[Senate Hearing 114-578]
[From the U.S. Government Publishing Office]
S. Hrg. 114-578
AMERICA'S HEALTH IT TRANSFORMATION: TRANSLATING THE PROMISE OF
ELECTRONIC HEALTH RECORDS INTO BETTER CARE
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING AMERICA'S HEALTH INFORMATION TECHNOLOGY (IT) TRANSFORMATION,
FOCUSING ON TRANSLATING THE PROMISE OF ELECTRONIC HEALTH RECORDS INTO
BETTER CARE
__________
MARCH 17, 2015
__________
Printed for the use of the Committee on Health, Education, Labor, and Pensions
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia BERNARD SANDERS (I), Vermont
RAND PAUL, Kentucky ROBERT P. CASEY, JR., Pennsylvania
SUSAN COLLINS, Maine AL FRANKEN, Minnesota
LISA MURKOWSKI, Alaska MICHAEL F. BENNET, Colorado
MARK KIRK, Illinois SHELDON WHITEHOUSE, Rhode Island
TIM SCOTT, South Carolina TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
BILL CASSIDY, M.D., Louisiana
David P. Cleary, Staff Director
Lindsey Ward Seidman Deputy Staff Director
Evan Schatz, Democrat Staff Director
John Righter, Democrat Deputy Staff Director
(ii)
C O N T E N T S
__________
STATEMENTS
THURSDAY, MARCH 17, 2015
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 1
Murray, Hon. Patty, a U.S. Senator from the State of Washington,
opening statement.............................................. 3
Baldwin, Hon. Tammy, a U.S. Senator from the State of Wisconsin.. 5
Cassidy, Hon. Bill, M.D., a U.S. Senator from the State of
Louisiana...................................................... 6
Warren, Hon. Elizabeth, a U.S. Senator from the State of
Massachusetts.................................................. 36
Isakson, Hon. Johnny, a U.S. Senator from the State of Georgia... 42
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
Island......................................................... 44
Franken, Hon. Al, a U.S. Senator from the State of Minnesota..... 49
Witnesses
Adler-Milstein, Julia, Ph.D., Assistant Professor of Information,
School of Information, Assistant Professor of Health Management
and Policy, School of Public Health, University of Michigan,
Ann Arbor, MI.................................................. 6
Prepared statement........................................... 8
Wergin, Robert L., M.D., FAAFP, President, American Academy of
Family Physicians (AAFP), Milford, NE.......................... 11
Prepared statement........................................... 12
DeVault, Peter, Director of Interoperability, Epic Systems
Corporation, Madison, WI....................................... 18
Prepared statement........................................... 20
Kennedy, Angela, Ed.D., M.B.A., R.H.I.A, Head of Department/
Professor, Department of Health Informatics and Information
Management, College of Applied and Natural Sciences, Louisiana
Tech University, Ruston, LA.................................... 28
Prepared statement........................................... 30
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Peter DeVault, Letter........................................ 52
Response by Julia Adler-Milstein, Ph.D. to questions of:
Senator Alexander........................................ 53
Senator Burr............................................. 58
Senator Warren........................................... 58
Response by Robert L. Wergin, M.D., FAAFP to questions of:
Senator Alexander........................................ 59
Senator Burr............................................. 65
Senator Cassidy.......................................... 66
Senator Murray........................................... 66
Senator Warren........................................... 67
Response by Peter DeVault to questions of:
Senator Alexander........................................ 68
Senator Burr............................................. 73
Senator Roberts.......................................... 74
Senator Cassidy.......................................... 76
Senator Murray........................................... 76
Senator Warren........................................... 77
(iii)
AMERICA'S HEALTH IT TRANSFORMATION: TRANSLATING THE PROMISE OF
ELECTRONIC HEALTH RECORDS INTO BETTER CARE
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TUESDAY, MARCH 17, 2015
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10 a.m. in room
SD-430, Dirksen Senate Office Building, Hon. Lamar Alexander,
chairman of the committee, presiding.
Present: Senators Alexander, Murray, Burr, Isakson,
Cassidy, Franken, Bennet, Whitehouse, Baldwin, Murphy, and
Warren.
Opening Statement of Senator Alexander
The Chairman. The Senate Committee on Health, Education,
Labor, and Pensions will please come to order.
This morning, we're holding a hearing on America's Health
IT Transformation: Translating the Promise of Electronic Health
Records into Better Care. Senator Murray and I will each have
an opening statement. Then we'll introduce our panel of
witnesses. After our witnesses, Senators will have 5 minutes of
questions.
We have two votes at 11. That should give us plenty of time
to get through our opening statements and hear from the
witnesses and some questions. We'll see where we are at about
11:20 in the first vote, and if we're through, we'll conclude
the hearing. If there are Senators who still want to stay and
ask further questions, we'll work it out where some of us go
vote and some of us come back. We'll work it out so Senators
will all have a chance to participate.
Health IT means many different things, everything from
wearable gadgets that monitor your heart rate to sophisticated
applications that help physicians track treatments. But today,
we're focused on electronic health records used by hospitals
and doctors in their practices.
Our committee hasn't had a hearing on Health IT since
January 2009, a month before the $35 billion HITECH Act became
a part of the stimulus package. The HITECH Act was warmly
greeted. It was meant to unleash a new IT era where our health
information would move seamlessly among doctors and hospitals
to help achieve better, more coordinated care.
After the bill's passage, doctors and hospitals rushed to
join the so-called Meaningful Use Program. There were $35
billion in incentives to encourage that. Adoption rates for
electronic health records grew dramatically. According to the
most recent data, 48 percent of physicians and 59 percent of
hospitals have at least a basic electronic health records
system, compared to 26 percent and 47 percent in 2009.
The hope was that the program would improve care,
coordination, and reduce costs. The evidence suggests these
goals have not been reached. Half of physicians have not met
the requirements of the program and are now facing penalties.
A Medical Economics survey last year found nearly 70
percent of physicians say their electronic health records
systems have not been worth it. One physician wrote:
``We used to see 32 patients a day with one tech, and
now we struggle to see 24 patients a day with four
techs. And we provide worse care.''
Doctors and hospitals have had so much difficulty meeting
the Meaningful Use requirements that CMS has had to delay or
change requirements three times. We're here today to find out
how this happened and what we should do about it.
Transitioning to electronic health records requires a real
transformation in how physicians practice. The administration
seems to have complicated the process by rushing ahead with
penalties for those who don't adopt electronic health records
systems. To be specific, doctors and hospitals that don't adopt
these records systems lose 1 percent of their Medicare payments
in 2015. That penalty grows to 5 percent by 2019.
To receive incentive payments, physicians and hospitals had
to buy systems certified to Federal Government specifications.
Providers assumed the certified systems would be of high
quality and meet program requirements. Instead, many providers
discovered that certified systems have to undergo costly
upgrades on short timelines to meet new requirements. Providers
have to pay for these upgrades or pay even more to switch
vendors.
Hospitals have spent hundreds of millions of dollars to
implement and continuously upgrade their systems. For example,
Wellmont Health System, which operates hospitals in Tennessee,
went through a complete IT conversion from one system to a new
one that guaranteed they'd be able to meet the requirements of
the Meaningful Use Program.
Wellmont spent $125 million and expects to receive $38
million in Meaningful Use dollars. Wellmont is also seeing an
approximately $10 million increase in annual IT costs, but
hasn't been able to calculate potential savings.
Many providers are struggling with interoperability.
Here's another example: Children's National Medical Center
in Washington spent $400 million on its health IT over the last
4 years to make a web of 138 different electronic health
records systems talk to each other and work together. That
medical center received $28 million in incentive payments.
The Eye Centers of Tennessee, with five locations, spent
$731,000 trying to comply with all the programs. Because they
were not able to meet one measure, they expect a $100,000
penalty.
This should have been a really good idea. For some, it has
been. Vanderbilt, for example, had an award-winning program
that includes patients' genetic information in their medical
records. That system prevented a patient in her eighties from
receiving a blood thinner that would have metabolized poorly
because of her genetic variation.
Instead of the government trying to make everybody do this
by taking away Medicare payments, a better route might have
been to find ways to enable and encourage their adoption.
Instead, the Administration seems to have rushed the process
with its penalties and at the same time made the Federal
Government the arbiter of IT quality.
It reminds me of a lesson I learned a long time ago. In
1980, when I was Governor, I flew out to Palo Alto to meet
Steve Jobs. I had the idea of having every eighth grader in
Tennessee computer literate.
We bought Macs, which then were about 4 tall, and we did
that for every middle school in the State. We had a mandate
that every child will become computer literate. I forgot one
thing: teacher training. It sounded like a good idea to make
everyone use computers, but I should have spent more time
finding ways to enable them to use computers.
Enabling instead of mandates--that appears to be a good
lesson for Washington policymakers who have rushed ahead with
penalties in this program that has now created so many unhappy
physicians and hospitals. I'm interested in learning today how
we can become enablers rather than mandaters.
Senator Murray.
Opening Statement of Senator Murray
Senator Murray. Thank you very much, Mr. Chairman.
Thank you to all of our witnesses for being here today.
When it comes to our healthcare system, I'm really focused
on making sure that we expand coverage, make coverage more
affordable, and, critically, ensuring we continue to improve
the quality of care that patients receive. Today's hearing
really is a great opportunity to focus, in particular, on that
third goal, improving quality, because we all know having more
and better information about a patient's healthcare can make
all the difference.
We have come a long way in this effort. Our country has
made significant gains in terms of adopting electronic health
records. In 2001, only 18 percent of physicians used electronic
health records, and today, 78 percent do. That is a real
transformation, and I'm proud that the HITECH Act we passed in
2009 was a big part of that.
I truly appreciate the work that's been done by so many
doctors and hospitals to help bring our healthcare system into
the 21st century and improve the quality and value of care for
families across the country. This progress does mean that
doctors can identify health problems sooner and help patients
get preventive care that will keep them healthy, and it means
patients can know more about their own health and be better
equipped to make decisions about the care that they need.
It also means patients are safer, since electronic health
records can alert providers to errors that hurt patients. I
look forward to hearing from Dr. Adler-Milstein and Dr. Wergin
about the important role health information plays in providing
high-quality, patient-centered care.
I'm very proud that in my home State of Washington,
patients are benefiting from better access to health
information. For example, a patient at Group Health Cooperative
in Seattle was able to switch her treatment and avoid serious
health risks, thanks to electronic medical records that showed
that a dangerous interaction between two of her medications was
the problem.
That's just one story of many across the country that show
how critical better health information is for patients. There
is, of course, a lot more that should be done to build on the
progress we've made so far.
Many physicians across the country are facing, as the
Chairman mentioned, a Medicare payment reduction this year
because they're struggling to meet the requirements for the use
of these electronic health records. I know that there's a lot
of frustration about that. I think we need to do more to both
set high standards and ensure providers have the support and
flexibility they need to reach them.
There are also important issues around interoperability
that I look forward to hearing about from our witnesses today.
It is critical that as electronic health records become more
and more integral to our healthcare system, information can be
securely and efficiently shared between doctors and across
systems developed by different vendors. This is something that
Mr. DeVault is deeply involved in, and I look forward to
hearing his thoughts on best practices to increase
interoperability.
As we do more to make sure electronic health information
can be shared between providers, I think there is much more we
can do to help patients stay informed about and involved in
their own care. In addition to our extensive work on health
information technology, I know Dr. Kennedy can speak personally
to how important it is that patients have access to their
medical records.
Thank you for coming today, Dr. Kennedy, and sharing your
daughter's story.
Of course, a critical part of making sure our country can
fully benefit from health IT is security. Patients and
providers need to know that their information is safe and
secure, and I'm glad to be working with Chairman Alexander to
ensure that that is a top priority.
Finally, I want to note that progress on health IT is
especially needed when it comes to the care of our service
members and our veterans. Those who bravely serve our country
deserve the absolute best care we have to offer, and that does
include a state-of-the-art interoperable electronic records
system. The VA and DoD missed an opportunity to develop that
infrastructure, and I really hope that both departments will
continue to work toward a better, modernized electronic health
records system for our service members and our veterans.
Again, I want to thank our witnesses for being here today.
As we continue working to strengthen our healthcare systems for
patients and families, expanding and improving our Nation's
health IT infrastructure cannot be more important. I truly
appreciate everyone's efforts today, and I look forward to
working with you in the coming weeks and months.
Thank you very much, Mr. Chairman.
The Chairman. Thank you, Senator Murray.
This is another bipartisan hearing, which means that
Senator Murray and I worked together to invite the witnesses.
Our purpose is to learn what's going on and figure out what we
need to do. We want to go straight down the middle and make
this work and create an environment in which it can work, if we
can.
I'm pleased to welcome the four witnesses. I want to thank
you for being flexible. We got snowed out the last time we
tried to have a hearing on this, and I know that was
inconvenient for you, and we thank you for rescheduling and
coming today. I want to introduce two witnesses, and then I'll
turn to Senators to introduce two others.
Our first witness is Dr. Julia Adler-Milstein from the
University of Michigan, Assistant Professor at the School of
Information with a joint appointment in the School of Public
Health. Her research focuses on policy and management issues
related to the use of IT in healthcare delivery. She has
expertise in health information exchange. She has conducted
four national surveys of health information organizations. She
also studies the productivity and efficiency of electronic
health records.
Our second witness is Dr. Robert L. Wergin from Nebraska.
Dr. Wergin is president of the American Academy of Family
Physicians where he advocates on behalf of family physicians
and patients nationwide. Dr. Wergin is a practicing physician
in the town where he was born and raised, Milford, NE. He
practices the full spectrum of family medicine, from obstetrics
to geriatrics, at the Milford Family Practice Center and is
medical director of Crestview Care Center.
Senator Baldwin, I believe you have a witness.
Statement of Senator Baldwin
Senator Baldwin. Thank you, Mr. Chairman and Ranking
Member. I am honored to introduce today Mr. Peter DeVault. He
is the director of Interoperability at Epic Systems in Verona--
Verona, WI, I might add. He joins us armed with a significant
amount of industry expertise and experience in electronic
health records.
Not only does Peter sit on the Health IT Policy Committee's
Information Exchange work group, which makes recommendations to
the national coordinator for health IT, but he also has held
leadership positions in several interoperability bodies,
including the Certification Commission for the Health
Information Technology Interoperability work group, HL7's EHR
Technical Committee, and the Electronic Health Record
Association, just to name a few.
He also works with Healthy Ways Quality Initiative, a
vendor effort to drive health information exchange to help Epic
accelerate connections between interoperability networks.
Peter, welcome to the committee, and thank you for joining
us to share Epic's story and your expertise in this area.
The Chairman. Thank you, Senator Baldwin.
Senator Cassidy will introduce our fourth witness.
Statement of Senator Cassidy
Senator Cassidy. It's my privilege to introduce Dr. Angela
Kennedy. Dr. Kennedy is from Louisiana, specifically from
Ruston, a beautiful little town in north Louisiana, where she
teaches.
Dr. Kennedy, welcome to you and your daughter. Thank you
for being here to share your story.
Dr. Kennedy is a professor and the head of the Department
of Health Informatics and Information Management at the College
of Applied and Natural Sciences at Louisiana Tech University in
Ruston, LA. She is here to share her personal story and her
daughter, Grace's, story. Grace was not properly diagnosed with
cystic fibrosis because of, frankly, a foul-up of the
electronic medical record and the usage thereof. It is both as
a person with expertise in health informatics, but, more
importantly, as a mom that she is here to present.
Dr. Kennedy, we look forward to your testimony, and I thank
you for coming from Louisiana--where azaleas are blooming and
the cypress trees are gorgeous--to Washington, DC.
The Chairman. Thank you, Senator Cassidy, for that
commercial.
[Laughter.]
I agree with you. This is a nice time of year in Louisiana.
Why don't we start with Dr. Milstein, and then we'll move
right down the line.
STATEMENT OF JULIA ADLER-MILSTEIN, Ph.D., ASSISTANT PROFESSOR
OF INFORMATION, SCHOOL OF INFORMATION, ASSISTANT PROFESSOR OF
HEALTH MANAGEMENT AND POLICY, SCHOOL OF PUBLIC HEALTH,
UNIVERSITY OF MICHIGAN, ANN ARBOR, MI
Ms. Adler-Milstein. Good morning, Chairman Alexander,
Ranking Member Murray, and members of the committee. Thank you
for inviting me here today.
This hearing is coming at a critical time in the evolution
of our healthcare system. Over the past 5 years, there's been a
multibillion dollar investment of both public and private funds
into adoption of electronic health records. This was driven by
widespread bipartisan agreement that using a first-century
technology, paper-based records, is not a good way to deliver
safe, effective, and efficient care.
The result is that we now have electronic health records in
place in the majority of hospitals and physician practices
across the country, and this is remarkable progress. However,
there are early warning signs that a set of key barriers are
preventing our investment in EHRs from resulting in the better
care we so desperately need.
These barriers can be boiled down into three domains:
ensuring that EHRs contain accurate data; ensuring that EHRs
have the capabilities to move data; and ensuring that patients
and providers can use that data. Careful policymaking can
tackle each of the barriers in these domains and ensure that
over the next 5 years, we leverage our new health IT
infrastructure to deliver the high-quality affordable care we
all want for ourselves and our loved ones.
In my remaining time, let me describe these barriers and
suggest some policy actions that could address them. First, I
often hear physicians using the technical term, gobbledygook,
to describe the information that they find was in the clinical
notes fields of their EHR. They also express frustration with
the amount of time they have to spend documenting information
that's not directly relevant to patient care.
Simply put, the multitude of clinical, billing, and
regulatory requirements for what must be documented in the EHR
is compromising the quality of the data in the EHR. And if the
data isn't good, simply having it be electronic isn't going to
get us anywhere. CMS is in a position to experiment with
introducing more flexibility into documentation requirements
and then assessing the effects.
Second and perhaps the most critical challenge is enabling
the data that now sits within the EHRs of healthcare
organizations across the country to move to where it is needed,
to providers who cannot provide safe or effective care with
missing information, and to patients who can use it to better
understand and manage their health and care and to do so within
a robust privacy and security framework.
Instead, only a minority of physicians, as few as 20 to 30
percent of physicians and hospitals, exchange clinical data
with other providers electronically. It may be surprising to
discover that the true barriers to such exchange are largely
not technical ones.
An agreed upon set of standards implemented in a consistent
way would undoubtedly facilitate interoperability. The
underlying issue is that we don't have the incentives in place
to make this a reality. EHR vendors do not have a business case
for seamless, affordable interoperability across vendor
platforms, and provider organizations find it an expense that
they often can't justify.
It is reasonable to ask in exchange for the large amount of
public funding that has been dedicated to EHR adoption that
vendors facilitate a robust market of new tools and
technologies by enabling better access to patient data. The
mechanisms to do this exist today in the form of EHR
certification criteria.
Third, despite the fact that IT is deeply interwoven into
the fabric of our lives, for most patients, health IT has meant
very little. This is true to such an extent that provider
organizations are struggling to meet the Stage 2 Meaningful Use
criteria that requires that 5 percent of patients view,
download, or transmit to a third party their health
information.
The reason is straightforward. Most patient portals and
personal health records are not making patient data
understandable, useful, and engaging. Despite the tremendous
explosion of patient-generated health and lifestyle data, few
patients are able to sync that data with their EHR data.
If we make real progress in patient-centric data sharing
from providers to patients and patients to providers, there's
no shortage of smart, creative companies that will work with
patients to help them make sense of the data and use it in ways
that are valuable.
In closing, I think we can all agree that newly adopted
EHRs have a critical role to play in improving our healthcare
system. It won't happen on its own. Smart policy interventions
can push to improve the data, as well as move it to where it is
needed in order to let physicians, patients, and the broader
market use it to innovate and create value.
Many other industries have shown us the power of what can
happen when high-quality data are at our fingertips and
incentives are aligned behind innovation. We've made great
progress in EHR adoption. Now is the time to do the things we
need to make sure the investment leads to safer, more
effective, and more efficient care.
Thank you.
[The prepared statement of Ms. Adler-Milstein follows:]
Prepared Statement of Julia Adler-Milstein, Ph.D.
summary
There has been remarkable consensus that the U.S. healthcare system
needs to adopt and use electronic health records. EHRs have been an
area of so much agreement because they hold the potential to do two
things: save lives and save money.
The good news is that use of electronic health records is
spreading. In 2008, just 17 percent of American physicians and 9
percent of hospitals were using EHRs. Since that time--and with the
passage of the HITECH Act--a majority of physicians utilize EHRs and 60
percent of hospitals have converted as well. These changes have
occurred in a wide range of provider groups, from small ambulatory care
practices to large teaching hospitals. Additionally, safety-net
providers have largely kept up with other providers, staving off a
digital divide.
While these gains are remarkable, we are not yet seeing the large
anticipated benefits of EHRs: the evidence fails to show consistent
improvement in patient care or a decrease in healthcare spending
because of our investment. While in most industries there is a time
lag--as much as a decade--between when IT is adopted and when we see
large productivity gains, in healthcare we don't have a decade to wait.
There is growing consensus about the challenges that need to be
addressed, and we need to channel the strong momentum behind EHRs to do
so.
First, and most critically, we need to enable the vast amount of
``digital'' data that now sits within EHRs to move to where it is
needed: to other providers who cannot provide safe or effective care
with missing information, and to patients who can use it to better
understand and manage their health and care. Only a small minority--as
few as 20-30 percent of physicians and hospitals--exchange clinical
data with other providers electronically. This is not, at its core, a
technological issue. The interoperability barriers that exist between
providers are driven by a lack of incentives. EHR vendors do not have a
business case for seamless, affordable interoperability across vendor
platforms, and provider organizations find it an expense that they
often can't justify.
Patient involvement is also critical to realizing the value of
EHRs. At this time, EHRs have not developed in a way that is meaningful
to most Americans. The reason is straightforward: most patient portals
and personal health records are not making patient data understandable,
useful, and engaging. There are few opportunities for patients to
provide the data they generate about their lifestyle and health
behaviors to create a complete picture of their health.
We also have work to do to improve the quality of data within EHRs,
and there is a tension between the information that needs to be
captured in EHRs for clinical care and the information needed for
billing (as well as other administrative and regulatory requirements).
We need to devote more attention to how to resolve this tension.
In each of these areas, solutions will come from the talents and
creativity of healthcare providers, entrepreneurs and the broader
industry. The job of policymakers is to enable those innovations and
there are concrete things we can do. The HITECH Act has done a
remarkable job of getting EHRs deployed widely, but our job is not
done. With smart policy actions that enable greater innovation in the
healthcare marketplace, we can realize the promise of EHRs--to drive
value in healthcare for all Americans.
______
Good morning, Chairman Alexander, Ranking Member Murray, and
distinguished members of the committee. My name is Julia Adler-Milstein
and I am an assistant professor at the University of Michigan. It is an
honor to appear before you to discuss how our Nation can ensure that
the substantial investment we have made in health information
technology over the past decade translates into improved healthcare for
all Americans. My research tracks the adoption of health IT in the U.S.
healthcare system as well as assesses the impact of health IT adoption
on the cost and quality of care, and it is for this reason that I am
here today.
A decade ago, President George W. Bush set an ambitious goal for
our Nation: by 2014 every American would get their care with the
support of an electronic health record.\1\ In 2009, President Obama
reiterated the same goal, calling for universal use of EHRs by 2014.\2\
Investing in health information technology has been area of remarkable
consensus, and the reason is clear: when done right, health IT can have
a profound impact on improving virtually all dimensions of care. No one
believes that paper-based records are a good way to deliver safe,
effective, high-quality care.
---------------------------------------------------------------------------
\1\ ``President Bush continues EHR push, sets national goals.''
Healthcare IT News. April 26, 2004. Available at: http://
www.healthcareitnews.com/news/president-bush-continues-ehr-push-sets-
national-goals.
\2\ ``Obama: EHRs for Americans by 2014.'' Healthcare IT News.
January 8, 2009. Available at: http://www.healthcareitnews.com/news/
obama-ehrs-americans-2014.
---------------------------------------------------------------------------
In response, an array of Federal and State-based strategies has
sought to spur the adoption and use of electronic health records. They
have been remarkably successful. Since the last time this committee met
to discuss health IT, the adoption of EHRs, which include key functions
known to improve the quality of care, has increased dramatically. Among
U.S. hospitals, the increase has been from 9 percent \3\ to nearly 60
percent \4\ in the most recent data (2014). Over the same period, the
increase among U.S. physicians has also been large: from 17 percent \5\
to 48 percent.\6\ These gains can be largely credited to the HITECH
Act--which provided nearly $30 billion in incentives to physicians and
hospitals to adopt and meaningfully use an EHR.\7\ For example, if
today you were to walk into your local hospital, you would find that
the majority of medications are ordered through the EHR.\8\ This was
not true only a few years ago, and the evidence is clear that just this
one use of EHRs avoids errors and saves lives.\9\ There is more good
news. We have seen EHR adoption among safety net providers mostly keep
up with everyone else, partly due to the alternative incentive program
that was created for safety-net providers. The increases in adoption of
EHRs have been widespread--across all regions of the country, across a
large variety of provider groups from small ambulatory care practices
to large teaching hospitals. We should feel proud of these successes.
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\3\ Adler-Milstein J, Desroches CM, Furukawa MF, Worzala C, Charles
D, Kralovec P, Stalley S and Jha A. More than half of U.S. hospitals
have at least a basic EHR, but stage 2 criteria remain challenging for
most. Health Affairs (Millwood). 2014;33(9):1664-71.
\4\ Adler-Milstein J, Desroches CM, Furukawa MF, Worzala C, Charles
D, Kralovec P, Stalley S and Jha A. More than half of U.S. hospitals
have at least a basic EHR, but stage 2 criteria remain challenging for
most. Health Affairs (Millwood). 2014;33(9):1664-71.
\5\ Desroches CM, Campbell EG, Rao SR, Donelan K, Ferris T, Jha A,
Kaushal R, Levy D, Rosenbaum S, Shields A, Blumenthal D. Electronic
health records in ambulatory care--a national survey of physicians. New
England Journal of Medicine. 2008;359(1):50-60.
\6\ Furukawa MF, King J, Patel V, Hsiao C-J, Adler-Milstein J, Jha
AK. Despite Substantial Progress In EHR Adoption, Health Information
Exchange And Patient Engagement Remain Low In Office Settings. Health
Affairs (Millwood). 2014;33(9): 1672-79.
\7\ Public Law 111-5, Title XIII.
\8\ Hospital Performance on Stage 2 Meaningful Use Measures. http:/
/www.healthit.gov/FACAS/sites/faca/files/
HITPC_Data_Analytics_Update_2014-11-04.pdf. Page 8.
\9\ Ammenwerth E, Schnell-Inderst P, Machan C, Siebert U. The
effect of electronic prescribing on medication errors and adverse drug
events: a systematic review. Journal of the American Medical
Informatics Association. 2008;15(5):585-600.
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Adoption of EHRs is, however, only the first step; EHRs are
necessary, but not sufficient, to drive large gains in healthcare
quality. The evidence to date suggests that EHRs do not consistently
lead to better care or lower healthcare spending. In some ways, this
should not be a surprise. In most industries, there is a time lag--as
much as a decade--between when IT is adopted and when we see large
efficiency and productivity gains. In healthcare, we don't have a
decade to wait. We need a strategy for figuring out how to use our new
information technology infrastructure to truly transform healthcare.
Here, there is growing consensus about the challenges that need to be
addressed and important places where careful policymaking can make a
big difference.
The first challenge is ``liberating'' the patient data that now
sits within electronic health record systems of healthcare
organizations across the country. By adopting EHRs, we have made a
tremendous investment in ``digitizing'' clinical data, and have asked
busy physicians to take extra time out of their day to enter this data.
We need to enable the data to move to where it is needed: to other
providers who cannot provide safe or effective care with missing
information, and to patients who can use it to better understand and
manage their health and care. Instead, only a small minority--as few as
20 to 30 percent of physicians and hospitals--exchange clinical data
with other providers electronically.\10\ That means that if, in the
middle of the night, you have to rush your child to the emergency room
in your community--the chances are very low that the treating physician
will be able to access all of your child's information. Much of my
research has focused on identifying the primary barriers to achieving
broad-based health information exchange and interoperability. It may be
surprising to discover that the barriers are largely not technical
ones. An agreed-upon set of standards, implemented in a consistent way,
would undoubtedly facilitate interoperability. The underlying issue is
that we don't have the incentives in place to make this a reality. EHR
vendors do not have a business case for seamless, affordable
interoperability across vendor platforms, and provider organizations
find it an expense that they often can't justify.
---------------------------------------------------------------------------
\10\ Adler-Milstein J, Jha A. Health information exchange among
U.S. hospitals: who's in, who's out and why? Healthcare. 2014: 2 (1)
26-32.
---------------------------------------------------------------------------
We are also struggling to engage patients through health
information technology and better access to their data. Despite the
fact that IT is deeply interwoven into the fabric of our lives, for
most consumers, health IT has meant very little if anything at all.
Despite much hype that personal health records would engage patients to
be far more involved in their care, there is little evidence that this
is happening. This is true to such an extent that provider
organizations are struggling to meet the Stage 2 Meaningful Use
criterion that requires that 5 percent of patients ``view, download, or
transmit to a third party'' their health information. The reason is
straightforward: most patient portals and personal health records are
not making patient data understandable, useful, and engaging. The
difference between getting my lab test result in the mail versus
viewing it online is small. The ability to sync my exercise and other
lifestyle data in order to understand how those choices impact my lab
results is a whole different ball game. If we make real progress in
patient-centric data sharing, from providers to patients and from
patients to providers, there is no shortage of smart, creative,
innovative new companies that will work with patients to help them make
sense of the data and use it in ways that are valuable.
