did the subcommittee will begin today is you know in our series of hearings on how to improve medicare and will focus on long term solutions to increase and assure the value of health care expenditures this we hope to deal with the issue of comparative clinical effectiveness that means comparing the relative value of different clinical treatments drugs devices test procedures bandages pill anything else you want to take and trying to get a comparative ranking too often physicians and patients have trouble understanding when a new product or test or procedure will be most helpful in how to choose among existing courses of treatment given the absence of information on comparative effectiveness it's hardly surprising the g a o and med pac find dramatic variation in the use to bed ical services across regions from different providers by different specialties and even worse researchers find that the areas with the highest use of some services aren't necessarily linked to higher quality or better outcomes to the contrary beneficiaries may be put a greater risk when they're subjected to more and more complicated tests and treatments as medicare is board of directors congress should ensure that medicare resources are used effectively and efficiently to provide high quality care and achieve the best possible outcomes getting reliable unbiased comparative information is our best chance of controlling health care spending while improving care and access even if mr or zag will give us savings immediately for our efforts we can identify ways that we could get the information we need to achieve this goal and lay the groundwork for a more efficient and effective system health policy experts across the political spectrum advocate that comparative information is sorely needed for the public good they argue that greater investment in comparative effectiveness research is critical to assuring high quality care and reducing on this expenditures better information about the relative strengths and weaknesses of various product procedures  services will help physicians and patients make wise decisions and will help the public service and private payers equitably manage rising health care costs many many countries have already made major investments to provide this information to physicians patients policymakers and it's high time we do the same many of my colleagues urged that we should pay for performance we already do that the providers perform and we pay it's just we pay the same whether the service is done on the right people at the right time of the wrong people to wrong time we really have to know what the effective and appropriate services are before we can know how to reward the care that she's the best outcomes various authorities both within and outside government of called for a substantial national investment in comparative effectiveness information and i but then if i did and options to help us determine the optimal financing governance for this activity my personal preference is to move toward a system that's accountable yet independent and free from both industry and political influence when i repeat that free from both the industry and political influence both clinicians and patients need to be confident that the work that will be done is in the best interests of the patient to me that points to a government led effort we are fortunate to have with us today some of the leading experts as well as representatives of the prominent stakeholders i'm particularly pleased to welcome our first witness  prior to that part of my introduction of to yield to mr camp for any remarks he'd care to make well thank you chairman stark the us health care system lacks the kinds of comparative information that would allow consumers to make informed health care choices choices and providers to prescribe the best course of care while we have agencies like the f d a to determine if drugs and devices are safe we have very little information that compares the actual effectiveness of drug devices in medical procedures frequently physicians lack the information that would allow them to compare what treatments work best particular types of patients this type of data could help health care providers identify best practices ultimately leading to improved clinical outcomes comparative effectiveness data will also be necessary if we are to ever move to a more consumer focused model of delivering health care for individuals are able to make more choices about the care they receive this information also has the ability to help reduce expenditures under the major federal health programs by helping to eliminate unnecessary procedures leading to a significant savings for taxpayers at the same time we can not allow comparative effectiveness to become another hurdle that slows patients access to new therapies the current healthcare bureaucracies especially those in the medicare and medicaid programs are often unable to keep up with the dynamic and changing nature of health care government agencies should not be required to use artists to rely solely on comparative effectiveness data to set reimbursements or make coverage decisions comparative effectiveness can be a building block that leads to better health outcomes but only if it's done in a transparent and timely way this will require a process that encourages independent research which also recognizes that not all therapeutic choices will be appropriate for all patients patient protections must be in place to make certain that unique patients are not harmed in the name of cost saving initiatives put simply comparative effectiveness should be viewed as a tool to influence decisions should not however be used to limit patient access to the best course of treatment i look forward to hearing the testimony of the witnesses today and hope that we can work together on legislation that will provide providers and patients with the information they can improve the quality of their health care thank you mr chairman i yield back the balance of my time you're welcome and mr graham i'd like to associate myself this often to other people we just went through an allergy season that was one of the worst my pediatrician tells us in fourteen years but you saw six or eight or ten at the histamines in every popular magazine but nobody really had good records of which one was the best to use for your kids and is i'd say to the people in the audience when the men in the audience get prostate cancer you won't know what is the best treatment you'll know that you'll live through the initial treatment but what do you do chemo or radiation or surgery we just don't have figures that are reliable it will tell you what happens to you ten years out the same with the ladies in the audience who man fortunately get breast cancer you won't have the kinds of statistics we need for you to predict with your physician what's the best course for you to follow and i hope that whatever comes out of the work we do on this committee will help providers beneficiaries of tax payers and everybody to understand that better and i'm to that and i'm pleased to welcome our first witness congressman tom allen from maine who has been a leader in the house on the issue of comparative effectiveness and has recently submitted legislation to address this problem the subsequent witnesses i'm sure will enlighten us on this on whatever their strategy is to improve health care in the united states and i look forward to their testimony tom would you like to enlighten us in any manner you care to and if you have a prepared statement it will appear in the record in its entirety without objection thank you mr chairman thank you for holding this hearing and i want to thank you and ranking member camp for inviting me to testify today i would ask my entire statement to be submitted and i will talk from that statement we have a huge gap in our health care system today the absence of independent evidence based information about the comparative effectiveness of prescription drugs medical devices and other treatments that deal with the same illness or condition better information and how various treatments compared to one another will enable doctors and their patients to make informed decisions about whether new or high priced drugs devices and other medical treatments do or do not provide better clinical outcomes the health marketplace will be greatly enhanced by independent information more widely disseminated we've seen remarkable innovations in health care in recent years but the aggregate healthcare costs have grown considerably faster than the overall economy united states spends more than any other nation on health care but we rank thirty seventh in the world in health outcomes nearly forty seven million americans are uninsured and millions more are under insured on may seventh of this year introduced h r twenty one eighty four the enhanced health care value for all act with representative jo ann emerson who's been with me on this issue for the last the this is the third congress the bill extends the success of the agency for health research in qualities effective health care program and provides more funding for research on the comparative effectiveness of health care services including prescription drugs medical devices procedures and other treatments and can include clinical trials as well as surveys of existing literature better clinical information on health care products and services is a public good and therefore the legislation creates a public private funding mechanism to pool federal resources with funds from health insurance plans and large employers with self insured plans the investment in comparative effectiveness studies provides a sound bipartisan approach to a fundamental challenge how to ensure that we get the best value for our health care dollar this initiative has gained the support of a very broad group of stakeholders as representing patients medical professionals health services researchers and health care purchasers my bill expands on section ten thirteen of the medicare prescription drug improvement and modern is that modernization act of two thousand and three that provision authorize to carry out systematic reviews of existing research on the clinical comparative effectiveness and safety of prescription drugs and other treatments section ten thirteen was based on legislation that representative emerson and i introduced in the hundred eighth congress and h r twenty one eighty four our current bill expands on the small initial investment in comparative effectiveness of fifteen million dollars altman and former c m s administrator gail wilensky have put forth bold visions of where increased investment in comparative effectiveness could take us to have the best medical outcome patients need the right here at the right time without good information on comparative effectiveness we can't be confident that we are using products in the optimal way the f d a approval process says mr camp indicated does not give us this data because it tests only for safety and for effectiveness compared to a placebo not effectiveness compared to other drugs or device or drugs in that case that treat the same illness or condition in closing i want to make for critical points number one more effective treatments mean better health outcomes and reduce side effects to overall competitive effect and this data doesn't negate the need for individualized care this is not as some critics argue a path to a one size fits all medicine three broadening comparative effectiveness studies will provide better information about differential impacts on sub populations and the interactive interaction of various treatments in patients with multiple and multiple illnesses in other words broader information and will be very helpful for a high quality compare of comparative effectiveness study shouldn't threaten innovation instead they will clarify the many reasons individuals can be exceptions to average outcomes and will facilitate transition to a system of affordable personalized health care i thank you very much for having me here today and look forward to working with you on this legislation tom thank you  if i understand your bill correctly the question of who gets to plead their product or service at this court of fact of this that the entry level key would be an f d a approval for example so yes first you'd have to go through the process of proving that it was safe and as opposed say to a placebo if it did something that you just to the table that's correct i don't think it's right to slow down the process of getting approval at the f d a level because i think that the the arctic ought to be able to decide the appropriate time to conduct research on a particular group of drugs or a particular group of devices or treatments  where the the stakeholders have formed the manufacturers the providers the physicians the pharmaceutical companies whomever would they have input into be fairly determine well what we've done is we've we have we create in this legislation we expand the authority for the comparative effectiveness advisory board and we want to make sure that the selection of the members of that board takes out  people with financial interests and stakeholders whether they be manufacturers of devices or manufacturers of prescription drugs then for each individual study there is a clinical advisory panel on the same we want the same transparency the same process to go there to make sure that the people with a financial interest in the outcome of the study are not choosing the people who will oversee it so to pick an example  what would that meet the standards that you have in mind the way it's formulated the panels pick yes we're looking we're looking for panels that have that  are here have some degree of political oversight because all of this is run eltham only through the secretary of health and human services but it is independent as possible and as transparent and fully transparent so that conflicts of financial interests are are weeded out so you really have the independent evidence based product at the end of the day that we need to do this research effectively now i i hesitate to bring this up but i know you're talking about funding it by in effect in an all payer system which makes sense but can you give us a ballpark idea of what what we're talking about and costs i know you have it coming out of the the money coming out of the trust fund  e and the congress as a whole but the legislation we think the appropriate scale of investment is three billion dollars over five years and that one third of that one billion dollars should be public money and should come from the medicare trust fund limited to a maximum of two hundred million a year the other we have support from the insurers and from large employers with self insured plans and they have bought into the concept of funding the other two thirds because remember this information is going to be of great help to insurers and to a large industry the large companies with self insured plans they're going to use it their own way what we're simply trying to do revenues of one sort or another the other two thirds would be contributed by the providers and or the manufacturers people with the commercial interests at stake well by the insurance plans and by large employers we are we are not suggesting that the pharmaceutical industry contribute to that that that fund we are saying those who use the information in  their own way this kind of research is being done down but done being done now by individual insurance companies but because