[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
HEALTH INFORMATION TECHNOLOGIES: HOW INNOVATION BENEFITS PATIENTS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
__________
MARCH 20, 2013
__________
Serial No. 113-21
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania GENE GREEN, Texas
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee LOIS CAPPS, California
Vice Chairman MICHAEL F. DOYLE, Pennsylvania
PHIL GINGREY, Georgia JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana JIM MATHESON, Utah
ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington JOHN BARROW, Georgia
GREGG HARPER, Mississippi DORIS O. MATSUI, California
LEONARD LANCE, New Jersey DONNA M. CHRISTENSEN, Virgin
BILL CASSIDY, Louisiana Islands
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
CORY GARDNER, Colorado BRUCE L. BRALEY, Iowa
MIKE POMPEO, Kansas PETER WELCH, Vermont
ADAM KINZINGER, Illinois BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
Subcommittee on Health
JOSEPH R. PITTS, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee JIM MATHESON, Utah
PHIL GINGREY, Georgia GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey JOHN BARROW, Georgia
BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin
BRETT GUTHRIE, Kentucky Islands
H. MORGAN GRIFFITH, Virginia KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
C O N T E N T S
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Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 2
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 3
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 4
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 6
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, prepared statement.................................... 163
Witnesses
Joseph M. Smith, M.D., Ph.D., Chief Medical and Chief Science
Officer, West Health Institute................................. 8
Prepared statement........................................... 11
Answers to submitted questions............................... 170
Christine Bechtel, Vice President, National Partnership for Women
And Families................................................... 67
Prepared statement........................................... 69
Jim Bialick, Executive Director, Newborn Coalition............... 74
Prepared statement........................................... 76
Answers to submitted questions............................... 173
Jacqueline Mitus, M.D., Senior Vice President, Clinical
Development and Strategy, McKesson Health Solutions............ 83
Prepared statement........................................... 85
Answers to submitted questions............................... 177
David Classen, M.D., Chief Medical Information Officer, Pascal
Metrics, and Associate Professor of Medicine and Consultant in
Infectious Diseases, University of Utah School of Medicine..... 130
Prepared statement........................................... 132
Answers to submitted questions............................... 179
Submitted Material
Letter of March 20, 2013, from Kevin McCarthy to the Committee,
submitted by Mr. Pitts......................................... 164
Statement of The Bipartisan Policy Center, submitted by Mr. Pitts 166
HEALTH INFORMATION TECHNOLOGIES: HOW INNOVATION BENEFITS PATIENTS
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WEDNESDAY, MARCH 20, 2013
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:00 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Joe Pitts
(chairman of the subcommittee) presiding.
Present: Representatives Pitts, Burgess, Hall, Shimkus,
Blackburn, Gingrey, Lance, Guthrie, Griffith, Bilirakis,
Ellmers, Pallone, Green, Barrow, Christensen, Sarbanes, and
Waxman (ex officio).
Staff present: Clay Alspach, Chief Counsel, Health; Matt
Bravo, Professional Staff Member; Debbee Hancock, Press
Secretary; Sydne Harwick, Staff Assistant; Sean Hayes, Counsel,
Oversight and Investigations; Robert Horne, Professional Staff
Member, Health; Carly McWilliams, Legislative Clerk; Andrew
Powaleny, Deputy Press Secretary; Chris Sarley, Policy
Coordinator, Environment and the Economy; Heidi Stirrup, Health
Policy Coordinator; Alli Corr, Democratic Policy Analyst; Eric
Flamm, FDA Detailee; Amy Hall, Democratic Senior Professional
Staff Member; Elizabeth Letter, Democratic Assistant Press
Secretary; Karen Nelson, Democratic Deputy Committee Staff
Director for Health; Rachel Sher, Democratic Senior Counsel;
and Matt Siegler, Democratic Counsel.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. The subcommittee will come to order. The chair
will recognize himself for an opening statement.
Today's hearing is part of a series of Energy and Commerce
subcommittee hearings this week that focus on health,
technology and innovation.
In the last few years, health information technologies,
including mobile medical applications, electronic health
records, personal health records, computerized health care
provider order entry systems, and clinical decision support,
have transformed the provision of health care in this country.
Electronic health records hold great promise for the delivery
of care given and the quality of care received in this country.
They have also been identified as key components of future
payment reforms such as those envisioned for medical providers
under the SGR.
There are now mobile medical apps for wireless
thermometers, apps that calculate body mass index, apps that
track the number of miles a runner has jogged and those that
can wirelessly transmit data to wearable insulin pumps. These
apps can range from the complex, like mobile cardiac outpatient
telemetry that uses wireless sensors, to those that allow users
to count calories.
To give you a sense of the scope of their importance, it
has been estimated that 500 million people will be using
medical apps by the year 2015. Therefore, it goes without
saying that these technologies hold great potential for
patients and providers. However, with the proliferation of
these technologies have come concerns about how their use may
negatively impact patients. Some have argued that federal
oversight of these health information technologies is important
to safeguard patients from malfunctioning technology.
In response to these concerns, the Office of the National
Coordinator in December of 2012 put out a proposal for a risk-
based regulatory scheme for electronic health records that
sought to address the needs of Americans both as consumers and
patients. The Food and Drug Administration has also put forward
a proposal, in the form of draft guidance issued in July 2011,
indicating its intent to regulate certain apps as medical
devices under section 201(h) of the Federal Food, Drug and
Cosmetic Act.
While FDA's attention to the needs of patients is
commendable, its action requires very close scrutiny. This
subcommittee has examined in the past the negative impacts that
FDA regulation, with its uncertainty, high costs, and long
approval times, has had on the medical device industry. If we
allow the same to happen in this space, such negative impacts
could cripple a still evolving and promising industry, where
the average developer is small and the cost of these apps is
relatively inexpensive.
Some have also raised concern that the FDA may further
expand the definition of ``medical device'' in the future to
include other technologies, such as smartphones or tablets, and
thus the medical device tax passed in the Patient Protection
and Affordable Care Act could apply to them.
Therefore, this hearing is an appropriate place to examine
the extent to which the FDA and other federal agencies should
be involved in regulation of health information technologies
and what such a regulatory framework might look like.
With these thoughts in mind, I want to thank our witnesses
for being here today and look forward to their testimony.
[The prepared statement of Mr. Pitts follows:]
Prepared statement of Hon. Joseph R. Pitts
Today's hearing is part of a series of Energy and Commerce
subcommittee hearings this week that focus on health,
technology and innovation.