There are other key challenges to ensuring that our national
investment in EHRs improves care. We need to address the competing
burdens on clinical documentation that are compromising the quality and
usability of the data captured within EHRs. EHRs serve multiple
masters, and there is a tension between the information that needs to
be captured in EHRs for clinical care and the information that needs to
be captured for billing (as well as other administrative and regulatory
requirements). We need to think creatively about how to resolve this
tension, and there is an opportunity for CMS to experiment with
solutions. Finally, we know that when some physicians adopt EHR
systems, they are worse off--slower, less efficient, struggling to
provide high-quality care. For others, the experience is very
different: they see big gains in productivity and the quality of care
they provide.\11\ Why do some do so well with technology while others
struggle? The answers are not as simple as age or tech savviness. It's
likely much more about how the IT is used, and the context in which it
is used.\12\ We need to identify these factors and work to spread them
in order to ensure that all providers translate EHR use into better
care.
---------------------------------------------------------------------------
\11\ Adler-Milstein J, Green CE, Bates DW. A Survey Analysis
Suggests That Electronic Health Records Will Yield Revenue Gains For
Some Practices And Losses For Many. Health Affairs (Millwood).
2013;32(3):562-70.
Kern LM, Edwards A, Kaushal R. The Patient-Centered Medical Home,
Electronic Health Records, and Quality of CarePatient-Centered Medical
Home and Quality of Care. Annals of Internal Medicine.
2014;160(11):741-9.
\12\ Adler-Milstein J, Scott KW, Jha AK. Leveraging EHRs to Improve
Hospital Performance: The Role of Management. American Journal of
Managed Care. 2014;20(11 Spec No. 17):SP511-SP519.
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We are at a critical moment for our healthcare system. We are
nearing the 5-year anniversary of the passage of the Affordable Care
Act and 6 years after the passage of HITECH. Whatever our beliefs of
those laws, we can all agree that our healthcare system has to get
better--and we can all agree that newly adopted health information
technology has a critical role to play. It won't happen on its own.
Smart policy interventions can push to improve the data, as well as
liberate it, in order to let physicians, patients, and the broader
market use it to innovate and create value. Many other industries have
shown us the power of what can happen when high-quality data are at our
fingertips and incentives are aligned behind innovation. Of course, we
need not be overly coercive or prescriptive. Policymakers won't have
all the solutions--but if we ask that, in exchange for the large amount
of public funding that has been dedicated to EHR adoption, vendors be
willing to facilitate and participate in a robust market of new tools
and technologies, we will begin to deliver on the promise of EHRs to
drive improvements in care and to engage patients and their families.
We have made great progress--now is the time to do the things we need
to make sure that the investments lead to safer, more efficient, more
effective care for all Americans.
The Chairman. Thank you.
Dr. Wergin.
STATEMENT OF ROBERT L. WERGIN, M.D., FAAFP, PRESIDENT, AMERICAN
ACADEMY OF FAMILY PHYSICIANS (AAFP), MILFORD, NE
Dr. Wergin. Chairman Alexander, Ranking Member Murray, and
members of the Senate HELP Committee, I want to thank you for
this opportunity to testify on behalf of the American Academy
of Family Physicians and over 115,000 members that I represent.
My name is Robert Wergin, M.D. I'm summarizing my written
statement and speaking both as president of the American
Academy of Family Physicians and as a rural practicing family
physician in Milford, NE.
Four years ago, my practice implemented an electronic
health record, and I have to say it wasn't pretty. The
transition was expensive, time consuming, and resulted in a
decline of office productivity and loss of patient volume. We
worked hard at it and learned the system, and productivity
improved.
Although our patient volume has never returned to the pre-
EHR levels, I am pleased to say that my clinic is running more
smoothly. In fact, we met Meaningful Use 2 requirements late
last year.
While it's difficult to provide a single characteristic of
how health IT is working, I can report that my EHR experience
is not unique. Today's hearing addresses a significant issue
that is on the mind of every physician across this country,
regardless of geography, practice size, or years in service.
Here are a few of my observations. First, technology is
improving healthcare at a practice level, such as accessing and
editing patient data, all the way up to advanced EHR functions
that allow for e-prescribing, clinical decision support, and
accessing lab results.
Family physicians were early adopters of health IT because
we saw its potential for improving patient care, and we still
see that potential.
Second, family physicians are excited about innovative
health delivery models, such as patient-centered medical homes,
ACOs, and telemedicine, that rely on health IT. For example,
medical homes that use EHRs have higher quality scores, and
telemedicine is increasing access to care, especially in rural
areas like mine, and physicians welcome those changes.
Third, health IT improves coordination between primary care
physicians and subspecialists, hospitals, pharmacies, labs, and
State health departments. But there's still room for
improvement.
I've discussed the opportunities and the major challenges,
and they can be summed up as follows. Regulatory burdens are
interfering with the doctor-patient relationship. Current EHRs
are expensive and do not function well within the physician's
work flow and are not fully interoperable. Payment structure
does not fully support coordinated care that is time intensive
and EHR dependent.
To fulfill the promise of health technology, the AAFP
respectfully submits the following recommendations. No. 1,
overhaul the current documentation requirements. The current
standards are time consuming, lead to bloated EHR, and
emphasize billing information rather than meaningful clinical
data exchanges.
For example, I recently saw a patient for a followup from
an emergency room visit. After reviewing 18 pages of patient
notes, all I knew was that her mother was of Mediterranean
descent, and I was not easily able to ascertain through the
medical history or relevant patient data why she was seen and
hospitalized. I didn't think it was because her mother was of
Mediterranean descent.
In addition, physicians like me are spending far too much
time typing on computers instead of face-to-face patient care.
Second, provide flexibility from the regulatory burdens.
The Meaningful Use incentive payments encourage health IT
adoption. The regulatory burdens are tremendous, and we thank
policymakers who have been supportive of regulatory relief.
CMS's recent proposal to allow a 90-day reporting period
for 2015 is a good example of regulatory relief.
In addition, CMS and Congress should revisit the all-or-
nothing requirement for Meaningful Use. HHS should also
harmonize quality and reporting standards.
Third, physicians are also dependent on their EHRs for
transition to ICD-10. As the deadline approaches, we urge the
administration to establish an ICD-10 contingency plan to
anticipate transition difficulties that may result in denials
and loss of revenue.
Fourth, Congress and the Administration must step up
efforts to require interoperability. It has now been 10 years
since the EHR incentive program was created, yet we still do
not have adequate levels of interoperability. HHS should
strengthen its EHR certification requirements, as the AAFP and
40 other medical organizations requested in a January 21st
letter. Policymakers should also delay Federal penalties for
Meaningful Use until interoperability is achieved.
Fifth, Congress should strengthen consumer and health
privacy laws to ensure that information is fully protected, not
hoarded for commercial purposes, and physicians should not be
at the mercy of their vendors to access patient data.
And, finally, we urge Congress to pass a permanent SGR
repeal that supports payment reform in the type of care
coordination that is health IT dependent.
Again, I appreciate the opportunity to testify and would be
happy to answer your questions when appropriate.
[The prepared statement of Dr. Wergin follows:]
Prepared Statement of Robert Wergin, M.D., FAAFP
Chairman Alexander, Ranking Member Murray and members of the Senate
Health, Education, Labor, and Pension (HELP) Committee, I appreciate
the opportunity to testify today on behalf of the American Academy of
Family Physicians (AAFP) and the more than 115,900 members we
represent.
My name is Robert Wergin, M.D., FAAFP. I am president of the AAFP
and a practicing family physician from Milford, NE, a small, rural town
with a population of around 2,100 residents. I am a meaningful user of
an electronic medical record and practice in a patient-centered medical
home (PCMH).
The AAFP is one of the largest national medical organizations, and
we represent the largest number of primary care physicians in the
country. We have members practicing in all 50 States and over 90
percent of all counties. The AAFP was founded in 1947 to promote and
maintain high-quality standards for family physicians who are providing
continuous, comprehensive, and connected health care to the public.\1\
Approximately one in four of all office visits are made to family
physicians.\2\ That is 214 million office visits each year--nearly 74
million more than the next largest medical specialty.\3\ Family
physicians provide more care for America's underserved and rural
populations than any other medical specialty. In addition, family
physicians provide a diverse range of care that includes pediatric,
women's health and end-of-life.
---------------------------------------------------------------------------
\1\ About the American Academy of Family Physicians, website:
http://www.aafp.org/about/the-aafp/history.html.
\2\ Ibid.
\3\ Ibid.
---------------------------------------------------------------------------
Today's hearing addresses a significant health practice issue that
is on the mind of every physician across the country regardless of
geography, practice size or years in service. In recent years, I have
traveled around the country and talked with dozens of family physicians
whose experiences adopting health information technology (health IT)
were much like mine.
Four years ago, my practice implemented an electronic health record
(EHR) system. The initial results weren't pretty. Transitioning from
paper to electronic files was expensive, time consuming, and resulted
in a decline in the productivity of my office. We worked at it, learned
the system and productivity has improved. Although our daily patient
volume has not yet returned to pre-EHR volumes, my clinic is running
more smoothly than it did initially because my staff and I have
adapted. We have embraced this change, and the benefits have been
numerous. In fact, our practice successfully met Meaningful Use (MU)
Stage 2 requirements late last year.
So, it is with that perspective, both as an AAFP leader and a
practicing physician in a rural area that I am speaking with you today.
Physicians around the country are anxious to know that policymakers
understand and appreciate the challenges and concerns associated with
successfully adopting health IT. Physicians also hope that decision
makers will not simply consider the importance of health regulations
but the context in which physicians are implementing a myriad of new
requirements with limited financial resources and available time that
can distract from the patient-physician relationship and impose
significant challenges on physicians' quality of life and for some
threaten the viability of their practice.
family physicians are early adopters of electronic health records
Physicians have used computerized medical records for well over 20
years. Successful utilization of EHRs, also known as electronic medical
records or EMRs, has long been a vision of family medicine well before
Congress approved the Health Information Technology for Economic and
Clinical Health (HITECH) Act, enacted as part of the American Recovery
and Reinvestment Act (ARRA) of 2009. Over 10 years ago, the AAFP
encouraged adoption of EHRs as part of its Future of Family Medicine
initiative.\4\ In addition, the AAFP created a Center for Health IT,
which is now the Alliance for e-Health Innovation, to educate
physicians about issues surrounding adoption and to work with IT
vendors on standards for primary care practice. The AAFP also published
health IT guides, shared best practices and reported on the most widely
used EHR systems. We have also worked to create interoperability
standards, which are represented in meaningful use. The organization's
leadership boosted EHR adoption among family physicians. In a 2014
survey conducted by the U.S. Department of Health and Human Services'
(HHS) Office of National Coordinator (ONC) for Health IT, over 77
percent of primary care physicians indicated that they were using
electronic health records and outpacing other medical and surgical
specialties.\5\
---------------------------------------------------------------------------
\4\ Sheri Porter, What Factors Influence EHR Adoption?, AAFP News,
December 10, 2014, http://www.aafp.org/news/practice-professional-
issues/20141210oncbrief.html.
\5\ Ibid.
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We are pleased Congress and the Administration implemented the
Medicare and Medicaid EHR Incentive Programs within ARRA to provide
payments to eligible professionals, eligible hospitals, and critical
access hospitals (CAHs) as they adopt, implement, upgrade, or
demonstrate meaningful use of certified EHR technology. According to
the 2014 HHS physician survey, however, lack of financial resources was
a significant barrier to adopting or upgrading systems, particularly
for physicians operating in rural, small and solo practices.\6\
---------------------------------------------------------------------------
\6\ Ibid.
---------------------------------------------------------------------------
Family physicians are proud to be early adopters and we remain
committed to pursuing the full potential of EHRs to enhance patient
care, support new health delivery systems, improve population health,
increase access through digital health technologies, and reduce the
costs of health care. Most importantly, family doctors recognize
successful EHR adoption will be the super highway for 21st century
medicine. It is a road stakeholders must travel together: physicians,
insurers, government agencies, patients, hospitals, community health
centers and other health providers. It also is a road EHR manufacturers
and vendors must travel with us. It is not enough for them to simply
build the products and point physicians on their way; they must accept
their responsibility to travel this road with the physicians and
hospitals that purchase and rely on their systems. We are not there
yet, but we are making progress toward that goal. In the final
analysis, we must not lose focus on how our endeavors may ultimately
impact patient care.
ehrs and health practices
Electronic health records continue to be an important part of the
future of health care delivery. There's no going back to paper
records--we all recognize this even if our levels of acceptance vary.
EHRs represent the potential for changing physician operations at a
practice-level and for supporting new health care delivery models. On a
simple level, EHRs use software that allows physicians to create,
store, organize, edit and retrieve patient records on a computer or
other device. An effective EHR is more than just the electronic
equivalent of paper.
Advanced EHRs automate a practice's many time-consuming, paper-
driven office tasks. They allow for electronic prescribing and
medication refills, automatic formulary checking, electronic lab,
imaging and referral ordering, automated charge capture, automated
coding advice, intra-office clinical messaging, multiple note creation
options, remote access to the chart, results flow charting, clinical
alerts, patient education and disease management.\7\
---------------------------------------------------------------------------
\7\ Kenneth Adler, MD, Why It's Time to Purchase an Electronic
Health Record System, Family Practice Management, 2004 Nov-
Dec;11(10):43-46. http://www.aafp.org/fpm/2004/1100/p43.html.
---------------------------------------------------------------------------
Advanced EHRs and health IT impact every process and individual in
a practice. Advanced health IT that is interoperable can improve the
safety of care through clinical decision support, robust data analysis,
tracking of results, and supporting routine application of evidence-
based medicine. It also has the capacity to improve care coordination
and the collaboration on patient care by our currently fragmented
health care system. It can assist in the reduction of duplicative
services and inappropriate utilization of services. To achieve these
potentials, we must continue to view health IT as a tool for
transformative change in health care and not a fancy electronic file
cabinet.
the future of health delivery reform
Health technology also holds the potential to help physicians
engage in delivery system reform efforts. EHRs could improve care
coordination between primary care physicians and subspecialists,
hospitals, pharmacies, labs and State health departments--but this is
not possible now in any meaningful way. Common standards are needed
across all entities to realize this benefit. Technology also is an
integral part of improving care access reform efforts with advances in
telehealth and is especially important for improving access to
preventive and primary care.
Research shows that preventive care, care coordination for the
chronically ill, and continuity of care--all hallmarks of primary care
medicine--can achieve better health for individuals and cost savings.
Published studies have demonstrated the positive impact of primary care
on a variety of health outcomes, including decreased mortality from
cancer, heart disease, stroke, and all causes combined. EHRs are
essential for many health delivery reforms aimed at improving the
quality of patient care and increasing primary health care access. For
example, team-based coordinated care is a foundational piece of the
patient-centered medical home (PCMH), and, when coupled with the use of
an EHR system, the primary care practice has the best opportunity to
improve the quality of care offered to patients.\8\ New research shows
that organizational changes associated with the PCMH combined with use
of an electronic health record can boost the quality of care delivered
in primary care practices of all sizes.\9\ Researchers found that the
odds of overall quality improvement in PCMH practices with an EHR were
7 percent higher than in paper-based practices and 6 percent higher
than in non-PCMH practices with an EHR.\10\ Specifically, improvement
was seen in 4 of 10 quality measures chosen by six participating health
plans. Unfortunately, today's EHRs do not yet possess the needed
functionality to fully support a PCMH.
---------------------------------------------------------------------------
\8\ Shari Porter, Combine Medical Home Culture, EHR for ``One-Two''
Punch, AAFP News, June 10, 2014, http://www.aafp.org/news/practice-
professional-issues/20140610pcmhehrstudy.
html.
\9\ Ibid.
\10\ Ibid.
---------------------------------------------------------------------------
As the health care industry begins to implement new value-based
payment models, the use of technology will be essential for collecting
patient data, measuring care quality, engaging patients in their health
care and evaluating the effective management of chronic care
conditions. Other health delivery reforms that rely on health IT
include Accountable Care Organizations and telehealth. These also have
important implications for our ability to increase access to
underserved communities, better serve the homebound, and improve health
at a population level.
challenges and recommendations
So far, I have focused on the great potential we see in health IT.
The challenge is that this potential is not being realized in the
majority of physician practices today. A recent RAND survey of
physicians showed that EHRs are negatively impacting professional
satisfaction.\11\ The goal of health IT is to make patient care more
efficient and less costly. For every success story, there are family
physicians and others struggling to make this a reality. While there
are many challenges and the testimony will not cover them all or in
great detail, I have highlighted the major concerns for AAFP's members,
along with potential solutions.
---------------------------------------------------------------------------
\11\ Mark W, Friedberg, et al., Factors Affecting Physician
Satisfaction and their Implications for Patient Care, Health System and
Health Care, Rand Corporation, September 30, 2013, accessed online:
http://www.rand.org/pubs/research_reports/RR439.html.
---------------------------------------------------------------------------
Current Documentation Requirements Distract from Patient Care.
Physicians are deeply concerned that Federal and State regulations
associated with EHRs can interfere with patient care and reduce patient
and physician satisfaction. Instead of interacting with patients,
physicians are typing into their computers and must spend hours keeping
up with paperwork requirements. This can be distracting for patients
and their doctors. In addition, physicians feel it can create a barrier
to the patient-physician relationship. A 2014 Physicians Foundation
survey indicated face time with patients care was among physicians' top
five concerns. A majority of the 20,000 physicians surveyed expressed
anxiety that patient care was suffering because they are spending more
time on administrative responsibilities.\12\
---------------------------------------------------------------------------
\12\ Top Five Concerns Include Consolidation, ICD-10, AAFP News,
January 14, 2015, http://www.aafp.org/news/practice-professional-
issues/20150114physfdtnwatchlist.html.
---------------------------------------------------------------------------
When my practice implemented EHRs, I certainly experienced this
challenge of balancing the need to provide the face-to-face care I know
patients need and fulfilling my paperwork requirements.
We need the government to take a new critical look at the current
medical documentation requirements required for Current Procedural
Terminology (CPT) coding. The current requirements were developed in an
era dominated by paper records and fee-for-service models. These
antiquated requirements are time-consuming for physicians and other
clinicians and lead to bloated medical records, both of which do not
lead to better patient care.\13\ The current documentation requirements
cause the generation of lengthy documents with critical clinical data
buried within them. Physicians waste their time sifting through pages
and pages of external ``billing'' documentation to find the critical
data to inform treatment for the patient.
---------------------------------------------------------------------------
\13\ Robert A. Berenson, M.D., Revisiting E&M Guidelines--A Missing
Piece of Payment Reform, New England Journal of Medicine, 2011, page
1892-95, accessed online: http://www.nejm.org/doi/full/10.1056/
NEJMp1102099.
---------------------------------------------------------------------------
Encouraging a wider range of patients to view or download their
data continues to be a challenge. A 2014 Health Affairs study found
that only 30 percent of physicians reported using secure messaging to
communicate with patients. Although 40 percent of physicians said their
systems have the ability to allow patients to view, download or
transmit information online, only half of those physicians said they
were using that technology. \14\
---------------------------------------------------------------------------
\14\ Michael Laff, Basic EHR Use Rising But Data Sharing, Patient
Engagement Lag Behind, AAFP News, August 22, 2014, http://www.aafp.org/
news/practice-professional-issues/20140822healthaffehrstudy.html.
---------------------------------------------------------------------------
Patients who have chronic disease and elderly patients whose care
is being managed remotely by their children are among the individuals
most likely to use patient portals. When my practice worked to achieve
Stage 2 Meaningful Use status, meeting the patient portal requirement
was particularly challenging. We have strong concern with requirements
for action by those outside the control of the practice to avoid
financial penalties.
The AAFP is pleased the Centers for Medicare and Medicaid Services
(CMS) has announced proposed rules to reduce the reporting period for
Meaningful Use from 365 days to 90 days, and we hope CMS will provide
physicians with certainty regarding this decision as soon as possible.
This type of flexibility will give physicians more time to implement
the guidelines without compromising patient care. We would like to see
further flexibility to address the all-or-nothing nature of meaningful
use. Today if a physician misses a single requirement by a mere 1
percent, the physician is ineligible for an incentive payment and will
see a penalty the following year under Medicare.
EHRs Have Limited Functionality for Physicians. Physicians across
specialties are deeply frustrated with EHR functionality and the fact
that systems do not meet their workflow needs. In addition, these
systems can reduce efficiency and have limited interoperability. These
concerns are reflected in a January 21, 2015 letter to ONC that AAFP,
along with 40 other medical and health organizations signed urging a
serious review of the current certification standards.\15\
---------------------------------------------------------------------------
\15\ EHRs Fails to Meet Physician, Patient Standards, AAFP News,
January 27, 2015, http://www.aafp.org/news/practice-professional-
issues/20150127EHRcert.html.
---------------------------------------------------------------------------
The letter outlined the following recommendations:
(1) Decouple EHR certification from the Meaningful Use program.
(2) Re-consider alternative software testing methods.
(3) Establish greater transparency and uniformity on UCD testing
and process results.
(4) Incorporate exception handling into EHR certification.
(5) Develop C-CDA guidance and tests to support exchange.
(6) Seek further stakeholder feedback.
(7) Increase education on EHR implementation.
The letter stated the urgent need to change the current
certification program to better align end-to-end testing to focus on
EHR usability, interoperability and safety. AAFP stands with the
medical community in urging ONC to address these certification
standards.
EHR Systems Lack Full Interoperability. The issue of
interoperability between electronic health records represents one of
the most complex challenges facing the health care community as we
pursue patient-centered health care reform. The ability to share and
utilize information between two or more information systems is critical
in today's increasingly interconnected health care environment, yet
significant challenges have impeded information exchange across the
spectrum of care.
To achieve better care, smarter spending and healthier people, both
patients and physicians must be able to securely access their health
care information when and where it is needed. When our patients leave
our practice and go to another--for a subspecialist consultation, for
example--my EHR most likely will not be able to communicate with the
subspecialist's EHR.
This is a major flaw in our health care system, and the AAFP
continues to push the Office of the National Coordinator for Health
Information Technology and EHR vendors on this important issue.
AAFP leaders continue to advocate for requirements that demand
interoperability from health IT vendors. The Federal Government should
require that vendors achieve a high level of interoperability before
expecting physicians and other clinicians to achieve current EHR and MU
requirements. We have expressed our concern with the lack of
interoperability and are pleased that the ONC has identified critical
actions and outlined a timeline for implementation. We are making
progress, such as with the Direct Project. This project was a
partnership between the Federal Government and the private sector to
establish the needed standardization for secure ``email'' in health
care. We encourage continued support for this exchange and agree with
many others that more work is needed to define the underlying data
standards.
Physicians Face Expensive Regulatory Burdens. Physicians face what
has been described as a tsunami of regulatory burdens associated with
health IT that include Meaningful Use, ICD-10, and CMS' Patient Quality
Reporting System (PQRS). Implementing each requirement requires a time
commitment, financial investment, and training to integrate into the
physicians' practices. In addition, physicians face growing Medicare
payment cuts for non-compliance. A 2014 Washington Post article states
that paperwork is contributing to physician burnout, particularly among
primary care physicians. \16\
---------------------------------------------------------------------------
\16\ Roni Caryn Rabin, A Growing Number of Physicians Are Burning
Out, Washington Post, March 31, 2014, accessed online: http://
www.washingtonpost.com/national/health-science/a-growing-number-of-
primary-care-doctors-are-burning-out-how-does-this-affect-patients/
2014/03/31/2e8bce24-a951-11e3-b61e-8051b8b52d06_story.html.
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We have written numerous letters to CMS calling for improvements to
the Meaningful Use program to ensure that family physicians can qualify
and thus avoid the penalties associated with non-compliance. In
addition, the AAFP has urged the Administration to push implementation
back to 2017.
The Federal Government's strategic plan for the future of health
information technology encompasses worthy goals. It should both seek to
ease the administrative burden physicians confront and build on goals
set a decade ago. The AAFP wrote in response to a public request for
comments on the draft strategic plan that the ONC released in December
2014 which outlines a working plan for the next 5 years. As the AAFP
outlined in our comments, we urge greater coordination among agencies
and efforts to reduce administrative burdens on physicians.
Another area of concern regarding administrative burden with little
impact on improved patient care is ICD-10. Many physicians worry that
even if they successfully transition to ICD-10, they may still face
potential claims denials or delays. Avoiding a disruption in the
practice's cashflow remains a serious concern with this transition.
Physicians heavily depend on electronic system vendors, claim
clearinghouses, and payment administrators and need to know that
testing is available and will be conducted to allow for corrections
prior to the transition date. ICD-10 transition concerns are
particularly acute for rural, small and solo practices.
We strongly urge CMS to establish contingency plans or establish
task forces that include payers, clearinghouses, and software vendors
to ensure that a system is in place to identify and address unexpected
process failures. In 2012, CMS mandated the roll-out of Health
Insurance Portability and Privacy Act (HIPPA) 5010 rule for claims
submissions. There were major issues across the Nation with payment to
providers. With many practices operating on very thin budget margins
and depending on normal revenue cycles, a payment delay of even 2 weeks
could be harmful to the financial health of a clinic, regardless of its
size.
We urge Congress to make sure that legislation includes adequate
timelines that take into account the complexity of health systems, the
many competing demands for physicians' time and planning to mitigate
the unintended consequences that could jeopardize patient care.
Vendors Engage In Data Hoarding. The AAFP also has written to the
Federal Trade Commission about anti-competitive practices that hinder
interoperability. The AAFP is concerned with the utilization of health
information technology to create competitive barriers against
physicians and patients. The lack of interoperability makes it
practically infeasible for a physician practice to switch electronic
health records should the vendor or health care community use
anticompetitive methods to limit the practice's access to needed health
information on their patients. This hoarding of data--this vendor
lock--negatively impacts care and distorts market forces trying to
decrease health care costs and improve quality. It is critical that
health data flow to where patients wish to be treated--in fact, these
records are the patient's records and should be electronically
available to any physician or other provider of care at any time. These
records and data do not belong to the EHR vendor. The current market
forces for EHR vendors and large (quasi-monopoly) health systems limit
interoperability to retain customers and patients and to elevate prices
artificially. We need to make sure the business incentives are aligned
to ensure continuity of care for patients and appropriate access to
data by providers.
Reimbursement for Care Coordination is Inadequate. The biggest
barrier to usable and interoperable health IT is the Nation's current
fee-for-service business model that stresses volume rather than value.
The system we have now is all about getting widgets out the door. In
this case, those widgets are real live people who depend on their
family physicians to provide quality care. It takes time and energy to
improve quality in a busy medical practice. Moving to a value-based
payment system can set the stage for a revolution in health IT that
will move us from automating the business of health care to automating
the delivery of that care. In a value-based payment-driven health care
system, interoperability is desired not mandated.
On January 26, 2015, HHS announced that a higher percentage of
Medicare payment systems would be tied to quality-based systems by the
end of 2016. Also, Medicare began paying for chronic care management
(CCM) effective January 1, 2015, recognizing the value that primary
care brings to health care. In addition, the bipartisan, bicameral
legislation to repeal the Medicare Sustainable Growth Rate (SGR)
proposes a payment system that focuses on the value of the health care
delivered and that supports health care delivery models centered on
care coordination. We support the Administration's efforts to advance a
quality-based payment system. We strongly urge CMS to expand this
program and to eliminate the co-payment requirement. Ultimately,
physicians need a long-term and permanent solution. Congress should
repeal and replace the SGR based on the 2014 legislative framework that
supports value-based payments, encourages health delivery reforms and
streamlines administrative requirements.
Conclusion
Again, thank you for inviting me to testify before the committee
today. I would like to reiterate our key recommendations to Congress:
(1) Overhaul the current documentation requirements. The current
standards are time-consuming, lead to bloated medical records which
emphasize billing information rather than helpful and important
clinical data.
(2) Provide flexibility from regulatory burdens. The Meaningful Use
90-day reporting rule is a good example of the type of flexibility
physicians need. In addition, HHS should establish a minimum threshold
necessary to meet the Meaningful Use standards instead of its all-or-
nothing requirement. Regulatory implementation is as important, in some
cases, as the regulation, itself. AAFP urges policymakers and the
Administration to take a ``do no harm'' approach when considering
current and future standards that factor in the current physician
workforce shortages, practice viability and patient care and safety.
Harmonizing quality and reporting standards across all payers,
especially for primary care, would also help physicians successfully
implement Federal standards and similar requirements in the private
sector.
(3) The Administration should take steps to put an ICD-10
contingency plan in place. Although the initial testing reports were
favorable, physicians have been advised to take out loans to prepare
for potential billing denials. Rural, small and solo practices may be
especially hard hit if the transition process is not implemented as
anticipated and there are weeks or months of claims denials.
(4) Congress and the Administration must step up efforts to require
interoperability and functionality. It has been 10 years since the EHR
incentive program was created, yet we have not reached an adequate
level of interoperability. This is not acceptable. HHS should use its
authority to strengthen certification requirements to advance
interoperability requirements and improve EHR functionality. We also
believe that Congress should take action to delay Federal penalties for
Meaningful Use until interoperability is achieved. In addition, until
national standards are established, EHR vendors should be required, at
a minimum, to use open Application Programming Interfacing technology,
which experts indicate would significantly advance interoperability, by
the end of 2016.
(5) Review current consumer and privacy data protections. Patients'
information should be fully protected and not hoarded for commercial
purposes, and physicians' should not be at the mercy of their vendors
as they are now. Physicians should not be charged by their vendors for
accessing their own patients' data. Congress should consider amending
medical privacy laws to strengthen consumer protections in ways that
address both patients' concerns as well as physicians' data management
responsibilities.
