[Senate Hearing 114-641]
[From the U.S. Government Publishing Office]
S. Hrg. 114-641
HEALTH INFORMATION EXCHANGE: A PATH TOWARDS IMPROVING THE QUALITY AND
VALUE OF HEALTH CARE FOR PATIENTS
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING HEALTH INFORMATION EXCHANGE, FOCUSING ON A PATH TOWARDS
IMPROVING THE QUALITY AND VALUE OF HEALTH CARE FOR PATIENTS
__________
JUNE 10, 2015
__________
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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, Republican Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
(ii)
C O N T E N T S
__________
STATEMENTS
WEDNESDAY, JUNE 10, 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
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina....................................................... 5
Warren, Hon. Elizabeth, a U.S. Senator from the State of
Massachusetts.................................................. 33
Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana... 35
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of
Pennsylvania................................................... 37
Franken, Hon. Al, a U.S. Senator from the State of Minnesota..... 39
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
Island......................................................... 40
Witnesses
Payne, Thomas H., M.D., FACP, FACMI, Board Chair-Elect, American
Medical Informatics Association, Medical Director, IT Services,
UW Medicine, University of Washington School of Medicine,
Seattle, WA.................................................... 6
Prepared statement........................................... 8
Richardville, Craig D., MBA, FACHE, Senior Vice President and
Chief Information Officer, Carolinas HealthCare System, Chair,
Premier Healthcare Alliance Member Technology Improvement
Committee, Charlotte, NC....................................... 13
Prepared statement........................................... 15
Bechtel, Christine, M.A., Advisor, National Partnership For Women
and Families, Chair, Health IT Policy Committee Consumer
Workgroup, President, Bechtel Health, Olney, MD................ 19
Prepared statement........................................... 20
Patterson, Neal L., MBA, Co-Founder, Chairman, Chief Executive
Officer, Cerner Corporation, Kansas City, MO................... 24
Prepared statement........................................... 26
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
AMIA, Jeffrey Smith, Vice President of Public Policy, memo... 47
Response by Thomas H. Payne, M.D., FACP, FACMI to questions
of:
Senator Alexander........................................ 48
Senator Murray........................................... 52
Response by Craig D. Richardville, MBA, FACHE to questions
of:
Senator Alexander........................................ 55
Senator Murray........................................... 59
Response by Christine Bechtel to questions of Senator Murray. 60
Response by Neal L. Patterson to questions of:
Senator Alexander........................................ 62
Senator Hatch............................................ 64
Senator Baldwin.......................................... 65
(iii)
HEALTH INFORMATION EXCHANGE: A PATH TOWARDS IMPROVING THE QUALITY AND
VALUE OF HEALTH CARE FOR PATIENTS
----------
WEDNESDAY, JUNE 10, 2015
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10:09 a.m., in
room SD-430, Dirksen Senate Office Building, Hon. Lamar
Alexander, chairman of the committee, presiding.
Present: Senators Alexander, Roberts, Burr, Scott, Cassidy,
Murray, Casey, Whitehouse, Warren, Franken, Bennet, and Murphy.
Opening Statement of Senator Alexander
The Chairman. The Senate Committee on Health, Education,
Labor, and Pensions will please come to order. Our hearing
today is on how to improve the exchange of health information.
Senator Murray and I will each have an opening statement. Then
we'll introduce our panel of witnesses. After our witness
testimony, Senators will have 5 minutes of questions for the
witnesses.
We're here today to outline our plans to conduct an
intensive review of electronic health records. To save a little
time, I'm going to summarize my comments and put my entire
statement in the record.
I have these things I'd like to say as we begin. There is a
great deal of bipartisan interest in this subject. Senator
Murray's staff and my staff have been meeting with experts
almost every day, the staff of our committee members have been
meeting once a week, and Senator Murray and I have been working
with Secretary Burwell and other members of the Administration
on this. They understand the importance of it.
Here's what we're talking about. The Meaningful Use
Program, as it's called, began in 2009 to encourage 491,000
physicians who serve Medicaid and Medicare patients and almost
4,500 hospitals to begin to adopt and use electronic health
records systems, and 456,000 of those physicians have received
some sort of Medicare or Medicaid incentive payment.
All hospitals and most physicians that tried were able to
meet the early requirements. So far, the government has paid
out about $30 billion in these incentive payments. The stage 2
requirements have been so complex that only about 11 percent of
eligible physicians have been able to comply so far, and just
about 42 percent of eligible hospitals.
The next step in the program is penalties for doctors and
hospitals that don't comply. This year, according to a CMS
statement recently, 257,000 physicians who serve Medicare and
Medicaid patients have already begun losing 1 percent of their
Medicaid reimbursements, and 200 hospitals may be losing more
than that.
Our committee's goal is to identify the five or six steps
that we can take, working with the Administration, to improve
electronic health records. It is a technology that has great
promise, but through bad policy and bad incentives has run off
track.
To put it bluntly, physicians and hospitals have said to me
that they are literally terrified of the next implementation
stage of electronic health records, called Meaningful Use 3,
because of the complexity and because of the fines that will be
levied. Our goal is--my goal, anyway, is before that phase is
implemented, we can work with physicians and hospitals and the
Administration to get the system back on track and make it a
tool that hospitals and physicians can look forward to using to
help their patients instead of something they dread.
Today we will start a series of hearings that we will hold
this summer to address various possible solutions. Senator
Murray and I are announcing the next two hearings in the
series, which will be chaired by different members of our
committee, to examine solutions to the problems we identify.
The first hearing is on the burden physicians face with
these systems. I have asked Senator Cassidy, who is a physician
himself, to chair that hearing.
The second hearing is on the question of whether you and I
control information about our healthcare, and I have asked
Senator Collins to chair that hearing.
The full committee held its first hearing on Meaningful Use
on March 17. Today, we'll set the table for this series of
hearings by discussing how we can solve problems.
The Precision Medicine Initiative that President Obama has
proposed, which we are working on and which I strongly support,
will only work the way it's supposed to work if electronic
health record systems work the way they're supposed to work.
The systems can help to assemble and understand the genomes of
the 1 million individuals required for the Precision Medicine
Initiative. And, second, if we want to make genetic information
useful to doctors when they write prescriptions, we'll need to
get things in order.
According to medical economic surveys recently published,
about 70 percent of physicians say their electronic healthcare
record system hasn't been worth it. They are spending more time
taking notes than taking care of patients, and they are
spending a lot of their own money on systems that have to
comply with government requirements.
Today we have invited experts representing various
perspectives--medical informatics, a records system vendor, a
health system chief information officer, and the perspective of
the patient--so we can hear these recommendations. I am
especially interested to hear from our witnesses the
recommendations they have to improve the system.
We're fortunate that a report was published in late May by
the American Medical Informatics Association offering several
strategies. They include simplifying and speeding
documentation, refocusing regulation, increasing transparency,
fostering innovation, and supporting person-centered care
delivery.
I look forward to our witnesses' recommendations, their
thoughts on the report I just mentioned, and also specific
advice on how we can make improvements as rapidly as possible.
Senator Murray.
Opening Statement of Senator Murray
Senator Murray. Well, thank you very much, Chairman
Alexander. Thank you to all of our witnesses for being here
today. I'm especially pleased to have a thought leader from
Washington State with us, Dr. Payne, who I'll introduce
shortly.
Thank you for taking the trip today and for everything you
are doing in Washington State to make our healthcare system
work better for families and patients.
As I've said before, I really believe strongly that when it
comes to our healthcare system, we really need to keep building
on the progress we've made so far. We need policies that
continue to make healthcare more affordable, not less; expand
coverage to more families instead of taking coverage away; and
improve the quality of care patients receive.
I'm really pleased our committee is focusing on improving
our Nation's health IT infrastructure, because effective health
information technology is essential to improving quality and
cost of care. I'm especially pleased that this is a shared,
bipartisan priority.
Members on both sides of the aisle have some great ideas
for ways we can move forward on these issues. I know that
Acting Assistant Secretary Dr. Karen DeSalvo also sees this as
a top priority as she moves into her new role.
I'm very hopeful we will be able to reach an agreement on
some ways to strengthen health IT in our country, because while
we have come a long way in a short time, there is a lot more to
do.
Over the last few years, our healthcare system has made
significant gains in terms of adopting electronic healthcare
records. Today, 78 percent of physicians use some form of
electronic health records, compared to just 18 percent in 2001.
The HITECH Act that passed in 2009 was a big part of that
transformation. I truly appreciate the work that so many
doctors and hospitals have done to bring our healthcare system
into the 21st century and improve the value and quality of care
patients receive. This is really making a difference.
In my home State of Washington, for example, Virginia Mason
Medical Center now has more than 100,000 patients who are able
to look up their own health information through Virginia
Mason's medical record. Virginia Mason is also helping patients
and their doctors keep in touch in more efficient ways.
Every week, doctors at Virginia Mason exchange more than
15,000 secure emails with their patients. That means patients
can get more of their questions answered without making an
appointment or being put on hold. It means they are more
empowered to work with their doctors to find the treatment that
is best for them.
Without question, there is a lot more we need to do to
build on this progress. Many physicians across the country are
facing a Medicare payment reduction this year because they are
struggling to meet requirements for the use of electronic
health records.
I'm very interested in speaking with our witnesses today
about the major gaps that still exist when it comes to
interoperability, because this problem is preventing doctors
from sharing information in a secure, efficient way. As we find
ways to help doctors share information across systems developed
by different vendors, we also need to continue helping patients
stay informed about and involved in their own care.
During our last hearing on health IT, Dr. Angela Kennedy of
Louisiana Tech University shared a story that really showed how
big a difference electronic health records can make for
patients. She explained that when she takes her adopted
daughter Grace to the doctor, she is always quick to note that
she does not know her daughter's biological family medical
history.
Last year, the importance of having these kinds of records
became very clear when, after Grace failed to respond to
allergy treatment, genetic testing revealed that she had a rare
form of cystic fibrosis. Without access to accurate, thorough
medical records or the ability to correct errors in medical
records, Grace's illness, one that is usually identified right
after birth, was not diagnosed until she was 11 years old.
As Dr. Kennedy's story makes clear, strengthening our
health IT system is absolutely critical to making sure patients
get the care they need. There are a few steps I will be
especially interested in looking at as we continue this effort.
I know the Meaningful Use provision has caused a lot of
frustration among physicians. We need to do more to both set
high standards and ensure providers have the support and
flexibility they need to reach them.
We should make sure that systems developed by different
vendors and used by different doctors are able to speak to each
other. That way, families like Dr. Kennedy's will not have to
spend countless hours tracking down and comparing documents
from different sources. Providers will have quick, easy access
to information about patients' unique medical needs.
We also need to continue supporting the development of a
network of networks so providers have many options for
trustworthy information sharing, and they don't have to
reinvent the wheel every time they need to exchange information
with a new facility. Similarly, we should look for ways to make
it easier for providers to shop for electronic records systems
and vote with their feet when one isn't working.
And, finally, as electronic health records become more
integral to our healthcare system, we need to look at ways to
ensure security that stands up to our 21st century challenges.
These and other steps would go a long way toward improving
our health IT infrastructure and making our health care system
work better for the patients and families we serve.
As I said before, I've been truly pleased by the great
ideas and interest that we have seen so far in this, and I want
to thank all of our committee members who are so willing to
work with us on this and for the hard work that everyone has
already put in.
I look forward to our efforts on this, Mr. Chairman, and
I'm hopeful that we can reach some bipartisan agreements on
this really critical topic.
The Chairman. Thank you, Senator Murray.
I'm pleased to welcome our witnesses, and I'll ask Senator
Murray and Senator Burr to introduce the first two.
Statement of Senator Burr
Senator Burr. Thank you, Mr. Chairman. I thank you and the
Ranking Member for holding this hearing, and I want to welcome
Craig Richardville from Carolinas HealthCare System in
Charlotte, NC.
Craig, thank you for being here and sharing your expertise
with us today.
Mr. Richardville is the vice president and chief
information officer overseeing all of the systems for
information services and strategies for the Carolinas
HealthCare System, a network of more than 900 healthcare
locations. Mr. Richardville also lends his expertise to a
number of organizations focused on health IT, including serving
as a Fellow with the Healthcare Information Management System
Society and the American College of Healthcare Executives, as
well as chairman of the Premier Healthcare Alliance Member
Technology Improvement Committee.
Prior to joining Carolinas Healthcare System in 1997, Mr.
Richardville spent 12 years with Promedica Health Systems.
I want to thank Craig for being here and lending his
expertise to this very, very important hearing.
Senator Murray. Mr. Chairman, thank you. I'm really pleased
to have a witness today who has come all the way across the
country from Washington State. Dr. Thomas Payne is the medical
director of IT Services for UW Medicine at the University of
Washington. He's an Associate Professor of Medicine, an Adjunct
Associate Professor in Health Services, Biomedical Information,
and Medical Education at the University.
He's also an attending physician in general internal
medicine at the University of Washington Medical Center and
Harborview Medical Center. Prior to his current position, he
led the installation of the Veterans Administration CPRS
electronic medical record at VA Puget Sound in Seattle, and
he's also the author of over 60 articles in this field,
including the recent EHR 2020 Task Force report which he wrote
as board chair-elect of the American Medical Information
Association.
Dr. Payne, thank you so much for all you've done. We really
look forward to the information you have to share with us
today.
The Chairman. Thank you, Senator Murray.
Our third witness will be Ms. Christine Bechtel from Olney,
MD. She's a long-time consumer advocate and the president of
Bechtel Health, a mission-driven organization focused on
accelerating innovation in patient and family engagement and
patient-centered care. She serves as chair of the Consumer
Workgroup of the Health IT Policy Committee, a Federal advisory
committee.
Our final witness is Mr. Neal Patterson from Kansas City,
MO. Senator Roberts was here to introduce him to me, so I'll
introduce him to the other Senators. Mr. Patterson is Chairman
of the Board and CEO of the Cerner Corporation, a company he
co-founded in 1979. He has led Cerner to invest more than $4
billion in the research and development of health information
technology. Today, Cerner's systems are in use at more than
18,000 healthcare facilities in over 30 countries.
Dr. Payne, why don't we begin with you and go down the
line. If each of you could summarize your remarks in 5 minutes,
we have lots of Senators who would like to ask you questions.
Dr. Payne.
STATEMENT OF THOMAS H. PAYNE, M.D., FACP, FACMI, BOARD CHAIR-
ELECT, AMERICAN MEDICAL INFORMATICS ASSOCIATION, MEDICAL
DIRECTOR, IT SERVICES, UW MEDICINE, UNIVERSITY OF WASHINGTON
SCHOOL OF MEDICINE, SEATTLE, WA
Dr. Payne. Good morning, Chairman Alexander, Ranking Member
Murray, and distinguished members of the committee.
My name is Dr. Thomas Payne. I am the medical director of
IT Services at UW Medicine and the University of Washington
School of Medicine, and I am chair-elect of the AMIA board of
directors. The American Medical Informatics Association
represents more than 5,000 doctors, nurses, clinicians,
researchers, and other informatics professionals who develop,
implement, and study ways to manage information for patients,
professionals in their clinical practice, public health, and in
clinical research.
It is an honor to appear before you this morning alongside
this distinguished panel. My comments will focus on positive,
near-term action items policymakers can take to capitalize on
the increased adoption of electronic health records and utilize
an expanding trove of health data to improve the quality and
the value of healthcare for Americans.
Recommendations, which I will describe in my comments, are
derived from a recent report published by a multidisciplinary
task force chartered by the AMIA board of directors. The EHR
2020 Task Force was established to develop recommendations on
how we, as a Nation, can resolve challenges related to EHRs,
challenges this committee has examined and will continue to
examine through a host of recent hearings. This report was
developed over the course of 12 months by a very diverse group
of informatics professionals representing a broad range of
perspectives.
Broadly, the report's 10 recommendations fall into four
categories, which I will briefly summarize as a need to, first,
improve documentation requirements and functionality to empower
patients so that all members of the care team can contribute
their perspectives and information; second, refocus regulations
so that patients and their caregivers can derive the most
benefit from a networked healthcare ecosystem; third, increase
transparency to improve usability and safety of EHRs; and,
fourth, foster innovation so that we can build toward the next
generation of EHRs and realize the benefits of the learning
healthcare system.
Congress can and should play a vital role toward
encouraging better EHR usability, improved interoperability,
and more meaningful patient engagement. For example, relatively
simple steps could be taken to improve documentation
requirements, such as encouraging regulatory guidance that
clearly delineates who is and who is not eligible to enter data
into the record for compliance and reimbursement purposes.
A more impactful and coordinated undertaking would be to
include the refinement and adoption of standards meant to
integrate clinical data from patients, medical devices, and
other sources into the EHR. Longer term, Congress should
develop policies that require CMS to revisit the entire billing
and coding system that drives documentation for reimbursement
and compliance purposes.
Congress should also continue to promote broad adoption of
alternative payment models, such as value-based purchasing, so
that reimbursement is contingent on outcome-oriented measures,
supported by less prescriptive and more flexible requirements
for documentation.
Documentation and the burdens associated with it are only
one piece of a larger, more complex puzzle. The EHR 2020 Task
Force also recommended that policymakers refocus the varied set
of regulations and policies shaping the development of the
health IT market and its use within healthcare.
The simple message resonating among the Tasks Force's
recommendations: slow down regulation to accelerate progress.
Ensuring CMS does not rush to get to the next stage of
Meaningful Use, but rather works to help the private sector
accelerate optimization of the tools and regulations that are
already in place; reorienting ONC's certification program to
test true interoperability by testing how systems both send and
receive information are among the key steps HHS should take in
the near term. Should the regulatory pressure continue,
stakeholders may look to Congress to intervene.
While these steps will help the private sector make
advancements toward more interoperable, safer health IT
systems, Congress would engender genuine and lasting impact by
enabling all patients to have their medical record, not just a
summary of their record, available in standardized, machine-
readable formats. It is unconscionable that in 2015, with the
widespread adoption of electronic health records, a patient
must still print and scan their medical record when they change
to a new physician.
The future of healthcare will be characterized by an
electronic, transportable record of care that provides
customized views depending on what the care team needs to
deliver and according to patient preference. The record will
have the ability to incorporate data from different sources,
including patient-generated data, population data, and
community context, into an EHR.
Should this committee take up legislation during this or
the next Congress, you should focus on the areas described in
the EHR 2020 Task Force report. If so, I am confident that we
can turn the page from frustrations of today's technology to
realize the promise of a truly integrated, modern healthcare
experience for all patients and their care providers.
A more detailed explanation of the recommendations and a
copy of the EHR 2020 Task Force report will be submitted as
part of the written record.
Thank you.
[The prepared statement of Dr. Payne follows:]
Prepared Statement of Thomas H. Payne, M.D., FACP, FACMI
summary
Recommendations, which I will describe in my oral and written
comments, are derived from a recent report published by a
multidisciplinary Task Force chartered by the AMIA board of directors.
The EHR 2020 Task Force was established to develop recommendations on
how we, as a Nation, can resolve challenges related to EHRs--challenges
this committee has examined through a host of recent hearings. This
report was developed over the course of 12 months by a diverse group of
informatics professionals representing a wide range of perspectives.
Broadly, the report's 10 recommendations fall into four categories,
which are briefly summarized as a need to:
1. Improve documentation requirements and functionality to empower
patients so that all members of the care team can contribute their
perspectives and information;
2. Refocus regulations so that patients and their caregivers can
derive the most benefit from a networked healthcare ecosystem;
3. Increase transparency to improve usability and safety of EHRs;
and
4. Foster innovation so that we can build toward the next
generation of EHRs and realize the benefits of the ``learning health
system.''
The steps Congress should take to help encourage better EHR
usability, improved interoperability and meaningful patient engagement
should focus near-term activities on Reducing documentation burdens for
clinicians by clarifying regulatory ambiguity and supporting adoption
of standards meant to integrate clinical data from patients, medical
devices and other external sources of data with the EHR. Second,
Congress should unleash the potential for every patient to enrich the
learning health system by requiring vendors to give patients an
electronic copy of their entire record, not just a summary, and require
that such information is available in machine-readable formats. Policy
development in this area will leverage existing requirements of HIPAA
and generate a host of positive externalities to facilitate health
information exchange among patients and their caregivers while fueling
an ecosystem of modern applications and research. Third, Congress
should streamline the Federal health IT certification program so that
the process is more flexible, more transparent, focuses on clinically
relevant functionality, and tests for true interoperability.
Finally, Congress should embrace the notion of slowing down
regulation to accelerate progress on EHR usability, interoperability
and innovation. Federal regulators should not rush to get to the next
stage of meaningful use, but should instead work to help the private
sector accelerate optimization of the tools and regulations that are
already in place.
The recommendations developed by AMIA's 2020 Task Force are
inclusive of a diverse group of informatics professionals and we think
they are sensible, feasible and will capitalize on the progress made
to-date. In combination, these recommendations represent the most
important work Congress can engage to help turn the page from our
current State problems. Lawmakers have a vital role in determining the
next evolution in EHRs, and AMIA stands ready to support Congress in
this important work.
______
Good afternoon, Chairman Alexander, Ranking Member Murray, and
distinguished members of the committee. My name is Dr. Thomas Payne. I
am medical director of IT Services at UW Medicine and the University of
Washington School of Medicine, and I am chair-elect of the AMIA board
of directors. The American Medical Informatics Association represents
more than 5,000 doctors, nurses, clinicians, researchers and other
informatics professionals, who develop, implement and study ways to
manage information for patients, professionals in their clinical
practice, public health and clinical research.
It is an honor to appear before you today, alongside this
distinguished panel. My comments will focus on positive, near-term
action items policymakers can take to capitalize on the increased
adoption of electronic health records, and utilize a burgeoning trove
of health data to improve the quality and value of healthcare for
Americans.
Recommendations, which I will describe in my comments, are derived
from a recent report published by a multidisciplinary Task Force
chartered by the AMIA board of directors. The EHR 2020 Task Force was
established to develop recommendations on how we, as a Nation, can
resolve challenges related to EHRs--challenges this committee has
examined through a host of recent hearings. This report was developed
over the course of 12 months by a diverse group of informatics
professionals representing a wide range of perspectives.
Broadly, the report's 10 recommendations fall into four categories,
which I will briefly summarize as a need to:
1. Improve documentation requirements and functionality to empower
patients so that all members of the care team can contribute their
perspectives and information;
2. Refocus regulations so that patients and their caregivers can
derive the most benefit from a networked healthcare ecosystem;
3. Increase transparency to improve usability and safety of EHRs;
and
4. Foster innovation so that we can build toward the next
generation of EHRs and realize the benefits of the ``learning health
system.''
Congress can and should play a vital role toward encouraging better
EHR usability, improved interoperability and more meaningful patient
engagement. For example, relatively simple steps could be taken to
improve documentation requirements, such as encouraging regulatory
guidance that clearly delineates who is and who is not eligible to
enter data into the record for compliance and reimbursement purposes. A
more impactful and coordinated undertaking would include the refinement
and adoption of standards meant to integrate clinical data from
patients, medical devices and other external sources into the EHR.
Longer term, Congress should develop policies that require CMS to
revisit the entire billing and coding system that drives documentation
for reimbursement and compliance purposes. Congress should also
continue to promote broad adoption of alternative payment models, such
as value-based purchasing, so that reimbursement is contingent on
outcome-oriented measures, supported by less prescriptive and more
flexible requirements for documentation.
Documentation--and the burdens associated with it--are only one
piece of a larger, more complex puzzle. The EHR 2020 Task Force also
recommended that policymakers refocus the varied set of regulations and
policies shaping the development of the health IT market and its use
within healthcare. The simple message resonating among the Tasks
Force's recommendations: slow down regulation to accelerate progress.