In the last few years, health information technologies,
including mobile medical applications (apps), electronic health
records, personal health records, computerized health care
provider order entry systems, and clinical decision support,
have transformed the provision of health care in this country.
Electronic Health Records hold great promise for the
delivery of care given and quality of care received in this
country. They have also been identified as key components of
future payment reforms such as those envisioned for medical
providers under the SGR.
There are now mobile medical apps for wireless
thermometers; apps that calculate body mass index; apps that
track the number of miles a runner has jogged and those that
can wirelessly transmit data to wearable insulin pumps. These
apps can range from the complex, like mobile cardiac outpatient
telemetry (MCOT) that uses wireless sensors, to those that
allow users to count calories. To give you a sense of the scope
of their importance, it has been estimated that 500 million
people will be using medical apps by 2015.
Therefore, it goes without saying that these technologies
hold great potential for patients and providers. However, with
the proliferation of these technologies have come concerns
about how their use may negatively impact patients. Some have
argued that federal oversight of these health information
technologies is important to safeguard patients from
malfunctioning technology.
In response to these concerns, the Office of the National
Coordinator in December 2012 put out a proposal for a risk-
based regulatory scheme for electronic health records that
sought to address the needs of Americans both as consumers and
patients.
The Food and Drug Administration (FDA) has also put forward
a proposal, in the form of draft guidance issued in July 2011,
indicating its intent to regulate certain apps as medical
devices under section 201(h) of the Federal Food, Drug and
Cosmetic Act (FFDCA).
While FDA's attention to the needs of patients is
commendable, its action requires very close scrutiny. This
subcommittee has examined in the past the negative impacts that
FDA regulation--with its uncertainty, high costs, and long
approval times--has had on the medical device industry. If we
allow the same to happen in this space, such negative impacts
could cripple a still evolving and promising industry, where
the average developer is small and the cost of these apps are
relatively inexpensive.
Some have also raised concern that the FDA may further
expand the definition of ``medical device'' in the future to
include other technologies, such as smart phones or tablets,
and thus the medical device tax passed in the Patient
Protection and Affordable Care Act could apply to them.
Therefore, this hearing is an appropriate place to examine
the extent to which the FDA--and other federal agencies--should
be involved in regulation health information technologies and
what such a regulatory framework might look like.
With these thoughts in mind, I want to thank our witnesses
for being here today and look forward to their testimony.
Mr. Pitts. And no one is seeking recognition. I will close
my statement and recognize the ranking member of the
Subcommittee on Health, Mr. Pallone, for 5 minutes for his
opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE JR, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you. Thank you, Chairman Pitts.
Today is an important examination of the ways in which
health information technologies can benefit patients, doctors,
and the health care system as a whole. HIT is an absolutely
essential underpinning to the future of delivery and payment
reform.
The notion that if we can improve the coordination of care,
patient safety, disease management, and prevention efforts, we
can save money for the entire system. It is not baseless. In
fact, it has the utmost merit. Modernizing our health care
system and moving into an electronic era is part of a national
conversation that is occurring, and politicians of both
political parties, providers, and patients all agree that HIT
holds tremendous promise for improving the performance of our
healthcare system in a way that will increase access, enhance
quality, and indeed lower costs.
That is why as chairman of this subcommittee, I worked
alongside many of my colleagues, Democrat and Republican alike,
and we passed the Health Information Technology for Economic
and Clinical Health Act, otherwise known as HITECH or the
HITECH Act. Together, we recognized with that bill that there
was a need for the Federal Government to commit to expanding
the use of information technology in the health care sector,
and that its widespread adoption would have significant long-
term benefits. This critical law contained unprecedented
funding to promote the adoption of health information
technology among hospitals, doctors, and health care providers
through initiatives by the Office of the National Coordinator
of HHS and through Medicare and Medicaid incentives. This
historic investment has begun to help modernize our Nation's
use of technology to truly ensure a high-performing 21st
century health system, and in building an infrastructure of
fundamental change.
The truth is that we have made great progress so far, and
there are even more opportunities that will be realized in the
future through the implementation of this law. As a result of
these programs, electronic health records, EHRs, and meaningful
use of those records has increased dramatically in recent
years, and we will hear today from some of the witnesses how it
is working to make life better for patients and serving as a
catalyst for innovation.
Now I am afraid that my Republican friends are going to
spend this day making up false stories about how the Affordable
Care Act and FDA regulation is stifling innovation--how our
smartphones are going to be taxed and Apple's manufacturing
plants will be inspected, but I have to say this is nonsense.
The reality is the future of mobile health is very bright. In
fact, there is an effort underway by the Federal Government to
open up large sets of data to be used by developers to create
these mobile applications, and many of these apps are designed
to assist both individuals and health care providers in
managing health care decisions and delivery. One industry
analyst estimates that the total revenues of the mobile medical
app market will grow to $26 billion by 2017, and because of the
HITECH Act, this open data will be able to be networked and
shared with providers to improve patient health and lower
costs.
But I believe, and I think all of our witnesses today will
agree with me, that if a technology developer is going to make
health-based claims, then there must be a role for FDA to
ensure it is safe and effective, and I hope that is what comes
out of today's hearing is a better understanding of how the
successful adoption of health information technology will have
a transformative effect on the quality of health care in the
United States, as well as the economy of health care.
So I thank you all, thank the chairman, and I would yield
back the balance of my time.
Mr. Pitts. Chair thanks the gentleman, and now recognizes
the vice chair of the subcommittee, Dr. Burgess, for 5 minutes
for an opening statement.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. I thank the chairman for the recognition. I am
grateful to the chairman for holding this hearing, grateful to
our panel for presenting to us today.
The title of the hearing is fitting. As somebody who worked
in health care, I recognize the benefit that innovation brings
to patients. From the newest means to detect and diagnose
conditions, to the cures and diseases that once were thought
untreatable, innovation has led the way to bettering the lives
of patients.
Health care innovation doesn't always lower costs, but it
always holds the potential to improve the quality of life and
therefore is a goal worth pursuing in and of itself.
The tools that future doctors will have at their disposal
will be unparalleled in the history of medicine for their
ability to alleviate human suffering and improve lives, but we
need to get the tools in their hands. From custom biologics to
nanotechnology to the promises of the human genome, we are on
the cusp of a medical revolution. The President, in an
Executive order, ordered federal agencies to review and remove
outdated regulations. I absolutely agree with Mr. President,
but the proof really remains to be seen.
