[Senate Hearing 111-498]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 111-498

                IMPLEMENTING BEST PATIENT CARE PRACTICES

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                                   ON

           EXAMINING IMPLEMENTING BEST PATIENT CARE PRACTICES

                               __________

                            FEBRUARY 5, 2009

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

               EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut       MICHAEL B. ENZI, Wyoming
TOM HARKIN, Iowa                       JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland          LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico              RICHARD BURR, North Carolina
PATTY MURRAY, Washington               JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island                JOHN McCAIN, Arizona
BERNARD SANDERS (I), Vermont           ORRIN G. HATCH, Utah
SHERROD BROWN, Ohio                    LISA MURKOWSKI, Alaska
ROBERT P. CASEY, JR., Pennsylvania     TOM COBURN, M.D., Oklahoma
KAY R. HAGAN, North Carolina           PAT ROBERTS, Kansas
JEFF MERKLEY, Oregon

           J. Michael Myers, Staff Director and Chief Counsel
     Frank Macchiarola, Republican Staff Director and Chief Counsel

                                  (ii)






                            C O N T E N T S

                               __________

                               STATEMENTS

                       THURSDAY, FEBRUARY 5, 2009

                                                                   Page
Mikulski, Hon. Barbara A., a U.S. Senator from the State of 
  Maryland, opening statement....................................     1
Kennedy, Hon. Edward M., Chairman, Committee on Health, 
  Education, Labor, and Pensions, prepared statement.............     3
Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio.......     4
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of 
  Pennsylvania...................................................     4
Hagan, Hon. Kay R., a U.S. Senator from the State of North 
  Carolina.......................................................     5
Pronovost, Peter J., M.D., Ph.D., Medical Director, Center for 
  Innovations in Quality Patient Care, Johns Hopkins University, 
  Baltimore, MD..................................................     5
    Prepared statement...........................................     6
Pearson, Steven D., M.D., MSc, FRCP, President, Institute for 
  Clinical and Economic Review (ICER), Boston, MA................    10
    Prepared statement...........................................    12
Fischer, Donald R., M.D., MBA, Senior Vice President, Integrated 
  Clinical Services and Chief Medical Officer, Highmark Blue 
  Cross Blue Shield, Pittsburgh, PA..............................    14
    Prepared statement...........................................    16
Gulcher, Jeff, M.D., Ph.D., Chief Scientific Officer, deCODE, 
  Chicago, IL....................................................    26
    Prepared statement...........................................    27
Bingaman, Hon. Jeff, a U.S. Senator from the State of New Mexico.    44

                                 (iii)



 
                IMPLEMENTING BEST PATIENT CARE PRACTICES

                              ----------                              


                       THURSDAY, FEBRUARY 5, 2009

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:14 a.m., in 
Room SD-430, Dirksen Senate Office Building, Hon. Barbara 
Mikulski, presiding.
    Present: Senators Mikulski, Bingaman, Brown, Casey and 
Hagan.

                 Opening Statement of Senator Mikulski

    Senator Mikulski. Working group on quality for the Health, 
Education, Labor, and Pensions Committee will come to order. I 
apologize to my colleagues and to the panel. It's called 
traffic tardiness.
    I commute everyday from Baltimore and traffic and I don't 
always gel. So I apologize for being late. I had a meeting.
    We're going to hold a pretty extraordinary hearing this 
morning. The hearing will focus on best practices on quality. 
We have a distinguished panel. I'm going to say a few remarks. 
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. What we want to hear 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 in 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 to controlling cost. There's tremendous 
potential for the U.S. health system to improve quality, reduce 
cost and increase the value of health care spending. Our health 
care system underperforms.
    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. 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. health care system does the 
right thing.
    Now my staff wrote this phrase and I had an argument with 
them. So I'm going to give it to you. Then I'm going to tell 
you what I said to them. You'll know what I mean. We had a good 
conversation about it.
    They said our goal is 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. 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 OK.
    My approach is that that is all so, but unless you really 
have patient-centered health care, 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 where we have to look at the totality of 
care. 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.
    With that maybe we can have two beers and talk about this. 
My view is to have patient-centered health care where we look 
at the totality that we do with prevention, intervention where 
you need to and then the case management from the appropriate 
follow through so that an illness is either treated and cured 
or if it's chronic, it does 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 a firm 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. I know my colleagues will be 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. Many call him the 
Father of the Medical Checklist. He will 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's 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 patients 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 will hear from actually somebody who's got to pay 
the bills, Dr. Donald Fischer from the very eminent, Highmark 
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 have 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.
    On the new frontier of thinking, will be our witness, Dr. 
Jeff Gulcher from deCODE genetics. From him when we had the 
biopharmical industries perspective having development in 
adoption of best patient care practices and also looking at 
genetic predisposition, 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 early 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 busy day. I'm going to acknowledge 
the very active role of Senator Casey. Because you see no 
Republicans, do not think that they're boycotting. It means 
that they're participating in other hearings that range from 
confirmation to oversight.
    Any questions that they might have or statements we will 
submit those for the record.
    I'm going to ask unanimous consent that all opening 
statements by my colleagues be included in the record.
    [The prepared statement of Senator Kennedy follows:]

                 Prepared Statement of Senator Kennedy

    Less than half of all medical care in the Nation today is 
supported by adequate evidence of its effectiveness. In other 
words, more than half of all medical care is not supported by 
adequate evidence about its effectiveness.
    The question that has been ignored for too long is: What 
are the best practices in health care? Part of the answer 
involves using modern health information technology--it will 
help to coordinate team-based care, reduce overuse utilization 
and duplication of procedures, and improve patient safety. 
Comparative effectiveness research will help identify what 
works and what we still need to find out. Knowledge gained from 
this research must also be made more widely available.
    Best practices obviously include knowing the prescribed 
course of therapy and continued management for a given disease. 
They include the policies and procedures that govern the day-
to-day workings of a medical organization and how things get 
done.
    They must also measure outcomes. In fact, we should start 
with outcomes, work backward to revise procedures to strengthen 
patient safety and satisfaction, improve efficiency and 
eliminate waste. We've already seen remarkable reductions in 
hospital acquired infections using this approach.
    Another effective approach has become standard in private 
sector initiatives to improve quality, and has been taken up by 
some public sector initiatives as well. It involves changes 
that coordinate the subject matter of experts and quality 
improvement facilitators to improve the procedures and outcomes 
for programs and services.
    Another way to make sure that the right thing gets done is 
to have uniform ``to do'' lists for various procedures. It's 
simple, and it's a low-tech, standard way, to achieve 
consistent and safe procedures.
    We can't afford any longer to have hospitals and 
practitioners ``winging it,'' when patient safety is at stake, 
and health costs continue to spin out of control.
    I look forward to working with President Obama and our 
Senate colleagues on the HELP and Finance Committees to expand 
access to the best possible care. I especially commend Senator 
Mikulski for her continued leadership on quality and delivery 
reform, and I look forward to learning more from each of our 
witnesses today about implementing these best practices.
    Senator Mikulski. I ask unanimous consent that all of our 
witnesses complete content-rich statements be included in the 
record.
    Senator Brown. Madam Chair, could I have 30 seconds to say 
something about the panel, if I could?
    Senator Mikulski. Sure.

                             Senator Brown

    Senator Brown. Thank you, Madame Chair.
    This panel is made up of very impressive thinkers. People 
who have influenced the thinking of many others in the health 
care system. I shouldn't single out, but I do, Dr. Pronovost 
and in the work he's done with his checklist and the increased 
quality of this huge cost savings.
    The ideas that all four of you have had and have begun to 
make a difference. We know what's happened to health care.
    We spend so much money. Our quality is not what it should 
be and our outcomes are not what it should be and our cost is 
too high. The little you four have done have contributed to 
beginning to change that.
    So, thank you.
    Thanks, Madame Chair.
    Senator Mikulski. Thank you, Senator Brown. Senator Casey, 
you're the guy from Pennsylvania. Did you want to say something 
about our witness from Pennsylvania?

                             Senator Casey

    Senator Casey. 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, Madame Chair.
    Senator Mikulski. Well I guess Senator Hagan I'm not going 
to let the two guys speak without you.
    [Laughter.]

                             Senator Hagan

    Senator Hagan. Madame Chairman, I'm just looking forward to 
hearing the testimony of these very distinguished individuals. 
Thank you.
    Senator Mikulski. Very good. Dr. Pronovost, why don't you 
lead us off and give us more on the checklist.

STATEMENT OF PETER J. PRONOVOST, M.D., Ph.D., MEDICAL DIRECTOR, 
 CENTER FOR INNOVATIONS IN QUALITY PATIENT CARE, JOHNS HOPKINS 
                   UNIVERSITY, BALTIMORE, MD

    Dr. Pronovost. Thank you, Senator Mikulski and other 
members of the HELP Committee. I appreciate your commitment to 
address this topic of patient safety. Quality of care 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 prevention 
mistakes at one of the world's best hospitals, at my hospital, 
Johns Hopkins. On the 4-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 to die today than 4 years ago. Are you safer?''
    The sad reality is I couldn't answer her. No hospital in my 
State could. The United States can't give her an answer. And 
fundamentally she deserves one.
    The National Health Care 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. We sequenced the human genome, all 300, or 
3.2 billion letters with 99.99 percent accuracy. How could we 
perform so differently?
    I think, Senators, the reason is that we haven't viewed the 
delivery of health care as a science. It's been solely the art. 
We've underinvested in it. We invest a dollar in discovering 
new knowledge and new genes for every penny we spend on 
improving quality of care.
    So, we have this enormous gap between what we know and what 
we do. It has to be bridged. We've been trying to bridge that 
with some science, very practical science that I'd like to 
share with you.
    We tackled the problem of catheter-related bloodstream 
infections. A type of infection that kills between 30,000 and 
62,000 people a year. We approached it much like you would drug 
development.
    In phase 1, we summarized evidence into a checklist, 
developed measures and identified barriers to using those 
evidence. Much of those barriers were team work and culture 
things. We then pilot tested a program at Johns Hopkins and 
virtually eliminated those infections there.
    In phase 2, with funding from AHRQ, we implemented this 
program in the entire State of Michigan, 103 intensive care 
units. Within 3 months their rates of infections went from 
three per thousand catheter days to zero, a median rate of 
zero, a 66 percent reduction. That has sustained for 4 years.
    We estimate that that intervention per year saved 
approximately 2,000 lives and $200 million. The investment from 
ARHQ was about $750,000 for 2 years. I wish my retirement had 
that kind of return on investment.
    In phase 3 now we're working with AHRQ to put this around 
the country. We have some funding to do 10 more States. We have 
philanthropic support to add about 10 more. But that still 
leaves 32 States out of the picture from this life saving 
intervention.
    Now there's many ills set before our health care system. 
These infections are but one. 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 
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.
    Committee, I would ask you to consider investing in the 
science of health care 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, consumers and providers, and scientists to make sure as 
you said Senator Mikulski, that we do what's right for the 
patients, that we take a systematic view of this.
    We design programs. We see if they work. And what works, we 
continue.
    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.
    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.
    President Obama told us that he's going to restore science 
to its rightful place. Indeed we need to do that if we're going 
to improve quality and reduce the cost of care. I think we have 
a model. What we haven't had is courageous leadership, which is 
clarity of what the task is at hand and a commitment to make 
resources available.
    I hope that this committee has that courage to bridge the 
gap between what we know and what we do so that I can look 
Sorrel in the eye and tell her, now indeed Josie is less likely 
to die throughout this great country of ours. I thank you.
    [The prepared statement of Dr. Pronovost follows:]
         Prepared Statement of Peter J. Pronovost, M.D., Ph.D.
                           Executive Summary
    A few years ago, 18-month-old Josie King died from preventable 
mistakes at one of the world's best hospitals: my hospital, Johns 
Hopkins. On the 4-year anniversary of her daughter's death, her mother 
looked me in the eye and asked: ``If Josie was admitted to Johns 
Hopkins today, would she be less likely to die than she was 4 years 
ago?''
    We cannot tell Sorrel that Josie is less likely to die. In the 10 
years since the IOM report To Err is Human raised healthcare quality 
and patient safety to the level of national priority, we have made only 
minimal progress, and for most areas, we do not even measure 
performance. Yet at the same time, advances in biomedical sciences have 
been astounding. In just 13 years, an international collaboration 
between governments, scientists and private industries sequenced the 
entire human genome, all 3.2 billion letters with 99.99 percent 
accuracy.
    This dichotomy between the success of biomedical science and the 
failure of patient care is because we have failed to view the delivery 
of healthcare as a science.
    My research team applied a scientific approach to reduce catheter-
related blood stream infections--a type of infection that kills between 
30,000 and 62,000 people a year and results in nearly $3 billion in 
excess costs. Within 3 months of implementing the interventions in 
Michigan, the median rate of infection in the 103 participating ICUs 
plummeted to 0, and has stayed at 0 for 4 years.
    Our national failure to view the delivery of healthcare as a 
science is also a significant factor in our limited success in learning 
from mistakes that do occur.
    Though it took over 9 years, we are now close to having a voluntary 
mechanism for reporting healthcare errors at a national level. Yet we 
do not have an infrastructure or standardized approach to learn from 
the errors that will be reported.
    There is something we can do to change this: to we can save lives 
and dollars, we can provide Sorrel an answer; are the Josie's in the 
world less likely to die?
    Specific suggestions for Improving Healthcare Quality and Patient 
Safety:

    1. Advance and invest in the science of health care delivery.
    2. Create an Institute for Healthcare Delivery.
    3. Coordinate public and private efforts to improve quality of 
care.
    4. Invest in Healthcare information technology (HIT).
    5. Build capacity.
    6. Support completion and rigorous evaluation of the national 
program to eliminate central line-associated blood stream infections 
(CLABSI).
    7. Support a new Program to reduce MRSA infections.

    Paraphrasing our President, those of us who provide healthcare, and 
those who manage the public's dollars need to spend wisely, reform bad 
habits, and do business in the light of day. Courageous leadership must 
hold all stakeholders accountable for results. My hope and expectation 
is that together we find this courage.
                                 ______
                                 
