on you, Senator, somewhere else, in some other forum, because I use it all the time. It essentially shows what we are now spending on the programs for the elderly at the Federal level: Medicare, Medicaid and long-term care, and Social Security. Senator Craig. Again, why do we not turn that to the audience who is here to listen and gain information. I have got copies here, and the chairman will also have, so we can share that with everyone. Thank you. Mr. Crippen. We are currently spending a little over 7 percent of gross domestic product (GDP), or a little more than a third of our budget, on these programs for the elderly. But as my generation retires, we will quickly, over the course of only two decades, drive that up to over twice as much--and those are relatively conservative projections. So we will be spending 15 percent or 16 percent of GDP on these programs--and we are now spending about 18 percent or 19 percent of GDP on the entire budget. What this means, of course, is there is likely to be a dramatic change in our fiscal policy. We will either need to dramatically raise taxes when the time comes, increase borrowing from the public, or significantly cut other government spending--and we have not seen that kind of tidal change for a long, long time. We could end up with a tax system, for example, that looks a lot more like a European country's than like what we have experienced here. For example, since World War II, we have taxed at the Federal level at an average of 18 percent of GDP. One could see a future here where that would be 28 percent. So it is a daunting challenge, to be sure, and something we cannot really avoid. The demographics are baked. The folks who will retire are alive today, and most of the folks who will be working are alive as well today. We cannot change those factors. All we can hope to do is change the growth of the economy, which is the denominator here, and perhaps reform the programs so that the numerator is not quite as onerous for our children. That brings us to the topic of today's hearing, Mr. Chairman. A little over 2 years ago, we began to ask the same kinds of questions you have posed for us today. That is, can we identify high cost procedures as well as high cost beneficiaries in the Medicare population? We quickly discovered that existing data were inadequate to thoroughly examine those questions, so we joined with a team at Stanford, who had received funding from the National Institute on Aging, to take the literally millions and millions of records that the Centers for Medicare and Medicaid Services (CMS) has accumulated over the years and construct a database, which at the moment covers 1989 through 1997. We will be adding 1998 and 1999 soon, so we will have records covering essentially 1989 through 1999. What we have done is accumulate, over these years and for each Medicare beneficiary, a great deal of detail on the nature of their health care needs and the services that they are using from Medicare. In fact, we have a month-by-month rack-up for each beneficiary over those 10-plus years of data. So we can now identify individuals as they enter the program, as they incur illness, and as they incur expenditures throughout Medicare, which is something we have not heretofore been able to do. We will soon publish a series of three papers, essentially explaining this database and how it was constructed, as well as the characteristics of the beneficiaries that the database covers. But I can tell you some of the preliminary findings today, which I think will enlighten the discussion of this topic. First, and of importance to this hearing, we confirm what earlier analysis has suggested--that is that there is a relative handful of beneficiaries each year who incur most of the expenses. Five percent of Medicare beneficiaries account for about 50 percent of the program's total costs, and 25 percent incur 90 percent of the costs. I am going to repeat that second point because I think it is an important number; that is, in any given year, 25 percent of the Medicare population incurred 90 percent of the program's total costs. That is not a new fact, Mr. Chairman. CMS and others have determined through sampling that it is a very heavy, very skewed distribution. But we can start from that point and further analyze our data now and see what some of the implications are. First, it might suggest that if 75 percent of the folks are only incurring 10 percent of the costs, we might want to figure out a way to handle them differently than we do the more expensive patients. That 75 percent might be able to go to any doctor they wanted to fill prescriptions or to do other things that an average Medicare recipient might do today without all of it being funded by the government and without all the current limitations in the Medicare program. Again, because this 75 percent of beneficiaries only incur 10 percent of the costs, it may not be worth imposing all of the limitations of the current Medicare program on them. But more to the point of today's hearing, that finding suggests that we need to examine the 25 percent of beneficiaries with the highest costs because as Willy Sutton has reportedly said, the reason he robbed banks is because that is where the money is. Certainly if we are going to examine this program from a cost view point, we need to look at that 25 percent. But it is also the 25 percent of the population in a given year that needs most of the health care, and so we can examine them as well from the point of view of determining their illnesses and, how they are being treated, in addition to their costs. There are questions we might ask as a first cut to look at both the data and the issue you have placed before us. Is it many of the same folks who incur high costs each year because of chronic conditions? If it is, that would suggest a particular kind of approach. What are their clinical characteristics, and can they possibly be treated in another way, such as with disease management, to produce better outcomes? That is the question you posed at the top of the hearing. Another question is, are these folks high cost largely because they are at the end of their life? We know that is a phenomenon that can be quite expensive. If it is, the case, what are we buying for those high expenditures? Heroic measures? Extended stays in hospitals? The question then is is there a better way to provide care for these elderly dying patients as well? Fortunately, we can now begin to answer some of those questions with a little more precision, but before I do, I want to offer a definition of disease management so that my statement, at least, can be taken in that context. Basically, and admittedly simplistically, disease management identifies the best evidence-based protocols and practices for a specific condition and tries to get both the patients and providers to follow those protocols. It is important to remember, however, that most of the best practices referred to here were developed for a single condition, not for one condition among multiple co-morbidities, and do not often account for unique characteristics of the elderly population, such as dementia. Many disease managers also try to predict which patients will ultimately become expensive, so as to target preventative measures more efficiently. Generally, the savings accrue because of fewer hospitalizations and emergency room visits. To begin answering some of the questions we identified, we examined in our data a cohort of beneficiaries for the years 1993 through 1997, beneficiaries who were the most expensive 25 percent in any of those 5 years. We then looked for patterns of expenditures and found that while many high-cost patients do die from one year to the next, a significant number have high expenditures in two or more consecutive years. It is those persistently expensive patients, Mr. Chairman, that I think disease management or case management might address more straightforwardly. Those patients account for only 20 percent of beneficiaries but nearly 60 percent of all spending. The clinical characteristics of this population, as you have already suggested, are quite complicated. Most of the spending is accounted for by patients with multiple chronic conditions rather than just, for example chronic heart failure. In fact, nearly 90 percent of spending--to translate the numbers of individuals you have in your charts--90 percent of Medicare spending is incurred by patients with three or more chronic conditions. Often, one or more of those conditions is among those that have been treated with disease management in a private, younger population, but as I noted above, it is unclear how successfully those protocols developed for single conditions for younger folks could be applied to an older population with several chronic conditions. An additional complication is that there is not anywhere near a perfect correlation between exhibiting a condition as a patient and incurring high, persistent costs. For example, 50 percent of those persistently high-cost patients that we identified have coronary artery disease, but only 35 percent of the patients with