Hearing of the Senate Health, Education, Labor and Pensions Committee - Implementing Best Patient Care Practices

Hearing of the Senate Health, Education, Labor and Pensions Committee - Implementing Best Patient Care Practices

HEARING OF THE SENATE HEALTH, EDUCATION, LABOR & PENSIONS COMMITTEE

SUBJECT: IMPLEMENTING BEST PATIENT CARE PRACTICES

CHAIRED BY: SENATOR BARBARA A. MIKULSKI (D-MD)

WITNESSES: PETER J. PRONOVOST, MD, PHD, MEDICAL DIRECTOR CENTER FOR INNOVATIONS IN QUALITY PATIENT CARE, JOHNS HOPKINS UNIVERSITY, BALIMORE, MD; STEVEN D. PEARSON, MD, MSC, FRCP, PRESIDENT INSTITUTE FOR CLINICAL AND ECONOMIC REVIEW (ICER), BOSTON, MA; DONALD R. FISCHER, MD, MBA, SENIOR VICE PRESIDENT, INTEGRATED CLINICAL SERVICES AND CHIEF MEDICAL OFFICER, HIGHMARK BLUE CROSS SHIELD, PITTSBURGH, PA; JEFF GULCHER, MD, PHD, CHIEF SCIENTIFIC OFFICER, DECODE, CHICAGO, IL.

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SEN. MIKULSKI: (The hearing of the ?) Working Group on Quality for the Health, Education, Labor Committee will come to order. I apologize to my colleagues and to the panel. It's called traffic tardiness. I commute every day from Baltimore, and traffic and I don't always gel. So I apologize for being late. I had a meeting.

But we're going to hold a really pretty extraordinary hearing this morning, and the hearing will focus on best practices on quality. We have a distinguished panel. And I'm going to say a few remarks, and then we'll go to the panel and go directly to questions, because we might be having votes this morning.

The goal of today's hearing is to learn from a panel of innovators. (Off-mike) And what we want to hear from is how the adoption of best patient practices has the potential to save lives and save money. We want to use this information to shape our thinking on public and private sectors and how they can do a better job of implementing best patient practices so that we can have better care for the patient and also more efficient care for either the taxpayer, or the private payer. We truly believe that providing quality means that we can also be a path controlling cost.

There's tremendous potential for the U.S. health system to improve quality, reduce cost, and increase the value of healthcare spending. Our healthcare system under performs. Twenty percent per -- we have a 20 percent higher per capita spending than Europe. We rank poorly on many key indicators, including infant mortality and life expectancy. People don't get the care they need. Some say only half of U.S. patients get the recommended services delivered by their doctor, and some get services that they don't need. And we also know that more service doesn't always mean better outcomes. So that's why we want to hear from you today. We in the public sector must work with the private sector to make sure that the U.S. healthcare system does the right thing.

Now, my staff wrote this phrase, and I had an argument with him, so I'm going to give it to you. And then I'm going to tell you what I said to them, and you'll know what I mean. We had a good conversation about it. They said, "Our goal to make sure the U.S. health system is getting the right care to the right patient at the right time for the right price. Yeah, team. And I said, oh, how old paradigm. This presumes that if you give the right technique, or the right test, or perform the right procedure to the right patient and not cut off the wrong leg or pierce the wrong ear or something it's all okay.

My approach is that that is all so, but unless you really have patient-centered healthcare, doing the right test or procedure doesn't tell you the story. So you could do the most perfect amputation, but if the patient is a diabetic who drinks two Coca-Colas every day for lunch and drinks two beers every night for dinner, you're just going to have one more amputation in the future.

So my view is to say yes to this, but this is like the fourth paragraph, that we have to look at the totality of care, and also, if you don't wash your hands while you're doing that amputation, that's a whole other thing. So sure, we want the right care to the right patient at the right time, but right care isn't always the perfect test, the most dramatic procedure, and so on, so -- and with that, maybe we can have two beers and talk about this.

My view is to have patient-centered healthcare where we look at the totality that would deal with prevention, intervention, where you need to, and then the case management for the appropriate follow- through, so that an illness is either treated and cured, of if it's chronic, it doesn't not escalate to an even more serious situation.

And even argue back with me. I really welcome that as well. We know that some of our tools will be health information technology, but I'm of the -- first believer that technology -- we can't just survive on techno-case management. It takes human beings as well. You can probably see that I'm a social worker, so I'm a big believer in case management, but I'm a big believer in what you do.

What a great panel of witnesses. I'm really excited about today, and I know my colleagues will as well. We have Dr. Peter Pronovost from Johns Hopkins University, my neighbor. He's identified low-tech ideas, that famous checklist that results in high value results. And many call him the father of the medical checklist. And we'll discuss how the adoption of best practices can provide pretty astounding results, but also the barriers to implement the current system.

Our second witness will be Dr. Steve Pearson from the Institute for Clinical and Economic Review. Dr. Pearson will -- work focuses on clinical effectiveness, which goes to some of the things we've been talking about, the cost effectiveness in medical innovations, compares effectiveness to treatment value, and informs payers how to reimburse and cover innovative therapies. We're interested in his views on the topic very timely today and even in the stimulus; comparative effectiveness research, and what is it that we get out of it?

We also hear form actually somebody who's got to pay the bills; Dr. Donald Fischer from the very eminent high-mark Blue Cross and Blue Shield. Dr. Fischer, as the chief medical officer -- and by the way, it's in Pennsylvania, Senator Casey. His job is to determine which practices had the best potential for patient success, and then how to devise those carrots and sticks to incentivize his network of patients and providers to adopt these standards.

And then kind of on the new frontier of thinking will be our witness, Dr. Jeff Gulcher from DeCode genetics -- to hearing on how the bio-pharmaceutical industry's perspective -- how the development and adoption of best patient care practices -- and also, looking at genetic -- a way of really focusing on our testing if we look not at genetic determinism, but genetic, I believe, predispositions, that if you have one, (say ?), to diabetes, you would focus a lot more earlier on in testing. So we want to hear from you, Dr. Gulcher.

So having said that, we're going to turn right to our panel.

I want to acknowledge here Senator Sherrod Brown, Senator Casey, and Senator Kay Hagan for their participation. I'm going to turn to our colleagues on the other side. Will Senator Enzi be joining us? You know, it's a pretty day. I want to acknowledge the very active role of Senator Casey, because you see no Republicans. Do not think that they're boycotting. It's -- mean that they're participating in other hearings that range from confirmation to oversight.

Any questions that may might have -- we -- or statements -- we will submit those for the record. I'm going to ask unanimous consent that our -- all opening statements by my colleagues be included in the record, and I ask unanimous consent that all of your complete content- rich statements be included in the record.

SEN. SHERROD BROWN (D-OH): Madam chair, could I have 30 seconds to say something about the panel, if I could?

SEN. MIKULSI: Sure.

SEN. BROWN: Thank you, madam chair. This panel is made up of very impressive thinkers, people who have influenced the thinking of many others in the healthcare system. I shouldn't single out, but I do, Dr. Pronovost, and the work he's done with his checklist, and the quality -- it is -- the increased quality, the huge cost savings, and ideas that all four of you have had. And it has begun to make a difference, and we know what's happened to healthcare. We spend so much money, and our quality is not what it should, and our outcomes are not what it should, and our cost is too high, and the work that you four have done have contributed to beginning to change that. So thank you.

Thanks, madam chair.

SEN. MIKULSKI: Thank you, Senator Brown. And Senator Casey, you're the guy from Pennsylvania. Did you want to say something about our witness from Pennsylvania?

SEN. ROBERT P. CASEY, JR. (D-PA): I'll just reiterate the gratitude of this committee for the testimony you're going to give today and the scholarship. I'll leave the kudos for the Pennsylvania fellow when my turn comes up.

Thank you, madam chair.

SEN. MIKULSKI: Well, now, Senator Hagan, I'm going to let the two guys speak without you, so --

SEN. KAY HAGAN (D-NC): Madame Chairman, I'm just looking forward to hearing the testimony of these very distinguished individuals. Thank you. Very good.

SEN. MIKULSKI: Dr. Pronovost, why don't you -- (inaudible) -- us down and give us the checklist for change?

DR. PRONOVOST: Okay. Okay, thank you, Senator Mikulski, and other members of the Health Committee. I appreciate your commitment to address this topic of patient safety and quality of care. It is by far the biggest opportunity to improve the health of U.S. citizens.

A few years ago, an 18-month old girl died from preventable mistakes at one of the world's best hospitals, at my hospital, Johns Hopkins. And on the four-year anniversary of that girl's death. Her mother, Sorrel, came back to the hospital and looked me in the eye and said Peter, could you tell me that she's less likely today than four years ago? Are you safer? And the sad reality is I couldn't. No hospital in my state could. And the U.S. can't give her an answer. And fundamentally she deserves one.

The National Healthcare Quality Report rather alarmingly said that for most areas of quality and safety, we don't even know how we're performing. Now, I ask you to contrast that with the remarkable success in biomedical science over the last decade. AIDS has become a chronic disease, we cure most childhood cancers, and we sequence the human genome, all 300 -- or 3.2 billion letters with 99.99 percent accuracy. And how could we perform so differently?