(6) Congress must pass a permanent SGR repeal legislation this
year. The SGR bicameral, bipartisan legislation included policies that
help bring the health care industry into the 21st Century through
value-based payment reform. This level of patient care emphasized in
the legislation is intensive, but it is not adequately reimbursed right
now. We urge Congress to enact SGR reform in 2015.
I appreciate the opportunity to share the perspective of America's
family physicians on what's working well and what challenges remain in
implementing successful health IT systems.
The Chairman. Thank you.
Mr. DeVault.
STATEMENT OF PETER DeVAULT, DIRECTOR OF INTEROPERABILITY, EPIC
SYSTEMS CORPORATION, MADISON, WI
Mr. DeVault. Thank you, Senators Alexander and Murray and
other members of the committee. It's quite an honor for me to
be here today.
I've been with Epic for 18 years, and during that time, not
only has our company grown from a small company to a larger
one, but we've seen the growth of the electronic health record
as a simple replacement for paper records to becoming a very
sophisticated platform for healthcare innovation, population
management, patient engagement, and the development of the
learning healthcare system. You have access to my written
testimony. I'll summarize a few thoughts in the areas of
adoption, innovation, and interoperability.
U.S. healthcare organizations have made great strides in
electronic health record adoption over the last 10 years, and
that's certainly an area in which the Meaningful Use Program
has helped. Epic's community of leading healthcare
organizations actually serves as a model for EHR adoption
success.
Epic has never had a customer fail to go live. No hospital
has ever replaced Epic by choice, and we have never lost a
customer due to dissatisfaction with our software or our
services.
The Epic community of customers represents a very diverse
cross section of the U.S. care industry, including academic
medical centers, safety net organizations, and some of the
world's largest EHR deployments, such as Kaiser Permanente, and
the care for patients in all 50 States and the District of
Columbia. By the time our current customers finish rolling out
the record to all of their users, they will be caring for about
half of the U.S. population and include more than 310,000
physicians.
Our customers lead the industry in objective measurements
of EHR adoption, including Meaningful Use attestation both for
hospitals and eligible providers, as well as achieving Stage 7,
which is HIMSS' categorization of EHR adoption. That's the
highest level you can achieve, and the majority of
organizations who have achieved Level 7 are Epic sites.
Epic's customers are most often large organizations.
Smaller organizations and smaller physician practices have a
more difficult time in adopting healthcare information
technology. One of the ways that we've sought to help with that
is to open up what we call the Community Connect Program, which
allows our customers, again, the larger organizations, to
extend the EHR out to those community physicians and practices.
More than 70 percent of our customers currently participate in
that program and have extended to more than 17,000 physicians.
Healthcare organizations adopt technology for a variety of
reasons, often several, including increased efficiency; better
and safer patient care; furthering their clinical research
missions, which is very important for many of our customers;
and the ability to adapt to healthcare payment reform.
Our customers have achieved benefits in a wide variety of
areas, including decreased wait times for appointments,
reduction in hospital-acquired infections, elimination of
duplicate tests, and engaging patients in their own care.
Today, more than 30 million patients access the MyChart patient
portal so they have access to their records and their families'
records, can manage their medications, can incorporate outside
data from their devices, and communicate securely with their
care team.
Increasingly, the ability to achieve these kinds of
benefits, especially with payment reform and the mobility of
patients, relies on a sharing ecosystem. It relies on being
able to get the patient's health information from one point of
care to another and to be shared among members of the care
team, whether that's between hospitals and independent
physicians or between a doctor's office in Wisconsin and an
emergency department in Florida.
Our interoperability platform, for which I'm responsible at
Epic, is called Care Everywhere--and it's in use now by every
customer in the United States--which gives access to more than
1,000 hospitals and 23,000-some clinics to the ability to share
patients' records. That doesn't mean that everybody is
accessing that capability, and during the course of this
morning's discussion, it would be useful to talk about what
further barriers there are to actually using that technology.
However, even though that is the case, today, our customers
share more than 8.8 million records a month with different
healthcare systems, almost 2 million of which are non-Epic,
whether those are health information exchanges, other vendor
systems, or Federal agencies on the e-health exchange, such as
the DoD and the VA and the Social Security Administration.
Healthy Ways tells us that we exchange more records with the VA
than users of any other system.
That being said, interoperability is certainly not a solved
problem, and there are still barriers to achieving everything
that it promises. Significant progress has been made, and it's
important to recognize that progress in the last several years.
We are certainly committed to sharing what we've learned and
furthering the adoption of interoperable technology for the
benefit of our country's patients.
Thank you, and I'll be happy to answer any questions you
have.
[The prepared statement of Mr. DeVault follows:]
Prepared Statement of Peter DeVault
Chairman Alexander, Ranking Member Murray and distinguished
Senators serving on the Health, Education, Labor, and Pensions
Committee, thank you for the opportunity to testify before you today to
help you address, ``America's Health IT Transformation: Translating the
Promise of Electronic Health Records Into Better Care.'' My name is
Peter DeVault. I am director of Interoperability for Epic and I would
respectfully like to share my views on the State of Electronic Health
Record adoption and interoperability as well as the success healthcare
organizations have achieved using our software to engage patients in
their own care. Additionally, I hope my testimony and answers to your
questions today address any concerns you may have and demonstrate our
commitment to advancing Interoperability for our Nations' health care
system.
electronic health record--state of adoption
Over the last 10 years, U.S. healthcare organizations have made
major strides in Electronic Health Record adoption. According to data
released from the ONC and the National Ambulatory Medical Care survey,
nearly 80 percent of office-based physicians and about 60 percent of
hospitals used an electronic health record (EHR) system.
The community of leading care organizations that use Epic have
served as a model of EHR Adoption Success. Epic has never had a
customer fail to go live. No hospital has ever replaced Epic by choice
and we have never lost a customer due to dissatisfaction with our
software or services. Our customers serve patients in all 50 States and
we estimate that when fully rolled out they will provide care for more
than 54 percent of the U.S. population and support efficient daily
workflows for more than 300,000 physicians and many more nurses,
physicians assistants, schedulers, front desk staff and others. They
include the Majority of U.S. News and World Report's Top Hospitals and
Top Pediatric Hospitals Honor Rolls as well as the clinical
organizations affiliated with the top medical schools.
They represent a diverse cross section of the U.S. care industry,
from the world's largest non-government electronic health record
deployment at Kaiser Permanente, to academic medical centers such as
Stanford, Yale, Cleveland Clinic, and the Mayo Clinic, to faith-based
organizations such as Mercy health and Providence, to the Nation's
``Safety Net'' of organizations that run the FQHCs and Critical Access
hospitals that provide access to care for the most vulnerable patient
populations.
More eligible hospitals and professionals have attested for the
first and second stages of Meaningful Use with Epic than any other
system. The Healthcare Information and Management Systems Society
(HIMSS) grades care organizations on a 7-point scale for Electronic
Health Record adoption. More hospitals and clinics at the highest
level, the HIMSS Stage 7 award, use Epic than every other Electronic
Health Record put together.
We are very proud of what they have achieved with our software:
In 2014 alone, groups using Epic handled nearly 400
million ambulatory visits, 34 million Emergency Department visits, 13
million hospital admissions and 48 million hospital outpatient visits.
They are using our software to improve patient safety.
Over 390 million medication warnings were presented in our system, and
our customers used bar code administration workflows to avoid nearly a
quarter of a million harmful or fatal events were prevented by stopping
medication from being administered to the wrong patient.
They are reducing the cost of care by avoiding duplicate
tests, unnecessary clinical visits, and hospital re-admissions due to
complications. Most importantly, they are helping their patients live
healthier lives and take active decisionmaking roles in their own
care--keeping patients out of the hospital, helping them manage chronic
conditions effectively, and ensure important screenings are performed
to catch minor issues before they become major.
It would be impossible to share everything our customers have done
to use the Electronic Health Record to improve quality of care and
reduce costs so I'll just touch on a few examples:\1\
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\1\ Customer statistics are taken from winning HIMSS Davies Award
Case Studies. These Studies are available at http://www.himss.org/
library/davies-awards.
University of Iowa Hospitals and clinics saw a 159 percent
return on investment in the first 5 years following implementation.
UIHC has netted over $50 million from July 2013 to June 2014
attributable toward the use of information technology.
Lakeland Healthcare achieved a 44 percent reduction in
sepsis mortality rate in one quarter due to adherence to EHR-based
clinical decision support order sets and analytical review of outcomes.
They also achieved a 100 percent reduction in transcription-related
adverse drug events.
Children's Medical Center of Dallas reduced Emergency
Department length of stay by 40 percent. They also used the system's
bronchiolitis and RSV pneumonia\2\ pathway\3\ to achieve:
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\2\ Bronchiolitis and RSV Pneumonia is the No. 1 cause of
hospitalization in the United States and accounts for approximately
1,000 inpatient admissions every year at Children's.
\3\ The Bronchiolitis and RSV Pneumonia Pathway was used for
previously healthy children less than 2 years old with a primary or
secondary diagnosis of bronchiolitis (ICD-9: 466.11 and 466.19).
19 percent reduction in median length of stay for
bronchiolitis (from 2.4 to 1.95 days).
34 percent reduction in chest x-rays (59 to 39
percent).
48 percent reduction in bronchodilator use (27 to 14
percent).
22 percent reduction in antibiotic use (32 to 25
percent).
epic's background in innovative healthcare information technology
Epic is 100 percent focused on developing, implementing, and
supporting industry-leading integrated software for a small client base
composed of the world's top academic medical centers, children's
hospitals and large integrated delivery systems. To ensure their
success, our staff to customer ratio is over 20 times higher than our
nearest global competitor. We have a relatively small client base, and
our development priorities are driven by their goals and vision.
The first Epic software systems were created more than 30 years ago
at an academic medical center. Since our founding we have contributed a
number of innovations to health information technology:
Groups using Epic were the first in the industry to have
access to a single system supporting both hospital and ambulatory
clinical care, patient access (i.e., admissions, registration,
scheduling), and medical billing.
Their patients were the first to have a secure web portal
that is part of the electronic health record. MyChart offers access to
medical information such as lab results and immunization records along
with self-service features for appointment scheduling, prescription
renewal requests, and co-pays.
Doctors using Epic were the first to be able to access
patient information, prescription writing, visit notes, and related
features on smartphone and tablet apps that are part of the same
electronic health record they use in the hospital and clinic. They do
it in way that does not store data on the smartphone or tablet, so that
even if the device is lost or stolen their patients' confidential
information is safe.
This level of innovation, coupled with a strong history of
clinician and IT staff satisfaction with our software and services
helped us become one of the most widely adopted and well-respected
health IT vendors. We support the goals and vision of our customer
community with one of the industry's largest research and development
commitments. Nearly 54 percent of our annual operating expenses are
dedicated to development. We conduct all of our development in the
United States, and we support all U.S. customers with U.S.-based staff.
KLAS Enterprises has ranked Epic the #1 overall software suite and
#1 overall practice management vendor based on the results of thousands
of surveys of U.S. healthcare organizations using major health IT
vendors' software. Our enterprise products lead the industry in the
following categories in the most recent Top 20 Best in KLAS report:
#1 Acute Care EMR
#1 Ambulatory EMR (75+ physicians)
#1 Ambulatory EMR (11-75 physicians)
#1 Practice Management (75+ physicians)
#1 Patient Accounting/Patient Management
#1 Health Information Exchange
#1 Patient Portal
#1 Surgery Management
#1 Lab
Over the past 10-15 years, we have helped drive the evolution of
the Electronic Health Record from a system used primarily to document
the care an organization has provided to one that actively supports the
growth of medical knowledge and improves the health of diverse
communities of patients. The Epic EHR underlies our customers'
activities in:
Medical Research and Discovery. The majority of the top 20
National Institute of Health grant recipients use Epic, as do most of
the Nation's most well-respected academic medical centers. Our software
improves the speed and efficiency of areas including research
participant recruitment and data analysis, allowing researchers to
accelerate the pace of discovery and get new knowledge into practice
faster and at a lower cost than was possible with older methods.
Our vision is that a research-enabling EHR should not just empower
the research department. It should empower the curious physician who
wants to investigate a hunch to make the best decision for the
patients. With Epic's self-service reporting, physicians can parse a
large quantity of clinical data and view the results within seconds to
find trends across patient populations or identify specific sets of
patients for whom they need to take followup actions.
Performance-based Reimbursement Models. The healthcare
industry is in the midst of a shift from volume-based payment models
where care organizations are paid based on the number of services they
provide to value-based models that take their quality of care and the
health of their patients into account. Epic's customers have used our
software to pioneer models of care that have emerged to address this
shift such as the Accountable Care Organization and the Patient
Centered Medical Home.
Business Intelligence and Population Management. Epic's
software automatically collects data on each stage of the care process
and the revenue cycle. This gives healthcare organizations a rich
source of data for reporting and analytics. Our analytics tools do more
than show what happened in the past. They include built in benchmarking
so that each Epic customer can see how they are performing against
national averages and against anonymized data from their peers in the
Epic community. They also support predictive modeling that can help
organizations anticipate and prepare for future trends.
Healthy Planet, Epic's population health management module, is the
Nation's fastest growing population health system. More than 115
million patients have already been added to registries to help
organizations manage their care. This makes it very easy for clinicians
and care managers to address the unique needs of diverse groups of
patients. The system helps them identify and engage patients at risk
for specific conditions such as diabetes and events such as hospital
re-admissions. It helps them manage care longitudinally, whether the
patient is seen in a hospital, clinic, post-acute care setting, retail
clinic, or at home--and it provides tools to reach patients in new ways
by taking advantage of emerging technologies for engagement and
telemedicine.
efforts to extend health it adoption
Epic has taken an active role encouraging health IT adoption,
serving with healthcare organizations, policy experts, and other
healthcare software developers in government and industry groups
dedicated to extending the benefits of the EHR nationwide. We have also
been an early supporter of the Government's Meaningful Use program,
becoming one of the first of the major Vendors to offer systems with
Stage 1 and Stage 2 certification.
As a program to accelerate health IT adoption, we view Meaningful
Use as a success. We saw a surge of interest from care organizations in
making the move from paper to EHRs as well as groups looking to move
beyond outdated and functionally limited systems.
One remaining challenge is encouraging health IT adoption among the
smaller and single-provider practices that deliver care for a large
percentage of the U.S. population. These groups encounter higher
barriers to EHR adoption than larger organizations. Even with
incentives that offset costs of acquiring systems the investment of
time and IT resources to install an EHR successfully can be prohibitive
for these groups. Epic is collaborating with its community of customers
to help address this challenge. Through the Connect program,
organizations that use Epic can extend their software to other
practices and hospitals. More than 70 percent of our customers are
helping boost IT adoption among smaller practices and hospitals through
the Connect Program--bringing thousands of new providers live on the
system.
engaging the patient
Advances in telemedicine coupled with a proliferation of affordable
consumer devices for healthcare monitoring continue to expand the reach
of the healthcare organization beyond the walls of the clinic and
hospital. This increases convenience for patients, allows them to
receive services at convenient times and locations, and helps them take
a more active role in managing their own care.
A survey of 12 large organizations using Epic showed that patients
have become the #1 consumer of EHRs (graphic below), echoing what we
see in the evolving healthcare industry, and we have aligned our vision
with this trend. Top MyChart adopters are engaging 65-95 percent of
their populations and reporting millions of dollars in savings.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
MyChart gives patients access to data from same Epic chart used by
clinicians. Patients can use MyChart to exchange secure messages with
members of their care team, review goals and instructions recorded by
their physicians, add data such as blood pressure readings to their
charts, see their upcoming preventive care needs, and schedule
appointments. Patients can access links to education materials curated
for their specific health issues from MyChart.
Patients can update their Epic records with data from home blood
pressure cuffs, glucometers, Fitbits, and other personal devices,
helping clinicians monitor those patients' health and well-being. Data
taken from monitoring devices using Apple's HealthKit will populate
Epic's medical record and similar integration will be available with
Google Fit in the future.
For the hospital, we offer MyChart Bedside, a tablet-based system
that helps improve the care experience for hospitalized patients and
their families. It provides access to personalized information on the
patient's treatment team, scheduled procedures, lab results, electronic
requests for services, and educational materials with support for rich
content such as streaming video, images and Web sites.
For the future, we are creating a MyChart dashboard which will
allow patients to monitor their progress toward their health goals and
give them access to tools that help them meet their goals. We are also
developing a ``Companion'' capability that will remind patients to take
medications, exercise, track blood glucose, or perform other tasks
according to post discharge instructions or their health maintenance/
disease management plan.
the interoperable ehr
The last concept I'll touch on is Interoperability. There's been a
lot of focus on the need for interoperable electronic health records
over the last couple of years, and a lot of confusion and
misinformation in terms of what Epic's software will support.
Epic does not own or claim rights to our customers' patient data.
We do not interfere with their ability to access patient data and we do
not re-sell patient data. We give our customers access to our source
code and developer support. We also provide tools that support the free
flow of information between different system and different
organizations.
We have a patient record exchange platform called Care Everywhere
to support the exchange of patient data between organizations. A
library of interfaces helps keep Epic systems communicate with hundreds
of other systems, transmitting billions of messages a year. And last,
we have application programming interfaces or APIs that we freely
publish along with testing tools on open.epic to support third party
innovation and connection to Epic's EHR.
Our efforts have been validated by independent surveys of live
customers conducted by KLAS. According to a KLAS survey of healthcare
organizations in 2014, we were the only vendor to successfully balance
success and depth of interoperability. We also had the highest ability
to support interfacing and keep interfacing costs low.\4\
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\4\ Source: ``EMR Interoperability 2014'', KLAS Enterprises,
September 2014.
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There are three major components that make up an interoperable
Electronic Heath Record:
Secure health information exchange between healthcare
organizations. Care Everywhere, Epic's standards-based patient record
exchange platform, debuted in 2005--years before the HITECH Act took
effect. Today, Care Everywhere uses the Consolidated Clinical Document
Architecture (C-CDA) as required for Meaningful Use Stage 2
certification. Epic has installed Care Everywhere in all versions of
its EpicCare EHR software in live use. One-hundred percent of customers
who are live with EpicCare also have the ability to exchange patient
records with any other system that supports the national
interoperability standards.
Organizations using Care Everywhere make up the largest active EHR
exchange group in the United States--over 1,000 hospitals and 26,000
clinics are live today and last month they exchanged nearly 8.5 million
records patient with each other and with about 7,500 other
organizations. This includes healthcare providers using other EHR
systems, Health Information Service Providers (HISPs), Health
Information Exchanges (HIEs), and groups connected to the eHealth
Exchange like the VA, the Social Security Administration and the
Department of Defense. According to Healtheway in July 2014,
``Organizations using Care Everywhere exchange more records with the VA
than any other vendor.''
Any Epic customer can exchange patient data with third party that
support national interoperability standards. There is no language in
Epic's contracts to restrict our customer's ability to exchange data.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Interfaces between products. With over 36 years of
experience creating and maintaining connections to other vendor
systems, Epic has one of the largest libraries of existing interfaces.
Each year, billions of data transactions happen between Epic and 600+
other systems through 12,500+ standards-based interfaces.
Along with our interfaces we supply BridgesTM, an
interface development and runtime toolkit that allows customers to
write new interfaces and enhance/modify existing ones as well as
efficiently maintain and monitor all the Epic interfaces they use.
These interfaces allow healthcare organizations to connect with
other vendors and outside groups such as pharmacies, specialty and
immunization registries, and lab systems. Connections to outside
agencies include public health agencies, research societies,
immunization registries for 46 States, and research registries.
An open system that encourages customer and third party
innovation. For third-party application providers and device
manufacturers, the open.epic initiative speeds the connection process
to Epic's systems through public documentation, application programming
interfaces (APIs), and online testing tools. Epic provides public test
harnesses for third party developers to test their integration with our
software using FHIR (Fast Health Interoperability Resources) at http:/
/open.epic.com/Interface/FHIR.
For healthcare organizations, we have a large set of Web services
and APIs for them to create add-ons, extensions, and new functionality.
We also offer them the same tools that we use to develop our systems,
as well as training for developers and access to source code.
This year, we debut the Epic app exchange to allow these developers
to offer their innovations to the Epic customer community.
We are also continuing our work as a founding member of the
Argonaut Project launched by Health Level 7, a non-profit driving the
development of international healthcare informatics interoperability
standards. Epic is working with healthcare and IT leaders such as Mayo
Clinic, athenahealth, Cerner Corporation, Intermountain Healthcare,
Meditech, and Beth Israel Deaconess Medical Center accelerate the
development and adoption of Health Level 7's Fast Healthcare
Interoperability Resources (FHIR). This development will enhance and
expand information sharing among EHR systems and other elements of
healthcare technology.
epic's efforts to encourage interoperability
Along with encouraging adoption, the Meaningful Use program was
intended to encourage seamless interoperability across electronic
health records. The goal is that a patient should be able to go to any
organization using an Electronic Health Record that meets national
interoperability standards and have their key medical information be
accessible to the provider treating them. While Epic views the
Meaningful Use program as a success in terms of encouraging Health IT
adoption, three key challenges still remain in achieving true
nationwide interoperability.
A single nationwide directory of exchange ready
organizations and providers. It should be fast and simple for a
provider to determine whether another organization has treated their
patient in the past. This can be challenging because the organization
they are looking for could be a member of one of several
interoperability networks--resulting in a time consuming search every
time the provider wants to share information. One nationwide network of
groups able to exchange patient data would make the process much more
efficient.
Consistent Standards. Products from light bulbs to cars
rely on standards, and healthcare is no exception. Healthcare
information technology has a variety of Standards Development
Organizations tackling a variety of challenges including: data
exchange/messaging standards, terminology standards, document
standards, conceptual standards, applications standards, and
architecture standards. At times, healthcare has too many options to
choose from, with multiple standards serving similar purposes. That's
why you can have multiple interoperability networks adopting different
standards for exchange of something as fundamental as a patient's
medications, or using different data exchange methods. One network may
choose to ``push'' messages to another participant using one standard
(e.g., Direct messaging), while another may choose to pull messages
from its participants using another standard (e.g., IHE profiles).
Legal Framework. Before care organizations can exchange
data, they must have a legal framework in place governing the use of
this connectivity. This ensures, for example, that use remains
consistent with the Health Insurance Portability and Accountability Act
(HIPAA) requirements. Today, the legal agreements used by one network
typically are not compatible with other networks. This means that every
time a care organization wants to connect with another group, they may
be required to negotiate a new agreement. This is an extremely time
consuming process and has created the misconception in the industry
that interoperability is being ``blocked.''
The result is that while many individual interoperability networks
have emerged (see graphic), no single network provides universal
interoperability. No single network attempts to address all
interoperability use cases and scenarios, and no single technical
platform operated by a single provider can meet the needs of all the
diverse players in healthcare. Just as ATMs and cell phones rely on
multiple, interconnected networks, healthcare must connect its
interoperability networks to achieve universal connectivity.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
To put this ATM-like structure in place for healthcare, Epic has
helped found Carequality, a public-private collaboration working to
create a unifying legal and technical agreement to accelerate
connection between networks regardless of platform or underlying
technology. Carequality participants include the largest public and
private interoperability networks in the United States like the
Surescripts network (largest e-prescribing network) and the eHealth
Exchange.
Carequality's work will build on the success of Epic's Care
Everywhere network. By providing a single directory of participating
organizations, one consistent legal agreement governing data exchange,
and a single set of technical standards, Epic allowed customers to make
connections with other network participants much faster and at lower
expense that is possible when making connections to groups outside the
network. That's what made Care Everywhere the largest open
interoperability network in the United States, and what allowed us to
achieve 100 percent adoption across all live customers. The CareQuality
Vision is illustrated in the graphic below.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
I look forward to answering any questions you may have for me and
welcome future dialog beyond this hearing. Thank you for this
opportunity.
The Chairman. Thank you, Mr. DeVault.
Dr. Kennedy.
STATEMENT OF ANGELA KENNEDY, Ed.D., M.B.A., R.H.I.A, HEAD OF
DEPARTMENT/PROFESSOR, DEPARTMENT OF HEALTH INFORMATICS AND
INFORMATION MANAGEMENT, COLLEGE OF APPLIED AND NATURAL
SCIENCES, LOUISIANA TECH UNIVERSITY, RUSTON, LA
Ms. Kennedy. I'm very honored to be here today. Certainly,
I don't want to over-simplify my testimony as Professor of
Health Informatics and past president of the American Health
Information Management Association. I will answer questions
related to policy and technical questions as appropriate.
Today, I really want the voice of the consumer to be heard, and
the importance of interoperable health IT for the consumer to
be shared with you.
As a parent of two adopted children, my desire for complete
and accurate medical information rests at the top of my to-do
list. My children, Zach and Grace, are siblings, adopted at the
ages of 2 and 4 from the State of Louisiana.
State laws vary on the provision of medical information and
the provision of family medical history to parents of adopted
children. We acquired a limited medical history for each child
and almost no family medical history. Through diligent
searching, I have been able to access additional information
and recreate missing medical information through claims data
and limited hospital medical records.
Many of the medical records for my children have been
destroyed by both hospitals and clinics. My children have been
treated for asthma and allergies for most of their lives. With
each visit, I'm quick to tell every physician that we encounter
that my children are adopted and that I do not have a family
medical history for them.
This is a statement that I've always believed to be
valuable to the care and treatment of my children. Recently,
the impact of that statement and the importance of carefully
maintaining their personal health information has become
paramount.
In January 2014, at the request of my physician, we changed
asthma and allergy specialists. After a review of Grace's past
medical history, the physician requested a followup appointment
for additional testing. The second visit changed our world
forever, and my daughter, Grace, was diagnosed with cystic
fibrosis at the age of 11.
Armed with a thumb drive and a 5-inch binder of medical
information, which included copies of every pulmonary function
test and every doctor's visit since the age of two, we
presented for our first visit with the pediatric pulmonary
specialist. When we returned for the second visit, our
physician had analyzed the data and concluded that Grace never
had asthma or allergies and removed her from medications that
she had been taking for 9 years.
Grace is just one example of why the commitment to the
consumer must be made that we can provide health information
where and when we need it, a guarantee that information will be
available, accessible, accurate, and complete. I experienced
many frustrations in my attempt to gather my child's medical
records.
Due to an inaccurate entry in my daughter's medical record,
the inheritable condition was overlooked. The records included
an inaccurate statement that had been copied and pasted into
subsequent records for 9 years. Copy-paste and copy-forward
pose risks to patient care.
In my daughter's case, perhaps if the information had been
reviewed or audited for accuracy, she would have received an
earlier diagnosis. If information governance practices would
have been in place, things could have been different.
Information governance is not just a program for hospitals.
It should be thought of as the gold standard for health
information and documentation practice across the healthcare
ecosystem. From creation to deletion, information governance
policies created and enforced by the provider can support a
data and information infrastructure that is as critical to
patient care as the care that is provided.
Governance policies must clearly define the legal health
record and address retention standards. Consumers shouldn't
have to recreate care from claims data or worry about their
data being stolen or destroyed. Things are rapidly changing,
but we must navigate that change in ways that drive better
decisionmaking for patients and the providers who treat them.
As healthcare professionals, we have been applying data
analytics and informatics techniques for many years. The
difference now is that the data is electronic with multiple
users at multiple settings applying multiple guidelines for
collection, creation, storage, use, and deletion. Care is
important, but the information generated is what remains when
the care is complete. We cannot neglect this consumer's legacy
that is left for us to preserve and to protect.
Healthcare professionals encounter healthcare consumers
daily. We know the benefits that access and use of personal
health information can bring to the consumer and their
families.
But consider this. Over the past year, I've written
numerous appeals to our insurance company to pay for an $18,000
vest for my daughter, and I've lobbied for prescription
medicine coverage and coverage for supplements, all of which
are vital to her care. I am a healthcare professional. What
about the average consumer who is just overwhelmed by a
diagnosis and just trying to make it to the next day?
As we address these barriers, we also must keep in mind
health literacy levels of healthcare consumers. Health literacy
can be defined as the degree to which individuals have the
capacity to obtain, process, and understand basic health
information and services needed to make appropriate decisions.
Only 12 percent of adults have proficient health literacy,
according to the National Assessment of Adult Literacy.
On our journey to remove barriers to accessible health
information, we must ensure that this is understandable and
actionable by consumers. It is our challenge to educate
consumers and local communities on the importance and value of
personal health information and educate consumers on the
importance of the opt-in and interoperability for continuity
for care.
For my daughter, personal health information is saving
Grace.
[The prepared statement of Ms. Kennedy follows:]
Prepared Statement of Angela Kennedy, Ed.D., M.B.A., R.H.I.A.
summary
As a parent of two adopted children, my desire for complete and
accurate medical information rests at the top of my ``Mom to-do list.''
My children, Zach and Grace, are siblings, adopted at the ages of two
and four from the State of Louisiana. State laws vary on the provision
of medical information and the provision of family medical history to
parents of adopted children. We acquired a limited medical history for
each child and almost no family medical history. Through diligent
searching, I have been able to access additional information and
recreate missing medical information through claims data and limited
hospital medical records. Many of the medical records for my children
have been destroyed by both hospitals and clinics.
My children have been treated for asthma and allergies most of
their lives. With each visit I'm quick to tell every physician that we
encounter that my children are adopted and I don't have a family
medical history for them. This is a statement that I have always
believed to be valuable to the care and treatment of my children, but
recently the impact of that statement and the importance of carefully
maintaining their personal health information has become paramount.
In January 2014, at the request of my physician, we changed asthma
and allergy specialists. After a review of Grace's past medical
history, the physician requested a followup appointment for additional
testing. The second visit changed our world forever. Grace was
diagnosed with cystic fibrosis at the age of 11.
Armed with a thumb drive and a 5" binder of medical information--
which included copies of every pulmonary function test and every
doctor's visit since she was two--we presented for our first visit with
the pediatric pulmonary specialist. When we returned for the second
visit, our physician had analyzed the data and concluded that Grace
never had asthma or allergies and removed her from those medications.