    Senator Mikulski and members of the HELP Committee, thank you for 
the opportunity to talk to you about this important topic.
    A few years ago, 18-month-old Josie King died from preventable 
mistakes at one of the world's best hospitals: my hospital, Johns 
Hopkins. On the 4-year anniversary of her daughter's death, her mother, 
Sorrel, looked me in the eye and asked: If Josie was admitted to Johns 
Hopkins today, would she be less likely to die today than she was 4 
years ago? ''
    I started telling her about our commitment to safety, listing all 
the quality and patient safety projects we were doing. She abruptly and 
appropriately cut me off. She did not care what we were doing. She 
wanted to know if care was safer. She wanted science. Unfortunately, at 
the time, we could not give her an answer.
    We know precious little about healthcare quality and patient 
safety. We do know healthcare is increasingly expensive; we can give 
you detailed cost reports, because we have standardized measures and 
regulated practices for reporting financial performance. We cannot tell 
Sorrel that Josie is less likely to die. The national report on 
healthcare quality is less informative. In the 10 years since the IOM 
report To Err is Human raised healthcare quality and patient safety to 
the level of national priority, we have made only minimal progress, and 
for most areas, we do not even measure performance.
    Yet at the same time, advances in biomedical sciences have been 
astounding. Thanks to recent science, AIDS is now a chronic disease and 
we have cured many childhood cancers. In just 13 years, an 
international collaboration between governments, scientists and private 
industries sequenced the entire human genome, all 3.2 billion letters 
with 99.99 percent accuracy. The results are publicly available so that 
scientists around the world can use the information to develop new 
therapies.
    How do we explain this dichotomy between the success of biomedical 
science and the failure of patient care? It is because we have failed 
to view the delivery of healthcare as a science.
    For every dollar of Federal health care research funding that goes 
towards learning how to better treat and understand disease, only one 
penny goes towards learning how to better care for patients. While it 
is essential that we continue to enhance funding for basic and clinical 
research, we need a more balanced research portfolio--a portfolio in 
which we view quality and safety research as essential to, rather than 
separate from, basic and clinical research. We need to eliminate the 
gap that exists between what we learn in a lab and what actually 
reaches the patient. We must have a method to create standards and to 
measure and track our progress with measures that are meaningful and 
valid to those providing care, to those receiving care and to those 
paying for care, for resources are too scarce and patient safety is too 
precious to ignore.
    Five years ago, wrong-site surgery--one of the most visible and 
troubling errors--was incorporated into the National Quality Forum 
``Never Events'' list. Reducing these errors became a national patient 
safety goal, and hospital accreditation standards were established to 
guide local hospital efforts. Yet these standards were developed based 
on common sense, not science, without evidence of their benefit or 
costs, and without a valid method to monitor their effectiveness. Since 
the standards were put in place, reports of wrong site surgery have 
increased yearly. We do not know if this is due to better reporting, if 
the interventions do not work, or if they are not used correctly. 
However, the results are not encouraging, and the public, the payers of 
healthcare and the providers of care deserve better.
    We need to approach patient safety the same way we approach curing 
a disease, through rigorous scientific research that produces hard data 
with clear measurable results. We need to summarize evidence into clear 
standards, develop measures and monitor performance with valid, 
reliable data, and work to improve teamwork and communication so 
evidence can be implemented.
    We applied the model to tackle catheter-related blood stream 
infections--a type of infection that kills between 30,000 and 62,000 
people a year and results in nearly 3 billion in excess costs. Prior to 
our study, little was known regarding how many of these infections were 
preventable.
    We approached the problem scientifically. In phase 1, we reviewed 
existing data and selected five key procedures that would most likely 
prevent these infections. We compiled these procedures into an easy to 
follow checklist. We identified potential barriers to using the 
checklist and developed tactics to overcome those barriers so we could 
optimize compliance. We then pilot tested the intervention at Johns 
Hopkins and measured performance. The result, we nearly eliminated 
these infections.
    In phase 2, AHRQ provided a matching grant to help us pilot test 
the program in the State of Michigan. Within 3 months of implementing 
the interventions, the median rate of infection in the 103 
participating ICUs plummeted to 0, and has stayed at 0 for 4 years. 
These infections were reduced by 66 percent. The work was not easy; it 
required hospital leaders, doctors and nurses to implement 
interventions, improve teamwork, and monitor performance. But the 
results were well worth the investment. In just 1 year, the reduction 
in infections were estimated to have saved the hospital system millions 
of dollars and thousands of lives.
    In phase 3, we are trying to implement this program across the 
United States, State by State, hospital by hospital. Thanks to funding 
from AHRQ we partnered with the American Hospital Association to 
implement this life saving program in 10 hospital systems in 10 States. 
Additional philanthropic support donated to my research team at Hopkins 
will permit us to reach another group of States. Most Sates are trying 
to reduce these infections, but they need support in order to be 
efficient, and to rigorously measure and improve performance.
    Similarly, the National Association of Childrens Hospitals and 
Related Institutions is developing efforts to bring this same program 
to pediatric centers in the United States. Indeed, my wife, Marlene 
Miller, is leading these efforts. They used the same model, developed 
pediatric specific standards and have impressive results in reducing 
infections in pediatric ICU's. Just as with our adult program, they 
struggle to fund, organize, implement and measure improvement.
    There are many ills that befall the U.S. healthcare system; CLABSI 
is but one. The fragmented approach to reducing these infections points 
to a deep problem with our healthcare system; vague or non-existent 
performance standards, poor or absent and often invisible measures of 
performance, misaligned financial incentives, fragmented and under 
resourced labors all cripple efforts to improve quality, reduce costs 
and implement health information technology.
    Our ability to produce measured and sustained reductions in 
infections and costs, point to a possible way forward.
    Reducing these infections could be a polio campaign for the 21st 
century--and we need one. These infections are common, costly, and 
often lethal. We know how to reduce them, yet support for this 
improvement has been left to a haphazard patchwork of local, regional 
and national efforts involving clinical, operational and policy levers. 
No one could argue that whatever the clinical effectiveness of such 
efforts, the inefficiency is glaring. A coordinated national effort to 
eradicate these infections should be an immediate priority.
    Beyond these infections, however, I believe a closer look at our 
model offers tremendous potential for use on a broad scale. In the 
model, we centralize development of evidence-based standards, measures 
and data collection standards for a nationally relevant set of patient 
safety goals. We hold healthcare organizations accountable for 
improving quality, and we advance the science needed to improve 
healthcare delivery, so that learning does not need to take place one 
patient, one physician, one hospital at a time. In this model, payers, 
consumers, insurers, administrators, clinicians and regulators, work 
together to solve the problem. Now that we have a proven system that 
can measure and prevent harm we should align payment policies to 
support safe care.
    Our national failure to view the delivery of healthcare as a 
science is also a significant factor in our limited success in learning 
from mistakes that do occur.
    Though it took over 9 years, we are now close to having a voluntary 
mechanism for reporting healthcare errors at a national level. Yet we 
do not know how to learn from the errors that will be reported. There 
is no national infrastructure to learn from common, costly and lethal 
mistakes that are beyond the capacity of any single health system to 
fix. For example, in all of the 6,000 U.S. hospitals, patients 
sometimes get epidural pain medicine connected to an intravenous 
catheter, a potentially lethal error. The intervention to prevent this 
error is to encourage doctors and nurses to be more careful, to re-
educate staff. Assume this education takes 1 hour: imagine the costs of 
re-educating all the doctors and nurses in the country and now imagine 
the probability that the education will work. Current methods for 
learning from this type of mistake are form over substance. They waste 
time, money, energy and the good will of caregivers who know they are 
human and will likely make the mistake again.
    There is a better way. We learned it from aviation. In aviation 
they recognized that it is foolish to have individual airlines 
investigate and learn from mistakes in isolation. They formed a public 
private partnership called The CAST (The Commercial Aviation Safety 
Team). The industry works together to prioritize the greatest risks, 
investigate them thoroughly and implement interventions that work. Most 
of the interventions are product redesign. We need cast in healthcare. 
We need to get the manufacturers to design the catheters so that the 
epidural and intravenous catheters do not fit together. We need to 
eliminate the possibility of making this mistake rather than hoping 
that re-education will work. Yet there is no mechanism to bring 
administrators, clinicians, regulators, and device makers together in 
healthcare to accomplish this. We have a small planning grant from the 
Robert Wood Johnson Foundation (RWJF) to pilot this concept. All 
parties are eager to participate. Yet we need Federal leadership. We 
need your wisdom, your expertise and your support.
    Through our work, we have learned that we can improve quality and 
reduce costs. Current efforts are too isolated, too weak on science, 
and too limited in focus. This will not get us where we need to go. 
There is something we can do to change this: to we can save lives and 
dollars, we can provide Sorrel an answer: Are the Josie's in the world 
less likely to die?
    Specific suggestions for Improving Healthcare Quality and Patient 
Safety:

    1. Advance and invest in the science of health care delivery.--Fund 
research under AHRQ so that rather than investing a penny in quality 
for every dollar in basic and clinical research we have a more balanced 
portfolio. Imagine the gains in quality and reduced costs if we 
increased the ratio to a quarter for every dollar.
    2. Create an Institute for Healthcare Delivery.--This institute, 
similar to the human genome project, should link provider 
organizations, insurers, payers, and regulators to design, implement, 
and evaluate interventions to improve quality, reduce costs of care, 
and implement Health Information Technology. The products from this 
group can inform payment policies.
    3. Coordinate public and private efforts to improve quality of 
care.--A ``supra agency'' should be established to facilitate and 
monitor integration of interagency activities to address deficits in 
the quality of U.S. healthcare. The agency should report directly to 
the Secretary of HHS.
    4. Invest in Healthcare information technology (HIT).--HIT is 
essential for monitoring and improving quality and reducing costs of 
care. Efforts to improve HIT need to be linked with efforts to improve 
quality and reduce cost; to date they have not. Such efforts should 
provide, at a minimum:

    a. A database of evidence-based standards.
    b. A database to monitor and report performance measures to the 
public, clinicians, healthcare leaders and government officials.
    c. Decision support tools to ensure patients receive the correct 
therapies.
    d. Tools to help educate patients, families, and clinicians.
    5. Build capacity.--Support training in quality improvement methods 
for physicians, nurses and other clinicians and administrators in order 
to improve the delivery of healthcare across the United States. At most 
academic medical centers, there are hundreds of faculty who can teach 
genetics, hundreds who can teach physiology, yet a precious few, if 
any, who can teach safety. This needs to change if we are to make and 
sustain progress.
    6. Support completion and rigorous evaluation of the national 
program to eliminate central line associated blood stream infections 
(CLABSI) and Support a new Program for MRSA.--Patients in all States 
ought to have access to safe ICU care and reduced CLABSI. MRSA has 
become the most common pathogen causing hospital-acquired infections 
(HAIs) in healthcare facilities in the United States and throughout the 
world. Researchers at the Centers for Disease Control and Prevention 
examined MRSA data from more than 1,200 intensive care units (ICUs) 
from 1992 to 2003. They found that in 1992, 36 percent of S. aureus 
isolates were drug-resistant; but in 2003, 64 percent of isolates were 
MRSA, an increase of about 3 percentage points per year.

    President Obama suggested the new administration would restore 
science to its rightful place . . . raise health care's quality . . . 
and lower its costs. To achieve this goal, programs that work--such as 
the model to reduce blood stream infections--should be expanded, and 
those that do not work should end. Paraphrasing our President, those of 
us who provide healthcare, and those who manage the public's dollars 
need to spend wisely, reform bad habits, and do business in the light 
of day.
    Substantial improvements in healthcare quality and costs are 
possible. For too long we have lacked clarity of purpose and the 
commitment to invest the necessary resources to make this vision a 
reality. Courageous leadership must hold all stakeholders accountable 
for results. My hope and expectation is that together we find this 
courage.

    Senator Mikulski. That was excellent. Dr. Pearson, we'll 
just go right on down and conclude with you, Dr. Gulcher.

  STATEMENT OF STEVEN D. PEARSON, M.D., MSC, FRCP, PRESIDENT, 
 INSTITUTE FOR CLINICAL AND ECONOMIC REVIEW (ICER), BOSTON, MA

    Dr. Pearson. 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. 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 to 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 produced optimum patient outcomes. 
Comparative effectiveness on the other hand is a newer term 
that is 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 
stents.
    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. Best practices research helps us learn how 
to get that right care delivery as safely, effectively and 
efficiently as possible.
    What are 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 last 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. These 
findings can then be used to support benefiting coverage 
policies that are flexible enough to recognize these 
differences.
    The second point I want to make about implementation is 
that in order 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 rating system that 
assigns a capital letter to grade the degree of clinical 
effectiveness of whatever it is we're evaluating and a separate 
lower case 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 decisionmaking and to align that process with 
coverage and reimbursement policies that can help shift 
patterns of care toward those higher value options.
    In conclusion, I believe that comparative effectiveness 
research and efforts to implement best practices are truly 
complementary and mutually supportive efforts. Finding out what 
works best and getting it done right, the left and the right 
hand, will both be needed to help us achieve a high quality, 
affordable health care system. Thank you.
    [The prepared statement of Dr. Pearson follows:]
       Prepared Statement of Steven D. Pearson, M.D., MSc, FRCP*
                           Executive Summary
    Health policy experts recognize ``best practices'' as referring 
primarily to systems for delivering care that lead to optimum patient 
outcomes. As for the concept of comparative effectiveness, the 
boundaries are still somewhat under construction, but in general the 
emphasis has been on studies that either assess existing evidence on 
the best treatment options for a condition, or that develop new 
evidence via clinical trials or registries. Therefore, one way to think 
of the relationship between ``best practices'' and comparative 
effectiveness is to view comparative effectiveness research as 
establishing which treatments are best for which kinds of patients, 
while ``best practices'' research helps us learn how to get that right 
care delivered as safely, effectively, and efficiently as possible.
---------------------------------------------------------------------------
    * Attachments to this statement: Assessing the Comparative 
Effectiveness of a Diagnostic Technology: CT Colonography may be found 
at http://content.healthaffairs.org/cgi/content/full/27/6/1503; and 
Final Appraisal Document--Brachytherapy & Proton Beam Therapy for 
Treatment of Clinically Localized, Low-Risk Prostate Cancer may be 
found at www.icer-review.org (look under Completed Appraisals and click 
on title).
---------------------------------------------------------------------------
     What are 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 different tools and policies that 
can be used by different stakeholders but that all re-inforce each 
other. Implementation strategies include the following:

    1. Patient information;
    2. Clinical guidelines;
    3. Physician group compensation incentives;
    4. Tiered benefit designs, in which patients would pay less out-of-
pocket for more effective and/or higher value alternatives; and
    5. Value-based coverage and reimbursement policies for emerging 
technologies, including the possibility of linking payment levels to an 
agreement to gather further evidence on clinical effectiveness.

    In order for the results of comparative effectiveness assessments 
to be communicated effectively to patients and clinicians, and to be 
``tied'' in a transparent way to coverage and reimbursement, some kind 
of common ``language'' is necessary. To meet this need at ICER we have 
developed a rating scheme that assigns a rating of comparative clinical 
effectiveness and an independent rating of comparative value, based 
largely on cost-effectiveness considerations. The purpose of these 
ratings is to transparently communicate ICER's overall judgment 
regarding the evidence on comparative effectiveness, and to provide a 
template for innovative patient-clinician decision support tools as 
well as value-based coverage and reimbursement policies.
    In conclusion, comparative effectiveness research and efforts to 
implement ``best practices'' are mutually supporting and complementary 
efforts. Using evidence to change practice is often challenging, but it 
is exactly this challenge that we must address moving forward in order 
to achieve a high quality, affordable health care.
                                 ______
                                 
    Thank you, Senator Mikulski, and members of the committee for the 
invitation to testify about the links between comparative effectiveness 
research and best patient care practices. My name is Steven Pearson. I 
am a general internist and the Founder and President of the Institute 
for Clinical and Economic Review, or ICER, at the Massachusetts General 
Hospital. ICER is an academic research group which works through a 
transparent process with patients, clinicians, manufacturers, and 
health insurers--with all stakeholders--to evaluate the comparative 
effectiveness of medical tests and treatments. ICER's approach is 
distinguished by our engagement with stakeholders, and by our 
commitment to provide decisionmakers with information on the cost-
effectiveness as well as the clinical effectiveness of medical 
services. Perhaps most germane for today's hearing, ICER has developed 
a method for translating comparative effectiveness results into a 
reliable rating format to enable the evidence to have traction; so that 
it can get off dusty academic shelves and into policy and practice in 
ways that will drive improvements in the value of healthcare.
    The backdrop to the interest and sense of urgency surrounding 
comparative effectiveness research is well known to you. Although 
technological innovation is essential to the advancement of health 
care, medical tests and treatments often become widely used while 
significant gaps in evidence regarding their effectiveness remain. The 
harmful effects of this evidence deficiency grow each year, with wide, 
unexplained variations in care patterns and escalating costs divorced 
from any indication that our health care resources are being wisely 
spent.
    I know you've heard this general theme before, so I'll provide a 
concrete example from an ICER comparative effectiveness review on the 
treatment options for prostate cancer. Prostate cancer is the second 
leading cause of cancer deaths in men in the United States, with nearly 
200,000 new cases found each year. Men with prostate cancer have many 
different options to consider, including several different forms of 
radiation therapy. Radiation can be delivered by the implantation of 
radioactive ``seeds,'' by a form of external radiation therapy called 
IMRT, or by proton beam therapy. The ICER review of these options found 
that radioactive seed implantation and IMRT had virtually 
indistinguishable net health benefits for patients; for proton beam 
therapy, the newest option, there have been only a handful of studies, 
and yet what little evidence is available does not suggest that it is 
any better than the other options. Our review also looked at upfront 
costs to Medicare and we also used cost-effectiveness analysis to 
estimate the downstream patient outcomes and costs for patients managed 
with each of these three treatments. We found that Medicare pays 
approximately $50,000 for proton beam therapy, $20,000 for IMRT, and 
$10,000 for radioactive seed implantation. Again, without any evidence 
of improved clinical outcomes, for any patients, Medicare pays doctors 
and hospitals as much as five times more for some treatments than for 
others. Not surprisingly, surveys of radiation oncologists suggest that 
these price differentials have led to impressive shifts in what kinds 
of treatments patients receive, and, as a result, it has been estimated 
that, without any evidence we are doing better by our patients, 
Medicare is now paying more than a billion dollars more per year just 
due to the shift to more expensive radiation therapy options for 
prostate cancer treatment. This is just one isolated example of how we 
continue to pay the highest prices in the world for many health care 
tests and treatments of dubious comparative value. And as we do so we 
put just that much further out of reach our hopes of making health care 
affordable for all Americans.
    Comparative effectiveness research is intended to help address this 
challenge. In my oral testimony, I want to try to cover two specific 
questions:

    1. What is the overlap between the concepts of comparative 
effectiveness and ``best practices? ''
    2. What are the mechanisms and the requirements for effective 
implementation of comparative effectiveness research findings?

    The term ``best practice'' has been around longer, and I think it's 
fair to say that health policy experts recognize ``best practices'' as 
referring primarily to systems for delivering care that lead to optimum 
patient outcomes. Dr. Pronovost's surgical checklist procedure for 
reducing hospital-acquired infections is a classic, and wonderfully 
effective, example. As for the concept of comparative effectiveness, 
the boundaries are still somewhat under construction, but in general 
the emphasis has been on studies that either assess existing evidence 
on the best treatment options for a condition, or that develop new 
evidence via clinical trials or registries. There is no a priori reason 
that research to evaluate alternative care delivery processes couldn't 
be considered comparative effectiveness. Nonetheless, we have long had 
a term for that kind of research: health services research, and 
comparative effectiveness as a distinct term came into being to 
emphasize the need for new kinds of head-to-head trials and of 
systematic evidence assessments to help decisionmakers with decisions 
about specific tests or treatments. So one way to think of the 
relationship is to say that comparative effectiveness research helps 
establish what treatments are best for which kinds of patients, and 
``best practices'' research helps us learn how to get that right care 
delivered as safely, effectively, and efficiently as possible.
    What are 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 different tools and policies that 
can be used by different stakeholders that all re-inforce each other. 
Implementation strategies include the following:

    1. Patient information;
    2. Clinical guidelines;
    3. Physician group compensation incentives;
    4. Tiered benefit designs, in which patients would pay less out-of-
pocket for more effective and/or higher value alternatives; and
    5. Value-based coverage and reimbursement policies for emerging 
technologies, including the possibility of linking payment levels to an 
agreement to gather further evidence on clinical effectiveness.