And I think, senators, the reason is that we haven't viewed the delivery of healthcare as a science. It's been solely the art, and we've under invested in it. We invest a dollar in discovering new knowledge and new genes for every penny we spend on improving quality of care. And so we have this enormous gap between what we know and what we do, and it has to be bridged.

We've been trying to bridge that with some science, some very practical science that I'd like to share with you. We tackled the problem of catheter-related blood infections, a type of infection that kills between 30 and 62,000 people a year. And we approached it much like you would drug development. In phase one we summarized evidence into a checklist, developed measures, and identified barriers to using those evidence. Much of those barriers were teamwork and culture things. We then pilot tested a program at Johns Hopkins and virtually eliminated these infections there.

In phase two with funding from AHRQ, we implemented this program in the entire state of Michigan, 103 intensive care units. Within three months, their rates of infections went from three per thousand catheter days to zero, a median rate of zero, a 66 percent reduction, and that is sustained for four years. We estimate that that intervention per year saved approximately 2,000 lives and $200 million. The investment from AHRQ was about $750,000 for two years. I wish my retirement had that kind of return on investment.

In phase three now, we're working with AHRQ to put this around the country. We have some funding to do ten more states, and we have philanthropic support to add about ten more. But that still leaves 32 states out of the picture from this life saving intervention.

Now, there's many (ills set ?) before our healthcare system. These infections are but one. And we need to develop a model to try to improve upon how we deliver care. We think this is a model that has strong, strong legs that finds the right balance between centralized approach or a regulatory approach and a free market approach. We've tried to centralize what works, the evidence and the measures, and then work with local leaders to implement that.

And so, committee, I would ask you to consider investing in the science of healthcare delivery. Imagine what could happen if AHRQ's funding were a quarter for every dollar rather than a penny. We ask you to create an Institute for Health Systems Research, an institute that brings together patients and payers and consumers and providers and scientists to make sure, as you said, Senator Mikulski, that we do what's right for patients, that we take a systematic view of this, we design programs, we see if they work, and what works, we continue, that we invest in building capacity. At my institution and around the country there's hundreds of people who you can find who study genetics, who teach physiology. You're rare if you can find anyone who can teach patient safety. It's just not being taught because there's no capacity.

And finally, I would ask you to support completing this CLABSI, this blood stream project, throughout the country and support a pipeline to develop one for MRSA. Senator Obama told us that he's going to restore science to its rightful place, and indeed, we need to do that if we're going to improve quality and reduce the costs of care. I think we have a model. What we haven't had is courageous leadership, is clarity of what the task (is at ?) hand, and a commitment to make resources available. And I hope that this committee has that courage to bridge the gap between what we know and what we do so that I could look Sorrel in the eye and tell her now, indeed, Josie is less likely to die throughout this country of ours.

I thank you.

SEN. MIKULSKI: That was excellent. Dr. Pearson? And we'll just go right on down and conclude with you, Dr. Gulcher.

DR. GULCHER: Sure.

SEN. MIKULSKI: Sure.

DR. PEARSON: Thank you, Senator Mikulski and -- thank you, Senator Mikulski, and members of the committee for the invitation to testify today. My name is Steve Pearson. I'm the founder and president of the Institute for Clinical and Economic Review, or ICER. ICER is a research group in the Institute for Technology Assessment at the Massachusetts General Hospital, and we work with patients, clinicians, manufacturers, and health insurers to evaluate the comparative effectiveness of medical tests and treatments.

In my oral testimony today I want two cover two questions; first, what is the connection between comparative effectiveness and best practices? And second, what are the mechanisms and the requirements for effective implementation of comparative effectiveness findings?

The term best practice is usually meant to refer to systems for delivering care, systems such as Dr. Pronovost's fabulous surgical checklist that produce optimum patient outcomes. Comparative effectiveness, on the other hand, is a newer term that has generally referred not to research on systems of care, but to evaluations of specific treatment options. For example, trying to determine which patients with coronary artery disease do better with medication and which do better with cardiac stints.

So best practices and comparative effectiveness can be viewed as feeding into different approaches to improve the quality and value of care, but they can also be quite complementary. Comparative effectiveness helps figure out what the right care is, and best practices research helps us learn how to get that right care delivered as safely, effectively, and efficiently as possible.

One of the mechanisms by which the results of comparative effectiveness research can be implemented -- the ideal framework is for the findings to be able to support tools and policies that can be used by different stakeholders and that all reinforce each other. Implementation strategies include the following, some of which, but not all, are also options for the implementation of best practices.

First, patient information, clinical guidelines, physician group compensation incentives, tiered benefit designs in which patients would pay different amounts out of pocket depending on the evidence of benefit and value, and lastly, value-based coverage and reimbursement policies.

Now, there are two key points I want to make about this list. First, insurance coverage decisions are not the sole, nor even the primary mechanism for implementing comparative effectiveness results. Sometimes concerns are raised that comparative effectiveness will only be translated into all or nothing, one size fits all coverage decisions. In fact, comparative effectiveness assessments are expressly designed to hunt out any evidence that specific types of patients may benefit more or less from certain treatment options. And these findings can then be used to support benefit and coverage policies that are flexible enough to recognize these differences.

The second point I want to make about implementation is that in order for implementation -- I'm sorry -- for assessment results to be truly useful to patients and clinicians, and for the results to be linked in a transparent way to coverage and reimbursement decisions, some kind of common language about the evidence is necessary.

To meet this need at ICER, we've developed a ratings system that assigns a capital letter to grade the degree of clinical effectiveness of whatever it is we're evaluating, and a separate lowercase letter indicating our assessment of the comparative value. These ratings can be looked at in isolation, or they can be put side-by-side to form an integrated evidence rating.

In a demonstration project in Massachusetts, we are now working with a coalition of employers, health plans, and provider groups to assess prostate cancer treatments. The ICER-integrated evidence ratings arising from these assessments will then be used to generate patient materials and new medical policies. The goal is to give patients better evidence to use in shared decision making and to align that process with coverage and reimbursement policies that can help shift patterns of care towards those higher-value options.

In conclusion, I believe that comparative effectiveness research and efforts to implement best practices are truly complimentary and mutually supportive efforts. Finding out what works best and getting it done right -- the left and the right hands will both be needed to help us achieve a high-quality affordable healthcare system.

Thank you.

SEN. MIKULSKI: Dr. Fischer, let's hear, then, from you.

DR. FISCHER: Senator Mikulski and other members of the committee, I'm Dr. Don Fischer, senior vice president and chief medical officer at Highmark Blue Cross/Blue Shield. I'm truly honored to have this opportunity to share with you what we are doing as a health plan to improve quality and affordability by helping to spread best patient care practices.

You're obviously aware that a quality chasm exists in the United States healthcare system. Improving quality of care will drive improving patient outcomes and significant cost deficiencies by eliminating under use errors, over use errors, and misuse errors. It is a myth that paying more buys you better care.

Our goal at Highmark is to help ensure that the right care is delivered to the right member at the right time, and that was already in remarks before you discussed that. Our quality improvement programs emphasized several guiding themes; one, we focus on measuring quality indicators that have been identified by national quality improvement organizations. Number two, we align financial incentives to improvements in those quality measures.

Number three, we provide practice coaching and guidance to physicians and hospitals so they can be successful. Number four, we provide education, coaching and incentives to members to improve their adherence to evidence-based guidelines and their use of preventive care.

A key success factor has been the development of collaborative relationships with our network providers and our members, rooted in mutually shared goals. I'd like to give four examples of results of these programs, starting with our work with hospitals. Our Quality Blue Hospital pay-for-performance program has focused on reducing the incidents of central line blood stream infections in intensive care units.

During 2008, hospitals in the program reported a significantly lower rate of central line infections compared to the national average, namely, one infection per thousand-line days compared to 2.7 infections per thousand line days nationally. That translates to an imputed savings just in our region of $21 million, and saving between 69 and 142 lives.

Second, we have a pay-for-performance program for primary care physicians. Give you one example of the program's impact. The percentage of generic drugs prescribed by our central Pennsylvania practices increased from 48 percent to 67 percent since the onset of the program in that region two years ago. Higher rates of generic prescribing not only results in financial savings to the member or to the employer, but also increases the likelihood that a patient will adhere to a treatment plan. And that's better quality.

Thirdly, let me talk about the consumer strategy. Highmark offers a program called Lifestyle Returns for our members designed to encourage wellness, increase use of preventive exams, and share decision making. Since starting the program, we've seen a striking increase in our employees who've obtained preventive exams going from nine percent each year to over 60 percent in the past year. That's over a three-year period.

We've also shown that a comprehensive and employee wellness program produced a $1.65 in cost savings for every dollar invested. And that is a short term. And that material was published in the Journal of Occupational Environmental Medicine in February of '08.