Gracie is just one example of why a commitment to the consumer must
be made . . . that we can provide health information where and when
they need it; a guarantee that information will be available,
accessible, accurate, and complete. I experienced many frustrations in
my attempt to gather my child's medical records. Due to an incorrect
entry in my daughter's medical record, the inheritable condition was
overlooked. The records included an inaccurate statement that had been
copied and pasted into all subsequent records for 9 years. Copy paste
and copy forward pose risks to patient care. In my daughter's case,
perhaps if the information had been reviewed or audited for accuracy,
she would have received an earlier diagnosis. If information governance
practices would have been in place, things could have been different.
Information governance is not a program just for hospitals. Information
governance should be thought of as the gold standard for health
information and documentation practice across the healthcare ecosystem.
From creation to deletion, information governance policies can support
a data and information infrastructure that is as critical to the
patient as the care that is provided. Governance policies must clearly
define the legal health record and address retention standards.
Consumers shouldn't have to recreate care from claims data or worry
about their data being stolen.
Things are rapidly changing, but we must navigate that change in
ways that drive better decision making for patients and the providers
who treat them. As healthcare professionals, we have been applying data
analytics and informatics techniques for many years. The difference now
is that the data is electronic, with multiple users at multiple
settings, applying multiple guidelines for collection, creation,
storage, use, and deletion. Care is important but the information
generated is what remains when the care is complete, and we can't
neglect the consumer's legacy that is left for us to preserve and
protect. Healthcare professionals encounter healthcare consumers daily.
We know the benefits that access and use of personal health information
can bring to the consumer and their families. But consider this: over
the past year, I have written numerous appeals to our insurance company
to pay for an $18,000 vest for my daughter, and I have lobbied for
prescription and supplement coverage, all of which are vital to her
care. I am a healthcare professional. What about the average consumer
who is overwhelmed by a diagnosis and just trying to make it to the
next day?
As we address these barriers, we must also keep in mind the health
literacy levels of healthcare consumers. Health literacy can be defined
as the degree to which individuals have the capacity to obtain,
process, and understand basic health information and services needed to
make appropriate decisions.\1\ Only 12 percent of adults have
proficient health literacy according to the National Assessment of
Adult Literacy. On our journey to remove barriers to accessible health
information, we must ensure that it is understandable and actionable by
consumers. It is our challenge to educate consumers and local
communities on the importance and value of personal health information.
For my daughter, personal health information is ``saving Grace.''
---------------------------------------------------------------------------
\1\ U.S. Department of Health and Human Services. 2000. Healthy
People 2010. Washington, DC: U.S. Government Printing Office.
Originally developed for Ratzan SC, Parker RM. 2000. Introduction. In
National Library of Medicine Current Bibliographies in Medicine: Health
Literacy. Selden CR, Zorn M, Ratzan SC, Parker RM, Editors. NLM Pub.
No. CBM 2000-1. Bethesda, MD: National Institutes of Health, U.S.
Department of Health and Human Services
---------------------------------------------------------------------------
______
As a health informatics and information management (HIIM)
professional and a parent of two adopted children, my desire for
complete and accurate medical information rests at the top of my ``Mom
to-do list.'' My children, Zach and Grace, are siblings, adopted at the
ages of two and four from the State of Louisiana Office of Family and
Child Services.
State laws vary on the provision of medical information and the
provision of family medical history to parents of adopted children. We
acquired a limited medical history for each child and almost no family
medical history. Through diligent searching, I have been able to access
additional information and recreate missing medical information through
claims data and limited hospital medical records. Many of the medical
records for my children have been destroyed by both hospitals and
clinics.
My children have been treated for asthma and allergies most of
their lives. With each visit I'm quick to tell every physician and
medical professional that we encounter that my children are adopted and
I don't have a family medical history for them. This is a statement
that I have always believed to be valuable to the care and treatment of
my children, but recently the impact of that statement and the
importance of carefully maintaining their personal health information
has become paramount.
In January 2014, at the request of my physician, we changed asthma
and allergy specialists. After a review of Zach and Grace's past
medical history, the physician requested a followup appointment for
additional allergy testing. The second visit changed our world forever.
With no known family history of autoimmune disease, Grace was sent for
a sweat test as a precaution when she failed to respond to the allergy
testing.
Grace was diagnosed with cystic fibrosis at the age of 11. Cystic
fibrosis is usually diagnosed shortly after birth. Grace was
immediately seen by a pulmonary pediatric research specialist at Texas
Children's Hospital. Armed with a thumb drive and a 5" binder of
medical information--which included copies of every pulmonary function
test and every doctor's visit since she was two--we presented for our
first visit.
When we returned for the second visit, our physician had analyzed
the data and concluded that Grace never had asthma or allergies and
removed her from those medications. Her analysis of the data also
helped her determine a correlation between seasons and when Grace's
pulmonary functions declined, finding that past episodes that were
labeled ``upper respiratory infection'' were due to her lungs not
clearing properly during periods of lower activity. Genetic testing
revealed that she has a rare form of cystic fibrosis.
Her plan of treatment focuses on wellness. Grace wears a Nike
FuelBand to track her levels of activity. The data collected helps to
keep Grace well. Grace journals and keeps records on her activity,
diet, and how she's feeling. All of the data that she collects is
shared with her care team and becomes a part of the medical record.
Grace reviews her electronic medical record and is aware when additions
are made to the documentation. Records that are not available
electronically are collected and added to the personal health record we
keep at home. Copies of those records are shared with her specialist on
each visit.
Grace communicates with her care team and is actively involved in
making decisions about her care. Personal health information is saving
Grace. When you meet my daughter, she appears to be the picture of
wellness. That's a picture that we want to see every day, a picture
that tracking data helps us to keep.
It is important to note that a comprehensive past medical history
enabled Grace's physician to quickly assess and create a plan of
treatment specific to her needs. A complete medical record, cradle to
current medical history, was not available electronically and was not
easy to obtain. I went to every care provider that has seen my daughter
since the age of two. I requested copies of complete medical records.
For those medical records prior to her adoption, I went to local
clinics and hospitals near the location where my children were placed
in foster care for the first few years of their lives and requested any
available medical or claims data. Most early medical records had been
destroyed but the claims data and with associated charges and ICD-9-CM
diagnosis codes remained. From claims data, I was able to reveal an
early history of acute and chronic respiratory illness and the
treatment that was provided.
Acquiring medical data from local family physician and pediatrician
was fairly easy. I requested the medical information and it was printed
from the electronic record on the day of request. All x-rays were
placed on a CD and the information was provided to me and sent directly
to the pediatric pulmonary specialist in Texas. While the critical
access hospital/clinic utilizes an electronic medical record,
interoperability between the two facilities was not possible. Not all
documentation was stored in the electronic record. Both a paper and an
electronic record existed for my daughter. While these records were
easy to obtain others were not.
The asthma and allergy clinic, where my daughter had been seen
every 6 months since the age of two, delayed the release of her medical
records. The office immediately provided me a copy of every pulmonary
function test since the age of two, but refused to release physician
notes. The office manager stated that the physician would need to
verify the notes and then information would be sent to the specialist
after review.
The office promised to fax to my husband's office and the research
clinic the following day (Saturday). The records were never received
and the office was closed on Saturday. On Monday, I requested the notes
be faxed directly to me at the hotel where we were staying and to the
research clinic. The office manager told me that the fax on Saturday
had been sent but to the wrong location. The first fax that was sent to
the hotel also went to the wrong location. On the third attempt the
records were received. The records were never sent from the physician
to the research clinic. After receiving the information I quickly began
to collate and review. Upon review, I found this statement this
statement in the family medical history: ``the mother states that there
is no family medical history of genetic disease.'' The statement was
entered on the first visit at the clinic. It was clearly a copy paste/
copy forward in the electronic record and the entry was made on every
visit that followed. That one statement ruled out cystic fibrosis as a
diagnosis for that care team and possibly any care team that utilized
that record.
Gracie is just one example of why a commitment to the consumer must
be made that we can provide health information where and when they need
it. We need a guarantee that information will be available, accessible,
accurate, and complete. Copy paste and copy forward pose risks to
patient care. In my daughter's case, perhaps if the information had
been reviewed or audited for accuracy, she would have received an
earlier diagnosis.
This audit is not just the responsibility of the care giver but
also the responsibility of the patient. Patients should routinely
access and review records for accuracy. Since 2003, the Federal HIPAA
privacy rule has given individuals the right to examine and obtain
copies of their health records, yet there is still widespread
misunderstanding about these rights in the healthcare community, and
barriers still exist for patients and families seeking full access to
health records and information.
For example (and anecdotally), the ``HIPAA law'' is still given as
the reason a patient or another provider cannot be provided with copies
of or access to health records or information--although this could not
be further from the truth.
Without full access to their health information, patients and
consumers are unable to make informed care decisions and the status
quo--care that is not patient-centric--continues. There is a need to
ensure that barriers to accessing health information are removed--both
through education of providers about patient rights and how to
administer HIPAA, and through increased implementation and effective
leveraging of health information technology to make information more
accessible to patients, consumers, and all providers caring for the
patient.
If information governance practices would have been in place,
things could have been different. Information governance is not a
program just for hospitals. Information governance should be thought of
as the gold standard for health information and documentation practice
across the healthcare ecosystem. From creation to deletion, information
governance policies can support a data and information infrastructure
that is as critical to the patient as the care that is provided.
Governance policies must clearly define the legal health record and
address retention standards. Consumers shouldn't have to recreate care
from claims data or worry about their data being stolen.
Effective implementation of regulations and laws and leveraging of
health information technology for sharing of health information with
both consumers and other providers highlights the need for ``rules of
the road'' or information governance. Without governance mechanisms
that are agreed upon across the larger healthcare ecosystem, the United
States will not be able to receive full benefit from its multi-billion
dollar investment in health IT, let alone advance patient-centric care.
Governance is needed to have high-integrity, reliable health
information that can be trusted for healthcare decisionmaking.
The American Health Information Management Association (AHIMA)
defines information governance as a framework for managing health
information throughout its lifecycle and which supports strategy,
operations, regulatory, legal, risk, and environmental requirements. It
includes the processes, standards, and tools necessary for establishing
decision rights, valuation of information, and improvement of data
quality and integrity. Most importantly, information governance is
based on principles. AHIMA has identified the set of Information
Governance Principles for Health Care as:
Accountability: Senior leadership oversight and
responsibility for information management.
Transparency: Information management practices and
processes that are open and verifiable.
Integrity: Reasonable and suitable guarantee of the
authenticity and reliability of information.
Protection: Appropriate levels of protection against
breach, loss, or corruption of information.
Compliance: Information complies with applicable laws,
regulations, standards and organizational policies.
Availability: Maintenance of information in a manner that
ensures timely, efficient, accurate retrieval.
Retention: Maintenance of information for the period of
time that takes into account its legal, regulatory, fiscal,
operational, risk and historical requirements.
Disposition: Secure and appropriate disposal of
information no longer required to be retained by law or organizational
policies.
Many of the current challenges in the healthcare industry
associated with health IT have been the result of inattention to these
principles at higher levels of the healthcare ecosystem--not just at
the level of the individual healthcare entity or organization.
In addition to principles, the adoption and use of functional,
semantic, and technical standards to support the interoperability
necessary for stakeholders to share information is a critical
information governance issue. This includes the ability to properly
identify patients as well as locate information about them. It also
includes ensuring the proper incentives are in place to encourage their
adoption, implementation and use.
If we continue with a narrow focus on technology and without a
focus on information governance processes and principles, the United
States will continue to experience daunting challenges related to
health information exchange and sharing, patient identification, and
privacy/security. Patients will continue to be at a disadvantage in
trying to manage their health without appropriate, trusted information.
Information governance is the new imperative for advancing the use of
health IT and health information to support patient-centric care. And
what about claims data? It was critical to providing a complete medical
history for my daughter and the codes that remained and the charges
associated with her visits helped to recreate the encounter.
Addressing the current classification system is important, too. We
should have been talking about the value of patient information and the
classification of disease for population health long before now. The
ICD-10 implementation delay presents implications for providers, health
plans, and State and Federal agencies, but we must continue to advocate
for ICD-10 implementation. ICD-10 will have tremendous value and impact
on population health data and the consumer. It is imperative we clearly
articulate to the consumer the value of accurately coded data.
Things are rapidly changing, but we must navigate that change in
ways that drive better decisionmaking for patients and the providers
who treat them. As healthcare professionals, we have been applying data
analytics and informatics techniques for many years. The difference now
is that the data is electronic, with multiple users at multiple
settings, applying multiple guidelines for collection, creation,
storage, use, and deletion. Data are being generated by mobile health
and personal health devices. We have to make certain that we are using
clean data to create health intelligence. Care is important but the
information generated is what remains when the care is complete, and we
can't neglect the consumer's legacy that is left for us to preserve and
protect.
Healthcare professionals encounter healthcare consumers daily. We
know the benefits that access and use of personal health information
can bring to the consumer and their families. Consider this: over the
past year, I have written numerous appeals to our insurance company to
pay for an $18,000 vest for my daughter, and I have lobbied for
prescription coverage for a $1,500 monthly prescription and supplement
coverage for my daughter, all of which are vital to her care. I am a
healthcare professional; I know how to get these things accomplished.
What about the average consumer who is overwhelmed by a diagnosis and
just trying to make it to the next day?
As we address these barriers, we must also keep in mind the health
literacy levels of healthcare consumers. Health literacy can be defined
as the degree to which individuals have the capacity to obtain,
process, and understand basic health information and services needed to
make appropriate decisions.\1\ Only 12 percent of adults have
proficient health literacy according to the National Assessment of
Adult Literacy. Fourteen percent of adults (30 million) have below
basic health literacy. These people were more likely to report their
health as poor when compare with those with proficient health
literacy.\2\ In our journey to remove barriers to accessible health
information, we must ensure that it is understandable and actionable by
consumers.
---------------------------------------------------------------------------
\1\ U.S. Department of Health and Human Services. 2000. Healthy
People 2010. Washington, DC: U.S. Government Printing Office.
Originally developed for Ratzan SC, Parker RM. 2000. Introduction. In
National Library of Medicine Current Bibliographies in Medicine: Health
Literacy. Selden CR, Zorn M, Ratzan SC, Parker RM, Editors. NLM Pub.
No. CBM 2000-1. Bethesda, MD: National Institutes of Health, U.S.
Department of Health and Human Services.
\2\ Kirsch IS, Jungeblut A, Jenkins L, Kolstad A. 1993. Adult
Literacy in America: A First Look at the Results of the National Adult
Literacy Survey (NALS). Washington, DC: National Center for Education
Statistics, U.S. Department of Education.
---------------------------------------------------------------------------
Today's models of healthcare demand a commitment to wellness. It is
our challenge to educate consumers and local communities on the
importance and value of personal health information. There is so much
each and every one of us can do to make an incredible difference.
The Chairman. Thank you, Dr. Kennedy.
Senator Murray. Mr. Chairman, if I could just say, I have
to go to the floor, and we have numerous Senators here. If I
could, I would like to submit my questions for the record. I
just want to thank all of the witnesses here today, and I will
allow one of the other Senators to take my time.
The Chairman. If you would like to go ahead and ask
questions, you're welcome to do that.
Senator Murray. No, that's OK. I'll submit mine for the
record. We have a lot of people here who want to ask questions.
The Chairman. All right. We have two votes. The first is at
11. What we'll do is we'll begin a round of 5-minute questions.
I'll go vote at 11, and then I'll come back, and we'll make
sure that as long as Senators want to ask questions, we'll keep
going until about noon. We'll work it out so someone is
presiding while I'm gone.
Thank you, Senator Murray.
We'll begin a round of 5-minute questions.
Dr. Wergin, about half the doctors, half the physicians who
are participating in Medicare and are eligible for the
electronic health records program aren't participating, and
they're about to be penalized this year. Why are they not
participating, and why are they willing to accept a penalty
rather than participate?
Dr. Wergin. Senator Alexander, that's a good question. A
lot of it has to do with the regulatory requirements to meet
Meaningful Use, and I'll use a personal story again.
I met Meaningful Use in the last day of the 90-day
reporting period when my staff came up at 3 o'clock--the
reporting period was going to end at 5 o'clock--and said,
``You're two patients short of having a patient send you a
question through the portal.'' I stopped what I was doing,
called two patients that I'd seen--``Could you send me a
question about your labs?'' They were a little confused. I met
it by the skin of my teeth.
The all-or-nothing quality of that--those two patients
allowed me to participate in Meaningful Use and avoid the
penalties. If they had not, I would not have met Meaningful Use
and got the penalty.
All or nothing, 100 percent or 0 percent. Many of the
providers, in terms of their work flow and the reporting
requirements, particularly small practices--I don't have an IT
support team. My staff and I worked very hard on this, spent
many hours, and, in fact, if I had calculated the hours I spent
on meeting Meaningful Use, it may have been a wash in terms of
the benefit, but also the penalty.
Many practices, as they look at it, say, ``We're engaged.
We were early adopters.'' About 77 percent that have electronic
health records say, ``The time, expense, and the effort it
takes makes it not worthwhile, and I'll have to take the
penalty.''
The Chairman. The penalty starts out at 1 percent, but it
will eventually go up to 5 percent. It gets to be a pretty
significant penalty for about a quarter of a million doctors.
Right?
Dr. Wergin. Yes, and that's significant. Again, in primary
care--and I can speak for my family physicians--we're in the
trenches, in day-to-day practice that--it's really small margin
care. We don't have large procedures with high margins, and we
have overhead to meet. You're exactly right. It becomes kind of
a business decision--the efforts to do that.
We, as an academy, try to provide them tools and support to
help them meet Meaningful Use. I'll use another example. I
practice in a Mennonite community. My Mennonites don't have
TVs, newspapers, or radios, so they surely don't have
computers. That removes them from the pool.
The Chairman. Let me go to Dr. Adler-Milstein. We live in
an era where it seems like almost everyone has a smart phone,
and we imagine all of these wonderful advances that could
happen with this sort of useful information. You mentioned
other industries that have done a good job of dealing with
data. What industries do you have in mind? Who has done
something like this better?
Ms. Adler-Milstein. Sure. I think there are two components
to it. One is if you look at industries that are sort of
regularly using data to improve the value that they deliver, we
look to technology service companies. Amazon, on a day-to-day
basis, is making decisions about its business strategy based on
the data that they see.
But that's just within Amazon. Amazon is certainly not
sharing their data with their competitors and other
organizations. When we look to the data sharing piece of it,
then we turn to the financial and banking industry, where you
do see that there is a national system that's been created that
allows you to put your ATM card into any ATM machine.
I don't want to say that the two scenarios are equivalent.
In healthcare, we're dealing with much more complex data. It is
very different from the financial industry, but we can at least
see that it is possible to achieve that level of information
sharing of a basic set of data.
The Chairman. You study this. You don't receive incentives
for all this.
Do you believe the penalties should be deferred until the
government does a better job of enabling physicians and
hospitals to use electronic healthcare data?
Ms. Adler-Milstein. That's a tricky question, because on
the one hand, we want to keep the pressure on to keep doctors
and hospitals from demanding more from these systems. We want
to keep that market demand piece there.
If we pull the penalties back, there's a risk that we'll
sort of accept the status quo and that pressure won't be there.
That's a reason to think carefully about it. If we were to pull
back penalties, we need to think carefully about how to make
sure that the market incentives are in place to make sure that
the systems continue to improve.
The Chairman. Senator Warren and then Senator Cassidy.
Statement of Senator Warren
Senator Warren. Thank you, Mr. Chairman.
As a result of the 2009 HITECH Act, most providers have
electronic health record systems right now. Many still can't
exchange patient information. For example, when a patient goes
to a new doctor for the first time, all of their background
information and their tests have to be collected from scratch,
even if it was collected just down the street a week earlier.
This leads potentially to unnecessary testing, to lost
time, to wasted money. A 2014 study performed by Dr. Adler-
Milstein and other University of Michigan researchers found
that emergency rooms connected to a regional health information
exchange ordered fewer duplicate tests. Patients in these ERs
were 59 percent less likely to have a redundant CT scan, 44
percent less likely to get a duplicate ultrasound, and 67
percent less likely to have a duplicated chest x-ray compared
with patients who went to unconnected hospitals.
In 2015, when cell phones can text pictures instantly
around the globe, it just doesn't make sense that potentially
lifesaving health information can't be transferred across the
street. The problem doesn't seem to be a lack of technology.
Instead, it seems that there must be other barriers that are
holding up the exchange of health information.
Mr. DeVault, you represent Epic, the largest electronic
medical record vendor in the country. You have testified that
you can set up systems that talk to each other. Doctors report
that it can cost tens of thousands of dollars for a single
office to set up a connection to another system.
The Department of Health and Human Services is working with
the industry to address one of the three key remaining
challenges that you identified in your testimony, and that is a
lack of consistent data standards. I want to ask once we have
uniform standards, can we expect that health information
exchange will be easier and cheaper?
Mr. DeVault. Thank you, Senator Warren. It's a very good
question. Often, I hear that the problem with interoperability
is the lack of standards, and I would argue that that's a minor
problem compared to some of the others. We've had standards for
several years now for being able to interoperate with some
kinds of data.
Senator Warren. I'm sorry. Let me just make sure I'm
following you. You're saying we already have uniform standards?
Mr. DeVault. We don't have standards for everything. We
have standards for being able to exchange some information,
such as medications, laboratory results----
Senator Warren. We saw the business here--x-rays, blood
tests----
Mr. DeVault. Absolutely. There's much more work to be done.
However, we can do a lot of important----
Senator Warren. The question I'm asking is when we get
standards, would we expect that the cost of creating
interoperability among systems would decline?
Mr. DeVault. It will eventually decline. Here are some of
the costs that----
Senator Warren. I just want to focus right now on this
question about what standards will do for us and how it is that
we get this cost down. I assume having better standards means
we get these costs beaten down, at least some. There may be
other issues going on here.
Mr. DeVault. Once they're implemented.
Senator Warren. Let me ask about some of these other
issues.
Dr. Adler-Milstein, even once we have consistent standards,
what barriers will stand in the way of health information
exchange?
Ms. Adler-Milstein. One of the key ones are these issues
around competition. Some of my research has shown that in more
competitive markets, hospitals are less likely to share data
with each other. It's, in some ways, an obvious point, which is
when you say, ``This is an entity you're used to competing
with. Now share all your data with them,'' most organizations
are going to say that makes no sense.
Senator Warren. Wait. Why do they not want to share the
data?
Ms. Adler-Milstein. Because they're competitors. They're
competing for the same patients. If you share the data, it
makes it easier for patients to go get care from your
competitor.
Senator Warren. Basically, it's a way to tie a patient to a
system, to say the system is not going to share data anywhere
else.
Ms. Adler-Milstein. Exactly, and I actually think it gets
factored in on the margin. When interoperability is expensive,
you have to justify that expense, and it makes it hard to
justify when there are these potential competitive implications
that get played in. The two barriers relate to each other.
If interoperability were cheap, it may be--hospitals and
doctors may be more willing to take that risk. As long as it's
expensive, as I said, It's an expense that becomes hard to
justify.
Senator Warren. Thank you. The Federal Government has
invested nearly $30 billion in electronic health records,
because exchanging health information in real time improves
patient safety, it saves lives, and it can reduce healthcare
costs.
We now have the technology, as you rightly point out, to
create an electronic records system that lets one part talk to
another. Soon we're going to have data standards that will make
the connection to the system both easier and cheaper. It seems
past time to eliminate the perverse incentives and
administrative barriers and just get this done.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Warren.
Senator Cassidy.
Senator Cassidy. Mr. DeVault, we're hearing over and over
again about the cost. You all have a 50 percent market share,
so I guess that kind of looks at you. How much do you all
charge each practice for each patient to interface with the--if
you will, to put each patient into Epic and to share their
data?
Mr. DeVault. Thank you, Senator. One thing that's important
to note is that we do not sell our systems at the practice
level. Most of our organizations are very large.
Senator Cassidy. If I work for Our Lady of the Lake
Hospital in Baton Rouge when I go see patients, and I have a
patient's data I'm entering, and imagine the Lake wants to send
that data someplace else, how much does the Lake pay for the
cost of that transaction?
Mr. DeVault. There are two costs that go into creating the
connection to begin with, and then the licensing cost for the
actual software. Creating the connection to begin with to that
other system can vary widely. We charge for that based on an
hourly fee.
Senator Cassidy. Let me ask, because it seems as if to a
certain extent there is common ground between all these
different interfaces.
Mr. DeVault. To some extent.
Senator Cassidy. It almost seems like you could plug and
play a little bit.
Mr. DeVault. It's getting there. It's not quite--with some
vendors, we've done it so many times that it is plug and play.
For example, when we connect to a Greenway, we've done that
many times----
Senator Cassidy. Now, back to the question. We have 1,000
patients that they are sending data elsewhere. How much is
charged on a per-patient basis, if you will, to send that data?
Mr. DeVault. We charge on a per-patient, per-year basis, so
it's not per transaction, and it's the same whether that
patient is sent to 100 different places or one other place, and
that charge is $2.35----
Senator Cassidy. Does both the receiver and the sender----
Mr. DeVault. No. We only have a relationship with the Epic
side of that, so we charge our customer.
Senator Cassidy. How much do the upgrades typically cost?
Mr. DeVault. We don't charge for our upgrades. All of our
customers have a perpetual license to the software. We did not
charge anything for the Meaningful Use upgrade. I know many
other vendors did. We didn't raise our licensing rate, so
somebody who bought our system last year paid the same with
differences in----
Senator Cassidy. The Office of the National Coordinator for
Health IT speaks of a cost of $15,000 to $70,000 per provider
to bring in an electronic medical record. Dr. Wergin is nodding
his head yes.
Can I ask how much your practice had to pay for your EMR?
Dr. Wergin. Easily in that range. I would say a little
more.
Senator Cassidy. It's a big range. So you paid more than
$70,000?
Dr. Wergin. Yes. Probably per provider, including training
and implementation, not counting reduced patient volume and
stuff, it was probably in that $70,000 to $80,000 per provider.
Senator Cassidy. Per provider?
Dr. Wergin. Yes, per provider.
Senator Cassidy. My gosh. How much was offset with the
Federal subsidies?
Dr. Wergin. It did not offset the entire amount, and one of
the----
Senator Cassidy. Substantially, or 20 percent, 100 percent,
90 percent--ball park.
Dr. Wergin. It was $44,000, so roughly half.
Senator Cassidy. Per provider.
Dr. Wergin. I'd say probably half of it. Also to meet
Meaningful Use, as Senator Alexander was saying, we didn't
often upgrade. Our vendors kind of had us hostage. We had to
pay for upgrades to meet Meaningful Use. Some chose not to do
that.
Senator Cassidy. So that was over and above the $80,000?
Dr. Wergin. Oh, yes.
Senator Cassidy. Somebody in one of the testimonies spoke
about the doc who formerly saw 30 patients a day--maybe you
mentioned this to Mr. Alexander--and is now seeing 24--was with
one tech, and now has four techs. Are you including the cost of
the extra personnel to maintain all this?
Dr. Wergin. No, but that's a standard story I hear as I
travel around the United States--lower patient volumes and more
cost.
Senator Cassidy. Mr. DeVault, this is an incredible
problem. I can tell you that we've just decreased productivity,
and frankly--by the way, I still teach. When I see medical
students--and we have Epic at the hospital--they're not talking
to the patient. They're entering data.
And as Dr. Adler-Milstein pointed out, sometimes the data
is data bloat. I'm thinking, ``I'm a doggone hepatologist''--
which is liver disease--``why in the hell am I asking about
cigarette smoking?'' Because I've got that much time with the
patient----
Mr. DeVault. It's not because the vendor wanted you to do
that.
Senator Cassidy. So who's driving that?
Mr. DeVault. That's often billing requirements or
Meaningful Use requirements.
Senator Cassidy. The Federal Government has said, ``Listen,
you've got to have this in order to have Meaningful Use, and so
the Federal Government is here to help you,'' and that's the
problem?
Mr. DeVault. That's a significant problem, yes. We take it
on the chin from our customers all the time, and it's not
because we have an interest in people filling out all those
fields.
Senator Cassidy. I'll also say I was told that the
interface--again, the interface is so 1990. You know what I'm
saying? I'm sitting there typing into a screen as opposed to
looking into someone's eyes.
Mr. DeVault. Oh, the user interface?
Senator Cassidy. Someone told me that that in part is
driven by the lack of venture capital. The HITECH Act basically
prescribed the interface, and, therefore, there's been no
investment in how to make that more efficient or friendlier to
the provider. Again, Dr. Wergin, who's kind of on the front
lines, is nodding his head.
Mr. DeVault. Speaking for us, we invest an incredible
amount of research and development on user interface design.
Senator Cassidy. It still seems to be, though, the screen--
and I'm using a keyboard, correct?
Mr. DeVault. Often, yes. There is an art to learning how to
do that with a patient, as you probably know.
Senator Cassidy. I'm told that by your data, it's about 17
minutes more per patient to enter electronically as opposed to
paper. Is that right?
Mr. DeVault. I don't have that information, but I can
followup with your----
Senator Cassidy. Somebody told me it's now 17 minutes per
patient.
Mr. DeVault. I can't imagine that's the case.
Senator Cassidy. I can. It's just incredible how much time
you spend on that.
Mr. DeVault. We have documented practices that have reduced
the amount of time that they spend per visit.
Senator Cassidy. Really?
Mr. DeVault. Yes.
Senator Cassidy. Dr. Wergin, relative to paper, how much
more are you spending per patient to enter data?
Mr. DeVault. Again, I don't have----
Senator Cassidy. No, I'm asking the doc.