that information is not widely sure shared it's not doesn't have the impact that it could  camp thank you mr chairman mr allen thank you for your testimony and obviously we we often lament the fact that we don't have good enough data or information even for policy decisions much less so that individuals and physicians can make the appropriate decisions on the kind of care as the chairman mentioned earlier in this hearing but obviously i think there's a broad agreement that this kind of information comparative effectiveness research could help informed decision making in the health care area but as you look at other nations that do this and they're further along than we are there's a concern that insurance companies maybe even cns in america could use this information to limit access to certain treatments because someone may not fit the average stereotype and i realize there could be subgroups that might sort of medicate that but does your legislation have any specific safeguards to ensure that access to patient centered treatments is still available i would put it this way the legislation is designed simply to deal with access to information to make that that information available we would obviously be open to suggestions along the lines that you are making here today but that the legislation itself is very clear in your opening you raise the concern about whether this and the information would inform decision and or drive decisions and it is not the intention of this legislation to drive decisions but we're obviously open to suggestions to clarify the point that you're making making today and why did you choose the comptroller general and not have this be a part of h selecting the the the sort of the authority or the chain of command of this group would report to the comptroller general and i just was wondering your thought process behind that choice and not some other model what we're trying to do is get a mix of some political oversight and some independence from politics we're trying to get this something like the med pac board i mean that's that's the that's the goal it's a bit of a difficult situation because though we call for a study of completely independent funded centers research centers we think that probably probably that leaves you know you never can be quite sure that you've got either the transparency and maybe the risk of being infiltrated by parties with interest in that kind of system we think we've got the right balance but that's why we're doing it trying to get a balance with some control and some in the right mix of control and independence all right thank you thank you mr chairman well thank you very much for your testimony i don't know of another member of congress who's given more thought then you have to different ways to improve our health care system and i think this is one important aspect of that as far as the funding chairman stark explored that with you a little bit i know that for example on in i that's all done through appropriated funds should we be considering an alternative that that focuses on appropriated funds to pay for this  important public purpose i would say that we believe i believe that in all payer system better reflects the sharing of the benefits that  can try to pay for this entirely through appropriated funds but then it becomes a heavier lift in terms of getting comparative effectiveness research on the scale that i believe it's needed and in fact already we already have buy in from insurance plans and some large employers who believe and understand that it will help both improve the quality of their plants and their management of their plants and drive down their cars so the benefits are both public and private they are saying the savings to the public system send their savings to the private systems and that's why we argue and all payer plan makes the most sense thank you very much for important recommendation i like many concepts i think complera comparative effectiveness sounds good in theory you can argue with a comparison and effectiveness comparative effectiveness but i do have concerns about what's covered by insurance again to follow up on mr camps questioning let me ask you specifically would this advisory board this comparative effectiveness advisory board as as provided in your legislation make specific recommendations about which procedures which devices which drugs medicare and private plans should cover or not cover my understanding of the legislation the way it's meant to work is is the answer is no the answer is by understanding that we are simply the studies will be done they will be available on a public web site for those who want the information to to review  use in making their own decisions this legislation does not try to drive the decision making process of other bodies so it wouldn't preempt current law with respect to that decision making process that is correct that effectiveness is potentially very very helpful to providers making that decision i do share the concern i think of the other side camp mentioned about how this information not being used in a way to limit access usually when it's a specific device or treatment is necessary for a particular person so it's a it's interesting information i think partly how do we expand how we get that information out there but then how do we actually make sure it's used in the best way possible to help ou of your questions to mr camp and mr ramstad this is basically a toothless tiger will gather up information and have information on a web site but have no impact no intended impact that correct i think that sound evidence based information on complicated topics that widely available to providers in the public has an impact that it drives decisions give you an example of where it might have been effective in the vioxx to drugs to treat osteoarthritis were advertised it is a level of you know several hundred millions of dollars went into advertising those drugs they were best use according to the research for those people who when taking ibuprofen had gastrointestinal troubles but they were marketed through dorothy hamill and others to a much broader well to the entire population as if the entire population had something to gain simple comparative effectiveness studies on celebrate vioxx and ibuprofen to give just one example might have driven a very different number one marketing strategy but also a very different strategy by those who were prescribing the those particular the the two prescription drugs and and i would add specifically in the case of those drugs if we had had broader information surveys of existing literature ongoing comparative effectiveness studies that were independent the problems with vioxx for example might have been discovered considerably sooner and that's why i don't believe that there is a need at this moment i think we need to create the system and provide the information and that information will drive decision making in a helpful way but the reason i asked the question is have you been here a while as sort of a leap see stuff and you see it happen and you wonder about it the quality control agency was a very effective agency in the past and once they did a study on back surgery and they suggested that back surgery in many instances was not useful at all and they immediately were attacked by those folks who were the beneficiaries of that kind of  not the patients but the professionals involved in it and their study was discredited and it was a great big hoo ha because they were about to use this in medicare in terms of making decisions about whether or not they were going to give it now i wonder about why more information i know insurance companies i've dealt enough with them when we did the effort with mrs clinton back in ninety three the insurance companies have panels where they decide what they're going to put out what they're going to pay for what they're going to use stem cell transplants for what they're going to use a bone marrow transplant for what illnesses they're going to what are they going to use and pay for and they don't share that information at all you can't find out from blue cross blue shield who makes those technical decisions and i guess i have some problem with creating another set of evidence based medicine evidence but not using it to drive decision making in terms of how we can control costs it seems to me that we just saying let the market do whatever it wants to do it anybody can come up with a new device comes in and somehow gets it approved and the way it goes there has to be some way you look at the evidence as to whether this device it's actually better than this device for this medicine better than this medicine otherwise there's no end of the cost and no cure and that's what we've got today that's where we've got the prices going out of sight and i don't did you just figure you didn't want to use it yet until you get the information gathered or you think it's not a good idea to have the government in the position of trying to protect the patients cost i would say that we believe that by itself all by itself better in for a a wider wider availability of better information evidence based interest from ation that's generated by independent studies not by the manufacturers of the device of the drug and that serves everyone that's available to everyone that's available to the public and people running the public bodies it's available to doctors and hospitals and and other health care providers that information is going to we believe just by being out there in and being of the kind of information of which there isn't enough now we think that is going to drive better health care decisions both in terms of quality and in terms of cost now i mean this is you know my crystal ball only works some days and not today but i think all by itself having a significantly more and better information on comparative effectiveness is going to drive better decision making and save and save costs at the same t hope you're right i hope i am too just clarify one in your when mr camp was questioning me i want to clarify some of the things i said right in the the comparative effectiveness advisory board reports ultimately to the secretary of health and human services and to congress not to the comptroller general the comptroller general is only role is to oversee the advisory board selection process as it does for med pac it's an attempt to get to and the you may have i didn't say this and you may have understood this but i the it's the attempt to make that selection process of the advisory board independent political considerations thank you i want to thank you for your efforts and your testimony and assure you that as soon as one of my colleagues plagiarize your good bill and introduces it under their own name it will probably scoot right through this committee and you'll be left out there wondering what very much and we appreciate your contribution to thank you our venture here and learning about this we're going to be followed by a panel of government experts in this case  dr carolyn clancy who is the director of the agency for health care research and quality and dr peter or zagged who is the director of congressional budget office through from through law blessings flow dr dr mark miller who is the director of med pac who buys us frequently and often and most helpfully on issues before us in the medicare reader will after you're seated get a chance to get settled will have you proceed in the manner in which i called you without objection your prepared testimony will appear in the record and you can in lightness in any manner in which you're comfortable and would you like to lead thank you good morning mr chairman and members of the subcommittee i'm very pleased to testify before before you on the exciting issue of comparative effectiveness in my written testimony and samples of our comparative effectiveness reports and other materials from a part of the record i am thrilled about the growing interest in attention to enhancing the role of comparative effectiveness research in our health care system and i'm particularly pleased to be able to tell you about the important work agency the agency for healthcare research and quality is doing in the area of comparative effectiveness arks mission is to improve the quality safety efficiency and effectiveness of health care for all americans affected nisson our mission includes comparative effectiveness what is the right innovation or treatment for the right patient at the right time comparative effectiveness research is a means to an end our mission is fulfilled when health care decision makers including patients clinicians purchasers and policymakers use up to date evidence based information about their treatment options to make informed health care decisions since they are making these decisions every day we have a sense of urgency and as arks director i'm very pleased that congress recognize the programs and infrastructure that our case established for providing the health care system with scientific evidence when it authorized us to do comparative effectiveness research this infrastructure enables our to establish our effective health care program and begin work rapidly without having to reinvent the wheel or create a new bureaucracy in addition our reputation as an unbiased  trusted source of information has moved the health care system to adopt and use the findings to improve the quality safety and effectiveness of health care an important hallmark of the of of healthcare program is transparency and all aspects of the process priorities for the program are set after receiving broad public input through federal register notices public listening sessions and other means we've been very fortunate to have developed very cooperative relationships with a broad range of stakeholders and we actively seek out comments and quotes from as many as possible the public and all interested stakeholders have the opportunity to comment on the initial research priorities framing of the specific questions and draft reports we also extensively focus chest and seek input from consumers on materials that we develop specifically for them based on our comparative effectiveness reports in addition to the open invitation to comments manufacturers are notified when a study is begun that affects their products and are invited to submit relevant studies and data input from manufacturers can raise questions and concerns we've worked with our researchers to develop a process to minimize conflicts so we can create public private partnerships with confidence as arc has implemented the effective healthcare program we have five significant observations to share first priority setting and important clear priorities that meet the needs of all the stakeholders in health care there for end users and stakeholders must continuously provide input through an open and transparent process second is framing the research questions research must follow how clinicians and patien make health care decisions every day after much deliberation we decided that our research should focus on conditions rather than interventions at the end of the day that is how health care decisions are made it's also very important to recognize the importance of updating findings frequently to incorporate new evidence that may change or modify the conclusions about what works best and for whom third relates to balancing benefits and harms compare of effectiveness research by definition must provide information on benefits and harms of a particular medication or intervention