Ensuring CMS does not rush to get to the next stage of meaningful use,
but rather works to help the private sector accelerate optimization of
the tools and regulations that are already in place; reorienting ONC's
certification program to test true interoperability by testing how
systems both send AND receive information are among the key steps HHS
should take in the near-term. Should the regulatory pressure continue,
stakeholders may look to Congress to intervene.
While these steps will help the private sector make advancements
toward more interoperable, safer health IT systems, Congress would
engender genuine and lasting impact by enabling all patients to have
their medical record, not just a summary of their record, available in
standardized, machine-readable formats. It is unconscionable that in
2015, with the widespread adoption of electronic health records, a
patient must still print and scan their medical record when they change
to a new physician. The future of healthcare will be characterized by
an electronic, transportable record of care that provides customizable
views and varied amounts of context depending on what the care team
needs to deliver care, and according to patient preference. The record
will have the ability to incorporate data from different sources,
including patient generated data, population data and community context
into an EHR. Once the complete medical record is available in an
electronic form, patients can more fully participate in clinical
research, precision medicine, and other activities in which they
control who can use their data. The first step toward this future is to
enable patients to have access to their entire record in a computable,
electronic form, not just a summary of their record. The electronic
standards are ready, and this is perhaps the single, most important
work Congress can engage to help turn the page from our current State
problems.
Should this committee take up legislation during this or the next
Congress, and should you focus on the areas described in the AMIA EHR
2020 Task Force report, I am confident that we can turn the page from
the frustrations of today's technology to realize the promise of a
truly integrated, modern healthcare experience for all patients and
their care providers.
A more detailed explanation of recommendations and a copy of the
EHR 2020 Task Force report will be submitted as part of the written
record.
Thank you.
______
The remainder of my comments will detail the action items
policymakers can take to improve the quality and efficiency of care
delivery, optimize patient safety, and improve interoperability of
health IT.
Recommendation 1: Improve documentation requirements and functionality
to empower patients so that all members of the care team can
contribute their perspectives and information.
For the last two decades, documentation requirements for
reimbursement and compliance purposes have increased dramatically in
healthcare. Rather than diminish the burdens associated with
documentation, as information technology has done for countless other
industries, EHRs have magnified the amount of time physicians and
nurses spend away from the bedside, increasing their workload and
contributing to worsened professional satisfaction. Because EHRs are
expected to serve the dual purpose of capturing data for clinical and
billing purposes, as well as envisioned to fulfill a myriad of quality
reporting requirements, EHRs do not inherently promote sensible
workflows. Quite the contrary, in many cases EHRs dictate workflows to
users in order to generate reports and satisfy documentation
requirements, creating a classic ``tail wagging the dog'' situation.
The EHR 2020 Task Force concluded that much of the information
relevant to the diagnosis and treatment of a patient could more
effectively be entered by other members of the care team, captured
automatically by devices or other information systems or captured and
entered by patients themselves. Further, the Task Force noted that
moving away from the current evaluation and management (E/M) billing
structure would free EHR developers to support more novel methods to
collect important data. In order to help the care team get back to the
bedside, Congress should:
Encourage regulatory guidance clearly delineating who is
and who is not eligible to enter data into the record for compliance
and reimbursement purposes;
Adopt standards meant to integrate clinical data from
patients, medical devices and other external sources with the EHR;
Encourage and support Federal agencies, such as AHRQ, NIH,
NLM, NSF and NIST to study alternative approaches to documentation
using different media and data sources to identify more efficient
documentation;
Finally, Congress should support and encourage further
adoption of alternative payment models, such as value-based purchasing,
so that reimbursement is contingent on outcome-oriented measures,
supported by less prescriptive and more flexible requirements for
documentation. This will focus attention on documenting outcomes and
clinically relevant information (rather than processes and procedures),
and will speed the adoption of better ways of capturing and documenting
clinical care.
Recommendation 2: Refocus regulations so that patients and their
caregivers can derive the most benefit from a networked
healthcare ecosystem.
Over the last 5 years, the Federal Government has been much more
proactive in shaping the market for health IT and informatics. The
Federal Government's centerpiece legislation, the HITECH Act, has
driven significant efforts by public and private stakeholders,
resulting in undeniable gains for the public good. The CMS EHR
Incentive Program has enabled a remarkable rise in the adoption of EHRs
and ONC's certification program has provided a long-overdue framework
to identify, harmonize and drive the adoption of health IT standards
across the fractured healthcare landscape. The impact of HITECH is
undeniable, but so too are the burdens associated with compliance--and
not just to meaningful use, but a host of other programs dependent on
the use of IT and informatics tools. The growth in adoption and use of
health IT has not been without its challenges.
Following completion of meaningful use Stage 1 and adoption of the
2011 Edition of Certified EHR Technology, many developers struggled to
produce upgraded versions--2014 Edition CEHRT--and many providers
struggled to meet Stage 2--more rigorous--requirements for meaningful
use. Seeing these challenges, policymakers turned to a flurry of
regulatory responses with exceptions, flexibility, and extended
attestation periods. The challenges faced by healthcare stakeholders
has also led to proposed legislation to increase flexibility in the
program. These changes suggest that the EHR incentive programs should
take a different approach to leverage the gains already made and
prevent further erosion of the program. Further, the Federal Government
needs to refocus the wider set of health IT and informatics policies
across agencies and programs.
The EHR 2020 Task Force recommended Federal health IT regulations
focus on (1) clarifying and simplifying MU regulations for providers
and vendors; (2) improving data exchange and interoperability; and (3)
Reducing duplicative quality measurement while prioritizing patient
outcomes over new functional measures.
clarify and simplify mu regulations for providers and vendors
In order to provide vendors with clarity on how to meet the MU
certification criteria, ONC provides precise instructions for each MU
functional objective. The advantage of this approach is that vendors
know with certainty how to qualify for MU certification. An unintended
consequence is that vendors believe their customers must follow the
workflow they programmed into the certified function and built into the
automated calculation of the MU threshold determination. This
predetermined workflow built into EHR products significantly affects
usability of the products, often in a negative way. The goal of
certification should be to assure that standards are consistently used
in vendor products, in how systems interact with each other, and how
quality is measured. Properly used, standards can lead to more
flexibility as best of breed and modular products allow customization.
The certification program, however, has led to preprogrammed workflows
that are intended only to meet the conditions of certification, and not
the needs of health care providers. Near-term action items for Congress
include:
Ensuring CMS does not rush to get to the next stage of MU,
but rather works to help the private sector accelerate optimization of
the tools and regulations that are already in place;
Create flexibility in the certification program by
encouraging vendors to develop testing methods that focus on
demonstrating a functional capability instead of adherence to a
predetermined, prescriptive test procedures.
improve data exchange and interoperability
New certification requirements should focus on technical
requirements that will improve interoperability and data exchange,
support better quality measures, and provide for safer and more secure
care. To do this Congress should:
Engage with HHS to ensure that ONC's certification program
tests not just conformance to the standards, but true interoperability.
This means testing both how systems send information and making sure
that they are flexible in how they receive information.
Require that health IT vendors provide all patients with
their entire medical record in a standards-based computable format.
reducing duplicative quality measurement while prioritizing
patient outcomes
Quality measurement and reporting has become the primary focus of
many FTEs within any given healthcare system due to a proliferation of
quality reporting programs, such as the Physician Quality Reporting
System (PQRS) Program, Inpatient Quality Reporting (IQR) Program,
meaningful use quality reporting requirements and a host of quality
reporting regimes applied by State-level health officials or
private-sector insurers and accreditation bodies. Many, if not most of
these quality reporting requirements befall providers simultaneously
and call for slightly different specifications of quality measures,
rendering multiple uses of the same measures impossible. As Federal
legislators look to quality measures as the basis for future
reimbursement models and consumer comparison efforts, Federal
regulators are looking to require submission of electronic clinical
quality measures, which are incomplete and inaccurate without the
addition of manual abstraction with current EHR systems.
The EHR 2020 Task Force recommended that quality measurement should
focus on outcomes that are consistent with national priorities while
also being relevant to patients, their communities and clinicians'
specialties. And, again, working with payers and other stakeholders to
develop payment alternatives that depend less on documentation and more
on quality and value is likely to promote EHR innovation and uses that
support these goals. In order to reduce duplicative quality measurement
and prioritize patient outcomes over functional measures, Congress
should:
Develop a special committee dedicated to harmonizing
quality measurement across Federal, State and private sector
stakeholders.
Encourage development of accurate, complete and reusable
electronically specified electronic CQMs, by building quality measures
from a consistent set of data ``building blocks''.
Study the value of complex versus simple quality measures,
and use the results of those studies to simplify data collection and
quality measure calculations. Complex quality measures will lead to
complex data collection requirements, and simple, high quality measures
may achieve the same goal at a lower cost.
Recommendation 3: Increase transparency to improve usability and safety
of EHRs.
Currently, purchasers of EHRs often do not have visibility into how
applications work. This lack of transparency inhibits an effective,
competitive marketplace. Those choosing EHRs need clear knowledge of
what commercial EHR systems offer and, importantly, what workflows are
incorporated into their use for frequent tasks such as creating notes,
entering data, reconciling medications, responding to decision support,
and extracting data for reports or research--so they can make more
informed choices.
However, transparency in how EHRs perform during certification
conformance testing is only one aspect of transparency. Users of health
IT also need transparency in how systems perform after they're deployed
in a live environment. Moreover, patients and their care providers
should have a clear understanding of the safety performance of health
IT and informatics tools. In order to improve usability and safety and
to foster innovation, health care organizations, providers and vendors
should be fully transparent about unintended consequences and new
safety risks introduced by health information technology systems,
including EHRs, as well as best practices for mitigating these risks.
In order to create the most transparent market for health IT, Congress
should:
Encourage ONC to modify its certification program to
streamline the certification process--as outlined previously in my
comments--and better convey the process by which developers program
common functionality and frequent tasks;
Make all the results of testing and how each vendor
satisfies the certification requirements open to the public for review.
This should include not just summaries, but videos, screen shots and
details of the workflow used to satisfy the certification requirements;
Move forward with recent Food and Drug Administration
Safety and Innovation Act (FDASIA) report recommendations to develop a
public-private Health IT Safety Center that would promote health IT as
an integral part of patient safety with the ultimate goal of assisting
in the creation of a sustainable, integrated health IT learning system;
and
Encourage a more inclusive ``culture of safety,'' by
affording similar safe harbors to vendors that are afforded to
providers that participate with Patient Safety Organizations (PSOs).
Recommendation 4: Foster innovation so that we can build toward the
next generation of EHRs and realize the benefits of the
``learning health system.''
Given the complexity of our healthcare system, the incomplete State
of several national efforts to modernize care, harness health data and
empower patients, a clinician could be forgiven for being overwhelmed.
But the future is bright and the possibilities are great. As a Nation,
we are closer than any other point in history where every patient
encounter could present an opportunity for patients and clinicians
alike to contribute to our understanding of health care and participate
in research and clinical trials. This is the essence of the learning
health system.
In addition to enabling the incorporation of research knowledge
into practice to support evidence-based medicine, EHRs can enable
evidence generating medicine thereby creating a virtuous cycle of rapid
evidence generation and evidence-based care delivery, an essential
element needed to create a learning health system and to advance
precision medicine.
Although we don't know what the next generation EHR will look like,
we know that it will likely be very different than the systems that we
have now. If we want to have the same successes that we've seen in the
internet, we need a stable base of standard building blocks that allows
us to create new technology to benefit patients. Unfortunately, there
is a disconnect between the promise of what we can do and the real-
world infrastructure required to actually make it operational and
scalable.
In order to foster innovation so that we can build toward the next
generation of EHRs and realize the benefits of the learning health
system, Congress should:
Support the adoption of standards for connecting different
systems together, such as Application Program Interfaces (APIs),
Require standards that allow patients to have a copy of
their entire medical record, not just a summary as previously
described;
Fund research on how to best capture data, integrate data
and design new user interfaces utilizing the best computer and human-
computer interaction science available; and
Support innovation in precision medicine by making it
easier to get information out of the electronic health records and into
the hands of patients who wish to participate in precision medicine.
We know that the IT sector has in many other domains driving
significant economic development and job growth. We believe the same is
possible in Health IT, but we must create the innovation ecosystem that
will allow everyone, not just the largest companies thrive in the
expanding marketplace.
Together, we are confident these recommendations will improve the
landscape for better, more usable EHRs that will lead to greater
interoperability, more engaged patients and improved clinical outcomes.
Congress can take tangible steps toward the improved future of health
IT by reducing documentation burden, requiring vendors to give patients
an electronic copy of their entire record, and by streamlining
certification so the process is more flexible and transparent. These
actions will enable advances in population health, precision medicine
and capitalize on the progress made to-date.
Lawmakers have a vital role in determining the next evolution in
EHRs, and AMIA stands ready to support Congress in this important work.
The Chairman. Thank you, Dr. Payne.
Mr. Richardville.
STATEMENT OF CRAIG D. RICHARDVILLE, MBA, FACHE, SENIOR VICE
PRESIDENT AND CHIEF INFORMATION OFFICER, CAROLINAS HEALTHCARE
SYSTEM, CHAIR, PREMIER HEALTHCARE ALLIANCE MEMBER TECHNOLOGY
IMPROVEMENT COMMITTEE, CHARLOTTE, NC
Mr. Richardville. Thank you, Chairman Alexander, Ranking
Member Murray, and the members of this committee, for your
leadership in holding this hearing today, and to you, Senator
Burr, for your gracious introduction.
I appreciate the opportunity to testify today on behalf of
Carolinas HealthCare System and the Premier Healthcare
Alliance, where I serve as chair of Premier's Member Technology
Improvement Committee.
Carolinas HealthCare System is one of the largest health
systems in the country. We have a diverse network that includes
more than 900 care locations, 3,000 physicians and ACPs, 39
hospitals, behavioral health centers, home healthcare, nursing
homes, hospice, and palliative care. In 2014, we touched the
lives of 11 million patients living throughout North Carolina,
South Carolina, and northeast Georgia.
Premier is a leading healthcare improvement company,
uniting an alliance of approximately 3,400 hospitals and
110,000 other providers to transform healthcare.
Improving health information exchange and achieving true
interoperability is one of the key challenges of our time,
especially given the drive from volume-based care to value-
based care, to increase the quality, efficiency, safety, and
well-being of our citizens. As this committee has heard earlier
this year, the current HIT ecosystem continues to be
challenging for healthcare providers due to the lack of
interoperability among various HIT systems.
Efficient, easy to use, and the integration of health
information is foundational to advancing and providing
excellent care in this country. The cost to build, test, and
maintain those integrations and interfaces is significant. At
Carolinas HealthCare System, we have had success in these
integrations. To date, we've integrated more than 125 different
systems into our EMR.
More than the impact on providers and hospitals is the
impact on the patients that we serve. In order to truly engage
our patients in the management of their care and to give them
the tools that they need to manage and understand their health
status, we must provide them with this clinical information.
Take, for example, a patient who has diabetes and other
chronic conditions. This patient may be receiving care from
multiple providers who are documenting their care in multiple
systems. In order that the care be coordinated, up-to-date, and
based on reliable current information, providers need to have
the information readily available.
The lack of easy exchange of this data amongst all
providers and patients is the challenge. The goal should be to
design and implement a secure HIT ecosystem that enables an
easy exchange of health information.
To accomplish this, we ask for a combination of
congressional leadership and administrative actions that
promote policy principles that further open health IT
infrastructures. These include:
Governance: Private-public partnership on HIT
interoperability governance should be established to provide
clear rules of the road.
Functional standards: The governance mechanism should focus
on the development of functional data and transport standards
in key areas including patient identifiers, terminologies,
clinical data query language, security, open APIs, and clinical
decision support algorithms as well as business practices and
policies.
Measures: Transparent and public measures of
interoperability should be developed in collaboration with the
Federal Government.
Transparency: Secure data should flow freely and easily.
Compliance enforcement: The Federal Government should be
enabled to enhance its enforcement tools to ensure functional
data and transport standards and measures are compliant in
vendor partners through its certified technology programs.
The impact of having true interoperability achieved through
the functional standards, metrics, and innovative technologies,
such as open and secure APIs, would be transformative in terms
of care, efficiency, safety, and patient engagement.
Let's go back to our patient with diabetes. With a more
robust and open system, the patient could securely send to his
or her provider daily glucose readings from a mobile device.
Those readings would be easily posted and translated to a care
management system where a coordinator is monitoring for
fluctuations.
During the visit, either in person or a virtual visit, the
physician sees all the data from the patient and the various
clinical systems. This allows the provider to understand not
only today's clinical data, but also the information that the
patient voluntarily shares from outside the office.
Thank you again on behalf of the providers at Carolinas
HealthCare System and Premier Healthcare Alliance members and
the patients that we serve for this considerable transformative
work that you are doing for the benefit of the communities that
we serve.
[The prepared statement of Mr. Richardville follows:]
Prepared Statement of Craig D. Richardville, MBA, FACHE
summary
Chairman Alexander, Ranking Member Murray and members of the Senate
Health, Education, Labor, and Pensions (HELP) Committee, I appreciate
the opportunity to testify today on behalf of Carolinas HealthCare
System and the Premier healthcare alliance, where I serve as the chair
of Premier's Member Technology Improvement Committee (MTIC), which
consists of member CIOs that advise Premier's leadership and the Board
on health information technology (HIT) matters.
hit interoperability is foundational to improving quality and value
of healthcare to patients
As this committee heard earlier this year, the current market
incentives are not aligned with open exchange of necessary healthcare
data in cost-effective ways. The sharing of data that sits in software
systems across the care continuum is not only technically complex, it
also is expensive. Data resides in many systems, not just electronic
medical records. Registration, billing, lab, pathology systems, medical
devices, sensors and monitors, to name just a few, all have vital data
that can and should be integrated and accessible across the care
spectrum, no matter what the underlying software system is.
More than the impact on providers and hospitals is the impact on
the patients we serve. In order to truly engage our patients in the
management of their care and to give them the tools they need to manage
and understand their health status, we must provide them with this
clinical information.
pathway to achieving interoperability
The goal should be to design and implement a secure HIT ecosystem
that enables an easy exchange of health information in timely and cost-
effective ways. To accomplish these goals, we ask for a combination of
congressional leadership and administrative actions that promote policy
principles that further open health IT infrastructures. In creating
these structures, we need clear rules of the road for providers and
vendors alike through establishment of functional data and transport
standards and methods to measure and test functionalities, with
enhanced enforcement tools for regulatory bodies to drive compliance in
the marketplace.
Governance: Private-public partnership on HIT
interoperability governance should be established to provide clear
rules of the road on interoperability. This should be done in
consultation and coordination with Federal agencies, such as HHS and
ONC, and the private sector. Providers, vendors, patients and payers
should be consulted. The government entities should provide regular
reports to Congress and the Administration on current standards
development status as well as ready to market timelines and assessments
for their applications.
Functional data and transport standards that promote
interoperability and innovation: The governance mechanisms should focus
on the development of functional data and transport standards in key
areas including: patient matching, terminologies, clinical data query
language, security, open application program interfaces (APIs), and
clinical decision support algorithms as well as business practices and
policies.
Public interoperability and cost efficiency measures:
Transparent and public measures of interoperability should be developed
in collaboration with the Federal Government, including HHS and ONC,
and standard-setting bodies in consultation with the private sector and
be required as part of ONC's certified technology program.
These measures should be validated and tested in
terms of functional standards, processes, and their maturity
for application in the marketplace in a timely way, and within
specific use case scenarios.
Measures should include business and implementation
approaches that deliver functional interoperability outcomes
and include operational processes and implementation practices.
Measures should also include assessment of cost
efficiency metrics achieved through incorporating innovative
technologies, such as existing API, which is an open source
code that enables third party applications to exchange data.
Transparency: Data should flow freely and easily.
Determinants of transparency should include:
Availability of ``free'' (no cost) export of
publishable EHR domains.
Prohibition of specific fees for access to necessary
data through API or other functional standard callable methods.
Publication of technical instructions on how to
interact with APIs, interface standards or other callable
methods. These should be published either publicly or broadly
to any authorized third party.
Technology and devices that generate health
information be required to publish clinical data to any other
authorized consuming applications, including EHR/EMRs, to
create interoperability. Consuming applications' ability to
develop methods to ingest information from other HIT assets,
including devices, should adhere to current and future medical
device interoperability standards.
Enforcement of functional data and transport standards and
measures of HIT interoperability: The Federal Government should be
enabled to enhance its enforcement tools to ensure functional data and
transport standards and measures compliance of vendors through its
certified technology program.
______
Chairman Alexander, Ranking Member Murray and members of the Senate
Health, Education, Labor, and Pensions (HELP) Committee, I appreciate
the opportunity to testify today on behalf of Carolinas HealthCare
System and the Premier healthcare alliance, where I serve as the chair
of Premier's Member Technology Improvement Committee (MTIC), which
consists of member CIOs that advise Premier's leadership and the Board
on health information technology (HIT) matters.
To start, I applaud the leadership of Chairman Alexander and
Ranking Member Murray for holding this important hearing today. This is
a vital topic, important to the well-being of our citizens and our
Nation.
Carolinas HealthCare System is one of the largest health systems in
the country. We have a diverse network that includes more than 900 care
locations, 3,000 physicians and advanced clinical practitioners, 39
hospitals, behavioral health centers, home health care, nursing homes,
hospice and palliative care. For 11 consecutive years, we have been
named one of America's Most Wired Hospitals by Modern Healthcare. We
are the only health system in North or South Carolina to have received
HIMSS Analytics Stage 7, the highest level, for adoptions of electronic
medical record (EMR) technologies in both outpatient and inpatient
settings. We also are a member of Healtheway, a founding member of
Carequality and being certified for the national eHealth Exchange. Just
last month, Carolinas was named by Forbes magazine as one of the
Nation's best employers.
Our mission is clear--to create and operate a comprehensive system
to provide healthcare and related services, including education and
research opportunities, for the benefit of the people we serve. In
2014, we had more than 11 million patient encounters, touching the
lives of those that live throughout North and South Carolina and
northeast Georgia. Each day, our 60,000 teammates dedicate themselves
to providing the best medical care possible. Much of the care they
deliver each day is extended, buttressed and enhanced by the advances
in technology.
Premier, Inc. is a leading healthcare improvement company, uniting
an alliance of approximately 3,400 U.S. hospitals and 110,000 other
providers to transform healthcare. With integrated data and analytics,
collaboratives, supply chain solutions, advisory and other services,
Premier enables better care and outcomes at a lower cost. Premier, a
Malcolm Baldrige National Quality Award recipient, plays a critical
role in the rapidly evolving healthcare industry, collaborating with
members to co-develop long-term innovations that reinvent and improve
the way care is delivered to patients nationwide.
hit interoperability is foundational to improving quality and value
of healthcare to patients
Despite its potential, the current HIT ecosystem continues to be
challenging for healthcare providers because of a lack of
interoperability between systems. Cost-effective, efficient, and easy
to use and integrate health information is foundational to advancing
and providing excellent care in this country. Patients and care
providers are missing opportunities to improve people's health and
welfare when information about care or health status is not easily
available. It is critical for us, all of us, to fully use and leverage
the health data that is vital to improving patient care. Doing so will
help us discover and develop better treatments while improving safety
and quality in the delivery of that care.
As this committee heard earlier this year, the current market
incentives are not aligned with open exchange of necessary healthcare
data in cost-effective ways. The sharing of data that sits in software
systems across the care continuum is not only technically complex, it
also is expensive. Data resides in many systems, not just electronic
medical records. Registration, billing, lab, pathology systems, medical
devices, sensors and monitors, to name just a few, all have vital data
that can and should be integrated and accessible across the care
spectrum, no matter what the underlying software system is. The
difficulty in achieving this has an impact not only in care quality but
also in cost.