Dr. Wergin. I would say it's 10 to 15 minutes per patient,
and that's why I've never gotten back to the same volume pre-
EHR. I hear that story pretty consistently across the country.
Senator Cassidy. I yield back.
Mr. DeVault. It is harder for family practitioners. I will
grant you that.
Senator Cassidy. I yield back, and I will say we have a big
problem here. Anyway, our productivity for the front lines is
down by 25 percent.
Thank you.
The Chairman. Thank you, Dr. Cassidy.
I'm going to go vote, and Senator Isakson is going to
preside. I'll be right back, so every Senator who is here will
have a chance to ask questions. The next Senator is Senator
Baldwin, then Senator Isakson, and I'll be back by the time he
is finished.
Senator Baldwin. Thank you, Mr. Chairman. Our health system
has made tremendous gains in the use of electronic health
records, and I'm proud to represent a constituent who has
played a major role in our health IT transformation, Epic
Systems in Verona, WI.
You mentioned, Mr. DeVault, in your testimony that in just
the last month, Epic users exchanged almost 8.5 million records
with each other and almost 7,500 with other organizations. We
all know that more work needs to be done, and our system has
not yet achieved the goal of being fully interoperable, which
is why, Mr. Chairman, I'm very glad that we're having this
constructive discussion here today about how we move forward.
We've all heard stories from providers arguing that some
vendors won't allow them to easily exchange patient records
with health systems that use a different EHR company. Mr.
DeVault, can you please address some of the issues and help us
understand what interoperability means, including why all
providers today can't seamlessly share and access data as part
of their workflow between healthcare settings?
Mr. DeVault. Thank you, Senator Baldwin. Interoperability
does mean different things to different people, and if you talk
to the Googles and the Facebooks of the world, they're
interested in data for different purposes than clinicians might
be interested in. I'll narrow that focus down to what we often
call health information exchange, getting a patient's record
from one point of care to another.
We have seen a lot of progress on this in the last few
years for a few different reasons. One, Meaningful Use 2 did
put a focus on health information exchange. It was not a focus
of Meaningful Use 1, so things have taken some time.
We have seen a large up-tick in the last year and a half of
our customers being able to connect easily to non-Epic systems.
Previously, that was not the case. Different implementations of
standards was an impediment, and now some of that has shaken
out. That's reducing the cost of those connections
significantly and the time to implementation.
There are some other things that were not anticipated by
ONC that are important for interoperability. There's a whole
ecosystem that needs to be in place. If we went back 150 years
ago and gave everybody a phone, that would not allow us to talk
to each other, because there's no operator, there's no
information, there's no white pages.
We need provider directories. We need the ability to find
resources. Those are starting to appear. We're starting to have
an ecosystem with provider directories where you can actually
look up somebody's phone number, which is obviously important
in order to be able to send somebody something.
The other thing that's made our Care Everywhere
interoperability platform so successful among the Epic groups
is something that we've shared with ONC over the last several
years and suggested that they take very seriously--and I'm
happy to see it's in their roadmap--which is the role of
governance.
People need to understand what are the rules of the road,
have common understanding of their rights and responsibilities
with regard to their patients' data, and they need to have
recourse to somebody when they believe that there is a bad
actor. We've had that in place within our Care Everywhere
network, and that is what has allowed us to, for one thing--and
I wanted to address something else.
Senator Baldwin. I do have another question that I'd like
to ask.
Mr. DeVault. I'll wrap that up, then.
Senator Baldwin. In your written testimony, you identify
several different networks of interoperability that operate
today, such as Commonwell, and, of course, you've just been
talking about Epic's Care Everywhere. Can you please elaborate
on how these networks are different, including why Epic is not
a member of Commonwell, and then discuss the work that Epic is
doing with other vendors to connect these various networks?
Mr. DeVault. Yes. Great. Thank you. There are different
networks, and there should be different networks, just like
there are different banking networks, and there are systems
that are out there to connect all of them together. Things work
best when there's a robust ecosystem, and there are multiple
players involved. Care Everywhere is one such network.
Commonwell is what I would call an aspiring network. They
aspire to be a nationwide network with a record locater service
that will tell you where every part of a patient's record is.
They are not that today. According to their latest report that
I've seen, they have four different sites live on their
network, fewer than 1,000 physicians, compared to 100,000
physicians in Care Everywhere and almost 10 million records
exchanged a month now.
That having been said, in terms of what they're doing,
architecturally, there's not a problem with that. When we were
approached by them and asked to join, we were told that it
would be multiple millions of dollars for us to join, and that
we would have to sign an NDA. And, to us, the only reasons to
have an NDA are if they're going to tell you something that
otherwise they wouldn't want people to know, for example, the
possibility that they might sell data downstream, or that they
want to make sure that their intellectual property doesn't
conflict with ours. That kind of lack of transparency did not
sit right with us.
Instead, we have engaged Commonwell through Carequality.
Carequality is meant to be that fabric that connects all of the
networks together. You've got health information exchanges.
You've got the Care Everywhere network. You will eventually
have Commonwell. Carequality then will be the fabric that
stitches all of that together. We hope that they will join
Carequality.
Senator Baldwin. Thank you.
Statement of Senator Isakson
Senator Isakson [presiding]. Thank you, Senator Baldwin. I
want to followup on your line of questioning, and I want to ask
a question to Dr. Wergin and Dr. Adler-Milstein. I want to
preface it by saying I'm not a physician. I'm not a high-tech
person. I was a salesman all my life before I came to Congress,
and I guess I still am if I'm in Congress.
I learned in business, though, that scarcity and
exclusivity drive cost and drive price. Is the interoperability
a competitive advantage for the people who sell the different
software for IT?
Ms. Adler-Milstein. It certainly is, because when you have
that, it makes it harder to switch vendors and much more
expensive to switch vendors. I do think the reality is that
that's playing a factor, because if you protect the data within
your system, it makes it harder for people to switch systems if
they were to decide that there's a better system on the market
for them.
Senator Isakson. Dr. Wergin, do you agree with that?
Dr. Wergin. Yes, I would. What I see in a pragmatic sense
as a practicing physician is the vendors are siloed, and you're
held somewhat hostage by the vendor you have, because it's very
difficult to change. Who owns the data is a point that makes it
difficult to make those changes.
It does make it difficult, and I think it does give them a
competitive advantage, plus updates are for your system. That
makes it difficult, and we're charged for updates. I'm glad to
hear Epic does not. You have to pick and choose with the small
margin care that we do. Yes, we have difficulty with those
kinds of exchanges or who owns the data.
Senator Isakson. Mr. DeVault, let me ask you a question.
I'm assuming it's to nobody's advantage, yours or Cerner's or
any of the others in the business, to try and create an
interoperable system because nobody would cooperate. Is that
correct? I don't mean that in a negative way. I mean that in a
factual way.
Mr. DeVault. I'm not sure I follow the question.
Senator Isakson. Let me preface it--would it not take the
cooperation of all the vendors, including sharing intellectual
property, in order to create an interoperable system?
Mr. DeVault. Not necessarily intellectual property, but it
certainly does require the participation of at least a core set
of vendors, and that's why we participate in HL7, which is a
standards development organization. We participated in the
development of Direct. I was actually the chair of the user
case work group that created the protocol for doing the
exchange. We participate in the EHR Vendors Association, now
called the EHR Association.
Senator Isakson. Let me interrupt you real quick.
Mr. DeVault. Yes.
Senator Isakson. I don't want to run out of time. What
would be a catalyst to cause you to get together with Cerner
and the other people and find a way to be interoperable?
Mr. DeVault. We already have, and another example of that
is what's called the Argonaut Project in HL7 right now, which
is developing state-of-the-art, web-based application
programming interfaces that will make it even easier for new
systems to talk to each other. In my opinion, it's not a
technological problem to create these standards.
The deficiencies in the system are--the ecosystem, as I
mentioned earlier--things like provider directories, and then
provider incentives, which is one reason why even though we
developed our Care Everywhere application in 2005, we did not
go live with it until 2008. That was how long it took for us to
find customers who were willing to say, ``We are not going to
compete over data.''
And we have a rule in our governance structure that says,
``If you're going to share data, you're going to share with
everybody,'' and I'm happy to say that all of our customers now
do that.
Senator Isakson. Does provider incentives mean incentives
to the physicians?
Mr. DeVault. Yes, or the hospitals or the health system, in
general.
Senator Isakson. To cooperate in sharing the data?
Mr. DeVault. That's right.
Senator Isakson. To a certain extent, that's a competitive
advantage right now for them as well, is it not?
Mr. DeVault. It could be, depending on the payment model.
There are lots of things that could influence what those
incentives are. Different kinds of payment models have
different kinds of incentives for data sharing. In an ACO, for
example, an Accountable Care Organization, you are highly
incentivized to share information with the other parts of your
network.
Senator Isakson. I am told that some people have a fear of
security--cyber security in terms of data----
Mr. DeVault. Well, they should, yes.
Senator Isakson [continuing]. And they should. We in
Congress have been reluctantly moving toward finally getting to
a cyber security bill, which, hopefully, we'll do pretty soon.
Is there anything we should be aware of or cognizant of in
terms of cyber security in terms of medical IT?
Mr. DeVault. Absolutely. I've seen draft legislation from a
variety of areas and heard lots of conversations about
radically opening up patient health information to a variety of
actors, and we need to think very carefully about who these
actors are and what kinds of security needs to be in place to
make sure that some foreign actor or a nefarious actor doesn't
have access to that information. That needs to be done at the
same time that we have these discussions about opening up
systems further.
Senator Isakson. Thank you all very much for your
testimony.
Senator Franken.
Oh, I'm sorry. Senator Franken disappeared or lost a lot of
weight, one of the two.
[Laughter.]
Senator Whitehouse.
Statement of Senator Whitehouse
Senator Whitehouse. Thank you for that comment, Chairman
Isakson. I agree with what a number of my colleagues have said,
that it's time for a reboot of the Meaningful Use Program. It's
been run for quite a while now.
It started from a little bit of a disability, which was
basically the equivalent of subsidizing cars or penalizing
people for not buying cars, and then figuring out that they're
all going to go and build the roads on their own. That's not
the way we do highways, and it's a pretty fair analogy for what
the problem has been with health information exchange.
We have put some money into health information exchanges.
Mr. DeVault, as you know, Rhode Island has worked very hard to
have CurrentCare, which is a very good health information
exchange, perhaps best in show, and we've been really fighting,
I feel, very much on our own, without much help from the
Federal Government. If you get the exchange part right, so much
of the rest falls into place.
We're doing this, very inefficiently, focusing on the most
remote parts of the system, the physicians' desks, without
building the internal infrastructure and supporting the State-
built, in our case, internal infrastructure that allows those
points to all connect. If you get that right, then people will
have to connect, because there'll be a value proposition from
the system, and you won't have to make an artificial value
proposition of subsidy and punishment. We need to reboot that.
I also think that we need to reboot the failure to include
behavioral health and nursing homes into it. I see lots of
heads nodding here. If you're looking at the expensive people
in the healthcare system, a lot of them are going back and
forth, cycling between nursing homes and the healthcare system.
I see more heads nodding here. If you don't capture that, and
if you don't require the nursing home to meet the Meaningful
Use standard or cooperate, then you've made a really stupid
tactical error in the rollout of health information technology.
Ditto if you are a patient who has a significant behavioral
health issue. Your behavioral health provider--guess what--is
your medical home. They're the ones who help you deal with the
rest of the healthcare needs that you have. When you cut out
the behavioral health provider from Meaningful Use, you've made
another stupid decision, and we refuse to fix those decisions.
I would love to work with my colleagues on rebooting
Meaningful Use in those directions and, particularly,
empowering the local information exchanges that have come up.
I'm tired of being a lead dog, carrying a huge load, and having
floods of money go into this in a whole bunch of different
areas, but having to struggle for support at trying to get
CurrentCare up and going, and we have.
To Epic's credit, Epic, through life-span, has just created
its CurrentCare link, and so it will be linked into our health
information exchange. Care New England, our second biggest
hospital chain in Rhode Island, is also an Epic customer. We
stand a real possibility of having our two largest hospital
chains and our health information exchange all linked in a very
meaningful way. As others have said, it's incredibly important
that we gather this data and that we use it to empower the
reforms that we need in healthcare.
I do think that there are some vendor business practices
that we need to be worried about. We need to be worried about
vendors who don't put the connecting fees into their pitch to
their clients, and then you find out, once you've budgeted what
you think your cost is to the vender, that now to hook you up
will cost tens of thousands of dollars more. That's just a bad
business practice.
We have not really resolved the question of ownership of
data, and as big data begins to move more and more, people want
less and less to share the data that they have with other
competitors. That data should be ultimately the property of the
patient, not of anybody else. These artificial divisions of
``you can have the data'' and ``you can't have the data'' do
none of us any good in the long run. They just provide
immediate private advantage in the short run.
Finally, there is a business model in which not being
interoperable is to the advantage of the company, because it
means you have to link up with them. You can try to get the
advantage of being the Microsoft operating system, that you're
everywhere, and then you can charge high prices because you're
the dominant player in the marketplace. That should not be a
factor. There's a role for government in protecting against
some of the abuses that are possible here.
And the last thing I'll say is that it's really important
that we solve the question of ownership of this data, so that
it's clear how privacy is protected, and it's clear that we
maximize the extent to which this data is available to the
patient and, on an anonymized basis, to anybody who is doing
really important research that will save lives and improve our
healthcare system. We've got a lot at stake.
I've used up my whole time and 1 minute more just saying
those things. I've been kicking at this for a while now, and so
thank you, Chairman, for allowing me to vent here. We can agree
as a panel that we have important work to do on this topic. We
are a long way from where we should be. The possibilities are
immensely positive, and the hazards, are solvable and
negotiable.
Thank you for the hearing, Mr. Chairman.
The Chairman [presiding]. Thank you, Senator Whitehouse.
Senator Franken wants to come back, so I'll wait a few
minutes and see if he does.
This is a sufficiently important issue, and there's
sufficient interest in the committee--Senator Cassidy, Senator
Whitehouse, and others--that we ought to focus--Senator
Whitehouse, I wonder if you agree, we ought to focus some extra
time on this and maybe organize a way to see how we can help
get a result.
Senator Whitehouse. I think we should. It might even be
helpful to have a group of us kind of meet on a regular basis
offline and try to put something together for the committee to
consider.
The Chairman. Yes.
Senator Whitehouse. This is a bipartisan issue. It's about
doing it right versus doing it wrong, doing it stupid versus
doing it smart, and we ought to be able to work together on it.
The Chairman. I agree with that. So we will do that. This
has been a helpful hearing. It's been 5 years since we've
really taken a look at this. We're moving into an era where,
after providing a lot of money, $30 billion, for incentives and
grants, we're now going to start collecting penalties.
Mr. DeVault, do you charge an hourly labor fee for
upgrades?
Mr. DeVault. If the customer needs assistance in the
upgrade, which often they do not, yes, we do.
The Chairman. Often they do?
Mr. DeVault. I'm sorry. Let me take that back. Not for
upgrades. That's part of the maintenance cost that's built into
the licensing fee. I misunderstood your question.
The Chairman. You do not charge an hourly labor fee for
upgrades.
Mr. DeVault. That's right. For creating those new
connections, we do. That's what I thought you were asking
about.
The Chairman. Let me ask a question in this way. Assuming
we on the committee wanted to spend the next several months
trying to fix the problem here, my own sense of it--and this
shows a bias about government--is that the Federal Government
does a much better job when it is an enabler or an encourager
rather than a mandater, and that there are also some things the
Federal Government just doesn't do as well as the private
sector.
Also, it's just an evitable law, whether it's Republicans
or Democrats, that regulations just pile up over time. Let me
ask each of you now if you would reflect on this, and then
maybe you could think about it after the hearing and either
provide in writing or in the subsequent activities so that we
have your thoughts.
If you were in our shoes, and you looked at the $30 billion
that's been spent, and you looked at the promise of the idea,
and if you looked at the fact that about half the doctors who
are a part of Medicare reimbursement would rather take a
penalty this year than be involved with electronic healthcare
records, what are the first two or three things that you would
do to try to realize the potential of expanding the use of
electronic health records for more physicians and more doctors
to the advantage of patients?
Let's start with you, Dr. Adler-Milstein.
Ms. Adler-Milstein. Sure. In the category of enabler, I
would begin with focusing on transparency, and this is really
about transparency in terms of how the frontline physicians
experience both the usefulness and usability of the system, the
connectivity of the system, and the cost associated with these.
Part of the challenge has been that it's been very hard to get
information on this, and, therefore, we have uninformed
consumers.
The Chairman. Information from whom?
Ms. Adler-Milstein. From the frontline physicians. It would
be great to be able to say we have a consumer report style set
of information that really compares the system, compares the
cost, compares the value. We don't have that basic information,
and we, therefore, can't have a robust market around these
tools.
The Chairman. Dr. Wergin.
Dr. Wergin. Well, a couple of suggestions I'd make is
interacting and having electronic health records that work with
the workflow of my day-to-day operation of what I do,
particularly in family medicine. We as an organization started
a task force that included an efficiency engineer we hired from
outside at the American Academy of Family Physicians to look at
just that instead of just complaining about how can we do it--
if there were standards that said that.
Regarding interoperability, I do want to say that it
shouldn't just be a data dump. I mentioned that patient I had
that I had to call and get a fax copy of the record. It was 18
pages long, and I wasn't sure why she was seen in the ER.
My own small system that I operate in, a 20-bed critical
access hospital, has a different EHR than mine. I have to log
out of mine, go to theirs, in my own system to find out if one
of my partners----
The Chairman. Where do we start to change that?
Dr. Wergin. I would say if there's some certification
standard--we're working on making specific suggestions on how
the interaction can take in workflow. From my standpoint--and
that's what this is all about, patient outcomes--the electronic
health record is a tool. It's not delivering care. It's helping
me deliver the proper care. Having meaningful data that I can
get from my partner to me, or from me to my other partner, and
set standards and move away from bullets on billing which is
what we have now.
The Chairman. Mr. DeVault.
Mr. DeVault. Thank you. The first few things that come to
mind are to be descriptive rather than prescriptive. The
Meaningful Use Programs were meant to be an adoption in an
interoperability program, as I understand it, largely
successful on the adoption front. Rather than focusing on
interoperability and describing the kinds of outcomes that
people wanted, it ended up becoming an EHR design session by
committee.
I would much rather see an incentive to have the kinds of
outcomes we all want to have. Then there will be incredible
innovation, both at the clinician level and at the vendor level
to make that happen in a variety of ways.
I agree with Dr. Wergin here, that we don't need just data
dump. That was also something that was very prescriptive, that
this is the data that needs to be shared, no matter what the
use case was. There are also very artificial incentives to do
that sharing.
You mentioned the fact that you had to get a patient to
send you a message about nothing so that you could qualify, or
send all of the information that you have on a patient because
you're transitioning their care, and for an electronic
transition of care, you have to send everything.
So getting rid of artificial incentives by incentivizing
the kinds of outcomes that we want to see and refocusing MU on
interoperability.
The Chairman. Dr. Kennedy.
Ms. Kennedy. I agree with the previous comments. I do have
one comment, though, the road to interoperability is long, and
it's a journey that we have to--it's critical that we continue
on. At some point, while I understand the business of business
is business, we have to stop leveraging profits at the expense
of the care that's given to the patient.
In my daughter's case, I created the record that is carried
across State lines to the provider. Both providers or all of
the providers did have electronic health records, yet none of
them could share the data. It was shared via fax, or it was
copied and given to me. We have to make sure that we can
exchange data in a way that providers receive the information
that they need to care for the patient.
In my daughter's case, two faxes went to organizations that
were not healthcare organizations before it ever arrived in my
hands. Had I not been diligent to copy and carry the records, I
don't think that they could have diagnosed or been able to take
my daughter off of some of the medications that she had
received for 9 years.
In looking at this from the consumer's perspective, it is
important, and while not every consumer is going to go in and
demand a copy of their information, certainly, they do own the
data, and they are entitled to it, because that data, wherever
it is created, is going to lead to better continuity of care
that's provided to me, you, everyone in this room.
It's critically important that we continue to work toward
interoperability and remove the barriers, whether they're on
the side of the developer, the provider, even maybe with the
consumer. I don't think that it should be prescriptive in terms
of what interoperability looks like. That is going to present
with another barrier to innovation, and we want companies to
continue to be innovative.
The current portal that my daughter uses is a widely used
electronic health records system. The information that is in
that portal is not adequate to support care across the line. If
we were to go in as a family and pull that information from
that portal, it is not every piece of information that we need
to continue her care when we cross the State line 6 hours away
and she needs something. I still continue, even with electronic
records, to copy and carry records with us wherever we go.
So much work needs to be done in this area. I don't
disagree with any of the comments. However, I don't think we're
moving fast enough on the issue.
The Chairman. Thank you.
I see Senator Franken, and we'll let him take 5 minutes of
questions, and then we'll wind up the hearing, and I'll wind it
up after Senator Franken has a chance to comment.
Senator Franken.
Statement of Senator Franken
Senator Franken. First, I'd like to thank the Chairman for
stalling until I got here, and thank you for holding this
hearing.
The HITECH was great, because it really spurred this
investment in health records. I have a hospital in New Ulm, MN,
and they're doing a thing with Allina called Heart of New Ulm,
and they wouldn't be able to do it if it hadn't been for
HITECH. Yet we've been hearing about all the barriers to
getting this done smoothly. It's incredibly essential that we
do this, because it helps operations, things like Accountable
Care Organizations and patient-centered medical homes and
bundled payments.
Ms. Adler-Milstein, in response to Senator Warren, you
talked about some of the barriers to data sharing between
healthcare organizations because of economic incentives which
discourages communitywide data sharing. Is that because they'll
worry that--and I've heard this before--they worry that you'll
steal your healthy patients? Is there anything to that?
Ms. Adler-Milstein. I don't know if it's so much stealing
the healthy patients. It's actually stealing the sick patients,
because those are the ones that need the care on which you have
the higher margins. It's a concern----
Senator Franken. An Accountable Care Organization would
want to steal your healthy patients.
Ms. Adler-Milstein. So true. That's what I think Dr. Wergin
was referring to.
Senator Franken. This is for Dr. Kennedy. How can we
leverage some of the new pay for performance reimbursement
models to create a business case for providers to connect and
actively share health information with each other, even their
competitors, to ensure the patients can receive the best
possible care?
Ms. Kennedy. You have to reduce some of the penalties that
are imposed on providers, and you have to encourage the use of
electronic health records. Maybe there are other incentives
that need to be given to our providers.
Also, in terms of payers, payers are receiving the data. We
know that the exchange is there. Some of my daughter's records
were recreated from claims data, and we had to rely on that
solely to get a picture of the care that was provided at that
time. Incentives to providers are probably going to enable
adoption or further adoption. Right now, we say we have
interoperability. However, that doesn't exist in every case.
Senator Franken. Dr. Adler-Milstein, we can have access to
everything, theoretically, right? I've heard that they do this
in other countries, and it's a lot easier. I remember when we
had--well, OK, I don't like that, so I'll ask what that meant,
but I'm human and I know kind of what that means, which is,
``yes, but''--right?
When we were having the discussion about ACA, I heard,
``Well, we have the best healthcare system in the world.'' I
heard that in Minnesota. And we have Mayo. Look at Mayo. It's
the best--we have the best healthcare in the world, but I'm not
sure we have the best healthcare system. I'm not even sure we
have a healthcare system.
It depends on--if you're getting Medicare, you're in the
Canadian system. If you're in the VA or Indian health services,
you're in the British system. If you get it through your
employer, you're in the German system. If you're paying for it
yourself, you're in the Cambodian system--is what we had. We
didn't have a system.
What do other countries do differently to be successful on
this front, and then--because you went like that, which for--is
someone taking a record of this? He imitated her doing what she
did.
[Laughter.]
What do some countries do better, and what don't they do
better?
Ms. Adler-Milstein. Sure. I sit on an OECD task force that
has looked at--first is trying to benchmark adoption of health
information technology in various countries so we can truly say
where we stand and from which countries we have an opportunity
to learn.
Senator Franken. Good.
Ms. Adler-Milstein. I will say that health information
exchange has been the common challenge across countries, and
that is despite the way they pay for care, despite the way they
deliver care. There have been real challenges with getting the
data to move across the systems and to be in front of the
providers when they need it.
I don't think that there's a country that we can point to
and say they have gotten it right, and the United States should
look toward that model. There are countries that I think have
done a better job of trying to centralize some of the data and
get patient-controlled access to that data. Again, I don't
think that there is a sort of silver bullet here, and it's been
a real challenge.
Senator Franken. Since you held this for me, and I'm the
last person, can I go over this? Or is that the reason for us
to go? It's one way or the other.
The Chairman. We've got to go vote again.
Senator Franken. Well, let's go vote again.
The Chairman. No, go ahead.
Senator Franken. I was wondering--like in France, I thought
that you have on your card a chip that basically has your
healthcare records in it. Is that not true, or is that a
limited thing?
Ms. Adler-Milstein. There are places--and Germany is
experimenting with it as well--where you have a basic set of
your information, and that at least gives the provider the
ability to see that when you go from place to place. They've
had relatively low patient opt-in rates, and even when the
provider goes to see that information, it doesn't always
seamlessly connect with that.
So if the provider wants to then keep that information in
their system from there on out, they would need to spend time
entering it. Again, there are solutions to this, but no one has
the sort of vision of seamless--I show up and my data is there
when it's needed.
Senator Franken. Thank you.
Again, Mr. Chairman, thank you for this important hearing,
and thank you for holding it for me.
The Chairman. Thank you for making the special effort to
get here.
I want to thank the witnesses for coming and, again, for
adjusting your schedules for our snow day. You've gotten the
interest of the committee. I anticipate additional hearings or
at least additional activities.We'd like to also hear from the
administration about this in a subsequent hearing. They have
some things they'd like to say.
What I'd like to ask you to do as you reflect on this is to
be very specific about what you think we should do. You have
been in some cases. To give you an example, four of us, two
Democrats, two Republicans, asked a group of higher education
people, who were complaining about over-regulation, to give us
a number of things, specifically, that we could do, and give us
the 10 that would make the most difference.
They actually did that, and it's very helpful, and we're
preparing bipartisan legislation to actually get it done. If
you could help us think of ways to get specific suggestions of
how we're going to fix the problem--start one, two, three,
four--that's what we need to know. Not everything needs to be
done by the Congress. Some of it can be done administratively,
and if that's the case, that can be said as well.
We've been focusing on this for a couple of years. We have
Senators like Senator Franken, Senator Whitehouse, Senator
Cassidy, Senator Burr, and others who want to pursue it. We'll
be spending more time on this issue as we go forward.
The hearing record will remain open for 10 days. Members
may submit additional information within that time if they
would like.
Thank you for being here. The committee will stand
adjourned.
[Additional material follows.]
ADDITIONAL MATERIAL
Epic Systems Corporation,
Verona, WI 53593.
Dear Senator Alexander, I thank you for the opportunity to testify
on March 17th during the HELP Committee's hearing entitled,
'``America's Health IT Transformation: Translating the Promise of
Electronic Health Records into Better Care.'' At the end of the
hearing, you asked the witnesses to send you a list of ideas that could
help the government in its efforts to increase interoperability and
foster adoption of electronic health record (EHR) technology by
``enabling rather than mandating.'' Below are four suggestions that we
believe will help:
1. Use the existing cross-industry definition of interoperability
rather than support new definitions based on complete and open access
that are unmanageable, unsafe and unnecessary to achieve national
goals.
2. Support public-private initiatives that are already working on
solving key interoperability problems; don't support new government-
centered governance.
3. Push to normalize public health reporting across the States.
4. For maximum adoption and benefit, be descriptive rather than
prescriptive
Use the existing cross-industry definition of interoperability
rather than support new ones that are unmanageable, unsafe and
unnecessary to achieve national goals.
To improve safety, the coordination of care and bring down costs,
we need providers to be automated and interoperable. There is already a
good definition of interoperability that is used by HHS and the FCC and
which was put forth by The Institute of Electrical and Electronic
Engineers (IEEE). It provides the generally accepted definition of
interoperability as ``the ability of two or more systems or components
to exchange information and to use the informatiom that has been
exchanged.''
In the healthcare context, this means the ability for different
systems to exchange data and for that data to appear meaningfully in a
care provider's workflow as actionable information. The data could be
part of a patient's record exchanged between an EHR and an ancillary
system or device. Or the data could be a more complete patient record
exchanged between two EHRs or an EHR and a personal health record
system managed by a patient.
This simple definition built around the ability to exchange and use
data is manageable, reportable and enforceable. Expanded definitions of
interoperability are not.
Recently there has been a push to redefine interoperability in
healthcare as access to patient health information. For example, the
draft legislation put forth recently by Congressman Burgess (some of
which appears in the SGR Bill) attempts to redefine interoperability
variously as ``open access,'' ``complete access'' and ``does not block
access.'' However, access and interoperability are different concepts.
Attempts to radically open up EHR systems to a wide variety of actors
has serious implications for privacy, cybersecurity oversight,
infrastructure costs, and the public's trust.
By focusing on interoperability as opposed to access, we can avoid
introducing unwieldy expectations that create either dangerous
scenarios or marginal value.
Support public-private initiatives that are already working to
solving key interoperability problems.
The healthcare industry has realized that beyond technical
standards, appropriate governance of interoperability networks is
critical to their success. This has been borne out in the development
of our network, Care Everywhere, with Healtheway's eHealthExchange,
which includes the DoD, VA, and Social Security Administration, as well
as in numerous State and regional health information exchanges. What is
also clear is that ubiquitous, nationwide interoperability will require
national governance so that all of the networks can interoperate with
each other. We were pleased to see this recognition in ONC's recently
published Interoperability Roadmap.