Finally, we work with the Blue Cross/Blue Shield Association spreading national programs, like Blue Distinction centers for specialty care. Capitalizing on the concept that those institutions that follow a standardized, systematic approach to management of complex conditions and do it frequently achieve better outcomes at lower cost -- that's a clear win for everyone.

In closing, you obviously see there's an imperative to improve the value equation in healthcare. We don't have all the answers, but we've see trends that speak to some key success factors; one, collaboration among all stakeholders, number two, better information sharing, three, a focus on process improvement, four, coaching for providers and members, and five, aligning financial incentives based on standardized quality metrics.

I would encourage you all to take bold action on this critical issue for our country. We are more than willing to help with solutions, and thank you for your attention.

SEN. MIKULSKI: All of it's excellent. Dr. Gulcher?

MR. GULCHER: Thank you, Senator Mikulski, members of the committee and staff. I trained and worked as a neurologist at Harvard Medical School for several years. Twelve years ago I co-founded DeCode Genetics with Cari Stuffensern (ph), and now serve as the chief scientific officer. Our company is a member of the Personalized Medicine Coalition Group that works to advance the understanding and adoption of personalized medicine, and I've attached our white paper on improving healthcare to my written testimony.

I'm here to tell you that personalized medicine probably saved my life. The traditional risk factors that we use for predicting some of the most common diseases, like heart attack, stroke and cancer, are not very effective. For example, most patients with prostate cancer or breast cancer have none of the risk factors. And furthermore, these are not cancer -- smoking-related cancers.

The better we can predict risk for common diseases, the more we can target higher-risk patients with prevention strategies and with more intensive screening for early detection. We've recruited most of the Icelandic population to participate in industrial-scale genetics studies, and we've been fortunate to discover some of the most important genetic risk markers for common diseases.

We've worked with numerous U.S. institutions as well, including the University of Pennsylvania, to confirm and validate those findings, and have already launched several genetic risk tests to make them clinically available for diseases such as stroke, heart attack, breast cancer and prostate cancer. And these tests measure genetic risk, even if the patient doesn't know their family history or even if they have a family history of that disease.

I personally have already benefited from one of these tests. Last spring, I received the results from my prostate cancer test, risk test, and this is a test that measures eight genetic changes in your genome, and it can define which ten percent of the population has twofold risk, higher risk for prostate cancer. And I fit that category. I was only 48 years old at the time, so best patient practices actually dictate that you wait for a prostate cancer screening until you're in your '50s, unless you have some other risk factor.

Given my higher genetic risk factor with this novel test, my primary care physician ordered a PSA test, a blood test, to see if I might have prostate cancer. That came back in the upper normal range, still within the normal range, but he was concerned enough to refer me to a urologist, Bill Catalona (ph) at Northwestern University in Chicago. He was concerned enough to recommend -- instead of watching and waiting, to actually do a biopsy of my prostate. It came back with -- I had high-grade prostate cancer on both sides of my prostate, and, of course, it was a shock to me that I was diagnosed with prostate cancer at such a young age, relatively young age.

But I took his advice that I should have it removed surgically, given that I have two young daughters, three and five, and that was successful. My PSA level has now gone down to 0.0 after I had my surgery six months ago. Had I waited until my '50s, according to a standard recommendations to get my first PSA or screen for prostate cancer, there's a good chance that this high-grade tumor would've spread by that time. And unfortunately for prostate cancer, we don't have any chemotherapy that works once the tumor has spread beyond the prostate into your bones. And so inevitably you have a long, painful, and very costly -- to the healthcare system -- course that -- and eventual death.

So I firmly believe that these genetic markers that we discovered and developed in the test were at least useful in my case to prompt me to have early detection and early treatment for my prostate cancer, and I expect that others may benefit from this approach of targeting high-risk patients who have -- high risk for common diseases, targeting prevention and early detection strategies.

For example, for every prostate cancer or breast cancer that is detected in the early stage, as opposed to late stage, saves the healthcare system hundreds of thousands of dollars in terms of treatment, palliative care, and complications. For every stroke that you prevent, you save the healthcare system $65,000. So I think personalized medicine has an opportunity of making our healthcare system much more affordable for all. Thank you.

SEN. MIKULSKI: Well, first of all, thanks to the panel. I'm going to go by the five minute rule so we all get a chance to ask our questions, and if there is the opportunity, we'll go back for even a second round.

I'm going to jump right in and target -- focus, not target -- focus my first area of questions to Dr. Fischer. Dr. Fischer, you're the author of "The Right Care at the Right Time to the Right Patient at the Right --

DR. FISCHER: No, I would not take authorship on that. It's a common patient safety --

SEN. MIKULKSI: That's exactly right, and it seems good. Yet, when I look at your four points, I think you also embrace the concept that I raised, which is doing the amputation for the diabetic who's drinking two beers and two Cokes -- Coca-Colas every day, and preventing infection using Dr. Pronovost's goes to what I'm talking about. What I note in your four points that are you guiding themes, in addition you talk about providing practice, coaching and guidance to support the hospitals and physicians who are your partners and also provide education, motivational coaching and incentives to members to adhere to that which has been prescribed to them, which then of course goes to having a medical home, health IT and so on.

Could you elaborate on your three points about what exactly does it mean in terms of quality and how did you provide or pay for incentives in for example this coaching? You know, the word coaching has just been bandied about, you know there are people who like of resin coaches and then you have a nurse practitioner or a physician's assistant or a diabetic educator who's a coach, Harvard educated, credentialed, certified, you know, meeting their own quality standards to be a quote, "coach". Could you elaborate because -- first of all, do you agree that we need the continuum? Obviously you do, and then how did you achieve that and how did you have the financial payments to accomplish it?

DR. FISCHER: Thank you for the question. First of all, right care I would include in the concept of right care prevention, an appropriate ownership by an individual of behavioral lifestyles that impact ultimate health. So that's embedded in there. We firmly believe the prevention and wellness programs have benefit and we need to focus more on that aspect.

If you look at our incentive program for physicians, the clinical quality indicators which I did not speak to it is in my written documentation, accounts for well over 50 percent of the bonus opportunity. And many of those have to do with preventive screenings and preventive exams. So well child care visits for instance at the appropriate age --

SEN. MIKULSKI: Can you give me a case example about how it all works?

DR. FISCHER: In three more minutes?

SEN. MIKULSKI: Yeah, go ahead.

DR. FISCHER: Okay. The --

SEN. MIKULSKI: Because your intention --

DR. FISCHER: -- a given practice for -- I'm sorry.

SEN. MIKULSKI: Your, each one of these has an area what it comes down to most of private payers come through I think Blue Cross or a variation of a high level health care provider. And really we use words like coaching and we do this with, nobody knows what it means.

DR. FISCHER: Okay.

SEN. MIKULSKI: And then we don't know how to do the legislation. And then we leave it to the Finance Committee to talk about financial incentives. We have to have health insurance reform, not health care financial reform.

DR. FISCHER: Let me talk about coaching then. What we have done and we've done it for about ten years now is we have a stable of about 15 medical management consultants along with medical directors and two pharmacy staff who go out to practices and help them do process improvement. Look at the data that we provide them, much of which is close to real time, look at a given indicator and help them find who is the denominator that's not an enumerator, how do we work to increase the rate at which say you get preventive exams for the three to six year old population, and set up a system. It may be that they have an electronic system that can help accommodate that. But first they need to understand systematic approaches so it may be a paper system.

But by doing that, learning process improvement, spending the time it takes to improve, they can get better results. And they have found these medical management consultants and medical directors to bring value to their practice. Initially there was resistance. Who are you as a health plan to come tell us what to do? Trust me, we do the right thing.

SEN. MIKULSKI: And looking over your shoulder --

DR. FISCHER: Right.

SEN. MIKULSKI: -- because we don't want to create a nanny state here.

DR. FISCHER: But we develop relationships over time, so they have the same individual coming to their practice, working with them. They see their bonus opportunity increase, they see that their results are better, and they see improved satisfaction frankly among their patients. So I think it does take a concerted effort working over time to be able to get that kind of result and that kind of trust. We're not adversaries, we are there with a common goal.

Now these medical management consultants, many of them are advanced practice nurses, some of them are people who'd spent time in prevention, if I look at our member coaching which is telephonic, the wellness coaching, some of that's done by exercise physiologists, by dieticians, but we try to get the right skill set to the right person to meet their needs.

SEN. MIKULSKI: So you actually do two types of coaching. One is to those who actually are the providers, the clinicians.

DR. FISCHER: Right.

SEN. MIKULSKI: And help them organize their practice or some of these others. And these are one set of professionals to another set of professionals.

DR. FISCHER: Correct.

SEN. MIKULSKI: Is it voluntary?

DR. FISCHER: It is voluntary. We asked physician groups to sign up for this program a number of years ago saying you have an increase opportunity for bonuses if you work with us. And the benefit is you get data and you get assistance with practice improvement and a better payout.

SEN. MIKULSKI: But you incentivized also for them to invite you in to look at what's going on?

DR. FISCHER: Right.