The cost to build interfaces and test and maintain those interfaces
is not insignificant. At Carolinas HealthCare System, we have been
successful with many of these integrations. In order to meet the needs
of our patients across our geographies and throughout the care
continuum, we have interfaced with more than 125 systems to get data
into our EMRs. One critical factor to our success has been with our
patient matching biometric program which uses palm vein scanning.
Patients scan their palms, and we are able to match them to the data in
many of our systems, ensuring that the right information about the
right patient is available. Using this system, which 99 percent of our
patients do voluntarily, results in less than .11 percent failure rate.
That means 99.9 percent of our patients are correctly matched in our
systems. The national average for this is 8 to 10 percent, while a best
practice is 5 percent.
Achieving this integration has not been easy or inexpensive. Today,
in order to build the bridges that connect disparate data sets
necessary to provide comprehensive and informed decisions or care,
providers must either pay their original system vendors thousands and
sometimes millions of dollars to custom code linkages so they can
``talk'' to other systems, or they often find paper-based workarounds
that are fraught with potential for both errors and wasted resources
and expense.
The costs of sharing this critical data among other health systems
is not just in dollars. It creates an environment of inefficient use of
some our most valuable resources, our people. Having care providers
faxing or mailing information to other providers is not the best use of
these highly skilled clinical people.
More than the impact on providers and hospitals is the impact on
the patients we serve. In order to truly engage our patients in the
management of their care and to give them the tools they need to manage
and understand their health status, we must provide them with this
clinical information. Take for instance a patient who has diabetes and
other chronic conditions. This patient may be receiving care from
multiple physicians who are documenting their care in multiple systems.
In order that the care be coordinated, up to date and based on reliable
current information, those physicians need to have the information
readily available when they are making clinical decisions. The lack of
easy exchange of these data amongst all providers and the patient is
the challenge.
pathway to achieving interoperability
The goal should be to design and implement a secure HIT ecosystem
that enables an easy exchange of health information in timely and cost-
effective ways. The system should promote collaboration among all
stakeholders, from patients to providers to vendor partners and payers.
We need a system of standards that focuses on improving healthcare
quality, efficiency, safety, affordability and access through
government and market incentives, while encouraging innovation and
competition.
At Carolinas, for instance, we care for more than 60,000 people
with diabetes. Continuing to manage their care through today's methods
is not optimal. The shift from volume-based care, where we are paid for
the numbers of things we do or the number of patients we see, to value-
based care where we are compensated for the quality of the care, leads
us to this new care delivery model. Population health programs like we
are implementing at Carolinas will advance the delivery of this value-
based care where providers and patients are linked and partners in the
care.
To accomplish these goals, we ask for a combination of
congressional leadership and Administrative actions that promote policy
principles that further open health IT infrastructures. In creating
those structures, we need clear rules of the road for providers and
vendors alike through establishment of functional data and transport
standards, and methods to measure and test functionalities, with
enhanced enforcement tools for regulatory bodies to drive compliance in
the marketplace. These include:
Governance: Private-public partnership on HIT
interoperability governance should be established to provide clear
rules of the road on interoperability. This should be done in
consultation and coordination with Federal agencies, such as HHS and
ONC, and the private sector. Providers, vendors, patients and payers
should be consulted. The government entities should provide regular
reports to Congress and the Administration on current standards
development status as well as ready-to-market timelines and assessments
for their applications.
Functional data and transport standards that promote
interoperability and innovation: The governance mechanisms should focus
on the development of functional data and transport standards in key
areas including: patient matching, terminologies, clinical data query
language, security, open application program interfaces (APIs), and
clinical decision support algorithms as well as business practices and
policies.
Public interoperability and cost efficiency measures:
Transparent and public measures of interoperability should be developed
in collaboration with the Federal Government, including HHS and ONC,
and standard-setting bodies in consultation with the private sector and
be required as part of ONC's certified technology program.
These measures should be validated and tested in
terms of functional standards, processes, and their maturity
for application in the marketplace in a timely way, and within
specific use case scenarios.
Measures should include business and implementation
approaches that deliver functional interoperability outcomes
and include operational processes and implementation practices.
Measures should also include assessment of cost
efficiency metrics achieved through incorporating innovative
technologies, such as existing API, which is an open source
code that enables third party applications to exchange data.
Transparency: Data should flow freely and easily.
Determinants of transparency should include:
Availability of ``free'' (no cost) export of
publishable EHR domains.
Prohibition of specific fees for access to necessary
data through API or other functional standard callable methods.
Publication of technical instructions on how to
interact with APIs, interface standards or other callable
methods. These should be published either publicly or broadly
to any authorized third party.
Technology and devices that generate health
information be required to publish clinical data to any other
authorized consuming applications, including EHR/EMRs, to
create interoperability. Consuming applications' ability to
develop methods to ingest information from other HIT assets,
including devices, should adhere to current and future medical
device interoperability standards.
Enforcement of functional data and transport standards and
measures of HIT: The Federal Government should be enabled to enhance
its enforcement tools to ensure functional data and transport standards
and measures compliance of vendors through its certified technology
program.
Let's go back to our patients with diabetes. With a more robust and
open system, the patient could send to his or her care provider, their
daily glucose readings from their mobile device. At Carolinas, they
soon will do that through MyCarolinas Tracker, which integrates data
from 60 consumer-based medical devices. Those readings would be easily
posted and translated in a care management system, where a coordinator
is monitoring for fluctuations. In the meantime, the coordinator is
scheduling the patient for a check-up with the physician. Before the
patient goes in for the visit, they log in to look at the latest lab
and test results on them. During the visit, the physician sees all the
data from the patient and all the data from the clinical systems in the
EMR. The physician can also view when the patient had an ER visit at
another hospital while on vacation. This allows the physician to
understand not only today's clinical data, but also the life of the
patient outside of the office visit.
The technology is now available to realize the goals of what the
Institute of Healthcare Improvement calls the Triple AIM--improve the
health of the population served, improve the experience of each
patient, and improve the affordability of the care.
Thank you again for the opportunity to testify today. As this
committee continues its work on improving HIT infrastructure and data
exchange, we urge the Members to require HIT interoperability as
foundational to facilitate research, storage and use of health data to
advance patient care, quality and safety, while reducing costs. Thank
you on behalf of the providers at Carolinas HealthCare System and
Premier healthcare alliance and the patients we serve for this
considerable transformative work you are doing for the benefit of the
communities we serve.
The Chairman. Thank you, Mr. Richardville.
Ms. Bechtel.
STATEMENT OF CHRISTINE BECHTEL, M.A., ADVISOR, NATIONAL
PARTNERSHIP FOR WOMEN AND FAMILIES, CHAIR, HEALTH IT POLICY
COMMITTEE CONSUMER WORKGROUP, PRESIDENT, BECHTEL HEALTH, OLNEY,
MD
Ms. Bechtel. Good morning, Mr. Chairman, Ranking Member
Murray, and distinguished committee members. I'm Christine
Bechtel. I'm a consumer advocate, and I'm an advisor to the
National Partnership for Women and Families. Thank you for
having me here today.
As you've just heard, the healthcare system is struggling
to foster the kind of exchange that will drive better care and
smarter spending. We're making progress, but many organizations
still treat health data as a close-hold business asset when it
should be treated as a public good.
I'm here to talk about how consumers can be a force for
change. The role of consumers in healthcare is changing
rapidly, thanks to emerging information technologies, evolving
economic incentives, and rising consumer expectations.
If we harness these forces, consumers can play a major role
in beginning to dramatically reshape the way we share
information in healthcare today. Simply put, if I can gather my
data electronically from all of my healthcare entities that
hold it, use a safe and secure app to store it, then I could
share it with any one of my healthcare providers for my care or
for other purposes, like precision medical research.
As the only one present at all of my healthcare encounters,
I can potentially amass more data more quickly and more
comprehensively than any single healthcare entity can today,
because I know where it is, and I have a legal right to it.
We're close to achieving this vision. Both the policies and
the technologies exist, but we aren't there yet, and my
personal experience demonstrates that we have work to do.
Eight weeks ago, I tried to gather my health records from
the patchwork of providers that hold it, and I started with my
primary care practice. Because the practice participates in
Meaningful Use, I should have been able to download my data
directly from the patient portal. Unfortunately, the portal was
broken, and the practice had no plan to fix it.
Instead, I asked for an electronic copy of my record, which
I now have a legal right to under HIPAA. The practice was
unaware of my right, and they had no established process for
complying. I had to drop off a copy of the Federal register to
demonstrate my right, and then the staff had to work through
how to meet my request.
After a lot of back and forth, they put two files on this
lovely CD-ROM, and I physically went to the office to pick it
up. The process took about 2 weeks, and then once I looked at
the CD's contents, I learned that the files alone aren't very
useful. I researched and I downloaded an app, as anybody would,
to display my medical record in a way that I could understand.
This simple medical records request was a lot of work. Most
consumers will not have the resources or the expertise to
persist as I did. They should, because my experience produced
results. My doctor's office is now changing their process so
that all patients can have an electronic option when they want
it.
If consumers writ large can do what I did, if they can
really ask for and demand their health information right now,
then I believe that this can enable systematic change. To do
that, there are several actions that we need to take in the
next 12 months to make this process easy, private, and secure.
Good news--none require legislation, but a little nudge
from Congress would certainly help. There's more detail in my
written testimony. In summary, we need to start by raising
consumer awareness and provider awareness about our rights to
our electronic health information and the use of patient
portals for downloading health data. HHS has many mechanisms
for doing this.
We should also use the Federal EHR certification program to
create the capacity for EHRs to receive consumer-generated data
and make it easy for providers to analyze it and act on it.
Next, we need to preserve the Meaningful Use patient access
requirement, including the requirement that a small percentage
of patients use their online access at least once. We can argue
over the exact percentage, but the fact remains that CMS's
proposal to drop this threshold to just a single patient will
completely undermine efforts to make consumer access to
healthcare data the norm.
Finally, we do need advancements in consumer privacy.
Consumers don't realize that once they download their data from
a provider into an app, most often, HIPAA no longer protects
them.
We need to do three things in the short term. One is to
encourage HHS to finalize best practice guidance for app
developers on privacy and security. The Federal Trade
Commission can enforce voluntary best practices for those who
adopt them.
Second, we need to incentivize more app developers to use
ONC's model PHR notice for consumers. That's a Personal Health
Record notice, and it enables quick and easy comparison of
otherwise complex privacy policies.
Finally, we should shorten the timeframe for meeting
medical records requests under HIPAA to less than 30 days. When
the data is digitally available, the law should not give us a
basis for delay.
The challenge before us is simple and straightforward, and
success, I believe, is within reach. The steps I outlined will
move us toward the day when consumers no longer have to use the
sneaker net, where we walk our medical records around from
doctor to doctor, and instead leverage the internet to drive
quality, value, and patient-centered care.
Thank you.
[The prepared statement of Ms. Bechtel follows:]
Prepared Statement of Christine Bechtel, M.A.
Our health care system is struggling to foster the kind of exchange
that will truly drive better care and spending. But consumers can be a
force for change. Namely--if consumers could leverage their legal
rights and gather data electronically from all of the health care
entities that hold it, then use a safe and secure app to store it, it
would enable us to share that data with health care providers and give
them a much better view of health and care. Yet my own personal
experience does not bear this out. My simple medical records request
required multiple trips to the doctor, several aggravating phone calls,
legal and technical knowledge, and persistence. Most consumers won't
have the resources to persist and succeed. My case is not unique; it
illustrates the challenges of our current system.
There are a range of actions we can take over the next 24 months to
achieve change. A little nudge from Congress can help:
Better educate consumers about their legal rights and
about the use of patient portals for downloading and using health data.
HHS has many mechanisms for doing so, including the Office of Civil
Rights (OCR).
Develop and disseminate tools to help consumers understand
how/where/what and what format to request, what to do with the data,
where to securely store it, and how to navigate roadblocks along the
way. Make the data request process frictionless for consumers.
Work through HHS to educate providers about how to meet
the demand for digital health information.
Use the Federal EHR certification program to create the
capacity for EHRs to incorporate consumer-generated data and make it
easy for providers to analyze and act on.
Finalize the proposal to include open Application
Programming Interfaces (APIs) in the Federal EHR Certification program.
APIs will help break down information silos in health care.
Preserve the Meaningful Use view/download/transmit
requirement: both the requirement that the technology is in place, and
the requirement that a percentage of patients use it at least one time
during the reporting period. Regardless of whether the number is 5
percent or something else, CMS's recent proposal to drop this threshold
to just a single patient will completely undermine efforts by consumers
who want to have and use their data. Requiring providers to actively
engage with a percentage of patients is an essential mechanism for
changing consumer expectations and enabling consumers as a force for
change.
Privacy protection--consumers want and support greater
online access, and consumers also care about privacy. We must encourage
ONC, FTC and OCR to finalize best practice guidance on protecting
privacy and security for app developers (most of whom are not covered
by HIPAA). The FTC can enforce voluntary best practices for those who
adopt them.
Incentivize more app developers to use ONC's model PHR
notice for consumers. It enables consumers to quickly and easily
compare privacy policies across apps, including whether or not the
developer sells consumer data for marketing or to employers and/or
insurance companies.
Shorten the timeframe for meeting records requests under
HIPAA from 30 days. Patients should have the data as soon as doctors
do, and where digital records make that possible, the law should not
provide a basis for delay.
Require providers to offer an ongoing data feed so
patients don't have to submit requests again and again. There are
technical standards that already enable this.
Establish that it is willful neglect to deny a patient
access (or even claim HIPAA precludes it), unless the provider in good
faith is relying on one of HIPAA's exemptions.
______
Good morning Mr. Chairman, Ranking Member Murray and distinguished
committee members. I'm delighted to be with you today to talk about
driving progress toward quality and value through health information
exchange.
The notion of ``health information exchange'' has been around for
decades, and we have tried many approaches. Yet our health care system
is struggling to foster the kind of exchange that will truly drive
better care and smarter spending. Entrenched payment policies that do
not reward better health outcomes or coordinated care continue to hold
us back. We are making progress, but many health care organizations
today still treat health data as a close-hold business asset, when it
should be treated as a public good.
I'm here to talk about how consumers can be a force for change.
We know that consumers want health information technology (IT).
According to a nationwide survey released by the National Partnership
in December, patients overwhelmingly believe that electronic health
records (EHRs) are essential to making sure providers have timely
access to information that can help avoid medical errors and repeat
tests.\1\ Consumers also want and use online access to their own health
information, largely through patient portals. Almost 9 in 10 patients
who have such access use it, and it has a significantly positive impact
on patient engagement, better care and improved outcomes. Notably,
individuals who use patient portals with some frequency are
dramatically more likely to say it motivates them to improve their
health.
---------------------------------------------------------------------------
\1\ Engaging Patients and Families: How Consumers Value and Use
Health IT. National Partnership for Women & Families, December 2014.
www.nationalpartnership.org/patientsspeak.
---------------------------------------------------------------------------
We also know that the role of consumers in health care is changing
rapidly, facilitated in part by these emerging technologies, along with
evolving economic incentives and rising consumer expectations.
These forces are converging, positioning consumers as a potentially
potent force for change that can dramatically reshape the way we share
and use information in health care--if we can make the process of
downloading, managing and sharing health information easy, private and
secure.
What does it take to unleash this consumer potential? Let's look at
how our system works today. In my case, I have a primary care physician
(PCP) who uses an EHR. I also have a high-deductible health plan, which
means that I often seek out care from places that have published price
lists and are convenient--like a web-based service that, earlier this
year, allowed me to ``see'' a doctor online on a Sunday morning for
just $49. As a result, health care data about me exists in several
different places--with my doctors, my health insurer, MinuteClinic, my
web-based doctor service, and more. This is not usual for most
Americans--all of us have data spread across a patchwork of providers
and systems.
Few if any of these systems talk to each other, which means that no
single provider can see a complete picture of my care. So how can I,
and the millions of consumers like me, become a force for change that
drives health information exchange in the marketplace?
If I could gather my data electronically from all of the health
care entities that hold it, and use a safe and secure app to store it,
then I could share it with any one of my health care providers, giving
them a much better view of my health and my care.
The fact is, as the patient, I am the only one present at all of my
health care encounters--so I can potentially amass more data, more
quickly and more comprehensively than any single health care entity can
today, because I know where it all is. And, in theory, I know how to
get it. If I have the data, I can spot errors, avoid repeat tests,
detect fraud, help facilitate coordinated care, and much more. I can be
the curator of my own health record, sharing it where and when it is
needed to improve my care, and for other important purposes like
research into precision medicine.
We are close to achieving this vision; both the policies and the
technologies exist. But we aren't there yet. I learned this the hard
way when I requested my data from my PCP 8 weeks ago. Because the
practice participates in Meaningful Use, I should have been able to
download my data directly from the patient portal. That is due to an
important Federal requirement that stipulates patients must be offered
online access to view, download or transmit their health information to
a third party. Unfortunately, the patient portal was broken and the
practice had no plan to fix it.
I decided on another approach that few consumers--and it turns out,
few providers--know about. Under the HIPAA amendments made by the
HITECH law, I now have a legal right to an electronic copy of my health
information. I can exercise this right with any covered entity that
holds data about me, as long as they can produce the data
electronically. And if they have a Meaningful Use-certified EHR, they
can. So I asked my PCP's office for an electronic copy of my health
record.
After convincing them that I wasn't trying to change doctors and
just wanted my record electronically, they told me they ``don't do
that;'' they only offer paper copies. I told them about my legal right
to an electronic copy since they have a certified EHR, and they again
simply said they don't do that.
I returned a few days later with a copy of the Federal Register,
demonstrating my legal right under HIPAA to an electronic copy. Over
the course the following week, and many phone calls back and forth, the
practice staff figured out how to meet my request. They created a text
file, and a second file in a format called CCR, which stands for
Continuity of Care Record, and placed both files on a CD-ROM that they
left at the front desk for me to pick up.
I quickly learned that having my record on a CD--ROM wasn't very
useful. I could read the text file (once I bought an external CD-ROM
drive), but text files aren't very actionable. So I did what anyone
would when faced with a problem--I downloaded an app. The app used the
CCR file to summarize and display my medical record in an organized way
that I can understand.
This simple medical records request was a big hassle--it caused a
lot of friction even though I was simply requesting information to
which I am legally entitled--information that is an essential part of
my health and care. It required multiple trips to the doctor, several
aggravating phone calls, legal and technical knowledge, and
persistence. Most consumers won't have the resources to persist and
eventually succeed.
My case is not unique, and it illustrates the many challenges of
our current system:
Many providers and their staff members don't know we have
a right to an electronic version of our records.
They don't have workflows to accommodate it--for example,
their medical records request forms don't ask if the patient wants
paper or an electronic copy.
Consumers don't know about this right. And if we do, we
don't know the best ways to ask for the data--that we should avoid PDFs
in favor of structured data, and what our options are to get structured
data. Many also don't know about their ability to download data via
their portals.
Most of us don't know what to do with the data once we get
it. Which app should we use? What are that app's policies and practices
on privacy and security? We also don't know that once we download data
from my doctor, hospital or other covered entity, and upload it into an
app like a Personal Health Record (PHR), that data is no longer covered
by HIPAA unless the app developer is itself a covered entity. That
means the developer could sell my identifiable health information.
And finally, to drive heath information exchange, EHRs
need to be capable of ingesting data from consumers, and making it
actionable.
These are challenges, to be sure, but they can be addressed in the
very near term. And if we overcome them, the potential of consumers to
unravel the knot that binds our health data in silos is enormous. If
consumers can make a concentrated tug on the rope and demand their
data, starting right now, it can enable systemic change.
To do that, we need to take the friction out of the process for
consumers. There are a range of actions we can take in three broad
areas over the next 24 months to achieve change. The good news is that
none require legislation. They can all be done by administrative
action, by the private sector or with public-private collaboration.
However, a little nudge from Congress can help:
1. Equip consumers with the tools and awareness they need to
exercise their rights to their digital health data.
Better educate consumers about their legal rights, and
about the use of patient portals for downloading and using health data.
The U.S. Department of Health and Human Services (HHS) has many
mechanisms for doing so, one of which is the Office of Civil Rights
(OCR). OCR has a Web page to help consumers understand and exercise
their privacy rights. Content should be updated to emphasize electronic
requests over paper-based ones.
Develop and disseminate tools to help consumers understand
how/where/what and what format to request, what to do with the data,
where to securely store it, and how to navigate roadblocks along the
way.
Make the process of requesting data easier. How can we
automate it? A small group of leading experts, consumer advocates and
former policymakers are catalyzing action in this area right now.
Developers are working on tools such as the Vocatus tool, which enables
consumers to request their health data online. Others are working to
fix problems with patient portal download features.
2. Give providers the tools and incentives to make consumer use of
digital data the norm in health care.
Work through HHS to educate providers about how to meet
the demand for digital health information--through patient portals and
through other means of downloading data such as Blue Button (which
Medicare and the Veterans Administration already use), or the Direct
protocol--a secure email link between patients and providers.
Use the Federal EHR certification program to create the
capacity for EHRs to incorporate consumer-generated data and make it
easy for providers to analyze and act on.
3. Advance Federal policies that enable consumers to routinely
request, download and use their own health data in private, secure and
valuable ways. Focus on two areas.
1. First, support policies that drive more information sharing by:
Finalizing the proposal to include open Application
Programming Interfaces (APIs) in the Federal EHR Certification
program. APIs will help break down information silos in health
care.
Preserving and strengthening the Meaningful Use view/
download/transmit requirement, most commonly met by offering
patient portals which deliver functions patients want like
secure messaging with their providers, online medication
refills and data downloads. We must preserve both the
requirement that the technology is in place, and the
requirement that a percentage of patients use it at least one
time during the reporting period. Regardless of whether the
number is 5 percent or something else, CMS's recent proposal to
drop this threshold to just a single patient will completely
undermine efforts by consumers who want to have and use their
data. Requiring providers to actively engage with a percentage
of patients is an essential mechanism for changing consumer
expectations and enabling consumers as a force for change.
2. Second, privacy protection--there is no question consumers want
and support greater online access to their own health information.
Consumers also care about privacy. Now that health data is increasingly
accessible in digital form, an app market is rapidly emerging, bringing
with it both benefits and risks. We need to enable the market and
protect consumers who are using apps to manage their data.
To do so, we should:
Encourage the Office of the National Coordinator
(ONC), the Federal Trade Commission (FTC) and OCR to finalize
and widely disseminate best practice guidance on protecting
privacy and security for app developers. Under its existing
authority, the FTC can enforce voluntary best practices for
those who adopt them.
Ask the public and private sectors to come together
and explore how to evaluate apps on a range of aspects,
including privacy, security and usability. My own research into
the privacy policies and data sharing practices of the apps I
considered for my record required hours of reading and the
ability to decipher a lot of legalese. We should incentivize
more app developers to use ONC's model PHR notice for
consumers. It enables consumers to quickly and easily compare
privacy policies across apps, including whether or not the
developer sells consumer data for marketing or to employers
and/or insurance companies. But it should be promoted much more
aggressively by the Federal Government.
Shorten the timeframe for meeting records requests
under HIPAA from 30 days. Patients should have the data as soon
as doctors do, and where digital records make that possible,
the law should not provide a basis for delay.
Require providers to offer an ongoing data feed, at
least where it is feasible, so patients don't have to submit
requests again and again. There are technical standards that
already enable this.
Establish that it is willful neglect to deny a
patient access (or even claim HIPAA precludes it), unless the
provider in good faith is relying on one of HIPAA's exemptions.
If all that sounds technical, the challenge before us really is
quite simple and straightforward. More than that, success is within
reach. By taking some of the steps I have outlined, we can make it
possible for consumers to finally stop being the ``sneaker net''--
patients who have to walk our records around to different doctors--and
start leveraging the Internet to drive quality, value and patient-
centered care.
The Chairman. Thank you, Ms. Bechtel.
Mr. Patterson.
