<DOC>
[109th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:30339.wais]
LEGISLATIVE PROPOSALS TO PROMOTE
ELECTRONIC HEALTH RECORDS AND A SMARTER
INFORMATION SYSTEM
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND
COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
MARCH 16, 2006
Serial No. 109-114
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/house
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COMMITTEE ON ENERGY AND COMMERCE
JOE BARTON, Texas, Chairman
RALPH M. HALL, Texas JOHN D. DINGELL, Michigan
MICHAEL BILIRAKIS, Florida Ranking Member
Vice Chairman HENRY A. WAXMAN, California
FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida RICK BOUCHER, Virginia
PAUL E. GILLMOR, Ohio EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia FRANK PALLONE, JR., New Jersey
ED WHITFIELD, Kentucky SHERROD BROWN, Ohio
CHARLIE NORWOOD, Georgia BART GORDON, Tennessee
BARBARA CUBIN, Wyoming BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
HEATHER WILSON, New Mexico BART STUPAK, Michigan
JOHN B. SHADEGG, Arizona ELIOT L. ENGEL, New York
CHARLES W. "CHIP" PICKERING, Mississippi ALBERT R. WYNN, Maryland
Vice Chairman GENE GREEN, Texas
VITO FOSSELLA, New York TED STRICKLAND, Ohio
ROY BLUNT, Missouri DIANA DEGETTE, Colorado
STEVE BUYER, Indiana LOIS CAPPS, California
GEORGE RADANOVICH, California MIKE DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire TOM ALLEN, Maine
JOSEPH R. PITTS, Pennsylvania JIM DAVIS, Florida
MARY BONO, California JAN SCHAKOWSKY, Illinois
GREG WALDEN, Oregon HILDA L. SOLIS, California
LEE TERRY, Nebraska CHARLES A. GONZALEZ, Texas
MIKE FERGUSON, New Jersey JAY INSLEE, Washington
MIKE ROGERS, Michigan TAMMY BALDWIN, Wisconsin
C.L. "BUTCH" OTTER, Idaho MIKE ROSS, Arkansas
SUE MYRICK, North Carolina
JOHN SULLIVAN, Oklahoma
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee
BUD ALBRIGHT, Staff Director
DAVID CAVICKE, General Counsel
REID P. F. STUNTZ, Minority Staff Director and Chief Counsel
SUBCOMMITTEE ON HEALTH
NATHAN DEAL, Georgia, Chairman
RALPH M. HALL, Texas SHERROD BROWN, Ohio
MICHAEL BILIRAKIS, Florida Ranking Member
FRED UPTON, Michigan HENRY A. WAXMAN, California
PAUL E. GILLMOR, Ohio EDOLPHUS TOWNS, New York
CHARLIE NORWOOD, Georgia FRANK PALLONE, JR., New Jersey
BARBARA CUBIN, Wyoming BART GORDON, Tennessee
JOHN SHIMKUS, Illinois BOBBY L. RUSH, Illinois
JOHN B. SHADEGG, Arizona ANNA G. ESHOO, California
CHARLES W. "CHIP" PICKERING, Mississippi GENE GREEN, Texas
STEVE BUYER, Indiana TED STRICKLAND, Ohio
JOSEPH R. PITTS, Pennsylvania DIANA DEGETTE, Colorado
MARY BONO, California LOIS CAPPS, California
MIKE FERGUSON, New Jersey TOM ALLEN, Maine
MIKE ROGERS, Michigan JIM DAVIS, Florida
SUE MYRICK, North Carolina TAMMY BALDWIN, Wisconsin
MICHAEL C. BURGESS, Texas JOHN D. DINGELL, Michigan
JOE BARTON, Texas (EX OFFICIO)
(EX OFFICIO)
CONTENTS
Page
Testimony of:
Nelson, Ivo, Healthcare Industry Leader, Global and
Americas, IBM 17
Braithwaite, William, Chief Clinical Officer, eHealth
Initiative and Foundation for eHealth Initiative 31
Mertz, Alan, President, American Clinical Laboratory
Association 40
Vaughan, Bill, Senior Policy Analyst, Consumers Union 45
Newman, Mark, President and CEO, Evanston
Northwestern Healthcare, on behalf of Healthcare
Leadership Council 56
Pyles, James C., Attorney Member, Powers, Pyles,
Sutter and Verville, P.C. 96
Detmer, Dr. Don E., President and Chief Executive
Officer, American Medical Informatics Association 127
Additional material submitted for the record:
Braithwaite, William, Chief Clinical Officer, eHealth
Initiative and Foundation for eHealth Initiative,
Response for the Record 154
Mertz, Alan, President, American Clinical Laboratory
Association, Response for the Record 155
Newman, Mark, President and CEO, Evanston
Northwestern Healthcare, on behalf of Healthcare
Leadership Council, Response for the Record 158
Pyles, James C., Attorney Member, Powers, Pyles,
Sutter and Verville, P.C., Response for the Record 161
Detmer, Dr. Don E., President and Chief Executive
Officer, American Medical Informatics Association,
Response for the Record 164
Blue Cross and Blue Shield Association, prepared
statement of 166
Peel, Deborah C., MD, Founder, Patient Privacy Rights
Foundation, prepared statement of 171
Advanced Medical Technology Association, prepared
statement of 177
LEGISLATIVE PROPOSALS TO PROMOTE
ELECTRONIC HEALTH RECORDS AND A SMARTER
INFORMATION SYSTEM
THURSDAY, MARCH 16, 2006
HOUSE OF REPRESENTATIVES,
COMMITTEE ON ENERGY AND COMMERCE,
SUBCOMMITTEE ON HEALTH,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:10 a.m., in
Room 2123 of the Rayburn House Office Building, Hon. Nathan
Deal (chairman) presiding.
Members present: Representatives Deal, Shadegg, Burgess,
Barton (ex officio), Brown, Waxman, Green, Capps, Baldwin, and
Gonzalez.
Staff present: Chuck Clapton, Chief Health Counsel; Melissa
Bartlett, Counsel; Ryan Long, Counsel; Nandan Kenkeremath,
Counsel; Bill O'Brien, Legislative Analyst; David Rosenfeld,
Counsel; Brandon Clark, Policy Coordinator; Chad Grant,
Legislative Clerk; John Ford, Minority Counsel; Chris Knauer,
Minority Investigator; Purvee Kempf, Minority Counsel Amy Hall,
Minority Professional Staff Member; Bridgett Taylor; Minority
Professional Staff Member; Jessica McNiece, Minority Research
Assistant; and Jonathan Brater, Minority Staff Assistant.
MR. DEAL. I will call the hearing to order. We are pleased to
have all of you with us today, and certainly another distinguished
panel for this hearing. Let me tell you at the outset that this is one
of those days where we have a lot of votes on the Floor. In fact,
we are going to be interrupted almost at the point we begin today
with a series of about 10 votes on amendments that were debated
yesterday, and we'll be on the Floor for an immediate vote this
morning.
We thought we would try to get started and call the committee
hearing to order and maybe get in a few opening statements before
we have to leave. We will try to accommodate your time
constraints because you are our guests and we appreciate your
presence with us today. We also have a great deal of interest in the
subject matter of this hearing and in the testimony that is going to
be presented. We will have several members of the full committee
who are not members of our Health Subcommittee who will
probably be joining us, and I invite them to join us on the dais. I
would ask unanimous consent for them to be allowed to submit
their written statements for the record, and without objection that is
so ordered.
There may come a time in the questioning stage where,
depending on how long we have been going in this hearing and the
availability of time, that we will address the issue of their ability to
ask questions at that point in the hearing process. We would
certainly at this point ask unanimous consent for those members of
the full committee to be allowed to submit written questions for the
record in the event time does not allow their oral questions, and
without objection that is so ordered.
I will now recognize myself for an opening statement. As I
said, we are pleased to have such a distinguished panel of guests
with us today, and I look forward to your testimony on a subject
that I think is certainly at the very top of most people's concerns
when we talk about healthcare reform. The use of better
information technology and healthcare holds the potential not only
to save lives but also money. In the creation of an electronic
system to track medical records hopefully we will reduce medical
errors and help eliminate inefficiencies and waste in the current
system.
These systems hold a potential to significantly improve
healthcare by eliminating illegible handwritten prescriptions,
providing immediate access to laboratory test results, and making a
patient's full medical history available to their treating physician
no matter where that patient may seek treatment. As many of you
are aware, several bills have already been introduced in Congress
to deal with this general subject matter of new technologies. These
proposals reflect a broad range of ideas about what can be done to
create the proper incentives to encourage more healthcare
providers to acquire and use healthcare information technology.
This hearing is hopefully going to be the first in a series of
hearings to explain these proposals and explore what actions
Congress needs to take in this area. However, we need to be
cautious of dramatic legislative proposals which largely seek to
regulate this budding technology area. Innovators, investors,
healthcare providers, healthcare payment systems and patients will
drive these changes. As a guiding principle, Congress should do
nothing that would impede or limit reforms which are already
transforming the market place. The President and the Health and
Human Services Secretary Michael Leavitt, have both shown
broad leadership in promoting this great discussion and
demonstration and initial activities that hopefully will be helpful to
our future.
We are also seeing many hospitals, physicians, pharmacies,
and payers moving forward in the implementation of this
technology. We neither want to interfere with this effort nor
overstate the government's role in innovations, applications, or
basic investment decisions. Ultimately investments and the
products, training, and activities to promote the use of structured
information will happen piece by piece and not by a grand
government design. We must also continue to provide patients
with the assurance that their personal medical records will remain
private and not be subject to inappropriate disclosures.
Such protections must also balance the need to be realistic and
workable so that patients can reap the benefits of better healthcare
through the use of IT. The adoption of new technologies holds the
potential to improve accountability and empower patients with
greater access to their own medical records. At the same time,
safeguards must be provided to prevent hackers and other
unauthorized persons from gaining access to confidential medical
records. As we move forward, let us look at the many legislative
proposals to promote electronic health records of health
information technology in a cautious fashion. Hopefully, we in
Congress can be helpful and not unintentionally slow down or
misdirect the growth in the many new innovations and applications
to come.
Again, I welcome our witnesses and thank you for your
participation. And in the absence of Mr. Brown, I am going to
recognize Mr. Waxman for an opening statement.
[The prepared statement of Hon. Nathan Deal follows:]
PREPARED STATEMENT OF THE HON. NATHAN DEAL, CHAIRMAN,
SUBCOMMITTEE ON HEALTH
<bullet> The Committee will come to order, and the Chair
recognizes himself for an opening statement.
<bullet> I am proud to say that we have a distinguished and expert
panel of witnesses appearing before us today that will help
us explore how to best increase the proper utilization of
information systems in our healthcare delivery system.
<bullet> The use of better information technology in healthcare
holds the potential to save lives as well as money. The
creation of an electronic system to track medical records
will sharply reduce the number of medical errors and help
eliminate inefficiencies and waste in the system.
<bullet> These systems hold the potential to significantly improve
healthcare by eliminating illegible handwritten
prescriptions, providing immediate access to laboratory test
results and making a patient's full medical history available
to their treating physician no matter where that patient
seeks treatment.
<bullet> Several bills have been introduced with the intent of
helping speed the adoption of these new technologies.
<bullet> These proposals reflect a broad range of ideas about what
can be done to create the proper incentives to encourage
more healthcare providers to acquire and use health
information technology.
<bullet> This hearing is hopefully going to be the first in a series of
hearings to examine these proposals and explore what
actions Congress needs to take in this area.
<bullet> However, we need to be cautious of dramatic legislative
proposals which largely seek to regulate this budding
technology area.
<bullet> Innovators, investors, healthcare providers, healthcare
payment systems, and patients will drive these changes.
<bullet> As a guiding principle, Congress should do nothing that
would impede or limit reforms which are already
transforming this marketplace.
<bullet> The President and the Health and Human Services
Secretary Michael Leavitt have both shown broad
leadership in promoting the many discussions,
demonstrations, and initial activities that will be helpful for
our future.
<bullet> We are also seeing many hospitals, physicians, pharmacies,
and payers moving forward in the implementation of this
technology.
<bullet> We neither want to interfere with this effort nor overstate
the government's role in innovations, applications, or basic
investment decisions.
<bullet> Ultimately, investments in the products, training and
activities to promote the use of structured information will
happen piece by piece and not by a grand government
design.
<bullet> We must also continue to provide patients with the
assurance that their personal medical records will remain
private and not be subject to inappropriate disclosures.
<bullet> Such protections must also balance the need to be realistic
and workable so that patients can reap the benefits of better
healthcare through the use of IT.
<bullet> The adoption of new technologies holds the potential to
improve accountability and empower patients with greater
access to their own medical records.
<bullet> At the same time safeguards must be provided to prevent
hackers and other unauthorized persons from gaining
access to confidential medical records.
<bullet> As we move forward, let's look at the many legislative
proposals to promote electronic health records of health
information technology cautiously.
<bullet> Hopefully, we in Congress can be helpful and not
unintentionally slow down or misdirect the growth in the
many new innovations and applications to come.
<bullet> Again, I welcome our witnesses and thank them for their
participation.
<bullet> I now recognize my friend from Ohio, Mr. Brown, for five
minutes for his opening statement.
MR. WAXMAN. Thank you, Mr. Chairman. I appreciate you
holding this hearing. It is an important issue. As we look forward
to electronic health records and promoting smarter information
systems, I want to raise the same caution that you just did.
Computerized medical records pose a threat to one of the most
basic privacy rights that an individual can have. Basic medical and
genetic information should not be shared without meaningful
informed consent, but even with consent protections against
release of information, the right to be informed of any breach of
privacy, the right to have access to one's own information and
strong protections against the discriminatory use of the information
are all critical.
Further, the maintenance of State laws that protect privacy
should be a bedrock principle. We cannot take such comfort in our
Federal rules that we can afford to eliminate any additional
protections. And, finally, I cannot help but comment on the irony
that we would even contemplate limiting State protections when
we have so clearly failed at the Federal level to adopt legislation
that assures basic protections against discrimination on the basis of
genetic information. This committee has jurisdiction in this area
and it should exercise it. It is an important one to keep in mind.
As we look at the positive side of it, we should also recognize that
there is a potential negative side to this new computerized health
world. Thank you, and I yield back the balance of my time.
MR. DEAL. Mr. Shadegg, you are recognized for an opening
statement.
MR. SHADEGG. Thank you, Mr. Chairman, and I want to
compliment you on the legislation you put in this area. I would
echo the remarks you made in your opening statement. I will not
make my own opening statement other than to say that while there
are important gains that can be made in this area, my personal
belief is we ought to also be looking at giving consumers more
choice. Choice works in so many other places, and in the
healthcare field we have given consumers virtually no choice.
Their healthcare plan is selected by their employer in the vast
majority of cases. It is handed to them from their doctor. They are
told who their doctor is in any given area, and I believe we have
taken them too much out of the equation. And it is critical while
the gains we can make here are very important and need to be
pursued, and I compliment the bill you have, we also need to be
looking at advancing choice and healthcare to the greatest degree
possible. With that, I yield back.
MR. DEAL. I thank the gentleman. Ms. Capps, you are
recognized for an opening statement.
MS. CAPPS. Thank you, Mr. Chairman, and I want to thank
you also. I am pleased that we are holding hearings on health
information technology because I believe that facilitating better
sharing of information between members of the healthcare
community is a very important aspect of improving patient safety
and quality of care. I am very excited to hear from our witnesses
today, and I thank each of you for coming. I am excited by the
prospect of eliminating unnecessary procedures and duplication of
examinations or lab work that is often caused because of the
inadequate filing and information transfer.
I am optimistic about how utilizing health information
technology has the possibility of removing many of the
administrative burdens that healthcare professionals, especially
nurses, must devote their time to. Thinking of the people who are
carrying the burden of delivery of care within our institutions and
settings and the time that is so often taken away from the patient to
fill out the duplicative records, and each time that is done it makes
the possibility of error creep in. As we all know, the current
nursing shortage crisis is only continuing to worsen. Less time
spend filling out paperwork, as I said, or combing through
extensive medical histories means that nurses and other patient
care providers can spend more time with their patients. That is
going to mean better healthcare for patients.
I am also interested in how health information technology has
the potential to reduce costly, often fatal, medical errors such as
adverse drug reactions, interactions. The prospects for expanding
the use of current information technology extend far beyond how
we treat current patients also. Finally, I am hopeful about how
digitalizing records may help serve the medical research
community as long as the privacy protections are maintained, and
that is a big as long as. But I think the possibility exists for doing
this, and I want us to explore the ways that technology can help us
with the privacy protections, as well as accessing medical research
which is imperative for future developments in healthcare.
As we work to reap the potential benefits of health IT, we will
face challenges in developing a method that is cost effective and
accessible to all providers. Furthermore, while evaluating the
different paths toward increasing the usage and improving the
interoperability of health IT, we must remain concerned, as I said,
about protecting patient privacy. As always, expanding the use of
information technology systems lends itself to greater access of
information in both positive and negative ways. We must ensure
safeguards are in place which protects information from being
accessed by the wrong parties or being used to discriminate against
individuals. So I look forward to hearing from our witnesses today
on how we can create a system that is beneficial to everyone
involved in the provision of healthcare, keeping our bottom line to
improve treatment and protect patient privacy. I yield back the
balance of my time.
MR. DEAL. I thank the gentlelady, and am pleased to recognize
my friend, Mr. Brown, the Ranking Member of the Health
Subcommittee.
MR. BROWN. Thank you, Mr. Chairman. I apologize for being
late and, thank the witnesses, all of you, for joining us today. We
have all heard according to the Institute of Medicine report to err is
human. Studies have found that deaths from medical errors range
from estimates of 44,000 a year to as high as 98,000. Among the
reasons cited in the report for such extremely high numbers of
errors are issues like illegible writing in medical records, and the
lack of coordination and communication across providers. I am
pleased the committee has called this hearing today because
increased use of electronic medical records is a very promising
means by which to address these errors, cut down on the number of
unnecessary deaths in this country, as well as improve the quality
of healthcare.
Electronic medical records provide the ability to coordinate
care across different healthcare sites. This means your general
practitioner can keep track of what treatments you are receiving
from different specialists, helping to oversee your care, and make
sure you get the services that you need. They can reduce
healthcare administrative costs as duplicate folders of paper
records are consolidated into one electronic record accessible from
any computer in the office. Hospitals and doctor offices can
establish support systems for their doctors to help them make the
best decisions for their patients. Right at the bedside doctors can
check for patient allergies and whether they have a family history
of stroke, for example.
According to the IOM, health information technology is a key
step to improving the quality of healthcare. Finally, the electronic
medical records means that records can travel with patients backed
up in case of emergencies. Katrina highlighted this point clearly in
the wake of the hurricane. Thousands of displaced individuals
with serious medical conditions found themselves with no access
to their medical records. Paper records in doctor offices were
unreachable or in many cases were destroyed. Patients had no
record of what medications they had been taking, what dosage,
what treatments they were receiving, whether these treatments had
been effective or not. Breaks in care can be deadly for individuals
with conditions like some forms of cancer or HIV/AIDS that
require ongoing and regular treatment.
In a system of paper records stored on shelves in doctors'
offices, displaced residents find themselves having to try and re-
create years of medical records. In circumstances like these,
electronic medical records can actually protect patients' health by
allowing doctors to immediately identify healthcare needs and
provide treatment in a timely manner. I do want to be clear,
however, that while there are many benefits to increased
implementation of health information technology we have to be
very cautious about how we move forward. Over time these
systems may result in savings for providers and for patients. Their
development and implementation is a costly process, one that can
be a heavy burden for family physicians and their practices.
We should never mandate the implementation of costly
technology without adequate support, particularly for small
physician practices that may not have the necessary capital.
Finally, there must be adequate protections for patient privacy. We
have all read the stories about stolen bank records in the last few
months. Imagine the cases of stolen medical records. My own
State of Ohio has enacted a series of laws expressly aimed at
protecting a patient's confidentiality, a patient's ability to
determine with whom and how medical information is shared in a
right of action in cases of inappropriate disclosure. In particular,
the State has enacted laws protecting information concerning birth
defects, HIV/AIDS, and genetic tests. These are important
protections. The last thing we want to do is see an individual
avoiding necessary and important medical care for fear of lack of
confidentiality.
We need to put resources in to developing standards and
guidance to assist physicians and medical institutions through the
process of developing electronic medical record systems.
However, we have to be keenly aware of finding an appropriate
balance between utilizing technology and protecting patients. I
look forward to hearing from all of our witnesses about how to
address these issues. Thank you, Mr. Chairman.
MR. DEAL. I thank the gentleman. I recognize Dr. Burgess
from Texas, a member of our subcommittee, for an opening
statement.
MR. BURGESS. Thank you, Mr. Chairman. I appreciate you
calling this hearing today. I do have an opening statement I will
submit for the record, but I would just like to make a few
observations. A few years ago in a graduate level course that I
took so that I would be better able to understand the business work
as I practiced medicine, I learned a startling fact that the insurance
industry spent between 7 and 12 percent of their budget on
information technology. The average small office such as mine
spent an average of 1 to 3 percent. Clearly, we could not keep up
at that rate.
We had an opportunity in this country with the Y2K, most
people do not remember that now, but it was a big deal in the
health industry for a time, and I used that opportunity to upgrade
the computer services in my office over the objection of my
partners because it did not return any real value. And it is going to
be a process of educating physicians, particularly physicians my
age, who did not grow up in the computer world to recognize what
that value is. But that brings me to another point, and it is not
really related to this discussion this morning but it is important in
that we are faced with the prospect of continually cutting Medicare
reimbursement for physicians year over year under the SGR
formula.
And, Mr. Chairman, we have to seriously deal with that
because we are going to drive out the best and brightest physicians,
and I am referring to physicians my age, the 40 to 50-year-old
doctor who is going to be driven away from the Medicare system.
If we are going to spend all of this money, all of this investment, in
information technology, you want to keep your best and brightest
involved in the field. So people have said we cannot tackle it this
year. It is just too big a bite, but I submit that there is no better
time than the present to do that. The Ranking Member brought up
health privacy issues with HIV and birth defects. As we move into
the genomic it is going to become even more critical, and we have
to be able to assure people, the public, that their medical
information will be private and not readily dispersible across half
of the civilized world.
And then finally, Mr. Chairman, I just have this observation.
In the 21st Century it almost makes no sense that we still fight
things the way we do here in Congress, and while I appreciate you
having this hearing here this morning, to me it just underscores that
there is no committee on health in the United States Congress. The
jurisdiction is divvied up between several committees, and I think
it is time for the Committee on Energy and Commerce to assert its
rightful place and take all of that jurisdiction so we can deal with
these problems without having to go through stove pipes. With
that, I will yield back.
MR. DEAL. I thank the gentleman. Another member from
Texas, Mr. Green, is recognized for an opening statement.
MR. GREEN. Thank you, Mr. Chairman, for holding a hearing
on electronic health records and legislation introduced by our
colleagues to facilitate further development of health information.
I would like my full statement to be placed in the record, and I will
just talk about two incidents recently. When we had Hurricane
Katrina and Rita, Katrina in Louisiana and obviously Rita in
southeast Texas and southwest Louisiana, there were a couple of
events that could show how important electronic records were. As
both hurricanes approached the area and everyone fled, including a
lot of our healthcare providers who closed their facilities, at the
time they had to figure out how they were going to store their
records. The benefit of electronic records is incalculable for
providers who had them in place.
In Beaumont, Texas, a 19-doctor practice knew that Rita was
coming and backed up their computer data with a server in a Dallas
hotel room. And a week after Rita hit the practice reopened and all
their data, including their patients' electronic records were there,
and it reappeared as if nothing happened. The hurricanes also
highlighted the need for interoperability within the EHRs. In my
hometown of Houston where we received 150,000 residents from
New Orleans, it was so chaotic to try to have people come in and
get them rediagnosed if they did not have their medication. You
did not know what dosage. But the VA stood out. If we received a
veteran from Louisiana the VA medical professionals at Houston's
VA medical hospital were able to access the records for these
evacuees who had typically received care at the VA hospital in
Louisiana.
Mr. Chairman, that shows in the real world, particularly in an
emergency situation disaster, how this can be done. And I think
we need to do it. I know it is costly, but the further we move it
along the better it will be, not only for I think the physicians who
practice for the sanctity of their records along with our privacy
concerns, but also for the delivery of medicine to our constituents.
Thank you.
MR. DEAL. I thank the gentleman. Ms. Baldwin, you are
recognized for an opening statement.
MS. BALDWIN. Thank you, Mr. Chairman. I am happy that we
are taking this time to focus on healthcare IT. Like other Members
who have spoken already this morning, I want to add my voice of
support for implementation of healthcare IT. It is the healthcare
topic that policy makers love to love these days. And it is easy to
understand why healthcare IT is so popular. The potential for
improving patient care, making better use of scarce resources, and
collecting data for research is huge. Imagine the opportunities for
medical collaboration that healthcare IT could provide for a rural
doctor who needs to consult with a specialist who is hundreds,
perhaps even thousands, of miles away or imagine the immensely
powerful research data that could be de-identified and then
analyzed to track the spread of Avian flu or widespread negative
side effects of a popular drug. So I am encouraged that we are
taking up this important topic and I hope that we will be able to
have some constructive discussions on issues involving advancing
healthcare IT.
But I also think we need to be very up front and clear about the
issues involved and the potential pitfalls. From a provider
standpoint there are many barriers to the adoption of healthcare IT.
These barriers may be financial, technical, cultural, or legal, and
these are all worthy of serious consideration discussing only the
inter-operability or the interconnectivity issue could take us hours
to fully understand it, perhaps years to reach agreement on. From
the patient perspective, while patients tend to have enormous
potential gains from increased access to and frankly ownership of
their own health records, there are also potential pitfalls,
specifically surrounding how to craft a healthcare IT system that
insures patient privacy protections are not sacrificed in the name of
increased efficiency.
Lastly, I think we need to be very cognizant of avoiding the
situation where we have healthcare IT haves and have nots.
Healthcare IT systems are expensive, and those who spend the
money to put healthcare IT systems into place are not always the
same people who benefit from these systems. So we need to keep
moving forward keeping this in mind and looking for ways to
bring responsible privacy protecting healthcare IT systems to all
Americans. Thank you, Mr. Chairman, for holding this hearing.
[Additional statement submitted for the record follow:]
PREPARED STATEMENT OF THE HON JOE BARTON, CHAIRMAN,
COMMITTEE ON ENERGY AND COMMERCE
Thank you, Chairman Deal, for holding this important hearing.
Medical records haven't changed much since doctors and paper
found each other. I suppose the filing cabinet was regarded as a
giant advance in technology. But masses of fragile paper stuffed
into large pieces of furniture are an anachronism here at the dawn
of the information age.
We're here today to discuss the next great advance. Electronic
health records will mean more than convenience for doctors'
assistants. They will mean faster, better, less expensive care, with
fewer of the medical errors that harm patients instead of help them.
I want to applaud President Bush and Secretary Leavitt for their
leadership on this issue. I also want to recognize the many
activities at HHS and in the private sector that will help speed the
adoption of health information technology. Several Members
have legislative proposals to help promote electronic health records
and promote smarter information systems. We will review these
ideas and see if there are areas where the Federal government can
be helpful.
This isn't about the government deciding what's best for you,
and then forcing it down the private sector's throat. The private
sector will also play an important role in the development of
smarter information systems. Any investment of time, resources,
or money needs to provide a return on investment in health care
quality and costs. When the utility is there, the investments will
follow. It is very likely some elements of electronic health
records will be in more standard use in the near future. I am
optimistic, for example, about greater near-term adoption of e-
prescribing and electronic reporting of laboratory results. Other
elements may take longer.
As we review our current regulatory programs, we need to
make sure that regulations promote improved coordination of care.
This may mean looking at things like government payment policies
and Stark and Anti-kickback provisions. The government may be
able to assist the private sector in encouraging the harmonization
of interoperability standards. No one should, however, see this as
an easy task.
I look forward to hearing from today's witnesses and to try to
identify legislative provisions that are clearly helpful, mindful of
the appropriately limited role of the Federal government in
choosing among innovations in technology.
PREPARED STATEMENT OF THE HON. JOHN D. DINGELL, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN
Mr. Chairman, thank you for holding this hearing on Health
Information Technology. Electronic medical records, electronic
prescribing, decision support services, and the ability for systems
to exchange information make it easier for physicians to do their
job and patients to have more coordinated care. But this
technology creates new challenges for keeping an individual's
information private and protected from disclosure. And is it
necessary to compromise other patient protections in order to
encourage the use of health information technology?
First, over the past week, one of the biggest security breaches
occurred when pin numbers for many top banks in the world were
compromised. Yet loss of money does not compare to the
irreparable damage that can result from sensitive health
information, such as mental illness records, HIV/AIDs status, or
genetic medical histories, being compromised.
In order to successfully implement electronic health records,
patient concerns need to be addressed at every level. Patients are
worried about the privacy and security of their health information,
whether they have the right to decide to keep sensitive information
out of the network, having access to their own records, and having
control over how the information is used. Providers and health
plans say they want to expand health information technology to get
better quality care and to coordinate care for patients. But without
including patients in the process of developing a national health
information infrastructure and addressing their needs, we will not
succeed in having a system that patients feel comfortable taking
part in and using.
Second, do patient protections need to be sacrificed?
Representative Nancy Johnson and Subcommittee Chairman Deal
have introduced a health information technology bill that creates
an exemption from Federal fraud and abuse laws. This broad
exemption would allow hospitals and health plans to give away
free health information technology and services to physicians.
Could this lead to biased decision-making by physicians about
where to send patients who need hospital care? Do we really need
to weaken the laws that protect vulnerable patients against abusive
activities at a time when they need health care?
Finally, I note that a serious commitment to health information
technology means putting funding behind our proposals, making
available grants, loan programs, or incentive payments through
Medicare and Medicaid. Without funding, we are merely
providing lip service to this very important effort.
I look forward to the testimony the witnesses will present
today. Thank you.
PREPARED STATEMENT OF THE HON. TOM ALLEN, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF MAINE
Mr. Chairman, thank you for calling this hearing today to
examine the current state of health information technology.
Advances in HIT has shown great promise in improving the quality
of health care, lowering costs, and reducing medical errors.
Maine has been at the forefront of adopting HIT. It is one of
the first states to implement a statewide electronic health record-
sharing system.
In January 2006, the board of directors of the "Maine Health
Information Network Technology System" formalized a not-for-
profit organization to implement an "Interoperable Health
Information Network," which is slated to be in place by 2010. This
electronic medical records system will bring critical medical data
to physicians and other health care providers across the state and
provide immediate and universal access to key medical
information.
Having a state-wide electronic medical records system in place
will ensure better, safer and more cost-effective care.
As we focus our attention on efforts to bolster the adoption of
HIT nationwide and consider specific legislative proposals, I urge
my colleagues to first "do no harm." We need to ensure that
current patient privacy standards are not eroded. Consumers need
to know that the confidentiality and security of their medical
records will be guaranteed.
PREPARED STATEMENT OF THE HON. TIM MURPHY, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF
PENNSYLVANIA
Thank you Mr. Chairman.
As a psychologist, I have experienced a great deal of success in
bringing people together. However, perhaps my greatest
achievement was hosting a press conference when Senator Hillary
Rodham Clinton (D-NY) and former Speaker Newt Gingrich (R-
GA) stood side by side to save tens of thousand of lives and
hundred of billions of dollars. In May of last year, Senator Clinton
and former Speaker Gingrich attended a kick-off ceremony to
discuss my introduction of the first health information technology
(Health IT) legislation of its kind aimed at dramatically
transforming the way health care is delivered in this country. The
21st Century Health Information Act (H.R. 2234) promotes the
move towards secure, confidential electronic health records and
interoperable regional health information networks.
I was pleased to work with my colleagues including Energy
and Commerce Health Subcommittee Chairman Deal (R-GA),
Ways and Means Health Subcommittee Chair Nancy Johnson (R-
CT) and U.S. Department of Health and Human Service Secretary
Michael Leavitt on legislative proposals to ensure that our 18th
century paper file system catches up with our 21st century medical
care. Many of the provisions from my legislation including a Stark
exemption to allow hospitals to buy this lifesaving technology for
their doctors was incorporated into H.R. 4157, the Health
Information Technology Promotion Act and I am proud to
cosponsor this legislation before the Subcommittee today.
Health IT is not computers, wires, hardware, software, and
PDAs, it is fewer errors, less infections and mistakes, lower cost,
better quality and a higher standard of care. It's as simple as that.
Today, voluminous paper medical records are frequently
scattered between multiple hospitals and doctors' offices resulting
in the likelihood that important records could be lost or not
retrieved when doctors need to be making informed decisions.
One study found that one in seven medical records was missing
vital patient information. The paper-based, often incomplete,
medical record-keeping system used by most health care providers
leads to redundant tests, medical errors, and misdiagnoses. All
told, the RAND Corporation reported these critical errors add $162
billion in health care costs per year. Electronic medical records
(EMRs) and electronic prescribing can reduce costly medical and
medication errors, while quickly and securely being able to provide
a patient's medical records and tests at a moments notice.
It is my hope that this hearing will focus on continued concerns
over protecting patient privacy, interoperable standards to avoid a
'Tower of Babel' where health systems can not speak to each other
and leveraging technology to improve the efficiency, quality and
safety of the health care system. Every day that we delay
implementation is costing lives and money.
Thank you, Mr. Chairman for allowing me to participate in
today's hearing, I look forward to working with you to transform
health care for the 21st Century.
PREPARED STATEMENT OF THE HON. FRED UPTON, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN
Mr. Chairman, I am encouraged that we are taking this big step
forward today to examine and evaluate what needs to be done
legislatively to foster the rapid development and dissemination of
health information technology, including electronic medical
records, and to do this in a way that will not impede further
technological advances. We've got some tough nuts to crack.
Protecting patient privacy, modifying anti-kickback laws to allow
the development of HIT networks, and modernizing our coding
systems are just three areas that come to mind immediately.
As an original cosponsor of H.R. 4157, the Health Information
Technology Promotion Act, that you and Mrs., Johnson
introduced, I think the bill gives us a solid starting point for
progress toward a 21st Century health care delivery system-a
system of efficient, coordinated, cost-effective and high-quality
care. While we are second to none in the world when it comes to
medical innovation, we have a system that is fragmented,
vulnerable, inefficient, and fraught with preventable medical
errors. We've got some catching up to do, to say the least.
Perhaps nothing offers a more compelling example of the
pressing need for the widespread use of electronic medical records
and health information technology than the aftermath of Hurricane
Katrina. Hundreds of thousands of residents were displaced from
their homes, many fleeing with only the clothes on their backs, and
living in shelters and temporary housing across the country.
Neither the evacuees nor their new health care providers had
access to their paper medical records, many of which were
destroyed. At least 40 percent of evacuees were taking
prescription medications before the storm, and many more needed
medications after it. Because our nation's pharmacies have been in
the forefront of electronic medical records and health information
technology, five days into the disaster, a website,
KatrinaHealth.org, was in the works, and shortly, doctors and
pharmacists across the country could go online and find out what
medications many of the evacuees they were seeing were taking
and how that might affect any new medications they were thinking
of prescribing.
Meanwhile, back in the Gulf, hospital roofs were dotted with
what sodden paper records may have survived, weighted down
with stones, and drying out in the sun.
MR. DEAL. I thank the gentlelady. And, Mr. Gonzalez, a
member of the full committee, we welcome him to the dais as well.
Thank you for being here. It is my pleasure now to introduce our
distinguished panel, and we are just about to be interrupted with
these votes but I will try to get your introductions in before that
time. First of all, Mr. Ivo Nelson, Healthcare Industry Leader with
IBM; Dr. William Braithwaite, who is the Chief Clinical Officer of
eHealth Initiative and Foundation for eHealth Initiative; Mr. Alan
Mertz, the President of American Clinical Laboratory Association;
Mr. Bill Vaughan, Senior Policy Analyst at Consumers Union; Mr.
Mark Neaman, President and CEO, Evanston Northwestern
Healthcare; Mr. James C. Pyles, Attorney and member of a firm
here in Washington, D.C.; and Dr. Don Detmer, President and
Chief Executive Officer of American Medical Informatics
Association in Maryland.