    There are a couple key points I want to make about this list. 
First, whereas coverage determinations are included, they are not the 
sole, nor even the primary mechanism. Sometimes concerns are raised 
that comparative effectiveness can only be implemented through all-or-
nothing, one-size-fits-all coverage decisions. To the contrary, 
comparative effectiveness evaluations are expressly framed to hunt out 
any evidence that specific types of patients may benefit more or less 
from certain treatment options, and these findings can be woven into 
patient materials and clinical guidelines, with any linked benefit or 
coverage policy made flexible enough to recognize these differences.
    In order for the results of comparative effectiveness assessments 
to be communicated effectively to patients and clinicians, and to be 
``tied'' in a transparent way to coverage and reimbursement, some kind 
of common ``language'' is necessary. To meet this need at ICER we have 
developed a rating scheme that assigns a capital letter rating of 
comparative clinical effectiveness on a six-part scale, and a separate 
lower-case letter rating of comparative value, based largely on cost-
effectiveness considerations, on a three-part scale. These ratings can 
be looked at in isolation, or they can be put side-by-side to form an 
integrated evidence rating. The purpose of these ratings is to 
transparently communicate ICER's overall judgment regarding the 
evidence on comparative effectiveness, and to provide a template for 
innovative patient-clinician decision support tools as well as value-
based coverage and reimbursement policies. We are now working with a 
coalition of employers, health plans, and provider groups in 
Massachusetts to implement ICER reviews of prostate cancer treatments 
through patient materials and policies linked to the integrated 
evidence ratings. The goal is to design specific patient and clinician 
materials to fit with coverage and reimbursement policies so that, 
working together, all the stakeholders can use comparative 
effectiveness results to increase shared decisionmaking and shift 
patterns of care to higher value alternatives.
    In conclusion, I believe that comparative effectiveness research 
and efforts to implement ``best practices'' are mutually supporting and 
complementary efforts. Using evidence to change practice is often 
challenging, but it is exactly this challenge that we must address 
moving forward; and using evidence more effectively is exactly the 
right way for us to achieve a high quality, affordable health care. 
Thank you.

    Senator Mikulski. Dr. Fischer, let's hear from you.

    STATEMENT OF DONALD R. FISCHER, M.D., MBA, SENIOR VICE 
   PRESIDENT, INTEGRATED CLINICAL SERVICES AND CHIEF MEDICAL 
    OFFICER, HIGHMARK BLUE CROSS BLUE SHIELD, PITTSBURGH, PA

    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 U.S. health care 
system.
    Improving quality of care will drive improving patient 
outcomes and significant cost efficiencies by eliminating 
underuse errors, overuse 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. That was already in my remarks before 
you discussed that.
    Our quality improvement programs emphasize several guiding 
themes.
    No. 1, we focus on measuring quality indicators that have 
been identified by national quality improvement organizations.
    No. 2, we align financial incentives to improvements in 
those quality measures.
    No. 3, we provide practice coaching and guidance to 
physicians and hospitals so they can be successful.
    And No. 4, we provide education, coaching and incentives to 
members to improve their adherence to evidenced-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.
    First, our Quality BLUE hospital pay-for-performance 
program is focused on reducing the incidence of central line 
bloodstream 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. I'll 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 2 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.
    Third, 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 shared decisionmaking. Since starting the program 
we've seen a striking increase in our own employees who've 
obtained preventive exams going from 9 percent each year to 
over 60 percent in the past year. That's over a 3-year period.
    We've also shown that a comprehensive employee wellness 
program produced a $1.65 in cost savings for every dollar 
invested. That is in a short term. That material was published 
in the Journal of Occupational Environmental Medicine in 
February 2008.
    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 health care. We don't have all 
the answers, but we've seen trends that speak to some key 
success factors.

    No. 1, collaboration among all stakeholders;
    No. 2, better information sharing;
    No. 3, a focus on process improvement;
    No. 4, coaching for providers and members; and
    No. 5, 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. Thank you for your attention.
    [The prepared statement of Dr. Fischer follows:]
           Prepared Statement of Donald R. Fischer, M.D., MBA
                           Executive Summary
    I am honored to be here today to share what Highmark and the Blue 
Cross Blue Shield Association (a national federation of 39 independent 
and locally operated Plans) are doing to improve quality and 
affordability by facilitating the implementation of best patient care 
practices for hospitals, primary care physicians, and members. There is 
ample evidence to show that a quality chasm exists in the U.S. health 
care system. Despite the highest per capita spending in the world, 
there is a widespread belief that we do not receive the value we should 
for our health expenditures. We believe that improving the quality of 
care will result in improved patient outcomes and significant cost 
efficiencies by eliminating underuse errors, overuse errors and misuse 
errors.
    Our goal at Highmark is to help ensure that the right care is 
delivered to the right member at the right time. If we can achieve that 
goal, we believe we can bring substantial value to the health care 
dollar for our customers. We work every day with three key 
stakeholders--physicians, hospitals and our members--with a purpose of 
achieving documented improvements in quality and patient safety, while 
also addressing costs.
    Highmark's quality improvement programs emphasize several guiding 
themes:

    1. Focusing on measuring quality indicators that have been 
identified by national quality improvement organizations as areas of 
opportunity.
    2. Aligning financial incentives to improvements in quality 
measures.
    3. Providing practice coaching and guidance to support the 
hospitals and physicians who are Highmark's partners in improving 
quality.
    4. Providing education, motivational coaching and incentives to 
members to improve adherence to preventive and chronic care evidence-
based guidelines.

    Highmark has used these approaches to address some of the most 
critical issues in health care today--with tangible results. Highmark's 
QualityBLUE hospital pay-for-performance program has focused on 
reducing the incidence of central line bloodstream-associated 
infections. Coaching and guidance combined with financial incentives 
have encouraged hospitals to follow best practices, and to standardize 
processes to avert these infections. During fiscal year 2008, hospitals 
in the program reported a significantly lower rate of central line 
infections compared to the national average, consistent with a savings 
of over $21 million and between 68 and 142 lives saved.
    The company has helped moderate increases in prescription drug 
costs through efforts to encourage prescribing and dispensing of 
generic drugs when they are clinically appropriate. Elements of the 
program include a generic medication sampling program in physician 
offices and a generic prescribing measure as part of its QualityBLUE 
physician pay-for-performance program. As a result of these activities, 
Highmark has sharply increased its generic dispensing ratio, leading to 
a reduction in the rate of rise of pharmacy costs. Reduced pharmacy 
costs can play a significant role in improving patient outcomes because 
they generally result in increased patient adherence to prescribed 
medications.
    Financial incentives and coaching are also important tools to help 
members 
make prudent health care choices. Using its own workforce as a testing 
ground, Highmark has demonstrated that health promotion and wellness 
programs can be cost-effective, and can reduce the underutilization of 
preventive care. According to a Highmark study published in the Journal 
of Occupational and Environmental Medicine, a comprehensive employee 
wellness program, including member financial incentives, produced $1.65 
in cost savings for every dollar of program costs. We are now spreading 
these programs to other accounts.
                                 ______
                                 
                              introduction
    Madame Chairwoman and other distinguished members of the committee, 
my name is Dr. Donald Fischer, Senior Vice President and Chief Medical 
Officer of Highmark Blue Cross and Blue Shield of Pennsylvania. I am 
honored to have the opportunity to testify before you today on behalf 
of the Blue Cross Blue Shield Association on best practices to promote 
quality health care. BCBSA is a national federation of 39 independent, 
community-based, and locally operated Blue Cross and Blue Shield (BCBS) 
companies that collectively provide health care coverage to 102 million 
individuals--one in three Americans.
    At Highmark, I have responsibility for overseeing the management of 
our clinical and non-clinical professionals who develop and deliver a 
comprehensive range of programs, including case management, pharmacy 
management, condition management, and wellness and prevention. BCBSA 
and Highmark strongly believe that all Americans should have health 
care coverage, and that the care delivered should be of high quality. 
There is ample evidence to demonstrate that there remains a quality 
chasm in health care in this country; despite the highest per capita 
spending in the world, we do not receive the value that we should for 
our expenditures. It is estimated that as much as 30 percent of all 
health care spending is wasted, going toward ineffective, redundant or 
inappropriate health care. It is our firm belief that improving quality 
of care will result in significant cost efficiencies.
    Highmark's efforts to improve the quality of care--and ultimately 
have an impact on costs--are built around trying to reduce the 
unwarranted variation in medical practice that cannot be explained by 
patient demographics or severity of illness. The variation can be due 
to the underuse of tests and treatment known to be effective, the 
overuse of tests and treatments that may not have significant clinical 
value, and the misuse of tests and treatments that contribute to 
medical errors. These are the significant factors that are preventing 
us from assuring patient safety. Our mutual goal with providers is to 
assure that the right care is provided to the right patient at the 
right time.
    Most physicians and hospital staffs are well trained and well 
intentioned, but need to spend more time focusing on improving the 
processes by which care is delivered, and using systems to support 
decisionmaking that adheres to the scientific evidence that is 
available. This requires training in process improvement techniques, 
and a realignment of financial incentives. Our current system includes 
misaligned incentives that drive increased health care costs, without 
regard to quality of care or outcomes. I am often asked why I left 
academic medicine, where I truly found great satisfaction in helping 
children with congenital heart disease and their families.
    My rationale is that I felt I could do much more to advance health 
in this country by having an opportunity to focus on championing 
patient safety and quality improvement for large populations of 
patients. My role at Highmark allows me to do that, and I believe we 
have demonstrated repeatedly that we bring value to our members and the 
caregivers in our network through our quality improvement programs.
    BCBSA also believes that we must change processes and incentives in 
our current health care system to advance the best possible care, not 
just drive the use of more services. We believe that by helping 
providers implement best patient care practices, we can deliver better 
value and efficiency to members, ensuring access to affordable and high 
quality health coverage.
    In my remarks today, I would like to focus on what Highmark is 
doing to improve quality and affordability by facilitating the adoption 
of best patient care practices for hospitals, primary care physicians, 
and members. Our main strategy with providers is to continue to raise 
the bar on quality through the use of pay-for-performance (P4P) 
programs that begin to align incentives through a program known as 
QualityBLUE. We also have pioneered an incentive program for members 
known as Lifestyle Returns, aimed at increasing adherence to preventive 
guidelines. These programs aim at aligning the incentives among the 
employer, the member, the physician, the hospital and the health plan. 
My testimony will emphasize four major lessons learned from these 
programs that are advancing best patient care practices:

     Focus on measuring quality indicators that have been 
identified by national quality improvement organizations as areas of 
opportunity.
     Tie significant financial incentives to improvements in 
these quality measures.
     Facilitate the improvement by providing practice coaching 
and guidance to support the hospitals and physicians who are our 
partners in improving quality.
     Provide education, motivational coaching and incentives to 
members to improve adherence to the evidenced-based guidelines for 
prevention and chronic care.

    Our approach to implementing best patient care practices has 
yielded significant, measurable outcomes--not only saving dollars, but 
also saving lives. As I share these results with you, please keep in 
mind that Highmark has many other programs to improve quality, such as 
worksite wellness programs performed in conjunction with our employer 
accounts. In addition, we regularly work with other BCBS Plans and the 
Association to continue to raise the bar on quality. As Highmark's 
Chief Medical Officer, I meet quarterly with the other Blue Plan CMOs 
to spread best patient care practices. I also help my Plan take full 
advantage of Association-wide initiatives such as Blue Distinction, a 
program to identify the best hospitals and healthcare facilities for 
cardiac care, bariatric surgery, transplantation, and the treatment of 
complex and rare cancers.
      improving quality and patient safety in the hospital setting
    I would now like to discuss examples of how Highmark has applied 
these guiding principles into practice to address important clinical 
issues. When Highmark launched QualityBLUE, we decided to focus on 
evidence-based measures of clinical quality that are in accordance with 
nationally recognized guidelines, and to utilize measures that will 
drive the greatest proportional improvements in quality. We also sought 
input from the primary care physician community and our network 
hospitals to ensure that the measures were valid and actionable.
    Our QualityBLUE program for hospitals focuses on the following 
major areas, with each hospital being mandated to participate in the 
first two, and electing to focus on two additional initiatives among 
the others:

     Reduction of Methicillin Resistant Staphylococcus aureus 
infections (MRSA).
     Reduction of Central Line Associated Bloodstream 
Infections (CLAB).
     Medical Technology Implementation.
     Reduction in Surgical Infections, using the Surgical Care 
Improvement Project (SCIP).
     Reduction of Deep Vein Thrombosis through use of SCIP 
venous thromboembolism project.
     Adoption of the American Heart Association's Get With The 
Guidelines (GWTG) programs for cardiac disease and stroke.
     Reduction of Clostridium difficile (CDAD) infections.
     Reduction of Catheter-Associated Urinary Tract Infections.

    In addition, all hospitals are scored on their performance on the 
Centers for Medicare and Medicaid Services' Hospital Compare Process of 
Care Measure Set.
    I would like to give examples of improvements related to the first 
two areas, because they represent among the greatest health threats to 
hospitalized patients.
Central Line Associated Bloodstream Infections (CLAB)
    A central line is an invasive catheter device inserted in a patient 
and used to monitor hemodynamic status, provide nourishment, and 
administer medication. These types of devices place a patient at an 
increased risk for a bloodstream infection. Bacteria introduced through 
these lines can lead to life-threatening infections. Unfortunately, 
these catheter-related bloodstream infections are common, costly and 
potentially lethal. Each year in the United States, central venous 
catheters may cause an estimated 80,000 catheter-related bloodstream 
infections and, as a result, up to 28,000 deaths among patients in 
intensive care units. In 2007, the Centers for Disease Control National 
Healthcare Safety Network published a national average of 2.7 
infections per 1,000 line days for intensive care unit patients. By 
comparison, the average hospital-wide rate for hospitals in QualityBLUE 
for 2008 was only 1.0 infections per 1,000 line days.
    To attain this result, we coordinate with QualityBLUE hospital 
participants to implement procedures to reduce central line associated 
bloodstream infections hospital-wide, working toward a goal of zero. 
This includes following evidence-based practices for insertion, 
maintenance, and use of central lines. Removing central lines, when no 
longer necessary, has also shown to be an evidence-based practice to 
reduce CLAB infections. For this program year, we instructed hospitals 
to implement procedures to assess daily the necessity of continued line 
use and, when appropriate, to remove the line.
    When comparing the baseline data (fiscal year 2007) to fiscal year 
2008, many hospitals improved their CLAB rate from baseline: 23 
hospitals reported a rate of less than 1.0 CLAB per 1,000 Central Line 
days, with four of 23 hospitals even reporting zero CLAB. The average 
reported CLAB rate for all hospitals at fiscal year 2007 baseline was 
1.15 and for fiscal year 2008 was 1.02.
    While there were still 341 CLAB infections at QualityBLUE hospitals 
in the past year, had CLAB infections occurred at the national average 
rate, there would have been a potential of 907 infections at these 
hospitals. At an estimated cost of $38,703 per case, that represents a 
potential savings to the health care system of more than $ 21.9 million 
compared to the cost had the network performed at the national average. 
More importantly, there was a reduction in mortality and morbidity 
compared to the national norm, with ``mortality savings'' estimated to 
be in the range of 68-142 lives saved.
                                  mrsa
    MRSA first emerged as a pathogen causing healthcare-associated 
infections (HAI) in hospitals throughout the United States in the late 
1970s. Since that time, MRSA has spread to hospitals throughout the 
country and has become the most common pathogen causing HAI in 
healthcare facilities in the United States and throughout the world. In 
2004, MRSA accounted for up to 60 percent of the Staphylococcus aureus 
infections acquired in the intensive care units (ICU) of healthcare 
facilities that reported data through the National Nosocomial 
Infections Surveillance (NNIS) system.
    Studies estimate the attributable medical costs associated with 
MRSA infections in U.S. hospitals average $35,367 per case. 
Additionally the Centers for Disease Control and Prevention (CDC) 
reported that approximately 120,000 persons were hospitalized in the 
year 2000 with an MRSA infection estimating an annual total cost of 
$3.2 billion to $4.2 billion for hospitals nationwide. For these 
reasons, and for the safety and welfare of our members, prevention and 
reduction of MRSA is an issue that we could not ignore.
    A key component of the QualityBLUE MRSA indicator is to develop a 
system to identify the prevalence of MRSA entering the hospital from 
the community. By identifying patients as carriers of MRSA, upon 
admission, a previously unknown ``reservoir'' of MRSA is determined. 
Infection control procedures can be implemented for these patients that 
help prevent the transmission of MRSA from this patient population to 
other hospital patients. With fewer new patients becoming colonized 
with MRSA, future MRSA infection development is avoided.
    Thus, to prevent and reduce the number of MRSA infections, 
QualityBLUE hospital participants implement active surveillance testing 
on their three highest risk units, and then take steps to minimize the 
likelihood of transmission of the MRSA to other patients. They screen 
hospital admissions to determine if a patient is a carrier of MRSA; 
when a carrier is identified, the hospital implements barrier 
precautions to reduce the likelihood of spreading the infection, uses 
dedicated equipment, adheres to strict hand hygiene practices, and 
requires staff to wear personal protective equipment at all times 
around the patient.
    The QualityBLUE program measures the rates at which hospitals 
screen patients for MRSA on admission, and again at discharge, as well 
as determining the rates of transmission within the hospital setting. 
We require hospitals to monitor active surveillance testing compliance 
and set a goal of 90 percent compliance with obtaining cultures on 
patients admitted to one of the three units and at the time of transfer 
from the unit or discharge from the hospital.
    For 1st quarter fiscal year 2008, the admission and discharge 
compliance with obtaining surveillance cultures for all QualityBLUE 
hospital participants was 92.0 percent and 81.5 percent respectively. 
By the end of the 3rd quarter of the program year, admission culture 
compliance improved by 4.5 percent over Qtr 1 (to 96.2 percent 
compliance) and discharge culture compliance increased by 11.8 percent 
over Qtr 1 (to 91.1 percent compliance). MRSA transmission rates ranged 
from 0.8 to 3.7 infections per 1,000 patient days, reflecting 
persistent unwarranted variation in practice among the participating 
facilities. That being said, it is only through measurement and 
awareness that these facilities can address the problem that was 
previously unquantified and unmanaged.
            increasing the quality in primary care practices
    Our QualityBLUE program for primary care physicians (family 
practice, internal medicine, pediatrics) focuses on the following six 
areas of quality improvement:

    1. Clinical Quality Indicators (focusing on eliminating 
underutilization of these evidenced base guidelines): Appropriate use 
of Acute Pharyngitis Testing; Appropriate Asthma Medications; 
Persistence of Beta Blocker Treatment; Breast Cancer Screening; 
Cervical Cancer Screening; Cholesterol Management for patients with 
Coronary Artery Disease; Comprehensive Diabetes Care; Adolescent Well-
Care Visits; Varicella Vaccination Status; Well Child Visits for the 
First 15 Months; Mumps-Measles-Rubella Vaccination Status; Congestive 
Heart Failure Annual Care; and Well Child Visits--3 to 6 Years.
    2. Increasing appropriate Generic Drug utilization.
    3. Improving Accessibility for members, providing evening and 
weekend hours for visits.
    4. Participating in a ``Best Practice'' process improvement 
project.
    5. Adopting Electronic Prescribing tools.
    6. Adopting Electronic Health Records.

    All six measures drive overall improved quality care for our 
members, as well as encourage increased levels of care coordination. 
Care coordination at the primary care level is a critical component of 
improving outcomes for patients with chronic conditions, and we 
continue to seek strategies and practices to increase its practice.
    As examples of success, the following are illustrative of the 
impact of the program during 2008.
Adoption of Electronic Health Records (EHR) and Electronic Prescribing 
        tools
    The implementation rate for EHR in 2008 increased by 50 percent, 
while the rate of use of electronic prescribing increased 52 percent, 
with 586 practices (40 percent of the total QualityBLUE practices) now 
using these electronic tools.
Generic Drugs
    In early 2004, we implemented the Generic/Brand Prescribing 
indicator in the western region QualityBLUE physician program. In April 
2006, the QualityBLUE physician program was implemented in the central 
region with the inclusion of the Generic and Brand drug measure.
    Evidence of the impact pay-for-performance programs have on 
advancing practice change can be seen in the rapid growth in the 
Highmark central region's use of generic drugs. The central region 
incorporated the Generic/Brand indicator in the second quarter of 2006. 
At that time, there was nearly a 10 percent difference in generic 
prescribing rates for internists between the two regions. As of 3rd 
Quarter 2008, both regions essentially shared the same Internal 
Medicine network percentage of 68 percent (western) and 67 percent 
(central). This is a significant accomplishment for both western and 
central networks but most importantly demonstrates the rapid 40 percent 
increase in central region performance once physicians in that region 
had an incentive for generic prescribing (see Figure 1 below).




    During 2008, the generic prescribing rate for Highmark's book of 
business increased by 3.8 percent, resulting in cost savings for our 
accounts of approximately $137 million, and direct savings to our 
members of over $24 million. These savings are also associated with 
increased adherence of our members to their medication regimens, a 
clear quality benefit related to the increased affordability of generic 
medications.
    Survey data from 2007 showed a 4 percent increase across all Blue 
plans in generic fill rates due to system-wide implementation of such 
strategies. That increase translates into an estimated $3.3 billion in 
health care cost savings in 2007 due to increased generic drug use. A 
recently-released CMS report supports these findings, noting that 
reduced growth in the United States in 2007 of retail prescription drug 
spending (only 4.9 percent, as compared to 8.6 percent growth in 2006) 
was due in large part to sustained growth in the generic dispensing 
rate.
         aligning financial incentives to quality improvements
    Our QualityBLUE programs for both hospitals and physicians have 
achieved clear successes in raising the bar on quality. One key driver 
behind this success has been a thoughtful restructuring of our 
reimbursement system to reward best practices that achieve good 
outcomes.
Hospitals
    Hospitals in the Highmark network are offered an opportunity to 
participate in QualityBLUE via their contract negotiation. The 
QualityBLUE Hospital program provides program participants a negotiated 
program reimbursement based on the attainment of identified performance 
objectives and targets throughout a contract year. The hospital places 
at risk a portion of their negotiated reimbursement based on the 
achievement of agreed upon clinical quality improvements targets, 
approximating from 1 to 3 percent of total hospital reimbursement. The 
earned reimbursement is paid to the hospital either via a lump sum 
payment at the conclusion of the program year or the reimbursement is 
integrated into the hospitals rates for the subsequent year (earn in 1 
year, paid in the next). In the fiscal year 2008 QualityBLUE program, 
Highmark paid more than $42 million in earned performance-based 
reimbursement. In this setting, quality departments of these hospitals 
are no longer simply tolerated as a requirement of JCAHO, but they 
become revenue centers bringing real value to their patients and to the 
hospitals' bottom lines.
Physicians
    Physicians participating in QualityBLUE receive quality scores 
based on the measures described earlier, up to a maximum of 115.


------------------------------------------------------------------------
                                                                Possible
           Quality Measure                   Description         Quality
                                                                  Score
------------------------------------------------------------------------
Clinical Quality.....................  Expected Quality               65
                                        Guidelines.
Generic/Brand Rx.....................  Prescribing Patterns...        20
Member Access........................  Weekly office                   5
                                        traditional and non-
                                        traditional hours.
Best Practice........................  Clinical Practice              15
                                        Improvement Activity.
Electronic Health Record.............  Uses evidence of                5
                                        implementation
                                        progress.
Electronic Prescribing...............  Uses evidence of                5
                                        purchase and
                                        functionality.
                                      ----------------------------------
  Total..............................                                115
------------------------------------------------------------------------

    Physicians are scored on a quarterly basis, and receive incentive 
payments for each evaluation and management claim filed during the 
subsequent quarter, based on their total score. Those who score less 
than 65 points do not receive incentive payments. Those scoring between 
65 and 89 receive $3 per filed claim; between 90 to 100 receive $6 per 
filed claim; and more than 100 points receive $9 per filed claim. These 
incentive payments are highly significant, comprising up to 15 percent 
of a practice's total reimbursement. Our experience is that only 
incentive opportunities of this magnitude have the potential to 
motivate changes in practice. In 2008, 60 percent of the 1,297 
physician practices participating in QualityBLUE earned bonuses. A 
total of $14 million was paid in incentive payments to primary care 
physicians in fiscal year 2008.
                    providing coaching and guidance
    Significant incentives are necessary to raise performance on key 
measures, but they are not sufficient without additional coaching and 
management support. That is why Highmark feels it is paramount to 
cultivate on-going relationships with its provider community by 
providing information and establishing forums to obtain feedback and 
share best practices, through newsletters, Lunch and Learns, and Best 
Practice Forums, and through the dedication of consultative resources 
that provide on-site program guidance.
Hospitals
    To support QualityBLUE hospital partners throughout the performance 
year, Highmark has developed engagement strategies designed to provide 
quality of care information to healthcare staff, facilitate inter-
facility communication, provide consultative support and encourage 
implementation of best practices. We have formed Highmark QualityBLUE 
teams of professionals that include medical technology experts, 
Registered Nurses, Certified Infection Control Professional, Speech 
Pathologists, Registered Health Information Administrators, and 
Certified Professional Healthcare Quality experts, including Medical 
Directors.
    The teams have established and led the following types of 
activities:

    Partners in Quality Newsletter: The Highmark QualityBLUE team 
developed the Partners in Quality Newsletter, a quarterly publication, 
as a tool to communicate with QualityBLUE hospital partners regarding 
program highlights. Topics of interest related to the program, as well 
as interviews with physician champions, submission of articles by 
QualityBLUE hospital participants and information on upcoming 
``important dates'' related to the QualityBLUE program are included.
    Best Practice Forum: Annually, Highmark hosts the QualityBLUE 
program ``Best Practice Forum'' inviting QualityBLUE participants to 
share their positive clinical improvements identified through 
participation in the program. The day-long event includes poster 
presentations, clinical break-out sessions, nationally renowned 
speakers, and presentations by clinicians recognized as experts in a 
wide range of clinical topics. In November 2008, more than 250 hospital 
staff attended this event.
    Program Orientation and Ongoing Clinical Consulting: Highmark 
QualityBLUE staff members are available to answer questions regarding 
the program throughout the year. As new hospitals consider entering the 
program, QualityBLUE staff members meet with healthcare facilities and 
discuss the QualityBLUE program with the hospital Quality teams. For 
new participants, orientation to the program is conducted early in the 
program year and prior to the mid-year evaluation. The QualityBLUE team 
provides consultative support throughout the program year. Currently, 
the hospitals are visited as part of the program requirements at mid-
year and year-end to facilitate quality improvement activities and to 
assess alignment to the current QualityBLUE program year.
Physician Support
    To support physicians in their quality improvement efforts, 
Highmark formed the Medical Management Consultant (MMC) Team over 10 
years ago. The team is comprised of 15 staff members, one Medical 
Director, and two Clinical Pharmacy Consultants. This experienced and 
dedicated staff provides consultative quality improvement support, 
education and training to more than 3,221 physicians. They have 
developed long term relationships with these physician groups, and have 
become trusted partners in bringing value to the delivery of healthcare 
in their practices.
    Specifically, MMC teams help physician practices by:

     Assessing where the practice's current performance is 
against quality performance criteria--the Quality Improvement Roadmap 
to Success.
     Evaluating the practice office operations to determine 
process improvement opportunities.
     Meeting with the physicians and staff to provide feedback 
and recommend a course of action to improve clinical quality and office 
operations.
     Collaborating with the physicians and staff to create a 
work plan that defines the problem; establishes baseline measures; 
specifies action steps; designates responsible team members; 
establishes a timeline for expected outcomes; and incorporates a 
control mechanism to ensure the operations don't falter.
     Scheduling meetings to monitor and report on the 
practice's performance against their clinical quality and process 
improvement activities, helping to assure they succeed in their efforts 
and maximize their incentive opportunity.

    We have demonstrated that practices which have the benefits of a 
Medical Management Consultant are more successful with every aspect of 
the QualityBLUE program. It is quite evident in Figure 2 that the 
practices with this resource were far more successful in implementing 
Best Practice projects leading to measurable quality improvement in 
their offices.



                engaging members in quality improvement
    In addition to health plans, hospitals and physicians, our members 
play an important role in helping to improve quality and manage costs. 
For many years, the challenge for health plans has been to consistently 
engage consumers in wellness and healthy lifestyle improvement 
programs. Our experience, using our own employee workforce as a testing 
ground, shows that financial incentives make a big difference.
    Since 2005, Highmark has encouraged our employees to participate in 
a program known as Lifestyle Returns, designed to improve adherence to 
preventive care guidelines, and encouraging use of personalized online 
programs that focus on weight management, stress reduction, smoking 
cessation and healthy eating habits. Employees receive financial 
incentives if they set and meet targeted health goals. Prior to 2005, a 
maximum of 9 percent of Highmark employees obtained a preventive health 
exam during the year. During 2008, over 60 percent of employees 
obtained all preventive exams and screenings recommended for their age 
and gender. We have also provided on-site fitness facilities and have 
encouraged employees and their managers to encourage regular use of 
these resources. In addition, all employees are able to access health 
coaches for management of chronic conditions, targeted health 
conditions, and wellness training.
    The results show that health promotion and wellness programs are 
cost-effective. Our study showed that employee participation in the 
program produced an estimated savings of $1.65 in avoided health care 
expenses for every dollar spent on the comprehensive employee wellness 
program, including the payment for the employee incentive. The study's 
findings were published in the February 2008 Journal of Occupational 
and Environmental Medicine. Equally important, empowering individuals 
to lead healthier lifestyles has an immeasurable positive impact--
higher quality of life, increased productivity, reduced time off work, 
and stronger communities of healthier people.
    We are now spreading these member programs to our Plan accounts, 
and seeing similar health and productivity gains.
           fostering quality improvement on a national scale
    As I mentioned at the beginning of my testimony, Highmark has 
implemented a number of other important strategies, some unique to 
Highmark, some established by the Blue Cross and Blue Shield 
Association. To give you an idea of other approaches to implementing 
best patient care practices, I would like to focus on one Highmark 
initiative and one Association initiative. BCBSA has designated nearly 
800 Blue Distinction Centers (BDC) across 43 States. This national 
program designates facilities that have demonstrated expertise in 
delivering quality healthcare in the challenging specialty areas of 
Transplantation, Bariatric Surgery, Cardiac Care, and Complex and Rare 
Cancers. To receive this designation, facilities within participating 
Blue Plans service areas must meet stringent quality criteria, as 
established by experts in the specialty field. To meet these BCBSA 
requirements, the Centers must demonstrate better outcomes and 
consistency of care, which provide greater value for Blue Plan members. 
Facilities that have the BDC designation are subject to periodic 
evaluations as criteria continue to evolve. At this time High-
mark's 49-county service area has facilities with Bariatric Surgery, 
Cardiac Care and Complex and Rare Cancer designations.
Cardiac Care
    The early results for the Cardiac Care BDCs are especially 
encouraging. Currently there are more than 410 Blue Distinction Centers 
for Cardiac Care across the country, including those in Highmark's 
network. The stringent clinical criteria that facilities met were 
developed in collaboration with the American College of Cardiology 
(ACC), the Society of Thoracic Surgeons (STS), and with the input from 
a panel of leading clinicians.
    For example, a study by HealthCore, Inc., found that readmission 
rates for certain procedures performed at Blue Distinction Centers for 
Cardiac Care were lower than at other hospitals. The study found:

     26 percent lower re-admission rates for bypass surgery and 
37 percent lower for outpatient angioplasty, based on 30-day cardiac-
related re-admission rates.
     21 percent lower re-admission rates for bypass surgery and 
32 percent lower for outpatient angioplasty based on 90-day cardiac-
related re-admission rates.
     Lower costs, 5 percent less for bypass procedures and 12 
percent less for outpatient angioplasty, with a 90-day episode of care.

    Similarly, there is a significant difference in the inpatient 
mortality of patients admitted to BDC facilities as opposed to those 
facilities that were denied the designation. Figure 3 demonstrates the 
difference in mean and maximum mortality levels between these two 
groups, findings which further support the value of the program.




