[Senate Hearing 109-1129]
[From the U.S. Government Publishing Office]
S. Hrg. 109-1129
HEALTH INFORMATION TECHNOLOGY
=======================================================================
HEARING
before the
SUBCOMMITTEE ON TECHNOLOGY, INNOVATION, AND COMPETITIVENESS
OF THE
COMMITTEE ON COMMERCE,
SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
__________
JUNE 30, 2005
__________
Printed for the use of the Committee on Commerce, Science, and
Transportation
U.S. GOVERNMENT PRINTING OFFICE
65-909 WASHINGTON : 2011
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202�09512�091800, or 866�09512�091800 (toll-free). E-mail, [email protected].
SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
TED STEVENS, Alaska, Chairman
JOHN McCAIN, Arizona DANIEL K. INOUYE, Hawaii, Co-
CONRAD BURNS, Montana Chairman
TRENT LOTT, Mississippi JOHN D. ROCKEFELLER IV, West
KAY BAILEY HUTCHISON, Texas Virginia
OLYMPIA J. SNOWE, Maine JOHN F. KERRY, Massachusetts
GORDON H. SMITH, Oregon BYRON L. DORGAN, North Dakota
JOHN ENSIGN, Nevada BARBARA BOXER, California
GEORGE ALLEN, Virginia BILL NELSON, Florida
JOHN E. SUNUNU, New Hampshire MARIA CANTWELL, Washington
JIM DeMINT, South Carolina FRANK R. LAUTENBERG, New Jersey
DAVID VITTER, Louisiana E. BENJAMIN NELSON, Nebraska
MARK PRYOR, Arkansas
Lisa J. Sutherland, Republican Staff Director
Christine Drager Kurth, Republican Deputy Staff Director
David Russell, Republican Chief Counsel
Margaret L. Cummisky, Democratic Staff Director and Chief Counsel
Samuel E. Whitehorn, Democratic Deputy Staff Director and General
Counsel
Lila Harper Helms, Democratic Policy Director
------
SUBCOMMITTEE ON TECHNOLOGY, INNOVATION, AND COMPETITIVENESS
JOHN ENSIGN, Nevada, Chairman
TED STEVENS, Alaska JOHN F. KERRY, Massachusetts,
CONRAD BURNS, Montana Ranking
TRENT LOTT, Mississippi DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas JOHN D. ROCKEFELLER IV, West
GEORGE ALLEN, Virginia Virginia
JOHN E. SUNUNU, New Hampshire BYRON L. DORGAN, North Dakota
JIM DeMINT, South Carolina E. BENJAMIN NELSON, Nebraska
MARK PRYOR, Arkansas
C O N T E N T S
----------
Page
Hearing held on June 30, 2005.................................... 1
Statement of Senator Allen....................................... 9
Statement of Senator Ensign...................................... 1
Statement of Senator Kerry....................................... 8
Witnesses
Basch, Dr. Peter, Medical Director, eHealth Initiatives, MedStar
Health......................................................... 61
Prepared statement........................................... 63
Bostrom, Susan L., Senior Vice President, Internet Business
Solutions Group and Worldwide Government Affairs, Cisco
Systems, Inc................................................... 51
Prepared statement........................................... 54
Brailer, David J., M.D., Ph.D., National Coordinator for Health
Information Technology, Department of Health and Human Services 20
Prepared statement........................................... 23
Clancy, Carolyn M., M.D., Director, Agency for Healthcare
Research and Quality, Department of Health and Human Services.. 12
Prepared statement........................................... 15
Enzi, Hon. Michael B., U.S. Senator from Wyoming................. 3
Glaser, John, Ph.D., Vice President/Chief Information Officer,
Partners Healthcare............................................ 56
Prepared statement........................................... 58
Ignagni, Karen, President/CEO, America's Health Insurance Plans.. 77
Prepared statement........................................... 79
Kolodner, Robert M., M.D., Acting Chief Health Informatics
Officer, Veterans Health Administration, Department of Veterans
Affairs........................................................ 35
Prepared statement........................................... 38
Pure, Pamela, President, McKesson Provider Technologies,
Executive Vice President, McKesson Corporation................. 71
Prepared statement........................................... 73
Semerjian, Dr. Hratch G., Acting Director, National Institute of
Standards and Technology, Technology Administration, Department
of Commerce.................................................... 27
Prepared statement........................................... 29
Stabenow, Hon. Debbie, U.S. Senator from Michigan................ 5
Appendix
Advanced Medical Technology Association (AdvaMed), prepared
statement...................................................... 125
eHealth Initiative and Foundation, prepared statement............ 104
Institute of Electrical and Electronics Engineers--United States
of America (IEEE-USA), prepared statement...................... 115
McNamara, Pam, Chief Executive Officer, CRF, Inc., letter, dated
July 7, 2005, to Hon. John Ensign.............................. 118
Pharmaceutical Care Management Association, prepared statement... 121
Robertson, Dr. Rose Marie, Chief Science Officer, The American
Heart Association; Professor of Medicine, Vanderbilt University
Medical Center, prepared statement............................. 119
Snowe, Hon. Olympia J., U.S. Senator from Maine, prepared
statement...................................................... 103
Thomas, D.O., George, President, American Osteopathic
Association, letter, dated June 27, 2005, to Hon. John Ensign.. 114
HEALTH INFORMATION TECHNOLOGY
----------
THURSDAY, JUNE 30, 2005
U.S. Senate,
Subcommittee on Technology, Innovation, and
Competitiveness,
Committee on Commerce, Science, and Transportation,
Washington, DC.
The Subcommittee met, pursuant to notice, at 9:30 a.m. in
room SR-253, Russell Senate Office Building, Hon. John Ensign,
Chairman of the Subcommittee, presiding.
OPENING STATEMENT OF HON. JOHN ENSIGN,
U.S. SENATOR FROM NEVADA
Senator Ensign. Good morning. I would like to call the
Subcommittee to order and welcome everyone to today's hearing
on health information technology. I think we have an exciting
topic to discuss this morning. I'm excited about our panels,
and am especially interested to hear from my two colleagues
that are here to testify today. I would like to begin with an
opening statement. When Senator Kerry arrives, we will turn to
him for an opening statement, and then we will hear from our
first panel.
Fragmented, disorganized and inaccessible clinical
information, adversely affects the quality of healthcare and
compromises patient safety. The Institute of Medicine estimates
that as many as 98,000 Americans die each year from medical
errors in hospitals. Many more Americans die or have permanent
disability because of inappropriate treatments, or
mistreatments. Furthermore, studies have found that as much as
$300 billion is spent each year on healthcare that does not
improve patient outcomes--treatment that is unnecessary, or
ineffective. Health information technology, which is used to
collect and store clinical, administrative, and financial
health information electronically, is a major part of the
solution to this problem. Technology such as electronic health
records, and bar coding of prescription drugs have been
proposed as means to lower healthcare costs and reduce medical
errors. We need to explore these areas.
We are constantly working on new ways to enhance and
improve the field of medicine in the 21st century. But
efficient, quality patient care is often compromised because
physicians and nurses still communicate vital information
through handwritten notes. Medical orders and prescriptions are
handwritten and far too often they are misunderstood or not
followed in accordance with the physician's instructions.
Patients often have multiple providers. In addition to seeing
their internist, patients often schedule appointments with
cardiologists, endocrinologists, rheumatologists, and other
healthcare professionals.
In this outdated paper-based system, a patient's medical
information is scattered across medical records kept by
numerous care givers in many different locations. As a result,
all of the patient's medical information is often unavailable
at the time of care. This is completely unacceptable. I believe
we need to begin transforming healthcare through information
technology. The development and adoption of interoperable
electronic health records is an important step that can be
taken to improve quality of care and reduce costs.
An electronic record is almost never lost or misfiled. It
is almost always exactly where it should be, even if you are
not. This means that an electronic record may be accessed from
any point in the healthcare system. So if you are traveling in
my home State of Nevada and you get sick or get in an accident,
a physician can instantly obtain medical information, such as
allergies, medications, and prior diagnoses, to determine how
best to treat you.
Electronic health records can also help ensure that
physicians have the information they need to make appropriate
clinical decisions. Because of the rapid growth of medical
information and new treatment methods, physicians must
accumulate a large volume of new knowledge in a short period of
time.
Information overload is, in general, an occupational
dilemma that has been complicated by wide variability in
treatment methods and patient care across geographic regions.
Best practices serves as a guideline for prevention or
treatment of a certain disease or condition. They consist of
quality-improving strategies which bring together the best
external evidence and other knowledge necessary for informed
decisionmaking about specific healthcare problems. These
guidelines can be easily incorporated into health information
technology.
Clearly health information technology has the potential to
revolutionize the U.S. healthcare system. If properly
implemented, health information technology will reduce
duplication, and cut down on administrative costs, such as
transcription and billing. In addition, this technology will
reduce medical errors and potentially reduce medical liability
insurance premiums for physicians and other healthcare
professionals.
I am eager to hear about the current state of health
information technology in both the public and private sectors.
It is my hope that this hearing will help us understand what we
need to do to create a more affordable, efficient, and high-
quality healthcare system in terms of patient care and safety.
I look forward to the expert testimony of our distinguished
panel of leaders in various Federal agencies, and the industry.
With that, I want to start with our first panel. We will
begin with the Chairman of the Health, Education, Labor, and
Pensions Committee, on which I have the honor of serving.
Chairman Enzi is doing a magnificent job taking on all aspects
of healthcare and how they affect our society and the reforms
we need to make.
So Chairman Enzi, we will hear from you and then we will
hear from one of my classmates, my colleague from Michigan,
Senator Stabenow. Senator Enzi.
STATEMENT OF HON. MICHAEL B. ENZI,
U.S. SENATOR FROM WYOMING
Senator Enzi. Thank you Mr. Chairman, I really appreciate
you holding this hearing today. It is one of the most exciting
things happening in America right now. It has the most
potential for helping people of anything in America. And you've
recognized that, and called this hearing. And of course I need
to recognize that you're also the Chairman of the Senate
Republican High Tech Task Force which has had a vital interest
in this. And you do serve on my Committee and you contributed
part of the bill that we'll be introducing later today that
deals with information technology. In fact the whole thing is
about information technology.
There are some amazing things that are about to happen. We
have got the tools already, we just haven't done the
applications, and one of the reasons we haven't done the
applications is there isn't a common set of standards. And I've
been working with Senator Kennedy who is the Ranking Member of
my Committee and we've been working on with the Finance
Committee because there are some finance pieces on this, and
Senator Grassley, and Senator Baucus have been doing some
tremendous work on it, and we have been working with the White
House through Secretary Levitt who has been very involved in
informational technology for a long time. He was one of the
founders of the Western Governors University, which is an
online university for people who can learn anywhere in the
world. You can even get your diploma online with that. But that
was a little invention from 9 years ago, and it's transformed
dramatically. There is no reason that this won't be the next
really dramatic change.
And one of the reasons is that healthcare expenditures are
a vast part of our economy. In 2003, we spent than $1\7/10\
trillion, I have trouble with that number. One and \7/10\
trillion dollars on healthcare. By 2014 that number is expected
to exceed $3\1/10\ trillion. Clearly we need to find ways to
increase the efficiency of our healthcare system, we are
looking at a number of bills, in our Committee in fact, we're
working on 18 bids for bills now that will increase access,
increase quality, and hopefully reduce costs.
We would like to dramatically reduce costs, we may have to
settle for slightly reducing costs, but it would be a huge
thing if we were just able to control costs. Now if we could
manage a quick trip into the future, and pay a visit to the
doctor's office with a health information technology system put
in place, we could see dramatic changes made in the ability for
doctors to diagnose, treat and provide warnings of current and
future medical problems. Somebody said to me that right now, if
you have surgery in a hospital, that can probably happen faster
than getting your records from one hospital to another. When
people go into a physician's waiting room, the first thing they
have to do is get a little clipboard and by hand, write down
all of their medical information. I don't know how many people
out there can remember all of the their medical information and
most of us don't even know what all of our medical information
is. Right now, there are little devices like this that will
plug into any computer in the world, and that can hold your
entire medical record. When you go to a gas pump you can run a
little key fob across the pump and that will access your
ability to get gasoline, pay for it, and you can drive off.
There isn't any reason we shouldn't we be able to check into a
doctor's office that same way; and provide them with all of the
information that he needs to be able to take care of us. One of
the things that always worries me, is that being out here in
the East, what if I'm in a car accident? Where do they get my
records from?
Now I'm in a position where it's a little bit easier to do
that, but the average person that is out here visiting doesn't
have any records out this way, and my records are partly here
and partly in Wyoming. So how do I know that the emergency
physician will know enough about me to be able to treat the
visible thing as well as the invisible? And there's no reason
in today's economy with today's technology that that doesn't
happen, except there aren't common standards. So one of the
things we'll be doing is putting together some common
standards, and as I mentioned we're working with Secretary
Levitt and he has developed an excellent program through 4 RFPs
that works with private sector and I think this will happen
faster than anyway that we ever put it, just in government
hands.
And so we're on the verge of being able to do a lot of
things with technology that we never imagined before. I have to
mention a little invention in Wyoming, there's a doctor out
there named Dr. Close. He's Glenn Close's dad, he spent most of
his life in Africa studying ebola. But he is retired now so he
is running a family practice in Big Piney, Wyoming. And I mean
a family practice, this guy makes house calls, and he sits with
people while they're dying. It's a level of care that we
haven't seen before, but one of the things he discovered when
he was in Africa, and even now, is that it would be really
helpful to have a little more confirmation on diagnosis. And he
talked to some programmers about it, and they went to work on
it, and there now is a program that fits in a Palm Pilot, or a
BlackBerry, and the Navy uses it on submarines. So that the
medical technician that is on the submarine, when he has
someone that has a problem can feed in the symptoms that he
sees, have a list of questions that help to narrow down what
the possibilities are and help to confirm a diagnosis. Before
they had that little program, the submarine had to surface,
they had to make radio contact with the information, keep
asking questions back and forth, so the sub of course was
exposed for a while, but the cost alone of the bringing that
sub to the surface for the year previous to getting to the
BlackBerries was costing $600,000. Now that isn't necessary
because of technology.
So we haven't begun to imagine the kinds of things that
we'll be able to do through technology, and we need to take
that first step to get it in place, to build some encouragement
through incentives in, and I'm certain that the private sector
will run with this, as we get things developed.
So I do appreciate your looking at this issue, finding out
the ways--stimulating people to new ideas, and in the months to
come we'll continue to encourage the participation of the
private sector. They've asked for, and I believe they deserve a
seat at the table when standards are being done since that is
also the area where ideas will be generated. Suggestions for
innovation will come forth and those will all be invaluable as
we do this.
So the bill that we will be introducing later today, and I
want to thank virtually all of the Senators I think, for
contributing ideas to it. There have been a number of bills
that have been written, this is one of the most exciting areas
right now in health and there is a tremendous interest. It is
time that we did something with it. And we can continue to make
healthcare services more affordable, more available and without
it, we run the risk of having the best healthcare system in the
world with few of us who can take advantage of it through
affordability. So I want to work with you, and ensure that the
healthcare technology is signed into law later this year.
Thanks for your help on the bill and your participation, and
for having this hearing today.
Senator Ensign. Thanks Mr. Chairman, Senator Stabenow.
STATEMENT OF HON. DEBBIE STABENOW,
U.S. SENATOR FROM MICHIGAN
Senator Stabenow. Good morning, thank you, Mr. Chairman,
for holding this very important hearing on a very exciting
topic. I share Senator Enzi's enthusiasm and optimism about our
ability to work together and really get something done, and I
would just as an aside indicate that I've enjoyed working with
Senator Enzi on a number of projects through the Banking
Committee, and know that when he is involved in it, we're going
to be in good shape. So I appreciate the chance to work with
you again.
I also want to just put a plug in, in terms of the private
sector. I couldn't agree more that there is an important
partnership that needs to take place. We know that in the
private sector investments have been made in technology; we
need to support those investments by providing Federal
financial incentives. Automation Alley, a technology consortium
in southeast Michigan and Detroit, is doing exciting work in
this area. They are partnering businesses, universities, and
governments to use health information technology to help bring
our healthcare systems to the point where they should be. And
Senator Enzi was talking about a key fob. I just have to brag
and say the automobile I drove in today, which is a Cadillac
STS, does not use a key, it uses a fob. I leave it in my
pocket, I get in and out of my car, push a button to start the
vehicle. That level of technology is the kind of technology
that we can bring to our healthcare system and that is what
we're really here today to talk about.
I also want to thank my colleague Senator Snowe who is a
Member of the Full Committee. She and I have been working
together and have introduced health information technology
legislation. I'm hopeful that we can, through the leadership of
everyone involved, bring together all of the legislation and
get the best ideas together and be able to pass a
comprehensive, bold approach that will really get the job done.
I'm very proud that Senator Snowe is working with me on this
legislation. We have announced a health IT caucus that we
welcome and invite everyone to be a part of, so we can all work
together on this very important effort. The evidence showing
the ability of health IT to reduce costs, save lives, and
improve quality of care is simply overwhelming, Mr. Chairman,
as you know, and as you indicated in your comments.
I was thinking as you were talking about going from one
facility to the other of a story that a businesswoman told me
about a couple of weeks ago. She came in with the Small
Business Association, we started talking about health IT, and
she told the story of her son who is disabled, and how she
lives up north in Michigan, goes down to Ann Arbor to
Children's Hospital, goes to different places. She actually
carries her records with her. Stacks, and stacks, because she
is worried that one hospital will not have the full records of
the other facility, and so she actually carries a huge file
with her, and we want to help her not have to do that.
Dr. David Brailer, who is the National Coordinator for
Health Information Technology, is speaking to the Committee
this morning, and has been instrumental in making evidence
known and understood about this issue. His office attributes
savings from widespread adoption of electric health records in
the range of seven and half percent to thirty percent in annual
healthcare spending. Which is amazing. It just is amazing.
Given that U.S. health expenditures amounting to $1.8 trillion
in 2004, we're talking about savings anywhere from $135 billion
to $540 billion a year, and even here that is real money. And
so this is why this is so important.
Manufacturers in Michigan and across the country are
struggling right now to remain competitive in a global
marketplace with skyrocketing healthcare costs, and we know
that health IT can, and should, play a key role in managing
these costs, as well as our costs at the Federal Government
level and for every family and every business. We really can
reduce costs without asking healthcare providers, or patients,
to take less. We really can, by this strategy. That would be
reason enough for an aggressive Federal role in promoting
adoption of health IT.
But equally compelling is the promise that health IT holds
for improving the quality of healthcare for our families, by
ensuring that patients get the care they need at the right time
and in the best setting. To realize these promises however, I
believe Congress must enact legislation providing meaningful
resources to physicians, hospitals and other healthcare
providers for health information technology, as well as setting
standards.
Healthcare providers are struggling to keep up with their
daily needs. A major barrier to the use of the types of systems
you will hear about today is the initial investment cost. The
cost of procuring and implementing health IT can be staggering.
Every day we delay providing Federal seed money, we delay
getting health information technology systems in place, and
businesses, taxpayers, and patients pay in both dollars and
lives.
But for the Federal investment to really make a difference,
there are several elements that are critical, and these are
included in the legislation we've introduced. First of all we
must do something substantial. We have over 470,000 physicians,
14,000 nursing homes, about 5,700 hospitals, over 1,200
community mental health centers, and over 1,000 community
centers all of whom need to have this technology. We need a
robust investment immediately so we can start reaping the
benefits and rewards immediately.
I also believe it needs to be real, whatever we do. We
frequently pass great pieces of legislation that are funded
through an authorization of appropriations from the General
Fund. But the appropriators are hard pressed to fund existing
programs, much less new initiatives, no matter how compelling.
And so I hope our strategy will be to identify a source, and
again in our legislation we have done that.
We will spend substantially less Federal healthcare dollars
if health IT is used by providers serving patients in Federal
health programs. So it makes sense to finance health IT through
the Federal Healthcare Trust Funds. It also makes sense to use
the tax code to fast track the potential IT systems.
I also believe it needs to be available to individual
providers and healthcare systems.
Again, it's critical we have standards. But at a time when
we're asking providers to take less, it's very difficult to
also ask them independently to make investments of the kind
that we're talking about to be able to adopt health IT systems.
We should work toward a system where all healthcare providers
are linked, but we do not need to wait for those networks to be
formed to see the benefits of health IT either. Some hospitals
and other providers have already begun using electronic health
records, computerized drug ordering systems, and systems that
alert them to adverse drug problems.
The benefits of these systems have been enormous already. I
talked with one system with seven facilities who saved $18
million in drug costs alone. So even before we get them
connected, if we can get them involved and investing in health
IT we will see dollar savings. There is no reason to delay a
community's opportunity to benefit from the quality, the
safety, and the financial savings of immediate health IT
adoption by its local providers even as we are putting together
the larger systems.
I know that you'll hear this morning about the importance
of interoperability. It is absolutely critical for healthcare
providers to be able to talk to each other electronically. And
the Federal Government has a role to play here as well in
promoting the adoption and use of open standards. But it is not
enough for the Federal Government to help develop standards, as
I indicated I hope that we can be a part of the solution that
will allow agencies to walk the walk, as well as talk the talk.
The Federal Government must allow healthcare providers to
submit data using open standards. Allowing data submission in a
way that allows computer systems to talk to each other--so the
information can be processed automatically and quickly--will
result in better care for patients.
CMS requires Medicare providers to submit measures on
healthcare, but we haven't begun to get the full benefits from
that data because providers aren't allowed to submit the data
using the open standards that exist.
Use of uniform standards and reporting of quality measures
is essential. And I believe, while essential though, it is not
sufficient. Standards and organizational efforts alone won't
get our providers where they need to be. This is especially
true for those who serve Medicare and Medicaid patients and
SCHIP patients. A real Federal financial commitment is
essential as well. And I think rarely has anything been this
unambiguous: Federal investment in health information
technology will come back to us many times over in reducing
Medicare, Medicaid, and SCHIP spending, reduced medical errors,
and greater quality and efficiency in our healthcare system.
So Mr. Chairman, you're on the right track, and I
congratulate you very much for your leadership, the leadership
of everyone involved, the leadership of Chairman Enzi, and I
look forward to working with you, and with all of our
colleagues because I really believe that we have the
opportunity to get this right and to make a major, major step
forward in reducing costs and saving lives, and I can't think
of anything more important.
Senator Ensign. I want to thank both of you for your
excellent testimony. Health information technology is one of
the more exciting issues we've come across in a long time. This
issue is exciting because it's really not an ideological issue.
There is no reason for health information technology to be a
partisan issue, and I'm excited about that aspect of the topic
as well. We've all had experiences with the healthcare system.
I received a call from my wife last night. She was at a
pharmacy and didn't have her health insurance card with her.
Electronic health records would be helpful in these types of
situations. Electronic health records would help manage this
type of information and keep track of prescription medications.
Since the Ranking Member has just arrived, I would like to
open it up to him for an opening statement, and then I will
turn to Senator Allen.
STATEMENT OF HON. JOHN F. KERRY,
U.S. SENATOR FROM MASSACHUSETTS
Senator Kerry. Mr. Chairman, thank you Senator Allen. I
apologize for being late, I apologize to my colleagues. Thank
you Mr. Chairman for holding this hearing, this is--I heard you
just as I came in, talking about how this is not a partisan
issue, it's obviously bipartisan. But what disturbs me is that
despite how obvious the benefits are, we don't have the
political will evidently, or the determination to put the real
funding which is what is so critical for our hospitals and
health centers, clinics, et cetera to be able to invest. If
you're struggling to pay your Medicare match, or you're
struggling to pay your Medicaid match, and hospitals are
already digging into their reserves, which they are, it's very
hard to capitalize and it takes a major capitalization to be
able to go out and put together the technology structure
necessary to do this. I don't know who among us, I mean for the
2 years I spent crisscrossing the country, talking to people
all over the country, people get it. They just get it. They're
thirsty for this, it costs you one penny, to go to an ATM and
take whatever amount of money out of the bank and have a
transaction. But if you go to a hospital, it costs you
somewhere between $15 to $25 per transaction to pull a medical
record, it's absurd.
Who among us has not gone to a doctor's office in the year
2005, or before that, had the assistant hand you a clipboard
with a pencil attached. Please fill out your record. How many
times have we filled it out? I mean you could walk in with a
Smart Card, hand it to them, plunk, they could put it in,
update and you could walk out with your records with full
security today.
There's an unbelievable amount of money that could be
saved. President Bush has allocated $150 million total for the
Office of the National Coordinator for Health Information
Technology, which is going to do little more than pay lip
service. Frankly, we've got hospitals in Boston, one of them is
going to testify. I think individually they spend more in that
one hospital. You're talking about a nationwide system. It's a
joke. We don't have our priorities straight.
Our priority in Washington is to have a great big tax cut
for people earning more than a million dollars a year, it's $32
billion next year, is it going to go to people earning more
than a million dollars a year? And the hospitals I promise you
will be struggling and they'll be back here saying why can't we
get more funding to be able to save money.
The fact is that out of the 44,000 to 98,000 deaths that
were attributed to medical errors annually, that's a big
figure, almost more people died than died in the 10 years of
the Vietnam War due to medical error, and more than 7,000 of
them are due to medication errors alone. One million serious
medication errors occur each year due to drug overdoses which
comes from the wrong drug, illegibility of doctor's orders, and
drug allergies and so forth. These errors translate into $2,000
in additional hospital costs per patient; two billion dollars
annually for the healthcare system as a whole. In 1998, Boston
Brigham and Women's Hospital was one of the first in the
country to implement an electronic prescribing system called
``Computer Physicians Order Entry'' and that has the ability to
significantly reduce medication errors which in turn will
reduce the hospitalizations that take place among seniors. One
of the largest--the largest percentage of unnecessary
hospitalizations come as a result of medications taken badly
and wrongly. Brigham and Women's spent $1.9 million on the
initial installation and about $500,000 annually for upgrades.
The financial return on its initial investment has been $5
million, and $10 million in annual savings. So let's understand
that, $1.9 million invested, $5 million to $10 million in
annual savings as a result.
So we can do an extraordinary amount, Mr. Chairman, if we
can really get the willpower to go out and do it. We've got to
zero sum gain budget, we all know what we're fighting about
right now. We had to adjust a billion dollars for Veterans
yesterday, this is a struggle. And I really think it is
critical to us, to try to get our priorities straight. I'm
working with Senator Cornyn on a bill that we hopefully could
introduce. I would like to get the Chairman, and we could all
work together to try to do this. But it seems to me that
there's a great opportunity for us to be able to modernize
America, save lives, save money, and frankly do a terrific job
of helping a number of industries create jobs at the same time,
and be far more efficient and effective. So thank you, Mr.
Chairman, for doing this. And I look forward to working with
you.
Senator Ensign. Thank you. Senator Allen.
STATEMENT OF HON. GEORGE ALLEN,
U.S. SENATOR FROM VIRGINIA
Senator Allen. Thank you Mr. Chairman, for holding this
hearing. I thank our two witnesses, and I share the comments
that they will make. I will be questioning witnesses and our
panel as we go forward, so I'll forgo a full blown opening
statement, other than to say that you, Mr. Chairman, and I have
worked over the years together. We want this country to be the
most technologically advanced in the world, and we need to be
embracing the advances in technology. Everything from
communications to video, to broadband, and clearly here in
healthcare.
I think this is the most pressing achievable improvement
that we can make in our healthcare system. There will be more
accurate treatment for medical injuries or illness. It will
save money, and more importantly I think that the whole issue
of our very mobile society, that no matter where you are, or
when you're injured you have that accurate approach. I was
listening to Senator Kerry, and for most of--clearly, the first
part of his remarks I would say great, Senator Kerry and I are
together on something. And this is a bipartisan effort. We need
not, I would say to my friend--my friends here, that we need
not get into tax cuts, we're not going to raise taxes.
But what we do need to do is find out the proper
incentives, the proper funding and to me this should be a
national priority. And I thank you, Mr. Chairman, for holding
this hearing so that we can focus on it, hear from our
colleagues. I've signed on as a sponsor on Senator Enzi's bill.
But also listen to the innovators, the technologists, as to how
we can best do this, whether encouragement, incentives, grants
and so forth, to do it right.
I would just ask this question of Senator Enzi, what did
you call this thing you have hanging around your neck?
Senator Enzi. I call it a fob, but it is a jump drive.
Senator Allen. That's all fine and dandy. I'm not going to
go around carrying something around my neck. And the point of--
but it is wonderful, and here's my question to you. This is
actually leading up to a friendly question.
Senator Ensign. I think it looks good on him.
[Laughter.]
Senator Allen. I don't see you wearing one, if you think
it's so stylish.
[Laughter.]
Senator Allen. At any rate, the one key thing we need to do
right here, in addition to determining what are the right
incentives to achieve this very important laudatory goal for
accurate, better healthcare treatment is to make sure, and you
used the term common standards. What we develop here in this
bipartisan manner should be a standard that clearly allows
interoperability. There may be some who don't want to do that,
or maybe a few years down the road, there may be a way. Just
like we do with driver's licenses, you just put a heart on it
in Virginia if you want to be an organ donor, not making people
write something on the back of it, and have witnesses all the
rest.
Maybe there's a way, that especially with nanotechnology,
and micro-electronics advances, that there's a chip that could
be put on a driver's license or something smaller. But then of
course that's going to have to interact with whatever the
hospital or the physician's office, or the pharmacist has. So
in your definition of common standards, how do you envision
that being put into effect as a practical matter? Because the
one thing that I've learned over the years is you can waste
more money, more quickly on technology than anything else
because there are always adaptations, always improvements with
new innovations. We do not want to be setting up a system that
stops technological advances and innovations because we have
set a standard that picks just one type of technology. But we
also ought to make sure that if there are improvements that
they will work within the system. How would you respond to that
concern with your legislation?
Senator Enzi. I would respond that that is why the
authorization amount in the President's or the budget amount
was $125 million. We don't want to get the cart before the
horse. Right now we don't have the interoperability of systems,
we don't have standards for the data that is to be collected so
that it can be shared easily. I grew up during the computer
generation when I went to college the government was the only
one virtually that owned computers and we had to do punch cards
and doing the very simple program that any child could do in
first grade now in about \1/2\ hour, would take us about 3
days. But the computers have advanced dramatically, they've
gotten smaller, I remember in 1980 they said that there would
be a computer--there would be the equivalent of a computer in
every home, by the year 2000.
By 1990, there was the equivalent of one computer for every
person in the United States already. And I don't know what it's
up to now, because everybody has more than one. But the reason
that came about was because we had some common standards for
operating systems now, that didn't happen in the beginning
there were about a half a dozen operating systems out there
that worked at cross purposes partly to capture part of the
market. And through the private enterprise system one of them
did capture the market. But there's no reason we have to go
through that kind of a process. We can get everybody to a
faster starting place by having standards, putting them in
place and then the market will be able to generate the revenues
that are needed. One hospital that spent--I can't remember how
many hundred--more than a $150 million already, one of the
problems we have is we have a start to a law that prohibits the
interaction between doctors and hospitals. And part of the bill
takes care of that problem, so that in providing equipment and
information they can have the interoperability without that, it
doesn't work.
There are a number of stages we have to go through to get
to the point where there can be significant money put into the
system, and there will be significant private money put into it
as we go along. We're also trying to come up with a mechanism
where the government can participate to be able to leverage
private dollars. And that's the way that most of the economy
has grown in the past and we want to make sure that that can in
the future.
Senator Stabenow. Mr. Chairman, if I might also just add, I
totally share Senator Enzi's comments in terms of standards. I
would just urge that while we are doing that which is critical,
that we're also supporting the efforts to get the individual
technology into hospitals and doctors offices. Because right
now what we have is a system where providers are being cut back
in terms of Medicaid and Medicare and so on, and it's virtually
impossible for them to be making that initial investment. So by
using the tax code we can allow a faster depreciation schedule,
and thus provide a financial incentive for health IT adoption.
We can create grants to be able to help our public hospitals
and nursing homes, and ensure they are able to get the
technology they need. I hope we're doing both at the same time.
Because even using independent systems we can save lives right
now, just by doing all that we have talked about this morning.
Senator Allen. Thank you both. Thank you, Mr. Chairman.
Senator Ensign. Senator Kerry, would you like to add a
comment?
Senator Kerry. I just wanted to comment that I hope we can
somehow get beyond this discussion. Senator Stabenow is
absolutely correct, and Senator Allen I appreciate the
mutuality of support in the early part, but there's a point
where you and others have got to kind of confront the reality
of language. Where you say on the one hand this is a national
priority, and then you say, but we shouldn't raise taxes.
Nobody's talking about raising taxes. We're talking about
whether we should give a tax cut.
Senator Ensign. Senator Kerry, let's stay away from this
debate. Hold on just a second. This debate can occur another
day, and I want to get to the next panel. I want to run this
hearing so that we hear from the experts. We started this
hearing in a bipartisan fashion and I want to keep it that way.
I don't want to get into the discussion of tax cuts--let's save
that for another day. I appreciate both of the witnesses here
today. Thank you both for your excellent testimony. I would now
like to call the next panel to the table. Dr. David Brailer,
National Coordinator for Health Information Technology, U.S.
Department of Health and Human Services; Dr. Carolyn Clancy,
Director, Agency for Healthcare Research and Quality; Dr.
Hratch G. Semerjian, Acting Director, National Institute of
Standards and Technology; Dr. Robert M. Kolodner, Acting Chief
Health Informatics Officer, Veterans Health Administration, and
Acting Deputy Chief Information Officer for the Department of
Veterans Affairs.
We welcome all of you. We will start from my left and go
down the panel. I would appreciate it if you could summarize
your remarks in 5 or 6 minutes so that there's plenty of time
for questions and answers. This will allow us to have a good
discussion. Your full statements will be made part of the
record. Again, if you could please summarize your testimony in
about 5 minutes, we'd very much appreciate it, so that we can
have the maximum amount of time for questions and answers.
Dr. Clancy.
STATEMENT OF CAROLYN M. CLANCY, M.D., DIRECTOR,
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Clancy. Chairman Ensign, Senator and members of the
Subcommittee, I am delighted to join Dr. Brailer in outlining
the ways in which the Department of Health and Human Services
is advancing the adoption, implementation, and effective use of
health information technology.
You asked us to address how health IT can achieve three
objectives: reducing medical errors, improving the quality of
patient care, and reducing the cost of healthcare. Our AHRQ
investment will help the Nation meet all three of these
objectives. The transformation into a healthcare system that
provides high quality healthcare reliably that meets patients
needs will not happen just because of health IT, but it is
impossible to imagine that that transformation can take place
without it.
For nearly three decades, AHRQ has funded the basic science
of health IT by supporting the pioneers and innovators. Many of
the Nation's leading health IT systems were founded on research
funded by AHRQ, and our task now is to spread that knowledge
and experience that we have gained more broadly; throughout the
healthcare system and we also need to support research targeted
to fill critical gaps in our knowledge.
In Fiscal Year 2004 AHRQ announced an investment of $139
million over 5 years to achieve these goals. This national
initiative is now supporting 108 grants and contracts in 43
states, with over half of the projects based in rural and small
hospitals and clinics. All told this investment will affect
more than 40 million Americans.
Our efforts are detailed extensively in the written
testimony, but I wanted to provide a few highlights right now.
Reducing medication errors is one area where health IT offers
the greatest and immediate potential to improve patient safety.
In some ways, its potential value is self evident in reducing
handwriting errors, cross checking prescribing errors, and
identifying dangerous interactions with other medications
before they occur. AHRQ supported the groundbreaking work of
David Bates and others, that demonstrated a 55 percent
reduction in serious medication errors with computerized order
entry systems in hospitals.
In anticipation of the Medicare drug benefit, we're now
supporting work on electronic prescribing, and in-office
practices. Many physicians now refer to their handheld devices
for electronic prescribing as their peripheral brain. And so we
find that they're as important to them as stethoscopes. Health
IT can also greatly improve the over all quality of patient
care by making the right thing the easy thing to do. As a
doctor, when I see a patient who's coughing and has a fever, I
can now use a AHRQ-funded electronic tool to help me decide
whether that patient needs to be hospitalized. I used to have
to go look up that information and then make a treatment
decision.
A hallmark of our efforts are initiatives that move health
IT into settings where traditionally it has not been available.
These include nursing homes, pharmacies, waiting rooms,
schools, and patient's homes. For example, a recent effort to
reduce bed sores in nursing homes was so successful, that a
large chain of nursing homes has adopted the idea and will be
spreading it across the country. The potential for cost savings
from the systematic use of health IT results from removing
inefficiencies, improving physician decisionmaking, enhancing
communication, and reducing the need for follow-up care due to
medical errors, or use of inappropriate services.
An AHRQ-supported survey found that approximately one third
of Americans report that they have to go back for a second
visit because their provider didn't have their medical
information available at the first visit, waste that could be
diminished through shared electronic health records.
Our research has also demonstrated that computerized
reminders can reduce hospital charges per admission by
approximately 13 percent. With your support we'll continue our
efforts to provide sound evidence on the financial benefits of
health IT.
Mr. Chairman, I can't overemphasize how essential practical
technical assistance is to the successful adoption and
implementation of health IT. We've created the AHRQ National
Resource Center for Health Information Technology, the largest
single commitment to technical assistance in AHRQ history. The
Resource Center leverages our investments in health IT by
offering help where it is needed in real world clinical
settings that may be ill-equipped to meet the health IT
challenge.
The Resource Center will do this by facilitating expert and
peer-to-peer collaborative learning, and fostering the growth
of online communities that are planning, implementing and
researching technology. One of our grantees has reported to us
that the provider transition to HIT is one part technical and
two parts culture, and work process change. Designed initially
to bring together our grantees, we recently announced that the
Resource Center's web portal will now be open to all of the
Nation's community health centers, and we also plan to make it
available to providers involved in the state-based QIO program,
to expand the use of health IT in small practice settings.
Mr. Chairman, I would like to conclude by offering a few
brief observations, based upon our work in health IT.
First, health IT alone cannot provide the improvements
needed in our healthcare system. These improvements will depend
upon the integration of high quality health IT into a variety
of settings, individual clinical practices, hospitals and other
settings.
Second, for most healthcare settings, health IT is not an
out-of-the-box solution. Effective use of health IT begins with
a careful examination of the healthcare setting and then
deploys the power of health IT to enhance its effectiveness and
efficiency. It's important to remember that health IT
applications need to serve clinicians and patients, not the
other way around. AHRQ's initiative is helping ensure that
user-friendly health IT will achieve its full promise in the
clinical setting.
Third, the financial exposure for providers, when added to
concerns about doing it right, increases the overall risk of
investing in health IT. In order to accelerate the pace of
health IT adoption and implementation, we must ensure that best
practices, and new knowledge and experience are disseminated
widely in order to maximize the potential for quality
improvement as well as reduce economic risk.
We look forward to continuing to work with Secretary
Levitt, Dr. Brailer and our other partners to make healthcare
better for all Americans through health IT.
Thanks for the opportunity to share my thoughts and I would
be delighted to answer any questions.
[The prepared statement of Dr. Clancy follows:]
Prepared Statement of Carolyn M. Clancy, M.D., Director, Agency for
Healthcare Research and Quality, Department of Health and Human
Services
Chairman Ensign and Members of the Subcommittee, I am delighted to
join Dr. Brailer in outlining the ways in which the Department of
Health and Human Services (HHS) is advancing the adoption,
implementation, and effective use of health information technology
(IT).
Achieving the President's goal of widespread use of interoperable
electronic health records requires us to address a number of complex
and technical issues, many of which are being addressed at the
Department level. My testimony will focus on how the activities of the
Agency for Healthcare Research and Quality (AHRQ) complement the
Department's efforts by harnessing the power of IT to improve the
effectiveness, efficiency, quality, and safety of health care.
While we work with the various divisions of HHS to ensure that the
fundamental IT infrastructure is in place, we are critically examining
how these IT tools can be used in real-world health care settings to
make care better. For many health care providers the need to address
specific local threats to the safety and quality of patient care is
immediate; an increasing number of practitioners and organizations have
made or will soon make investments in health IT. To enable them to make
informed investment decisions, AHRQ's program and research activities
support evaluation of the impact of selected health IT applications on
quality, safety and cost. We also have recognized the need for a strong
emphasis on the needs of providers who care for rural and underserved
populations. That is why we have made awards to local and regional
organizations that affect the care received by more than 40 million
Americans.
Leaders in health care recognize that improvement requires both
incentives and the capacity to respond to those incentives. Our focus
is on building the capacity within healthcare settings--large and
small, urban and rural (including frontier areas)--for effective use of
health IT, and disseminating findings rapidly. The benefits of health
IT need to begin now for as many Americans as possible. The results of
these investments represent tangible benefits that will be accelerated
as the private-public collaboration to facilitate a nationwide
information infrastructure develops.
We are also addressing a critical stumbling block to the widespread
adoption of health IT, the human dimension of the use of IT, which
focuses on the intersection between IT and the health care providers
who need to use it. Unlike the baseball field in the movie Field of
Dreams, we have dramatic examples of the building of health IT systems,
whose designers found physicians and other clinicians neither came nor
played. Unless we address these issues as well as technical ones, we
risk falling far short of a safer, higher quality health care system.
The Importance of Health IT
When we look at the challenges facing our healthcare system in the
years and decades ahead, there is no job more important than getting
health IT into place, and getting it right. As the Institute of
Medicine noted in their second report on patient safety, Americans
should be able to count on receiving health care that is safe. This
requires, first, a commitment by all stakeholders to a culture of
safety, and second, to improved information systems. While
transformation of our heath care system--with higher quality, patient-
centric and cost-effective care--will not happen simply as a result of
health IT, it is difficult to think how transformation could possibly
take place without the capacities it brings. We have a fundamental
problem of fractured healthcare delivery that results in needless waste
of resources. Health IT can bind this system together, even as it
preserves its diversity.
Think for a moment about what is happening in health care settings
around the country. Millions of decisions are being made about people's
lives without the right information in hand:
--Is chemotherapy the best treatment for a patient with breast
cancer, or should she be treated with radiation and
chemotherapy?
--Which of our young athletes should be screened and with what
type of diagnostic test for heart abnormalities, as a front-
page story in The Wall Street Journal asked last week?
--How does a person with diabetes, high blood pressure, and
obesity manage all the different demands of their conditions?
Patients and consumers struggle with even more basic decisions:
Which provider to see? When to seek care? Which treatment option is
best for their needs?
Many of these decisions are difficult even in the most ideal
circumstances, when there is sufficient time to assess good, reliable
information. But as we all know, these decisions frequently must be
made at times and places where information is not available, and time
is of the essence. The power of IT can help us to regularly assess
quality and outcomes while bringing us reliable data that can be
accessed at the point-of-care.
For nearly three decades, AHRQ and the National Library of Medicine
(NLM) at the National Institutes of Health have funded the basic
science of health IT, developed and tested tools to facilitate its use,
and supported the work of innovators. Many of the leading systems of
our Nation were created on the backbone of AHRQ and NLM grants over the
last three decades. Two prominent examples are Intermountain Healthcare
in Utah and the Regenstrief system in Indiana, which are now models for
the effective use of health IT. The task we have now embarked upon is
to move that knowledge and experience into the health care system more
broadly and to support targeted research to fill the gaps in our
knowledge base that are critical to widespread diffusion of health IT.
Successful implementation of health IT in turn provides the best
possible platform for delivering scientific evidence to clinicians and
patients when decisions are made.
AHRQ's Current Health IT Activities
In FY 2004, AHRQ awarded 108 grants and contracts to find solutions
for a number of gaps in our knowledge and to advance the use of health
IT. Reflecting a commitment of $139 million over 5 years, these awards
were truly nationwide in scope. They spanned 43 states, with over half
of the projects based in rural and small hospitals and clinics. In
combination, these community-based health care institutions provide
health care to more than 40 million Americans.
Mr. Chairman, in announcing this hearing you asked how health IT
can further three objectives: reducing medical errors, improving the
quality of patient care, and reducing the cost of health care. AHRQ's
research activities are making significant advances in meeting all
three of these objectives.
Reducing Medical Errors
Medication errors are a grave threat to patient safety and present
one of the greatest opportunities for reducing medical errors. The
potential value of health IT here seems intuitively obvious: reducing
handwriting and other communication errors, electronic cross-checks for
errors in medication strength, identification of interactions with
other medications or other adverse events reflecting the patient's
overall medical condition. Our projects span the spectrum from
prevention to detection and prompt treatment of medication errors, and
identify the most effective ways to use health IT to achieve each of
these goals.
Our first priority is to prevent medication errors from ever
occurring. In a series of studies, we are finding that electronic
prescribing with decision support using personal digital assistants
(PDAs) reduces illegibility, omissions, and the overall incidence of
prescribing errors. However, we also discovered some of the barriers to
PDA adoption, including the interface and its interoperability with
existing systems. We have developed tools to assist practices in
assessing their readiness and designing their workflow to accommodate
the use of tools like PDAs.
Patients, especially patients with chronic illnesses, can play an
important role in preventing medication errors. Some of our projects
are developing Internet-based portals to enable patients to manage
their own care, including medications. In the course of deploying this
technology, we are learning valuable lessons about how patients want to
participate. Patients are very enthusiastic about documenting their
medications, giving their clinicians new insights about medication
compliance, as well as other supplements the patients may be taking on
their own initiative. An unexpected side benefit from the move to an
Internet-based system was that the children of elderly patients who are
living in a different state were able to assist in their parents' care
in a new and engaged manner, when parents authorized access by their
children.
Recognizing that medication errors can still occur even when health
care providers are vigilant, a team at Duke University is attempting to
minimize the potential for serious patient harm. They are testing a
monitoring system for hospital patients that will detect the onset of
an adverse drug effect, immediately alert the hospital staff, and
suggest the most appropriate intervention. AHRQ is also funding systems
for the voluntary reporting of errors.
In short, health IT is a critical element in our efforts to improve
patient safety but it is not the complete answer. The Administration
continues to support passage of patient safety legislation, which will
provide the confidentiality and privilege protections that will enable
health care providers to foster a climate of continuous quality and
safety improvement.
Improving the Quality of Care
The linkage between health IT and improving the quality of care
occurs on multiple levels. We know that we cannot improve the quality
of care unless we can measure performance. But monitoring and reporting
the quality of care is time-consuming, inaccurate and incomplete
without IT systems. A challenge shared by AHRQ and the Centers for
Medicare and Medicaid Services (CMS) is how to best translate measures
of quality into computable, automated quality reporting systems in
settings such as hospitals and physician offices.
The maturation of IT for use in daily practice comes at a time of
increasing recognition that good healthcare delivery requires better
coordination across all sites of care. Many patients obtain care from
multiple providers and experience the effects of poor coordination of
information and care. Indeed, 69 percent of Americans report that poor
coordination among their providers is a serious problem for them, and
32 percent report that they or a family member have created their own
medical record to assure that all health care professionals they see
have accurate, current information about their health issues. Health IT
can reduce this burden by facilitating the transfer of information
among providers, customizing knowledge for the patient, and
facilitating communication between providers. AHRQ has funded cutting
edge research into how to translate medical knowledge into specific
information, tailored to the patient at hand and immediately available
to the clinician when decisions are being made. These include alerts
about inappropriate therapies, reminders about preventive care, and
assistance in automatically doing the right thing. Health IT has the
potential to rapidly disseminate knowledge previously available only in
large, urban, academic health centers. For example, our project in
rural Tennessee brings cutting edge cancer care to the rural population
through decision support systems and telecommunication with cancer
experts.