Gentlemen, we are pleased to have you here, and how about
that for timing. We will let the buzzer ring for its required period
of time here, and we have five more buzzers to go and they will
start in just a second. But, Mr. Nelson, we will at least try to get
your opening statement in. Let us wait for these bells to ring
again. Mr. Nelson, you may proceed.
STATEMENTS OF IVO NELSON, HEALTHCARE INDUSTRY LEADER, GLOBAL AND AMERICAS,
IBM; WILLIAM BRAITHWAITE, M.D., Ph.D., CHIEF CLINICAL OFFICER, eHEALTH
INITIATIVE AND FOUNDATION FOR eHEALTH INITIATIVE; ALAN MERTZ, PRESIDENT,
AMERICAN CLINICAL LABORATORY ASSOCIATION; BILL VAUGHAN, SENIOR POLICY
ANALYST, CONSUMERS UNION; MARK NEAMAN, PRESIDENT AND CEO, EVANSTON
NORTHWESTERN HEALTHCARE; JAMES C. PYLES, ATTORNEY MEMBER, POWERS, PYLES,
SUTTER AND VERVILLE, P.C.; AND DON E. DETMER, PRESIDENT AND CHIEF EXECUTIVE
OFFICER, AMERICAN MEDICAL INFORMATICS ASSOCIATION
MR. NELSON. Thank you, Chairman Deal, and members of the
subcommittee. My name is Ivo Nelson. I am actually here from
Texas so I feel quite at home with the people that are here today. I
do lead the IBM Healthcare Business Consulting Services Group.
IBM appreciates this opportunity to testify in support of legislative
proposals to promote electronic health records in a smarter health
information system. Today, there is growing consensus that a
more intelligent, innovative healthcare system is within reach
through better use of information technology. The IBM
Corporation is fully committed to helping a smarter health system
emerge as a model of 21st Century American innovation.
One of IBM's core values is creating innovation that matters to
the company and to the world. Today, almost everyone agrees that
dramatically improving healthcare is the innovation that matters.
To that end, we are collaborating with other large employers,
agencies, providers, and standards bodies to transform healthcare.
Today, it is a fragmented paper-based problem. Soon it will
become a highly connected system for fluid exchange of digital
health information and innovative new services. As a company,
we are striving to do for healthcare what the ATM system, which
we helped to invent, did to launch the global infrastructure for
electronic financial transactions or what the Internet browser did to
catapult the Web from an academic network into the platform for
innovation it is today.
With respect to pending legislation proposals, IBM supports
provisions that serve three objectives: drive adoption of open
standards by the Federal government in private industry; commit
initial seed funding and make early policy choices; and create
incentives in Medicaid and Medicare to reward quality of care.
These three areas are keys, we believe, to a smarter system of
health. This new model of care will unlock the value of health
information and help healthcare become properly organized around
its core constituents, patients.
Let me expand briefly on the three topics I have outlined.
Standards interoperability are the front and center in a project
called the Nationwide Health Information Network or NHIN. IBM
is one of four companies developing prototype architectures
through a contract awarded in 2005 by the Office of the National
Coordinator of Health IT at the Department of Health and Human
Services. The NHIN project can be thought of as a foundation for
a medical Internet and digital infrastructure for healthcare. It was
also structured with the ingenious requirement the four contractors
must make their respective efforts interoperate with each other via
open standards.
The success of the Internet itself is overwhelmingly due to
open standards and protocol such as HTML, XML, IP, and many
others. Some healthcare standards have had long use within care
settings and new standards are emerging. What is needed today is
to expand the use of these standards across multiple care settings
and across all of government healthcare. Federal adoption of an
open standard for these core elements of medical is critical. For
example, Federal agencies mandate reporting of extensive amounts
of clinical information, yet do not allow information to be
submitted via standardized electronic formats. I have actually
attached the FDA drug adverse event reporting requirement,
MEDRA, for you to take a look at.
While this example is drawn from the FDA, each of the
agencies has comparable examples of reporting that does not
utilize health information technology built on standards. Turning
to the government's role as an early funder and policy maker,
history demonstrates that a new innovation often proceeds slowly
at first before a catalystic inflection point causes it to accelerate.
The Internet remained an obscure academic network for decades
before browsers drove its explosive growth. With nearly half of
healthcare spending in the U.S. originating with the government,
the public sector can have a decisive role in sparking a smarter
health system for all Americans. Committing initial seed funding
in making early policy choices will set the stage for growth of
health information exchange. The funding for Dr. Brailer's office,
the national coordinator, and projects like NHIN and PHRS are
good examples of catalyzing funding. Efforts to resolve privacy
issues are another.
IBM hopes to play a complimentary leadership role as an
innovation partner for the business of healthcare and as a large
employer providing healthcare to more than half a million IBMers
and their families. Finally, establishing electronic health records
for millions of citizens will require a range of incentives to
accelerate adoption especially among physicians and providers.
The benefits of a smarter health system will enable a historic shift
in medicine when designed to reward outcomes and improve
quality of care rather than today's fee for service model. Health IT
is needed for this shift in reimbursement because it can ease the
burden of measuring and reporting performance.
Creating powerful incentives is necessary if we are to
transform healthcare, and this committee can start by
implementing pay-for-performance model in Medicaid. To
summarize the three points I leave you with are the Federal
government can advance a smarter health system by widely
deploying standards. You can accelerate the transformation of
healthcare through bold seed funding and active leadership in
policy areas such as privacy. Strong incentives are needed to drive
adoption of electronic health records and rewarding the quality of
care in medicine, and Medicaid is one of the most powerful tools
available.
Mr. Chairman and members of the subcommittee, thank you
for the opportunity to testify today, and I look forward to
answering any questions you may have. I spend most of my time
in the field with hospitals and payers so I have got a very
pragmatic view, I think, of the industry we are all operating in.
Thank you.
[The prepared statement of Ivo Nelson follows:]
PREPARED STATEMENT OF IVO NELSON, HEALTHCARE INDUSTRY
LEADER, GLOBAL AND AMERICAS, IBM
Chairman Deal and members of the Health Subcommittee of
Energy and Commerce. My name is Ivo Nelson and and I lead
IBM's Healthcare Business Consulting Services. IBM appreciates
the opportunity to testify in support of legislative proposals to
promote electronic health records (EHRs) in a smarter health
information system.
Today, there is growing consensus that a more intelligent,
innovative healthcare system is within reach. Through better use of
information technology, experts agree that healthcare quality can
be improved and costs restrained, while protecting the privacy of
patients and the security of their health data.
The IBM Corporation is fully committed to helping a smarter
health information system emerge as a model of 21st century
American innovation. We are focusing our software, services and
expertise and combination of business and technology experience
to support the transformation of healthcare from its fragmented,
paper-based current state into a coherent, interconnected system.
The objective is to enable the fast and fluid exchange of digital
health information, applications and services that will revolutionize
all facets of healthcare.
Healthcare is closely aligned with one of the three core values
around which IBM organizes and manages our global enterprise:
creating "innovation that matters, to the company and the world."
Today, almost everyone agrees that dramatically improving
healthcare is the innovation that matters. To that end, IBM is
collaborating with other large employers, agencies, providers and
standards bodies on a host of efforts to spur the transition to digital
healthcare. As a company we are trying to do for healthcare what
the ATM system (which IBM helped invent) did to launch a global
infrastructure for electronic financial transactions, or what the
Internet browser did to catapult the World Wide Web from an
academic network into the platform for innovation that it functions
as today.
IBM supports legislative provisions that:
<bullet> Drive adoption of open standards by the federal
government and private industry;
<bullet> Commit initial seed funding and make early policy choices
that will set the stage for growth of health information
exchange; and
<bullet> Create incentives in Medicaid and Medicare to reward
quality of care, including those that can be measured and
rationalized through the use of health information
technology (Health IT).
These three areas - open standards, seed funding and policy
commitment that catalyze change, and new incentives to reward
the quality of healthcare - are the keys we believe, the keys that
will open up a smarter information system for healthcare. Not only
will this new model of care unlock the value of health information
in a networked world, it will help healthcare evolve into a system
properly organized around its core constituents-patients-and
begin to make costs and quality more transparent to all.
In 2004, the President launched an initiative to make electronic
health records (EHRs) available to most Americans within the next
10 years. In 2005, the Senate passed legislative reforms to
Medicare reimbursement and Health IT legislation that drives
toward these goals. We encourage similar action by your
committee and the House in 2006.
Today, I would like to talk about the steps that this committee
could take to improve healthcare, first through better use of open
technology standards. Where possible, I will use examples of our
own conduct and efforts at IBM.
I. Driving Standards Adoption
Achieving the vision of a nationwide health information
exchange first requires interoperability: the ability for disparate
health information systems to be able to talk to each other and
share data in a safe and secure manner. Interoperability and
standards are often mistakenly lumped together. Standards are
much narrower and specify technical details. Interoperability, on
the other hand, is a much broader concept that involves both
atechnical and business context.
The success of the Internet itself is overwhelmingly due to the
implementation of open standards, protocols, languages and
architectures such as HTML, XML, HTTP, PDF and many others.
In fact, almost all digital dataflow today depends on an open
standard for packets of digital information called IP, or Internet
Protocol.
Open standards have been profoundly embraced by most
technology companies, as well as governments and the public
sector around the world for many years, and for many reasons.
Chief among them is that open standards work to ensure
compatibility and interoperability that benefits all participants.
Broadly speaking, standards have long proven their value in
business and society in everything from measurements of weight
and size to transformative technologies such as wireless networks.
"Open" standards are those that are freely available to all, and
are created by an open decision-making process. In our world of
networked information, they speed innovation, integration and
collaboration in countless dimensions, including supply chain
management, consumer electronics and many forms of
communications.
Why is better use of standards so important? In short, better
use will facilitate the easier exchange of health information,
thereby helping lower costs (e.g. transaction costs), provide better
information to physicians and caregivers at the point of care and
improve patient safety and clinical quality.
Until we have unambiguous, clinically-relevant coding of chief
complaints, prescriptions, laboratory and imaging orders and
results, we hobble our ability to learn from this vast corpus of
information. Outcomes analysis, long-term effects, and the
identification and encouragement of best practices and quality-of-
care are all dependent on capturing this information at the source.
Open standards are nothing less than the means to advance the
industry towards richer, more evidence-based medicine and a
smarter health system.
In many cases, the standards have had long use within care
settings and are simply being pressed into use for broader networks
that extend across multiple care settings. Standards are used in all
phases of patient care and cover everything from messaging and
content, to measurement and communication. In some cases, these
protocols have already achieved wide adoption, such as the Digital
Imaging and Communications in Medicine (DICOM) format.
More recently, the National Council for Prescription Drug
Programs, Inc. (NCPDP) telecommunication standard was named
the official format for pharmacy claims under the Health Insurance
Portability and Accountability Act (HIPAA).
IBM's Standards Efforts in Healthcare
IBM has worked with providers, hardware and software
vendors to develop and adopt standardized ways of describing
health data, transmitting it to other computers, and requesting
processing related to that data from other computers. As specific
needs for collaboration across networks become clear, new
standards are developed and adopted. For example, one of the
earlier standards, DICOM, was developed so that x-rays and other
medical images could be shared.
IBM is a member of many key healthcare standards bodies
including HL7, and was a founding member of the Eclipse
Organization a leading open source community. Most recently,
IBM made its entire patent portfolio available, royalty-free, to
standards bodies working on open, interoperable infrastructure for
healthcare and education.
Integrating the Healthcare Enterprise IBM's work on
building a nationwide infrastructure for clinical information
exchange (the NHIN prototype) has lead it to join an initiative
called Integrating the Healthcare Enterprise (IHE). Under the
leadership of HIMSS and the Radiological Society of North
America, IHE is an architectural framework for exchanging
information across the enterprise that can incorporate established
standards to allow different healthcare enterprises to use their own
choice of hardware and software. In fact, our NHIN prototype is
based on IHE's work, as well as the open-standards based
Interoperable Healthcare Information Infrastructure (IHII)
architecture developed by IBM Research.
What is Still Missing: Federal Transition to Broad Standard's
Adoption
Federal adoption of open standards for healthcare diagnoses,
treatments and other core elements of medicine is critical to tip the
use of these innovation drivers from desirable to necessary. When
the government has adopted standards, such as the use of
International Classification of Diseases and Related Health
Problems (ICD-9) system for billing purposes, its market power
provides a sufficient voice to finalize consensus within healthcare.
The government was a principle driver for the adoption of ICD-9,
CPT/HCPCS, and DRG reporting.
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However, beyond the initiatives cited here, the broader federal
government has been somewhat slow to adopt and drive electronic
healthcare standards, and often requests that health information be
exchanged using phone, mail, or manual means that don't advance
open electronic standards and data exchange. As a result,
healthcare care costs are higher and quality is lower than they
would be if the federal government was more proactive about
implementing electronic standards.
For example, federal agencies mandate reporting of extensive
amounts of clinical information, yet don't require information to be
submitted via standardized electronic formats. I have attached
FDA drug adverse event reporting requirement - MEDRA - and
an illustration from the FDA website depicting their reporting
process. http://www.fda.gov/medwatch/ While this example is
drawn from the FDA, each of the agencies has comparable
examples of reporting that does not utilize health information
technology built on standards.
Agencies need the resources, guidance and clear leadership to
move away from these manual reporting systems in favor of
standards-based electronic reporting. The Senate legislation
includes provision to move the federal government towards
standards adoption by establishing an additional requirement for
standards in procurement, and requiring the option of standards
based reporting to federal agencies. The provision would build on
the standards identified several years ago by Secretary Thompson,
while allowing further standards to be adopted as they are
identified. It also allows the provider the choice of either
continuing to report manually or in electronic standards.
II. The Role of Initial Funding and Policy Leadership in
Sparking Healthcare Transformation
A smarter health system is clearly desirable - however, history
demonstrates that innovation often proceeds slowly at first, before
accelerating after a catalytic inflection point. The Internet, for
example remained an obscure academic network for several
decades before the Mosaic Web browser drove its explosive
growth in the 1990s. The DVD player became the most rapidly
adopted new technology only after manufacturers resolved two
competing technology standards.
The government's role as an early funder and policy driver is
vital during the initial phase of a major innovation such as the one
dawning around digitally networked healthcare. Initial funding is
the seed that allows healthcare system participants to develop
prototypes that translate concepts into implementations. The
government also plays a key role as a consensus builder on policy
issues, to the benefit of both citizens and businesses. As lessons are
learned from prototypes and policy development, new business
models emerge over time that can carry innovation forward.
Meanwhile the nature of innovation itself is becoming more
collaborative-between commercial enterprises as well as between
the public and private sectors-government has a highly
constructive role to play in sparking work that will unleash the
ability of businesses to drive growth and productivity. A smarter
healthcare system is just such entrepreneurial fire ready to be lit.
Finally, with nearly half of all healthcare spending in the U.S.
originating with the federal government, the public sector can have
a decisively influential role in helping engender a smarter health
system for all Americans. IBM hopes to play a similar leadership
role, both as large employer seeking to innovate how it delivers
healthcare to its workforce, and as a business and innovation
partner for many parts of the healthcare ecosystem.
Nationwide Health Information Network Architectural
Prototypes.
Funding included in President Bush's Health Information
Technology Plan is an important source of prototype funding. The
President has requested $116 million for his health information
initiative in FY 2007. While this represents a small portion of the
$5.5 billion that will be spent on health related information
technology, it provides key seed money for prototypes and early
learning.
The importance of standards and interoperability are front and
center in a several projects pertaining to development of a
Nationwide Health Information Network (NHIN). As you may
know, IBM is one of four companies awarded a contract to develop
NHIN architectural prototypes through a contract with the
Department of Health and Human Services, Office of the National
Coordinator for Health Information Technology. The four
architecture prototype contractors are not building the Network,
per se, but each vendor is building a prototype architecture.
The goal of the Nationwide Health Information Network
(NHIN) prototype is to demonstrate major concepts that build
towards the ultimate goal of a smarter, more connected information
infrastructure for healthcare, including the abilities:
<bullet> To enable secure electronic exchange of healthcare
information between and within healthcare marketplaces
that allows for the gathering of necessary public health data
while preserving patient privacy.
<bullet> To demonstrate how various healthcare marketplaces can
be part of this communications network in a manner that is
cost-effective and not disruptive to their current models of
doing business.
These contracts complete the foundation for an interoperable,
standards-based network for the secure exchange of health care
information. HHS previously has awarded contracts to create
processes to harmonize health information standards, develop
criteria to certify and evaluate health IT products, and develop
solutions to address variations in business policies and state laws
that affect privacy and security practices that may pose challenges
to the secure communication of health information.
IBM is following several key principles in developing a
prototype architecture for the developing nationwide network.
These principles are the result of IBM's experience in healthcare
and other sectors. They also arise from IBM's work with many
broad-based organizations in this area such as the Healthcare
Information & Management Systems Society (HIMSS), the
eHealth Initiative, and other information technology vendors, and
privacy and technical organizations with whom we collaborate
with on a daily basis.
The NHIN project promises to bring about a smarter health
system by leveraging the expertise and market interests of the
private sector. But it was also structured with an ingenious
requirement: the four participating contractors, IBM included,
must make their respective efforts interoperate across competing
healthcare marketplaces via open standards. If the NHIN project
can be thought of as the foundation of a "medical Internet" or
digital infrastructure for healthcare, then the importance that the
evolving nation-wide integrated system will be based on open
standards is quite obvious.
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In developing this prototype architecture for the evolving
nationwide network, IBM is following several key principles that
are the result of our experience in healthcare and other sectors.
They also arise from IBM's work with many organizations in this
area such as the Healthcare Information & Management Systems
Society (HIMSS), the eHealth Initiative, and other information
technology vendors, as well as privacy and technical organizations
with whom we collaborate on a daily basis.
The NHIN project promises to bring about a smarter health
system by leveraging the expertise and market interests of the
private sector. But it was also structured with an ingenious
requirement: the four participating contractors, IBM included,
must make their respective efforts interoperate across competing
healthcare marketplaces via open standards. If the NHIN project
can be thought of as the foundation of a "Medical Internet" or
digital infrastructure for healthcare, then the importance that the
evolving nation-wide integrated system will be based on open
standards is quite obvious.
Through the NHIN, it is envisioned that healthcare consumers
would be empowered to access their personal health records
(PHRs) using the same network that allows them to share their
medical records with healthcare providers that they see in other
communities. IBM's architectural prototype for the NHIN system
would not be a single repository of everyone's medical records, but
rather an index that points to information stored at the originating
provider site. IBM believes that independent healthcare
consumers, providers, and communities (as well as regional health
information organizations) will set the rules for who can see what
information and for what information they need.
Healthcare systems or RHIOs wish to retain control over their
enterprise-wide data and will also set the business rules for how
data will be exchanged. The NHIN will be a practical,
community-centric approach to exchanging healthcare information
in a secure, standardized way between healthcare communities in
the United States.
At the conclusion of the NHIN prototype project, HHS will
have four architectural prototypes to choose from or to incorporate
into the adopted NHIN architecture and a dozen communities will
have developed practical experience with information sharing.
IBM's prototype architecture, along with the other vendors, is
part of a broader effort sponsored by the ONC including related
efforts to advance the national health IT agenda. IBM continues to
participate in and monitor the other ONC-sponsored efforts by The
American Health Information Community, the Healthcare
Information Technology Standards Panel (HITSP), Certification
Commission for Health Information Technology (CCHIT), and
Health Information Security and Privacy Collaboration (HISPC).
The ONC awarded contracts and named inter-related groups
may supersede some of the functions and activities related in other
aspects of this testimony as they evolve during the coming months.
Through a series of contracts, public meetings and coordination
activities, these named groups are collectively addressing standards
harmonization, compliance certification, processes to develop
solutions that address variations in business policies and state laws
that affect privacy and security practices.
Personal Health Records
IBM can offer several examples to the Committee of our own
funding and policy initiatives that may provide some guidance for
similar efforts involving Medicaid. In 2005 IBM announced that it
would provide personal health records (PHRs) to its entire U. S.
workforce. To protect employees' privacy, the personal health
record (PHR) system available to IBMers today is managed by an
outside vendor and we have instituted contractual provisions and
process controls in order to prevent inappropriate access to
employee-specific data.
To establish their personal health record (PHR), our U.S.-based
employees begin by entering basic information: medicines,
allergies, major conditions, and details on their doctors and
insurance coverage. Later this year, employees' personal health
records (PHRs) will grow to automatically include medical and
prescription drug claims history.
Even this basic information has real utility today. It can be
emailed or faxed to a provider-and even sent from a Web-enabled
mobile device-or simply stored or printed out for easy access in
an emergency or when traveling. The ultimate goal is to enable all
types of electronic health information, including one's lab results,
prescription histories, medical images and more to flow into the
record to form a comprehensive portrait of a patient. Equipping
and empowering patients with personal health records (PHRs) is
only the start. Enabling such data to flow electronically to doctors,
hospitals and other providers authorized by the patient will allow
healthcare to become a highly interoperable and innovative -
something it is far from today.
Early this week, CMS also issued an RFP on personal health
records (PHRs) for Medicare beneficiaries. Yesterday, IBM
testified to the Federal Workforce Committee about legislation to
extend interoperable Personal Health Records (PHRs) to all federal
employees. This Committee has the same ability to leverage
existing claims data in state Medicaid programs. IBM urges you to
examine the role that our federal government can play in
catalyzing interoperable personal health records (PHRs) by
providing them to Medicaid beneficiaries.
Just as the value of a network rises exponentially with the
number of devices connected to it-the so-called network effect-
the power of the personal health record (PHR) will rise
dramatically the faster we can build a critical mass. What's more,
with a large enough base of personal health records (PHRs), the
private and public sectors will create strong incentives for
physicians, hospitals, and other health system participants to begin
to adopt the infrastructure for healthcare that will improve quality
and reduce costs.
Interoperable personal health records (PHRs) will also drive
two vital changes in the nature of healthcare itself. First, they will
increasingly make the patient the center-point around which
healthcare organizes itself. And second, interoperable personal
health records (PHRs) and their related systems will support
greater transparency across healthcare, and in many dimensions,
including price and quality.
At IBM, the personal health records (PHRs) that we are
providing to all of our employees in the U.S. are a prime example
of this patient-centered approach. When an IBMer first goes to the
Web site for their personal health record, they are offered a
financial incentive to complete an employee health risk appraisal,
develop a personal preventive care action plan and identify quality
hospitals in their area. The process surveys a range of issues
including exercise level, family histories and cholesterol control, if
applicable. Based on the results, an IBMer can subscribe to receive
expert information, articles and advice on how to reducing their
risks. It identifies eligibility for additional benefits and services
such as disease management and refers employees to those
resources. Decision support tools for drug comparison and
interactions, hospital quality and Leapfrog results (from the
Leapfrog Group's performance measurement system) provide
individual support for optimizing benefits quality and costs.
For IBM, the risk assessment tools and the personal health
records (PHRs) we provide our workforce are an investment that
we recoup through improvements in employee health and the
significant cost savings that result. For individual employees, the
incentives we provide-to take the assessment, or track their self-
paced exercise regimens -are essential to helping us capture these
business benefits.
Consumer Centric Healthcare
To put IBM's experience with personal health records (PHRs)
in some context, I would first like to describe our broader efforts
on improving employee health and reducing costs. That backdrop
is, in fact, how we progressed to offer personal health records
(PHRs) for our employees.
IBM provides health and health benefits of over 500,000 IBMers,
retirees and dependents. In total, the IBM Corporation spends over
$1.7 billion on healthcare each year. As a result of our consumer-
centric health programs for our employees, IBMers are healthier
and have lower health expenses than others in our industry. We
have demonstrated that information-rich, patient-centric wellness
programs aren't marginal benefits. They are very good business:
<bullet> IBM's employee injury and illness rates are consistently
lower than industry levels.
<bullet> We have documented significant decreases in the number
of health risks among IBM employees as a result of
participating in our wellness initiatives.
<bullet> IBM's disease management programs have demonstrated a
9%-24% reduction in emergency room visits and a 13-37%
reduction in hospital admissions resulting in an overall 16%
reduction in medical and pharmacy costs adjusted for
medical trend over a 2 year period.
With the health improvements, we have seen cost benefits --
IBM healthcare premiums are 6% lower for family coverage and
15% lower for single coverage than industry norms. Our
employees benefit from these lower-cost as well -- they pay 26 to
60% less than industry norms. And IBM healthcare premiums
have been growing significantly more slowly than U.S. health
insurance premiums.
<GRAPHICS NOT AVAILABLE IN TIFF FORMAT>
Critical Areas for Initial Policy Choices:
Privacy in electronic healthcare is an area of policy
development with deep importance, diverse viewpoints, and great
need for government leadership, both in terms of driving standards
and providing catalytic early funding.
According to a 2005 survey, two-thirds of all Americans report
high levels of concern about the privacy of their personal health
information, with ethnic and racial minorities and the chronically
ill showing the greatest concern:
<bullet> Is of a racial/ethnic minority: 73%
<bullet> Is not of a racial/ethic minority: 52%
<bullet> Has been diagnosed with a disease: 67%
<bullet> Has not been diagnosed with a disease: 63%
One in four consumers reports being aware of incidents where
the privacy of personal information was compromised. In addition,
they believe, erroneously, that paper records are more secure than
electronic ones (66% vs. 58%). (California HealthCare
Foundation)
These attitudes about privacy are reflected in the requirements
consumers believe are important for electronic health information
exchange. Nine of ten consumers want a system that confirms the
identity of anyone accessing it. Eight of ten want to personally
review who has accessed their information, and to be asked before
their information is shared. (Markle) Clearly, privacy issues, and
the public's perceptions of those issues, must be addressed in order
for the PHR to succeed.
The HIPAA Privacy Rule has provided the bedrock for patient
privacy in the U.S. and has established a baseline for privacy and
security requirements for electronic health information. Many
states have gone further then HIPAA to ensure patient privacy and
have adopted policies that further protect patient data when stored
and moved in an electronic format. These variations in policies
present challenges for widespread electronic health information
exchange. To assess these challenges, HHS awarded a contract
devoted to privacy and security. The Health Information Security
and Privacy Collaboration (HISPC), a new partnership consisting
of a multi-disciplinary team of experts and the National
Governor's Association (NGA), will work with approximately 40
states or territorial governments to assess and develop plans to
address variations in organization-level business policies and state
laws that affect privacy and security practices and pose challenges
to interoperable health information exchange. Overseeing the
HISPC will be RTI International, a private, nonprofit corporation
who has been selected as the HHS contract recipient.
While many see privacy as a potential barrier to health
information exchange, most computer systems today include a
variety of privacy protections. Most people are familiar with
identity-based limitations - personal IDs and passwords that must
be entered in order to access a system. With little effort, privacy
controls can include roles as well as identity authentication so that
a billing clerk or a doctor will have the appropriate level and
access to a patient's personal health information. Information
technology can also provide tools to monitor who accesses data,
create an audit trail for changes the data, and a watermarks to deter
data theft and assert ownership of pirated copies. With paper
records, there is no automated way to know, for example, if
someone has accessed a record inappropriately, or even removed it
or copied it.
We have the technology today to protect patients' but if
privacy policies are unclear, or built on concepts such as "intent"
that are difficult to translate into computer rules, technology will
be of little help in formalizing privacy. Creating a smooth
interface between privacy policy and technology will require a
significant commitment of political will and resources. Here again,
the government can play a pivotal role in stimulating and
encouraging the development of privacy policies that will enable
electronic healthcare to move forward faster.
III. Creating Incentives in Medicare and Medicaid to Reward
Quality
Establishing a system of electronic health records (EHRs) for
millions of citizens is a major societal shift, and will require a
range of incentives to accelerate adoption among various
constituencies. Physicians and other healthcare providers will bear
the direct costs of implementing electronic health records (EHRs),
as well as the indirect cost to transform their established workflow
processes to take advantage of these new technologies.
The current healthcare system has well-known flaws in how
treatments are reimbursed. The current model rewards the volume
of services and not the quality of outcomes. This paradigm results
in low quality and rising costs. Those reimbursement flaws reduce
the incentive for quality improvement tools such as interoperable
electronic health records (EHRs). Reforms in reimbursement
methodologies and additional sources of funding will have a
dramatic impact on the adoption of the electronic health records
(EHRs), and the multitude of systemic benefits they reap.
The effectiveness of "carrots" for performance are why IBM
supports incentives to providers to adopt electronic health records
(EHRs) and other related health information technology
applications (Computerized Patient Order Entry, e-prescribing,
etc.).
In fact, IBM is already implementing a "pay-for-use" incentive
plan to drive the use of electronic prescriptions.
In New York's Hudson Valley, where many of our employees
live, we are funding a program that rewards doctors each time they
use a new system for writing prescriptions electronically. Working
with Dr. John Blair and Taconic Health Information Network and
Community (THINC) regional health information organization, or
RHIO, IBM has agreed to increase the reimbursement physicians
receive if they submit prescriptions electronically. We believe that
the additional reimbursement we are offering will pay for itself by
reducing medication errors and increasing the use of generic drugs.
We urge this Committee to examine approaches to rewarding
value through the Medicaid program. This coming year, the
federal government will provide over $300 billion through the
Medicaid program. It makes no sense to pay all those providers
the same reimbursement rates, if the quality for some greatly
exceeds - or severely lags behind - that of others. But today,
Medicaid is at best neutral, and at worst negative, toward quality.
Medicaid pays for the delivery of a service, not for the
achievement of better health.
A number of pay-for-performance demonstration projects in
Medicare are underway (see box, right). IBM would encourage the
expansion of these pioneering efforts and application to the
Medicaid program.
<GRAPHICS NOT AVAILABLE IN TIFF FORMAT>
Barriers & Indicators for Success:
Electronic health records (EHRs) and a digital infrastructure to
support them will enable a historic shift in medicine: rewarding
outcomes and improved quality of care rather than simply paying
for procedures in today's fee-for-service model. Health IT is
invariably linked to this shift in reimbursement because it is
needed to help document and measure performance.
Health information technology is a key to successful pay-for-
performance for two reasons. First, electronic reporting can reduce
the significant burden that performance reporting places on
providers. Current performance measures often involve manual
chart review and manual processing by skilled professionals.
Electronic reporting can reduce the performance reporting burden
and ease participation by providers in pay-for-performance
programs.
Second, electronic reporting can align with the ongoing care
process to actually improve the quality of care a patient receives,
not just by documenting end results, but by alerting providers in
realtime to any gaps or best practices that may have been
overlooked. As a result, performance measurement carried out
electronically can move from a description of quality to an
operational tool that improves care. Those patients that do not
receive appropriate care may be highlighted while they are
interacting with providers rather than much later in reports that are
submitted to reimbursers.
<GRAPHICS NOT AVAILABLE IN TIFF FORMAT>
Naturally, the pay-for-performance model will require the
support of doctors and the medical community. Financial
incentives under a pay-for-performance program must be:
<bullet> Non-punitive (i.e. physicians who are unable to participate
in the program should not be subject to negative updates);
<bullet> Prioritized, so that physicians are rewarded for achieving
improvements for the top 20 conditions identified in the
Institute of Medicine's (IOM) "Crossing the Quality
Chasm" report;
<bullet> Considerate of the critical role of primary care physicians
in achieving such improvements; and
<bullet> Sufficient to offset physicians' investment in health
information technology and other office redesign required
to measure and report quality.
We also advise that pay-for-performance programs be
implemented along with reforms to change the way that physician
services are valued and reimbursed, rather than grafted onto an
underlying payment methodology that pays doctors for doing
more, instead of doing better.
Of course, one of the most important factors in making pay-
for-performance a success is the size of the incentive or bonus
relative to a physician's or hospital's total revenues. While no
formal studies have yet clearly documented this issue, empirical
data suggest that physicians will respond to incentives only if they
represent 5% or more of their total revenues.
In conclusion, creating powerful incentives in the federal
health programs is necessary if we are to drive improvements in
healthcare through the intelligent application of technology.
Incentives for quality will undoubtedly lead toward better use of
health information technology to improve healthcare. The
information technology industry would like the opportunity to
drive such a virtuous circle - incentives leading to better use of
health IT which leads to improved quality and lower costs. This
Committee can start by implementing the pay-for-performance
model in Medicaid.
Summary
<bullet> The federal government can advance a smarter health
system by deeply adopting and supporting open standards.
<bullet> The federal government can accelerate the transformation
of healthcare through judicious seed funding of prototypes
and communities and active leadership in policy areas such
as privacy and security.
<bullet> Strong incentives are needed to drive adoption of electronic
health records (EHRs), and one of the most powerful levers
would be to reward the quality of care in Medicare and
Medicaid via a "pay-for-performance" model.
MR. DEAL. Thank you, Mr. Nelson. And I again apologize but
we are going to stand in recess pending these votes. There will be
ten votes, so we will probably be somewhere an hour or
thereabouts before we will be able to get back, but hopefully we
will have a little better attendance perhaps after those first series of
votes. Thank you, and we will stand in recess.
[Recess.]
MR. DEAL. We will call the hearing back to order. Thank you
for being patient during the break. Dr. Braithwaite, we will hear
from you at this time.
MR. BRAITHWAITE. Thank you, Mr. Chairman. Chairman
Deal and distinguished members of the subcommittee, I am
honored to be here today. My name is Bill Braithwaite, and I am
testifying today on behalf of the eHealth Initiative and its
foundation otherwise known as eHI. I serve as the chief medical
officer of both organizations, which are independent, national,
non-profit organizations whose missions are the same: to improve
the quality, safety, and efficiency of health and healthcare through
information and information technology. In addition to our main
work with communities, we work actively with Congress and the
Administration to support these goals and applaud their strong
commitment. eHI looks forward to working with you on potential
legislation in this area.
I would like to talk a little bit about the big picture. The field
of healthcare today is so vast and so complex that practicing
medicine with an acceptable error rate is proving to be humanly
impossible without the support of integrated information
technology. The number of deaths caused by medical errors in our
healthcare system every year has been estimated to be around
100,000 or higher if you include all the different aspects of
healthcare. I think we would all agree that this is not acceptable.
In most cases the healthcare system is at fault. We still practice
medicine under the old paradigm where the doctor and the patient
interact from memory to arrive at recommendations of healthcare
decisions for the patient.
The only way to significantly improve the quality, safety, and
efficiency of our healthcare system is to bring the information
system into the exam room, as it were, and to change the paradigm
of clinical practice so that it routinely involves the doctor, the
patient, and the computer working together to provide the best
healthcare advice possible. The way to implement this new
approach is through direct interaction of clinicians and patients
with a Clinical Decision Support System. Such a system must be
integrated into the clinical environment in a way that supports,
rather than disrupts, the efficient flow of the process of healthcare.
But since most of the data on which clinical decisions are made
actually originate outside the exam room, the Clinical Decision
Support System by itself cannot function without a way to access
the sources of the clinical data, the laboratories, pharmacies,
radiology centers, et cetera. This is the impetus for eHI's emphasis
on interoperable health information exchange initiatives.
There are three critical prerequisites for successful
implementation of health information exchange initiatives:
incentives for implementation; assurances about privacy and
security; and full interoperability between disparate clinical
information systems. Even though all three are crucial, I will
restrict this testimony to interoperability, and you will hear about
the others from others on the panel.
There is still confusion in the healthcare industry about the
meaning of the term interoperability. The definitions in my written
testimony on page 5 come from an analysis of over 100 such
definitions done by the international standards developing
organization, HL7. Basically interoperability is the secure
electronic communication of clinical data, like lab results from a
computer in one institution in such a way that a computer in
another institution can understand the precise meaning of what was
said. In this case computer understanding means that the
information could be processed by the receiving computer to reach
conclusions about what advice to give to optimize patient care.
The terminology used to describe clinical concepts must be
standardized, controlled, and coded in enough detail to
differentiate between closely related conditions that might require
different treatments. For example, the synonyms were originally
used to identify the condition at the local hospital. At last count,
for example, there were 17 different terms used in different parts of
this country that all referred to the same concept of high blood
pressure. Larger categories of clinical concepts typically used for
reimbursement transactions are not sufficiently detailed for this
purpose. Interoperability also implies that there is a standard
mechanism that all participants can use to exchange the
information securely. Most of us use the World Wide Web every
day and understand the power of having such a communications
infrastructure available to all. Healthcare, of course, requires iron
clad security as part of its infrastructure, including features not
required in the standard Internet such as authentication,
authorization, auditing, encryption, and digital signatures.