    And in a striking confirmation that improved quality leads to 
better affordability, allowed charges for CABGs were $45,215 in BDCs, 
$2,260 less than in non-BDC hospitals. Keep in mind that economic 
criteria were not used to designate facilities as BDCs--it just turned 
out that facilities that offered better care were associated with 
better clinical outcomes and generated more affordable care, an 
important insight for national policy. Quality pays.
                               conclusion
    The best care is that which assures that the right care is provided 
to the right patient in the right setting at the right time. Providers 
should be rewarded for delivering high quality healthcare with 
financial incentives to have full information about their patient at 
the point of care, coordinate their care with other caregivers, and use 
a systems approach to adhere to evidence-based guidelines to assure 
appropriateness. This is especially true for the increasing number of 
individuals with chronic conditions. Properly aligned incentives can 
reinforce the adoption of evidence-based practice standards and are a 
necessity to providing transparent quality information for consumers to 
make informed choices about their care. Raising the bar on quality--
which will lead towards elimination of wasteful spending--will result 
in better outcomes and more prudent use of valuable resources.
    As leaders in the health care community for over 80 years, BCBSA 
and the entire Blues system looks forward to working with the new 
Administration, Congress, and all stakeholders to enact healthcare 
reforms that improve the quality of care delivered to all Americans.
                                 ______
                                 
    Attachment.--Provider Operations Quality Performance Management 
                         (Achievements FY 2008)
                    i. introduction--why it matters
2008 Provider Quality Improvement Program Results
    Highmark's strategy to improve the quality of care provided to our 
members is to continue to raise the bar on provider quality through the 
use of pay-for-performance programs and provider engagement. This 
strategy allows Highmark to differentiate payment among providers based 
upon their performance on key quality and clinical measures. The 
commitment to develop and enhance quality programs that promote 
clinical care and safety improvements is central to this strategy. The 
following pay-for-performance programs are currently being administered 
by Highmark:


------------------------------------------------------------------------
        Physician Specific Programs           Hospital Specific Program
------------------------------------------------------------------------
QualityBLUE Physician Pay-for-Performance   QualityBLUE Hospital Pay-for-
 Program.                                    Performance Program
Provider Quality Performance Management
 Department--Medical Management Consultant
 Supported Practices..
------------------------------------------------------------------------

    These programs support and advance the corporation's commitment to 
helping members receive the right care at the right time and are 
aligned with national quality organizations and philosophies in an 
effort to ensure the consistency and relevance of quality topics.
    It is important to Highmark that providers participating in these 
programs achieve the highest levels of performance possible. Highmark 
feels that its strategy to maintain collaborative, supportive and 
productive relationships with providers is paramount to the success of 
not only quality programming, but the company as a whole. Since 
providers are the front line of care delivery, Highmark works 
diligently to cultivate on-going relationships with its provider 
community by providing information and establishing forums to obtain 
feedback and share best practices (newsletters and conferences) through 
the dedication of consultative resources that provide on-site program 
guidance.
    Highmark is committed to providing consumers with cost-effective, 
high-quality health care. By continuing to seek innovative approaches 
to quality improvement, staying engaged with the provider community to 
drive high levels of performance, being an advocate and providing 
programs that serve the community, Highmark remains committed to its 
mission to ``provide access to affordable, quality health care enabling 
individuals to live longer healthier lives.''
    The contents of this report include 2008 program achievements for 
our QualityBLUE Hospital Pay for Performance Program, QualityBLUE 
Physician Pay for Performance Program, achievements derived from our 
Provider Quality Performance Management Department's provider 
engagement efforts and our designated Blue Distinction Centers.
    I am pleased to present the results of our provider quality 
improvement efforts.

                                             Linda Weiland,
                               Vice President, Provider Operations.

    Senator Mikulski. That was excellent, all of it's 
excellent.
    Dr. Gulcher.

   STATEMENT OF JEFF GULCHER, M.D., Ph.D., CHIEF SCIENTIFIC 
                  OFFICER, DECODE, CHICAGO, IL

    Dr. 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 Kari Stefansson and now serve 
as the Chief Scientific Officer. Our company is a member of the 
Personalized Medical Coalition, a group that works to advance 
the understanding and adoption of personalized medicine and 
have attached our white paper on improving health care to my 
written testimony.
    I'm here to tell you that personalized medicine probably 
saved my life. The traditional risk factors that were used 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. Furthermore these are not 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 genetic studies. 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. 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. This is a test that measures eight 
genetic changes in your genome. It can define which 10 percent 
of the population has two-fold 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 prostate cancer 
screening until you're in your fifties 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 an upper normal range, still within 
normal range. But he was concerned enough to refer me to a 
urologist, Bill Catalona 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. 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 6 months ago. Had I waited until my fifties, according 
to the standard recommendations to get my first PSA or screen 
for prostate cancer, there's a good chance that this high grade 
tumor would have spread by that time. Unfortunately for 
prostate cancer, we don't have any chemotherapy that works once 
the tumor has spread beyond the prostate into your bones. 
Inevitably you have a long, painful and very costly to the 
health care system, course then eventual death.
    So I firmly believe that these genetic markers that we 
discovered and developed in a test were at least useful in my 
case to prompt me to have early detection and early treatment 
for my prostate cancer. I expect that others may benefit from 
this approach of targeting higher risk patients who have high 
risk for common diseases, targeting prevention and early 
detection strategies. If, for example we, for every prostate 
cancer or breast cancer that is detected in the early stage as 
opposed to late stage, saves the health care system hundreds of 
thousands of dollars in terms of treatment, palliative care and 
complications.
    For every stroke that you prevent, you save the health care 
system $65,000. So I think personalized medicine has an 
opportunity of making our health care system much more 
affordable for all. Thank you.
    [The prepared statement of Dr. Gulcher follows:]
            Prepared Statement of Jeff Gulcher, M.D., Ph.D.
                           Executive Summary
    The U.S. taxpayer funded the bulk of the human genome project 
creating the draft sequence of 3 billion letters of our genome. 
Combining this knowledge with more cost-effective ways of measuring DNA 
variation in very large patient collections in Iceland, United States, 
and Europe, we have discovered and validated the strongest genetic risk 
markers for prostate cancer, breast cancer, heart attack, and stroke. 
These markers are not determinative as are the genes associated with 
rare genetic diseases like Huntington's disease; rather, they are used 
to define patients who are at higher risk than the general population. 
Genetic risk tests using these markers are clinically available now and 
may be implemented into best patient care practices to target patients 
at highest risk for these common diseases for prevention and early 
detection. This may lead to more cost-effective allocation of 
established diagnostic and prevention strategies to higher risk 
patients, resulting in saving of money and lives.
    While some advocate waiting until we have shown through large 
randomized clinical trials that these markers ultimately change 
outcomes over a 10-year period, such trials would cost billions of 
dollars and ultimately delay the benefits that come from measuring and 
targeting risk today. In contrast to new drugs with unknown safety 
profiles which do indeed require clinical trials to determine risk and 
benefit, the benefit of defining and targeting risk with diagnostic 
tools has been well-validated for these common diseases--the genetic 
risk tests only provide a more complete targeting of higher risk 
patients when added to traditional factors. Therefore, they can 
complement already established best patient care practices today. The 
approach that emphasizes early detection and prevention will transform 
the health-
care from a reactive system to a proactive preventive system with more 
efficient use of resources.
    The costs of genetic testing have also greatly decreased, 
especially when testing for 25 of the most common diseases in parallel. 
DNA fingerprinting using a million markers allows for future updates 
without incurring additional testing charges.
    For example, targeting patients with higher genetic risk for breast 
and prostate cancer for earlier screening or more sensitive screening 
with established diagnostic tests will lead to earlier diagnosis of 
cancer in many who otherwise would be diagnosed with late cancer. For 
every late case of cancer moved forward to early cancer, saves the 
health care systems hundreds of thousands of dollars in treatment, 
complications, and palliative care. My own case of prostate cancer was 
diagnosed and treated in my forties after genetic testing revealed that 
I was at two-fold risk.
    Cardiovascular disease remains the No. 1 cost driver and cause of 
death despite improvements due to LDL-cholesterol treatment. Stroke 
rates continue to climb every year. Genetic risk markers for heart 
attack allow for more accurate assessment of risk and more aggressive 
prevention strategies for those at higher risk than originally thought 
based on conventional risk factors. Genetic risk markers for stroke 
show that the health care system is misdiagnosing the cause of almost 
100,000 stroke patients each year--instead these patients likely had a 
stroke related to atrial fibrillation. Patients who have atrial 
fibrillation as their cause for stroke do not benefit from aspirin or 
Plavix used for other types of strokes. If instead these patients are 
more accurately diagnosed, their stroke rate would be cut by at least 
60 percent through warfarin treatment. By targeting patients with 
higher genetic risk for this common type of stroke for extra outpatient 
cardiac monitoring, tens of thousands of strokes could be prevented 
with billions of dollars in savings by CMS.
                                 ______
                                 
    The U.S. taxpayer funded the bulk of the human genome project 
creating the draft sequence of 3 billion letters of our genome. 
Congress also supported the HapMap project which catalogued the bulk of 
common genetic variation across several populations. Combining this 
knowledge with more cost-effective ways of measuring DNA variation in 
very large patient collections in Iceland, United States, and Europe, 
we have discovered and validated the strongest genetic risk markers for 
prostate cancer, breast cancer, heart attack, and stroke. These markers 
are not determinative as are the genes associated with rare genetic 
diseases like Huntington's disease; rather, they are used to define 
patients who are at higher risk than the general population. Genetic 
risk tests using these markers are clinically available now and may be 
implemented into best patient care practices to target patients at 
highest risk for these common diseases for prevention and early 
detection. This may lead to more cost-effective allocation of 
established diagnostic and prevention strategies to higher risk 
patients, resulting in saving of money and lives.
    The costs of genetic testing have also greatly decreased, 
especially when testing for 25 of the most common diseases in parallel. 
DNA fingerprinting using a million markers allows for future updates 
without incurring additional testing charges.
    While some advocate waiting until we have shown through large 
randomized clinical trials that these markers ultimately change 
outcomes over a 10-year period, such trials would cost billions of 
dollars and ultimately delay the benefits that come from measuring and 
targeting risk today. In contrast to new drugs with unknown safety 
profiles which do indeed require clinical trials to determine risk and 
benefit, the benefit of defining and targeting risk with diagnostic 
tools has been well validated for these common diseases--the genetic 
risk tests only provide a more complete targeting of higher risk 
patients when added to traditional factors. Therefore, they serve to 
complement and enhance the established best patient care practices of 
today. The approach that emphasizes early detection and prevention will 
transform the healthcare from a reactive system to a proactive 
preventive system with more efficient use of resources.
 i. early cancer detection saves money and lives--resources need to be 
   shifted from expensive treatments to smarter screening strategies
    Avastin is thought by many providers to be a wonder drug for late-
stage breast cancer. It chokes off the blood supply to tumors and can 
save the lives of women with late stage cancer. However, it is an 
expensive drug to manufacture and costs up to $100,000 for just the 
drug--accessory costs and palliative care for those who do not respond 
pile on to explode the price tag. Clearly our healthcare system cannot 
sustain such great but expensive technology. For every woman, driven by 
her genes and environment to develop breast cancer, whose cancer is 
diagnosed early instead of late, the health care system saves hundreds 
of thousands of dollars. Like breast cancer, the most common cancer in 
women, prostate cancer is the most common cancer in men. Both cancers 
are the second leading cause of death for their respective sexes and 
major sinkholes of medical costs. These two cancers cannot be blamed on 
lifestyle ills like smoking--so that claiming we can solve this problem 
just by convincing citizens to lead a healthy life is not the answer.
    To save our healthcare system from fiduciary collapse, we need to 
move as many women and men from the late cancer category to the early 
category. How do we do that? Only 5 percent of the health care dollar 
is used to diagnose diseases while 95 percent is devoted to treatment 
of disease after it is diagnosed, early or late. If we can somehow 
allocate a little more of the budget to early detection and prevention 
in patients diagnosed as high risk, we could substantially decrease the 
huge treatment side of the healthcare budget. However, until now, we 
did not have the diagnostic risk tools to measure intrinsic risk for 
future common diseases. The explosion in genetic studies of common 
diseases such as breast and prostate cancers after the sequencing of 
the human genome has led to the discovery of widely replicated genetic 
variants that we are born with that confer risk to common diseases--
that is, we have found a small number of key differences in the 3 
billion letter genetic code that are more common in patients with a 
disease than in normal individuals and can be used to determine who is 
most at risk. These markers are also independent of whether the patient 
has a family history of cancer and so can be useful to define genetic 
risk in individuals without known family history of these cancers, 
which includes 85 to 95 percent of us.
Genetic screening for prostate cancer can identify the 15 percent of 
        the population accounting for 30 percent of cases.
    For example, the only conventional risk factor for prostate cancer 
in white males is family history of early prostate cancer in the father 
or brother--this doubles the risk for prostate cancer from 16 percent 
to 32 percent lifetime risk. Fewer than 5 percent of males have this 
risk factor--therefore, 95 percent of white males are considered 
average risk and are told to wait until age 50 to begin screening for 
prostate cancer by a yearly rectal examination to feel for hard nodules 
of cancer in prostate and yearly blood test measurement of prostate 
specific antigen (PSA). The higher risk patients are encouraged to 
begin screening by age 40 or 45.
    Through our large genetic studies using over 10,000 patients and 
30,000 controls in Iceland, United States, and Europe we recently found 
eight genetic differences which together define 10 percent of the male 
population with a two-fold risk for future prostate cancer. This is the 
same level of higher risk contributed by a family history of early 
prostate cancer. These markers have been confirmed by our laboratory 
and others in tens of thousands of patients and controls and published 
in the leading scientific journals. About 1 percent of the male 
population has a three-fold risk or almost 50 percent chance of 
developing prostate cancer in their lifetime. These genetic risks are 
independent of family history--so about 15 percent of white males 
either have a family history of early prostate cancer or are higher 
risk based on our genetic test--these 15 percent of men account for 30 
percent of all prostate cancer. Some of these markers also further 
increase risk for African-American males who already have a higher 
baseline risk for prostate cancer than white males. Just imagine if we 
can direct extra resources to identifying these higher risk patients 
and then follow them closely and earlier using the existing diagnostic 
methods including yearly examination and blood sampling for PSA, and 
then ultrasound with biopsy as indicated. Higher risk patients who have 
a more subtle rise in PSA may benefit from earlier biopsy as 
recommended by some professional societies. Early detection of prostate 
cancer when the tumor is still restricted to the walnut size prostate 
gland usually results in a cure by surgery or local radiation. In fact, 
no one should die of prostate cancer and the healthcare system should 
not be saddled with the costly treatments of late stage cancer, if most 
patients can be targeted for earlier diagnosis.

Targeting women at higher genetic risk for the common forms of breast 
        cancer even if they do not have a family history.
    Breast cancer may also benefit from focusing on higher risk women 
even if they do not have a family history of breast cancer. Our 
validated test of seven genetic markers can define the 5 percent of 
women who have about a two-fold risk and about 1 percent with a three-
fold risk of the common forms of breast cancer. This test does not 
predict risk for women who have the rare form of breast cancer with a 
strong family history of early cancer, covered already by BRCA1 and 
BRCA2 testing. Instead the test covers risk for the common forms of 
breast cancer which account for 95 percent of breast cancer. The test 
defines another 5 to 15 percent of women who may be higher risk despite 
the lack of family history and who therefore may benefit from earlier 
mammography or breast MRI, which is more successful than mammography 
alone in picking up early breast cancer. Higher risk women may also 
benefit the most from chemoprevention with tamoxifen and raloxifene.

My own case study of how measuring my genetic risk for prostate cancer 
        led to successful early detection and treatment of high grade 
        cancer.
    I have already benefited from these new genetic risk tests for 
common diseases. Last spring I received the results of deCODEme, our 
comprehensive genetic test which measures 1 million markers and 
annotates the genetic risk of 25 common diseases; it also includes our 
prostate cancer test. I found through my online genetic profile that my 
risk for prostate cancer was about twice that of the general 
population. As I was 48 years old at the time, the best patient care 
practice guidelines recommended that I wait until my fifties to be 
screened for prostate cancer by rectal examination and the blood test, 
PSA. However, given my higher risk, my primary care physician ordered a 
PSA, which came back in the high normal range as 2.0 (conventional 
normal range is 0.0 to 4.0 but some have lowered the bar to improve the 
sensitivity of the test). Because the PSA test is not highly accurate, 
patients will normally have repeat measurements of PSA over an 18- to 
24-month period to see if the PSA is rising, indicating that a tumor is 
growing. However, I was referred to a urologist who agreed that I 
should be more aggressively screened for cancer than other men with 
average risk. The urologist biopsied my prostate and found high grade 
cancer on both sides of my prostate which was surgically removed for 
presumed cure. Had I waited a few years before getting screened for 
prostate cancer, there was a good chance that the tumor would have 
spread beyond the prostate. As there is no useful chemotherapy for 
prostate cancer, spread beyond the gland often leads to a long painful 
and expensive course and eventual death. I think it is likely that the 
genes that we discovered and developed into a genetic risk test saved 
my life and will be useful to prioritize resources to early detection 
in other higher risk patients.
ii. targeting more aggressive prevention therapy for patients at higher 
                genetic risk for heart attack and stroke
A common genetic risk factor for heart attack can target some patients 
        who have higher risk than thought based on conventional risk 
        factors.
    Cardiovascular disease is still the No. 1 killer and health care 
expense despite the demonstrated benefit of LDL-cholesterol reduction 
by statin therapy. The number of heart attacks and death rate from 
heart attacks have decreased over the last decade showing the benefit 
of screening for higher risk patients using traditional risk factors 
like blood pressure, cholesterol, diabetes, and smoking, and treating 
each risk factor. Best patient care practice guidelines also recommend 
compensating for overall risk by further reducing LDL-cholesterol 
levels below normal in higher risk patients. However, we do not yet 
know all risk factors for cardiovascular disease and further 
improvement can be made by more accurately measuring cardiovascular 
risk once we do. We and others discovered a new major risk factor for 
heart attacks that is based on a common genetic factor that 20 percent 
of the general population has. This genetic marker has been replicated 
in tens of thousands of patients and controls in the United States, 
Europe, and Asia and is very easy to measure in a blood sample or inner 
cheek swab. It is clinically available from our regulated reference 
laboratory. It is as important as LDL-cholesterol in terms of its 
magnitude of risk. Prospective studies have shown that the genetic 
marker significantly improves the accuracy of MI prediction--it 
reclassifies some who are thought to be of average risk into a higher 
risk category. Best patient care practice guidelines would suggest that 
those patients would benefit from a lower LDL cholesterol target level 
to compensate for their higher risk.