SEN. MIKULSKI: To --

DR. FISCHER: So we provide claims data that may show that there's a care gap or that they're not doing as well on an indicator. The usual response was no, you're wrong, you're data's wrong. And so we might have, we might have said well 60 percent of your patients got a retinal eye exam for diabetes and they said you're wrong. Well then we would say okay, let us help you pull charts and let's really look through the charts. And the real number would turn out to be 61 percent. And we'd say well guess what, it really doesn't matter, but 60 percent, 65 percent, there's an opportunity here. People aren't getting the care that they need.

And so it's almost a death and dying process for many physicians to recognize there is a quality problem, that you've got to recognize it, you grieve a little bit, you move on, how do we fix it, and the fact that we've had relationships using people with skills that can help them, they've shown value. Now with the member, we're doing telephonic coaching to help educate, help motivate, help them to adhere better to what the physician has asked them to do.

SEN. MIKULSKI: And then would you escalate, escalate's not the right term but elevate it. Let's take the case I gave you of the diabetic and that person got a call but say they're A1C was still in the danger zone, obviously when I just describe you their lifestyle and so on. Would you then escalate that to counseling, to family counseling, what would you do in a situation where someone, first of all, would anybody actually say what is it that you eat and drink every day?

DR. FISCHER: Yes.

SEN. MIKULSKI: I mean, a practical question like that and then the next question is why are you doing that to yourself. Not quite as directly as I'm presenting it to you, but that's pretty heavy duty because what the man said to his wife, see, I heard this through the wife after all the man eventually died was that's what they invented insulin for.

DR. FISCHER: Um-hum. And I think that takes some education, it takes behavioral change tactics. What we do is we use our claims data, we use a variety of data --

SEN. MIKULSKI: But what would happen with this type of patient in your system? How would that, how would the problems be identified? A dangerously elevated A1C, what would that trigger because both with the primary care or the specialist doing diabetic, you know, endocrinology, but where would this be telephoned that they call him every day and say don't drink your Coca-Cola? I mean, what would happen here?

DR. FISCHER: Two ways it could be identified. Either the practice calls and says we have a patient that we're just having terrible problems with. Will you spend the time and your health coach call out, reach to them, and spend the time, get them in a program that will be helpful? And we have a variety of programs that can be done in person, online or with a telephonically.

The other way is through claims, that we would be able to find people who are at the highest risk, who've had the greatest number of care gaps who are not doing well and reach out to them as a cold call. But once they're engaged, be able to have a one-on-one relationship with a health coach to be able to get them to understand, get them to comply better, and if there're in fact there's a crisis, to contact the physician's office and say, you know, we've got this patient we're working on with you who's really an issue. Here's what we think may help, you know, how can we help.

SEN. MIKULSKI: Well I'm going to now turn to my colleagues. But this is where health IT though standard and interoperable would work because you would all have the data, there would be flashing yellow lights both for an individual patient, but maybe even trends into practice, et cetera.

Well thank you, that was --

DR. FISCHER: And I would just say that you need to have interoperability among the health plan data, among the physicians, the hospitals, all of it needs to talk together. We shouldn't have a strategic advantage over information. We need to have information shared and it should be a health plan neutral.

SEN. MIKULSKI: Great. That was great.

SEN. SHERROD BROWN (D-OH): Thank you, Madame Chair.

Dr. Pronovost, your comments about seeing health care delivery as a science are just exactly right.

And by your illustration of a penny on a dollar, the incredible advances we've made in science far and away the best ever in the human history, obviously, and the best of any place in the world and the way we deliver is such a huge gap and thank you for that. And your suggestion that there should be an institution, which I think might be something that we look at, I mean, I would like to see us seriously consider an institute and I think we might look at locating an institute like that somewhere outside of Washington and outside of, I should not say that with the Chair sitting here, but perhaps outside of the campus of NIH in the heartland and several places that would be closer to the real delivery, but that's an issue perhaps for another day.

I want to talk for a moment Dr. Pronovost with you about the checklist and Dr. Fischer with you about antibiotic resistance and some, but I'll start with Dr. Pronovost. The (capital ?) eye infection issue the checklist and I know you've looked at check lists and to prevent other kinds of hospital infections and other kinds of medical mistakes. I've been working with the Ohio Hospital Association and many of them are very interesting in figuring out how we bring this lifesaving mechanism and cost cutting mechanism to my state. The system is so fragmented obviously that it's difficult state-by-state or any other way. How do we do this? How do we only do this through, it is through NIH? I mean, obviously setting up an institute's one way to it? I mean is it through HHS? Obviously setting up an institute makes a lot of sense, but in terms of the practicality of beginning to do the things that you've done in Michigan that have happened in Rhode Island that I want to bring to Ohio, talk that through how prescriptively we should do that.

DR. PRONOVOST: Sir, thank you for that question, Senator Brown. Senator Mikulski very carefully crafted these witnesses and if you arranged our order, you would have the whole spectrum of biomedical research at this table, what's called the translation superhighway. So you would have the genetics basic discovery that we need. You would have the comparative effectiveness, finding out what works. You would have learning the science how to put into practice, not just telling that diabetic not to drink Coke, but finding out the science of what leads to behavior change, what do we actually do and then you would have management and financial incentives putting that science into practice. Right now, that flow of knowledge is discontinuous, there's no gaps and this detail that I'm on is virtually non-existent, it's not funded, compared to effectiveness isn't much better. And there needs to be this continue of knowledge so how does it work?

Well I think we have to find out programs. And one of the things we learned, Senator Brown, is that it is neither efficient nor effective for every hospital to reinvent the wheel. Developing measures takes scholarship and thousands of hours, summarizing evidence is a science and takes hours. But once we find that we in this country need a distribution channel to put that evidence into practice, and we don't have one. In our model right now, we believe a state by state model is a distribution channel. And the reason is there's infrastructure at the states, people care about the care that their citizens receive, and I think that model works so in this case, we've been partnering with the insurers, with the consumers to say let's put this in, the efforts have been coordinated by the state hospital associations.

And one of the reasons why we do that is the science clearly shows that social support in these efforts are very effective. That people get motivated when they say, you know, I'm just not improving the care of the Cleveland Clinic, but I have a commitment to say the citizens of Ohio deserve safe care and we're going to make sure that no matter where they go, we're not competing on safety or high quality care, that a health system that spends $2 trillion should guarantee safe care to our citizens. And in this case to the citizens of Ohio that wherever they choose care, it will be safe.

And someone has to coordinate what I call the technical components, how you're going to measure that, how, what's the evidence summary is. Ideally as we're working now, it could be federal agencies so the CDC has a way to measure these things and we ought to be partnering with those federal agencies. But ultimately it's the doctor, the nurse at the bedside individual hospitals, it's the managers creating financial incentives with insurers, with management and without this whole spectrum, we're going to lose our preeminent position in the world of health care. We already don't have it on the outcomes, we still have it on the science, but they have to be coupled together.

SEN. BROWN: Thank you.

Let's shift fairly dramatically. Dr. Fischer, the whole issue of antibiotic resistance is obviously complex. There's the use of antibiotics, prophylactic use in animals as pack chickens or beef closer and closer together and feed them antibiotics partly for growth, partly for prophylactic purposes. And the antibiotics, that might create the over prescribing from doctors, the demands from patients that even if my young daughter has a virus, I want an antibiotic because I think I want to antibiotic and the doctor sort of goes along. And then the lack of enough antibiotics in the research pipeline all is conspiring for obviously a serious national health problem. What do you do as an insurer, what makes the most sense in how we pursue physicians not overprescribing antibiotics?

DR. FISCHER: Well there are two pieces to our program with pay for performance for primary care that touch on that. One is advocating for greater use of generic medications and very often the first line medication for common bacterial infections has a generic alternative. The second is that through an indicator we call the pharengitis indicator which is also a heatis indicator, we measure practices who have filed a claim for a patient with a diagnosis of pharengitis where they ordered an antibiotic and did they in fact do a strep test to see if it is a bacterial infection.

The logic there is that the only pharengitis, the only cause of pharengitis that requires an antibiotic is strep throat. Strep is a dumb germ, it's killed by penicillin still. Okay. And there are very few people, some people who are allergic, so there'd be a small percentage of people who you'd have to give something other than a generic penicillin or amoxicillin to for that diagnosis. There are still many physicians out there who are looking in the throat and saying, it looks like strep throat, you know, here's a prescription, not going through the diagnostic process of saying is it strep? So you have people with viral sore throats who are getting an antibiotic and also often getting one that is a second line, third line antibiotic that is expensive and a brand name and fosters antibiotic resistance.

SEN. BROWN: Well I get the second part of your answer. The first part sounds more like cost containment, which is fine, than it does dealing with antibiotic resistance because if you're just substituting a generic you're still, the doctor if he wrongly prescribes is still contributing to perhaps the antibiotic resistance, right? If you're only substituting a generic it seems to me that the second part of your answer --

DR. FISCHER: Not if you're treating the correct diagnosis. So if you've gotten a diagnosis of strep, you're not going to contribute to antibiotic resistance by prescribing penicillin.