The biggest impediment to innovation is the uncertainty of
regulation. If the Federal Government thinks about regulating
something, that almost always means it is planning to over-
regulate. There is the difficultly, because the lifeblood of
innovation, venture capital, will be drained away from the
cures that might have been.
As a doctor, first do no harm. I don't want to do anything
that will harm a patient. But while the FDA struggles with
their core requirements that they propose to venture into new
areas like mobile apps and research only products and health
information technology, it really does require a soft touch.
Instead of talking to stakeholders, including members of
Congress, where updates may be needed from time to time, and
significant proposed regulatory changes could stop innovation
in their tracks, we are just not seeing it happen. Companies
will build it, doctors will use it, patients will benefit if we
could just get out of the way and ensure responsible regulation
in a timely fashion.
The reason I care about this so much is because not just
today, this is about the future. This is about the men and
women that will follow after us in the practice of medicine.
These are about the ideas that somebody hasn't even had yet.
The lack of a reliable and consistent regulatory process
signals an inability to handle the events for technology in the
future.
Mr. Chairman, this hearing is timely. It is in conjunction
with other hearings being done in other subcommittees and the
full committee. Technology had a hearing yesterday. We will
have a hearing in Oversight and Investigations tomorrow. But it
is part of a process.
I would like now to yield the balance of the time available
to the gentlelady from Tennessee, the vice chair of the full
committee.
Mrs. Blackburn. I thank the gentleman for yielding, and
welcome to each of you. We are delighted that you are here.
As Dr. Burgess said, we had a Telecom Subcommittee hearing
yesterday, and looked at the impediments to innovation. It was
fantastic to have a group of innovators sitting at your table
and talking to us about the problems that they are seeing.
Now, one of my colleagues said that he feared we would
spend our time making up stories about how HHS and FDA kind of
get in the way, but we don't have to make them up. All we have
to do is read the testimony from yesterday.
One of the things that came through regularly in their
words was that the uncertainty that is there from the FDA, this
big gray area in the center, that you don't know if you are
going to be regulated as a medical device. If you don't know
how far that arm of government is going to reach and how
massive the overreach will be, or will it be contained and will
there be some certainty?
Now, I don't think it is up to the FDA to provide that
certainty. I think it is up to Congress to decide what FDA's
role should be. We are seeking your thoughts and the panel
yesterday and tomorrow to make certain that we approach this in
the appropriate manner. What we want to be certain that we do
is allow the environment for innovation to take place. As Dr.
Burgess said, these are tools that today's doctors and future
doctors are going to be able to use. I think 15 percent of apps
are used by providers. That is something that will yield to
cost savings. At the same time, patients are able to have a
more active participation in their health care, from managing
diseases and chronic conditions, by having access to an app
that goes with them everywhere they go.
So we look forward to hearing from you to setting the right
path forward, and we thank you for your time.
I yield back.
Mr. Pitts. Chair thanks the gentlelady, and now recognizes
the ranking member of the full committee, Mr. Waxman, for 5
minutes for an opening statement.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you, Mr. Chairman.
Today is our second day of hearings on this subject. This
is the week that this committee decided that in three of its
subcommittees, we would hold hearings to scare people that they
won't be able to develop what we want to see developed,
innovative ways to communicate in the health space. The Energy
and Commerce Committee has a history of bipartisan
accomplishments, and even in this area, and that is one of the
reasons, to me, why the partisan hyperbole we have heard from
some on this topic is so disappointing.
Yesterday, the Telecommunications Subcommittee examined
mobile medical applications and the FDA regulation of medical
devices. Both sides of the aisle agree we must promote
innovation in the dynamic mobile medical applications market.
Both sides agree that it is essential for the FDA to ensure the
safety and effectiveness of potentially dangerous medical
devices, even if they are also connected to a mobile platform.
But we spent far too much of yesterday's hearing debating an
imaginary tax on smartphones, because in the Affordable Care
Act, there is a tax on medical devices. So you have got two
things to worry about. If you innovate, FDA might look at it
and regulate it, and two, if it is a medical device, it may be
taxed. Oh, you shouldn't sleep anymore at might worrying about
these problems Republicans are dreaming up.
So they said FDA is going to regulate these iPhones, the
same way it regulates heart valves. Well, that is a political
talking point and it is just not real. I hope today we can
focus on this committee's real bipartisan accomplishments in
health information technology.
In the 111th Congress, the Congress before the last one,
our committee passed what was called the Health Information
Technology for Economic and Clinical Health Act as part of the
Recovery Act. They called this the HITECH--that is the way we
do it, so we got a new acronym. This law resulted in an
explosion of electronic health records and other advanced
health information technology--exactly what we wanted to see.
Physicians, hospitals, pharmacies, health care providers across
the country are building an infrastructure network as important
to our Nation's future as the interstate highway system. It is
just like the construction of the interstates. Building this
infrastructure is challenging. Hundreds of thousands of
physicians, tens of thousands of hospitals, clinics, pharmacies
are going to connect to this network and HHS is--made a lot of
progress by engaging a wide variety of stakeholders and driving
coordination without mandating a ``one size fits all''
solution. So we are trying to develop the ability
technologically to communicate, and it is an ambitious goal. A
seamlessly connected health information infrastructure protects
privacy while demanding the highest quality, most efficient
care. We haven't reached that goal yet, but I believe we are on
track to get there.
So given our enormous progress, it would be rash and unwise
to turn back now. This is worth doing. Similar to the health
IT, our approach to mobile health applications has to strike
the correct balance between innovation and patient safety.
Well, we had a hearing yesterday where we made it clear that
FDA wouldn't take mobile apps and regulate mobile apps, even if
they had information on general health and wellness, and even
if it functioned as electronic health record system. I think it
is wise. We shouldn't regulate this in any way as a medical
device. But if you had something on your iPhone that purports
to help diagnose skin cancer or congenital heart defects, well,
you got to have some appropriate regulatory scrutiny. You get a
lot of false positives, you get false negatives, people are
being confident in these devices, and we better know whether
you can be confident in these devices, if they are going to
tell you that a mole, don't worry about it, it is not
cancerous, when, in fact, it could be melanoma.
We don't believe in this country that buyer should beware.
Well, my colleagues in Congress should act. Congress has acted,
and in fact, when we had the Medical Devices User Fee Act in
the last Congress, we specifically rejected in that bill a
moratorium on FDA's use of its authority over medical devices
that happened to be implemented as mobile applications.
My last point is even if it is regulated as a medical
device, it is not going to be charged with a tax. That tax only
goes to certain kinds of devices. So don't be scared. Look at
the law, look at the reality, and don't listen to the political
rhetoric which this week has been orchestrated very carefully
by my Republican colleagues.