STATEMENT OF NEAL L. PATTERSON, MBA, COFOUNDER, CHAIRMAN, CHIEF
EXECUTIVE OFFICER, CERNER CORPORATION, KANSAS CITY, MO
Mr. Patterson. Thank you, Senator Alexander and Senator
Murray. This is a privilege and a pleasure, and I was told
yesterday it would be fun to testify. This is my first.
Just to give you a quick thumbnail of Cerner, there's about
21,000 Cerner associates around the world. I had the privilege
of being the co-founder of it in 1979. The first thing I want
to do is thank you for the opportunity to be born in such a
great country that a poor farm boy from Oklahoma that went to a
land-grant college actually could go and create something that
is significant.
It was pure fortune that I found the intersection of
healthcare and IT. That is the world I live in. I wake up every
morning and I go to sleep thinking about that. I think it is
the most--I think information technology is the greatest lever
we have to change our healthcare system. I also have the
privilege of basically agreeing almost wholeheartedly with
everything that has been said here today.
My lift is relatively small. My biggest challenge as an
entrepreneur is to talk within 5 minutes, and the clock is
running.
We have a huge opportunity. We've invested as a country to
digitize the entire content of the most important and largest
sector of our economy. That's healthcare. Information
technology is the biggest lever to create change.
We are, I believe, at the dawn of a new era, and I think
there is huge opportunity for it to be a golden era. There are
significant things, though, in front of us that are barriers to
realizing all of those benefits, and the fact that you are
having these hearings, the fact that you are as informed as you
are about the issues, I think is a very, very good deal.
One thing that we say at Cerner about healthcare is that
healthcare is too important not to change, and also healthcare
ultimately becomes personal. My wife has stage 4 cancer since
2007. I have my version. My version of this with Jeanne are
bags and bags, and you continuously update these. You do go to
see doctors that are outside of the organization, and you need
all that information in those bags.
I think it is a crime. I think that--I shouldn't say crime
here. I think it is a failure of all of us to have in 2015 the
fact that Jeanne carries bags to her doctors' appointments
where she's going to see a new doctor or a specialist if she
wants specific opinions. We have to fix that.
Interoperability is high on my list, both professionally
and personally, to fix. From the role, I guess--what's your
role as government in interoperability? I hold up this card.
This is my ATM card. I'm old enough to basically remember when
that was issued by my bank, and I had to use the bank's
machine.
I'm old enough to remember that I was so excited when I
could go to other banks in other cities. As long as I had a
network--my card had the network that was on the machine--I
could get money out of it, and today, we go--my youngest son
just flew last night to Sri Lanka, and he will get currency out
of an ATM machine there.
We, as an industry, are behind around access to
information, enabling the person, the patient, to have that. I
believe industry should solve that. I think all of my
associates up here believe that, too. It takes, frankly, my
part of the industry to solve that, and we have to work
together to do that.
That has not happened to date. I'm moderately optimistic it
will happen. I commit--I will do everything I can to make that
happen so that we collaborate as an industry, and our networks
that we build as companies, where we have our clients
connected--that those private networks connect, and it will
work like the ATM, I hope, by the end of this decade, so that
you can expect to go to any physician anywhere in the country,
and they can push one button and the relevant part of your
lifetime record would appear on that screen.
I think what you--one other quick thought on your role.
Make sure when you do regulations and you do legislation that
you put rounded edges on it. One of the issues with Meaningful
Use is it was defined specifically, and physicians felt like
they had to follow the specifics every time for every patient,
and, in reality, that was not--and they felt like they had to
do it, and their assistants could not do it.
We need thoughtful regulations coming from here. Thank you
very much.
[The prepared statement of Mr. Patterson follows:]
Prepared Statement of Neal L. Patterson, MBA
Dear Chairman Alexander, Senator Murray, and members of the HELP
Committee, thank you for inviting me to share my ideas about how to
improve health information exchange for the benefit of every American.
I appreciate your openness to ideas and action from the private sector
as well as administrative and legislative change.
My name is Neal Patterson. I am co-founder, chairman and CEO of
Cerner. We are a leading health information technology company with a
projected $4.7 billion in revenues in 2015. We will spend more than
$650 million on research and development in 2015. We employ 21,000
associates who operate in more than 30 countries worldwide.
The intersection of health care and IT is one of the most important
in modern society. Every citizen touches and depends on both.
I appreciate the opportunity to share Cerner's perspective on what
can be done to create a more interoperable health system. We believe
that every individual has a right to access their complete health
record, regardless of where it's located or what system contains the
data. It is immoral for any organization to block the flow of
information that could help individuals--and their providers--make
better-informed decisions about their care.
In other industries beyond health care, from retail and
entertainment to banking to manufacturing and distribution, information
technology has wrought massive change and materially improved our
lives. It is not simply the efficiencies of IT. When things are
digitized, they change.
Digitizing content drives transformation. Digital music recording
paved the way for file sharing and iPods to change our music
collections. The movement of news online changed how quickly we receive
the news. ATM cards changed how we bank. Social media has enabled
political mobilization against dictatorships. The second-order effects
of content digitization are profound.
You don't always see these effects coming. They happen when data
liquidity allows innovators to use information in new ways.
In health care, HITECH and Meaningful Use are not perfect, but they
are helping move health care onto a digital platform. As a society, we
may be closer than we think to a golden era when science, intelligence
and insights from big data can become a natural, unforced part of
health care.
Two qualities are important to enable this type of transformation.
Health IT platforms must be open, and they must be interoperable.
The quality of being open is what allows independent developers to
build ``apps'' and extensions that work with existing health IT
platforms. After years of little movement, our industry is finally
making real progress toward being open to outside development. It will
fuel an entrepreneurial wave of novel health IT apps and services that
will address particular needs of providers and patients.
For all the progress and promise, however, our current efforts are
insufficient if they still serve a bunch of disconnected digital silos.
Current health IT systems lack true interoperability, and the lack of
true interoperability is failing patients. Without it, we risk missing
the moonshot transformation that has positively changed other
industries and lives.
My wife has been fighting breast cancer since 2007. I have her
permission to share her story. She has had procedures in the last 8
years ranging from mastectomy, radiation and chemo to brain surgery and
genome sequencing. Her diagnostic and treatment journey has taken her
to multiple providers, and her records have wound up in more than 20
different health organizations' EHRs. Everyone has a piece of Jeanne's
record, but no one has the whole picture.
Because there is not widespread interoperability, Jeanne carries
printed copies of her records around in shopping bags. Each record she
carries represents a phone call, a wait in a line at a records desk, a
fax or a photocopy. The burden of assembling those records is what she
calls the ``train wreck.''
It's, of course, not just cancer patients who live this reality.
It's almost all people with chronic conditions who have to see
specialists--and people who move--and people who rely on emergency
rooms for their care. In reality, everyone in the chamber today has
experienced this issue. In the United States, the average person has
seen 18 different doctors. If you're over 65, the number increases to
28.\1\ It doesn't matter if the records are across the country or
across the street. If the systems are not interoperable, the result is
the same.
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\1\ Practice Fusion survey conducted by GfK Roper, 2010.
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Here is my litmus test and vision for real, patient-centered, true
interoperability. It is when you as a patient can go to a new doctor
who hasn't seen you, sign your name electronically giving your consent,
and then the doctor can click a button in the EHR and compile what is
most relevant from your lifetime record that you want to be shared,
pulling information from many places. We actually are quite close to
being able to realize this vision, and the issues in realizing it are
largely not technical ones.
Over the past decade, there has been some good progress on
interoperability. Standards have progressed that define how and what
information is shared to whom and when. Governance and privacy
standards are also progressing. We are members of Carequality, an
industry coalition focused on governance. I think Congress's recent
focus and sensitivity to the behavior of data blocking (intentional or
inadvertent) is a good thing. There are current efforts to create the
concept of ``semantic interoperability,'' which is extremely powerful
and has the potential to unleash enormous innovation that will interact
with the EHR platforms. But it is my testimony that, while this
progress is good and necessary, it will not realize the vision I shared
above. I want Jeanne's doctors to have access to her full lifetime
record. That vision requires a system for national patient
identification, for record location tracking and for patient-driven
consent.
There is a tendency to use isolated interoperability success
stories as the poster children for progress and defense of the status
quo. Some regard largely single-vendor networks or ``intra''-
operability as equivalent to interoperability. It's a form of progress,
but it's not the same, because your records and Jeanne's records are
not all on one vendor's system. They're spread out across every vendor
in the industry. It's just not enough. If we remain satisfied with this
progress, patients could wait decades to see real interoperability. It
will leave too many patients carrying too many bags for too long.
As a health IT industry, the electronic health record community has
grown up alongside each other--Meditech, Cerner, Epic, McKesson,
Allscripts and many others. We were out conquering the map. Each of us
has had our own version of building our core capabilities. Competition
has been healthy, and it has driven a lot of innovation. But too often
these competitive instincts led to technological silos.
Outside of health care, there are plenty of examples where
competing business interests, spurred by consumer pressure, came
together to solve interoperability problems. Apple and Android phones
can talk nationwide. The Verizon network connects with the Sprint
Network. My Microsoft Outlook email communicates seamlessly to Google
Gmail. My ATM card works at nearly every machine worldwide. Government
may have helped, but industry played the biggest role.
In 2013, in an effort to augment the standards and governance work
playing out in Washington, our industry sought to take on a set of big
issues that are impeding true interoperability and data liquidity.
Along with some other vendors, we created a non-profit called
CommonWell with an eye toward addressing three barrier issues to true
patient-centered interoperability: patient identification, record
location and patient-driven consent. CommonWell invited all electronic
health record vendors to come together.
To solve for the needs of patients, we wanted an approach that was
national in scale. The service it offered had to be available at a very
low, utility-like cost to providers. And it goes without saying that it
had to safeguard privacy and the trust of individuals and providers.
Achieving this level of interoperability in health care requires a
virtuous cycle of product innovation and standards development and
evolution. It also requires all the players in the industry to agree
that patient-centered interoperability needs shared networks between
vendors, not just a trickle of individually negotiated connections.
Waiting around to fulfill the next request to connect two hospitals to
each other or to a local HIE meets the letter of the law. But getting
to full interoperability requires active cooperation among all the
vendors, and their acceptance that once technological silos are
eliminated, they will have to compete on innovation, quality and cost.
We do not have this yet in health IT, but this kind of dialog at the
national level has a chance of creating real change.
What we do have is CommonWell, a non-profit vendor-to-vendor
network, national in approach, which providers and hospitals can access
on behalf of individual patients. It is open to the entire industry,
and its members include Allscripts, Athenahealth, Brightree, Cerner,
Evident (formerly CPSI), Greenway, McKesson, Medhost, Meditech, Merge
Healthcare, Sunquest, and other companies--which includes every major
acute care EHR company in the industry with the exception of one.
Cerner is committed to any effort to advance true interoperability, and
the CommonWell network is in my opinion our industry's best cooperative
effort so far. I have made it clear that if someone establishes another
open network that has a reliable method of patient identity management,
record location tracking and patient-driven consent, it will also have
my support and participation.
As for Washington's role, it must be clear to all that the policy
of this country is true interoperability. The Office of the National
Coordinator (ONC) must continue pressing its framework for
interoperability, convening, facilitating and evolving important
standards work. Vendors and providers must enable sufficient
transparency around data sharing to allow keeping a watchful eye on
behaviors in our industry. Congress should not be afraid to act.
Whether intentional or unintentional, behaviors that restrict patient
choice, throw up roadblocks to true interoperability, or use control
over data to further market share should be challenged. None of us have
a perfect record, and we can all do better.
The subject of interoperability can quickly become blurred into an
alphabet soup of acronyms, nomenclature, standards, governance and use
cases--so much so that we lose the point. In the end, you will know it
when you see it. It's when you can go to your doctor and they can push
a button and assemble the relevant parts of your lifetime record that
you want to be shared with your doctor.
We all can cite how the rising cost of health care is consuming
more of our resources as a family, community and country. I am
convinced that information technology is the single greatest lever for
creating value in health care by eliminating waste, variance, error,
delay and friction. It can put a system into health care.
We have a chance to deliver a golden era of health care. It's a
system where consumers not only have a right to their data, but also
have the ability and the financial incentives to mobilize it in pursuit
of better health.
We have a chance to make Jeanne's shopping bags a thing of the
past.
I look forward to working with the industry, as well as members of
the committee, to advance that vision.
The Chairman. Thank you, Mr. Patterson, and thanks to all
the witnesses. We'll now begin a round of questions. I'll call
on the Senators in the order they were here at 10 a.m. Senator
Murray after me, and then Senator Burr, Senator Warren, Scott,
Casey, Cassidy, Bennet, Franken is the order that I have.
Dr. Payne, in March, the department released proposed rules
for Stage 3 of Meaningful Use and the 2015 edition of the
Certification Program for Electronic Health Record Technology.
The comment period ended in May, and we expect the
Administration to release the final rules this fall. Meaningful
Use 3 will go into effect in 2018. Parts of 2015 certification
could go into effect later this year.
A hospital that should know what it's doing has told me
it's terrified by Meaningful Use 3. Do you think that it would
be a good idea to delay some or all of these proposed rules
until Congress and the Administration have a chance to work on
the five or six things that seem to be the biggest impediments
to making our electronic healthcare records something people
look forward to instead of dreading?
Dr. Payne. Thank you for the question. The answer is yes.
We think Stage 3 needs some improvements. There are many
elements to it. A good example of an improvement would be that
it tests whether a vendor conforms to a standard, but it
doesn't test whether the vendor systems are truly
interoperable.
We should be sure that the record can be sent and that it
can be received and used. The certification program also needs
to be improved so it can make certain that both the sending and
receiving is possible. Some of the standards in it are in a
draft state.
The Chairman. My question is do you think it should be
delayed or not, in part or in whole?
Dr. Payne. We think it should be delayed until it's
improved.
The Chairman. Mr. Patterson, in your comments earlier, you
seem to think that physicians are being asked to do some
things, or they think they're being asked to do some things
that's not necessary for them to do. Senator Cassidy is going
to chair a special hearing on physician documentation.
As I understand your position, you feel that physicians--
there is some documentation that physicians certainly should
do. There are other things that an aid could do. To some
extent, the billing system has gotten mixed up with the
electronic healthcare records and made it even more onerous on
physicians. Is that a fair summary?
Mr. Patterson. I would agree with your summary.
The Chairman. Would you be able to suggest to us or perhaps
to Senator Cassidy's work the specific things that you think
doctors should do and other things that others shouldn't do--or
aren't necessary for them to do, and how we might change the
regulations or the law to make that clear?
Mr. Patterson. Yes. We certainly can provide some followup
to that in writing.
To give you an example, meds reconciliation, I think, as
written and the intent of the regulation is that the physician
is to do the meds reconciliation. I think that's appropriate in
many cases, but that was--but I think in many cases, that
function could be done by a nurse or an aid to the physician
under their supervision. They review the work and basically
accept it. That's the, if you will, rounded corners, rounded
edges on the regulation.
The physician's time is one of and if not the most critical
resource inside of the healthcare system, and then the person
they're serving--the patient's time is the other part of that.
We need to preserve the physician's time with the patient, and
I think, current state, we have impacted that amount of time
that they can spend negatively.
The Chairman. Mr. Richardville, all of you have mentioned
the importance of having agreed upon standards by the various
participants in healthcare, and it's critical to enabling real
interoperability, the kind of ATM card that Mr. Patterson
talked about. To what extent would you propose that the Federal
Government get involved in mandating or otherwise requiring
health information technology standards to be adopted?
Mr. Richardville. A couple of points, and thank you for the
question. There are current initiatives out there today that
help promote--that are trying to promote some of this
interoperability--Carequality, CommonWell, Epic Care
Everywhere, Argonaut--and there are successful----
The Chairman. My question is on standards. To what extent
should the Federal Government get involved?
Mr. Richardville. Well, I think what the Federal Government
needs to do is to come in from a governance perspective and
help define what those rules of the road are so that these
organizations can all abide by those rules. I think, as Senator
Murray talked about, that the ability for the network of
networks, which is similar to Neal's point, like the Cirrus
network that connects the ATMs, would be a viable opportunity
for the healthcare industry.
If those rules are set up----
The Chairman. Do you want the Federal Government figuring
out the standards?
Mr. Richardville. No.
The Chairman. Or do you want it encouraging the development
of standards developed by private industry?
Mr. Richardville. Encouraging the development of--I think
it's a multidisciplinary team of payers, patients, vendor
partners, and providers that should get together and develop
what those standards are. We do need regulation to help define
what the timelines are, the aspects of defining what those
rules of the road are that we all need to play into so we can
participate in a very multidisciplinary approach and allow that
network of networks to develop.
The Chairman. Thank you.
Senator Murray.
Senator Murray. Thank you. Our hearing today is focused on
health IT because of its potential to improve the quality and
value of healthcare for our patients. Health IT can support
research that unlocks innovative new treatments. It can support
better coordinated care at critical times like when a patient
is being discharged from a hospital. To achieve any of those
objectives, patients themselves need to be engaged in this
work.
Ms. Bechtel, I want to ask you: How does health IT enable
better partnerships between patients and families and their
doctors?
Ms. Bechtel. Health IT does quite a lot to enable those
partnerships. It lends a lot of transparency, so I can see
what's in my medical record. I can correct errors. I can add to
it and complete information. It also helps me engage more in
not just managing my care, but in managing my own health.
There's a lot of data that shows us the many ways, from reading
my physician's notes to looking at lab results, that health IT
really supports and enables that.
I think the one thing that is essential to also think
about--and this is going to point back to Senator Alexander's
question about delaying Stage 3. There are aspects of patient
engagement that we would give up if we delayed Stage 3
wholesale. I just want to note that we would also, ironically,
give up requiring a greater percentage of doctors to share
information electronically, not just with patients but with
other doctors.
We would also lose a technical fix that would help us to
unlock the data that is currently siloed in patient portals.
It's called an API, an application programing interface, where
we would be able to download that. We would give up some gains
on patient-generated health data.
I just want to recognize that wholesale delay of Meaningful
Use Stage 3 should be very thoughtfully considered in light of
the items that we would impact, give up, that I know we all
support.
Senator Murray. OK. Great.
Dr. Payne, in your testimony, you talked about enabling
patients to receive an electronic copy of their entire medical
record, that that would have the most genuine and lasting
impact on smoothing the flow of electronic health information.
I'm really proud that in our home State of Washington,
including the University of Washington, we are pioneering the
Open Notes Project, which is working to give patients access to
the visit notes written by the doctors and nurses that Ms.
Bechtel just talked about.
Talk a little bit about how enabling patients to access and
download their entire electronic record would improve the flow
of information.
Dr. Payne. Well, just as the Open Notes Project makes
sense, we think that providing access to the entire record also
makes sense, and it's the right thing to do. The notes are very
important, but elsewhere in the record are also pieces of
information that are very important and that are still today
very difficult for people to access.
If we set the standard that the record that is truly the
right of the person to see is available to them, they will have
other benefits beyond just reading the notes. We think there
will be innovation that will be based on having access to the
entire record that we don't see today. We think it is the
logical next step, now that we have a good deal of the Nation's
health record in electronic form, that the person who owns it
has a right to see it.
Senator Murray. Well, in order to make sure that patients
and clinicians have better access to electronic health
information, we need to make sure that no one is deliberately
blocking it.
Mr. Patterson, I'm glad that in your written testimony you
agree. We need to prohibit data blocking. HHS tells us that it
can be difficult to distinguish between contract terms and
pricing policies that are normal business practices and those
that are designed to deliberately block information.
In your view, can you share with us how vendors and
providers deliberately block data?
Mr. Patterson. The word, deliberate, is a bit caustic from
the way I think it actually happens today. I think their
historic practice is we're not to share data. I think business
strategies get in the way, and business models get in the way,
saying, ``I'm better off if I don't share it.''
In my written testimony, I frankly, if it's you or your
loved ones, and that information is vital, I consider it
immoral for people to block that data and force us to carry it
in bags. I think we're just crossing over into a new era. I
think, as I said earlier in my oral comments, your asking that
question, is extraordinarily powerful, and I think you should
continue to talk about it.
We individuals, the citizens, the people who are served by
the health system--those are our records, and I think you
should pass a law that says we should have a copyright to
that--we should have a legal standing in that information,
because too many times, healthcare thinks it's theirs. They
should have a copy, too. They produced it. It's a part of
their--they have all kinds of reasons for that record.
But when it's digital, I can have my copy, too. I think it
happens. It happens from a historical practice point of view.
We need to change those practices or we're never going to get
rid of the bags.
Senator Murray. Thank you very much.
Thank you, Mr. Chairman.
The Chairman. I should repeat that one of our next hearings
this summer is on precisely the subject of who controls my data
and how do I get hold of it. Senator Collins is going to chair
that hearing for the committee.
Senator Burr.
Senator Burr. Mr. Richardville, why is this so hard?
Mr. Richardville. Great question. There are actually
multiple factors that makes interoperability difficult. First
and foremost, it's technically complex. You have a varied
amount of different systems that have different rules of the
road that they're participating in, and we're expected to try
to connect that information that they're producing together.
Second, in terms of prioritization, when you look at the
incentives, especially those that came out through Meaningful
Use, a lot of the investments that healthcare providers had to
make--it was not one of the top incentives. When you have
limited resources, looking to try to achieve things that you
need to have done--those are things that kind of fall a little
bit more down to the bottom of the list.
Senator Burr. What's your definition of interoperability,
and is your definition different than anybody else on this
panel?
Mr. Richardville. I hope it's not different. My definition
of interoperability is the open, free exchange of secured data
between providers and patients, utilizing health information
technology systems as the road to provide that kind of
activity.
Senator Burr. Let me throw it out to any of you. Why would
a provider not want to make a patient's information available
to a patient?
Ms. Bechtel. Well, I can tell you that when I asked for my
health record electronically, I first had to convince them that
I wasn't trying to leave the practice. They have real endowed
business reasons, because of the way we pay for healthcare in a
fee-for-service environment, to try to hold my data as a
business asset so it's not as easy for me to actually go get an
office visit somewhere else.
From a consumer perspective, it makes it much more
challenging for me. Yet every piece of data says that if you
give me my data, and you give me access to it, it actually
increases my loyalty to the practice. Other folks may have
comments.
Mr. Richardville. You know, at Carolinas HealthCare System,
our motto is patient first always. For us to engage and involve
the patient in everything that we do is part of how we are able
to move forward and progress.
The only thing that I would say in addition to what Ms.
Bechtel has said is that sometimes some of the language and
some of the data structures that are put in place may be
difficult for a patient or a consumer to digest without some
easier way to translate that into meaningful pieces that they
can then absorb.
Senator Burr. Dr. Payne.
Dr. Payne. One friendly amendment to Craig's definition--I
would add that interoperability includes the ability to use the
information when it is exchanged. There are many ways to
exchange information, some of which leave it dormant. If we
make the exchange occur in a way that it's useful for its
intended use, that's an important element of interoperability.
Senator Burr. Mr. Patterson.
Mr. Patterson. To have true interoperability nationally or
get close to the ATM card functionality, there's really three
things that have to be in place. One is there has to be an
identification. When you're going to send Neal Patterson's
record from physician to physician, provider to provider, there
has to be an identifier of Neal. We do not have a national
identification system in this country. It's a subject that's
been discussed a lot, and it's one that's basically been
tabled.
In today's world, we can solve that as an industry without
you doing anything. But it has prohibited, because to curate
who I am on the other receiving side is a lot of work. We lack
a functionality around identification.
We lack a functionality--there's no place that knows where
my records are, other than me, and, frankly, that's--you know,
Jeanne has been to 35 different places. I can figure it out,
but it's a--so we don't have a system that says where my
records are.
And third, we really need a consent--everybody is very
afraid--providers are very cautious of letting records out
because HIPAA has some very stringent penalties in there around
sharing information, patient information. We need a consent
system.