Successful implementation of electronic health information
across institutions requires specificity, standards, and conformance
testing of the results, features not currently found in most of the
standards available today even after up to 20 years of development
because of course the standards developing organizations have
been focused on something else, the exchange of information
within institutions between information systems. The sometimes
heard proclamation that health information exchange should wait
until the standards are done is made by those who are not fully
aware of the tasks involved. Enormous progress has been made in
the understanding, specification, and adoption of standards so far,
but standards are not static. They must evolve to meet the
continuous advances in the delivery of healthcare and can never be
done. On the other hand, there are some low hanging fruit that we
can address. Given that the timeline for full interoperability
between clinical information systems, in my opinion, is likely to be
measured in decades, what can we do in the meantime to reap
some of the value of the Health Information Exchanges that we can
implement today?
If we focus our resources on a few projects that can
successfully reach interoperability in the short term, we can
demonstrate immediate benefits for people who are working
toward the same goal using consistent standards. If you ask
clinicians what information is most important when they are seeing
a patient without a medical record as they had to do after Katrina,
they quickly list medication history, allergies, lab results, problem
list, and interpretive reports. The patient, however, first wants to
do without the need to fill out the same data multiple times on the
medical clipboard at each provider that they go to. So let us start
with those needs in mind and solve some of the immediate
problems.
The industry has already made much progress on these
particular needs because the demand is there, and the efforts under
the contracts issued by HHS through the Office of the National
Coordinator are focusing on the same situations in the context of
prototypes for a nationwide health information infrastructure.
Results from these funded efforts are expected by the end of this
year. In addition, the important private-public sector partnerships
such as the Markle Foundation's Connecting for Health initiative,
with additional support from the Robert Wood Johnson
Foundation, have provided a great deal of guidance on the
technical aspects and the key principles and policies for
information sharing.
The standard for exchanging medication history and laboratory
results is already being tested, although integration with lab test
ordering is still being worked on. One approach for interpretive
reports, which is one of the sort of early wins that people are
looking for, is an electronic standard message that contains both a
human readable representation of the data, and a structured and
coded form suitable for processing by a computer. Thus, those
source systems that are only capable of producing the human
readable form, similar to a web page, can still participate in the
electronic Health Information Exchange while those systems with
more capability can include the data that is fully understood by a
computer program in full interoperability. This will allow a
migration over time from a simple and easy to produce form of
data that is still compatible with the more sophisticated forms in
both directions of communication.
MR. DEAL. Could I ask you to summarize for us, please?
MR. BRAITHWAITE. Yes. Vendors are reluctant to spend
money implementing standards without customer willingness to
pay for it. Providers are reluctant to pay for such features if they
cannot see immediate payback. Therefore, purchasers have to be
shown that the present and future value of standards-based systems
and convinced to buy them whenever feasible. In conclusion, I
believe we can provide appropriate incentives to implementation,
adequate assurances to providers and patients about the privacy
and security of their information, and support for full
interoperability of our healthcare information systems. In doing so
we will have set the stage for a high quality, safe, and efficient
healthcare system for all Americans in their communities. eHI will
be there to help you if you can do this through legislation. I would
like to thank the committee for providing me the opportunity to
share these insights on behalf of eHI and its foundation.
[The prepared statement of William Braithwaite follows:]
PREPARED STATEMENT OF WILLIAM BRAITHWAITE, M.D., PH.D.,
CHIEF CLINICAL OFFICER, EHEALTH IMITATIVE AND FOUNDATION
FOR EHEALTH IMITATIVE
Summary
Health Information Exchange (HIE) initiatives are the
underpinnings for a system to improve how healthcare is practiced.
Recognizing that healthcare is local, the eHealth Initiative and its
Foundation are supporting multi-stakeholder HIE collaboration at
the state, regional and community levels through the Connecting
Communities program. Important knowledge related to every
aspect of health information exchange is resulting from this work.
[see http://toolkit.ehealthinitiative.org] The current paradigm of
clinical practice limits our ability to avoid errors and control costs.
Only with clinical decision support systems (CDSS) integrated into
the routine of clinical practice can the system support better
healthcare decision making. HIE is a necessary precursor to the
operation of CDSS. Requirements for HIE implementation include
incentives to stakeholders, assurances regarding privacy and
security, and health information system interoperability.
Interoperability is defined with three levels of standards
required, from controlled clinical vocabularies, to standardized
message structures and entity identification, to a secure
communications infrastructure. However, standards are not
enough for interoperability. The necessity for inter-institutional
exchange of data is forcing a change in the character of standards
from the traditional, flexible standards currently in use between
systems in the same institution to more complete, rigorous, and
tested implementation specifications integrated across standards
for specific use cases. Systemic barriers to the rapid deployment
of this evolution must be addressed.
This process is likely to take decades before full
interoperability of clinical information systems is a reality. There
are some low hanging fruit that can be harvested in the near-term,
however; medication history, lab results, and interpretive reports,
for example. There is an existing suite of standards that addresses
these areas of interoperability but most of the standards are not
rigorously defined for specific use cases and are inconsistently
implemented by vendors. While the HHS AHIC and ONC efforts
to kick-start interoperable health information exchange is a good
and positive process; it is the start of a very long road. Sustained
federal leadership is crucial to achieving these goals and to
promoting a smarter healthcare system over time.
Introduction
Chairman Deal, Congressman Brown, distinguished members
of the Subcommittee, I am honored to be here today. My name is
Bill Braithwaite and I am testifying today on behalf of the eHealth
Initiative and its Foundation (eHI). I serve as the Chief Medical
Officer of both organizations, which are independent, national,
non-profit organizations whose missions are the same: to improve
the quality, safety, and efficiency of health and healthcare through
information and information technology.
In addition to our main work with communities, we work
actively with Congress and the Administration to support these
goals and applaud their strong commitment. eHI looks forward to
working with you on potential legislation in this area.
The big picture
The field of healthcare is now so vast and complex that
practicing medicine with an acceptable error rate is proving to be
humanly impossible without the support of integrated information
technology. The number of deaths caused by medical errors in our
healthcare system every year has been estimated to be 100,000 or
higher. I think we would all agree; that is totally unacceptable.
And in most cases it is the system that is at fault: we still practice
medicine under the old paradigm where the doctor and the patient
interact from memory to arrive at healthcare decisions for the
patient. The only way to significantly improve the quality, safety,
and efficiency of our healthcare system is to bring the information
system into the exam room, as it were, and to change the paradigm
of clinical practice so that it routinely involves the doctor, the
patient, and the computer working together to provide the best
healthcare advice possible. The way to implement this new
approach is through direct interaction with a Clinical Decision
Support System (CDSS). Such a system must be integrated into
the clinical environment in a way that supports rather than disrupts
the efficient flow of the process of healthcare. Since most of the
data on which clinical decisions are made actually originate
outside the exam room, the CDSS by itself is not functional
without a way to access the sources of the clinical data, the labs,
pharmacies, radiology centers, etc. This, then, is the impetus for
eHI's emphasis on interoperable health information exchange
initiatives.
Of course, none of these technological innovations will be
implemented unless there are sufficient incentives to get these
systems incorporated into healthcare practice under a sustainable
business model. The needed incentives can take many forms,
including pay-for-performance programs that pay providers for
higher quality care delivered, and they are discussed in detail in
our paper entitled, "Parallel Pathways to Quality Healthcare". In
addition, none of the required information sharing will be allowed
unless there are sufficient assurances to patients and providers
alike that the shared information will be private and secure. In the
interest of time, I will leave these two critical prerequisites for
others to discuss and refer you to the eHI website for further
background material [see http://www.ehealthintitiative.org/].
Interoperability
Since most data on which clinical decisions are based come
from outside the exam room or other locations where clinical
decisions are being made, interoperability for clinical data
exchange is a basic and necessary requirement. However, in the
healthcare industry there has been some confusion about the
meaning of the term, 'interoperability'. The following definitions
come from a meta-analysis of over 100 such definitions done by a
technical committee of HL7, an international healthcare standards
setting organization.
Interoperability is the ability of two or more systems or
components to exchange information and to use the
information that has been exchanged accurately, securely, and
verifiably, when and where needed.
Healthcare interoperability also assures the clear and reliable
communication of meaning by providing the correct context
and exact meaning of the shared information as approved by
designated communities of practice. This adds value by
allowing the information to be accurately linked to related
information, further developed and applied by computer
systems and by care providers for the real-time delivery of
optimal patient care.
It is important to understand all the implications of the term,
'interoperability', at different levels of abstraction from binary bits
of information flowing through a wire at the bottom to the transfer
of clinical knowledge at the top. At the highest levels, the context
and the exact meaning of information must be preserved and made
available for use. In this case, 'use' means that the information can
be processed by a computer to reach conclusions about what
advice to give to a clinician to optimize patient care. That means
that the terminology used to describe clinical concepts must be
standardized, controlled, and coded in enough detail to
differentiate between closely related conditions that might require
different treatments, for example. Larger categories of clinical
concepts typically used for reimbursement transactions are not
sufficiently detailed for this purpose. There are also a large
number of clinical concepts which are referred to by different
names in different geographic locations. Where locally defined
terms are used in lieu of terms from a national standard controlled
terminology, then mechanisms must be in place to make the
translation to the national standard, a process called
'normalization', so that another location that uses its own local
terms for a clinical concept can preserve the correct context and
exact meaning. As simple examples that require such
standardization, there are 17 different terms that represent the same
concept of high blood pressure and there are 27 different potential
values for the concept of sex and many different ways to encode
them.
At the lowest levels, interoperability implies that there is a
standard mechanism that all participants can use to exchange the
information securely. Most of us use the world-wide-web every
day and understand the power of having such a communications
infrastructure available to all. Healthcare, of course, requires such
an infrastructure to include more security features than the
standard internet connectivity we all use, including authentication,
authorization, auditing, encryption, and digital signatures.
In the middle levels are the standards for aggregating discrete
data elements together into a meaningful message sent from one
system to another in response to an event or 'trigger', standards for
identifying the healthcare providers and the patients, and standards
for a plethora of other elements that are unique and specific to the
use case being implemented.
Clearly, interoperability requires the consistent and rigorous
integration of standards of many types and necessarily from many
sources. When the only electronic information exchange being
considered was that between one system and the next operated by
the same institution, it was easy for the technical team(s) to discuss
all the specific technical decisions that have to be made before
even a well defined standard can be used in a particular business
use case. Once the problem is expanded to include the exchange
of information among many institutions that may not even be in
the same region of the country, the required degree of specificity is
sorely lacking in most of the consensus standards available today
and the standards development and maintenance process is
perceived to be slow and cumbersome.
It is also critical, with the increasing number of participants in
inter-institutional health information exchanges, that the
implementations of the standards be tested be conformant to those
standards. For example, HL7 standards for transmitting numeric
lab results from a laboratory information system to a clinical
information system or repository within an institution were some
of the earliest implementations of HL7 standards. [Note that HL7
celebrated its 20th anniversary as a standards developing
organization in 2006.] However, there are still implementations
today where a laboratory (part of a national reference laboratory
company) transmits the numeric result of a test in the comment
field of a "standard" HL7 message, instead of the result field. This
is accommodated in today's world by writing tailored interfaces
for each data flow to bring them to a common implementation of a
standard. This is expensive in the short term and untenable in the
long term.
The full implementation of standards requires an effective
processes for, and ongoing investment in, standards development,
support and maintenance, migration, and integration. A range of
supporting tools need to be developed and implemented to assist
organizations in migrating to standards, including implementation
guides, conformance processes, and educational materials.
Demonstration and implementation projects are critical to the
migration toward an interoperable, electronic healthcare system, in
that they test and evaluate feasibility, uncover additional barriers
and workable solutions to overcome them, provide replicable
practices and tools for others, confirm value for a wide range
community stakeholders, and build awareness of the benefits.
The sometimes heard proclamation that, "HIE should wait until
the standards are done," is made by those woefully ignorant of the
tasks involved. The many issues discussed above indicate the
enormous progress that has been made in the understanding,
specification, and adoption of standards. Standards are not static,
however, and they must evolve to meet the continuous advances in
the delivery of healthcare and can never be 'done'. To become and
remain acceptable, the standards process requires some effort and
participation by everyone concerned.
Low hanging fruit
Given that the timeline for full interoperability between clinical
information systems is likely to be measured in decades, what can
we do in the meantime to reap some of the value of the HIE that
we can implement today? If you ask clinicians what the most
important information is when they are seeing a patient without a
medical record, they quickly iterate medication history, allergies,
lab results, problem list, and interpretive reports (e.g., radiology,
pathology, and operative reports that are already in electronic form
through dictation). The wish list from the patient, however, starts
with the data they now have to fill out multiple times on the
medical clipboard. Great progress has already been made on many
of these and the efforts under the contracts issued by HHS through
the Office of the National Coordinator of Health Information
Technology (ONC) [see http://www.hhs.gov/healthit/] are focusing
on these early wins as well as prototypes for the nationwide
infrastructure. Results from these funded efforts are expected by
the end of this year. In addition, important public-private sector
partnerships, such as the Markle Foundation's Connecting for
Health initiative [see http://www.connectingforhealth.org], with
additional support from the Robert Wood Johnson Foundation,
have provided a great deal of guidance on the technical aspects of
health information exchange as well as key principles and policies
for information sharing.
Although medication history is not directly involved in most
ePrescribing initiatives, it is closely related and likely to evolve
quickly based on existing standards as ePrescribing
implementations proceed. Laboratory results are being exchanged
in some environments today and standards for exchanging most
types of results already exist. Full integration with lab test
ordering is still being worked on. One approach for interpretive
reports that looks promising is the use of a standard electronic
message that contains both a human readable representation of the
data and a structured and coded form suitable for processing by a
computer. Thus, those source systems that are only capable of
producing the human readable form (similar to a web page) can
still participate in the HIE while those systems with more
capability can include data that is fully understood by a computer
program. This will allow a migration over time from a simple and
easy to produce form of data that is still compatible with the more
sophisticated forms in both directions.
It should be absolutely clear from this discussion and these
examples, however, that we are still many years away from the
fully interoperable health information exchange environment of
our vision and there are several intractable barriers to more rapid
progress of which we should be aware.
The business case for a vendor to incur the costs of switching
to a standard is often muddled at best: short-term narrow objectives
are the enemy of long-term, broad interoperability goals. Even
when a vendor understands that implementing standards is good
for the product, the resources to do it are not always available.
Purchasers have to be informed and insist on standards-based
implementations whenever feasible.
Existing standards must be 'constrained' (a term of art used by
standards setting organizations) into rigorous implementation
guides for each particular 'use case' (another term of art). A use
case is like the outline of a play that defines the goal, the actors,
the roles they play, the trigger event(s) that cause them to interact,
the data elements that they must exchange, etc. Given a general
use case, an implementation guide will allow an implementer to
program an information system in a consistent way. It may take
several implementation guides based on several standards to
implement a particular use case, and the combination of these is
often called an 'integration profile'.
There is a fairly well recognized first set of standards that are
already being adopted for HIE. These include: HL7 data
interchange standards, the HL7 Reference Information Model, the
DICOM standard for imaging, the NCPDP SCRIPT prescription
drug information standard, the LOINC vocabulary for laboratory
tests, the IEEE/CEN/ISO 1073 medical device communication
standard, the ASC X12 administrative transaction standard, HL7
Data Types, HL7 Clinical Document Architecture (CDA), and the
HL7 Clinical Context Management Specification (CCOW). Work
remains to be done in a number of other domains, including
standards related to terminology (and their uniform distribution
within the National Library of Medicine's Unified Medical
Language System (UMLS)), clinical templates, clinical guidelines,
representation of business rules, representation of decision support
rules, data elements, disease registries, tool sets, security,
identifiers, and the electronic health record.
Conclusion
In conclusion, I'd like to thank the Committee for providing
me the opportunity to share my insights and expertise on behalf of
eHI and its Foundation today. There is a long road ahead but it is
filled with the promise of better health for all Americans in their
own communities if we work together and get it right on
interoperability. Nothing could be more important and eHI will be
there to help every step of the way.
APPENDIX A
Health Information Exchange: The eHealth Initiative and
Foundation's State, Regional and Community-Based Program
Work
Recognizing that healthcare is local-and that to stimulate
change in how healthcare is delivered, one must drive change both
at the national level and local levels-eHI has been focusing its
efforts on supporting multi-stakeholder collaboration at the state,
regional and community levels, bringing its common principles,
policies and standards developed nationally to those who are
delivering healthcare in markets across the U.S. This work is being
conducted through the direct funding of learning laboratories at the
community level and advocacy and education for additional
funding to support local efforts; the building of a coalition or
"community" of over 2,000 stakeholders working on health
information exchange within over 250 states, regions and
communities across the U.S. to share insights and effect change;
and the provision of direct technical assistance to leaders within
states and regions who are developing strategies and plans to
facilitate HIT adoption and health information exchange.
The eHealth Initiative Foundation began its Connecting
Communities program in FY 2003, through the leadership and
foresight of Congressman C.W. Bill Young (R-FL). Though a
special appropriation administered by the Department of Health
and Human Services' Office of the Secretary, and in years past by
the Health Resources and Services Administration's Office of the
Advancement for Telehealth (HRSA/OAT), Connecting
Communities continues to provide seed funding and technical
support to a set of "learning laboratories" led by multi-stakeholder
collaboratives, who are experimenting with the development of
models for sustainability for their health information exchange
efforts. This program will yield valuable lessons learned. Learning
laboratories will inform the efforts of policy-makers, and national
leaders both in the public and private sectors who must take
actions to clear barriers to interoperability and health information
mobility.
The 2006 Connecting Communities award program will
provide learning laboratories for the development and
implementation of sustainable business models for health
information exchange and build healthcare purchaser and payer
awareness of the value that health information exchange
capabilities can provide in improving the quality, safety and
efficiency of care to stimulate ongoing interest in supporting such
activities at the state, regional and local levels. Successful
awardees will have engaged the commitment of purchasers and
payers representing at least 30 percent of covered lives within their
markets, to participate in a pilot or implementation of an incentives
program that will not only support quality goals, but also directly
or indirectly, support the health information exchange capabilities
which are necessary to achieve those quality goals. They will also
have engaged the commitment of a large percentage of practicing
clinicians--including small physician practices--who have
committed to both utilizing the health information exchange
capabilities, and participating in the incentives program.
The Connecting Communities program is also directly aiding in
a task vital to our nation in the wake of Hurricane Katrina: helping
to strengthen Gulf Coast healthcare services and regional
electronic health information infrastructure in Alabama, Florida,
Louisiana, Mississippi, and Texas by supporting public-private
sector partnerships as well as assessment, planning, operational,
and communications activities related to the development of health
information networks within and across the Gulf States. Prior to
Hurricane Katrina, work was being conducted by the Foundation
for eHealth Initiative in the Gulf Coast state of Louisiana to assist
in general health information technology policy efforts.
The program is also producing informative research and tools
valuable to emerging health information exchanges and related
policy formation. For example, the Connecting Communities
Toolkit is a unique, multi-layered, one-stop resource offering
structured, how-to synthesis of principles and tools designed to
equip states, regions and local communities with the information
and expertise to begin or advance local health information
exchange initiatives and organizations. It offers insight into areas
crucial to start-up and successful survival such as organizational
structure, value creation, financing, practice transformation,
quality, information-sharing policies, technical aspects and public
policy and advocacy. Importantly, it is a distillation of cumulative
knowledge resulting from working with multiple stakeholders in
different communities. Communities contribute toolkit resources
themselves in the spirit of sharing insights with their peers. Its
release comes at a critical time as health information exchanges are
coming into existence across America and seeking expert advice.
Through eHI's activities on health information exchange, the
organization has: become the hub of best practice development and
sharing for driving transformation through health information
exchange, providing a full range of tools and resources for states,
regions and communities who are navigating the organizational,
legal, financial, clinical and technical aspects of health information
exchange. It is also actively supporting stakeholders engaged in
transformation and health information exchange efforts in more
than 250 states, regions and communities across the U.S.
In regards to states, the eHealth Initiative has or is in the
process of actively supporting 13 states across the country in
developing strategies, policies, and plans for improving health and
healthcare through health information technology and exchange
through its State Policy Summit Initiatives. The goal of these
initiatives is to help state public policy officials and key
stakeholders in the healthcare and business communities develop
state policy agendas and frameworks which support the rapid
development and implementation of healthcare information
technology and exchange. Some of the states currently being
supported by eHI include Arizona, Kansas, Minnesota, New
Hampshire, New York, and Ohio.
MR. DEAL. Thank you. Mr. Mertz.
MR. MERTZ. Thank you, Mr. Chairman. I am Alan Mertz,
President of the American Clinical Laboratory Association. The
ACLA represents the Nation's leading national, regional, and local
laboratories. Mr. Chairman, most patients are probably familiar
with our members, mostly by the boxes they see out in front of the
doctor's office that are Quest Diagnostics or LabCorp. That is
where the specimens are put in those boxes, and our members are
the people who collect those specimens, transport them to a
laboratory, do the testing overnight, and then report of those results
usually back the next morning. Some times millions every day,
and testing is absolutely a critical part of our healthcare system. It
provides the physicians with the objective data they need to not
only diagnose, but effectively treat and monitor disease.
Our members also have, part of the reason we are here today,
an extensive history of providing these doctors and hospitals with
health information technology involved in streamlining laboratory
test requisition, and also speeding the delivery of test results. Let
me give you just a little bit of background about laboratory testing
and how important it is to the medical record, and then I will talk
about some of the legislative proposals. Laboratories and the
information they provide are really the heart of the medical record.
It is not well known to the layman that laboratory data actually
represents 60 percent of the medical record, and while the
diagnostic tests we do comprise only 1.6 percent of Medicare
spending and about 5 percent of overall health spending, they
influence 70 percent of clinical decision making. Not only does
this information improve outcomes and decrease costs, but
laboratory data is becoming an even more essential building block
for assessing quality care and it is playing an increasingly critical
role for quality and pay-for-performance initiatives.
The laboratories, Mr. Chairman, have made a tremendous
investment in connecting to physician offices and hospitals, and it
sort of served as the catalyst in the evolution of health IT. Just let
me give you one example of the penetration that they have had
with the physician's offices. Quest Diagnostics, our largest
member, has business relationships with half of the physicians and
hospitals in the United States, and this is just one laboratory
company. Quest Diagnostics receives 40 percent of its orders and
sends 60 percent of its results via the Internet. This is a critically
important and highly valued function. It is so important that since
1995 our labs have had a limited exception under the Stark law so
that they can provide these electronic connections and interfaces
with physician offices.
This has been a fundamental capability for laboratories to
render services to providers. It is a function that must be
maintained in any changes that are made to Stark. Congressman
Brown made a point at the beginning about the IOM report on
errors and duplication cost and electronic ordering and results with
laboratories. It is a critically important part of improving
legibility, decreasing error rates, producing more timely results,
and even monitoring duplicatation of testing.
Let me talk just about three quick points about H.R. 4157. We
believe it has several needed improvements. Number one, we
believe that if it is enacted it would further prompt adoption of
health IT. We believe that any exemption in the law for Stark for
IT should be carefully crafted to guard against abuses while still
allowing the diffusion of IT, and we believe it strikes that balance.
We also support the legislation's Federal preemption of State laws
that contradict the Stark law exceptions and anti-kickback safe
harbors. Today there are several State laws that are complicated
and have different requirements than the Federal Stark law, and we
believe that the preemption provisions there are very important.
H.R. 4157 also addresses the need for Federal preemption in
State laws related to privacy. We support this provision because of
the patchwork of State laws as an impediment to health
information exchange. Let me give you one example. LabCorp,
another large national laboratory, has been invited to participate in
regional Medicare chronic care or health support pilot programs.
Chairman Deal, LabCorp has been invited to participate in an
effort in your own State with CIGNA HealthCare in Georgia, as
well as a program operating in central Florida operated by Green
Ribbon Health. These entities will offer self-care guidance and
support to chronically ill Medicare beneficiaries to help them
manage diabetes and chronic heart disease problems.
LabCorp's role in the programs will be to transmit critical
laboratory data to CIGNA and to Green Ribbon Health for those
beneficiaries who voluntarily participate in the program. However,
the State laws in Florida and Georgia governing the release of lab
results have prevented LabCorp from transmitting these results. In
essence, Florida and Georgia laws preclude providing test results
to anyone other than the ordering physician, and there is no
provision in the State laws that would allow even the patient to
give their consent. These laws would effectively bar any
transmittal, and even the patient's consent does not allow us to
transmit those results.
Let me conclude also with the needed provisions regarding
moving from ICD-9 diagnostic codes to ICD-10. Under the
Medicare program the laboratories are paid by including these
ICD-9 codes on their claims to provide medical necessities. These
codes are provided by the physician to the laboratory, and are
subsequently attached to the claim and submitted to CMS. So we
really have no control of what diagnosis codes are put into the
claim, and if they are not done correctly, we are not paid. So
moving to the ICD-10 we want to be very careful about doing that
because it is immensely more complicated. ICD-9 provides about
13,000 diagnosis codes. Moving to the ICD-10 provides 120,000
diagnosis codes, making it much more complicated.
I have attached an example to my testimony of where today
there is one ICD-9 code for a sports injury, it will be replaced by
something like 39 different codes, diagnosis codes included. You
have to now tell whether you were struck by a baseball, golf ball, a
baseball bat, and so forth, whereas you used to be able to just say
this person was injured in the head by a ball. So it is much more
complicated. What we are asking for here not to go ahead with
this, but to give us a five-year transition period instead of two
years, because of the complexity of this, and we have to train
doctors as to how to do this, otherwise, we will not be paid.
So in conclusion the ACLA supports the Health Information
Technology Promotion Act's new anti-kickback safe harbors and
Stark law exception, the bill's proposed preemption of State
privacy laws like the example that I gave, and the replacement of
the ICD-9 code but with a five-year transition period. Thank you,
Mr. Chairman.
[The prepared statement of Alan Mertz follows:]
PREPARED STATEMENT OF ALAN MERTZ, PRESIDENT, AMERICAN
CLINICAL LABORATORY ASSOCIATION
Chairman Deal, Ranking Member Brown, and distinguished
subcommittee members, thank you for the opportunity to testify
today on behalf of the American Clinical Laboratory Association
(ACLA) representing national, regional, and local laboratories.
My name is Alan Mertz, President of ACLA, and I appreciate your
interest in legislative proposals that will accelerate the widespread
adoption of the electronic health record. ACLA members have an
extensive history of providing the nation's hospitals and physicians
with leading-edge health information technology (IT) streamlining
laboratory test requisition and speeding the delivery of test results.
The Health Information Technology Promotion Act of 2005
(HR 4157) proposes several needed improvements to facilitate the
diffusion of health IT throughout the United States. These changes
will help promote better outcomes for patients. Among the
improvements are new Anti-kickback Safe Harbors and Stark Law
exceptions; a study of, and subsequent authority to preempt some
state privacy laws; and the replacement of ICD-9 diagnosis codes
with ICD-10 codes.
Laboratories play a critical role in healthcare delivery by
allowing for the rapid and timely utilization of health information
by providers. Laboratories and the medical information they
provide are the heart of the medical record. Laboratory data
represent 60% of the medical record. Diagnostic tests comprise
only 5 % of total hospital costs and only 1.6% of Medicare costs,
but they influence a much larger portion (as much as 60-70%) of
clinical decision-making that improves care and decreases cost.
Virtually every health care community (i.e. Regional Health
Information Organizations or RHIOs) that is trying to develop an
electronic health information infrastructure is looking to
laboratories first. A recent nationwide survey by the eHealth
Initiative found that, of those who have electronic health
information exchange efforts under way, 60% plan to exchange
laboratory information within six months to support quality, safety
and efficiency goals. In a survey of hospitals, the number one IT
function in the majority of hospitals today is the electronic order
entry and review of results for diagnostic services.
The reach of laboratories into physician offices and hospitals
vis-�-vis the provision of this hardware and software has served as
a 'catalyst' in the evolution of health IT. For example, Quest
Diagnostics Incorporated, a member of ACLA, has business
relationships with approximately half of the physicians and
hospitals in the U.S. Quest Diagnostics Incorporated receives 40%
of orders and sends 60% of its results via the internet. Similar
means of laboratory connectivity are offered by other ACLA's
other members.
The federal government, quality organizations, the Medicare
Payment Advisory Commission (MedPAC) and others recognize
that laboratory data are the essential building block for assessing
quality care and will have a critical role in pay-for-quality
initiatives. Laboratories can and have been used to measure a
provider's performance as a critical component of health care
delivery; however, this contribution cannot be realized without
incurring additional cost that must be recognized and reimbursed.
In a detailed study of practice and laboratory connectivity, the
eHealth Initiative recently recommended incentives that could be
provided for including electronic laboratory data as part of pay-for-
performance reporting. One example from the report would be to
provide short term incentives, based on the volume of laboratory
messages processed, up to a monthly dollar limit per clinician that
would encourage implementation of interfaces. Incentives such as
these can be an important driver of adoption of new technologies.
By providing incentives encouraging the transmission of
laboratory test requisition and results reporting, the healthcare
system will actually save money through reductions in duplicative
testing, better coordinated care and decreases in morbidity and
mortality.
Because of the value that laboratories convey in the data they
transmit, they have pioneered the provision of secure, streamlined
IT solutions to order and transmit laboratory tests. This is a
critically important and highly valued function. So important that
since 1995 laboratories have had a limited exception under the
Stark Law to provide "items, devices, or supplies that are used
solely to.order or communicate the results of tests or procedures
for such entity." This is a fundamental capability for laboratories
to render services to providers and a critically important function
that must be maintained. Clinicians place a high value on being
able to order laboratory services and receive laboratory results
electronically because it improves legibility, decreases error rates,
produces more timely results (including STAT testing), and allows
the monitoring of redundant or duplicative testing. The result is
improved clinical outcomes, and improved clinical care efficiency
with the long-term benefit of reduced healthcare costs.
We recognize physicians, hospitals and other providers
routinely cite the fear of legal action/debarment from Medicare as
one of the biggest deterrents towards adoption of health IT.
Accordingly, HR 4157 establishes a new exemption for the
provision of health IT and related training. ACLA believes this
legislative proposal, if enacted, would help to address some of
these concerns and prompt further adoption of the health IT;
however, ACLA believes such an exemption should be crafted
carefully to diffuse the technology while guarding against abuses.
By doing so, providers will continue to compete on the services
they are providing and not, for instance, the size of a monitor.
However, in any law or regulation laboratories must be among
those entities permitted to offer these items or services because of
the critical role laboratories have, and continue to play in
facilitating health IT adoption in the health care community.
ACLA was particularly perplexed with HHS' Office of the
Inspector General's recent notice on the establishment of new
Stark Law exceptions and Anti-Kickback Safe Harbors which
proposes to exclude laboratories from the newly created
exemptions.
ACLA also supports the legislation's federal preemption of
state laws that contradict the Stark Law exceptions and Anti-
Kickback Safe Harbors established under the bill. Today, there are
several states whose 'Stark' laws are complicated and have
different requirements than the federal law. Similar to the privacy
issue (which I'll talk about shortly), the problem is not just that
these state laws are more stringent, but that there are many
different standards. The differences in these state laws fall into
several categories, e.g. the scope of the exceptions to the
prohibition or the scope of what is considered a 'designated health
service.' By creating a federal preemption, Congress can help
address the fear and confusion many providers continue to have as
they contemplate adoption of various health IT solutions.
Another of the much-needed changes that HR 4157 addresses
is the need for federal preemption of state laws related to the
security and confidentiality of health information. HR 4157
requires a study of: 1) the degree to which laws vary among the
states; 2) between state laws and HIPAA; 3) how such variations
adversely impact confidentiality and the electronic exchange of
health information. Upon enactment, Congress will have three
years to pass legislation establishing uniform federal standards and
preempting state laws with regard to confidentiality and privacy.
If not, then the Secretary of HHS is permitted to adopt regulations
based on the results of the study.
ACLA supports this provision because the patchwork of state
privacy laws is an impediment to health information exchange.
For example, LabCorp, a large national laboratory, has been
invited to participate in two of the eight regional Medicare Health
Support pilot programs (previously known as the Chronic Care
Improvement Program) authorized by section 721 of the Medicare
Modernization Act. Chairman Deal, LabCorp has been invited to
participate in an effort with CIGNA HealthCare in your home state
of Georgia as well as a program operating in central Florida being
operated by Green Ribbon Health, LLC. These entities will offer
self-care guidance and support to chronically ill Medicare
beneficiaries to help them manage their health, adhere to their
physicians' plan of care, and ensure that they seek the medical care
and Medicare-covered benefits that they need. LabCorp's role in
the pilot programs would be to transmit laboratory data to CIGNA
HealthCare and Green Ribbon Health for those beneficiaries who
voluntarily participate in the program. This information would
then be used to help monitor the conditions of participants and
ultimately, improve their outcomes.
Unfortunately, despite the well-intended efforts of these
programs, more restrictive state laws in Florida and Georgia
governing the release of lab results have prevented LabCorp from
transmitting these important results to Green Ribbon Health or
CIGNA HealthCare until its concerns about the application of
those laws to these requests have been addressed. More
specifically, the Florida and Georgia laws preclude providing test
results to anyone other than the ordering physician or provider (or
to a person specifically authorized by the ordering physician). In
this case, had there been a federal preemption of state laws we
would be talking about the successes/failures of these program and
not 'red tape.'
HR 4157 also addresses the needed replacement of the
International Classification of Diseases, 9th edition, Clinical
Modification (ICD-9-CM) diagnosis and procedure billing codes
with ICD-10-CM/PCS codes. ICD diagnosis codes are used by
inpatient and outpatient providers for billing and reimbursement.
Under the Medicare program, laboratories are paid by including
ICD-9 codes on their claims to provide medical necessity. These
ICD-9 codes are provided by the physician to the laboratory and
are subsequently attached to a claim and submitted to CMS.
Today, as many laboratories will attest, problems persist with
physicians not providing the appropriate ICD-9 codes in order for
laboratories to get paid. Currently, ICD-9 provides approximately
13,000 diagnosis codes. Take into account that ICD-10 provides
120,000 diagnosis codes, and one can see the potential for massive
delays in reimbursement for laboratories and many other providers
and thus the need for an extended phase in of the new system.
To give you an example of the difference between ICD-9 and
ICD-10 consider how a physician would document an accidental
sports injury. Under ICD-9, a diagnosis of a sports injury caused
by striking against or being struck requires a single code: E917.0,
described as "Striking against or struck accidentally in sports
without subsequent fall; includes kicked or stepped on during
game (football, rugby), struck by hit or thrown ball, struck by
hockey stick or puck. Under ICD-10, a similar diagnosis requires
one of 24 codes, meaning that the physician must document the
causation (see attachment).
ACLA recommends that the implementation period for the
transition to ICD-10 be changed from a two-year phase in period to
a five-year period. Doing so would provide adequate time to
reprogram all health care providers' and payers' computer systems
to accommodate the new, longer ICD-10 codes. In addition,
considerable time and expense will also have to be spent on client
education and testing of the new systems. During this 'transition
period' it should be permissible for providers to bill using either
the ICD-9 or ICD-10 standards.
In conclusion, ACLA supports the Health Information
Technology Promotion Act's new Anti-kickback Safe Harbors and
Stark Law exceptions, the bill's proposed preemption of some state
privacy laws, and a replacement of the ICD-9 with ICD-10 with a
five-year transition period.
I'd like to end on this note. It has been said that every effort in
the health care public policy arena aims to improve three different
aspects of health care: better, faster, and cheaper. Nothing to date
has been able to meet all three objectives - some systems provide
two of the three but always at the expense of the third. I believe
health IT is the answer. Health IT will make health care better by
improving outcomes; faster, by facilitating not only the delivery of
information but the coordination of care; and cheaper, by reducing
the costs of doing business, be it a reduction in duplicative testing
or by saving precious time previously spent on data entry.
Mr. Chairman, thank you for the opportunity to share ACLA's
perspective on ways to promote electronic health records and a
smarter health information system. We are ready to work with you
on this important and vital legislation. If you have questions or
need any additional information, please do not hesitate to contact
us.