At least two manufacturers have now incorporated a decision support
system developed by one of our grantees into EKG machines. By helping
emergency medical service teams and emergency room physicians better
determine when a patient with chest pains actually has suffered from,
and may still be vulnerable to a heart attack, quality of care will be
greatly enhanced. Those who truly need care will receive it and those
who may be suffering from less serious problems, like indigestion, will
be spared the unnecessary risks, worries, and costs that accompany
unnecessary hospitalizations. As this improved diagnostic capability is
deployed throughout the Nation, annual savings are estimated at $720
million.
Improving quality is also about improving communication among care
providers through IT systems that allow clinicians to quickly access
patient information, including remote information such as radiology or
laboratory studies performed off-site. It is about improving the
complicated coordination required when patients transfer from one care
setting to another. We have several projects supporting the transition
of patients, such as pregnant women or post-surgical adults, from the
intensive hospital setting into an outpatient clinic. And improving
quality is about supporting the communication between the provider, the
patient, and the patients' caregivers through electronic mediums such
as e-mail.
Our research also has made clear the importance of system issues
such as organizational culture and workflow. Our investments evaluate
specific strategies to close the gap between the potential of health IT
to improve care quality and the less promising reality experienced by
many providers due to sub-optimal product design or challenges in
integrating health IT with the work of clinicians. For example, we are
funding studies of technology integration, using time-motion studies,
culture surveys, and observational techniques to understand why
technologies are accepted or sabotaged by the clinical users. But we
don't stop there. AHRQ funds research projects to explore how the
technology can adapt in intelligent ways to clinician needs. We have a
suite of projects with Partners HealthCare System in Boston to develop
``SmartForms'' for various settings--smart because they anticipate the
physicians' needs for information based on the patient, and
automatically assist the physician in pulling together the various
action plans necessary to execute the right care plan.
Finally, the breadth of our current portfolio has been instrumental
in enabling AHRQ to take health IT into settings where traditionally
there has been underinvestment. These include nursing homes and
pharmacies, waiting rooms, schools and homes, in rural and small
settings. These projects have benefited parents and caregivers,
including the blind, chronically ill and those recovering from serious
acute events. Each of these new frontiers requires the discovery of the
unique needs of the targeted population, growing new partnerships, and,
creatively transferring knowledge about lessons learned.
Reducing the Cost of Care
The potential for cost savings from systematic use of health IT
includes avoidable expenditures in the administrative and financial
aspects of health care institutions, improved efficiencies in workflow,
improved physician decisionmaking (especially when decision support
systems provide immediate access to information on comparative
effectiveness and cost effectiveness), and in the reduced need for
additional patient care that medical errors often entail. There are
also significant financial and non-financial costs to patients that can
be reduced through the introduction of health IT: the potential for
bringing health care to the patient's location (which can be a serious
issue for those geographically isolated, homebound, or in nursing
homes), removing the inconvenience, expense and increased risk of harm
associated with inpatient admission, reducing or eliminating the need
to return to a tertiary care hospital for follow-up consultations, and
the potential for patients to substitute e-mail or other web-based
consultations in place of office visits with their physicians. One-
third of Americans reported that they needed to return for a repeat
visit because their clinical information was not available during their
first visit.
AHRQ's prior investments provide evidence of the potential for
savings in selected care settings and our work in progress will
demonstrate the value obtained from investments in health IT in a broad
array of settings. Over the last decade work by one of our grantees
demonstrated that computerized reminders can reduce the cost of tests
ordered for hospitalized patients by approximately 10 percent. Another
example is the Utah Health Information Network, developed a decade ago
by then-Governor Leavitt, which demonstrated the potential for savings
in administrative and billing costs through the use of health IT. By
creating a more efficient way to submit bills, UHIN both reduced costs
and reduced the administrative burden of re-entering the same data for
different payers. AHRQ now is working with UHIN to add clinical data to
their statewide system to enhance its potential to improve the quality
and safety of patient care as well.
AHRQ is funding another statewide regional health information
exchange in Indiana, for which the Regenstrief Institute, a national
health IT leader, is a key player. This statewide initiative builds
upon the successful NLM-funded Indianapolis patient care network, which
was developed to make health care information reliably available for
patients seen in Emergency Departments regardless of where they usually
get care and to improve the exchange of information between health care
providers and the public health authorities. When current data are
available, redundant testing can be avoided and the right care can be
delivered more rapidly. In an effort to more definitively identify the
cost savings of health IT, we are concurrently funding an evaluation of
the value of that exchange, not only in the hospital system but also
throughout the Indiana primary care and specialty clinics. This well-
designed evaluation will provide the Nation with clear evidence of
whether the actual savings are as significant as many hope. It will
provide crucial evidence for those seeking to make a business case for
health IT.
AHRQ will also understand the costs and benefits of the statewide
electronic prescribing roll-out in Massachusetts, undertaken by a
consortium that includes Blue Cross Blue Shield. AHRQ researchers will
have access to claims and utilization data for over 1,000 prescribers,
translating to approximately 480,000 prescriptions over the course of
the year.
The results of AHRQ's current research will also inform America
about the wide-ranging effects of the large investments in health IT by
integrated delivery systems. One evaluation project studies the effects
on patient outcomes and resource utilization resulting from Kaiser
Permanente's $3 billion investment in electronic medical records for
ambulatory physician practices. The evaluation findings from these
major investments will be available to the public. This may accelerate
adoption by enabling health care institutions to learn from the early
adopters.
National Resource Center for Health IT
Mr. Chairman, I cannot over-emphasize how essential technical
assistance is to the successful adoption and implementation of health
IT. To assure that as many Americans as possible benefit from our
research, we are committed to exporting lessons learned from current
demonstrations rapidly and widely. We have been inundated with requests
for help from providers and health care systems attempting to adopt
health IT. In response, we have created a National Resource Center for
Health IT, the largest single commitment to technical assistance in
AHRQ's history. The Resource Center leverages our investments in health
IT by offering help where it's needed--real world clinical settings
that may feel ill-equipped to meet the implementation challenge--
facilitating expert and peer-to-peer collaborative learning and
fostering the growth of online communities who are planning,
implementing, and researching health IT. Our initial needs assessment
led to the development of a series of educational teleconferences on
critical topics for health IT implementers: how to comply with rules
and regulations, how to design workflow, how to evaluate effectiveness,
and how to tackle clinical decision support systems. Early this month,
we convened a highly successful, week-long meeting attended by over 700
doctors, nurses, pharmacists, and IT professionals to share practical
knowledge about health IT, and linked it closely with the Department's
goals for patient safety. As one of our grantees from Kentucky said,
``this meeting brought real life case study experience to so many of
the issues facing us today.''
AHRQ has also used the Resource Center to assist states that are
initiating statewide clinical data sharing. We have convened small,
round-table working meetings of experts to share detailed expertise
with states that are starting the process of determining the governance
and technical architecture of their data-sharing organizations. The
first of these was in Tampa, at the invitation of the Florida
Governor's Health Information Infrastructure Advisory Board on
Healthcare; we have planned expert roundtables in New York, Wyoming,
and Montana, with further assistance to Delaware, Maryland, and
Georgia. In these roundtables, AHRQ has been fortunate to draw upon the
expertise of our state contractors who are intimately involved with
this work in their own states, as well as consultants from our Resource
Center.
The Resource Center provides a web portal with critical
infrastructure for convening practitioners, encouraging collaboration,
and disseminating best practices. The portal gathers communities of
practice with similar interests and concerns to share and learn. While
it was initially only open to AHRQs grantees, we are opening this rich
resource to other Federal grantees. We recently announced that AHRQ
will support a special portal for the Nation's community health centers
as they struggle to adopt health IT, with plans to expand to providers
involved in the Medicare initiative to expand the use of health IT in
physician offices known as DOQ-IT and to providers in the Indian Health
Service (IHS). In recognition of the widespread interest in rapid
turnaround of health IT knowledge, the Resource Center will be
expanding its practical, educational teleconferences to any
organization, and providing in-depth ``learning collaborative''
curricula for a smaller subset of interested organizations.
Working in Partnership
To advance health IT, AHRQ is working closely with public and
private organizations, such as the National Governors Association
(NGA), eHealth Initiative, Markle Foundation, Connecting for Health,
and America's Health Insurance Plans to promote solution development
for many of the challenges I have described. With the NGA, we will be
participating in developing and providing leadership resources for
State officials on investing in health IT and healthcare quality
improvement.
Health IT can accelerate improvements in safety and quality if
there are clear objectives. Working closely with leading medical
professional organizations (including the American Medical Association,
American Academy of Family Physicians, and American College of
Physicians), America's Health Insurance Plans, payers, consumers and
other stakeholders, AHRQ's leadership has been essential for
prioritizing goals for improving physician performance in ambulatory
care. The results of this collaboration, known as the Ambulatory care
Quality Alliance (AQA) will be adopted broadly in early 2006 in the
private sector as well as by CMS. The AQA is now developing strategies
to collect and report the requisite data including the use of health IT
when feasible. Improvements in care will start now and can be
accelerated by efforts to establish a nationwide information
infrastructure led by Secretary Leavitt.
AHRQ is working with the Leapfrog Group, an organization of leading
employers to develop an evaluation tool that allows hospitals and
physicians to ensure that their computerized physician order entry
(CPOE) systems and electronic prescribing are effectively reducing
medical errors. These tools will be available by the end of the year.
AHRQ is also providing support to the Medical Group Management
Association (MGMA) Center for Research to understand the level of
adoption of electronic health records and other new technologies in
medical groups and the issues associated with their successful
implementation. By documenting barriers encountered in adopting these
technologies and mechanisms, we will know better how to target our
research to overcome these barriers.
AHRQ is collaborating with other Federal agencies to align our
health IT efforts. With CMS, we are active participants in the design
and evaluation of health IT projects in pay-for-performance, electronic
prescribing, and the implementation of the Medicare Modernization Act.
With the IHS, we have supported enhancements to their electronic health
record, and, incidentally, that system has been chosen by the National
Aeronautical and Space Administration (NASA) to be its electronic
health record. With the Food and Drug Administration and NLM, we are
supporting standards development and coordination efforts. In all of
our efforts, AHRQ maintains close relationships with other agencies, in
order to maximize the Federal investment of health IT dollars. We
maintain these relationships, in part, through working with the Federal
Health Architecture (FHA)/Consolidated Health Informatics (CHI)
Initiative managed by the Office of the National Coordinator for Health
Information Technology. The FHA has been tasked to provide an
architecture, or framework, to guide Federal health IT investments, and
to foster interoperability through the selection and adoption of health
data standards.
The Agency is working directly with the Office of the National
Coordinator for Health Information Technology on a number of issues
including an analysis of the intersection health IT forms with various
state privacy laws and business practices. This FY 2005 $11.5 million
initiative, working with up to 40 states or territories, will assess
variations in business policies and state laws that affect health
information exchange and identify practical solutions while assuring
the preservation of privacy and security. These important efforts will
assure patients, providers and other stakeholders that personal and
sensitive health data will remain safe and secure.
Concluding Observations
Mr. Chairman, I would like to conclude by offering a few brief
observations based upon our work in health IT.
First, health IT alone cannot provide the improvements needed in
our healthcare system. These improvements will depend upon the
integration of high quality health IT into the very fabric of care by
incorporating systems into our individual clinical practices, hospitals
and other settings.
Second, for most health care settings, health IT is not likely to
afford an ``out-of-the-box'' solution. Effective use of health IT
begins with a careful examination of the health care setting and then
uses the power of IT to enhance its effectiveness and efficiency.
Third, to accelerate the pace of health IT adoption and
implementation, we need to facilitate the sharing of both knowledge and
experience through additional opportunities for voluntary peer-to-peer
learning. Given the level of economic investment that is required,
providers are understandably worried that a mistake in judgment could
prove financially catastrophic.
Finally, the development of an interoperable health IT
infrastructure will be a critical element in our Nation's effort to
accelerate the pace of innovation and the speed with which patients
will benefit from new medical breakthroughs. The inherent delays in our
current system for assessing the effectiveness of new drugs, devices,
and procedures will decrease dramatically with widespread use of health
IT and advance our common goal of evidence-based medicine.
Mr. Chairman, this concludes my prepared statement. I will be
delighted to answer any questions.
The Chairman. Thank you, Dr. Clancy. Dr. Brailer.
STATEMENT OF DAVID J. BRAILER, M.D., Ph.D., NATIONAL
COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Brailer. Thank you Chairman Ensign, and members of the
Committee, I am pleased to be here with my colleagues today to
talk about health information technology. And let me start with
the Executive Order of April 2004 that established my office
and the activities that the Administration has under way today.
The goals that we had for that Executive Order have already
been outlined. But again, they are to lower costs, reduce
medical errors, improve quality, and reduce the hassle that
consumers face when they come to healthcare. We seek to have
widespread adoption of interoperable electronic health records
within 10 years. The goal of the interoperability, simply put,
is to have information that follows patients where they want it
to, and not follow them where they don't.
Over the course of the past year we've been working to set
the foundations for this work, and there are three that I would
like to highlight.
The first is a Clinical Foundation, and this raises the
question that many of us are very aware of today: What are the
benefits that health information technology brings? You've
already heard cited today that the Institute of Medicine
reports on deaths that result from inpatient medical errors,
from ambulatory medical errors, and from related other
accidents and incidents. We also know from the literature that
missing information when a physician sees a patient can be
harmful. Thirty-two percent of Americans report that they
create and carry some form of a personal health record, because
they don't want to come to an emergency room and not have their
information available, or see a specialist and not have them
know what has happened to that patient in the past. You've
heard citations of the potential savings that come from the use
of health information technology ranging from 7.5 percent of
expenditures, to 30 percent, depending upon the level of
concomitant industry transformation. We've seen studies that
have demonstrated that use of electronic health records and
appropriate order entry can reduce adverse drug events by 70 to
80 percent. That's an astounding reduction.
We know that health information technology can save lives,
improve care, and reduce costs. Now, in addition to this
Clinical Foundation, we've been working to understand the
business or industry foundation, in a Technical Foundation. We
recently released a report from the CEOs of Fortune 100
companies that we convened to help us understand the Business
Foundation. The CEOs are not only the leaders of larger
purchasers, but they're also leaders of industries that had
been through an information transformation. IT has changed the
structure and the efficiency of their industry, retailing,
financial services, manufacturing, banking, transportation and
shipping. These CEOs reported to us two major findings. First,
they believe that healthcare could derive the same kinds of
benefits that their industries have, in terms of sustainable
productivity from widespread use of point-of-service
information technologies and second, that, as purchasers, they
believe this is an urgent priority. They called on the Federal
Government to act as a leader and a catalyst and a convener to
take a market-based approach and to bring this forward on a
basis that can engage the private sector on an active basis.
The Technical Foundation was also recently released which was
the summary of the RFI that we asked the industry to respond
to. These were numerous questions about technology, about
policy, about the use of technology, and the changes that are
needed to create positive opportunities in healthcare. We had
more than 500 responses, totalling more than 5,000 pages of
responses. We had a 100-employee Federal Task Force to review
these, and that report was released 3 weeks ago. This
discussion lead to a number of key findings. These findings
include the critical role of standards, and not just to have
standards communicated but to have them detailed to a level of
specificity, and a level of clarity that allowed our software
developers, our hospitals and physicians to be able to have
absolute clarity about what these standards mean and how they
can be used. They need to have an architecture; they need to
have an capacity to share and move information. The standards
create a framework by which information can flow and advances
in privacy and security that allow us to have both flexibility
and the ability of information to be portable.
Building on these three foundations, we saw two critical
challenges that have become the focus of the Administration's
policy. The first is how do we create portability of health
information. Second is, how do we close the electronic health
record adoption gap.
Speaking to the latter we know there's a gap between the
adoption rates of large and small health systems. Very large
health systems, some of which you will hear from today, have
been adopting electronic health records over the past 2 years,
and have accelerated in the past year. Many, many small
doctors, small hospitals, and rural providers have not been
able to do so. This has resulted in an overall low adoption
rate in the industry. We believe we have an opportunity now,
because of the low adoption rate, to create the foundation for
interoperability so that, as we move forward, we're able to
have portability, and to build this into the infrastructure
that will be put in place over the next few years. Toward this
end we've begun a number of public/private initiatives that
have been going forth from RFPs we have out now. There are four
that I'll briefly highlight.
One is for standard harmonization, this is to allow the
standards development organizations and others that are in
place today to come together to give us a single set, a
national fabric of standards, that is unambiguous, clear, non-
duplicative, and complete.
Second is compliance certification, which allows for a
process to be developed to base inspection of electronic health
records and other products to ensure that they meet minimal
standards for safety, for security, and for protection. We know
that not all electronic health records are created equal and
until we get this in place we're not able to ensure that the
software that is used by physicians on patients will deliver
the kinds of quality, and safety, and privacy results that we
want to have.
The third is to develop architectures, solutions for
information sharing that can be designed in the public interest
to allow not only capacity for information to move, but also
motivating commercial investment in the health information
technology and interoperability industry.
Fourth is to advance security and privacy, particularly to
identify mechanisms that can preserve the flexibility that is
built into Federal and many state laws, and at the same time,
allow seamless portability of information, so information can
follow patients wherever they go.
We've allocated $85 million in this fiscal year to these
goals and have requested $125 million to achieve these goals in
2006.
I appreciate the leadership of this committee and look
forward to the work that will come in the future. Thank you.
[The prepared statement of Dr. Brailer follows:]
Prepared Statement of David J. Brailer, M.D., Ph.D., National
Coordinator for Health Information Technology, Department of Health and
Human Services
Chairman Ensign, and members of the Subcommittee, I am Dr. David
Brailer, the National Coordinator for Health Information Technology.
The Office of the National Coordinator for Health Information
Technology is a component of the Department of Health and Human
Services (HHS). I, along with my colleague Dr. Carolyn Clancy, will
provide a brief overview of some of the Department's health information
activities underway.
Setting the Context
On April 27, 2004, the President signed Executive Order 13335 (EO)
announcing his commitment to the promotion of health information
technology (IT) to lower costs, reduce medical errors, improve quality
of care, and provide better information for patients and physicians. In
particular, the President called for widespread adoption of electronic
health records (EHRs) within 10 years so that health information will
follow patients throughout their care in a seamless and secure manner.
Toward that vision, the EO directed the Secretary of the Department
Health and Human Services (HHS) to establish within the Office of the
Secretary the position of National Coordinator for Health Information
Technology (National Coordinator), with responsibilities for
coordinating Federal health information technology (health IT) programs
with those of relevant Executive Branch agencies, as well as
coordinating with the private sector on their health IT efforts. On May
6, 2004, Secretary Tommy G. Thompson appointed me to serve in this
position.
On July 21, 2004, during the Department's Health IT Summit, we
published the ``Strategic Framework: The Decade of Health Information
Technology: Delivering Consumer-centric and Information-rich Health
Care,'' (The Framework). The Framework outlined an approach toward
nationwide implementation of interoperable EHRs and in it we identified
four major goals. These goals are: (1) inform clinical practice by
accelerating the use of EHRs, (2) interconnect clinicians so that they
can exchange health information using advanced and secure electronic
communication, (3) personalize care with consumer-based health records
and better information for consumers, and (4) improve public health
through advanced bio-surveillance methods and streamlined collection of
data for quality measurement and research. The Framework has allowed
many industry segments, sectors, interest groups, and individuals to
review how health IT could transform their activity or experience,
consider how to take advantage of this change, and to participate in
ongoing dialogue about forthcoming efforts. My office has obtained
significant additional input concerning how these four goals can best
be met.
We have consulted with, and actively partnered with,
numerous Federal agencies in the U.S. Government including the
Departments of Veterans Affairs, Defense, Commerce, and
Homeland Security.
We have met with many organizations and individuals
representing stakeholders of the healthcare system to obtain
their individual views.
We have reached out to states and regions through site
visits and town hall meetings to understand the health IT
challenges experienced at the local level as well as best
practices for the use of, and collaboration regarding, health
IT.
We have regularly testified before, and been informed by,
the National Committee on Vital and Health Statistics (NCVHS)
on issues critical to the Nation's health IT goals.
We have monitored, and coordinated with, the efforts of the
Commission for Systemic Interoperability. (The Medicare
Modernization Act called for the Secretary to establish the
Commission to develop a comprehensive strategy for the adoption
and implementation of health care information technology
standards that includes a timeline and prioritization for such
adoption and implementation.) and
We have met with delegations involved with health IT from
other countries, including Canada, the Netherlands, Japan,
Australia, Great Britain, and France to learn from their
individual country experiences.
Building on the EO, The Framework, and this input, we have
developed the clinical, business, and technical foundations for the HHS
health IT strategy. Let me turn to some of those now.
The Clinical Foundation: Evidence of the Benefits of Health IT
We believe that health IT can save lives, improve care, and reduce
costs in our health system. Five years ago, the Institute of Medicine
(IOM) estimated that as many as 44,000 to 98,000 deaths occur each year
as the result of medical errors. Health IT, through applications such
as computerized physician order entry can help reduce medical errors
and improve quality. For example, studies have shown that adverse drug
events have been reduced by as much as 70 to 80 percent by targeted
programs, with a significant portion of the improvement stemming from
the use of health IT.
Every primary care physician knows what a recent study in the
Journal of the American Medical Association (JAMA) showed: that
clinical information is frequently missing at the point-of-care, and
that this missing information can be harmful to patients. That study
also showed that clinical information was less likely to be missing in
practices that had full electronic records systems. Patients know this
too and are taking matters into their own hands. A recent survey by the
Agency for Health Care Research and Quality (AHRQ) with the Kaiser
Family Foundation and the Harvard School of Public Health found that
nearly 1 in 3 people say that they or a family member have created
their own set of medical records to ensure that their health care
providers have all of their medical information.
There are mixed signals about the potential of health IT to reduce
costs. Some researchers estimate that savings from the implementation
of health IT and corresponding changes in care processes could range
anywhere from 7.5 percent of health care costs (Johnston et al., 2003;
Pan et al, 2004) to 30 percent (Wennberg et al., 2002; Wennberg et al.,
2004; Fisher et al., 2003; Fisher et al., 2003). These estimates are
based in part on the reduction of obvious errors. For example, a
medical error is estimated to cost, in 2003 dollars, about $3,700
(Bates et al, 1997). If poorly designed or implemented, health IT will
not bring these benefits, and in some cases may even result in new
medical errors and potential costs.
Therefore, achieving cost savings requires a much more substantial
transformation of care delivery that goes beyond simple error
reduction. But, health IT must be combined with real process change in
order to see meaningful improvements in our delivery system. It
requires the industry to follow the best diagnostic and treatment
practices everywhere in the Nation.
So, this is the clinical foundation for our work, which
demonstrates that health IT can save lives, improve care, and improve
efficiency in our health system; now let me turn to the business
foundation.
The Business Foundation: The Health IT Leadership Panel Report
Recognizing that the healthcare sector lags behind most other
industries in its use of IT, an HHS contractor convened a Health IT
Leadership Panel for the purposes of understanding how IT has
transformed other industries and how, based upon their experiences, it
can transform the health care industry.
The Leadership Panel was comprised of nine CEOs from leading
companies that purchase large quantities of healthcare services for
their employees and dependents and that do not operate in the
healthcare business. The Leadership Panel included CEOs from FedEx
Corporation, General Motors, International Paper, Johnson Controls,
Target Corporation, Pepsico, Procter & Gamble, Wells Fargo, and Wal-
Mart Stores. The business leaders were called upon to evaluate the need
for investment in health information technology and the major roles for
both the government and the private sector in achieving widespread
adoption and implementation. Based upon their own experiences using IT
to reengineer their individual business--and by extension, their
industries--the Leadership Panel concluded that investment in
interoperable health IT is urgent and vital to the broader U.S. economy
due to rising health care demands and business interests.
As identified by the Lewin Group, the Leadership Panel unanimously
agreed that the Federal Government must begin to drive change before
the private sector would become fully engaged. Specifically, the
Leadership Panel concluded:
Potential benefits of health IT far outweigh manageable
costs.
Health IT needs a clear, broadly motivating vision and
practical adoption strategy.
The Federal Government should provide leadership, and
industry will engage and follow.
Lessons of adoption and success of IT in other industries
should inform and enhance adoption of health IT.
Among its multiple stakeholders, the consumer--including
individual beneficiaries, patients, family members, and the
public at large--is key to adoption of health IT and realizing
its benefits.
Stakeholder incentives must be aligned to foster health IT
adoption.
The Leadership Panel identified as a key imperative that the
Federal Government should act as leader, catalyst, and convener of the
Nation's health information technology effort. The Leadership Panel
also emphasized that Federal leverage as purchaser and provider would
be needed--and welcomed by the private sector. Private sector
purchasers and health care organizations can and should collaborate
alongside the Federal Government to drive adoption of health IT. In
addition, the Leadership Panel members recognized that widespread
health IT adoption may not succeed without buy-in from the public as
health care consumer. Panelists suggested that the national health IT
vision must be communicated clearly and directly to enlist consumer
support for the widespread adoption of health IT.
These findings and recommendations from the Leadership Panel were
published in a report released in May 2005 and laid the business
foundation for the HHS health IT strategy. Now, let me turn to the
technical foundation.
The Technical Foundation: Public Input Solicited on Nationwide Network
HHS published a Request for Information (RFI) in November 2004,
that solicited public input about whether and how a Nationwide Health
Information Network (NHIN) could be developed. This RFI asked key
questions to guide our understanding around the organization and
business framework, legal and regulatory issues, management and
operational considerations, standards and policies for
interoperability, and other considerations.
We received over 500 responses to the RFI, which were reviewed by a
government-wide RFI Review Task Force. This Task Force was comprised of
over 100 Federal employees from 17 agencies, including the Departments
of Homeland Security, Defense, Veterans Affairs, Treasury, Commerce,
Health and Human Services, as well as multiple agencies within the
departments. The resulting public summary document has begun to inform
policy discussions inside and outside the government.
We know that the RFI stimulated substantial and unprecedented
discussions within and across organizations about how interoperability
can really work, and we have continued to build on this. These
responses have yielded one of the richest and most descriptive
collections of thoughts on interoperability and health information
exchange that has likely ever been assembled in the U.S. As such, it
has set the foundation for actionable steps designed to meet the
President's goal.
While the RFI report is an illustrative summary of the RFI
responses and does not attempt to evaluate or discuss the relative
merits of any one individual response over another, it does provide
some key findings. Among the many opinions expressed by those
supporting the development of a NHIN, the following concepts emerged:
A NHIN should be a decentralized architecture built using
the Internet, linked by uniform communications and a software
framework of open standards and policies.
A NHIN should reflect the interests of all stakeholders and
be a joint public/private effort.
A governance entity composed of public and private
stakeholders should oversee the determination of standards and
policies.
A NHIN should provide sufficient safeguards to protect the
privacy of personal health information.
Incentives may be needed to accelerate the deployment and
adoption of a NHIN.
Existing technologies, Federal leadership, prototype
localized or regional exchange efforts, and certification of
EHRs will be the critical enablers of a NHIN.
Key challenges to developing and adopting a NHIN were listed
as: the need for additional and better refined standards;
addressing privacy concerns; paying for the development and
operation of, and access to the NHIN; accurately verifying
patients' identity; and addressing discordant inter- and intra-
state laws regarding health information exchange.
Key Actions
Building on these steps, two critical challenges to realizing the
President's vision for health IT are being addressed: (a)
interoperability and the secure portability of health information, and
(b) electronic health record (EHR) adoption. Interoperability and
portability of health information using information technology are
essential to achieve the industry transformation goals sought by the
President. Further, the gap in EHR adoption between large hospitals and
small hospitals, between large and small physician practices, and
between other healthcare providers must be addressed. This adoption gap
has the potential to shift the market in favor of large players who can
afford these technologies, and can create differential health
treatments and quality, resulting in a quality gap.
To address these challenges, HHS is focusing on several key
actions: harmonizing health information standards; certifying health IT
products to assure consistency with standards; addressing variations in
privacy and security policies that can hinder interoperability; and,
developing an architecture for nationwide sharing of electronic health
information. HHS has allocated $86.5 million to achieve these and other
goals in FY 2005 and has requested $125 million in FY 2006.
Standards Harmonization
We have issued a Request For Proposal (RFP) to develop, prototype
and evaluate a process to harmonize industry-wide standards
development, and also unify and streamline maintenance of and
refinements to existing standards over time. Today, the standards-
setting process is fragmented and lacks coordination, resulting in
overlapping standards and gaps in standards that need to be filled.
Additionally, within the Federal Government, National Institute of
Standards and Technology (NIST) will develop a process to take output
from the standards harmonization process and consider them as Federal
Information Processing Standards (FIPS) relevant to Federal agencies.
We envision a process where standards are identified and developed
around real scenarios--i.e., around use cases or breakthroughs. A ``use
case'' is a technology term to describe how actors interact in specific
value-added scenarios--for example, rapidly assembling complete patient
information in an emergency room; we also call them ``breakthroughs.''
Compliance Certification
We have issued an RFP to develop, prototype and evaluate a process
to specify criteria for the functional requirements for health IT
products--beginning with ambulatory EHRs, then inpatient EHRs, and then
the infrastructure components through which EHRs interoperate (e.g.,
NHIN architecture). This RFP will also evaluate a process for
inspection based on conformance with these criteria. NIST will
collaborate with the RPF contractor in this effort, where appropriate,
as directed by HHS.
NHIN Architecture
We have issued an RFP to develop models and prototypes for a NHIN
for widespread health information exchange that can be used to test
specialized network functions, security protections and monitoring, and
demonstrate feasibility of scalable models across market settings. The
NHIN architecture will be coordinated with the work of the Federal
Health Architecture and other interrelated RFPs. The goal is to develop
real solutions for nationwide health information exchange and
ultimately develop a market--particularly the supply side--for health
information exchange, which does not exist today. This RFP will fund 6
architectures and operational prototypes that will maximize the use of
existing resources such as the Internet, and will be tested
simultaneously in three markets with a diversity of providers in each
market. HHS intends to make these prototype architectures available in
the public domain to prevent control of ideas and design. Through the
RFP process, we encourage the development of a complete open source
solution.
Security and Privacy
We issued an RFP, which Dr. Clancy will discuss further, to assess
variations in state laws and organization-level business policies
around privacy and security practices, including variations in
implementations of HIPAA privacy and security requirements that may
pose challenges to automated health information exchange. Variations in
organizational level policies and state laws may create barriers to
interoperability. This RFP, administered by AHRQ, will seek to define
workable mechanisms and policies to address these variations, while
maintaining the levels of security and privacy that consumers expect.
We expect to award contracts for these RFPs by October 2005.
Fraud and Abuse Study
HHS has a 6-month project underway to determine how automated
coding software and a nationwide interoperable health information
technology infrastructure can address healthcare fraud issues. The
project is being conducted through a contract with the Foundation of
Research and Education (FORE) of the American Health Information
Management Association (AHIMA)
While only a small percentage of the estimated 4 billion healthcare
claims submitted each year are fraudulent, the total dollars in
fraudulent or improper claims is substantial. The National Health Care
Anti-Fraud Association (NHCAA) estimates that healthcare fraud accounts
for 3 percent of U.S. health expenditures each year, or an estimated
$56.7 billion. They cite other estimates, which may include improper
but not fraudulent claims, as high as 10 percent of U.S. health
expenditures or $170 billion annually.
At present, the contractor is working to perform two main tasks.
One task is a descriptive study of the issues and the steps in the
development and use of automated coding software that enhance
healthcare anti-fraud activities. The second task is identifying best
practices to enhance the capabilities of a nationwide interoperable
health information technology infrastructure to assist in prevention,
detection and prosecution, as appropriate, in cases of healthcare fraud
or improper claims and billing. An expert cross-industry committee
composed of senior level executives from both the private and public
sectors is guiding this second task.
The project's final report is scheduled for completion in September
2005.
Conclusion
Thank you for the opportunity to present this summary of the
activities of the Office of the National Coordinator for Health
Information Technology. A year ago, the President created this position
by Executive Order. In that time, we have established the clinical,
business and technical foundations for the HHS health IT strategy. Now,
we have begun to execute key actions that will give us real, tangible
progress toward that goal.
HHS, under Secretary Michael Leavitt's leadership, is giving the
highest priority to fulfilling the President's commitment to promote
widespread adoption of interoperable electronic health records--and, it
is a privilege to be a part of this transformation.
Mr. Chairman, this concludes my prepared statement. I would be
delighted to answer any questions that you or the Members of the
Subcommittee may have.
Senator Ensign. Thank you, Dr. Brailer. Dr. Semerjian.
STATEMENT OF DR. HRATCH G. SEMERJIAN,
ACTING DIRECTOR, NATIONAL INSTITUTE OF STANDARDS
AND TECHNOLOGY, TECHNOLOGY ADMINISTRATION,
DEPARTMENT OF COMMERCE
Dr. Semerjian. Thank you, Mr. Chairman. Chairman Ensign,
Senator Kerry, and Senator Allen, I would like to thank you for
the opportunity to add to this discussion regarding health
information technology. I certainly was very pleased to hear
some of the discussion earlier, discussion on standards and
interoperability. And, in fact, NIST has a long and productive
history of engaging industry sectors and overcoming
interoperability and data exchange barriers to improve
competitiveness and reduce costs.
Inadequate interoperability problems have been found to
cost the automotive industry, for example, some $5 billion a
year. The semi-conductor industry $4 billion, and construction
industry more than $15 billion. And, we have been working with
industry and standards organizations to address these issues.
With the increasing use of information technology in healthcare
delivery, issues associated with health-related information
sharing, security, privacy, and interoperability issues need to
be addressed. NIST has been working with the healthcare
community to improve the reliability and reduce the costs of
U.S. healthcare since the 1960s. We've developed, for example,
standards that are used by the College of American Pathologists
as their benchmark for purposes of testing for more than 15,000
U.S. clinical laboratories. Manufacturers are, for example,
turning to NIST for accurate measurements, for emerging medical
treatments and clinical diagnostics, in areas such as coronary
stents, and radioactive seeds for heart attack and cancer
patients. In the mid to late 1990s, as part of our Advance
Technology Program on information infrastructure for
healthcare, NIST and our U.S. industry partners invested over
$300 million in health information technology to aid the U.S.
healthcare enterprise in developing an infrastructure to
improve coordination and enable administrative efficiencies,
avoid medical errors, reduce cost, and open new technological
opportunities.
NIST has worked with the healthcare industry to establish
concensus-based standards and to develop tests, prototypes and
diagnostic tools for building robust interoperable commercial
solutions. In fact, early on, NIST built a prototype that's
called a remote procedure, a call broker for the Veteran's
Health Administration (VHA), my colleague here, to enable
communication among their geographically disparate hospital
system. More recent efforts in support of VHA included
prototyping, emerging technology solutions such as the use of
Smart Cards by veterans, and single sign-on capabilities for
doctors.
Building on this initial interest in health enterprise
integration, NIST is collaborating on integrating the
healthcare enterprise project sponsored by the Radiological
Society of North America, Healthcare Information and Management
System Society, and the American College of Cardiology.
As part of this approach, NIST has been instrumental in
developing the Cross-Enterprise Document Sharing standard. This
standard provides a mechanism to securely access a patient's
multifaceted clinical information, especially when they're
remotely located and controlled.
In addition, NIST works within Health Level 7, in defining
standard functionality and conformance criteria for electronic
health record systems, forming the basis for their
certification. Similarly within the medical device community
NIST is applying the expertise in automatic test generation to
develop tests and associated tools for devices within intensive
care units. In accordance with the National Technology Transfer
and Advancement Act of 1995, NOMB Circular A119, NIST supports
the development of voluntary industry standards as the
preferred source of standards, to be used by the Federal
Government.
In addition, if there are specific Federal Government
requirements that cannot be fulfilled by voluntary standards,
NIST develops Federal Information Processing Standards, FIPS,
to meet these needs. This extensive record of promoting
standards and the technical expertise on NIST's staff will be
extremely useful in meeting the President's goal of making our
country's premier healthcare system safer by reducing medical
errors, improving the quality of care, making it more
affordable by reducing the cost of care and making healthcare
more accessible, by making health-related information available
at the point of care.
As a football coach, who we loved and cherished would have
said, the future is now for healthcare, health IT. At NIST
we're committed to supporting the Department of Health and
Human Services, in the implementation of the President's health
IT initiative.
We're looking forward to working with Dr. Brailer's office
and other organizations to help harmonize health information
standards, to certify health IT products, to ensure conformance
with these standards and assisting in the development of a
nationwide architecture for sharing electronic health
information. In doing so NIST's widely recognized technical
expertise in cybersecurity and privacy will be applied to
secure the nationwide health information network.
Once again thank you for inviting me to testify about NIST
activities, and I'll be happy to answer any questions you may
have.
[The prepared statement of Dr. Semerjian follows:]
Prepared Statement of Dr. Hratch G. Semerjian, Acting Director,
National Institute of Standards and Technology, Technology
Administration,
Department of Commerce
Introduction
Chairman Ensign and Members of the Committee, I am Hratch
Semerjian, Acting Director of the National Institute of Standards and
Technology (NIST), part of the Technology Administration of the
Department of Commerce. I am pleased to be offered the opportunity to
add to this discussion regarding health information technology.
I will focus my testimony on the role that timely and reliable
measurement and consensus-based standards can play in increasing the
accuracy, privacy, security, and reliability of health information to
meet the President's mandate to make our country's premier healthcare
system safer, more affordable, and more accessible through the
utilization of information technology (IT). A cultural transformation
of our Nation's $1.9 trillion \1\ national healthcare system can
reverse troubling statistics such as 44,000-98,000 Americans dying each
year from inpatient medical errors; \2\ Americans are being injured or
are dying each year from adverse drug events; \3\ and a significant
annual expenditure on treatments that may not improve health, may be
redundant, or may be inappropriate.
---------------------------------------------------------------------------
\1\ National Healthcare Expenditures Projections: 2004-2014. Office
of the Actuary. Centers for Medicare and Medicaid Services.
\2\ Institute of Medicine.
\3\ ADE.
---------------------------------------------------------------------------
As a result of the President's initiative, the Nation will have a
healthcare revolution that will connect IT systems for payment,
prescriptions, and patient care. In order for this model to succeed, it
will require interoperable IT standards and clinical diagnostic tools
that are technically sound, robustly specified, and traceable to
national standards and reference materials.
These standards and measurements go directly to the heart of NIST's
core metrology mission. Several years ago, NIST recognized the growing
importance of critical measurements and standards needed to advance the
healthcare industry, and improve the quality and cost-effectiveness of
health care delivery systems. Accordingly, NIST established a cross-
disciplinary effort to address these needs. While a good portion of
NIST healthcare portfolio makes a priority of providing the healthcare
community with standards and diagnostic tools, our involvement is
actually much broader. NIST has a long and effective history in working
with health-related organizations to improve our Nation's healthcare
system.
In Fiscal Year 2005, NIST health-related projects encompassed many
areas of the healthcare sector, including screening and prevention,
diagnostics, treatments, dentistry, quality assurance, bio-imaging,
systems biology, and clinical informatics. Recognizing the importance
of this area and NIST's crucial responsibilities, President Bush has
requested an additional $7.2 million for this area for Fiscal Year
2006. In all aspects of this Strategic Focus Area in healthcare-related
activities, NIST recognizes the importance of directly addressing the
needs of the doctors, clinics, and patients.
NIST's experience in managing the Baldrige National Quality
Program, which promotes performance excellence among U.S.
manufacturers, service companies, educational institutions, and health
care providers, is another way in which NIST stays connected with
health-related organizations. A large number of healthcare providers
now are using or beginning to learn more about the Baldrige Quality
Program as a framework for performance excellence within their
organizations. The ways in which organizations manage and protect
critical, electronic healthcare information and use IT systems to
improve their performance is a major aspect of the Baldrige Health Care
Criteria. Dealing with this sector and its senior leaders closely has
provided NIST special insight into how these organizations operate and
their special needs.
NIST is committed to supporting the Department of Health and Human
Services (HHS) in the implementation of the President's Health IT
initiative. Commerce Secretary Gutierrez and NIST stand ready to be
helpful in ensuring the success of the President's initiative.
Secretary Leavitt is aware of NIST's capabilities and we look forward
to his guidance as to how we can best utilize our resources to assist
the initiative.
As you know the President has set a goal of widespread adoption of
electronic health records within 10 years so that health information
will follow patients throughout their care in a seamless and secure
manner. To achieve this goal, NIST and the Department of Health and
Human Services have developed a strategic partnership that leverages
each Department's core expertise and resources to facilitate science
and technology innovation to improve human health and the U.S. economy.
This agreement to work together on the key actions that will enable us
to achieve the President's goal, which the HHS witnesses will discuss
in more detail, builds upon already-existing and successful
collaborations between NIST and HHS in cancer research and treatment,
standards for medical devices, and a host of other areas.
To assist HHS in the first phase of NHIN development, NIST will:
Assist in evaluating responses to the Request For Proposals
(RFP) recently issued by HHS;
Provide technical expertise for Nationwide Health
Information Network (NHIN) architecture;
Assist in Standards Harmonization;
Develop Performance and Conformance Metrics for NHIN;
Assist in the development of procedures for certifying
conformance; and
Provide guidance for Security.
Specifically, HHS is soliciting proposals for a series of
government contracts that will help advance health IT adoption. To
support this effort in the near term, NIST has been asked to
participate in the review and evaluation of responses to the Request
For Proposals and will work in a technical advisory capacity to the
contractors selected, as requested by the HHS National Coordinator for
Health IT. To support the long-term vision of a NHIN where clinicians,
laboratories, pharmacies, and patients have secure access to key
medical information, NIST will continue its research with standards and
emerging technologies, and provide testbeds for technology evaluation
and standards harmonization for the NHIN.
NIST is uniquely situated to contribute significantly to the
advancement of this plan. NIST draws upon the expertise that exists in
many of its programs. NIST's scientific measurement laboratories
respond to the measurement, standards and technology needs of U.S.
industry, government, and academia. NIST's industrial programs seek to
further U.S. technology development, as well as help ensure the growth
of U.S. small manufacturers, and have developed rigorous review and
evaluation procedures for responses to open solicitations.
As the lead Federal agency for measurements and standards, NIST has
a long and successful history of collaborating with industry sectors to
respond to their needs, and is poised to be successful in a strong
collaboration with both industry and government partners in the
development of widespread interoperability of healthcare applications.
It bears repeating that in all aspects our healthcare-related
activities, NIST recognizes the importance of directly addressing the
needs of the doctors, clinics, and patients
In the remainder of my testimony, I will provide details on NIST's
track record in evaluating technical proposals and in IT standards
harmonization, certification, accreditation, and measurement science to
support the rigorous testing that is required for the development of
the NHIN. The real value of a health IT system will only be achieved if
such systems are interoperable and electronic connectivity is achieved,
so that clinicians have key information, related to past patient
experiences, laboratory results, and prescriptions, when and where it
is needed--at the point of care. The development of such a health IT
system will depend upon interoperability standards and clinical
diagnostic tools that are technically sound, robustly specified, and
traceable to national standards and reference materials. It is critical
that all systems be secure and reliable. Sometimes, it is literally a
matter of life and death.
Based on many decades of expertise in information technology,
clinical measurements and decision support, NIST will contribute to
both the short-term and long-term goals of establishing a National
Health Information Network.
NIST Experience in Evaluating Responses to RFPs
NIST has valuable experience reviewing requests for proposals in
several of its programs, including the Advanced Technology Program's
Information Infrastructure for Healthcare. NIST evaluates each
submission against specific criteria, locating appropriate reviewers
for technology areas represented, formulating Source Evaluation Boards
as decisionmaking bodies, maintaining confidentiality of proprietary
information, securely moving large number of documents and maintaining
complete and accurate records, providing each submission full
consideration and fair treatment, and providing unsuccessful candidates
in-depth debriefings. A recent National Academy of Sciences report
applauds NIST for its effectiveness and efficiency in this effort.
Those capabilities will assist HHS in making very important health
information technology awards.
Second, NIST researchers have specific technical and business
expertise that would add value to the review and evaluation of the
submissions to the current RFP's. This expertise spans broad areas of
healthcare informatics and includes, but is not limited to:
architectures, networks, interoperability, security and privacy,
electronic health records, automation of clinical notes, expert alert
systems, decision support systems, telemedicine, virtual reality
training modules and simulation of minimally invasive surgery.
NIST Technical Expertise for NHIN Architecture
NIST works with industry, government, and academia to establish
consensus-based standards, develop associated test metrics to ensure
that implementations or devices perform according to the defined
standard, and establish comprehensive certification capabilities for
the IT industry. NIST has for many years been focused on developing
metrics for the information technology industry. We develop tests and
diagnostic tools for building robust, interoperable, commercial
solutions. Applying such tools early in the life cycle process helps
industry determine whether its products conform to the standard, and
ultimately, will interoperate with other products. In addition, the
development and use of these metrology tools fosters thorough review of
the standard, which will, in turn, aid in resolving errors and
ambiguities. The integration of information technology into the health
industry has the potential to reduce medical costs by as much as 20
percent, a significant savings in an annual healthcare bill that was
14.9 percent of the GDP $1.6 trillion--in 2002,\4\ estimated to be $1.9
trillion in 2005 \5\ and projected to rise to $3.6 trillion by 2014.\6\
---------------------------------------------------------------------------
\4\ National Center for Health Statistics. Health, United States,
2004. With Chartbook on Trends in the Health of Americans. Hyattsville,
Maryland: 2004. Table 116. Page 326. Available at: http://www.cdc.gov/
nchs/data/hus/hus04trend.pdf#116.
\5\ National Healthcare Expenditures Projections: 2004-2014. Office
of the Actuary. Centers for Medicare and Medicaid Services. Available
at: http://www.cms.hhs.gov/statistics/nhe/projections-2004/
proj2004.pdf.
\6\ Ibid.
---------------------------------------------------------------------------
(a) Standards Harmonization
As the U.S. National Measurement Institute, NIST is frequently
looked to for research and measurements that provide the technical
underpinning for standards, ranging from materials test methods to
standards for building performance, and for a range of technologies,
from information and communications technologies to nano- and bio-
technologies. As a matter of policy, NIST encourages and supports
participation of researchers in standards developing activities related
to the mission of the Institute. More than a quarter of NIST's
technical staff--363 employees--participate in standards developing
activities of 90 organizations. These include U.S. private sector
standardization bodies, industry consortia, and international
organizations. The NIST staff hold 1,183 committee memberships, and
chair 142 standards committees.
In the information technology area, 40 NIST researchers have taken
leadership roles and served with distinction in 80 national and
international standards committees promoting the interests of many
essential U.S. industries. Participation varies across a number of core
information technology disciplines, including advancing and securing
Internet and wireless networks, data exchange, data imaging, security
and privacy, biometrics, and usability and accessibility of IT systems.