Senator Burr. It's a shared feeling. We're scared about
opening up HIPAA to try to tweak it, because it may become more
cumbersome and more onerous.
Let me just say this to all of you. If you will think
about, when you leave here, anything else that we might need to
look at from a provider's standpoint that's a disincentive to
sharing information, so that we know what we're up against as
we begin to look at legislation, as regulators begin to look at
regulations, I think therein holds the key.
If we're just down to an economic decision, Ms. Bechtel, I
think we can find a trigger for that.
I've got to believe that there's more than that, and I
think it revolves around interoperability in some way, shape,
or form. It may be what they chose to put their electronic
medical records in and their inability to merge that into
something else.
I think that we're going to find things that are out there
that maybe, by themselves, you wouldn't look at and say,
``Here's the problem,'' but, collectively, they probably
contribute greatly to this inability.
I thank the chair.
The Chairman. Thank you, Senator Burr.
Senator Warren.
Statement of Senator Warren
Senator Warren. Thank you, Mr. Chairman. So far, the
Federal Government has invested $30 billion in electronic
health records, in part because sharing health information
between doctors can improve patient care. It's still the case
that the health record systems can't always match a particular
scan or test result to the right person, and mismatches can be
very dangerous. As more patient information is stored
electronically and as doctors exchange more health records with
other doctors, the risk of mismatching patient information goes
up.
We've got at least two studies that I know about on this. A
2008 Rand Corporation study estimated that even with database
management software and personnel that were dedicated to
preventing such mistakes, hospitals mismatch patient
information about 8 percent of the time. A 2012 study conducted
by the Council of Health Information Management Executives
found that one in five physicians encountered mismatched
information that put a patient at risk during the previous
years.
I would like to start--Mr. Richardville, can you explain to
us what tools Carolinas HealthCare used to solve this problem?
Mr. Richardville. Yes. CHS on many pieces are on the
forefront of innovation. What we looked at several years ago
and was the first, actually, to bring into the country was a
biometric palm vein scanning system. It actually scans the
veins in the palm. It's not a palm print, but it's the veins,
like a snowflake, in the palm. We have that at all of our
locations. We've had that for many years.
Since then, when you quantify like the 8 percent, our
medical record number duplicator error rate is .11, which is 80
times better than the average that you talked about. At least
within our system, we've been able to mitigate that issue.
As we try to match across the systems, I'm not saying that
that is the answer for others. I think there's probably other
successes in the country, and we need to put those heads
together and see if there is a way that we can expand that
across.
Senator Warren. Let me ask the question about, then, among
systems. Mr. Patterson, in your written testimony, you
discussed CommonWell, an alliance of health IT companies that
connects health records that are managed by different vendors.
What has CommonWell done to avoid the mismatches? We've got
between systems here.
Mr. Patterson. Right. In broad terms, CommonWell allows you
to create an account that is used for--and you, as an
individual, create it. You say, ``Here's what consent I give to
share my information, and here is my identification.'' It's
like having your Google email account, and you are controlling
that account as the person.
Senator Warren. This is done patient by patient.
Mr. Patterson. Patient by patient at enrollment. Once you
have that account--obviously, to start your first email
account, there's a process to it. Once you have your
identification, then information can be sent and moved.
CommonWell has solved the identification problem on a voluntary
basis.
Craig's solution is much more precise and elegant, but I do
not think we can implement that nationally. I'm not going to--
you'll have to have a hearing on that. That's much more
precise.
Also CommonWell basically provides the software--we have
near 30 members of CommonWell. All of us as software companies
agree to also--when we record the fact that there is
information about a person under that ID in our records at
these locations. We solve the record location issue.
Senator Warren. Carolinas HealthCare and CommonWell and
others around the country are all working to prevent patient
matching errors within their own systems. There are obviously
limitations on what you can do alone.
Mr. Patterson, I'd like to ask you: What can Congress or
the Office of the National Coordinator of Health IT do to help
scale individual efforts to reduce matching errors and at the
same time to protect patient privacy?
Mr. Patterson. The ability to have an identifier that we
all share would be an enormous help in reducing the risk and
improving the value to patients. If it were possible for it to
be simple to do and accurate, then it would happen more often,
and I think patients would benefit enormously from that.
In the absence of such an identifier, algorithms that help
us do the next best thing, which is to use existing information
to make sure that we know who the person is when the
information is sent or received, would also be very helpful.
Much work has already been conducted in this arena.
It is a complex and very important question, and I'm glad
that you are focusing on it. We also have people who come to us
in our trauma center who are unconscious, unable to tell us who
they are. It is a risk to them and requires enormous effort on
the part of our staff to be sure we know who this is as we
provide care to them in the safest way we can.
Senator Warren. Thank you. You know, accurately matching
health information to the correct patient record is critical
for the safety and the effectiveness of electronic health
records. I look forward to seeing more research in this area. I
hope that industry and government can work together to find a
solution that keeps patients safe and that protects their
private health information.
Thank you very much.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Warren.
Senator Cassidy, I've already noted that you'll be chairing
a hearing for the full committee. I think Senator Whitehouse
may serve as the ranking member for that hearing on physician
documentation. We appreciate your willingness to do that.
Statement of Senator Cassidy
Senator Cassidy. Thank you.
Mr. Patterson, you mentioned in your testimony semantic
interoperability. Is that a challenge? Because it sounds like
once you go through CommonWell, and you have this kind of ID
that I volunteer and it goes to others, that there should be
some sort of way to communicate. How much of an issue is that?
Mr. Patterson. Dr. Payne would be probably the subject
matter expert on it. I'm very impressed--so there is work on
standards to create the next level of interoperability. In my
testimony, I call that semantic interoperability. It's one
thing to move safely information about ourselves. For it to be
consumed by the physician, if we can understand what's in that
record and it can be worked into the----
Senator Cassidy. Simply, as Ms. Bechtel said, not
necessarily as a pdf but rather structured so I can follow
blood pressure over time with some chart relative to medicine.
Mr. Patterson. Right.
Senator Cassidy. That would somehow structure it between
records.
Mr. Patterson. Yes, you've got it near--you are perfect on
that.
Senator Cassidy. Thank you.
Mr. Patterson. And that's a huge deal.
Senator Cassidy. Will you talk to my wife about that and
extrapolate the other things?
[Laughter.]
CommonWell, you mentioned in your testimony that all major
players except one are participating in CommonWell. Who is the
major player not participating in CommonWell?
Mr. Patterson. Epic is not participating in CommonWell.
Senator Cassidy. Senator Murray asked about business
practices, or somehow that developed in the conversation--is it
deliberate or is it business practices. The effect is the same,
that data is not--I feel like Epic is the elephant in the room.
It was implied in your testimony that a business practice
which does not allow sharing somehow furthers their business
model. If you want to share data with another Epic hospital,
you have to have Epic, and they have such a market share that
people will migrate. That's my opinion, but is that a fair
opinion? Is that defensible?
Mr. Patterson. That would be my experience, that they would
use that as a marketing technique.
Senator Cassidy. Again, as Senator Murray----
Mr. Patterson. I might add that I believe--and I hope Epic
will join CommonWell and that we work together as an industry.
The only way this is going to get solved is that we work
together.
Senator Cassidy. I accept that totally. On the other hand,
sometimes we set this up--I say Congress--giving billions of
dollars, and now a major player is not participating in a
common effort to create the sort of structured data that Ms.
Bechtel would find so useful and that you agree would be a nice
way to do it. We need to have them come to say it.
But that is a problem, and I say that as a physician who
shakes my fist at the computer because I can't get the data
that I need as I am seeing a patient. Let me ask, and I'll open
this up. What can we legislate that would--if people don't want
to come forward voluntarily--we can say you've got to--it's
hard to say you have to participate in CommonWell, because
CommonWell may become something different.
Mr. Patterson. Right.
Senator Cassidy. Yet I have a sense that you prefer the
private sector to be the setter of the standards as opposed to
a Federal agency. Really, it may be that we have to have a
Federal agency that says, ``We shall solve these problems by
this deadline or else we shall prescribe.'' Do you have
opinions on that? Is that what's required?
Dr. Payne?
Dr. Payne. I think one move that we as a nation and
Congress could take is to move toward reimbursement for value,
for quality. If that movement accelerates, there will be a big
drive for interoperability.
Senator Cassidy. That just may be a big drive to continue
business practices which say,
``Listen, if you want to play, you've got to play
with me because I'm the big guy on the block, and so,
therefore, I'm the only person that can give you
everything.''
Dr. Payne. I think it would also be a strong incentive for
industry, but also provider organizations, to use standards
that exist now for interoperability. We should do a better job
with interoperability----
Senator Cassidy. I'm not sure you're answering my question.
My question is: Do we have to be more coercive than we are now
in order to crack it open?
Mr. Richardville.
Mr. Richardville. I would say, Senator Cassidy, several
things. One is I do think congressional action is needed so we
can set up what I would call functional standards that we can
all play by. I also think that the measures of the outcomes
that was referred to needs to be part of it. Most importantly,
is the enforcement. Make sure that compliance takes place as we
start doing this.
In addition to what Neal Patterson talked about and with
CommonWell, I do think there are a handful of other integrative
efforts that are going on in play. We at Carolinas HealthCare
System actually--one of the unique systems that we actually
have--Cerner, Epic, McKesson, Allscripts within our system, and
we've built a core competency of interoperability with our
health information exchange to actually change information
within our system with different vendor partners that we work
with.
Senator Cassidy. Does it cost you per transaction, or can
you do that without charge?
Mr. Richardville. It is not per transaction. It's per
member. We pay based upon the number of people who actually
participate in it. For us, as we have more physicians come into
that, we actually pay based upon the people that consume and
participate in our health information----
Senator Cassidy. That's interoperability with a charge.
Mr. Richardville. It's interoperability with a charge based
upon usage.
Senator Cassidy. OK. I yield back. Thank you.
The Chairman. Thanks, Senator Cassidy.
Senator Casey.
Statement of Senator Casey
Senator Casey. Thank you, Mr. Chairman.
I want to thank the panel for your testimony and for
helping us to better understand and, we hope, figure out a
complex problem.
I wanted to start this morning with children. We have over
many years developed programs that enhance children's health
insurance, whether it's in the Children's Health Insurance
Program or Medicaid or otherwise. We often don't ask, I think,
an essential question, which is--just as we do in the context
of protecting the environment, we say, ``What's the
environmental impact of a particular policy?'' or the
environmental impact, more particularly, on a project.
We should ask the same question in the context of children:
What will be the impact on a child or children if we take this
step with regard to healthcare and, in this case, with regard
to healthcare records? I wanted to start in a very particular
way.
Dr. Payne, you've heard child advocates say for a long time
that children are not small adults. We need to make sure that
we have strategies and approaches to children's health
insurance that may not be applicable or transferable from the
strategies for adults.
In particular, I wanted to highlight immunizations, so
critical to pediatric healthcare and also providing a great
public health benefit. Access to immunization records is
necessary to ensure that children receive the recommended
vaccinations at the appropriate time.
What can you tell us in the context of this discussion with
regard to the fundamental question, which is ways that having
electronic health records that are interoperable--how can that
improve access to immunizations?
Dr. Payne. That's a great question and a great example of
the benefit of interoperability. In our report, we addressed
just that issue, that there are a growing number of registries
for children's immunizations, because children, as do adults,
move from city to city, and those registries contain the record
of their immunizations. Most importantly, the record tells us
what they have not received so that we can make sure that they
do receive it.
The challenge here is that the information in those
registries is not flowing seamlessly into the electronic health
records that the pediatrician or family doctor would use to
look to see what's needed next. That's an example of where
improved use of existing standards or refined standards would
help children in a very direct way. This is an important
preventative care measure, and we should make sure we use it
every time it is appropriate for a child's health.
Senator Casey. I want to open it up to the panel, if anyone
else has any comments on this, and I'll have a followup for Dr.
Payne. Anyone on the panel?
Ms. Bechtel. Sure. I think this is a terrific use case for
the kind of consumer demand for their health information that I
was describing earlier. I think as moms and caregivers can
begin to get and request an electronic copy of their health
information from their doctor, they can begin to catalog those
things, and, at least, until we fix the standards and fix the
registries, I can build a comprehensive list of my
immunizations. I can share that with my provider. I can manage
that. I can set alerts when things are due.
It really enables me as a caregiver to have a much more
complete picture of my child's health, including immunizations.
Enabling that kind of consumer demand, that pulling on the rope
right now, would be a really essential strategy to make very
quick progress in the short term.
Senator Casey. I appreciate that.
Mr. Patterson. I might add that immunizations is a very
good example of something where IT creates a lot of value.
Immunizations at birth--you know for the next 7 years when,
approximately, immunizations need to be done. The systems
should know what--not just help document what is happening. It
should know what isn't happening, and it should be able to then
report back to the pediatrician, report to the family that
these events need to happen.
There's just too much reliance on well-intended--and the
systems are increasingly getting smarter--would need to get
smarter. That's a great example of population health.
Senator Casey. I appreciate that. I'm almost out of time.
Maybe for a fuller answer to this question, I'll start with Dr.
Payne--or I should say a fuller answer from everyone. It might
be better just to put it in the record.
I wanted to ask, in the context of transparency, what can
we do more broadly now--not just with regard to children, but
more broadly--to increase transparency as it relates to
electronic health records? If you can give a short answer, and
everyone else can put it in writing if that's all right so I
don't get the chairman upset.
Dr. Payne. I think you can highlight its importance and its
value and encourage other regulatory bodies to embrace it.
Senator Casey. Thanks very much.
The Chairman. Thanks, Senator Casey.
Senator Franken.
Statement of Senator Franken
Senator Franken. Thank you, Mr. Chairman.
I'm co-chair of the bipartisan Senate Rural Health Caucus,
and I've had a lot of roundtables around Minnesota--I think
about 30 between me and my staff having roundtables. At
practically every roundtable, they bring up this issue of
health records, electronic health records. In rural America, we
have a lot of small providers, and one of the issues is the up
front cost.
I guess this is for Mr. Patterson, since you're in this
business. Even those who can afford the initial investment are
often sort of--end up with the most basic out-of-box product
because they don't have the resources or the influence to
demand a custom tailored solution from vendors.
Are there ways that EHR vendors like Cerner can structure
their sales models to help lower or eliminate the up front cost
of implementing a new EHR system?
Mr. Patterson. You're talking to an old farm boy, and rural
health is actually on my, if you will, professional bucket list
to fundamentally make a difference in. We have been very
aggressive in using kind of shared services and shared domains
to create as low price points as we can to get out into
critical access in smaller facilities. It's been, frankly,
fairly successful, both from the client side and from our side.
Yes, they're on very thin budgets, and I started that--they get
advantages of very sophisticated technologies.
My wife's brother, who is still the farmer down there in
Oklahoma, unnecessarily died from sepsis. I went to the local
healthcare community and said that didn't need to happen, and
sepsis is a predictable condition. That community now has an
intelligent set of algorithms looking over the entire community
and identifying the people that look like they're on a path to
become septic, and it has fired over 60 times this year. It
would have saved his life.
They need, really, everything we talk about. You've got to
create business models and get low price points.
Ms. Bechtel. Senator, if I might, I think one of the things
we haven't really addressed--yet it plays a huge role in all of
the challenges that clinicians and other providers are facing--
is the fact that we don't actually pay for and reward the kind
of care that clinicians can deliver when they're enabled by
health IT and by an interoperable system.
Senator Franken. Sure.
Ms. Bechtel. The up front costs would be worth it, as they
were for the banking industry, right? If we were able to start
paying for coordinated care, paying for health outcomes, paying
for better patient experiences, I think it would drive this
discussion in a far different direction. The banks didn't
struggle with standards for 30 and 40 years as we have in
healthcare, right? We didn't actually talk ever about bank IT.
Senator Franken. Well, this is supposed to lead to savings.
This is supposed to lead to coordinated care. This is supposed
to lead to value. I think the next questioner has some thoughts
about that. Senator Whitehouse does.
I want to talk about interoperability. Why, why, why can't
the VA and the Defense Department become interoperable? This is
just a mystery to me. A lot of resources have been spent trying
to do this. Does anybody have any thoughts on that?
Mr. Richardville. Senator, if I could just make a couple of
comments, I do think that the lack of the standards, functional
standards, in place that allows this transport of data back and
forth between systems is difficult. It is expensive. You talked
about the EHR with the rural facilities. We look at
interoperability. It's just as expensive and complex to try to
connect them to other care providers when they do referrals
back to other complex organizations. Until we actually have the
government action in place to help us to have the functional
standards, the measures, and the compliance to take place,
we're going to have this difficulty in this country.
Senator Franken. These are two government entities that are
dealing with the same population. If they can't get it
together, I don't understand how we're supposed to be
optimistic about us setting standards. I'm out of time.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Franken.
Senator Whitehouse.
Statement of Senator Whitehouse
Senator Whitehouse. Thank you, Chairman.
This is such an important issue, and Chairman Alexander and
Ranking Member Murray have embarked on a committee-wide process
to take a look at health information technology and information
exchange. I would invite each of you, in terms of what a law
student would call issue spotting, to feel free to send in to
us the list of issues you think our process should be sure to
be addressing, even if you haven't had the chance to get to it
in this hearing. I know that we would be interested in that.
My particular concern comes from my Rhode Island
experience. Many years ago when I was the attorney general in
Rhode Island, I established an organization called the Rhode
Island Quality Institute, and we embarked on, first, electronic
prescribing and then electronic health records, and now full-on
health information exchange through a nonprofit organization
called CurrentCare which has been very effective in terms of
how broadly it has reached out and connected all the providers,
connected with the Epic system in both of our major hospital
chains. It's been quite good.
Here's my concern. We've spent an enormous amount of money
on Meaningful Use. Most of that has gone to end users,
subsidizing the machinery on the doctors' desks. We kind of
take a bank shot off of that back into the information exchange
piece by defining Meaningful Use in ways that require things to
happen.
For a lot of those providers, the healthcare providers,
they don't really have a big say in whether or not there's a
statewide health information exchange in their State. They just
have to sort of live with the consequences of whatever their
world is.
Rhode Island has worked really hard to get the health
information exchange up and going. I think they've done a
terrific job. I believe that they've won every available grant
every single time that there's been one available. Even with
all of that, they've had such a heavy load to carry. It's like
this little donkey trying so hard at the head of the pack with
all these burdens of solutions that have to be achieved, and
the Federal Government kind of over there in the next field
throwing billions at Meaningful Use and not paying as much
attention as it should to those States and those localities--
it's not always a full State--that are really trying to get the
exchange piece right.
If you're going to have health information exchange, I
think there has to be an exchange. Maybe it can happen in the
cloud. I think it works a lot better if there's actually an
exchange, and I'd love to hear your thoughts on how, as we
reconsider a Meaningful Use 2.0 or try to reboot this issue--
how should we be focusing on exchange?
The easy way to do it is to give money to big systems, and
then they exchange data within the system, and a CEO gives a
rule, and everybody complies. It gets harder when you're doing
it by State, and you've got a whole bunch of people together. I
think that's where we have to end up, is with cross-corporate
exchange, and it seems to me that that is something that needs
direct attention, not just the attention of conditions being
put on Meaningful Use.
If you could take that right down the line, starting with
Dr. Payne, I'd appreciate it.
Dr. Payne. I agree with your premise that we're really
after health information for its being used, and exchange makes
that happen. I think one element that would really help with
exchange would be to include the patient in that so that they
get the entire record, because we will not be able to
anticipate all the uses they might have for that.
I think also that for critically ill patients who need
exchange of information, such exchanges as you described in
your region would be incredibly helpful. There are other
solutions, also. I'll be brief. We have much more information
we can provide because we agree with you that that is really
how we're going to get the best use out of these systems that
we've invested so much in.
Senator Whitehouse. Mr. Richardville.
Mr. Richardville. Yes, thank you. I would make two points.
One is we talked earlier about the patient match or the patient
ID. We have to solve that problem. It's a foundational
component of exchanging information back and forth in between
providers.
And second is how we do it. We have to do it in a very
cost-effective way. Today, it's onerous and it's very
expensive, and many cannot afford to do what some other systems
have been able to do. For me, it would be kind of moving toward
the open API, a more innovative type of technology, to allow
you to freely share information back and forth.
Also, it allows innovation from other companies who
actually have access to that as well, and they can start
generating apps and other things for patients and others, but
it can also consume the data from the different EMRs that we've
all installed and put together. Those would be the two
components.
Senator Whitehouse. Ms. Bechtel.
Ms. Bechtel. I couldn't agree more. Far as I understand it,
ONC has invested about $570 million in State health information
exchanges, so that pales in comparison to the Meaningful Use
price tag. No question about it. They have tested a couple of
different models, one, of course, that looks a lot like--
suspiciously like Rhode Island's.
Also is consumer-mediated exchanges I testified to earlier.
This is certainly an area where I think Congress could help
invest in developing the infrastructure further.
Senator Whitehouse. Mr. Patterson.
Mr. Patterson. Finally, I might be a bit contraire in here,
but I think you all pioneered some real meaningful work in
Rhode Island. You implied, though, in your statements there's
not a fundamental business model for the exchange. It has to
either be financed through grants and/or through the healthcare
providers that are exchanging information.
The people that are actually benefiting from the
information aren't actually funding that. It did not solve all
of the fundamental--so you still are curating an
identification--identification is still an issue, and it's part
of the cost of you running it.
What we're saying is through standards--and then get the
software manufacturers--people who make software and sell into
these marketplaces--and if CommonWell is not the answer, show
it--I think we need a national system, because you've got
boundaries. You've got water on one side but you've got
boundaries on the other side, and people are transient. We need
a national approach to this and one that is sustainable.
Senator Whitehouse. Chairman, thank you for the hearing. I
think this is very helpful and constructive, and we clearly--I
think one thing that the witnesses will all agree on is that we
have work to do.
The Chairman. Well, thank you, Senator Whitehouse. I
mentioned earlier that I thank Senator Cassidy, who I've
asked--and you, who Senator Murray has asked, who will chair a
hearing on physician documentation later, and that will be an
important part of what we do.
Senator Murray, do you have any final comments?
Senator Murray. I don't have any additional questions. I
just want to thank all of our witnesses for being here today. I
think this is really a critically important conversation. I
think we all know that effective health information technology
is really essential to improving quality and the cost of care.
We've got to find a way, and the best way, for providers
and patients to share information securely and efficiently in
order to get people the best care possible. I'm really glad
that we're making this a bipartisan priority on this committee
and doing the work that I think is so important to get us to a
better place. Thank you.
The Chairman. Thank you, Senator Murray. This has been very
helpful. I think you can see that we're pretty committed to
this, given the amount of time we're spending on it, and that
we're working in a bipartisan way, not just among ourselves,
but with the Administration.
Of course, the best way to solve whatever problems exist
are, first, for the community to do it itself, for the industry
to do it itself; second, for the Administration to be able to
do it; and, third, we might have to pass a law. In my view,
those are the steps of preference.
Just so I can get it clear, Mr. Patterson, you held up an
ATM card. Would you say this is the goal, that a patient-
centered electronic medical system--that the goal is that I
would have the ability to have all my medical information on a
card? If we started from there and worked back to where we are
today, would that be the way to think about this? Or am I
simplifying it too much?
Mr. Patterson. I think it is the goal, but it's the fact
that the real information about what my bank account is isn't
on that card. We have to have a way of identifying ourselves in
accessing highly critical information at almost any point, any
time.
The way the ATM system works--that card does not have your
bank balance on it. That bank balance is somewhere--I don't
want to say in the cloud, but it is on a database. If you're in
France, you're not going to get----
The Chairman. If the card works, the bank needs to know my
bank balance.
Mr. Patterson. That's what I'm saying. I'm just saying your
bank balance isn't on the card.