coronary artery disease are persistently expensive. In other words, persistently expensive patients--by our definition, patients with high expenditures in two or more consecutive years--are likely to have multiple chronic conditions, but having any one of those conditions does not mean the patient will become high cost in the future. So the conditions are not a good predictor of who the high-cost patients are going to be. It becomes difficult to identify, therefore, which patients should receive the additional attention of an intervention such as a disease management protocol in order to avoid hospitalizations. For non-Medicare populations, disease management companies use predictive modeling and additional data to increase the likelihood of picking out those with future high costs. Some of those additional data, such as pharmaceutical spending, are not readily available for the Medicare population, and the models may not fit the elderly very well. Because we do not have a pharmaceutical benefit as part of Medicare today, we therefore, do not have, pharmaceutical data for this same group of elderly people. We hope at some point in the future to be able to augment our database with things like that. A number of companies have offered to let us try applying their models to the Medicare population, and it is an exercise that we will pursue shortly. As I suggest, though, it is likely that the lack of comparable data on the Medicare population will prove to make these models less effective for predicting future expenditures. Before I move on, let me simply sum up at this point. While there are Medicare beneficiaries who exhibit persistently high costs, it is not clear that disease management as it is now practiced could be utilized successfully for that population. But if we assume for a moment that it could, then we can examine what we know about the health results and potential savings, at least, of utilizing disease management as it is currently practiced in the private sector. A recent study by the Employee Benefits Research Institute found that while case studies of particular programs have shown positive results, there is no--and this is a quote, I believe-- ``There is no conclusive evidence that disease management programs in general improve health or reduce costs in the long term.'' We at the Congressional Budget Office (CBO) are reviewing other research, but many studies examine the process of health care delivery, not the outcomes or the frequency of utilization of services. Admittedly, evidence on quality and cost is difficult to construct, especially for this population, and I know many are loathe to conduct what is usually considered to be a rigorous study--with a control group that does not receive the better treatment, to provide comparisons. It may well just be that we are going to have to let more time pass to see the results of some of these interventions. My colleague here on the panel obviously is in a much better position to describe to you in more detail the various studies and demonstration projects being conducted by CMS to begin to answer some of those operational questions and questions of savings. In the meantime, or at least for the moment, until more clear and compelling evidence materializes on health outcomes and costs, I cannot tell you how CBO would evaluate a legislative proposal promoting disease management. First, of course, there are a great many design issues that, as outlined in my written testimony, come into play. But more to the point, we remain to be convinced of significant savings from disease management as it is currently practiced, especially when applied to the Medicare population. I would hasten to add, however, that we are not agnostic on the issue. We expect that the continued examination of persistently expensive Medicare patients will enlighten us further, and perhaps, if companies offering disease management were willing to take on some of the financial risk for the medical care provided to those patients, as opposed to putting only their own fees at risk--we would be more confident that companies would have incentives to watch those costs more closely. The key, ultimately, at least to savings is the avoidance of hospital costs through lower admission rates and the avoidance of emergency room visits probably both for persistently expensive patients and for those at the end of their lives. So on both sides of this distribution, Mr. Chairman, we have work to do in identifying both the patients who are likely to become high cost and these who are at the end of their lives and how they are being served through Medicare. Thank you. [The prepared statement of Mr. Crippen follows:] [GRAPHIC] [TIFF OMITTED] T3477.001 [GRAPHIC] [TIFF OMITTED] T3477.002 [GRAPHIC] [TIFF OMITTED] T3477.003 [GRAPHIC] [TIFF OMITTED] T3477.004 [GRAPHIC] [TIFF OMITTED] T3477.005 [GRAPHIC] [TIFF OMITTED] T3477.006 [GRAPHIC] [TIFF OMITTED] T3477.007 [GRAPHIC] [TIFF OMITTED] T3477.008 [GRAPHIC] [TIFF OMITTED] T3477.009 [GRAPHIC] [TIFF OMITTED] T3477.010 [GRAPHIC] [TIFF OMITTED] T3477.011 [GRAPHIC] [TIFF OMITTED] T3477.012 [GRAPHIC] [TIFF OMITTED] T3477.013 [GRAPHIC] [TIFF OMITTED] T3477.014 [GRAPHIC] [TIFF OMITTED] T3477.015 [GRAPHIC] [TIFF OMITTED] T3477.016 [GRAPHIC] [TIFF OMITTED] T3477.017 [GRAPHIC] [TIFF OMITTED] T3477.018 [GRAPHIC] [TIFF OMITTED] T3477.019 [GRAPHIC] [TIFF OMITTED] T3477.020 [GRAPHIC] [TIFF OMITTED] T3477.021 Senator Craig. Well, Dan, thank you very much. Before I ask questions of you, let us hear from our second member of this panel, the Honorable Ruben King-Shaw, Deputy Administrator, Chief Operating Officer, Centers for Medicare and Medicaid Services. Ruben, welcome before the committee. STATEMENT OF RUBEN KING-SHAW, JR., DEPUTY ADMINISTRATOR AND CHIEF OPERATING OFFICER, CENTERS FOR MEDICARE AND MEDICAID SERVICES, WASHINGTON, DC Mr. King-Shaw. Thank you, Mr. Chairman. I appreciate being here. It is always good to talk about what we are doing over at CMS, and particularly on this very important topic as it relates to our overall strategy to modernize Medicare for all the people that we serve. As the Chief Operating Officer of CMS, I am very much, you know, responsible for the day-to-day operations of the nation's, if not the world's, largest insurance company and financial services firm. In that sense, I have got two major product lines in the insurance business, an indemnity fee-for-service Medicare product and Medicare+Choice product. My comments in the oral testimony will be focused on the fee-for-service, or indemnity environment. The written statement does have more information on what we are doing on managed care. But, as you can appreciate, most of the world outside of Medicare has moved away from the indemnity model toward more types of managed indemnity or managed care or care coordination. In the insurance benefit administration field we are a good 20 years if not more behind in that. So there are implications for that for Medicare, and as you heard from Dr. Crippen's testimony, in fact, a relatively small number of beneficiaries do account for a disproportionately large amount of our expenditures, and so we are looking at the possible ways that a disease management, population management, care management strategy can impact those costs, and beyond that improve our product, again, referring to the fact that we are very much an insurance company among other things. We need to make sure that we continue to improve our product, better serve our beneficiaries and deliver on the true promise of Medicare, and so disease management gives us an opportunity to talk about ways we will do that. My comments will go through some of the environmental factors that we are looking at and the demonstrations we are currently pursuing to answer some of the very same questions that we have talked about already here this morning, keeping in mind that the promise of disease management is most realized in having a positive impact on both the performance, the outcome, the clinical condition of the patient, as well as the cost, the overall cost of care. So it's the integration of resources, of information, of strategies, of data, the elevation of evidence-based practices, best practices, in a patient-centered way where these outcomes and cost savings can be realized. So we do look to disease management as a way of identifying the best ways to improve or increase access to care, the best strategies for intervening in the development of disease or the maintenance of illness--I'm sorry--of wellness for beneficiaries. We are looking for ways we can improve the clinical outcomes by having clinical performance of caregivers and physicians and patient participation brought to the mix so that we can produce a better outcome for the patient, the Medicare system overall. So as we are looking at the ways to do this, we have a few demonstration programs under way. One of these consists of 15 different demonstrations that are the more the disease management variety. These demonstrations are focused on conditions such as congestive heart failure or coronary heart disease or hypertension or asthma. These individual