SEN. BROWN: Okay. Okay. Fair enough.

DR. FISCHER: If you're giving the right drug for the right diagnosis, you're fine.

SEN. BROWN: If I could add one quick point, Madame Chair. Is all this part of, this doesn't save you money except for later illness perhaps in the patient which does save you money, but is part of this making sure the doctor spends the time with the patient to make sure the antibiotic is taken correctly? Is that contributing significantly to the problem of antibiotic? I mean, I just go back to years ago before I ever thought about any of this, if I had something, you know, some gum surgery and was taking penicillin or some other antibiotic, I was supposed to take ten days and after seven days I felt okay. Just like, you know, particularly with tuberculosis, we see that all the time and particularly in developing world but in other places where they quit taking it after they quite coughing. Is that part of your regiment to make sure it's taken through the whole course?

DR. FISCHER: We do not take that on, that is in fact a real problem. Adherence to any medication regiment is a problem. And in the antibiotic world that leads to resistance. We have focused on adherence to other kinds of medications that are supposed to be taken chronically. And whereas for instance we have seen marked increased in the rate at which beta blockers are prescribed to patients with acute myocardial infarction when they leave the hospital, that's something that we really don't need to incent anymore, but if you look at what's happened to those same patient six months later, it drops to about 30 percent of that patient population is still taking the medication they're supposed to be on chronically. That's a problem and we now use that as an indicator, what's the persistence of adherence.

And that is both a physician issue and a patient issue. Both need to be educated in incentives to work on that.

SEN. MIKULSKI: And a discharge planning issue.

DR. FISCHER: Yes.

SEN. MIKULSKI: We're going to turn to Senator Kay Hagan but if you watch people leave a hospital, they usually get a bag of drugs, they get their bag of drugs, but nobody talks to them about what do they take, why are they taking it, and when should they take it. Do they take all seven of them at one time in the morning? And I think that goes to something else.

But Senator Kay Hagan's time.

SEN. KAY HAGAN (D-NC): Thank you, Madame Chairman.

This is a question for Dr. Pronovost. I appreciated your paper on the results oriented and the scientific approach, especially for the catheter related bloodstream infections, but you also talked about the patient sometimes get an epidural pain medicine connected to an IV catheter which could then have lethal errors. And then you talked about have that most of this could be solved through product designs and intervention. And that if the manufacturers designed the catheters so that the epidural and IV catheters don't fit together, you wouldn't have that kind of medical error. And since people are human and you talked about you educate but at some point in time, something's going to happen. What would it take to have that small design take place? And I think about just putting gasoline in my car. I mean, the diesel's not going to fit in the unleaded, the leaded's not going to fit in the unleaded, basic, basic product design.

DR. PRONOVOTS: Thank you for picking it up, Senator, because I didn't have time to go about it. And our work to improve safety, what we recognize that there's a type of problems that are not putting evidence into practice what you've heard about. But there's another type of problems that we say not learning from mistakes. And the epidural catheter is so striking. In our literature review, literally every one of the 6,000 hospitals in this country, we connect those two things, an epidural catheter to an IV that can kill someone.

And our response is to re-educate and if the probability that re- education works scientifically is close to zero. And yet if you take it an hour to educate every doctor or nurse, that's an awful, awful expensive waste of money. What we learned from aviation was that they created a public private partnership to find these design problems and then work with the manufacturers to either require or to say hey, we're not going to buy this Boeing engine if this thing isn't fixed, but if it's fixed we will but we want it designed right. That forum does not exist in health care.

And it's a shame because we've been working now for nine years to get a national air reporting system, as you know we now have that with the patient safety organizations, but there's no mechanism to create this forum. We were fortunate enough to get a seed grant from the Robert Woods Johnson Foundation to pilot test what would this system look like in health care, to plan it out, and we're working with people from aviation, from the FAA, to advise us. But that needs federal leadership, I mean, it shouldn't be a researcher at Johns Hopkins is creating, this public private partnership ought to be created and funded because it's much more cost effective to redesign equipment.

We did this same thing, Senator, where we found that when patients had heart attacks in the hospital, 30 percent of the time the doctors or nurses pushed the wrong button on the defibrillator or delayed pushing it because they couldn't figure out what to push. We can tell them to be smarter, but that's a design problem, we have to design it so they don't happen to -- I love your example of the gasoline so they can't stick the wrong hose in. And we need a mechanism with federal leadership to do that. We have the model. We're partnering with our colleagues around the country, but it does need federal leadership to create it.

SEN. HAGAN: Thank you.

And Dr. Gulcher, you talked about the potential for the genetic testing for improving patient outcomes and obviously reducing cost to the system at some point, but what is the availability of genetic testing and the sort of predisposition of somebody to actually want to spend that money and go forward with that?

DR. GULCHER: Right. So we've made several of these tests already clinically available through a federally regulated clea(?)- laboratory where we run the tests and provide that they're not FDA approved, but they're under the CMS regulations for clea(?). Each of the markers --

SEN. HAGAN: For what now?

DR. GULCHER: For the gec(?) test that we offer. So we offer --

SEN. MIKULSKI: She wants to know what clea(?) is?

DR. GULCHER: Sorry. These are the federal regulations that cover laboratory derived tests, tests that are performed just by one laboratory where the laboratory itself has to document that they are accurate and clinically validated.

These tests that we offer are for prostate cancer, breast cancer risk for the Komen form of breast cancer as distinguished from the highly familial form that myriad runs their tests for, bracket one, bracket two, also for stroke, and we also have tests for myocardial infarction in type two diabetes.

But from those tests, the way some physicians are using them today is to help identify patients who might best be screened earlier or more intensively for cancer like prostate cancer or breast cancer. And in some cases they change how they treat the patient in terms of prevention for heart diseased based on the extra genetic risk factor that's independent of a conventional risk factors for heart disease.

So there are already being used today. In terms of evidence that saves money in the long run, we don't have data like that and we'd certainly would like to work with payers and other organizations to actually demonstrate that as a demonstration project to do comparative effectiveness and also look to see how it might save money. But I have to say that your example about how one can change behavior of payers, the sick holders, payers, physician, and patient let's say in the context of type two diabetes, we heard from Dr. Fischer that they have a coaching staff, right, but they're going to have to make decisions on who gets coaching, perhaps, or maybe there's more intensive coaching for those who are at highest risk.

So for those who let's say have prediabetes, they're already at high risk for type two diabetes, some of our tests show that patients who have prediabetes are even at higher risk for converting to type two diabetes ultimately. Here's an opportunity to help prevent type two diabetes if they lose weight or if they're put on certain medications, so it's an opportunity to use the genetic test to maybe motivate the patient himself to lose weight or to do something different with their diet. Motivate the patient to call on the services of coaching, perhaps, to try to get the patient to change the behavior. And for the more for the payer to optimize their coaching resources to those at highest risk to begin with.

I mean one size hopefully you know will eventually fit all, but we don't have the resources, we don't have the manpower, we don't have the funding to do that, but maybe we can prioritize the highest risk patients first and demonstrate that those approaches work even better.

SEN. HAGAN: Thank you, Madame Chairman.

SEN. MIKULSKI: Those were excellent.

I want to turn to Senator Bingaman who brings a lot to the table. He's also chairing one of the three working groups here on coverage and is also a member of the Finance Committee and has spent a great deal of time on this topic and we really welcome his participation today.

SEN. JEFF BINGAMAN (D-NM): Well thank you very much and thanks for having this hearing. Thank you all for testifying.

You know what occurs to me and this may be something that was discussed before I arrived, but this whole subject of how do you implement best patient care practices, it would seem to me that since the federal government is the largest purchaser of health care services in the world, I guess, there are some particular ways in which the federal government ought to be able to move the ball forward in this regard. The medical care system that the military has, the VA system, the Indian Health System, to what extent are the kinds of clinical guidelines that ought to be put in place in place in those settings?

For example, I think Dr. Pronovost, you've talked about the five procedures that you've implemented there at Johns Hopkins with regard to the catheter related bloodstream infections. Are those procedures being followed in the government funded health care systems that I referred to?

DR. PRONOVOST: Thank you, Senator. Excellent question. One of the things that you brought up so importantly is evidence is exploding so much and if you look at the geographic variation in the use of care, I'm sure you've seen how there's regional we overuse or underuse. There's some evidence that when you have more doctors, but what is much more important for that is uncertainty about what to do. When there's uncertainty, we either hedge our bets and as a group, as a region you over treat or under treat. And linking this stuff to health technology as science grows, as we get genetic medicine, we're going to need checklists for individual patients that say, "Okay, for Ms. Smith with this genetic variation, this is what you need" or "You respond to this therapy."

Its one of my pleas that health technology, if its not linked to quality measurement and cost reduction, it will simply be an expensive electronic charting system because what we care about is answering that question; are we getting better value. So, that link has to be --

Your question about is the VA and the DOD -- we've worked with Jim Bagin (ph) at the VA and DOD to use this, so I believe they've taken it up, but what I don't believe they can answer, Senator, is what are the rates of infections. That, for me, is a fundamental question because when I talked to Cirel (ph) King, she doesn't really care if I tell her I'm using a checklist. What she wants to know is am I likely to get infected in your hospital.