In the area of telemedicine, NIST has worked in conjunction with the
American Telemedicine Association to define standards and guidelines
that enable the development and advancement of telemedicine. ATA and
NIST have conducted a series of workshops to identify standards needed
to provide ocular care through telecommunications technology.
In the health IT arena, the NIST staff participates in the
following key IT standards-related efforts:
ANSI Healthcare Informatics Standards Board (HISB).
ASTM International--Operating Room of the Future.
Markle Foundation's Connecting for Health.
American Telemedicine Association (ATA).
Federal Health Architecture/Consolidated Health Informatics
(FHA/CHI).
Medical Device Communications, Wireless Networks (IEEE).
Healthcare Information and Management Systems Society/
Integrating the Healthcare Enterprise (HIMSS/IHE).
Health Level 7 (HL7).
In accordance with the National Technology Transfer and Advancement
Act of 1995 (Pub. L. 104-113) and Administration policies, NIST
supports the development of voluntary industry standards both
nationally and internationally as the preferred source of standards to
be used by the Federal Government. NIST collaborates with national and
international standards committees, users, industry groups, consortia,
and research and trade organizations, to get needed standards
developed.
NIST will work with HHS to develop a strategy to promote such
voluntary consensus standards, or Federal Information Processing
Standards for use in the Federal sector.
As part of this process toward standardization of Federal health
information, NIST will begin to formalize the first set of data
standards agreed upon in the Federal Health Architecture/Consolidated
Health Informatics Initiative, through the development of appropriate
Federal Information Processing Standards and guidance to Federal
agencies through NIST Special Publications. This will help the Federal
Government to achieve a greater level of interoperability of Federal
health data.
(b) Performance and Conformance Metrics for the NHIN
NIST works with industry to establish credible, cost-effective
metrics to demonstrate software interoperability and conformance to
particular standards. These metrics often form the basis or criteria
upon which certifications are based. Typical NIST metrics include
models, simulations, reference implementations, test suites, and
testbeds.
Specific activities in support of health information technology
include:
HIMSS/IHE: A key problem today in the realization of electronic
health records for the patient's continuity of care is the
inability to share patient records across disparate
enterprises. To address this problem, NIST is collaborating
with industry to develop standardized approaches to sharing
electronic clinical documents across healthcare organizations
and providers. NIST staff have built reference implementations
and developed validation tools to demonstrate the feasibility
and correctness of implementations, and worked with
implementers to create integrated solutions based on these
approaches. In particular, NIST is collaborating with the
``Integrating the Healthcare Enterprise'' (IHE) project
sponsored by the Radiological Society of North America,
Healthcare Information and Management Systems Society (HIMSS)
and the American College of Cardiology. The goal is to develop
an approach called: Cross-Enterprise Document Sharing (XDS).
This standards-based approach provides a mechanism to access a
patient's multi-faceted clinical information, regardless of
where it is physically located, while maintaining local control
and ownership of that information and without compromising the
privacy and security of the patient's clinical history.
HL7: Health Level 7 is a standards development organization
that provides standards for the exchange, management and
integration of data that support clinical patient care and the
management, delivery and evaluation of healthcare services.
NIST is collaborating with HL7 in defining standard
functionality and conformance criteria for EHR systems. These
criteria form the basis for EHR certification efforts and will
help ensure that HL7 messaging and EHR systems' conformance can
be defined and measured at an appropriate level. NIST is also
developing a conformance-testing tool that automatically
generates test messages for HL7 Version 2 message
specifications.
IEEE Medical Device Information: In a typical intensive care
unit (ICU), a patient may be connected to one or more vital-
sign monitors and receive medicine or other fluids through
multiple infusion pumps. More acutely-ill patients may also be
supported by devices such as ventilators, defibrillators or
hemodialysis machines. Each of these medical devices has the
ability to capture volumes of data, available multiple times
per second. NIST is collaborating with the IEEE Medical Device
Communications working group in developing conformance tests
and associated tools to provide the medical device industry
with the necessary tools to ensure that critical devices
properly implement the medical device standards.
Operating Room of the Future: It is estimated that 10-20
percent of hospital errors occur in the perioperative
environment (before, during, and after surgery). Technology can
play a major role in increasing the overall patient safety in
such situations through the development of the operating room
of the future (ORF). The ORF will consist of a network of
interoperable plug and play medical devices, where the
utilization of advanced technologies, such as robot-assisted
surgery, sensor fusion, virtual reality, workflow integration,
and surgical informatics, will result in a higher quality of
healthcare by considerably increasing patient safety. NIST is
working with the Center for the Integration of Medicine and
Information Technology (CIMIT) in the development of an
architectural framework for medical device integration,
development of clinical requirements for device plug-and-play
standards, identification of current interfaces, and
development, testing and simulation of interfaces.
Clinical Informatics: Building on past experience in
information modeling and research to support interchange
standards for the manufacturing industry, NIST is preparing a
comprehensive report of all clinical information-oriented
standards, their development organizations, their scope and the
vocabularies/ontologies they employ. NIST will use the report
as the basis for developing a plan for applying NIST's
experience to assist in clinical information-oriented standards
development and closer harmonization.
Improved Internet Protocols: The Internet Engineering Task
Force (IETF) is a large, open international community of
network designers, operators, vendors, and researchers
concerned with the evolution of the Internet architecture and
the smooth operation of the Internet. NIST is actively
participating in IETF efforts in the areas of: IP security, key
management, Internet Protocol version 6, integrated services
and resource reservation, IP switching, advanced routing and
mobile ad hoc networks. NIST leads the IETF effort to develop
and deploy a secure Internet naming and routing infrastructure.
NIST metrics are used within this premier organization to
expedite the development and deployment of standardized
Internet infrastructure protection technologies. A secure
infrastructure is an absolute first step in developing a
National Health Information Network that can assure the
confidentiality of electronic patient records.
WPAN's for Health Information: NIST is assisting industry in
the development of an universal and interoperable wireless
interface for medical equipment, expediting the development of
standards for wireless technologies, and promoting their use in
the healthcare environment. In close collaboration with the
Institute of Electrical and Electronics Engineers (IEEE) and
the U.S. Food and Drug Administration, NIST developed
theoretical and simulation models for two candidate Wireless
Personal Area Network (WPAN) technologies including the
Bluetooth and the IEEE 802.15.4 specifications. NIST evaluated
their performance for several realistic healthcare scenarios
and contributed our results to the appropriate IEEE working
group. NIST contributions will constitute the basis of standard
requirements on the use of wireless communications for medical
devices.
(c) Certification
NIST has an established history of developing procedures for
certifying conformance to consensus-based standards. Conformity
assessment activities form a vital link between standards, which define
necessary characteristics or requirements for software products, and
the performance of the products themselves. Conformity assessment
procedures provide a means of ensuring that the products, services, or
systems produced or operated have the required characteristics, and
that these characteristics are consistent from product to product,
service to service, or system to system. Conformity assessment
includes: sampling and testing; inspection; certification; management
system assessment and registration; accreditation of the competence of
those activities and recognition of an accreditation program's
capability. NIST has been in the certification business since its
inception in 2001, and is well positioned to provide technical guidance
in the development of a technical certification regimen, including
specific certification metrics, software to perform comprehensive
certification tests, and certification procedures.
(d) Security
For many years, NIST has made great contributions to help secure
our Nation's sensitive information and information systems. Our work
has paralleled the evolution of IT systems, initially focused
principally on mainframe computers, now encompassing today's wide gamut
of information technology devices. Our important responsibilities were
re-affirmed by Congress with passage of the Federal Information
Security Management Act (FISMA) of 2002 and the Cyber Security Research
and Development Act of 2002.
Beyond our role to serve the Federal Agencies under FISMA, our FIP
standards and guidelines are often voluntarily used by U.S. industry,
global industry, and foreign governments as sources of information and
direction for securing information systems. Our research also
contributes to securing the Nation's critical infrastructure systems.
Moreover, NIST has an active role in both national and international
standards organizations in promoting the interests of security and U.S.
industry. Current areas that are applicable to the NHIN include:
Security Management and Guidance;
Cryptographic Standards and Applications;
Security Testing; and
Security Research/Emerging Technologies.
Recent activities specifically related to health IT include:
Guidance for Understanding the HIPAA Security Rule: The
Security Rule issued under the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) directs certain health care
entities, known as ``covered entities,'' to comply with
standards for keeping certain health information that is in
secure electronic form. NIST has published a document, An
Introductory Resource Guide for Implementing the HIPAA Security
Rule that summarizes and clarifies the HIPAA Security Rule
requirements for Federal agencies that are covered entities. It
also directs readers to other NIST publications that can be
useful in implementing the Security Rule.
Healthcare Accreditation Guidance: NIST in conjunction with
URAC (not an acronym) and the Workgroup of Electronic Data
Interchange (WEDI) sponsors the NIST/URAC/WEDI Health Care
Security Workgroup. The group promotes the implementation of a
uniform approach to security practices and assessments by
developing white papers, crosswalks (of regulations and
standards), and educational programs. The group brings together
stakeholders from the public and private sectors to facilitate
communication and consensus on best practices for information
security in healthcare. Ultimately, these best practices will
be integrated into accreditation criteria used by hospitals and
other healthcare facilities. The group draws heavily upon
information technology security standards and guidelines
developed by NIST.
Clinical Decision Support
In addition to our contributions to building a NHIN, NIST is
developing measurements and technologies that can be used in providing
advanced clinical decision support. Doctors rely on diagnostic tests to
optimize patient care. Many of these tests owe their high accuracy to a
variety of NIST standards, measurements, and calibrations. These
measurements are essential for patient care and the most efficient use
of available health care funds. NIST is contributing to increased
efficiency in health care delivery by ensuring that the measurement
quality assurance tools--reference measurement methods, certified
reference materials and calibrations--are available and well integrated
in the NHIN. Some examples of NIST work include:
In Vitro Diagnostic Medical Device Measurements;
Standard Reference Materials for Clinical Diagnostic
Markers;
Joint Committee on Traceability in Laboratory Medicine;
Gene Expression Analysis;
Point-of-Care Testing; and
Analytical Information Exchange.
Conclusion
As the Committee can see by the few examples I have cited, NIST has
a very diverse portfolio of activities supporting our Nation's health
information technology effort. With its long experience as well as a
diverse array of expertise, NIST is able to assist the Department of
Health and Human Services in achieving the President's goal and respond
meeting both the short-term and long-term needs of the Nationwide
Health Information Network.
Once again thank you for inviting me to testify about NIST's
activities, and I would be happy to answer any questions you may have.
Senator Ensign. Thank you.
Dr. Kolodner.
STATEMENT OF ROBERT M. KOLODNER, M.D., ACTING CHIEF HEALTH
INFORMATICS OFFICER, VETERANS HEALTH
ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS
Dr. Kolodner. Thank you Mr. Chairman. Good morning, Mr.
Chairman and Members of the Subcommittee. Thank you for
inviting VA here today to discuss our work in the field of
health information technology. Dr. Jonathan Perlin, VA's Under
Secretary for Health, regrets that he is unable to be with you
today, and has asked me to talk with you on his behalf about
VA's successes in the area of health IT. VA's electronic health
record system, known as VistA, is recognized as one of the most
comprehensive and sophisticated electronic health records, or
EHRs, in use today. As a doctor and as a patient, I am
passionate about the use of this technology and the very real
effects it can have on patients' lives. It can mean the
difference between life and death.
In addition to describing, and then actually showing, VistA
I want to reinforce two areas that I think are pivotal to the
successful widespread adoption of electronic health records,
and have been mentioned here today; and those are
interoperability and data standardization. In VA today,
virtually all clinical documents created by VA providers are
stored in VistA. To give you an idea of the magnitude of data
now available; there are over 650 million progress notes,
discharge summaries, and other clinical documents, more than
1.3 billion orders, and 300 million images in VistA as of March
2005.
An estimated 40 percent of veterans treated by VA each year
also receive care from non-VA health providers. Just imagine
the benefit to veterans when VA is able to exchange electronic
health data with their other doctors in real time,
appropriately and securely, so that their complete health
information is available regardless of where the veterans seek
care. Interoperability of health information systems is
crucial, and we need to make sure that we share not only data
but meaning, which brings us to data standardization.
We're working with our public- and private-sector health
partners on a variety of standards-related activities, as
mentioned previously, and these also include key collaborations
with FDA and the National Library of Medicine on drug
information standards. Our standardization efforts have already
improved our ability to share information with other agencies.
For example, we can now share selected health information back
and forth with DoD in real-time. And by this fall, we will be
performing immediate drug-allergy and drug-drug checks on all
outpatient medications a veteran receives from either VA or
DoD. Use of health data standards is crucial.
Before I demonstrate our current VistA system, I just want
to briefly mention our next-generation health information
system, HealtheVet-VistA, which will build on our successful
VistA system. Like VistA, this software will be in the public
domain. This means that providers, other Federal, state, and
local agencies, and small medical practices, as well as the EHR
system vendors can leverage our country's investment in VA's
world-class EHR. HealtheVet-VistA, along with my HealtheVet,
which is a personal record we provide for use directly by
veterans, will help us to continue to transform VA's healthcare
system from being organization-centric to being truly patient-
centric.
We in VA look forward to sharing our systems, knowledge,
and expertise with our partners throughout the healthcare
community to contribute to and support the President's plan for
transforming healthcare in the U.S. I know that I can't do our
EHR justice just by talking about it. So I would like to show
you how it works.
I have on this laptop the entire VistA system that runs in
hospitals across the Nation, as well as an imaging system. I've
opened here the application called ``CPRS.'' That's the
electronic chart that our providers use whenever they're taking
care of the patients. When I've signed on, the system gives me
notifications that are specific to me--notes that I need to
sign or abnormal results I need to follow up on. The
information I'm going to share with you is real patient data,
but it has been scrubbed so there is no patient identity--it's
protected. And we're going to start by looking at Mr. Madl's
chart. When I select Mr. Madl, I have a screen that looks like
a chart that you might have on paper--that is, it has tabs
across the bottom--so physicians are familiar with the
structure. And I can open up a cover sheet that has lots of
information. From the information on this sheet, I can drill
down and get information directly on diagnosis or medications.
And where it becomes more useful is when I bring up the
patient's vital signs--in this case, the blood pressure. I can
immediately graph years and years of data, and engage the
patient by actually having the patient look at the screen
together with me. And I can talk to Mr. Madl about the increase
in his blood pressure and why we need to get this under
control. And it's very clear to him that his blood pressure has
been rising, and I can engage him much more effectively in
terms of his care.
Mr. Madl is here today because of something that is
reflected in his abnormal blood results. I can look quickly at
what that blood work is. I'm going to bring up his hematocrit,
his red count, and look at all the results and review his
record. You can see the normal range at the top here. Mr. Madl
has been anemic most of his life. But there are a couple of
episodes where his blood count drops even more dramatically.
You can notice a rapid drop and a rapid rise, since the body
can't make the red cell count that is increasing quickly. That
means he's received a blood transfusion on at least two
occasions during this episode. So we're looking for where Mr.
Madl is bleeding. We can do something else that is unique to VA
and that is open up images. This can include everything that
can be imaged. It can be records from another hospital; it can
be papers the patient signs, or in this case we can actually
look at his colonoscopy and see that he has diverticulosis.
These are blind alleys in his colon, but more importantly, he
actually has bleeding while we're doing the colonoscopy. As I
mentioned, this was a real case. In 1992 before we had our PACS
systems--our radiology images--this was the film that was
collected on what's called an angiography study, where dye is
injected into the arteries. We look for where the blood vessels
are not sharp and the bleeding is occurring. When we put the X-
ray up against the light box, we were not able to find where
the bleeding was. One of the physician assistants said, ``Wait
a minute. We've got this new-fangled imaging system. Can we use
it? '' So they scanned in the X-ray, and this is the image of
the scanned piece of film. You say, ``OK it's a scanned piece
of film. What can you do with it? '' Well, once it's
electronic, you actually can manipulate it very nicely. You can
adjust the contrast as I am doing now. If you want to look at
the boney structures in the spine, you can change the contrast
to see the bones better. But today we're looking for where the
bleeding is, so we look out into these areas near the sides.
We're looking for a fuzzy area. By inverting the image, we can
see over here where a blood vessel's a little fuzzy. Let me
zoom in so you can see where the bleeding was. The treatment
team was able to locate it because of this technology and stop
the bleeding for this particular veteran.
Let me just show you one more patient. This is Mr. Green.
We'll select Mr. Green, and bring up his chart very quickly.
You notice that the veteran's picture changes. This gentlemen
may look familiar to you, probably a relationship in the past.
Mr. Green came to the VA for a different reason.
We talked about safety, and the importance of saving lives.
For Mr. Green, we went to prescribe a medication for him--in
this case, penicillin. I entered all of the necessary dosage
information to order the penicillin. When I went to accept the
order, CPRS displays a warning to me, because Mr. Green is
allergic to penicillin. It has now stopped me from giving him
medication that he is allergic to.
Today, Mr. Green is here because of chest pain. If you look
at his progress notes, we can see one with a little icon. When
we open up the note, it brings up the associated images. Mr.
Green had a cardiac catheterization. At any of the PCs
throughout the hospital, and soon across the country, Mr.
Green's cardiac angiography can be retrieved and viewed. What's
important is that the study shows us where the narrowing is,
and why Mr. Green is having chest pain. We can then do the
corrective procedure, in this case a balloon angioplasty. You
can see the balloon in place in this picture. Finally, we can
see following that procedure that the blood vessels are now
open, and Mr. Green can go on without the chest pain.
As a follow-up, in his next clinic visit, we can show these
images to Mr. Green, explain to him why it is important for him
to follow his diet, for him to take his medicine, and exercise.
Again, it is that teachable moment that we have for helping Mr.
Green to lead a better, safer life.
Mr. Chairman, that's the end of my remarks. I look forward
to any questions you might have.
[The prepared statement of Dr. Kolodner follows:]
Prepared Statement of Robert M. Kolodner, M.D., Acting Chief Health
Informatics Officer, Veterans Health Administration, Department of
Veterans Affairs
Good Morning, Mr. Chairman and Members of the Subcommittee.
Thank you for inviting me here today to discuss our work in the
field of health information technology.
One year ago, Dr. Jonathan B. Perlin, M.D., Ph.D., MSHA, FACP,
Under Secretary for Health, Department of Veterans Affairs, appeared
before the House Committee on Veterans' Affairs, Subcommittee on
Oversight and Investigations to discuss the importance of electronic
health records and the role of the Department of Veterans Affairs (VA)
in the development, use, and sharing of this valuable technology.
President Bush had just outlined an ambitious plan to ensure that most
Americans have electronic health records within 10 years. The President
noted a range of benefits possible with the expanded use of information
technology, including reduced costs; improved health care quality;
reduced frequency of medical errors; advancements in the delivery of
appropriate, evidence-based medical care; greater coordination of care
among different providers; and increased privacy and security
protections for personal health information.
A lot has happened in the field of health information technology in
the year since the President's call to action announced at the VA
Maryland Health Care System in April 2004, and discussions about the
potential of electronic health records have become part of the national
conversation. I have included, for the record, a brochure that
highlights President Bush's April visit to the Baltimore VA Medical
Center.
Today I'd like to talk about VA's leadership in the field of health
information technology, and tell you about our next-generation health
information system, known as HealtheVet. I'd also like to highlight our
work in three areas that I think are pivotal to the broader, successful
adoption of electronic health records: data standardization,
interoperability, and privacy.
A History of Innovation
With one of the most comprehensive electronic health record (EHR)
systems in use today, VA is a recognized leader in the development and
use of EHRs and other information technology tools. VA's work in health
information technology goes back almost 30 years, when VA created the
Decentralized Hospital Computer Program (DHCP), one of the first
automated health information systems ever developed to support multiple
sites and cover the full range of health care settings. VA has
continued to lead the health care community in the development of new
health IT tools, building on the foundation of DHCP to create the VistA
system in use today--a suite of over 100 applications which support the
day-to-day clinical, financial, and administrative functions of the
Veterans Health Administration (VHA). These applications form the
foundation of VistA--the Veterans Health Information Systems and
Technology Architecture, the automated health information system used
throughout VHA.
Many VistA enhancements were designed to support the transformation
of the VA health system over the past decade, as VA shifted its
emphasis from inpatient care to outpatient care, and introduced
performance measures and performance-based accountability throughout
its health care system. In the mid-1990s, VHA embarked on an ambitious
effort to improve the coordination of care by providing integrated
access to these applications through implementation of an electronic
health record, known as the Computerized Patient Record System or CPRS.
CPRS provides a graphical user interface, or GUI, to the information
captured in VistA.
With CPRS, providers can access patient information at the point of
care--across multiple sites and clinical disciplines. CPRS provides a
single interface through which providers can update a patient's medical
history, place a variety of orders, and review test results and drug
prescriptions. The system has been implemented at all VA medical
centers and at VA outpatient clinics, long-term care facilities, and
domiciliaries--1,300 sites of care throughout VHA.
The Benefits of Electronic Health Records
Electronic health records, or EHRs, are appealing for a number of
reasons, including convenience, availability, and portability. The most
compelling reason to use information technology in health care is that
it helps us provide better, safer, more consistent care to all
patients. The President referred to an oft-cited 1999 report in which
the Institute of Medicine (IOM) estimated that between 44,000 and
98,000 Americans die each year due to medical errors. Many more die or
suffer permanent disabilities because of inappropriate or missed
treatments in ambulatory care settings. IOM cited the development of an
electronic health record as essential for reducing these numbers and
improving the safety of health care. In its 2002 publication,
Leadership by Example, IOM noted that ``[c]omputerized order entry and
electronic medical records have been found to result in measurably
improved health care and better outcomes for patients.''
How can EHRs improve patient safety and quality of care? First,
with an EHR, all relevant information is available to clinicians when
they need it, where they need it--and it's legible. A provider can
quickly review information from previous visits, have ready access to
clinical guidelines, and survey research results to find the latest
treatments and medications. All of this information is available
wherever patients are seen--in acute settings, clinics, examining
rooms, nursing stations, and offices.
Many of us see different doctors for different medical conditions.
How many of these physicians have access to all of the information that
has been collected over the course of these visits? In VHA, patient
records from multiple sites and different providers can be viewed at
the same time at the point of care. This is simply not possible with
paper records.
In addition to making medical records more accessible, EHRs can
help clinicians better document the reasons a patient sought care and
the treatment that was provided. Given the time constraints they face,
many physicians resort to writing brief, sometimes cryptic notes in a
patient's chart, and then write more complete documentation when they
have time. EHRs enable clinicians to document care quickly and
thoroughly, and can provide reminders based on the specific medical
conditions and test results that have been documented.
CPRS, for example, allows clinicians to enter progress notes,
diagnoses, and treatments for each encounter, as well as discharge
summaries for hospitalizations. Clinicians can easily order lab tests,
medications, diets, radiology tests, and procedures electronically;
record a patient's allergies or adverse reactions to medications; or
request and track consults with other providers.
Even if we could transfer paper records quickly and reliably from
one provider to another, and make sure that the information in records
was complete, many hard-copy patient records simply contain too much
information for a clinician to sift through effectively. There is
always the possibility that something crucial could be missed. When
health information is stored electronically, however, we can make use
of software tools to analyze that information in real-time. We can
target relevant information quickly, compare results, and use built-in
order checks and reminders to support clinical decisionmaking. These
capabilities promote safer, more complete, more systematic care.
Consider the benefits we have seen in VHA in the area of medication
ordering. When orders for medications are handwritten or given
verbally, errors and mistakes inevitably occur. However, when
physicians use computerized order-entry systems to enter medication
orders electronically, errors caused by illegible handwriting or
misinterpretation of dosages, strengths, or medication names are
virtually eliminated. CPRS includes automated checks for drug-drug or
drug-allergy interactions, alerting the prescribing physician when
potentially dangerous combinations occur. Currently, 94 percent of all
VHA medication orders are entered by the ordering provider directly
into VistA using CPRS.
Information technology can also serve to reduce the number of
errors that occur when medications are given to a patient. VHA's Bar
Code Medication Administration system (BCMA) is designed to ensure that
each patient receives the correct medication, in the correct dose, at
the correct time. In addition, the system reduces reliance on human
short-term memory by providing real-time access to medication order
information at the patient's bedside.
BCMA provides visual alerts--prior to administration of a
medication--if the correct conditions are not met. For example, alerts
signal the nurse when the software detects a wrong patient, wrong time,
wrong medication, wrong dose, or no active medication order. These
alerts require the nurse to review and correct the reason for the alert
before actually administering the drug to the patient. Changes in
medication orders are communicated instantaneously to the nurse
administering medications, eliminating the dependence on verbal or
handwritten communication to convey these order changes. Time delays
are avoided, and administration accuracy is improved.
BCMA also provides a system of reports to remind clinical staff
when medications need to be administered or have been overlooked, or
when the effectiveness of administered doses should be assessed. The
system also alerts staff to potential allergies, adverse reactions, and
special instructions concerning a medication order, and order changes
that require action.
The VistA Imaging system is another application which has extended
the capabilities of VistA and CPRS. VistA Imaging stores medical images
such as x-rays, pathology slides, scanned documents, cardiology exam
results, wound photos, and endoscopies directly into the patient record
as soon as they become available, providing clinicians with additional
information essential for diagnosis and treatment.
I have used VA's electronic health record system for years. As a
doctor--and as a patient--I am very enthusiastic about the benefits of
this technology. I don't think I can fully do the system justice by
talking about it. I'd like to show you how it works.
[Demonstration]
The Importance of Standards
The richness of VA's EHR is evident, in terms of both clinical
features and health data. Imagine the benefits of sharing this data--
appropriately and securely--among VA's health delivery partners, so
that relevant health information would be available regardless of where
a veteran sought care. As we move toward this goal, we need to make
sure that we share not only data, but meaning. And to do this, we need
health data standards.
Virtually all clinical documents created by VA providers are stored
in the EHR, and data from commercial medical devices can be transmitted
automatically directly into a patient's health record. To give you a
sense of the magnitude of EHR use in VA, let me give you some round
numbers: As of March 2005, VA's VistA systems contained 658 million
progress notes, discharge summaries, and other clinical documents; 1.35
billion orders, and 300 million images. More than 550 thousand new
clinical documents, 910 thousand orders, and 475 thousand images are
added each workday - a wealth of information for the clinician.
And yet, with an electronic health record--as with a paper record--
more information isn't always better if we can't use it. How can we be
sure we can take full advantage of the voluminous information we
collect in the EHR? The key is data standardization.
There's an old joke in the standards field: ``The great thing about
standards is that there are so many to choose from.'' For nearly every
kind of clinical data--from diseases, procedures, and immunizations, to
drugs, lab results, and digital images--there are multiple sets of
standards to choose from. For example, there are at least 12 separate
systems for naming medications, and the ingredients, dosages, and
routes of administration associated with them.
It is often necessary to use a combination of data standards to
transmit a single message from one system to another. Even health care
organizations committed to using standards have a difficult time
figuring out which standards to use.
Consolidated Health Informatics (CHI) is an eGov initiative
involving Federal agencies with responsibility for health-related
activities. CHI participants evaluate and choose health data and
communication standards to be incorporated into their future health IT
systems. VA was instrumental in the formation of CHI, and works closely
with the Department of Defense (DOD) and the Department of Health and
Human Services (HHS) to help foster the Federal adoption of the agreed-
upon standards as part of a joint strategy for developing Federal
interoperability of electronic health information. To date, CHI has
endorsed 20 communications and data standards in areas such as
laboratory, radiology, pharmacy, encounters, diagnoses, nursing
information, and drug information standards developed through a
collaboration between VA and HHS.
Within VA, we have established a formal program to coordinate the
adoption, implementation, and verification of health data standards
across all sites of care. We also work with external Standards
Development Organizations (SDOs) to augment and refine available
standards to ensure that they meet health care delivery needs in VA and
elsewhere. The work involved in adopting and implementing data
standards is deliberative and difficult. It requires collaboration
among clinicians, health information professionals, developers, and
business process experts. Yet, the use of data standards can have a
very real effect on a patient's care.
When VA developed its first EHR, the technological environment in
VA hospitals--as in other hospitals at the time--was very different
from the environment today. There was not a computer on every desk.
There were no graphical user interfaces, only text-based displays on
``dumb terminals.'' There were no multi-color screens, no Windows, no
pull-down menus. No one had a mouse. When you wanted to enter data in
an electronic health record, you didn't point-and-click, you typed.
For example, when a clinician wanted to document a patient's
allergy to penicillin, he typed the word ``penicillin'' in the allergy
section of the patient's electronic health record. To save time, many
clinicians entered ``PCN'', a common abbreviation for penicillin.
As part of our data standardization effort, we went back and looked
at the allergy data that had been collected over the years. We found
that ``penicillin'' and ``PCN'' had been typed in more than 75,000
times. We also found thousands of entries in which penicillin had been
misspelled. Not only is it a waste of time to type the same information
over and over, it introduces a potential patient-safety issue. Let me
give you an example.
Suppose a veteran comes in for a check-up and tells the physician
that he is allergic to sulfa drugs. The physician enters this
information in the patient's record under allergies, but because he is
typing quickly, he inadvertently misspells the word ``sulfa''. Suppose
that on a subsequent visit, another clinician orders Sulfamethoprim,
which is a type of sulfa drug. When a clinician orders a medication,
CPRS checks the patient's record to see if the patient is allergic to
the medication. Although the system checks for common misspellings, it
can't predict every possible misspelling of every medication. In this
case, CPRS might not alert the second physician that he had ordered a
drug the patient was allergic to, simply because the word ``sulfa'' was
misspelled when it was entered by the first physician. By eliminating
misspellings and establishing a standard vocabulary across sites, we
will ensure that medication order checks work as intended, and that the
EHR supports patient safety and clinical decisionmaking to the fullest
extent.
Data Standards and Interoperability
The use of electronic health records and other information
technology tools in a single medical office can improve health care
quality, reduce medical errors, improve efficiency, and reduce costs
for the patients treated there. However, as the President noted a year
ago, the full benefits of IT will be realized when we have a
coordinated, national infrastructure to accelerate the broader adoption
of health information technology.
The problems created by a lack of standardized data are magnified
when interacting with other organizations. Even seemingly
straightforward information can be misconstrued when it is interpreted
by different organizations.
Consider two simple terms: yes and no. In many computer systems,
the number ``1'' is used to indicate ``yes'', and the number ``2'' is
used to indicate ``no''. In some systems, it is reversed: ``1'' means
``no'', and ``2'' means ``yes''. Some systems use ``0'' and ``1'',
instead of ``1'' and ``2''. In still other systems, ``Y'' is used to
indicate ``yes'', and ``N'' is used to indicate ``no''. Sometimes
lowercase ``y'' and ``n'' are used. Sometimes, ``yes'' is actually
stored as ``y-e-s'', and ``no as ``n-o''. In VA, we found 30 different
combinations of codes for ``yes'' and ``no'', stored in nearly 4,000
different data fields. We can standardize our representation of ``yes''
and `no'' within VA computer systems, but unless our healthcare
partners employ the same standards to exchange data with us, we cannot
be sure that we are conveying the intended meaning of the data we are
exchanging.
The Office of the National Coordinator for Health Information
Technology (ONCHIT) recognizes the importance of data and
communications standards in developing a comprehensive network of
interoperable health information systems across the public and private
sectors. Without data standards, we might be able to exchange health
information, as we do now when we copy and send paper records, but we
won't be able to use it as effectively to deliver safer, higher-quality
care using clinical alerts and reminders. True interoperability between
providers simply cannot be achieved without data standardization.
VHA has a long history of participation in standards development
organizations. As a health care provider and early adopter of health IT
on a large scale, VHA frequently identifies areas for standards
development and works with other public- and private-sector
organizations to develop consensus-based solutions. HHS Secretary Mike
Leavitt recently announced the formation of the American Health
Information Community. ONCHIT has released a Request for Proposal
calling for standards harmonization. This effort will foster a more
cohesive, integrated approach to standards development, replacing the
existing fragmented, inefficient approach in which standards are
developed topic-by-topic. VHA supports these HHS activities and looks
forward to participating, along with other Federal partners, in these
activities as they develop.
Our data standardization efforts at VA have already improved our
ability to share information with other agencies. I'd like to highlight
our work with the Department of Defense.
In April 2002, VA and DOD adopted a joint strategy to develop
interoperable electronic health records by 2005. This cross-cutting
initiative, known as the VA/DOD Joint Electronic Health Records
Interoperability (JEHRI) Plan--HealthePeople (Federal), is based on the
common adoption of standards, the development of interoperable data
repositories, and joint or collaborative development of software
applications to build a replicable model of data exchange technologies.
The progress made by VA and DOD has served as a catalyst to move the
health care industry toward the use of interoperable health information
technologies that have the potential to improve health care delivery,
increase patient safety, and support the provision of care in times of
crisis.
Through collaborative efforts, VA and DOD will be better positioned
to evaluate health problems among service members, veterans, and shared
beneficiary patients; to address short- and long-term post-deployment
health questions; and to document any changes in health status that may
be relevant for determining disability.
VistA-Office EHR
As a physician, I have seen first-hand the benefits of electronic
health records in VA: immediate access to information, elimination of
duplicate orders, increased patient safety, improved information-
sharing, more advanced tracking and reporting tools, and reduced costs.
VHA is now working with the Centers for Medicare and Medicaid Services
(CMS) to make the benefits of electronic health records available to
providers in rural and underserved areas, as directed by President Bush
in Executive Order 13335 issued in April 2004. CMS is sponsoring the
development of VistA-Office EHR, an enhanced version of VA's VistA and
CPRS designed specifically for use in non-VA clinics and physician
offices. With the targeted release of VistA-Office EHR in August 2005,
CMS hopes to stimulate the broader adoption and effective use of
electronic health records by making a robust, flexible EHR product
available in the public domain.
The HealtheVet Program
The spirit of innovation that inspired the development of VistA,
CPRS, BCMA, and VistA Imaging has led VA to the next step in the
evolution of health care IT--HealtheVet. HealtheVet-VistA is VA's next-
generation health information system, designed to support more
personalized care for our veterans, more sophisticated clinical tools
for our doctors and nurses, and more advanced communication with our
health care partners. HealtheVet builds on decades of VA expertise in
health care IT to support the strategic goals of the Department, meet
interagency obligations, take advantage of new developments in
technology to address weaknesses in the current system, and most
importantly, improve the safety and quality of health care for
veterans.
VA has been recognized by IOM and the mainstream press as having
one of the most sophisticated EHR systems in the world. VistA and CPRS
are in the public domain and have served as models for healthcare
organizations in the public and the private sectors alike. VistA has
been adopted for use by the District of Columbia Department of Health,
and State veterans homes in Oklahoma. A number of other countries have
either implemented VistA or expressed an interest in acquiring the
technology. VA's DHCP system was modified for use in DOD and DHCP, and
VistA is used in modified form by the Indian Health Service. By the
late-1990s, the three largest Federal systems providing direct health
care were using derivatives of VA's EHR, although only VA was using the
current and more robust version including CPRS.
Under the HealtheVet-VistA program, VA will incrementally enhance
and supplement the current functional capabilities of VistA and will
provide increased flexibility, more sophisticated analytical tools, and
support for seamless data sharing among providers both within and
outside VA. Like VistA, software developed under the HealtheVet program
will be available in the public domain. Federal agencies, small medical
practices, and EHR system vendors will all benefit from the advances
made through HealtheVet-VistA.
Given the success of VistA, some people have asked why we are
changing it. The short answer is ``to benefit the veteran.''
VA health IT systems have been forged and tested in the real world
of health care. I can think of no other successful organization, with a
history of innovation and a world-class system, that would simply rest
on its laurels.
One reason there is so much interest in VistA is that it has never
been a static system. The health care environment of today is not the
health care environment of 10 years ago. Nor is the VistA system today
the VistA system of 10 years ago--or even of 1 year ago. VA has
continued to refine and enhance VistA since its introduction to reflect
advances in clinical practice, the availability of new commercial
products, the changing VA health care model, new Congressional mandates
(such as those related to current combat engagements), and new Federal
laws (such as the Health Insurance Portability and Accountability Act
and cybersecurity requirements).
We have to make these types of changes all the time--that's the
nature of health care. The current VistA system has served us well
through decades of transformation in health care. But VA has outgrown
its facility-centric architecture, and the system has simply become too
expensive to maintain. HealtheVet-VistA will give us a more flexible
architecture so that we can support integrated ambulatory care and
home-base health care, maintain continuity of operations in the event
of a disaster, and improve response time by increasing system capacity
and communications speed.
HealtheVet-VistA will also allow us to strengthen privacy and
security protections through use of features such as role-based access.
We will be able to limit access to information based on the user's
identity, location, job function, or legal authority, for example. We
will strengthen our ability to track exactly who looks at the
information, at what time, and for how long.
An estimated 40 percent of veterans we treat at VA each year also
receive care from non-VA physicians. VA is working with DOD, ONCHIT,
and other partner organizations to develop a longitudinal health record
that will incorporate information from DOD, VA, and private-sector
health providers from whom the veteran has sought care. Throughout
these collaborative projects, safeguards have been implemented to
ensure that the privacy of individuals is protected in accordance with
the various confidentiality statutes and regulations governing health
records, including the Privacy Act, the HIPAA Privacy Rule, and several
agency-specific authorities. As we work toward greater data exchange
and true interoperability with our health care partners, privacy and
security of medical information will be a top priority.
Personal Health Records and My HealtheVet
I'd like to highlight another key component of the HealtheVet
initiative: the My HealtheVet personal health record system, designed
specifically to meet the needs of veterans.
Personal health records are an adjunct to the electronic health
records used in a clinical setting, providing patients a secure means
of maintaining copies of their medical records and other personal
health information they deem important. Information in a personal
health record is the property of the patient; it is the patient who
controls what information is stored and what information is accessible
by others. Personal health records enable patients to consolidate
information from multiple providers without having to track down,
compile, and carry around copies of paper records. By simplifying the
collection and maintenance of health information, personal health
records encourage patients to become more involved in the health care
decisions that affect them.
The VHA My HealtheVet project was conceived as a way to help
veterans manage their personal health data. My HealtheVet is a secure,
web-based personal health record system designed to provide veterans
key parts of their VHA health record as well as enabling them to enter,
view, and update additional personal health information. Patients who
take over-the-counter medications or herbs, or who monitor their own
blood pressure, blood glucose, or weight, for example, can enter this
information in their personal health records. They can enter readings
such as cholesterol and pain, and can track results over time. My
HealtheVet includes the Medlineplus.gov library of information on
medical conditions, medications, health news, and preventive health
from the National Institutes of Health and other authoritative sources.
Veterans can use the system to explore health topics, research diseases
and conditions, learn about veteran-specific conditions, understand
medication and treatment options, assess and improve their wellness,
view seasonal health reminders, and more.
The implications of My HealtheVet are far-reaching. Clinicians will
be able to communicate and collaborate with veterans much more easily.
With My HealtheVet, veterans are able to consolidate and monitor their
own health records and share this information with non-VA clinicians
and others involved in their care. Patients who take a more active role
in their health care have been found to have improved clinical outcomes
and treatment adherence, as well as increased satisfaction with their
care.
The first version of My HealtheVet was released on Veterans Day
2003, and more than 50,000 veterans are now registered to use the
system. The My HealtheVet user community is growing, with over 300 new
registrants joining each day. By the end of this summer, veterans who
receive their health care at VA will be able to use My HealtheVet to
refill prescriptions online. By this time next year, veterans receiving
care at VA medical centers will be able to request and maintain copies
of key portions of their health records electronically through My
HealtheVet and to grant authority to view that information to family
members, veterans' service officers, and VA and non-VA clinicians
involved in their care. This would allow a relative to provide support
and care--even at a distance--by being better informed about the
veteran's health and medical status. Subsequent releases will provide
additional capabilities, enabling veterans to view upcoming
appointments and see co-payment balances.
Summary
For decades, VA has developed innovative IT solutions to support
health care for veterans. Over the past several years, VA has worked
with Federal, state, and industry partners to broaden the use of
information technology in health care. We have continued to enhance the
capabilities of the EHR while protecting the privacy of our veteran
population and maintaining the integrity of our systems. These efforts
have laid the groundwork for the President's health IT initiative.
The team of VHA developers, clinicians, and administrators who
designed VistA changed the practice of medicine in VA by creating IT
tools such as these to support the interaction between providers in VA
and their patients, increase patient safety, and improve reporting and
tracking of clinical and administrative data. VA is now involved with
public- and private-sector partners in the development of a new
national model for the use of IT in health care, featuring more
sophisticated clinical decision support tools, increased data sharing
among health care providers, and the availability of affordable EHR
technology to providers large and small.
When he announced his plan to transform health care through the use
of information technology, the President noted our country's long and
distinguished history of innovation--as well as our failure to use
health information technology consistently as an integral part of
medical care in America.
We still have a long way to go in optimizing our use of information
technology in health care; yet, we are not starting from scratch.
Electronic health records, personal health records, data and
communication standards, and sophisticated analytical tools--the
building blocks of a comprehensive, national health information
infrastructure--have already been implemented in some communities and
settings and are maturing quickly. Our challenge is to create a
technology infrastructure that will revolutionize health care without
interfering with the human interaction between physicians and patients
that is at the core of the art of medicine.
The President recognized America's medical professionals and the
skill they have shown in providing high-quality health care despite our
reliance on an outdated, paper-based system. At VA, we know that the
support of clinicians is essential to the successful implementation of
electronic health records and new IT tools. Clinicians, while often the
greatest proponents of health information technology, can also be the
greatest critics. At VA, physicians, nurses, and other providers are
actively involved in defining requirements and business rules for
systems, prioritizing enhancements, and conducting end-user testing.
This involvement improves system usability, increases user acceptance,
minimizes disruption during upgrades, and most importantly, enables us
to tailor systems to the needs of the health care community.
Throughout VA, the electronic health record is no longer a
novelty--it is accepted as a standard tool in the provision of health
care. For 20 years, VA has been an innovator in health care IT. We are
now at the brink of a new era in health care, in which a new national
model for the use of IT will support the development of more
sophisticated clinical decision support tools, increased data sharing
among health care providers, and the broader availability of affordable
EHR technology to providers large and small. As VA refines and expands
its use of information technology, we look forward to sharing our
systems and expertise with our partners throughout the health care
community to support the President's plan for transforming health
care--and the health of our veterans.
Mr. Chairman, this completes my statement. I will now be happy to
answer any questions that you or other members of the Subcommittee
have.
Senator Ensign. Thank you. I would like to thank the entire
panel for its fascinating testimony. I would like to start with
a round of questions. I think there is great work occurring at
the VA and I am impressed with some of the health information
technology projects that are occurring around the country.
There is certainly excitement concerning the issue or health
information technology. Dr. Clancy, you mentioned something
that I think is really important--and something that we need to
try and incorporate into health information technology--and
that is the idea of best practices.
If we can incorporate best practices with health
information technology, I believe the savings range you're
talking about would be more toward the higher end, rather than
the lower end. In addition, the outcomes would obviously
increase much more. From what I understand, only a quarter of
physicians routinely use best practices in their daily clinical
practice. So my question to you is, how can we incorporate best
practices into health information technology?
Dr. Clancy. We have supported the development of evidence
that is the foundation for the kind of best practices you're
talking about. What health IT is going to allow, is that
information to be delivered to a specific patient for a
particular encounter.
Consider the example of an electronic rule that helps
decide whether patients with pneumonia need to be hospitalized.
I don't really need that if someone is in with a sprained
ankle. So the real trick--and I think what will come out of the
efforts to establish the infrastructure, and harmonized
standards and so forth--is to develop the capacity; as better
evidence develops, to be able to deliver relevant information
at the point of care.
If you think about all the investments that we have made in
biomedical science both in the public and private sectors,
there are more and more times when a clinician and patient are
facing really a host of choices--which is great news for all of
us. The trick is trying to have easy access to the evidence
underlying those choices so you can figure out what is right
for the patient. And that I think is going to be the great
potential and one we're very excited about.
Senator Ensign. I realize that the use of evidenced-based
medicine and best practices are good. Is this something we just
allow to happen, or is it something that we need to try and
force to happen, or encourage to happen? We're policymakers.
When we're writing laws, should we incentivize through payment
systems, through Medicare, Medicaid, and the VA? How do we make
sure that appropriate information is communicated? Do we try to
incentivize in some way?
Dr. Clancy. Through the support that you provide for the
development of science at AHRQ, and NIH, and other places, you
certainly are giving support for the substrate for that.
Applying it locally, I think, is probably best done as it's
customized to that setting. How that's going to be delivered to
the point of care, in a very small practice is probably much
different than how Dr. Kolodner will use it in VA and so forth.
Senator Ensign. Dr. Kolodner, the VA has obviously invested
quite a bit of money in health information technology. Do you
have any figures on how much the VA has invested in health
information technology? I would also like to know more about
the return on investment, and how much is saved. I am not only
interested in paperwork reduction, but also in decreased costs
of care. Have there been any studies like this conducted in the
VA? In other words, are there studies that show that a patient
gets out of a hospital faster because a proper diagnosis was
made? I don't know if any long-term studies have been
conducted, or if any peer-reviewed studies have been conducted
on cost savings and outcomes since health IT was introduced
within the VA.
Dr. Kolodner. Mr. Chairman, our system was developed over
about 20 years, so it started when the technology was very
rudimentary. Thus, the figures for the development of our
system are probably not meaningful today. However, there are
some studies that we have regarding the treatment of pneumonia.
Because we are able to vaccinate such a high percentage of our
veterans, in fact our benchmarks for vaccination exceed
anything that is published in the country, what we have been
able to show is that each vaccination we give saves about $290
of our healthcare costs. We have actually had a decrease in the
total number of hospitalizations for pneumonia in patients with
chronic pulmonary disease, despite the fact that we doubled the
number of veterans we treated over that period of time. This is
one of the pieces of evidence that we have for the cost savings
and the cost avoidance we have achieved from using our health
IT.
Senator Ensign. Dr. Brailer, I have one quick question as
my time is about to expire. You mentioned interoperability.
We've heard a lot about that issue today. To address Senator
Allen's concern, how do we make interoperability technology-
neutral so that we aren't limiting technology as it is
advancing? A few years ago, I remember that the French wanted
to be ahead of the world consequently, so they bought everybody
in the government a certain type of hardware and software. They
were only ahead of the rest of the world for about a month--
because technology advances so quickly. Then, they were stuck
with a certain type of information technology system. How do we
make sure that interoperability standards are written in a
manner that is technology neutral so that we're not
unintentionally mandating and trapping ourselves into old
technology?
Dr. Brailer. Thank you, Mr. Chairman. The first precept
that we want to follow, to make sure that technology stays at
the state-of-the-art and we don't lock it in, is to make it a
fluid process, which means to not require it through
regulations which are very difficult for us to update. We have
gone out to the private sector to develop a process for
standards, not only to harmonize today, but to develop a
roadmap and a process to keep them into the future. This way it
can be a living and breathing part of the industry.