vendors come from a variety of sources. Some of these are proprietary, commercial vendors that have been successful in the commercial market. Some of these are academic medical centers including historically black colleges and universities and other types of institutions. Some of these are not-for-profit entities that specialize in, for example, coronary heart disease. But through a variety of combinations of expertise, these vendors, if you will, partner with us to bring these best practices to organize a delivery system on behalf of the patient in a way that they believe will have a positive impact on the cost and the outcome of the patient. They are free to use various degrees of technology. Some of them are quite technologically advanced in their applications; some of them use a more traditional model of coordination of care. Some of these are telephonic. Some of these are face-to- face. Our objective here would be to have these 15 different demonstrations that serve currently over 3,000 Medicare beneficiaries explore the different strategies so we can collect data at the end of demonstration to identify some of these best practices and what the cost implications were, what the performance measures were, as a result of different interventions, different types of organizations, different populations, and, in fact, different parts of the nation. Another type of these demonstrations were enabled by BIPA legislation, where again these demonstrations do give us an opportunity to include a prescription drug benefit, not just for a specific disease, but for all of the prescription drug needs of the enrolled population. It is commonly known that if you are going to do an effective job at managing the overall care of a patient, then a major part of that care plan would be the inclusion of the appropriate prescription drug therapies. So by including prescription drugs in the mix, the attempt here would be to have a disease management organization work with the entire continuum of care including pharmacology to produce this outcome. We have just, you know, recently gone through a process. We are finalizing that information. We hope to get those underway very quickly, but again that is a second variety of demonstrations that we are pursuing. We are looking soon to move into a demonstration environment for various strategies to better improve the performance of the ESRD, end-stage renal dialysis patients, a significant cost factor in the Medicare program, and also one that is very ripe, we think, for the kind of interventions a disease management program can bring. So in a very few words what I hope I have done in this introduction is give a sampling of what we are doing in this field of disease management with the understanding that we at CMS, the Federal Government as a whole, the trust funds, are at full risk in the fee-for-service environment. There is no intervening force, and so if you have a disorganized, if you will, non-coordinated system of delivering care, which is what we have in fee-for-service, and you have a small number of people who are disproportionately consuming your resources, one of the strategies would be to have an integrator, a coordinator, use data techniques to identify those individuals and build a community of care, a system of care, coordination of care, to have a positive impact on those individuals, but again the Medicare program overall. Thank you very much, Mr. Chairman. I would be happy to answer whatever questions you and others may have. [The prepared statement of Mr. King-Shaw follows:] [GRAPHIC] [TIFF OMITTED] T3477.022 [GRAPHIC] [TIFF OMITTED] T3477.023 [GRAPHIC] [TIFF OMITTED] T3477.024 [GRAPHIC] [TIFF OMITTED] T3477.025 [GRAPHIC] [TIFF OMITTED] T3477.026 [GRAPHIC] [TIFF OMITTED] T3477.027 [GRAPHIC] [TIFF OMITTED] T3477.028 [GRAPHIC] [TIFF OMITTED] T3477.029 [GRAPHIC] [TIFF OMITTED] T3477.030 [GRAPHIC] [TIFF OMITTED] T3477.031 Senator Craig. Well, thank you very much. I appreciate both of your testimonies and let me ask several questions of you. Dr. Crippen, you have provided I think an excellent testimony on what appears to be a fairly complicated issue, trying to understand if, in fact, you can affect the current trends significantly. You discuss the problem of identifying best candidates for disease management and referred to the concept of regression to the mean. Now that sounds a bit like an economist speaking. Mr. Crippen. It is. Senator Craig. I am not. From the testimony I was not sure if this theory applied to the Medicare population because you did identify a persistently expensive group in your analysis. Question therefore is: does the regression to the mean concept apply to Medicare enrollees? Mr. Crippen. The answer is yes, but probably not in the same way. The term regression to the mean is roughly saying that a person will over their lifetime, exhibit average spending. These, if we had a Medicare recipient who in one year was a very high-cost patient, there is some probability that over the next year they will be a low-cost one--that is, if their are expenditures episodic, or acute expenditures and not for chronic conditions. There are certainly many of those folks in this population. Indeed, there are two things that you need to look for as we look at the data. One is unfortunate but true: those folks who die are not representative of the future costs of beneficiaries of the program, for an obvious reason: and those who incur high costs in one year may not be representative of those who will incur high costs in following years. That is why we looked for people who had high costs in at least two consecutive years. That is the population that we think you would first want to look at to say do they have chronic conditions, are they treatable in a different way like disease management or case management, because if they are just an acute health problem, there is no use trying to manage that very much. You are going to experience expenditure in the next year that will be out of this group. Likewise if folks die. But it's a very important thing, as you pointed out, to keep in mind. Some of the studies frankly that have been done over the years looking at this population have done things, partly because of data necessity, like throw out anyone who died during the course of the year, and then look at costs. That is not a representative sample certainly for this population. So your question is very much on point. We do not have the complete phenomenon of regression to the mean, but we certainly do have that show up to some extent here as well. Senator Craig. OK. The end of your testimony lays out several obstacles for achieving direct scoreable savings with any Medicare disease management program. If successful, will the Medicare demonstration projects that Mr. King-Shaw is talking about provide enough evidence to show a scoreable savings; do you think? Mr. Crippen. I expect so; it always seem too soon to tell, particularly for those that are being designed with capitated payments. That is important so that providers have some financial risk as well, in looking at the costs, but any additional data on how much it takes to support this population and how these disease management concepts could apply will enlighten this discussion. As I said, part of our reluctance at the moment to say that we know this is going to save money is not because we do not think it will. It is because we do not have enough evidence, and these demonstration projects should be quite informative in that as well as other research we and others intend to do. Senator Craig. OK. Is there a way to design a Medicare fee- for-service disease management program without creating adverse incentives among providers? Mr. Crippen. The answer is yes. I suspect, however, that there are a lot more ways to create a program that does have adverse incentives, so it is important to keep our eye on that--as you are suggesting by this question. Let me digress for a minute, if I might, because I think, as my colleague here suggested, that we do not often think of this population as an insurable pool, even though we are effectively providing some types of insurance. We think of it more as the Federal beneficiaries who are participants in this program, and the benefits we are providing, and how to pay for them. But if you think of these groups as risk pools, it can sometimes be informative. We have, by our simulations, estimated that it takes about 100,000 Medicare recipients to have a pool with average risk. We do not have insurance pools that are in the country, that large although clearly we could, because we have 39 million, roughly, people in this program. But given the division between providers and geography and other factors, we do not have pools that large. So you need to look at the risk within the pools, which is one of the things that drives our interest in this topic. If you look for high-cost procedures or patients, that is the risky tail of this pool. If you devise a system for removing those beneficiaries from the risk pool--because you are paying for them differently, independently--you would then create a much more