MR. DEAL. Thank you. Mr. Vaughan.
MR. VAUGHAN. Mr. Chairman, members of the committee,
thank you for inviting us today. Consumers Union is the
independent, non-profit publisher of Consumer Reports, and we do
not just test toasters, we work on health issues, and had a large
article on this topic in the March issue. We strongly support the
movement toward electronic health records as a way to improve
quality and moderate health costs.
But we believe that the American public will not fully support
or fully use or fully benefit from the great potential of such
systems unless more is done soon to ensure the privacy of medical
information. As IBM's testimony just said, the privacy issues and
the public's perceptions of those issues must be addressed in order
for personal health records to succeed. Patients need meaningful
control over their medical records, the right to keep their records
private, and they should not be forced to give up privacy as a
condition of treatment. We talk of consumer-directed healthcare,
an ownership society, and personal empowerment. Mr. Shadegg
was talking about choice. The right to privacy is the heart of all of
that.
There must be a strong enforcement of privacy laws, and if
privacy is violated, people should be notified of that breach and
given a private right of action, as Georgia is one of the States that
allows that. The State should have the right to enact privacy laws
above and beyond HIPAA's terribly minimalist provisions in our
opinion. Dr. Detmer's testimony has a neat point about how
complex that could be, particularly if you look at Virginia,
Maryland, and D.C. How would a computer keep track of all that?
But rather than coming down to the Federal level, could we work
with the governors and the State legislators to say what did the
States feel they needed to do and see if there was a model law that
we could come up to rather than come down.
Privacy needs to be strengthened, not weakened, and we urge
you to oppose legislation that would preempt stronger State laws or
let HHS bureaucrats weaken the Fourth Amendment. As we like
to say, one size does not fit all, and this is the way we look at that.
Attached are a set of consumer privacy principles on my statement
that we hope you might look at as you consider legislation.
Assuming we can get true privacy, we would like to see quick
dissemination of good systems. We recommend, however, against
making broad exceptions to the anti-kickback and physician
referral laws for donations.
Given the Federal budget situation, it is very understandable if
people would look for a sort of free way to promote dissemination,
like suspending these anti-fraud laws. We believe, however, that
such action would have a very limited impact on the adoption of IT
and would not be always good for consumers. This approach may
not be free. It may have a cost. Basically there are no free lunches
in life. I would bet you that Adam Smith would say most
businesses do not give away something of value to another
business unless they expect a return on the investment.
When a hospital system offers an IT package to doctors, it
hopes the ease of communication between them and the goodwill
generated by the gift will encourage referrals, regardless of
whether that facility is the best quality or value facility for the
patient. There is a parallel example in an area we know that causes
higher and more costly utilization. Why do pharmaceutical
companies give away free drug samples? It is because in our
culture the act of giving a gift, even a trinket, conveys a
psychological sense of obligation, I owe you one. That is human
nature. In the case of free drugs, it leads to higher utilization and
high costs products.
So please be skeptical. Companies, many for profit, who spend
98 percent of the year telling Congress they are not paid enough by
Medicare and Medicaid, they are all going broke, they have found
some money that they now want to donate to a bunch of small
businessmen making about $160,000 a year, who are very smart
businessmen, but have not been smart enough to realize they need
to move to IT. It is kind of strange. I think it would increase care
coordination under the right situation, but please be careful in how
you draft this.
We think there are better ways to encourage more adoption of
IT that do not weaken the anti-fraud laws. For example, you might
explore with CBO whether, as you fix the Medicare doctor
payment system in a budget neutral, time-limited way you could
voluntarily encourage physicians to install certified IT by adjusting
the practice expense payment and then collect it back at the end of
the five-year cycle. It might be tough but worth talking to CBO
about. Representative Murphy's bill kind of gets into that a little
bit in section 8.
In conclusion, these anti-fraud laws are very delicate things,
and we hope you will be careful, as I know you will be. Thank
you, sir.
[The prepared statement of Bill Vaughan follows:]
PREPARED STATEMENT OF BILL VAUGHAN, SENIOR POLICY
ANALYST, CONSUMER'S UNION
Mr. Chairman, Members of the Committee:
Thank you for inviting us to testify today. Consumers Union is
the independent, non-profit publisher of Consumer Reports, and
we work on a wide range of health issues, including prescription
drug safety and effectiveness, health insurance and health care
costs.
The Potential
We strongly support the movement toward electronic systems
of health records (EHR) and information exchange. By harnessing
the power of modern information technology systems we can
improve the quality of American health care and moderate health
costs by:
<bullet> reducing errors,
<bullet> eliminating service duplication,
<bullet> promoting pay-for-performance, and
<bullet> providing the data necessary to evaluate the true
comparative effectiveness of various treatments and drugs.
As just one example of the tremendous improvements in
quality and cost savings that are possible, Consumers Union has
been conducting a national campaign to promote the disclosure of
hospital infection rates (www.StopHospitalInfections.org). Each
year, there are about 2 million patients who acquire infections in
hospitals, and about 90,000 die. The increased cost to the health
care sector is in the tens of billions of dollars. We have been
working at the state level to pass laws to require hospitals to report
their rate of infection in the belief that public disclosure will
prompt hospitals to adopt effective methods to reduce their
infection rates. Electronic medical records technology and the
public disclosure of more types of de-identified patient care data
will make it easier for consumers to reward those who provide
quality.
The Critical Need to Ensure Privacy
While there can be important public and private benefits of
creating an effective electronic medical records system, we believe
(and polls demonstrate ) that the American public will not support,
fully use, or benefit from the great potential of such systems
unless more is done-now--to ensure the privacy, security, and
appropriate use of medical information. This requires enabling
patients to decide when, with whom, and to what extent their
medical information is shared. As Dr. David Brailer, head of the
Office of the National Coordinator for Health Information
Technology, responded March 3 to a letter (see Attachment #1)
from consumer groups, "we will achieve our goal of widespread
[EHR] adoption only if patients are confident that their health
information is private and secure." Today, it is not private or
secure.
This concern should especially resonate with public officials
such as you, who are so subject to prying eyes and gossiping
tongues. I think we all have to admit that there is no hack-proof
database or system. Once our medical data is moving
electronically, it is subject to threats from hackers, identity thieves
and others. That is simply a fact of life, re-confirmed almost daily
by new stories of financial and medical record data violations.
Beyond the likely scenarios of security breaches, the value of
electronic health information is such that many organizations will
want to exploit secondary data sources for private financial gain,
rarely (if ever) with patient knowledge, let alone consent.
So what can we do to minimize concerns and improve privacy
in electronic health records?
The American public needs to be given meaningful control
over their medical records. That means they must have a right to
keep their records private and that they cannot be forced to give up
control of their most private medical information as a condition of
treatment.
The penalties for violations of privacy are inadequate and have
major gaps. There must be strong enforcement of privacy and
security laws, and if a person's privacy is compromised or
violated, they should be notified of that breach and have a private
right of action.
The States should have the right to enact privacy laws above
and beyond HIPAA's absolutely minimal provisions and that right
must not be pre-empted. Privacy needs to be strengthened, not
weakened, and we urge you to oppose legislation that would pre-
empt stronger State laws or delegate to the Secretary of HHS
authority to pre-empt such laws. These State laws offer extra
protection and peace of mind to patients with mental health, STD,
cancer and other treatment issues. As 30 organizations in the
Mental Health Liaison Group wrote Congress on November 15,
2005, adding improved privacy protections to proposed EHR bills
is essential in the mental health sector.
Some will say that it is too complex or too expensive to allow
people to control their medical information. But that's why
computers are so wonderful! They can be designed to deal with
huge numbers of variables-like 50 state laws-- and to create
special files where certain data (such as a mental health record) is
only available to a designated provider on a "need to know basis."
If we do not meaningfully address the privacy issue, polls show the
public will not trust this system, many will go to a medical
underground 'off-the-books' , and we will just increase public
cynicism about big government and big business controlling our
lives. In an age when the talk is of consumer driven health care,
and ownership, and empowerment, forcing people to share their
most secret personal medical information is not the path to take.
Attached are a set of consumer principles that was developed
under the leadership of the National Partnership for Women &
Families and that Consumers Union, AARP, and seventeen other
groups are supporting. We urge you to include these principles in
whatever legislation you may develop.
Oppose Incentives to Promote Technology Give-Aways that
may Distort Health Care Delivery
Assuming true privacy and increased security, we all would
like to promote the fastest possible movement to EHRs and a
'networked' health care system so as to benefit from the quality
and cost savings potentials. We recommend, however, against
making blanket exceptions to the anti-kickback and physician
referral laws for donations of EHR systems.
Given the Federal budget situation, it is understandable that
some are attracted by the idea that such blanket exceptions might
be a 'free' ways to promote EHR technology dissemination. We
believe, however, that such action would have a very limited
impact on the adoption of EHR systems and would not be good
for consumers. This approach is not free-it has a cost, as we
describe below.
Most businesses don't give away something of value to another
businessperson unless they expect a return on the investment.
When a hospital system offers an IT package to a non-affiliated
physician group, it hopes the ease of communication between them
(and the goodwill generated by the gift) will encourage referrals to
its facilities, regardless of whether that facility is the best quality or
value facility for the patient.
There is a parallel example in an area we know causes higher
and more costly utilization: Why do pharmaceutical companies
give free drug samples (and pens and pads of paper, etc., etc.) to
doctors? Because in our society and culture, the act of giving a gift,
even a trinket, conveys a psychological sense of obligation-"I
owe you one." That is human nature. In the case of 'free' drugs, it
leads to increased utilization of high cost products. That is what the
anti-kickback and physician referral rules tried to deal with: the act
of giving something of value creates "ties" that cause referrals and
utilization to go up, without regard to need, cost, or quality.
It is worth spending a minute more on the 'free' drug example.
There has been a great deal of concern about the way drugs are
promoted and the impact that has on costs and quality of care. The
January 25, 2006 issue of JAMA (Vol. 295, No. 4, p. 429ff) carried
an article by some of America's most distinguished physicians
entitled, "Health Industry Practices That Create Conflicts of
Interest: A Policy Proposal for Academic Medical Centers," that
calls on the nation's teaching hospitals to lead an ethical revolution
and reject all industry gifts, since those gifts distort the practice
and integrity of medicine. As the doctors wrote:
Social science research demonstrates that the impulse to
reciprocate for even small gifts is a powerful influence on
people's behavior. Individuals receiving gifts are often unable
to remain objective: they reweigh information and choices in
light of the gift. So too, those people who give or accept gifts
with no explicit "strings attached" still carry an expectation of
some kind of reciprocity. Indeed, researchers suggest that the
expectation of reciprocity may be the primary motive for gift-
giving.
Researchers have specifically studied industry gifts to
physicians. Receiving gifts is associated with positive
physician attitudes toward pharmaceutical representatives.
Physicians who request additions to hospital drug formularies
are far more likely to have accepted free meals or travel funds
from drug manufacturers. The rate of drug prescriptions by
physicians increases substantially after they see sales
representatives, attend company-supported symposia, or
accept samples. The systematic review of the medical
literature on gifting by Wazana found that an overwhelming
majority of interactions had negative results on clinical care.
If medical practice is distorted by the relatively small value of
drug company gifts, imagine the consequences of large EHR
technology "gifts"!
What if Congress proposed (though it would not take a law)
that companies and providers could give money or equipment to a
truly neutral charity in an area (for example, the Red Cross, the
American Public Health Association, a State Medicaid Agency)
that would then distribute the gift on some basis of need and there
would be no tie between the donor and the recipient? I think most
potential donors would find lots of reasons why that wouldn't
work. And that should tell you everything: the donor wants a "tie"
with the recipient that will result in goodwill and increased
referrals. For consumers, the problem is that the "tie" and
resulting increased referrals may not be the best for the patient
because the donor may not be the best or lowest-cost provider in an
area. And donors who have the resources to give may just increase
their economic dominance in an area, thus reducing future
competition and driving up costs.
Look for real solutions to speeding dissemination of IT
There are better ways to encourage more adoption of EHRs.
Once progress is made on technology and process standards and
there is more agreement on the best hardware and software paths,
Congress may want to promote the dissemination of such
technology and pay for it in a way that does not distort practice
patterns. You might explore with CBO whether, as you try to fix
the Medicare physician payment system (SGR), a budget neutral,
time-limited way to encourage physician installation of certified
EHR could be possible. For example, would CBO score as neutral
a system where on a voluntary basis, a physician could greatly
increase their practice expense payments for several years so they
could more easily finance the installation of a 'certified' EHR
system. Then in the next several years they would repay that
'advanced' amount through reduced practice expense payments, on
the grounds that the installation of the equipment will reduce
paperwork and clerical practice expense in future years. Another
encouragement to take advantage of this opportunity would be a
requirement that by a date certain all Medicare-Medicaid EHRs
would have to be through certified systems.
Congress could also help providers in the future by using the
certification process to obtain a discount price for EHR hardware
and software.
In summary, we urge you to consider alternatives to
encouraging the dissemination of this new generation of equipment
in ways that do not weaken the nation's anti-fraud laws.
If Congress feels compelled to proceed with anti-kickback and
anti-referral law changes, we urge you to consider limited
exceptions based on modifications to the Administration's October
2005 proposed regulations.
These draft regulations would permit exceptions-but not
blanket exemptions--to the anti-kickback and physician referral
laws for EHR donations. Consumers Union, the National
Partnership for Women & Families, and five other national
organizations filed formal comments expressing serious concern
about the exceptions and urging major changes (see attachment
#2).
For example, we recommend changing the regulations to:
--delay the effective date of the exceptions until the product
certification process for ambulatory care that the
Administration is now aggressively supporting is in place
(otherwise you encourage donations that may lead to
technological dead-ends and wasted time and effort-e.g.,
Beta v. VHS competing donations);
--limit the exception to donations to physicians or clinics
that provide a certain level of uncompensated charity care
or serve a significant number of Medicaid patients; or if
that is not possible, require donors to offer the technology
to all (their) physicians, not just those who provide high
volumes of profitable business;
--sunset the exemptions;
--require recipients to copay a portion of the cost: totally
free equipment is likely to sit in the closet. The equipment
needs to be something that the recipient wants enough to
put some of his own resources into.
Thank you all for your time and attention.
Attachment #1
Health Information Technology - Consumer Principles
March 2006
An interoperable system of electronic health information holds
many potential benefits for consumers, including: better
coordination of health care regardless of patient location, higher
quality and more efficient care, increased system transparency, and
patient access to information about providers that allows them to
make better decisions. At the same time, such a system raises
serious concerns among consumers about personal privacy, data
security, and the potential misuse of their information. And while
an interoperable system of electronic health information holds
great promise, the many possible benefits will not be realized
unless appropriate policy measures are established up front.
Consumer protections and potential benefits from health
information technology (HIT) should not be left to chance. The
success of efforts to promote widespread adoption of HIT,
including electronic connectivity and data exchange across health
care institutions, ultimately will depend on the willingness of
consumers to accept the technology. Given the pervasive concerns
expressed by the public about unauthorized disclosure and use of
their health information, it is critical to build a foundation of public
trust. To that end, as efforts move forward to develop networks for
the electronic exchange of information between institutions, there
must be a clear, deliberate, and open forum for addressing and
setting matters of policy. As organizations representing a broad
and diverse set of consumer interests, we believe that the following
set of principles should underpin such efforts.
Principles
Individuals should be able to access their personally identifiable
health information conveniently and affordably.
<bullet> Individuals should have a means of direct, secure access to
their electronic health information that does not require
physician or institutional mediation.
<bullet> Individuals should have access to all electronic records
pertaining to themselves (except in cases of danger to the
patient or another person).
<bullet> Individuals should be able to supplement, request
correction of, and share their personally identifiable health
information without unreasonable fees or burdensome
processes.
Individuals should know how their personally identifiable health
information may be used and who has access to it.
<bullet> Individuals should receive easily understood information
identifying the types of entities with access to their
personal health information and all the ways it may be used
or shared. The explanation should include any sharing for
purposes other than the immediate care of the individual,
and should explicitly identify intentions for data use such
as public health protection, quality improvement,
prevention of medical errors, medical research or
commercial purposes.
<bullet> Access to personal health information must be limited to
authorized individuals or entities.
<bullet> Tracking and audit trail systems should be in place that
permit individuals to review which entities have entered,
accessed, modified and/or transmitted any of their
personally identifiable health information.
Individuals should have control over whether and how their
personally identifiable health information is shared.
<bullet> Individuals should be able to opt out of having their
personally identifiable health information - in whole or in
part - shared across an electronic health information
network.
<bullet> Individuals should be able to limit the extent to which their
health information (with or without personal identifiers) is
made available for commercial purposes.
<bullet> Individuals should be able to designate someone else, such
as a family member, caregiver or legal guardian, to have
access to and exercise control over how records are shared,
and also should be able to rescind this designation.
Systems for electronic health data exchange must protect the
integrity, security, privacy and confidentiality of an individual's
information.
<bullet> Personally identifiable health information should be
protected by reasonable safeguards against such risks as
loss or unauthorized access, destruction, use, modification,
or disclosure of data. These safeguards must be developed
at the front end and must follow the information as it is
accessed or transferred.
<bullet> Individuals should be notified in a timely manner if their
personally identifiable health information is subject to a
security breach or privacy violation.
<bullet> Meaningful legal and financial remedies should exist to
address any security breaches or privacy violations.
<bullet> Federal privacy standards that restrict the use and
disclosure of personally identifiable health information
should apply to all entities engaged in health information
exchanges.
The governance and administration of electronic health
information networks should be transparent, and publicly
accountable.
<bullet> Independent bodies, accountable to the public, should
oversee electronic health information sharing.
<bullet> Consumers should have equal footing with other
stakeholders.
Recognizing the potential of electronic patient data to support
quality measurement, provider and institutional performance
assessment, relative effectiveness and outcomes research,
prescription drug monitoring, patient safety, public health,
informed decisionmaking by patients and other public interest
objectives, systems should be designed to fully leverage that
potential, while protecting patient privacy.
Implementation of any regional or national electronic health
information network should be accompanied by a significant
consumer education program so that people understand how the
network will operate, what information will and will not be
available on the network, the value of the network, its privacy and
security protections, how to participate in it, and the rights,
benefits and remedies afforded to them. These efforts should
include outreach to those without health insurance coverage.
AARP
AFL-CIO
American Federation of State, County and Municipal Employees
American Federation of Teachers
Center for Medical Consumers
Communications Workers of America
Consumers Union
Department for Professional Employees, AFL-CIO
Childbirth Connection
Health Care for All
Health Privacy Project
International Association of Machinists and Aerospace Workers
International Union, United Auto Workers
March of Dimes
National Coalition for Cancer Survivorship
National Consumers League
National Partnership for Women & Families
Service Employees International Union
Title II Community AIDS National Network
United Steelworkers International Union (USW)
Attachment #2
Comments of Groups on HHS Proposed Regulations on anti-
kickback and physician referral
Comments on Office of the Inspector General Proposed Rule
OIG-405-P
As organizations representing a wide range of consumer
interests, we are pleased to have the opportunity to comment on the
proposed rule OIG-405-P that would add a new paragraph (x) to
the existing safe harbor regulations at 42 CFR 1001.952. The
proposed safe harbor would protect donation of specific items and
services for prescribing drugs electronically. The preamble to the
regulations also describes the scope of two planned additional safe
harbors for electronic health records software and directly-related
training services, but the Office has not proposed actual regulatory
language for such a safe harbor.
We recognize the potential of health information technology
(HIT) to improve health care quality. Furthermore, we support
efforts by the Department to promote the use of HIT by physicians
and other health care providers, and are encouraged by the
prospect of reduced errors and higher quality if e-prescribing is
implemented. Below are our comments on the proposed safe
harbor.
Pre-interoperability Electronic Health Records Safe Harbor
The Office is considering the creation of a safe harbor for
donations of electronic health record technology made prior to the
adoption of product certification criteria by the Secretary. We
oppose this provision and recommend it not be included in the
final regulations.
The Department is moving aggressively to put product
certification criteria for ambulatory care in place in 2006.
Promoting investment in this technology before DHHS adopts
those criteria may seriously impede reaching the goal of a common
platform - a goal which is part of the rationale for making this safe
harbor. Furthermore, allowing the safe harbor to be in effect prior
to certification could encourage providers and manufacturers to
press for delay in adoption of the certification standards in order to
avoid having to make new investments or to retain the market
advantages they have created by installing their systems in
physician offices.
Post-interoperability Electronic Health Records Safe Harbor
In a parallel proposed rule, CMS-1303-P, the Department has
included the actual text of a proposed regulation to provide an
exception to the Stark statute for donations of electronic health
records software if the donation is made after the product
certification criteria are adopted and if the software is compliant
with the certification requirements. We support the intent of this
exception but have some concerns about some of the text; we have
outlined our concerns in comments filed today on CMS-1303-P.
The Office has asked for comments on its plans for a similar safe
harbor, described in section II.B.2 of proposed OIG-405-P. Our
comments on the potential safe harbor are similar to those
expressed with regard to the Stark exception. For convenience, our
views are set forth below in the context of the proposed CMS Stark
exception text.
Subsection 411.357(x)(4) [of CMS 1303-P] requires that
neither the selection of the physician nor the amount or nature of
the items and services donated can turn on the volume or value of
referrals or other business generated between donor and recipient.
The section then enumerates six specific criteria that a donor might
use that would be deemed compliant with the exception
requirements:
1) total volume of prescriptions the recipient writes;
2) size of the medical practice;
3) number of hours the physician practices medicine;
4) extent of use of automated technology in the recipient's
medical practice;
5) if the donor is a hospital, whether the physician is on its staff;
or
6) another method that "is based on any reasonable and
verifiable manner that is not directly related to the volume
or value of referrals or other business generated between the
parties."
This section is the heart of the proposed rule. The widespread
adoption of EHR and EP technology can bring great benefits to
patients, providers and insurers. Health information technology can
help reduce medical errors, encourage patient activation and
adherence to recommended regimens, and provide tools to evaluate
clinical effectiveness, population health status, and the quality of
medical care. The drive to promote the wider use of EHR and EP
technology should not, however, trump the consumer protection or
program integrity brought by the antifraud and abuse prohibitions.
Donors should not be allowed to selectively fund physicians based
on the volume of their prescribing, size of practice, or whether they
are likely to be high users of technology since these could be
proxies for the generation of referrals and revenue. We therefore
recommend the following changes:
--Eliminate item #6, above. It is too open-ended and subjective
and could become a major loophole.
--Our preference would be to require that donors offer the
technology to all their physicians. In the case of hospitals that
would be all physicians with privileges; for MCOs, all
physicians in the MCO network; for group practices, all
physicians in the group. In the case of an MCO, where it might
be impractical to include all network participants, donors could
be permitted to give priority to those physicians or clinics that
have a certain percentage of their patients in the MCO.
Similarly, for hospitals the alternative might be all physicians
with privileges of a general category such as: a) practice
privileges, or b) admitting privileges.
--Add a new exception that permits the donation to a physician
or clinic that provides a certain level of uncompensated charity
care or a combination of charity care and Medicaid patients. It
is these providers - the community clinics, solo practitioners in
rural communities or medically underserved areas - who are
least likely to have the resources to make the health information
technology investments on their own.
In the preamble to the proposed regulations the Department
asks for comments on a cap on the value of the EHR donation,
either a maximum percentage of the value of the technology
(which would require the physician to share the costs) or the lower
of a fixed dollar amount or the percentage of value. We believe it
would be hard to use a fixed dollar amount cap. The cost of
technology will change over time and vary depending on the nature
of the system. A cap on the percentage of the value of the
technology being donated appears to be the more viable option.
The physicians or clinics with high
Medicaid and/or charity care caseloads should be exempted from
cost-sharing.
Subsection 417.357(x)(9). This subsection requires that any
donated EHR software contain electronic prescribing capability
that complies with the electronic prescription drug program
standards under Medicare Part D at the time the items and services
are furnished. In the preamble the Department states that it "wants
to ensure that integrated packages that could positively impact
patient care are not excluded from the postinteroperability
exception." We support the development of software in ways that
promote avoidance of medical errors, improve quality of care,
and/or enhance public health preparedness. It would be desirable
that, as the Secretary adopts additional standards for EP, and for
EMR systems, any donations qualifying for this exemption also
have to comply with those standards without the necessity that the
Department amend these regulations. We suggest the Department
consider that possibility in shaping the final regulations.
Sunset section 411.357(x) entirely at a designated date. The
rationale for allowing an exception to antifraud prohibitions
decreases with the passage of time. Physicians may not purchase
EHR technology now, but in the future having such technology
will be a standard and necessary part of medical practice. At that
point there will be no need for third parties to donate such
technology. Furthermore, if interoperability becomes the norm,
incompatibility across a network of providers ceases to be an issue.
We therefore strongly urge that this entire section authorizing the
Stark law exception for EHR be eliminated not later than five years
from the date of publication of the final regulations. Alternatively,
the sunset date could be delayed for up to two additional years if
the Secretary makes an administrative finding that there is still a
need for the exception to promote adoption of EHR technology.
While we support some limited exceptions to the physician
self-referral prohibition, and the creation of additional safe harbors
under the Anti-Kickback statute, for donations of EP and EHR
technology, we believe these exceptions will have only a modest
impact on the expansion of their use. Of much more importance
are the standards harmonization and product certification efforts
the Department already has underway. Equally important will be
direct funding of loans and grants to states and providers and
financial incentives for the adoption of HIT being incorporated in
federally supported health care programs, including Medicare,
Medicaid, FEHBP, TriCare, and SCHIP.
Thank you for considering our comments.
National Partnership for Women & Families
AFL-CIO
American Federation of State, Federal and Municipal Employees
Consumers Union
Department for Professional Employees, AFL-CIO
National Consumers League
Service Employees International Union
MR. DEAL. Thank you. Mr. Neaman.
MR. NEAMAN. Chairman Deal and members of the
subcommittee, good afternoon. On behalf of the Healthcare
Leadership Council, thank you for the opportunity to testify before
you this afternoon on the importance of health information
technology and some of the important steps that need to be taken to
create a national health information network. I am here this
afternoon wearing two hats, first as the Chairman of the Healthcare
Leadership Council, a coalition of many of the Nation's leading
healthcare companies and organizations. The HLC has a
longstanding interest in this issue and shares the President's and
this Congress' commitment to achieving widespread adoption of
health information technology.
I am also here today speaking as the President and Chief
Executive Officer of Evanston Northwestern Healthcare, a large
academic medical center in northern Illinois comprised of three
hospitals, a 500-physician multi-specialty group practice, and a
medical research institute that has over $100 million of NIH
grants. At our organization the dream of electronic medical
records is no longer a dream. It is a reality across all three of our
hospitals and over 70 of our doctor offices and clinics. We have
had a full electronic medical record up and running for over two
years, and I can tell you that it is powerful and transformational
and really makes a difference in the quality of care and the
reduction of medical errors, improvement of life for our nurses and
our pharmacists and our staff, and improving the efficiency for all
consumers.
In 2003 we launched the EPIC comprehensive electronic
medical records system that indeed provides all of our hospitals
and physicians with a single, legible, unified source of clinical
information. The healthcare professionals at Evanston can tell you
firsthand, and with great confidence, that health information
technology can and must transform our Nation's healthcare system
for the better. We have been able to deliver medications to
patients faster. We have significantly reduced medical errors, and
in one specific example when the manufacturer of Vioxx took the
drug out of commission, we were able to communicate and
identify over 2,000 patients on the drug, communicate with their
physicians and the patients, and make changes to this drug in three
hours. That would be impossible to achieve with paper records.
The task before us is to make sure that this capability is
available to all patients in the United States through interoperable
electronic health records, and today I would like to highlight three
challenges that must be met in order to achieve this goal. First, we
have to have a multi-State interoperable health information system
that must have uniform Federal standard governing patient privacy.
Our current confidentiality framework rests upon literally
thousands of State statutes, regulations, common law principles,
and advisories. Not only do States differ from each other on their
privacy rules, but virtually no State requirement is identical to the
Federal HIPAA privacy regulation. This checkerboard of varying
rules would definitely stand in the way of an interoperable multi-
State information network.
To address this problem, we urge Congress to act on H.R.
4157, the Health Information Technology Promotion Act of 2005,
which is co-sponsored by several members of this subcommittee.
This bill establishes a process to ensure a uniform national
standards is achieved that preserves and protects the security and
confidentiality of patient health information. We believe this
legislation is critical to achieving the Nation's HIT objectives.
Another challenge we face concerns HIT financing. Developing
the EPIC system at Evanston Northwestern Healthcare required
over $40 million of investment and our operating expenses initially
went up by over $5 million per year to make sure that the system
runs and runs well.
Many healthcare providers, I would suggest most, do not have
the capital on hand to make this kind of investment, not only in our
hospitals but certainly in our physician offices. We believe that is
in the Nation's interest, given the importance of interoperable HIT
to patient safety and the Nation's emergency preparedness to drive
implementation through financial incentives and creative funding
mechanisms, and we are prepared to work to help you shape such
an initiative. Finally, we believe that greater physician adoption is
essential for electronic health records to occur in our hospitals and
medical groups and to occur well.
This will lead to greater integration of physician and hospital
information systems that will result in better quality of care for
patients and saved lives. For this to happen though, Congress
needs to provide exceptions to the current physician's self referral
prohibitions and anti-kickback rules that were not intended to
prohibit the kind of beneficial patient-centered actions we are
discussing today. Let me close, Mr. Chairman, by again thanking
the subcommittee for spotlighting the vital importance of these
issues. We look forward to working with you in the months ahead
to bring advances in technology closer to the patients and families
that we are privileged to serve, and we would be very pleased to
address your questions. Thank you.
[The prepared statement of Mark Neaman follows:]
PREPARED STATEMENT OF MARK NEAMAN, PRESIDENT AND CEO,
EVANSTON NORTHWESTERN HEALTHCARE, ON BEHALF OF
HEALTHCARE LEADERSHIP COUNCIL
Chairman Deal and Members of the Subcommittee, I want to
thank you on behalf of the members of the Healthcare Leadership
Council (HLC) for the opportunity to testify on legislative
proposals that will promote electronic health records and a smarter
health information system.
My name is Mark Neaman and I am president and CEO of
Evanston Northwestern Healthcare of Evanston, Illinois. We are
an academic health center connected with Northwestern
University, comprised of three hospitals, a 463-physician medical
group, a home health services agency and a medical research
institute.
My interest in coming before you today is twofold. First, I am
chairman of the Healthcare Leadership Council (HLC), a not-for-
profit membership organization comprised of chief executives of
the nation's leading health care companies and organizations.
Fostering innovation and constantly improving the affordability
and quality of American health care are the goals uniting HLC
members. Members of HLC - hospitals, health plans,
pharmaceutical companies, medical device manufacturers, biotech
firms, health product distributors, pharmacies and academic
medical centers - envision a quality driven system built upon the
strengths of the private sector.
More to the point, the Healthcare Leadership Council shares
President Bush's goal that most Americans have electronic health
records by 2014. And we appreciate the bi-partisan commitment
by Congress to encourage widespread adoption of health
information technology.
I'm also here to share my own institution's experiences with
health information technology. In July of 2001, the Board of
Directors of Evanston Northwestern Healthcare gave the go-ahead
to design and implement a patient-centric electronic health record
system, a system that we call EPIC. Our goal was to utilize health
information technology in a way that would improve clinical
outcomes, enhance patient safety, provide greater patient
satisfaction, and create a better working environment for our
system's health care professionals.
I can testify, from our own experience, that all of the
discussion about the promise of health information technology is
not hyperbole. It is quite real. Let me give you some examples.
EPIC was launched in our Medical Group offices in January
2003 and then introduced incrementally in our hospitals over the
next 12 months. We now have, throughout our three hospitals and
all of our physician offices, a single, unified source of clinical
information. With this accessible, comprehensive database, we
have cut in half the amount of time it takes to deliver the first dose
of an antibiotic to an inpatient, because of the speed with which we
can check the possibility of conflicting medications or allergic
reactions. In one year, we reduced by 20 percent the number of
reported medication errors.
I think it would be useful for the committee to hear of a
particular anecdotal benefit of the EPIC system. When the drug
Vioxx was pulled from usage by the drug's manufacturer, we were
able to use the EPIC system to remove the drug from our hospitals
and physician offices, block future orders, send notices to
physicians regarding which of their patients were on the drug, and
send electronic links to websites with information on Vioxx
substitutes. This process affected over 2,000 patients and was
completed in just three hours. To undertake this same task
manually, utilizing paper records to try to find which patients were
taking Vioxx, would have taken days if not weeks.
It is important to note that Health Information Technology is
not just limited to electronic medical records, it also includes
integrated medication delivery systems that reduce bedside
intravenous medication delivery errors and the resultant harm to
the patient. These state-of-the-art systems enable communication
between doctors, patients, and pharmacies to ensure that the proper
patient is receiving the proper drug in the proper dosage after the
proper precautions were taken.
The Healthcare Leadership Council has such a strong interest
in this issue because we've seen firsthand what widespread
adoption of HIT can mean for patients and health care providers.
Several HLC member organizations have been among the earliest
adopters and pioneers of health information technology. We
believe HIT has the power to transform our health care system and
provide increased efficiencies in delivering health care; contribute
to greater patient safety and better patient care; and achieve clinical
and business process improvements.
Our interest in this issue is long-standing. In the summer of
2003, HLC established a Technical Advisory Board, comprised of
clinicians and others with information technology expertise within
HLC's member companies to provide information about their HIT
implementation experiences.
Attached to my testimony is a copy of the White Paper that
resulted from this effort. The paper attempted to quantify key
benefits of HIT along with barriers to HIT implementation. The
paper concluded with the following recommendations:
<bullet> Standards to assure interoperability;
<bullet> Financial incentives and funding mechanisms;
<bullet> Liability protections to facilitate sharing of safety and
quality data; and
<bullet> Stakeholder collaboration on best practices.
In looking at these recommendations, it is clear that there has
been significant progress since 2004.
Last summer, the President signed into law the, "Patient Safety
and Quality Improvement Act." HLC advocated for this
legislation as an important step toward fostering a culture of safety
- through liability protections to allow voluntary information-
sharing and reporting. I thank the Subcommittee members for all
of your work to enact this important legislation.
In the area of standards, several public and private sector
initiatives are making great strides to identify or develop health
information interoperability standards that will enable disparate
systems to "speak the same language." And the work of the
Certification Commission for Health Information Technology will
complement these efforts by certifying that products are compliant
with criteria for functionality, interoperability and security. This
will help reduce provider investment risks and improve user
satisfaction.
As important as it is to applaud the progress that has been made,
it is necessary to focus on the barriers that stand in the way of
widespread HIT implementation. We have some significant
challenges ahead of us, and I'll begin by discussing patient privacy
regulations and standards.
Developing a multi-state, interoperable system depends on
national technical standards as well as national uniform standards
for confidentiality and security. The Health Insurance Portability
and Accountability Act (HIPAA) governs the privacy and security
of medical information. Though HIPAA established federal
privacy and security standards, it permits significant state
variations that create serious impediments to interoperable
electronic health records, particularly when patient information
must be sent across state lines.
We believe Congressional action to establish a uniform federal
privacy standard is essential in order to ensure the viability of a
national health information network.
Because the HIPAA Privacy Rule's preemption standard permits
significant state variation, providers, clearinghouses and health
plans are required to comply with the federal law as well as many
state privacy restrictions that differ to some degree from the
HIPAA privacy rule.
State health privacy protections vary widely and are found in
thousands of statutes, regulations, common law principles and
advisories. Health information privacy protections can be found in
a state's health code as well as its laws and regulations governing
criminal procedure, social welfare, domestic relations, evidence,
public health, revenue and taxation, human resources, consumer
affairs, probate and many others. Virtually no state requirement is
identical to the federal rule.
HLC is not alone in calling for action in this area. The 11
member Commission on Systemic Interoperability, authorized by
the Medicare Prescription Drug, Modernization, and Improvement
Act to develop recommendations on HIT implementation and
adoption, recommended that Congress authorize the Secretary of
HHS to develop a uniform federal health information privacy
standard for the nation, based on HIPAA and preempting state
privacy laws, in order to enable data interoperability throughout
the country.