evaluating the balance of harms and benefits is a critical component of informed decision making few interventions are risk free and for many chronic conditions the therapeutic goal is management of symptoms and disease state rather than cure oftentimes the decision comes with some assumption of harm by both patient and clinician but with the understanding that the benefits are worth that risk us research is a means not an end the ultimate goal of our research efforts is to develop timely relevant information for decision making this requires us to go well beyond the products of traditional research namely scholarly articles and translate findings into language and formats that are appropriate for different audiences our goal is that valid reliable and useful information be there when and where people need it fifth trust is incredibly important and we view it as a process not a structure as gail wilensky has said compared comparative effectiveness research can be risky business and there are there may be winners and losers well we've learned that there are often no clear winners and losers but differing risks and benefits between different interventions it's still important that there be a level playing field among all stakeholders for that reason our program has adopted a policy of transparency and inclusion in addition it's clear that the program's success to date is dependent on effective collaboration with scientists from industry as well as academia we're working very carefully to minimize conflicts in the analysis and development of knowledge while taking advantage of the collective knowledge of a variety of different researchers studies for that reason it's critically important to recognize that these findings need to be carefully translated so that patients can receive the benefits of this knowledge and making their decisions we all need to learn from the knowledge gained in research but for it can be a matter of life and death mr chairman at some point we are all consumers of health care so we can all recognize the importance of having unbiased trustworthy information to inform our decisions our it's effective health care program is a model for how this vision can be achieved it's a transparent participatory approach that is driven by the needs of users and which encourages broad engagement of stakeholders to explore and mitigate any controversies and to expand opportunities for the rapid diffusion findings of this research in short the effective health care program represents a foundation which a large investment in comparative effectiveness can be built thank you very much and i'd be pleased to answer any questions  you mr chairman and members of the committee my oral testimony this morning will make three basic points first the central fiscal challenge facing the united states is the growth of health care costs not aging despite what many media portra would suggest this chart illustrates the point over the past four decades the cost for beneficiary in medicare and medicaid have grown two point five percentage points faster than income per capita if that rate of growth continued you wind up on the top line medicare and medicaid would grow from four and a half percent of the con me to twenty percent of the con me by two thousand and fifty the bottom dotted line shows you what happens if that excess cost differential words zero and isolates the pure effect of aging on the programs i think you can see that where you wind up on that bottom line is higher than where you start and so there is some effect of aging but that that difference is much smaller than the difference between the bottom dotted line and the top line in two thousand and fifty and other words the central long term fiscal challenge is facing the united states is how rapidly health care costs grow compared to income per capita not aging of the population or the the coming retirement of the baby boomers these rising health care costs by the way also represent a challenge not only for the federal government but for private payers and indeed costs for beneficiary in the public programs have tracked costs for beneficiary in the rest of the health sector over long periods of time my second point is that a substantial opportunity exists to constrain health care costs both in the public programs and in the rest of the health system without adverse health consequences perhaps the most compelling evidence in favor of this observation is the substantial geographic variation in cost per beneficiary across parts of the united states that cannot be explained by the underlying riskiness of the patient and i present the chart here with the darker areas being higher spending regions and which do not translate into higher life expectancy are measured improvements in other health statistics in the higher spending regions furthermore hard evidence is often unavailable but which treatments work best for which patients are whether the added benefits of more expensive but more effective care are worth the cost the variation in treatments across the united states is often greatest for those types of care for which very for which evidence about relative effect of this is lacking various federal efforts to conduct this kind of comparative effectiveness have been undertaken in the past and some continue today but on a scale that is significantly smaller than most observers believe is warranted if policy makers want to expand federal efforts to study comparative effectiveness dafur could be organized in funded in various different ways by written testimony describes some of these options and a forthcoming cvo report that has been requested by the senate finance and senate budget committees will go into even more details now says of them however the effort is organized having more health records available in the electronic form would facilitate the use of existing data for research which could cry new opportunities for examining what works and what doesn't in a rigorous way finally comparative effectiveness research holds the potential to reduce health care spending significantly over the long term without having adverse effects on health to affect medical treatment and reduce health spending in this way the results of comparative effectiveness research would have to be used in ways that change the behavior of doctors other professionals and patients for example the higher value care identified by comparative effectiveness research could be promoted in the health system through financial incentives the payments that doctors receive or the ca sharing that patients face making substantial changes in payment policies or coverage under the medicare program to reflect information about comparative effectiveness would almost certainly require legislation i must also note that getting to the point where additional research and comparative effectiveness could have a noticeable impact on health care spending would take time in addition to the time required to get the new activities underway and up to scale a lag would exist before the results were generated particularly if they depended on new clinical trials as a result of these lags and other implementation lags it is relatively unlikely that there would be any significant net reduction in costs over the next decade or so but despite all these caviar it is so rare a c b o director that i get to have the ability to say that anything holds the potential to reduce costs over the long term that i want to repeat that final observation and repeat my basic conclusions which are the united states is on the unsustainable fiscal course largely because of projected health care costs there is a substantial amount of variation in those costs that cannot be explained by the underlying riskiness of the patients and that does not translate into better health outcomes for the population and additional research on comparative effectiveness if combined with incentives to implement the results of that research hold substantial potential to reduce health care costs over the long term without impairing and perhaps even improving the health of a marriage thank you very much mr chairman thank you very much dr miller chairman start ranking member camp and distinguished members of the subcommittee much of med pac's work is devoted to improving the efficiency of the medicare program either through reducing unnecessary costs or improving the quality of care for the dollars that we do spend the commission is acutely aware of the long run sustainability problems facing the medicare program in addition to what peter said i would add that the party trust fund is currently looks like it will be exhausted in twenty nineteen had historical rates of taxation medicare will consume twenty four percent of personal and corporate income tax by twenty thirty and the rate of change in part b premiums and co payments is faster than beneficiaries in incomes making it medicare more and more on affordable medicare needs a broad range of policy change to gain control of spending without sacrificing quality and one of the changes is to better understand what works in health care and what does not work comparative effectiveness analysis evaluates the relative effectiveness of drugs devices therapies and procedures the outcomes of this analysis can be evaluated in terms of clinical outcomes such as mortality and morbidity functional outcomes like quality of life and patient satisfaction and economic outcomes such as cost effectiveness the private sector is unlikely to produce this type of information on the scale that is needed because it is because it is costly and what it is produced it it can be used by anyone including their competitors moreover private payers fear litigation and being the first to act on comparative effectiveness information we also point out that there is recent research in jam and other clinical journals that indicate that the results of studies sometimes are influenced by the source of funding there is a lot of positive work being done by federal agencies arc and i a here the commission however has two concerns no federal agency has its mission and budget devoted solely to the production of comparative effectiveness information and consequently the information will not be produced on a sufficient scale secondly none of these or agencies are organized and funded in a way that allows them to be truly independent for the medicare program comparative effectiveness information could be used to differentiate payment among providers to encourage the pursuit of evidence based medicine it can be used to avoid higher cost of expensive services when there is no clinical evidence that they are better than existing treatments and other researchers have discussed the idea of requiring manufacturers to enter rish year in relationships where payments are rebated to a pair if a product does not perform as expected the commission has examined this issue over the last three years and in our forthcoming june report we recommend that the congress charge an independent entity to sponsor comparative effectiveness research and disseminated to patients providers and payers to be clear this organization would not be involved in coverage and payment policy decisions that would generate information only information to be used by patients and providers in making clinical decisions and by payers to determine coverage and payment the commission has discussed the characteristics of the sanity it should be independently governed and have a stable funding source and all return to those two points should have a transparent processes in terms of the agenda setting the research results and the methods used it should seek input from all stakeholders establish consistent research methods and ethical standards for the conduct of this research and as i mentioned it should disseminate the information returning to governance the commission has concerns that any federal agency is truly independent when it comes to financing and disseminating on popular studies and results the commission however is also equally concerned that a wholly pride that organization would not be transparent and objective enough in to assure credibility the commission favors a public private governance structure that would resolve these concerns and broadly represent patients providers and payers in the two sectors on financing public financing specifically the commission discussed a continuum of options from the appropriations process to mandatory funding streams the commission favors a stable funding source and on violence that probably means a mandatory source would be more stable whilst retaining congressional oversight similarly the commission discussed a continu of private financing mechanisms from voluntary donations to taxes again the commission favors a more stable funding stream and some researchers have suggested for example proposing a small tax on health insurance premiums to fund this effort in closing the commission was also concerned that this endeavor not entail creating or recreating existing resources there is an available infrastructure in the federal agencies the states and the private sector based on new authority arc has created research networks and networks to disseminate study results one could envision an entity with a public private governance structure which sets an agenda agenda sponsors research that is conducted by both private organizations and federal agencies and then disseminate spam from ation to payers private patients payers and pay providers i look forward to your question one could could use you know the notion of you know like a federal reserve board where you have a board that's appointed and operates with some degree of independence there are arrangements in the federal agencies where you have combinations of the federal agency and a not for profit corporation which can take federal and private dollars to execute agendas such as  there's a list in in our testimony but these things can be things like the jet propulsion laboratory associated with the nasa things i'm not necessarily expert in but there's a list of them  our testimony the concern there would be in a situation like that whether the federal agency would be truly able to operate independently and i think that's what drove the commission in the direction of considering a public and room what would you suggest well first let me just say that the department and secretary leavitt have been very supportive of that this work and he believes that this is quite critical to focus on getting better value in health care which i think you and your colleagues share a strong interest in as well we believe that doing this research well and rapidly and bringing the kind of information to patients and clinicians that they need today is by definition a team sport and that we have the teams and infrastructure in place to make the most of an investment as rapidly as possible if one starts all over again it's a little bit like that movie we are marshall you can get there but it's going to take some time to build a new infrastructure and so forth more important i think that we're very proud of the relationships that we have built with a variety of stakeholders even some industries that felt were worried about work that we were doing came around we were done to say thank you we were treated fairly this was transparent we had to say to the extent that we had information to share that could also be shared broadly you were there to help us and so forth so i think that we've   and in fact those draft reports are often covered by electronic