average risk for the remainder of the pool. We are convinced that it takes some financial risk by providers and probably beneficiaries, as well, to get the incentives right. By bearing some risk, everyone has a bit of an incentive to watch how much of a service they use. That is not to say there has to be a large risk, but at least there needs to be some. So, until disease management companies are part of a provider system that bears some financial risk, they will not have those incentives that we as economists think are important to control costs. It is entirely possible, I think, to construct a system that could avoid adverse selection--or the incentives that encourage. We also have an opportunity here--and it is one of the few silver linings to the cloud that is the doubling of this population, from 40 million to 80 million, over a relatively short period of time. With all those new entrants, we would have the ability to assign them to risk pools in, say, a random fashion. As a result, there may be some opportunities with the rapid expansion of this population to compensate for any selection that becomes evident; even after the fact, a risk pool that showed lower-than-average spending, for example, or a healthier population could be repopulated with random assignment of folks who are coming into the program. Senator Craig. OK. I thank you not only for your interest in this and the involvement of the Congressional Budget Office. I think that is critically important because those of us who are spending time looking at these issues and seeing this phenomenal explosion of costs out there---- Mr. Crippen. Yes. Senator Craig [continuing]. Trying to understand how we get this all done, and I think your example of talking about moving from the, well, nearly doubling, 18 to 28, is a very high factor here. Mr. Crippen. Absolutely, and this kind of approach might also be useful as you develop other policies on pharmaceutical benefits---- Senator Craig. Yes. Mr. Crippen [continuing]. As my colleague here suggested. It is entirely possible that you could give pharmaceutical benefits through a disease management protocol where most of the pharmaceutical costs probably are anyway. Senator Craig. Well, in one of the versions of the pharmaceutical effort, at least here, prescription drug effort in the Senate this year, a piece of legislation I supported dealt with allowing pharmacists to become skilled in education, training, cross-referencing, really working with, if you will, the client or the patient in a much broader knowledge of the use of, the application of pharmaceuticals as an important part of not only understanding and creating and disallowing the problems that can result, but also bringing down some of those costs. So, thank you. Mr. King-Shaw, you talk about, I guess I would have to say, quite a few different management demonstration projects. Why so many? Mr. King-Shaw. Well, I think it is important as we go down this road to have really good research, good information on what works and what does not. I think it is also true that different approaches have been successful in the commercial sector or in the Medicaid sector. They may not all be successful in the Medicare space, and so it is important, we think, to have very good credible data about the range of activities that are possible before we would select any one or even a few to become the mainstream effort in disease management. I think it is also important for us to stay current with the developments of technology. For example, one of the realities in the Medicare program is that there is no natural coordinating force. We have many different people paying claims, organizations paying claims on one individual. There is no easy way to pool data together on either patient performance or outcomes or utilization or anything like that, and so when you do not have anyone in the system who has the ability to coordinate across the system, obviously you have weaknesses and concerns from that alone. There are different strategies underway to organize or galvanize or centralize information and coordination on behalf of patients. We need to know which ones work better than others and with which populations. Senator Craig. OK. In January, you selected 15 demonstration sites for coordinated care projects, as I read it, four rural, one rural urban, ten urban. The reason I ask this particular question, my State by definition is a rural State, is the availability of Medicare+Choice programs is very low. As an appropriator and a senator from the rural State, I have worked hard to develop a couple of demonstration projects to try to bridge this urban-rural gap, and one of those that is developing a good deal of interest is the tele-health demonstration projects. Can you tell me if any of your disease management demonstration projects are using tele-health or tele-monitoring devices? Mr. King-Shaw. We believe that there are programs out there, disease management vendors, who will use and, in fact, are beginning to implement those strategies. All of them will not. We have encouraged these disease management demonstration proposers to come up with the best approaches based on who they are and where they are. The tele-medicine/tele-health capabilities are extremely applicable in the rural areas and in some of the urban environments as well. So it is our understanding, it is our belief, and, in fact, our expectation that those tele-medicine/tele-health applications will be used in some of the demonstrations, and at least one of them in the rural areas. Senator Craig. OK. Your written testimony discusses potential payment options and the idea of a competitive bidding process is notably absent. Is this an oversight or an omission by design? Mr. King-Shaw. Actually neither. Senator Craig. OK. Mr. King-Shaw. There is a competitive process that we use for identifying these disease management programs. We have a process that can work in two ways. We can actually release a statement saying we are interested in proposers in this way, and so individuals can submit their responses to us. They are vetted thoroughly. We select the best ones. There is a series of criteria that we use. There is a panel of experts that we bring together from throughout CMS, and at times we will consult with entities outside of CMS. But there is a competition for the best, most robust, most tested proposals. Now, that is slightly different from competitively bidding for a commodity where you would just pick the lowest price or the best deal, so to speak. Many of these proposals are submitted with nuance and strategies and different approaches, and so you are comparing the various strategies that people will use to achieve an outcome. So a commodity like competitive bidding process is probably not well suited, but they are quite competitive. The selection criteria, you know, is quite intense, and so when we do have a series of winners, they have been thoroughly vetted. Senator Craig. OK. Of course, the ultimate question is how long? How long before we see any published final results in these demonstration projects? Mr. King-Shaw. We think that the final results are about 2 years, at least a year beyond the completion of a demonstration. So we have these demonstrations that are running from 1 to 3 years, more often 2 to 3 years in length. So a year after that, we would have some conclusive data. They are staggered, and so we will begin to have some data coming in over a period of time. I think what is also important to note is that many of these disease management demonstrations, population management demonstrations, are built around evidence-based practices, and once evidence-based practices are made available and disseminated to the delivery system, there tends to be relatively rapid adoption of them among the caregivers, the clinical community. So you can begin to see very quickly changes in behavior, patterns of utilization, some outcome data. We will be getting regular reports from these disease management demonstration projects that we can compile into some type of interim report card or update. But for something final and conclusive, that would take longer and it would include some external verification as well. Senator Craig. Well, gentlemen, thank you. Thank you both very much for your time and your valuable testimony this morning. Of course, as you all know, this committee is not an authorizing committee; it is an investigative committee, an information-gathering committee, a record-building committee, that we hope can supply information and evidence to authorizers as we get into these critical areas of policy design and decisionmaking. Thank you both very much. Mr. King-Shaw. Thank you. Mr. Crippen. Thank you. Senator Craig. I would ask our second panel and panelists to come forward please. Thank you all very much. That is the difficulty of cell phones when you do not turn them off. I apologize. Let me welcome our second panel and let me start with Sister Anthony Marie Greving, Director of the Pocatello, Idaho Area Agency on Aging. I always foul that up, Sister. I apologize. We welcomed you before the panel. Please