Second, we want to put intellectual property, particularly
the architecture, or the blue prints, in the public domain. We
are not going to support, if you would, proprietary standards,
or royalty bearing, or copyrighted standards that have some
kind of a burden imposed on users, nor would we do so with
architecture. While in our RFPs we allow proprietary
implementations of the actual software, so the commercial
market will come and invest, we want the architecture to be put
in the public domain so they can be reviewed and turned into
requirements for the whole industry.
While we are relying on the private sector for
developments, we're relying on governance that is public and
private, and we're relying on an organic process that continues
to stay ahead of technology.
Senator Ensign. Very good, thank you. Senator Kerry.
Senator Kerry. Thank you Mr. Chairman, thank you all for
your testimony. Dr. Brailer, in the long time I've been here
now in this committee, I guess I've been 21 years in the
Senate, we've had a lot of fights about standards, and
standards have often been able to become a roadblock unto
themselves. What concerns me a little bit is that if you put
everything on hold until we quote ``get the standards,'' we're
going to ignore the reality of what's happening. A lot of other
places, including the private sector in the United Kingdom for
instance, they don't have standards across the board, they're
developing them. But they have proceeded to put the technology
out and they have--almost every desktop in the healthcare
industry is crisscrossing information, and they're working it
through to the great savings of the system and the savings of
lives and greater efficiency.
And to a degree the standards are evolving as they do that.
So I mean my question to you is, can we afford to not provide
significant incentives for the basic technology to get in
place--and to many of healthcare delivers throughout the
system, particularly given the experience of others in this
field, including the VA over 20 years?
Dr. Brailer. Well Senator, your question is a very good one
and it is one that we've spent a lot of time looking at, not
only within our own strategies but with success stories in the
United States, and abroad. There are two strategies going
forward. There is an adoption gap you've just described and
second, there is this interoperability problem, making sure the
data is portable. We are concerned about the taking, if you
would, of an adoption forward strategy where we pushed that
forward as a principal effort, because that could foreclose the
one time opportunity we have in the United States to have
interoperability and portability. For example, in the case of
an electronic health record today, it's hard for a buyer to
know which ones could be connectable to a system, which ones
are interoperable and which ones are not.
Senator Kerry. Well can I just--I don't want you--but I
want to try to follow up on that if I can Dr. Kolodner. I was
introduced I think to the VA system, I can't remember, maybe
eight, 10 years ago, when I went through the VA hospitals. Let
me ask you a question. Is the pain management system within the
VA part of the VistA?
Dr. Kolodner. Yes it is.
Senator Kerry. It is, that's what I thought, because I
remember seeing the pain management at the bedside a number of
years ago, and I was struck by it. What really got me
interested in this was, frankly, a visit to the VA and I became
aware that the VA is already doing this way ahead of everybody
else. Give us a kind of ballpark figure of what we're talking
about, about the VA investment even if you discard the early
startup years where you were kind of dealing with primitive
technology et cetera. What would you--put it into sort of
current dollars in effect?
Dr. Kolodner. The current estimate is that about $450
million a year is spent operating and maintaining the VistA
system. That amounts to about $78 per enrollee per year, so if
we avoid one or two lab tests, certainly one hospitalization,
that more than covers the cost.
Senator Kerry. Does that include the purchasing cost,
capitalization cost?
Dr. Kolodner. That includes all the costs that we have.
Senator Kerry. What would you figure the capitalization
costs was?
Dr. Kolodner. I really couldn't give a figure.
Senator Kerry. Well $450 million, you're talking about
several billion dollars, correct?
Dr. Kolodner. In terms of the hardware, probably a billion,
a billion and half for the whole system. I think some of the
people on the second panel may actually be able to give you a
better number for that.
Senator Kerry. I'm sure they will, but I'm trying to get--
Dr. Brailer, what's your estimate of what it would take. And
one of the interesting things is with respect to the alignment
of incentives. I think that's a really important issue here.
Because the benefits, the expenditure has to come out of the
pocket of the doctor. A doctor's office. The expenditure has to
come out of the hospital or clinic, but the benefit doesn't
flow to them. The benefit flows to Medicaid, Medicare, to the
health insurance company, the HMO, correct?
Dr. Brailer. That's right.
Senator Kerry. So the question is, how do we provide an
adequate incentive? It seems to me it's got to be through some
kind of either tax incentive, tax credit, grant, direct grant,
or low loan, some combination thereof, isn't that accurate?
Dr. Brailer. Well again, I think the question we focused on
is making sure that what is put in place ultimately serves the
goal of portable information for consumers. And, the examples
that we have of VA or Kaiser, or the Cleveland Clinic, or that
in Britain are closed systems. Closed systems are not
interoperable with others. And most of healthcare involves
small doctor practices and hospitals.
Senator Kerry. Let's take the healthcare system, what we
saw is pretty effective.
Dr. Brailer. Yes, absolutely.
Senator Kerry. I would assume some people would love to
replicate that. But they can't. Not so much because of
operability but because of costs. I mean people would grab at
that. I've heard that from people all through the system, they
would love to have that, they just can't afford it. So how much
are you figuring it really would cost to put a first rate,
state-of-the-art, information system, health record system in
America?
Dr. Brailer. Well, we've not done our own estimates.
Estimates range between $30 billion and $250 billion; and
obviously, you can imagine with estimates that broad, there are
numerous assumptions about technology cost, about changes, and
about the way the industry operates. We have not developed our
own estimate, but I think it's fair to say that it is
expensive.
Senator Kerry. Let's take the low ball on that $30 billion,
the high ball is $250 we're spending $150 million. It's
interesting you know, the VA is a government program using
taxpayer dollars. They've got the system and the other place
where we don't spend the money doesn't. Thank you Mr. Chairman.
Senator Ensign. Senator Allen.
Senator Allen. Thank you. And thank you to all of our
witnesses for your insightful leadership and knowledge, and
movement in the right direction, plus an example from Dr.
Kolodner as to what the VA is doing.
I do think that everyone does benefit, not just the
taxpayers, from this, I think physicians and healthcare
professionals also benefit from more accurate diagnoses, fewer
errors. Obviously the goal of every healthcare professional is
to have a successful outcome as best they can achieve it, in
their profession. All of this gets to a few questions, and it
is good that Dr. Brailer, that you all--you and Dr. Clancy are
also talking with the clinicians, the people who are involved
in it. We all could say, ``isn't this great and wouldn't that
be wonderful,'' but if they don't think that works, and it's a
burden, it's an aggravation, they're not going to want to do
that as opposed to this paper-based system which I guarantee
you most people undoubtedly don't like. But whatever the
changes need to be accepted by them.
Dr. Semerjian, in your testimony, you said that NIST is
going to be certifying a standard for use in electronic patient
records across government. How long will it take for that to
take place?
Dr. Semerjian. I would like to clarify that, I did not mean
we would do the certification. When you set a standard, that's
only part of the process. Then you need to establish a process
that enables you to assess the compliance with the standards
you have established. You need criteria for that assessment.
We usually help with the development of that criteria,
usually the certification is done by private sector entities.
So first we have to set the standards, once the standards are
set then we have to develop certification criteria.
Senator Allen. All right. I'm using two words, but how long
will it take you all to develop a standard?
Dr. Semerjian. That standard has to be developed by the
entire community. As a matter of fact, that is what Dr. Brailer
is trying to do.
Senator Allen. How long will that take? Since you brought
up that the future is now.
Dr. Semerjian. It is not going to be in months certainly.
It will be in years.
Senator Allen. What can we do? You all are the experts.
It's going to take you a while to do this. What can we do, and
that's the purpose of this hearing really, what can we do in
Congress to assist you, or facilitate the development of
uniform standards in this area? Maybe it's just leave you all
alone and let you do your work. But is there anything we can
do?
Dr. Semerjian. I think Dr. Brailer's office already has the
marching orders. Certainly I'm sure he wouldn't mind having
some cheers on the sideline to encourage that work. But I think
the process is pretty much in place. I think you should perhaps
encourage--there are clearly a lot of players in this process
as you heard VA, quality issues, and NIH et cetera. Certainly
encouragement of further collaboration et cetera, but I think
the process is in place. And everybody is working as hard as
they can to make this happen.
Senator Allen. Thank you. Dr. Kolodner, you showed this
demonstration, and so that's all interoperable within the VA
system and also within the Department of Defense. That may be
the state-of-the-art right now, and in five, 10 years from now
that may not be the state-of-the-art method of keeping track of
veterans, or any non-veteran patient.
However, and this is what the gist of all of this is, is
that if one of these veterans, who you have all of this
information, let's assume he or she gets injured and they go to
the University of Virginia Emergency Room, or the Reno Nevada
Emergency Room, and it's not a veteran's hospital they would
not have that information, right? Is that correct or is there
some way of making that available to the University of
Virginia, or University of Nevada Hospital?
Dr. Kolodner. There are some universities we have
affiliations with and we're able to provide remote access, but
if it is something as you described, where someone is injured
and shows up today, that university capability is not there,
that is why we're very eager to work with Dr. Brailer's office
to move that forward. But one of the other possibilities is
next year, when we provide the HealtheVet record to the veteran
and are uploading the data from VistA, then the veteran
themselves would have the capability of taking that information
and sharing it with whomever they want. So that would be
another mechanism for tying things together.
Senator Allen. Real quick. Is this system able to
communicate with the current commercially available systems?
Dr. Kolodner. Right now, none of the systems out there
communicate with each other.
Senator Allen. The answer is no then. Real quickly, if you
could each and everyone of you, I already asked Dr. Semerjian
what can we do, and I guess you've looked at Senator Enzi's
bill, but what if you could give us two sentences, what the
Congress ought to do to assist you all in your missions?
Dr. Clancy. Well, we appreciate the continued support for
the practical technical assistance and the development of the
evidence, and for deploying those as best practices, as the
Chairman noted. I would also say that your interest in this
topic is itself an incredibly potent stimulus across the
country.
Dr. Brailer. Sir, I think it is fair to say the
Administration welcomes the interest that the Senate has shown
in this topic. Our concern is making sure that given that we
are now underway and moving as quickly as possible, that we
don't actually have events that could slow us down. There is
concern about legislation slowing down this process.
Senator Allen. Do you see any such legislation introduced?
Dr. Brailer. I wouldn't comment on specifics. I think I'm
speaking more generally about creating a lot of uncertainty, or
concern about which direction to go.
Senator Allen. Would Senator Enzi's bill be a help or a
hindrance?
Dr. Brailer. I can't comment on that bill in particular,
but I think as a general construct we are moving forward and
it's very important for us to get these standards put in place
quickly. We're working with the available parts and with the
authority we have to do this. So we want to be able to make
sure this is done quickly so we can speak to the issue that
Senator Kerry raised about making sure that we can get
interoperability done--then to move on to the other issues.
Senator Ensign. Senator Allen, if I could interrupt quickly
on that point I would greatly appreciate it. I think what
Senator Allen is trying to convey, is that we would like to
obtain suggestions from any and all, on how we can be a help,
not a hindrance. We definitely don't want to be a hindrance in
this case, we want to be helpful. We are open to suggestions.
One of the purposes of this hearing is to listen to any
suggestions you have now, or any suggestions you want to make
in writing. We want to obtain your suggestions, so that we can
incorporate your views and insights within legislation that we
bring forward in the Senate, and include in any final product.
We want to make sure that any legislation that moves forward is
helpful, not hurtful.
Senator Allen. We want to be good teammates. That's the
point of this, is if you do see something, and I think that
we're all well intentioned in a bipartisan manner on this. And
sometimes people can help, and get in the way. On the other
hand, there are things we can do to help propel and set the
parameters that will help as you all interact with the people
who are actually delivering the healthcare services in our
country.
Senator Ensign. And by the way, I have just one quick
question on that issue. Do we have to make any modifications to
HIPAA to make health information technology move forward? The
VA has certain policies that it can get around. But if the VA
system is connected to the private system, are there changes
that need to be made? There was mention about the Stark laws
and HIPAA--and I know there are other things that can be done
to accelerate the deployment of this technology.
Dr. Semerjian. If I may Mr. Chairman, this is a huge
undertaking as everybody realizes, so clearly your continued
support and interest I think will go a long way in making it
happen.
Senator Allen. Dr. Kolodner do you have anything to add?
You all are doing it. We're trying to get the rest of the
private sector moving that way as well, maybe not under the
same system. Do you have any insight as to what the Congress
should do?
Dr. Kolodner. In terms of supporting the efforts that are
going on in the Administration and with the standards
community, I think your continued support is the best course of
action, sir.
Senator Allen. Thank you. Thank you, Mr. Chairman.
Senator Ensign. Thank you. I would like to excuse this
panel. I appreciate your comments, wonderful testimony, and
great discussion. I would now like to welcome the second panel.
On the second panel, we will hear from Ms. Susan Bostrom,
Senior Vice President, Cisco Systems; Dr. John Glaser, Vice
President and Chief Information Officer, Partners HealthCare
System; Dr. Peter Basch, Medical Director for eHealth, MedStar
Health; Ms. Pamela Pure, Executive Vice President, McKesson
Corporation; and Ms. Karen Ignagni, President and Chief
Executive Officer, America's Health Insurance Plans.
Once again we will start to my left, and work our way down
the table. We will start with you, Ms. Bostrom.
STATEMENT OF SUSAN L. BOSTROM, SENIOR VICE
PRESIDENT, INTERNET BUSINESS SOLUTIONS GROUP AND WORLDWIDE
GOVERNMENT AFFAIRS, CISCO SYSTEMS, INC.
Ms. Bostrom. Thank you, Chairman Ensign, for inviting me to
testify today. It's good to see you and Senator Allen, and we
certainly appreciate the focus on healthcare information
technology. As you mentioned, I'm the Senior Vice President at
Cisco, I have responsibility for Internet Business Solutions
Group, and also Worldwide Government Affairs. I also have the
privilege of serving on two boards of directors that may be
relevant, first is the Stanford Hospital in Palo Alto and
second is Varian Medical Systems, which is a provider of cancer
radiation treatment equipment. And both of these positions have
given me an opportunity to see some of the challenges that the
healthcare industry is facing, up close and personal.
As Dr. Brailer mentioned, and as many of you are aware over
the last 10 years the implementation of information technology
and Internet applications specifically has been a major
contributor to U.S. productivity growth, across a wide range of
industries, retail, manufacturing, financial services, and in
contrast the healthcare industry actually has been a drain on
the U.S. economy, it's ranking in the bottom five industries in
terms of its contribution to U.S. productivity based on a
Harvard study.
More recently Cisco, and other members of the IT industry
have been asked the question, why is it that the productivity
improvement that we've seen come from IT and other industries;
why don't they apply this to the U.S. healthcare industry,
especially when IT can be used not only to help control
increasing costs, but also to help save the lives of our
citizens? And my answer to that question is that now is the
time for IT to move into that major contributor part as it
relates to U.S. healthcare, and the reason being that there are
really three factors that we're seeing in the healthcare
industry right now, that say that it's ready for IT.
First of all, there's a real sense of urgency for change.
Because as you mentioned this is going to be tough, and so you
need to really have those driving pressures for change.
Second, there have been early pioneers in the industry,
whether it's the VA, or whether it's private hospitals that
have been moving forward and demonstrating that this is all
possible.
And then finally, there have to be significant returns. So
is it going to be worth the financial and human capital
investment that is going to be required to get some of these
benefits? Is it going to be worth the kind of change that is
going to be required?
Regarding the first factor, the need for change, I think
this point has been articulated this morning. As we all know
the aging population combined with the advances in medical
error are really driving up the increases in the healthcare
cost structure. By 2010, healthcare spending could reach $2.5
trillion and that would be about 15 percent of the U.S. GDP.
One study as you mentioned has suggested that 30 percent of
this spending is what we call waste, unnecessary test, errors,
et cetera. And as a result half their insurance premiums are
rising at four to five times the growth of inflation. Employers
are reaching their limit. And employees are unwilling, or
unable to bear anymore of the cost. And still we have a
situation where 45 million Americans are uninsured. So the
situation from a cost increase perspective, none of us want to
give up quality care says that now is the time for change.
The second factor affecting the use of IT in healthcare is
that there are numerous success stories, from early adopters in
the provider community. The hospital, the clinic, the doctor,
this is where 80 percent of healthcare costs occur. And we've
seen evidence across the board that early adopters of IT are
getting benefits. There's a 400 bed community hospital in
Silicone Valley that implemented a computerized position order
entry system based on an EHR. They've got it spread across
their 500 doctors and the results are that they've got order
errors down by 50 percent, adverse drug reaction errors down by
70 percent, and they're reducing the length of stay of the
average patient by a day.
A health system in Virginia has implemented what is called
an EICU, or Electronic Intensive Care Unit. It allows one
doctor to view six or seven different hospitals and those
patients. ICUs account for 30 percent of our hospitals cost. In
this case, this health system is reducing its ICU costs by 25
percent. The average patient stay is down 20 percent, and of
course the mortality rate is decreasing. They're seeing more
and more patients coming out with better outcomes because
they've got an ICU specialist present.
These healthcare IT pioneers have embraced technologies
that are now available, whether it be broadband, or whether it
be wireless, to drive improved results at lower costs. But
unfortunately these pioneers in healthcare are the exception,
not the rule. While industries on average in the U.S. spend
about $8,000 per employee per year on information technology
capital, the healthcare industry spends $1,100 per employee per
year.
It's discouraging to think about the investment that is
going to be required for the healthcare industry to catch up.
But if they do, the returns can be significant. Based on our
analysis at Cisco, we believe that up to $280 billion a year,
that is 17 percent of the $1.6 trillion spent on healthcare
could be saved, if just 8 to 10 proven IT applications could be
adopted across the entire industry.
Just look at some of the examples, EICUs spread across the
entire industry could save $10 billion a year. In addition to
controlling costs, these applications could help to reduce the
hundreds of thousands of medical errors that occur each year,
so that doctors have up-to-the-minute information at the point
of care with the patient. Despite the proven value of these IT
solutions though, when we look at the adoption of them they
range anywhere from 5 to 20 percent within the provider
community, and I think we're all too familiar with what some of
the road blocks have been. Lack of interoperable data
standards, across the industry. It's a highly fragmented
industry. It's so much different than you would see in
financial services, where they've been able to implement
standards, and there's a misalignment of financial incentives.
So who pays the bills, and who provides the care, the
incentives are quite different there. But all of these road
blocks can be tackled through the private sector and the
government working together. Many of these actions are already
underway, but if you look at it, the Federal and the state
governments pay for 50 percent of all healthcare cost, so
therefore you can be highly influential in determining how
providers decide to invest, and where they should invest, and
where will they get returns. Both from the government and in
terms of quality of care when they make those investments.
Accelerating IT----
Senator Ensign. If you could wrap up please.
Ms. Bostrom. In conclusion, if we could save this $280
billion, we could get down to a gross domestic product
healthcare spending being like it was in the 1990s in terms of
representing GDP and we could use that money for ensuring that
all Americans have healthcare insurance and coverage. Thank
you.
[The prepared statement of Ms. Bostrom follows:]
Prepared Statement of Susan L. Bostrom, Senior Vice President, Internet
Business Solutions Group and Worldwide Government Affairs, Cisco
Systems, Inc.
Thank you, Chairman Ensign, for inviting me to testify today. I
would also like to thank Ranking Member Kerry and the other Senators on
the Subcommittee for holding and participating in this important
hearing on health information technology.
My name is Sue Bostrom, Senior Vice President of the Internet
Business Solutions Group (IBSG) and Worldwide Government Affairs at
Cisco Systems, Inc.
I also have the privilege of sitting on the board of directors at
Stanford Hospital and Varian Medical Systems, a manufacturer of
radiation equipment for cancer treatment. These positions have given me
the opportunity to witness first-hand the challenges facing major
sectors of the healthcare industry--providers, payers, pharmaceutical
and medical device firms, and government agencies.
My goal here today is to share with you what we've learned through
Cisco's customers and in our own practice in the area of improving
healthcare quality, increasing productivity and driving down costs
through technology.
There is one overwhelming challenge faced by all sectors--the
spiraling cost of health care. As you well know, healthcare spending in
the U.S. has topped $1.6 trillion a year and will reach $2.5 trillion
by 2010--that's more than 15 percent of the Gross Domestic Product.
Meanwhile, healthcare insurance premiums are rising at four to five
times the rate of growth in wages and inflation.
Much of these rising costs can be attributed to underlying
demographic trends and advances in medical care. The healthcare
industry is being asked to offer ever-more sophisticated and expensive
treatments for an aging population.
Another major cost driver is the enormous amount of ongoing
paperwork, waste, and re-work. For instance, of the 30-billion
individual healthcare communications in the United States, more than 90
percent of them are sent by fax, surface mail, or telephone. A full 30
percent of the cost of healthcare can be attributed to these poor
healthcare practices. In fact, this industry ranks among the bottom
five industries in terms of contribution to U.S. productivity,
according to a Harvard University study.
If we look at other industries, we see a direct correlation between
productivity gains and investment in information technology (IT)
capital and solutions. These industries, on average, invest about
$8,000 per year per employee in IT. In comparison, the healthcare
industry invests only $1,100 per worker.
But saving money is only one part of the equation. Information
technology can also help reduce medical errors and save thousands of
lives each year.
Estimates vary, but experts believe between 44,000 and 98,000
people die in the United States each year from preventable medical
errors.
The greatest impact on cost, productivity, and quality can be
driven at those points where patients receive care--in the physician's
office and in the hospital.
If healthcare organizations widely adopted just one information
technology solution--electronic health records (EHR)--the industry
could save close to $78 billion annually.
Taking a quick look at the IT trends in healthcare, we find that
deployment of technology has been relatively slow, with implementation
of each wave of new applications taking decades rather than the 5 to 10
years it takes in other IT-oriented industries.
The first applications implemented in the late 1980s to early 1990s
were departmental applications--lab automation, pictorial archiving
systems, human resources systems, and patient admitting applications--
all solutions designed to make specific departments in a healthcare
provider more efficient.
The next two waves of applications in healthcare have been broader,
including both enterprise solutions--such as electronic health record
systems, clinical decision support systems--and inter-enterprise
applications that cross institutional boundaries, such as remote
patient monitoring, and automated payment programs that link providers
with payors.
Despite the proven value of these applications in specific
institutions, less than 5 percent of healthcare organizations have
deployed electronic health records, 10 percent computerized physician
order entry systems (CPOEs), less than 3 percent have adopted clinical
decision support and less than one percent have instituted support for
Tele-Specialty--specifically electronic Intensive Care Units (eICU).
The most challenging roadblocks to adoption overall are: a lack of
precise interoperable standards, a misalignment of financial incentives
across the industry, and, finally, the inherent reluctance to change--
especially when human life could be on the line.
Like many enterprises, we have found at Cisco that IT can play a
significant role in improving the quality of care while driving down
costs. Cisco Systems provides healthcare benefits for more than 65,000
employees and dependents worldwide. Looking to expand the use of
technology to improve the healthcare provided to our employees and
dependents, Cisco is now focused on promoting the more rapid adoption
of electronic health records, electronic prescribing and secure
physician-patient messaging, and will be adopting a pay for performance
program in 2006 that supports these objectives with key physician
groups serving Cisco employees and dependents.
The advantages of e-prescribing alone are significant, given that
50 percent of calls to physician offices are for prescription issues,
and the average physician writes 30 prescriptions a day. The potential
impact of e-prescribing includes an increase of 27 percent generic
prescribing, a reduction in adverse drug prescribing of 15 percent, and
an average per physician savings of $28,000 per year based on existing
studies.
Cisco has also had the privilege of participating in a number of IT
healthcare deployments that clearly demonstrate the significant role
information technology (IT) plays in improving healthcare quality,
reducing costs, and enhancing industry productivity.
For example, we helped a community healthcare center in Florida
deploy an electronic health records solution, which has cut lab
turnaround time by 89 percent and is saving the center over $2 million
annually.
In Virginia and North Carolina, we assisted a healthcare delivery
network in establishing a picture archive and communications system
(PACs)--that delivers radiology reports to doctors in minutes instead
of days.
And in the Mountain West, we helped a regional medical center set
up a computerized physician order entry system (CPOEs), which reduced
antibiotic-related adverse drug events by 70 percent.
I offer these examples to illustrate that health information
technology is working to fix the major problems facing the healthcare
industry today.
Imagine if electronic health records (EHR), picture archive and
communication system (PACs) and physician computer order entry system
(CPOE) could be implemented worldwide? Tens of thousands of lives could
be spared and billions of dollars saved.
Indeed, study after study demonstrate the impressive impact
healthcare IT solutions have on rising costs and quality of care.
With broad adoption of proven technology solutions, the industry
could save over $200 billion annually, enough to bring healthcare costs
in line with the current rate of inflation, or cover all the uninsured
according to a variety of studies and presentations from Center for
Information Technology Leadership (CITL), and American Health Quality
Association (March 2004).
It's clear that the next revolution in healthcare will use
information to drive patient-centric, safe, and efficient care. A
fitting term for this model is ``Connected Health.''
What is Connected Health?
Connected Health is the power of technology--not simply to
automate old tasks--but to facilitate richer and better health
care interactions between patients, physicians, and insurers.
Connected Health is the power of technology to place
information at the point of care, empowering both providers and
patients to make better, more informed decisions.
Connected Health is the power of technology to connect
doctors with hospitals, hospitals with pharmacies, pharmacies
with insurers, insurers with patients, and finally, patients
with doctors so that no one is stranded on their own island of
information.
Changing the way information is handled may not seem like a
development to rival antibiotics or X-rays, but it has the potential to
be every bit as revolutionary.
So what's the hold up? Why is healthcare among the five lowest
ranking industries in information technology spending per employee?
For one, the industry has historically under-invested in IT, partly
because healthcare spending is decoupled from healthcare funding.
And clearly complexity plays a part. Connected Health systems
require significant investment, standards, metrics, effective change
management and, above all, a top-down commitment to transformation.
Healthcare organizations can get started by looking at their
greatest needs, studying what other institutions have done, and
strategically deploying first-strike applications with proven impact.
The challenge is great, but the stakes are higher.
Healthcare information technology has proven its efficacy. All
that's needed now is the willpower and resources to deliver the
solution nationwide.
Thank you again, Mr. Chairman, Ranking Member Kerry, and other
members on the Subcommittee for inviting me here today. I am happy to
answer any questions.
Senator Ensign. Thank you. Dr. Glaser.
STATEMENT OF JOHN GLASER, Ph.D., VICE PRESIDENT/
CHIEF INFORMATION OFFICER, PARTNERS HealthCare
Dr. Glaser. Thank you Senators, my name is John Glaser, I
am the Chief Information Officer for Partners HealthCare in
Boston. Partners provides medical care. Our academic medical
centers, community hospitals, health centers, physician
offices, and visiting nurses take care of over a million unique
people a year.
For 18 years I've been responsible for the implementation
of information technology to support the care that is delivered
by our physicians and nurses, and these technologies, include
the electronic medical record, e-prescribing, tele-medicine and
medical imaging system, are used daily by over 10,000 care
providers across Partners. I was actually responsible for the
implementation of the provider order center at Brigham--that
Senator Kerry mentioned, in his comments. I think it's fair to
say that Partners is one of the most extensive healthcare users
of information technology. Not only in this country but across
the world.
Now based on our experience, I think there is no question
at Partners that the systems when thoughtfully implemented can
lead to significant improvements in the care that we deliver.
When we study ourselves, we find that serious medication errors
on the inpatient side have been reduced by 55 percent. We find
that the appropriateness of our care to our diabetic population
increased by 30 percent. We find we've reduced our expenditures
on expensive medications by 15 percent, and we've increased the
productivity of our visiting nurses by 25 percent. Now if you
use our experiences, and the experiences of others, the Center
for Information Technology Leadership, a research group within
Partners IS, has estimated that if you took these systems and
made them interoperable and deployed them across the country,
it would provide a net savings of $78 billion a year,
equivalent to about 5 percent of the Nation's healthcare
expenditure. A fairly conservative estimate, but nonetheless a
sizable amount of money.
More importantly from the human side, there would be a
reduction of about 2 million medication errors a year across
the country from these kinds of technologies. Partners commits
about $50 million a year to doing these kinds of systems and is
committed to doing so for the foreseeable future, and the
commitment grows by 15 percent a year.
In fact the application of these systems is the most
strategic, critically important initiative that we have across
Partners, and I believe, in working with my colleagues across
this industry, that the industry as a whole is committed to
advancing IT use. Healthcare providers, joined by employers, by
insurance companies, by patients, by the industry overall are
leading this effort and will continue to do so.
Nonetheless, I think the Federal Government can be quite
helpful to us, and there are five things that I think you all
ought to do.
Number 1, these systems pose a very difficult financial
challenge for most healthcare providers. This is what I brought
up earlier. In our experience the electronic medical record can
cost the physician $100,000 over 5 years. That's what they're
going to pay out of their pockets. Yet 89 percent of the
financial value that results accrues to others. So if we reduce
medication errors, there's value to the payer, there's a value
to the employer, there's obviously value to the patient, but
there may be no fiscal reward for the physician. So the
physician while investing may see very little of the reward.
Healthcare's rather peculiar in this country. The physician is
generally not financially rewarded for delivering high-quality
care and not surprisingly they will hesitate to make
investments which cause them to lose money.
As the country's largest insurer and the largest employer,
you can decide to reward the physician for delivering better
care, and for making the investments needed to deliver the best
care that they can. I also think there's some stuff you can do
regarding Stark, that allows us to share the cost with the
physicians who are out in our community.
Number 2, the country does need to settle on standards that
enable us to connect these systems and share, as appropriate,
the patient's data between those that are involved in care.
This is not always a shortage of standards, but rather failure
to decide which standards to use across the country. The
Federal Government can convene, and through its size, stature,
and role can work with us to make decisions regarding
standards. We're not going to wait for standards. A lot of
people are dying today. We need standards. But we're not going
to wait. Nonetheless progress should be made along those lines.
Number 3, implementation of these systems is a difficult
challenge for the physician. They must choose applications that
involve complex technology and they must change the way they do
work. Now if you're a Partners physician, I can help you. If
you're an independent physician, or a small hospital, you have
no one you can turn to. Confronted with this daunting
implementation challenge and lack of someone to help you,
physicians will either hesitate to adopt, or face an
unnecessarily risky implementation. The Federal Government can
help establish mechanisms to support the independent physician
and small hospital, and it has begun to do so through the
quality improvement organizations.
Number 4, in my 18 years I've seen many advances in
information technologies and these advances will continue
through the rest of my career. The industry needs to learn
which of these new technologies hold great promise, and which
of these are of relatively minimal value. For example, if we're
able to actually integrate all of the providers in Eastern
Massachusetts, how much unnecessary testing can we avoid. We
don't know the answer to that kind of question. Throughout the
years the Federal Government most notably through AHRQ and the
National Library of Medicine has been a significant sponsor of
research and innovation design to answer these questions. This
supported sponsorship is essential, and it's essential that it
continue.
Number 5, across the country, over 100 communities have
come together to begin to put in place the infrastructure
necessary to share electronic health records across their
region, or their community, or their state. In Eastern
Massachusetts, MA SHARE, and Massachusetts eHealth
Collaborative lead these efforts. These efforts hold great
promise, but they're very early and there's much to be learned.
The Federal Government can provide seed funding to help these
initiatives get started, and the government can work with
organizations such as the eHeath Initiative, CHIME which is the
healthcare CIO gathering, to establish mechanisms through which
these communities can share experiences, ideas, and work with
each other. The Health Research, and Service Administration has
done a nice job in the Federal Government of assisting a lot of
this.
So anyway, I hope my comments are useful, and I look
forward to the discussion that follows. Thank you.
[The prepared statement of Dr. Glaser follows:]
Prepared Statement of John Glaser, Ph.D., Vice President/Chief
Information Officer, Partners HealthCare
Mr. Chairman and Members of the Subcommittee: Good morning. My name
is John Glaser. I am the Vice President and Chief Information Officer
of Partners HealthCare. Partners HealthCare is an integrated system of
medical care whose members include the Brigham and Women's Hospital,
the Massachusetts General Hospital, community hospitals, health
centers, physician practices and visiting nurses. Over the course of a
year, Partners physicians and nurses will deliver care in 4,000,000
outpatient visits and 160,000 admissions.
I am also the President of the Board of the eHealth Initiative
(eHI). The eHealth Initiative represents the multiple and diverse
stakeholders in healthcare and health information--consumer and patient
groups, employers and purchasers, health plans, hospitals,
laboratories, practicing clinicians, public health agencies, HIT
suppliers and others--dedicated to driving improvement in the quality,
safety, and efficiency of healthcare through information and
information technology.
Implementation of Electronic Medical Records (EMRs)
For the past 18 years, I have had the overall responsibility for
the implementation of electronic health records (EHRs) at the Brigham
and Women's Hospital and then Partners HealthCare.
During this time, we have implemented computerized provider order
entry (CPOE) at Brigham and Women's Hospital, the Massachusetts General
Hospital, the Faulkner Hospital and the Dana Farber Cancer Institute.
Physicians use CPOE to enter 30,000 clinical orders a day. Medical
logic is applied to the order to ensure, for example, that the
requested medication is safe or the radiology procedure being ordered
is appropriate. Implementation across all our community hospitals will
be completed by the end of next year.
Currently, we have 2,600 Partners physician users of our electronic
medical record (EMR) and over the course of the next 4 years, we will
add an additional 2,000 physicians. Our implementation efforts are
currently focused on physicians in our community practices.
We have applied telemedicine to offer specialist second opinions to
patients around the country and the world. And we support the home
monitoring of patients with chronic diseases and recent surgical
patients.
We provide technologies to enable patients to converse with their
physician and access their medical record. Our base of 25,000 patients
is growing at a rate of 7,000 new patients a year.
More recently, we have begun to invest in the information
technology necessary to help our physician researchers understand the
genomic basis of disease. These systems help the researcher, for
example, to determine why most asthma patients respond to steroid
therapy, while 10 percent do not.
In collaboration with regional providers and payers, we have
recently begun to integrate our EHRs with those of other providers
across the Commonwealth of Massachusetts.
Health Information Technology and Patient Safety
Based on our extensive experience, and those of others, there is no
question that information technology, when thoughtfully applied, can be
leveraged to effect significant improvements in the safety, quality and
efficiency of the care that we deliver.
Studies of CPOE with decision support, at the Brigham and Women's
Hospital, show that medication errors were reduced by 80 percent and
serious medication errors were reduced by 55 percent.
Additional studies of CPOE show decreases in the time spent by
patients in the hospital, significant reductions in inappropriate
antibiotic use, increased appropriateness of medication and radiology
procedure orders and significantly faster notification of physicians
regarding alarming patient test results.
Electronic medical record reminders resulted in a 30 percent
increase in diabetic patients and 25 percent increase in patients with
coronary artery disease receiving recommended care.
Our electronic medical records medication ordering system provides
guidance to the physician and has led to 15 percent of all orders being
changed to lower cost, but equally effective medications.
Remote monitoring of elderly patients with congestive heart failure
not only leads to earlier detection of possible deterioration in heart
function, but also results in a 25 percent improvement in productivity
for our visiting nurses.
When data such as ours and others are extrapolated across the
country, the Center for Information Technology Leadership, a healthcare
information technology analysis group at Partners, finds that the
widespread implementation of interoperable EHRs would provide a
national net savings of $78B per year (5 percent of the Nation's total
healthcare costs) by avoiding medical errors, reducing unnecessary care
and improving administrative efficiency. Such systems are projected to
eliminate 2,000,000 adverse drug events per year across the Nation.
Challenges of Health Information Technology
While offering significant gains, the implementation of these
systems and the achievement of improvements in patient care are very
complex and difficult undertakings.
Physicians and nurses must learn new ways of doing their work.
Hospital and physician practice workflow must change. At times,
performing a task using a computer takes longer than using paper. For
providers already facing extreme demands on their time, these changes
and time commitments can be overwhelming.
Healthcare providers confront a complex financial decision when
they seek to invest in these applications. While they are committed to
the mission of delivering the best possible patient care, these systems
represent significant capital commitments. With a reimbursement system
that very often does not reward them for improving quality, or support
them in making these investments, their precarious financial positions
and limited resources prevents them from pursuing these systems. For
example, an EMR can have a five-year cost of $100,000 per physician.
This cost can pose an insurmountable barrier for a physician who is
facing decreasing Medicare reimbursement.
Assuming that physicians and hospitals can overcome the difficult
changes in clinical practice and can find the necessary funds, the
majority of them have little experience with the acquisition and
implementation of EHRs. They want to proceed but they don't know how
and they are rightfully concerned with making significant mistakes.
This is particularly true for the small physician practice and small
community hospital.
At Partners we confront these challenges every day. And every
hospital, physician practice, health center and visiting nurse agency
in the country confronts these challenges.
Community Health Information Exchange
To these challenges, we are beginning to add a new dimension of
complexity: the formation of regional and national networks to
integrate EHRs across providers. There is no question that
interoperable EHRs are a necessary step in our efforts to improve
patient care. But there is also no question that there is very little
experience with how to organize communities, develop the necessary
information technologies, identify strategies for addressing complex
issues such as privacy, and mechanisms to ensure the ongoing financial
stability of these efforts. This complexity is compounded by the
bewildering array of standards that are often inconsistent, hindering
our ability to efficiently connect our systems.
There is much that provider, payers, employers, and patients can do
to address these challenges and further the thoughtful adoption of
EHRs. Partners HealthCare is an example of an organization that is
committed to improving care through the use of information technology.
We spend over $50M annually to acquire, implement and support EHRs.
(This investment is in stark contrast to the $150M annual budget of the
Office of the National Coordinator for Health Information Technology. A
budget that, while well intentioned, is clearly insufficient to move
the Nation toward the widespread adoption of interoperable electronic
health records).
Partners is not alone. Many provider organizations are making
significant investments in EHRs. Across the country, the healthcare
community and its stakeholders are coming together in national and
regional forums to discuss the industry's collective efforts, learn
from each other and jointly develop analyses, guides and positions.
The eHealth Initiative
The eHealth Initiative is supporting these efforts through its
formation of working groups of physicians, employers/purchasers and
community collaboratives whose members come together to address the
mutual challenges. The eHI, national meeting, Connecting Communities
for Better Health (CCBH), held 1 month ago, was attended by
representatives of over 100 communities that have begun to implement
local interoperability. The Parallel Pathways Framework of eHI has been
hailed as an important guide to the industry as it seeks to integrate
financial incentives, quality reporting, EHR adoption and community-
based interoperability.
Federal Leadership
And while, the healthcare industry and those who have a stake in
the industry's efforts to improve care, must lead and are leading these
efforts, the Federal Government must play a critical role in supporting
this work.
A very significant national hurdle is the misalignment of financial
incentives for EHR adoption. The provider must bear 100 percent of the
costs of these systems and yet studies suggest that 89 percent of the
economic benefit flows to groups and organizations other than the
provider. Improvements in the safety of patient care will benefit the
employer, payer and patient but there is little economic benefit to the
provider. Hence the provider is confronting an investment that, while
improving the care that they deliver, has a high likelihood of leading
to an economic loss for the practice. At Partners, we have begun to
address this problem through very constructive discussions with local
payers that have led to modest reimbursement to physicians who adopt an
EHR by the end of 2006.
The Federal Government is the country's largest employer and payer.
The Federal Government can alter its Medicare reimbursement approaches
and the provider arrangements for its employees such that improvements
in care and investments in necessary information technology will be
financially rewarded.
The inconsistency, and at times dearth, of necessary data and data
exchange standards hinders our ability to create the necessary
interoperability between EHRs and our ability to report on the quality
and cost of the care that we deliver. The Federal Government can use
its powers of convening and persuasion to help the industry resolve
these problems. And the government can insist that the Federal health
sector adopts and implements standards.
A community hospital or small physician group in Massachusetts that
wants to invest in information technology can turn to me and my staff
for assistance. However, if you are small physician practice or a small
community hospital, there may be no one who can provide this
assistance. Mechanisms are needed to bring information technology
support to those providers who do not have the benefit of an
information technology staff. The Federal Government can leverage its
resources to help establish and sustain needed support mechanisms. The
current Doctors Office Quality Information Technology program (DOQ-IT)
is an example.
The Federal Government should consider changes in the Stark and
Anti-Fraud laws to enable organizations such as Partners to extend its
EHRs and its implementation expertise to physician practices and share
the costs with the physician.
Partners is an active member of MA SHARE and the Massachusetts
eHealth Collaborative efforts to provide Commonwealth-wide
interoperability of EHRs. And at the eHealth Initiative, we see over
100 comparable efforts across the country.
These efforts need to be nurtured and they invariable need access
to seed funds. While they should strive to be financially self-
sustaining within a couple of years, the availability of federally
sponsored grants and loans will be a critical contributor to these
early efforts.
While we at Partners have been implementing EHRs for many years,
there is still much that we do not know about their impact on patient
care. New technologies and innovations bring new opportunities, but
studies are needed to help the industry understand the potential
contributions of these opportunities. We know even less about the value
of regional and statewide interoperable EHRs. The Federal Government,
in particularly AHRQ, has been a major supporter of research on the
value and impact of information technology in medical care. These
studies provide very important insight for all of our efforts and
should continue.
The Federal Government has extraordinary leadership leverage. Both
elected and appointed officials can use this role to convene the
industry, to encourage its participants to resolve problems, to use
speeches and appearances to continuously stress the need for
interoperable EHRs and to respond, as needed, to industry problems by
crafting appropriate legislation. This role is not a transient one;
rather it will be needed for years to come. The industry does listen.
Conclusion
I know that many of the recommendations described above are being
analyzed and several are in the process of being put in place. And I
know that I will have undoubtedly failed to appreciate the complexity
and nuances of carrying out these recommendations. However, I live the
reality of implementing EHRs every day and I see the reality of my
colleagues across the country. From those perspectives I believe that I
can see what is needed.
All of us, and those who we love, seek healthcare. I won't recite
the now well-known numbers that illustrate the litany of problems that
afflict our healthcare system. I do know that I want my kids and my
eventual grand kids to have a healthcare system that has made major
strides in safety, appropriateness and efficiency. And I have committed
my professional life to helping to create that system through the
application of information technology.
Providers, payers, employers and patients must shoulder most of the
burden to improve healthcare. And they are willing to do so. I am often
struck, during conversations with health care leadership across the
country, by the depth of their commitment and that they will continue
their EHR efforts, even if the Federal response is minimal.
However, the Federal Government actions or inactions will have a
very significant impact on the pace of change, the degree to which we
avoid mis-steps and our eventual success.
Thank you for the opportunity to testify. I welcome the opportunity
to respond to your questions.
Senator Ensign. Dr. Basch.
STATEMENT OF DR. PETER BASCH, MEDICAL DIRECTOR, eHealth
INITIATIVES, MedStar HEALTH
Dr. Basch. Good morning, thank you, Mr. Chairman, Senator
Allen. And thank you for the opportunity to address you today.
I've also submitted more detailed testimony for the record. My
contribution to this panel is to provide the input of a
practicing general internist who has used an EHR, in practice
for almost a decade, and also to show the Subcommittee concrete
examples of how the EHR can be used to transform care
particularly in the setting of a small practice, where 80
percent of outpatient care is delivered in this country. I also
hope that my testimony answers the Chairman's questions to Dr.
Clancy regarding how to bring best practices to the level of
the physician practice.
I wholeheartedly agree that the EHRs and HIT have the
potential to make healthcare better, safer, and more
affordable. But I wish to introduce this note of caution. The
mere adoption of interoperable EHRs by themselves is not likely
to result in the significant value that has been talked about
today. Realizing the full potential of the EHRs requires
additional advanced software, secure connectivity, and most
importantly a sustainable business case for care management and
quality. Without these additional components, coupled with
reimbursement and policy changes, EHRs are more likely to be
used simply to automate the administrative functions in
practice, such as documentation, and coding for billing
purposes.
This is a view of the electronic health record that I use
in my own office, and as good as it is by itself, it's
essentially a digital filing cabinet. I agree that what it does
give me is the potential to see it anywhere, anytime; as well
as to be able to look at vitally important things such as
problem lists, medications, allergies, and other important
clinical data.
However when we add in advanced decision support, it
becomes far more powerful. I'm not quite sure how well this
shows up, but let's assume in a real practice setting of a 7 to
10 minute office visit, this patient comes in for a sinus
infection. What this advanced EHR reminds me of, by having the
little boxes on the bottom which are all chronic conditions,
(defined as important by my health system) other conditions
that this patient has. So while I am there to treat the patient
for the problem he came in with, I see I also should address
these other conditions. In this instance that of him being on a
blood thinner, having diabetes, hypertension, and high
cholesterol.
We can go a step further in using advanced decision
support, and this is what it could look like in a physician's
office. Here it is granular, tailored to the specific patient
and focused on his or her age, sex, labs, diagnoses, and meds.
And it's actionable. I'm able to look at it and take immediate
action.
In this decision support prompt for example, while this
patient is here for a sinus infection, if I chose to look and
pay attention to it, I would see that I have made some critical
errors. I have not created a stop-date for this medication (a
blood thinner) or set a target level. And let me reiterate
this, this is an exceedingly dangerous medication and without
paying attention to those particular issues, patients can be
harmed.
In this next slide, which is showing decision support for
diabetes, here I'm reminded of several key aspects of diabetic
care, such as the fact that I haven't enrolled this patient in
a diabetes education program; or this patient is not at target
goals for cholesterol management; and I haven't done any of the
necessary diabetes monitoring tests that we all recognize are
important.
My point is, that very few EHRs provide what I've just
shown you in these last two pictures. Either this level of
detail, or decision support that is actionable. But given these
tools and the incentives to use them, we can do more than what
I would call informed care. We can begin to transform care.
Now, what do I mean by transform care?
Well the first step in care transformation is realizing
that all care does not have to occur in a doctor-to-patient
office visit. The first step in my view is forming a
partnership with the patient. Here the EHR can facilitate this
collaboration with patient-level decision support. And this can
be done through a secure patient portal, interconnected with an
EHR, as you can see on the screen, or with a personal health
record (PHR). For example if I'm hounding my patient about
getting something called microalbumin, the patient can click on
the question mark and actually see what that means.
Taking healthcare transformation to the next step requires
using a registry. This allows us to practice proactive care, or
population management, and this is integrated with my records
so it's fed with real clinical data. It allows me to address
guidelines and best practices, not just when patients come for
a visit, but for my entire population. I can use this to look
at all of my diabetic patients, for their blood sugars, their
cholesterols, and so forth.
Here's an example of a secure patient portal, linked to the
EHR for chronic care management, as well as some acute care
management, which can be done safely and more efficiently
without requiring a face-to-face office visit.
What I've just shown you is the use of the EHR to not just
automate care, but to inform care through detailed actionable
decision support, and to transform care through the use of
patient-directed education, an integrated registry, and a
patient portal. This is where I believe the majority of the
benefit of EHRs will arise.
And this can be done by ordinary physicians even in the
small practice settings. These value-laden activities are
rarely performed even in technologically advanced practices as
they add cost to the already expensive EHR. And more
importantly, their use can substantially reduce the physician's
income, as unlike office visits or procedures, time spent on
care coordination, population management, and e-care is
currently uncompensated. However if coupled with new payment
paradigms including thoughtful pay-for-performance, these
advanced features of the EHR can help them make the decade of
the EHR a success, with care that truly becomes better, safer,
and more affordable.