H.R. 4157, the "Health Information Technology Promotion Act
of 2005," which several Members of the Subcommittee have
cosponsored, anticipates and addresses this need.
The bill sets forth a process by which the Secretary of HHS
develops a uniform standard for privacy laws. The bill does not
simply adopt HIPAA "as is." Rather, the legislation requires the
Secretary to conduct a study of state and federal security and
confidentiality laws to determine the degree of variance and how
such variation adversely impacts the privacy and security of health
information as well as the strengths and weaknesses of such laws.
The Secretary then submits a report to Congress including a
determination as to whether state and federal security and
confidentiality laws should be conformed to create a single set of
national standards; and what such standards should be. If the
Secretary determines that a single federal standard is necessary and
Congress does not act to create a standard in three years, the
HIPAA privacy regulation, as modified by the Secretary based on
the results of the study, will become the national standard. We
believe that this legislation is critical to achieve our critical HIT
objectives.
Since 1996, HLC has led the Confidentiality Coalition, a broad-
based group of organizations who support workable national
uniform privacy standards. The Confidentiality Coalition includes
over 100 physician specialty and subspecialty groups, nurses,
pharmacists, employers, hospitals, nursing homes, biotechnology
researchers, health plans, pharmaceutical benefit management and
pharmaceutical companies.
Many organizations and companies that are members or
supporters of the Confidentiality Coalition sent a letter to
Chairman Deal in support of a national standard for privacy and
the provisions of H.R. 4157 that lay the groundwork for
developing such a standard.
In discussing this issue, let me make one point abundantly clear.
While we believe strongly in the need for a national privacy
standard, HLC believes just as strongly that any regional or
national system designed to facilitate the sharing of electronic
health information must protect the confidentiality of patient
information.
Health care providers and others involved in health care
operations have appointed privacy officers, adopted compliance
plans and conducted training with their employees to assure
patients that they will protect their privacy in accordance with the
HIPPA privacy rule.
Addressing this issue appropriately will be essential to achieving
the interoperability necessary to improve the quality and cost
effectiveness of the health care system - while still assuring
patients' confidence that their information will be kept private.
To further underscore the importance of this issue to HIT
development, I have attached to my testimony a map developed by
the Indiana Network for Patient Care. Each dot represents a
patient seen at an Indianapolis hospital during a six month period.
While the dots are stacked very deep around Indianapolis as you
would expect, patients served by the Indiana health providers
during this period were also located in 48 of the 50 states. Today's
health care providers, meeting the needs of a mobile society, serve
patients from multiple and far-flung jurisdictions. Looking at this
map it is easy to see why regional agreements will not be adequate
to address the myriad regulations with which providers and others
will need to comply to achieve "interoperability."
In addition to national privacy standards, the lack of funding or
adequate resources - combined with the high costs of HIT systems
- was repeatedly cited in our member study as a barrier to effective
implementation of HIT systems. There are significant front-end
and ongoing maintenance and operational costs for HIT, including
software, hardware, training, upgrades, and maintenance. Systems
are virtually unaffordable for those providers who do not have
ready access to the operating capital needed for such an
investment.
Developing the EPIC system at Evanston Northwestern
Healthcare required hard capital costs of $35 million. This does
not include an additional $7.5 million for consultants to write code
for the system and undertake other essential tasks. Furthermore,
our annual operating costs are increased by $5.5 million to support
additional IT staff, training and software maintenance agreements.
In an age in which health care providers, in many cases, must
deal with rising costs associated with uncompensated care, medical
liability rates, homeland security needs and addressing staffing
shortages, it is a simple fact that many providers do not have the
financial wherewithal to invest in these new systems.
HLC believes that the federal government should drive the
nation's implementation of HIT through financial incentives and
funding mechanisms to help providers defray the huge costs of
acquiring and operating HIT. Rapid implementation of
interoperable HIT is also a critical component of the nation's
emergency preparedness.
While the Agency for Healthcare Research and Quality (AHRQ)
and Office of the National Coordinator for Health Information
Technology (ONC) contracts and grants will support the
development of a national information network and
interoperability standards, we need to do more to get every
provider using electronic health records now.
HLC advocates the consideration and implementation of
multiple HIT funding mechanisms. However, we also recognize
that current fiscal deficits and budget constraints will limit the
ability of Congress to directly fund any new program or initiative.
HLC is working with the chief financial officers of our member
companies and organizations to develop workable, creative
financing proposals for HIT. We look forward to sharing those
ideas with the subcommittee.
There is one other critical issue I need to address today. One
way Congress can facilitate greater physician adoption of
electronic health records is to allow hospitals and medical groups
that have successfully implemented electronic health records to
share their expertise and IT investment with physician offices.
This will facilitate better integration of hospital and physician
information systems to improve continuity of care, decrease
duplicate tests and provide greater safety and quality of care to
consumers. By providing exceptions to the physician self-referral
prohibition (Stark) and anti-kickback rules for HIT, Congress can
accelerate physician use of electronic health records.
Current law prohibits anyone who knowingly and willfully
receives or pays anything of value to influence the referral of
federal health care program business, including Medicare and
Medicaid. Physicians are also prohibited from ordering designated
health services for Medicare patients from entities with which the
physician has a financial relationship - including compensation
arrangements. The penalties for violating Stark and anti-kickback
rules are significant. The Stark law is a "strict liability" statute and
no element of intent is required. Violators are subject to
significant civil monetary penalties and risk being excluded from
participation in the Medicare and Medicaid programs. The anti-
kickback law is a criminal statute that also provides significant
penalties - including fines and imprisonment - for knowing and
willful violations.
Though HHS has released proposed regulations that would
provide limited exceptions to the Stark and anti-kickback rules for
e-prescribing and electronic health records, industry analysis
suggests that the exceptions will be of little value to hospitals and
medical groups wanting to assist physicians with the adoption of
HIT because they are too restrictive and contain overly
burdensome requirements on donors and recipients of IT products.
Due to the severe consequences of violating these laws,
providers need a workable safe harbor for HIT. Congress must
provide a clear roadmap for hospitals, medical groups and others to
provide HIT hardware, software, and related training maintenance
and support services to physicians.
Pending legislation, such as H.R. 4157, establishes a safe harbor
to the anti-kickback and physician self-referral rules for the
provision of health information technology and related training
services to health professionals.
Under the safe harbor, non-monetary remuneration in the form
of HIT and training services is allowable if the remuneration is
made without conditions that limit the use of HIT to services
provided by physicians to individuals receiving services at the
entity; restrict the use of HIT in conjunction with other HIT; or
take into account the volume or value of referrals.
We believe that enactment of this type of safeharbor will help
spur adoption of electronic health records and provide immediate
benefits to consumers in the form of improved quality of care and
patient safety.
In conclusion, HLC believes that HIT legislation should
especially focus on areas in which Congress and the President must
act to remove barriers and facilitate successful implementation of
HIT. Therefore, HIT legislation should accelerate the adoption of
health information technology and interoperable electronic health
records by ensuring uniform IT standards including privacy and
security and providing exceptions to Stark and anti-kickback rules
to allow hospitals, medical groups and others to share their
expertise and investment in electronic health records with
physician offices. HLC will continue to work with Congress to
continue to explore other funding mechanisms to promote wide
spread adoption of HIT.
The Healthcare Leadership Council appreciates the opportunity
to testify on the development of health care information
technology, and I will also be pleased to discuss in greater detail
with the subcommittee our firsthand experiences with health
information technology at Evanston Northwestern Healthcare.
Any questions about my testimony or these issues can be addressed
to me or to Ms. Theresa Doyle, Senior Vice President for Policy,
Healthcare Leadership Council (telephone 202-452-8700, e-mail
tdoyle@hlc.org).
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MR. DEAL. Thank you. Mr. Pyles.
MR. PYLES. Good afternoon, Mr. Chairman. I am pleased to
be here. I am Jim Pyles, representing the American Psychoanalytic
Association, and I would like to just associate my remarks a bit, I
guess, with the remarks of Mr. Vaughan, who I think beautifully
expressed the concerns of consumers, and those are largely the
same concerns by our members because we found that
psychotherapists are essentially the canaries in the coal mine when
it comes to medical privacy. When there is a threat to medical
privacy you cannot provide effective psychotherapy. It just does
not happen.
I have worked on this issue now for about 15 years, and I found
that there is absolutely no end to the number of people who want to
eliminate your medical privacy so they can help you. So I would
urge you to think carefully about that. The fundamental question I
think we have to ask ourselves as we look at a health IT system is
are we going to compel Americans to disclose all of their most
sensitive health information about themselves and their families
into or from a national interoperable health information system
without meaningful, informed patient consent, against their will,
without adequate enforcement against unauthorized uses,
disclosures, and just essentially disregarding their views.
One of the things I have not heard much of in the testimony
today is what do the patients want, and I will be addressing that. I
have learned in working on this issue that if you have no privacy,
you have no liberty, and if you have no privacy, we do not have
access to effective healthcare. It just does not happen. If
Americans do not have a right to privacy to their innermost
thoughts and their genetic makeup, what possible privacy could
they have, what other things could be more private than that?
What does meaningful consent and privacy mean? According to
HHS it means the ability of individuals to determine for
themselves when, how, and to what extent information about them
is communicated. I think if you ask any person on the street they
will have the same definition.
Courts have said it really is essentially the right to control the
disclosure of your information, at least in some routine
circumstances. Why is the right so important? Again, HHS
concluded that in short the entire health delivery system is built
upon the willingness of individuals to share the most intimate
details of their lives with their healthcare providers. If that does
not happen, an IT system is irrelevant, so that is the most
significant concern when it comes to effective healthcare. HHS
also concluded that unless public fears are allayed, it will be unable
to obtain the full benefits of an electronic health information
system. And yesterday former Speaker Newt Gingrich presented
testimony before the Subcommittee on the Federal Work Gorce,
and here is what he had to say about the patient's right to control
their information: "Individuals have the right to control and must
have the ability to control who can access their personal
information." I could not agree with Mr. Gingrich more.
We know that we have sources already of national privacy
standards. They appear in the Hippocratic Oath. It dates back to
the 5th Century B.C., which is administered by 98 percent of the
medical schools in this country to their graduates. We know that
established standards for the ethical practice of medicine adopted
by every segment of the medical profession to essentially assure
the patients that their information will not be disclosed without
their consent. The AMA standard, for example, says, and I quote,
"The physician should not reveal confidential communications or
information without the express consent of the patient unless
otherwise required to do so by law." We also know that this right
to privacy for personal information is a fundamental concept of our
system of government. It is embedded in the Fourteenth
Amendment, the Fifth, the Fourth, and the First Amendments to
the U.S. Constitution. This is the informational branch of the right
to privacy, not the decisional branch where there is so much
controversy. The Supreme Court is rock solid on protecting the
right to informational privacy, and as I said, consent must be
voluntary and it must be informed.
We also know that this right to privacy is grounded in the
physician-patient privilege recognized in most States, including
your own. The psychotherapist-patient privilege is recognized in
all 50 States and the District of Columbia and in Federal common
law. The right to privacy is also reflected in the tort laws and the
statutory laws of all 50 States, and the States of Tennessee and
California have the right to privacy in their State constitutions. We
know also that the citizens of Georgia and the citizens of Ohio
think pretty keenly about their right to privacy, and they have
enacted a lot of laws to specifically protect it.
And if you look at tab two, which I will not go into, it lists the
privacy laws in the State of Georgia that could be preempted by a
bill such as H.R. 4157. Both of these States also recognize the
private act of action which HIPAA does not. There are many other
States that recognize similar privacy protections in areas of mental
health information, genetic testing information, cancer diagnosis
and treatment information, HIV/AIDS, drug and alcohol abuse
diagnosis and treatment, birth defects, and many of these States
give a private right of action. So I would urge you to be very
careful about any bill that would preempt these laws the citizens of
these States have said they need and want.
There are many other privacy protections under State law.
Twenty-nine States now have breach protection or breach
notification laws. I mentioned private rights of action are there.
Let us look for a moment at the right of privacy under HIPAA.
The HIPAA privacy rule really should be named a HIPAA
disclosure rule because it provides regulatory permission for all
covered entities and business associates to use and disclose
identifiable health information for all routine purposes defined as
treatment, payment, and healthcare operations, without notice to
the patient, without the patient's consent over the individual's
objection, even if the individual pays privately, and even
retroactive to the beginning of time, even information that was
created prior to the compliance date.
Treatment, payment and healthcare operations, the reason for
which this information can be disclosed without permission is a
lengthy list. If you look at tab four you will see that list of
purposes. HHS responded to many of the concerns that consumers
had in adopting that regulation by saying it was only a floor, that
still practitioners could still obtain consent, that more stringent
laws remain in effect, and that ethical standards retain their vitality.
I would urge you that with any law that you are thinking of today
you preserve those protections. What does the public want and
expect? If you look at HHS' findings they have found that the
public has a common belief and strong expectation that their
identifiable information will not be disclosed without their consent.
Sixty-five percent of Americans would not disclose sensitive
information and necessary information to their physicians and
providers if they thought it would go into the electronic record.
Seventy-five percent are concerned about the loss of medical
privacy due to the use of electronic information, and we know that
this concern translates into adverse effects on healthcare. Six
hundred thousand people a year according to HHS, 600,000 people
a year, do not seek early diagnosis and treatment for cancer, 2
million more annually do not seek needed treatment for mental
illness. Thousands do not seek treatment for sexually transmitted
diseases. One in six Americans takes evasive actions to avoid
privacy violations, including providing inaccurate information,
changing physicians or avoiding healthcare altogether, and 87
percent of physicians report withholding information from a
patient's medical record due to privacy concerns.
So we would urge you to start this process with strong privacy
protections. Also, we know that an IT system poses a greater
threat to health information privacy. The President's Information
Technology Advisory Committee concluded that the Nation's
electronic information systems are highly vulnerable to corruption
by hackers and others, that the threat is growing by over 20 percent
annually, and the increasing vulnerabilities cannot be addressed by
current technology.
MR. DEAL. May I ask you to summarize rather quickly,
please?
MR. PYLES. I will. In conclusion, I would just like to say that
the the right course of action for Congress to take, I believe, is
ground any health IT system in strong privacy protections reflected
in the history of the Nation in its medical and professional
standards, the law of psychotherapy patient privilege, and the
constitutional common law provide for meaningful, informed
patient consent, provide a private right of action, and prompt
notification for any breaches. Lastly, I would just mention the
concern for the loss of medical privacy should be a particular
concern for Members of this body because under the Supreme
Court's decision in 2001, Bartnicki v. Vopper, the court held that
information about a public official or a public event which is
obtained, even if it is obtained unlawfully, can be published by the
press and the press has a First Amendment right to do it, and
Congress cannot prevent that publication.
So we know these electronic information systems cannot be
rendered secure. It is very likely that elections in the future are
going to turn on what is in a politician's medical record as well as
his talents he brings to the table. Thanks very much.
[The prepared statement of James C. Pyles follows:]
PREPARED STATEMENT OF JAMES C. PYLES, ATTORNEY MEMBER,
POWES, PYLES, SUTTER AND VERVILLE, P.C.
<GRAPHICS NOT AVAILABLE IN TIFF FORMAT>
MR. DEAL. Thank you. Dr. Detmer.
MR. DETMER. Good afternoon, Chairman Deal, members of
the Health Subcommittee. I am Don Detmer, President and CEO
of the American Medical Informatics Association, whose 3,500
members include physicians, nurses, other health professionals,
computer and information scientists and managers, biomedical
engineers, academic researchers, and educators. Over the years
AMIA's members have been the pioneers of information
knowledge relating to healthcare. In the early days of HIPAA
rulemaking from 1996 to 1998, I served as the Chairman of the
National Committee on Vital and Health Statistics, and I also was a
member of the IOM committees that produced the Errors report
and the Chasm report. More recently, I was one of the Speakers
appointments to the Commission on Systemic Interoperability.
It is a pleasure to appear before you today. I would like to
briefly summarize a few key points, and my written testimony
expands on those to some extent. The need for Federal leadership.
Today, too few individuals have access to electronic health record
systems and there is little interconnectedness of the systems that
exist. And yet, significant improvements in healthcare safety and
quality cannot be achieved without robust secure electronic record
systems that can be securely communicated across a national
information network as we heard from Mr. Neaman. Without
Federal leadership our national goal of safe, efficient, effective,
equitable, timely, and patient-centered care will remain unfulfilled
dream because the necessary integrated health information systems
will not be there.
My comments will touch on a few points that are needed to
move our national vision forward at this time. First, the Office of
the National Coordinator for Health Information Technology,
ONC, led by Dr. David Brailer, is doing an excellent job. H.R.
4157, the Health Information Technology Promotion Act would
establish the ONC in statute and AMIA applauds this. Second, the
Department of Health and Human Services should be given
explicit responsibility and sufficient ongoing resources for the
National Library of Medicine to assure that the ongoing
maintenance and open dissemination of agreed health information
standards can be pursued as Dr. Braithwaite mentioned.
Similarly, we are pleased that H.R. 4157 provides explicit and
reasonable rulemaking procedures for the Department to undertake
long overdue upgrades of data vocabularies and classification
systems, the U.S. thus showing the world and shaping global
vocabularies and classifications as a source of primary data in
electronic health records, including contemporary disease
classifications and coding systems, specifically ICD-10, for a host
of legitimate purposes that go well beyond reimbursement. Today
they just do not accurately reflect modern medical practice, nor do
they help the needs of medical researchers.
HIPAA. From my perspective as a physician, the privacy rule
has been largely successful in clarifying the individual rights of all
patients in relation to their health data on a national basis in
establishing the responsibilities and legal obligations of all
providers to whom patients interact. It is now time to take a
rigorous look at lessons learned. Some argue that States must have
the capacity to enact more stringent requirements for privacy. In
the name of better health and healthcare, I must respectfully
disagree. In fact, I do not see how, in practical terms, we can get
to widespread adoption of electronic health records without
establishing meaningful floor to ceiling standards that preempt
idiosyncratic State approaches. Speaking realistically, only
through Federal and State leadership can we truly connect our
Nation for healthcare purposes.
As a matter of record, AMIA has supported the need for
appropriate Federal protection of genetic data. H.R. 4157 calls for
a study of the impact of varying State statutes on the rights and
protections afforded to patients and importantly on the impact of
the requirements on the quality, cost, and effectiveness of
healthcare. The study of HIPAA privacy and security standards
represents an absolute minimum. Two other items will be valuable
to add to the study. First, in addition to the effects on care, the
study should examine effects on legitimate biomedical research.
And, second, our Nation genuinely needs a consistent way to
reliably and accurately authenticate the identity. Both safety and
privacy are compromised when the right health information for one
patient gets associated with or sent to the wrong patient.
Addressing disincentives to HIT dissemination. Reasonable
safe harbors to permit dissemination of health information
technologies and services intended to improve healthcare quality,
efficiency, and access would encourage the deployment of
essential health information systems. And I am very pleased that
provisions to that effect are included in Chairman Deal's bill.
Educating the workforce. Ultimately health IT comes down to
healthcare workers and patients being sufficiently skilled to take
real advantages of the opportunities for improved care, efficiency,
and access that health information technologies and the
interconnected national health information infrastructure can
provide.
In November 2005, AHIMA, the American Health Information
Management Association, and AMIA, my organization, convened
a workforce summit to develop initial strategies to address
challenges relating to effective implementation of electronic health
records and personal health records. The resulting white paper, I
guess you might call it line paper, Building the Workforce for
Health Information Transformation, presents nine targeted
recommendations that key stakeholders, including government, can
use to support the existing workforce and ensure that sufficient
number of well-qualified health information specialists are
available to achieve the necessary health transformation through
IT.
We commend this report to you, and AMIA and AHIMA stand
ready to help address this challenge. I firmly believe that the
development and deployment of an interoperable, interconnected
national health information system is not purely a healthcare issue.
It is a matter of national security. Whether we face, God forbid,
another Hurricane Katrina or an outbreak of avian flu in humans or
another episode of bioterrorism, we simply must have a reliable
health information and communication system for our people's
well-being. Our Nation's safety depends on it. Thank you again
for the opportunity to testify, and I look forward to responding to
questions.
[The prepared statement of Don E. Detmer follows:]
PREPARED STATEMENT OF DR. DON E. DETMER, PRESIDENT AND
CHIEF EXECUTIVE OFFICER, AMERICAN MEDICAL INFORMATICS
ASSOCIATION
Good morning. Chairman Deal, Ranking Member Brown,
members of the Health subcommittee: thank you for the
opportunity to appear before you today. My name is Don Detmer.
I am President and CEO of the American Medical Informatics
Association, whose 3200 members include physicians, nurses,
computer and information scientists and managers, biomedical
engineers, academic researchers and educators. Over the years
AMIA has provided many of the thought leaders who have
pioneered the innovative use of information technologies in
healthcare. In addition to my role with AMIA, I am a Professor of
Medical Education in the Department of Public Health Sciences at
the University of Virginia. I practiced as a vascular surgeon for
twenty-five years.
From 1996 to 1998 I had the privilege of serving as Chairman
of the National Committee on Vital and Health Statistics, whose
mission, broadly, is to advise the Department of Health and Human
Services on shaping a national information strategy to improve the
nation's health. My tenure at NCVHS coincided with the
expansion of the Committee's charge enacted in the Health
Insurance Portability and Accountability Act of 1996, which gave
the Committee significant responsibilities in regard to
administrative simplification and privacy. More recently, I was a
member of the Commission on Systemic Interoperability, which
was created by the Medicare Modernization Act, and which made
a series of recommendations concerning the adoption and
implementation of health information technology in an October
2005 report to Congress entitled, Ending the Document Game:
Connecting and Transforming Your Healthcare Through
Information Technology.
As you consider, and I hope pass, legislation that aims to
facilitate movement toward a 'smarter' health care system through
the promotion of widespread adoption of electronic health records
(EHRs) and personal health records (PHRs), let me comment today
on three important issues:
<bullet> first, there is a critical need for ongoing Federal
leadership in encouraging and shaping a national health information
system that benefits all stakeholders, especially patients;
<bullet> second, we should focus on "lessons learned" from the
rollout of HIPAA standards to date and identify issues to be
considered as additional health information standards and
initiatives are developed and disseminated;
<bullet> and, third, we should address some current disincentives -
both real and perceived - that slow the implementation of
health information technologies in our healthcare system,
the most information-intensive enterprise in our economy.
The Continuing Need for Federal Leadership
While it is the undoubted world leader in high technology
clinical care and biomedical research, the US healthcare system is
an incredibly fragmented mix of very large and very small players
- a conglomeration of 21st century medical science and cottage-
industry business practices, and too often characterized by uneven
access, delivery and outcomes. Significant improvements in
healthcare safety and quality will not be achieved for Americans
without robust, secure electronic health records within a national
health information infrastructure (NHII). Market forces alone have
not driven the necessary integration of the interests and needs of
disparate participants: hospitals - physicians and other providers -
payers - employers - researchers - educators - and, most
important, patients. As a result, too few individuals have access to
electronic health record systems today and there is little
interconnectedness of the systems that exist. Without Federal
leadership to encourage the deployment of interconnected,
interoperable health information systems, our progress toward
integrated and quality-based care delivery will continue to be
lurching and inconsistent.
AMIA has been encouraged by Congressional attention to
health information issues as evidenced by the introduction of HR
4157, the Health Information Technology Promotion Act, and HR
2234, the 21st Century Health Information Act, as well as the
passage by the Senate late last year of S 1418, the Wired for Health
Care Quality Act. And, we have been pleased to provide input to
several legislative proposals to make personal health records
(PHRs) available to Federal Employee Health Benefit Plan
(FEHBP) beneficiaries. These bills are important not only for their
specific provisions, some of which I will focus on today, but also
because they convey an important message to the public - that
their elected representatives recognize the critical importance of
improving the health care system in ways that will empower
consumers, while also improving the quality, safety, cost-
effectiveness and accessibility of healthcare.
Over the last two plus years, the Office of the National
Coordinator for Health Information Technology (ONC), which is
headed by Dr. David Brailer, a Fellow of AMIA's College of
Medical Informatics, has done an excellent job in communicating a
vision to support widespread adoption of interoperable electronic
health records within the next 10 years. AMIA is pleased that
among the projects currently funded by the ONC are contracts for
an Internet-based national health information network and for the
development of processes for the harmonization of the various
health information standards that are emerging. AMIA itself has a
contract with the ONC to create a plan for a national framework
for clinical decision support. In regard to interoperability
standards and the development of processes to certify health
information technologies that can actually 'talk' to each other and
will allow the seamless integration of information systems to
facilitate quality care, AMIA is also very supportive of the work of
the public-private American Health Information Community
(AHIC).
We believe strongly that HHS should be given explicit
responsibility for ensuring the ongoing maintenance and
dissemination of health information standards, with authorization
for licensing and/or other types of support. To give you a
successful example of Federal leadership, I would point to
Secretary Tommy Thompson's drive to complete the licensure and
distribution of SNOMED-CT, a vital 'dictionary' of medical
terminology, by the National Library of Medicine in 2004. AMIA
firmly believes that the Department should draw heavily on the
resources and expertise of the NLM, and we support additional
funding for the Library to ensure that approved vocabulary and
other data content standards are maintained, coordinated and
updated regularly to permit appropriate alignment and uniformity
of the sets of standards that underlie genuinely workable EHRs and
PHRs. Just like the NLM's PubMed, these standards should be
openly available on the internet.
Importantly, HR 4157, the Health Information Technology
Promotion Act, introduced by Chairman Deal and Representative
Nancy Johnson, provides explicit and reasonable rulemaking
procedures by which HHS can undertake long overdue upgrades to
data vocabularies and classification systems. Simply, if we are
going to facilitate development of an interoperative nationwide
network of electronic health records (EHRs), we must address the
issue of interoperative data. This means that we must have
standard vocabularies as the source of our primary data in the
electronic health record, and use contemporary disease
classifications and coding systems, (ICD-10), not only for
traditional reimbursement purposes but to permit meaningful and
accurate secondary uses of data for quality, biosurveillance, and
public health monitoring, health research, injury prevention and
policy making. As a physician and a health informatician, I find it
unacceptable that the US remains one of a true handful of countries
in the world to use a 30-year old classification system for
diagnoses and inpatient procedures. If we are serious about
deploying electronic health record systems for the benefit of
individual patients and the nation as a whole, we must attend to the
need to improve data standards and speed our capacity to update
those standards. At the end of the day, our data systems and
standards should primarily foster better care, not better
reimbursement.
HR 4157 establishes the Office of the National Coordinator for
Health Information Technology in statute, and I believe this step is
a crucial one in clarifying Federal leadership. As part of our
support for the Office of the National Coordinator, AMIA will
continue to urge the appropriators on both sides of the Hill to
provide for adequate funding of the ONC.
Examining HIPAA Lessons Learned So Far
As we move to develop an interconnected, interoperable health
information system that will facilitate quality, access and patient-
centeredness on a national and international basis, it is prudent to
identify lessons we have learned so far from the administrative
simplification provisions of HIPAA. Though the road was often
difficult, if not actually painful, we have made a great deal of
progress in establishing the rights of individuals to expect that their
health information will be used appropriately and their privacy and
confidentiality protected, and in imposing meaningful and
reasonable obligations on health care providers, plans and payers,
and others to comply with consistent Federal standards for the use,
disclosure and transmission of health information.
Where once some people in the healthcare system may have
treated individual health information too cavalierly on at least
some occasions, from my perspective it is manifestly clear that
since the Privacy Rule took effect in 2003, doctors, hospitals,
pharmacies, health plans and others have made really extraordinary
efforts to inform individuals of their rights and to establish policies
and procedures that protect sensitive health information. Today
every individual has a Federal right to access his or her medical
record and to expect that the healthcare system will keep that
record secure and confidential. And these norms are national - no
longer are your rights, or the legal responsibilities of those
healthcare providers you deal with, defined by the unique features
of the State in which you live. Even if HIPAA may have 'backed'
the nation into reasonable privacy and confidentiality protections,
the roll-out has proved, on the whole, successful.
Notwithstanding what I think have been extremely good faith
efforts to ensure that personal data is adequately protected, I do not
discount that some people - for instance, those with concerns
about the security of especially sensitive information, such as HIV
status or relating to mental health treatment - have continued
concerns about health privacy. To my knowledge there have not
been reports of any large-scale violations of the framework set in
place by the HIPAA Privacy Rule. That is, individually
identifiable health information is used and disclosed only for
"treatment, payment and health care operations" or as otherwise
specifically authorized by the individual. Does the Privacy Rule
protect against patently unethical or extraordinarily careless acts -
like the leaking of a celebrity's medical record to a tabloid
magazine or the disposal of old medical records in a dumpster or a
straightforward instance of identity theft? Of course not - but we
cannot expect even the most carefully crafted information
standards to prevent all illegal behavior. In such instances, active
pursuit and strong penalties are needed when intrusions and
misuses are identified, as a lesson to dissuade others from similar
illegal behavior.
Some argue that the States must have the capacity to enact
'more stringent' standards for health information - as is true under
the current Privacy Rule - for all health information standards,
including those that are absolutely necessary for the development
of an interconnected, interoperable national health information
system. In the name of better healthcare, I must respectfully
disagree. About half of all Americans live near State lines and
multiple State approaches complicate the efficient and seamless
transmission of crucial health information. For example, it is
hardly unusual for an individual to work in the District, live in
Maryland, and receive health care in Virginia, with payments made
by an insurer located in still another state. If we are to ensure real-
time availability of accurate and complete clinical information at
the point of care, we simply cannot have the standards for the use,
disclosure and transmission of the patient's health information
subject to idiosyncratic requirements of individual States.
Personally, I don't see how we can get to the common
standards and interoperability that underlie the widespread
adoption of electronic health records without Federal preemption
of conflicting State laws. But rather than simply assert that
proposition, let me note that, in relation to the Privacy Rule, since
1999 AMIA has called for a study of the impact of the lack of
Federal preemption and the impact of varying State statutes on the
rights and protections afforded to individuals and upon the quality,
cost and effectiveness of health care. Thus, I am very pleased that
HR 4157 calls upon the Secretary to undertake such a study in
relation to standards that have been adopted subsequent to HIPAA.
This is a prudent approach; however, if the study shows that
varying State laws and requirements have a negative impact on
health care delivery, quality and access, and that HIPAA has
established meaningful privacy and security protections, it makes
sense to move forward without delay on Federal preemption for all
adopted HIPAA standards.
As you may recall, the original HIPAA legislation called for
the development of a unique personal healthcare identifier for
individuals. All other developed economies in the world have
already or are currently implementing such identifiers to assure
proper authentication of people seeking care services. Whether we
do so with via a voluntary opt-out approach or through the use of
reliable identification algorithms, the United States needs a
uniform approach to authenticating one's identity, and having the
benefit of a unique identifier to help increase the ease and accuracy
of this authentication is not trivial. Indeed, I fear that short of such
a move, we will be left behind the other nations with whom we
should be seeking secure ways to collaborate on global standards.
This topic was a key recommendation from the Commission on
Systemic Interoperability, and I would strongly recommend that
consideration of the issues involved in the reliable authentication
of individuals be included in the Secretarial study called for in HR
4157.
Disincentives That Have Slowed Implementation of Information
Technologies
From 1999 through 2003 I had the privilege to serve as the
Gillings Professor of Health Management at Cambridge University
in England and to consult to the National IT programme of the
National Health Service. As you may know, the British
government is investing billions of pounds to implement a fully
functional, patient-friendly, electronic health record and system.
While this task might appear to be easier in some aspects because
of Britain's single-payer system, of particular note to me was the
observation that, even before the government's new investment,
well over 80 percent of England's primary care physicians were
facilitating patient care electronically. Today they are moving
forward with booking appointments, writing prescriptions, making
electronic referrals, recording clinical notes and tracking treatment
compliance. By contrast, it is estimated that fewer than 20 percent
of US primary care physicians utilize electronic health records.
Interestingly, England's primary care practices were 'wired'
initially not because of government investment, but because the
British pharmaceutical industry years ago offered to supply the
necessary hardware and software to primary care doctors in return
for access to anonymized prescribing information. In the United
States I think such an arrangement would be seen as unseemly at
best, and illegal at worst; certainly in the U.K. there were those
who held the same view. While the British are neither less ethical
nor more permissive of the misuse of identifiable health
information than are Americans, in this country hospitals,
physicians and other providers are incredibly reluctant to pursue
any innovative financing for health IT, including networks that can
securely link together a region's providers, because of their
concerns about the Stark self-referral prohibitions and other fraud
and abuse standards.
Whether these concerns are reasonable, today we have hospital
lawyers who absolutely insist that it is simply not acceptable for
any third party to furnish any information technologies - whether
hardware, software, training or other services - to any provider at
less than a full, fair market price. Yet, the aims of HIT
dissemination are to improve the availability of accurate and
timely health information in order to improve the quality of care,
and I am aware of no evidence that such dissemination by a
hospital, for instance, could actually serve to drive 'new' referrals
or business into that hospital. While some healthcare systems and
providers are moving forward under the current standards, the
general consensus in the healthcare community is that the Stark
provisions, while quite important in many respects, are
significantly constraining progress on the roll-out of electronic
health record systems.
It is in the interest of all stakeholders, particularly patients, that
functional electronic health records and an interoperable health
information system be deployed as promptly as possible. But the
entities that are one key to making crucial progress with that
deployment, the small and rural physician practices that still
provide a majority of health care services in this country, are those
that are least able to afford the capital investment for the purchase
and hassle of implementing state-of-the art IT systems. Especially
because most of the 'savings' of health IT accrue to other system
participants, including employers, health plans and patients,
financial outlays necessary for the purchase of the very building
blocks of an NHII should reasonably come from a wide variety of
sources, including government outlays and pay-for-performance
programs. Actually, pay-for-performance programs represent a
clear argument for payers to provide some of the financing for
health IT - because in order to pay-for-performance you have to be
able to track performance and quality in the delivery of care, and to
do that efficiently you need sophisticated information capabilities
embedded in the healthcare system. Reasonable safe harbors for
dissemination of health information technologies and services
intended to improve healthcare quality, efficiency and access
would encourage deployment of essential health information
systems, and I am very pleased that provisions to that effect are
included in Chairman Deal's bill.
Educating the Healthcare Workforce
There is no question that momentum for bringing healthcare
into the information century is building, but this won't happen
purely through a widespread distribution of hardware and software
and standards and certifications. Ultimately, IT comes down to
healthcare workers and patients being sufficiently skilled to take
real advantage of the opportunities for improved care and
efficiency and access that health information technologies and an
interconnected national health information infrastructure can
provide. Assuring these skills throughout the workforce will
necessitate sufficient numbers of well educated health
informaticians. Because the field is advancing so rapidly, we are
seriously undersupplied to meet this challenge.
Last year to help address this challenge, AMIA announced its
10 by 10 program, which aims to realize a goal of training 10,000
health care professionals, especially in applied clinical informatics
by the year 2010; we just passed our first 100 graduates of a
largely web-based course developed by William Hersh and his
colleagues at the Oregon Health and Science University. Other
universities intend to participate as well. Our program uses
classes, tutorials, web-based and in-person sessions to equip health
care professionals to use health information and health information
technologies to benefit patient care and to advance medical
knowledge. In fact, we know from the research of AMIA
members that well-trained health providers combined with robust
IT systems can produce safer, higher quality care delivery.
With the supply of physicians essentially constant and the
nursing workforce aging along with the baby boomers, we will
only be able to address the increasing demands for care of a
growing and aging population by developing a better trained
workforce, especially more nurses skilled in the use of information
and information systems. Increased Federal support for education
and training will be needed to address this workforce reality - and
in November 2005 AMIA, in conjunction with our colleagues of
the American Health Information Management Association
(AHIMA), convened a workforce summit, which included broad
representation of stakeholders across the healthcare enterprise, to
develop initial strategies to address challenges related to effective
implementation of EHRs and PHRs. The resulting white paper,
Building the Workforce for Health Information Transformation
presents nine targeted recommendations that the industry -
including employers, employees, vendors, the government and
professional organizations - can use to prepare the existing
workforce to use technology tools and to ensure that we have a
sufficient number of well-qualified health information specialists
to achieve the promise of health IT transformation.