newsletters and so forth words with people voice their concerns which are issues there are other particulars they want to raise and we think that's great that's good to know i am going to thank you or saying just one question i'm afraid i know the answer but it's also troublesome to us of good and bad i guess that we can't get scored for savings where we're not required by law to spend the money for example everybody in this room would probably agree that for every dollar we spend on early childhood  preventive medicine we'd save five dollars over the next ten years of that child's life but the five dollars we save you won't score us as a savings because we're not required to spend it is there thought any hope that we i guess you'd call it would cause more dynamic scoring but that would turn the whole budget process on its head but is there any way out of that dilemma where the perspective i guess social savings to the to the country as a whole would help us you mention that and you bring you bring you know we we spent five times as much on medical care today as we spend on of the whole automobile industry think about that you know that all of the traffic jams we have we are spending five times as much of our gross domestic product on medical care as we do on automobiles which is something to think about when you're commuting but what about what about it is there any chance we could find a different way to score some kinds of savings let me say  things three things actually the first is that preventative medicine example that you raise often has very long term payouts payoffs in terms of cost savings the budget window which is chosen by the congress not by c b s has been five to ten years so that's one inherent limitation in this process that in many cases cost savings over very long periods of time are just outside the window that you normally you normally look at the second thing is that cvo is reexamining many issues to see whether there are offsetting behavioral responses and other things that do not get into dynamic scoring which involves macroeconomic responses and there are a variety of questions that we are currently re examining as new evidence comes to light and we would welcome evidence that would would help us that in that effort the final thing is on dynamics analysis itself see below and the  on taxation other official entities have in recent years started to do dynamic analysis on some legislative proposals and we are reexamining how we do that also so that to the extent that on the spending side of the budget there are things that have high economic returns and evidence in that favor that could be incorporated at some point into the process but we're currently just re examining the evidence to build the evidence base and we're not at the point where we're able to do that yet hearing in a few minutes from dr weil and he about maybe having a federally funded research element center that is mainly funded by the government but attached to a q is that one of the examples i thought i heard you describe yeah it is one of the models that is reviewed it in our report and you know the the the various pros and cons of that are talked through i would just say that in making that point the concern would be that the federal agency that it's attached to would have the latitude to disseminate research even set an agenda and disseminate research even if it was reaching conclusions that are unpopular and i think that's why the commission moved was moving more towards some governance structure that was more separate than a federal agency but it is one of yes it is one of the models i mean your concern is that the federal agency would disseminate information that effectiveness with the right incentives could be a real help and i notice in your written testimony you mention that there might be the incentive might be to pay for additional costs of less effective treatment for example the concern being that and i would ask both the un dr clancy to comment on this you know there are certain chronic just conditions that have unique circumstances that respond to different treatments or different drug regimens and there may not be one medication that fits every particular situation just for example there are fifteen drugs to treat patients with epilepsy and two patients with epilepsy could suffer the exact same seizures but they require different medications based on their their body composition or other factors how can we ensure that a system that has comparative effectiveness ensures each unique patient has access to the medication that's most effective well and as a written testimony emphasizes one of the goals of compar research should be to identify the sub populations for which different treatments are interventions are more or less effective so that it's not such a blunt conclusion and incentive structures could then be tied off of that more disaggregated sort of more nuanced data i agree with you that a blunt approach could not only be counterproductive but backfire and one of the goals of this effort presumably would be to get a fi level of this aggregation about what works and what doesn't dr clancy any comment if yes just to make the point that the question you're raising in my mind reinforces exactly the importance of this kind of research you know today the vast majority of patients who are lucky enough to have insurance actually do make differential decisions based on tearing of pharmaceutical benefits and so forth and oftentimes they have to do that in the absence of information and their clinicians actually don't have they have bits of information but it's not organized in a way that helps them sit down with a patient and say that you know this is these are the options that would be best for you so that's actually the vision that we have of how this information would work and give any thoughts just on dr miller's comments that if if this research were connected with a federal agency they'd be unable to release anything unpopular given how do you square that with your other comments about the transparency well the point about transparency is that you've got broad engagement of many people in health care who care a lot about the information so you'll be hearing from the american college of physicians and others in the next panel and if they care about it they're going to be saying ok so where is it i mean in the event that something that has not been in our experience were to occur and that's actually very very helpful and not only that they become a very helpful and supportive dissemination partner because at the end of the day i'm an internist and many internists would actually prefer to get information that's coming from the college of physician than from any government agency i don't take that personally because the college brings a certain level of credibility to it so we see that engagement throughout the process is quite critical to the success of this work all right thank you thank you mr  radiologists greatly increases the burden and it encourages insurance companies to require pre certification and other types of utilization management restrictions to limit imaging services how do we very pleased that we've had a number of collaborative opportunities and ongoing relationships with the college of radiology and others in many ways that college kind of gets the work we do more than some others which is a good thing i don't think you can entirely guard against it but i do think if the information is transparent s'posed in terms of what are the facts and what do we not now then people have grounds to ask questions and to push back if there are policies that are actually getting in the way of what's good patient care i know that you've done one report on the effectiveness of noninvasive diagnostic test for breast abnormalities do you have plans to investigate the comparative effectiveness for any other conditions were imaging is used as a diagnostic tool i believe that i don't know but i'll be happy to provide that answer in writing i don't have a good list with me and should comparative effectiveness data also be used to develop imaging certification standards that would assure that the provider is properly trained to provide the imaging scan has suitable equipment and has the training to read the scan affectively we think that's very important in terms of getting at dimensions of improving quality of care but i would say that most people would say that is not a part of comparative effectiveness per se thank you very much dr or zog you talked about the regional differences that  exist how do you take the comparative effectiveness information and disseminate it in a way to reduce those regional variations well certainly the first step is to develop the information because in a lot of that variation is arising in situations where there is new evidence on what works and what doesn't and therefore doctor norms in different parts of the country take hold which are not based on scientific evidence and therefore don't translate into improvements in life expectancy or other metrics of health quality even though they cost more so the first thing is the provision of the information as i think most of the written testimony emphasized whatever entity is designed to do this or expanded to do this  kind of research would have to pay a lot of attention to the dissemination of the information to health professionals having a more developed a backbone health information technology backbone could facilitate that and then finally to the extent that the information is  ultimately incorporated into financial incentives for providers or for patients that's a very direct way of signaling information i was interested also in the graph that you had because it is so dramatic do  you have it broken down into percentages as to how much if you assume that health care cost of medicare continue rising at the current right how much is attributed to just an increase in the population of aged beneficiaries and how much of that is related to rising cost yes in fact on that first chart the bottom dotted line is precisely what you identified that demographic effect so there are more  beneficiaries and they're getting older and that drives up costs but that cost increases pretty modest and if i added social security to the curve it would be a little bit more it's much much smaller than how much is driven by the rate at which health care costs grow compared to income per capita and i think we have woefully under invested in options that could help bend that curve which is the central long term fiscal challenge facing the country thank you is that this new standard or model the comparative effectiveness analysis call it what you will that it could end up denying patients life saving medical technology appropriate medical technolog and i've seen them purple data and they all suggest at least the studies i've seen that medical technology saves dollars in the aggregate rather than costing dollars some policy makers don't understand that i i realize but anyway that 's not my question but i think it needs to be taken into account and my question is this how would we insure under this new paradigm if you will how we ensure that complex study results such as evaluation of a surgical procedure versus a medical therapy be properly conducted now analyzed what would be the the mechanism to insure such a quality study well a few comments first i think the institutional design of the entity or entities that was charged that were charged with conducting this kind of analysis would have to have include standards for what how the research would be conducted so for example that the researchers not have financial ties to  the companies that might be producing certain things that the statistical techniques used and i want to pause on that per second because i do think if we're going to significantly expand this kind of research it is not likely that we will be able to rely solely on randomized trials and so the expanded use of statistical analysis of health records basically will be necessary and having a dramatically expanded system of electronic health records would facilitate the kind of rigorous studies that could provide detailed analysis of sub populations in a way that we currently have only a limited ability to do so you think it would be better able to  to consider highly nuanced situations across populations with that with an expanded electronic health record backbone there would be a much greater ability to study subpopulations yes partnership with private sector healthcare organizations that have made the investments in electronic health records so that we can actually in effect work with them to create a distributed network both to do the kind of work that doctors are just described but also to make sure that those organizations can use the findings as rapidly as possible which is i think a point here that i don't want us ever to lose again just make lean dark mean one other part of the structure is to be sure that the results are open to public review and comment much like you have an academic process so that other researchers and other analysts and other parties can comment on the work and of course there'd be a mechanism for the dissemination to all concerned parties patients as well as providers practitioners let me ask you a final question if i may dr miller once one of the things i've learned over the years is the effectiveness of a medical device often depends on the skill of the physician using the device and certainly physicians have to learn how to best use a device determine which patients are the appropriate candidates for treatment and so forth how can we make sure that the comparative effectiveness of device is assessed in the context of physicians developing the skills to use that particular device address the skills that are needed to you know if it happens to be a device or a particular procedure i mean some of that can be built into the study itself i mean some of the idea here is real world use of the intervention so we're not going to determine comparative effectiveness before doctors develop the skills to use whatever device i mean in a in a you know when you have a control trial i mean you're actually  doing the procedure or testing the drug itself and some of that would be some of what you would need would come out of that process well thank you my time is up i appreciate your responses thank you chairman thank you i want to especially congratulate dr or first testimony i couldn't have laid it out more clearly we're heading to a financial train wreck health spending is the driver the largest single driver of this fiscal train wreck ahead and that if you look at it we are seeing money pour out of the treasury in differing ways across the country ways that don't seem to be giving us anything in terms of health care return to getting to the bottom of that one i couldn't lay that out more clearly for us and i wouldn't think there'd be any a bipartisan disagreement across this pan but anyway we got to get after it right now i had a i've heard from some associations that essentially the procedure for data collection and analysis launched by legislation passed late last year was not built on a collaborative basis at all and doesn't have as not going to work very well dr clancy can you reflect on those concerns i'm not sure which legislation that you're referring to i'm very pleased with the collaboration that we've had today but i'd be happy to follow up on specific concerns that you've been hearing ways and means committee