Mr. Chairman, and Senator Allen, and other members of the
Committee, I thank you for the opportunity to address you
today, and I'm available to answer your questions.
[The prepared statement of Dr. Basch follows:]
Prepared Statement of Dr. Peter Basch, Medical Director,
eHealth Initiatives, MedStar Health
Mr. Chairman and the members of the Subcommittee:
I am pleased to appear before the Subcommittee to discuss the
promise of electronic health records (EHR), and the barriers to their
optimal use in outpatient medical practice. I have been a practicing
primary care physician for 25 years, and have used an EHR in my
practice for the past 8 years. In addition to practicing medicine
within a small practice located here on Capitol Hill, I also serve as
the Medical Director for eHealth at MedStar Health, with the
responsibility of determining and directing strategies for physicians
regarding e-health applications in ambulatory care, which are oriented
toward improving patient care and quality, and improving practice
efficiency and efficacy. MedStar Health is a not-for-profit community
healthcare system that includes seven hospitals in the Baltimore-
Washington corridor, including Georgetown University Hospital and the
Washington Hospital Center. In addition, I represent the American
College of Physicians within the Physicians' EHR Coalition (PEHRC); a
coalition of twenty-one medical professional and specialty societies,
dedicated to furthering the adoption and optimal use of electronic
health records, and serve as the PEHRC's Co-Chair. Furthermore, I am
the Co-Chair of the eHealth Initiative's Working Group for HIT in Small
Practices. While my testimony is consistent with stated positions
regarding EHR adoption and use of these organizations, I am here today
testifying solely on my own behalf.
By all accounts, I am an early adopter of electronic health
records; having employed them in my practice since the mid-1990s. Since
that time, the capabilities of EHR have advanced dramatically, as has
our understanding of their value in medical practice. The initial
impetus for my adoption of an EHR was a response to the pressures of
managed care, which required primary care doctors like me to see more
patients in less time, as well as produce and manage increasing amounts
of paperwork. At that time, I saw the potential of EHR quite narrowly--
as an electronic filing cabinet--an administrative tool that would help
relieve me of some of the paperwork burden and also allow for added
productivity; something to automate care.
Today, after years of using an electronic health record in my own
practice, and years of working more broadly in the health information
technology field, I believe the analogy of an EHR as electronic filing
cabinet is not only inapt, but wrongheaded as well. Advanced EHRs are
not and should not simply be about digitizing the information
associated with existing care processes. In my view, that would do
little more than digitize dysfunction. The real power of an EHR
optimally integrated into practice is far greater. Properly
implemented, an EHR can be a tool for better informing multiple care
processes, and even lead to healthcare transformation, leading to
further enhancements in quality, safety and efficiency, and efficacy.
Having said that, it is important to put EHRs in perspective. They
are a powerful healthcare technology, not a cure-all for the many
challenges facing medicine today. Unless the adoption of an EHR is
coupled to both significant process change (practice redesign) and
payment reform that creates a sustainable business case for quality and
care management, EHRs will not meet their promise.
Properly implemented, EHRs can be the cornerstone of a redesigned
twenty-first century healthcare system that harnesses information to
empower patients and care providers and improve quality. The
integration of EHRs into practice exponentially raises the value of
information in the clinical process, enabling a fundamental
transformation for doctor and patient. For physicians, EHRs bring
advanced and actionable knowledge to the point-of-care, putting
excellence in healthcare delivery within the reach of all doctors. For
patients, EHRs enables true partnerships and collaborations with their
healthcare team. The vision of a patient-centric healthcare system
where quality, safety and efficiency are enabled by cutting-edge
technology is a compelling one:
Patients will be empowered and actively involved in their
care. They will collaborate with providers in decisionmaking
around care and have ready access to accurate and trusted
healthcare information, including their own medical histories,
disease-specific information and decision support tools for
self-care;
Reliability and safety will increase because physicians will
practice evidence-based medicine, have access to knowledge and
information at the point of care, be guided by active decision
support tools and routinely communicate and cooperate with
other care providers;
Care will move from episodic encounters to a continuous care
model where providers have access to patient data in context;
care is delivered proactively, chronic illnesses are monitored
by caregivers, patients are able to engage in informed self-
care and duplication and waste are minimized; and
Accountability for quality will increase. Quality will be
measured and the information shared with all stakeholders; and
quality care will be rewarded.
While we are still a long way from realizing this vision (only
about 10-15 percent of physicians are using EHRs in their office
practices), the future is now in my own practice, and within 18-24
months will also be in the practices of all of the clinicians at
MedStar Physician Partners, a group of outpatient practices owned by
MedStar Health. My colleagues and I use an advanced EHR that provides
access to the full patient record--including all relevant clinical
information such as diagnoses, immunizations, medications and test
results, which is always available in a highly organized and
contextually-appropriate format, improving the quality of our
decisionmaking at the point of care. Computers are located in each of
the exam rooms, making it easy to share information with patients and
better include them in their own care decisions.
For example, at the start of each visit, the patient is encouraged
to look at his or her medication and allergy list and confirm its
accuracy (see Figure 1). Patient educational materials are integrated
into the system, and soon the EHR will provide clinical decision
support for patients, which will allow them to make better decisions
about self-care for chronic illnesses (see Figure 2). The EHR is also
designed to link to new medical information, practice guidelines and
even recent reference articles, dramatically shortening the time from
discovery of new knowledge to its application into clinical practice.
Our EHR is also integrated with electronic prescribing, further
increasing safety and efficiency of prescribing (see Figures 3 and 4).
And because the EHR is also available remotely, on-call physicians can
view patient records and make care decisions based on the full context
of a patient's clinical information anytime and anywhere.
With our fully integrated EHRs, lab reports flow directly from
reference and hospital labs securely into the patient record, showing
up on the physician's PC for immediate review. This not only makes
report review quicker--it also makes it better; new results can easily
be viewed or graphed and interpreted in the context of prior results
and the patient's full history. Even digital EKGs can be reviewed and
compared with earlier tests.
EHRs become more powerful when they use decision support tools that
not only provide timely information, but also help clinicians turn that
information into actionable knowledge. Active decision support tools
are designed to connect key information such as a diagnosis with links,
pop-ups, prompts and reminders that encourage discrete changes in
patient management. While passive decision support puts key information
in front of the clinician, active support links patient information,
guidelines and best practices, and provides an immediate opportunity to
take action. For example, in the case of a diabetic patient, an active
decision support tool will trigger reminders about clinical management
of diabetes such as an overdue test, even if the patient has made an
appointment about a sinus infection (see Figure 5). Robust uses of
decision support tools thus have the power to inform an episode of care
(the visit for a sinus infection) into an opportunity to also include
and optimize chronic care management (see Figures 6 and 7).
But by far the greatest potential for an EHR to improve quality,
efficiency, and efficacy comes from its use to transform care. The
transformative uses of an EHR include integration of a registry for
proactive care and population management (see Figure 8); integration
with a secure patient portal or personal health record (see Figure 9)
for appropriate use of non-face-to-face care or eCare; and use of the
EHR to optimize team-based care or care coordination.
EHR integration with a population or disease registry allows
clinicians to proactively review subsets of patients and take
affirmative steps to ensure adherence to nationally accepted best
practices. For example, Washington Primary Care Physicians was recently
recognized by the Delmarva Foundation, our regional Quality Improvement
Organization, for its high rate of pneumonia vaccination in Medicare
patients--a process made possible by our use of an EHR with patient
registry functions. And when the arthritis medication Vioxx was
recently recalled, all of our patients on the medication, among the
25,000 in the practice, were identified within minutes and then
contacted.
What is critical to understand is that in order to fully harness
the power of an EHR for transformation, the role of the physician and
other caregivers in a medical practice must also change, from providers
of discrete episodes of medical care, only when patients sense that
they are sick or due for a particular service, to a more proactive
model of chronic and ongoing care management. The care manager or
coordinator, utilizing a patient-centric and physician-guided approach,
would use an EHR and other health information technologies to create a
medical home for all necessary information about his/her patients,
focusing particularly on those with complex and chronic illnesses, and
coordinating care between multiple specialists in order to optimize
care, and to avoid conflicting treatment plans and duplicative tests.
Why isn't this vision now a reality in every doctor's office? Much
progress has been made in recent years in making EHRs better and more
affordable. And I believe that we are on target to meeting the
President's goal of universal EHR adoption by 2014. However, I also
believe that this universal adoption and use of EHRs per se, will do
little to making care better, safer, and more efficacious. To
accomplish those goals will take more than placing a computer on a
desktop; as discussed above, it will require using the EHR as a tool to
inform and transform care and care processes. And EHRs that can inform
and transform care are even more expensive; and more importantly, the
more EHRs are used for informational and transformational purposes, the
more negative the business case for the physician.
Right now, the healthcare reimbursement system is designed to pay
clinicians for procedures and episodic clinical care. Proactive care,
care coordination, information management and eCare that lead to
overall quality improvements and cost savings are generally not
reimbursed. If as a matter of national policy, we want physicians not
only to invest in EHRs, but also to use them in an optimal manner that
will improve quality and safety, (that is as a care management tool,
not just an electronic filing cabinet), we have to do more than mandate
EHRs, and address what the Institute of Medicine has called our ``toxic
payment system.''
What does this look like to the average physician? Moving beyond
the basic EHR to one that informs care, as mentioned above, adds
thousands of dollars of cost, and by adding necessary time and
complexity to each office visit (for chronically ill patients), reduces
the number of patients that a physician can see each day. Adding an
integrated registry implies that the clinician will intentionally take
time out of the practice day to use the registry to manage patients who
are not coming in when they should, or who are not at target treatment
goals. And adding in eCare means that reimbursed office visits are
substituted for free virtual care. While the use of a registry and
eCare for some specialties would have little impact on daily practice;
their optimal use by family physicians and internists could reduce
their income to zero.
Fortunately, pay-for-performance and pay-for quality initiatives
recognize this problem, and seek to address it with a mix of financial
incentives including support for the initial EHR investment as well as
increased pay for adherence to quality performance measures, as well as
reimbursement reform that pays for care coordination and eCare. My
practice, for example, has recently been selected by CareFirst to serve
as its first pilot site for the pay-for-performance Bridges to
Excellence program, which will provide us with additional financial
incentives for optimal use of our EHRs for care coordination and
quality improvements--which by the way, is the only reason that we were
able to afford the EHR enhancements I have been discussing. However, if
we want EHRs to enable excellence globally, we have to move from pilots
to policy reform.
In conclusion, enormous progress has been made within the last few
years in advancing the vision and reality of EHR use and interconnected
electronic healthcare. The credit for this remarkable work belongs to
many--within government and the private sector; and on both sides of
the political aisle. As a practicing physician, I can personally attest
to its value in my everyday practice. But as we get closer to realizing
this vision of technology implementation for all clinicians, there
remains a substantial risk that defining success as universal EHR
adoption will actually do very little good for the American people. For
success to be seen more broadly than IT adoption, and more
appropriately as EHRs integrated into practice to both inform and
transform care--fundamental changes must occur within payment and
reimbursement policies. As advanced EHRs, combined with these
enlightened incentives, will make care better, safer, and more
effective, efficient, and equitable.
The MedStar eHealth Initiative report entitled, At A Tipping
Point: Transforming Medicine with Health Information
Technology--A Guide for Consumers, has been retained in
Committee files.
Senator Ensign. Ms. Pure.
STATEMENT OF PAMELA PURE, PRESIDENT, McKESSON
PROVIDER TECHNOLOGIES; EXECUTIVE VICE PRESIDENT, McKESSON
CORPORATION
Ms. Pure. Mr. Chairman, Senator Allen, I'm Pam Pure. I'm
the Executive Vice President of McKesson Corporation. And I'm
President of McKesson Provider Technologies, our healthcare
information business.
For over 170 years McKesson, a Fortune 15 Company, has led
the industry in the delivery of medications and healthcare
products. In addition, McKesson is the largest provider of
healthcare IT. Our only business is healthcare. I have
personally spent the last 20 years witnessing first hand the
benefits of healthcare IT and the challenges associated with
its adoption.
For me this is not just a job, it's really a personal
passion. Congress is considering numerous bills to promote
healthcare IT and the President has outlined a bold vision to
ensure every American has an electronic medical record.
McKesson applauds these initiatives, but, to spur the adoption
of healthcare technology, we really must start now, and we must
start with proven technologies that can be deployed
immediately.
Technologies that will save lives, reduce errors, improve
quality, and lower costs. And we can do this while we begin to
develop the standards. Once the information is collected, we
can share it in a safe and secure environment. What I would
like to do is spend just a minute to describe three high impact
technologies that can deliver great value to the American
public, while providing a strong foundation for safe care.
First, Bedside Bar-Code Scanning. All medications should be
bar-coded and scanned at the bedside. When you think about it,
it's really intolerable that people die every single day from
medication errors that could easily be prevented with bar-code
technology. Technology that exists at our grocery stores.
Today, on average, 30 people touch a medication before it's
actually administered, providing tremendous opportunity for
missed hand-offs, and errors. Imagine the complexity for the
nurse who typically administers 10 meds per patient, per day.
Or the safety risk for a transplant patient who might receive
36 different medications in a single shift. Imagine how quickly
we could eliminate medication errors if a med was bar-coded and
scanned.
As a country, wouldn't it be great to have confidence that
the right meds were being delivered to the right patient every
single time? You know it's actually very simple. You can
deliver meds like this, and, when it's candy, it doesn't matter
if you pick a yellow M&M or a yellow Skittle, but, when it's
medication, picking the wrong one can cost you your life.
That's why we have to work like this: we have to use hand-held
scanning, we have to insist on individual unit dose, bar code-
labeled meds that can be scanned at the bedside. Then it
doesn't matter if the meds look alike, or if they sound alike.
It's simple, if their scan doesn't match, the nurse doesn't
administer the meds.
You know, we looked at 75 hospitals that use McKesson bar-
code scanning technology everyday, and these numbers are
actually quite staggering. These hospitals generate 400,000
alerts weekly to warn nurses or other healthcare professionals
that the wrong med or the incorrect dose is about to be
administered. Each week, in these 75 hospitals, these systems
prevent 56,000 medication errors. With the ability to reduce
errors by up to 90 percent, imagine how many lives we could
save if every hospital in the country simply started with bar-
code scanning? We have to get moving.
The second high impact technology available today is
electronic prescribing. It's simple; we have to eliminate the
paper prescription. Each year, there are more than three
million avoidable medication errors, in doctor's offices, or
outpatient settings. Eighty percent of prescriptions are
scribbled on paper today. Systems like McKesson's e-prescribing
solutions check for drug allergies, they check for conflicts
and they help to ensure that safe scripts are legible. There's
no excuse; prescriptions must be electronic.
Finally, we must provide physicians with secure access to
patient information. We're talking about the basics. Today we
provide healthcare in a paper world. In a world of blind
encounters, where doctors give patients advice, place orders in
the emergency room, and recommend treatment changes without any
access to the patient's chart.
Kind of crazy, at a time when you bank online, book your
travel online, purchase gifts on the computer, but your
healthcare record is still on paper. McKesson gives doctors and
nurses immediate electronic access to essential patient
information securely with just one click of a mouse. Each
month, we have users logging onto our physician portal 1.8
million times, so clearly the technology is ready. Our
challenge is accelerating adoption. You know there are
innovative health institutions across the country using
technology to provide safer care. They are saving lives, and
saving money. But, you know, it's just not happening fast
enough. We must accelerate the adoption of these basic
technologies. I would ask the two of you, would you choose a
bank that didn't offer an ATM? Should you choose a hospital
that doesn't provide bar-code scanning of medications? You
know, the biggest obstacle to rapid adoption is the lack of
funding. The Federal Government can play a key role by
providing financial incentives. One creative option would be
government-sponsored entities that would provide government-
backed loans for healthcare providers so they could get started
and buy these solutions.
If you combine financial and pay-for-performance
incentives, I believe you will spur rapid adoption. Ten people
die from medical errors every hour in the United States. As a
Nation, we have a moral responsibility to do better. We have a
moral responsibility to save these lives, and as a country we
must adopt and use these proven technologies today.
Let me reiterate the critical steps toward automation. One,
medications must be bar-coded and scanned at the bedside. Two,
all prescriptions must be electronic; no more illegible paper.
And, three, doctors and nurses must have access to patient
information before critical decisions are made. As a Nation we
now have the will and the means to make healthcare safer. We
can leave a remarkable legacy. Thank you. I would be happy to
answer any questions.
[The prepared statement of Ms. Pure follows:]
Prepared Statement of Pamela Pure, President, McKesson Provider
Technologies, Executive Vice President, McKesson Corporation
My name is Pamela Pure, and I am the Executive Vice President of
McKesson Corporation and President of McKesson Provider Technologies,
the company's health information technology business. I thank Chairman
Ensign, Ranking Member Kerry, and the Members of the Subcommittee for
the opportunity to submit testimony on behalf of McKesson. McKesson
strongly supports the goal of improving healthcare quality by using
healthcare information technology (IT) to reduce medical errors and
lower costs.
For more than 170 years, McKesson has led the industry in the
wholesale delivery of medicines and healthcare products. Today a
Fortune 15 corporation, McKesson delivers vital pharmaceuticals,
medical supplies, and healthcare IT solutions that touch the lives of
more than 100 million patients each day in every healthcare setting. As
the world's largest healthcare services company with a customer base
that includes more than 200,000 physicians, 25,000 retail pharmacies,
5,000 hospitals and 600 payers, McKesson is well positioned to help
transform the healthcare system.
As the largest provider of automation and information technology in
the healthcare industry, we deliver innovative technologies at each
point in the healthcare system to reduce medication errors, lower
costs, and improve the quality and efficiency of healthcare. We are
dedicated to making healthcare safer, a goal that requires a deep
understanding of healthcare delivery processes and a clear focus on
what is required by key stakeholders such as physicians, nurses,
pharmacists, and patients. My colleagues and peers know that for me
this is not a job; it is a passion. After 20 years of advocating the
use of technology and witnessing first-hand the benefits and challenges
associated with its implementation, I am delighted to have this
opportunity to share my insights with the Congress.
McKesson fully supports the President's goal that every American
should have an electronic health record (EHR) in 10 years. To meet this
bold vision, McKesson believes that the Federal Government should
pursue a two-pronged strategy to spur the adoption of automation and
healthcare IT. First, we need broad deployment today of high-impact
technologies that provide unquestionable benefits in the delivery of
healthcare. Second, on a parallel track, we need to develop the
standards and promote the interoperability of systems that are
essential for medical information to be shared among healthcare
providers, patients, and public health agencies in a safe, secure
manner.
At McKesson, we know that technology itself is not the inhibitor of
change in the healthcare system. The technology is available and
working. It is intolerable that people die every day from medication
errors that could be prevented with bar-code technology, the same
technology that is used in every major retail outlet in this country.
We conduct sophisticated banking and other business transactions
electronically across continents; yet most physicians in the United
States still rely on their memories for complex medical information,
and write orders using pen and paper.
While deployment of healthcare IT is growing, less than 20 percent
of hospitals in the United States today use bar-codes to verify the
administration of patient medications, and fewer than 10 percent of
physicians in hospitals enter patient prescriptions and medical orders
electronically. The numbers are only slightly better outside the
hospital: only about 25 percent of large physician offices enter their
prescriptions electronically. The number drops considerably for small
physician practices.
Three Areas Where High-Value, High-Impact Technologies Already Make a
Difference
We can and must make the healthcare system safer and more efficient
by accelerating the use of technology in all hospitals and physicians'
offices in the United States. There are three areas where high-value,
high-impact technologies already make a significant difference:
1. Bar-code technology. Medications should be packaged in unit-
doses labeled with bar codes and scanned at the bedside before
they are given to patients. Today, on average, there are 27
steps in the medication use process that involve many
decisions, multiple hand-offs and various people, ranging from
the physician who prescribes the order to the pharmacy staff to
the nurse who ultimately administers the medication to the
patient. Healthcare IT and automation can reduce the hand-offs
and eliminate, on average, 40 percent of the steps with
dramatically improved accuracy, efficiency and safety. In a
group of 75 hospitals that use McKesson's bedside bar-coding
technology, 400,000 ``alerts'' are triggered weekly to nurses
or other healthcare professionals to advise them that the wrong
medication or incorrect dosage is about to be administered. As
a result of these on-line warnings, we estimate that these
hospitals prevent 56,000 errors each week; a staggering
statistic! Hospitals that deploy bar-code scanning technology
report dramatic error reduction in medication administration,
as high as 90 percent.
2. Electronic prescriptions. We must eliminate paper
prescriptions. Each year more than three million preventable
adverse drug events occur in physicians' offices or other out-
patient care settings. Imagine a world where a patient's list
of current medications is available to the physician and the
physician can order initial scripts or refill them online. All
the medication names would be legible, and all orders checked
for drug-drug interactions and allergies. Today, McKesson's
systems help to ensure safe prescriptions are written and
filled 100,000 times each month, but, nationwide, 80 percent of
prescriptions are still on paper, and many are illegible.
3. Secure web-based access to patient information. We must
equip physicians and clinicians with the information needed to
make informed decisions about patient care. Today, most
healthcare is delivered in a paper-based world. It is not
uncommon for physicians to provide patients with advice, give
directions to other staff and recommend treatment changes
without any access to a patient's chart. These blind encounters
happen every day. Secure web-based access to clinical patient
information, such as laboratory results, the patient's medical
record and diagnostic images, enables physicians to find,
within seconds, the information they need to make more informed
decisions and initiate or adjust treatment. McKesson currently
records 1.8 million logins each month to its web-based
physician portal, almost double compared to a year ago. Remote
access via web-portal technology is in common use across many
industries; yet, in healthcare, its deployment is only in the
50-60 percent range.
Funding to support these focused initiatives can lead to dramatic
progress very quickly. McKesson applauds the leadership shown and
initiatives undertaken by the Congress and this Administration.
Implementing these three forms of technology will build the required
momentum and provider support for adoption of healthcare IT.
Technology Is Improving Healthcare Quality Today
Healthcare technologies today save lives, reduce medical errors,
improve the quality of care, and reduce overall health costs. The
following healthcare organizations are just a few of our customers that
have taken these important first steps to improve care for their
patients:
Concord Hospital, an affiliate of Capital Region Health Care
(CRHC), Concord, NH: Concord was one of the first hospitals in the
United States to introduce bedside bar-code scanning of medications in
1994, which reduced its already low medication error rate by 80
percent. This reduced error rate, which has been sustained for more
than 10 years, has improved productivity and efficiency as well as
increased clinician satisfaction and retention.
Medical Associates Clinic, Dubuque, IA: Medical Associates is
deploying an ambulatory electronic health record and e-prescribing
system for more than 100 physicians and medical providers, which
represent 30 specialties dispersed across 16 locations in three states.
With the implementation still underway, physicians are already entering
26,000 e-prescriptions each month, and patient information is available
electronically regardless of location. Nurses spend far less time on
medication management; they have reduced the time spent on paper
charting activities by 24 percent, and they spend 16 percent more time
with patients and their families. In addition to improved quality and
better decisionmaking, this clinic projects an annualized net gain of
$1.7 million with full system deployment.
Regional West Medical Center, Scottsbluff, NE: A regional referral
center covering more than 12,000 square miles in rural Nebraska,
Regional West has used information technology to streamline the
delivery of healthcare. Through secure Internet access, physicians and
other clinicians can view a single electronic medical record for each
patient, which includes diagnostic medical images, pharmacy data and
laboratory results. A McKesson pharmacy robot dispenses bar-coded,
unit-dose medication packets virtually error-free. Electronic patient
charting at the bedside has cut nurses' daily paperwork by nearly 1.5
hours, enabling them to spend more time caring for patients. The
hospital has reduced its medication error rate by 30 percent to less
than 1 percent. Before giving a medication, the nurse must capture a
three-way bar-code match between his/her badge, the medication and the
patient's wristband to check the five ``rights'': the right patient is
receiving the right dose of the right medication at the right time via
the right route.
Mary Lanning Memorial Hospital, Hastings, NE: The largest employer
in Hastings, Nebraska, Mary Lanning Memorial Hospital has served the
healthcare needs of the surrounding community for the past 83 years.
Although the hospital's medication error rate was low, a single tragic
event highlighted the need for standardized medication administration.
Bedside bar-code scanning technology was implemented along with a
pharmacy information system to reduce the risk of medication errors.
Additionally, medications scanned at the bedside are compared to orders
reviewed by pharmacists and screened for allergies, interactions and
therapeutic duplications. Preliminary data has shown a 35 percent
increase in the reporting of near-miss events related to wrong drug and
wrong patient.
Presbyterian Healthcare Services in Albuquerque, NM: Using
McKesson's bar-code technology solutions, Presbyterian reduced
medication administration errors by 80 percent. Technology has also
allowed pharmacists to be redeployed to critical care units to work
directly with patients and physicians and enhance the quality of care.
These innovative health systems and others across the country are
saving lives and saving money. Physicians, nurses, and pharmacists now
spend more time interacting with patients and less time performing
administrative functions. More importantly, these organizations are
creating a new baseline for patient care in the United States. While
making healthcare safer through seamless, rapid and accurate
information flow, they are also addressing one-third of healthcare's
overall costs: administrative paperwork, clinical errors, manual hand-
offs and re-work.
Developing Standards and Promoting Interoperability
McKesson fully supports efforts of Congress and the Administration
to facilitate standards harmonization, encourage the formation of
regional health information organizations and establish a National
Health Information Network. Development of the requisite technology
standards will allow the computer systems of doctors, hospitals,
laboratories, pharmacists and payers to efficiently communicate and
share information. We are honored to work with Dr. David Brailer and
the Office of the National Coordinator for Health Information
Technology as he moves to create a foundation for the transformation of
our healthcare system. We are also pleased to be a member of the
Commission for the Certification of Health Information Technology, a
collaborative public-private partnership to develop standards and
certify health information technology systems.
We all remember the incremental steps that were taken by other
industries as they moved toward connectivity and interoperability.
First, they automated individually and then, collectively, they
collaborated to connect the information. Consider the banking industry.
A full decade elapsed between the early proliferation of bank-specific
automatic teller machines (ATM) and the formation of ``shared ATM
networks'' in the 1980s. Once the automation was complete, connectivity
and interoperability occurred very quickly. In the interim, banks were
able to realize the cost and efficiency savings of ATMs, and consumers,
appreciating the convenience of ATMs, quickly adapted to this new
banking system. Connectivity is a natural evolution of automation. We
are confident the same evolution will happen in healthcare. Once our
Nation's healthcare providers are fully automated, it will be possible
to connect previously isolated healthcare systems.
Understanding and Overcoming Barriers to Rapid Adoption of Health
Technology
The biggest obstacle to healthcare information technology adoption
is securing the needed funding and resources. Today, physician
practices and hospitals do not have access to the capital necessary to
invest in their own technology or, on a larger scale, to fund
connectivity.
The Federal Government can play a key role in financing this
healthcare transformation through creative funding arrangements. One
option is through the creation of government sponsored entities, which
would provide indirect Federal support through guaranteed loans for
healthcare providers to purchase, adopt, and implement proven health
technology solutions that are focused on error elimination and safety.
Coupled with the pay-for-performance initiatives that reward providers
for the quality of healthcare delivered rather than for services
rendered, guaranteed loans or other financial incentives will spur
technology adoption.
A combination of financial and performance incentives would help
mitigate the initial expense of technology implementation. The
reduction in medication errors and improved efficiencies in delivering
improved healthcare will also provide a return on investment for
healthcare organizations, thereby enabling them to repay the loans.
Conclusion
McKesson believes our healthcare system must adopt and deploy
proven technologies today that reduce medical errors in order to save
lives, improve the quality of care, and reduce costs. These initial
steps should include:
1. Implementation of bedside bar-coded medication
administration systems across the United States.
2. Elimination of paper prescriptions through use of e-
prescribing in physicians' offices.
3. Secure, online, ``anytime, anywhere'' access for physicians
to critical patient information.
Automated information will enable our healthcare organizations to
store and collect patient data, which will ultimately lead to a
comprehensive electronic health record. Concurrently, we need to adopt
the standards necessary to ensure interoperability among systems that
will facilitate communication within our health system. If we execute
these initiatives simultaneously, McKesson strongly believes that this
Congress and this Administration will be able to deliver visible and
measurable results with a lasting impact on the quality of healthcare
for the American public.
As a Nation, we have both the will and the means to transform
healthcare for the better. This will be a remarkable legacy, and one we
should act on today.
Mr. Chairman and members of the Subcommittee, thank you for your
interest in this important subject. I will be happy to answer any
questions.
STATEMENT OF KAREN IGNAGNI, PRESIDENT/CEO,
AMERICA'S HEALTH INSURANCE PLANS
Ms. Ignagni. Thank you Mr. Chairman, our testimony this
morning is focused on four areas. First, the opportunity to
deploy health information technology, and the role that our
members are playing in this regard. Second, the importance of
making a system consumer centric and we haven't talked about
that very much this morning, we've talked more about the
provider aspects of it. I would like to speak to the consumer
centric aspects. And then finally key policy issues. And I
appreciate the opportunity to make some recommendations.
First on the opportunity, there has been much discussion
about the fragmentation in our system. And what a deleterious
effect it has had. But I think there has been little focus on a
very important piece of information. That is that the Rand
Corporation in 2003 determined that only 55 percent of what is
done in healthcare is best practice. We wouldn't tolerate that
standard in any kind of a manufacturing situation, whether it
be auto, computers, or anything of that sort in our society, so
it is a matter of prioritizing productivity increases in
healthcare technology. And we're glad to be able to provide
some recommendations on how to do that this morning.
It is not simply the technology itself, it is the
application of the technology. So you are on the precipice of
an important decision, an important issue. Are we talking about
adopting technology for the sake of adopting technology? Or are
we going to marry that with quality performance and
improvement? We think that it should be the latter not the
former. We're pleased to provide a great deal of evidence about
the role that our members are playing, we've appended it to our
testimony, and I would be delighted to talk about that
specifically.
There are five areas that we pointed out. First, our
members are in the front lines of rewarding quality, beginning
to align payment with performance, and working collaboratively
with physicians to do that, and hospitals as well. We've talked
about measuring performance. We're proud to be part of the AQA,
the Ambulatory Quality Alliance, which is a ground-breaking
initiative that leverages technology to develop a uniform,
coordinated strategy for measuring, aggregating and reporting
clinical performance. We think this type of collaborative
offers a road map for the kind of collaboration necessary to
develop uniform standards we've been talking about, and indeed
we're going to be offering some specific recommendations in
that regard.
Electronic prescribing, we've been on the front lines of
this issue and we've offered very specific evidence of that.
Homeland Security, we've been working closely with the Centers
for Disease Control because our members have developed the
capability to identify illness patterns that might represent
the initial warning signs of a bio-terrorism event. Oftentimes,
individuals call nurse advice lines in the health plan before
they actually begin to show up in the hospital emergency rings.
And finally we've provided evidence of various
collaborations among our members including the CORE project
which is a group of our health plans under the Council for
Affordable Quality Healthcare, working on standards such as the
banking industry has done to create operating rules that
facilitate real transfer--real-time transfer of information.
Despite all this progress we know that more needs to be
done, so that's why our board of directors is embarking on an
initiative aimed to develop uniform approaches to personal
healthcare records. We're delighted that this conversation
about health information technology is beginning to evolve.
Earlier on, the focus had been on regional health
organizations, on only electronic health records, or EMRs. Now
it's important, we believe, to look at the full continuum, to
look at the national standards, to look at personal health
records, how they are married with the EMR, the EHR, and begin
to talk about what is the appropriate thing from the patient
perspective.
We provided a little chart which compares a personal health
record to an electronic health record system to easily
distinguish one from the other. The goal here is to create, in
our view, a personal health record that can be complimented and
fully compatible with the electronic health record, so it's not
either/or, and we're pleased that the conversation is being
enlarged so we can provide an opportunity to move the
advancement of the technology, as well as the opportunity for
consumers to receive the best care in every setting they're
involved in.
If we only focus on the electronic health record,
electronic medical record and often the two are used
interchangeably, then we're likely to miss the opportunity for
an individual who may get some services, at Georgetown
Hospital, or GW, or Hopkins, while getting other services at
Holy Cross, Reston Hospital. So if we continue to look in a
silo only from an institutional perspective, we miss the
opportunity to leverage what physicians can do when they're
confronting patients who are ill. They need to have the full
picture.
In terms of the policy issues we think that they're five
that we hope that the Committee takes up, and we're happy and
encouraged at this bipartisan examination of these matters.
First the uniform standards. Everyone has talked about the
importance of uniform standards. We agree with that, we've been
concerned in the past that the discussion was overly reliant on
regional health information organizations, in the absence of
uniform standards approach. And we were concerned that it would
result in an isolated island of information systems.
Privacy and security in terms of what you can do, we would
strongly urge you to consider preemption so that we can have a
national standard with respect to privacy and security and not
have barriers for the exchange of information. Financing, we
think public and private efforts are warranted. And the Federal
Government can compliment private sector investment. But on
this question we believe it would be a mistake to relax Federal
fraud and abuse laws for the purpose of allowing hospitals to
support physician use of health information technology.
We're concerned about unintended consequences in light of a
recent Federal Trade Commission report, talking about the
impact of consolidation in healthcare, and how it has related
to rising healthcare costs. So we would hope that the Congress
would ask for the opinion of the FTC, or to consider moving
forward in this direction. We talked about AHRQ funding as my
colleagues have, and we haven't talked about this morning about
liability of reform. When we're talking about large ticket
items in terms of improving healthcare when we're going to a
situation where $100 billion is being added to the system every
year for defensive medicine. Surely that should be an important
part of the considerations.
Mr. Chairman, we thank you for the opportunity, and we look
forward to engaging in the question and answer period.
[The prepared statement of Ms. Ignagni follows:]
Prepared Statement of Karen Ignagni, President/CEO,
America's Health Insurance Plans
I. Introduction
Good morning, Mr. Chairman and members of the Subcommittee. I am
Karen Ignagni, President and CEO of America's Health Insurance Plans
(AHIP), which is the national trade association representing nearly
1,300 health insurance plans providing coverage to more than 200
million Americans. Our members offer a broad range of products in the
marketplace and also have demonstrated a strong commitment to
participation in public programs.
We appreciate this opportunity to testify about the role health
information technology can play in improving the delivery and quality
of health care. We applaud Congress and the Administration for
prioritizing this issue. It is encouraging to see Members of Congress
addressing this priority on a bipartisan basis, and we thank you for
the opportunity to discuss the positive contributions our members are
making in this area.
Our members are strongly committed to advancing an interconnected
health care system in which health information can be exchanged
electronically to empower individual consumers and clinicians to make
better health care decisions and, at the same time, to improve quality,
value, and efficiency throughout the U.S. health care system.
Our testimony today will focus on six areas:
Opportunities to deploy health information technology to
improve quality, value and efficiency for health care
consumers;
The role health insurance plans are playing in advancing
health information technology;
Specific health information technology initiatives
implemented by AHIP member companies;
The importance of personal health records (PHRs) in an
interconnected health care system;
Keys to the successful implementation of health information
technology; and
Our concerns about certain policy issues imbedded in pending
legislation to expand health information technology.
II. Opportunities To Improve Quality, Value, and Efficiency
In the U.S. health care system, the organization and management of
personalized health information have not always kept pace with the
advancement of modern medicine. Personal health information is often
fragmented and incomplete, and can result in unnecessary and
preventable medical errors, inappropriate care, and duplication of
services--all contributing to rising health care costs and missed
opportunities to improve patient care.
At the same time, variation in medical decision-making has led to
disparities in the quality and safety of care delivered to Americans. A
1999 report \1\ by the Institute of Medicine (IOM), found that medical
errors could result in as many as 98,000 deaths annually, and a 2003
RAND study \2\ found that patients received only 55 percent of
recommended care for their medical conditions. A wide range of
additional studies indicate that Americans frequently receive
inappropriate care in a variety of settings and for many different
medical procedures, tests, and treatments. Such inappropriate care
includes the overuse, underuse or misuse of medical services. Studies
also show that patterns of medical care vary widely from one location
to another, even among contiguous areas and within a single
metropolitan area--with no association between higher intensity care
and better outcomes.
---------------------------------------------------------------------------
\1\ ``To Err is Human,'' Institute of Medicine, 1999.
\2\ ``The Quality of Health Care Delivered to Adults in the United
States,'' Elizabeth A. McGlynn, RAND, June 25, 2003.
---------------------------------------------------------------------------
The widespread practice of defensive medicine to minimize the
threat of litigation is another factor contributing to inappropriate
care and higher costs. According to a study recently published in the
Journal of the American Medical Association, \3\ 93 percent of
specialty physicians reported that they engage in defensive medicine.
When asked about their most recent act of defensive medicine, 43
percent reported using imaging technology in clinically unnecessary
circumstances.
---------------------------------------------------------------------------
\3\ ``Defensive Medicine Among High-Risk Specialist Physicians in a
Volatile Malpractice Environment,'' Journal of the American Medical
Association, June 1, 2005.
---------------------------------------------------------------------------
To meet these challenges, it is critically important for the public
and private sectors to work together to develop an interconnected
health care system that provides consumers and clinicians with access,
through PHRs, to a history of each individual's health information
wherever and whenever it is needed. Doing so will yield benefits for
consumers and other stakeholders on several levels:
Meaningful information will be available to patients and
providers in a usable form and in a timely fashion to improve
the overall safety, effectiveness, and efficiency of an
individual's care;
Wasteful and duplicative care will be reduced. A well-
coordinated health care system will remove the need or
justification for repeating or performing unmerited
interventions;
Increased transparency in the health care system will allow
for a meaningful comparison of health outcomes and resources
expended;
The latest advances in evidence-based medical practices will
be disseminated broadly and rapidly;
Consumers and purchasers will benefit from a system that
deploys resources more efficiently and effectively;
Clinicians will be able to increase their productivity when
they have the complete picture of a patient's health care,
including services received from other caregivers; and
Quality performance will be rewarded.
Cost Savings
While it is difficult to predict the cost savings that will be
achieved through health information technology, a number of studies
suggest that the savings will be significant. In a January 2005 study
published by Health Affairs, \4\ the Center for Information Technology
Leadership (CITL) estimated that implementation of an interconnected
and fully standardized health care system would yield $77.8 billion in
annual savings. This study focused specifically on the benefits of a
system in which hospitals and medical groups can exchange information
electronically, using uniform standards on a nationwide basis, with
five key stakeholders: payers; pharmacies; public health departments;
radiology centers; and independent laboratories.
---------------------------------------------------------------------------
\4\ ``The Value of Health Care Information Exchange and
Interoperability,'' Health Affairs, January 19, 2005.
---------------------------------------------------------------------------
Separately, the Government Accountability Office (GAO) issued a
report \5\ in October 2003 on the cost savings achieved through health
information technology. The GAO found that one health insurance plan,
Blue Cross and Blue Shield of Alabama, reduced its data entry costs by
$20 million annually by applying health information technology to its
claims processing functions. The GAO reported that health insurance
plans also achieved other benefits including ``increased staff
productivity, improved timeliness in processing claims, improved
customer satisfaction, and improved clinical care to members.''
---------------------------------------------------------------------------
\5\ ``Information Technology Benefits Realized for Selected Health
Care Functions,'' Government Accountability Office, October 2003.
---------------------------------------------------------------------------
III. Role of Health Insurance Plans
Quality-Based Programs
AHIP's member companies are on the front lines of developing
information technology systems to improve health care quality and
administrative efficiencies.
Health insurance plans have a strong track record of using health
information technology to implement programs that reward providers for
quality performance. Health insurance plans have instituted a range of
provider payment arrangements--often referred to as pay-for-performance
programs--that are promoting high quality and efficiency throughout the
U.S. health care system. Our members' experiences clearly indicate that
paying for quality is a promising strategy for improving overall
wellness and advancing evidence-based medicine, which translates into
better health outcomes and greater value for employers and consumers.
Some quality-based payment programs provide financial awards to
physicians in the form of increased payments, while others offer non-
financial rewards in the form of public recognition, preferential
marketing or streamlined administrative procedures. Additionally, some
plans are offering consumers reduced co-payments, deductibles, and/or
premiums in exchange for using providers deemed to be of higher
quality, based on specific performance measures. In all of these
programs, health information technology plays a role in collecting data
to evaluate the performance of health care providers and determining
the extent to which they are achieving desired goals.
Collaboration Through the AQA
A critically important step in moving forward with programs that
reward quality performance is the development of a uniform, coordinated
strategy for measuring, aggregating and reporting clinical performance.
To address this challenge, AHIP has been working with the American
Academy of Family Physicians (AAFP), the American College of Physicians
(ACP), other medical specialty organizations, the Agency for Healthcare
Research and Quality (AHRQ), consumers, and employers.
This collaborative effort--called the Ambulatory Care Quality
Alliance (AQA)--recently reached a consensus on a common set of 26
ambulatory care performance measures that are intended to serve as a
``starter set'' that will provide clinicians, consumers, and purchasers
with a set of quality indicators that can be used for quality
improvement, public reporting, and pay-for-performance programs. This
starter set will be expanded in a multi-phase process, resulting in a
more complete set of measures to address a wide range of additional
quality indicators addressing efficiency, patient experience, sub-
specialties and other key areas.
In addition, the AQA is developing strategies for uniform data
aggregation and for reporting reliable and useful quality information
to consumers, providers and other stakeholders. The AQA recently
developed two sets of fundamental principles for reporting. The first
set of principles, which addresses reporting to consumers and
purchasers, aims to facilitate more informed decision-making about
health care treatments and investment. The second set of principles,
which addresses reporting to physicians and hospitals, is designed to
facilitate quality improvement and to inform providers of their
performance.
The AQA will continue to move forward in the areas of measurement,
data aggregation and reporting, and encouraging additional key
stakeholders to become involved in this important effort to improve
health care quality and patient safety. The dissemination of
information derived from aggregated performance data ultimately will
yield benefits on several levels. Consumers will be able to make more
informed decisions about their health care treatments. Physicians,
hospitals and other health care professionals will be better able to
improve the quality of care they provide. Purchasers will receive
greater value for their investment in health care benefits. Health
insurance plans will continue to develop innovative products that meet
consumer and purchaser needs.
Electronic Prescribing
Electronic prescribing--a key element of the overall strategy for
interconnectivity--is another area where health insurance plans are
making significant contributions.
Many of AHIP's members use web portals to give individual members
access to their pharmacy-related personal information, including
pharmacy claims, benefits information, up-to-date formulary listings,
and online search tools to find participating pharmacies. Some health
insurance plans also allow members to fill or refill prescriptions
online, send questions electronically to a pharmacist about their
medications, and purchase over-the-counter medications online at
discounted prices. Others are working with health care providers to
incorporate health information technology into practice settings--in
some cases through personal computers and handheld devices for patient
order entry and electronic prescribing.
These programs demonstrate our members' strong commitment to the
development of electronic prescribing technologies at the point-of-
patient-care.
Public Health Surveillance
The unique capabilities of health insurance plans also are
evidenced by their active involvement in the development of early
warning health surveillance systems. Following the events of September
11, 2001, a number of AHIP member companies collaborated with the
Centers for Disease Control and Prevention (CDC) to develop a
demonstration program to identify illness patterns that might represent
the initial warnings of a bio-terrorism event.
This demonstration program includes a rapid response capability to
identify unusual clusters of symptoms or illness from daily encounters,
to alert public health officials about these clusters, and to
facilitate the ability of public health officials to obtain detailed
clinical information about specific cases when needed. Health insurance
plans report only aggregate de-identified data to the surveillance
system, thus providing maximum protection of patient confidentiality.
In cases where unusual clusters are identified, the state or local
public health team will work with clinicians to decide if additional
information is needed.
By arming public health officials with real-time data on clusters
of emerging symptoms and illnesses, health insurance plans have
established themselves as an important part of an advanced disease
surveillance system to help protect our Nation from emerging infectious
diseases and potential bio-terrorism agents. This is possible because
our members have a unique set of skills and competencies based on their
integrated care coordination systems, large defined populations, and
comprehensive data sets. These same assets will enable health insurance
plans to play a central role in helping the Nation transition to an
interconnected health care system.
Initiatives By AHIP Member Companies
To provide a better understanding of health information technology
initiatives developed by our members, we are attaching an appendix that
provides brief examples of some of the programs being implemented
across the country. We are providing these summaries to give the
Committee a better understanding of the depth and breadth of
initiatives that are being adopted.
IV. Personal Health Records (PHRs) as the Cornerstone of an
Interconnected Health Care System
Our members' vision for an interconnected health care system
involves the creation of a PHR that contains information key to the
safety, effectiveness, and efficiency of an individual's care, and will
be linked to and fully compatible with electronic health records (EHRs)
initiated by health care institutions or clinicians.
The delivery of health care requires three basic inputs as
illustrated by the diagram below:
the individual, with his or her personal history, needs, and
preferences;
the clinician with the knowledge, skills, and experience
necessary for the evaluation and treatment; and
facilities and other resources necessary for care to be
conducted, such as a radiology department or an ER.
As the Committee is aware, an individual's encounters with the
health care system may consist of a family practitioner, a specialist
who deals with heart disease, a physiotherapy service at a local
clinic, and a local pharmacist. Some relationships between an
individual and the health care system may be episodic, such as a visit
to the emergency room; others may endure for many years. A healthy
individual will have only infrequent health encounters. By contrast, a
person with multiple chronic diseases will have numerous complex
relationships and encounters with the health care system that span
multiple institutions and physicians. Some relationships will arise as
part of a prescribed treatment, while others will be ad hoc or
consumer-initiated.
What is certain is that individual relationships and encounters
with the health care system are becoming more complex and diverse with
growing rates of chronic disease, an aging population, and greater
consumer choice. Each health care event may result in a diagnosis or
treatment that has widespread and enduring significance for an
individual's future care and overall health. The information that
populates a personal health record (PHR) comes from these events.
AHIP's Board of Directors has launched an effort that is designed to
result in each consumer having a PHR containing information about their
health and their care, based on key information from health plan-based
claims management systems, other health plan administrative data, and
in some cases data from health care provider-based EHR systems. The
goal is to integrate information from all sources to create a coherent
and useful understanding of the individual's overall care. The
information in a PHR should be owned by the individual and maintained
securely and confidentially on their behalf.
The PHR will be complemented by EHRs, which are more than a record
of care. An EHR focuses on the details of care ``processes'' within a
hospital, a doctor's office, or other care setting. It is required to
manage information that is as much about the professionals, the
organization, and medicine in general, as it is about the individual
patient. These two characteristics--the comprehensive support for tasks
and the recording of information about the provision of care--mean that
an EHR is a strong reflection of the particular institutional context
and the clinical services it supports. The EHR represents not only
patient information, but information for medical and/or legal uses by
the institution--the EHR is designed to someday become the legal and
permanent institutional health record regarding the care of a patient.