The Chairman. What I'm really trying to get at is there are
different ways to approach this. One way to approach it is from
the point of view of what you do, or the point of view of what
each of you do. The other way to think about the whole thing,
it seems to me, would be to start with this and work back to
all the other issues that there are.
Mr. Patterson. I don't disagree with that. At least, it
should work as simple as that.
The Chairman. As I'm hearing you, what you're saying--and I
think Senator Cassidy's comment was an important one, and I
haven't made my mind up about this yet. Do we need to do
something to cause to happen here what needs to happen, for
example, standards for all the people who do what Mr. Patterson
does, to work together?
My very strong bias is that the less we have to do, the
more efficient it will work. The ATM card probably doesn't work
because of a law that Congress passed. The terrific airplane
reservation system that we enjoy every day probably doesn't
work because of anything we did, and if we had done it, it
probably wouldn't work as well.
What we need to know from you is what are the things that
we have to do to get you to do it? That is the question, and we
don't have to know that today. It sounds like standards is one
of those. My bias is that we are better as enablers rather than
mandaters--the government is, and that the more we have to
mandate, the less successful we're likely to be.
Senator Whitehouse. Mr. Chairman.
The Chairman. Yes, Senator Whitehouse.
Senator Whitehouse. Can I address your point just for one
moment?
The Chairman. Sure.
Senator Whitehouse. I think that having the card and having
a mechanism by which the individual patient has access to their
data is one of the important goals that we need to achieve. I
think we also need to achieve the goal for the patient who is
unconscious, who is very elderly and perhaps at the end of
their life, who is perhaps not at their full mental capacity,
to have the data system work, even when the patient is not a
participant.
I think we've all had the experience, either ourselves or
with loved ones, of being in a hospital and having to be there
at the bedside to help manage what's going on just in that
hospital, just for that patient. I think there are two goals.
One is the ownership and command of information by the patient
themselves, and the other is a system whose information support
will take care of that patient even when they are alone and
incapable and eliminates a lot of the confusion and
misinformation that bedevils modern complex practice.
The Chairman. Dr. Payne mentioned that example, and I see
what--Ms. Bechtel, I wonder if you are thinking something.
Ms. Bechtel. I am, always. How did you know? I think that,
conceptually, you're right. The challenge is I have two ATM
cards and three credit cards in my purse. My bank card isn't
linked across the data systems. What is, though, is Mint,
right, Mint.com, where I can connect it to all of my accounts.
We still do need the electronic--the systems to connect to each
other.
I think you're fundamentally right, which is this is my
electronic health record right now, and I can add to it in this
particular version. It's not particularly secure. You saw Neal
grabbing it earlier, and I hope I don't lose it today. The
concept that I described around how consumers can ask for,
aggregate, and hold their health information, at least in the
near term, would start to unlock that data and enable me to
share it with the providers who do need it and who can rightly
have access to it.
Mr. Richardville. Senator, if I could add to the comment, I
do think that where we're moving toward, or where we'd like to
move toward, is truly changing the culture of how health and
care is looked at by the patients and by other consumers, and
really move that to be part of your daily life. One aspect of
doing that, like we've all done with our smart phones and with
apps, for those that have those--and it keeps growing and
growing--is that open API infrastructure that allows people
like Mint.com and others to grab that information and present
it back to the patient or back to the provider.
The action that we need is to help support us to move this
so this becomes part of the rhythm of life. You wake up every
day. You check your email. You check your texts. You check your
Facebook. You need to check your health status, and this is
part of what we want to try to incorporate as we continue to
move toward the value-based system of prevention.
The Chairman. Dr. Payne, everyone else has had a last word.
Would you like to?
Dr. Payne. I would just add that innovation can help in
coming up with ways to solve this problem. I agree with your
approach that we want to have something we can work toward
that's practical, and the way to come up with that is probably
to leverage the ideas of people who are not at this table and
maybe not even a health IT at the moment, but are clever people
who can help us solve that problem. Our report encourages the
development of innovation to help solve some of these problems.
The Chairman. Senator Murray, anything else?
Senator Murray. No.
The Chairman. Thanks to all of you. It seems to me a couple
of unresolved questions that I'll be looking for answers to
are, No. 1, to followup on Senator Cassidy's point, to what
extent do we need to use coercion to cause things to happen so
that you can do what needs to be done? And, No. 2, I take the
point about delay of the Meaningful Use 3 regulations. There's
probably some downside to that.
For something that seems to have as much resistance right
now and as much need to improve, human nature tells me that it
may be better to step back a little bit on at least some parts
of the rules and work with physicians and vendors and hospitals
and take some advice about how to improve things, and then once
they're better, to accept and go forward. We want to do this as
rapidly as we can. We don't want to lose the impulse to cause
people to do this.
At the same time, the more important thing, I would think,
is to make sure that we get it done in a way that causes
patients, doctors and hospitals to look forward to the
experience of this system rather than to dread it. If you have,
after you leave, specific suggestions about these parts of the
regulations that absolutely not be delayed, these parts might
be delayed while we continue to work together to try to improve
them, that would be very helpful.
The hearing record will remain open for 10 days. Members
may submit additional information if they would like.
The next hearing will be Achieving the Promise of Health
Information Technology: What Can Providers and the U.S.
Department of Health and Human Services Do To Improve the
Electronic Health Record User Experience? That's the one which
the shorthand name would be physician documentation, and
Senator Cassidy and Senator Whitehouse will chair that. Senator
Whitehouse will be the ranking member on that hearing.
Thank you for being here today. The committee will stand
adjourned.
[Additional Material follows.]
ADDITIONAL MATERIAL
July 14, 2015.
To: Alicia Hennie, Health Policy Advisor, Sen. Alexander (R-Tenn.);
Colin Goldfinch, Health Policy Advisor, Sen. Murray (D-Wash.)
From: Jeffery Smith, Vice President Public Policy, AMIA
Re: Strategies to improve interoperability of health IT through
changes to certification and adoption incentives
This memo outlines ways to amend and enhance Federal health IT
policy to further widespread interoperability. Recommendations focus on
ONC's Health IT Certification Program and potential changes to CMS's
incentive structure for meaningful use and other value-based
reimbursement programs.
onc health it certification program
As part of the HITECH Act, the Office of the National Coordinator
(ONC) for Health IT established a health IT certification program to
help ``ensure that health IT conforms to the standards and
certification criteria adopted by the Secretary of Health and Human
Services.'' \11\ The Federal health IT certification program is meant
to provide assurances to users that the technology meets certain
capability, functionality and security requirements adopted by HHS, and
provides assurance that the products are interoperable (the systems can
exchange information and use that information for a specific purpose
once it's received). As the Federal Government's only policy lever to
impact the technical development of information technology in
healthcare, ONC's Certification Program should be seen as vital pathway
to improve interoperability, usability and patient safety.
---------------------------------------------------------------------------
\11\ ONC Health IT Certification Program, ``About the ONC Health IT
Certification Program,'' http://bit.ly/1FLG7ip accessed June 11, 2015.
---------------------------------------------------------------------------
Recommendations
Improve interoperability through more robust testing.
Require interoperability testing on both the sending
and receiving of data.
Incorporate exception handling into EHR
certification.
Develop C-CDA guidance and tests to support exchange.
Contract for--or otherwise solicit--testing methods from
developers and other stakeholders.
This is a current policy option, but ONC has had
limited success engaging with others to help develop testing
methods.
Without more ``skin in the game'' vendors may
continue to ``develop to the tests'' that government
policymakers design.
Force transparency into obfuscated market.
Require additional information to be submitted for,
or captured during, certification testing, and make these
publicly available. This includes:
Establish greater transparency and uniformity
on UCD testing and process results.
Screen shots and/or video of workflow
configurations.
Screen shots and/or video of exception
handling with data provided by testing body, not the
developer.
Participation in on-going interoperability
testing with an ONC-ACB or other entity, as designated
by the HHS Secretary.
Require ONC-ACBs to conduct post-market surveillance
through in situ testing.
This will require resources and agreement on
how to test, which will require stakeholder buy-in.
This is in keeping with anti-information
blocking efforts.
Promote pathways and protocols for users of certified
technology to report information blocking.
Provide regulatory clarity and certainty to an emerging
market.
Support ONC efforts around the Standards Advisory and
regular updates to Certified Health IT Editions.
This supports policies already underway at
ONC, but will require on-going leadership when the
inevitable pushback comes.
Make ONC develop a multiyear--3- or even 5-year--
Edition development plan.
This would be similar to a vendor's product
development plan and it would help vendors know what to
expect long before its officially proposed as part of a
regulation.
An example might be a certification for LTPAC
or behavior health, improvements to quality measure
report generation, etc.
Limit the scope of ONC certification to areas with a
``demonstrated need''.
This will help assuage fears that ONC will
start certifying everything in health IT and it would
create an opportunity to define some kind of rationale
identifying circumstances when certification would be
more harmful than helpful.
cms incentives: meaningful use and other value-based payments
Should ONC make substantive improvements to its certification
program, it will not have the intended impact unless there are
continued incentives (positive and negative) to drive further adoption
of health IT and to compel continued upgrades of certified health IT
technology. While we acknowledge that financial incentives are not the
domain of Senate HELP, we felt it was important to complete the logic
model of how to improve interoperability from a policy and program
perspective.
Recommendations
Provide relief to a highly regulated sector of the
economy.
Prohibit CMS from issuing a final Stage 3 rule until
at least 60 percent of EHs and EPs are successfully
demonstrating Stage 2 (as defined in an upcoming rule--expected
August 2015).
Provide incentives rather than deadlines.
Sunset MU penalties and make CMS incorporate MU
``status'' as part of reimbursement updates ala MACRA/MIPS.
This provides long-term sustainability in
incentive to participate in the program; without which
all other policy levers are substantially weakened.
Hospitals are not impacted by MACRA and so
their market basket update would be a good candidate to
make this happen.
______
Response by Thomas H. Payne, M.D., FACP, FACMI, to Questions of
Senator Alexander and Senator Murray
senator alexander
Question 1a. Many stakeholders have suggested that the health
information technology industry could come up with many solutions to
the problem of interoperability on its own. However, so far, we are
stuck with a system that does not work even though the government has
spent over $30 billion.
What areas would be best determined by private industry? What areas
should the government decide, if any?
Answer 1a. Overview: Americans benefit when their health
information is available when and where needed. To get there, the
private sector should be responsible for developing technical standards
to support interoperability that have consensus across stakeholders.
The government should help convene stakeholders, support pilots and
enforce adherence to standards--their use in certified products, their
implementation in provider settings and their application toward the
widespread use of ``open'' EHRs.\1\ The government should also continue
to create and integrate incentives for use of health IT as part of
evolving alternative payment models. Further, the government should
conduct a full review of Federal and State privacy laws, harmonizing
legal inconsistencies, correcting misinterpretations and prosecuting
bad actors who inhibit exchange or improperly disclose information.
---------------------------------------------------------------------------
\1\ Sittig DF, Wright A, J Am Med Inform Assoc 2015;0:1-3.
doi:10.1093/jamia/ocv060.
---------------------------------------------------------------------------
Detail: The current state of interoperability cannot be addressed
solely by the health information technology (health IT) industry. As
you and your committee have heard, the lack of interoperability--the
ability of two or more systems to exchange data and use that data to
care for patients once exchanged--is a multifaceted problem. Numerous
technical, business and cultural barriers have converged to inhibit the
free flow of information in healthcare and nothing short of on-going
public-private collaboration will change this current State of
challenges.
Policymakers should focus their efforts on refining the mechanisms
and policy levers already at their disposal and consider augmenting
those levers with new ones. Specifically, the Federal Government's
primary policy lever when it comes to interoperability is the Federal
Health IT Certification Program and health IT adoption incentives.
Certification has the potential to produce harmonized technology that
conforms to foundational standards upon which developers can innovate
and augment technology for their customer's needs. This has always been
the goal of the Federal certification program, but only recently has it
been possible.
Prior to 2012, there was no national conversation, nor agreement,
on standards prerequisite for interoperability: namely, content
standards, vocabulary standards and transport standards. Prior to 2014,
and perhaps even true to this date, the technology bundle containing
these standards--the 2014 Edition of Certified EHR Technology (CEHRT)--
had not been widely adopted, as required for Stage 2 of meaningful use
(MU). Also, prior to 2014, no hospital or physician had met the
objectives for Stage 2, which included process requirements to exchange
health information across care delivery settings and technology
platforms. According to the most recent data available from the Centers
for Medicare & Medicaid Services (CMS) only 36 percent of hospitals and
10 percent of eligible professionals have met the requirements of Stage
2, using the 2014 Edition of CEHRT.\2\ Moreover, 91 percent of
hospitals and 82 percent of professionals chose to defer the
requirement to send a summary of care record at transitions of care,
which is the process requirement in MU Stage 1, preceding the most
straightforward ``interoperability requirement'' in Stage 2 to
electronically send a summary of care record at transitions of care.\3\
In other words, the ecosystem of technology and processes which would
demonstrate interoperability to a degree worthy of $30 billion in
taxpayer investment is highly underdeveloped and the vast majority of
providers do not even practice the processes laid out in regulation
that would move data from place to place. This is true even without
considering the business and policy barriers that inhibit
interoperability.
---------------------------------------------------------------------------
\2\ Centers for Medicare & Medicaid Services, ``May 2015 CMS HITPC
Report,'' http://go.cms.gov/1MhJ924 (accessed July 9, 2015).
\3\ Ibid.
---------------------------------------------------------------------------
I will not go into detail here, but as it pertains to your
question, Congress should continue efforts to change Medicare &
Medicaid fee-for-service reimbursement by helping CMS develop, evaluate
and scale alternative payment models. Changing how we pay for care can
lead to great advances in interoperability. Congress should also
reassess Federal & State privacy laws--with broad input from patients,
providers, researchers and the informaticians who support them.
In my testimony, I mentioned the need to,
``streamline the Federal health IT certification program so
that the process is more flexible, more transparent, focuses on
clinically relevant functionality, and tests for true
interoperability.''
The practical application of this phrase is provided in a memo
developed by AMIA staff, and included as an enclosure to this response,
but I would reinforce the notion that to improve interoperability,
Congress should focus on improving ONC's certification program,
especially as it relates to testing for interoperability, and
reconsider ways to incentivize further adoption and continued upgrade
of certified health IT technology.
Finally, Congress should embrace the notion of ``slowing down
regulation to accelerate progress on EHR usability, interoperability
and innovation.'' Federal regulators should not rush to get to the next
stage of meaningful use, but should instead work to help the private
sector accelerate optimization of the tools and regulations that are
already in place. Again, the enclosed memo goes into more detail, but I
reiterate my previous statement that Stage 3 rules not be finalized in
haste. I believe it is imperative that Congress keep MU requirements,
with penalties for noncompliance, in place over the near and mid-term.
The forthcoming ``meaningful use modifications'' rule has proposed a
number of changes to help streamline and simplify participation.\4\
These changes would apply to the current program year through to 2018
and they will give providers a stationary set of requirements while
technology optimization and workflow enhancements occur.
---------------------------------------------------------------------------
\4\ Centers for Medicare & Medicaid Services, Notice of Proposed
Rulemaking (CMS 3311P) http://go.cms.gov/1HqJNqV.
Question 1b. Does the government need to set deadlines or otherwise
encourage industry to make decisions?
Answer 1b. Overview: Deadlines are not as impactful as providing
strong incentives.
Detail: Both positive and negative government incentive programs
have been successful in converting health information from paper to
electronic form. This was necessary for interoperability, but not
sufficient. There have also been encouraging efforts for greater
interoperability in the private sector, such as CommonWell Health
Alliance,\5\ the Sequoia Project\6\ and others. However, the vast
majority of work--and all of the regulatory consequences--of exchanging
and using healthcare data falls to hospitals, physicians, clinics, and
other providers. And few are happy with the result we've achieved to-
date. Today, the best way to ensure data can be used at the point of
care across settings is to have a single EHR vendor across all
settings. This single-system approach is counter to prevailing trends
in technology, which allow for substitutability and modularity. The
most successful utilizers of information technology know that diversity
is far preferable than expecting one system to do all functions well.
But adherence to common standards is prerequisite for a diverse
ecosystem to work.
---------------------------------------------------------------------------
\5\ http://www.commonwellalliance.org/.
\6\ http://sequoiaproject.org/.
---------------------------------------------------------------------------
As an example of the current state, there are enormous national
meetings for customers of EHR vendors. There is no comparable meeting
devoted to interoperability across EHR vendor products, or in caring
for patients whose health records are dispersed. The unspoken message
is that the simplest route to interoperability is to use one vendor,
but this does not fit how Americans live and receive health care.
And this is where government can help.
Incentives should be changed so all government-certified EHR
vendors whose products are used to care for Medicare/Medicaid
beneficiaries work together to have the same rapid advance in
interoperability that we have seen in EHR adoption. This doesn't mean
government creates interoperability. It means government moves the
market toward rapid rise in interoperability.
New incentives are not needed, nor are heavy-handed penalties. The
recently passed MACRA may provide a template for incentives that can be
long-lasting and impactful. For physicians participating in the Merit-
based Incentive Program System (MIPS) meaningful use penalties will
sunset in 2018, and participation in MU will constitute \1/4\ of a
composite score that will determine a physician's reimbursement rate.
This dynamic provides a pay increase for successful participation in
MU, which is significant because there are very few--if any--incentive
dollars left from the HITECH Act in 2018. For physicians participating
in MIPS who fail to meet meaningful use requirements, they forego the
possibility of obtaining a full increase in payment, but it does not
necessarily translate to a penalty, or a negative payment adjustment.
Congress should look at this model and determine if a similar
approach can be used with hospitals and clinicians not participating in
MIPS. Increases to hospitals' market basket update, or additional funds
for ACOs, bundled payments, et cetera, could be leveraged to encourage
participation. Nonparticipation will not be penalized, yet money will
be ``left on the table,'' so to speak. Key to this recommendation is
adjusting the meaningful use ``all or nothing'' paradigm where
providers must meet all requirements or receive no incentives/full
penalties. Such flexibility will be needed to keep providers engaged in
the only Federal Government program that dictates use of modern
information and communication technology in healthcare.
Likewise, Congress needs to examine ways to incentivize--or
compel--interoperability between and among competing EHR developers as
a business imperative, rather than just pressuring providers and care
delivery system.
Question 2a. If you could change all or parts of the rules for
Stage 2 and 3 of Meaningful Use and the 2015 certification rule, what
would you change?
Are there particular parts that should be delayed and others that
should go forward? What changes would you make to them?
Answer 2a. On the macropolicy level, the ``Stage 2 modifications''
rule, issued by CMS April 10, 2015, should be finalized as soon as
possible and it should be finalized largely as proposed. The
certification rule, likewise should be finalized on schedule and
according to general consensus received through the open commenting
process. Stage 3 meaningful use rules should not be finalized until
2018--at the earliest--or until 60 percent of EHs and EPs are
demonstrating Stage 2 as modified. This dynamic keeps provider
requirements set for a time where technology and workflows can be
optimized to deliver on the promise of modern communication and
information technology. It also allows for ONC to move forward with
updates to certified technology to incorporate fixes to known ``bugs''
or to accommodate emerging national standards.
On the program design-level, participation in meaningful use cannot
continue 365-days per year ad infinitum. Much-needed downtime for
upgrades, bug fixes and workflow re-design is necessary during any, and
most likely every, year. For this reason, and for related reasons of
patient safety, CMS should not require 365-day EHR reporting periods,
but something closer to 180-days or 270-days. Likewise, more
flexibility needs to be built into the program by removing the ``all or
nothing'' construct. Especially as the program is integrated into MIPS,
there are rational policy changes that could allow for this to happen
because meaningful use becomes part of a composite score dictating
reimbursement. A rudimental example could be that if a physician meets
80 percent of MU objectives, they receive 80 percent of the available
meaningful use points that are part of the composite score.
On the program content-level, it will be difficult for various
stakeholders to agree on all the necessary program components.
Meaningful use was developed with broad input from various stakeholders
and because of this, it has requirements important to many groups of
health professionals and patient advocates. The problematic areas of
the program are well-documented--patient action requirements, such as
patient portals and secure messaging and summary of care requirements
for transitions of care are among the most often cited. Despite the
challenges associated with these objectives, they have strong support
from different segments of the stakeholder community, and they have
illuminated technical, cultural and business barriers that are signals
of progress. We would not be as cognizant of our ``interoperability
problem'' without the requirement that data be exchanged and used after
transitions of care--or at least we would not know the extent of the
challenge.
Question 2b. Do you think that the proposed rules will make health
information technology better? If so, which parts?
Answer 2b. The degree to which MU and the Federal health IT
certification program have advanced the ecosystem for health IT cannot
be overstated. The regulations have served as an important catalyst and
the work to develop and implement them has enabled the entire sector to
evolve at an incredibly fast rate. We can't exchange health information
electronically if it is on paper. The proposals in question will
undoubtedly have a positive impact on the health IT landscape, but they
will also engender more disdain unless they are implemented properly--
at a pace the industry can handle and with flexibility to accommodate a
dynamic system.
Specifically, the Stage 2 modifications rule will make several
changes to remove topped-out measures and provide a single definition
for all providers beginning 2015. Keeping the requirements steady for a
period of 3 to 5 years will give providers time to optimize the
technology they have and developers the time to innovate on the
versions already deployed. Lowering the patient action thresholds,
while controversial, is the right step absent a more nuanced
conversation over how to encourage--and measure--patient engagement.
ONC's 2015 Edition Certification rule contains many proposals that
should improve the State of health IT, including:
A proposal to expand the ONC Health IT Certification
Program to additional types of care and practice settings;
An expansion of existing surveillance efforts of health IT
under the ONC Health IT Certification Program, where ONC-ACBs
(authorized certification bodies) would conduct annual randomized in-
the-field surveillance;
A significant expansion of health IT developer
transparency and disclosure requirements for certified health IT;
Expansion on the 2014 Edition transitions of care
criterion by using updated C-CDA standard and requiring capabilities to
detect valid and invalid C-CDA documents;
Enhanced requirements for data portability to facilitate
the accessibility and exchange of data; and
A new requirement that health IT would have to demonstrate
that an API responds to data requests for any one, and for all, of the
data referenced in the Common Clinical Data Set (CCDS). This criterion
would rigorously assess a product's C-CDA creation performance (for
both C-CDA version 1.1 and 2.0) when presented for certification for
exchange capabilities.
The net-effect of these changes should be more usable, safer and
more interoperable health IT. However, passing a regulation with these
changes does not ensure these outcomes. Developers must build
technology that performs these functions in a way that corresponds with
how care is delivered; providers must adopt, implement, test, train and
use the technology as its intended and a large share of providers must
do this before the impacts will be noticeable.
Question 2c. Are there any parts of the proposed rules that you
think would make health information technology worse? If so, which
parts?
It may be premature to know which parts of the proposed rules will
make HIT worse, but there are a number of proposals that necessitate
close watch; that will be very difficult to operationalize and scale;
or that will create stress on an already-stressed system. For example,
the Stage 3 proposed requirements to incorporate patient-generated
health data and requirements related to ``clinical information
reconciliation'' fall across several of the aforementioned categories.
There are well-documented use cases where PGHD or reconciliation have
added value and safety to care, but these are domains with little
experience and immature standards.
senator murray
In your testimony, you suggest that in order to,
``see the same success that we've seen in the internet, we need
a stable base of standard building blocks that allows us to
create new technology to benefit patients.''
You also note that these ``building blocks'' will support the
development of new electronically specified clinical quality measures
to help streamline and improve Medicare's quality incentive programs.
Question 1. How would these building blocks allow for the
development of better measures and streamlined processes for reporting
electronically specified measures? Could they help align reporting
requirements across quality reporting programs and accelerate
interoperability between electronic health records and registries?