Yield back the balance of my time.
Mr. Pitts. Chair thanks the gentleman.
That concludes our opening statements. We have one panel
today. I would like to thank our distinguished panel of experts
for providing testimony today, and I will introduce them at
this time.
First, Dr. Joseph Smith, Chief Medical and Chief Science
Officer, West Health Institute; secondly, Ms. Christine
Bechtel, Vice President, National Partnership for Women and
Families; third, Mr. Jim Bialick, Professor of Public Policy,
Georgetown Public Policy Institute; fourth, Dr. Jacqueline
Mitus, Senior Vice President, Clinical Development and
Strategy, McKesson Health Solutions; and finally, Dr. David
Classen, Chief Medical Information Officer, Pascal Metrics,
Associate Professor of Medicine and Consultant in Infectious
Diseases, University of Utah School of Medicine.
Thank you all for coming this morning. You will each be
given 5 minutes to summarize your testimony. Your written
testimony will be entered into the record.
Dr. Smith, we will start with you. You are recognized for 5
minutes for your opening summary.
STATEMENTS OF JOSEPH M. SMITH, M.D., Ph.D., CHIEF MEDICAL AND
CHIEF SCIENCE OFFICER, WEST HEALTH INSTITUTE; CHRISTINE
BECHTEL, VICE PRESIDENT, NATIONAL PARTNERSHIP FOR WOMEN AND
FAMILIES; JIM BIALICK, EXECUTIVE DIRECTOR, NEWBORN COALITION;
JACQUELINE MITUS, M.D., SENIOR VICE PRESIDENT, CLINICAL
DEVELOPMENT AND STRATEGY, MCKESSON HEALTH SOLUTIONS; AND DAVID
CLASSEN, M.D., CHIEF MEDICAL INFORMATION OFFICER, PASCAL
METRICS, AND ASSOCIATE PROFESSOR OF MEDICINE AND CONSULTANT IN
INFECTIOUS DISEASES, UNIVERSITY OF UTAH SCHOOL OF MEDICINE
STATEMENT OF JOSEPH M. SMITH
Dr. Smith. Chairman Pitts, Ranking Member Pallone, and
members of the subcommittee, thank you for the opportunity to
testify today. I am Dr. Joseph Smith, Chief Medical and Science
Officer for the West Health Institute, a nonpartisan,
nonprofit, applied medical research organization dedicated to
lowering the cost of health care for public good by research
and development of innovative, patient-centered solutions.
Our Nation's health care system is in dire need of dramatic
change as we lead the world in health care spending, lag many
of our peer nations in critical health outcomes, and face into
a growing aging population a tsunami of chronic disease, with a
relative shortage of physicians, it is difficult to overstate
our challenges, but suffice it to say that our health care
delivery system is exceeding both our Nation's budget and our
provider's bin without yet meeting our patient's needs.
We see an enormous opportunity to use information
technology, device innovation, mobile and wireless technology,
and smart and learning systems to both transform health care
delivery and create empowered, informed consumers of health
care. Health care must be allowed and encouraged to rapidly
evolve using the same innovations that have already
revolutionized banking, education, retail, computing,
photography, and communication. We must take proactive steps to
assure that those technologies that have enabled a revolution
of decentralization, democratization, automation, and
personalization, and other aspects of our lives and our economy
have the same beneficial impact on health care.
To enable this transformation, three elements appear
required. One, streamlined, predictable, transparent, risk-
based regulation that fosters innovation and investment for the
benefit of patients, as well as our ailing health care system;
two, a proactive regulatory and reimbursement stance on true
functional interoperability, not only EHR interoperability, but
specifically, medical device interoperability to create an
integrated, fully coordinated web of patient-centered health
care technology; and three, reimbursement policy that aligns
stakeholder incentives and drives adoption of appropriate
technology to improve safety, efficiency, and cost of care.
At this point in time, when health care is truly a
``burning platform,'' we need to stimulate innovation and
experimentation. This requires a clear, consistent, and timely
approach to regulation. Outside of health care, we have
witnessed a revolution in information, communication, and
device technology driven by innovation and investment, all
encouraged by a predictable regulatory posture. Within health
care, however, we have yet to fully exploit the potent
intersection of these technologies.
With respect to medical apps, while we have witnessed an
explosion of innovation in the health and wellness
applications, we have seen relatively little activity in the
critically important, but more heavily regulated, areas of
remote monitoring, diagnosis and treatment of those chronic
diseases that burden patients, and make up the lion's share of
our health care spending. And for medical apps and clinical
decision support, it is an open question of whether the
existing medical device regulatory framework can be
sufficiently modified to provide the applicability, clarity,
predictability, and timeliness required.
The FDA's draft guidance on mobile medical apps offered
some improved clarity, but still described significant areas of
regulatory discretion, and now after lengthy delay without
becoming finalized has left an industry in limbo.
Going forward, considering the frequency with which both
general app user interfaces and medical treatment guidelines
used in clinical decisions support algorithms that are
routinely updated, the prospect of having all such changes
subject to the complex regulatory process for medical device
revision seems more than daunting. Whatever the process, we
must drive regulation at the pace of innovation, and not vice-
versa.
The second priority is to use regulatory and reimbursement
policy to encourage true functional interoperability of
information systems, and medical devices. Health care needs to
exploit a truly connected and coordinated med app technology
that can be seen as originating at the patient with those
surrounding or even implanted medical devices with seamless
sharing of relevant information among all such devices and the
background EHR. The current lack of such true functional
interoperability results in safety hazards and inefficiencies
that we do not tolerate in other less critical areas, and it
creates additional barriers for new innovative entrants.
Standards-based interoperability allows the information
required for commerce and banking and communication and
education to move at the speed of innovation, and yet, when it
comes to our health care, information is stuck in multiple non-
communicating silos as lifesaving devices are forced to work
independently, despite being inches apart, all in service of
the same critically ill patient.
Today we released a study illustrating that true functional
medical device interoperability not only brings improvements in
patient safety and efficiency, but may also result in savings
of more than $30 billion annually. Established labeling for
medical device interoperability and inclusion of such stage
three meaningful use could encourage adoption of such
functional interoperability for patient benefit and health care
savings.
The third priority area is regulation of reimbursement
policy that promotes aligned incentives. Reimbursement systems
that disproportionately reward hospital-based procedures over
office-based procedures, or face-to-face encounters over remote
encounters need to give way to reimbursement based on outcome,
not location, and value, not volume. Only in this way will we
unleash the power of information communication and medical
device technology.