It is vital to understand that PHR and EHR systems are not
alternatives. They are complementary, work together, and together
achieve the goal of both managing the overall care of the individual
and managing the delivery of health care services that are required to
have an interconnected and electronic health care system. The diagram
below illustrates the separate roles of PHRs and EHRs:
The PHR has the potential to influence both the resourcing side of
the health care system and the delivery of individual care. The prime
purpose of the PHR is to ensure that the information most valuable for
the overall quality and efficiency of the individual's care is
available wherever and whenever it is needed. The PHR links together
and coordinates an individual's many health encounters.
V. Keys to Successful Implementation of Health Information Technology
To accomplish the successful development of an interconnected
health care system, it is important for the public and private sectors
to work together to address a number of priority issues. These include
creating national, uniform interoperability standards; assuring the
privacy and security of health information; and financing the adoption
of health information technology.
Uniform Standards and a National Framework
AHIP supports the creation of voluntary, national, uniform
interoperability standards that facilitate the interconnectivity of
health information systems. It is widely recognized that the
development of an interconnected health care system that improves
health care quality and efficiency is dependent on the creation and
adoption of such standards. We believe that the Federal Government and
the private sector, working together, can implement uniform standards
and operating rules to facilitate the exchange of information and make
the process transparent, without stifling innovation.
AHIP and our members are looking forward to being active
participants in this process. We intend to launch an effort to involve
a diverse group of key stakeholders in developing common standards and
core content areas for PHRs that take into account issues of importance
to consumers, providers, and purchasers. At the same time, we encourage
HHS to pursue a similar process for EHRs.
Uniform, consensus-driven standards will bring together different
health information technology systems into a National Health
Information Network by specifying common data formats, communication
protocols, and operating rules. Government and private stakeholders
need to work cooperatively through the existing standards development
organization process to create and maintain standards and push them
into the marketplace. Such standards should be designed through an open
model that allows sufficient flexibility to be adopted by various
organizations in diverse and changing environments. The AQA's work on a
strategy for measuring and reporting clinical performance, which we
discussed earlier, could serve as a model for stakeholders to move
forward in developing interoperability standards.
Another promising example is the Council for Affordable Quality
Healthcare's CORE program. CAQH is an alliance of health plans--which
includes AHIP and many of our member organizations--that promotes
collaborative efforts to streamline health care administration. Its
CORE program has brought together multiple industry stakeholders to
create and, ultimately, disseminate and maintain operating rules to
facilitate real-time, comprehensive, secure transfer of patient
eligibility and benefits information.
The initiative was launched because the private sector recognized
the need for an interoperable solution for communicating member data to
physician practices. Currently, practices do not have easy access to
consistent information on plan coverage, co-pays, deductibles and other
benefits information. CORE will change that by creating a variety of
standards, including clear definitions and interpretations of data
elements, technical transmission standards and formats, and standards
for data transactions.
The CAQH program is modeled on the strict information-exchange
rules that make possible direct deposits and ATMs in banking. If the
initiative's rules can be as successful in unifying the health care
industry, the projected administrative savings for physician practices
would be significant.
Uniform standards will spur the development of a national framework
that facilitates the creation, maintenance, and sharing of electronic
health information. It is critically important for this framework to be
national, rather than regional, to ensure that health information can
be exchanged electronically whenever and wherever it is needed to
improve patient care.
Privacy and Security
AHIP supports efforts to assure privacy and security for health
information. Consumers must have confidence that portable and Internet-
enabled health information systems are maintained in a secure and
confidential manner.
We believe that significant protections for health information
already are provided through HIPAA and corresponding regulations. HIPAA
governs the use, disclosure, and security of health information by
health care providers, health care clearinghouses, and health plans. As
a result, these HIPAA-covered entities should encounter few, if any,
issues that would compromise privacy or security when participating in
a National Health Information Network.
Two issues, however, merit additional consideration. One question
is the extent to which entities that may use or disclose electronic
health information should be required to institute privacy and security
safeguards if they do not meet the definition of a ``covered entity''
for purposes of the HIPAA rules. The Department of Health and Human
Services should develop a regulatory strategy to ensure that these
entities (e.g., banks and financial institutions that administer credit
card transactions when patients pay co-payments in a doctor's office)
provide privacy and security protections as appropriate.
Another issue involves the interaction of other Federal and state
privacy laws and the electronic exchange of health information. Some
Federal and state laws may serve as a barrier to interconnectivity by
unduly restricting the types of information that can be shared and the
methods used to exchange information. For example, state laws that
restrict the disclosure of information related to specific diseases or
medical conditions may limit the ability of clinicians to participate
in a National Health Information Network.
State laws may provide other barriers, including impediments to the
use of electronic prescribing devices. Additionally, inconsistent state
laws may prevent the electronic exchange of certain health information
across state lines; such laws may be particularly burdensome for
providers that treat consumers who reside in areas near the border of
one or more states. HHS should work with Congress and other
stakeholders to identify potential conflicts and consider whether such
laws should be preempted. Policymakers should consider the importance
of clear rules for the exchange of health information, while at the
same time recognizing the impact that privacy rules have on health care
quality.
Financing
AHIP supports public and private efforts to finance the adoption of
health information technology with the goal of improving the quality
and delivery of health care.
The health care community is investing significant resources in
health information technology. For example, many health insurance plans
and health care providers are using equity, loans, and venture capital
to fund the adoption of health information technology and electronic
record systems. This trend will continue as more members of the health
care community recognize a return on these investments through improved
health care and greater administrative and business efficiencies. In
addition, health insurance plans and the Medicare program are
developing incentives to compensate providers for using health
information technology and evidence-based outcomes measures to promote
better quality care.
The Federal Government can also play an important role by assisting
solo practice physicians and others who may not have the financial
resources to develop and adopt the necessary infrastructure to
participate in the national health information network. This assistance
can be provided in the form of incentives, low-interest loans, grants,
and tax credits that reward quality through the adoption and
integration of technology solutions. Tax credits would be a
particularly effective approach to stimulating improvements in
productivity through the use of information technology. This assistance
should be directed toward achieving the overall objective of improving
the quality and delivery of health care.
VI. Concerns About Pending Legislation
AHIP and our members appreciate the strong Congressional interest
in health information technology. We believe it is particularly helpful
that this issue is being addressed on a bipartisan basis in both the
Senate and the House. At the same time, we do respectfully suggest that
legislative efforts in Congress should avoid prescriptive rules (e.g.,
regulating the design and operation of PHRs) that could hinder ongoing
collaborative efforts. Instead, we hope that any legislation considered
by Congress will allow a public-private process to move forward to
develop and implement uniform standards and operating rules for
interconnectivity.
Additionally, we would like to highlight our concerns about two
specific issues addressed by pending legislation.
Regional Health Information Organizations (RHIOs)
AHIP supports efforts to define an appropriate role for community-
based efforts--such as Regional Health Information Organizations
(RHIOs)--within the overall development of a national health
information system. First, however, a national framework needs to be
developed to pave the way for regional initiatives. This framework is
essential to ensure interoperability across the health care system, not
only in local regions, but across state lines and nationally.
We recognize that RHIOs can play a constructive role in fulfilling
health information needs at the regional level, yet we also believe
that an overreliance on RHIOS--in the absence of Federal standards--
would complicate efforts to achieve compatibility across the country. A
key factor for a successful national health information network is the
ability to move information whenever and wherever it is needed. This
goal cannot be achieved by regional systems that are unable to exchange
information outside their geographic area. Therefore, it is important
for regional projects to comply with national interoperability rules.
Otherwise, stand-alone regional networks will be unable to facilitate
national information exchange.
We look forward to working with Congress to discuss how RHIOs can
operate within a national framework to ensure that practice patterns
can be compared across regions, quality monitored, and efficiency
improved.
Safe Harbors
We also believe it would be a mistake to relax Federal fraud and
abuse laws for the purpose of allowing hospitals to support physician
use of health information technology. We are concerned about the
unintended consequences of tying physicians to hospitals financially
through equipment subsidies or electronic record sharing. Moreover, the
ability of physicians to cooperate with other providers--and deliver
services in a range of hospitals--may be hindered if they become
dependent on a hospital-based information sharing network.
Another serious concern is that the proposed safe harbors could
unintentionally lead to information sharing programs that are isolated,
and would therefore impede the development of the interconnected system
that is needed to exchange information on a national basis. Instead of
encouraging isolated pockets of record sharing, we should focus on
promoting open and interconnected systems that assure the free flow of
information.
We believe that creating new exceptions to current fraud and abuse
laws is not only unnecessary, but will undermine the integrity of the
existing regulatory framework.
VII. Other Elements of a Broad-Based Strategy
While health information technology can go a long way toward
addressing cost and quality challenges, this is only one component of
the broad-based strategy that is needed for transforming the health
care system. Policymakers should at the same time encourage and pursue
a variety of other programs and initiatives to further advance quality
and efficiency.
Invest in Cost Effectiveness and Translational Research
While the Federal Government invests heavily in clinical research,
it makes only modest investments in research that compares the relative
effectiveness of existing versus new therapies that are designed to
treat the same condition. The Federal Government should assign a high
priority to this kind of research and also direct more funding to
promote the widespread adoption of best practices and reduce the
overuse and misuse of health care.
A National Center for Effective Practices should be created to
ensure that the results of cost effectiveness research are translated
into usable information for providers and consumers. This new entity
could identify and make publicly available the latest advances in
evidence-based medical practices, and also shed light on procedures
determined to be less effective.
Develop a Framework for Evaluating Technologies for Effectiveness and
Efficiency
To address the rapid development of new procedures, devices and
other technologies, a public-private framework should be established to
evaluate and compare the effectiveness and efficiency of these
technologies. Moreover, new post-marketing surveillance models should
be developed to assess the appropriate use and long-term value of
certain breakthrough drugs, devices and biologicals.
Overhaul the Medical Liability System to Ensure Effective Dispute
Resolution and Promote Safety and Value
The flaws in the current medical liability system should be
addressed with reforms that place reasonable limits on health care
litigation. Additionally, patient safety legislation is needed to
establish legal protections for medical error information reported by
health care providers, and to permit the aggregation of data that can
be used to determine the causes of medical errors and develop
strategies for improving patient safety. Also needed is a uniform,
national administrative process to resolve malpractice disputes between
patients and health care providers in a fair and efficient manner, thus
avoiding the need for litigation as often as possible.
Modernize and Maximize the Effectiveness of the Regulatory System
Encourage choice with uniform rules in the small group
market: A common set of rules would encourage competition,
enhance consumer choice, and provide greater predictability for
employers. The solution is not to waive all requirements for
particular groups, but to establish an appropriate and
consistent framework for all participants to ensure that small
employers have maximum options to meet their needs. This means
that the Federal and state governments need to work together to
encourage ``best practice'' regulation. This process has begun
with the development of draft legislation--known as the State
Modernization and Regulatory Transparency (SMART) Act--that
would promote uniformity in plan processes, particularly
internal and external review of coverage disputes, speed-to-
market and market conduct standards.
Encourage prompt product approval and consistency in
regulatory processes. Steps should be taken to ensure that
states adopt a mechanism by which health insurance plans can
bring innovative products to the market in a timely manner.
Ideally, the Federal Government should encourage states to be
forthcoming regarding their standards for policy rate and form
filing requirements and to abandon unwritten ``desk-drawer
rules.'' This ultimately will create oversight mechanisms that
allow companies to provide consumers with the products they
need in a timely manner.
Establish an independent advisory commission to evaluate the
impact of mandates on health care costs and quality. Such a
commission could advise policymakers on the safety and
effectiveness of proposed and existing mandated health
benefits, and assess whether proposed mandates result in
improved care and value. The commission's findings also could
inform public program coverage and decision-making to ensure
that evidence-based standards are applied consistently in
Medicare, Medicaid, and other public programs.
Provide Funding for High-Risk Pools
AHIP's Board of Directors approved a statement in June 2004,
indicating support for Federal funding for state high-risk pools to
cover individuals who have unusually high health care costs. This
legislation fits within the parameters of what Congress is able to
accomplish from a budgetary standpoint at this time. This initiative is
one of the next steps Congress should take as part of a long-term
strategy for strengthening our Nation's health care safety net.
Expand Tax Credits to Encourage the Purchase of Health Care Coverage
To address the needs of working Americans who are uninsured and
ineligible for public programs, Congress can help make health coverage
more affordable by expanding tax credits for low-income persons. This
approach will be particularly helpful to Americans who do not have
access to employer-sponsored coverage and to those who decline such
coverage because of the high cost. Moreover, tax credits could prompt
more small businesses to offer employee health benefits. The Employee
Benefits Research Institute (EBRI) \6\ has reported that among small
employers that do not offer employee health benefits, 71 percent would
be more likely to seriously consider offering health benefits if the
government provided assistance with premiums.
---------------------------------------------------------------------------
\6\ ``Small Employers and Health Benefits: Findings from the 2002
Small Employer Health Benefits Survey,'' Employee Benefits Research
Institute, January 2003.
---------------------------------------------------------------------------
Provide Adequate Funding for Public Programs
More than 75 million Americans rely on government health programs--
including Medicare, Medicaid and SCHIP--to meet their health care
needs. It is important for policymakers to recognize that funding
shortfalls in these programs can lead to cost shifting, which
translates into higher costs for employers, individuals, and other
purchasers of private sector health coverage. This underscores the
importance of ensuring that Medicaid and other government health
programs are adequately funded.
VIII. Conclusion
We appreciate this opportunity to testify on this crucial priority.
AHIP and our members are committed to playing a leadership role in
developing an interconnected health care system--based on national,
uniform standards--in which consumers and providers have access to
patient-owned PHRs that provide integrated health information, from all
clinicians and all settings of care, in a usable form and in a timely
manner.
As Congress addresses issues surrounding health information
technology and quality, we are eager to continue working with you to
support the transition to a modernized health care system that is
effective for patients and valuable for all stakeholders.
______
Appendix: Health Information Technology Initiatives
by Health Insurance Plans
Aetna is applying innovative health information technology to
provide its members and providers evidence-based decision support tools
to improve quality of care and patient safety. Aetna's MedQuery program
applies evidence-based clinical rules to data derived from members'
medical claims and pharmacy and laboratory data to uncover
opportunities to improve care and avoid potential medical errors. The
MedQuery program generates patient-specific diagnostic or therapeutic
suggestions called Care Considerations that are communicated to the
treating physician.
In addition, Aetna Navigator TM, a member self-service
website, is a web-based portal that allows members to access a wide
range of tools and information. These resources are focused on giving
members the information and guidance they need to navigate the health
care system and to make the most informed decisions. Aetna Navigator
TM is secure, private, and accessible anywhere a member has
an Internet connection.
Blue Cross Blue Shield of Massachusetts, Neighborhood Health Plan,
and Tufts Health Plan are working with providers and employers to
provide access to affordable, quality health care for all Massachusetts
citizens through their e-prescribing initiative. The e-prescribing
initiative was established in October 2003, and represents a
collaboration among the health plans, DrFirst, and Zix Corporation. The
program subsidizes handheld devices for providers, a one-year e-
prescribing application license, installation, training and support,
and 6 months of Internet connectivity where applicable.
At the end of the first quarter of 2005, over 2,600 providers had
joined the program; over 2,000 prescribers had the technology
incorporated into their offices; and over 40,000 electronic
prescriptions were sent during the final reporting period in March
2005--a 41 percent increase from the highest weekly prescription count
of the previous quarter.
BlueCross BlueShield of Tennessee formed a new company, Shared
Health, with the goal of improving the delivery of health care for
patients, doctors, hospitals and health care payers. Shared Health has
developed Community Connection, a patient-centered community health
record (CHR) that securely connects medical professionals to a database
that merges individual patient health care information, including
claims data, lab results, prescription drug information, and
immunization history. Shared Health Community Connection effectively
removes a key obstacle in the health care delivery system--a lack of
information that impedes health care decisions and drives up costs.
Shared Health's CHR is currently serving Tennessee's TennCare
population. Next year, BlueCross BlueShield of Tennessee will make
Community Connection available to its commercial and private health
plan clients. Other private health insurers will then be invited to
participate. Ultimately, Shared Health's Community Connection will be
accessible to consumers to review their own personal community health
record. Based on an extensive cost-benefit analysis, Shared Health
Community Connection will ultimately provide an estimated return on
investment to the State of Tennessee of more than $4 saved for every $1
spent, within 4 years of implementation.
CIGNA HealthCare, in 2004, launched myCIGNAplans.com, a national
award-winning website for consumers who are considering a CIGNA
consumer-directed health plan. The site offers an unbiased, side-by-
side comparison of the medical and pharmacy costs of CIGNA health plans
and helps consumers choose the one best suited for their needs. The
website is customized to include information specific to the
individual's plan options and is highly interactive, allowing consumers
to model various health scenarios to determine how health events may
impact their benefits and costs. The site was introduced with the
launch of CIGNA's new suite of consumer-directed health plans; in a
three-month period, 100,000 consumers enrolled for these new health
plans.
In addition, in April, CIGNA launched an integrated online Hospital
Value Tool to help consumers choose a hospital. The online tool
provides ``star-based'' health care patient outcome and cost efficiency
ratings for hospital-based treatments of 19 medical conditions using
both CIGNA and third-party hospital data. The new tool is available to
the general public at no charge and rates Patient Outcomes (a
combination of quality measures--risk-adjusted, complication and
mortality rates, and The Leapfrog Group Patient Safety Index) and Cost
Efficiency (based on the hospital's risk-adjusted total costs) for a
particular medical procedure or condition. CIGNA HealthCare members may
also access more extensive and detailed quality information for more
than 150 hospital-based procedures and conditions through the CIGNA
member web portal, myCIGNA.com.
Group Health Cooperative in Seattle, Washington, utilizes a
clinical information system (CIS), created by Epic Systems and called
EpicCare, that facilitates the rapid, accurate, and secure sharing of
patient medical records among providers involved in a patient's care.
EpicCare continually stores and updates a patient's entire medical
record, providing doctors with instant access to a far more
encompassing knowledge base than was previously available.
This system enables e-prescribing, provides information on
recommended and appropriate drug prescriptions, generates warnings for
potential safety conflicts between multiple drugs, and allows patients
direct access to information including lab results and prescription
refill reminders. Patients can access their own online medical records
through secure access to the MyGroupHealth website. In addition, the
MyGroupHealth website provides a host of online services for patients
including secure messaging between patients and their health care team,
online appointment scheduling, online access to immunization records,
access to Healthwise* Knowledgebase, and condition centers and
moderated discussion groups.
Harvard Pilgrim HealthCare, in 2003, launched an updated version of
its member web portal, HPHConnect. Through this web portal, Harvard
Pilgrim members can view their prescription drug history; check the
status of doctor and hospital bills; check the status of referrals and
authorizations for care; compare hospitals using information about
quality and patient safety; understand and compare treatment options
for health care they may need; and securely communicate with Harvard
Pilgrim.
In addition, HPHConnect provides online transaction tools that are
used by thousands of employers, brokers and providers. By the end of
2004, providers and billing agents were conducting a million electronic
transactions a month using HPHConnect and other electronic channels.
HPHConnect provides instant checks on patient eligibility and claims
status, and ensures that referrals arrive before patients do. This
means less paperwork and more control over cash-flow for clinicians,
and fewer administrative hassles for patients, before and after they
receive care. Almost 99 percent of member eligibility checks and 87
percent of claims inquiries by provider offices are completed
electronically, rather than by phone or fax.
Harvard Pilgrim is also participating in two Massachusetts regional
health initiatives--Massachusetts-SHARE (MA-SHARE) and the
Massachusetts eHealth Collaborative (MAeHC). MA-SHARE's aim is to
encourage the exchange of health care data through information
technology, standards and administrative simplification, to ensure that
clinical health information is available wherever needed in an
efficient, cost-effective and safe manner. MAeHC is bringing together
the state's major health care stakeholders to establish an EHR system
that would enhance the quality, efficiency and safety of care in
Massachusetts.
Health Alliance Plan (HAP) awarded a grant to the Henry Ford Health
System for its Picture Archiving and Communication System (PACS), which
replaces x-ray films with digital images. This initiative makes care
more seamless for patients as they do not have to repeat tests,
provides almost immediate access to results for providers enabling the
delivery of timely medical care, and greatly reduces administrative
costs. Physicians can simultaneously call up diagnostic images and
related information online allowing for multiple consultations. The
initiative reduces overuse and misuse of services, and prevents medical
errors as radiologists avoid unnecessary retakes of tests and
procedures. In 2004, PACS produced a cost savings of $8.84 million.
In addition, General Motors, Ford Motor Company, DaimlerChrysler
Corp., and the UAW joined together to launch the Southeast Michigan e-
Prescribing Initiative (SEMI) in partnership with HAP, other Michigan
health plans, electronic prescribing technology providers, and pharmacy
benefit manager Medco Health Solutions, Inc. Eleven medical centers now
use e-prescribing technology as a result of this initiative and
physicians have written over 70,000 prescriptions. The Henry Ford
Medical Group improved its generic use rate by 7.3 percent, which
potentially will save $3.1 million in pharmacy costs over a one-year
period.
HAP also has implemented an online reminder tool to help physicians
keep more patients up-to-date with crucial preventative health
services. The Member Health Manager (MHM) shows primary care physicians
and OB/GYNs electronic, on-screen reminders for breast, cervical and
colorectal cancer screenings, well-child visits, and flu and pneumonia
immunizations. During a six-month pilot for MHM, more than 3,000 HAP
members received preventative services after physicians viewed online
reminders. The guidelines are evidence-based, offering recommendations
that are well-supported in medical literature.
Lastly, HAP has implemented an automated process to identify and
stratify chronically ill members according to the severity of their
illness so that HAP providers can deliver the most appropriate and
personalized interventions. This process gathers medical claims, ER
visits, inpatient hospitalizations, pharmacy claims and lab data. An
algorithm then uses this data and ICD-9 codes to assign a Health Risk
Indicator score to each member and ensure that they receive the proper
case management. The ultimate impact on clinical and financial outcomes
is currently being monitored.
Kaiser Permanente is currently in the process of rolling out Kaiser
Permanente HealthConnect--a $3 billion, 10-year initiative focused on
deploying electronic medical record systems to ensure the best care for
their members and provide doctors, nurses and others caregivers with
real-time information. In addition to an electronic medical record,
Kaiser Permanente HealthConnect involves the development and deployment
of a highly sophisticated nationwide information management and
delivery system that integrates the clinical record with appointments,
registration, and billing. The Kaiser Permanente HealthConnect program
is expected to deliver improvements in care delivery and promote cost
savings across the entire Kaiser Permanente organization. Through
advanced technology and an integrated care delivery system, Kaiser
Permanente will eliminate the inefficiencies and error proneness of
paper-based systems.
Patients, physicians and other authorized health care staff will
have access to complete, up-to-the-minute medical records, including
test and lab results. Immediate access to the best-practice medical
science will help physicians and other health care professionals
streamline patient care processes and improve health outcomes.
Referrals to specialists can be made on the spot; prescriptions are
sent to pharmacies electronically; and two doctors treating the same
patient from different locations can share information in real-time.
Through the new system, patients will also be able to schedule
appointments, request medication refills, and ask for referrals. Full
deployment of Kaiser Permanente HealthConnect across all of Kaiser's
regions will be completed by 2007.
Southwest Medical Associates (SMA), the largest multi-specialty
physician group practice in Nevada and a subsidiary of Sierra Health
Services, began investing in information technology in 2002 to
transform the way health care is delivered and managed in Nevada. The
first step was the implementation of an electronic prescribing tool
from Allscripts Healthcare Solutions. E-prescribing has increased the
appropriate use of generic drugs from 59 percent to 65 percent, saving
millions of dollars in drug costs for patients and their health plan
sponsors.
SMA also migrated all patient paper medical records to an
electronic environment. The medical record data for all patients is now
documented electronically and is accessible immediately to all SMA
providers from any location within SMA and remotely through a secure
web-based interface. The end result is that administrative costs for
maintaining paper records have declined while the quality and
timeliness of the information available to providers at the point of
care is dramatically improved. In addition, SMA has implemented a
digital radiology environment that allows images to be made available
immediately for review and evaluation at any site. The reduction in x-
ray film lowered the average cost of a study from $2.67 to $1.58.
In the near future, SMA plans to expand use and access to their
TouchWorks EMR beyond health care professionals at SMA to other
providers within the Las Vegas Valley as well as to patients
themselves. By expanding access of summary medical information to
patients, SMA will be contributing to the development of a PHR. In
addition, in partnership with Health Plan of Nevada (HPN), SMA will
provide a secure web-based link to summary EMR information. This
initiative will enable all providers within the HPN network to view
critical medical information and allow patients to view and print their
medical record information to share with providers wherever they seek
care. The rollout of the PHR for HPN members is expected to begin in
the third quarter of 2005.
WellPoint Health Networks launched an extensive private health
initiative to equip physicians with health information technology tools
in 2004. Approximately 19,500 technology packages were distributed--
17,000 of which were desktop computers designed to help physicians use
the Internet for administrative transactions and enhance general
medical knowledge. E-prescribing solutions were given to 2,700
providers.
This initiative has resulted in over 60,000 electronic
prescriptions to date and the number continues to grow. In addition,
WellPoint currently has its own electronic medical record using claims-
based data deployed at Blue Cross Blue Shield of Missouri (owned by
WellPoint), and will soon launch a plan to make this data available to
emergency rooms throughout Missouri.
Senator Ensign. I would like to thank all of you once
again, for your excellent testimony. I understand, Ms. Bostrom,
that you have to testify on the House side, so I will start
with you. Exciting companies are investing in a lot of health
information technology. I know there are a lot of companies. I
visited Cisco and McKesson when I was in California. Health
information technology was part of my own personal experience
and practice. And, I enjoyed visiting some of the information
technology companies and seeing some of the products that are
being offered. I think health information technology is very
exciting.
I want to ask one question, and maybe even one comment
before you leave. Many physicians service several hospitals.
They drive from place, to place, to place. This can be
frustrating for the patient and family members. Before my
grandmother passed away, she was in a hospital for a few weeks.
As a family member, I was waiting, and waiting, and waiting,
and waiting, for the physician to show up to the hospital for
an update. It seems to me that if a physician had the ability
to access electronic health records from home, the physician
could see what went on at night. Dr. Glaser, it would seem to
me that the number you mentioned, which indicates that only 11
percent of savings are accruing back to the physician might be
a little more than 11 percent. Physicians are still going to
have to make hospital visits, but electronic health records
would seem to make their time a lot more efficient. Electronic
health records assist in improving the quality of care and
reduce physician driving time. If the physician accesses health
records from multiple points, including the records that are at
the hospital, and several other health care facilities, it
seems to me that electronic health records can facilitate more
efficiency. And, for the physician who is treating a patient
from back east, or out west, or wherever the other person is,
they could have access to all of the necessary electronic
health records.
Obviously, there are significant benefits, but are products
being developed, to allow physicians to do this?
Ms. Bostrom. The points you've raised about the healthcare
industry are interesting, because if you look at our high tech
industry, the employees are people that work for our company.
What is different of course in healthcare is the doctors, as
you mentioned they work for and with a number of providers and
the independent. And so the question is how do you provide them
with access to this information. How do you motivate the
hospital or the clinic to help the doctor get access to this
technology or these applications?
So I think number one, on the application side there are a
number of applications being developed, many of them have been
deployed.
The question is, are there financial incentives for the
providers, or the doctors as was mentioned earlier to adopt
there. If they accrue the savings, where does that savings go?
Does it go to them, so they can reinvest, or does it go
somewhere else? And will they be assured that they're going to
get that reimbursement? I mean right now, if you want to do an
e-mail exchange with a doctor, that doctor may or may not get
reimbursed for that. He is not highly incented to do it. So I
think that's where the government can help motivate this.
I would say the second factor is an area I know you're
familiar with, which is the idea of broadband, and broadband
access. Because many of these doctors, and many of these
smaller clinics are located in pockets of the country where
they're not located near a major medical facility. So the idea
of can they get easy access to X-rays, or other types of
diagnostic equipment, is the connectivity in place for them to
do that? So I think the combination of financial incentives,
and universal broadband are going to be two factors where the
government can help. I think if you talk to most of the
technology providers, we're ready with the applications, and
the technology. We need to make sure the motivation is out
there and the encouragement to move forward rapidly.
Senator Ensign. Dr. Glaser, I would like to hear more about
the comments you made concerning the physician, versus hospital
settings, and your references to small hospitals. A lot of
people have talked today about financial incentives for health
information technology, including initiatives through the tax
code, and through other direct means. These types of
initiatives are always very difficult. We're hearing about huge
savings, and in this case, to the hospitals, to the insurance
companies, and some to the physician. However, it sounds like
the majority of the savings would be realized by others--not
just by the practitioner. We have to be careful when it comes
to an investment in health information technology. We don't
want to establish a program that then creates a life of its
own. If there is an initial investment, we have to be very
careful. I believe we have to be careful in how we structure
any type of incentive. My question for you Dr. Glaser is with
regard to the small hospital. You said that a lot of small
hospitals can't afford to adopt and implement health
information technology. Well if those hospitals put pen to
paper, or if these hospitals have a lot of Medicaid patients,
it would seem to me, that if they put health information
technology in place, there would be a huge return on the
investment. So have studies been conducted on this matter? For
every dollar spent on health information technology, how much
of a return is obtained, and why wouldn't a small hospital
obtain the same kind of return? I understand the physician's
point of view on this topic, but I don't understand the
hospital situation you mentioned.
Dr. Glaser. I think what we find even in our studies, for
Partners, it's a net economic loss. While we're better at
treating diabetic patients, and we paid the expense of doing
that, there's no revenue upside for doing that. So whether
you're big or you're small, it's a loss. We happen to be large
enough and have vision, and that's not to demean the visions of
others, that we're going to go off and do this. Because of
this, we have begun to work with our local payers to increase
the incentive if we do better diabetes care, or we reduce
errors, then there are additional funds. And people are
learning about what's the right mix of dollars, and the right
format of all of those things.
So the economic--and that's not to say that there's no
economic gain at all; because there is a reduced paperwork, and
a variety of other things. But net--it's pretty much an
economical loss regardless of size, small doctors, 50-person
group, physicians, small hospital, big hospital.
Senator Ensign. It's an economic loss, even to a hospital,
is what you're saying?
Dr. Glaser. If we reduce medication errors, in the study
that Dr. Carolyn Clancy cited of several thousand dollars
associated with the medication errors. That is expense to
someone who is underwriting the care. And in a very perverse
way, if we have to keep you another day because we hurt you, we
make money on that. It's kind of this odd thing that we
actually net up on an error rather than net down. Because if we
send you home early, we've got a vacant bed that we now have to
fill.
Senator Ensign. Well, that brings us to Ms. Ignagni. You've
been around Washington long enough to know that every time we
try to come up with a payment system for the Medicaid and
Medicare programs, we go through all of the machinations of how
to perfect a payment system, and none of them seem to work very
well. There are perverse incentives, some of which you have
mentioned. We don't pay for performance right now. We put
artificial numbers on things and we don't pay for best
practices. But it would seem to me, Ms. Ignagni, that your
industry needs to help us come up with a way to incentivize
providers based on performance. Does that require changes in
Stark laws? What is required for you to be able to give us a
model that can be used? Hopefully we can change our Medicare
reimbursements and our Medicaid reimbursements to reflect some
of the changes you are asking for.
Ms. Ignagni. Thank you Mr. Chairman, as you know, we're way
ahead of the public sector programs in terms of pay-for-
performance, quality measurement and prioritizing, this value
question that you're inviting. We believe that we are an
important focal point, where all of this information comes
together. In fact we've provided evidence where a physician
group affiliated with the Sierra health plan in your area is
actually working on a personal health record with the health
plan, and this I think will presage what will happen throughout
the healthcare system. So we're launching now.
Is a consolidated, organized effort going to be doing it
hand-in-hand, with physician groups, with consumer groups to
begin to develop the rules of the road for personal health
records so that plans will not compete on the way that personal
health records are organized, what is in them and so on? We can
make it Internet-capable. We can make it patient-owned. We
could make it portable. That is what patients want. That is
consumer-centric and we're excited about that, and we can work
with a broad collaborative to get the rules of the road
established. At the same time, the goal is to synch this up
with what is going on in the area of electronic health records,
and electronic medical records so that they can all be
compatible. So that's what we're about to launch, we're on the
precipice of that, we're very excited about it. Because this is
the area of our core competency, that we can bring to the
delivery system, to help patients, to help providers, to align
the quality and the incentives through the payment system in a
way that I think the public sector will ultimately adopt as
well.
Senator Ensign. I would like to follow up quickly, and then
I'll turn it over to Senator Allen. The savings that everybody
seems to be talking about, appears to accrue more to health
plan members than they do to others in the healthcare system.
And so are you reflecting your payment incentives. You said
that you're paying for performance. I imagine that if you have
electronic health records, you have better performance. But,
are there direct incentives for those who adopt certain
electronic health records?
Ms. Ignagni. I think what you see all over the country is
indeed that there are, and there will be more as we go through
this year and next year. But the incentives are not disembodied
from the quality of performance, and so it is the point about
do you incent the adoption of technology, or do you incent the
quality goal which will require the adoption of technology.
We're focusing on the latter not the former, because that will
achieve the kinds of efficiencies and effectiveness that we
need.
In terms of the results accruing to the health plan, the
dollars that go to the health plan then get passed-back in
terms of more affordable rates, for public and private sector
purchasers and increasingly consumers that are buying on their
own, and so that's the pass-back in terms of the folks who are
using the healthcare system. And so that is what happens to
that.
Senator Ensign. Dr. Basch, would you like to comment on
that?
Dr. Basch. I would agree completely. And thank you Mr.
Chairman for the opportunity to add a comment. I was surprised
I didn't get a question from you about this--why did I adopt
these advanced tools that not only cost me more money, but take
more uncompensated time.
Senator Ensign. Actually, as a veterinarian, I adopted some
of the same kinds of systems that you did. I understand why
health information technology cost you a significant amount of
money, especially in a small practice. But I recognize that you
want to practice better.
Dr. Basch. Right. But I also responded to an opportunity
afforded me by a private payer, and to be the first, ``Bridges
to Excellence'' practice in the District of Columbia. This is a
pay-for-performance program through a private payer which
rewards us for achieving certain processes. They're made easier
with information technology, but the technology is not
required. And what I like about that program, and programs that
look at quality and process improvement, is they're focused on
what we achieved, not necessarily focused on the IT tools
purchased.
So in this case my practice was given the opportunity to
achieve a bonus for 3 years if we made certain process
improvements. This made the purchase of information technology
and practice redesign for my small practice, a smart business
choice, rather an onerous mandate.
Senator Ensign. Did the program help you see how process
and quality of care would improve?
Dr. Basch. They would have. However, I was aware of this
program long before it was offered to me, and I was waiting for
it to come to this region. But certainly as part of the
program, yes sir, they do make you aware of what it can do and
what kinds of technology are necessary to best reach those
goals.
Senator Ensign. Thank you. Senator Allen.
Senator Allen. Thank you, Mr. Chairman, and thank you all
for your testimony. I'm just trying to get a theme through all
of this from the different perspectives, and this is an
outstanding panel. Both panels were. But this is just from the
delivery system. Listening to first Ms. Bostrom, who did have
to leave. She was talking about how much less $8,000 versus
$1,000 per worker invested, in non-medical versus medical, so
you wonder why that's the case and that fits in very closely
with Dr. Glaser's testimony. And then Dr. Basch was saying,
well what in the heck does it matter, because of reimbursement.
So as we're trying to figure out incentives, we need to
understand what will incent someone to make--what will motivate
someone to do as Dr. Basch has done, or we would like others to
do similar to McKesson. When you hear and read testimony of the
400,000 alerts triggered weekly to nurses to advise them of
wrong medication. In all the stats, the numbers of incorrect
diagnoses, wrong medications, and so on, and the loss of life,
or added injuries that are caused by that. That's a great
concern. Just for the delivery of health, much less the
question of ethical, or proper professional services. So going
through all of this, you get the reimbursement situation, which
is probably not clearly going to be the purview of any of this
legislation, but something that ought to be addressed. You
would think that in Susan Bostrom's testimony, she's talking
about Virginia where Cisco has provided a system that enables
radiology reports to be delivered to doctors in minutes, rather
than days.
You would think that as healthcare professionals you would
want to do that. It's just faster, quicker and obviously, get
on to whatever treatment is necessary. Then we hear from the
insurance folks. And I was glad your last question got into it,
because one of the things I hear a lot from physicians about,
is medical liability cost and how it is skyrocketing. And it's
one of the reasons there are no physicians in rural areas or
small towns, regardless of whether they have access to
broadband or not. They want to be--which I'm very much in favor
of. But they're going to need to be with a hospital, because
they just cannot afford all the costs of medical liability
insurance. So when you look at the adverse outcomes, due to
incorrect medications. And that's usually, or maybe not knowing
what someone's allergy is, and therefore prescribing the wrong
medicine, or somebody reads it wrong because doctors are famous
for their handwriting. Or infamous I should say. If what this--
the use of these tools, and these safeguards, and these double-
checkings, you ended up with fewer lawsuits. I'm not saying
everyone of these ends up in a lawsuit, not every adverse
medical outcome ends up in a lawsuit. However some do and that
drives up the cost of insurance to settle those claims, whether
they're litigated the whole way through or not. If you could
end up with fewer medical liability or medical malpractice
suits then could insurance companies, and this is an incentive,
this is from the private sector, discount for such safeguards,
or for assisted living facilities, which have really high
liability costs. Obviously it's 24-hour service that may have
these bar codes and so forth on them, or anything like that.
Could there be a discount, for each professional, or each
facility that adopts these sort of practices? Because that is
an economic matter which I think would relate also to lessened
liability, because of the more careful practice of medicine. It
seemed like Dr. Basch said that he was doing it anyway.
But I would ask Ms. Ignagni, if any sort, and I know you
don't speak for all insurance companies, but could something
like that be put forward to incent, and I think reduce the
liability risk from outcomes that are due to negligence?
Ms. Ignagni. I think you're appropriately pointing out, we
have two issues of medical liability. One is the direct cost of
the lawsuits. The other is far greater: the defensive medicine
that goes along with that. It's a $100 billion premium for
defensive medicine, so you're quite right to probe. Just as
we've seen from an insurance perspective we're incenting
providers to reach goals and objectives in the area of quality
and reimbursing more when they reach those goals. One could
imagine my members write health insurance, we're health
insurance plans. We don't do liability insurance or malpractice
insurance, but one could reasonably suspect that the same logic
would apply and you could tie some of these things with the
presence of moving in this direction, having these tools and
techniques--because it would lessen the ability of lawsuits, or
risk, or it would have use. So I think it's a very reasonable
idea.
And I can tell you in the policy community, more and more
people are beginning to talk about it, so I think you're onto
something there.
Senator Allen. Ms. Pure, have you found any benefit from
the approaches that you all take with your bar-coding and
checking and so forth, insofar as any insurance, or liability
insurance costs?
Ms. Pure. A number of our customers have gone to their
malpractice insurers to ask for some compensation relief when
they have basic safety standards in place. But it's really
state-to-state practice, insurer-to-insurer. There is nothing
across the board that we have seen happen. You know, one of the
things we don't count into the cost savings is nursing
turnover, nursing retention, and nursing satisfaction. We have
study after study that shows that nurses are happier, more
satisfied, and their retention rates go up dramatically if they
feel like they're practicing care in a safer environment. So I
think there are a lot of intangible costs that we need to look
at as well.
Senator Allen. That's a very good point. The nurses,
they're in such great demand and they are there all the time.
To the extent that you can maximize their assistance, and I
will tell you they are the key people in every hospital.
Nothing against the physicians, but the nurses are the ones who
are there, giving comfort, assurance, and monitoring. And if
they can't handle it, obviously they have to bring in a
physician. Dr. Basch you ended up getting in a roundabout way,
you ended up getting some sort of insurance break, or
incentive. I was listening closely, what is your insurance
company? Do you think others--if I discern that correctly, do
you know if there are any other insurance companies that
provide such incentives, or reduced premiums let's say?
Dr. Basch. Senator, actually what we ended up getting was
the opportunity for participation in a program from a payer, a
private payer to increase payments to us for quality
improvement. Not a reduction in malpractice. And if I may
expand my answer a little bit about the issue of malpractice in
the outpatient setting. This has been looked at extensively,
and most lawsuits in the outpatient or ambulatory setting are
not that similar to ones that occur in the inpatient or
hospital setting.
In the hospital setting there is clear evidence that the
use of advanced systems such as computerized physician order
entry has been demonstrated to reduce medication errors. These
medication errors in the hospital setting have a higher
potential to cause harm and lead to lawsuits, compared to the
outpatient setting. We see the advantage of the advanced EHR
not just in reducing mistakes but in helping to move mediocre
care to excellent care. And I hope we don't have malpractice
lawyers coming up with a new business schema here. Patients
don't typically sue for just getting mediocre care, if they did
we would have a many more suits in this country.
Senator Allen. Thank you. Dr. Glaser, did you have anything
to add?
Dr. Glaser. Senator, I think it's interesting, I give you
one set of points, when we put in a provider order entry.
Senator Kerry mentioned earlier we did a pre/post examination
of our malpractice experience. We self insure with all the
other Harvard teaching hospitals. Our malpractice cost dropped
3 percent, which we attribute to CPOE even though there are a
small number of cases, and there's a tail on these things you
can take years between suit and settlement for example. So
there was evidence of a decrease. And the one question is why
not more? Why was there only 3 percent? It could have been
whatever set of numbers you want. And it turns out the bulk of
the malpractice experience is surgical mistakes and children
born with defects or problems et cetera. And those form the
bulk of the malpractice experience. Which a lot of these
technologies won't do much for. So the leverage points may not
be largely in the malpractice arena. It may be much more
significantly on whether we do routine care well, or whether we
administer the right drugs and a variety of other things which
may not always, in fact rarely, wind up in the courts.
Senator Allen. Thank you. Thank you, Mr. Chairman, and
thank you ladies and gentlemen for the outstanding
perspectives. I appreciate it.
Senator Ensign. Senator Kerry?
Senator Kerry. Thank you, Mr. Chairman. I apologize to the
panel but unfortunately we have competing hearings, so I had to
go over quickly to another one. I understand from the Chairman
however that the testimony has been just terrific and we
certainly appreciate that very, very much. Dr. Glaser, you also
hold a position do you not as the President or Chairman of the
National e-initiative. eHealth Initiative?
Dr. Glaser. Senator, I'm the head of the board of the
eHealth Initiative, which is a non-profit coalition of multiple
stakeholders in the industry who come together to see how we
can solve, resolve a variety of issues that go on.
Senator Kerry. How long has that group been in existence
now?
Dr. Glaser. Senator, I'm going to hazard to guess about 5
years I believe.
Senator Kerry. How many players are there in it?
Dr. Glaser. There are approximately 120 to 140 members who
come from a wide range of stakeholders.
Senator Kerry. They're all focused on this one concept?
Dr. Glaser. Correct.
Senator Kerry. What would you say if there is a concensus?
What would be the order of priority of concensus about what is
needed, and how we might be able to proceed?
Dr. Glaser. Well I think, Senator, the concensus would be
number one, we have to change the financial incentive system
here. We suggest the doctor invest, but nonetheless the
economic value is insufficient, and they balk at that. So
that's number one.
And the eHealth initiative has drafted a framework called
Parallel Pathways * which you all may want to include in the
record, there are copies of it at the table here, that outlines
approaches to the financing. And I'm not sure how the mechanics
work of adding it to the record on all of that. So that would
be number one, looking at the incentive structure and migrating
it to increase the sophistication over time.
---------------------------------------------------------------------------
* The information referred to has been printed in the Appendix.
---------------------------------------------------------------------------
Number two is helping the small physician practice. If
you're Dr. Peter Basch and you're a solo practitioner who in
the world do you turn to? There are 300 EMR vendors out there.
How do you pick the right one, who's going to help you? And so
it would be the second area that we focus on, and the third is
the standards realm.
Senator Kerry. Is that in order of priority?
Dr. Glaser. Yes sir.
Senator Kerry. So you believe we could proceed to get
technology out into the marketplace, before we actually had
this broad standard in place?
Dr. Glaser. I think Senator, we ought to go after the
standards and be very serious about that, and support a lot of
the Secretary of Health and Human Services, and Dr. Brailer's
activities in this regard. Nonetheless, I don't think we can
wait. We've talked about the number of people who will die
today because of errors. The railroads couldn't wait, the
electrical power people didn't wait. All kinds of people didn't
wait. You had to have them along the way, but they didn't wait.
Senator Kerry. Dr. Basch, what are the principal incentives
that would make a difference? You've spoken about the view from
the practitioner, what do you think would make the most
difference to that practitioner?
Dr. Basch. Senator, I think----
Senator Kerry. If you've answered any of this incidentally,
just say it's in the record and I'll get it. I don't want to
have everybody repeat stuff.
Dr. Basch. I haven't really addressed this in particular,
and I'm happy to answer your question. I think the most
important issue in terms of incentives is aligning them not
just as has been stated by other panelists, with technology
adoption; but aligning them for the optimal use that we would
like to see from the technology. I want to reiterate that my
testimony focused on those optimal uses, and not just a narrow
conformance to a performance measure, or quality standard. But
it is understanding that the way we're really going to
transform the healthcare system enabled by this technology, is
to use it to accomplish other goals such as e-visits. One thing
we could do is start paying for e-visits. This would help
doctors and patients to not waste time by doing everything in
the context of an office visit.
Second, we could incentivize care coordination. I showed a
slide during my presentation of a patient registry that is
integrated with my electronic health record, and while the
slide perhaps didn't show as well as it does on my screen when
its close up, what it really does is give me the same powerful
tools in my EHR to use on all of my patients; not just the ones
who remember to come in, or feel sick at that moment. But I can
look at all of them, and make sure based on whatever my
practice, my health system, or national goals are, are acted
on. So if diabetes is a condition that we're not doing a good
job on I can focus on it. But for me to use that tool in my
practice requires that I take time away from the reimbursable
activities of office visits, and require patients to come in
for other visits or simply just ignore patients who don't come
in.
Senator Kerry. What's the most effective way to do that,
because it sounds labor intensive. I mean it's now somebody has
got to invest time, and somebody has got to instruct. Who's
going to do that?
Dr. Basch. Sure. I think there are actually some work-
through mechanisms that have been sorted out that work quite
well in the office setting, and it's a combination of office
staff, and the physician. There are certain things, certainly
that the physician doesn't have to do, for example using the
registry to see who needs to get certain tests. That can be
done by staff, that can be automated, that can even be sent in
terms of reminders to the patient by secure e-mail. In terms of
managing the actual numbers and the fine points of care, I
think a clinician does have to be involved in looking at who
the patient is, their age, their concurrent conditions because
one of the things we want to avoid as we try and move medicine
from mediocrity to best practices is to make sure that we don't
commit other errors. For example, taking a patient who is
toward the end of life and looking inappropriately at their
cholesterol, and saying ``well the number says I should put you
on a cholesterol medication,'' when obviously it's
inappropriate.
So I think we need to always remember good clinical
judgment.
Senator Kerry. Interesting. Ms. Pure, I was looking at what
you sent up here, and I have a relative who was recently in the
hospital who was given one of these, and looked in it and it
was the wrong medicines. Self-determined, thank heavens. But
that happens all the time and these I gather are sort of the
antidote to that. What would it take to get the industry to do
this?