Overview: Congress is well-positioned to help advance quality
measurement in healthcare by moving toward outcomes-based clinical
quality measures (CQMs) and by supporting technical improvements to
CQMs produced in the digital age. Given Federal plans to accelerate
toward reimbursement based on value and outcomes, rather than volume,
now is the right time to think systematically about quality
measurement. This means simplifying the process, streamlining the
number, and harmonizing the types of CQMs required for public
reporting. Alignment of CQMs across programs is largely a policy issue;
whereas the need to generate accurate and complete CQMs, and accelerate
interoperability between EHRs and registries is a technical one.
In order to accelerate development of quality measures to improve
Medicare's quality incentive programs, and to improve interoperability
between EHRs and registries, policymakers must take three important
steps: (1) review and adopt a national format standard for common data
elements (CDEs) used to generate CQMs; (2) simplify quality measures by
rethinking exclusion criteria for CQMs and (3) improve the quality of
data in CQMs by encouraging broader adoption of up-to-date EHRs.
Detail: Similar to the internet, there are foundational ``building
blocks'' that support flexible, standards-based interoperability. For
health IT there are five building blocks that we need to facilitate
standards-based exchange of information and streamlined
interoperability:
1. Standardized Meaning
2. Standardized Format (or structure)
3. Standardized Transport
4. Standardized Security
5. Standardized APIs or services
Standardized meaning
Standardized vocabularies and terminologies like SNOMED and ICD-10
allow a computer to understand that ``heart attack'' and ``myocardial
infarction'' are the same concept, because they have the same
standardized code. MU provides for four major vocabularies--LOINC for
lab tests, RxNorm for medications, SNOMED for problem and symptom
descriptions and ICD-10 for billing diagnoses. These should be used for
all quality measures and registries so that the vocabularies are the
same as those used in EHRs.
Standardized Format
MU has adopted a number of document-centric ways to standardize
information that include a patient care summary or a transitions of
care document. However, two additional standardized formats are needed:
(1) A standardized format for granular data that can be used to build
quality measures and new kinds of documents; and (2) a standardized
format for unstructured data so that patients can share their entire
medical record in an electronic format. Both of these play an important
role in improving quality reporting.
Standardized Transport and Security
These standards are typically drawn from fundamental building
blocks that support the internet and the WWW. In healthcare, we should
leverage these mechanisms like email and Web page interactions, or
secure ways to encrypt data or authenticate users, but not develop
specific transport or security standards .
Standardized Services, such as Application Programming Interfaces
(APIs)
APIs provide very specific channels or connections between two
systems. These are useful to connect systems, but cannot substitute for
a full export of a medical record for a patient to access their
information.
By focusing development on format standards that are more data-
centric and less document-centric, different pieces of medical data can
be used in modular ways. Perhaps no better example of this is quality
measurement. Development of granular data standards would most
certainly yield positive benefits for quality measurement reporting,
measure specification alignment and facilitate interoperability of EHRs
and registries.
Quality measures are made up of three kinds of information: (1)
Meta-data; (2) a data value; and (3) a formula. The meta-data describes
what the quality measure is, when it was developed, who developed it,
and other provenance data. Data value, includes the actual values for
things like lab test result, medication, or problem list, for example.
Finally a formula is needed to calculate the quality measure; for
example a formula to identify all patients with diabetes who have an
elevated HbA1C.
If one had a granular data element that defined diabetes (all
patients with a problem list that had a SNOMED code for diabetes) and
defined what an ``elevated HbA1C level'' is, one could identify those
patients who need more help caring for their diabetes. In the diagram
below, each of the boxes represents a granular data building block that
are reusable.
This approach is generalizable. If there was a national common data
element structure that used standardized vocabularies, the same
structure could be used to describe the data values in a quality
measure, the data values in a registry, and the data values in the
electronic health records. This common format would accelerate
interoperability for granular data elements, and provide a fundamental
building block for other initiatives such as precision medicine and
decision support.
Candidate standards for common data elements (CDE) currently exist.
For example, a CDE standard was developed through the standards and
interoperability framework at ONC (http://hl7.org/fhir/2015May/
sdc.html), and has been balloted through HL7 as a FHIR resource;
however the standards has yet to be adopted by Federal agencies. Such a
format standard, if adopted nationally, would be an important step
toward accelerating quality reporting programs, registry and EHR
interoperability.
Once there was a common format standard for granular data elements,
additional work to agree on the standardized meaning would be greatly
accelerated. Domain experts in medicine and quality assessment can
focus on reaching agreement on the definitions of data elements,
knowing that once an agreement is reached on the definitions, the
technical format will allow for rapid adoption and use for quality
measures, registries, and EHRs.
Last, I would urge Congress to use the upcoming development of the
MIPS as an opportunity to focus more work toward simplifying quality
measures in healthcare. Many measures have tens of hundreds of data
elements that are of dubious quality and that complicate the user
interface and documentation requirements for clinicians. Each
additional data element creates additional cost and complexity while
adding only marginal value. One source for this problem is a
proliferation of exclusion criteria, which are highly variable across
programs and CQM specifications. We would do better to have quality
measures with simple, but high-quality data.
Question 2. How would you recommend that clinicians and HHS
identify these building blocks, and what process should be used to
translate them into quality measures?
Answer 2. The Federal Government has a process to develop and
maintain quality measures, and this process has gone through several
evolutions since EHRs were used to generate quality measures. The
unfortunate truth is that the current process is still new and still
evolving, and I fear that it will need further modification and
improvement before it will yield the intended results. This means
dedicated resources are needed and the process must include individuals
with deep clinical and technical expertise.
Generally speaking, the National Quality Forum (NQF) and CMS have
worked to ``regularize'' a process to identify areas of quality
measurement and update those quality measures over time. Through the
Measure Applications Partnership (MAP) HHS has convened multiple
stakeholders to guide ``the selection of performance measures for
Federal health programs,'' to provide ``a coordinated look across
Federal programs at performance measures being considered.'' \7\ This
effort has been developing recommendations since 2011 and has played an
important role in helping define core measures for Medicaid
populations, including adults, children and dual eligible
beneficiaries. However, work related to eMeasures or eCQMs (measures
generated by EHRs) is still on-going with little demonstrable success,
due to a lack of aforementioned building blocks. The original notion
was to ``retool'' paper-based measures as electronically generated
measures. This approach has been largely abandoned and now most eCQMs
are de novo, or newly constructed. The foundational problem is that
some data needed to complete eCQM specifications are not currently
captured by EHRs, or not captured in a way that can be used to generate
quality measure reports.\8\ \9\
---------------------------------------------------------------------------
\7\ National Quality Forum, Measure Applications Partnership,
http://bit.ly/1dW7VJq (accessed July 10).
\8\ Amster A., Jentzsch J., Pasupuleti H., Subramanian K
``Completeness, accuracy, and computability of National Quality Forum-
specified eMeasures,'' J Am Med Inform Assoc, http://dx.doi.org/
10.1136/amiajnl-2014-002865 409-16, October 2014.
\9\ Garrido T., Kumar S., Lekas J., et al, ``e-Measures: insight
into the challenges and opportunities of automating publicly reported
quality measures'' J Am Med Inform Assoc, http://dx.doi.org/10.1136/
amiajnl-2013-001789 181-84 Jan. 2014.
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As is often the case in the regulator-regulated relationship,
requirements developed by the regulators are often incomplete because
regulators have little direct exposure to the regulations they develop.
In this instance, measure developers, technology developers and
government regulators are not required to gather/input data necessary
to generate eCQMs--clinicians gather these data at the point of care,
often in ways unreflective or disjointed from clinical workflows. This
has contributed to poor usability in EHRs and incomplete quality
measures.\10\
---------------------------------------------------------------------------
\10\ Parsons A., McCullough C., Wang J., Shih S., ``Validity of
electronic health record-derived quality measurement for performance
monitoring,'' J Am Med Inform Assoc, July 2012 http://bit.ly/1HqDUtK.
---------------------------------------------------------------------------
One potential approach would provide dedicated resources to quality
measure experts, inside and outside government, developers and
clinicians to develop measures consistent with realistic clinical
workflows. Bringing together clinical and technical expertise could
then help inform the process already developed by CMS and the NQF MAP.
Stated simply, measure developers and EHR developers must incorporate
the views of practicing clinicians and their workflows. However,
without a granular data standard, as outlined above, we will continue
to have little success measuring quality as a ``byproduct'' of care
delivery.
______
Carolinas HealthCare System,
July 13, 2015.
Hon. Lamar Alexander, Chairman,
Health, Education, Labor, & Pensions Committee,
U.S. Senate,
Washington DC, 20510.
Hon. Patty Murray, Ranking Member,
Health, Education, Labor, & Pensions Committee,
U.S. Senate,
Washington DC, 20510.
Dear Chairman Alexander and Ranking Member Murray: Thank you for
the opportunity to testify on behalf of Carolinas HealthCare System and
the Premier healthcare alliance at the ``Health Information Exchange: A
Path Toward Improving the Quality and Value of Health Care for
Patients'' hearing on June 10, 2015. Attached are my responses to the
Questions for the Record posed by the Chairman and the Ranking Member.
Sincerely,
Craig Richardville,
Senior Vice President & Chief Information Officer,
Carolinas HealthCare System,
Chair, Premier Healthcare Alliance,
Member, Technology Improvement Committee.
______
Response by Craig D. Richardville, MBA, FACHE, to Questions of
Senator Alexander and Senator Murray
senator alexander
Question 1. Many stakeholders have suggested that the health
information technology industry could come up with many solutions to
the problem of interoperability on its own. However, so far, we are
stuck with a system that does not work even though the government has
spent over $30 billion.
What areas would be best determined by private industry? What areas
should the government decide, if any?
Does the government need to set deadlines or otherwise encourage
industry to make decisions?
Answer 1. Despite its potential, the current HIT ecosystem
continues to be challenging for healthcare providers because of a lack
of interoperability between systems. Cost-effective, efficient, and
easy to use and integrate health information is foundational to
advancing and providing excellent care in this country.
As this committee heard earlier this year, the current market
incentives are not aligned with open exchange of necessary healthcare
data in cost-effective ways. The sharing of data that sits in software
systems across the care continuum is not only technically complex, it
is also expensive and time-consuming to integrate. Data resides in many
systems, not just electronic medical records. Registration, billing,
lab, pathology systems, medical devices, sensors and monitors, to name
just a few, all have vital data that can and should be integrated and
accessible across the care spectrum, no matter what the underlying
software system is. The difficulty in achieving this has an impact not
only in care quality but also in cost.
Despite the challenges, significant strides have been made with
digitizing health information in the last 6 years. More than 80 percent
of eligible providers and more than 90 percent of hospitals have begun
the work to digitize their patient health data. Still, achieving
necessary data integration to move forward has not been easy or
inexpensive. Today, in order to build the bridges that connect
disparate data sets necessary to provide comprehensive and informed
decisions or care, providers must either pay their original system
vendors thousands and sometimes millions of dollars to custom code
linkages so they can ``talk'' to other systems, or they often find
paper-based workarounds that are fraught with potential for both errors
and wasted resources and expense.
In order to achieve the goal of having data that is secure,
accessible and actionable by providers and patients, one of the key
prerequisites is creation of patient matching systems. It is imperative
that for the patient data to be interoperable we have a rational and
effective method to match the right data to the right patient. A
patient matching system is also foundational to interoperability. This
goal of a secure HIT ecosystem that enables an easy exchange of health
information in timely and cost-effective ways could be achieved with
foundational work in patient matching.
To accomplish these goals, we ask for a combination of
congressional and administrative actions that promote policy principles
that further open health IT infrastructures. In creating those
structures, we need clear rules of the road for providers and vendors
alike through establishment of functional data and transport standards,
and methods to measure and test functionalities, with enhanced
enforcement tools for regulatory bodies to drive compliance in the
marketplace. These include:
Establishing governance: A private-public partnership on
HIT interoperability governance should be established to provide clear
rules of the road on interoperability. This should be done in
consultation and coordination with Federal agencies, such as HHS and
ONC, and the private sector. Providers, vendors, patients and payers
should be consulted. The government entities should provide regular
reports to Congress and the Administration on current standards
development status as well as ready to market timelines and assessments
for their applications.
Identifying functional data and transport standards that
promote interoperability and innovation: The governance mechanisms
should focus on identifying and setting the development of functional
data and transport standards in key areas including: patient matching,
terminologies, clinical data query language, security, open application
program interfaces (APIs), and clinical decisions that support
algorithms as well as business practices and policies.
Focusing on public interoperability, cost and quality:
Transparent and public measures of interoperability should be developed
in collaboration with the Federal Government, including HHS and ONC,
and standard-setting bodies in consultation with the private sector and
be required as part of ONC's certified technology program.
These measures should be validated and tested in
terms of functional standards, processes, and their maturity
for application in the marketplace in a timely way, and within
specific use case scenarios.
Measures should include business and implementation
approaches that deliver functional interoperability outcomes
and include operational processes and implementation practices.
Measures should also include assessment of clinical
quality and cost efficiency metrics achieved through
incorporating innovative technologies, such as existing APIs,
which are open source codes that enable third-party
applications to exchange data.
Encouraging transparency: Data should flow freely and
easily. Determinants of transparency should include:
Availability of ``free'' (no cost) export of
publishable EHR domains.
Prohibition of specific fees for access to necessary
data through API or other functional standard callable methods.
Publication of technical instructions on how to
interact with APIs, interface standards or other callable
methods. These should be published either publicly or broadly
to any authorized third party.
Requiring technology and devices that generate health
information to publish clinical data to any other authorized
consuming applications, including EHR/EMRs, to create
interoperability. Consuming applications' ability to develop
methods to ingest information from other HIT assets, including
devices, should adhere to current and future medical device
interoperability standards.
Enforcing functional data and transport standards and
measures of HIT: The Federal Government should be enabled to enhance
its enforcement tools to ensure functional data and transport standards
and to measure compliance of vendors through its certified technology
program. Enforcement also can be encouraged through measurement and
adherence to Meaningful Use standards.
Question 2. If you could change all or parts of the proposed rules
for Stage 2 and 3 of Meaningful Use and the 2015 certification rule,
what would you change?
Are there particular parts that should be delayed and others that
should go forward? What changes would you make to them?
Do you think that the proposed rules will make health information
technology better? If so, which parts?
Are there any parts of the proposed rules that you think would make
health information technology worse? If so, which parts?
Answer 2. Given the complexity of the objectives proposed under
Stage 3, we believe meaningful use of EHRs can only be achieved if and
when data captured in various EHRs and other data systems are
interoperable. Being able to fully leverage the robust clinical and
health data in various disparate systems is essential not only to
deliver efficient, high-quality, and patient-centered care but also to
provide patient access and engagement. The data is digitized. Now it
needs to be shared freely and easily. The HIT assets within the current
ecosystem continue to be challenging for healthcare providers; however,
due to the lack of interoperable HIT infrastructure as market
incentives are not aligned with the open exchange of necessary
healthcare data in cost-effective ways. As a result, data is locked in
proprietary software systems.
As we have commented to CMS on the proposed rules for Stage 3,
without an interoperable HIT infrastructure in place first, the
increased thresholds for the various objectives proposed under Stage 3
will be challenging for providers. While we applaud the optional
measures utilizing APIs to meet some of the objectives proposed, we
have requested that CMS minimize and keep consistent the baseline
compliance thresholds when it comes to most of the objectives and
patient access and engagement provisions in particular. More
specifically:
Calendar Year Reporting Period for 2015 CEHRT. Under the
CMS proposed rule, the EHR reporting period for all providers,
including eligible professionals (EPs), eligible hospitals and critical
access hospitals (CAHs), would be a full calendar year, beginning with
calendar year (CY) 2017. In particular, for the first year in which the
2015 edition of certified EHR technology (CEHRT) must be used and Stage
3 meaningful use requirements met, providers would have a full CY 2018
EHR reporting period.
We strongly oppose requiring a full calendar year reporting
requirement for the first year of Stage 3, whether that first year
occurs in 2017 (by a provider's choice) or in 2018 (as required under
the proposed rule). It is unrealistic to expect all providers to adopt
a new edition of CEHRT and initially meet the full array of Stage 3
meaningful use requirements for an entire year, whether or not they
have previously been able to satisfy Stage 1 or Stage 2 EHR meaningful
use requirements. We, therefore, urge CMS to allow for a 90-day
reporting period for the first year. We argued for similar treatment
for 2015 and CMS has recently, and somewhat belatedly, proposed to
provide this recommendation. We believe it would be a serious mistake
to fail to give providers the flexibility to use a 90-day reporting
period for the first year in which they adopt the 2015 Edition of CEHRT
to meet Stage 3 requirements.
Objective 4: Computerized Order Entry. Objective 4 focuses
on computerized provider order entry (CPOE) for medication orders,
laboratory orders, and diagnostic imaging orders. The proposed
objective calls for such orders to be directly entered by any licensed
healthcare professional, credentialed medical assistant, or a medical
staff member credentialed to and performing the equivalent duties of a
credentialed medical assistant who can enter orders into the medical
record per State, local, and professional guidelines. CMS emphasizes
that a layperson is not qualified to perform functions associated with
order entry, and that medical staff whose organizational or job title,
or the title of their credential, is other than medical assistant may
enter orders if these staff are credentialed to perform the equivalent
duties of a credentialed medical assistant by a credentialing body
other than their employer.
Providers' primary concern with this proposed objective is the
demand that medical staff member credentialing be conducted by an
entity other than the staff person's employer. In the case of
providers, that would mean that a hospital would be unable to
credential such individuals, even though hospitals are in the regular
business of credentialing members of their medical staff. We see no
additive value to imposing such external credentialing costs and
burdens on the Nation's hospitals and we strongly oppose this aspect of
the CMS' proposal.
Objective 5: Patient Electronic Access to Health
Information. Objective 5 focuses on providing access for patients to
view online, download and transmit their health information (e.g.,
through a portal), or retrieve their health information through an API,
within 24 hours of its availability.
Provider's primary concern with this proposed objective is the
unrealistic timeframe for making the information accessible, moving
from the current Stage 2 requirements of 4 business days for EPs and 36
hours post discharge for hospitals to 24 hours for all providers. We
believe this is unrealistic from a workflow perspective and also risks
forcing information to become accessible before its content can be
adequately assessed for accuracy and before actions can be taken by the
provider to educate or prepare the patient, if this is necessary. Since
the thresholds for the objective are being increased and since CMS is
interested in having near-identical requirements for both EPs and
hospitals, we urge adoption of the same four business day timeframe for
all providers.
In contrast to our concerns regarding timeframe, we heartily
endorse CMS' proposal to offer providers the option to use an API-based
mechanism to provide patient access to their health information, in
addition to the existing option of viewing online, downloading and
transmitting such information. To enable this option, however, it will
be essential for CEHRT vendors be required to provide open and
functional standard APIs that will enable secure applications to
facilitate the exchange of information. We encourage CMS to look beyond
data in EHRs and also consider the growing usage by patients and
consumers of tools where they store, track and can share their own
health data with providers.
Objective 6: Coordination of Care through Patient
Engagement. Objective 6 focuses on provider use of the communication
functions of CEHRT to engage with patients and their authorized
representatives about the patient's care. For this objective, providers
would be expected to attest to the numerator and denominator of all
three proposed measures and successfully meet the threshold for two of
these three measures. Proposed measure 1 would, for example, require
that more than 25 percent of all unique patients discharged from the
hospital inpatient or emergency department during the EHR reporting
period view, download or transmit to a third party their health
information or access their health information through the use of an
ONC-certified API that can be used by third-party applications or
devices. Similarly, proposed measure 2 would require hospitals to send
a secure message using the electronic messaging function of CEHRT to
more than 35 percent of such unique patients. Proposed measure 3 would
also require hospitals to incorporate into the CEHRT patient-generated
health data or data from ``a non-clinical setting'' for more than 15
percent of such unique patients.
We have concerns with Objective 6, especially its proposed increase
in percentage thresholds. First, in the case of measure 1, we believe
it would be unfair to providers to hold them accountable for patients'
ability and willingness to electronically access their health
information, especially given the proposed 25 percent threshold. CMS
itself notes that median hospital performance for Stage 2 (for a
related measure) is only 11 percent. Additionally, CMS has recently
proposed to change the Stage 2 threshold for this measure so that
providers would be able to meet the measure if at least one patient
views, downloads or transmits his or her health information to a third
party.
Given all the other changes being contemplated for Stage 3, and
given CMS' proposed change for Stage 2, we urged CMS to adopt a 5
percent threshold for Stage 3, which is the threshold previously
finalized under Stage 2 for the comparable measure. This would more
realistically recognize that the patient populations served by
providers vary widely in terms of their medical literacy, their access
to computers and other technologies, their desire to access their
health information under various scenarios, and even their interest in
doing something they have never done before: electronically access
their health information (that is, be early adopters of a new option).
We would also note that the current broadband availability exclusion is
inadequate, especially as measure thresholds increase; some providers
have indicated that the current exclusion does not apply to their
locale even though a significant proportion of their patient population
do not have ready access to computers and/or the Internet. In addition,
CMS also needs to recognize that some patients with multiple chronic
conditions who are receiving care from multiple providers during an EHR
reporting period may have no interest or need to access information
from all of these providers. For all of these reasons, a 25 percent
threshold for measure 1 would be unrealistic. Providers need more
experience with electronic patient access to health information to
better understand which patients take advantage of and value such
accessibility before being able to provide advice regarding a threshold
greater than 5 percent.
We also consider proposed measures 2 and 3 for this objective to be
extremely problematic. We do not believe these measures should apply to
hospital inpatients or to individuals presenting themselves to hospital
emergency departments. We do not understand CMS' objective in requiring
emails to be sent to patients after their discharge from the hospital
or emergency departments. The issue with hospital-based providers being
held accountable for sending secure messages is that it does not
acknowledge how that care differs from an ambulatory setting and how
care is delivered through hospitals. Patients often are cared for by
hospitalists and then when the patient is discharged, care is returned
to the patient's primary care provider. Oversight and coordination of
care happens with the primary provider.
Further, a 35 percent threshold for measure 2, which is a new
measure, is unrealistic. Similarly, we do not believe that hospitals
should be expected to incorporate patient-generated data or information
from ``non-clinical'' settings for patients' post-discharge from the
hospital inpatient setting or emergency department. Thus, for
hospitals, we believe that only measure 1 should apply and only if a 5
percent threshold is adopted. Even for EPs, we believe that measure 3
would be challenging, as this is a brand new concept and fails to
recognize the diversity of patient health literacy and willingness or
need to furnish patient-generated data.
Objective 7: Health Information Exchange. Objective 7
focuses on the provision of a summary of care record when providers
transition or refer their patients to another setting of care,
retrieval of a summary of care record by providers receiving a
transitioning or referred patient (or upon the first encounter with a
new patient), and incorporation into the EHR of summary of care
information from other providers using the functions of CEHRT. For this
objective, providers would be expected to meet two of the three
proposed measures. Measure 1 focuses on the creation and electronic
exchange of summary of care records by the providers initiating a
transfer or referral. Measure 2 focuses on the incorporation of
electronic summary of care documents by the receiving providers (or
those seeing a new patient for the first time). And measure 3 would,
for example, require hospitals to perform clinical information
reconciliation for more than 80 percent of transitions or referrals
received and for new patient encounters. This reconciliation could, for
example, address the reconciliation of medication, medication allergy
or patient problem lists.
We have significant concerns with Objective 7. For measure 1, our
primary concern is the lack of adequate infrastructure for
electronically exchanging summary of care documents with many providers
likely to be on the receiving end of transitions of care or referrals,
such as post-acute care providers. We do not believe it would be
reasonable to hold hospitals accountable for other providers' inability
to electronically accept a document. Thus, at minimum, the 50 percent
threshold for measure 1 is unrealistically high.