The strongest genetic risk factor for strokes can help diagnose and 
        treat a hundred thousand patients, annually, who have 
        undiagnosed atrial fibrillation as their cause for a stroke.
    Despite the successes in reducing the number of heart attacks using 
risk measurement and targeted statin therapy, the annual rate of 
strokes continues to rise-- this year there will be an estimated 
800,000 strokes and 300,000 ministrokes (TIAs) in the United States. 
Soon strokes will surpass heart attacks as the most frequent 
cardiovascular event. Much of the increased stroke rate is due to the 
aging of the population stemming in part from reduction of death rates 
due to heart attacks. However, statins are not as effective in 
prevention of strokes as they are for heart attacks, probably because 
the causes of strokes are not all tied to atherosclerosis (hardening of 
the arteries).
    We discovered and validated genetic markers that doubles a 
patient's risk for atrial fibrillation, a common cause of heart rhythm 
disturbance. Atrial fibrillation (AF) is known to cause about 15 
percent of strokes (causing a blood clot to form in the heart and to 
move to the blood vessels to the brain). However, we have shown and 
confirmed in numerous populations that the genetic markers for AF are 
the strongest genetic risk factors for strokes in general. Our work 
showed that AF is a much more common cause of a stroke than originally 
thought. As many as a third of patients diagnosed with carotid strokes 
or with strokes of unknown cause, instead have AF that is not 
originally detected while they were hospitalized for their stroke. We 
estimate that at least 100,000 patients each year are misdiagnosed as 
having carotid stroke or a stroke of an unknown cause instead of having 
AF as their cause for stroke. This means that AF strokes are twice as 
frequent as currently thought. This is a large problem because 
prevention of an AF stroke is different than prevention of other types 
of strokes. Anti-platelet drugs like aspirin and Plavix reduce carotid 
and small-vessel stroke risk, but they have little or no effect on AF-
related strokes. Instead, warfarin is the drug of choice for AF strokes 
and reduces the stroke rate by 60 percent to 70 percent. AF-related 
strokes are the worst strokes to have since they cause greater 
disability and higher death rates than other types of strokes. The 
recurrence rate of an AF-related stroke is higher as well--12 percent 
to 19 percent of AF stroke patients will have another stroke within the 
first year.
    Defining patients at highest risk for AF using genetic markers and 
other risk factors may lead to more targeted outpatient cardiac 
monitoring, resulting to better primary and secondary prevention of AF 
strokes. Because each stroke prevented saves the health care system an 
average of $65,000 over 4 years, the ramifications of targeted 
prevention are immense in terms of saving of costs and lives. For 
example, successful prevention of just half of the 100,000 AF strokes 
per year could save CMS billions of dollars. Because African-Americans 
have a higher risk for a stroke than whites, this approach may have an 
even greater benefit to address this healthcare disparity.
                                 ______
                                 
           Attachment.--Personalized Medicine Coalition (PMC)
   Personalized Medicine and Healthcare Reform: Policy that Protects 
              Innovation While Improving Value and Quality
    Policies intended to bring about healthcare reform could have 
significant implications for the adoption of personalized medicine. The 
Personalized Medicine Coalition (PMC) has developed a set of policy 
recommendations to ensure that the potential for personalized medicine 
to improve healthcare quality and affordability is appropriately 
reflected in policies that may emerge as a result of the healthcare 
reform debate.

    The PMC represents a broad spectrum of academic, industrial, 
patient, provider, and payer communities, and it supports healthcare 
reforms that improve quality and affordability while fostering 
continued medical progress. PMC believes meaningful healthcare reform 
must encourage continued advancements in personalized medicine and 
that, to help achieve the goals of high-quality, affordable care for 
all Americans, health reform should:

     Support and incentivize medical research in the public and 
private sectors;
     Establish a national initiative to advance collaboration 
in support of personalized healthcare across Federal health agencies;
     Encourage adoption of a national health information 
infrastructure;
     Research and identify care delivery and management models 
that encourage effective, evidence-based disease prevention and care 
coordination;
     Develop and apply research findings in ways that empower 
providers and patients by reflecting differences in individual needs; 
and
     Ensure that relevant provider performance measures and 
incentives support the adoption of new personalized medicine 
interventions.

    Reform of our national healthcare system has gained fresh 
prominence as a top-line issue for Americans and will be high on the 
agenda of the new Congress and presidential administration. Covering 
the uninsured, improving healthcare quality, and controlling rising 
healthcare costs all will be central themes in this debate.
    The renewed discussion of healthcare reform coincides with a time 
when significant and rapid advancements in genomics and other relevant 
areas of science and technology are accelerating the emergence of 
personalized medicine. Personalized medicine uses new methods of 
molecular analysis to better manage a patient's disease or to assess 
that patient's pre-disposition toward a disease. The field includes 
genetic tests and other types of diagnostics, as well as targeted 
therapies. It helps providers and patients achieve optimal health 
outcomes by preventing or intervening early in the onset of disease and 
by identifying the approaches to treatment and care that are best for 
each individual.
    Medical advances arising through the science of personalized 
medicine, particularly when combined with health information 
technology, hold great promise for improving the quality and value of 
healthcare. In turn, healthcare reform holds significant implications 
for personalized medicine. In particular, policy measures designed to 
control costs and expand access--but that fail to encourage continued 
development and adoption of personalized medicine--could substantially 
delay or diminish opportunities for meaningful, measurable improvements 
in healthcare value and quality.
                 thinking differently about healthcare
    There is no question that the U.S. healthcare system needs reform. 
Almost 46 million Americans are uninsured.\1\ Nearly $2 trillion is 
spent annually on healthcare in the United States, and national health 
spending as a percentage of gross domestic product is projected to hit 
20 percent by 2016.\2\
---------------------------------------------------------------------------
    \1\ ``Household Income Rises, Poverty Rate Unchanged, Number of 
Uninsured Down.'' U.S. Census Bureau. http://www.census.gov/
PressRelease/www/releases/archives/income_wealth/012528.htm/. August 
28, 2008.
    \2\ Poisal JA, ET al. Health Spending Projections Through 2016: 
Modest Changes Obscure Part D's Impact. Health Affairs. 21 February 
2007:W242-253. Via ``Health Insurance Costs.'' National Coalition on 
Health Care. http://www.nchc.org/facts/cost.shtml. Accessed October 21, 
2008.
---------------------------------------------------------------------------
    When considering the growing burden healthcare costs place on our 
national economy, our healthcare and research infrastructure, and on 
our individual finances, policymakers may be tempted to focus on 
seemingly expedient fixes, such as aggressive government price controls 
and access restrictions, applying rigid evidence standards to achieve 
short-term cost-containment goals, or by cutting back on covered 
benefits.
    While such solutions may provide some short-term relief in 
healthcare spending (likely accompanied by a sacrifice in quality and 
health outcomes), they would ultimately raise system-wide costs, stifle 
valuable opportunities for improvements in care and outcomes, and 
undermine the continued development and adoption of personalized 
medicine as the model for effective, state-of-the-art healthcare 
delivery in the United States. For example:

     Proposals that seek to contain costs by promoting the 
least expensive treatment on average, rather than the best care for the 
individual, will discourage the development and adoption of gene-based 
diagnostic tests and targeted therapies, which can have a higher up-
front cost but will offer substantial clinical and economic benefits 
over the long-term;
     Cost containment proposals that impose access restrictions 
based on average, population-wide study results will overlook the 
different needs of individual patients and discourage adoption of 
personalized tests and therapies based on these differences;
     ``Pay for performance'' programs focused on short-term 
provider efficiency could discourage physicians from using gene-based 
tests and targeted therapies to optimize care for the individual; and
     A focus on cutting costs in narrow healthcare sectors will 
fail to optimize patient care and improve care coordination across care 
settings, which is essential to achieving the promise of personalized 
medicine.

    Alternative approaches are available that support medical progress 
in areas like personalized medicine while improving healthcare quality 
and affordability. An overview of such approaches is provided below.
 the policy agenda: delivering on the promise of personalized medicine
    Reforms to achieve care that is preventive, coordinated, evidence-
based, and personalized hold the greatest promise for improving 
healthcare quality and affordability. To support continued progress in 
personalized medicine, policymakers should support healthcare proposals 
that:

    1. Invest in the science and practice of personalized healthcare 
by:

    (a) Supporting basic research in the public and private sectors by 
creating new incentives for private sector research and expanding 
funding for the National Institutes of Health and public-private 
initiatives to accelerate the science of personalized medicine. Of 
particular importance is the growth of Federal investment and resources 
for educating and training the next generation of research scientists, 
especially those focused on genomics and personalized medicine.
    (b) Support Federal research and policy to identify and support 
timely adoption of the medical interventions and health system tools 
needed to support the emergence of personalized medicine through a 
national ``Personalized Medicine Advisory Commission'' (PMAC). The 
advisory commission would oversee and provide input on Federal 
activities to conduct and synthesize outcomes research in support of 
evidence-based, personalized health care decisions by physicians, other 
providers and patients. Commission activities would include: 
recommending research priorities on the range of medical and health 
system interventions (such as diagnostic tests, therapies, and 
approaches to organizing and managing care) that are important to the 
advancement of personalized medicine; supporting development of methods 
for conducting and communicating research in ways that enable or 
enhance the delivery of personalized medicine; and recommending policy 
approaches that support delivery of personalized medicine.

    2. Support for research to identify what works in healthcare 
(comparative effectiveness research) that:

    (a) Encompasses all of the elements of care relevant to high-
quality, personalized healthcare, including research on diagnostic 
tests and therapies, processes of care, chronic care prevention and 
management programs, and approaches to healthcare delivery and benefit 
design.
    (b) Generates and communicates evidence in ways that support 
personalized medicine by accounting for differences in treatment 
response and preferences among individuals and sub-groups.
    (c) Applies evidence in ways that support personalized medicine by 
ensuring that emerging health information technology platforms and 
performance measurement initiatives support the physician's ability to 
optimize individual care based on the range of treatment options.

    3. Support coverage for preventive services that are facilitated 
through emerging personalized medicine advances. The science of 
personalized medicine promises new tools--like genetic predisposition 
testing--that enhance the ability of individuals and caregivers to 
engage in early disease prevention and pre-emption. Steps should be 
taken to identify and support evidence-based screening, predisposition, 
and risk-assessment tools that can help predict an individual's risk 
for future disease. Additionally, as described above, health reform 
proposals should include provisions to identify approaches to care 
delivery and coordination and benefit design that support adoption of 
predictive and preventive care for these patients.
    4. Adopt Federal health information technology (HIT) and e-
prescribing standards that inform treatment decisionmaking based on the 
range of treatment options--taking individual genetic characteristics 
and other factors into consideration.
    Adoption of HIT is an important building block to support 
preventive, predictive medicine and early disease intervention and to 
enable higher quality, more efficient healthcare. According to the RAND 
Corporation, HIT adoption could save and improve many patients' lives, 
as well as cut up to $81 billion a year in health costs.\3\
---------------------------------------------------------------------------
    \3\ ``RAND Study Says Computerizing Medical Records Could Save $81 
Billion Annually and Improve the Quality of Medical Care.'' RAND 
Corporation. http://www.rand.org/news/press.05/09.14.html. September 
14, 2005.
---------------------------------------------------------------------------
    HIT and e-prescribing standards adopted by the Federal Government 
should provide for transmitting and communicating information on 
personalized healthcare technologies. HIT decision-support platforms, 
including e-prescribing, should facilitate communication of information 
in ways that enable physicians and patients to consider risk and 
benefit trade-offs of a range of treatment options and to understand 
how these trade-offs may vary depending on an individual's genetic 
profile. Tools that obscure these differences by applying overly 
simplistic population-based comparative evidence or narrow cost-cutting 
targets will discourage the evolution of personalized healthcare.
    To give patients and providers all of the information that they 
need to deliver personalized care, e-prescribing platforms should be 
integrated with the individual's electronic medical record (so that 
information on diagnostic test results, co-morbidities, etc. can be 
used for optimal treatment decisionmaking). HIT and e-prescribing 
standards also should enable rapid appeals and prior authorization 
decisions based on results of molecular diagnostics and other 
personalized medical information.
    5. Adopt performance measures/incentives that facilitate healthcare 
interventions based on personalized healthcare technologies. Healthcare 
performance measures adopted by Federal agencies should help physicians 
tailor interventions (including tests, treatments, and care management 
approaches) based on personalized healthcare technologies. Healthcare 
measures that cover a broad ``episode of care'' and longer-term 
outcomes, rather than point-in-time interventions and short-term 
outcomes, may be one step that supports this approach.
    Provider incentives based on performance measures should allow for 
exceptions based on individual genetic variations. This allowance will 
ensure that physicians are not penalized for delivering optimal care 
for patients who differ from the ``average'' patient population.
    Performance measures that define economic outcomes should account 
for differences in treatment cost that may arise as the result of 
delivering optimal, personalized care based on genetic test results and 
other information.
    6. Improve care coordination. Health policies that shift the focus 
to disease prevention and care coordination will support the adoption 
of personalized medicine and also offer a key solution for healthcare 
quality and affordability. Ultimately, through policies that help move 
us toward consistent delivery of the right treatment for the right 
patient at the right time, the entire system will benefit from higher 
quality, more affordable, personalized care.
    Developing chronic care management tools that make use of the 
science of personalized medicine, for example, can help the more than 
133 million Americans who suffer from one or more chronic 
conditions.\4\ They also can make healthcare more affordable: By making 
basic improvements in preventing and managing chronic disease, the 
United States could save $1.1 trillion in 2023, including $218 billion 
in savings from direct treatment costs.\5\
---------------------------------------------------------------------------
    \4\ ``The Growing Crisis of Chronic Disease In the United States.'' 
Partnership to Fight Chronic Disease. http://
www.fightchronicdisease.org/pdfs/ChronicDiseaseFactSheet.pdf. Accessed 
October 21, 2008.
    \5\ ``An Unhealthy American: Economic Burden of Chronic Disease--
Charting a New Course to Save Lives and Increase Productivity and 
Economic Growth.'' The Milken Institute. http://
www.chronicdiseaseimpact.com/ and http://www.milkeninstitute.org/. 
October 2007.
---------------------------------------------------------------------------
     personalized medicine: a critical element of healthcare reform
    Advances in personalized medicine exemplify the opportunity for 
meaningful improvement and greater value in the healthcare system--
central objectives of healthcare reform. As a result of targeted 
therapies and other advances in cancer care, for example, survival 
times of metastatic breast cancer increased by 30 percent during the 
1990s.\6\ New, biomarker-based treatments are dramatically enhancing 
diagnosis and increasing effectiveness and safety of medical 
interventions, which in turn can help contain overall healthcare costs 
by avoiding expense from complications that might otherwise result from 
the wrong diagnosis or treatment, improving patient adherence to 
therapy, and helping to prevent disease before it emerges.
---------------------------------------------------------------------------
    \6\ Chia SK, ET al. The impact of new chemotherapeutic and hormone 
agents on survival in a population-based cohort of women with 
metastatic breast cancer. Cancer. 2007;110(5):973-979.
---------------------------------------------------------------------------
    In contrast, health reform approaches that seek to contain costs by 
restricting access to and delaying the adoption of medical innovation 
will hamper the continued development of personalized medicine and 
ultimately perpetuate outdated approaches and inadequacies that 
continue to drive system-wide costs up.
    Based on our growing understanding of human genomics and related 
fields, personalized medicine can give us an unprecedented ability to 
address unmet health needs in ways that:

     Prevent disease by identifying an individual's likelihood 
of developing it in the future and by enabling individualized 
approaches to address key risk factors;
     Detect the onset of disease at the earliest stages based 
on new biological markers and changes at the molecular level to pre-
empt disease progression; and
     Tailor treatments to each patient based on genetic and 
other factors, so each individual receives the safest, most effective 
care available for them.