towards the second half of last year do something about data you maybe talking about physicians reporting on quality yes yes that would be an essential component of this effort it's a little bit separate where physicians might be involved with quality that will illustrate what you're paying for those providing value versus what you're paying for this not providing value terms of expanded health outcomes correct what the quality data is looking at right now are those areas just a few where we are pretty sure with the right thing to do is for example diabetics should have a certain type of test on the surgeons should be doing something to minimize the occurrence of infections after surgery and so forth it's a very small subset of samples i think where many physicians are feeling frustrated right now particularly those in small prac it is that it feels like a burden and not much value added and that's a concern we take very seriously it's a bit peripheral to our topic of conversation today at the same time that they're not really loving that quality reporting a number have been coming to us saying we want to create our own registration about physicians about potential harms and how people do over time and we're very much looking forward to working with them on that it strikes me that consists clear as this is conceptually getting into is quite difficult then who works with what what is measured how you measure it dr miller i do see the quality time directly into this this whole effort at trying to evaluate what's on necessary to pay for and try and get it disparate practice  information can be collected from the claims strain so for example if a physician ought to be for a diabetic ordering certain types of tests or having you know foot exams you know that type of thing some of that information came whether it occurred because they're billing for can be collected through this claim strength without a significant burden on the physician themselves i want to be clear this is not to say that we don't think that there may be information that should come from the physician themselves for example we talked about the notion of physician offices reporting on their functionality do they have the ability to do a patient register do they do those types of things but there is a lot of information that can be collected from the claims stream without putting a burden on the physician now just one last point on the collection the connection here is if we have comparative effectiveness information through analysis clinical trials that type of thing that can tell you which measures you might want to be collecting from physicians thank you more when it comes to figuring out how to best compare different services devices and all the rest to cut back on the costs of health care med pac is probably going to issue a report that says that we need to do more in comparative effectiveness to get get better results right on friday doctor or zag i think you've talked about how this mr pomeroy said this looming crisis in our budgeting and how health care such a big part of it and i think most people would agree that if we do a good job with this comparative effectiveness we're going to save some money but i don't believe that you're prepared or we're prepared to see come out of those who do the analysis of how this affects dollars will you're going to come out and say the score is well and has a big savings for us at least not at this stage what i would say is this hold substantial potential to reduce costs over the long term if it's implemented aggressively savings over the next decade is a lot harder because you have to get the thing up and running you've got to do the studies and then you've got to get it implemented and so if you're looking at bending the curve over the long term there might be a material effect if you're looking for cost savings for the next ten years that's a that's a much harder yeah over the next ten years again i would not be expecting any significant cost savings over that period so dr clancy i come to you i believe you have about fifteen million dollars or so to try to do some of this research you were authorized to get up to fifty million but you got fifteen through the appropriations process far less than what you were authorized to get far less than you probably needed to be authorized to get but you have fifteen million were if we were to do legislation in this paygo world where we have to pay for everything that we propose it's new spending we're going to have a tough time figuring out how to get you the dollars you need to do the research we need so we can start saving the money that everyone acknowledges that we can gain from this so it seems like we're in this awful dilemma this catch twenty two where we know that there are savings we know long term they'll be there but for our purposes we can't score them is saving it and as a result you get these meager allocations of money through the appropriations process which never leaves you enough time and resources to the to do the research that will prove what we say we know and so i'm wondering if you can help us out of this quicksand and tell us how can we persuade our colleagues that we must do much more than just provide fifty million dollars in research dollars so you can do the work to prove that effectiveness of this first of all the great question thank you very much the section ten thirteen i think only had a limit for the first year and you're right that it took the appropriations process another year to catch up to that i do think that we've heard considerable private sector interest in being part of a serious public private collaboration and i think that's a good thing with all the caveats about minimizing conflicts and so forth and i think that may be part of the answer ultimately i think the answer is going to be in the return on investment and i think that we're beginning to make a down payment now will actually lead a contract in the next few weeks to see the extent to which we can take advantage of all the investments that organizations have made in electronic health records to create this kind of network where we can learn much faster beyond that if dr orders i can't help you out i have to say i would never defer to his expertise you mention the private sector funding obviously they have a folks in the private sector have a massive interest in this is well my concern is as we said before we need these fire walls to make sure that the influence doesn't drive us in the wrong direction you believe that we could create those far walls that the tendencies wouldn't be to try to direct the research in ways that benefit those that are from the private sector who are providing the resources i think with this problem private partnership we will have a terrific opportunity to begin to test that because we're going to start with issues that no single health care system is big enough to address on their own we're actually going to be examining the impact of breakthrough treatments sometimes referred to as personalized health care to find out how rapidly those treatments are diffused do they have the impact that's expected that we see in the laboratory what happens to them when they're used off label and so forth and i think that might be one frame where to begin i think the concern is if the private sector interested coming up to saying i like this study can but and i'll contribute here but not over assembled tween our providers volunteer bases but there's stablish in standards reporting requirements transparency and it appears to be really paying great dividends especially in light of recent report issued by the federal agency for health care research and quality ranking wisconsin hospitals number one in this endeavor and we appreciate that recognition but of course wisconsin too is one of the law reimbursed states in the nation when it comes to the federal programs and medicare reimbursement rates so there's a great interest and drive for outcomes based of performance based measures and standards which will drive these reimbursements but to me it seems the key is making sure that we've got a totally integrated health information technology system out there governor doyle just announced a state wide project for all of our providers but how we get there and how soon we get there is going to be crucial as far as establishing the standards the measurements the effectiveness which would then drive reimbursements and best practices throughout the country my question is can we get there without mandating it without the threat of no medicare reimbursements unless you have a fully in place but if we can do it through an incentive basis what is the best incentive so to provide because this is expensive and right now is very little financial incentive for some providers to do it a lot of providers are but there is proprietary interest being built up now with the systems that they're using and question is can we integrate that across the board what type what type of incentive should we be looking at to help drive the whole movement throughout the country so we can establish these standards and measurements and then start doing some real comparison across the board so we'll be looking at accelerated depreciation for these  implementing these systems or to the providers of these systems through the tax code should there be grants offered to schools for training purposes for implementing technology should we be looking at grants for leaner six sigma programs where health care providers to to go after the low hanging fruit was dr miller yeah i mean the commission looked at this issue a couple of years ago and it didn't rule out things like the grants and trying to to put money on the table to bring people together in a community but i think the feeling of the commission was is that the first and strongest signal and i think there's been some reference to this elsewhere is to start to build it into the payment system so for example does a physician's office have the capability to have patient registries does it have prompts to say that from my diabetics i need to do this next test and you wouldn't say i am paying you to purchase this software but it would say your payments will being creased if you have this capability and then let the market work in behind it to say what is the best way to get that capability and then you change the return on investment ratio that right now so physicians office look at it and say i have a lot of expenditures but i'm not sure what i'm getting back and if you can change that ratio you can change the incentives so i think the and then we made recommendations for physicians or hospitals and managed care plans success or a and the point was is that the first signal should be through the payment system to say if you have these capabilities or these measures your payments will increase from that will be on temporary basis i assume otherwise we're paying more money to try to make providers more efficient and more all comes oriented no i mean the commission's view was is that paying for these kinds of outcomes should be something that would be an ongoing basis so that we don't pay and i think this was a statement made early on we don't say that pay the same to each provider we pay more to the providers who have greater better quality outcomes greater capabilities to track their patients and this would be on an ongoing basis and then they did talk about some of those other things that you talked about but i think their feeling was first  get medicare to drive this signal pretty hard through its payment system clancy yes first let me just say we work closely with the wisconsin collaborative for health care quality and they are terrific so i just want to let you know that  secondly we have been supporting grants program of close to two hundred million dollars for the past several years evaluating impact of selected applications of health information technology and improving quality and safety with a special focus on those providers in rural and under served areas we also support these health information exchange projects similar to what governor doyle would like in six states right at the moment so we have a resource center that i think can give a lot of lessons to providers having said that i think we do keep coming up against the issue of what is the incentive to adopt and what's going to make it worthwhile it is an issue we're pushing on very hard right now in the department as we speak the american health information community is meeting today we're likely to see a demonstration coming out of c m s in the near future and there are a number of instructions on going now that i think get right at this incentives issue the issue i'm working on very specifically and we recently heard from the collaborative which was great  is how can we make sure that certified electronic health records in the very near future include the functionality to report on quality right now providers have made that investments have sometimes been disappointed after they made a big investment to find out that there's no way to just kind of hit have seven and after the reality measures but that problem will get solved over the next year or so and it will include the reminders so that we don't just get better at driving we don't just figure out how to drive faster through the rearview mirror roy and i guess i'd like to reframe it is a question to dr clancy as for civically how will you update the comparative effect of those measures to be reasonably sure that you're not dampening the innovation in patient treatment and medical devices that is occurring today if a plan for example limits access or bases coverage on formulas derived from comparative effectiveness studies how does the plan avoid penalizing doctors who are on the cutting edge and who are trying new surgical techniques or new interventions to help their patient thank you and that's a concern that many people have we are committed to updating our reports to reflect the latest changes in science and we recognize in particular that that for devices this is a particularly unique challenge because they are constantly being updated and this is an area where clinical trials are unlikely to be the answer to that particular question we think it's very consistent with the kind of observational studies we are finding right now through a network that we call decide  and it would be very interested in additional input on this question because as these devices get better and as we learn more and collect information about which patients benefit and under what circumstances we'll all be better off and again we think that transparency throughout the process from setting the agenda to framing the questions to reviewing their reports and so forth is the greatest protection against information being used in a way that's contrary to patients interests dr i i think that's a good answer and i guess my concern would continue to be a process one that simply how can you as a government entity you know stay on top of this in real time and stay on top of  significant gaps between what we know based on current science and evidence and what actually gets implemented in the every day clinical practice in your view should we be doing more research to get at the best approaches  closing some of those gaps if i understand the question the answer is yes and that's a lot of what we were talking about today and will be discussed in the report that's going to come out on friday but maybe i didn't quite understand your doing that on the basis of a very