In the case of measures 2 and 3, we oppose the application of these
measures to patients who are not the subject of a transition of care or
referral. We believe it is unrealistic, for example, to apply this
requirement to first patient encounters in hospital emergency
departments. In many cases, there will be no referring physician or
even a physician of record, and no clinical information available to
reconcile. Further, we believe that any such requirements would be
extremely disruptive to emergency department workflows. These measures
also presume the existence of an infrastructure that is capable of
efficiently exchanging available information and such infrastructure
does not currently exist in many or most cases.
In sum, for Objective 7, we believe that only measure 1 should
apply to hospitals for Stage 3 purposes and only if a much more
reasonable measure threshold is adopted. As infrastructure
interoperability capabilities improve, we believe it would then be
reasonable to reconsider the appropriateness of applying measures 2
and/or 3 in the hospital context for specified patient populations.
Objective 8: Public Health and Clinical Data Registry
Reporting. Objective 8 focuses on active provider engagement with a
wide range of public health agencies (PHAs) and/or clinical data
registries (CDRs). As proposed, this objective would require EPs to
meet three of five possible measures (with two of these measures able
to count more than once if more than one PHA or CDR were involved),
while hospitals would be required to meet four of six possible measures
(with measure 6 focusing on electronic reportable laboratory result
reporting).
With respect to Objective 8 and its many associated measures, we
believe that the number of measures that need to be met by providers
should be uniformly set at two, rather than the proposed three for EPs
and the proposed four for hospitals. We recognize that the proposed
rule includes a number of exclusions that would have the effect of
reducing the number of measures that a given EP or hospital would need
to meet, in some cases below the required three or four, but we believe
that the proposed thresholds of three and four are too high given the
current state of readiness and the lack of provider experience. While
we understand that CMS views Stage 3 as the final stage, CMS also
acknowledges that future changes to the objectives and measures are
likely to be warranted for a variety of reasons. Therefore, we believe
that additional experience with provider reporting to PHAs and CDRs
should precede any decision about the reasonableness of requiring
provider reporting to three or more PHAs or CDRs.
senator murray
Question 1. The private sector is beginning to make progress toward
standards, including the development of Fast Healthcare
Interoperability Resources (FHIR) that will promote the
interoperability of health information technology. In your testimony,
you note that, ``the Federal Government should be enabled to enhance
its enforcement tools to ensure functional data and transport
standards.'' What enforcement mechanisms should be enhanced?
Answer 1. As this committee heard during the hearing, the current
market incentives are not aligned with open exchange of necessary
healthcare data in cost-effective ways. The sharing of data that sits
in software systems across the care continuum is not only technically
complex, it is also expensive.
The costs of sharing this critical data among other health systems
is not just in dollars. It also results in inefficiently using some of
our most valuable resources--our people. Having care providers faxing
or mailing information to other providers is not the best use of these
highly skilled clinical people.
Thus, the reform goals should be to design and implement a secure
HIT ecosystem that enables an easy exchange of health information in
timely and cost-effective ways. The system should promote collaboration
among all stakeholders, from patients to providers to vendor partners
and payers. We need a system of standards that focuses on improving
healthcare quality, efficiency, safety, affordability and access
through government and market incentives, while encouraging innovation
and competition.
To accomplish these goals, we ask for a combination of
congressional and Administrative actions that promote policy principles
that further open health IT infrastructures. In creating those
structures, we need a combination of clear rules of the road for
providers and vendors alike through establishment of functional data
and transport standards, and methods to measure and test
functionalities, with enhanced enforcement tools for regulatory bodies
to drive compliance in the marketplace. More specifically:
On standards, we need functional data and transport
standards with a focus on key areas including: patient matching,
terminologies, clinical data query language, security, open application
program interfaces (APIs), and clinical decision support algorithms as
well as business practices and policies. Although FHIR is promising, we
need government leadership to prioritize the need for functional data
and transport standards that are necessary within a care context to
enable adoption as they become market-ready.
On the enhancement of enforcement tools, enforcement
should focus on compliance by technology vendors and entities who
choose to do business in the CEHRT marketplace. Through the ONC
certified technology program, they should be required to demonstrate
through testing results that they meet functional data and transport
standards to validate that they meet the metrics for interoperability.
The Federal Government should be enabled to use its existing
enforcement tools as well as be provided with additional tools to
ensure compliance through the ONC certified technology program with
impactful consequences for noncompliance. The provider consumers who
suffer the consequences and disruption due to technology vendors or
entities who fail to comply with the standards and metrics of
interoperability should be provided with hardship exemptions from
meaningful use penalties.
response by christine bechtel to questions of senator murray
Question 1. How would you recommend that the Department of Health
and Human Services (HHS) leverage rulemaking to enhance patient
engagement in health information technology products?
Answer 1. Thank you for the opportunity to expand on this essential
issue. There are several ways in which rulemaking can advance patient
and family engagement in health IT, as well as in their own care.
We recently launched the GetMyHealthData campaign, spearheaded by
the National Partnership for Women & Families, in collaboration with
Amida Technology Solutions; Code for America; Genetic Alliance; Health
Data Consortium; and NATE.
What we have learned so far, unequivocally, is that most patients
and most providers don't know about patients' right to an electronic
copy of their records under HIPAA--an important provision of the HITECH
law. What's more, many providers often don't refer patients to their
own portal, which should be capable of permitting downloads of records
if the provider participates in Meaningful Use. These problems are not
caused by ill-intentioned or bad actors; these providers and their
staff are simply unaware of the law and do not have a workflow designed
to produce e-Copies.
To remedy this, and facilitate broader patient engagement,
rulemaking can help:
Guidance from the Office of Civil Rights regarding the
HIPAA right of access. OCR should strengthen its guidance around this
right, and conduct significant outreach and education efforts to
providers and consumers.
The Meaningful Use program has been and continues to be a
powerful lever for patient and family engagement. Its power lies in the
requirement to genuinely engage patients in using online access to
their health data, as well as in new proposed requirements that
facilitate care coordination. Specifically:
Stage 3 would also increase the percentage of
patients, or authorized family caregivers, that use online
access and secure messaging. Nationally representative data
demonstrate beyond any doubt that electronic access to health
information is a significant catalyst for engaging patients and
families in their care: Almost 9 in 10 patients who have such
access use it, and it has a significantly positive impact on
better care, better communication with providers and improved
outcomes.\1\
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\1\ National Partnership for Women & Families. (2014, December).
Engaging Patients and Families: How Consumers Value and Use Health IT,
from http://www.nationalpartnership.org/research-library/health-care/
HIT/engaging-patients-and-families.pdf.
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However, many patients today do not know that they
have online access and can download their records, because they
are not told by their providers. The requirement implemented in
Stage 2 and continued in Stage 3 for providers to actively
engage a percentage of patients to use their data is mission-
critical in addressing these challenges and making consumers'
use of their own data a reality.
Stage 3 would also introduce Application Programming
Interfaces (APIs) into Meaningful Use for the first time.
These, and the health applications they make possible, could be
a significant benefit to many patients and providers. APIs
could give patients the ability to more easily download the
data they need, in ways they find more useful, and incorporate
the data into their comprehensive record, to be shared and used
by primary care providers and others involved in the patient's
care on an ongoing basis.
A new requirement would also enable providers to not
only send patients' health data electronically, but also to
incorporate patients' health data sent by other providers.
New abilities would also enable patients and
caregivers to contribute information to their medical record
that is specific and material to their care, including
correcting errors in doctors' records.
Therefore, measures of patient electronic access and health
information exchange must be left intact for Stage 3, and these aspects
of Stage 3 cannot be delayed. Further, CMS's proposal for Stage 2 to
reduce the required threshold for patients accessing their health data
to just a single patient should not be finalized.
The EHR Certification rule also offers an important
opportunity to create the necessary technical ability to deliver on the
policy promises outlined above. Through the Certification rule, the
ability to download and transmit patients' own data, as well as the
additional Stage 3 proposed requirements described above, will become
feasible for providers using certified systems.
Alternative Payment Model (APM) rules also offer an
important opportunity to advance patient and family engagement via
health IT. APMs should require the use of certified EHRs, as well as
include at least Stage 2 of Meaningful Use as a basic requirement of
qualification for participation in APMs.
Question 2. What would you identify as key short- and long-term
objectives for patient engagement in the Health Information Technology
for Economic and Clinical Health (HITECH) Act.
Answer 2. Short-term patient engagement objectives:
Accelerating health data access for consumers. HITECH
established in law the policies, technology standards and education
outreach that permit and encourage patient electronic access to and use
of health data. HITECH not only created the Meaningful Use program, but
also created a new right of access to an electronic copy of one's
health record. Also included in the Act was an education campaign
focusing on health IT, privacy and this new right of access.
Reducing health disparities. HITECH included a provision
to advance standardized ways of collecting data on race, ethnicity,
language and gender so these data may be used to reduce health
disparities in the short term, and advance health equity in the long
term.
Giving consumers a voice. HITECH also established
important Federal advisory committees with specifically designated
consumer seats, in recognition of the essential role consumers and
their advocates should play in Federal policymaking. Meaningful Use may
not have had a priority focus on patient engagement without these
consumer voices, and more consumer voices are needed as current
policymakers consider the future of health IT policy, including
interoperability and Meaningful Use.
Long-term patient engagement objectives: Based on the short-term
objectives laid out in the HITECH law, it is clear that long-term
objectives for patient engagement include:
Making consumer access to data ubiquitous, seamless and
easy to use.
Advancing health equity, including equal access to
health information for all individuals, in languages of their
choice, as well as measures of quality that are stratified by
disparity variables (specifically race, ethnicity, language,
gender, sexual orientation and gender identity).
Achieving patient- and family-centered care, including
care that is coordinated, affordable, planned, effective and efficient.
Thank you again for the opportunity to provide input. Please don't
hesitate to contact me with any questions.
______
Cerner,
Kansas City, MO 64117,
July 13, 2015.
Hon. Lamar Alexander, Chairman,
Senate HELP Committee,
428 Dirksen Senate Office Building,
Washington, DC 20510.
Hon. Patty Murray, Ranking Member,
Senate HELP Committee,
428 Dirksen Senate Office Building,
Washington, DC 20510.
Hon. Orrin Hatch,
Senate HELP Committee,
428 Dirksen Senate Office Building,
Washington, DC 20510.
Hon. Tammy Baldwin,
Senate HELP Committee,
428 Dirksen Senate Office Building,
Washington, DC 20510.
Dear Chairman Alexander, Ranking Member Murray, Senator Hatch and
Senator Baldwin: Thank you for the opportunity to testify at the June
10, 2015, HELP Committee Hearing entitled, ``Health Information
Exchange: A Path Toward Improving the Quality and Value of Health Care
for Patients.''
Please find attached my responses to your Questions for the Record.
I welcome any opportunity to discuss these questions or any others
as you continue your very important work.
Respectfully yours,
Neal L. Patterson,
Chairman and CEO.
______
Response of Neal L. Patterson to Questions of Senator Alexander,
Senator Hatch and Senator Baldwin
senator alexander
Question 1. You have mentioned that there are four specific things
that physicians complain about the most relating to the burden of
documentation. You've also said that three of those four things could
be shifted to other members of the care team to free up more physician
time.
What do you think providers should continue to document and what do
you think could be shifted to other members of the care team?
Answer 1. Capturing the patient's health history, present illness,
and course of treatment through observations, evidence of medical
decisionmaking, treatment plans and outcomes is critical for
facilitating treatment and continuity of care, driving accurate coding
to maximize revenue, and calculating a facility's quality of care
indicators. These needs are not new--they existed in the paper world
and are deeply embedded in the Fee-For-Service model.
Further confounding the automation of the clinical workflow through
electronic health records is the effect of narrowly interpreting
prescriptive regulatory requirements, resulting in workflows that have
driven physicians to become highly trained, highly specialized data
entry experts.
State licensure, State boards governing specific professions,
Medicare conditions of participation, and hospital or practice policies
dictate patient care activities dependent on physician involvement, as
well as permitted activities for non-physicians, such as physician
assistants and advanced practice nurses. Specific to Meaningful Use
requirements, according to CMS FAQ10071, computerized physician order
entry (CPOE) is the only Meaningful Use objective that has limitations
on who can perform the activities necessary for that particular
objective to meet the measure--it must be performed by a licensed or
certified provider with clinical knowledge.
What we have seen implemented at hospitals and physician practices,
however, are complicated physician workflows that go beyond traditional
approaches and attempt to address multiple objectives: e-prescribing
(eRx), medication reconciliation, clinical summary, patient education,
transition of care summaries (for which the physician must verify that
the summary contains a problem list, medication list and medication
allergy list), and patient portal.
I believe that government needs to ``round the corners and smooth
the edges'' of regulations and provide guidance so that critical data
can still be captured as part of the patient's record, yet care team
members--including nurses and physician assistants--are able to proxy
for physicians, particularly in the areas of medication reconciliation,
orders, clinical documentation and discharge planning, where exclusive
physician responsibility for these activities is not required.
The shift away from the Fee-For-Service payment model is a major
step in the right direction. CMS could speed this process by relaxing
the complex evaluation and management (E/M) documentation guidelines or
by expressly allowing non-physicians to complete the aspects of that
work that do not require physician judgment, but with physician final
review. Further, Meaningful Use must not impose any additional
requirements--either actual or perceived--that hospitals and physician
offices should presume physicians must perform when State licensure and
State medical and health professional board regulations allow non-
physician roles to do so.
Question 2. Many stakeholders have suggested that the health
information technology industry could come up with many solutions to
the problem of interoperability on its own. However, so far, we are
stuck with a system that does not work even though the government has
spent over $30 billion.
What areas would be best determined by private industry? What areas
should the government decide, if any?
Does the government need to set deadlines or otherwise encourage
industry to make decisions?
Answer 2. EHRs should be built to be interoperable--to exchange
critical information with providers and organizations across the
patient's entire continuum of care. Clinical data should always flow
unimpeded to wherever it is needed for direct clinical care of the
patient.
It is true the industry has not yet ``solved interoperability'' for
seamless exchange, yet we have made significant strides and learned
valuable lessons.
Standards alone will not create interoperability.
Standards must be developed and tested by the private industry based on
real-word use cases. Deployment and use of the standards must be to
achieve a business purpose. Government should continue to facilitate
emergence of appropriate business drivers through changes in provider
payment that reward managing care over a continuum, and perhaps other
regulatory pressures if market forces prove to be inadequate.
Government could also play a role in funding pilots and demonstrations
of up-and-coming standards. Government should facilitate transparency
around the degree of actual data sharing so that ``data blockers'' will
be exposed to market scrutiny.
Nationwide interoperability requires an open network that
has a reliable method of patient identity management, record location
tracking and patient-driven consent.
The network must manage contractual and legal
arrangements necessary to share health data, as well as deploy
a governance mechanism to ensure the arrangements are followed.
Government could play a role in ``blessing'' material elements
of such arrangements to reduce the amount of time needed to
negotiate new relationships and to ensure that participants are
comfortable that such an arrangement complies with appropriate
regulations. The government could encourage and/or require
public transparency of business practices, and provide
enforcement mechanisms when a business entity falls short of
its obligations.
These networks require the active engagement and
collaboration of their participating entities. They cannot be
simply created by a legislative vehicle.
CommonWell Health Alliance is such a network.
The government should define the ``what'' and ``when''--the U.S.
health care stakeholders should define and achieve the ``how.''
Question 3. If you could change all or parts of the proposed rules
for Stage 2 and 3 of Meaningful Use and the 2015 certification rule,
what would you change?
Are there particular parts that should be delayed and others that
should go forward? What changes would you make to them?
Do you think that the proposed rules will make health information
technology better? If so, which parts?
Are there any parts of the proposed rules that you think would make
health information technology worse? If so, which parts?
Answer 3. For more detailed responses to your questions, I have
attached Cerner's responses to each respective proposed rule:
Modification of Stage 2, Stage 3 and 2015 CEHRT.*
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* Due to the high cost of printing, the attachment referred to have
been retained in committee files.
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Two key points:
1. A wholesale delay of the Stage 3 timeline could create a major
disruption in momentum of health IT adoption that could interfere with
payment reform and advanced initiatives such as precision medicine.
January 1, 2018, should remain as the start date for Stage 3; however,
the final rules should proceed with a purposeful focus on requirements
that advance interoperability and increase patient engagement.
2. ONC should propose certification criteria beyond what is
necessary for Meaningful Use only at the point in time they are
required by other Federal program requirements, and not presume a
market role absent a Federal policy interest.
senator hatch
An HIT vendor change brings with it new challenges, including data
collection and reporting, which are both part of Meaningful Use
requirements, as well as patient safety issues. One hospital system in
my State estimated that it could take as long as 19 months to safely
transition EHRs.
Question 1. From your experience, can you tell us how long
installing an EHR takes and give us a sense of all of the steps
required? Please describe the timing and the complexity of the problem
for a physician office, for a hospital, and for a multi-hospital
system.
Answer 1. The answer varies based on organization size and profile.
For example, we can have a stand-alone physician office live in 3
months. A single hospital system typically requires 14 months, as is
our standard recommendation for a community-based health system;
however, a larger, multi-facility health system could reasonably expect
18-24 months.
Most EHRs are highly configurable so they can meet the needs of a
variety of different kinds of provider organizations. At a high level,
steps accomplished in the implementation timeframe include:
Planning: Project governance, organizational change
management, resource allocation, current State assessment, definition
of measurable project outcome.
Execution: Executing the plan, defining future State
(people, process, technology), building the configurable parts of the
EHR, testing and training.
Conversion/System Adoption: Includes post conversion
assessment, adoption confirmation, outcomes measurements.
Question 2. In what ways would transitioning to a new HIT vendor
interfere with a provider's ability to comply with Meaningful Use
requirements? What considerations would ease the burden on providers
looking to transition from one vendor to another? What are the merits
of a hardship exemption from Meaningful Use penalties for such
circumstances, and what other options would you suggest? What would be
an appropriate amount of time for a hardship exception from Meaningful
Use penalties for providers who transition vendors?
Answer 2. Even with a fairly seamless transition to a new system,
the provider or hospital must be live on this new system for some time
to reach productive use in the same (or improved) mode and manner
experienced before. Expecting immediate par level results with a new
conversion may not be realistic for at least a period of months.
The challenge of transitioning to a new technology is much greater
than simple data migration--the provider/hospital must essentially re-
implement and roll out all features. This likely requires process and
workflow changes, database customiza-
tion, education, and so on. Post implementation, a client may
experience a re-adoption curve where performance levels may dip, or a
dual system period with multiple reporting approaches.
Some measures allow for consideration of activity that occurs
before, during or after the reporting period. That data may not be
available to the new system, as the old system's mechanism may not be
``translatable'' for how the new system recognizes numerator credit,
the data that was the basis of proof in the old may not be able to be
converted, or it simply may be a process not available to the new. To
that extent, any such functional measures need time to build that
history for the activity data, which may require more than simple data
conversation but actual new rounds of seeing existing patients to
establish or re-establish that history.
In Cerner's experience dealing with technology transitions, one of
our clients' biggest issues is related to the patient reminders
objective for Stage 2 Eligible Providers (EPs). Fortunately, this issue
would be addressed under the proposed Stage 2 Modification Rule. As way
of example, however, on that measure, there is a requirement that the
provider send patient reminders to 10 percent of patients that have had
two or more encounters in the 24 months prior to the reporting period.
If the provider switched vendors, pulling relevant data could be a
potentially expensive and time-consuming process for that one measure.
Public health reporting may create another issue. If a provider/
hospital is submitting on an ongoing basis for public health and then
switches technologies, the rule is not clear as to whether there will
be a new time to enter into ``active engagement'' again.
To help facilitate a technology transition, we suggest, at a
minimum, a hardship exemption that avoids penalties. To support ongoing
incentives, and/or in lieu of a hardship exemption, allowing the
provider/hospital the ability to attest in good faith--without being
judged strictly on measurement achievement--may also be a helpful
option. So would allowing a temporary break in reporting, focusing on
attestation when the provider is fully operational on the new system,
but not necessarily the entire year. In general, regulatory measures
that focus on ``process'' rather than ``outcome'' will be harder to
transition to a new system. This is one reason why we favor focus on
the ``what'' rather than the ``how.'' If a new system has a better
approach to certain processes, then those process changes should not
adversely effect achievement of incentives.
senator baldwin
Question 1. I am encouraged by progress made on vendor-developed
exchanged networks, such as Epic's Carequality and Cerner's CommonWell.
How many patients have opted in to CommonWell as of the date of this
hearing? What percentage of hospitals and clinics using Cerner's EHR
software are currently connected to CommonWell?
Answer 1. CommonWell Health Alliance, an open, industry-driven,
vendor-led Alliance consisting of 29 health IT organizations including
Cerner, concluded its year-long pilot testing and began nationwide
rollout of services in January 2015. Seventy-three facilities were
connected and live on CommonWell services as of June 10 (the date of my
testimony), with 5,000 facilities anticipated to be enrolled by years'
end.
While CommonWell is in early deployment across the country, we are
reporting promising patient adoption. As of June 10th, over 30,000
patients were actively enrolled in CommonWell, and active data exchange
was occurring nationwide. We fully anticipate that growth in these
numbers will accelerate as the national rollout expands, as new members
extend services, and as provider utilization increases.
Specific to Cerner, 336 acute facilities using Cerner's EHR are
currently enrolled in CommonWell services. This represents
approximately 10 percent of Cerner's acute client base.
Of course, even as CommonWell adoption grows, we continue to
support a number of interoperability activities, including connections
to more than 130 HIEs and numerous point-to-point connections, many
facilitated by Cerner's open, standards-based exchange network. All
told, last month (June), we generated more than 7.7 million CCD records
across our client base. Most were for consumption by non-Cerner
systems.
If you have additional questions specific to CommonWell, I
encourage you to contact: Jitin Asnaani, Executive Director, CommonWell
Health Alliance. 617.396.4009; [email protected],
commonwellalliance.org.
Question 2. It is important that we support putting into place a
national structure to enhance and connect existing networks so they can
seamlessly and securely share patient records with each other.
Therefore, it is critical to identify any barriers to participation in
networks, as well as barriers that may inhibit connecting of networks.
Do you see potential drawbacks in charging for the licensing or use of
interoperability software? Does this create any barriers for
participation?
Answer 2. The pricing of interoperability services is a great
concern, particularly as we try to encourage a State of true nationwide
interoperability. Point-to-point interfacing has traditionally been
very labor intensive and costly, and that is one of the reasons we saw
a need for CommonWell. Interoperability should be free for patients,
and priced like a public utility (like water or electricity) for
provider organizations. As the beneficiary of all the public investment
in health IT, it doesn't bother me if the industry/vendors have to pay
a little more to make this happen.
It is Cerner's goal to provide interoperability services at a low
cost to health care providers, and to engage in fair practices that do
not financially penalize connections that flow outside of our own
network to other vendors or other networks. We endeavor to embrace the
notion of FRAND (fair, reasonable and non-discriminatory) pricing. A
good example of FRAND pricing at work: when a Cerner client signs up
for CommonWell, they pay a low, one-time setup fee, and that covers all
their standards-based connections, whether those connections are to the
CommonWell network or to organizations using non-CommonWell vendors
such as Epic. Right now we don't have direct bridging between
CommonWell and the entire Care Everywhere network, but we support
unlimited connections to points inside that network. We believe that
direct bridging of networks will follow. When that happens, our work
will be easier, not harder.
Countless dollars have been spent as a nation on health information
exchange networks, yet they rarely scale to all the venues where any
given patient actually receives care. I believe the greatest barriers
to participation in networks are associated to the creation of the
networks themselves, not a result of connecting them. These are the
exact frustrations--governance and data sharing agreements, patient
identification, record location and consent management--that sparked
the need for CommonWell to provide more services than simply bridging
limited network infrastructures. In other words, problems within the
networks themselves must be addressed--not just the efforts--and
costs--necessary to connect them.
[Whereupon, at 11:45 a.m., the hearing was adjourned.]
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