proceed. STATEMENT OF SISTER ANTHONY MARIE GREVING, DIRECTOR, AREA AGENCY ON AGING, POCATELLO, ID Sister Greving. Thank you very much. I appreciate the opportunity to showcase our health promotion program in southern Idaho. As Senator Craig says, I am Sister Anthony Marie Greving, Director of the Area Agency on Aging in Pocatello, ID. The southeast Idaho area encompasses 9,200 square miles of rural and desert areas, sagebrush and juniper trees. The area is dotted with people not in large metropolitan areas or cities, but in small rural towns. Elderly in southern Idaho number a little over 22,000 or 15 percent of the total population. I come today to share with you our health promotion program for the low income elderly. The Area Agency on Aging contracts with the Southeast Idaho Community Action Agency, Retired and Senior Volunteer Program, to provide health promotion services to some 1,500 rural elderly. This program has seen a monumental growth. Over the past 7 years, the Southeast Idaho Health Promotion Program has received a total of some $90,000 in Older American Act funds, an increase of 38 percent since initial funding in 1996. The current year contract, however, with the RSVP program is not $90,000, but a mere $18,300. In service numbers, 176 people were served the first year, and now over 1,500 rural elderly are being served, a monumental 752 percent over the past 7 years. We are talking about commitment of dedicated staff and volunteers who see the need for services to the underserved and vulnerable. This program began with medication reviews called brown baggers in local senior centers, and has now grown beyond belief in assisting the homebound elderly with home safety checks, as well as a medication assistance program for those elderly who cannot afford the full cost of prescription drugs. Permit me to cite an example here which happened in southern Idaho. We have an elderly gentlemen who is 66 years of age, who has no primary physician, yet he has many diseases for which he takes many medications daily. On his kitchen table were two coffee cups. He would fill each coffee cup with 23 medications, take one cupful in the morning with breakfast, the other cupful in the evening with dinner, whether he needed them or not. Through our health promotion staff medication review, we assisted him in getting a primary doctor, who prescribed only seven medications on a daily basis. I am here to say that now he is serving as a volunteer within his local community. Elderly people have voiced to me that greater coordination is needed between physicians and pharmacists on prescribing drugs for elderly people. So many doctors do not take the time to know what drugs elderly people are now taking, all the while prescribing another better pill to ease the pain. They have also stated that pharmacies need to write not only in large print, but also give very specific directions on the medication label when to take the meds, not just the phrase ``take as directed.'' Those are two of the concerns that local elderly people have. Besides the standard health promotion program, the RSVP staff coordinate with Idaho State University Senior Health Mobile Clinic to provide medication review for the rural Idaho homebound elderly. This interdisciplinary mobile team travels the isolated areas of southeast Idaho in a van clinic that is equipped with health-related supplies, equipment, and educational resources. Yes, Idaho is a very rural State. Its population is made up of a shifting trend from those who have aged in place to those who are moving around the country as they age. In our health promotion program, we are seeing a number of older adults who are taking 16 to 18 medications daily, prescribed by a number of health care professionals to make the individual feel better. But the picture is by no means bleak. I highlighted what one health promotion program can do with drive, determination, and a readiness to solve problems in small rural communities. Disease management is possible in some rural areas, especially to those elderly desirous of a home and community- based service system, those who are homebound and those who wish to remain independent. I have given you a brief portrayal of how southeast Idaho has utilized the Older Americans Act funds to implement an effective health promotion program with a limited budget. There is always room for more services to our vulnerable elderly. I would ask for greater support of a disease management program like health promotion and medication management under the Older Americans Act, so elderly as Medicare beneficiaries can continue to maintain their health and quality of life and gain greater longevity and independence. I thank you for this opportunity. [The prepared statement of Sister Greving follows:] [GRAPHIC] [TIFF OMITTED] T3477.032 [GRAPHIC] [TIFF OMITTED] T3477.033 [GRAPHIC] [TIFF OMITTED] T3477.034 [GRAPHIC] [TIFF OMITTED] T3477.035 Senator Craig. Sister, thank you very much for that very valuable testimony about effective utilization of resource. Now, let me introduce before the committee Dr. John Rusche, Senior Vice President and Chief Medical Officer, Regence BlueShield of Idaho, headquartered in Lewiston, ID. Doctor, I am traveling to Lewiston, ID tomorrow morning. Dr. Rusche. Say hi for me. Senator Craig. I will do that. I think I am going to beat you home. Welcome before the committee. Please proceed. STATEMENT OF JOHN RUSCHE, M.D., SENIOR VICE PRESIDENT AND CHIEF MEDICAL OFFICER, REGENCE BLUESHIELD OF IDAHO, LEWISTON, ID Dr. Rusche. Thank you, Senator. I appreciate the opportunity to give testimony to the committee. I am Senior Vice President and Chief Medical Officer of Regence BlueShield of Idaho. We are a mutual health insurer and an independent licensee of the BlueCross BlueShield Association. We are a member of the Regence Group, which is four northwest Blues, BlueCross BlueShield of Utah, BlueCross BlueShield of Oregon, Regence BlueShield in Washington, and ourselves. I appreciate this opportunity to discuss disease management programs from the health plan point of view. I believe that this model of care coordination will be an important tool over the next few years as we continue to struggle with the issues of cost and quality. Disease management works by focusing effort and limited resources on those individuals who are most likely to utilize services and whose clinical course can be improved by the intervention. You saw from the charts before that in the Medicare population, half have three chronic diseases. From an analysis of our population, 2\1/2\ percent of our insured population account for 60 percent of the cost. It really is concentrated. The range of interventions can extend from patient education and self-management to medication and therapy management and reminders to intense, individually crafted care plans involving the entire array of physician, facility, drug and nursing care available. In our experience, there are four components of a successful population health program. First is identification. Of any population, only a subset has a condition. Second is stratification. Once you have identified the members with the condition, you need additional data. Not all people with a condition are of the same likelihood to incur expense. Third, the intervention has to be palatable. The program must be acceptable to the members and providers it supports. Simplicity, ease of service, and customer service are really important. Finally, outcome data. Any program needs to be able to show that the end effects are there in order to be able to judge the value of the intervention, or if you make later changes, that you have had a positive effect. In my more than 15 years of clinical practice, it has become clear that optimum care of complex chronic disease could be handled in better ways than our current one-on-one physician and patient behind a closed door system. As the managed care organizations of the 1990's become the care management organizations of the future, we will be doing a lot less utilization management, the authorization and approval approach, and more guidance in the best evidence-based approach to care. We will be more focused on the opportunities for greatest success. The written testimony I have provided describes our use of a cardiovascular program and a high risk psychosocial program for our Medicare HMO population. We will be looking at other chronic conditions that have modifiable courses. Currently, we are evaluating renal disease, cancer, depression, and arthritis programs. Some will be internally managed with our staff. Some will be contracted with vendors. The nature of the population served really defines the best model, I believe, for financing these programs. For example, we operate our maternity program internally. We could get a good result at as low or lower cost than from a vendor. The services and expertise in our cardiovascular program provided by QMed could not be replicated internally, so contracting was our best bet. A predictable rate of complications or disease incidence in a large population ordinarily allows a health plan to accept risk