A Few Conclusions
In terms of the development and implementation of integrated
health information systems with sophisticated capabilities, we have
seen a great deal of progress in the last few years. Within the
Veteran's Administration, for instance, the case for improved
safety and higher quality through the proper use of IT systems -
including electronic records, decision-support programs, and
process tracking and change analyses - has been largely made. We
have seen the creation of the Office of the National Coordinator for
Information Technology and a Commission to Certify Health
Information Technology. The Commission on Systemic
Interoperability mandated by the MMA has provided an important
set of recommendations to Congress, and Secretary Leavitt has
pressed the American Health Information Community (AHIC) to
take on a range of public-private initiatives to develop information
standards, certify new technologies, and provide long-term
planning and governance for the electronic health environment.
Someday we may look back at this moment and say, "The rest
is history" - but not just yet. Additional legislation and Federal
support, and the development of accepted, enterprise-wide
standards will be required if true interoperability and
connectedness are to occur. Clearly, HR 4157 does not try to
address all of the issues involved in creating an NHII to improve
healthcare quality, access and patient-centeredness. But it does
forthrightly address some key 'sticking points' that are keeping the
nation from moving forward as quickly as we should and among
them are first, establishment of the Office of the National
Coordinator in statute; second, addressing the impact on patient's
rights and on healthcare quality and safety of varying and
conflicting State and Federal information standards; and, third,
reducing some current disincentives to the adoption of available
health information technologies. AMIA looks forward to prompt
consideration of the legislation and to supporting its
implementation.
Finally, let's not forget that an interoperable, interconnected
national information system is not only a healthcare issue; it is a
matter of national security. When I testified to the House Ways
and Means Committee on July 25, 2005, I stated that it wasn't
clear what would bring this reality to the American public. I
mentioned an outbreak of avian flu in a US population center or an
episode of bioterrorism or the occurrence of transmissible disease
in our food supply chain. Instead, a few months later Hurricane
Katrina drove home my point. In the first weeks and months after
this national disaster, two contrasting points were made abundantly
clear. First, public health and individual patient care of thousands
of Americans was jeopardized as paper medical records were
destroyed by mud. Second, the electronic medication and health
records of veterans were available wherever and whenever their
availability was authorized, offering immediate help to hundreds.
People's lives do hang in this balance.
We must have a reliable, ubiquitous electronic health
information system for our nation. It is crucial for personal health,
public health and the economic interests of our country. While
widespread dissemination of electronic health record systems and
the development of a functional NHII will facilitate broad
improvements in health care quality, access and affordability, it
will also assist in protecting our security and I would urge your
leadership in facilitating this development with all due speed.
Thank you for the opportunity to appear before you today. I
will be happy to answer any questions.
MR. DEAL. Thank you very much. Thanks to all of you.
There were some very interesting comments. I think with maybe
one exception, Mr. Pyles being the exception, most of you have
agreed we need to do something in this area. Mr. Vaughan has his
reservations about it. I understand the privacy issue, and I
certainly agree with it. Hearing some of the testimony sort of
reminds me of the old joke about the fellow who went to his
doctor, and the doctor asked him, what is wrong with you, and he
says that is what I am paying you to figure out. We all want to
protect our privacy but there has to be some degree of sharing of
that. Now I think that the question of preemption of State law is
one of the more significant issues that we have to deal with here.
I understand too that there are some very pragmatic problems
when you allow States to have their own set of rules. My
congressional district borders three States, and the Chattanooga
area is to the immediate north of my district. We have doctors who
have patients that go to the hospitals in Chattanooga. Other parts
of my State, of course, Augusta, which is on the South Carolina
border, Columbus, which is on the Alabama border, if we do not
have some degree of uniformity of those kinds of regulations
statutorily, how do we avoid, if nothing else, those cross-State
dealings back and forth of the hospitals and doctors who may be in
different States, how do we avoid those kind of problems where
one State's rules may be different from the other State's rules? Is
that a problem or is that not a problem? Mr. Pyles.
MR. PYLES. I would be glad to address that, and I also want to
say that I do not disagree that something needs to be done in this
area. I think something needs to be done particularly with respect
to HIPAA because you have got HIPAA authorizing disclosure for
treatment and payment of healthcare operations in your State and
most others and standards of medical ethics prohibiting it, so it
causes confusion in the consumer community. They do not know
if they have a right to privacy or not, and this leads to confusion in
the practitioner community. I think a good argument can be made
for having greater uniformity and therefore understandability in the
privacy standards across the country.
MR. DEAL. Should we not be able to all agree on what those
would be?
MR. PYLES. I would agree with that, and that is why I cited the
standards of medical ethics which apply across the country that
contain a consistent privacy standard that has been applied for
years, cited the constitutional common law that applies in every
State, the psychotherapist-patient privilege, and the patient
physician privilege which again applies under the State. What we
are suggesting is let us look at the common standards we now have
that apply across the country and all three of the States your district
borders on. Every doctor in those States is subject to standards of
medical ethics, everyone is subject to the constitutional common
law and physician-patient privilege. We have national standards
for privacy. We just do not have them in Federal law.
MR. DEAL. Mr. Vaughan, you made reference to a possible
model law. Is there one that has been proposed by the National
Association of State Legislators, for example?
MR. VAUGHAN. Not to my knowledge. I am just reading
Don's testimony. This is a problem and how do we deal with it.
And it strikes me that under your leadership you could call for the
NGA and the National Conference of State Legislators to come
together and to really identify where the differences are and where
the commonality is, and like when you make a change in long-term
care insurance you give the NAIC a couple years to come up with
a model, Reagan stuff, and then it goes into effect. You could set
up a structure that kind of brings the States together and say what
is really important to us and let us try to talk a common language
and not this tower of babble, and you have a couple years to do it.
It is such detailed work. You do not want this all on your desk,
I would think. Get these groups together and see where the
commonality lies, and let us try to bring this up for the American
public rather than down to a minimum.
MR. DEAL. Mr. Mertz.
MR. MERTZ. Mr. Chairman, I just wanted to comment on that.
We think that the HIPAA standard does create some uniformity.
The weakness of it is that it does not preempt these literally
thousands of conflicting State rules that are creating an obstacle.
And the examples I gave you were various States that actually bar
the laboratories from providing lab results. If you set up regional
organizations or web-based electronic health records, under the
State laws that exist today, we could not transmit laboratory results
which make up 60 percent of someone's medical record. That
medical record that is on the web would be missing 60 percent of
the data that a physician needs. And so we think that the HIPAA
standard is a very good one and very protective and sets the
standard.
We believe that preemption is necessary. You are only doing a
study which I think would hopefully identify these conflicting
State laws to have the States go back and try to undo the laws. I
was involved in doing a study of State laws. There are thousands
and thousands and thousands of rules that would take 100 years for
the States to unravel all of those. That is why we need one good
strong Federal standard.
MR. DEAL. My time is expired. Mr. Waxman.
MR. WAXMAN. Thank you, Mr. Chairman. Following along
the same inquiry, I am concerned about creating a national health
information infrastructure without strong privacy protections for
patients. HIT will allow providers to not only keep their patients'
healthcare records electronically, but share them with others more
easily. I do not presume that any of you would be comfortable
letting an employer or a health plan know if you were genetically
predisposed to mental illness or have the public know your
grandchild had been exposed to AIDS or allow a co-worker to
learn that your husband or wife has a fertility problem. These
clearly are very private matters.
With the expansion of the use of electronic medical records
comes an increase in the potential for breaches of privacy and the
pirating of sensitive personal medical information by unauthorized
parties. HIPAA, the Health Insurance Portability Accountability
Act, set minimum Federal standards for use in disclosure of
personal information. However, when HIPAA was passed,
Congress was unable to come to agreement in certain areas so
States were allowed to enact additional consumer protections.
Similarly, Congress has been unable to come to agreement and
pass a Federal genetic non-discrimination law prohibiting
employers from learning about and using genetic information
about their employees in the work place. Still, there are some HIT
proponents who would be comfortable with HIPAA as a Federal
privacy standard that would also preempt all State privacy and
security laws such as State genetic non-discrimination laws. So
Mr. Pyles, could you comment on what would have to be included
in a Federal privacy law for it to be protective, especially if it were
to supersede State laws?
MR. PYLES. Thank you. I will be glad to do that. First and
foremost, I think we would want to see a law grounded in the
principles, as I said, of standards of medical ethics, otherwise, we
would have Congress perhaps authorizing the unethical practice of
medicine, which I do not think any physician would want to see
happen or any practitioner. It ought to be granted, and the right to
privacy reflected in our founding principles of the Constitution,
and again those are remarkably similar. There was a comment
about thousands of State laws. In fact, there are core concepts in
those laws that are remarkably similar. As I said, every State
protects mental health information, recognizes a psychotherapist-
patient privilege, but beyond that we would need things that
HIPAA does not provide. Things like breach notice requirements
where patients whose privacy has been breached will be notified
and the Secretary will be notified so that we can see a list of
companies that do not do a very good job of protecting medical
privacy. That could probably be the best enforcement measure we
could have.
There should be a private right of action that nearly every State
recognizes because we know that HHS has done a very poor job.
There are over 17,000 privacy complaints that have been filed
since April 14, 2003, the implementation date of HIPAA, and only
one enforcement action. So we think that there should be an
opportunity for patients to establish electronic black boxes. We do
not think IT and privacy are incompatible. We think you can
actually enhance privacy through the use of health IT, but you need
to establish the principles at the beginning. You cannot retrofit an
IT system for privacy.
MR. WAXMAN. Some States know the ways personal health
information can be used without consent. Many States have more
protective laws about specific types of sensitive information,
HIV/AIDS, mental health records, genetic tests and more. And
many States have more meaningful consent requirements. These
are the kinds of things you think ought to be in a Federal law if we
are going to have preemption.
MR. PYLES. I would agree. I would support perhaps a study
done by the Secretary as H.R. 4157 provides. But it would have to
be a study that is first and foremost directed to identify the
commonalities that we see across the country in medical ethics and
State laws, in constitutional law. We should build on the
foundations we have and that we've formed in this country. We
should not assume that we have to operate with a blank slate.
MR. WAXMAN. The Federal law only directly applies to
providers, health plans, and health clearinghouses. Many States'
privacy laws directly apply to a broader range of individuals and
entities like those that transcribe records or those that copy or
transport files. Do you think that ought to be a Federal law?
MR. PYLES. Absolutely, Mr. Congressman. Oddly enough,
HIPAA does not apply to hackers unless they happen to be
providers or insurers or healthcare clearinghouses. We would
think that as with many State laws, Congress should provide for
privacy protections that run with the information and should apply
to whoever handles the information. It is the same to the patient
whether a private individual breaches their privacy or an insurer.
MR. WAXMAN. Thank you very much, Mr. Chairman.
MR. DEAL. Thank you. I hope we will have a second round
too. If we do not have more Members show up, we may have a
chance to go around again. Dr. Burgess.
MR. BURGESS. Thank you, Mr. Chairman. I forget who it was
in their opening statement that referenced the disasters down on the
Gulf Coast, which there is no place clearer that we do need to fix
this problem. The records room at LSU, you walk through there,
the place is ruined and will be ruined for the rest of our natural
lifetimes. Contrast that with the parking lot at the arena at Dallas,
Texas where you had 400 private doctors show up to triage people
after they got off the buses from the Superdome. And I do not
remember the drugstore precisely, I think it was Walgreen's, set up
one of their remote computer terminals there. They did not have
medical records, but at least they had pharmaceutical information
on a lot of the people that got off the buses, and it made piecing
together the medical story a lot more straightforward, so the value
was proven to me that day, but it a difficult climb.
And, Mr. Nelson, I just wondered if you had a thought as to
how much, looking forward, how much is this likely to cost? If we
just look at the Federal government component of healthcare,
Medicare, Medicaid, VA, Federal prison system, Indian Health
Service, Federal qualified health centers, about 50 percent of the
healthcare expenditures are accounted for by the Federal
government. Do you have an idea as to what it is going to cost
Secretary Levitt when he says he is going to build this platform?
MR. NELSON. I cannot give you a specific number. I can say
that some of the building blocks that have been put in place, I think
by Dr. Brailer if you take the proposal, for example, it essentially
was a lot like what a venture capitalist would do when they are
trying to infuse an investment and then get a return on that
investment. Although that may have been about a $20 million
investment on his part spread out across four major corporations, I
could tell you for a company like IBM we are taking that and we
are starting to build on it. At the end of the day, I suspect that we
will probably invest 10 to 20 times that amount into helping to fix
the healthcare problems as a part of our replicating the opportunity
that he has provided us across this country.
So, you know, I applaud that immensely without necessarily
having a number that the actual Federal government itself has to
invest. I think private enterprise is going to go a long ways in
helping solve the problem.
MR. BURGESS. When I think back to my days in practice, it is
a big expense for a single physician's office to do this. If a
hospital puts in an expensive system they of course have borne the
cost of that, then to bring individual doctors offices on board
would be a relatively inexpensive process because most of the
software expense has already been handled. But if the doctors
offices then have to individually go out and contract with the
software licenses and what have you it does become a good deal
more expensive. So, Mr. Neaman, I wonder if there are any
thoughts you have of how we might reform some of the Stark laws
to allow this to be a more facile process.
MR. NEAMAN. Thank you. Your comments are absolutely on
track in terms of the relative cost and the ability of extending from
the hospital systems to doctor offices. In our own experience for
our three hospitals, again we invested a little bit over $40 million
to get the system up and running. In our experience it takes on an
incremental basis of approximately $50,000 per physician to
incrementally bring additional doctors up on the system, so it is a
rather large expense. It is also a time consuming expense. We are
inhibited by Stark and the anti-kickback provisions from extending
our system to other physicians who are in independent or private
practice, and that is a big hurdle to overcome, not a risk that we
want to take given the penalties that are involved with those
statutes. So it would be a relatively easy thing to extend the
systems and the software to other physicians if we are permitted to
do it under the Stark regulations.
MR. NELSON. If I could comment on that, please.
MR. BURGESS. Yes, please.
MR. NELSON. The $50,000 is certainly a substantial amount of
money. To put that in perspective, our data shows that that will
represent the cost. The actual market pricing and what physicians
are willing to bear, the costs that they are actually willing to pay, is
probably more than $300 to $400 per doctor per month range, so
there is a bit of a gap there between what the cost is and what the
delivery is. Of course, with the Internet and hosting services they
do not necessarily have to go out and buy complete systems. The
average size of a physician's group is like 2.5 or less, so they are
small groups. They do not have the capital to be able to spend the
money, and so we are going to have to come up with alternate
solutions that are very cost effective to make that work.
MR. MERTZ. Congressman, can I make a quick comment on
that? We represent the labs and you were not in the room at the
time.
MR. BURGESS. Let me make one other point because I am
about to run out of time. If we get a second round, I will be happy
to come back to you. From the physician's perspective too it is
also a question of time for us to do electronic prescribing or even
electronic medical records. The average physician has to see
between 30 and 50 patients a day in order to pay the overhead and
take something home, and if you add a minute and a half to two
minutes to every transaction in order to be up to date with
electronic medical records or prescribing that is two hours, and
how are we going to compensate the physician for that time?
MR. NELSON. We are actually doing this right now in
Westchester County up north of New York City. There are 60,000
IBM employees. The HR department of IBM actually provided an
incentive to the physicians to the tune of 50 cents per member per
month to actually use the system, so they get paid in order to get
the cost benefits, and what not on a minimum level of adoption.
The ROI on that was less than two years. We are seeing a much
higher level of adoption than what we expected, you know, but it is
a great model, I think, that we could use across other endeavors
like this. And I agree 100 percent with your comments on time
and doctors.
MR. BURGESS. But there the insurance plan bore some of that
expense to incentivize the doctors to practice.
MR. NELSON. And we need to keep in mind that a great deal of
benefit that comes from these systems goes back to the employer
and to the payer.
MR. BURGESS. Sure. Thank you, Mr. Chairman.
MR. DEAL. Ms. Capps.
MS. CAPPS. Thank you, Mr. Chairman. I have about four or
five questions I want to try to get into the brief time so I am maybe
asking for brief responses. Mr. Nelson, I will start with you. We
have been hearing from others on the panel about the complexity
of multiple State privacy laws. I wanted to know technologically
do we have--can you speak to the capability of technology to
accommodate different State privacy laws?
MR. NELSON. I do not think it is a technical problem at all.
MS. CAPPS. Okay.
MR. NELSON. The technology can handle it and we have
experience with ATMs, the banking industries, all of which have
their own unique regulatory issues.
MS. CAPPS. So that is not the issue. But then let me ask about
privacy, and I guess I will address you, Mr. Pyles, but I do not care
who jumps in. Under current legislative proposals do patients have
to consent to having anonymous information shared with
researchers? Do they have to give their approval?
MR. PYLES. I am sorry. Could you restate the question?
MS. CAPPS. Under current legislative proposals, or at least
some of them, do patients have to consent like give some
significant assent either in writing to having anonymous
information shared with researchers?
MR. PYLES. Well, I do not know about pending legislation. If
it is de-identified information then it certainly could be disclosed
under HIPAA.
MS. CAPPS. Without them even knowing if it is anonymous.
MR. PYLES. Without them knowing, that is correct. Yes. And
under the proposed legislation, I cannot think of any of the
proposed legislation that addresses that issue.
MS. CAPPS. The way it is now then, who is responsible for
determining whether this is legitimate, you know, if lines have
been crossed if there has been boundaries, and in proposed
legislation?
MR. PYLES. Well, under HIPAA it is very, very difficult to
know that their information has been disclosed and therefore, since
they get no consent or opportunity, so that in effect is no notice, I
am stunned that there are 17,000 complaints that HHS has received
because I do not know how those patients would have known. So
there must be many thousands, tens of thousands more breaches of
privacy that are out there that people would object to if they just
knew about it, but they probably do not.
MS. CAPPS. And they do not know about it. In some of the
proposed legislation, is this dealt with?
MR. PYLES. No, that is one of the things most disturbing about
all of the legislative proposals I see. It seems that privacy is
always the last issue to be discussed, if it is discussed at all. A
number of the proposals do not mention anything about privacy at
all.
MS. CAPPS. They do not mention privacy at all.
MR. PYLES. Correct.
MS. CAPPS. Well, that is certainly something I would hope,
given the questions today that certainly is on our minds, and we
reflect our constituents so I am hopeful that this will be interjected
into any kind of studies. Mr. Chairman, I would hope that that
would be the case. I am wondering now with the little more time
that I have if you, Mr. Pyles, or anyone could comment on some of
the shortcomings in Federal law currently with regard to
enforcement of Federal uses of personal health information. You
touched on it a bit. The disparity is, are there States that do a
better job, for example?
MR. PYLES. Well, States can do a better job but even with the
authorization for disclosures, without consent under HIPAA, it also
means that patients often cannot even assert the rights they have
under State law because many States prohibit the disclosure of
many types of information. But HIPAA allows the disclosure, and
if a practitioner follows HIPAA then not even a patient would
know enough to assert their State rights. Plus HIPAA requires a
notice of privacy practices to be given to every individual. The
notice compels the practitioner to describe the disclosures that are
made under HIPAA, authorized under HIPAA, even if that is not
their practice.
So they are all supposed to include a notice of rights the
patients would have under State laws, but I have seen very few
notices that include any reference to State rights.
MS. CAPPS. But Mr. Nelson, if we can use him as the standard,
says there is no barrier in the technology for allowing--
MR. PYLES. I have total confidence in Mr. Nelson. If
Congress said that a national privacy standard had to reflect the
right to privacy under medical ethics, constitutional law, and law
of privilege, that tomorrow morning Mr. Nelson would have a
product on the street that did just that, and also accounted for
variations in the State laws.
MS. CAPPS. And accounting for the variations in State laws, so
there is nothing that should stand in the way of this being pursued
in the interest of consumers or patients.
MR. PYLES. Well, I am not the--
MR. MERTZ. Could I comment?
MS. CAPPS. I would love to hear--
MR. MERTZ. I am with American Clinical Labs. What is a
technological barrier, the example I gave there is definitely a
barrier in State laws. I gave the example of in Florida and
Georgia, the laws do not allow the laboratories to transmit results
to an electronic health record. If there is a disease management
program that has been mandated under Medicare, we cannot
transmit because they forbid us transmitting lab results to anybody
except the ordering physician, even with the patient's consent. We
cannot provide lab results for disease management, for an
electronic health record.
So with all due respect, maybe you could build a computer that
could do it but we cannot transmit the results, so that is a State
barrier that is absolutely insurmountable for us with these
programs.
MR. DEAL. That would be a very remarkable State law that did
not allow a disclosure with patient consent.
MR. MERTZ. Well, it is not remarkable in Georgia and Florida.
MR. DEAL. Well, I know one thing. The citizens of Georgia
care a lot about their privacy judging from the laws you have on
the books.
MR. MERTZ. Well, it is not remarkable there because there are
dozens of States that have those laws, so it is not unusual at all,
Mr. Chairman.
MR. DETMER. I do think that one of the really strong points is
that you do mandate a study and I think there will be things we will
learn from that, and I think that is why in fact I really am so
supportive of that part of the legislation.
MS. CAPPS. Mr. Chairman, this has been a good hearing.
MR. DEAL. Thank you very much. Mr. Green.
MR. GREEN. Thank you, Mr. Chairman. Having served years
in the legislature before, I tell people I lost my mind and came to
Congress. I am surprised a lot of States have it where they prohibit
the individual patient from receiving that information. I assume it
is not just Georgia and Florida. It must be a number of States.
MR. MERTZ. Well, it is unusual and it is one of those areas
where the State law actually prohibits the patient from having
access to their own records, which we find kind of odd. Again, we
are the labs. We do the testing, and our business is really to get the
data back to the physician. But, you know, Congressman, there are
so many important things. Diabetes management, they need to get
hemoglobin H1C tests every six months. We have almost 10,000
people die a year just because they are not tested for their
hemoglobin regularly. So these programs are so important to save
people's lives, or cholesterol, people with heart disease. It is
essential that these programs be able to manage their disease, and
so that is why, while we are very careful, we do not want to give
results out to everybody. Genetic tests, we are the people who do
the genetic tests. We certainly do not want to send those out to
anybody who does not have an absolute need for disease
management, hemoglobin, diabetes, asthma, heart disease, yes,
those are important tests but we will be careful about it.
MR. GREEN. Mr. Vaughan, do you have a response to that?
MR. VAUGHAN. We are very much for consumers being able
to have access to their medical records and if there is an error in
there and it asks for an edit and a correction, yes, this is the kind of
thing that we need to work out.
MR. GREEN. Can you tell me, does Texas have that
prohibition?
MR. MERTZ. I have not looked at Texas specifically. I know
that Georgia, Florida, New York, California do have them. I
would have to get back to you on Texas.
MR. GREEN. We can check because--
MR. MERTZ. Generally what the State laws say is that the
ordering physician or his or her designee may get the lab results,
and unfortunately it has been interpreted to mean the designee is
only someone in the doctor's office can get the results so generally,
almost in every State, we cannot report to a RIO or to a disease
management organization, so I think Texas would be the same.
MR. GREEN. I will have to talk to my legislators because that
is a concern because I think the patient ought to make that decision
anyway. Mr. Vaughan, you give some examples of your concern
about the abuses under the Stark and anti-kickback laws, and Dr.
Burgess talked about, and the panel all morning has talked about
some of the things we have to do to be able to protect that. How
are physicians' choices influencing the patients affected now on
some of the examples?
MR. VAUGHAN. Well, the law was designed to deal with the
fact, and started with labs, that doctors who invested in a lab
everybody who walked in, you know, maybe just, gee, am I
pregnant, would get a full lab workup. There was just
documentation by GAO and OIG of tremendous over-utilization,
and then we found the same things in X-rays and MRI machines
and so forth, and so it spread to try to get a bright line because the
anti-kickback laws, you have to prove intent. This was meant to be
a bright line to say, gee, people who make these investments or get
remuneration tend to, whether they are aware of it or not, start
over-ordering and start doing more of a particular service, and it
was driving up cost something awful.
The worry is that if stuff is provided free or at a reduced rate to
a doctor it makes you a good friend of that person who gave it to
you, and you tend to gravitate that way. Maybe that is not the best
place to send your patient, and so that is what we are trying to be
careful about, opening that door to over-utilization or
misapplication of medicine. It is important to coordinate care,
goodness, yes, but how about making that part of pay-for-
performance or finding other ways to coordinate the care.
MR. GREEN. One of the suggestions I know--in fact, we are
having enough trouble dealing with our lobbying reform, much
less looking too much at the physicians situation, but on the
electronic records technology that is something that has obviously
a greater good. Not that a doctor having immediate access to the
test, but if we are looking at the good as a whole, is there a way
that we can draft something if we are trying to actually have that
that maybe we would not run afoul of those whether it is IBM or
whoever is selling this equipment that they do not all decide that is
the one.
I know one of the suggestions I heard is that, for example, for
the greater good we might want to have some non-profit or maybe
the medical society in a given community or a State saying this is
the depository, this is the information, and anyone who is a
member, for example, could then access that without someone
feeling like maybe they are utilizing that.
MR. VAUGHAN. I mean a way to deal that you would not have
to change any laws or get any IG opinions is if people have some
money and they want to encourage the spread of this technology to
doctors in a State who maybe do not have the resources or behind
the eight ball on it, give it to a foundation, Robert Wood Johnson
or some State foundation and they would give out the money. I
think you will find a lot of opposition or objections to that idea,
and that should tell you something. The people who want to give
this hardware and software, they want a tie with that doctor. They
want a tie that binds so that that doctor will send patients to that
hospital. Coordinating care with the patients is great, but if that
hospital that gives the data or the software, is it the best place for
that patient.
MR. GREEN. I see I am out of time. Mr. Chairman, if you
would allow me just to ask if anyone else on the panel would like
to respond.
MR. DETMER. Yes. I just wanted to weigh in on this. Right
now our biggest challenge in the U.S. is particularly the small
provider office. That is really our biggest challenge. The hospitals,
frankly, are getting there and they are building their systems. The
thing is our country is a very complex, large place, and I think
some of these issues are working, do work, can work, and will
work in some settings, but in other settings that opportunity and
that kind of option is just maybe going to be very hard to put in
play. I think what we are really advocating for, if we can get the
regulations right, security and those kinds of design features. Then
our feeling is to have this connectivity means that actually a doctor
in West Bicycle, Texas can easily get a consultation with the Mayo
Clinic electronically, as easy as they can actually with the provider
that maybe gave them that connection.
In actual fact I think it is that kind of connectivity that really
has significant offsets in terms of these arrangements. So I would
like to think you could craft it. I certainly hope you could craft it
because I think we need it.
MR. GREEN. Thank you, Mr. Chairman.
MR. DEAL. Thank you. I believe we will start a second round.
Is that okay with you all? Okay. Let me start it off. I am going to
try to simplify because I think of it in rather simplistic terms, in
terms of the problems that I see are encountered. First of all, with
regard to a hospital sharing its software with physicians, virtually
all of my physicians practice in only one hospital. It does not
make a whole lot of sense to me that they should not have some
way when the patient goes to the hospital instead of asking the
patient when he comes back to the doctor's office, well, what did
they tell you. It sort of reminds me of a story of one of my clients.
I asked him one time, I said, well, what did the doctor tell you? He
said I have no idea. I do not even think he spoke English.
We have got to have a better way of transmitting information
that helps the patient. The one situation, the hospital sharing what
their tests were, what their findings were back with the treating
physician, he needs to know that. Also, let us suppose there is a
consult with a specialist in the same community who does
something. He prescribes some medication. Instead of the patient
then going back to his primary doctor and being asked, well, what
did he give you? Well, I do not really know. What did he tell
you? I am not really sure. I did not understand all that. There has
to be a better way of doing this. Now there are several things that
pop out to me as major problems of what I am talking about. We
have alluded to them in some of your testimony.
One is the coding and whether we are talking about the ICD-9
versus the ICD-10. Mr. Mertz alluded to some of the potential
problems with the additional codings that are there. Let us talk
about that for just a minute. How many of you believe we should
go to a broader coding such as the ICD-10? Would anybody care
to comment? Dr. Detmer.
MR. DETMER. Yes. Actually I am actually a fellow of the
American College of Sports Medicine, and you held up your sheet
talking about some of these sports issues. I practiced surgery,
vascular surgery, as well as sports medicine for about 25 years, and
for 15 years I published a fair amount of work that was
internationally verified as being valid. To this day, the coding
words or the diagnosis I made in athletes, sometimes Olympic
athletes, still does not exist in ICD-9, as well as being able to for
payment purposes, I would have to find a code that is sort of
related to the leg. In actual fact, what works for billing does not
capture what you really need to really try to do research as well as
even just talk about. For example, asthma today does not have a
lot of the codes in 9 that really are in 10. So there is a set of these.
We do not know how slippery this all is because it is very hard
to track down. But suffice it to say there has been a lot of progress
in medicine in 23 years, and that is how old that coding system is.
So, yes, it does create problems. We not only need to worry about
10, but that is why I talked about the National Library of Medicine.
We need to put in this process that can keep that going over time
so that we do not have these very tough dislocations every ten or
so years. We really need to put in process something that will
catch us up but then hopefully keep us up.
MR. DEAL. Mr. Mertz.
MR. MERTZ. Yes. Just briefly on that. ACLA labs, we
support moving to the ICD-10, but I would just remind you, first of
all, you are going from 12,000 or 13,000 codes to 120,000 codes,
so it is ten times as complex. You may recall that we are just now
after four or five years finally adjusting to the HIPAA transaction
codes, the new claim standards that took us years to get that. That
was much less complicated than moving to this. We almost had a
train wreck where providers were not going to get paid by payers
because of the complexity of it. So we just want to make sure as
we move to this, two years is not enough. We need at least five
years to train the people on new systems.
We have to train all of the doctors who submit the diagnosis to
us. They are going to have to put eight or ten times as much
information on the form that the doctor sends to the lab. If every T
is not crossed and every I is not dotted, we do not get paid. We
perform the test. We do no get paid, and the system will really
shut down. So I would just urge some caution in having a long
enough transition period so that we can go there.
MR. DEAL. Yes, Dr. Braithwaite.
MR. BRAITHWAITE. Mr. Chairman, I think that many of the
systems that are in electronic health record systems today are based
on these coding systems. We get paid for practicing medicine
when we submit a certain code. The problem is that those codes
are very broad, they are very general, and they do not really reflect,
this is what Dr. Detmer said, what is actually done to the patient. If
we cannot come up with a coding system that is detailed enough so
that what we record in our electronic health systems actually
represents what is done to the patient, then we cannot even look
forward to that vision I put forward about how we can practice
medicine better in the future by actually having computers help us
to interpret what those codes mean with respect to the rest of the
data about that patient, not necessarily ICD-10, SNOMED CT is a
national coding system for example that has that level of clinical
information.
As we implement electronic health record systems we now
have computers to help us to come up with the right code. It does
not have to be done manually out of a book with pen and paper as
it is done now in most places for ICD. So I think there is a good
balance.
MR. DETMER. You also mentioned the importance of the
patient being in play here, and if you have terminology where the
patient can see some of these codes that do not really reflect
particularly what happened you really help bring that patient into
that care environment.
MR. DEAL. Very good points. Ms. Capps.
MS. CAPPS. Thank you again, and you are talking about
barriers of some kind and maybe we need to pursue that line of
questioning that you started, Mr. Chairman, but I want to see about
HIT implementation, what barriers there might be there. And I
will continue with you, Dr. Braithwaite. Everyone seems to agree
that adoption of electronic health records and a move toward
interoperability would allow different providers, health plans, labs,
and others to talk to each other, and that that is a good thing. It
would improve quality, save resources, eliminate harmful errors.
Yet, a recent Rand study found only about 20 to 25 percent of
hospitals and 15 to 20 percent of physicians offices have an HIT
system. Talk a little bit more, I know we brought this up, but focus
in on barriers to implementation. And if we design some
legislation, we are going to hopefully have a study, but what
should we do or could we do that might help get past some of those
barriers? And anyone else can jump in as well.
MR. BRAITHWAITE. Well, as I mentioned, one of the major
barriers is the incentive system. We are reimbursed in the system
for piece work. We are not reimbursed for the health of the
patient. And so coming up with several different mechanisms to
incent the appropriate implementation of health information
technology in the clinical practice would be appropriate. I think in
surveys that we have done, people have problems with up front
funding as has been discussed. The capitalization of this in
practices that do not really have that much capital is difficult.
Coming up with the changes in the reimbursement policies so that,
for example, a pay-for-performance program under Medicare that
actually paid for improved outcomes of the patient based on the
data that is produced from an electronic health system would in
fact encourage the physicians to get information technology in
their clinics and provide higher quality care, as long as the result
was not that their incomes actually went down because of these
strange reimbursement policies that come out sometimes.
I think in aligning incentives so that the people who purchase
the systems and the people who benefit from them are
appropriately aligned with the implementation of health
information technology.
MR. MERTZ. May I address that? As I mentioned in my
statement, some of our national labs, they are connected with about
50 percent of the physician offices, and the figure that was given is
right. It costs $30,000 to $50,000 to create this conductivity with
the physician office. It is not just the hardware and the software
but the training, marrying all the different systems. It is extremely
complicated. Half of the offices that we do not have relationships
with tend to be the smaller practices where they do not have the
resources to do it.
The labs, we have been the ones who invested millions and
millions of dollars. We pay for this conductivity. But you get to a
small physician office, and they do not have the volume of lab tests
to make it economical for the labs to make a $50,000 investment
so that they can order the results of their tests and get the results
electronically. So that is, I think, one of the key areas where help
is needed to provide incentives and resources. We get paid for
doing the test. We do not get paid for spending $50,000 to hook
them up electronically. So that is where we need some help.
MR. NEAMAN. If I could just comment from the perspective of
somebody that has done it and been there, I think half of the issues
relate to financing, where are you going to find the money to do it.
MS. CAPPS. Right.
MR. NEAMAN. The other half relates to the huge behavioral
changes for electronic medical records, and the hospitals and the
doctor's offices--
MS. CAPPS. Behavior changes by whom, everybody?
MR. NEAMAN. Every clinician, every nurse, every physician,
every technologist under an electronic medical records system
must change the way they practice. It is no longer writing things
out by hand or trying to decipher the physician's handwriting.
Everything changes, and for the most part it changes for the better.
MS. CAPPS. Several of you have mentioned incentives.
Voluntary, is that sufficient? If we are the ones who would design
legislation, is it significant enough for our national interest to
mandate some things, or are we even to the point of talking about
that?
MR. NEAMAN. I think, from the providers' side, the hospitals
and the physicians lack trust. If there is going to be anywhere near
the sufficient level of funding to bring doctor offices or hospitals
up when we are facing another $36 billion of Medicare cuts.
MS. CAPPS. I hear you on that one.
MR. NEAMAN. I think it is going to have to be again some kind
of opportunity included in the private sector to invest monies to
make this a real reality, unless the Congress wants to take on a
project like rebuilding the Federal highway system of hundreds of
billions of dollars to really make this a reality in the near future.
MR. DETMER. I think I would like to comment on that, I think
that puts tension in this, as it is not like there is an EHR system.
MS. CAPPS. Right.
MR. DETMER. In fact, there have been some very good studies
done that show that if you go for EHR light, in other words, the
cheapest kind of way to just get something in, you do not have the
decision support infrastructure where you really get your quality,
safety, and your ROI pay back. By one calculus of that, if you are
willing and can find the scratch to pay four times more you will get
12 times back. So it is not like it is just sort of the thing to do.
And so education and change management is a major piece of this.
The other thing that I want to echo, again, that I mentioned earlier
in my testimony has to do with authentication.
It was interesting, the day that the commission report on
systemic interoperability was put out, and I was on that
commission, we happened to have our annual meeting. The same
afternoon we had a presentation of some of the folks that were on
the commission and talking about it. A woman in the audience
said I have a problem for you. She says I am Mary Smith. I have
a problem with authentication.
MS. CAPPS. Great.
MR. DETMER. She says I get other people's bank statements
when I do on line banking. I need some unique way both for my
protection as well as for everybody else's to identify who that is.
This issue of being able to have at least a national way of uniquely
identifying folks is really something that is a barrier that, again I
think is a Federal issue if we are going to address it. Thank you.