Ms. Pure. Well, it's really interesting, Senator Kerry, if
you look in this packet, some are M&Ms and some are Skittles,
and with candy it doesn't really matter. But that happens
everyday in a hospital and people die when they take the wrong
medication. So what we see is a major trend to bar-code meds,
and actually label them on the back for the patient who is
supposed to receive those meds. The patient wears a wrist band.
The nurse wears a wrist band. The nurse scans herself, scans
the patient, scans the med. And if it's not the right time, or
the right dose, or the right med, it prevents the nurse from
administering the drug. So it's a tremendous safety check.
You know, the frustrating thing is we talked about billions
and billions of dollars to change the whole healthcare system
and that's certainly going to take us to the end state that we
all want to get to. But your average hospital could be scanning
meds in 6 months, for somewhere between half a million, and a
million dollars.
Senator Kerry. For that hospital?
Ms. Pure. For that hospital.
Senator Kerry. So system-wide what are you talking about?
Ms. Pure. System-wide, in the hospital, at every nurse
station, every med could be scanned. Of course it costs more if
it's a really large hospital like John's but for your average
hospital around the country in 6 months you could be up and
scanning meds and eliminating errors.
Senator Kerry. And what kind of incentive? Is there one
that's needed to get people to do that? Have you got a cost
analysis on what the savings are, in terms of the error?
Ms. Pure. The savings unfortunately for medication
scanning, are soft savings, in terms of preventable mistakes.
Nursing satisfaction. The only real dollar savings are
potentially in better management of the medication inventory.
But a lot of people don't give the technology credit for just a
reduction in inventory. So the savings are soft.
Senator Kerry. Well the savings are the 7,000 lives lost
due to inappropriate medications.
Ms. Pure. Exactly, in terms of dollars. But the loss is
intolerable in terms of not doing it.
Senator Kerry. But I would assume that there's a medical
malpractice cost associated with that, which is calculatable.
Ms. Pure. Right. And what we haven't seen is a broad scale
change in malpractice insurance. Insurance premiums based on
hospital scanning.
Senator Kerry. Well you have a great name for selling this.
Ms. Ignagni, just quickly from the health insurance plans'
point of view, what's the most important incentive here? How do
you get the companies across the board to rapidly embrace this?
Is it financial incentive of a significant amount, or is there
some other trick?
Ms. Ignagni. Actually Senator, this is a most important
question and I appreciate it. We're doing a number of things
already to incent quality performance, to align objectives and
reimbursement. To move in the direction of computer order
entry, to pay more for that. For example to pay more for
achieving certain goals with respect to diabetes management,
chronic care management with respect to cardiac disease, et
cetera. So we're well on our way to doing that. But what we
realize is that we're a focal point for all of these data in
the system through the claims picture. So what we're doing now
is we're launching an effort with provider specialty societies,
consumer groups, similar to one that we have just completed on
ambulatory care in terms of quality measurement. We're moving
now to this area where we're launching a patient record, and
have an opportunity to develop rules of the road across our
health plan, so that they're not competing on the standards.
Therefore how it looks and what goes on, it can be portable, it
can be patient-owned, and we're working hand-in-hand with
speciality societies and patients to move as quickly as we can.
So when we talk about uniform standards, the reason we raised
it today is that we've come a long way in about 6 months. Six
months ago the entire discussion was about regional healthcare
organizations. And we were worried about regional organizations
being disembodied from a national framework and that is why we
raised the issue. Not that the government needs to do
something. We're well on the way to doing something. We want to
make it sync up with electronic medical records, that the
hospitals are developing et cetera, so it can all be part of a
whole.
What we see as the number one thing that Congress could do,
is to really give serious thought to preemption in the area of
privacy and security. Let me explain that. We have a HIPAA law,
as everyone knows. We also have 50 state privacy laws. We have
states acting in security with respect to data security. We're
going to get a national health information system with respect
to healthcare, and one needs to give real thought to the
preemption question. We also need to consider the obligations
under HIPAA, to banks and financial institutions that now have
some involvement in this arena, Who are not subject to HIPAA
guidelines and restrictions. So we're very, very focused on
that.
And finally, although I know that there's some disagreement
about this, we are concerned about proposals that have been
made to waive the Stark fraud and abuse laws. We're very
concerned about that, because of what the FTC has already
discussed with respect to the impact of consolidation in the
system and what that could do to healthcare costs. So we would
like to be helpful in terms of trying to solve this problem,
both from the health plan standpoint and assisting providers in
making this conversion in the best way possible. And we think
there's a public and private role.
Senator Ensign. Senator Kerry, before you continue
questioning, I need to excuse myself.
Senator Kerry. I'm finished actually.
Senator Ensign. I apologize, but I have a funeral to attend
in Arlington. That is why I need to leave.
Senator Kerry. If I could just say, maybe we could join
together, the Administration has asked for the $150 million,
the House has only given $125 million. I'm told the Senate may
do less. So perhaps you and I could join together to try to
write a letter to Senator Specter to at least get the $125
million if not better, so that we could guarantee that minimal
sort of effort. And I would love to try and do that with you.
You raise some very interesting questions. Those are big
issues, we're going to have to deal with those. And I think we
need to sit down and figure out because that's a big mouthful,
all of that. But all of you, thank you, very very much. This
has been enormously instructive, and I appreciate it. Thank
you, Mr. Chairman.
Senator Ensign. Thank you, Senator Kerry. Without objection
the Senators' written statements, and witnesses' written
testimony will be made a part of the record. The record will
remain open for 7 days for Senators to submit questions or
statements, without objection so ordered. This hearing is
adjourned, and I thank all of the witnesses for their
testimony.
[Whereupon, at 12:15 p.m., the hearing was adjourned.]
A P P E N D I X
Prepared Statement of Hon. Olympia J. Snowe, U.S. Senator from Maine
I join my colleagues in a growing bipartisan effort to use
technology to address two critical problems we face in health care.
The first of these is a serious patient-safety problem. The
Institute of Medicine (IOM) reports that medical errors claim up to
98,000 lives every year. The good news is that solutions exist: We can
apply information technology (IT) in health care to dramatically reduce
errors and save lives. Many of us have heard about how drug
interactions can be avoided by software systems which check a patient's
prescriptions for hazards. Yet there are so many other applications
which can improve health. For example, by reviewing and analyzing
information, a health provider can help a patient better manage chronic
diseases such as diabetes and heart disease, and avoid adverse
outcomes.
A second critical problem is the escalating cost of health care. As
we spend more and more of our GNP on health care, we become less
competitive internationally. At the same time, as health care becomes
less affordable, more Americans join the ranks of the 45 million
uninsured. Health care simply must become more efficient.
Costs can be reduced when tests don't have to be repeated and data
isn't delayed. In fact, a patient may obtain faster, higher quality
care when, for example, multiple practitioners can review diagnostic
test results right at their desktops. In an age where millions of
Americans share family pictures over the Internet in seconds, isn't it
long past time that a physician should be able to retrieve an X-ray
just as easily?
The President recognizes the disparity in technology utilization in
health care versus other sectors of our economy. He has declared a goal
for every American to have an electronic medical record within 10
years. I concur--we need this and more. In fact, once that record is in
place we can do so many things better. From preventing drug
interactions, to managing chronic diseases, to simply helping providers
operate more efficiently. Most of us have been told at one time or
another, ``we're waiting to get the test results mailed,'' or ``we're
still waiting for your chart.'' Health care is one of the last realms
of such inefficiency.
It will be essential to achieve common standards to ensure the
investment which must be made will be secure. Health care providers
must know that their investment in systems will allow the exchange of
data--for providing higher quality, more efficient care; for financial
management, and for continued evaluation and improvement. One must know
that a system purchased will be compatible with others, and that--no
matter what may happen in the future to a vendor--the huge investment
one makes in building an electronic medical record won't be lost. In
other words, your system must be able to communicate with other
systems, and your investment in building electronic medical records
must be preserved. So when a patient moves, their electronic ``chart''
should be able to move right along with them, and their continuity of
care shouldn't be interrupted.
The efforts of Dr. David Brailer at HHS. and of a number of my
colleagues in addressing the need for standards and interoperability
are absolutely essential to making health IT a reality.
The bad news is that even with standards in place high start-up
costs could prevent us from reaping the benefits of new technologies.
Today many providers are struggling to make these investments, and for
those which serve beneficiaries of Medicare, Medicaid and SCHIP, it can
be exceedingly difficult. That is why I have joined with Senator
Stabenow to also address the means of implementing technology.
We know we will realize significant savings through information
technology. On that there is bipartisan consensus. Yet as providers are
facing ever declining payment rates, they also are being told they must
institute changes in the way they practice, including implementing
information technology. We know that much of the savings in health care
IT will accrue to the patient and payer--in such aspects as fewer
duplicate tests, greater efficiency, and better health management. Thus
it is appropriate that, as we establish standards, the Federal
Government also assists providers in helping them adopt the technology.
This is particularly critical for those providers who see serve our
Medicare, Medicaid and SCHIP beneficiaries. That is why Senator
Stabenow and I have developed a means to see that standards are
implemented expeditiously.
Today, we have this technology at our disposal, and I strongly
believe that we cannot afford to delay implementation. Waiting will
result in not just a loss in dollars which could be saved, but also in
lives lost.
I am optimistic that so many of my colleagues are engaged in
developing health IT solutions. Working together we can realize the
promise of health care that is safer and more accessible to all.
______
Prepared Statement of the eHealth Initiative and Foundation
Parallel Pathways for Quality Healthcare--A Framework for Aligning
Incentives with Quality and Health Information Technology--
Recommendations of the Working Group for Financing and Incentives *
---------------------------------------------------------------------------
* Supported in Part by the Connecting Communities for Better Health
Program Conducted in Cooperation with HRSA/OAT.
---------------------------------------------------------------------------
Executive Summary
The eHealth Initiative and its Foundation launched in December 2004
a diverse group of stakeholders through its Working Group for Financing
and Incentives to develop a set of principles and a Framework for
incrementally aligning incentives with both quality and efficiency
goals and the health information technology infrastructure required to
achieve such goals. The Framework, entitled ``Parallel Pathways for
Quality Healthcare'' describes both the enabling HIT infrastructure for
physician practices as well as the standards-based connectivity
required within regions and communities. The Framework provides a
phased, integrated approach that recognizes the varying stages of
evolution with regard to regional multi-stakeholder collaboration,
focus on quality and performance, and health information technology
penetration within markets across the United States.
The following summarizes a set of ``Principles for Financing and
Incentives'' developed by the Working Group:
1. Any incentive program focused on quality should also include
some level of incentive--either direct or indirect--for the
health information technology (HIT) infrastructure required to
support improvements in quality.
2. Any financing or incentive program implemented by either the
public or private sector involving HIT should:
Result in improvements in quality, safety, efficiency
or effectiveness in healthcare.
Incentivize only those applications and systems that
are standards-based to enable interoperability and
connectivity.
Address not only the implementation and usage of HIT
applications but also the transmission of data to the point of
care, both of which are required to support high-quality care
delivery.
Allow for internal quality improvement or external
performance reporting as mutually agreed upon by purchasers/
payers and providers.
3. Financing and incentive programs should seek to align both
the costs and benefits related to HIT and health information
exchange.
The following Framework developed by the Working Group, provides
guidance to purchasers, payers, practicing clinicians, and regional or
community-based collaborations focused on health information exchange
who are seeking to improve the quality, safety, effectiveness and
efficiency of healthcare in their markets, through HIT and exchange of
healthcare data. The Framework provides staged guidance in four focus
areas related to aligning goals for quality healthcare: (1) quality
capabilities; (2) HIT capabilities within the physician practice; (3)
health information exchange capabilities; and (4) financial incentives.
The following summarizes at a high-level the three phases of
evolution.
In Phase I, rewards would primarily focus both on reporting
of measures that rely on manual chart abstraction and claims
data and physician usage of standards-based, interoperable HIT
applications with certain basic functionalities.
In Phase II, rewards would focus on the reporting of
measures that rely on clinical data sources; connectivity of
standards-based, interoperable HIT applications to clinical
data sources to support information needs at the point of care;
and physician usage of HIT with more advanced functionalities.
In Phase III, rewards would focus on performance against
process and outcomes measures, while phasing out rewards for
HIT.
It is expected that value will continue to increase through each
stage to purchasers and payers who engage in the implementation of the
Framework.
We are at a unique point in time, where public and private sector
interests are at an all-time high in two key areas: improving the
quality and safety of healthcare and moving forward on a health
information technology agenda. Approaching these two key issue areas in
a siloed manner--without strong integration across both areas--will
result in missed opportunities, unintended consequences, and possibly
reduced impact in both areas. By laying out an integrated, incremental
strategy, which incorporates goals related to quality, safety, and
efficiency as well as health information technology and the
mobilization of data across organizations, the principles and Framework
included in this document offer the foundation for building a
healthcare system that is safer, of higher quality, and more effective
and efficient.
Full Report
Introduction and Background
The eHealth Initiative and its Foundation are independent, non-
profit affiliated organizations whose missions are the same: to drive
improvement in the quality, safety and efficiency of healthcare through
information and information technology. The eHealth Initiative is a
multi-stakeholder consortium representing a wide range of stakeholders
who share this common goal, including clinicians, health plans,
healthcare IT suppliers, healthcare purchasers and employers, hospitals
and other providers, laboratories, patient and consumer groups,
pharmaceutical and medical device manufacturers, public health
agencies, and representatives of state, regional and community-based
health information initiatives and organizations.
Reports from a wide range of philanthropic and private sector
organizations including the Commonwealth Fund, Institute of Medicine,
the Markle and Robert Wood Johnson Foundations, and several non-profit
organizations, as well as representatives from the public sector such
as the U.S. Government Accountability Office, the U.S. Department of
Health and Human Services, the U.S. Department of Veterans' Affairs,
the Department of Defense, the Medicare Payment Advisory Commission,
and several Members of Congress, recognize the value of health
information technology (HIT) in addressing quality, safety and
efficiency challenges in the U.S. healthcare system. Interest has now
turned to the development of policies and practices for accelerating
the effective implementation and use of such systems in a way that will
assure that expected quality, safety and efficiency outcomes will be
achieved.
At the same time, the development and implementation of incentives
or pay-for-performance programs is on the rise, stimulated by reports
from the Institute of Medicine and leadership demonstrated by
organizations such as the Leapfrog Group. Pioneering efforts around
pay-for-performance are now emerging from Bridges to Excellence (BTE),
the Integrated Healthcare Association (IHA), the Centers for Medicare
and Medicaid Services (CMS), as well as several other programs
initiated by both payers and purchasers. According to one report,
almost one-third of health plans say that they now have a pay-for-
performance program in place, but most are in the earliest stages of
development or implementation.
Pay-for-performance systems provide higher reimbursement for those
who perform well on a wide variety of quality, cost and efficiency
measures (which are both process and outcome-oriented). Many of these
systems have been launched based on the recognition that current
reimbursement methods are not effectively curbing both rising
healthcare costs and addressing issues related to quality and safety.
Many, but not all, of the emerging programs integrate information
technology expectations, recognizing that information technology can
not only help with the reporting of the quality data typically required
for such programs, but can also assist with the achievement of better
outcomes--in both quality and efficiency.
While there is recognition of the value of information technology
usage by providers and the exchange of information across institutions
to support a comprehensive view of the patient at the point of care,
adoption by providers--in particular practicing clinicians--continues
to be low, due to a number of reasons, including the lack of standards
and resulting perceived risk of purchase as well as the significant
changes in work flow required to move toward implementation. Many
believe that the largest barrier to HIT adoption pertains to both the
lack of capital to purchase such systems, and even more so, prevailing
reimbursement methods which reward volume of services as opposed to
outcomes or activities (such as usage of clinical applications) that
would result in higher quality, safer, more efficient healthcare.
Recent reports from the Markle Foundation's Connecting for Health
initiative with additional support from the Robert Wood Johnson
Foundation, the Center for Information Technology Leadership, and
MedStar Health, as well as ongoing work by organizations like Bridges
to Excellence all highlight the issue of misalignment of incentives;
i.e., in other words, the economic imbalance that exist between those
who purchase HIT (e.g., practicing clinicians, hospitals and other
providers) and those who also benefit from its use (e.g., patients,
healthcare purchasers, and health plans).
In December 2004, with the support of the eHealth Initiative
Foundation's Connecting Communities for Better Health Program conducted
in cooperation with the Health Resources and Services Administration,
the eHealth Initiative Foundation assembled a diverse group of
stakeholders under the leadership of Co-Chairs Marianne E. DeFazio,
CEBS, Director, Global Health Benefits, IBM Corporation and John
Glaser, Ph.D., Vice President and Chief Information Officer, Partners
HealthCare System, to launch the Working Group for Financing and
Incentives (Working Group). The Working Group, which includes
practicing clinicians, healthcare purchasers, health plans, healthcare
IT suppliers, and hospitals, came together to define a set of
principles and strategies for providing financing and incentives to
improve healthcare through HIT adoption within ambulatory care.
The purpose of this paper is to summarize key results and findings
of the first phase of the Working Group's efforts, including the
insights that were gained, a set of principles for financing and
incentives, and a framework for designing such programs to align
incentives with both quality goals and the HIT infrastructure required
by both practicing clinician offices and health information exchange
initiatives within markets to support those goals. This framework is
currently entitled the ``Parallel Pathways for Quality Healthcare''
(the Framework).
Overview of the Goals and Objectives of the Working Group
The purpose of the Working Group was to achieve multi-stakeholder
consensus on a set of policies and principles for improving health and
healthcare by leveraging HIT through financing and incentives,
targeting both physician practices and regional and community-based
health information initiatives and organizations.
The Working Group and eHealth Initiative Foundation staff conducted
a wide range of activities to support this work, including the
following:
Reviewing the experiences of a number of incentives and pay-
for-performance initiatives involving HIT that are operating
today;
Reviewing the results of research and initiatives exploring
the need for and results of incentives programs and pay-for-
performance initiatives; and
Developing and vetting a set of principles and best
practices for incentives with multiple stakeholders across the
healthcare system.
Results of Our Review
The following summarizes the key findings that emerged from our
work.
The number of incentive programs for quality and ``pay-for-
performance'' is on the rise. Over the last several months, the
number of incentive and ``pay-for-performance'' programs has
significantly increased, fueled by the recognition that current
reimbursement methods are not adequately addressing issues
related to quality and safety and rising healthcare costs and
signals that the U.S. Government is experimenting with similar
programs.
The value of information technology accrues to many
stakeholders. The value of HIT and health information exchange
accrues to many stakeholders including clinicians, health
plans, hospitals, purchasers, patients and public health.
Coordination and collaboration within the region or
community is critical. Widespread adoption of HIT across
physician practices may not be possible without broad-based
community collaboration and coordination. Physician practices
ordinarily contract with a large number of purchasers and
payers. As a result, incentives offered by a small number of
purchasers or payers generally are not effective. In addition,
most of the data required to deliver care within physician
practices resides somewhere else (hospital, lab, pharmacy,
health plan, etc.) and therefore collaboration and coordination
are necessary to facilitate the transmission of data to the
point of care. Coordination and collaboration offer many
benefits, including providing leverage to achieve widespread
participation, reducing the potential for the ``free rider''
effect (in which some purchasers and payers reap the benefits
of HIT adoption without sharing the costs), reducing the burden
created by physician practices participating in multiple
reporting initiatives, and significantly reducing the per
participant cost of both transmitting and receiving common data
elements for various healthcare needs (e.g., healthcare
delivery, performance improvement, etc.).
Rewards should emphasize the use (not purchase) of HIT
applications and eventually focus on performance or outcomes.
Most of the market experiments reviewed initially focused on
rewarding the acquisition and use of HIT, sometimes in
combination with additional incentives for performance. In
some, but not all cases, the reward for acquisition/use was
designed to diminish or be eliminated over time, while
incentives for performance (i.e., outcomes that are linked to
increased HIT use) were designed to ramp up. In many cases, the
goal appears to be to reward the innovators who adopt HIT
fairly early, in hopes of creating a critical mass and reaching
a ``tipping point''.
Incentive amounts offered should be meaningful. According to
various reports, incentives offered to stimulate adoption and
use among practicing clinicians should be meaningful. Many
programs have lacked widespread participation due to the level
of amounts offered. In one case (Integrated Healthcare
Association), the amount of incentive funding tied to HIT was
doubled (from 10 to 20 percent of the overall package) after a
lukewarm initial response. According to the recent Connecting
for Health report on financing and sustainability, such amounts
should total anywhere from $10,000 to $24,000 per physician per
year.
Purchaser or payer sponsors of the incentive program should
represent a meaningful proportion of the clinician's patient
panel. Because practicing clinicians often work with a large
number of health plans and purchasers, in order for incentives
to be effective, they must be delivered by a meaningful
proportion of the clinician's patient panel. This is evidenced
in a number of current market experiments. To address this
issue, a significant percentage of the purchasers and payers in
a market should be recruited to the incentive program to have
impact. According to the recommendations of the National Group
for the Advancement of Health Information Technology, regional
and community-based initiatives should use a combined 50
percent market share as a target. In addition, the National
Group suggests that at least 30 percent (and optimally 50
percent) of a clinician's patient panel should be covered by
some combination of participating patients and purchasers.
Giveaway programs have had little impact. Some initiatives
reviewed in our work had experimented with giving away
applications or hardware (e.g., PDAs, desktop computers) to
physician practices, with little impact. Programs in which
clinicians have had to invest in such systems have demonstrated
greater sustainability.
Any applications covered by the program should be
``interoperable'' and standards-based. In order to derive the
full value of investments in HIT, payers and purchasers should
only reward the use of clinical applications that are
interoperable, using agreed-upon data standards. Over time,
incentives programs should require that the interoperability of
such applications is actually leveraged--in other words, the
transmission of certain data required for clinical care (e.g.,
lab, pharmacy, etc.) to the HIT application to support the use
of such information at the point of care should be required.
Certification and accreditation can offer purchasers and
payers confidence. As purchasers and payers begin to adopt
incentive and pay-for-performance programs, they will likely
need assurance that systems adopted by physicians are
interoperable, functional, and utilized. Several groups have
emerged to address these various certification needs including
the National Committee for Quality Assurance and the
Certification Commission for HIT.
Policies related to information sharing should be built into
expectations. As information flow accelerates, it is necessary
to establish ``rules of the road'' for information sharing. The
adoption of agreed-upon principles related to the use, access,
privacy and security of health information are crucial to
assuring public trust in emerging health information exchange
initiatives. Connecting for Health is spearheading a
collaborative approach for the development of such principles
with a delivery date of Fall 2005.
Emerging health information exchange initiatives, networks
and organizations should be leveraged to facilitate effective
and efficient information sharing. Over the last year, a number
of state, regional and community-based multi-stakeholder
initiatives have emerged to begin to address the need for
information mobility within markets across the country. These
initiatives and the organizations that evolve from them should
be leveraged to facilitate information sharing and the
transmission of data to both physician practices and purchasers
and payers participating in incentive programs that need
performance data to support their requirements. The National
Coordinator for HIT has referenced in its Strategic Framework
for Action the creation of organizations that would conduct
such activities, calling them ``Regional Health Information
Organizations'' or ``RHIOs''. The eHealth Initiative Foundation
is developing common principles (organizational, legal,
financial and technical) for such health information exchange
initiatives and organizations through its Connecting
Communities for Better Health Program, to provide guidance to
and assure public trust in such organizations and initiatives
as they develop across the United States.
Bringing it All Together: A Set of Principles and Framework for
Implementing Incentives for Higher Quality, More Efficient
Healthcare
Based upon the work conducted to date, the Working Group developed
a set of high-level principles for financing and incentives, and an
incremental framework designed to align incentives with purchaser and
payer expectations around quality and efficiency as well as the HIT
infrastructure--both within the physician practice and across the
region or community through health information exchange--to support
those expectations.
Principles for Implementing Incentives
The following set of ``Principles for Financing and Incentives''
were developed by the Working Group:
1. Any incentive program focused on quality should also include
some level of incentive--either direct or indirect--for the
health information technology (HIT) infrastructure required to
support improvements in quality.
2. Any financing or incentive program implemented by either the
public or private sector involving HIT should:
Result in improvements in quality, safety, efficiency
or effectiveness in healthcare.
Incentivize only those applications and systems that
are standards-based to enable interoperability and
connectivity.
Address not only the implementation and usage of HIT
applications but also the transmission of data to the point of
care, both of which are required to support high quality care
delivery.
Allow for internal quality improvement or external
performance reporting as mutually agreed upon by purchasers/
payers and providers.
3. Financing and incentive programs should seek to align both
the costs and benefits related to HIT and health information
exchange.
An Incremental Framework for Aligning Incentives Around Quality and HIT
Early on in the process, participants in the Working Group and
several other stakeholders involved in the vetting process, recognized
the importance of aligning incentives with not only quality and
efficiency improvements in healthcare, but also the HIT infrastructure
needed to support those improvements.
Most incentive programs in place today use claims-based information
and manual patient record abstraction as the means to determine the
quality of care received by patients. There are well researched and
documented shortcomings to the use of claims data to determine the
quality of care delivered, including the lack of timeliness, in some
cases, its inaccuracy, and the lack of its ability to provide important
physiological data on patients that are the true markers of clinical
outcomes. In addition, manual extraction of data from paper-based
charts is time-consuming and expensive. And, according to some reports,
charts for patients cannot always be located. The use of clinical
applications and health information exchange dramatically increase the
accuracy, timeliness, and availability of information to support the
determination of quality of care by purchasers and payers administering
performance-based incentive programs. The development of this
infrastructure also builds the foundation for an evolving set of
expectations without building in additional reporting burden.
Finally--and more importantly--the use of clinical applications and
the mobilization of patient data through health information exchange
also creates the foundation and infrastructure for quality and safety
improvement by supporting the provision of important patient
information at the point of care and enabling clinicians to improve the
quality and safety of care as it is being delivered to patients.
Markets across the country are in various stages of evolution in
terms of performance expectations, HIT penetration, and cross-community
collaboration. Recognizing these various stages of evolution, the
Working Group developed a staged process designed to support a wide
range of markets as they transition to an electronic and more
performance-based healthcare environment.
The Framework that follows, entitled ``Parallel Pathways for
Quality Healthcare'', provides guidance to purchasers, payers,
practicing clinicians, and regional or community-based collaborations
seeking to improve the quality, safety, effectiveness and efficiency of
healthcare in their markets through the use of HIT and health
information exchange.
The Framework provides staged guidance in four focus areas related
to aligning goals for quality healthcare: (1) quality capabilities; (2)
HIT capabilities within the physician practice; (3) health information
exchange capabilities; and (4) financial incentives.
The following summarizes at a high-level the three phases of
evolution:
In Phase I, rewards would primarily focus both on the
reporting of measures that rely on manual chart abstraction and
claims data and physician usage of standards-based,
interoperable HIT applications with certain basic
functionalities.
In Phase II, rewards would focus on the reporting of
measures that rely on clinical data sources; connectivity of
standards-based, interoperable HIT applications to clinical
data sources to support information needs at the point of care;
and physician usage of HIT with more advanced functionalities.
In Phase III, rewards would focus on performance against
process and outcomes measures, while phasing out rewards for
HIT.
Ongoing (ex-post) incentives that can be utilized for financial
incentives include the following:
Bonus or ``add-on'' payments--an addition to the normal
payment--for HIT in accordance with the criteria included in
the Framework.
A portion of the pay-for-performance incentive is directed
to HIT adoption--higher in the early years, lower (and
eventually phased out) in the later years.
Payment for structured e-mail consultations or other
telehealth services.
Chronic care management fees.
Upfront (ex-ante) incentives that can be utilized to defray some of
the up-front infrastructure costs associated with the initial adoption
of standards-based, interoperable HIT, include the following:
Seed funding provided by governmental, philanthropic or
private sector contributors.
Advance payment of future services from health information
exchange initiatives or clearly articulated expectations and
commitments from clinicians.
Low cost or guaranteed loans.
Tax incentives.
It is expected that value will continue to increase through each
stage to purchasers and payers who engage in the implementation of the
Framework.
In the first phase, the staged Framework will enable
purchasers and payers to clearly articulate and communicate a
common set of expectations through a staged process. The
Framework provides clinicians with the tools needed to improve
performance in the early years and that ultimately results in
payment for outcomes. Immediate gains in quality and safety
will be achieved, as documented by several market experiments.
In the second phase, the efficiency, timeliness, and
accuracy of reporting will significantly improve with the
reduction in the use of manually extracted chart information
and claims data in the calculation of measures and the increase
in the use of clinical data derived from electronic sources.
The type and number of measures required can be increased based
on the more robust HIT infrastructure. Increased gains in
quality, safety and efficiency should be achieved given the
information available to the clinician at the point of care.
In the third phase, purchasers and payers can phaseout HIT
rewards and move to payment based on outcomes and performance.
A robust and flexible HIT infrastructure will be in place to
support evolving science and changing expectations of
purchasers, payers, providers, and consumers.
A detailed overview of the Framework is outlined below.
------------------------------------------------------------------------
Area of Focus Phase I Phase II Phase III
------------------------------------------------------------------------
Quality 1. Create an 1. Expand 1. Report
Capabilities environment that capabilities to achievement of
supports utilize clinical certain outcomes
improvements information. and processes.
quality and
safety.
2. Agree on and 2. Report
report common set measures that
of standardized leverage
measures to be expanded
reported over the clinical data
three phases capabilities.
based on the
National Quality
Forum set.
3. Leverage claims
data and manual
chart
abstraction.
------------------------------------------------------------------------
Physician 1. Direct usage of 1. Direct usage 1. Robust IT-
Practice HIT HIT by physicians of HIT with supported
Capabilities with certain expanded clinical
basic functionalities. environment
functionalities. supporting
chronic care
management.
2. Secure 2. Electronic
standards-based health record
connectivity with integrated
between HIT and decision support
clinical data and ability to
sources for lab, accept and
prescription and integrate
demographic data structured,
(health computable data
information from other
exchange). organizations.
------------------------------------------------------------------------
Health 1. Engage 1. Operate secure 1. Expand
Information practicing health services to
Exchange clinicians, information provide value to
Capabilities hospitals and exchange, making users as
other providers, available to all appropriate.
purchasers, authorized
payers and healthcare
consumers in organizations
health who agree to
information terms for
exchange information
initiative. sharing.
2. Launch health 2. Send
information standardized
exchange data to
capability using physician
agreed upon practices.
technical and
information
sharing
standards.
3. Develop 3. Send reports
sustainable model of quality
based on agreed- measures to
upon services. purchasers and
payers with
provider
consent.
------------------------------------------------------------------------
Financial 1. Reward use of 1. Reward use of 1. Reward
Incentives standards-based interoperable electronic
HIT. HIT with documentation of
connectivity improved
with clinical clinical
data sources. outcomes.
2. Reward 2. Reward 2. Phase out
reporting of reporting of rewards for HIT.
subset of expanded set of
measures based on performance
data primarily measures that
derived from require clinical
manual chart data sources.
abstraction and
claims.
------------------------------------------------------------------------
Value to 1. Communicate 1. Enhanced 1. Full migration
Purchasers common set of efficiency, to payment based
and Payers expectations and timeliness and on outcomes.
incremental accuracy of
roadmap for reporting.
getting to
outcomes.
2. Achieve 2. Improved 2. Flexible HIT
immediate gains ability to infrastructure
in quality. target areas in to support
need of focus. changing
expectations.
3. Significant
improvements in
quality, safety
and efficiency
------------------------------------------------------------------------
Stepping Through the Process
The following summarizes in detail, the staged approach for
aligning incentives with quality and efficiency goals, as well as the
HIT and health information exchange capabilities needed to support
these goals. As noted above, this incremental, staged approach
recognizes the various stages of evolution within each market including
the history of regional collaboration, focus on quality and performance
and HIT penetration. The phased approach allows for multiple natural
experiments to occur throughout the country, to determine the best
course of action, based on their current stage of evolution.
Phase I of the Framework
1. Quality Capabilities
Phase I of the framework begins to create an environment that
supports improvements in quality and safety. The intent of the Working
Group is not to create new measures of quality healthcare, but to align
with a common set of consensus-based standardized measures developed by
others (e.g., the National Quality Forum). The quality expectation in
this phase is that providers will electronically report a subset of
this adopted full set of quality and efficiency measures. The principle
is that providers are not being paid or rewarded for implementing HIT
systems in their practices, but they are given incentive to do so
because the only cost-effective method to electronically produce these
clinically-oriented quality data in the long-run is to implement such
systems. As providers become more capable of collecting and
transmitting this data electronically, the expectation is that they
will report the full set of quality measures adopted at this stage to
receive the full range of incentives.
2. Physician Practice HIT Capabilities
In the first phase, physicians are expected to directly interact
with standards-based HIT systems. These may be self-contained EHR
systems, prescription writers, and other forms of electronic
recordkeeping and healthcare process support systems. At this stage,
the ability of practices to purchase, install, train, and use HIT
systems is very much dependent on a means of justifying a relative
large outlay of time and money. Short term incentives can take many
forms, but must help to address the bolus of resources required to get
set up and started.
3. Health Information Exchange Capabilities
In the first phase, diverse stakeholders within the region or
community will be engaged to define common principles and priorities
for working together. Organizational and legal infrastructures as
appropriate, will be developed and information sharing policies will be
determined, based on emerging national standards. Technical models for
health information exchange will also be launched based on national
standards. A sustainable model for the financial and functional health
of the health information exchange capabilities will be developed and
agreed upon by stakeholders.
4. Financial Incentives
In the first phase, providers will be rewarded for the use of HIT
to electronically report a subset of quality measures (pay for quality
data). Although ``start-up'' incentives can take many forms, it is
appropriate, whether they take the form of up-front funding or back-end
payment, to base the reward on a common set of criteria that will focus
the providers' efforts in the direction of future stages of
development. One way to do this is to tie the rewards to the electronic
reporting of a subset of predetermined data elements which are thought
to be tied to the quality of care. Although at this stage the reward is
not dependent on the data showing that the quality of care has been
improved, it sets the stage for later phases that do so.
5. Value to Purchasers and Payers
In the first phase, purchasers and payers will be able to
communicate a common set of expectations that build over time and
establish an incremental roadmap for getting to payment for higher
quality outcomes. They will achieve immediate gains in the quality of
healthcare delivered and some cost savings, depending on the extent to
which HIT resources are implemented and used at this stage, while
laying the foundation for a robust infrastructure to support higher
quality, more efficient healthcare.
Phase II of the Framework
1. Quality Capabilities
In the second phase, providers are expected to report measures that
leverage their expanded clinical data capabilities to document improved
processes of care. Reports of clinical lab results that indicate that
the percentage of diabetic patients in a practice that has reached a
predetermined level of receiving a periodic Hemoglobin A1c test, is an
example of the performance improvements that can be documented.
2. Physician Practice HIT Capabilities
Advancement to the second phase of HIT capabilities requires secure
HIT connectivity with clinical data sources such as those associated
with lab and prescription data. Capabilities must include secure
communications with more than one other organization using national
standards (labs, pharmacies, hospitals, etc.). These capabilities not
only support the needs of purchasers and payers that provide
incentives, but also the information needs of clinicians at the point
of care.
3. Health Information Exchange Capabilities
In the second phase, a fully operational, secure health information
exchange capability is made available to all authorized healthcare
organizations who agree to terms of health information sharing. Sending
standardized data to physicians (from data sources such as labs,
pharmacies, and hospitals) becomes much easier to accomplish. Sending
reports of quality measures electronically to purchasers (with provider
consent under contract) can be done routinely.
4. Financial Incentives
In the second phase, providers who implement interoperable HIT with
connectivity and electronic reporting of a full set of measures,
including those that leverage clinical data source, are rewarded.
5. Value to Purchasers and Payers
In the second phase, reporting to purchasers and payers is more
accurate, efficient and timely. The ability of the data reporting to
target areas in need of focus is improved. Increases in the types and
level of data to support improvements should result in considerable
improvements in quality, safety and efficiency.
Phase III of the Framework
1. Quality Capabilities
In the third phase, providers are required to achieve certain
process measures and outcomes to receive rewards. Having built the
health information infrastructure with incentive support in Phases I
and II, the provider has many of the tools necessary to support a
transformed care delivery process.
2. Physician Practice HIT Capabilities
Movement to the third phase requires a robust IT-supported clinical
environment that supports clinical decision support and chronic care
management. The provider's electronic health record must integrate
decision support and have the ability to accept and integrate
structured, computable data from other organizations. It should be
noted that Phase III provides the opportunity to remove the artificial
barrier between clinical systems and administrative (billing) systems.
3. Health Information Exchange Capabilities
In the third phase, health information exchange initiatives and
organizations can expand services to support physician adoption of HIT
and quality improvement. Examples include the provision of electronic
access to evidence-based, national clinical decision support rules (for
integration with computer-aided decision support systems in EHRs).
4. Financial Incentives
In the third phase, providers are rewarded for the electronic
documentation of improved clinical outcomes as well as progress against
process measures. Purchasers and payers begin to phase out rewards for
HIT given that most of the HIT infrastructure has already been
developed and that getting to this phase requires providers to
effectively utilize interoperable, connected, clinical applications.
5. Value to Purchasers and Payers
The third phase enables full migration to payment based on
outcomes. It also enables a flexible HIT infrastructure to support
changing expectations (different or expanded measures). It should be
noted that the infrastructure required in the third phase has the
opportunity of enabling payers to move ``coding'' for reimbursement
into their adjudication processes through automation based on actual
clinical documentation. Re-engineering of reimbursement systems could
result.
Summary
Creating pay-for-performance and other incentive programs in the
marketplace that are not consistent with the principles in this
document can have negative consequences. Without common, agreed upon
pathways for moving forward, the transition of physician practices
toward electronic systems along with increasing performance
expectations will be confusing, difficult and costly. Providing a
process that clearly communicates purchaser and payer expectations over
time using a staged approach will help clinicians anticipate, prepare
and build the infrastructure required to achieve those expectations
over time.
Providing incentives for quality and efficiency without at the same
time, supporting the development of the HIT within physician practices
and health information exchange capabilities within regions and
communities to support improvement will result in the creation of
siloed systems that might be quite effective in producing performance
reports, but are not conducive to providing information back to
providers where it is needed most--at the point of care. In addition,
providing incentives for HIT alone, without connectivity expectations,
has the potential of simply automating the highly fragmented, paper-
based, ineffective system that exists today, wasting limited resources.
It should also be noted that the HIT and health information
exchange capabilities described in the Framework are suitable for many
needs, including those related to population and public health,
provision of patient-centric health information to consumers, clinical
research, performance reporting, and most importantly--delivery of
healthcare. All stakeholders within healthcare should strive to move
toward a common system--decentralized but based on national standards
and policies--to support our Nation's health and healthcare needs.
Next Steps: Where Do We Go From Here?
The eHealth Initiative and its Foundation intend to expand upon and
accelerate the adoption of the principles and Framework developed by
the Working Group through a wide range of activities in 2005 and 2006.
1. We will further develop the principles and policies
contained in the Framework. This work will be conducted through
eHealth Initiative Foundation's various stakeholder-focused
working groups, including the Working Group for Small
Practices, the Employer Purchaser Advisory Board, and the
Working Group for Connecting Communities (which is made up of
state, regional and community-based health information exchange
initiatives and organizations). In addition, a health plan-
focused group will be organized to facilitate significant input
from and collaboration with payers in the enhancement of the
Framework.
2. We will translate the principles and policies contained in
the Framework into practical ``how to'' guides, detailed
policies, and tools that will support understanding and
implementation by healthcare purchasers, business coalitions,
health plans, practicing clinicians, and health information
initiatives/organizations in markets across the United States.
One of the tools that will emerge from this work will include
detailed technical specifications (using nationally accepted
data standards) for ambulatory performance measures that are
emerging from the National Quality Forum's consensus process.
We will also develop various tool-kits and guides to support
the implementation of those measures both within physician
offices and by health information exchange initiatives. The
guides and tools developed will leverage the work of Federal
agency-commissioned projects related to standards, the work of
Connecting for Health and other national standard-setting
initiatives both within the public and private sectors and be
supported by eHealth Initiative Foundation's various
stakeholder-focused working groups, including the Working Group
for Small Practices, the Employer Purchaser Advisory Board, and
the Working Group for Connecting Communities.
3. We will support implementation through both funding and
providing technical assistance to a set of pilot projects or
``market experiments'' that test and evaluate various
components of the Framework. These same pilot projects will
also implement and evaluate the technical and information
sharing policy deliverables that emerge from Connecting for
Health. This work will be conducted through the eHealth
Initiative Foundation's Connecting Communities for Better
Health Program. The challenge award process will be announced
this summer.
4. We will conduct working meetings and symposia designed to
facilitate dialogue and learning among healthcare stakeholders
that are experimenting with incentives around quality and HIT
in their markets to further inform and enhance the Framework,
through the Working Group for Financing and Incentives.
5. We will utilize the policies and principles contained within
the Framework to inform emerging policy vehicles at the Federal
and State levels, through eHealth Initiative's Policy Working
Group. It is anticipated that a number of policy vehicles will
emerge during 2005. We will work to educate policymakers on the
principles and components of the Framework to assure that goals
around HIT and quality/safety are integrated.
6. We will utilize the insights gained from each of the above-
identified activities to enhance the Framework through the
Working Group for Financing and Incentives. The Working Group
will continue to serve as the ``hub'' for this work,
synthesizing the input and learning derived from each of the
above-identified activities, to continually enhance the
Framework and principles.
7. We will widely disseminate the Framework, through a wide
range of vehicles including eHealth Initiative's diverse and
influential membership, AHRQ's National Resource Center for
Health Information Technology, targeted outreach to key groups
and associations, eHealth Initiative's Connecting Communities
for Better Health Program conducted in cooperation with DHHS;
our State and Regional HIT Policy Summit Initiative; targeted
outreach to policymakers at the Federal and state levels, and
general public relations activities.
Conclusion
We are at a unique point in time, where public and private sector
interests are at an all-time high in two key areas: improving the
quality and safety of healthcare and moving forward on a health
information technology agenda. Approaching these two key issue areas in
a siloed manner--without strong integration across both areas--will
result in missed opportunities, unintended consequences, and possibly
reduced impact in both areas. By laying out an integrated, incremental
strategy, which incorporates goals related to quality, safety, and
efficiency as well as health information technology and the
mobilization of data across organizations, the principles and Framework
included in this document offer the foundation for building a
healthcare system that is safer, of higher quality, and more effective
and efficient. In addition to offering guidance to stakeholders
involved in these two areas of interest, it also develops a framework
for dialogue regarding how incentive programs can be designed for
integration.
Over the coming months, the eHealth Initiative and its Foundation
will work closely with all key stakeholders--including practicing
clinicians, purchasers, health plans, hospitals, healthcare IT
suppliers, consumer groups, policymakers at the national and state
level, and other key constituencies, as well as other non-profit and
government groups focusing in this area--to further develop the
Framework and principles, test their effectiveness in markets across
the United States, and widely disseminate their results to build
awareness and support implementation.
______
American Osteopathic Association
Washington, DC, June 27, 2005
Hon. John Ensign,
Chairman,
Senate Subcommittee on Technology, Innovation, and Competitiveness,
Commerce, Science, and Transportation Committee,
Washington, DC.
Dear Chairman Ensign:
As President of the American Osteopathic Association (AOA), I want
to thank you for conducting a hearing to explore the value of health
information technology (HIT) in improving the safety, quality, and
efficiency of the health care delivery system. The AOA, which
represents the Nation's 54,000 osteopathic physicians practicing in 23
specialties and subspecialties, extends its sincere gratitude to you
for your leadership on this important issue.
Osteopathic physicians provide care to millions of patients each
year. Care ranges from basic office visits to complex procedures. As an
organization and individual physicians, we continually strive to
improve the safety, quality, and efficiency of care provided. HIT has
the potential, if developed and implemented with the patient-physician
relationship as a core component, to be an invaluable tool in a
physician's arsenal of care. The AOA remains committed to advancing the
development of HIT.
In December 2003, President Bush signed the ``Medicare Prescription
Drug, Improvement, and Modernization Act of 2003'' (MMA) (Pub. L. 108-
173) into law. The Act, which contained electronic prescribing (e-Rx)
provisions, served as a catalyst for efforts to develop and utilize
technologies to improve the delivery of health care. Since enactment of
Pub. L. 108-173, rapid development and adoption of HIT has been
advanced through Congressional activities such as hearings and the
introduction of legislation, the creation of the Office of the National
Coordinator for Health Information Technology (ONCHIT), and other
regulatory activities. Additionally, the private sector and physician
organizations have undertaken activities aimed at fostering the
development and implementation of HIT. It is paramount that all
stakeholders remain involved in the dialogue.
There are numerous parties driving the development of HIT. Overall
success will be contingent upon the interoperability and functionality
of systems put in place. Efforts must be advanced to ensure that
software and hardware used throughout the healthcare system are
interoperable. There is no benefit to be found in the utilization of
systems unable to communicate with others. Systems developed and
implemented must not compromise the essential patient-physician
relationship. Medical decisions must remain in the hands of physicians
and their patients.
The AOA appreciates the potential benefits provided by the adoption
of HIT. We remain committed to advancing the utilization of technology
in the practice of medicine. However, we urge a moderated approach to
ensure measures do not create unintended consequences. There are
various issues that must be addressed to allow for the successful
adoption of HIT. To this end, existing Federal regulations and laws
should be reviewed to ensure they do not serve as impediments to the
adoption and utilization of technology in the healthcare delivery
system. In addition, attention must be paid to costs associated with
acquiring and maintaining HIT. These concerns are compounded in small
practices and rural and underserved areas where physicians are unable
to benefit from economies of scale and infrastructure may present
additional hurdles. Furthermore, patient confidentiality must be
protected at all levels. If done with careful deliberation and
consideration for the various issues that arise with creation of
standards and implementation, HIT has the potential to be a driving
force in enhancing the safety, quality, and efficiency of the
healthcare delivery system.
The AOA will continue to work with Congress, regulatory bodies, and
other interested parties to ensure patients continue to benefit from
the development and implementation of HIT systems. On behalf of my
fellow osteopathic physicians, thank you for conducting this important
hearing. The AOA applauds your commitment to advancing the utilization
of health information technology. Please do not hesitate to call upon
the AOA or our members for assistance on this and other health care
issues.
Sincerely,
George Thomas, D.O.,
President.
______
Prepared Statement of the Institute of Electrical and Electronics
Engineers--United States of America (IEEE-USA)
IEEE-USA and its Medical Technology Policy Committee commends the
Subcommittee on Technology, Innovation, and Competitiveness for
examining how information technology can be applied in the medical
industry to reduce medical errors, lower healthcare costs and improve
the quality of patient care. We are pleased to offer the following
statement for the June 30 hearing record.