I don't know that we're doing -- I know Rep Waxman, after the GAO report, surveyed the country and only 11 states in his report actually were measuring these infections right now.

SEN. BINGAMAN: And as you understand it, the VA doesn't measure them.

DR. : I don't think as a system that they are measuring --

SEN. BINGAMAN: And neither does our medical healthcare system -- I mean our military healthcare system.

DR. : I don't -- as I said, I know that we've met with them, they are interested in using it, but when we had discussion about overall, like we can say for the state of Michigan, for example, the rate of infection in Michigan is X. I wish we could say it for the whole country; I don't know that we could.

SEN. BINGAMAN: Well, obviously -- at least it strikes me at first impression that we ought to be requiring that they do measure those types of issues.

DR. : I completely agree.

SEN. BINGAMAN: And we ought to be requiring that they do adopt these best practices where there's general agreement that these are best practices. If this guideline that you folks have put in place over at Johns Hopkins with regard to these catheters, these infections, is generally agreed as the best practice for this particular aspect of medical care, I don't see why we shouldn't require that it be implemented in all federally funded facilities.

DR. : Right. Senator, I agree.

What we've seen in this, the financial incentives is often the politics of the payments policy far exceed the science. So, we're designing payment systems to incentivize that we're not really sure how to measure or if we can prevent them. I think we have it to flip -- the science has to drive, its got to go back to its rightful place and drive the payments.

In this case, we know we can virtually eliminate these, or dramatically reduce them. That is something we ought to have really clear payment policies on. I completely agree --

SEN. BINGAMAN: The policy would be that --

DR. : That the marginal costs of these infections are not paid for, that as CMS has done for this -- but for other things that we don't know yet --

SEN. BINGAMAN: -- Medicare and in Medicaid --

DR. : I completely agree that we ought to require that states monitor and report these in a valid way; like the CDC has definitions.

What I'm less sure about is do we legislate the use of this checklist because legislation is blunt and slow and science emerges. We may learn next week that there is a better thing on the checklist. What could require is that they participate in these quality improvement programs to reduce the infections, so we don't have to legislate that they actually -- the items on the checklist -- but that there's a mechanism with the DOD or with states to get together to work to reduce these infections and that we're going to monitor their performance.

They will be held to account how well we do for these.

SEN. BINGAMAN: Thank you, Madame Chairwoman.

SEN. MIKULSKI: We have time to go another round if member are interested. Senator Bingham, we're going to -- given where we're working at our schedule, one of the things I'm contemplating is a hearing just on lessons learned from military medicine.

Rather than having the VA do it, we actually invite them in from what we've been learning through both military medicine and VA; they've done a lot of pioneering in this. We hope to be able to do that. Also, we hope to be able to go over to Hopkins one day.

Let me go to my question; first, to Dr. Pronovost, about the checklist and then a question about the implementation and goes to Dr. Pearson and everybody.

You said that in 32 states they don't use this. One of the questions that I had was why doesn't everyone introduce a checklist? It's a piece of paper, its not buying a new technology, its not redesigning the catheter interlocking gadget system with FDA and all of that. Then someone said that no one's paying for it.

What is there to pay to implement? Why do we need to pay people to implement a checklist? That's a general question; more abstract.

Second, what are the barriers in the way of a (low-tech ?) solution that could either be paper or digital? I'm going to ask you that question and I'd like to zip down to anyone on the panel who would like to jump in and then I'm going to come back to -- we have a National Institute of Health but not a National Institute of Quality -- which goes to your question, Dr. Pearson's really important contribution in the comparative research effectiveness issue.

You want to kick that off?

DR. : I absolutely will. You're experience as a social worker is clearly coming through in thinking of these barriers.

Let me be clear -- when the GAO report, after they surveyed all the states, everyone of the states said, "Of course we're using it", but only 11 monitored infection rates. The question is, "Is that good enough?" To me, the answer is no. It's easy to say that I'm doing something, but there to be held to account for performance.

What are the barriers? Though the checklist was popularized and it is a simple concept, I think its naïve to think that if we hand doctors or nurses a piece of paper with a checklist on it, its going to be used because we have to create a culture and incentives where we're allowed to work together.

So, I'll give you a very concrete example. When I put this in Hopkins, I asked the nurses to use the checklist to make sure the doctors did these five things all the time. When I did that, you would have thought I was causing World War III.

The nurses said my job is not to police the doctors and if I do, I get my head bit off. The doctors said there is no way a nurse could second guess me in public. It makes me look like I don't know things.

Nobody debated the evidence; the checklist was clean, the evidence is sound. What was debated was the hierarchy and politics, so we pulled people together and said, "Is it tenable that we harm people at Johns Hopkins?" Everyone says no. I said then, "Nurses, you will question the physicians and physicians you will listen and if you give the nurses flack, nurses page me anytime of day or night", and I had the backing of our CEO and Dean, Ed Miller. It will be supported.

We've learned now that the barriers are some systems the supplies have to be available on the checklist. You have to be able to get the supplies and you need a culture of team work and collaboration that, frankly, does not exist in U.S. healthcare systems. So, we've coupled these interventions and why they have been successful, with efforts to improve culture and team work.

It's a program called CUSP (ph) and its what we're rolling out. Once you have that teamwork, you could then rotate whether you're doing these infections or MRSA, or VRE, or diabetes care.

SEN. MIKULSKI: You shouldn't pick one based on who's got the safest pilot. It should be a national standard that's adhered to. Every day you get on the plane, and when you have a stunning situation like what we recently had in the Hudson, all of that comes through, so that's it.

But let's go down and say anybody who wants to -- where I said why, what does it take to do this, and why do we pay to do it? I've got your picture. Dr. Fischer and then anybody else who would want to jump in on this one.

DR. FISCHER: I think if you look at the challenge that Hopkins has had being able to spread this kind of knowledge and change behavior, I would say that it is even more difficult as you move out into the periphery in the country. What you have at Hopkins, and what you have the potential for, even on a grander scale say at the VA, is an organized system. And you have people where the physicians and the hospital are aligned about common goals.

But very often -- having been the medical director of a children's hospital and an academic center -- I know that trying to get things to change involves cajoling physicians to do something different very often, or cajoling the nurses to change what has been a pattern. And if we focus on teamwork -- if we focus on the common goal and we get incentives aligned, it's much more likely to happen. Right now, many physicians -- most physicians are smart. They're well-trained; they're well-intentioned. But their system is saying I'm smart; I'll remember. That is not a system. And many of them say, trust me, I do it my way. It's always worked.

But they haven't done the chart review, the research to show, in fact, what their results are. They don't know what their results are. So being able to put systems in place, and frankly, starting where you have the greatest opportunity, which is at programs like the VA where there is interoperability, there is a common attitude across the system as to what needs to happen, there are also other integrated systems in the country who have made great progress. And if you've not been exposed to it already, the Dartmouth Institute came out with a White Paper on an approach to organized care, much of it based on the work of Dr. Jack Winberg. But I think there is much good information there about how we can be transformational with spreading these kinds of systems to our advantage -- to our all mutual advantage.

SEN. MIKULSKI: Before I move onto another -- that question about the National Institutes of Quality, Dr. Pearson, Dr. Gulcher, did you want to comment on this line of conversation?

DR. PEARSON: I would, just briefly to say that, in some ways it's ironic, because we're talking about the difficulty of implementing a checklist, which as you said, it's so tangible. It seems so easy just to -- and people can come and see it, and they can see how it works. And sometimes the light just goes off. But much as there are other types of difficulties when you try to do this outside of academic settings, most of the types of implementation of best practice or best evidence doesn't come in something as neat a package as a checklist. And we do need -- and this may verge into a response to the question about some kind of institute to help codify or come up with ways to help people do this.

It's just very hard for clinicians of any type and for systems of care to try to grasp how to implement ideas about changing practice, unless it is put into a format that they can understand and that they can clearly see how it can fit into their system, because we have all these different systems of care across the country. Some of them might actually think a checklist, you know, they might put it up on the wall. Others might hand it to the -- you know, they have to figure out how to do this. And so working at that level to translate best evidence into things like a checklist is something that, again, we really need more work on.

SEN. MIKULSKI: Did you want to comment on that part, Dr. Gulcher?

DR. GULCHER: I just want to talk about quality. But when it comes to trying to get physicians to go by even standard guidelines issued by NIH supported boards, for example like the National Cholesterol Education Program, we found that as we're trying to educate physicians on how to use our genetic test for heart attack that they're not always going by the guidelines. So what we do is we try to provide that information as a checklist of how they can catalogue other risk factors and then how that fits into the genetic risk. So we've actually been implementing that aspect of it in the context of our test, so.