What was not mentioned in the Roadmap is that there is already a
public-private collaborative well down the road of creating such a
national governance framework: Healtheway's Carequality. On the
contrary, based on the Roadmap itself and a roundtable ONC recently
held on governance, ONC seems poised to create a governance
superstructure from scratch. If they were to do so, this would create
market confusion as well as perpetuate a reliance on government to
administer interoperability networks.
We were pleased to see the ONC recognize Healtheway at the recent
Health Information Management Systems Society (HIMSS) conference. The
ONC should support the activity already underway in Carequality and
other existing bodies and public-private collaboratives.
Push to normalize public health reporting across the States.
Bidirectional communication between Electronic Health Records and
State and Federal registries, such as immunization registries, is
necessary to deliver safe and efficient care and to better manage the
health of populations. However, there are no common standards and
capabilities that registries in different States currently have. This
requires EHR developers and care providers to build and maintain dozens
of different interface formats at great ongoing expense. Additionally,
some registries can be queried for information by an EHR while others
are only an information destination. The Federal Government should
recommend standards and minimum capabilities for State registries and
incentivize their adoption.
For maximum adoption and benefit, be descriptive rather than
prescriptive.
Rather than mandate how systems are built and used, describe the
results you want and incentivize the desired outcome. For example, one
way to reduce costs of care is to eliminate duplicate laboratory and
radiological testing. A prescriptive measure might be to mandate the
use of EHR technology that alerts a physician when she is about to
place an order for a test that the EHR knows is a duplicate. This may
or may not solve the problem: the EHR may not know about a prior test
performed at another facility. And if the physician bypasses the alert,
there's no downstream check (for example in the lab itself) to make
sure that the test is not performed unnecessarily.
A descriptive approach with appropriate incentives might be for CMS
to declare that they no longer will pay for duplicate testing. This
would incentivize the entire health system to innovate ways to avoid
such tests. It would also incentivize EHR developers to find novel ways
to support clinical decision making. Further, it would incentivize care
providers to use the interoperability technology many of them already
have in order to find tests that took place in other facilities.
I hope these recommendations are helpful. As always, please do not
hesitate to call on me to contribute further in any way.
Sincerely,
Peter DeVault,
Vice President, Epic,
[email protected]
(608) 271-9000.
______
Response by Julia Adler-Milstein to Questions of Senator Alexander,
Senator Burr, and Senator Warren
senator alexander
Question 1. With the rapid digitization of health data, is the
industry effectively protecting personal health information?
(a) What additional resources would be valuable in encouraging
organizations to prioritize health data security?
(b) Is the government offering proper guidance and/or resources to
inform industry decision making relative to data security?
(c) Is threat information readily shared throughout the industry?
Or with other industries?
(i) If so, is the information useful?
(ii) If not, what incentives could be offered for
organizations to share threat information with other
organizations?
Answer 1. Health data security is not my area of expertise and so
these questions are best answered by someone better versed with the
current state of practice. I do know that it is an area in which the
Office of the National Coordinator for Health IT (ONC) is offering
guidance and they have issued a ``Privacy and Security Guide'' with
resources for provider organizations.\1\ In addition, the most recently
issued Stage 3 Meaningful Use criteria include a domain that seeks to
ensure protection of patient health information through appropriate
technical, administrative, and physical safeguards. Specifically,
attesting providers must conduct an annual security risk analysis to
ensure that data security, including encryption of stored data, meets
standards set by Federal regulations. This is estimated to take 6 hours
and, since providers are not data security experts, its success seems
heavily dependent on whether the guidance can be both robust and simple
to follow.
---------------------------------------------------------------------------
\1\ http://www.healthit.gov/sites/default/files/pdf/privacy/
privacy-and-security-guide.pdf.
---------------------------------------------------------------------------
Overall, my sense is that there is more that could be done to
prevent PHI breaches, but it is not clear whether these actions are
cost-effective. This is because of limited evidence that breaches
result in harm. While the number of breaches reported to HHS has
increased over time and is expected to continue increasing, the effects
of these breaches, and subsequent costs to identify and repair the
security problem, are difficult to estimate. Currently, all breaches of
PHI must be reported to HHS. Reports for breaches involving 500 or more
individuals must include detailed information to pinpoint the data
security vulnerabilities. To date, the vast majority of breaches seem
to be occurring as a result of ``poor data hygiene'' (i.e., theft of
portable electronic equipment, unauthorized access, or improper
disposal) as opposed to intentional data hacking.\2\ This is to be
expected given the large number of healthcare professionals who come
into contact with PHI. Addressing the human behavior element is,
unfortunately, far more challenging than addressing a purely technical
problem.
---------------------------------------------------------------------------
\2\ Liu V, Musen MA, & Chou T. (2015). Data breaches of protected
health information in the United States. JAMA, 313(14), 1471-73. http:/
/doi.org/10.1001/jama.2015.2252.
Question 2a. Half of the Nation's physicians have chosen not to
participate in the Meaningful Use program to date. How can this change?
Answer 2a. If we look at the trends in terms of physician adoption
of EHRs and meaningful use (MU) attestation rates, it does not appear
that we are on the flat of the curve.\3\ In fact the number of Medicaid
eligible physicians who have registered for MU has been increasingly
linearly from January 2011 to January 2015, showing that there is a
steady growth of eligible professionals who seem to intend to attest
each quarter.\4\ Given this, I don't think we are at the point of
needing to say that the MU program needs a wholesale overhaul. But we
do need to consider why so many physicians have chosen not to
participate, in order to try to speed the rate of response.
---------------------------------------------------------------------------
\3\ http://dashboard.healthit.gov/quickstats/pages/FIG-Medicare-
Professionals-Stage-One-Meaningful-Use-Attestation.php.
\4\ http://healthit.gov/FACAS/sites/faca/files/
HITPC_Data_Analytics_Update_2015-04-07_FINAL.pdf.
---------------------------------------------------------------------------
When assessing physician participation in MU, it is important to
differentiate between those who cannot attest due to cost/resource
reasons and those who could but choose not to because they do not find
it valuable to do so. Solving the first problem is, relatively
speaking, easier. We could make available more resources to help
physicians to adopt. This strategy has proven successful with programs
like the Regional Extension Center Program. And I feel that there is
more that could be done to take what we've learned from past
implementations and better deploy it to reduce the cost of future
implementations. Addressing the second problem--how to make MU
participation feel more valuable--is trickier because the MU program
has to balance the need to identify a national set of criteria (both
for simplicity of understanding and administering the program, and
ensuring societal benefits from it), with the greater physician
response that is likely to emerge from allowing more customization of
the criteria to better meet the varied needs of physicians
(particularly for specialists). With the Stage 3 criteria, CMS/ONC are
trying to structure them in a way that allows more customization (i.e.,
picking 2 of 3 possible criteria), and this could perhaps go even a bit
further (i.e., expanding the possible criteria).
Question 2b. Continually, physicians call for the all-or-nothing
nature of the program to be rethought. Why are rulemakers so hesitant
to adjust this rigid mandate?
Answer 2b. First, I think it is important to acknowledge that there
is a reasonable degree of flexibility built into the program, evident
in the core versus menu measures, a qualification period that gives
organizations the flexibility to meet requirements within any 90-day
window, and staging the criteria to ramp up over time. I also think
that there is strong justification for having attestation thresholds;
they define a minimum level of utilization that is needed in order for
there to be a real shift from paper to electronic processes, and for
EHR benefits to be realized at a meaningful level. For a subset of
measures, thresholds are also needed to realize network effects--in
particular, for health information exchange. In addition, having a set
threshold reduces the complexity of administering the program (for CMS)
and understanding it (for providers). Finally, data from Stage 1 MU
attestations reveal that very few attesters are right at the threshold.
Most of those attesting well exceed the thresholds.
That said, we can all agree that it feels profoundly unfair for a
provider to get no compensation for being just shy of a cutoff for a
single measure. It would be worth exploring whether there could be a
provision that allows a provider to fall just short (e.g., within 5
percent) of the threshold on a single measure, and still receive the
full incentive.
Question 2c. Are there any additional resources, other than
additional incentive payments, that the Federal Government should
provide to increase physician participation?
Answer 2c. We have heavily invested in Regional Extension Centers
and they have the most experience with helping physicians adopt EHRs. I
think it would be valuable to pursue Regional Extension Centers version
2.0 in which there are stronger incentives for them to take what they
have learned over the past 4 years, and demonstrate that they can help
providers adopt EHRs more quickly, less expensively, and with less
disruption. A second factor that is likely to help is to continue the
push to streamline requirements of various Federal programs. This is
proposed in Stage 3 MU and is included in the new SGR approach. If MU
is clearly tied to broader healthcare delivery reform efforts that
physicians are pursuing, this will help it feel more valuable. To the
extent that this could be done more broadly across payers, it would be
even better.
Question 3a. The goal of HITECH was to improve patient care while
decreasing costs--has there been a change in the cost to health care
because of HITECH?
Answer 3a. It is very difficult to attribute the healthcare cost
reductions we have seen over the past few years specifically to HITECH.
Because HITECH is a national program, there is no ``control'' group to
which to compare outcomes. In addition there are many other health
reform (and broader economic) changes occurring in parallel, notably
the ACA. If the experience in other industries, most of which adopted
IT in the 90s, is any indication, the answer to this question is that:
(1) benefits from IT take time (up to a decade), and (2) during that
time, some organizations figure out how to use IT well and others do
not. So we will undoubtedly get some benefit from the HITECH
investment, but it could be greatly increased by figuring out how to
minimize the number of provider organizations that never learn how to
take advantage of EHR capabilities to improve the care they deliver.
Question 3b. Since EHRs have become more common place, are there
any metrics of public health improvement being observed?
Answer 3b. If we limit our evaluation to the subset of measures
that specifically characterize public health domains (e.g., disease
surveillance, immunization rates, cancer and lab data), there is scant
evidence of improvement in ``hard outcomes'' from EHRs. The greatest
impact of EHRs so far is on key processes that we would expect to
facilitate improvement in outcomes. Most notably, there has been a
large increase in the volume of data reported to public health
departments. Electronic reporting of public health data greatly
improves the timeliness and completeness of data, while reducing
variability in data quality and error. Public health data is used
primarily to identify and track disease outbreaks (including contact
tracing) and track disease trends over time. However, there are still
some gaps to close in terms of the ability of public health departments
to receive electronic public health data. As of 2014, 21 percent of
hospitals attesting to Stage 2 MU were unable to submit syndromic
surveillance data electronically because their local public health
department was unable to receive them, 15 percent were unable to submit
lab results electronically, and 9 percent were unable to submit
immunization data.\5\
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\5\ http://www.healthit.gov/sites/default/files/
databrief22_hospitalreporting.pdf.
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EHRs also have the ability to enhance public health by allowing
providers to access repositories that include public health data. This
two-way exchange of data may be extremely effective for clinical care
in public health clinics for certain chronic conditions such as
tuberculosis or STDs, or identifying resistance patterns to certain
drugs. It may also assist providers in identifying which of their
parents are in need of immunizations.\6\ However, significant
improvements in EHR interoperability and usability are necessary for
these benefits to be fully realized.\7\ In addition EHR data can be
used to assist in emergency situations. For example, in the aftermath
of Hurricane Sandy, patients leveraged the New York State Health
Information Exchange to easily grant permission for providers to access
their health records.\8\
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\6\ Shapiro, J.S., Mostashari, F., Hripcsak, G., Soulakis, N.,
Kuperman, G. Using Health Information Exchange to Improve Public
Health. American Journal of Public Health. [Article]. 2011;101(4):616-
23.
\7\ Dombkowski, K.J., Clark, S.J.. Redefining Meaningful Use:
Achieving Interoperability with Immunization Registries. American
Journal of Preventive Medicine. 2012;42(4):e33-e5.
\8\ Shapiro, J. S., Mostashari, F., Hripcsak, G., Soulakis, N., &
Kuperman, G. (2011). Using Health Information Exchange to Improve
Public Health. American Journal of Public Health, 101(4), 616-23.
http://doi.org/10.2105/AJPH.2008.158980.
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The primary challenge to leveraging EHRs for public health purposes
is assisting public health departments to modernize their health IT
infrastructure. Under HITECH, public health departments were not
provided with the resources to do so, and 72 percent of local public
health departments identified funding as a significant barrier to
system development.\9\ This is particularly problematic because as they
receive an increasing amount of data, they may not be able to fully
leverage it to improve public health. For example, in 2005, only eight
State public health departments had the ability to electronically
report lab results related to public health issues (e.g., lead, HIV,
STD). By 2014, 48 States supported this capability.\10\ However, we do
not have evidence that this increase in reporting has had any impact on
public health outcomes.
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\9\ Linert, L. & Sundwall, D. (2012). Public health surveillance
and meaningful use regulations: A crisis of opportunity. American
Journal of Public Health, 102(3), e1-e7.
\10\ http://www.healthit.gov/sites/default/files/phissuebrief04-24-
14.pdf.
Question 3c. What can government do to further the goal of using
this technology to decrease costs?
Answer 3c. If the target is specifically cost reduction, I believe
that the most effective way to use HIT to reduce wasteful spending is
to facilitate health information exchange. If done well, HIE would help
reduce duplicative utilization (such as redundant lab tests), prevent
avoidable errors, and improve care coordination. However, as you know,
HIE progress has been slow and there are a range of barriers that need
to be addressed.
In addition, clinical decision support (CDS) can also be tailored
to targeted cost reduction. Thus far, CDS has largely focused on
ensuring appropriate care (i.e., recommending immunizations, preventing
medication errors) but it could be instead focused on detecting misuse
and waste, as well as on promoting cost-effective treatments, both of
which would reduce costs. A related idea is using EHR data to profile
physicians as this feedback may lead to changes in practice patterns
that could reduce spending. Many physicians do not realize that they
are higher than their peers in terms of how often they order high-cost
tests, or admit patients from the ED into the hospital. This could be
bolstered by not only showing physicians their relative performance
data, but also using algorithms to help them identify when they are
making a decision that might deviate from their peers.
Question 4a. What are the biggest barriers inhibiting nationwide
interoperability?
What is the biggest barrier blocking providers from sharing
information with each other?
What is the biggest barrier blocking patients from sharing their
information with different providers?
Answer 4a. At the highest level, the challenge stems from two
interrelated dynamics: EHR vendors earn substantial revenue from the
lack of interoperability (they can design their systems however they
think best, and then charge for custom interfaces) and provider
organizations don't have a clear business case for being interoperable
(therefore, they are not willing to pay the high costs or demand
interoperability out of the box). Patients simply haven't shown much
interest in being the stewards of their own health information--so
patient-facing solutions such as portable personal health records do
not appear to be a viable national alternative to work around the lack
of interoperability among providers. We therefore have to decide if we
want to tackle the problem by changing the incentives for the EHR
vendors, for the provider side, or for both. Targeting vendors seems to
be the most effective option--there are policy levers in place and it
is a more clearly defined, manageable group. ONC has proposed a good
set of first steps, as outlined in their recent report on health
information blocking.\11\ There are some challenges, however, in
operationalizing the steps described in the report. Nonetheless, there
is an opportunity for Congress pass legislation that gives ONC and
other Federal agencies more ability to reign in the behavior of those
engaging in information blocking.
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\11\ http://www.healthit.gov/sites/default/files/reports/
info_blocking_040915.pdf.
Question 4b. Is ONC's nationwide Interoperability Roadmap a
reasonable guide to widespread interoperability?
Answer 4b. The Interoperability Roadmap offers a set of guiding
principles that ONC has committed to follow when designing policies to
promote interoperability. Efforts are currently underway to figure out
how best to operationalize these principles. Currently, the ONC is
focusing on key issues of data governance, but much work remains in
terms of gaining agreement on next steps and turning it into a true
``guide.''
Question 4c. The lack of enforceable, consistent standards has been
an industry concern. Does the 2015 Interoperability Standards Advisory
fill the void? If not, what else can or should the Federal Government
do to ensure a single set of standards is used within the industry?
Answer 4c. I would also encourage you here to consult someone with
deep expertise on standards. In my opinion, the issue seems to be more
related to generating broad consensus on an effective set of standards,
not just a consistent set of standards. Effective standards need to be
detailed and prescriptive enough to enable receipt of data without
extensive customization; however, standards that allow for flexibility
and optionality are easier for vendors to implement. A single set of
effective standards would have to balance both of these needs, and
could be developed through closely coordinated work among various
participants to make key decisions on the tradeoffs. To do this, key
use cases for interoperability must be identified and the diverse needs
and interests of stakeholders have to be addressed to achieve
consensus. Furthermore, there must be a mechanism through which
participants are held accountable for their decisions, such that they
have an incentive to adhere to the consensus solution.\12\
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\12\ Email Correspondance with Dr. Walter Sujanky, Sujanski &
Associates; see Sujansky, W. V., Overhage, J. M., Chang, S., Frohlich,
J., & Faus, S. A. (2009). The development of a highly constrained
health level 7 implementation guide to facilitate electronic laboratory
reporting to ambulatory electronic health record systems. Journal of
the American Medical Informatics Association: JAMIA, 16(3), 285-90.
http://doi.org/10.1197/jamia.M2610.
Question 4d. Patient matching is a consistent concern raised by
industry. How can government and industry ensure that patient data can
be reliably shared across care settings?
Answer 4d. Patient matching is another area in which ONC is issuing
guidance.\13\ Specifically ONC has identified consistent implementation
of best practices across healthcare organizations as key to successful
patient matching across systems. These best practices include:
standardizing patient identifying attributes (possibly by enforcing
these standards through EHR certification criteria), encouraging
patients to keep their identifying information up to date, and
systematically verifying patient identifying information. ONC also
recommends exploring the use of other types of patient information as
alternative options for patient identifiers. These are good areas, but
the key is consistent use and ensuring that all stakeholders put effort
into maintaining data integrity. As with data security, this requires
organizational and individual behavior change, which is not easy.
Another suggestion is to make clear that HHS is allowed to experiment
with national patient identifiers, which (somewhat counter-intuitively)
have the potential to be more secure than the current approach of using
name, birth date, etc.
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\13\ http://www.healthit.gov/sites/default/files/
patient_identification_matching_final_
report.pdf.
Question 5. Physicians consistently voice concerns with product
usability. What can be done to foster user-centered design rather than
technology built to meet regulatory and billing mandates?
In the near term, we should consider including in EHR certification
a key set of usability metrics, and either require that they be met, or
publicly report on their performance. I feel that user-centered design
is tricky because it is not clear that there is consensus across users
(particularly in different specialties, with different patient panels,
etc.) on what constitutes optimal design. A promising medium-term
direction is to work toward a substitutable app-based model for EHRs,
like the one advocated by SMRT (smarthealthit.org). This would allow
users to configure displays and functions to a much greater extent
(like we have a choice of map applications on our smart phones).
Ultimately, we don't want a single vendor to be in charge of the user
experience. We want each physician to be able to choose what they like
best and have a robust ``market'' for creating the best apps to improve
user experience. Thinking longer term, I think we could learn a lot
from allowing CMS to experiment with relaxing regulatory and billing
mandates (i.e., creation of safe harbors) to see what can happen in
terms of improving EHR usability when EHRs can be wholly focused on
supporting clinical care.
Question 6. A lack of a ``business case,'' both for vendors and
providers, is often cited as a hindrance to information sharing. What
can be done to create the ``business case'' to generate
interoperability?
Answer 6. We need to decide if we want to tie incentives to the
process (like MU) or the outcome (stop paying for outcomes that we
think could be avoided with good interoperability). Right now we are
doing a bit of both but neither approach has been very effective. Going
back to answer (1), I think the key to promoting the business case for
interoperability is bringing down the cost for providers. I think we
are clearly on a path toward stronger pay-for-value incentives, and
while in theory, this should lead to higher provider willingness to pay
for interoperability, if the cost of interoperability is high,
providers may decide to invest in other areas. Bringing down the cost
of interoperability could also speed provider willingness to take on
more risk-based contracts.
Queston 7a. Stakeholders often voice concerns that the electronic
health record product as certified is quite different from the products
deployed in individual care settings. How can we ensure that the
certification program delivers capable technology not just upon initial
testing but once deployed in the field?
Answer 7a. This is important and there is a lot to be said for
considering extending certification to include post-market
surveillance. Some of these ideas are discussed in the health
information blocking report. Currently, ONC implements post-market
surveillance through ONC-Authorized Certification Bodies (ONC-ACBs).
ONC-ACB's have been asked to prioritize the monitoring of EHR safety-
related capabilities and assuring that vendors have processes in place
for addressing user concerns.
One option that has been suggested for improving post-market
surveillance of EHR products is to implement a centralized reporting
system where end-users can report issues with their EHR systems,
especially those concerning patient safety, for further analysis and
followup by an ONC committee. In this way, issues that are common
across EHRs can be identified and addressed, and individual vendors can
also be held accountable for addressing user concerns.\14\ Random
auditing seems like another approach to post-market surveillance that
could be quite effective and create minimal opportunity for vendors to
meet the certification standards while failing to deliver a well-
functioning product in the field.
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\14\ Sittig DF, & Classen DC. (2010). Safe electronic health record
use requires a comprehensive monitoring and evaluation framework. JAMA,
303(5), 450-51. http://doi.org/10.1001/jama.2010.61.
Question 7b. How can we create transparency in cost, satisfaction
and vendor responsiveness?
Answer 7b. As mentioned above, this issue could be addressed
through systematic data collection and public reporting. A public
reporting model, coupled with consequences for bad vendor behavior
(such as financial penalties for not addressing consumer concerns with
a certain time period) are likely to incentivize vendors to increase
responsiveness.
Question 7c. Does ONC have the proper resources to employ enhanced
testing capabilities relative to the Certification Program?
Answer 7c. The testing is performed by ONC certified labs, and so
it seems that with more resources, their scope could be extended to
include post-market surveillance.
senator burr
Question. Your testimony states that even though there has been a
large uptake of EHR systems, only 20 to 30 percent of physicians and
hospitals exchange electronic health data with other providers. What
are the biggest barriers to the interoperability of these systems? What
incentives need to be in place that are not today?
Answer. Please see answers 4 and 6 above.
senator warren
Question 1. As you know, our electronic health record systems often
have trouble matching a particular scan or a test result to the right
patient, and those mismatches endanger patients. As more providers move
to electronic health records and databases contain records for more
patients, the risk of mismatching information to patients only goes up.
A 2008 RAND Corporation study estimated that even with database
management software and personnel dedicated to preventing these
mistakes, hospitals mismatch patient information about 8 percent of the
time. A 2012 survey conducted by The Council of Health Information
Management Executives found that one in five physicians encountered
mismatched information that that put a patient at risk at least once
over the previous year. Accurately matching health information to the
correct patient record is critical to creating an electronic health
information exchange that works. How can we reduce these errors?
Answer 1. Please see answer 4D above.
Question 2. Today, 90 percent of hospitals have certified that they
meaningfully use electronic health records. And in some areas,
hospitals and providers have taken the next step of creating regional
health information exchanges to share patient information. This sharing
has enormous benefits to patients. A 2014 study performed by University
of Michigan researchers found that Emergency Departments that were
connected to a regional health information exchange ordered fewer
duplicate tests--patients in these Emergency Departments were 59
percent less likely to have a redundant CT scan, 44 percent less likely
to get a duplicate ultrasound, and 67 percent less likely to have a
duplicated chest x-ray compared to patients who went to hospitals that
were not connected to a regional health information exchange. We've
made real progress, but we can't get the full value of electronic
health records until hospitals and providers from around the country
can exchange patient information with each other. To what extent would
expanding these small regional systems to a nationally interoperable
electronic health record system reduce duplicative tests and how much
money could that save our health care system?
Answer 2. There have been two estimates of the savings from
nationwide interoperability. A 2005 Rand study found that fully
interoperable EMR systems could generate savings of $142-$371 billion
nationwide; this estimate includes efficiency and safety savings, as
well as short- and long-term effects on patient health and
productivity. Of that estimate, $1.3-4.6 billion would be generated
from efficiency savings in lab tests.\15\ A 2005 Partners HealthCare
study estimated savings of $77.8 billion a year that could be generated
through the implementation of a nationwide interoperable exchange
network that includes payers and public health departments as well as
labs, radiology centers, pharmacies, physicians, and hospitals. This
study estimated that an average of $17.41 per person could be saved
from reductions in redundant lab tests per year.\16\
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\15\ Hillestad, R., Bigelow, J., Bower, A., Girosi, F., Meili, R.,
Scoville, R., & Taylor, R. (2005). Can Electronic Medical Record
Systems Transform Health Care? Potential Health Benefits, Savings, And
Costs. Health Affairs, 24(5), 1103-17. http://doi.org/10.1377/
hlthaff.24.5.1103-17.
\16\ Walker, J., Pan, E., Johnston, D., Adler-Milstein, J., Bates,
D. W., & Middleton, B. (2005). The Value of Health Care Information
Exchange And Interoperability. Health Affairs. http://doi.org/10.1377/
hlthaff.w5.10.
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What is not clear is how to best realize these savings--and how to
interconnect the varied regional systems. ONC has laid out a nationwide
interoperability roadmap, but we are in the early stages of
operationalizing it. Response to Question 4B above speaks more to the
roadmap.
Response by Robert L. Wergin, M.D., FAAFP to Questions of Senator
Alexander, Senator Burr, Senator Cassidy, Senator Murray, and Senator
Warren
senator alexander
Question 1a. With the rapid digitization of health data, is the
industry effectively protecting personal health information?
Answer 1a. Privacy of health information is of the utmost concern
to family physicians. A confidential relationship between physician and
patient is essential for the free flow of information necessary for
sound medical care. Only in a setting of trust can a patient share the
private feelings and personal history that enable the physician to
comprehend fully, to diagnose logically, and to treat properly. The
American Academy of Family Physicians (AAFP) supports full access by
physicians to all electronic health information. Medical information
may have legitimate purposes outside of the physician/patient
relationship, such as billing, quality improvement, quality assurance,
population-based care or patient safety. However, the AAFP believes
that patients and physicians must authorize the release of any
personally identifiable information to third parties.
Electronic health information communication systems must be
equipped with appropriate safeguards (e.g., encryption, message
authentication, user verification) to protect the physician-patient
confidentiality. Individuals with access to electronic systems should
be subject to clear, explicit, mandatory policies and procedures
regarding the entry, management, storage, transmission and distribution
of patient and physician information.
The AAFP supports the use of patient record information for primary
care research, biomedical and pharmaceutical research and other health
research, provided there is appropriate protection for research
subjects, i.e., Institutional Review Board approval.\1\
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\1\ AAFP Policy Confidentiality, Patient/Physician Relationship,
2013, http://www.aafp.org/about/policies/all/patient-
confidentiality.html.
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In a January letter to the U.S. Department of Health and Human
Services (HHS), the AAFP indicated that we have seen a significant
increase in adoption of health information technology (HIT) by family
physicians and we are beginning to see a robust network of secure,
interoperable exchange via Direct, supported by a security and trust
framework, accreditation programs, and trust anchor services
established by DirectTrust under the Exemplar Health Information
Exchange (HIE) Governance Program's Cooperative Agreement with the HHS
Office of the National Coordinator for Health IT (ONC).\2\ More could
always be done, but we must balance confidentiality and integrity of
data with appropriate access.
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\2\ Blackwelder, Reid, AAFP letter to Karen DeSalvo, January 15,
2015, http://www.aafp.org/dam/AAFP/documents/advocacy/health_it/
interoperability/LT-ONC-HITPlan-011515.pdf.
Question 1b. What additional resources would be valuable in
encouraging organizations to prioritize health data security?
Is the government offering proper guidance and/or resources to
inform industry decisionmaking relative to data security?
Answer 1b. Physicians would benefit from resources that help
promote security in ways that do not reduce efficiency or work flow.
The Federal Government could better support physicians, and small
practices, in particular by sharing best practices and providing simple
tools that would help physicians learn from mistakes or implement
secure HIT in a cost-effective manner. For example, a 2013 article
published in Family Practice Management discussed many of the concerns
physicians face and pitfalls to avoid.\3\ The article noted that many
physicians believe sharing brochures would encourage patients to use
the portal, but ultimately other methods proved more effective. Also,
some practices learned how an electronic messaging set up can ensure
that offices follow the best methods for ensuring patient information
will not be compromised. Providing resources for effective ways to
satisfy Meaningful Use requirements regarding the use of the patient
portals and secure messaging would also be helpful.
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\3\ Rachel Franklin, M.D., Fam Pract Manag. 2013 Jan-Feb;20(1):21-
24.
Question 1c. Is threat information readily shared throughout the
industry? Or with other industries?
If so, is the information useful?
If not, what incentives could be offered for organizations to share
threat information with other organizations?
Answer 1c. Currently, there is no system for sharing threat
information among organizations. Perhaps the creation of an information
working group might provide a forum for greatly needed dialog on
privacy and security issues. Such a forum should include vendors,
medical associations, and patient advocates.
Question 2a. Half of the Nation's physicians have chosen not to
participate in the Meaningful Use program to date. How can this change?
Answer 2a. Several published reports indicate that many physicians
opt-out of the program due to the administrative burden of the
requirements they are required to satisfy. These views were reflected
in a 2014 Medspace Electronics Health Record (EHR) poll.\4\ The survey
data suggest that physicians are concerned that Meaningful Use
requirements interfere with the doctor-patient relationship and
interfere with how they can effectively and efficiently practice
medicine.
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\4\ Medsape EHR Report, July 14, 2014, accessed online: http://
www.medscape.com/features/slideshow/public/ehr2014#24.