In closing, the West Health Institute believes that
streamlined, predictable, transparent, risk-based regulation, a
proactive regulatory and reimbursement stance on medical device
interoperability, and realistic and actual policy to align
stakeholder incentives can help to unleash a needed and long
overdue transformation of our health care delivery system to
allow it to sustainably address the needs of today's patients
and meet tomorrow's challenges.
Thank you very much.
[The prepared statement of Dr. Smith follows:]
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Mr. Pitts. Chair thanks the gentleman, and now recognizes
Ms. Bechtel for 5 minutes for an opening statement.
STATEMENT OF CHRISTINE BECHTEL
Ms. Bechtel. Good morning. I am Christine Bechtel with the
National Partnership for Women and Families. We are a
nonprofit, nonpartisan consumer advocacy organization. I also
serve on the Federal Health IT Policy Committee.
I am honored to speak today about how the EHR Incentive
Program, commonly known as ``Meaningful Use'', is catalyzing
fundamental change in our health care system and advancing
innovation.
Almost 3 years ago before this same subcommittee, I shared
a story of Susan Crowson, and she is a family caregiver from
Maryland, and she cared for her father, Pop. Pop was seeing
five different doctors, taking three different prescription
drugs, two over-the-counter drugs, and daily vitamins to manage
a host of complex conditions, including Alzheimer's Disease,
and arrhythmia. Susan diligently tracked all of Pop's
medications, tests, lab results, and visits on a spreadsheet to
help his doctors avoid medical errors and provide the best care
possible in our highly fragmented system.
Today, the Meaningful Use Program is making care better for
people like Pop and caregivers like Susan. Providers with
certified EHRs now maintain up-to-date electronic lists of
patient's health conditions, diagnoses, and medications, and
doctors can automatically track for drug interactions and
allergies. Pop and Susan can get a summary at every office
visit so they know the diagnosis and the plan. If Pop is
admitted to the hospital, they can send a summary of his
admission to his primary care doctor. These are just some of
the early innovations in health IT.
Sadly, many of these advances were not put in place quickly
enough to help the Crowson family. Since I last testified, Pop
has passed away. But thanks to Meaningful Use, patients and
family caregivers like Susan are less likely to face these same
struggles. They are now coming to expect health IT, just as
technology has revolutionized so many other aspects of our
life.
Indeed, the arc of adoption has surpassed our expectations.
At the last subcommittee hearing in 2010, we wondered if
incentive payments would be effective drivers of EHR adoption.
We asked if providers would be able to achieve Meaningful Use.
Federal officials then offered a high end estimate of 53
percent of office-based physicians would adopt EHRs by 2015.
But as of this February, 2 years before the 2015 projection,
CMS reports that 40 percent of eligible professionals have
already completed phase one of Meaningful Use, either in
Medicare or Medicaid, and more than 70 percent have registered
for it. Hospitals have been even more successful. Seventy
percent are already Meaningful users, and 85 percent have
registered.
But there is much more work to do. To foster continued
innovation, we must deploy a wider array of standards through
HHS's certification program, which has been essential to
breaking down technical barriers to the secure sharing of
health information. It is this federal leadership which occurs
in collaboration with the private sector that is critical to
innovation.
We also need new approaches to payment that moves us beyond
fee-for-service and creative business case for care
coordination and improved health outcomes. This can only be
done by rewarding quality and value over volume. But we simply
cannot measure and reward this kind of care without health IT.
Even within these limitations, though, advancements in
standardization spurred by the Meaningful Use regulations are
catalyzing innovation. So for example, Medicare and the VA
implemented a feature called Blue Button that allows
individuals to securely view and download their health
information online, and this innovation is making a world if
difference for people like Beth Schindele, who cares for her
father, William Graves. With his permission, Beth went to
mymedicare.gov and downloaded his health information when he
was in the hospital. The data from Blue Button showed that he
had more than 63 providers caring for him over the course of
four hospitalizations in the last year and a half, and she told
me last week ``Having the data in my hands during his
hospitalization allowed me to prevent the hospital from
erroneously placing him on Coumadin, which is a blood thinning
medication, and he had stopped taking that 2 years ago. I am so
thankful that I did. Within hours of discharge, he fell and he
suffered severe head and arm lacerations that would have been
life-threatening had he been on Coumadin, and would have
resulted in a readmission within just 5 hours of leaving the
hospital.'' Blue Button is a simple, yet powerful, innovation
that will help consumers play a critical role in promoting
safer, more affordable, and more coordinated care.
For this kind of innovation to accelerate, the challenge
before us is to ensure that every provider in the country has
health IT. We must expand the Meaningful Use program to connect
other providers like long-term care, behavioral health, and
home health. No other program in history has done this much
this quickly to advance the adoption of health IT, and I am
confident that along with payment reform, it will result in
better care at a lower cost. Thank you.
[The prepared statement of Ms. Bechtel follows:]
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Mr. Pitts. Chair thanks the gentlelady and now recognizes
Mr. Bialick for 5 minutes for an opening statement.
STATEMENT OF JIM BIALICK
Mr. Bialick. Chairman Pitts, Ranking Member Pallone,
members of the subcommittee, thank you for the opportunity to
testify on this important issue. And thank you, Mr. Pitts, for
the promotion, but I am actually the Executive Director of the
Newborn Coalition. We are an all volunteer organization that
came together to promote the development and use of mobile apps
and technology in newborn and infant health.
The catalyst for our beginning was the birth of a baby
named Eve, who at 40 hours old was diagnosed with a critical
congenital heart defect, the most common birth defect in the
U.S. affecting nearly 1 in 100 births. Had it not been for an
attentive nurse, Eve would have been discharged with a
partially formed heart. While a simple screening tool, pulse
oximetry, exists to identify these conditions, there is still
no national requirement for routine screening. Her mother, our
co-founder, started a crusade to ensure that babies like Eve
would never again be sent home without first being screened.
We estimate that since our efforts began, the number of
babies screened for heart defects in the U.S. has increased by
4,500 percent. To date, we have aided in the drafting of
legislation in 23 States and the enactment of nine laws. The
first was in New Jersey, where a baby was identified with a
heart defect before a discharge on the very first day of
screening, and most recently, in California.
We are very proud of these numbers, but we have learned
that it is not enough just to screen, but we also have an
obligation to accommodate the lifelong needs of those diagnosed
by the screening, and consumer technology, such as mobile apps,
play an important role in fulfilling that responsibility.