fragmented information basis and in some it cases information that is not completely on yes and i think one of our arguments here is that you know if we want a market to work well we shouldn't be afraid of complete information i think your concern about being sure that we're on top of it is well taken but right now the information is very fragmented and incomplete but driving lots of investment and lots of dollars well i'll yield back t you do a pretty good job of what you do and having one of the evidence based practice centers on thirteen of them having one of them in my district and i have visited with them and there's a lot and ask people in the community or providers and payers and tremendous respect for the information that is that comes out of every which is in plymouth meeting pennsylvania thing to do a good job and and your shop as well so you think you've already answered the question that has been asked a reason one is why why create a new system to do this when we already have one that is really a public private partnership in a way already because there are these eleven so in some  private in my case sites and they all are evidence based research institutes that actually do this work on your behalf and allow you to do all the helps you do all the work that you do is that not true that there is a mechanism in place now and as was pointed out before if you actually just do more of what you're doing again with the right priorities that you could have more of an effect in controlling some of cost or at least providing information to the providers and to the really hospitals and doctors to know that they're using the most affective treatments and devices the vast majority of the investments we make in this program are indeed to private sector energy some are academic medical centers some like a are freestanding independent institutes or like blue cross blue shield check association and so forth so yes i would say that this is very much a public private partnership and thank you for your comments on x rated they are also very very interested in this issue and making contributions and i know that they would be happy to do more if they had fun doing to be a part of this you know do you have any evidence yet about when you do do a comparative study and get that information out that you have even anecdotal information coming back saying from hospitals or physician practices that they change their behavior because of information you put out to that is the point i think that doctors are made is that we need we need to have some sense that it is being used in the real world of health care so i'm taking that action saying you know i used to use this treatment because i always did and i'm not up on  information actually made a difference or in fact i was buying the cheapest thing out there and your information is help me actually buy something else because it's more effective we have information that a variety of organizations have been very very enthused about this information  some of it much of it is anecdotal or more like case studies we work very closely with the college of physicians that you'll be hearing from from a variety of consumer groups consumer reports takes advantage of information that is produced by another one of the evidence based practice centers and so forth i think you would probably be more helpful if i could get us thoughtful written response to that question and i think would be helpful to the committee in particular as we move forward to make sure that it's being used is being used in a timely fashion and of course kept kept up to date my other my other question actually productive or exact more and that is you suggested that because of the regional differences that the i assume doctors and hospitals are not using evidence based information and they make the decisions they're making the decisions on a lot of the variation seems to occur where there simply is no evidence so i'll give you an example you fracture  go in for surgery the variation in surgery costs for hip fractures is very small across the united states for the follow up costs that hip fracture surgery there's no evidence on whether you should go see your doctor four times a month or twice a month should you get an m r i or not she do physical therapy or not there's just no evidence for the follow up cos they have fracture surgery there's a lot of variation i think what happens is in some parts of the country the doctors have been trained in a particular way or believe that a certain thing works without any scientific evidence behind that and that's what happens so the standard of practice is just different in a way the doctor norms are differ and that's why you see this variation even within relatively small geographic areas where different doctor groups are practicing in different ways do you think cost comes into this that people i mean these are you're suggesting that even the decision about what device or you might buy that the cost comes into that as much is information  effective it is as if cost is availability is of who comes to the hospital and sells it i mean what what is it that's what i was sort of warning about too is that based on just access to the information our payment was then speaks to how do we get out the good information broadly enough to that that actually is available in the helping to make these decisions payment system seems to doesn't seem to does accommodate or facilitate these variations in doctor norms because especially within medicare we basically provide we pay for whatever doctors order to first approximation so if in one area of doctor practice in a certain way they get paid for that and if another area they practice and in a more cost effective way they get  facilities and providers in a particular area often has a lot to do with say the follow up costs are other examples of variation so for example if there are few some physical therapists in an area doctors are going to order less of it as compared with  community where there are a lot of terrific physical therapists and so forth and when you look at different providers and how they are distributed across the country it kind of makes you scratch your head but that clearly i think does have an impact on norms as well do any of the members of the other burning issues before i think the battle for your patience and your efforts in helping us wind our way through this process thank you very much dr david de o's present the american college of physicians to scale sure who is the director of health policy analysis for consumers union dr susan hearn who is the senior project manager in environmental health and safety at the dow chemical company of mental in michigan and dr steve  that without objection your testimony will appear on the record in its entirety and we'd ask you to summarize for us or add to it any way that you're comfortable gale you want to lead thank you mr chairman and members of the subcommittee it's a pleasure to be here the comments i'm going to be making reflects my training as an economist my experience i had been met pack and also my membership on a committee a stablished by how to look at the issue of placement structure and financing of comparative effectiveness research but my comments here reflect my personal views and that those of these organizations i've included in my testimony an article that was published online in health affairs late last year that lays out my thinking and some of the fundamental issues regarding placement financing and functions this is been a very topical subject in the comments today reflects some of the evolution of my thinking since then the rationale for such a center i think is been stated well we have an unsustainable rate of spending growth and we have that in a world where there's clear persistent indications of problems with both patient safety and with quality to be sure better information will not by itself be enough to moderate spending you've heard that from several people before and maybe not even enough to alter practice behavior changing the incentive structure that faces patients and clinicians using comparative clinical fact of misinformation along with cost data to set reimbursement rates and a whole myriad of other changes will be needed on the other hand without better information on what works when for whom provided under what circumstances it's hard to imagine how the us will learn how to spend smarter i am been advocating for a center that would have an information function rather than a decision making function as it would pertain both to coverage decisions and reimbursement decisions although i primarily see the information in such a center as informing better clinical decision making and helping in the design of smarter decisions regarding reimbursement as opposed to setting any additional criteria for coverage these are different and fundamental roles compared to some of the centers that exist in other parts of the  world i believe that the function for such a center should be to fund new research synthesize existing research and make sure that information is available about what is likely to result from using different treatment options for different subgroups in the population  we need to be functioning on medical condition rather than specific interventions or therapeutics that is cardiovascular disease or orthopedic surgery in that a particular device we need to be sure medical procedures are being included and not just look at a particular therapeutic or medical device we need to recognize that technologies are rarely always effective or never effective and that's a role for a center is to inform decision making about the likelihood that a favorable outcome will occur we need to recognize that it's likely that the outcomes will differ from different some groups in the population and as was asked in the previous panel we need to really understand that this is a dynamic process and not a once done finish forever process i have only that the characteristics of the data to help determine where the center might best lie the data needs to be regarded as objective credible transparent protected from the political process and also from the interest of affected parties needs to be timely and understandable to me having looked at the various choices i believe the best combination is a federally funded research and development center like the lawrence livermore labs attached to are close but not too close to government anough to give it a little protection and in terms of both the use of the private sector and the academic  d other community it is one that would be sponsored by an executive branch agency are and make sure that it has a strong tide are think it's important that the center have both intramural that is in house research and extramural that is contract research capability the governance also needs to make sure that it can stand the test of credibility activity and transparency staggered appointments my the executive  subject to senate confirmation so that no one administrator and has too much control with specialized scientific boards in terms of finding i think you can make an argument for direct appropriation but given the real ism of the difficulties that m present i think you could also make an argument for a contribution from the medicare trust fund and also one that has an assessment i'm privately covered lives because the payers will be the major users but let me summarize  then such a center would be an information center and that a decision making center providing credible information to clinicians patients in payers to make better decisions i think it would have many important purposes including the development of a reimbursement system in which co payments could be what makes the most sense clinically and economically informed by credible objective transparent data different payers can and should make different decisions if medicare is to be able to make use of this kind of information you will need to have additional authority in setting reimbursement rates according to what makes sense for various groups of the population and i believe granted the agency will be one of the many changes that needs to occur if we are ever to learn how to washington i'll highlight our positions on this and refer the members to the written testimony previously submitted the college strongly supports congressional efforts to provide medicare and all stakeholders with improved access to availability of sound effectiveness data has direct clinical usefulness for example i regularly advise man about the diagnosis and treatment of prostate cancer and many other problems in my general internal medicine practice when a patient a close friend recently asked me for advice i tried my best to give him a complete and unbiased comparison of the risk and benefits of various treatment strategies but there is really very little comparative data available similarly women with breast cancer are currently treated with a wide range of therapies we know relatively little about their comparative effectiveness but certainly the long term effectiveness and the adverse effects of these therapies but we could  more through gathering data from current clinical practice if we had the mechanisms in place to do so the united states does not currently have a systematic means of producing the information to compare the relative effecti of drugs durable equipment therapies and procedures this is in marked contrast to the organized activities in a number of other countries including canada great britain germany and australia the college recommends that the congress take efforts including allocation of secure and sustained funding to support a trusted into data that systematically develops evidence on the relative effectiveness of health care services the college believes that these this trusted into the should be unbiased and independent organization have transparent procedures with strong stakeholder involvement prioritize to ensure the evidence produced has the greatest impact present its findings promptly in a way that is accessible and comprehensible to all stakeholders the entity in the united states that currently best matches this of list of characteristics is the agency for health care researching  r q the college commands the efforts of h r q and has recently urged congress to increase its level of funding in a joint letter signed by the american medical association and over eighty other medical organizations the college believes that the greatest value of comparative effectiveness data is to help answer the question of what works best and for whom it works best given the clinical conditions of the patients and the patient's preferences we believe that the primary use of this information right now is for patient centered care in counseling better information will enable physicians and empower patients to engage in well informed shared decision making shared decision making is a key and essential element for improving care through the patient centered medical home a model of care now supported by provider groups representing over three hundred thirty thousand primary care providers the college is aware of suggestions concerning the potential use of comparative effectiveness data by medicare and other payers to redesign their health benefits based on reimbursement  patient call sharing of comparative evidence evidence on effectiveness the college recognizes the potential savings obtained through this approach but we recommend that congress proceed cautiously experience and evidence are required