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As an AAFP leader, I travel across the country and consistently
hear physicians. concerns about cost and workflow. As I mentioned in my
testimony, lowering the Meaningful Use requirements and reducing
penalties would help alleviate some of those concerns. In addition, for
those physicians who are later in their careers, the program is simply
viewed as too burdensome and expensive for their practices.
This issue could be addressed by requiring certified EHR systems to
be organized in cooperation with physician experts. In addition, HHS
could use its authority to ensure that systems achieve greater degrees
of usability and interoperability. Both will be important issues to
consider as the Meaningful Use Stage 3 regulatory process moves
forward. Under current proposals regarding Stage 3, physicians will
face more complex requirements, and some will be attesting for the
first time. Also, new certification requirements will be in place,
which will require costly upgrades to their EHRs. In addition to these
challenges of achieving Stage 3, there is uncertainty on what will be
required to successfully participate in the Merit-Based Incentive
Payment (MIPS) approved as part of the Medicare Access and CHIP
Reauthorization Act (MACRA). Given these challenges and uncertainty, a
strong consideration of delaying Meaningful Use Stage 3 is needed until
the MIPS regulations are written and approved.
Although MIPS adjustments will not go into effect until 2019 and
Meaningful Use penalties will sunset in 2019, implementing the new law
presents an opportunity to address numerous HIT priorities. Currently,
ONC is reviewing both the proposed rule for Meaningful Use Stage 3 and
the EHR certification requirements. New standards will be in place that
will harmonize Meaningful Use, Physician Quality Reporting System
(PQRS) and the Value-Based Modifier.
MACRA also requires HHS to establish metrics by July 1, 2016, for
measuring how hospitals and providers progress in moving toward the
goal of widespread interoperability of EHR systems. The new law
requires the administration to submit a report to Congress if this goal
has not been met by December 31, 2018. In this report, HHS would be
required to make recommendations for achieving this goal, such as
adjusting payments and decertifying certain EHR technology. MACRA also
requires the Meaningful Use Program to require attestations by eligible
hospitals and physicians that they have ``not knowingly and willfully
taken action (such as to disable functionality) to limit or restrict
the compatibility or interoperability of the certified EHR
technology.'' Finally, HHS is also required to submit a report to
Congress (within 1 year from the date of enactment of MACRA) on methods
to aid providers in comparing and selecting certified EHR technology.
This new policy is a welcome change to help harmonize requirements with
new Medicare policies. While physicians and hospitals work to prepare
for a myriad of policy and regulatory changes focused on patient care
coordination, the administration and Congress should strongly support
Meaningful Use Stage 3 delay.
Question 2b. Continually, physicians call for the all-or-nothing
nature of the program to be rethought. Why are rulemakers so hesitant
to adjust this rigid mandate?
Answer 2b. AAFP officials have been informed that there is limited
executive branch authority to relax certain Federal standards. We urge
Congress to authorize the Centers for Medicare and Medicaid Services
(CMS) to allow for partial credit for achieving components of
Meaningful Use by eligible professionals. Congress should also
encourage HHS to incorporate more flexibility into the requirements.
Question 2c. Are there any additional resources, other than
additional incentive payments, that the Federal Government should
provide to increase physician participation?
Answer 2c. Any changes that would make EHR/Health IT use less
burdensome would increase physician participation. While eligible
professionals are penalized for not performing health information
exchange under Meaningful Use, HIT vendors are not. Eligible
professionals are dependent on their HIT vendor to be interoperable and
support health information exchange. We believe that vendors should
also see penalties if they are not interoperable. We would urge
Congress to explore how vendor financial penalties could be used to
further interoperable HIT.
We urge Congress to request that current Medicare documentation
policies, which were developed in an era of paper records and fee-for-
service, be updated to reflect the new era of electronic records and
value-based payment.
We would urge Congress to consider funding additional research into
the science of practice for primary care with the purpose to better
understand how best to design, implement, and use HIT in practices
focused around the new goals of value-based payment.
During the hearing, Senators mentioned a desire to ``reboot'' the
Health Information Technology for Economic and Clinical Health Act
(HITECH). The AAFP agrees with that sentiment, particularly regarding
Clinical Quality Measures (CQM). It is an AAFP principle for physician
performance measurement that the purpose of performance measurement
should be to identify opportunities to improve patient care so that
these programs lead to better-informed physicians and consumers.\5\ Our
policy on electronic health records is such that we believe every
family medicine practice should leverage health information technology,
such as EHRs and related technologies needed to support the patient-
centered medical home.\6\ These capabilities can support and enable
optimal care coordination, continuity, and patient centeredness,
resulting in safe, high-quality care and optimal health of patients,
families, and communities. Physicians remain concerned that the current
CQM fail to reflect why HIT is meaningful for facilitating care
coordinate and improving health outcomes. The CQM should be updated to
improve the clinical discipline that the measures evaluate, rather than
meeting an arbitrary reporting requirement imposed by either the
quality improvement program or a vendor data submission process.\7\
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\5\ Stream, Glen, Letter to Margaret Tavenner, April 5, 2013--
http://www.aafp.org/dam/AAFP/documents/advocacy/health_it/emr/LT-CMS-
ClinicalQualityMeasures-040513.pdf.
\6\ Stream, 2013.
\7\ Ibid.
Question 3a. The goal of HITECH was to improve patient care while
decreasing costs--has there been a change in the cost to healthcare
because of HITECH?
Answer 3a. The evidence is unclear if HITECH has changed healthcare
costs. New research, however, does suggest that it can help facilitate
team-based systems that have shown to produce modest reductions in
healthcare spending.\8\ In addition, a study published in the Annals of
Internal Medicine indicated that physicians who implemented a medical
home and used electronic health records experienced improved quality
scores compared to physicians who used paper records.\9\
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\8\ Porter, Shari, AAFP News, April 18, 2014, ``Modest Changes Can
Lead to Better Quality, Lower Costs in Health Care.'' Accessed online:
http://www.aafp.org/news/practice-professional-issues/
20140408continuityofcare.html.
\9\ Lisa M. Kern, M.D., MPH; Alison Edwards, MStat; and Rainu
Kaushal, M.D., MPH, Annals of Internal Medicine, Ann Intern Med.
2014;160(11):741-49. doi:10.7326/M13-1798.
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Indeed, we know that the potential exists to lower costs and
improve quality. A study to further evaluate the HITECH's impact on
healthcare costs would be beneficial. Furthermore, we need an
infrastructure to establish a research agenda around the science of
practice (i.e., what makes for an effective and efficient work
environments and system designs).
Question 3b. Since EHRs have become more common place, are there
any metrics of public health improvement being observed?
Answer 3b. The AAFP cannot report specific public health
improvements at this time, but the Center for Medicare and Medicaid
Innovation (CMMI) is examining patient-centered health innovations and
the use of technology.\10\ For example, its Comprehensive Primary Care
initiative is engaging 500 practices and 2.5 million patients. During a
recent meeting, health experts observed that programs are lowering
costs and improving health outcomes, including reductions in mortality
rates.\11\ Further, there are two observations worth highlighting.
First, electronic records are capturing crucial patient data that is
not being extracted. Second, technology is lagging behind reforms in
healthcare delivery. As I mention in my testimony, technology still
holds tremendous potential for health delivery. CMMI may possess
evidence to demonstrate public health improvements.
---------------------------------------------------------------------------
\10\ Laff, Michael, AAFP News, Panel Considers Health Care
Innovations in Technology, Payment, April 28, 2015, http://
www.aafp.org/news/practice-professional-issues/20150428inno-
vation.html.
\11\ Ibid.
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The AAFP also is concerned that the discussion about practice
transformation has been limited to technology. HIT is a tool for
increasing access to services. We should focus on how to improve the
capabilities of the physician's practice. For example, quality
improvement efforts should mean looking for ways to engage patients in
their healthcare rather than simply pushing for the adoption of patient
portals. Practice transformation requires thinking about workflow,
personnel, content and the technology that supports those elements of
the sociotechnical system. For example, using HIT to promote more
telehealth services, such as e-consultations, online health evaluation
and coaching and tele-visits hold tremendous potential for improving
health outcomes.
Question 3c. What can government do to further the goal of using
this technology to decrease costs?
The Federal Government can help decrease health costs by continuing
to align financial incentives with value-based services that are time-
intensive but rely on or utilize health technology. Essentially, the
healthcare community should consider how to make basic healthcare more
accessible to the patients. The AAFP applauds Congress' support for
alternative payment models within MACRA.
As implementation moves forward, HIT will be essential for
physicians. Telehealth helps increase access without compromising care.
Policymakers should consider ways to eliminate barriers to telehealth
services, particularly for primary care services to address chronic
health conditions, like diabetes, and for certain patients who lack
transportation to followup medical appointments.
We are pleased that Section 106(c) with MACRA requires the
Government Accountability Office (GAO) to draft two reports to evaluate
and report on telehealth programs, barriers, potential healthcare
outcomes and patient monitoring technology. The evaluation may provide
some valuable input into the ongoing debate about HIT, the value of
these services is well-documented. We urge policymakers to push for
expedited GAO review. Physicians need concrete policies to eliminate
barriers, particularly for primary care services.
Question 4a. What are the biggest barriers inhibiting nationwide
interoperability?
Answer 4a, Achieving interoperability requires the ability to
exchange information in real time, but the ultimate goal is to achieve
optimal care coordination for patients.
The biggest barrier to achieving interoperability and care
coordination is the system of incentives. The financial incentives for
HIT vendors are misaligned. Instead of promoting interoperability,
vendors focus on locking in practices, which will find it too expensive
and burdensome to change EHRs after a current system has been
installed. In addition, ending the current reliance on documentation
requirements for Evaluation and Management services from the paper era
could produce positive results. These regulations lead to bloat in the
EHR, which interferes with patient care and interoperability. They
decrease the signal-to-noise ratio in the patient's record and
exchanges of health information, where the signal is the clinically
relevant information. The requirements are administratively burdensome
and are not helpful in today's practice environment. We urge Congress
to communicate that message to CMS.
Our position from the onset has been that true interoperability
will not be achieved without fundamental changes in healthcare payment
reform. We are excited to see the acknowledgment of this position by
both the private sector and CMS. A good example of the latter is the
recent announcement by Secretary Burwell on the desired deployment of
value-based payment by CMS. Also, MACRA supports payment reform that
incentivizes value-based care. We believe that payment reform is the
keystone to a nationwide interoperable healthcare delivery system.
HITECH incentives helped accelerate the adoption of HIT through
incentives. In 2013, 59 percent of hospitals and 48 percent of
physicians had at least a basic EHR system, respective increases of 47
percentage points and 26 percentage points since 2009, the year HITECH
was signed into law.\12\ As of June 2014, 75 percent (403,000+) of the
Nation's eligible professionals and 92 percent (4,500+) of eligible
hospitals and CAHs had received incentive payments.\13\ As we examine
healthcare interoperability, we must turn our focus on ways to support
care coordination across health sectors and among stakeholders.
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\12\ Office of the National Coordinator for Health IT, Annual
Report to Congress, October 2014, http://www.healthit.gov/sites/
default/files/rtc_adoption_and_exchange9302014.pdf.
\13\ Ibid.
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While eligible professionals are penalized for not performing
health information exchange under Meaningful Use, HIT vendors are not.
Eligible professionals are dependent on their HIT vendor to be
interoperable and support health information exchange. We believe that
vendors should also see penalties if they are not interoperable. We
would urge Congress to explore how vendor financial penalties could be
used to further interoperable HIT.
Question 4b. What is the biggest barrier blocking providers from
sharing information with each other? What is the biggest barrier
blocking patients from sharing their information with different
providers?
Answer 4b. The biggest barrier for physicians is often their
practice's HIT systems. Physicians often purchase a system that they
believe will be an effective means of communication. It is difficult to
know if the system will work and communicate across diverse platforms
until after physicians invest the time and money into an EHR. The
investment and costs for moving data that has been warehoused into a
new system also create significant barriers for physicians who want to
change vendors.
In its letter to HHS regarding the nationwide Interoperability
Roadmap, the AAFP highlighted this concern and recommended a process to
collect real-world feedback of certified electronic health record
technology in use. ONC should create a resource to accept complaints
from users when real world use of certified technology does not allow
for the interoperability required by certification criteria. This
feedback would be used to inform the certification testing tools and to
inform ONC of bad actors as far as the interoperability is
concerned.\14\
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\14\ Blackwelder, AAFP letter to Karen DeSalvo, January 15, 2015.
Question 4c. Is ONC's nationwide Interoperability Roadmap a
reasonable guide to widespread interoperability?
Answer 4c. Overall, the Interoperability Roadmap is a good
framework for advancing this important issue. The AAFP agreed with ONC
on several points such as the principles for an interoperable health
ecosystem. The AAFP also agreed with the plan's recommendations for
establishing common clinical data sets. Further, there also was
consensus about the nationwide privacy and security framework.
The AAFP, however, identified several areas that need improvement.
First, AAFP strongly urged ONC to address workflow and documentation
requirements. Also, AAFP expressed concerns about the lack of a
detailed short-term plan for how its goals would be achieved. In
addition to interoperability, standards need to address the real-world
environment in which HIT systems are utilized.\15\
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\15\ Ibid.
Question 4d. The lack of enforceable, consistent standards has been
an industry concern. Does the 2015 Interoperability Standards Advisory
fill the void? If not, what else can/should the Federal Government do
to ensure a single set of standards is used within the industry?
Answer 4d. The AAFP has dedicated significant resources over the
last decade to support the achievement of healthcare interoperability.
We have worked on key clinical and transport standards and participated
in the national policy dialogs. Our position from the onset has been
that true interoperability will not be achieved without fundamental
changes in healthcare payment reform. We are excited to see the
acknowledgment of this position by both the private sector and CMS. A
good example of the latter, as stated previously, is the recent
announcement by Secretary Burwell of the desired deployment of value-
based payment by CMS. We believe that payment reform is the key to a
nationwide interoperable healthcare delivery system.
Question 4e. Patient matching is a consistent concern raised by
industry. How can government and industry ensure that patient data can
be reliably shared across care settings?
Answer 4e. Proper patient identification is essential for wide-
scale interoperability. The support of consistent, unambiguous patient
identification is needed. According to a 2014 Health Affairs study,
only 40 percent of physicians reported having electronic exchanges of
any sort with other providers. To further break down the numbers, only
one of seven physicians shared data with providers outside their
organization. Privacy concerns and incompatible technology systems were
cited as the two primary reasons for the slow growth of information
exchanges.
Question 5. Physicians consistently voice concerns with product
usability. What can be done to foster user-centered design rather than
technology built to meet regulatory and billing mandates?
Answer 5. There is a discipline of industrial and systems design
that includes the human factors that could be applied to healthcare and
HIT. Support is needed to establish an infrastructure to study the
science of practice, which would include user-centered design.
On a separate track, we must continue to make progress on real-time
interoperability. The AAFP has been active in efforts to develop
standards for packaging of data; e.g., Continuity of Care Record (CCR),
and Consolidated Clinical Document Architecture (C-CDA). Additionally,
the AAFP has worked on the development of standards for the transport
of data (e.g., Direct Project). These efforts must continue alongside
CMS' efforts to make claims data available.
As outlined in the testimony, EHR usability is an area of
significant concern. Often, physicians must sort through pages of
documentation to access information that is often not relevant to
patient care. The Medicare Documentation guidelines are out of date and
structured around billing data versus patient information. Amending
these standards would change how EHR systems are created. In addition,
physicians should have significant flexibility to delegate requirements
to qualified staff as members of the healthcare team.
To change product usability, the AAFP recommends the following: (1)
Incentivize value not documentation; (2) Support more research into the
science of practice by supporting research in the application of
industrial and systems engineering to healthcare; (3) Simplify
regulatory requirements that have been created over many years which
require significant effort by providers and vendors to modify and
expand the work of providers without positive impact on patient care,
quality or cost.
Some key areas of regulatory simplification include the following:
Elimination of requirement dictating who within the care
team (i.e., physician, nurse, medical assistant, patient, etc.) can and
cannot perform certain tasks. With the support of HIT, the roles in the
care team can change, and team-based care is needed to be efficient and
effective.
Elimination of documentation requirements that were
designed for cost control and not for supporting care delivery.
Ease external reporting requirements. We have heard from
many members about the hours of extra work needed to report for
Meaningful Use. We also heard about the added checkboxes and restricted
workflows in HIT just to ensure the external reporting is performed.
Harmonize programs. Each Federal program is created in a
silo yet they have overlap in goals and requirements. It is a struggle
for practices to understand the varied regulations and rules. These
programs need to be integrated to ease the administrative burden to
understand and comply with these multiple programs. We appreciate the
changes included with MACRA, but harmonization needs to be a systemic,
ongoing and serious endeavor.
Question 6. A lack of a ``business case,'' both for vendors and
providers, is often cited as a hindrance to information sharing. What
can be done to create the ``business case'' to generate
interoperability?
Answer 6. The best business case for interoperability would be the
creation of a system in which physicians can see notable improvements
in clinical efficiency, patient care, and revenue. Physicians' major
priority is to provide high-quality patient care. The creation of an
interoperable system that facilitates patient visits and supports
meaningful data exchanges across different platforms would benefit
physicians and their patients. Two-thirds of physicians work in a small
or solo practice. Helping these small practices implement best
practices and maintain financial viability would also be an important
return on investment.
EHR adoption requires a high initial investment and ongoing
maintenance fees. The costs combined with the regulatory burdens are
creating a highly diminished sense of return on investment at this
time. If Congress and the administration aligned physician payment with
technology-driven and high-value care, it would certainly represent a
strong business case for many primary care physicians. Doing so would
require stronger interoperability standards and systems that complement
physicians. workflow.
Question 7a. Stakeholders often voice concerns that the electronic
health record product as certified is quite different from the products
deployed in individual care settings. How can we ensure that the
certification program delivers capable technology not just upon initial
testing but once deployed in the field?
How can we create transparency in cost, satisfaction and vendor
responsiveness?
Answer 7a. The AAFP recommends a quality rating system to create
greater transparency in cost, satisfaction, and vendor responsiveness.
In addition, field testing would help ensure that only interoperable
products are being utilized. Also, we strongly recommend that
policymakers establish penalties for vendors that do not meet quality
and interoperability standards.
Question 7b. Does ONC have the proper resources to employ enhanced
testing capabilities relative to the Certification Program?
Answer 7b. No, it is our view that ONC lacks sufficient resources
to employ enhanced testing relative to the Certification Program. This
is an issue that Congress must address.
senator burr
Question 1. Please expand on the suggestion in your testimony that
physicians not be charged by their vendors for accessing their own
patients. data. Is this occurring for existing patients, new patients,
or both?
Answer 1. In my testimony, I mentioned that a patient's data should
not be restricted because of the vendor's business practices. Concerns
about these practices apply to both new and existing patients within a
physician's panel. We have heard of members being required to pay to
have their data extracted from the EHR if they wish to use that
information in other information systems. Recent analysis indicate that
because the market for creating new electronic records is saturated,
vendors require physicians to pay a range of different fees to access
their patients' data.
Question 2. According to a warning the FBI issued to healthcare
providers last year, the healthcare industry has the highest volume of
cyber threats and the slowest response time. What are your suggestions
of steps that could be taken to make this information more secure?
Answer 2. Patient safety is of the utmost concern to physicians. To
address this issue, physicians need access to best practices and the
highest quality support to protect patient data. To respond to the
FBI's concerns, the AAFP recommends ONC and other entities focus on
assisting providers rather than penalizing those that happen to get
breached. Physicians and hospitals want to avoid data breaches and are
willing to implement reasonable safeguards.
senator cassidy
Question 1. As a physician, I have concerns that mandated
``Meaningful Use'' of health information technology such as EHRs, while
providing useful medical data, has complicated physician-patient
encounters and distracted the physician from what they have been
trained to do--provide patients with personalized care and give
patients their undivided attention.
In over 46 States and in a variety of settings--emergency rooms,
hospitals, urgent care clinics, and practices including OB/GYN,
cardiology, orthopedics, and oncology--medical scribes are used as a
means of significantly reducing the healthcare practitioner's burden of
entering data into the EHR. The scribe accompanies a provider into the
exam room and documents the physician-patient encounter into the EHR in
real-time and at the point of service. This relationship allows the
physician to spend more time delivering care directly at the patient's
bedside and less time in front of a computer screen navigating EHRs.
The use of a scribe allows a physician to focus on the patient and
think clinically, not clerically. One of the unintended consequences of
the ACA is that ED volumes have risen, some argue this is due to access
to care issues. Scribes could help provide greater access to
appropriate levels of care. Has adoption of EHRs altered the physician-
patient encounter?
Answer 1. The AAFP shares your concerns about the negative impacts
Meaningful Use and poor HIT implementation has had on the patient-
physician relationship. The organization is currently undertaking a
study to measure this impact on patient care by Meaningful Use. We are
hopeful to have results to share in mid to late summer of 2015.
The AAFP has heard of the positive impacts of scribes. One concern
we have is that this is treating a symptom and not the underlying
problem. Hiring scribes or re-tasking clinical support staff would
increase the cost of practices. We would like to see reforms in the
documentation requirements to update those requirements from an era
dominated by paper records to one leveraging HIT. That said, we also
think that practices should have the ability to determine the best
personnel to perform the work (within the constraints of State law).
Federal requirements that dictate who can and cannot perform tasks do
not support a team-based approach to care and these unnecessary
requirements must be eliminated. Team-based approaches are needed to
achieve the Triple AimTM and to help with the shortage of
primary care.
Question 2. A recent study of using scribes in a cardiology clinic
in St. Paul, MN, found that scribe-use produces improvements in
physician-patient interaction and results in large increases in
physician productivity. Specifically, patients seen per hour increased
by 59 percent, from 2.2 patients per hour to 3.5, and the amount of
time that physicians interacted with patients increased. Based on your
clinical experience incorporating EHRs into your practice, do you agree
that a physician could deliver care to more patients per hour if they
did not have to navigate an EHR while also examining a patient? If the
provider is seeing more patients per hour then are they driving greater
access to care?
Answer 2. Currently, the EHR does not work well with the work flow
of a practice. The note created has more to do with ``bullets on
billing'' than sharing meaningful clinical information with other
providers. Some practices do use scribes with an extra expense to the
practice and overhead. While this may be an option for large-margin
consultation practices, it may not be a viable business option for
small primary care practices with smaller margins per visit. If one is
employed by a healthcare system, the extra expense in personnel has to
be justified to the bottom line of the practice.
senator murray
Question. Since 2009, physicians and hospitals have made an
unparalleled investment in HIT. In Washington State, providers have
received over $500 million in HITECH incentive payments to help with
the cost of adopting electronic health records. Yet many providers are
reporting that the cost of implementing HIT doesn't end with
installation in the hospital or clinic. Is the AAFP aware of providers
who have paid substantial sums to connect their electronic health
record with other systems? How commonplace are these fees? Are they a
barrier to helping providers and families make full use of electronic
health records?
Answer. Health data ultimately belongs to the patient, not to EHR
vendors, and an EHR vendor should not be permitted to ``hoard'' patient
data in order to gain a business advantage.
There is typically an interface fee, which is in the neighborhood
of $5,000, and some also charge a service fee requiring a monthly or
yearly payment. A practice's current vendor holds a monopoly over
interoperability for the practice. That monopoly is preventing
reduction of the price of connectivity. More study and transparency
around these costs are needed and this vendor ``lock'' should not be
allowed.
senator warren
Question 1. Today, 90 percent of hospitals have certified that they
meaningfully use electronic health records. And in some areas,
hospitals and providers have taken the next step of creating regional
health information exchanges to share patient information. This sharing
has enormous benefits to patients. A 2014 study performed by University
of Michigan researchers found that Emergency Departments that were
connected to a regional health information exchange ordered fewer
duplicate tests--patients in these Emergency Departments were 59
percent less likely to have a redundant CT scan, 44 percent less likely
to get a duplicate ultrasound, and 67 percent less likely to have a
duplicated chest x-ray compared to patients who went to hospitals that
were not connected to a regional health information exchange. We've
made real progress, but we can't get the full value of electronic
health records until hospitals and providers from around the country
can exchange patient information with each other.
To what extent would expanding these small regional systems to a
nationally interoperable electronic health record system reduce
duplicative tests and how much money could that save our healthcare
system?
Answer 1. With most healthcare being delivered in a local or
regional manner for the vast majority of patients, extending to a
nationwide exchange likely would not dramatically impact those
duplicative costs like a regional exchange does. A model more like
Direct Exchange would support those cost reductions without the large
expense of maintaining a nationwide health information exchange.
Question 2. It is important that HHS is developing data standards
for providers covered by the Meaningful Use Incentive Programs, but not
all providers are covered by these standards and not all providers
receive incentives for setting up Electronic Health Records. For
example, nursing homes, independent laboratories, and behavioral health
providers are exempt, and many of these providers have no electronic
records system at all.
Answer 2. The AAFP has been vocal in its advocacy for the need to
develop data standards. It is clear that the amount of health data will
continue to grow geometrically. Ultimately, this data will be most
useful if it is standardized, i.e., encoded in a standard vocabulary
(in the way that SNOMED CT and CPT are standard codes for diagnoses and
procedures, respectively). The task of fully standardizing health data,
however, is a monumental one and represents a very long process that
will be achieved incrementally.
Until a national consensus on data standardization emerges, at a
minimum, EHR vendors should be required to use open application
programming interfaces (open APIs). Open APIs facilitate the move
toward interoperable health records by allowing developers to assist
providers and patients to access and interpret health data that
otherwise would be inaccessible. The committee's leadership in this
area is critical--we cannot wait for data to be fully standardized
before achieving interoperability. Health data ultimately belongs to
the patient, not to EHR vendors, and an EHR vendor should not be
permitted to ``hoard'' patient data in order to gain a business
advantage. Of course, a mandate for a vendor to have an API does not
redirect the business drivers against interoperability and subsequent
data hoarding.
Question 3. Is the ability to exchange information electronically
with labs, residential care facilities, and behavioral health providers
important to improving patient outcomes?
Answer 3. Exchanging information among numerous stakeholders is a
goal the AAFP shares with ONC.\16\ Having accurate information helps
with care transition when patients are discharged from the hospital. In
addition, it helps coordinate drug prescriptions and lab work. Many
family physicians are using health information technology to partner
with their subspecialists to integrate and improve patient care,
including behavioral health providers.\17\
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\16\ Stream, Glenn, AAFP Letter to Farzad Mostashari, M.D., ScM,
April 18, 2013, http://www.aafp.org/dam/AAFP/documents/advocacy/
health_it/interoperability/LT-ONC-Interoper-
abilityHealthInfoExchange-041813.pdf.
\17\ Arvantes, James, AAFP News, Health IT Forges Medical
Neighborhoods as FPs Collaborate with Subspecialists, August 6, 2013,
http://www.aafp.org/news/practice-professional-issues/
20130816hietechnology.html.
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Health information exchanges (HIE) allow family physicians to join
with local subspecialists and hospitals to create medical neighborhoods
that provide seamless healthcare transitions and a more effective
healthcare foundation. These HIEs represent a model for effective
interoperability and continuity of care. Managing chronic health
conditions require a behavioral health approach. HIT programs are
helping promote the integration of primary and behavioral health, an
important priority for patient-centered health improvements.
______
Epic Systems Corporation,
Verona, WI 53593.
Dear Senator Alexander and the honorable members of the HELP
Committee: I thank you for the opportunity to testify on March 17th
during the HELP Committee's hearing entitled, ``America's Health IT
Transformation: Translating the Promise of Electronic Health Records
into Better Care.'' Below are responses to the questions you sent me
following my testimony.
Please do not hesitate to contact me at [email protected], 608-271-
9000, if I can be of any further assistance.
Sincerely,
Peter DeVault,
Vice President.
______
Response by Peter DeVault to Questions of Senator Alexander, Senator
Burr, Senator Roberts, Senator Cassidy, Senator Murray, and Senator
Warren
senator alexander
Question 1a. With the rapid digitization of health data, is the
industry effectively protecting personal health information?
Answer 1a. The healthcare industry shares the cyber-security
challenges that have affected other industries, such as banking and
retail. We believe that healthcare, and every other industry, is at the
beginning of an intensifying cyber-threat era that will require strong
public-private partnership to ensure that we are protecting patient
information.
Healthcare data is much richer than financial or credit card
information. For example, it can include Social Security numbers,
illnesses, medical vulnerabilities, medical device information,
birthdays, addresses, email and employment information and income data
for customers and employees. In addition to data theft, there is also
the threat of intentional disruption of medical devices.\1\ Malicious
altering of electronic health record data could threaten lives.
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\1\ Healey, Pollard and Woods, ``The Healthcare Internet of Things:
Risks and Rewards'' Atlantic Council in partnership with Intel Security
http://www.mcafee.com/us/resources/reports/rp-healthcare-iot-rewards-
risks.pdf.
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The expanding value of healthcare data on the black market
alongside increased hacker sophistication has made 100 percent
effective cyber security in healthcare elusive. As we have seen in the
recent attacks on Premera Blue Cross \2\ (11 million records), Anthem
\3\ (80 million records), and Community Health Systems Inc.\4\ (4.5
million records), we are an industry under attack by sophisticated
domestic and foreign State-sponsored hackers.
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\2\ Finkle ``Premera Blue Cross breached, medical information
exposed'' Reuters March 17, 2015 http://www.reuters.com/article/2015/
03/17/us-cyberattack-premera-idUSKBN0MD2FF201503
17.
\3\ Abelson and Goldstein, ``Anthem Hacking Points to Security
Vulnerability of Health Care'' The New York Times February 5, 2015
Industry http://www.nytimes.com/2015/02/06/business/experts-suspect-
lax-security-left-anthem-vulnerable-to-hackers.html?_r=3.
\4\ Bosshart, ``Data Breach Notification'' Community Health
Services http://www.chs.net/media-notice/.