or retain the risk. Unpredictable risks, small populations, make risk-sharing or guaranteed return contracting with a vendor more attractive. Chronic disease increases with age. Complications and co- morbidities increase with age. Our senior population is what one might call a target-rich environment for disease management tools. If there is any population that the tools will benefit, if there is anywhere they will prove their value in health improvement and cost avoidance, it is among seniors. Senator, this concludes my oral comments. I would like to thank the committee for this opportunity to discuss disease management programs, and would be happy to answer any questions that you might have. [The prepared statement of Dr. Rusche follows:] [GRAPHIC] [TIFF OMITTED] T3477.036 [GRAPHIC] [TIFF OMITTED] T3477.037 [GRAPHIC] [TIFF OMITTED] T3477.038 [GRAPHIC] [TIFF OMITTED] T3477.039 [GRAPHIC] [TIFF OMITTED] T3477.040 [GRAPHIC] [TIFF OMITTED] T3477.041 [GRAPHIC] [TIFF OMITTED] T3477.042 [GRAPHIC] [TIFF OMITTED] T3477.043 [GRAPHIC] [TIFF OMITTED] T3477.044 [GRAPHIC] [TIFF OMITTED] T3477.045 Senator Craig. Thank you very much, Doctor, for being here and for offering the testimony and the experience that your companies are going through. Now, let me introduce before the committee Dr. Alan Wright, Senior Vice President and Chief Science Officer, Centers for Health Improvement, AdvancePCS--I will let you explain that--in Fort Hunt, MD. Doctor, thank you. STATEMENT OF ALAN WRIGHT, M.D., SENIOR VICE PRESIDENT AND CHIEF SCIENCE OFFICER, CENTERS FOR HEALTH IMPROVEMENT, ADVANCEPCS, HUNT VALLEY, MD Dr. Wright. Thank you, Senator Craig. I would like to thank the committee for calling this hearing today. Senator Craig. Pull your mike a little closer down maybe just a bit. Thank you. Dr. Wright. How is that? Senator Craig. That is better maybe. Dr. Wright. Our company, AdvancePCS has been creating disease management programs to improve the delivery of health care in this country for many years. We are pleased that Congress is interested in exploring the integration of disease management into the Medicare program and look forward to working with Congress. My name is Alan Wright. I am a physician and I am the Chief Medical Officer of AdvancePCS. During my tenure at AdvancePCS, I have been responsible for the development and oversight of disease management programs. I am currently focused on integrating new and emerging technologies into these programs. By way of background, AdvancePSC is the nation's largest independent provider of health improvement and pharmacy benefit services, touching more than 75 million lives. Our clients include BlueCross and BlueShield programs, health plans, self- insured employers, other employer groups, labor unions and government agencies including the Federal Employee Health Benefits Program. AdvancePCS health improvement capabilities range from pharmacy benefit management to clinical programs to disease management programs to specialty pharmacy services. We believe that these services are critical components in helping our clients balance their objectives of cost containment and quality. What I would like to do in my testimony today is first describe our current disease management programs and our approach and delivery of these programs. Second, highlight the current status and future plans for our programs. Third, describe the potential value of these programs to Medicare. Disease management programs are application and management strategies for the chronically ill, relying on a wide array of delivery models that improve the overall health of targeted populations. The benefit of our disease management programs are numerous. Aggressive management of chronically ill patients typically enables individuals to require less intensive care which enhances the quality of life and reduces the medical costs. In addition to providing health and financial benefits, disease management also reinforces care standards and strengthens physician-patient relationships. AdvancePCS disease management programs are developed internally, using established national guidelines such as the Joint National Committee on Hypertension, sponsored by the AMA; the guidelines created by the National Institutes of Health; the American Hospital Association; and the American Diabetes Association. We select programs for development based on the potential improvements of quality of life and cost impacts in the population. Quality and quantitative effectiveness of AdvancePCS disease management programs are measured using specific indicators that compare results to clinical benchmarks or goals. We enhance programs continually based on changes in clinical guidelines, feedback from practitioners, patient experience and program effectiveness, basically determining what works, what does not work, and adopting those things that work. We use principles of continuous quality improvement in collaboration on behalf of our sponsors in execution of programs so they achieve compliance with NCQA, the National Committee on Quality Assurance. AdvancePCS has a clinical research division called Innovative Medical Research that is devoted to clinically assessing and improving these programs through cooperation with numerous Federal agencies. The agencies that we work with include the Centers for Education Research and Therapeutics, sponsored by AHRQ. We also work with the FDA in post-marketing surveillance programs, and we have participated with other agencies as well in projects. Our programs have evolved over time. We maximize the number of methods available to communicate and educate patients and physicians. Our disease management programs are now tailored to specific conditions with interventions that extend from telephone outreach, mail and web-based interventions to personal nursing counseling. A good disease management program begins with a specific plan-sponsored goal, and when we initiate programs with a sponsor, in this case Medicare, we would begin discussing what is the objective of the program, and then build a program out from that objective. Without that kind of conversation, it is very difficult for everybody to be satisfied at the completion of the program. I would like to emphasize that patient privacy is a priority in our program, and we work closely with our plan sponsors to ensure protection of patient confidentiality. We would like to recognize that the Congress and the administration have made progress in bringing disease management approaches into the Medicare program, but there is more work to be done. We believe that Medicare can greatly benefit from appropriately designed and tailored disease management programs. As evidenced earlier in the exhibit from the Kaiser Foundation, patients in the senior population, the Medicare population, vary dramatically from those in the commercial population. The problems are more complex and those issues need to be directed and addressed when developing programs for a Medicare population. However, there are a number of disease management programs that could be adopted within Medicare today by focusing on pharmaceuticals and interventions already sponsored by Medicare. Given the high cost of illness, disease management programs that are focusing on some of the new and innovative biotech interventions that are paid for by Medicare Part B are suitable areas for disease management intervention and continue and will continue to be a rapidly growing area of both cost and quality within the Medicare population. Ultimately implementation of disease management into a Medicare program on a large scale requires consideration of payment reform and creation of financial systems that improve and enhance the deployment of disease managed services. We look forward in working with Congress to develop flexible payment systems for these types of disease management tools, and Congress can support CMS by ensuring that the agency has broad authority and latitude within the Medicare program to test new models. We believe that disease management programs directly address the challenges faced by Medicare in coming years by delivering high cost, cost-effective, quality care to chronically ill populations and would encourage further studies. That concludes my comments, and thank you for this opportunity to testify. [The prepared statement of Dr. Wright follows:] [GRAPHIC] [TIFF OMITTED] T3477.046 [GRAPHIC] [TIFF OMITTED] T3477.047 [GRAPHIC] [TIFF OMITTED] T3477.048 [GRAPHIC] [TIFF OMITTED] T3477.049 [GRAPHIC] [TIFF OMITTED] T3477.050 [GRAPHIC] [TIFF OMITTED] T3477.051 [GRAPHIC] [TIFF OMITTED] T3477.052 Senator Craig. Doctor, thank you very much. Let me turn to our last panelist, Matthew Michela, Senior Vice President from American Healthways in Nashville, TN. Matthew, welcome before the committee. STATEMENT OF MATTHEW A. MICHELA, SENIOR VICE PRESIDENT, AMERICAN HEALTHWAYS, NASHVILLE, TN Mr. Michela. Thank you, Senator. How is that? Is that all right? My name is Matthew Michela, and I am Senior Vice President of Operations of American Healthways which is headquartered in Nashville, TN. Thank you for the opportunity of appearing this morning