It is important to remember that of the more than four
million babies born in the U.S. every year, the majority aren't
born in advanced cardiac surgery centers. They may be sent to
several hospitals, be seen by more than a few doctors, be given
a number of medications, which in today's less than
interoperable health care system means mom and dad will be
responsible for managing and reconciling most of this
information on the best and worst day of their lives.
After leaving the hospital, babies can be monitored
continuously from home using a pulse oximeter. These babies are
special because they have heart defects, but they are still
just babies and their parents are still exhausted. So what do
parents do? They use the same smartphone or tablet that they
use to manage all of their other important information.
Families and providers have come to rely on mobile apps to
allow them to capture readings from remote monitoring devices.
This means less time having to focus on being a nurse and more
time available to be a parent.
The availability of these technologies has created a
revolution in how we interact with our data and engage in our
health, but it has also created legitimate safety concerns that
must be addressed. However, the FDA draft guidance as written
would seemingly attempt to regulate the future of health care
technology as a standalone medical device. In my written
testimony, I have laid out a model for a risk-based framework
that very intentionally delineates between health information
management apps and actual medical devices.
Applications and the platforms that support them have the
ability to integrate and interoperate with any device that will
allow it. Consumer demand for integrated technology solutions
will drive the market to a wholly interoperable system that can
be accessed at any time, anywhere, and by any device, and we
would be foolish to believe that this integration will happen
and will not include health information.
Consumer technologies have evolved to leverage the Internet
to share data, including with medical devices, functionally
eliminating the difference between being on a network and
physically linking devices with a cord. As a result, we need to
be thinking about the regulation of technology differently.
What we need is a new patient-centered risk-based regulatory
framework for evaluating health technologies that is flexible
enough to regulate what we are using today and adaptive enough
to accommodate the technologies that have yet to be conceived.
I know the concept of a new regulatory process is daunting,
but an existing framework does not create the certainty that
the emerging health care technology marketplace needs to
flourish. I cringe when I hear from patient organizations that
are dedicating a significant amount of their budget to develop
a mobile app, because I know their product may have to go
through a process that would cost them more than they can
afford, rendering their initial investment worthless. I was
disheartened when my wife, who is now 4 months pregnant, asked
me which app she should use to track her pregnancy. I told her
the one with the fewest, least complex features, because I
wanted to make sure that she didn't lose all the data that she
would enter throughout the pregnancy in the event the
manufacturer depreciated certain functionalities to avoid the
FDA. To me, that is not certainty and that is not pro-patient.
This committee has the foresight to hold--has had the
foresight to hold this hearing because collectively, you
recognize that mobile apps are transforming how patients,
families, and providers engage in the delivery of health care.
Reform will not be without controversy, but it is far better to
address this issue now than to wait for traditional approaches
to fail at the expense of patients and families.
Thank you again for this opportunity to testify. I look
forward to working with you on this important issue, and I am
happy to answer any questions.
[The prepared statement of Mr. Bialick follows:]
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Mr. Pitts. Chair thanks the gentleman, and now recognizes
Dr. Mitus for 5 minutes for an opening statement.
STATEMENT OF JACQUELINE MITUS
Dr. Mitus. Good morning, Mr. Chairman and distinguished
members of the subcommittee. My name is Jackie Mitus, and I
currently serve as Senior Vice President of Clinical
Development and Strategy for McKesson Health Solutions. I
appreciate the opportunity to appear before you today.
My background as a practicing hematologist/oncologist at
the Brigham and Women's Hospital in Boston, and faculty member
of Harvard Medical School, as well as my responsibilities at
McKesson, have provided me with a unique perspective on health
information technology. I have seen first-hand how critical
health IT is to advancing the care and safety of patients.
As the largest health IT company in the world, McKesson has
actively engaged in the transformation of health care from a
system burdened by paper to one empowered by interoperable
electronic solutions.
I would like to make two key points today.
First, health IT is foundational to improving the quality,
safety and affordability of healthcare.
Second, to ensure continued innovation and leverage the
power of health IT, we need a new regulatory framework that is
risk-based and specific to health IT.
Health care in our country is undergoing fundamental
changes to make it safer, better, and more efficient. Health IT
is the foundation of these efforts. It provides access to
current, accurate patient information such as medication
history, and it supports the clinician in preventing errors,
identifying gaps in care, and suggesting appropriate diagnostic
and treatment paths. Health IT does not replace physician
judgment, but rather, provides guidance and support. The
ultimate responsibility for the care and safety of a patient
always rests with the treating clinician.
Today, the FDA has authority to regulate medical devices
under amendments to the Food, Drug, and Cosmetic Act adopted in
1976. The definition of a medical device in the Act is broad
and can be interpreted to include all health IT, including
medical software. The current regulatory approach for medical
devices, however, is not well-suited for health IT. For
example, does an iPad that reminds a patient to refill a
prescription make it a traditional medical device? What about
an application that allows a clinician to access a medical
journal or review an x-ray online? Should these applications
and the iPad each be subject to FDA regulations?
Medical software is fundamentally different from medical
devices in two important ways. First, the safety of a medical
device is almost entirely dependent upon how it is
manufactured. The safety of health IT, on the other hand,
hinges upon how it is developed and perhaps more importantly,
on how it is implemented. Thus, health IT cannot safely be
ensured simply through good manufacturing practice.
Second, medical devices, unlike health IT, are directly
involved in the treatment of a patient with little, if any,
opportunity for a clinician to intervene. The majority of
medical software does not directly or independently act upon a
patient, but rather, provides data and guidance. The ability of
a learned intermediary to utilize professional judgment
distinguishes this technology from traditional medical devices.
Mr. Chairman, we risk using a law enacted nearly a half
century ago to regulate a rapidly changing and dynamic era of
technology.
In closing, I would like to highlight the work of the
Bipartisan Policy Center, BPC, which last month released a
report in response to the FDA Safety and Innovation Act. With
the input of nearly 100 organizations, including McKesson, the
BPC recommended dividing health IT into three risk categories.
The first and highest risk category includes technology linked
to or used to operate a medical device. This technology would
continue to be regulated as a medical device. The second
category includes medical software that merely guides the
physician, such as clinical decision support or electronic
health records. This group would be subject to rigorous
accreditation by an independent third party, or perhaps ONC.
Finally, the third category, non-clinical technology, such as
billing and scheduling software, would not be subject to
regulatory oversight. The BPC approach is flexible, protects
patient safety, promotes innovation, and leverages existing
quality and safety standards.