IEEE-USA supports the advancement of eHealth and its potential of
providing improved information flows. We believe that promoting the
common use of information technologies across the Nation to reduce
medical errors and delineate quality metrics of health information,
combined with interoperability and standards adoption, can lower costs
and improve outcomes. In addition, national health threats--such as
biological, chemical and nuclear terrorist attacks--require uses of
these technologies for purposes of detection planning, preparedness and
response.
eHealth needs to be approached recognizing the needs of patients
and implemented with consumer approaches that have been successful in
other economic sectors. These approaches range from language usability
to rating systems that will aid purchasers in the determination of
quality. We support implementation of technology to promote patient
health, but understand that without clear guidelines, standards and the
removal of barriers such as syntactic and semantic interoperability and
privacy, security and confidentiality concerns, the goal will remain
elusive.
Major goals for improving the health care system in the U.S. are
improving patient safety including reducing errors; improving the
interoperability of health information systems; and improving the
capability for exchanging patient information while increasing the
effectiveness and containing costs. Federal reimbursement policies need
to reflect the contributions of information technologies for improving
the quality of the healthcare system.
The balance of this statement offers our recommendations on three
related subjects: how to build the National Health Information Network
with an appropriate emphasis on security and privacy, the use of
voluntary health care identifiers, and appropriate roles for government
in promoting the development of home healthcare technologies.
Building the National Health Information Network
IEEE-USA advocates transitioning from our current state of
disconnected health information systems to a National Health
Information Network (NHIN) that would make use of leading-edge
networking technologies, such as web services, mobile communications,
and multimedia communications to provide secure and reliable transport
of healthcare information. To that end, IEEE-USA makes the following
recommendations to the Department of Health and Human Services, the
Office of the National Coordinator for Health Information Technology,
legislators, administrators and healthcare regulators:
1. Transition to the desired National Health Information
Network should be accomplished by building upon existing
systems by increasing the reliability, availability and
security of these networks. To the extent feasible, the NHIN
should support appropriate authorization for access to the
distributed nature of health information where it currently
resides. It should not rely upon developing and maintaining
new, government-controlled, centralized databases or personal
health information repositories.
2. Economic policies covering provider expense for transition
to the National Health Information Network and adopting an
electronic health record should be favorably designed to
facilitate provider conversion.
3. Development of the National Health Information Network
should not compromise the security and privacy of personally-
identifiable health information, as currently defined in the
HIPAA Privacy and Security Final Rules.
4. Use of the National Health Information Network should adhere
to the guidelines on use of genetic information cited in IEEE-
USA's position statement on ``Non-discrimination in Employment
Based on Genetic and Other Health Information,'' August 2002.
5. The National Health Information Network should implement the
capability to provide public warnings about bio-terrorism,
epidemic disease, safety and efficacy of vaccines, etc.
6. The National Health Information Network should encourage
patient access to medical records and establish ``cradle to
grave'' longitudinal medical records.
7. The standard of such ``cradle to grave'' records should not
be restricted to data pertinent to acute care settings, and
should include key data fields from long-term care's minimum
data set to make such records useful throughout the different
care settings, including long-term care.
8. The National Health Information Network should develop and
implement metrics to document the costs, benefits and
unintended favorable and adverse impacts of sharing healthcare
information and electronic health records.
9. The NHIN should support Federal and state government public
health surveillance activities--relative to reportable
diseases, health conditions, injuries and risk factors. It
should enable these respective public health authorities to
secure necessary statistical data by providing a direct means
by which they could trace the reports back to individual health
providers, and an indirect means by which individual patients
could be contacted, if needed, for epidemiologic investigation.
10. The National Health Information Network should be
supportive of quality control efforts at institutional, state
and national levels by having a means by which quality control
staff at all three levels can obtain appropriate authorization
to access current statistical data for comparison with like
facilities, baselines and benchmarks.
11. The NHIN should have a provision so that appropriately
authorized persons in academic and governmental settings can
access detailed statistical data for research purposes.
12. The NHIN should support individually-specifiable privacy
preferences for all healthcare consumers. It should include
provisions so that patients could indicate their willingness or
unwillingness to be solicited as subjects of medical research
by authorized investigators from academic and governmental
agencies.
Development of a National Health Information Network would require
a joint effort by Federal, state and local governments and the private
sector. Working jointly would increase interoperability, reduce risk,
and ensure that a competitive market existed for products intended for
producing healthcare services in a networked environment. However,
creating a NHIN also creates new requirements for reliability,
availability and maintaining healthcare information privacy and
security.
For additional information, see IEEE-USA's position statement on
the National Health Information Network, with emphasis on Security and
Privacy Issues at: http://www.ieeeusa.org/policy/positions/NHIN.asp.
Use of Voluntary Healthcare Identifiers
IEEE-USA believes that the use of voluntary healthcare identifiers
can significantly enhance healthcare efficiency and patient safety.
Consistent with the framework of the HIPAA legislation, IEEE-USA
recommends that legislators and regulators develop and implement
policies to create a Voluntary Healthcare Identifier Program and
establish demonstration projects to document these benefits.
Policies needed to facilitate adoption include:
Congressional authority and resources for the Department of
Health and Human Services and the National Committee on Health
and Vital Statistics to develop and maintain a Voluntary
Healthcare Identifier System;
Strong penalties, including monetary, civil and criminal for
privacy and security abuses;
Safeguards against current or future unintended use of the
information; and
Incentives for healthcare stakeholders to encourage adoption
of Voluntary Healthcare Identifiers.
For additional information, see IEEE-USA's position statement on
the Voluntary Healthcare Identifier at: http://www.ieeeusa.org/policy/
positions/healthcare
identifier.html.
Promoting Development of Home Healthcare Technologies
IEEE-USA urges Congress and policymakers, in both the public and
the private sector, to take the actions needed to expand uses for
electronic devices, assistive and monitoring software, and home health
communication technologies to provide home health care to those in
need. Further, we support developing guidelines for reimbursement of
these technologies--both for developers and users.
IEEE-USA believes that using electronic technologies to assist and
monitor elderly, disabled, and chronically ill individuals in the home
can improve quality of life, improve health outcomes, and help control
health care costs.
Accordingly, IEEE-USA supports:
Public and private sector research on the effectiveness,
cost-efficiency, and potential return on investment for each
class of home care technology; and research on how such
technological innovations can best be integrated into a
comprehensive package for home health care.
Tax incentives to stimulate research, development and
deployment of home care technologies.
U.S. Department of Health and Human Services' Centers for
Medicare and Medicaid Services action to streamline and
expedite exemption, clearance and approval processes for home
care technologies. Reimbursement should not be limited to U.S.
Food and Drug Administration approved devices.
Medicare and other health insurance carrier action to
provide reimbursement for home care technologies that meet
specified qualifications (see Background).
For additional information, see IEEE-USA's position statement on
home healthcare technologies at: http://www.ieeeusa.org/policy/
positions/health
technologies.asp.
Conclusion
IEEE-USA strongly believes that implementation of information
technologies into the national healthcare infrastructure will advance
clinical care, drive economic efficiencies, facilitate the linkage of
fragmented systems and provide consumers access to information by which
they can better understand and address their own healthcare needs.
Policy barriers, implementation impediments and funding limitations
have slowed or limited adoption by healthcare stakeholders of complex
information databases, electronic medical records and advanced
communication technologies. At times the barriers have seemed
impenetrable, but with the current attention of Congress, the White
House, the Department of Health and Human Services, regulators and
private industry, we are hopeful progress can be made.
IEEE-USA is an organizational unit of the IEEE. It was created in
1973 to advance the public good and promote the careers and public
policy interests of the more than 220,000 technology professionals who
are U.S. members of the IEEE. The IEEE is the world's largest technical
professional society. For more information, go to http://
www.ieeeusa.org.
______
CRF, Inc.
Waltham, MA, July 7, 2005
Hon. John Ensign,
Chairman,
Senate Subcommittee on Technology, Innovation, and Competitiveness,
Commerce, Science, and Transportation Committee,
Washington, DC.
Senator Ensign,
I am writing regarding the Commerce Committee's Subcommittee on
Technology, Innovation, and Competitiveness recent hearing on ``eHealth
Initiatives.'' We at CRF, Inc. are pleased that your Subcommittee has
devoted the time and attention to this important topic. Upgrading
America's healthcare system will require a thorough understanding of
the technologies that exist to improve patient health and safety. The
distinguished panel of witnesses addressed many of these issues.
However, as often happens, the discussion focused almost exclusively on
electronic health records. While electronic health records are an
important part of a 21st century healthcare system, there are other
important technologies to consider as well, such as electronic patient
diaries.
Electronic patient diaries (eDiaries) are handheld devices used
primarily in clinical trials to exchange information between patients
and clinical teams. These devices make it easier for patients to report
on their health over the course of a clinical trial and play a critical
role in increasing the reliability and safety of clinical drug trials,
assuring that high-quality drugs make it on the market in timely
manner. .
Currently, many clinical studies are conducted with paper diaries,
where patients record their experiences with a medication by hand each
day. There are numerous problems involved with using paper diaries in
drug trials including a low rate of patient compliance, which has
serious implications on the reliability and accuracy of clinical trial
data. Traditional paper diaries have compliance rates of 11 percent to
60 percent as measured by when the patient entered the data versus when
they should have entered the data. In contrast, eDiaries have very high
rates of compliance--over 90 percent in most cases. Furthermore, the
comfort level patients have with eDiaries leads to regular data entry,
resulting in a strong level of consistency in electronic information
and more valid trial results.
Recent drug recalls have illustrated all too well the risks
involved with unreliable or inaccurate trial data. In addition to
offering far superior compliance rates, eDiaries provide real-time
patient monitoring, which allows the immediate identification of
dangerous side effects. eDiaries directly benefit patients and the
American public by ensuring safe and efficient clinical trials.
eDiaries have been proven to make a tremendous difference in data
accuracy, trial safety and efficiency, which clearly impacts the
findings of clinical trials as well as has positive implications for
the final drug product. eDiaries also are providing an easy-to-use,
cost-effective means to capture important patient health information
and enable timely sharing and communication between patients and their
physicians.
CRF, Inc. is the market leader in eDiaries, providing diaries to 13
of the top 20 pharmaceutical companies and connecting more than 100,000
patients across 58 countries and in 48 languages. In any future eHealth
endeavors, we would welcome the opportunity to be a resource for your
office. If you have questions about electronic patient diaries or CRF's
work, please do not hesitate to contact us.
Sincerely,
Pam McNamara,
Chief Executive Officer.
______
Prepared Statement of Dr. Rose Marie Robertson, Chief Science Officer,
The American Heart Association; Professor of Medicine, Vanderbilt
University Medical Center
My name is Rose Marie Robertson, and I am a cardiologist, a
Professor of Medicine, and the Chief Science Officer of the American
Heart Association. On behalf of the American Heart Association and its
more than 22 million volunteers and supporters, I am pleased to submit
this statement for the hearing record. We wish to thank the Senate
Committee on Commerce, Science, and Transportation Subcommittee on
Technology, Innovation, and Competitiveness for the opportunity to
submit written testimony regarding the importance of health information
technology and Congress' potential role in promoting and supporting
health information technology initiatives.
Overview
Since 1924, the American Heart Association has dedicated itself to
reducing disability and death from cardiovascular diseases, including
stroke, through research, education and advocacy. Providing widespread
access to effective, credible scientific information is vital to our
mission. The American Heart Association and the American Stroke
Association, a division of the American Heart Association, actively
participate in efforts to improve the delivery of cardiovascular health
care by promulgating scientifically-based standards and guidelines,
sponsoring and overseeing clinical research, publishing peer-reviewed
journals, and researching and developing programs to assist providers
and patients.
Two forms of cardiovascular disease, heart disease and stroke, are
the first and third leading causes of death in the United States. Some
60 million Americans--about one in five--suffer from some form of
cardiovascular disease, ranging from high blood pressure to myocardial
infarction, angina pectoris, stroke, congenital vascular defects and
congestive heart failure. The estimated annual direct and indirect cost
to the Nation of these diseases is approximately $400 billion.
The use of health information technology presents a number of
important opportunities to improve the lives of Americans by enhancing
their access to efficient and appropriate health care services for the
prevention, diagnosis and treatment of cardiovascular diseases,
including stroke.
Health Information Technology Can Address Barriers to Care
Although the United States health care system is among the best in
the world, a number of researchers--including those at the Institutes
of Medicine (IOM) and the U.S. Department of Health and Human Services'
Agency for Healthcare Research and Quality (AHRQ)--have documented
serious shortcomings in our Nation's health care system.
Important concerns exist regarding the fragmented nature of our
health care system and the resulting barriers to effective
communication among the various providers who treat each patient. For a
multitude of reasons, patients often do not receive the full scope and
level of recommended care that is well-described in the existing
clinical literature and the national treatment guidelines for
cardiovascular disease, stroke and other serious diseases.
In its March 2005 report to Congress, the Medicare Payment Advisory
Commission (MedPAC) echoed many of the concerns raised by IOM, AHRQ,
and others about the these serious shortcomings in our health care
system. In their report, MedPAC highlighted the important role that
health information technology systems can play in improving health
care. Too often, the strategies and services that we know will improve
patient outcomes (including such basic interventions as treating high
blood pressure to goal levels) are not being translated into the day-
to-day lives of patients in the United States.
Potential Solutions Through Health Information Technology
Wider use of health information technology systems is critical to
the improvement and success of our Nation's health care system, and
ultimately, ensuring improved health outcomes for Americans. Health
information technology is already helping to improve the efficiency of
the health care system and to ensure that providers have comprehensive
and up-to-date clinical records to facilitate their clinical decision-
making. Health information technology is providing powerful tools to
help improve health care efficiencies by connecting providers and
facilitating the coordination of care.
Health information technology also has the potential to improve
patient care by incorporating tools that support and assist providers
in making clinical decisions. Such clinical decision support tools
integrate state-of-the-art clinical knowledge and practice guidelines
with patient-specific clinical information.
We applaud the Subcommittee's interest in health information
technology. To further innovation and significantly improve the
delivery of health care, we urge the Subcommittee to consider
legislative proposals that facilitate the adoption of health
information technology and that include provisions fostering the
integration of clinical decision support tools into this technology.
Properly designed clinical decision support tools can provide many
benefits to providers and their patients. Such tools can provide
physicians and other health care professionals with the ability to
review relevant patient data in ``real time'' with integrated prompts
that reflect well-established treatment guidelines for patients. These
programs do not dictate physician practice, but rather assist
physicians and other providers in remembering and considering the
clinical options that are most likely to be of proven benefit. In
addition, such tools can provide a continuous quality improvement
function, which can allow providers to compare their improvements in
achieving performance measures over time and to compare their
performance against averages for providers of similar size and
resources. Finally, such tools can facilitate communications between
the various providers who care for each patient.
One successful example of a clinical decision support tool is Get
With the Guidelines, a program developed by the American Heart
Association and in use by over 800 hospitals today. \1\
---------------------------------------------------------------------------
\1\ Honore T. American Heart Association's hospital-based quality
improvement program receives award from Health and Human Services
Secretary Tommy Thompson. AHA News. 2004 (December 13, 2004).
Get With The Guidelines provides integrated, real-time
prompts based on the American Heart Association's scientific
guidelines. These prompts remind physicians and other members
of the care team, in real time, of specific, evidence-based
treatment interventions to consider as they review each
patient's clinical information and develop a treatment plan
---------------------------------------------------------------------------
prior to hospital discharge.
Get With The Guidelines also supports continuous quality
improvement activities that allow providers to compare current
treatment data against both their own past performance and
aggregate benchmarks from other providers.
As demonstrated in the clinical literature, the combination of
these functions results in significantly improved patient care and
outcomes. \2\ \3\ \4\
---------------------------------------------------------------------------
\2\ LaBresh KA, Ellrodt AG, Gliklich R, Liljestrand J, Peto R. Get
With The Guidelines for cardiovascular secondary prevention: pilot
results. Archives Internal Medicine. 2004;164:203-209.
\3\ Berthiaume JT, Tyler PA, Ng-Osorio J, LaBresh KA. Aligning
financial incentives with ``Get With The Guidelines'' to improve
cardiovascular care. The American Journal of Managed Care. 2004;10:501-
504.
\4\ LaBresh KA, Gliklich R, Liljestrand J, Peto R, Ellrodt AG.
Using ``Get With The Guidelines'' to improve cardiovascular secondary
prevention. Joint Commission Journal on Quality and Safety.
2003;29:539-550.
---------------------------------------------------------------------------
The United States has reached a critical point in the formation and
implementation of health information technology initiatives. We commend
this Subcommittee for its foresight in investigating potential
initiatives and opportunities to foster health information technology
development.
At this critical juncture, we urge the Subcommittee and Congress to
ensure that the momentum and innovation in the health information
technology area continues to accelerate, resulting in widespread use of
health information technology. Nonetheless, it is imperative that the
Congress find ways to minimize the burden of such systems on providers,
especially small providers and those institutions caring for low-income
patients.
The American Heart Association has enthusiastically endorsed the
Health Information Technology Act of 2005, S. 1227, introduced by
Senators Snowe and Stabenow and the Better Healthcare Through
Information Technology Act of 2005, S. 1355, introduced by Senators
Enzi and Kennedy. These bills include grant programs and other
initiatives that would promote investment in health information
technology programs. These bills also include provisions that would
foster the integration and use of meaningful clinical decision support
tools within health information technology systems.
Conclusion
On behalf of the millions of American Heart Association
professionals, volunteers and donors, I sincerely thank the
Subcommittee for its interest in health information technology systems.
The innovative use of health information technology has the ability to
dramatically improve the health outcomes of Americans, including those
with heart disease and stroke--the number one and number three causes
of death among Americans.
As Congress considers initiatives to develop and implement
innovative health information technology, we urge you to promote
systems that take full advantage of the tools that health information
technology can support, including clinical decision support tools.
Integration of patient-specific clinical data with well-established
treatment guidelines and ongoing continuous quality improvement
functions are essential to ensuring that these systems reach their full
potential in providing effective assistance to physicians and other
providers.
______
Prepared Statement of the Pharmaceutical Care Management Association
Introduction
PCMA is the national association representing America's
pharmaceutical benefit managers (PBMs). PCMA represents both
independent, stand-alone PBMs and health plans' PBM subsidiaries.
Together, PCMA member companies administer prescription drug plans that
provide access to safe, effective, and affordable prescription drugs
for more than 200 million Americans in private and public health care
programs. PCMA appreciates the opportunity to submit testimony.
PCMA strongly supports the role health information technology can
play in ensuring patient safety, reducing costs and creating a more
efficient health care system. As leaders in developing workable
information technologies for pharmacy benefits, PBMs have developed
sophisticated systems for allowing real time fulfillment of
prescriptions at the pharmacy counter and drug utilization review
systems that notify pharmacists of potential drug to drug interactions
based upon an individual's medication history. PBMs combine these
technologies in ePrescribing so doctors can directly link to a pharmacy
and purchaser without the need of a pen and pad.
Value of ePrescribing
In the 2004 eHealth initiative report titled ``Electronic
Prescribing: Toward Maximum Value and Rapid Adoption'' it is stated
that Americans made more then 823 million visits to physicians' offices
in 2000 and, according to the National Association of Chain Drug Stores
(NACDS), four out of five patients who visit a doctor leave with at
least one prescription. More than 3 billion prescriptions are written,
and prescription medications are used by 65 percent of the U.S. public
in a given year. The study goes on to state that 25 percent of patients
who received at least one prescription reported an adverse drug event,
and 39 percent of these events were deemed either ameliorable or
preventable.
Electronic prescribing can help prevent medication errors because
it instantly connects the health care provider, the pharmacy, and the
payers. Patient medication history and insurance information can be
available for the physician when prescribing and, at the pharmacy, each
prescription can be checked electronically for dosage, interactions
with other medications, and therapeutic duplication. Patient safety can
also be improved through avoiding hard-to-read physician handwriting
and by automating the process for determining drug interactions and
allergies.
Eprescribing can also improve efficiency and reduce costs by
providing information about the formulary, including lower-cost
generics, and co-pay information. It can help ensure that patients and
health professionals have the best and latest medical information at
hand when they make important decisions about medicines, helping
patients get the most benefits at the lowest cost. In addition,
eprescribing shows promise in creating efficiencies in the physician's
office and the pharmacy. This can be done by reducing the costs
associated with patient eligibility checks and creating timely
interfaces with formularie s to make sure the correct drug is
prescribed the first time.
One Uniform Eprescribing Standard
PCMA believes that creating unified eprescribing standards through
appropriate and full preemption of state laws is a critical component
to the ultimate success of health IT initiatives, including
eprescribing. State laws and regulations, if they deal with
eprescribing, tend to make the eprescribing process less efficient, or
even illegal, and therefore not likely to be utilized by payors,
physicians and pharmacists. [See Attachment] The National Association
of Boards of Pharmacy (NABP) model act states that electronic
prescriptions must be transmitted directly to the pharmacy ``with no
intervening person or third party having access to the prescription
drug order.'' For those states that have adopted this language, this
would mean that electronic prescriptions that convey any formulary
information or comprehensive medication history would not be allowed.
With the increased attention on the value information technology
(IT) can provide the health care system, policymakers are becoming more
familiar with the barriers that exist to broad health IT adoption. An
often noted barrier to adoption is the possibility of numerous,
disjointed standards that directly impact how these systems will work
in the practice setting.
In fact, the Department of Health and Human Services (HHS) press
release in announcing the release of this proposed rule stated, ``The
current lack of common standards is a barrier to the use of health
information technology, including eprescribing.'' \1\ Also, HHS stated
in its Goals for a Strategic Framework for Health IT adoption ``the
government has made a commitment to using common standards and
architecture . . . The result will be a more cost-effective and
efficient healthcare system.'' \2\
---------------------------------------------------------------------------
\1\ ``Eprescribing proposed rule,'' Department of Health and Human
Services--Press Release.
\2\ ``Goals of Strategic Framework.'' Department of Health and
Human Services, Office of the National Coordinator for Health
Information Technology (ONCHIT).
---------------------------------------------------------------------------
The GAO has identified in its 2004 report, ``HHS Efforts to Promote
Health Information Technology and Legal Barriers to Its Adoption,''
specific barriers to adopting health IT include financial, technical,
and cultural aspects. Technical barriers, including a ``lack of uniform
standards for data submission and reporting'' clearly show that a
uniform standard is critical for the Federal Government to reduce or
eliminate as many barriers to adoption as possible.
Medicare Part D Eprescribing
The Centers for Medicare and Medicaid Services (CMS) issued an NPRM
to establish foundation standards for eprescribing that are expected to
go into effect at the start of the Part D program in 2006. \3\ All
health plans and drug plans must support eprescribing although
providers are not required to use eprescribing.
---------------------------------------------------------------------------
\3\ 70 FR 6256-6274.
---------------------------------------------------------------------------
The Medicare established eprescribing standards should be adopted
in a manner that does not require a standard-by-standard evaluation to
determine which individual state standard may or may not be preempted.
This would create a burdensome review to compare the Medicare standards
to that of each relevant state law and regulation to determine where
Medicare has created a standard and where it has not.
We believe CMS has the authority necessary to govern all electronic
prescription of any drugs included in the Part D program, so as to
ensure a single, national electronic prescription drug program that
would be adopted and used consistently by prescribers to the benefit of
Medicare and the rest of the health care system.
Examples of state eprescribing laws or regulations that are
burdensome include: requiring a fax or hard copy to follow an
ePrescription, prohibiting specific scheduled drugs, and prohibiting
interstate transmission of prescriptions.
With a large focus of resources and time needed by all partners in
the eprescribing system to overcome the obvious challenges of
prescriber start-up costs and broad education about the value
proposition of eprescribing, it is critical that the standards and
processes that make the technology function not add to this formidable
challenge.
In conclusion, we look forward to working with the Committee on a
common goal of an interoperable health information technology system,
particularly eprescribing, that can fully realize the benefits to
patients and the health care system.
2003-2004 National Association of Boards of Pharmacy Survey of Pharmacy
Law
XXII. Electronic Transmission of Prescriptions: Computer-to-Computer
----------------------------------------------------------------------------------------------------------------
Is Prescription Is Prescription Is Prescription Does Board
Transmission from Transmission from Is Prescription Transfer from Out- Recognize
In-state Out-of-State Transfer Between of-state Pharmacy Electronic
State Prescriber Prescriber In-state Computer to In- signatures for Non-
Computer to Computer to Pharmacy state Pharmacy controlled
Pharmacy Computer Pharmacy Computer Computers Computer Substance
Allowed? Allowed? Allowed? Allowed? Prescriptions?
----------------------------------------------------------------------------------------------------------------
Alabama Yes I Yes I Yes Yes No
Alaska Not addressed Not addressed Not addressed Not addressed No
Arizona Not addressed Not addressed Yes G Yes G Yes E
Arkansas Yes Yes Yes Yes No
California Yes Yes Yes Yes No
Colorado Yes I Yes I Yes I, M Yes I, M Yes
Connecticut Yes D, S Yes D, S Yes S Yes S Yes
Delaware Yes Yes Yes F Yes F Yes
District of No No No No No
Columbia
Florida Yes Yes Yes Yes Yes
Georgia No No Yes F Yes F No
Guam Not addressed E Not addressed E Not addressed E Not addressed E Not addressed E
Hawaii Yes W Yes W Yes W Yes W Yes W
Idaho No No Yes F Yes F Yes
Illinois Yes Yes H Yes M Yes M Yes S
Indiana H H Yes Yes ----
Iowa Yes Y Yes Y Yes B, F, M Yes B, F, M Yes L
Kansas Yes Yes Yes Yes Yes
Kentucky Yes I Yes I Yes K Yes K Yes
Louisiana Yes Yes Yes B Yes B Yes
Maine No No Yes F Yes F No
Maryland Yes Yes Yes M Yes M Yes J
Massachusetts Yes N Yes N Yes N Yes N No
Michigan Yes Yes O No No Yes
Minnesota Yes Yes Yes Yes Yes
Mississippi Yes Yes Yes Yes Not addressed
Missouri Yes Yes Yes Yes Yes A
Montana Yes Yes Yes Yes Yes
Nebraska Yes Yes Yes Yes No
Nevada Yes T Yes T Yes Yes Yes
New Hampshire Yes E Yes E Yes F, O Yes F, O Yes E
New Jersey No No No No No
New Mexico Yes Z Yes Z Yes S, X Yes S, X Yes
New York Yes P Yes P Yes P Yes P Yes
North Carolina Yes Yes Yes Yes Yes
North Dakota Yes Yes No No Yes
Ohio Yes R Yes R Yes M Yes M Yes R
Oklahoma Yes (Guidelines) Yes (Guidelines) Yes Yes Yes
Oregon Not addressed Not addressed Yes M Yes M E
Pennsylvania Not addressed C Not addressed C Yes Not addressed E
Puerto Rico Not addressed Not addressed Not addressed Not addressed ----
Rhode Island Not addressed Not addressed Yes F Yes F Not addressed
South Carolina Yes (Guidelines) No Yes Q No Yes
South Dakota No No Yes F Yes F Yes E, AA
Tennessee Yes Yes Yes Yes Yes
Texas Yes I Yes U Yes Yes U No BB
Utah No Not addressed No No Not addressed
Vermont Yes Yes Yes Yes Yes
Virginia Yes Yes Yes V Yes V Yes
Washington Yes Yes Yes N Yes N Yes
West Virginia Yes S, T Yes S, T Yes S, T Yes S, T No
Wisconsin Yes Yes Yes Yes Yes
Wyoming Yes Yes Yes Yes Yes
----------------------------------------------------------------------------------------------------------------
LEGEND
A--Electronic prescriptions recognized.
B--Regulations require pharmacist to perform certain functions.
C--Regulations are currently being considered and/or drafted.
D--Exclusive access or direct lines not allowed.
E--No rules at this time.
F--Only by pharmacies with a common electronic file.
G--Must comply with Rule R423-408.
H--Not prohibited.
I--No Schedule II substances allowed.
J--With proper security precautions.
K--Must fully comply with 201 KAR 2:165 and 21 CFR 1306.26, and
must be online, real-time transmission.
L--Electronic signature defined as ``Confidential personalized
digital key, code, or number used for secure electronic data
transmissions, which identifies and authenticates the
signatory.''
M--Must satisfy the requirements of state regulations for
prescription transferral. Stores that access the same records
electronically are not required to cancel the original
prescription.
N--Prescriptions may be transmitted intrastate and interstate
from pharmacy to pharmacy. If controlled substances, DEA rules
must be followed.
O--For non-controlled drugs.
P--With assurances for confidentiality of the electronic
message. No controlled substances.
Q--The transfer of prescription information for the purpose of
dispensing authorized refills is permissible between pharmacies
where all pharmacies are under common ownership and access
prescription information through a common computerized data
system, subject to subsection (G)(1)(c), (G)(2), (G)(6),
(G)(7), (G)(8), (G)(9), and (G)(10).
R--Prescription not valid unless Board-approved system assures
that only authorized prescribers have issued the electronically
transmitted prescription.
S--Electronic transmission of prescription requires same
verification as any oral or telephone prescription.
T--No access to the prescription information can be made by
other than the practitioner and the pharmacy.
U--For dangerous drugs only.
V--Pharmacist to pharmacist ``real time'' communication of
information found on or with prescription hard copy.
W--Under jurisdiction of Department of Health, Food and Drug
Branch.
X--Only during normal business hours.
Y--Specific rules regarding electronic transmission computer to
computer.
Z--Must comply with 16.19.6.23 of Board regulations.
AA--Allowed as long as pharmacist is satisfied with legitimacy
of signature.
BB--Prescriber signature not required.
______
Prepared Statement of the Advanced Medical Technology Association
(AdvaMed)
AdvaMed and its member companies would like to thank the Committee
for holding this important hearing on health information technology
(HIT). HIT promises to revolutionize the health care delivery system
and have a dramatic effect on patient safety, quality of care, and
efficiency. HIT products and applications are greatly expanding
throughout vital sectors of the American health care delivery system,
including clinical operations, decision support, devices, equipment,
distribution, administrative tasks, and the interface with payers. As a
result, HIT is helping to significantly reduce medical errors, improve
the quality of care, speed paperwork, and reduce administrative costs.
AdvaMed is the world's largest medical technology association
representing manufacturers of medical devices, diagnostic products and
medical information systems. AdvaMed's more than 1,300 members and
subsidiaries manufacture nearly 90 percent of the $75 billion of health
care technology purchased annually in the United States and more than
50 percent of the $175 billion purchased annually around the world.
Many of these technologies--such as electronic infusion pumps that
administer intravenous (IV) drugs, verify correct drugs, and check
dosages, as well as remote physiological monitoring (RPM) technology--
save lives and improve the quality of life for patients by preventing
medication errors and managing disease.
The Role of Technology
Universally interoperable electronic health record (EHR) holds
great promise in reducing health care costs and improving the quality
of care delivered to patients. The Department of Health and Human
Services (HHS) cites two studies that estimate savings from
implementing EHRs to be between $78 and $112 billion. HIT, however, is
expanding far beyond the EHR to include devices that are already
dramatically improving patient safety, quality of care and health care
efficiencies. Combined, the EHR and these other innovative technologies
will ultimately play a major role in reducing overall health care
costs.
The Advanced Medical Technology Association, AdvaMed, represents
the innovators of these smart medical technologies. Examples of these
innovations, which include:
Records
Application of computer-assisted physician order entry to
increase patient safety and health system efficiency.
Personal digital assistants (PDAs), hand-held devices that
allow doctors making rounds to immediately access each
patient's complete medical record.
Lab results that are stored and sent to physicians
electronically, which streamlines and speeds up testing and
retrieval.
Pharmacies that are receiving electronic prescription orders
from physicians. Pharmacists are prevented from filling orders
if critical patient data is missing, potential adverse drug
interactions are flagged, and medication alerts are issued for
high-risk medications. The electronic record of all of this is
available in real time by any authorized health care provider.
Devices
Infusion pumps that are preventing drug overdoses and
enabling hospitals to re-engineer their systems to avoid
medical errors.
Image-guided or computer-assisted surgery (CAS), which
allows surgeons to more precisely position their instruments
and to document the procedure. Procedures are shorter and less
invasive, and CAS appears to be improving quality of care and
reducing morbidity in some cases.
Devices with computerized components such as implantable
cardioverter-defibrillators (ICDs), which allow heart patients
subject to life-threatening cardiac arrhythmias to send vital
data to their physicians via a secure Internet connection.
Off-Site Monitoring and Communication
Remote monitoring technologies that are eliminating trips to
the doctor and enabling improved monitoring of patients with
chronic diseases and improved monitoring of intensive care unit
(ICU) patients.
Telemedicine to improve care, for instance, of both rural,
less accessible populations and urban populations.
Picture archiving and communication (PAC) systems, which
store and permit the transmittal of radiological images such as
X-rays when and where they are most needed.
Virtual patient visits via e-mail.
Improving Patient Safety
The Institute of Medicine estimates that 44,000 to 98,000 deaths
each year result from preventable medical errors in hospitals. Each
year, hundreds of thousands of preventable adverse drug events also
occur. Different studies find that there are errors in 24.9 percent of
hospital patient records. \1\ Other estimates, including one from the
Food and Drug Administration, indicate that as many as 372,000
preventable adverse drug events occur each year. \2\ These errors
result from administering incorrect dosages, errors in filling
prescriptions, and adverse drug interactions.
---------------------------------------------------------------------------
\1\ Terri Simmonds. ``Using The Trigger Tool to Detect Potential
Harm in Medication Management.'' Infusion Safety: Addressing Harm with
High-Risk Drug Administration. The ALARIS' Center for
Medication Safety and Clinical Improvement. San Diego, California.
2004, pp 10.
\2\ Steven Tucker. ``Analysis of Impact of the Food and Drug
Administration's Proposed Bar Code Label Requirements for Human Drug
Products and Blood.'' Hospital Pharmacy. 38 (11), Supplement 1, pp S11.
---------------------------------------------------------------------------
Recent studies on the impact of medical technology in reducing
medical errors have targeted IV drug administration and computerized
physician ordering systems. Technologies that support IV drug
administration prevent medication errors using automated dosage limits
and alerting systems. Electronic physician ordering systems and data
management software reduce transcription and dosing errors, promote
process standardization, increase access to patient-specific medical
information, and reduce laboratory turnaround time.
Case Study: Computerized Physician Order Entry
Late in 2003, the National Academies, the Nation's advisers on
science, engineering and medicine, released a report that strongly
recommended health care organizations adopt information technology
systems capable of collecting and sharing health information about
patients and their care. For some organizations, the first step may
involve computerized physician order entry (CPOE), which links the
health care worker with the facility's computer system to avert medical
errors.
CPOE can help physicians avoid errors because the doctor enters the
prescription on the computer. For example, handwriting errors and
missed decimal points should be a thing of the past. Also, a
computerized system can automatically alert the practitioner to past
drug allergies, potential drug interactions with medications the
patient is already taking, and incorrect dosing.
The 1999 Institute of Medicine (IOM) report, To Err is Human,
estimates 7,000 deaths from medication errors alone each year.
According to the Leapfrog Group for Patient Safety, more than a million
serious medication errors occur each year in U.S. hospitals; Leapfrog
estimates that computerizing prescriptions can reduce that number by 88
percent. Two Journal of the American Medical Association studies
concluded that about half of serious medication errors were the result
of ordering errors. \3\ \4\ These included inappropriate medications
for the patient's condition, an incorrect dosage considering the
patient's physiological state, such as renal problems or age, and
prescribing medications to which the patient was known to be allergic.
---------------------------------------------------------------------------
\3\ Bates DW, Cullen DJ, Laird N et al. Incidence of adverse drug
events and potential adverse drug events. Implications for prevention.
ADE Prevention Study Group. JAMA 1995;274:29-34.
\4\ Leape LL, Bates DW, Cullen DJ et al. Systems analysis of
adverse drug events. ADE Prevention Study Group. JAMA 1995;274:35-43.
---------------------------------------------------------------------------
Children's Hospital of Pittsburgh (Children's) launched
Children'sNet in October 2002. Since pediatric hospitals have a special
challenge with medication errors due to their patients' weights, POE
seemed the logical first step toward the hospital's goal of achieving a
completely electronic patient record.
Besides reducing weight-related adverse drug events, Children's
hoped CPOE would help in other areas. Health care regulatory bodies
often require compliance with specific standards in order for the
institution to reach certain benchmarks. Children's was challenged to
reach compliance with these goals:
1. Verbal orders had to be co-signed by physicians within 24
hours.
2. Respiratory therapists had to complete documentation in the
patient's record.
3. Physicians had to order nutrition screens.
Children's built these into its CPOE so the system would prompt
physicians or allied health professionals to address these concerns on
the spot. Finally, physician surveys at Children's showed that the
doctors were not happy with turn-around times for lab and diagnostic
tests.
The CPOE system at Children's consists of wireless computers on
mobile carts that can travel on rounds with the physician. Doctors can
show lab or diagnostic test results to parents at the child's bedside;
a charting function easily enables doctors to graph progress. Of
course, the calculator tool helps obtain a clear weight/dosing picture,
and its warning system provides an alert if a dose seems out of line,
based on predetermined standards.
In addition to the mobile computers, each floor also accommodates
four wall computers and, where possible, additional desktop computers.
These provide ample opportunity for allied health professionals to
complete their charts as well. As it completed its second year with
CPOE:
Children's has eradicated handwriting transcription errors
completely and cut harmful medication errors by 75 percent.
By electronically requiring that a child's weight be entered
before a medication order may be placed, Children's virtually
eliminated weight-related adverse drug events.
Both physician sign-off of verbal orders within 24 hours and
documentation by respiratory therapists have reached the 97
percent level. Physicians are now ordering nutrition screens 90
percent of the time.
Physician satisfaction with response times for lab and
diagnostic test results is much better.
Improving patient safety was Children's primary goal, but the
hospital staff soon learned that patients benefit in a variety of ways:
Clinicians are redirecting time previously spent on
administrative tasks to patient care.
Clinicians have instantaneous and reliable access to
information that enables better patient care, including lab
tests, imaging results, and drug information.
By enhancing the ability to provide better care, Children's has
created a safer environment.
Improving the Quality of Care
The concept of pay-for-performance is a growing trend as a way to
reward health care providers who efficiently deliver quality care to
their patients. Three types of measures are under consideration:
Structural measures: Based on the infrastructure within
which the provider operates, such as whether or not he or she
uses electronic prescription order entry.
Process measures: Based on adherence to accepted clinical
guidelines that improve care outcomes, such as prescribing beta
blockers to heart attack patients or successfully monitoring
and controlling high blood pressure or glucose levels.
Outcome measures: Based on care outcomes that result in
reduced morbidity or mortality. In myriad ways, health
information technology both helps health care professionals
deliver quality of care to their patients and provides an
automatic way to measure that delivery for a variety of
assessment purposes, including pay-for-performance incentive
remuneration.
Today's medical field is replete with illustrations of how HIT is
improving the quality of care for American patients. Quality of care
enhancers include remote patient monitoring, remote ICU oversight,
cardiac and implantable device monitoring, mobile telemetry of hard-to-
diagnose heart arrhythmias, expanding telemedicine possibilities and
decision support software that is helping physicians provide the right
care.
Case Study: Remote Patient Monitoring Increases Quality of Care
Remote patient monitoring (RPM) uses an electronic device in a
patient's home to assist with disease management. The device collects
data on the patient's condition and transmits analysis of those data to
a care delivery service that uses those data to communicate with and
monitor the patient. In addition, the devices can help providers
analyze that data to refine and improve ongoing monitoring activities,
make clinical diagnoses as necessary, and assess the need for
treatment.
With its ability to link patients to their doctors, remote patient
monitoring also is a particularly useful and increasingly more
important tool in providing rural health care. Patients typically use
electronic home monitoring devices once a day to collect basic
physiological data--such as weight, blood pressure, blood oxygen
levels, and heart rate--and to answer specific questions about their
condition. The patients' information is transmitted electronically to a
central monitoring station, where the data is analyzed by nurses and
care managers. These care managers can track early warning signs and
symptoms and contact patients, providing feedback, education, and
medication changes long before the patients need to be hospitalized.
Reducing Costs
By reducing duplicative care, lowering health care administration
costs and avoiding care errors, health information technology could
save approximately $140 billion per year, according to HHS. That is
close to 10 percent of total U.S. health care spending. Studies cited
by HHS in its 2004 Health IT Strategic Framework Report suggest the use
of EHRs can reduce laboratory and radiology test ordering by 9 percent
to 14 percent, lower ancillary test charges by up to 8 percent, reduce
hospital admissions ($16,000 average cost) by 2 percent, and reduce
excess medication usage by 11 percent. Two studies have estimated that
ambulatory EHRs have the potential to save all payers $78 billion to
$112 billion annually. HHS also cites evidence that EHRs have the
potential to reduce administrative inefficiency and paperwork.
Depending on the HIT technology involved, near-term return on
investment will vary in both time frames and resulting financial
margins. However, studies to date suggest that in the long-term, as HHS
notes, the economic benefits of HIT could be large.
For example, a study in the New England Journal of Medicine \5\
concluded that both costs ($26,325 vs. $35,283) and length of stay (10
days vs. 12.9 days) in an intensive care unit were reduced when the
CPOE system included suggested advice regarding antibiotic ordering.
---------------------------------------------------------------------------
\5\ Evans RS, Pestotnik SL, Classen DC, et al. A computer-assisted
management program for antibiotics and other anti-infective agents. N
Engl J Med. 1998;338:232-8.
---------------------------------------------------------------------------
Besides improving clinical outcomes, using remote Intensivists
(intensive care specialists) to monitor patients electronically from a
remote location as part of an ICU telemedicine program to supplement
in-house specialists also enhances hospital financial revenues,
according to a 2004 study in Critical Care Medicine.\6\ Although ICU
beds account for only 10 percent of total inpatient beds, the cost of
caring for ICU patients can exceed 30 percent of total hospital costs.
Due to this high cost of ICU care, improved clinical outcomes can
theoretically offset the costs of superior care.
---------------------------------------------------------------------------
\6\ Breslow MJ, Rosenfeld BA, Doerfler M, Burke G et al. Effect of
a multiple-site intensive care unit telemedicine program on clinical
and economic outcomes: An alternative paradigm for Intensivist
staffing. Crit Care Med 2004;32:31-38.
---------------------------------------------------------------------------
In the study, lower variable costs per case and higher hospital
revenues (from increased case volumes) generated financial benefits in
excess of program costs. Cost savings resulted both from a reduction in
the average length of stay in the ICUs (3.63 days vs. 4.35 days) and
from a decrease in daily costs. Both before and after the remote
telemedicine program was instituted, the ICUs had high occupancy rates.
But, the authors concluded, greater patient turnover during the
supplemental Intensivist program generated additional contribution
margins to the hospital.
Case Study: Digital Information System
Picture archiving and communication systems (PACS) enable
hospitals, imaging centers and multi-site health care organizations to
manage, store and transmit patient medical images such as digital X-
ray, MRI and CR images. Access to these images is fast and easy.
Combining this kind of technology with a digital patient information
system can pay significant financial dividends. Such a system shared by
several Boston-area hospitals reported saving an estimated $1 million
annually by, in part, reducing the time spent searching for files and
the time spent admitting patients. Projected annual income revenues
from better patient retention as a result range between $3 million and
$4 million.\7\
---------------------------------------------------------------------------
\7\ Networking Health: Prescriptions for the Internet, Institute of
Medicine, National Academy of Sciences, p. 81, 2000.
---------------------------------------------------------------------------
Call to Action: Policies That Foster HIT Adoption
To assure appropriate access to life-saving and life-enhancing
medical technologies for patients, AdvaMed believes that policies
should continue to evolve with technology and transform into a system
that supports technological advancement. AdvaMed supports developing
incentives that will overcome the barriers to implementation and foster
the timely adoption of these health information technologies (HIT).
Providers, payers, and HIT/medical technology manufacturers will all
have to address these barriers to enable interoperable, effective, and
efficient use of these technologies to improve the quality of care,
patient safety, and health outcomes overall.
In order for the dream of interoperable health information
technology to become a reality--for a universally accessible electronic
health record to become as ubiquitous and as commonplace as financial
ATM cards and supermarket ``courtesy'' cards--AdvaMed believes the
following must occur:
Regulatory Reform: Unless an exception is met, provisions of the
Federal health care program anti-kickback statute prohibit the offer or
acceptance of anything of value in return for patient or item/service
referrals. Likewise, unless an exception is met, the physician self-
referral law (the ``Stark'' law) bars hospitals from billing for items
or services provided by physicians who have financial relationships
with the hospital. An exception to Stark has been promulgated by the
Centers for Medicare and Medicaid Services for community-wide health
information systems.
The exception is not well defined or understood, however, and a
much broader, clearer exception is needed to cure the obstacles
presented by the Stark law. A parallel safe harbor to the Federal
health care program and anti-kickback statute is also necessary. These
barriers to the dissemination of resources (financial, equipment or
otherwise), such as a hospital financially supporting its referring
physicians in the acquisition and use of health information technology,
must be removed.
Without such reforms, these two laws represent huge obstacles that
will have tremendous chilling effects on any efforts, no matter how
broad, well financed, or well intentioned, to champion the use of HIT.
Standards: The FDA is currently revising its software regulation
policies. AdvaMed endorses the FDA's current policy, under which it
only regulates software if its output directly results in software-
directed treatment or diagnosis of patients. We also believe that the
FDA's regulation of any software associated with medical devices should
be risk-based and only at the minimum level necessary to protect public
health.
As for the electronic health record (EHR), it is not a medical
device; it stores data for retrieval by a health care professional. EHR
algorithms do not make diagnostic or treatment decisions. Therefore,
FDA regulation is not appropriate or warranted under the FDA's own
standards.
Financial Incentives: Many providers lack the financial ability or
consistency of commitment required to make the up-front investment
needed to install and operate an advanced health information technology
system. Therefore, the Federal Government and other payers should
provide financial incentives sufficient to spur widespread, rapid
adoption of health information technology throughout the health care
system, including universal adoption of electronic health records.
``Pay-for-performance'' proposals should include incentives for
adoption and use of health information technology.
Direct Reimbursement: Reimbursement systems should reward new modes
of providing services that result in quality improvement or cost
reduction for patient care, e.g., remote patient monitoring, computer-
assisted surgery, imaging, telemedicine, and virtual physician visits.
Quality and Safety Studies: Finally, the eHealth system should be
designed to assure that data from the electronic medical record would
be available, with appropriate privacy protections under HIPAA, for
studies to improve patient safety and quality of care.
Conclusion
Again, we thank the Committee for holding this hearing today and we
appreciate the opportunity to submit testimony for the record. HIT
holds great promise for improving patient safety, improving the quality
of medical care, and increasing efficiency. While EHR is one of the
many medical devices that can attain this goal, HIT is expanding far
beyond this and dramatically improving patient safety, quality of care
and health care efficiencies.
Despite the existing and growing body of evidence that HIT will
improve patient safety, enhance the quality of care, and increase
efficiency of care provided, many barriers to adoption remain.
Regulatory barriers like the Federal health care program anti-kickback
statute and the ``Stark'' physician self-referral law remain an
obstacle to widespread adoption of HIT. When clinical and
interoperability standards are developed by Congress and the private
sector, it is paramount to ensure that patients have access to new and
innovative technologies. Financial barriers for health care providers
to purchase and maintain HIT is a particular problem, especially for
solo and small group practitioners.