MS. CAPPS. And I know I have overstayed my time but this is
our last round. I started out by talking as a nurse about patient
safety and the benefits of IT. Somewhere in our study, I would
hope we could find some way of demonstrating that in the long run
the initial outlays will be significant of resources. There ought to
be a pay back to society at least for mortality rates dropping, and I
would--we get to that as IT--can the study even demonstrate some
things?
MR. NEAMAN. In our studies, we can tell you that right now.
It does not take a long term. We have shown in our studies in our
hospitals, our doctor offices, there is a payback, economic, clinical,
saving lives. It works. It absolutely works.
MS. CAPPS. And is there demonstration of that already?
MR. NEAMAN. In our system, yes.
MR. DETMER. Speaking of the nurse and the education
challenge, the strategy we really need is educating nurses in
particular.
MS. CAPPS. I do not believe we will end up doing all of this,
not all of it, but a fair amount of it at least in the--
MR. NEAMAN. If I might, just get a lot of great benefit out of it
too.
MS. CAPPS. I should say.
MR. NEAMAN. Better care. In our studies we saved 20 percent
of the nurse's time instead of babysitting the chart and trying to
decipher the doctor's handwriting.
MS. CAPPS. And you are all talking about it in acute care
probably, but look at long-term care and who delivers that care and
who has to take a huge chunk out of every hour of patient care to
documenting.
MR. NEAMAN. Absolutely.
MR. DEAL. Let me go to Dr. Burgess next.
MS. CAPPS. It is tough for the doctors, isn't it? Thank you.
MR. DEAL. Dr. Burgess.
MR. BURGESS. You know, I think back over 25 years of
medical practice, the two things that came out of Washington that
destroyed a better part of the joy of life were the Stark laws and
HIPAA, and I cannot help but feel we are today with the grand
daddy of them all, and I do worry about what the world will look
like so it is terribly important for us to get that right. So with that
sort of onus, Mr. Mertz, I interrupted you before. Let me let you
finish what you were trying to tell me about the Stark laws.
MR. MERTZ. Well, actually the point I was trying to make, I
eventually made which was that it is a sizable investment, $50,000
or so, to set up that conductivity between the labs and the
physician offices. So it is going to take a lot of money and the labs
have made that investment. I just want to reiterate, we very much
support the Stark law in many ways because it does not allow the
abuses that happened many, many years ago. We are able to only
provide the equipment that is needed just very narrowly to ordering
tests and reporting results.
But we see the need to expand it a little bit to allow more
investment and IT. We just want to make sure that we are still
included in an exemption, but that it is done carefully. So I
appreciate the opportunity to finish up. Thank you.
MR. BURGESS. And, Mr. Vaughan, on that, does it ever
increase the cost of care to not share information?
MR. VAUGHAN. Sure.
MR. BURGESS. I can tell you in my hometown of Denton,
Texas that I encounter that situation every day where they've got
two hospitals that are competing, and not only do they not
communicate with each other, they are forbidden from
communicating with each other. So a CAT scan in one hospital on
a Friday night means you get a CAT scan in the next hospital if
you go into the other emergency room on the next Friday night
because you did not like the care you got across town. It is a
system that creates more expenditure, I believe, by not
communicating.
MR. VAUGHAN. Absolutely. This is where so much of the
savings will be, but how you can get this information, the software,
the hardware, into doctors offices, how can we do it where it does
not lead to some distortions that we might not even see for a while
where one hospital that has got good cash flow in a year, the other
one has been doing charity care, might be a little starved. This one
donates some stuff. Just consciously or unconsciously doctors will
say I like those guys. They have been helping me. They have
been helping my office. I move my patients there and they may
not have the best department and everything.
So you get those goofy, almost unconscious distortions, can't
we pay for this up front? I know with the Federal budget situation,
you know, get a life. There is no cash lying around.
MR. BURGESS. Mr. Neaman has found the savings for us in the
Medicare, is that what you just told us a minute ago?
MR. NEAMAN. In our system, yes.
MR. BURGESS. So how much money are you going to save us?
If the Chairman and I are successful in getting this done and your
company is the one that gets the contract, are we going to save that
$34 billion in Medicare this year that we can then turn back over?
MR. NEAMAN. I can only comment on our system and what we
have actually found. The point being is that the systems that we
have experienced really do save lives and they do less testing, not
more testing, and they protect patients from abuses of testing. We
have even shown in our studies that the efficiency improves so
much that we were able to save cost-wise $17 million a year in our
system by doing things right the first time, not having to do them
time and time and time again, so there is a small incremental
savings once you get the system up and running.
Again, all the other benefits are tremendous. I think Mr.
Vaughan's examples might be a little confused with what the real
issues are here. In the examples of over-testing, such as too many
lab tests or too many X-rays when a physician owns that
equipment, that is not what we are talking about here. If you want
to preclude that, then do not let physicians own MRI machines, a
whole other issue.
MR. BURGESS. It is not a good idea, by the way, but continue.
MR. NEAMAN. I was not advocating it as a principle,
particularly my orthopedic surgeons would let me know about that.
But what we are talking about here is the sharing of data, and
shouldn't we be focused on the patient here, to share that data
between our hospitals and our physicians. Doesn't the American
public expect our hospitals and doctors to work together around a
central point of data? The answer is quite clear in our experience.
Absolutely yes.
MR. BURGESS. Mr. Pyles.
MR. PYLES. I have been wanting to get this in. You asked a
question in your last round, and I think it touches on what you are
asking now. How much you save I think is going to depend on
how much you need. The numbers I have seen on the cost of
wiring the country for health IT are $176 billion initially as start
up-front costs and $46 billion annually. Now keep in mind you are
going to have to replace that information system. They have a life
span of about, as I understand it, three to four years, so you are
going to be continually replacing them.
It is not to say you should not do it, but when you are talking
about a solo practitioner in Shady Side, Maryland where my family
physician is, that is a big chunk. His share of that is a big chunk.
He was chosen actually as one of 200 physicians in Maryland to
use an electronic information system by Blue Cross. He has found
that it is out of order. He carried around a little box that he is
supposed to input information in. He cannot communicate with
the system, at least a minimum of three times a day, and the
information he gets back is often times so garbled he cannot
understand it. So he is a little frustrated. I have heard healthcare is
the last area where we do not have IT. It may not be such a bad
thing because we are dealing with people's lives, and we would not
impose a drug or a procedure on the public unless it was proven
safe and effective for patient use. So I would just urge you to be
careful.
As a lawyer, one of the questions I have always had too is what
is the standard of care for an electronic health information system?
When you go into the hospital and a patient has a seizure you
punch the screen to get the patient's current status and what they
are on, and it says access denied and you prescribe something and
the patient dies. What is the standard of liability there? A judge is
going to have to figure that out. Were you negligent? Was the
hospital negligent? Was it expected for the system to be down
once a week, once a month, once a year? My computer is down a
minimum of twice a week. Maybe these systems are more reliable
but that is a whole area that is completely unexplored as far as I
can tell. I do not see any standard of care like a Xerox standard.
Xerox will tell you the copier machine will never be down more
than four hours.
MR. BURGESS. Can Dr. Detmer respond, Mr. Chairman?
MR. DEAL. Sure.
MR. DETMER. I agree with him on one point, and I disagree
with him on another. I agree with him that IT is not some kind of
magic. It has got to be done right for it to work, and we have heard
from some places that are doing it right, and, boy, it does work.
That is why this education issue is also a huge piece of this,
because if you just try to do it, I am not sure in fact you will ever
see a ROI.
On the other hand, if you do it right I think we now do have
enough body of evidence to be able to speak to safety, efficiency,
cost effectiveness, patient centeredness, timeliness. As prices
drop, you do start improving equity as well, and that is a U.S.
problem.
MR. DEAL. Why don't we let Mr. Nelson defend his industry?
MR. NELSON. I think the comment that I would make is we've
got to keep in mind that the bulk of the healthcare dollar really
goes to chronic disease, and there are not a lot of them.
Interesting, you know, there is various data out there to support
this, but the average patient when we get down to actually looking
at it on a by patient basis, they have on average between five and
ten physicians if you have a chronic disease. Those doctors do not
talk to each other. So it is real obvious that the only way that we
are going to actually make that work and reduce the redundant
tests and improve the quality of medical errors and all that is if we
give smart people information so that they can make smart
decisions, but allow those smart people and physicians, I think as
Dr. Burgess mentioned earlier, it has got to be in a way so that the
physician is not penalized in the process.
We got 16 percent of the gross national product right now
going to healthcare which is far over any other country in the
world. Any other outcomes are not even in the top ten right now,
you know. I think it is a shifting of the dollar that we are talking
about. Medicare and Medicaid employers and payers are the ones
that are the biggest beneficiaries of these systems, and we shift the
dollars to some extent from there to the primary care physician,
which are the guys who really I think are in control of the
healthcare system today.
MR. DEAL. Well, thank you.
MR. BURGESS. Mr. Chairman, could I ask a question?
MR. DEAL. Sure.
MR. BURGESS. We are going to have a bill before us either in
this subcommittee or the full committee about this, and if it would
not be out of order to ask each of our respondents to give us their
impressions about what they like, what they dislike about the bill.
This is important that we get it right because this could be the
headache for the next two or three generations of physicians or the
benefit for the next two or three generations of physicians.
MR. DEAL. Certainly. That would be appropriate, and there
may be other questions from other members of our committee that
were not here that may be submitted to you in writing. We would
appreciate your response on that. I commend all of you.
Somewhat different points of view on some issues, but generally I
think there is a consensus that this is an area that is worth
exploring. It is worth us trying to move forward on the issue. We
appreciate your various points of view. As Dr. Burgess indicated,
if we can move a legislative agenda, we would appreciate your
further comments with regard to that as we attempt to refine those.
We do appreciate your time, and thank you for your attention and
your being with us on this occasion. I am not going to adjourn the
hearing because we expect to have in the next few weeks a follow-
up panel that will be from a Federal point of view and so therefore
in light of the fact that that further panel will elaborate on the same
general issue, we will simply just suspend this session of the
hearing on IT. Thank you all for being here.
[Whereupon, at 1:56 p.m., the Subcommittee adjourned.]
RESPONSE FOR THE RECORD BY WILLIAM BRAITHWAITE, MD, PHD,
CHIEF CLINICAL OFFICER, EHEALTH INITIATIVE AND FOUNDATION
FOR EHEALTH INITATIVE
Responses to Questions following March 16, 2006
Subcommittee on Health Hearing entitled: "Legislative Proposals
to Promote Electronic Health Records and a Smarter Information
System"
1. How important is it to think realistically and not try to
do everything at once in terms of a complete electronic
medical record, but instead focus on things like e-
prescribing, lab results, and patient information?
Through eHI's Working Group for Value Creation, Working
Group for Practice Transformation and other organizational efforts,
eHI is exploring important issues in this topic area. To the question
specifically, trying to do everything at once in terms of a complete
electronic medical record, to me, is like trying to boil the ocean.
Although an electronic health record system for every clinician,
including functional clinical decision support systems, is a
necessary vision and goal to work toward, this development and
implementation process will take decades to complete. It is much
better to implement some "low hanging fruit" for which a return on
the investment can be demonstrated as a way to support the longer
term effort.
To the functions you mentioned, e-prescribing, lab results, and
patient information, I would add medication history (including
allergies) and clinical reports to complete the set of commonly
mentioned electronic health information exchange functions that
clinicians agree would help provide higher quality healthcare in the
short term.
2. Can you give an example of some of the decision
support systems that are possible by moving towards
smarter information systems?
Some examples of decision support functions include:
<bullet> Advising a clinician that a drug he/she is trying to
prescribe has contraindications that must be considered (and possibly
explained or justified) such as allergies, potential drug-drug
interactions, instance of another prescription or OTC drug
the patient is taking with similar physiological activity and
existence of a less expensive alternative with similar
activity.
<bullet> Advising a clinician that a lab test that he/she is trying to
order was done recently on the same patient and present the
results of that test for consideration to avoid redundant
procedures.
<bullet> Advising a clinician that a result of a test (laboratory,
radiology, pathology, or other) indicates an abnormality
that has not been documented and/or acted upon.
<bullet> Advising a clinician that a screening or follow-up test
judged to be appropriate for the particular patient (age,
weight, sex, diagnoses, health status, etc.) has not yet been
ordered or has been ordered but not produced a result in the
expected timeframe (e.g., results of ordered Hgb A1c test
have not been received within 2 weeks of follow-up patient
visit for diabetes control).
<bullet> Advising a patient that a refill of a prescription for a drug
that should be taken daily to treat a chronic disease is
overdue.
RESPONSE FOR THE RECORD BY ALAN MERTZ, PRESIDENT,
AMERICAN CLINICAL LABORATORY ASSOCIATION
April 18, 2006
The Honorable Nathan Deal
Chairman, Subcommittee on Health
House Energy & Commerce Committee
2125 Rayburn House Office Building
Washington, D.C. 20515-6115
Dear Chairman Deal:
Thank you for the opportunity to testify before the
Subcommittee on Health at the March 16, 2006 hearing entitled,
"Legislative Proposals to Promote Electronic Health Records and a
Smarter Information System." Per your request, attached are
answers to the questions posed in the April 11th letter to the
American Clinical Laboratory Association (ACLA).
The Honorable Nathan Deal
1. What particular function of healthcare do labs provide
that makes them a good starting ground for smarter
health information systems? Laboratory data are the
heart of the medical record. Laboratory data represent 60-
70% of the medical record while comprising only 5% of
total hospital costs and only 1.6% of Medicare costs. The
vital information provided by laboratory data directs the
diagnosis and treatment of disease, improves the efficiency
of the clinical care provided, and most importantly,
improves clinical outcomes for patients. The long-term
benefit of these effects is reduced health care costs. For
instance, 62% of the Health Plan Employer Data and
Information Set (HEDIS) effectiveness of care measures
are informed by diagnostic tests. Diagnostic tests are
specified as important to measure in 80% of the clinical
evidence based guidelines for the most costly disease
conditions in the U.S. It is for these reasons that virtually
every health care community trying to develop an
electronic health information infrastructure is looking to
laboratories first. In a survey of hospitals, the number one
health care information technology (IT) function in use by
the majority of hospitals today is the electronic order entry
and review of results for diagnostic services. For example,
ACLA member Quest Diagnostics, a commercial
laboratory with business relationships with over half of the
nation's physicians and hospitals, currently sends 60% of
its results and gets 40% of orders via the Internet. The
investment that laboratories have made in health IT also
includes public health - ACLA member companies report
to over 3,000 public health agencies at the local, regional,
and national level - much of which is done via electronic
means.
2. I understand that labs have a limited exception under
the Stark law. Can you explain how this exception
works and whether there are any examples of abuse in
this area with respect to labs? The terms of the Stark law
are defined to exclude from the law's scope the provision
of hardware or software by a clinical laboratory to an
ordering clinician provided such items are "used solely to
order or communicate the results of tests or procedures for
such entity." This provision was added to the Stark law
when it was amended by Congress in 1993. Under the
terms of this provision, laboratories are not permitted to
include other types of functionality in the hardware or
software they are providing to the ordering physician
without charging fair market value for this added
functionality. For example, one of ACLA's members
currently offers a product which, in addition to being able
to order tests and transmit results, also enables the
physician the means to electronically order prescription
drugs. Due to the limited nature of the Stark law provision
discussed above, this laboratory must charge fair market
value to the participating physician for this additional e-
prescribing functionality. The laboratory provision has
helped shepherd health information technology into
numerous physician offices and hospitals throughout the
country today. The ability to provide clinicians with this
limited hardware and software is fundamental to rendering
efficient, comprehensive laboratory services to patients - a
critically important function that must be maintained.
Clinicians place a high value on being able to order
laboratory services and receive laboratory results
electronically because it improves legibility, decreases
error rates, produces more timely results, and allows the
monitoring of redundant or duplicative testing. ACLA
member laboratories strive to fully comply with the
parameters of the Stark law and we are not aware of any
examples of abuse in this area.
3. With respect to ICD-9/ICD-10 issues, would it be safe to
say that we would get more detailed and accurate
information by switching to ICD-10? If yes, why have
we been so slow to move toward this code change?
Transition from ICD-9 to ICD-10 does hold great promise
- provided clinicians accurately use the more detailed
diagnosis and procedure codes offered by the ICD-10
Clinical Modification (CM) and Procedural Coding System
(or PCS). More detailed procedure codes could allow for
enhanced tracking and analysis of clinical and economic
benefits and better outcomes research. However, the
transition to ICD-10 has justifiably been slow due to the
massive overhaul to providers and payers' computer
systems, and the time and expense needed to provide
appropriate client education, training and testing of the new
systems. This transition would be particularly difficult for
laboratories since they bill Medicare directly, yet depend
on the ordering physician for the diagnosis codes to include
on the claim they submit to Medicare. While the current
iteration of ICD-9 consists of roughly 13,000 diagnosis
codes, problems persist today with physicians not providing
the appropriate ICD-9 codes in order for laboratories to get
paid. ICD-10's 120,000 codes have the potential for delays
in reimbursement if providers are not well educated on how
to use the new system. Finally, other regulatory changes
(including the replacement of Version 5010 of the 837
claim standard) must occur before ICD-10-CM can be
implemented
4. Having uniform standards for the transmission of
laboratory results is an essential part of promoting
electronic health records and a smarter health IT
system. Can you share with the Subcommittee what
progress has been made in establishing such uniform
standards? Much work has already been accomplished in
developing uniform standards for laboratory result
reporting. Currently, most laboratories and other
diagnostic services use HL7 to send their results
electronically from their reporting systems to their care
systems. In that transmission most laboratories utilize
Logical Observation Identifiers Names and Codes (LOINC)
to facilitate the exchange and pooling of results, such as
blood hemoglobin or serum potassium for clinical care,
outcomes management, and research. The laboratory
portion of the LOINC database contains the categories of
chemistry, hematology, serology, microbiology (including
parasitology and virology), and toxicology. The
Consolidated Health Informatics (CHI) initiative, one of the
Office of Management and Budget's eGov initiatives
adopted LOINC as one of its core uniform standards on
March 21, 2003. However, what is also needed is an
implementation guide for this system, given the variability
among laboratories in reporting different LOINC codes for
the same test (there are over 25,000 LOINC codes for
laboratory tests). The EHR-Lab Interoperability and
Connectivity Standards (ELINCS) project, a non-
proprietary effort involving various players within the
health care delivery system (including those focused on the
transmission of lab results), has been doing just that. In
March of 2005, ELINCS, through the leadership of the
California Healthcare Foundation, began developing an
implementation guide to 'map' the top 80% of performed
laboratory tests. This 'mapping' essentially creates
uniformity among laboratories, providers and vendors alike
in terms of which LOINC codes refer to which laboratory
results. The initial effort was completed in late 2005 (v1.0)
and additional work on v2.0 is nearing completion, which
expands the project to cover the top 95% of all performed
tests (around 170 tests). In September of 2005 the
Certification Commission for Health Information
Technology (CCHIT), which was awarded an HHS contract
for health IT product certification, included ELINCS v1.0
among the handful of interoperability specifications it has
proposed for its first round of certification criteria for
electronic health record systems.
5. Establishing an electronic connection between labs and
physicians or hospitals for ordering tests and receiving
results can be very costly. This cost is a significant
barrier for many physician offices, particularly smaller
practices. How costly is it to establish such interfaces,
why is it so costly, and what is the impact on health care
practices? The eHealth Initiative, in a recent report
entitled, "Practice and Laboratory Connectivity," estimated
that establishing custom interfaces between physicians,
hospitals and laboratories can cost anywhere between
$30,000 to $50,000. This high cost is due to two factors:
(1) the cost of the actual hardware/software, installation
and training of staff; and (2) the cost to "marry' the existing
data streams of the participating provider and the
laboratory. This cost burden, most often paid to a vendor,
is the direct result of the lack of uniform electronic test
requisition and result reporting standards. Due to the
significant cost involved with establishing this
connectivity, the provision of this technology is a business
decision - one which often times prevents this technology
from reaching both rural and small physician/hospital
locations. However, with the ongoing work of the ELINCS
project in creating an implementation guide for electronic
results reporting (and plans to tackle the test requisition in
the near future), it is our hope that in the next few years the
cost prohibitive nature of custom interfaces will abate,
thereby leading to greater access to this technology for
physicians/hospitals both in rural areas and in smaller
practices.
Thank you once again for the opportunity to testify before the
Subcommittee. If you have questions or need any additional
information, please do not hesitate to contact me.
Sincerely,
Alan Mertz
President
RESPONSE FOR THE RECORD BY MARK NEAMAN, PRESIDENT AND
CEO, EVANSTON NORTHWESTERN HEALTHCARE, ON BEHALF OF
HEALTHCARE LEADERSHIP COUNCIL
<GRAPHICS NOT AVAILABLE IN TIFF FORMAT>
RESPONSE FOR THE RECORD BY JAMES C. PYLES, ATTORNEY
MEMBER, POWERS, PYLES, SUTTER AND VERVILLE, P.C.
April 25, 2006
Dear Mr. Grant,
Please accept my response to the letter from Chairman Deal of
April 11. I was unable to respond to the letter when it arrived
because I was completing the petition for certiorari to the Supreme
Court in Citizens for Health v. Leavitt which challenges the
constitutionality of the HIPAA Amended Privacy Rule. That
petition had to be filed on April 13, and I had to be out of the
office until this week. My secretary reminded me that this was due
today. I think you will find the answers helpful.
Question 1:
The question does not accurately state the question I raised. My
question was, " Will Congress compel Americans to disclose all
of their most sensitive health information about themselves and
their families to and from a national "interoperable" health
information system without meaningful, informed patient
consent, against their will and without adequate enforcement
against unauthorized uses and disclosures?"
The question to me also incorrectly states that "under current
health care operations providers may exchange identifiable health
information for the purpose of treatment and billing." In fact, the
Amended Health Information Privacy Rule that is currently in
effect, authorizes covered entities (including doctors, other
providers, health plans and health care clearing houses as well as
their business associates) to use and disclose virtually any of an
individual's identifiable health information for the purposes of
treatment, payment and health care operations. These are separate
terms and purposes. Treatment and payment are generally defined
as uses for the patient's treatment where the patient has requested
that treatment and payment where the patient has requested that an
insurance claim be filed. So these uses and disclosures are
somewhat within the patient's control. Health care operations, by
contrast, are a broad list of uses generally for the benefit of the
covered entity that are completely outside of the patient's control
that include underwriting and premium rating, business planning
and development, management activities, and due diligence in
connection with the sale of a business. 45 CFR 164. 501, 65 Fed.
Reg. at 82,803-04. As the American Medical Association said in
its comments on the Amended Rule, "As currently defined, "health
care operations" includes a broad array of activities unrelated to a
patient's individual treatment or payment and extending far beyond
the necessary disclosures and uses patients would expect when
they seek health care...An optional consent provision combined
with a broad definition of health care operations would
effectively compel patients, as a condition of obtaining health
care services, to allow uses and disclosures of their protected
health information that are not routine or necessary for a
covered entity to run its business." AMA letter to HHS, p. 7
(April 26, 2002).
The question also states, "Of course, doctors may also not
disclose information if they choose or other rules do not constrain
it." That choice is not as available as the statement implies.
Covered entities may provide a consent process for disclosures for
treatment, payment and health care operations, but only by
entering into an agreement with the patient to restrict uses and
disclosures. 45 CFR 164.522; 67 Fed. Reg. at 53,213. Covered
entities are further discouraged from entering into such
arrangements because failure to act in accordance with such
agreements can result in a violation of the Rule and civil penalties.
67 Fed. Reg. at 53,213.
The statement, however, reveals the real change that the
Amended Rule made in the practice of medicine and the right to
medical privacy. It is correct that under the Amended Rule, for the
first time in the nation's history, covered entities have been given
the federal authority to decide whether a patient's health
information will be disclosed without the patient's consent and
even over the patient's objection. The practice under constitutional
law, medical ethics and the laws of most states, prior to the
Amended Rule, was for THE PATIENT to be able to decide
whether his or her identifiable health information would be
disclosed. In other words, a patient's identifiable health
information could not be disclosed without the patient's consent.
This long established principle was recognized in the Original
Health Information Privacy Rule. 65 Fed. Reg. at 82,474.
When many consumers and practitioners raised the concern
that the proposed Amended Rule would violate medical ethics and
state laws, HHS responded that The Amended Rule was only
intended as a "floor" of protections and that more stringent state
privacy laws and standards of medical ethics would remain in
effect. 67 Fed. Reg. at 53,212. However, the decision making
power was taken from the patients and vested solely in the hands
of covered entities.
So in answer to the specific question whether current law fails
the test, the answer is that the Amended Rule does fail that test to
the extent that it authorizes covered entities to disclose Americans'
identifiable health information without their consent and against
their will. But HHS contends that current law is only a "floor" of
privacy protections and was not even intended to be a "best
practices" standard. 67 Fed. Reg. at 53,212. Some who testified at
the hearing desire for the Amended Rule to become the national
privacy standard. The effect would be for the "floor" to also
become the "ceiling" which would leave little room for consumers'
ethical and constitutional rights to health information privacy. The
HIPAA Amended Rule cannot be made the national privacy
standard because it essentially eliminates the individual's right to
health information privacy rather than protecting it.
Question 2:
Should a patient be able to "block" a doctor who needs to send
certain medical information for the purpose of billing?
Answer-A doctor should always act in accordance with
standards of medical ethics. The standards of medical ethics of the
American Medical Association, as well as virtually every other
medical society, state that, "The physician should not reveal
confidential communications of information without the express
consent of the patient, unless required to do so by law." See Tab 1
to my testimony, item 16.a. HHS also found that this is has been
the established practice throughout the history of the country. 65
Fed. Reg. at 82,474.
So if a patient, a Congressman for example, wishes to file an
insurance claim for treatment of the flu, he or she should be able to
expect that their psychiatric record or genetic test for a
predisposition for cancer will not be disclosed without their
consent. If the insurance company insists that they have to have the
entire medical record to pay the claim, the Congressman should
have the right to pay privately and not have to disclose this
information against his or her will. If we do not allow patients to
assert their traditional right to privacy, they will avoid seeking
needed health care and/or instruct their physicians to falsify their
medical records. HHS has found that many Americans already are
taking such self protective measures and physicians are
withholding information from patient records. 65 Fed. Reg. at
82,468. Thus, protection of the right to privacy is essential for
effective, high quality health care. See HHS determination to this
effect. 65 Fed. Reg. at 82,467.
So the short answer to your question is that a doctor should
only be able to disclose a patient's identifiable health information
for billing purposes with the patient's consent. If this means that
the claim cannot be paid, the patient will have to pay privately (as
has always been the case). The physician can determine this, as
they always have, by determining prior to providing the services
whether the patient will consent to the disclosure of information
necessary for insurance coverage or agree to pay privately.
What a physician cannot do in the ethical practice of medicine,
is disclose a patient's identifiable health information for billing or
other purposes without the patient's consent, unless required to do
so by law.
Question 3:
Should a patient be able to edit or block the sharing of identifiable
health information between a physician and a specialist?
Answer-Again, we believe in the ethical practice of medicine
under which a patient's identifiable health information cannot be
disclosed, even to another physician, without the patient's consent.
There is no reason why this consent cannot be obtained at the time
the patient is accepted for treatment by the first physician. This is
not a novel concept. This has been the established practice, as
reflected in standards of medical ethics, throughout the history of
the country.
For example, psychoanalysts often seek consultations from
other practitioners, but they never do so without obtaining the
patient's consent. Certainly, no physician, even a physician to
whom a patient was referred, would ever treat a patient without his
or her consent.
We do believe, however, that there are situations in which a
physician should be able to infer consent where it is necessary to
carry out treatment that a patient has requested. This is essentially
the approach that was taken in the Original Privacy Rule which
allowed health care providers in an "indirect treatment
relationship" (such as a consult) to review an individual's
identifiable health information without express consent. 45 CFR
164.506(a)(2)(i) (65 Fed. Reg. at 82,810).
The point that must be appreciated is that if the individual's
right to privacy for identifiable health information is not protected,
the information will simply not exist, because the patient will
refuse to disclose it. This was expressly recognized by the
Supreme Court in Jaffee v. Redmond, 116 S. Ct. 1923, 1929
(1996). That decision has now been followed in over 150 other
cases.
The right of consent is not new or novel. It is the core concept
of medical ethics and the right of all law abiding citizens "to be let
alone" as protected by the First, Fourth, Fifth, Ninth, and
Fourteenth Amendments to the Constitution. As HHS has found,
the right to privacy is a "fundamental right" of all Americans. 65
Fed. Reg. at 82,464.
Do not hesitate to contact me if you have further questions.
Jim Pyles
On behalf of the American
Psychoanalytic Association
RESPONSE FOR THE RECORD BY DON E. DETMER, PRESIDENT AND
CHIEF EXECUTIVE OFFICER, AMERICAN MEDICAL INFORMATICS
ASSOCIATION
1. It seems important that when we're talking about electronic
health records that we would need to come up with a
common medical terminology. Is the licensure of
SNOMED the final step in coming up with this common
terminology or does more need to be done?
Response: The initial comment is accurate; that is, we need to
have a common medical terminology. The licensure of SNOMED
was not the final step in coming up with a common terminology
and more does need to be done. Today, we have three problems.
First, we don't have a global system that brings SNOMED and
ICD-10 together and, second, we don't have an agreed-upon
manner by which the world will maintain the terminology and
classification system going forward. Medicine constantly changes
due to new discoveries about human biology and diseases, new
technologies, and new treatments. The challenge is to find a way
to support those groups who can do this kind of work well and also
support a method and manner of giving the world timely open
access to the terminology and classification into the future. The
USA would be very wise to license SNOMED and subsequent
terminology and classification for use by the world and not just for
USA institutions from the National Library of Medicine as well as
support the ongoing maintenance of the standard terminology and
classification systems through the NLM; an extra $6-8 million per
year would give the NLM the funding it would need to support this
but the benefit to the USA itself would more than offset this cost.
A joint task force of AMIA and AHIMA experts is currently
working on a white paper that discusses this issue in some detail
and a copy of that report will be sent to you as soon as it becomes
available. Additional funding for informatics research on this and
related issues such as that mentioned in the next paragraph is
needed.
The third problem relates to the movement within the USA of
giving patients electronic health records populated upon
information used in paying insurance claims. The current
terminology on insurance claims that used ICD-9 is so outdated
that it will only serve as an approximate representation of a
person's health status, treatment, or disease condition(s). We have
very little data to show us just how well or poorly it reflects reality
but many experts are concerned about the potential distribution of
millions of records of dubious accuracy and the confusion this will
cause physicians as well as patients as they seek to sort out reality
from 'billing' data. We will have integrated computer-based
personal and clinician health records in the future and this makes
the challenge of addressing the remaining terminology and
classification issues for now and going forward.
2. You mentioned the need for ways to authenticate or
identify individual patients - what are the privacy aspects
associated with a unique personal identifiers, as was called
for in the original HIPAA legislation?
Response: The privacy aspects of authentication or
identification of individual patients fall into two categories based
upon what one consider 'privacy rights' to entail in a free society.
If 'privacy rights' are defined as a 'right to be left alone', they
imply something different than if 'privacy rights' are defined as the
'right to remain unknown'. Since I do not believe a modern
society can exist by operating with the second definition as the
dominant operating policy, I will respond to policy dimensions
relating to the first definition. Indeed, the testimony of one witness
at the hearing reflected that latter perspective.
The original HIPAA legislation called for unique personal
identifiers for health for a number of reasons. First, all developed
economies in the world have adopted this approach as the most
reliable and cost-effective manner of personal identification for
health purposes. Today, we are seeing rising interest and indeed
rapid movement to give citizens their personal health information.
It is crucial for both health care safety and personal privacy that
both doctors and patients exchange data solely to those to whom it
is intended and no one else. In all likelihood we will use an
algorithm in addition to a unique identifier. If one does not have
access to a person's social security number (SSN) for example, the
accuracy of the algorithm drops considerably. To assure the
greatest accuracy, a unique personal identifier is the most sensible
approach.
At the minimum we need national public policy that will assign
a unique health identifier with an opt-out arrangement for those
citizens who fall into the latter category mentioned above.
Suggestions have included the SSN plus a four digit PIN and a
range of other suggestions have been made. There is ample
testimony before the NCVHS on this topic. I see some value for
using the first five digits of the SSN plus a four digit PIN that the
individual selects.
3. We have heard complaints about the negative impact of the
HIPAA privacy rule on clinical research - how would
legitimate clinical research uses of information be better
facilitated?
This question has many potential responses. Unfortunately, the
potential for HIPAA to be revised so that it could better support
clinical research without legislation being passed or regulations
being developed that would in reality make clinical research even
more difficult to undertake is a compelling consideration. In light
of this, only one recommendation follows. As the nation moves
toward an approach to authenticate all individuals in order to
improve patient safety and protect the privacy of their data, the
citizen at the time of identifier selection could be given the option
of 'ticking a box' to allow him or her to be contacted by
researcher(s) having clinical research protocols approved by a
legitimate institutional review board to see if the individual had
any interest in participating in such a study or studies.
Those citizens who chose neither to have a unique identifier
nor participate in research would not be able to be notified but
certainly millions of citizens both could and would choose to
participate. This would be enormously helpful to the clinical
research community. Obviously, those who chose not to
collaborate would still gain the benefits from any findings coming
from those sharing their data. Of course, if sufficient numbers of
people opted out in a certain category of age or sex, no valid
research would be achievable since sample sizes might be too
small. This creates a problem known as 'free riders'. Too many
free riders and the train won't leave the station. If there is interest
in other ways to improve clinical research, I can respond further.
Don E. Detmer, MD, MA, President and CEO, American Medical
Informatics Association
SUBMISSION FOR THE RECORD BY THE BLUE CROSS AND BLUE
SHIELD ASSOCIATION
Introduction
The Blue Cross and Blue Shield Association (BCBSA)
appreciates the opportunity to provide testimony to the Committee
on H.R. 4157, the Health Information Technology Promotion Act
of 2005, and applauds the effort to facilitate and encourage the
widespread adoption of health information technology (health IT).
BCBSA is made up of 38 independent, locally operated Blue
Cross and Blue Shield companies that collectively provide
healthcare coverage for more than 93 million people - nearly one-
in-three Americans. Blue Cross and Blue Shield Plans across the
country are leaders in advancing health information technology,
giving providers and consumers tools and information to help them
make better health care decisions. Plans are sharing clinically
relevant claims information with physicians; giving consumers
access to their medical information through personal health records
and other internet-based tools; and helping providers adopt health
IT, including e-prescribing and electronic health records (EHRs).
BCBSA is committed to a health care system that can assure
greater patient safety, improved quality of care and increased
efficiency. We believe that achieving this goal requires nationwide
adoption of health IT based on interoperability standards that
support the exchange of information among providers, payers,
consumers and government. That is why we strongly support the
requirement in H.R. 4157 to establish interoperability standards
through a public-private collaborative process.
However, we are concerned that the provision calling for switching
from ICD-9 to ICD-10 billing codes by October 1, 2009 would
threaten the goal of widespread adoption of health IT. Switching
to ICD-10 by 2009 is unworkable because:
<bullet> ICD-10 is a massive undertaking, not only for payers and
hospitals but also for physicians;
<bullet> Industry is running at maximum capacity with HIPAA
mandates;
<bullet> Much preliminary work is needed to make the switch
feasible; and
<bullet> Medicare would be put at great risk.
Our testimony below will explain these factors, and offer as an
alternative three additional years to switch to ICD-10, with full
compliance no sooner than October 1, 2012.
In addition, we would like to draw the Committee's attention to
a specific issue concerning the provision creating new safe harbors
under the federal anti-fraud and anti-kickback laws: the prohibition
on taking into account the volume or value of referrals by entities
donating health IT to physician. As explained below, this
prohibition would have a chilling effect on donations of health IT
that are already taking place today.
Switching to ICD-10 by 2009 is Unworkable
In 2003, the Robert E. Nolan Company - a respected business
consulting firm - estimated that implementing ICD-10 would cost
providers and payers up to $14 billion. This cost is indicative of
the complexities involved in switching from ICD-9 to ICD-10.
Provider and Payer Systems will require a Massive Overhaul
ICD codes are ubiquitous in health care. Providers process and
store diagnosis and procedure codes in virtually every one of their
computer systems, many of which are linked to share information.