to determine the impact of such research on the quality of care and patient satisfaction while for it is integrated into the payment process finally the college ask congress to recognize the value of health information technology better health information at the level of the practicing physician will facilitate the collection reporting aggregation of  data to support evidence based research on a wide range of important critical problems the path way for development of comparative data through implementation of interoperable health information technology throughout our health care system thank you thank you share mr chairman and members of the subcommittee thank you very much for the invitation to testified today  strategies to increase research on the comparative full effectiveness of medical treatments we believe that legislation on this issue is the single most important investment you can make to moderate runaway health care costs and pave the way for a health care system that better meets the needs of all americans getting better value for health care dollars is an essential building block for health reform regardless of stripe of reform in so called consumer centric models that embrace health savings accounts consumers need to know where their dollars are most effective in a system of predominantly employer based health coverage employers have a strong financial incentive to learn how to achieve the best health outcomes at the lowest cost in a universal health care system whether through an individual mandate public private expansions of coverage or even a medicare for all type of model the key to success will be getting the maximum value from each premium our tax dollars spent this is why we believe so strongly in the need for a marshall plan like commitment to transform our knowledge base about the comparative effectiveness of medical treatments to fill the gaps in clinical research armed with this knowledge providers and consumers could identify and choose the best treatment options and payers could find to benefit packages and modify cost sharing amounts to encourage the most cost effective care today i want to concentrate on one public education program that we have developed that can that uses the best available scientific evidence to help consumers with their health care professionals choose the most effective safest and affordable drugs i highlight this work because it provides a tangible example of the potential that expanded government funded comparative effectiveness research holds for improving health care quality and lowering health care costs consumer reports best buy drugs is based on systematic reviews unbiased medical reviews of the clinical research on drug comparative effectiveness safety and side effects conducted by the drug effect in this review project derp is a preeminent example of the pioneer and lea the states have taken with financial support from our funding of evidence based practice centers in the world of evidence based medicine specifically the research that is necessary to enable states and other health care payers to shape benefit policy based on unbiased scientific evidence our best buy drugs program translates d'oeuvres complex medical reports into consumer friendly reports that provide information the public needs to understand the comparative effect of this safety side effects and costs of drug options one of the reports is attached to my testimony today it's on proton pump inhibitors which are anti heartburn medicines we found that there is not a large difference between the effectiveness of many drugs in this category the big story though is that there's a ten fold difference between the monthly price of a heavily heavily advertised purple pill nexium and the over the counter alternative prolific o t c that the best science shows it's equally effective and safe for almost all of us a month's supply of nexium costs about one hundred ninety three dollars while month supply of priceless echo t c cost about one thousand dollars to twenty six dollars having said this i want to stress that we always urge consumers to consult with their doctors and we urge all health plans have effective and easy to use exceptions policies for the small amount of people who may not respond as well to one of the best buy drugs in most categories that we have studied and we have studies seventeen now we have found that by switching from a high priced typically highly advertised brand drug to a best buy drug alternative consumers can typically save between one thousand dollars and two thousand dollars a year helping consumers and health plans substitute effective safe lower cost medicines medicines for the newest heavily advertised alternative can save the nation billions of dollars without sacrificing quality and in fact better information about comparative effectiveness can help us as a nation improve health care quality by educating consumers physicians pharmacists and policymakers about the comparative effectiveness of alternative treatments educating the public about low cost effective alternatives can help make health care treatments and prescription drugs more affordable and this in turn will increase the number of patients who can get the treatment or drugs that they need and ultimately improve health outcomes consumer's union believes that it is appropriate for the government to fully fund and sponsor this important research which should be available to all and constitutes the epitome of a public good the benefits should be shared will be shared by everyone of us who uses health care in this country mr chairman members of the subcommittee the rapidly rising cost of health care threatens the budgets of federal and state governments and ultimately of health care consumers we believe that establishing a new program with sufficient reliable funding to assess the comparative effectiveness of alternative treatments is a necessary part of the solution to this growing problem and acting this legislation is probably the most important thing that you can do in this congress to save lives and money and to build a foundation for further reforms of our health care system thank you thank you dr heard mr chairman ranking member camp and members of the subcommittee dow thanked the subcommittee for holding this hearing to examine the benefits of expanding the availability of comparative effectiveness research we along with members of the broader business community believe that improvements in quality and effectiveness of health care are absolutely essential in addressing the many challenges facing health care comprehensive timely generation and effective demp dissemination of comparative effectiveness effectiveness research is paramount in making progress most unfortunately this is one of the most significant voids in information we face today south revive comprehensive health care benefits to over one hundred ten thousand employees retirees and their dependents in the united states in total we spent over three hundred million dollars on health benefits in the u s last year which is equivalent to about thirty one cents a share or twenty five percent of what we spend on research and development and when you factor in indirect hidden costs for productivity from chronic diseases like obesity the economic impact multiplies by a factor of two or three absenteeism and presenteeism play a big role  pushing our costs up to seven hundred million dollars a year or about seventy percent of our r and d budget for the money we spend and for the peace of mind of our employees and their families we want to ensure that we're getting the best value in health care available and today that is not the case medical errors are the leading cause of death in the united states costing billions of dollars a year and in appropriate care represents up to thirty percent of medical expenses comparative effectiveness research may greatly improve health care quality and patient outcomes and sharing the consumer's receive the best care at the best value it is extremely important that patients and payers are assured the delivery of quality evidence based health care with adequate funding comparative effectiveness research can provide information to enable physicians to make better decisions based on the scientific information elicited in evaluating very treatment option consumers to need comparative information to make better informed choices about their health care and as consumers are encouraged to get more involved in management of their health care and as consumer driven health plans become more prevalent consumers will need to know which treatments are more effective in treating their particular condition currently there are relatively few compared clinical effectiveness research studies conducted each year and increasing funding this research could pay off substantially by reducing ineffective treatment thus improving the quality of care improving health outcomes and saving significant health care dollars the agency for health care research and quality conduct such research through their effective health care program to examine the effectiveness of alternative treatments and this research is producing good results and valuable information to help improve outcomes at the current funding levels this research however is just scratching the surface we encourage congress to significantly increase the funding for comparative effectiveness research this research has the potential to improve health care delivery and ultimately benefit the health of all americans by reducing inappropriate and ineffective care employers like dow will ultimately benefit from the availability of high quality effective treatment and the potential cost savings that are expected through a significant reduction in wasteful spending on less effective ineffective or inappropriate care our employees will benefit through improved health outcomes and the peace of mind knowing that they have good information to help make better health care decisions for themselves and their families this will also benefit doubt by reducing the stress and anxiety that can often accompany a personal or family illness within direct contribution to our productivity having our employees at the top of their game always will help us achieve our vision of being the most profitable most respected and most largest chemical company in the world and we have a very clear health strategy which emphasizes prevention quality and effectiveness of care and health with the management we're strongly committed and very engaged at the local and national levels working with many partners to drive in proven and achieve better health outcomes as well as an improved economic  we can only do so much without the critical information provided by comparative effectiveness research we urge you to significantly increase funding for comparative effectiveness research and continue to support this tremendously important program and expand the good work of the agency for healthcare research and quality thank you thank you dr deutsch good afternoon mr chairman and members of the subcommittee i am dr stephen toy to executives director of the outcomes research group in the office of external medical and scientific affairs at merck thank you for the opportunity to discuss issues of comparative effectiveness in health care merck supports the role for comparative effectiveness analysis we understand the needs of payers providers and patients for better information not on what works and for whom and believe that comparative effectiveness is an important mechanism for producing that information we're collaborating with the with america's health insurance plans to develop a road map to provide guidance on how comparative effectiveness can be incorporated into coverage decisions and of co sponsored reform last fall with a hip and kaiser permanente on the same topic company such as merck has extensive experience in the methods for assessing effectiveness as well there's a lot at stake in a greater national effort to conduct systematic comparative effectiveness of medical treatments consumers and patients one continue to access to new possibilities life saving medical intervention providers want the ability to practice the best medicine for their individual patients and to keep up with the latest information payers one rapid diffusion of scientifically valid information about what works best for home and in what circumstances and innovative suppliers like merck want continued incentives to develop and market those treatments finally welcome part of effectiveness analysis generally produces analyses at the group or sub population level patients and physicians want to find the best treatment for each individual it will be important to bring the individual and population sciences and perspectives together to optimize patient management the science of comparative effectiveness has come a tremendous way in recent years and there is a consensus about many of the methods there remain a number of legitimate concerns about the scope of comparative effectiveness as well as some specific methods and policy consideration among those or whether economic analyses should be included and if so from whose perspective what level of scientific rigor is needed for each type of decision how do we assure transparency of the scientific process which observational methods are sound replicable and transparent and how best to proceed when the available evidence is insufficient despite the worries and reservations i think it's fair to say that there is an emerging consensus among various systems stakeholders on the shape and purpose of a larger national effort to conduct comparative effectiveness this emerging consensus seems to be shaping up as follows comparative effectiveness analysis should be guided by input from a broad array of public and private stakeholders it should be applied to the full array of health care interventions including diagnostics procedures and devices as well as drugs resources should target research for diseases or conditions that impose a high clinical and economic burden on the health care system in society and where the information can lead to improvements in h efficiencies in the health care system the analyses should be scientifically sound rigorous predictable replicable transparent and fair new stable as a finding are needed to generate evidence since much of what is needed does not exist we also need to further develop the methods assure that the results can be used by decision makers and develop the human capital necessary to perform the work compar analysis should be conducted by an entity independent of payers including the government payers and industry the results should inform clinical guidelines for use by medical professionals quality improvement as well as by payers for coverage and reimbursement there are other points that mark would like to emphasize result should be used equally by payers and others when the results are positive as when the results are negative for example where the outcome of an evaluation is positive payers should commit to reasonable coverage and encourage appropriate use as payers use comparative effectiveness analysis to help assess the value of an intervention they should consider the short and long term value to patients the purpose should not be to hinder access to new technologies but to assure their appropriate use comparative effectiveness information cannot be static it must remain current with the state of the science and s m s be timely processes to incorporate new evidence