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According to the Identity Theft Resource Center, about 44 percent
\5\ of all registered data breaches in 2013 targeted medical companies.
Between 2013 and 2014, the number of breaches increased 60 percent
\6\--almost double the increase seen in other industries--according to
PricewaterhouseCooper's (PwC) Global State of Information Security
Survey 2015.
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\5\ Li ``The Next Cybersecurity Target: Medical Data'' The
Atlantic, March 2015 http://www.theatlantic.com/technology/archive/
2015/03/the-next-cybersecurity-target-medical-data/388180/.
\6\ Harries, ``The prognosis for healthcare payers and providers:
Rising cybersecurity risks and costs'' December 2014 http://
usblogs.pwc.com/cybersecurity/the-prognosis-for-healthcare-payers-and-
providers-rising-cybersecurity-risks-and-costs/.
Question 1b. What additional resources would be valuable in
encouraging organizations to prioritize health data security?
Answer 1b. We encourage membership in the Health Information Trust
Alliance (HITRUST) which is the most active cyber threat intelligence
and incident coordination center in the industry.
HITRUST \7\ is a group of healthcare, business, technology and
information security leaders helping to ensure the security of personal
information. Their programs \8\ help healthcare organizations
understand current and probable threats, prioritize their cyber
security efforts and share best practices for cyber threat defense and
response. HITRUST is a federally recognized cyber Information Sharing
and Analysis Organization (ISAO) and has partnered with the U.S.
Department of Health and Human Services to conduct cyber threat
briefings \9\ and preparedness exercises.\10\
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\7\ https://hitrustalliance.net/.
\8\ https://hitrustalliance.net/content/uploads/2015/03/
HiTrustKeyPrograms.pdf.
\9\ http://hitrustalliance.net/cyber-threat-briefings/.
\10\ http://hitrustalliance.net/cyberrx/.
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HITRUST is best known for their Common Security Framework (CSF)
\11\ which is now in its 7th major release. It is the most widely
utilized approach by healthcare organizations and third-party risk
assessments--adopted by 83 percent of the hospitals and 82 percent of
the health plans. The Common Security Framework provides organizations
with the needed structure, detail and clarity relating to information
security tailored to the healthcare industry. The framework, along with
sound risk management practices, harmonize with the requirements of
existing healthcare standards and regulations including Federal (HIPAA,
HITECH), third party (PCI, COBIT) and government (NIST, FTC).
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\11\ http://hitrustalliance.net/common-security-framework/
understanding-leveraging-csf/.
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Standards Incorporated Into the CSF
HIPPA: Security, Breach, and Privacy Rules
ISO/IEC 27001, 27002, 27799
CFR Part 11
COBIT 4.1, COBIT 5
NIST SP 800-53 Revision 4
NIST SP 800-66
NIST Cyber Security Framework
PCI DSS version 3
FTC Red Flags Rule
JCAHO IM
201 CMR 17.00 (State of Mass.)
NRS 603A (State of Nev.)
CSA Cloud Controls Matrix v1
HHS Secretary Guidance
CMS IS ARS
MARS-E v1
IRS 1075
Texas Health and Safety Code (THSC) 181
Title 1 Texas Administrative Code (TAC) 390.2
Question 1c. Is the government offering proper guidance and/or
resources to inform industry decisionmaking relative to data security?
Answer 1c. The government could substantially improve private-
private and public-private cooperation by changing the current approach
to health information security. More coordination is warranted, as
opposed to more regulation, penalties, or the prospect of unlimited
liability for those organizations whose data is breached. Much like the
Patient Safety Act,\12\ we need to create a safe environment where
groups who follow best practices can openly share safety issues so the
whole industry can learn and aren't publicly and financially devastated
by an attack.
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\12\ http://archive.ahrq.gov/news/newsroom/press-releases/2008/
psoact.html.
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Congress could create a better environment by (1) encouraging
providers and health information technology vendors to adopt the
HITRUST Common Security Framework (CSF), (2) creating a protected place
to disclose breaches (HITRUST or AHRQ \13\), (3) declaring attackers
who breach a CSF compliant organization to be a common enemy and beyond
reasonable control, and (4) removing the legal liability of HITRUST CSF
compliant organizations that are breached.
---------------------------------------------------------------------------
\13\ http://www.ahrq.gov/.
Question 1d. Is threat information readily shared throughout the
industry? Or with other industries?
Answer 1d. Yes, threat information is shared through HITRUST. Other
organizations also receive threat information, publish recommendations
and standards like the National Institute of Standards and Technology
(NIST) \14\ and the combined effort of the International Organization
for Standardization (ISO) and the International Electro-technical
Commission (IEC) to support a family of mutually supporting information
security standards (ISO/IEC 27000).\15\
---------------------------------------------------------------------------
\14\ http://healthcare.nist.gov/.
\15\ http://www.itgovernance.co.uk/iso27000-
family.aspx#.VTfd6JMyY9Q.
If so, is the information useful?
Answer. We have found participation in HITRUST very useful.
If not, what incentives could be offered for
organizations to share threat information with other
organizations?
Answer. Eliminating liability and fines for CSF-complaint
organizations would encourage the sharing of threat and breach
information.
Question 2a. Half of the Nation's physicians have chosen not to
participate in the Meaningful Use program to date. How can this change?
Answer 2a. Simplicity and flexibility are the keys to encouraging
participation.
Over 70,000 physicians have participated in Meaningful Use (MU)
using Epic's software, which is evidence that widespread participation
is possible with good support. However, while our customers are on
track in their attestations, portions of MU are burdensome and go
beyond the definition of the meaningful use of an EHR. For many,
especially those in smaller practices, the administrative costs
outweigh the returns.
On April 10th, we were encouraged by the Centers for Medicare &
Medicaid Services (CMS) Proposed Rule \16\ with Meaningful Use changes
for 2015 through 2017. As summarized by HIMSS, ``the new rule is
attempting to reduce reporting burden, eliminate redundant and
duplicative reporting, better align the objectives and measures of
meaningful use, and focus Stages 1 and 2 of the Electronic Health
Record (EHR) Incentive Programs on advanced use of EHR technology. Most
importantly, this proposed rule would change the Medicare and Medicaid
Incentive Program reporting period in 2015 to a 90-day period aligned
with the calendar year rather a full-year reporting period.''
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\16\ https://s3.amazonaws.com/public-
inspection.federalregister.gov/2015-08514.pdf.
Question 2b. Continually, physicians call for the all-or-nothing
nature of the program to be rethought. Why are rulemakers so hesitant
to adjust this rigid mandate?
Answer 2b. We can't say what has caused their hesitation, but from
the looks of the Proposed Rule, they are trying to adjust the program
to provide more flexibility and simplicity.
Question 2c. Are there any additional resources, other than
additional incentive payments, that the Federal Government should
provide to increase physician participation?
Answer 2c. No. We do not believe additional resources are
necessary. The resources that are already in place should evaluate the
existing Meaningful Use requirements, eliminating those that have not
been shown to improve patient care or decrease healthcare costs in
proportion to the additional effort they require.
Some requirements in Meaningful Use are not core to the
individualized care of the patient, or in some cases apply an
inappropriate one-size-fits-all approach. Although requirements are
designed with good intentions, a number of them do not add value to the
provider workflow. In some cases, Meaningful Use creates complications
that inhibit usability and provider efficiency.
CMS could also move to reimburse telehealth workflows and
coordinated care beyond specific advanced payment programs such as
Accountable Care Organizations (ACO), both of which necessitate the
meaningful use of an EHR to be successful.
Question 3a. The goal of HITECH was to improve patient care while
decreasing costs--has there been a change in the cost to health care
because of HITECH?
Answer 3a. We have observed numerous examples statistically and
anecdotally of our electronic health record system (EHR) reducing
costs, increasing quality and access, and improving efficiency. This is
caused by provider and patient adoption which was seen before, during,
and after HITECH, both domestically as well as in countries that are
not under Meaningful Use regulation.
Examples include:
The University of Iowa Hospital & Clinics saved $9.5
million by using EHR decision support to reduce unnecessary blood
transfusions.
Lakeland Healthcare in St. Joseph, MI, used their EHR to
reduce their average cost of care by $1.6 million.
Sentara Healthcare in Virginia used EHR medication safety
tools to avoid 117,400 potential med errors and saved $14.7 million.
Kaiser Permanente achieved an estimated $1 billion in
savings from reduced office visits and lab tests.
HITECH reduced costs by increasing automation; Meaningful Use on
the other hand has probably increased costs in certain domains by
increasing software development, physician documentation, and reporting
burdens.
Question 3b. Since EHRs have become more common place, are there
any metrics of public health improvement being observed?
Answer 3b. Yes, we have observed numerous examples of our EHR
enabling improved population health. MetroHealth, a safety net health
system in Cleveland, OH, increased immunization compliance 54 percent
over baselines and reports this data to the Ohio Impact Statewide
Immunization Information System and the CDC.
Essentia Health in Duluth, MN, uses Epic and home monitoring scales
to prevent congestive heart failure (CHF) patients from being
readmitted. Their 30-day readmission rate for CHF patients is less than
2 percent, compared to a national average of 25 percent.
Reliant Medical Group in Massachusetts uses our EHR for a rigorous
diabetes management program. Their diabetes control is up 6 percent
while costs per patient are $1,200 less than the average Massachusetts
ACO.
Question 3c. What can government do to further the goal of using
this technology to decrease costs?
Answer 3c. The government could simplify the Meaningful Use program
to spur adoption and reimburse coordinated care and telehealth
workflows which necessitate this technology.
It has also been widely accepted that utilization costs will be
reduced in tandem with payment reform. Likewise, health information
exchange, which can reduce duplicative healthcare utilization and
adverse medical events, can best be incentivized by value-based
reimbursement arrangements (cf. Accountable Care Organizations) as
opposed to fee-for-service arrangements.
Question 4a. What are the biggest barriers inhibiting nationwide
interoperability?
Answer 4a. There remain four main barriers to increased nationwide
interoperability:
Technical capabilities: Not all providers are technically
ready to exchange records. With so many eligible providers not
participating in Meaningful Use, especially those not affiliated with
large practices or integrated delivery networks, they likewise do not
have systems that are Meaningful Use certified, or are not on the
required version of that software, and therefore are incapable of
robust health information exchange.
In contrast, 100 percent of Epic EHR users are live with our Care
Everywhere patient exchange platform, and 89 percent are interoperating
with providers on other vendor platforms.
Payment models: The move to value-based payment models
where providers are compensated for coordinated care will likely
increase the use of interoperability capabilities.
National Rules of the Road for information sharing:
Neither technical capability nor economic or clinical incentives can
overcome the lack of a universally adopted national ``rules of the
road'' and governance framework. In this absence, individual providers
or healthcare organizations must forge individual data sharing
agreements with each other, which may take months of legal discussion
between the two entities.
This problem was recently acknowledged in the ONC's
Interoperability Roadmap. We are pleased that ONC has recognized
Healtheway \17\ as a potential convener on the issues of national rules
of the road and governance.
---------------------------------------------------------------------------
\17\ http://healthewayinc.org/.
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Healtheway's Carequality \18\ initiative is the broadest collation
of public-private healthcare stakeholders that include the United
States' largest active exchange networks as well as smaller networks
like CommonWell. In early April this year, Carequality released their
national trust framework \19\ to accelerate national interoperability.
In mid-April, 11 exchange networks,\20\ including Epic, agreed to
rollout the national interoperability framework to connect over 200,000
physicians. (CommonWell has been participating in the Carequality
initiative but did not elect to be one of the early rollout
participants.)
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\18\ http://healthewayinc.org/carequality/.
\19\ http://healthewayinc.org/carequality-news/carequality-
introduces-trust-principles-for-secure-interoperability-among-u-s-data-
sharing-networks/.
\20\ http://healthewayinc.org/carequality-news/carequality-
launches-national-framework-for-inter-network-interoperability/.
Question 4b. What is the biggest barrier blocking providers from
sharing information with each other? What is the biggest barrier
blocking patients from sharing their information with different
providers?
Answer 4b. In addition to those items identified above, Stage 2
being delayed from 1 year to 90 day reporting has delayed
interoperability by 9 months; creating hardship exemption allowing
organizations to attest to Stage 1 instead of Stage 2 which required
interoperability caused further delays.
If we simplify Meaningful Use to encourage more physician
participation and reduce hardship exemptions and program delays, we
would be on the doorstep of broad interoperability, enabling the
healthcare ATM for patient records.
Question 4c. Is ONC's nationwide Interoperability Roadmap a
reasonable guide to widespread interoperability?
Answer 4c. Yes. The core of the ONC Roadmap provides a reasonable
guide to widespread interoperability. ONC should avoid over-regulation
in this emerging space and instead encourage support of existing
public-private partnerships that will foster creativity and lead to
competition for low-cost, widespread interoperability.
Question 4d. The lack of enforceable, consistent standards has been
an industry concern. Does the 2015 Interoperability Standards Advisory
fill the void? If not, what else can/should the Federal Government do
to ensure a single set of standards is used within the industry?
Answer 4d. Yes, assuming ONC focuses on the exchange of patient
health information among providers. ONC should not mandate specific
architectures, technologies, or design approaches, as these would
inhibit innovation, openness, and competition. The industry has already
coalesced on reasonable standards that allow providers to share records
and continues to develop more robust standards and capabilities.
Question 4e. Patient matching is a consistent concern raised by
industry. How can government and industry ensure that patient data can
be reliably shared across care settings?
Answer 4e. A single, national patient identifier would be the best
approach to addressing this issue. The industry has done reasonably
well navigating the challenges of patient matching given the lack of
such an identifier.
Question 5. Physicians consistently voice concerns with product
usability. What can be done to foster user-centered design rather than
technology built to meet regulatory and billing mandates?
Answer 5. Much of what the market is experiencing is not actually
due to a lack of user-centered design. Rather, physicians are
increasingly frustrated by regulatory requirements that dictate their
workflows. Physicians we work with in other countries routinely express
shock at the documentation requirements created to meet the regulatory
and billing rules of the U.S. healthcare system.
Fewer regulatory and billing mandates would lead to more satisfied
users.
Question 6. A lack of a ``business case,'' both for vendors and
providers, is often cited as a hindrance to information sharing. What
can be done to create the ``business case'' to generate
interoperability?
Answer 6. The current Meaningful Use incentive for interoperability
in Stage 2 was not a sufficient step to encourage the adoption of
interoperable electronic healthcare records systems. It required the
technical capability to interoperate without changing the incentive
structure that hinders it. Payment reform is the instrument that is
needed to alter this incentive structure.
As we move from process measures to outcome measures, methods to
compensate providers for coordinating care across organizations will
further increase the demand for and use of interoperability.
All of Epic's customers have the technical capabilities to
interoperate with other systems above and beyond what is required by
the Meaningful Use program.
Question 7a. Stakeholders often voice concerns that the electronic
health record product as certified is quite different from the products
deployed in individual care settings. How can we ensure that the
certification program delivers capable technology not just upon initial
testing but once deployed in the field?
Answer 7a. We may not be in the best position to answer this
question. This is not feedback we've received about our software,
although we have heard it about other vendors. Our customers are
leading the Nation in EP and EH attestations. We ensure all customers
have the capable MU technology deployed.
Question 7b. How can we create transparency in cost, satisfaction
and vendor responsiveness?
Answer 7b. This is already being done by impartial industry
reviewers, such as KLAS, which survey healthcare organizations to
evaluate vendors in many areas including user satisfaction, vendor
responsiveness, and cost transparency.
We fully disclose our costs prior to purchase and our users report
high levels of satisfaction, as reported by KLAS, which ranks us #1 in
health information exchange and highly for responsiveness and avoiding
``nickel-and-diming'' (cost transparency).
Question 7c. Does ONC have the proper resources to employ enhanced
testing capabilities relative to the Certification Program?
Answer 7c. Yes, we believe so.
senator burr
Question 1. Please provide some insight into how products certified
as being interoperable are not interoperable in every sense of the
word. Why would an electronic health record, in many cases in which a
doctor or hospital has already made a significant investment and that
is certified to be interoperable, require additional interfaces with
other health care providers outside of their facility?
Answer 1. A purchaser of a certified EHR as certification is
performed today should have the technical capabilities necessary for
interoperability. The purchaser may still wish to contract for
assistance in configuring the interfaces. Typical configuration may
include initial setup, consent workflows, and implementation of State
or local data sharing requirements. Additionally, a purchaser may need
to contract with other third parties for connections to healthcare
information service providers (HISPs), State or local HIEs, to obtain
and load provider directories, or for certificate-granting authorities
which enable secure authentication of parties exchanging healthcare
information.
Question 2. Will we reach a point in which the significant
investments already made in health IT will realize lower costs? Or will
the maintenance costs associated with EHRs prevent the overall cost
savings from ever being realized?
Answer 2. Yes. The vast majority of our EHR customers already
report savings and lowered costs. As mentioned above, they experienced
this before, during, and after HITECH. Former Kaiser CEO, George
Halverson said that he attributed nearly $5 billion of savings a year
to their Epic and other IT projects. Sentara's CIO, Burt Reese
attributes over $53.7 million in savings in 2011 alone. Hawaii Pacific
CIO, Steve Robertson, attributes Epic to saving their health system
from bankruptcy. For Epic customers that may need more return on their
investment, we have several programs to help assess their system use
and create targeted plans to realize more savings.
In our customers' experience, the overall savings and benefits of
our EHR exceed their long-term maintenance costs. This is one of the
reasons that many customers have moved to Epic's acute care EHR, but
none have gone the other direction. For example, Cooper University, in
New Jersey, chose Epic to lower their long-term maintenance costs. They
calculated that by year three after implementation, the system will
have paid for itself, saving the health system over $700,000 per year
in IT savings alone.
Question 3. In Dr. Wergin's testimony he states that,
``HHS should use its authority to strengthen certification
requirements to advance interoperability requirements and
improve EHR functionality.''
In what ways could certification requirements be improved?
Answer 3. Certification requirements as they exist today are
adequate. Increasing these requirements will not result in better EHRs;
the market will reward better functionality over time but only if it is
not artificially distorted by burdensome regulation. As we discuss in
previous answers, simplifying the Meaningful Use program will encourage
broader adoption which will lead to higher levels of interoperability.
We recommend that any EHR requirements mandated be specified at a high
level while the design of EHR functionality be performed by the
software developers and their clinical customers.
senator roberts
Question 1. In your testimony, one of the reasons you cited for
Epic not joining the CommonWell Alliance was the requirement during
early stages of CommonWell's formation for members to sign a Non-
Disclosure Agreement. At the time of the hearing, were you aware that
CommonWell does not currently require members to sign a Non-Disclosure
Agreement?
Answer 1. We were asked to sign an NDA with CommonWell after it was
created and announced publicly. To the best of my knowledge, an NDA was
still required at the time of my testimony. According to a Politico
article published after my testimony, CommonWell changed that
requirement.
Question 2. Does Epic require any of its clients, business
partners, or participants in the Care Elsewhere network to sign Non-
Disclosure Agreements? If yes, please explain why Epic believes those
Non-Disclosure Agreements are necessary.
Answer 2. No. We do not now and have not ever required a non-
disclosure agreement for the use of Care Everywhere, our patient record
exchange platform.
Question 3. Another reason you gave for Epic not joining the
CommonWell Alliance was a concern about whether CommonWell data could
be sold. Has Epic ever voiced that concern to CommonWell or its
representatives? Did Epic receive any assurances that data could not be
sold, and if yes, why did Epic nonetheless voice those concerns to the
committee?
Answer 3. In my testimony, I expressed concerns about the
transparency of CommonWell's business practices.
Information relating to CommonWell has been reported in the media.
This includes their launch \21\ when they were presented as a
repository-based model, their legal designation change and their
changing membership requirements.\22\ CommonWell has released
statements about not selling ``personal health data.'' CommonWell
doesn't actually have patient data to sell. However, RelayHealth, the
sole contractor for the transport of patient data in the CommonWell
network, which was recently ordered to stop selling the VA's data,\23\
has historically monetized the information transported through its
infrastructure. Other CommonWell members, like Cerner also have a
history of selling de-identified data or data products. Epic does not.
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\21\ http://www.healthcare-informatics.com/news-item/report-epic-
wasn-t-invited-alliance-six.
\22\ http://www.politico.com/morningehealth/0415/
morningehealth17818.html.
\23\ http://www.amsus.org/wp-content/uploads/2014/05/June-2014-
Minutes.pdf.
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CommonWell's monetization strategy is still unclear although the
CEO of McKesson, the parent company of RelayHealth, expressed
enthusiasm for betting on CommonWell and RelayHealth to ``pay off ''
during an earnings call \24\ (``So there's a bunch of interesting
places that we're placing bets, including CommonWell Health, that we
think will pay off.'')
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\24\ http://seekingalpha.com/article/2891376-mckesson-mck-q3-2015-
results-earnings-call-transcript?page=8&p=qanda&l=last.
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We believe that competition in the industry to provide low cost and
successful exchange is important and we feel we can offer more to our
customers and their patients through open standards and connected
networks.
One network will not solve all interoperability problems for all
healthcare's stakeholders just as one bank can't solve all financial
problems or one cellular networks can't connect the world. Networks
(e.g., CommonWell, Epic's Care Everywhere, eHealth exchange, State and
Federal HIEs) require a cell phone or ATM-like framework, a ``network
of networks'' to get data moving smoothly through the systems.
Epic's Care Everywhere exchanges with all CommonWell founders today
(e.g., Cerner, McKesson, Allscripts, Athena, Greenway, etc). CommonWell
is also participating with Epic in the Heathway's Carequality
initiative that has just released an interoperability framework--the
ATM-like framework for healthcare. Epic is one of the first 11
organizations to pilot the rollout which will exponentially change the
number of records exchanged in the United States.
We fully expect patient records to flow across a wide variety of
open, standards-based networks including CommonWell and Care
Everywhere.
Question 4. Your testimony focused a lot on Care Everywhere, Epic's
interoperability tool for providers who use Epic. Your testimony
indicated that for Care Elsewhere, the interoperability tool for Epic
clients to share information outside of Epic systems, Epic charges on a
per member per year basis. What is that cost? What is the median number
of members for Epic clients who participate in Care Everywhere? What
other fees might be involved to join and exchange information on Care
Elsewhere, such as licensing fees, maintenance fees, consulting fees,
or hourly labor fees, including instances when a client needs
operational or technical expertise beyond what is included in Epic's
standard contracts?
Answer 4. At the time of my testimony, the charge was $2.35 for a
record exchanged on the network. Since then, we have eliminated fees
for Care Everywhere exchanges until at least 2020.
Those costs were small and experts have told us we were one of the
least expensive in the industry.
Epic charges a standard hourly labor fee for building a Care
Everywhere connection, whether that is the initial connection to the
Care Everywhere network, a single connection to the eHealth Exchange or
an HIE, or directly with another vendor's system at a different
healthcare organization. The number of hours required to establish
these connections varies widely based on the capabilities of our
customer as well as the capabilities of the organization or vendor on
the other side of the connection. Our goal is for such labor to be
reduced as closely to zero as possible as the industry gains experience
in building these connections.
Care Everywhere is one of the largest exchange networks in the
United States. Its participants include 320 healthcare organization
comprising over 1,000 hospitals and 23,000 clinics. Every group that is
live on our electronic health record system is live with Care
Everywhere. Our customers rank us No. 1 for Health Information Exchange
in KLAS surveys.
Question 5. In a March 5, 2015, ONC Health IT Policy Committee
Interoperability and Health Information Exchange (HIE) Workgroup
meeting, Epic's President, Carl Dvorak, advocated for CMS to create a
nationwide record locator service. Why should CMS spend government
funds to stand-up such a network, when CommonWell Alliance already has
a record locator service? Do Care Elsewhere, e-Health Exchange, or any
other HIEs have record locator services?
Answer 5. Carl Dvorak made the observation that CMS has the
knowledge of all of the places a patient has been seen for services
covered by Medicare and Medicaid and that as a result of this,
healthcare providers could easily locate such patients' records if that
knowledge were made available. The standard way to make that knowledge
available would be through a record locator service (RLS). Other payors
could easily do the same for the patients they cover.
CMS doesn't need to set up an RLS, but they should provide an open
data set so that another group could create an RLS to inform networks
of where patients have received care (e.g., Care Everywhere, eHealth
Exchange, State HIEs, CommonWell) and regulate pricing of open record
locator services so search costs do not inhibit exchange.
The largest record locator service in the United States is
Surescripts. They have a master patient index of over 230,000 patients,
span 700 electronic health record providers, 93 percent of all
pharmacies and over 900,000 health professionals. We recently announced
our connection to their RLS services which can exponentially expand our
network's effectiveness to close the information gaps in care
transitions.
CommonWell's RLS service is new and has been described by
CommonWell staff as currently supporting a small number of initial
organizations and their patients.
senator cassidy
Question. As a physician, I have concerns that mandated
``meaningful use'' of health information technology such as EHRs, while
providing useful medical data, has complicated physician-patient
encounters and distracted the physician from what they have been
trained to do--provide patients with personalized care and give
patients their undivided attention.
In over 46 States and in a variety of settings--emergency rooms,
hospitals, urgent care clinics, and practices including OB/GYN,
cardiology, orthopedics, and oncology--medical scribes are used as a
means of significantly reducing the healthcare practitioner's burden of
entering data into the EHR. The scribe accompanies a provider into the
exam room and documents the physician-patient encounter into the EHR in
real-time and at the point of service. This relationship allows the
physician to spend more time delivering care directly at the patient's
bedside and less time in front of a computer screen navigating EHRs.
The use of a scribe allows a physician to focus on the patient and
think clinically, not clerically. One of the unintended consequences of
the ACA is that ED volumes have risen, some argue this is due to access
to care issues. Scribes could help provide greater access to
appropriate levels of care.
I'm curious about how your products are being used by medical
professionals in the ``real world.'' Are EHR capabilities being fully
maximized in the marketplace today? Or do the EHR products and
platforms that you (and your competitors) offer have robust features
enabled that users are not currently employing (such as coding, ICD-10
modules, Population Health Management and Care coordination)? After
all, there's a limit on the amount of attention a physician can give
the EHR vs. the actual patient during an encounter. As professionals
that have been expertly trained in EHR use, would you agree scribes
could enhance the degree to which useful features that currently sit
fallow due to a physician's capacity to do only so many things at once,
are utilized?
Answer. Our customers have found scribes to be beneficial in
certain settings such as the Operating Room or when documenting certain
procedures in real time such as placing a stent into an artery of the
heart.
In general however, the use of most of the EHR features by
clinicians themselves is still very important.
senator murray
Question. Providers are reporting difficulty achieving meaningful
exchange of electronic health information across electronic health
records produced by different vendors. In other cases, providers report
that creating interfaces between electronic health records produced by
different vendors involves paying substantial fees to vendors. Why does
it cost so much to connect electronic health records that have been
produced by different vendors? Why is it more complicated to share
clinical information than billing information?
Answer. A typical billing transaction includes about 60 well
defined fields, as exemplified in the CMS medical claim form.\25\
Fields include time, date, SSN, provider, charge code, diagnosis code,
quantity, fee, etc. These are generally consistent across all clinical
specialties and rarely change through time.
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\25\ http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/
CMS1500805.pdf.
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By comparison, clinical data is magnitudes higher in complexity
than billing data. A typical ophthalmology exam might include over one
hundred measurements and observations. An EHR that focuses on Bone
Marrow Transplant might collect hundreds of data element specific to
that specialty. There are more than 120 specialties and subspecialties
recognized by the Association of American Medical Colleges. Each of
these specialties has many data items unique to its practice and
routinely identifies new measurements and data elements to collect.
Consider genomics alone adding thousands of new data points and
changing frequently with new discoveries. In addition, each specialty
shares hundreds more data elements with other specialties.
Flexibility is essential to allow growth and changes in data
elements and definitions as our knowledge in medicine grows. The
evolution of medicine will require that we continually modify and
enhance our ability to share more and more clinical information through
time.
Cooperation in the industry is working to standardize more of these
elements and to share them fluidly across multiple networks at a
reduced cost. ONC is wise to focus on the Core Clinical Data Set,
useful to all specialties, as defined in the interoperability road map.
senator warren
Question. As you know, our electronic health record systems often
have trouble matching a particular scan or a test result to the right
patient, and those mismatches endanger patients. As more providers move
to electronic health records and data bases contain records for more
patients, the risk of mismatching information to patients only goes up.
A 2008 RAND Corporation study estimated that even with database
management software and personnel dedicated to preventing these
mistakes, hospitals mismatch patient information about 8 percent of the
time. A 2012 survey conducted by The Council of Health Information
Management Executives found that one in five physicians encountered
mismatched information that that put a patient at risk at least once
over the previous year. Accurately matching health information to the
correct patient record is critical to creating an electronic health
information exchange that works. How can we reduce these errors?
Answer. There are two kinds of patient matching errors that can
occur: false negatives and false positives. A false positive means that
you believe you've matched a patient's record but it is in fact the
wrong one. The false negative means you believe there is no match when
there actually is a matching record. The false positive is typically a
much more severe problem. In our experience, false positives have been
greatly diminished while false negatives have been significantly
reduced over the years by using a few reproducible techniques. These
techniques include:
Using more durable identifiers. An example is a person's
mobile phone number. While a patient may change her address many times
and even her name, she usually retains her mobile number.
Searching intelligently for record locations. Most
healthcare is local--searching for a record near a patient's home or
work address will usually yield the best results. This does require a
searchable phonebook that is indexed by address. This is a cornerstone
of Epic's national Care Everywhere platform and could be easily
reproduced in other networks.
In our experience these errors have been significantly reduced
since the time of the studies you cited.
[Whereupon, at 11:30 a.m., the hearing was adjourned.]