Payers use diagnosis and procedure codes not only to process
claims, but also to design benefit packages, construct fee
schedules, operate disease management and quality improvement
programs, make medical necessity determinations, and prevent
fraud and abuse.
The new ICD-10 coding systems are significantly more
complicated than ICD-9. ICD-9-CM (volumes 1 & 2) uses about
13,000 codes for diagnoses; ICD-10-CM uses 120,000 codes for
diagnoses. ICD-9-CM (volume 3) uses about 11,000 codes for
procedures; ICD-10-PCS uses 87,000 codes for procedures.
To handle these new ICD-10 codes, provider and payer
systems must be completely redesigned: field sizes will have to be
expanded, alphanumeric composition allowed, and code values and
their interpretation completely redefined. IT staff will have to
install new code sets, remap and testing every interface used with
vendor software (front-end and back-end) and modify all reports
used by providers and payers in clinical, financial, reimbursement
and quality analyses.
Such far-reaching changes demand adequate time to avoid
costly mistakes and disruptions in claims payments.
Physician Practices will Require a Massive Overhaul
If the advantages of the new coding system are to be realized,
physicians will need to become substantially more precise and
detailed in documenting patients' medical records. To make sure
they get the right information from patients to assure proper
coding, physicians will need to know ahead of time all of the
information that will be required to code according to the new
standard - an impossible task without new electronic decision
support systems that take physicians through the "decision tree"
for each possible diagnosis. Unfortunately, fewer than 15% of
physicians currently have electronic health records systems that
could be modified to provide such decision support. A report
published last year in the Annals of Internal Medicine projects on
the basis of current trends that in five years' time only 25% of
physicians in solo or small group practices will have electronic
health records.
Once they gather the needed information, physicians will need
to put additional time and effort into documenting patients'
medical records, and completing what is sure to become a greatly
expanded "superbill" to assure proper reimbursement. In turn, the
physician's coders will need to increase their medical knowledge,
and the medical staff will need to be aware of the challenges to the
physicians and be prepared for greater interaction between the
coding staff and the physicians.
Industry is Already at Maximum Capacity with HIPAA
Implementing ICD-10 by 2009 would cause system overload.
Payers and providers are currently working hard to implement
pending and planned HIPAA tasks. These need to be completed or
well underway before implementing ICD-10 because they require
the same staff resources. Providers, payers and vendors will all
have resources stretched thin over the next several years.
Currently the health care industry is still working to fully
implement all of the initial HIPAA transactions. For payers this
work includes trading partner testing and making improvements to
the level of response in both the claims status and eligibility
response transactions.
Another major task currently underway is implementation of
the National Provider Identifier (NPI). This project has proven to
be much more difficult than originally contemplated because of the
complex relationship between NPIs and legacy identifiers.
Crosswalks or maps between the two sets of identifiers need to be
developed, and in some extremely complex cases re-contracting
may be required. The compliance date for this implementation is
May 2007, and will most likely require continued use of support
staff for the remainder of that year.
Other HIPAA projects on the horizon include electronic claims
attachments, which will probably need to be implemented starting
in 2007, implementation of the 5010 version of the current HIPAA
transactions, and the National Payer Identifier (which has the
potential to become as complex as the National Provider
Identifier). Each of these projects individually will require
substantial human and capital resources. All of this work, coupled
with the scope and complexity of the move to ICD-10, would
severely overload system resources and expose the providers and
payers to unnecessary risk.
Much Preliminary Work Is Needed
Important steps must happen before the switch to ICD-10 can
begin.
First, industry must move to a new version of HIPAA
transactions (5010) because the current (4010) will not work with
ICD-10. This change alone is a significant upgrade that will
require the two years allowed under HIPAA to analyze, program,
test, and implement this more complex version. The
"implementation guide" that is part of the new 5010 version shows
that thousands of changes will need to be made, from
comparatively simple tasks like making a change to a single
document, to extremely complex tasks like adding the ICD-10
code list. Only after these changes are made should providers and
payers begin implementing ICD-10
H.R. 4157 seeks to hurry the process of implementing version
5010 by eliminating notice and comment rulemaking. This would
be a mistake. The notice and comment process is industry's
primary opportunity to raise business issues that have broad policy
implications. To take claims attachments as an example: the SDO
might focus on the business requirements around a specific
interaction between trading partners such as an unsolicited claim
attachment; but CMS would focus on the larger business/policy
issue of whether or not to allow claims attachments.
Only the agency's comment and review process gives industry
the opportunity to consider the proposed mandate from an
enterprise or industry-wide perspective. We believe that global
perspective review is essential for the industry and we strongly
believe that global review opportunity must be preserved under
any revised system for HIPAA changes.
Second, the government must release automated crosswalks
that map ICD-9 and ICD-10 - a complete set is not yet available -
and providers, payers, and vendors must analyze and test those
crosswalks to minimize problems. If the crosswalks do not work
properly, historical data will be lost, resulting in an inability to run
incentive ("pay-for-performance") programs and the risk of
increased fraud and improper payments.
Any change in the underlying code set for claims will undo
years of work on fraud detection and control based in ICD-9
coding. Payers have put logic into place within their systems that
enable them to see patterns of utilization (such as multiple surgical
procedures, assistant surgeon charges, unbundling, upcoding,
appropriateness of care, excluded procedures), draw comparisons
among providers, and detect claims that fall outside norms.
All of this logic will have to change - which involves the
manual process of rewriting all the validity edits - to detect claims
irregularities. Depending on the detail and accuracy of the
crosswalks, this could be a significant undertaking. Meanwhile,
even a small increase in fraud could pose significant risk in a $1.5
trillion health care system.
Medicare Would Be Put At Great Risk
In the largest contracting change since Medicare's inception,
CMS is transitioning more than 50 fiscal intermediary and carrier
contracts to 15 Part A/B Medicare Administrative Contractors
(MACs) by 2009. This will require multiple claims workloads to
move from multiple contractors to a single MAC with new
jurisdictional lines. At the same time, CMS will be consolidating
Medicare workloads into two data centers, which must be done
carefully to avoid service disruptions.
The MAC transition will be made in three cycles of
competitive bidding, scheduled for completion by summer, 2009.
This is a mammoth undertaking with multiple data systems being
transitioned to a single entity. The GAO has noted that this
massive consolidation in itself has the potential to cause major
service problems for Medicare, and the schedule allows little time
for CMS to make adjust for any problems.
Switching to ICD-10 by 2009 would further overwhelm
Medicare contractors' IT departments, leading to claims backlogs,
improper payments, increased opportunities for fraud, and provider
and beneficiary dissatisfaction.
BCBSA Recommendation
As switching to ICD-10 by 2009 is unworkable, BCBSA
recommends a minimum of three additional years, with
compliance no sooner than October 2012. An additional three
years would reduce the risk of HIPAA overload and Medicare
meltdown, and would provide time for the adoption of decision
support systems and significant training and education that
physicians and other health care professionals will need.
Pilot Testing
An additional three years would also provide time for pilot
testing, which BCBSA believes is critical for any major systems'
change. Adequate pilot testing is crucial to ensure the new system
works, providers are educated, and claims will be paid: A key
lesson from HIPAA is the importance of pilot testing to avoid
costly mistakes and assure smooth implementation. ICD-10 is
vastly different from the current billing system, with more than
200,000 codes (compared to 24,000 now). The World Health
Organization (WHO) also recommends this essential step: "Before
starting full-scale countrywide use of ICD-10, it is advisable to test
adapted data registration tools and procedures in a number of pilot
areas and hospitals. It will help early identification of outstanding
problems and fix these before the countrywide implementation
starts."
Once comprehensive, automated crosswalks are released, ICD-
10 should be pilot tested. Providers and payers would then be able
to adjust their systems, and develop a coordinated implementation
strategy based on the pilot results. CMS could then set a
compliance date that allows the industry to complete the needed
adjustments.
Safe Harbors and Limits on Volume
H.R. 4157 stipulates that in order for non-monetary
remuneration (in the form of health information technology and
related training services for a physician) to fall within the safe
harbor, the entity offering the remuneration must not take into
account the volume or value of referrals (or other business
generated) by the physician to the entity. The problem with this
provision is that it would have a chilling effect on donations that
are already taking place today by health plans.
For example, it is increasingly common for health plans to
promote electronic prescribing by donating e-prescribing hardware
and software to physicians. To optimize the allocation of scarce
resources, the donation programs commonly target physicians on
the basis of volume of prescriptions written or the value of the
drugs prescribed. By taking into account volume and value, health
plan donations have the most impact on improving physician
prescribing habits and improving services provided to the greatest
number of health plan members.
Unlike hospitals and group practices, health plans as private
payers actively seek to control the fraud and abuse activity the
legislation seeks to address-it is a business imperative. As
partners with the government on Medicare and Medicaid, health
plans are designed to, and have every financial incentive to control
utilization costs to compete effectively-the incentives of plans
and of the government are aligned by the contractual arrangements
to promote gains in efficiency and quality, and to control fraud and
abuse.
BCBSA Recommendation
BCBSA recommends that the legislation specifically allow
health plans to determine eligibility or the amount or nature of the
items and services in a manner that takes into account the volume
or value of referral or other business generated between the
physician and the health plan.
Conclusion
A minimum of three additional years is critical to switch to
ICD-10 - with full compliance by no sooner than 2012 - not only
to avoid costly missteps in transitioning from ICD-9 to ICD-10,
but also to avoid derailing important health IT initiatives to
improve safety, quality, and efficiency. Health IT innovations are
exploding as providers and payers devote significant resources to
advancing the national priority of widespread adoption of
interoperable electronic health records (EHRs) and personal health
records (PHRs). For example, many Blue Cross and Blue Shield
Plans are building payer-based EHRs and PHRs using claims data
and developing regional networks for exchanging administrative
and clinical information. Having to redirect resources for an
immediate switch to ICD-10 could hinder initiatives promising
direct consumer benefit.
SUBMISSION FOR THE RECORD BY DEBORAH C. PEEL, MD,
FOUNDER, PATIENT PRIVACY RIGHTS FOUNDATION
Chairman Deal and Members:
The Committee on Health deserves thanks for holding hearings
to examine legislative proposals to build a national health
Information technology network.
I appreciate the opportunity to provide written testimony on
this matter of critical importance, not only to the future of our
healthcare system but also to the future of our Democracy and our
cherished rights to personal liberty and freedom.
H.R. 4157, the "Health Information Technology and Promotion
Act of 2005" promotes the adoption of information technologies to
streamline and improve the healthcare system, but at the expense
of Americans' most cherished values: personal liberty and privacy.
What is Privacy?
What exactly does it mean to have the right to privacy? The
Original Privacy Rule states, "The right of privacy is: 'the claim of
individuals, groups, or institutions to determine for themselves
when, how, and to what extent information about them is
communicated'." 65 Fed. Reg. at 82,465
The two key reasons HR 4157 and the other HIT bills (with the
exception of HR 2234) will eliminate every American's right to
privacy are:
1) HR 4157 relies on the HIPAA Privacy Rule as a privacy
standard. But the Amended Privacy Rule deprives all
Americans of the right of consent, thereby depriving them
of the right to control access to their medical records.
[citation: "The consent provisions.are replaced with a
new provision.that provides regulatory permission for
covered entities to use and disclose protected health
information for treatment, payment, healthcare
operations." 67 Fed. Reg. at 53,211]
2) HR 4157 sets up a process to study and eliminate all
stronger state laws protecting medical privacy. Setting up a
process to eliminate more privacy-protective state laws in
the absence of a very high national standard set by
Congress is a mistake. States' rights to determine how best
to protect citizens must not be eliminated without a strong
national standard in place.
These two elements of HR 4157 will create a national
electronic health system with open access to the nation's medical
records by over 800,000 private individuals, corporations, and
government agencies; and eliminate states' rights to retain privacy
protections stronger than HIPAA.
Other aspects of the bill can be negotiated, but privacy rights
cannot. Privacy must be the lynchpin of any system for storing and
sharing the nation's medical records.
Consequences of Building a National Health IT System
Without Privacy
Without privacy, HR 4157 will have damaging effects that
reach far beyond the healthcare system by making electronic
medical records instantly accessible for business uses that have
nothing to do with healthcare. Broad dissemination of the nation's
medical records to hundreds of thousands of covered entities will
facilitate discrimination against every man, woman, and child. HR
4157 will enable electronic access to a mother lode of the most
commercially valuable databases on earth: the nation's medical
databases.
Armed with detailed medical records, private businesses and
government agencies will be tempted to discriminate against
people based on fears about their future health, rather give them
opportunities based on their qualifications and abilities. Will we
get jobs, promotions, or bank loans?
Our children's opportunities and livelihoods will be more
severely limited than ours, as opportunities will be denied to them
earlier in their lives. Will our children and grandchildren get into
colleges, get jobs, or be able to buy their first homes?
As the health care system increasingly becomes the province of
big business and government, threats to patient privacy will
increase exponentially. The immense commercial value of
identifiable medical records explains why corporations and the
government want unfettered access to everyone's medical records.
Privacy (the right to control personal health information) is an
important substantive limit on the power of the government and the
power of corporations; it limits what they can do.
HR 4157 without privacy is a prescription for disaster.
Introduction
My name is Deborah C. Peel, MD. I have been practicing
medicine for 32 years. My specialty is adult psychiatry and
Freudian psychoanalysis. My career as a mental health
professional put me at ground zero for privacy.
No one would tell me anything if their treatment could be used
to harm them. People paid me cash long before managed care or
computers were invented, in order to assure their privacy.
Mental health treatment requires the most stringent privacy
protections so people will trust mental health professionals with
their most painful and terrifying thoughts, feelings, and memories.
Patients need privacy and the trust it engenders to speak freely and
fully. Mental health professionals need privacy to offer effective
psychotherapy, just as surgeons need sterile fields to operate.
I've seen so many people be harmed over the past 32 years
when their medical or prescription records were disclosed without
their consent.
Without privacy, people will refuse to get treatment and the
help they need when they are sick. They will lie and omit data, and
refuse genetic and other tests and treatments that could stigmatize
them. People will risk worsening illness and even death, rather
than risk losing their jobs or reputations.
As a physician, mother, patient, and consumer, I could not
stand idly by and watch the destruction of our privacy rights.
No national medical privacy watchdog organization dedicated
to fighting to save our rights to privacy existed, so I started Patient
Privacy Rights Foundation about three years ago. Our mission is to
inform and empower Americans to save their human and civil
rights to medical privacy.
Consequences: What happens when patients can't control
access to their medical records
1) Diane O'Leary (permission was granted to tell her story).
Ms O'Leary is a journalist by profession, living in NY. She
developed a rare neurological condition. After the first
neurologist she sought treatment from did not help her and
the medications he prescribed made her worse, she stopped
going to him and sought care elsewhere. But the doctor she
fired sent her medical records with his opinions to the new
specialists she consulted, without her knowledge or
permission. He claimed the HIPAA Privacy Rule gave him
the right to disclose her medical records. The disclosures
effectively kept her from getting the correct diagnosis and
treatment for three years. She was partially disabled and
can no longer work as a journalist.
2) Patricia Galvin (permission was granted to tell her story).
Ms Galvin is a lawyer who was being seen in a sleep
disorders clinic at Stanford University. She saw a therapist
in the clinic who repeatedly assured her that the
handwritten records she kept of their therapy sessions
would not be entered into Ms Galvin's general medical
record. But they were. Once her therapy records were
scanned and placed in her general medical record, Ms
Galvin could not prevent the records from being repeatedly
disclosed by the hospital without her permission, because
HIPAA allows disclosures of medical records for all
routine uses. Her medical records were sent to her insurer
and employer, who fired her and because of some errors in
the records and she also lost her disability coverage for an
unrelated back injury.
3) A physician whistleblower wrote Patient Privacy Rights
about his concerns that the VA's electronic medical records
system allows anyone with access to the system to see any
patient's medical records without the patient's knowledge
or permission (permission was granted to share his story).
He gave 3 examples of very sensitive records that VA staff
could view:
<bullet> a man had a device inserted into his penis, the
nursing notes described the time, length, and size of
his erection
<bullet> a woman suffering from painful intercourse had
detailed chart notes about the depth and timing of
her partner's vaginal penetration to remedy her
symptoms
<bullet> an x-ray technician who took a shoulder x-ray of a
man had read his mental health notes and asked him
if he was still suicidal. The man went to the VA
psychiatrist and fired her and refused further
treatment
4) Parents of children diagnosed with autism expressed
outrage that the CDC was obtaining their children's
medical records and school records without notice or
consent, a use the HIPAA Privacy Rule makes fully legal
for covered entities. [National Autism Association Press
Release - 3/1/2006 - CDC Obtains Children's Confidential
Records Without Parental Consent For Autism Study]
5) A college student was expelled from GWU because his
medical records concerning his depression were disclosed
to the college without his consent. [GWU Suit Prompts
Questions Of Student Liability; School Barred Depressed
Student, Washington Post - 3/10/2002]
6) Insurers now ask doctors to disclose patients' complete
medical records, using HIPAA to justify access without
patient consent:
Email from Robert Charles Powell, MD, PhD on 3/11/06 to
a psychiatric listserv (permission was granted to share the
email for testimony): "Now that HIPAA is attempting to be
lord of the land, there are more and more requests for "all
medical records and notes" -- which is an illegal request of
a psychiatrist under the Illinois Confidentiality Act. I don't
know how this ultimately will shake out, but it is worth
noting that the Ohio Supreme Court recently upheld that
state's confidentiality act -- almost as good as Illinois' --
noting (a) that the state act offered the patient more
protection than HIPAA and therefore should be followed
plus (b) that the physician had a responsibility to protect the
patient's privacy regardless of whatever piece of paper the
patient might have signed [the Illinois act specifies likewise
that a patient can NOT sign away protected confidentiality
rights. [Grove v. Northeast Ohio Nephrology Associates
(Ohio Ct. App., Nos. 22594, 22585, 12/26/2005)]
7) Wal-Mart:
Quotes from the Memorandum to Wal-Mart's Board of
Directors:
<bullet> "Redesign benefits and other aspects of the
Associate experience, such as job design, to attract a
healthier, more productive workforce."
<bullet> "The team is also considering additional initiatives
to support this objective, including: all jobs to
include some physical activity (e.g., all cashiers do
some cart gathering)."
See New York Times story October 26, 2005: Wal-Mart
Memo Suggests Ways to Cut Employee Benefit Costs, By
Steven Greenhouse and Michael Barbaro.
[Supplemental Benefits Documentation, Board of Directors
Retreat FY06, Wal-Mart Stores, Inc., Reviewing and
Revising Wal-Mart's Benefits Strategy, Memorandum to
the Board of Directors,
http://www.patientprivacyrights.org/site/DocServer/WalMa
rt_memo.pdf?docID=501]
8) FDIC Notice on Medical Privacy. This example is included
to show how access to medical records is widespread, far
beyond the direct uses in the healthcare system. Enough
medical records were in the hands of banks and financial
institutions for the FDIC to issue a formal memo on April
28, 2004. Furthermore, the Gramm-Leach-Bliley Financial
Services Act permits banks and financial institutions to
share medical and financial records with all their affiliates
and non-affiliates without consumer consent.
The FDIC acknowledges that banks and financial
institutions have medical records, "section 411 prohibits
creditors from obtaining or using medical information to
make credit determinations. Except as permitted by the
regulators or the FACT Act itself, section 411 treats
medical information as a credit report when a creditor
shares it with an affiliate." Further, section 411 states that
"a creditor may not obtain or use a consumer's medical
information, as defined in the Act, in connection with a
determination of a consumer's eligibility, or continued
eligibility, for credit...section 411 states that when
affiliates share certain medical information, that
information will be considered a consumer report under the
FCRA."
9) Patients' medical records can be sent around the world
without their knowledge for transcribing, because under
HIPAA patients have no right to consent to or even be
notified of this "routine" practice.
See San Francisco Chronicle story by David Lazarus: A
tough lesson on medical privacy, Pakistani transcriber
threatens UCSF over back pay Wednesday, October 22,
2003 URL:
sfgate.com/article.cgi?file=/c/a/2003/10/22/MNGCO2FN8
G.DTL
10) "Placentas taken, but moms were not told." Susan
Goldman of the Oregonian reported on Sunday February
12, 2006, that "as many as 700 afterbirths, many involved
in difficult deliveries, made their way to a Portland registry,
records show." Not getting consent to analyze women's
body parts following births of children with injuries or
defects is a severe violation of their privacy.
[http://www.oregonlive.com/search/index.ssf?/base/news/1
139707514288820.xml?oregonian?lctop&coll=7]
11) Patients can no longer control who can access their
records, so as our medical records are disclosed over and
over to people we do not about, our records will be stored
in many more locations we have no knowledge of,
exposing us to high risk of identity theft because electronic
systems are NOT secure.
See: TechWeb News March 9, 2006, by Gregg Keizer: PIN
Scandal 'Worst Hack Ever'; Citibank Only The Start "The
scam has hit national banks like Bank of America, Wells
Fargo, and Washington Mutual, as well as smaller banks,
all of which have re-issued debit cards in recent weeks, says
a Gartner research vice president."
http://www.informationweek.com/story/showArticle.jhtml?
articleID=181502474 ]
12) There is no meaningful recourse or right of action under
HIPAA if your privacy is violated. You can only complain
to HHS. The woman caught in an FBI sting operation is
only the second conviction for a privacy violation since
HIPAA took effect. The first was a conviction for identity
theft that was later overturned. The second story from
TMCNews reported that of the 17,000 complaints of
privacy violations made to the government, only one
person was prosecuted. 70% were dismissed because they
were legally permitted disclosures. Because HIPAA grants
legal access to over 800,000 individuals, corporations, and
government agencies, patients have no right or opportunity
to stop access by any of them.
See Laredo Morning News - 3/7/2006, Alamo Woman
Guilty of Selling Medical Information at:
http://www.patientprivacyrights.org/site/News2?page=New
sArticle&id=5807&news_iv_ctrl=-1
See also TMCNet News, February 24, 2006 at
http://www.tmcnet.com/usubmit/2006/02/24/1404832.htm
Don't Confuse Privacy and Security
It is important not to confuse the privacy with security.
Security can help protect medical records from illegal users like
hackers, but it cannot restore or substitute for the right to control
who can see and use your medical records. The terms are often
used interchangeably, confusing their different effects on access to
medical records.
Privacy means that patients control who can see and use their
electronic medical records, which means they can exclude any
individual or corporation from having access to their medical
information.
Security measures such as encryption, firewalls, passwords,
levels of access, and other physical and technical measures can
help protect medical records from illegal access by hackers and
identity thieves. But security measures do nothing to stop the over
800,000 covered entities that currently have legal access to medical
records from using them. Strong security measures are not a
substitute for privacy.
Need for a system of trusted couriers and trusted custodians
The health IT system should be designed and engineered to be
a system of trusted couriers and custodians. It should be structured
to permit access to medical records only with patient permission
(emergencies could be specifically excluded). That is how FedEx
works. We trust FedEx to deliver our packet of information to only
the person we specify.
Instead, in the electronic world, any data broker, data
warehouse, and any healthcare business that handles, stores or
processes medical records simply appropriates them for corporate
use. If FedEx operated like that-where anyone who happened to
handle the packet of information could tear it open, make copies,
and use and sell the data, it would not have any customers.
Surely our sensitive health information should not be
accessible to all covered entities to copy and steal just because they
happen to be in a business that is connected to the healthcare
system.
Conclusions
<bullet> Congress should intervene when private actions have such
vast public consequences. The failure of Congress to
intervene and specify the rights patients should have---the
right to control access to their medical records----will
undermine significant Constitutional values and impair
important individual privacy rights.
<bullet> Congress should set privacy standards, not delegate the task
to unelected officials with no Congressional or public input
or oversight.
<bullet> With ironclad privacy standards and patient privacy rights
in place, patients will be willing to trust and use the
national electronic health system and the incredible and
transforming benefits that IT can bring to the healthcare
system will be fully realized.
Solutions to Insure the Privacy Of Medical Records In
Electronic Networks and Systems
<bullet> Patients must control who has access to their personal
health information over any electronic health networks
<bullet> Allow patients to opt-in and opt-out of health information
networks
<bullet> Allow patients to segregate their most sensitive medical
records
<bullet> Require audit trails of all disclosures
<bullet> Require patient notification of all suspected or actual
privacy and security breaches
<bullet> Deny employer access to employee medical records
<bullet> Allow access to de-identified medical records for research,
public health, and other legitimate uses
<bullet> Preserve stronger state laws protecting medical privacy
<bullet> Enact criminal penalties for use or possession of medical
records without permission
Deborah C. Peel, MD
Chairman, Patient Privacy Rights Foundation
Austin, Texas
512-732-0033
www.patientprivacyrights.org
SUBMISSION FOR THE RECORD BY ADVANCED MEDICAL
TECHNOLOGY ASSOCIATION
AdvaMed and its member companies thank the Committee for
holding this hearing on health information technology (HIT). HIT
promises to revolutionize the health care delivery system and
dramatically effect 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 records (EHR) hold
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. Examples of these innovations
include:
<bullet> Computer-assisted physician order entry devices to increase
patient safety and health system efficiency;
<bullet> Hand-held Personal Digital Assistants (PDAs) to allow
doctors making rounds to immediately access each
patient's complete medical record;
<bullet> Electronic lab results to allow test results to be stored and
sent to physicians electronically;
<bullet> Electronic prescription orders to allow physicians to send
prescriptions directly to pharmacists to ensure accurate
order submissions and allow pharmacists to conduct drug
interaction reviews;
<bullet> Infusion pumps to prevent drug overdoses and enable
hospitals to re-engineer their systems to avoid medical
errors;
<bullet> Image-guided or computer-assisted surgery (CAS) to allow
surgeons to more precisely position their instruments for
less invasive operations and to document procedures;
<bullet> Remote monitoring, telemedicine, and other devices with
computerized components, such as implantable
cardioverter-defibrillators (ICDs), to allow heart patients to
send vital data to their physicians via a secure Internet
connection, often reducing trips to the doctor; and
<bullet> Picture archiving and communication (PAC) systems to
store and permit the transmittal of radiological images,
such as X-rays.
Improving Patient Safety and Quality of Care
The Institute of Medicine (IOM) estimates that 44,000 to
98,000 deaths each year result from preventable medical errors in
hospitals. Studies have shown that there are errors in 24.9 percent
of hospital patient records. An estimate by the Food and Drug
Administration (FDA), found that as many as 372,000 preventable
adverse drug events occur each year. These errors result from
administering incorrect dosages, errors in filling prescriptions, and
adverse drug interactions.
Technologies that support IV drug administration can help
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.
For example, a report by the National Academies in 2003
recommended that health care organizations adopt information
technology systems capable of collecting and sharing health
information about patients and their care. Computerized physician
order entry (CPOE) devices can link the health care worker with
the facility's computer system to avert medical errors. These
computerized systems can automatically alert the practitioner to
past drug allergies, potential drug interactions with a patient's
current medications, and incorrect dosing.
The Children's Hospital of Pittsburgh (Children's) launched its
CPOE program, Children's Net, in October 2002. It helps this
pediatric hospital with its special challenge with medication errors
due to their patients' weights, as well as meeting the regulatory
requirements for compliance to reach certain care benchmarks.
Children's CPOE system allows doctors to show lab or diagnostic
test results to parents at the child's bedside, chart functions, and
graph progress. Its warning system provides an alert if a dose
seems out of line, based on predetermined standards, and the
CPOE has reduced medication errors by 75% and virtually
eliminated weight related adverse drug events.
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. 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.
A 2004 study in Critical Care Medicine found that using
remote Intensivists (intensive care specialists) to monitor patients
electronically from a remote location as part of an ICU
telemedicine program not only improves clinical outcomes, but
also enhances hospital financial revenues. 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.
In addition, 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. Combining this
kind of technology with a digital patient information system
allowed several Boston-area hospitals to save an estimated $1
million annually by, in part, reducing the time spent searching for
files and manually admitting patients.
Policies to Foster HIT Adoption
To assure appropriate access to continued innovations in health
information technologies for patients, AdvaMed believes that
policies should evolve with the technologies. We support
developing incentives that will overcome the barriers to timely
adoption HIT. Providers, payers, and medical technology
manufacturers should all be involved in developing the ways to
address these issues and enable interoperable and efficient use of
these technologies to improve the quality of care, patient safety,
and health outcomes overall. Specifically, we support the
following provisions for inclusion in HIT legislation:
Regulatory Reforms: The implementation of the International
Classification of Diseases, version 10 (ICD-10) will have an
impact on the timely adoption of life-saving and life-enhancing
medical technology. ICD-10 is the next generation of the coding
system that will modernize and expand CMS's capacity to keep
pace with changes in medical practice and technology. Its unique
structure will incorporate all new procedures as unique codes that
would explicitly identify the technology used to perform the
procedure. The transition from the currently used ICD-9 system to
the internationally used ICD-10 system is time-sensitive as the
number of available codes under ICD-9 is rapidly dwindling. The
availability of new codes has been raised in public meetings as a
potential basis for CMS to deny applications for new codes, and
this reluctance to issue new codes will hinder appropriate tracking,
identification, and analysis of new medical services and
technologies.
In 2003, after several years of hearings, the National
Committee of Vital and Health Statistics (NCVHS) raised concerns
about the viability of the ICD-9-CM as it was "increasingly unable
to address the needs for accurate data for health care billing,
quality assurance, public health reporting, and health services
research." NCVHS also noted in 2003 that these concerns have
been "well documented" in the testimony and letters provided to
the NCVHS over the past several years. HHS has yet to begin this
important transition.
Without adoption of ICD-10, it will be difficult to track new
and emerging public health threats, such as avian flu. ICD-10 is
also the key to collecting the information needed to implement a
proper pay-for-performance system for providers and carry out
Medicare's road map for the future, which depends on accurate
data on the effectiveness of treatments. ICD-10 will also enable
better patient care through better understanding of the value of new
procedures, improved disease management, better understanding of
patients' health care outcomes, and an improved ability to study
patient outcomes.
While concerns have been raised about the cost of
implementing ICD-10, we note that the 2004 RAND study found
that the financial benefits of ICD-10 significantly outweigh the
costs, and the study did not even account for the significant costs
that will accrue for not adopting the system in a timely fashion.
Additionally, several cost estimates that have been circulated to
attempt to dissuade support for ICD-10 are flawed by failing to net
out costs of the normal upgrading of all payment systems that
would occur independent of ICD-10.
We believe that the long term and ongoing benefits of
improved measurements of efficiency, complications, resource use,
and improved accuracy of payments would more than offset the
one-time or short-term costs of the conversion to ICD-10.
Some existing laws and regulations present barriers to the
adoption of HIT. Currently, 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. While 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, and a
much broader, clearer exception is needed.
A parallel safe harbor to the federal health care program 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. While the proposed EHR and e-prescribing exceptions
to both the anti-kickback and Stark laws are an important step in
the right direction, they do not go far enough to protect the
adoption of HIT.
In addition, AdvaMed is concerned with the impact of an
increasing array of state and local laws on interoperable health
systems that resulted from the enactment of the Health Insurance
Portability and Accountability Act (HIPAA). Our member
companies operate in a multi-state, multi-jurisdictional
environment, and the overlapping multiplicity of these laws makes
it costly and complex to develop compliant processes and systems
for protecting confidentiality and securing information. AdvaMed
believes that uniform federal standards for privacy, security, and
technical regulations are critical to achieving a nationwide
electronic health information exchange, and the lack of uniform
federal standards should not delay this effort.
Standards: AdvaMed endorses the FDA's current software
regulation policies, 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.
Since the EHR is not a medical device and simply stores data for
retrieval by a health care professional (EHR algorithms do not
make diagnostic or treatment decisions), FDA regulation is not
warranted for EHRs under the FDA's own standards.
Financial Incentives: Many providers lack the financial ability
to make the upfront investment needed to install and operate an
advanced health information technology system. 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 EHRs. "Pay-for-performance" proposals should
include incentives for adoption and use of HIT.
Direct Reimbursement: Reimbursement systems should
reward new modes of providing services that result in quality
improvement or cost reduction for patient care. Remote patient
management of chronic diseases is one example of a quality-
enhancing technology for which health care practitioners are not
directly reimbursed under Medicare. Many Medicare beneficiaries
living in rural or underserved urban areas are unable to make
regular visits to their physicians. As a result, patients with
treatable chronic diseases such as diabetes, cardiac arrhythmia, and
heart failure do not receive the care they require to manage their
conditions.
Remote patient management would ensure that Medicare
beneficiaries would have access to real-time disease management
services for covered chronic conditions. Direct reimbursement to
health care practitioners for utilization of remote patient
monitoring devices would facilitate use of this technology and lead
to improved patient outcomes. AdvaMed also supports providing
physicians with a quality-of-care incentive bonus for meeting
specific standards of care for covered chronic diseases.
Quality and Safety Studies: The e-health 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.
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. We urge expeditious implementation by CMS of the ICD-
10 system and federal preemption of HIPAA rules to ensure that
data may be stored, updated, and transmitted electronically
anywhere in the United States. Legislation is needed to address the
regulatory barriers to HIT adoption, like the federal health care
program anti-kickback statute and the "Stark" physician self-
referral law. As clinical and interoperability standards are
developed by Congress and the private sector, it is paramount that
the standards are designed to evolve with advancements in
technologies and that financial incentives are provided to allow
providers to purchase and maintain the HIT.
42 USC 1395nn(h)(1)(C)
See as just one example Caroline Broder, "Survey: Consumers Concerned About Control, Access
to Medical Info," Healthcare IT-News, January 18, 2006.
For example, polling of Americans shows 63% to 75% would not participate in, or are concerned
about loss of medical privacy in an electronic system. See work of Professor Alan Westin, February
23, 2005; California Health Care Foundation, January 2000; and 65 Federal Register 82,466.
Testimony of Joy Pitts, Assistant Research Professor, Georgetown University, July 27, 2005
before the Ways and Means Health Subcommittee, citing the Rep. Velasquez and former President
Clinton examples, page 2. See also Robert Dallek's An Unfinished Life (p. 261ff) for a description
of LBJ's efforts to obtain medical information on JFK and how Kennedy avoided certain important
medical tests so as not to have a medical record.
As HHS said in the Federal Register, "there is no such thing as a totally secure [electronic
information] system that carries no risk." 68 Federal Register at 8,346. For very recent examples of
hacking and intentional misuse of data, see Information Week, March 9, 2006, "PIN Scandal 'Worst
Hack Ever'; Citibank Only the Start," and The Washington Post, March 14, 2006, Business Section,
page 2, "Datran Media Settles Probe."
Joy Pitts, op. cit., p. 4.
See letter from National organizations representing consumers, family members, advocates,
professionals and providers, c/o Peter Newbould, American Psychological Association Practice
Organization, 750 First Street, NE, Washington, DC 20002.
Reportedly millions of Americans already forgo sensitive treatments because of privacy concerns.
65 Federal Register 82,778.
Eleven footnote references to sources for statements omitted from quote. For a less scholarly
description, see "The Drug Pushers, by Carl Elliott, MD, Ph'D in The Atlantic Monthly, April,
2006: "After awhile even the most steel-willed doctors may look forward to visits by a [drug] rep, if
only in the self-interested way that they look forward to the UPS truck pulling up in their driveway.
A rep at the door means a delivery has arrived: take-out for the staff, trinkets for the kids, and, most
indispensably, drug samples on the house. Although samples are the single largest marketing
expense for the drug industry, they pay handsome dividends: doctors who accept samples of a drug
are far more likely to prescribe that drug later on. Such gifts do not come with an explicit quid pro
quo, of course. Whatever obligation doctors feel to write scripts for a rep's products usually comes
from the general sense of reciprocity implied by the ritual of gift-giving."
This is the comment on anti-kickback proposed rule. Basically identical comments were filed on
CMS-1303-P, relating to the physician referral proposed rule.
1 Terri Simmonds. "Using The Trigger Tool to Detect Potential Harm in Medication Management."
Infusion Safety: Addressing Harm with High-Risk Drug Administration. The ALARISr Center for
Medication Safety and Clinical Improvement. San Diego, California. 2004, pp 10.
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.
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.
Networking Health: Prescriptions for the Internet, Institute of Medicine, National Academy of
Sciences, p. 81, 2000.