emerged support and actions that bring new resources to bear on this work in this country we believe that properly implemented it has great potential to issue a better decision making and improves clinical management the pharmaceutical industry has a great deal of experience in this area and we believe that we have a vision of a better future based on an expanded role for evidence based medicine in general and comparative effectiveness in particular i thank you for your time and would be pleased answer question you're a member in good standing of pharma you have been kicked out yes the company is definitely a member and dr hern you're a member of good standing of the national association of manufacturers you have been thrown out  you're not going to lose your five zero one status i gather it could be everybody's in good shape but the questions it seems to me are that we should proceed with outcomes research or effect of this sort there's a question of who where what ails gave us four choices in hers but what what ended the does this the question of who pays for it and i think that kick in through the a m a i don't know but that everybody pays some portion of the cost of maintaining this and that the world has free access and i guess i'm asking this of any of us i'll get around to to the information that they're sure i can think of no reason other than to protect personal identities but that this information should be publicly available to researchers  companies or or consumers anybody wants to use it so that i guess the next question is how do we get started how do i cell my colleagues on both sides of the aisle that we should proceed with this and where the police start with with gayle you suggested i think most prominently as a model place to start would be are is that a fair assessment of i believe the better strategy is to have what's called a federally funded research and development center attached to arc of so it would have i think the cause linkage to arc is very important i'd like just a little distance to try to make sure the objectivity and credibility is conferred i guess i would just ask if there are any of the witnesses who would kind a lot of it's evidence based development projects and they provided incredible leadership we believe that there really should be some public private partnership to make it work in gale obviously has given us an example of what such a model might might look like and we believe that there needs to be a structure that does that and but that there's also a group of stakeholders as part of the leadership that can guide the process to make sure it meets the needs of the of the users wasteful as far as i'm concerned said two or three years getting some kind of a commission to decide where we're going to start this and my instinct would be to say started with arc have some kind of sunset three or so years out to see how they're progressing and then legislators could make a change if it wasn't working and i'm would there be anybody on the panel that would be uncomfortable with that sort of  procedure the only hesitation and the answer's no but as a temporary measure if this grows to be the size that i think it needs to be which is a couple billion dollars when we spending two trillion dollars on health care that kind of a size would totally overwhelm our would become the center for comparative clinical effectiveness analysis actually only place where anyhow services research gets done there's so many other questions that once this started i think it needs to be in a slightly removed place and this is a question i've had with carolyn clancy and several locations and my understanding is she is quite comfortable with this savings to stakeholders or that it be required and i'm afraid if that's what i understood your testimony to be that we ought to have a mechanism for saying if something appears as consumers union might show us that it saves us thousands as individuals a lot of money i'm not sure we could get much further than that and i would be troubled by saying we have we would do anything except require that the information be put out there and that the stakeholders never they maybe use it as they choose without any mandates from us i don't think politically that would but maybe i misunderstood what you were saying well we're certainly not talking about mandates in ensconced in legislation but this is a partnership for which we all have to contribute in order to reach that common good of getting appropriate care to patien and getting the value that we have for our health care dollar and that's going to require a commitment to a common goal on all part so that we then develop the kind of quality improvement reimbursement and other kinds of systems that all align to try and deliver that value what we're talking about here is understanding where that value will be and providing that information but we believe all stakeholders are and have and have to have a common connect meant to a to that common goal ok i commit i like the idea of a commitment like a pledge of allegiance but i that's ok but to to memorialize it in legislation would trouble these because as good a job as you may do something for my kids if you don't get rid of the bubblegum flavor they never going to buy a merck product that can tell you so regardless of what the commission would say they should do so there are some levels at which you may never get to consumers t know i actually like what i've been hearing thank you mr chairman and i think there's a lot of bipartisan support on this entire concept and the way to move forward i think it's been a good hearing so thank you for having it i noticed  your testimony you mentioned that the political vulnerability of the senator is probably the most critical issue dr mark miller earlier said you know if it's connected to a federal agency able to deliver any bad news this center i notice you've got a model where there's a a tie to our but somewhat independent how how do you think we best avoid this problem of the difficult issues and this will be very very controversial information i think at times obviously very helpful at times as well there is no perfect placement and when people understand that everything's involving a tradeoff between information is able to be released directly to the public i mean that is something legislation could do i'm more concerned i've spoken to a number of groups industry but academic health centers or individuals and there was too close to government and that was why to me having the link to our was appealing because on the other hand you want to make sure you have accountability i mean there's a lot of ways to remove it from government you could put it in medicine which i think is another option you could have a just free standing but if there's going to be a lot of public money here i've heard from members and rational staff interest in having make sure that there's a real accountability and that's why the notion of having it linked to arc was so appealing as the best tradeoff close but not too close to government  that seemed to strike so that i've moved forward in the last six months of my thinking of being more specific that i believe that's the best tradeoff but i would certainly not object to other other kinds of well it's a good suggestion and  advocates the consumers have to be involved if they're not there they're going to be lobbing grenades from the outside so they need to be on the governing board as to how decision making how priorities are set making sure the information is fair and credible  g physicians in addition to the academic medical community have to be represented everybody to be affected by this i appreciate that and i wondered if anyone would like to comment first i want to thank you all for your testimony it's very helpful  noticed this best buy drugs program really looks at the presence of a single disease and many people particularly have multiple products illnesses and take multiple prescription drugs and it's really that dynamic that i think we have to be concerned about is as we move ahead my concern is if you look at the best buy for a particular drug it may not relate with the entire  sort of health regimen the individuals on can you comment on that yes that's a very very important point and that's really goes to the heart of why each of our report says that recommends that the patient talk with their doctor each of compay the systematic reviews that form the basis of our analyses to look at co morbidities so there and we do try to include that information if a person has various conditions there may be a different recommendation so to the extent possible we try to address that in our ports but we always say that this is not about consumers taking their medicine but they should talk with their health care provider and lastly dr whelan you're viewing this organization has up to thirty percent of the funding to come from the private sector and it is frequent that these f r d c's and there's a good description i think in med pac and also the institute of medicine has a very good description of some existing  r d c so you can look at what's out there how long how big it could be through voluntary contributions we have some very large foundations that are interested in this type of work robert wood johnson foundation but also  several of the insurance companies when they've converted to for profit status have set aside these large foundations and they're all expressing an interest so one possibility is to have that another is to have just a direct assessment and then you  decide this does that really count for being private or if it's a direct assessment is that public and i don't know what the legal ruling would be ok it's the flexibility in particularly in the start up but even ultimately having some private sector dollars in there to make people feel like they're directly a part of the process but of course you need to make sure there are a lot a lot of rules in place so that you can't have that influence what goes on in terms of the studies but of course that happens with process so i think there are some models as to how that part of it could work all right thank you thank you deutsch you know how do you ensure that comparative effectiveness research is not misused in ways to discourage medical advances how do we make sure that the are the medications and in the innovation that in an industry delivers and we believe that by developing products to provide real value making sure that value is clearly understood and then that we have the processes to help translate that so that the right patients get them at the right time are all ways to assure that that innovation is adequately rewarded so we actually see this is very much part of that solution to stimulate innovation and be even personalized healthcare as we as we go forward ok so the the docs are going to buy and well doctors do need that information and dr dale can talk but it's very difficult to keep up with all the current information that's available out there and we and you heard earlier that there is a wide variation in care and what we not want is not homogeneous of care we want to have doctors with the right information to the liver the best information to patients and that when we talk about comparative effectiveness it doesn't mean one size fits all it means understanding the tradeoffs among these different innovations so that to where they fit most appropriately into care and how we take advantage of the diagnostic products and other kinds of information so doctors can make better information and this feeds into the systems of decision support that will allow doctors to have the information that they need so that they can have the information that scientific or giant which i mean it's kind of i don't know i'm trying to figure out how you ease into this and can establish a protocol for example dr dale i don't think we could start right away with surgical procedures because i think you've got to wait for five years or so to find out did you live through the operation but how was your life five years later to really get to really study the effectiveness of visits i get to be to the point that and i don't mean to pick dr deutsch on your industry but we do have an awful lot of information about pharmaceuticals already starting from the genesis of the f d a and zocor is the same zocor in california as it is in michigan is it is in maine so we're not talking  about different i may use it differently in different parts of the country but what if we started with of that area admittedly physicians would be involved because some physicians would administer the pharmaceuticals differently and then proceed maybe take up devices or physician practices as we get the ability to collect the information would there be any  the pharmaceutical side is life is a bit like looking under the lamp post because we do have good information in fact the real positive information tends to be on the utility of diagnostic devices and procedures that's where some ninety percent of the cost is so it's going to be important to look at those and help drive the generation of of that of that information so that we do need to look broadly and in fact not look at the information is best but actually try to figure out where there's a positive information where decisions are probably suboptimal because of the lack of there rob dr dale was just calm and i think there's room for good work and for the next patient how do you describe what's likely to happen to that person so i think surgery and in device but i would also say in terms of the long term use of drugs as well many side effects are not recognized in the early phase of make sure everyone is clear why this is a good investment but looking at areas that are either high cost or high volume because look at a couple of the major where are we spending our money where there are significant differences about how you could go about delivering the care and there are a lot of dollars attached recent study that was released that looked at the whole issue of stenting versus angioplasty versus conservative treatment of medicine versus bypass surgery indicated the kinds of questions that are still out there it is only the first look at a broad based set of questions in cardiovascular disease but cardiovascular disease orthopedic surgery i mean these are areas where there's a lot of money and a lot of uncertainty and variation trying to inform who actually gains because the answer's always almost always going to be for some people these aggressive interventions are really important the question is what about the other groups what can we say about how to help them that may result in a lot of reduced spending because they don't need such aggressive treatment it's the binary all or nothing thinking that tends to get us in trouble if it's really important for one small subgroup of the population does that mean it's useful for everybody that might have something that looks related but that's the kind of work that we've got to get started on or will never be able to get peter or zagged money scored that the drug effect this review project is already being huge savings on behalf of states that use that information for their medicaid programs so i think that there is tremendous potential and and i think that it could be realized sooner than questions written questions by members and you may find in the coming days that members will send some of you requests which we hope you might be willing to respond to for the record i want to thank you for your