    Advances in personalized medicine can help bring about a new era in 
which medicine is pre-emptive, predictive, and patient-centered. 
Policies crafted with personalized medicine in mind will empower 
clinicians with the tools and information they need to deliver the 
right treatment to the right patient at the right time (the first 
time)--and ultimately benefit patients by significantly enhancing the 
quality, value, and safety of the treatment and care that they receive.
                               conclusion
    America stands on the cusp of significant scientific advances that 
promise to usher in a new era of personalized medicine. We also stand 
at the threshold of a new debate about how to address challenges with 
healthcare access, quality, and cost.
    A supportive policy framework is needed to foster and help sustain 
research, development, and adoption of personalized medicine-based 
technologies and treatments. The Personalized Medicine Coalition 
supports healthcare reforms that improve quality and affordability 
while fostering continued medical progress, and it commits to advancing 
patient care through development and adoption of evidence-based, 
personalized medical technologies and care delivery models. By 
incorporating the elements described above, healthcare reform can 
facilitate the advancement and adoption of new personalized medicine 
technologies while meeting the challenge of improving access, quality, 
and affordability.
                         Additional References
``Genomics and Personalized Medicine Act of 2008.'' 110th Congress, 1st 
    Session, S. 976.
``Genomics and Personalized Medicine Act of 2008.'' 110th Congress, 2nd 
    Session, H.R. 1A6498.
``Priorities for Personalized Medicine.'' The President's Council of 
    Advisors on Science and Technology. http://www.ostp.gov/galleries/
    PCAST/pcast_report_ 
    v2.pdf. September 2008.
``Personalized Health Care: Opportunities, Pathways, Resources.'' U.S. 
    Department of Health and Human Services. http://www.hhs.gov/
    myhealthcare/news/personalized-healthcare-9-2007.html. March 23, 
    2007.
``The Obama-Biden Plan to Combat Cancer.'' Obama for President. http://
    www.barackobama.com/pdf/issues/healthcare/
    Fact_Sheet_Cancer_FINAL.pdf. Accessed October 20, 2008.
``2008 Republican Platform on Healthcare.'' The Republican Party. 
    http://www.gop.com/2008Platform/HealthCare.htm. Accessed October 
    20, 2008.
Deverka, ET al. Integrating molecular medicine into the U.S. health-
    care system: opportunities, barriers, and policy challenges. 
    Clinical Pharmacology and Therapeutics. 2007;82(4):427-34.
Tucker L. ``Pharmacogenomics: A Primer for Policymakers.'' National 
    Health Policy Forum. http://www.nhpf.org/pdfs_bp/
    BP_Pharmacogenomics_01-28-08.pdf. January 28, 2008.
``Former CMS Administrator: `Blunt instrument' policies an increasingly 
    bad fit in era of personalized health care.'' http://
    www.reuters.com/article/pressRelease/idUS228875+16-May-
    2008+PRN20080516. May 16, 2008.
A Letter from the Personalized Medicine Coalition to Senator Max Baucus 
    on Comparative Effectiveness Research (CER). http://
    www.personalizedmedicinecoa- lition.org/objects/pdfs/
    PMC_CER_Baucus_2007_1116.pdf. November 16, 2007.
``The Case for Personalized Medicine.'' The Personalized Medicine 
    Coalition. http:
    //www.ageofpersonalizedmedicine. org/personalized_medicine/
    today_case. asp. November 16, 2006.

    Senator Mikulski. Well, first of all thanks to the panel. 
I'm going to go by the 5-minute rule so we all get a chance to 
ask our questions. Then if there's 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 time.
    Dr. Fischer. No, I would not take authorship on that. It's 
a common patient safety.
    Senator Mikulski. 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 during the amputation for 
the diabetic who's drinking two beers and two Coca Colas 
everyday in preventing infection using Dr. Pronovost then goes 
to what I'm talking about.
    What I note in your four points that are your guiding 
things, 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 the 
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. 
There are people who like, kind of resent coaches. Then you 
have a nurse practitioner or a physician's assistant or a 
diabetic educator who's a coach. Highly educated, credentialed, 
certified, you know, meeting their own quality standards to be 
a ``coach.'' Could you elaborate?
    First of all, do you agree that we need the continuum? 
Obviously you do. Then how did you achieve that? How did you 
have the financial payments to accomplish it?
    Dr. Fischer. Well thank you for the question. First of all, 
right care. I would include in the concept of right care, 
prevention and appropriate ownership by an individual of 
behavioral lifestyles that impact ultimate health.
    So that's embedded in there. We firmly believe that 
prevention and then wellness programs have benefit. 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 and is in 
my written documentation, accounts for well over 50 percent of 
the bonus opportunity. Many of those had to do with preventive 
screenings and preventive exams. So well child care visits for 
instance at the appropriate ages.
    Senator Mikulski. Can you give me a case example about how 
it all works?
    Dr. Fischer. In 3 more minutes?
    Senator Mikulski. Yes, go ahead.
    Each one of these has an area. But it comes down to most of 
our private payers come through, I think, Blue Cross or a 
variation of a high level health care provider. And we use 
words like coaching but nobody knows what it means.
    Dr. Fischer. OK.
    Senator Mikulski. We don't know how to do the legislation. 
Then we leave it to the Finance Committee to talk about 
financial incentive. We have to have health insurance reform, 
not health care financial reform.
    Dr. Fischer. Let me talk about coaching then. What we have 
done for about 10 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 in the numerator.
    How do we work to increase the rate at which, say, you get 
preventive exams for the 3- to 6-year-old population and set up 
a system? It may be that although they have an electronic 
system that can help accommodate that, but first they need to 
understand systematic approaches.
    It may be a paper system. But by doing that learning 
process improvements, spending the time it takes to improve, 
they can get better results. They have found that these medical 
management consultants and medical directors 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.
    Senator Mikulski. And looking over your shoulder 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 the practice working 
with them. They see their bonus opportunity increase. They see 
that their results are better. They see improved satisfaction, 
frankly, among their patients.
    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're there with a common goal.
    Now these medical management consultants, many of them are 
advanced practice nurses. Some of them are people who've spent 
time in prevention. If I'd look at our member coaching which is 
telephonic, the wellness coaching, some of that is done by 
exercise physiologists, by dietitians. But we try to get the 
right skill set to the right person to meet their needs.
    Senator Mikulski. So you actually do two types of coaching? 
One is to those who actually are the providers, the clinicians.
    Dr. Fischer. Yes.
    Senator Mikulski. And help them organize their practice and 
these are one set of professionals to another set of 
professionals.
    Dr. Fischer. Correct.
    Senator 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 increased opportunity for bonuses if you work with us. The 
benefit is you get data and you get assistance with practice 
improvement and a better payout.
    Senator Mikulski. But you incentivized also for them to 
invite you in to look at what's going on.
    Dr. Fischer. Right. 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. Your 
data is wrong.''
    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, ``OK.''
    Let us help you pull charts and let's really look through 
the charts. The real number would turn out to be 61 percent. 
And we would 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 they need.
    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? 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, and help them to adhere better to what 
the physician has asked them to do.
    Senator Mikulski. Then would you escalate? Escalate is not 
the right term. But elevate it?
    Let's take the case I gave you of the diabetic. That person 
got a call. But say they're A1C was still in the danger zone, 
obviously when I just described to 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 ask what is it that you eat and 
drink every day?
    Dr. Fischer. Yes.
    Senator Mikulski. I mean a practical question like that. 
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 of 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. 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.
    Senator Mikulski. What would happen with this type of 
patient in your system? How would the problems be identified? A 
dangerously elevated A1C, what would that trigger, because both 
the primary care and the specialist in diabetic endocrinology 
would be aware of this.
    Would contact be made by telephone? Would they call the 
patient 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 have 
your health coach call, reach out to them and spend the time? 
Get them in a program that will be helpful. We have a variety 
of programs that can be done in person, online or 
telephonically.
    The other way is through claims. That we would be able to 
find people who are at the highest risk, who 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.
    If, in fact, there's a crisis, 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. We could say, ``How can we help?''
    Senator Mikulski. Well I'm going to now turn to my 
colleagues. But this is where health IT, that was standard and 
interoperable, would work because you would all have the data. 
There would be flashing yellow lights from the individual 
patient.
    Well, thank you.
    Dr. Fischer. Well, 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. It should be health plan neutral.
    Senator Mikulski. Great. That's great.
    Senator Brown. Thank you, Madame Chair. Dr. Pronovost, your 
comments about seeing health care delivery as a science are 
just exactly right. By your illustration of a penny on the 
dollar, the incredible advances we've made in science are far 
and away the best ever in human history, obviously. The best of 
any place in the world in the way we deliver is such a huge 
gap.
    Thank you for that and for your suggestion that there 
should be an institute which I think might be something that 
we'll look at. I mean, I would like to seriously consider an 
institute. I think we might look at locating those--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 and 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 something else. But I will start with Dr. 
Pronovost.
    The catheter line infection issue, the checklist and I know 
you've worked the checklist 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 interested in figuring out how we bring this life saving 
mechanism and cost cutting mechanism to my State. The system is 
so fragmented, obviously, that's it's difficult State by State 
or any other way.
    How do we do this? Do we only do this through NIH? I mean, 
obviously setting up an institute is one way. 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. I want to bring to Ohio. Talk that through how 
prescriptively we should do that.
    Dr. Pronovost. Sure. Thank you for the 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 of 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?
    Then you would have management and financial incentives 
putting that science into practice. Right now that flow of 
knowledge is discontinuous. There are no gaps in this.
    The tail that I'm on is virtually nonexistent. It's not 
funded. Comparative effectiveness isn't much better. There 
needs to be this continuum of knowledge.
    How does it work? Well I think we have to find out 
programs. 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.
    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. The reason is, there's 
infrastructure at the States.
    People care about the care that their citizens receive. I 
think that model works. 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.
    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 at the Cleveland Clinic. But I have a 
commitment to say the citizens of Ohio deserve safe care.
    We're going to make sure that no matter where they go, 
we're not competing on safety or high quality of care that a 
health system that spends $2 trillion should guarantee safe 
care to our citizens. In this case to the citizens of Ohio that 
wherever they choose care that it will be safe. Someone has to 
coordinate what I call the technical components. How you're 
going to measure that? What is the evidence summary?
    Ideally as we're working now it could be Federal agencies. 
So the CDC has a way to measure these things. We ought to be 
partner-
ing with those Federal agencies.
    But ultimately it's the doctor and nurse at the bedside, 
individual hospitals. It's the managers creating financial 
incentives with insurers, with management. Without this whole 
spectrum we're going to lose our pre-eminent 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.
    Senator Brown. Thank you. Let me shift fairly dramatically. 
Dr. Fischer, the whole issue of antibiotic resistance is 
obviously complex.
    There's the use of antibiotics, of prophylactic use in 
animals as we pack the chickens or beef closer and closer 
together and feed them antibiotics partly for growth, partly 
for prophylactic purposes. The antibiotic resistance that might 
create the overprescribing from doctors on demands from 
patients. That even if I have a virus, if my young daughter has 
a virus I want an antibiotic because I think I want an 
antibiotic. The doctor certainly goes along. 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 over prescribing antibiotics?
    Dr. Fischer. Well there are two pieces to our program with 
paper performance for primary care that touch on that.
    One is advocating for greater use of generic medications. 
Very often the first line medication for common bacterial 
infections has a generic alternative.
    The second is through an indicator we call the pharyngitis 
indicator which is also a heatus indicator. We measure 
practices who have filed a claim for a patient with a diagnosis 
of pharyngitis 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 cause of pharyngitis that requires 
an antibiotic is strep throat.
    Strep is a dumb germ. It's killed by penicillin still. OK. 
There are very few people, some people who are allergic. So 
there would 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.
    Senator Brown. Well, I get the second part of your answer. 
The first part sounds more like cost containment, which is fine 
that it does dealing with antibiotic resistance because if 
you're just substituting generic you're still--the doctor if 
he/she wrongly prescribes is still contributing to perhaps 
antibiotic resistance, right? If you're only substituting 
generic, it seems to me that it's 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.
    Senator Brown. Right. OK, OK, fair enough.
    Dr. Fischer. If you're giving the right drug for the right 
diagnosis, you're fine.
    Senator Brown. Well if I could add one real quick point, 
Dr. Fischer. This doesn't save you money except for later 
illnesses perhaps in the patient which does save you money. But 
is part of this making sure that the doctor spends the time 
with the patient to make sure the antibiotic is taken 
correctly? Is that contributing significantly to the problem of 
antibiotics? I mean I just go back to years ago before I ever 
thought about any of this if I had gum surgery or something and 
was taking penicillin or some other antibiotic I was supposed 
to take it for 10 days and after 7 days I felt OK.
    Just like, particularly with tuberculosis we see that all 
the time. Particularly developing a role in other places where 
they quit taking it after they quit coughing. Is that part of 
your regimen 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 regimen is a problem. 
And in the antibiotic world that leads to resistance.
    We have focused on adherence to other kinds of medication 
that were supposed to be taken chronically. Whereas for 
instance we have seen marked increases in the rate at which 
beta blockers are prescribed to patients with acute myocardial 
infarction when they leave the hospital. That's something we 
really don't need to incent anymore.
    But if you look at what's happened to those same patients 6 
months later, it drops to about 30 percent of that patient 
population still taking the medication they're supposed to be 
on chronically. That's a problem. We now use that as an 
indicator. What's the persistence of adherence?
    That is both a physician issue and a patient issue. Both 
need to be educated and incented to work on that.
    Senator Mikulski. And a discharge planning issue.
    Dr. Fischer. Yes.
    Senator Mikulski. We're going to turn to Senator Kay Hagan.
    But if you watch people leave the 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? I think that goes to something else.
    But it's Senator Kay Hagan's time.
    Senator Hagan. 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 blood stream infections.
    But you also talked about how patients sometimes get an 
epidural pain medicine connected to an IV catheter which could 
then have lethal errors. Then you talked about how most of this 
could be solved through product design and intervention and 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. Since people are human and you talked about 
you'd educate, but at some point in time something is going to 
happen.
    What would it take to have that small design take place? I 
think about just putting gasoline in my car. I mean, the diesel 
is not going to fit in the unleaded. The leaded is not going to 
fit in the unleaded. Basic, basic product design.
    Dr. Pronovost. Thank you for picking that up Senator 
because I didn't have time to go about it. In our work to 
improve safety, we recognize that there are types of problems 
that are not putting evidence into practice that you've heard 
about. But there's another type of problem that we talk about--
not learning from mistakes.
    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. Our response is to re-educate. The 
probability that re-education works scientifically is close to 
zero.
    Yet, if you think it's an hour to educate every doctor and 
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. Then work with the 
manufacturers to either require or 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. It's a shame 
because we've been working now for 9 years to get a national 
error reporting system. As you know we now have that with the 
Patient Safety Organizations. But there is no mechanism to 
create this forum.
    We were fortunate enough to get a C grant from the Robert 
Wood Johnson Foundation to pilot test what would this system 
look like in health care, to plan it out. We were 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 
creating this. This public/private partnership ought to be 
created and funded because it's much more cost-effective to re-
design equipment. I mean 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 push the wrong 
button on the defibrillator or delayed pushing it because they 
couldn't figure out what to push. Right. And that we can tell 
them to be smarter, but that's a design problem. We have to 
design it so they don't happen to go and just--I love your 
example of the gasoline so they can't stick the wrong hose in.
    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.
    Senator Hagan. Thank you.
    Dr. Gulcher, you talked about the potential for the genetic 
testing for improving patient outcomes and obviously reducing 
costs 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. We've made several of these tests already 
clinically available through a federally regulated CLEA 
laboratory where we run the test and provide that. They're not 
FDA-approved, but they're under the CMS regulations for CLEA.
    Each of the markers----
    Senator Hagan. Right, for what now?
    Dr. Gulcher. For the genetic tests that we offer.
    Senator Mikulski. She wants to know what CLEA is.
    Dr. Gulcher. I'm 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 common form of breast cancer as 
distinguished from the highly familial form that Myriad runs 
their test for, BRAC-1, BRAC-2, also for stroke. We also have 
tests for myocardial infarction and Type II diabetes. But from 
those particular 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. In some cases they change how they treat the 
patient in terms of prevention for heart disease based on the 
extra genetic risk factor that's independent of the 
conventional risk factors for heart disease. So they're already 
being used today.
    In terms of evidence that it saves money in the long run, 
we don't have data like that. We certainly would like to work 
with payers and other organizations to actually demonstrate 
that as a demonstration project to do comparative effect and 
also look to see how it might save money. But I have to say 
that with your example about how one can change behavior of 
payers, the stakeholders, the payers, physicians and the 
patient.
    Let's say in the context of Type II diabetes. We heard from 
Dr. Fischer they have a coaching staff, right? But they're 
going to have to make decisions on who gets coaching, perhaps 
or maybe there is more intensive coaching for those who are at 
highest risk.
    So for those who let's say have pre-diabetes. They're 
already at risk for Type II diabetes. Some of our tests show 
that patients who have pre-diabetes are even at a higher risk 
for converting to Type II diabetes ultimately.
    Here's an opportunity to help prevent Type II 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 do something different 
with their diet. It will motivate the patient to call on the 
services of coaching, perhaps, to try to get the patient to 
change their behavior and 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 man 
power. 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.
    Senator Mikulski. Senator.
    Senator Hagan. Thank you, Madame Chairman.
    Senator Mikulski. Those were excellent. I'm going 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. We really welcome his participation 
today.