In conclusion, health IT is imperative to the successful
transformation of health care. It improves the quality of
patient safety, enables payment and delivery reform, and
promotes efficiency and lower cost. That is why it is so
important that we regulate health IT thoughtfully to advance
care and support innovation. That is why we need a new risk-
based framework such as that proposed by the BPC.
On behalf of McKesson, I thank you for the opportunity to
share our thoughts.
[The prepared statement of Dr. Mitus follows:]
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Mr. Pitts. The chair thanks the gentlelady, and now
recognizes Dr. Classen for 5 minutes for an opening statement.
STATEMENT OF DAVID CLASSEN
Dr. Classen. Good morning, Chairman Pitts and Ranking
Member Pallone, members of the subcommittee. Thank you for the
opportunity to testify on this very important issue. I am a
practicing infectious disease physician at the University of
Utah School of Medicine, and I am the Chief Medical and
Informatics Officer at Pascal Metrics, a patient safety
organization. I also chair the AHRQ Formats Committee at the
National Quality Forum. My background is as an infectious
disease physician, medical informaticist and patient safety
researcher. As such, I have been on several Institute of
Medicine committees that have focused on how to improve patient
safety, most recently, the one I will draw my testimony from
today, Health IT and Patient Safety: Building Safer Systems for
Better Care. One of the focuses of that report was how do we
improve the safety of care for our patients most effectively
with health IT? How do we do it in a way that doesn't injure
our patients or harm them, and how do we do it in a way that
does not stifle innovation?
From that report, we looked back through the original To
Err is Human report from the Institute of Medicine that
suggested that as many as 98,000 lives a year are lost due to
medical errors. In our most recent report, we suggest that
those estimates of patient safety problems are probably lower
than is really the story, based on newer detection problems
both in hospitals and in the ambulatory setting of care. So
there clearly is a large opportunity for us to use health IT to
improve safety of care, both on the inpatient setting in
hospitals and on the ambulatory setting.
So one strategy that the Nation has turned to for safer,
more effective care is the widespread use of health IT. As we
have heard from other panel members, this really is the case
over the last several years. We are investing billions of
dollars in Meaningful Use to more broadly adopt this health IT.
It is clearly playing an ever larger role in the care of
patients, and clearly there is evidence that it has improved
health care and reduced medical errors.
Continuing to use paper records places patients at
unnecessary risk for harm and substantially concerns the
ability to reform health care. However, there are concerns
about harm that has come from the use of health IT that led to
the generation of this IOM report. In this IOM report, health
IT and patient safety was defined broadly to include EHRs,
patient engagement tools, personal health records, secure
patient portals, health information exchanges, and mobile
applications.
Practicing clinicians, such as myself, expect health IT to
support the delivery of high quality in several ways, including
storing comprehensive health data, providing clinical decision
support, facilitating communication, and reducing medical
errors. It is widely believed that health IT, when designed,
implemented, and used appropriately, can be a positive enabler
to transform the way care is delivered. Designed and applied
inappropriately, health IT can add complexities to the already
complex delivery of health care, which can lead to unintended
consequences, for example, dosing errors, failing to detect
fatal illnesses, and delaying treatment due to poor human to
computer error, actions or loss of data. Merely installing
health IT in health care organizations will not result in
improved care or safety. Taking together the design,
implementation, and use of health IT affects its performance on
improving the safety of care.
Safe implementation and safe use of health IT is a complex,
dynamic process that requires a shared responsibility among
vendors, health care workers, and health care organizations, a
partnership, if you will. Many features of software contribute
to its safe use, including usability and interoperability, and
can also contribute to patient safety problems if we have poor
user design, poor work flow, or complex interfaces, which could
be a threat to patient safety. The lack of system operability
is clearly a major problem in patient safety. We do have some
success stories here. Laboratory standards have added--actually
facilitated the free flowing of laboratory information.
However, we are not there yet and information such as problem
lists and medication lists are not currently easily transmitted
between health IT systems.
Safety considerations need to be embedded throughout the
whole health IT implementation process, including planning,
deployment, stabilization, optimization, and transformation.
Vendors take primary responsibility for the design and
development of technologies ideally with iterative feedback
from users. The users assume responsibility for safe
implementation at work with vendors throughout the health IT
implementation process. This partnership to develop, implement
and optimize system is a shared responsibility where vendors
and users help each other achieve the safest possible
applications of health IT.
It is important to recognize that health IT products
generally cannot be installed out of the box. Users often need
to ensure that products appropriately match their needs and
capabilities in both functionality and complexity of operation.
So therefore, in operation health IT can look very different
from what it looked like on the shelf.
Ongoing safe use of health IT requires diligent
surveillance of evolving needs, gaps, performance issues, and
mismatches between user needs and system performance, unsafe
conditions, and adverse events. The IOM report believes certain
actions are required by both private and public entities to
monitor safety in order to protect the public's health, and
provided the following recommendations to improve health IT
nationwide. In my testimony, I have the recommendations in that
report, but in the interest of time, I will leave them in the
testimony and conclude my remarks.
Thank you very much.
[The prepared statement of Dr. Classen follows:]
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Mr. Pitts. The chair thanks the gentleman.
Let me ask--start a question. I recognize myself for 5
minutes for this purpose. I will ask each of you this question.
Do you believe that data, Dr. Smith, for the purposes of
regulation should be classified as a medical device?
Dr. Smith. Data, no, sir.
Mr. Pitts. Ms. Bechtel?
Ms. Bechtel. I have to say this is not my area of
expertise.
Mr. Pitts. Mr. Bialick?
Mr. Bialick. Data, no.
Mr. Pitts. Dr. Mitus?
Dr. Mitus. Data per se, no.
Mr. Pitts. Dr. Classen?
Dr. Classen. Data, no.
Mr. Pitts. Thank you.
Now, Mr. Bialick, do you believe that the newborn patients
you are here representing today will be best served by the FDA
classifying medical apps as medical devices?
Mr. Bialick. As the draft guidance is written, no.
Mr. Pitts. Speaking of the FDA draft guidance, many have
argued that the FDA is proposing to only regulate apps that are
essentially medical devices and does not intend to go any
further. And while I may disagree with this presumption, I do
think it is very instructive for the purposes of today's
hearing. Many years of dealing with the FDA have taught me that
it is not what they say they are going to regulate today, but
what they could regulate tomorrow.
Are you familiar--I will stay with you, Mr. Bialick--with
the term regulatory creep?
Mr. Bialick. I am.
Mr. Pitts. And what could regulatory creep mean for a
combination who seek to innovate in this space and to the
patients whose lives may depend upon this innovation for their
health and welfare?