SEN. MIKULSKI: Well, we've raised two points; one, that which goes on in an acute care facility, which is hierarchical, centralized, and you can give mandates; and then that which goes into clinical practice, and also that occurred at an academic center -- in an academic center of excellence by all standards of measurement. So we see how tough that is.

Then when you go into actual practice, most physicians' practices, as I understand it, are onesies, twosies. That's a lot to put on them. In the old days of just going to the monthly medical society meeting is -- you know, is pretty dated. But actually even, Dr. Gulcher, what you're saying about genetic testing, the basic tool that a physician uses is the family history. They do a history when you come in, and they say tell me about yourself, the presenting symptomatology and then second; tell me about your family. Well, my father, my grandfather, and so on all died of, and my mother dah, dah, dah, dah. Wouldn't that be the one that would trigger then the genetic testing, because you would see, in a family history, propensity?

DR. GULCHER: Uh-huh, yes, certainly --

SEN. MIKULSKI: But it's not a substitute -- but it says, oh wow, you know, every adult woman and every first child gets a whatever, a --

DR. GULCHER: Right. Yeah, that's been certainly a valuable technique and certainly there are sites. The Surgeon General for example, just put up a site to help facilitate taking family histories for physicians, and we certainly encourage that. But one of the things one has to emphasize is that most common diseases tend to skip generations. So they won't be evident in your parents or even your siblings. And most of us don't know our family history of our cousins or our great grandparents, or maybe we don't know precisely what that is, and so we can't use that information.

So what the new genetics is for common diseases is these genetic variants tend to be common -- ultimately common to the population, and it's what you're born with. But for example, most patients with prostate cancer don't have a family history of prostate cancer.

But yet, we can find genetic determinants that they actually have -- genetic risk factors, I should say, that they have that put them at higher risk, even if they don't have a family history. If they do have a family history, it compliments that. But unfortunately, 95 percent of men do not have a family history of early prostate cancer.

SEN. MIKULSKI: Oh, that's interesting. So family history always has to be essential to any -- taking to providing good clinical care.

DR. GULCHER: Uh-huh.

SEN. MIKULSKI: But it wouldn't be the trigger --

DR. GULCHER: But it's not enough.

SEN. MIKULSKI: -- not enough, yeah.

DR. GULCHER: There's a benefit to also doing genetic testing for people who don't have a family history of whatever disease you're interested in. Or better yet, to actually have a panel of genetic tests that actually allow the physician to survey not just cancer but also heart disease, glaucoma, macro degeneration, things that we could actually do things about if we detect it early. By the time you are diagnosed with glaucoma, many times you've already lost part of your vision. So here's a simple way of, once again, optimizing care to those who are at highest risk but actually scan the entire genome. And we know many genes for the most -- for the 25 most common diseases we have. We already have genetic risk factors that have been well- validated in tens of thousands of patients, in tens of thousands of controls. So these are real risk factors. The question is, how do they fit into the health care system, and are they useful.

SEN. MIKULSKI: Senator Hagan, do you have a question?

SEN. HAGAN: Thank you, Madam Chairman. Listening to the testimony today, it just reemphasizes to me the need that we need in this country for health care information technology, across the spectrum, the broad spectrum of diseases and hospitals and best care, best patient care from physicians and practices all over. And I know that Dr. Pearson, in some of your material, you've described the rating system that you've developed at the Institute for Clinical and Economic Review to translate the results of comparative effectiveness research into concrete results that can help improve patient care. And it seems to me that a health information technology across the country would certainly be of great benefit.

And I know this is going to take years to put together, but I think it's something that you will see this administration start working on very quickly. But I was just wondering what do you see as the major challenges to developing this system for translating the results of comparative effectiveness research into actionable information? And in the work that you've done so far, have you found that both doctors and patients are comfortable with the system that you've developed?

DR. PEARSON: Thank you. That's a wonderful question. The challenges to translating evidence come on different levels, but I think the most important one is that anytime you try to take a large body of evidence -- let's say there have been 10 studies done to compare two different options for prostate cancer. All 10 of these studies are going to say slightly different things. They don't always say the exact same thing, there were different types of patients enrolled in them and you have to make a judgment at a certain level about how to synthesize that information for patients and for clinicians.

Anytime you synthesize and formulate it so that people can actually understand it and take action, you run the risk of over- simplifying and maybe making people feel that you are creating a cookie cutter approach to medicine.

This always rings bells for physicians; they don't like the idea of that there's one way to do something, patients are always rightly concerned that the special aspects of their health history or their personal family factors, whatever it might be, are not being considered accurately. So, for me as an evidence review group, I think our greatest challenge is to be able to communicate tangible findings that people can really do something with and yet not lose the important nuances; to look for the different types of patients who might have different kinds of reactions or benefits from certain treatments.

We have to be able to keep that nuance with our information as we pass it on to insurers, to physicians, to patients.

The rating system is there to, in a sense, trigger an initial conversation about what we think are the balance of benefits and harms and the comparative aspects of that, but it's not meant to, in a sense, shut out those other aspects.

SEN. HAGAN: Madame Chairman, if I could ask just one more question --

There's such a propensity today for patients in hospitals to get the MRSA and I was wondering if any of you on the panel today had any comments on an update of what's going on and what may be the best practices in that concern.

DR. : I can take it --

I want to just -- in with your last question about health information technology because one of the things that it offers the potential for is if we go one disease at a time to make checklists on, I'm going to be long dead before we simplify evidence. One of the great uses of information technology would be literally to create the program for checklist makers that is openly available so that no matter what area you're working in, that's transparent for patients because these things democratize knowledge. So, when you go to your doctor, you can say, "This is the checklist that everyone says if I have diabetes this is what you ought to do for me", and you could have a discussion about it. It's a very powerful tool, but we don't have the technology to make it out there and available so no matter what disease you're talking about, its there.

With MRSA, that's actually the pipeline that we're working on. There's a lot of evidence that says what we should do and there's some small stories of successes. I think the biggest problem is that we don't really have yet widely accepted ways to measure who we gave it to and that's a real barrier. What docs want to know, what you want to know, is not so much am I using the checklist but did you infect me.

When I go to my hospital, there has been a couple of success stories -- I think the Pittsburg Regional Health Initiative has done some -- but what I would put forth to you is, picture this model like we presented of drug development.

So, phase one, you get the experts to find out what the evidence is and how do you measure it accurately. Phase two, pilot test it in a couple places to see if it works and when it works -- phase three, have an infrastructure to put it across this country.

That's the kind of pipeline we need if we're going to made substantial improvements in quality and reducing costs of healthcare.

DR. : We've been a partner with the Pittsburgh Regional Healthcare Initiative for many years and that work -- PRHI was one of the first to say zero is the goal for nozacoleon (ph) infections.

So MRSA transmittal in the hospitals, central line blood stream infections, zero is the right rate. As I talked about, we're done to one per thousand line days -- that's not close to zero yet, but we had four hospitals out of thirty who were at zero. We are making progress.

MRSA and central line blood stream infections are two mandatory indicators for all the hospitals and we have 30 now in our pay for performance program for hospitals. We have seen -- the approach is screening on admission, screening on discharge, measure and isolate those who are positive, using full precautions for those patients so you lessen transmission.

We have seen a marked decrement in transmission of MRSA in those 30 hospitals. We're having an impact, we not at zero, but we're making progress and those are the kinds of things where the health plan is representing employers and the members or patients, the hospital, the physicians, everybody wins. Ultimately, these programs are in place at the hospitals that are seeing CMS patients. So, the government's winning by the private payer being out there doing these kinds of programs.

I just want to add one more thing about why pay for performance. We have explained this to our accounts. They are saying this is the right thing to do, why would you pay them to do what's supposed to be right?

The problem is, it takes time to do process improvement. You have to not see some patients or not do something else in order to get people around the table, be trained, understand there is a problem, put in place a system to fix it. we're paying for the process improvement effort, but the goal is you get performance to change and so we call it pay for performance; but its not blindly paying a difference, its paying for the effort it takes to do process improvement.

SEN. MIKULSI: Thank you.

Senator Casey.

SEN. CASEY: Senator Mikulski, thank you very much for calling yet another important hearing on healthcare and you've been so good to bring us together and you've labored in this vineyard a long time; we've made progress already this year and I just appreciate your leadership on this issue.

I know on the last one -- and I know I've been in and out of here; I have to apologize, its one of those days of juggling. I want Senator Murkowski to know and our witnesses to know I have one question. It's broad and it would take a long time to answer, but you guys only have a couple minutes so you got to be brief.

It's really this -- by asking it, I run the risk of being too brief, but also being a little redundant because you've covered this question in a lot of different ways. It is basically this -- the political reality question, in a sense.

We've had tremendous success already with the new Congress and new President. Senator Murkowski led the way to pass the Lily Ledbetter Act; a tremendous achievement for those who are victims of discrimination.

President - former Senator Obama -- Obama signed into law the Children's Health Insurance Bill. Great achievement. It wasn't going to happen in the last Congress with the last administration, but if look at this realistically, in calendar year 2009 I would love to be able to say that we're voting in calendar year 2009 on a major piece of health care legislation beyond children's health insurance.