                            Senator Bingaman

    Senator Bingaman. Well thank you very much. 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--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 at Johns Hopkins with regard 
to the catheter-related blood stream 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.
    If you look at this geographic variation in the use of 
care, I'm sure you've seen how those regionally 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.
    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, OK for Mrs. Smith and with this 
genetic variation this is what you need or you respond to this 
therapy.
    It's one of my pleas that health technology, if it's 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? And so that link has to be.
    As to your question about the VA and the DOD, we've worked 
with Jim Bashin at the VA and the 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 Sorrel 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 Representative Waxman, 
after the GAO Report surveyed the country and only 11 States in 
his report actually were measuring these infections right now.
    Senator Bingaman. As you understand it the VA doesn't 
measure them?
    Dr. Pronovost. I don't think as a system that they are----
    Senator Bingaman. And neither does our military health care 
system.
    Dr. Pronovost. Yes, I don't. As I said, I know that we've 
met with them. They are interested in using it.
    But when we had discussions about overall, you know 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.
    Senator 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. Pronovost. Completely agree.
    Senator Bingaman. 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 at Johns Hopkins with regard to these catheters 
is--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. Pronovost. Right. Right. Senator, I agree. What we've 
seen in the financial incentives is often that politics or 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 to flip it, the science has to drive. It's got 
to go back to its rightful place and drive the payment on.
    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. I completely agree.
    Senator Bingaman. That policy would be that the----
    Dr. Pronovost. That the marginal cost of these infections 
are not paid for. That as CMS has done for this, but for other 
things on the list that we don't know yet how to do.
    Senator Bingaman. In Medicare and in Medicaid.
    Dr. Pronovost. Correct. 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. Science emerges. We may learn next week that 
there's a better thing on the checklist.
    What we 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 do the items on the 
checklist. If 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.
    Senator Bingaman. Thank you, Madame Chairman.
    Senator Mikulski. We have time to go another round if 
members are interested.
    Senator Bingaman, looking 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. Do 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.
    But let me go to my question, first to Dr. Pronovost about 
the checklist and then a question about the implementation goes 
to Dr. Pearson and everybody.
    You said in 32 States they don't use this. One of the 
questions that I asked was, Why doesn't everyone introduce a 
checklist? It's a piece of paper.
    It's not find a new technology. It's not re-designing the 
catheter, interlocking gadget, you know, system with FDA and 
all of that. Then somebody said, ``Well, no one's paying for 
it.''
    What is there to pay to implement the package? What is it 
that we need? Why do we need to pay people to implement a 
checklist?
    And second, so that's a general related question. That's 
more abstract. But what are the barriers in the way of a new 
tech? A solution that could either be paper or digital?
    I'm going to ask you that question. I'd like to zip down to 
anyone on the panel who'd like to jump in. And then I want to 
come back to we have a National Institutes of Health, but not a 
National Institutes of Quality which goes to your question--Dr. 
Pearson's really important contribution on the comparative 
research effectiveness issue.
    So do you want to kick that off ?
    Dr. Pronovost. I absolutely will. Your experience as a 
social worker is clearly coming through in thinking of these 
barriers. Now let me be clear when the GAO Report, after they 
surveyed all the States, every one of the States said, ``Oh, of 
course we're using it. But only 11 monitored infection rates.''
    The question, say is that good enough? To me, the answer is 
no. It's easy to say I'm doing something. But there has to be 
help to account for performance.
    Now what are the barriers? Though the checklist was 
popularized and it's a simple concept. I think it's naive to 
think that if we hand doctors or nurses a piece of paper with a 
checklist on it, it's going to be used because we have to 
create a culture and incentives where we're allowed to work 
together.
    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. 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. And 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 any time 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 check--you have to be able 
to get the supplies. You need a culture of teamwork and 
collaboration that frankly doesn't exist in the U.S. health 
care system. So we've coupled these interventions and why 
they've been successful with efforts to improve culture and 
teamwork. It's a program called CUSP. It's 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. 
You have a collaborative network of people working together 
trying to solve problems. That's the fundamental fabric that we 
need to tackle and that these programs rather painstakingly 
have accomplished.
    Senator Mikulski. But one, Hopkins has been listed as the 
No. 1 hospital for a decade now in U.S. News World Report. So 
it goes to part of what's been said here, a culture for 
quality. You also had a phrase earlier that we don't compete on 
quality. That should be a threshold. But we don't compete on 
safety. That was what you said, so that there is a threshold.
    Even when you pick an airline, 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 that comes through. So that's it.
    But let's go down and say anybody who wants to comment when 
I said, ``Why, what does it take to do this and why do we need 
to pay to do it?'' I drew a picture. Dr. Fischer and then 
anybody else who'd 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 
changed 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. 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. 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. 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've made great progress. 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 on 
Dr. Jack Wenberg.
    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 all our mutual advantage.
    Senator Mikulski. Before I move on to another issue, 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. They 
can see how it works. Sometimes the light just goes off.
    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. 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 could fit into 
their system because we have all these different systems of 
care across the country. Some of them might actually think a 
checklist--they might put it up on the wall, others might hand 
it to the doctor. You know, they have to figure out how to do 
this.
    Working at that level to translate best evidence into 
things like a checklist is something that, again, we really 
need more work on.
    Senator Mikulski. Alright. Did you want to comment on that 
part?
    Dr. Gulcher. I just want to comment on quality. But when it 
comes to trying to get physicians to go by even standard 
guidelines issued by NIH supported wards, for example like the 
National Cholesterol Educational Program. We found that as 
we're trying to educate physicians on how to use our genetic 
tests for heart attack that they aren't always going by the 
guidelines.
    So what we do is we try to provide that information as a 
checklist of how they can catalog 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.
    Senator Mikulski. Well, we've raised two points.
    One which goes on in an acute care facility which is 
hierarchical centralized and you can give mandates.
    Then that which goes into clinical practice and also that 
occurred in an academic center and an academic center of 
excellence by all standards of measurement.
    So we see how tough that is. Then we need to go out to 
actual clinical practice. Most physicians' practices, as I 
understand it, are Wednesdays through Tuesdays. That's a lot to 
put on them, you know, those days of just going to the monthly 
medical society meeting is pretty dated.
    Dr. Gulcher what you're talking about when you talk about 
genetic testing is the basic tool that a physician uses--the 
family history. They do a history when you come in. They say 
tell me about yourself, the presenting symptomotology.
    Second, tell me about your family. Well my father, my 
grandfather and so on, all died of--and my mother da da da dum. 
Wouldn't that be the one that would then trigger the genetic 
testing because you would see in a family history propensity?
    Dr. Gulcher. Yes, certainly.
    Senator Mikulski. It's not a substitute but it says, ``Oh 
wow.'' Every adult woman, every first child gets a whatever.
    Dr. Gulcher. Right.
    Senator Mikulski. So.
    Dr. Gulcher. Yes. That's certainly a valuable technique. 
Certainly there are sites, the Surgeon General for example just 
put up a site that helps facilitate taking of some family 
histories for physicians. 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. Most of us don't 
know our family history of our cousins or maybe 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 genetic says for common diseases is these 
genetic variants tend to be common, ultimately common in 
population. 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 complements that. 
But unfortunately 95 percent of men do not have a family 
history of early prostate cancer.
    Senator Mikulski. Wow, that's interesting, so family 
history always has to be essential to providing good clinical 
care. But it wouldn't be the trigger.
    Dr. Gulcher. But it's not enough. It's not enough. 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, macular 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 by actually scanning the entire genome. We know many genes 
for the 25 most common diseases. We already have genetic risk 
factors that have been well validated in tens of thousands of 
patients and 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?
    Senator Mikulski. Senator Hagan, do you have a question?
    Senator Hagan. Thank you, Madame Chairman. Listening to the 
testimony today it just re-emphasizes to me the need in this 
country for health care information technology across the broad 
spectrum of diseases and hospitals and best patient care from 
physicians and practices all over. Dr. Pearson, in some of your 
material you've described the waiting 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.
    It seems to me that health information technology across 
the country would certainly be of great benefit. 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? In the work that you've done so far have you found 
that most doctors and patients are comfortable with the system 
that you've developed?
    Dr. Pearson. Thank you. It's a wonderful question. The 
challenges to translating evidence come on different levels.
    But I think the most important one is that any time 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. 
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. Maybe making people feel that you are creating a 
cookie cutter approach to medicine.
    Now this always rings bells for physicians. They don't like 
the idea that there's one way to do something. Patients are 
always concerned, 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. 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.
    So 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.
    Senator 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. I was just wondering if any of you 
at the panel today had any comments on sort of an update on 
what's going on and what may be the best practices is in that 
concern.
    Dr. Pronovost. I can take a crack at that. I want to just 
end 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, I'm going to 
be long dead before we simplify evidence. One of the great uses 
in information technology would be literally to create the 
program for a checklist maker that is openly available.
    So 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, ``Hey, this is the 
checklist that everyone says if I have diabetes this is what 
you ought to do for me.'' You could have a discussion about it.
    But 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, it's there.
    With MRSA that's actually the pipeline that we're working 
on. So there's a lot of evidence that says what we should do. 
There are some small stories of successes.
    I think the biggest problem is we don't really have, yet, 
widely accepted ways to measure who we gave it to. That's a 
real barrier, because what docs want to know and what you want 
to know is not so much am I using the checklist? Did you infect 
me?
    When I go to my hospital there's been a couple success 
stories. I think the Pittsburgh Regional Health Initiative has 
done some. But what I would put forth to you is picture this 
model that we've presented of drug development.
    So Phase I, you get the experts to find out what the 
evidence is and how do you measure it accurately.
    Phase II, pilot test it in a couple places to see if it 
works.
    When it works Phase III, have an infrastructure to put it 
across this country.
    That's the kind of pipeline we need if we're going to make 
substantial improvements in quality and reducing costs of 
health care.
    Dr. Fischer. We've been a partner with the Pittsburgh 
Regional Health Care Initiative for many years. And that work, 
PRHI was one of the first to say, zero is the goal for 
nosochomial infections. So MRSA transmittal in the hospitals, 
central line blood stream infections, zero is the right rate.
    You know whereas I talked about we're down to one per 
thousand line days, that's not close to zero yet. But we had 4 
hospitals out of 30 who were at zero. OK, so, 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. And we have 
seen and the approach is screening on admission, screening on 
discharge, measure and isolating those who are positive, using 
full precautions for those patients so you'd lessen 
transmission. We have seen a marked decrement in transmission 
of MRSA in those 30 hospitals.
    So we're having an impact. We're not at zero. But we're 
making progress.
    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 is winning by, you know, the 
private payer being out there doing these kinds of programs.
    Just wanted to add one more thing that's about why pay for 
performance? We have to explain this to our accounts. They're 
saying this is the right thing to do why would you pay them to 
do what's supposed to be right.
    Senator Mikulski. Right.
    Dr. Fischer. 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's a problem, put in place a system to 
fix it. So 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 it's not. It's not blindly 
paying for a difference. It's paying for the effort it takes to 
do process improvement.
    Senator Hagan. Thank you.
    Senator Mikulski. Thank you.
    Senator Casey.
    Senator Casey. Senator Mikulski, thank you very much for 
calling yet another important hearing on health care. You've 
been so good to bring us together. You've labored in this 
vineyard a long time. And we've made progress already this year 
and I just appreciate your leadership on this issue.
    I know I'm the last one. I know I've been in and out of 
here. I have to apologize, one of those days of juggling.
    I want Senator Mikulski and our witnesses to know I have 
one question. It's broad. It would take a long time to answer 
but you guys only have a couple minutes. So you've got to be 
brief.
    But it's really this, and it's not--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. But it is basically this. It's the political reality 
question in a sense.
    We've had tremendous success already, with a new Congress 
and new President. Senator Mikulski led the way to pass a Lilly 
Ledbetter Act, a tremendous achievement for those who are 
victims of discrimination.
    President, former Senator Obama, President Obama signed 
into law the Children's Health Insurance Bill. Great 
achievement. That wasn't going to happen in the last Congress 
with the last Administration. But if we 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 U.S. Senate could take to give meaning and integrity to the 
quality initiatives that all of you have articulated and have 
put into practice. You've actually gotten results.
    What is it, absent an overhaul our health care 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 on? I do want to start with Dr. Fischer because he's a 
Pennsylvanian. 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 the systematic approach to improving 
health care. 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, Highmark put $30 million out there 
for physicians 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 paper performance is just primary care and 
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. I don't believe that physicians will 
make the investment on their own without some help.
    Senator Casey. OK. Anyone else? We've got a little more 
than a minute. Sorry for the shortness.
    Dr. Gulcher. We all talked about the 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 of the discoveries, complementing the work of what 
some of us have done in private industry.
    If 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's been a call to actually do a large 
number of either ammonize clinical trials or other clinical 
utility studies to 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, force them to allocate 5 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.
    Senator Casey. Doctor, we're out of time. But with the 
Chair's indulgence you can have----
    Dr. Pronovost. Yes, I agree. Health information technology 
is going to be important and it needs to blink to measures of 
quality. But I think what you could do is invest in the science 
of how we deliver care. Then with that science the market will 
align payment policies and the insurers will drive costs.
    There's a hunger for new knowledge of works. I mean this 
checklist is one thing and it's gotten so much attention 
because it's the rare sample of a performance improvement 
program that worked. And that's a sad statement.
    We need to have scores of these things that work. That's 
going to come with I think, wise investments in the science of 
health care delivery.
    Senator Casey. Thank you very much.
    Senator Mikulski. Great question. Thank you. I'm going to 
wrap up with my one question. But Dr. Pronovost, I note behind 
you are two young ladies. Are they your children that came to 
provide support? You want to introduce them here, Dr. Pearson?
    Dr. Pearson. Absolutely. Thank you.
    Senator Mikulski. Now I'm sorry Senator Hagan left. I mean 
this is what change looks like.
    Dr. Pearson. Well, thank you. We are residents of Maryland, 
by the way, so.
    Senator 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.
    Senator Mikulski. Great.
    Dr. Pearson. Thank you for recognizing them.
    Senator Mikulski. So you brought a choice of your backup 
team too.
    Dr. Pearson. Yes.
    Senator Mikulski. I want to pick up on Senator Casey's 
question and what was said about the science of health care, 
also taking part of NIH's budget and getting it out into 
clinical practice. Also one of the topics we didn't even talk 
about here today was public health.
    In addition to great federally-funded health delivery, 
whether it's VA or some of the others that were mentioned, we 
have something called CDC, FDA, and so on. And often missing 
from the conversation is public health, the safety of our 
drinking water, food supply, all of these other things.
    While we've got a lot of agencies, what is needed to get 
out where there's the hands-on practice, whether it's from a 
physician, a diabetic educator, ET cetera.
    We'll start with you, Dr. Pronovost and just go right on 
down the panel to give a response to 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, if you'll pardon the colloquialism, to 
get ``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 5 
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 can we combine 
our levers that we pull?
    What do we learn about these financial incentives? How do 
we get that diabetic to stop drinking the Coke? And that those 
programs then become publicly available. So I think it's got to 
be bigger than just 5 percent.
    I think if we're going to make substantial improvements 
this has to be invested. It's what I said about this institute 
of health system delivery. We need a learning lab to put a lens 
at what's working in all this mess including economic 
incentives and behavior change incentives and population 
health. Then share those lessons widely.
    I think if it's just State--Federal agencies have to have 
part of it. I don't think they could own this because this 
lives in the community where health care is delivered.
    Senator Mikulski. Dr. Pearson.
    Dr. Pearson. Again, it's an excellent question. It is a 
time when many of us are thinking of new things, new goals, ET 
cetera. 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.
    I do think that with that kind of structure, particularly 
of Senator Baucus' work in this area so far, but others as 
well, there's 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 the investment. Health plans have said that they're 
interested in supporting it. I do think that it would be a 
structure, outside of the existing agencies that we have, that 
could really make a difference.
    Dr. Fischer. I would emphasize 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're looking 
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 health plans, 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.
    Senator Mikulski. Excellent.
    Dr. Gulcher. Great. I just want to point out that it's been 
estimated that the NIH spends less than 0.1 percent on clinical 
utility or translation studies. So already that budget is 
quite, quite, quite small. The reason I mention them is because 
certainly they've been trying to push the bar when it comes to 
finding new biomarkers 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 as you mentioned Muin Khoury 
who runs the genetics there at CDC has been trying to foster 
both public and private partnerships along with the NIH, along 
with some of the other stakeholders. But I think what everybody 
seems to recognize is there's 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 
a clinical practice is going to require some investment.
    Senator Mikulski. Well, this was an excellent hearing. It 
was titled best practices, but I think we've gotten excellent 
thinking. On behalf of the committee I'm going to thank you for 
your participation, the time and effort that you put into this 
is very evidenced-based.
    We would invite you to submit to us, after you've heard our 
questions upon further reflection, recommendations on concrete 
ways we can proceed as we move forward.
    I do believe that we will be, for everything we've heard 
from our President, that we will be doing health care reform. 
That's different than health insurance reform. But 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. It's 
patient-centered because at the end of the day that's why we're 
all here and work so hard for this. Yet at the same time we 
have to be stewards of the taxpayer's money and also cognizant 
of those who have to pay for it whether it's the taxpayer or 
business or whatever.
    Again we thank you for your participation. This committee 
stands in recess until February 23d when we will hold a hearing 
on integrative health care. 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, it goes to 
the heart of what you're working on.
    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 
Wood Johnson. But ultimately at the end of the day it's people 
like you who are actually out in the world working to make a 
difference. So thanks a lot.
    [Whereupon, at 11:55 p.m. the hearing was adjourned.]





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