to highlight our previously submitted written testimony. American Healthways is the nation's largest independent disease management organization, providing services to approximately 600,000 Americans with chronic diseases in all 50 States, Puerto Rico and the District of Columbia. Our programs were the first in the country to be accredited by both the NCQA and URAC, and are provided to a wide variety of populations including HMO, PPO, Medicare+Choice, and for some of our programs the Federal Employee Health Benefits Program. We are also the only disease management organization providing services to a Medicare fee-for-service population today, as we know. Because of commitment to quality we have led the way in submitting our outcomes, both clinical and financial, for third-party validation and peer review. Of particular pertinence to this committee, we believe, is the unpublished study reflecting our first 10 months' results with approximately 6,000 Medicare fee-for-service beneficiaries with diabetes in Hawaii. This study shows improvement in all clinical and a net reduction in total health care costs of about $5.1 million or a 17.2 percent net savings on an inflation-adjusted basis. Now, disease management is a treatment-support concept predicated on the principle that the way to reduce health care costs is to actually improve health. The goal of all disease management programs is to create and sustain behavior change among patients and providers to assure the most effective management of each patient's health. But while the precepts of disease management are uniform, program design and the method of delivery reflect significant differences, and as a result, so do the outcomes. Accordingly, the key factor in our success is not really a matter of what we do; rather, it is a matter of how we do it. Our programs are based on three underlying principles. The first holds that the fundamental interaction in health care is the one between the patient and physician, and that the rest of the health care system exists solely to make that interaction more effective, more efficient or preferably both. Between office visits, patients are essentially responsible for their own care and management. The current delivery system provides little or no support for them in that effort. That is what our programs do. The second foundation principle holds that creating and sustaining behavior changes necessary to improve the health of people with chronic disease is best achieved through personal, trusting relationships between patients and caregivers. Accordingly, our program interventions are delivered by over 600 highly trained, experienced and caring registered nurses who not only help patients deal with their condition or conditions, but also with the reality of living with chronic disease. That approach underscores the third principle that holds that patients we work with are people and are not diseases. By meeting each patient's needs, wherever that patient is, we are sure that we always prepared to support whatever behavior change the patient is willing to make. Another important issue is accreditation. American Healthways' early advocacy for accreditation had two bases. First, we believed that every health care organization ought to open itself to meaningful third-party scrutiny. Second, the historical absence of a uniformly recognized definition of disease management has allowed many programs, really thinly disguised marketing efforts, to prey on a vulnerable population by masquerading as disease managers. Accordingly, we needed, the industry needed a reliable external body to certify program quality. Whether or not accreditation programs serve that role effectively, however, will depend on their acceptance and use by private and public purchasers. The last topic I will address in my summary is how Congress can help. At a conference last week, David Kreiss, special assistant to the CMS Administrator, said ``The last frontier in disease management demonstration projects is population-based projects focused on outcomes.'' That he anticipated a request for proposals that would be released in the month or two. We urge this committee to provide whatever support may be required for CMS' efforts in this regard. Finally, we would ask Congress to revisit the issue of Federal preemption with respect to HIPAA and State privacy laws. Health care while delivered locally is no longer bought or paid for in that way. Health plans must provide uniform services to national corporations. The continued ability of individual States to enact laws more restrictive than HIPAA presents a significant barrier to meeting that requirement. So let me conclude, Senator, by emphasizing that disease management programs properly designed, properly implemented, and properly delivered improve health care outcomes and reduce the cost of care. As we have shown in Hawaii and in many other places, effective disease management programs can improve the health of Medicare beneficiaries and reduce the cost of care sustained by the trust fund. Further, the introduction of disease management services to Medicare beneficiaries does not require reform of either the health care system itself or the Medicare program. What it does require, however, is the support of this committee and this Congress. Thank you very much. [The prepared statement of Mr. Michela follows:] [GRAPHIC] [TIFF OMITTED] T3477.053 [GRAPHIC] [TIFF OMITTED] T3477.054 [GRAPHIC] [TIFF OMITTED] T3477.055 [GRAPHIC] [TIFF OMITTED] T3477.056 [GRAPHIC] [TIFF OMITTED] T3477.057 [GRAPHIC] [TIFF OMITTED] T3477.058 [GRAPHIC] [TIFF OMITTED] T3477.059 [GRAPHIC] [TIFF OMITTED] T3477.060 Senator Craig. Matthew, thank you very much. I am going to spend probably no more than the next 15 minutes with questions, because I have got other commitments to make this morning. So what I am suggesting in asking you questions is there may be some I will have submitted in writing to you, and if you would respond, if we do not get to all of them, I would appreciate that as we build this record. Sister, I think we are all impressed over time when I have associated myself with the senior community and programs of the phenomenal volunteer effort that can be generated in a community of interest to provide service and educational training and programming. Have you received any interest from other area agencies on aging to replicate your pharmacy management program? Sister Greving. I would answer yes, and it was probably a jealous nature that we have such a good program in Pocatello, ID. I have had inquiries not only from our other five Area Agencies on Aging Directors within Idaho, but also from neighboring States, and their question is how do we do it on a limited budget? I keep saying to them it is only because of the coordination efforts that we can really do it. We do not duplicate what someone else has already done. I think that is our secret within southern Idaho, and we would really like to replicate it throughout Idaho and the United States. Senator Craig. Is your health promotion program linked in any way to the tele-health demonstration program at Idaho State? Sister Greving. I can honestly answer with an affirmative yes. Dr. Beth Stamm and I are in constant coordination because we see the needs of the elderly, especially the rural elderly in Idaho, as someone who really needs these kinds of services, especially in relation to the lack of transportation that the elderly people might not have within rural communities. So if tele-health care serves those rural communities in that way, the linkage will have been served, yes. Senator Craig. Thank you. Sister Greving. Thank you. Senator Craig. Dr. Rusche, how many disease--I should say how many diseases does Regence have disease management programs for at this moment? Dr. Rusche. Currently, we have five. We started out with maternity---- Senator Craig. Yeah. Dr. Rusche [continuing]. For a commercial health insurer makes a lot of sense, but include cardiovascular disease, psycho-social problems, in particularly our Medicare-managed care, diabetes and migraine or chronic headache. Senator Craig. How did you first recognize the value of the disease management approach? Dr. Rusche. By an analysis of the data, the Willy Sutton approach of going where the money is. We had for a long time identified that there was a small sub-set of members that were the most expensive, and part of what a health plan does or an insurance company does is underwrite. You take information and you assign a financial risk or a price to it. Well, that same information can direct your services. Those people that are your members that have a likelihood of consuming resources deserve an opportunity to do better. It does not make the disease go away. It just kind of puts things off, delays or decreases complications, and that is all we are hoping to get with disease management programs. Senator Craig. Well, then ultimately the question is have these management programs met your expectation? Dr. Rusche. I would have to say definitely yes and no. Senator Craig. OK. I would like to hear why yes and why no, but more about why