Let's assume, for purposes of this question, what if that does not happen? If there's one bill or initiative or action the United States Senate could take to give meaning and integrity to the quality initiative that all of you have articulated and have put into practice and actually gotten results -- what is it, absent an overhaul of our healthcare system -- what's the one action that we could take to give meaning and integrity to what you've testified to and what you've worked so hard at?

I do want to start with Dr. Fischer because he is in Pennsylvania and I'll be in big trouble if I don't give it to you first.

DR. FISCHER: Tough question to ask for one thing.

I am clearly an advocate of a systematic approach to improving healthcare. Although you cannot computerize chaos, many practices -- especially in this cottage industry -- do not have systems in place that they could simply computerize. I do believe that Health IT is absolutely essential. Interoperable Health IT is essential to making quantum leaps in patient safety and quality improvement.

We have made strides in getting to nearly a tipping point where people are adopting tools. As you probably know, High Mark (ph) put $30 million out there for positions in our network to adopt electronic prescribing tools and electronic health records. We're at the point where nearly 40 percent of the practices in our program for pay for performance -- that's just primary care -- have adopted some form of electronic tools.

That being said, we're a long way from being able to capitalize on that kind of opportunity, but I think we do need to support Health Information Technology and I don't believe that physicians will make the investment on their own, without some help.

SEN. CASEY: Okay.

Anyone else? We've got a little more than a minute. Sorry for the shortness.

DR. : I think we've all talked about wonderful discoveries that have been made, a lot of work has been done to look at some of the evidence for quality improvement, but there's not really a way of translating those discoveries or those better practices as efficiently.

We have a very large budget within the NIH that's done a great job sequencing the human genome, making some the discoveries complimenting the work that some of us have done in private industry, but the concern has been there's not been enough studies to actually show markers that have been well validated and demonstrate risk for certain diseases, whether or not they're clinically useful.

There has been a call to actually do a large number of either anomize (ph) clinical trials or other clinical utility studies that translate that information. The same thing in the case of Dr. Pronovost, in terms of translating some of the quality data. Why not force the NIH, whose mission really it is to help improve health care, to allocate five percent of their budget to nothing but clinical translation and clinical utility and safety practices as a way of fostering the discoveries that we're making into clinical practice that, hopefully, will improve and save health care costs in the long run.

SEN. CASEY: Doctor, we're out of time, but with the Chair's indulgence, you can answer.

DR. : Health Information Technology is going to be important and it needs to link to measures of quality, but I think what you could do is invest in the science of how we deliver care.

With that science, the market will align payment policies and insurers will drive costs, but there is a hunger for new knowledge of works. This checklist is one thing, and it's gotten so much attention because it's the rare example of a performance improvement program that worked and that's a sad statement. We need to have scores of these things that work and that's going to come with, I think, wise investments in the science of health care delivery.

SEN. CASEY: Thank you very much.

SEN. MIKULSKI: Great question, thank you.

I'm going to wrap up with my one question. Dr. Pearson, I note behind you two young ladies. Are they your children that came to provide support? Are they your -- you want to introduce them here, Dr. Pearson?

DR. PEARSON: Absolutely and thank you.

SEN. MIKULSKI: I'm sorry Senator Hagan left. This is what change looks like and --

DR. PEARSON: Thank you, and we are residents of Maryland, by the way. so we --

SEN. MIKULSKI: Oh and there's a young man behind you as well.

DR. PEARSON: Yes there is. This is my family -- my wife Kim, Dr. Pearson also, my daughter Deanna, my son John and my youngest daughter Brett. Thank you for recognizing.

SEN. MIKULSKI: You brought your back up team too.

I want to pick up on Senator Casey's question and what was said about the science of health care and also taking part of NIH's budget and getting it out into clinical practice.

My question and also one of the topics we didn't even talk about here today was public health. We have, in addition to the great health delivery we have in federally funded health delivery, whether it's VA or some of the others that were mentioned, we have something called CDC, FDA and someone that's often missing from the conversations is public health.

The adequacy and safety of our drinking water, food supply and all of these other things; we've got a lot of agencies, but what (does it need?) to get out where there's the hands-on practice; whether its from a physician, a diabetic educator, etc. That then goes -- we'll start down with you Dr. Pronovost and just go right on down.

Do we need a new agency, do we need to take an agency that we have to get what we know out there and in a way -- pardon the colloquium -- news you can use to the people who are actually involved with patients? That's what we're here to talk about.

DR. PRONOVOST: Excellent question.

I would love to see five percent of NIH's budget go for this. I don't think that's going to be sufficient. I think we need, like the human genome was, a public-private partnership to advance the science; that links, like the human genome did, some of the top research universities that are doing this that links the community hospitals and doctors who are delivering it, that links insurers, that links federal agencies all with the common goal to say, "How could we combine our levers that we pull?" "What do we learn about these financial incentives?" "How do we get that diabetic to stop drinking Coke?"

Those programs then become publically available. So, I think it's got to be bigger than just five percent. I think if we're going to make substantial improvements, this has to be invested in. When I said this Institute of Health system delivery, we need a learning lab to put a lens on what's working in all this mess, including economic incentives, behavior change incentives and population health. Then, share those lessons widely.

I think if it's just state -- federal agencies have to be part of it. I don't think they could own this because this lives in the community where health care is delivered.

SEN. MIKULSKI: Dr. Pearson.

DR. PEARSON: Again, an excellent question and it is a time when many of us are thinking of new things, new goals, etc.

It's always wise to think couldn't we just either increase investment in existing structures or tweak them a little bit. Thinking about comparative effectiveness specifically, I actually think that we do need a new structure. I think that in order to help doctors and patients out there who wrestle everyday with so many questions in clinical practice for which they don't feel like they have adequate evidence, they don't feel like they have a trusted source that they can go to that has synthesized the evidence, tried to make some judgments and is also launching new research to try to fill the evidence gaps.

I really think our health care system needs that. Other developed countries have similar institutes or agencies that have been viewed as very positive contributions to their overall health care system and I do think that with that kind of structure -- and I think particularly of Senator Baucus' work in this area so far, but others as well.

I think there is reason to think that with that structure, it wouldn't take a huge amount of initial investment to start to drive the appreciation of what that brings in terms of return on an investment. Health plans have said that they are interested in supporting it and I do think that it would be a structure outside of the existing agencies that we have that could really make a difference.

DR. : I would emphasis that government can play a major leadership role in making this happen, but clearly, you need collaboration from the other parties.

What health plans do is population health. We look at the big picture, we look at populations of patients and how we can impact that population by what's known about public health.

What you need, I think, is the collaboration with the health plans. Certainly the Blue system is willing to partner. I'm sure the other major health plans would as well, but I would also invite the large organized health systems who are more capable of making an impact quicker.

DR. : I just want to point out that I think the NIH -- its been estimated that the NIH spends less than .1 percent on clinical utility or translation studies, so already that budget is quite small.

The reason I mention them is because certainly they have been trying to push the bar when it comes to finding new bio-markers and risk markers, aren't they well positioned if they are encouraged to fund some more of the clinical utility studies. You mentioned the CDC; they have a very small budget compared to the NIH, but certainly I should mention Amuen Corey (ph) who runs the genetics there that the CDC has been trying to foster, both public and private partnerships, along with the NIH, along with some of the other stake holders.

I think what everybody seems to recognize is there is a lack of support or funding to move that ball forward. I'm not sure where that money comes from, but certainly to move these rapid discoveries forward in clinical practice, it is going to require some investment.

SEN. MIKULSKI: Well, this was an excellent hearing. It was titled "Best Practices", but I think we've got excellent thinking.

On behalf of the committee I want to thank you for your participation, the time and effort that you put into this; its very evidence based.

We would invite you to submit to us after you have heard out kinds of questions, upon further reflection if you have recommendations on concrete ways we can proceed as we move forward. I do believe that we will be for everything that we've heard from our President, that we will be doing health care reform and that's different from health insurance reform.

It is the goal of this committee, under Senator Kennedy's leadership, with the support of Senator Enzi, to do health care reform that's on a very sound fiscal footing. That's why we're so committed to the quality debate. Its patient centered because at the end of the day, that's why we're all here and work so hard for this and yet at the same time, we have to be stewards of the tax payer's money and also cognizant of those who have to pay for it, whether it's the tax payer or business or whatever.

So, we again want to thank you for your participation. This committee stands in recess until February 23 when we will hold a hearing on integrative healthcare. And we also want to advise our colleagues that the Institute of Medicine is holding a summit on the concept of integrative health care, which goes to personalized health care, patient centered, but goes to the continuum Dr. Pronovost that you talked about and I believe Dr. Fischer, you're trying to fund, and Dr. Pearson, goes to the heart of what you're working.

So we are looking forward to the IOM report. This committee is very influenced by the thinking that is going on at the Institute of Medicine, the Commonwealth Foundation and Robert Woods Johnson. But ultimately the end of the day, its people like you who are actually out in the world working to make a difference.

So, thanks a lot.

END.

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