no? Dr. Rusche. Why yes, because I do think they showed demonstrated cost savings. No I think is two reasons. One is that the way the medical system is structured, the way I was trained, the way most doctors are trained, is to work one-on- one with a patient without coordination into a system. To do things otherwise is kind of like walking uphill. You know it really is not the easiest thing to do. So I think that is difficult. The second is that while we have in the subset of the population that we have looked at or treated for a particular condition shown an effect in their costs, we have not done a whole lot to lower the high rate of premium increase for our members, and that has been somewhat disappointing. Senator Craig. Not only obviously providing the service but controlling costs, and then that cost being reflected in premiums was part of---- Dr. Rusche. That is right. Senator Craig [continuing]. Your goal that you did not achieve as well? Dr. Rusche. That is true, Senator. Senator Craig. OK. Thank you very much, Doctor. Dr. Wright, you notice that I picked up on tele-medicine as an extension of capabilities and services. You have mentioned the technologies. Could you tell us about any that you have used in the tele- medicine area? Dr. Wright. Well, yes, over the years, we have had numerous tele-medicine pilots, anywhere from devices that were essentially alarm clocks that would remind people when to take their medication to peak flow meters that could assess how lungs were functioning, and you could put these in a holster and it would upload clinical parameters to glucometers. One of the issues that we encountered through our pilots was that the tele-medicine, the medical device industry in this particular sector is emerging, and is unstable. Companies are in business. They go out of business, and working with these new and emerging companies and bringing them along remains a challenge in that industry. Currently, we are working with a program looking at blood pressure cuffs that we distribute in populations and they upload their blood pressures and make that determination, and it seems to be working well right now on a pilot basis. Senator Craig. Good, good. You also discussed the necessity of Medicare payment reform before a large-scale implementation of disease management could be undertaken. Would you elaborate on that statement? Dr. Wright. I think that the thought process of approaching management of disease as a system rather than individual transactions between paying for the device, paying for the physician, how do we reimburse tele-medicine, for instance, how do we work that into payment schemes? How do we make sure when we are modifying physician reimbursement, we are not adversely affecting the delivery of a new biotech drug, or does the compensation for a particular device correctly reflect in the reimbursement of the health care professional of getting that device up and running or installed or educating the patient? In particular, with tele- medicine, training of individuals, you give a senior a computer-based, internet-based device in the home, that requires training and installation. As an example, how is that going to work into the 21st century reimbursement scheme? Senator Craig. Good points. Thank you very much. Matthew, you have talked about an unpublished study in Hawaii, 17 percent reduction in health care spending over a 10-month period. Based on what you know now, do you think those results are sustainable? Mr. Michela. Those results are absolutely sustainable. We have multiple years of experience in the commercial marketplace working with health plans, and our typical contractual relationships start at a minimum of 3 years, and are typically five, and we even have 10-year agreements with health plans that require sustained clinical and financial improvement every successive year of that agreement, and we have internal studies and some studies that are published and to be published that demonstrate how that is measured and how that is accomplished. So the answer to the question is, yes, it is sustainable. Additionally, with our programs, which is very important in the commercial marketplace, we produce results, both clinical and financial results, in the first year of operation, which has historically been a problem in this industry in the sense that you have an infrastructure investment that you need to buildup, plus getting out and establishing relationships in many ways with the physician community takes time to do. But we have been able to demonstrate that that is achievable in all of our programs here. The other thing I guess I would add is we have also demonstrated to our satisfaction and to our customer satisfactions with some studies that when you remove the interventions that you are providing in disease management, presuming you are applying them correctly, those cost savings do return. So as you are effecting behavior change, which ultimately is improving health, which ultimately reduces cost, if you stop applying those interventions, then it returns back to the trend that it would have been previously. Senator Craig. Good. Good. If you have seen one disease management program, you have seen one disease management program. Now that is a comment I heard recently and I guess the implication is that there are many ways to deliver disease management services and many different results. You have mentioned that program design, method of delivery, and outcomes can be different with different programs. What contracting arrangements seem to have the best results from your experience? Mr. Michela. I think the comment that if you have seen one, you have seen one is absolutely correct, which is why we advocate and challenge everyone to become accredited by external third parties so that that can be obvious on where those differences are to everyone. But specifically to your question, disease management achieves its best success when it interacts with patients in a variety of settings and interacts both with patients and physicians. When you talk about contracting for disease management services, what we would maintain is the best way to do that is to contract for outcomes, not for the process itself. Be less concerned about how many pieces of mail or reminder cards a person gets and be far more concerned with what actually is achieved on a clinical basis and what actually is achieved on a financial basis, and that is the umbrella under which you can balance both costs and quality. Additionally, we would maintain that you need to contract for a total population with an identified disease condition. Do not attempt to identify a condition such as diabetes and then apply interventions to only 1 or 2 percent of that disease condition population, because you will over time encounter what had in the previous testimony this morning been discussed about regression to the mean. On a population-based approach, what you do is you start to prevent folks from becoming more chronic over time before they would have otherwise been identified in only the sickest of the sick category here. That is a fundamental part of success of the long-term viability of these programs is to engage as many people as possible in a variety of ways. The third is to support the patient, not the disease. Manage all of the co-morbidities and conditions that that patient occurs or may have in the first place, because they do develop certainly over time multiple conditions that need to be managed, and one of the problems in the industry historically has been with an approach that will manage only the impacts of a cardiovascular problem on a patient and not recognize that that may be caused by conditions with diabetes or over time develop into COPD, as an example. The third in the contracting approach and how we work in the commercial market is to balance a risk-reward relationship, not to just pay for services on a fee-for-service unit cost basis, but provide incentives that if targets are met, clinical and financial targets are met and exceeded, that there may be opportunity for bonuses and other incentives that continue to drive the industry to achieve beyond the targets that are accomplished within a specific contract. Senator Craig. Thank you very much. To all of you, thank you. We appreciate your testimony and the record that is being built here. This is the first of I suspect a good number of hearings this committee will hold over the next few years as we develop a record on this, as other, well, as some of demonstration programs in CMS mature and evidence comes from those. Clearly, as we debate and deal with Medicare reform and prescription drug programs, this kind of information or policy development is going to be, I suspect, very important in cost management and quality of delivery over the next number of years. Thank you all very much. With that, the committee will stand adjourned. Mr. Michela. Thank you. [Whereupon, at 10:58 a.m., the committee was adjourned.] A P P E N D I X ---------- [GRAPHIC] [TIFF OMITTED] T3477.061 [GRAPHIC] [TIFF OMITTED] T3477.062 [GRAPHIC] [TIFF OMITTED] T3477.063 [GRAPHIC] [TIFF OMITTED] T3477.064