Mr. Bialick. The draft guidance, as it was written, I think
refers or relies on terminology like an app that even now is a
little bit outdated. The concept of an app is a discreet piece
of software on a device. That is really being changed by how
the market has embraced cloud technology. The idea that you
would have a discreet piece of an app or software that is one
little piece, that is different now when an app is also the
browser on your smartphone. These technologies are becoming
platform agnostic, and so how do we talk about that in
reference of, when the draft guidance was written, even the
definition of an app has changed during this time, so the idea
that we can regulate an app--but these apps are expanding, we
need to have clearer lines as to how these things are--where
the regulation is going to stop.
Mr. Pitts. OK. Well, let me ask, and each of you can
respond. Do you believe the FDA has the expertise to regulate
medical app technology, and do you foresee them gaining that
expertise in the foreseeable future? Let's just start and go
down the line. Dr. Smith?
Dr. Smith. I think it is, to a point in my testimony,
making sure that regulation moves at the speed of innovation. I
think it is quite challenging for the FDA and for many reasons
to stay as current as possible on those things which are simply
just emerging. And so the simple answer to your question is no.
I think the opportunity for external expertise needs to be
exploited much more thoroughly than it has been to date.
Mr. Pitts. Mr. Bialick?
Mr. Bialick. I think that the FDA absolutely has the
experience and knowledge in-house to evaluate apps that are
actually medical devices. When it talks about just some of
these apps that are connecting, sharing information on
networks, then no, they don't have the regulatory expertise in-
house.
Mr. Pitts. Dr. Mitus?
Dr. Mitus. Concur with my colleagues. Today, the FDA plays
a very, very important role in health care. McKesson has many
solutions that are regulated by the FDA, whose expertise really
is in the regulation of medical devices. Health IT, we believe,
it really requires a different paradigm that is not well-suited
to the current infrastructure and process under the FDA. It is
less about the organization and more around the process.
Mr. Pitts. Dr. Classen?
Dr. Classen. Just citing from the IOM report, the IOM said
that if the FDA were to get further involved in the oversight
of HIT beyond medical devices, a new framework to do that
should be created.
Mr. Pitts. OK. Now Mr. Bialick, can you share any real
world examples of patient's lives being changed through the
application of new medical technologies?
Mr. Bialick. Absolutely. I think, from my own experience
that I can talk to you with our spread of legislation around
congenital heart defect screening, like I said, not everybody
is born in a city center so access to some of these remote home
monitoring devices is very functional. Not only that, but the
telemedicine capacity that we are seeing, especially through
some of these devices, is really expanded. Someone said in the
hearing yesterday, it is the new house call, and that is
absolutely true. We want to keep making sure that these devices
are getting to the patients that need them.
Mr. Pitts. My time is expired. Chair recognizes the ranking
member for 5 minutes for questions.
Mr. Pallone. Thank you, Mr. Chairman.
I wanted to ask some questions of Ms. Bechtel. You
testified before this subcommittee in July, 2010, in the early
days of the HITECH Act and the Meaningful Use Program, and at
that point, the program was just getting off the ground and we
heard estimates from CMS that between 21 percent and 53 percent
of the eligible providers would adopt EHRs by 2015, and we have
come a long way since then. As of February, 2013, 2 years
before the 2015 deadline, CMS data shows that more than 70
percent of eligible providers have registered and nearly 40
percent have already successfully completed the first phase of
Meaningful Use. The data for hospitals is even more promising.
Eighty-five percent of those that are eligible have registered,
and more than 70 percent are Meaningful Users today. So Ms.
Bechtel, these adoption rates have exceeded expectations, if
you would confirm or talk about that, and are we just seeing
providers purchase an EHR to check a box or are we actually
seeing real Meaningful Use, and then finally, other than
adoption of EHRs, what other signs of progress do you see? I
will throw those all into one question.
Ms. Bechtel. Great. Thank you so much, Congressman.
Yes, I think it is really remarkable that we have made the
progress that we have, and it is a testament to the hard work
of health care providers and vendors, and the regional
extension centers who are helping primary care doctors and
critical access hospitals every day to adopt and to implement
and really use EHRs in a meaningful way. I think there are some
terrific additional signs of progress, like the fact that in
2006 there were almost no e-prescribers, which is really key to
eliminating handwriting errors. It creates an enormous amount
of efficiency for consumers and their families, and today there
are more than a half million. So there is really some amazing
work that has been done, and I think number one, it is the key
to helping us get to this system we all want through payment
reform, and getting there faster, and number two, we have to
keep up the pace and we have to keep up the progress. The
design of the Meaningful Use Program is such that in the
beginning, providers are adopting and they are beginning to
implement and use it in some ways like I outlined in my
testimony that are very meaningful to patients and families.
But as they stay in the program, it is designed to create even
more capabilities that benefit patients and families, improve
quality, and lower costs, and so future stages will deliver
even more societal benefits. I think the key now is just
keeping up the pace.
Mr. Pallone. All right, let me ask you another question
about the mobile apps. I am afraid this hearing is really
missing the forest for the trees when it comes to the
government's role in the growth of mobile apps and health
information technology. Far from inhibiting the growth of
mobile health applications, the Administration has taken
unprecedented steps to open up federal data to app developers
and coders, and this public-private collaboration has led to
extraordinary growth in the mobile health application space.
One example is iTriage, an application created using HHS data
that helps consumers locate nearby health care providers. The
app has over three million downloads from the iTunes store, far
from being slowed down by the Federal Government. If iTriage
and scores of other apps have grown and they have grown
enormously because of cooperation and openness of the Federal
Government. So if you could just tell us about how open
government data has contributed to the growth of mobile medical
apps, and what that has meant for patients.
Ms. Bechtel. Yes, I think this is a terrific example of
federal leadership that is really driving innovation. Three
years ago, HHS launched the Open Health Data Initiative. They
created a Web site called healthdata.gov, and if you think
about the absolute richness of health data that HHS as an
agency has, it is really phenomenal, whether it is FDA or CDC
or NIH or even CMS. And so the model for this work was actually
NOAA, the National Oceanic and Atmospheric Administration,
where once NOAA began to release their weather data publically,
we use it in weather forecasts on television, we have it on our
smartphones, and so the innovation that occurred is really the
model for opening up health data. The Blue Button functionality
that I talked about earlier is a great example. That was one of
the first initiatives of the open health data effort, and
application developers have taken what is claims data--it is
not even the rich clinical data from EHRs yet, but it will be
next year. They have taken the claims data and built
applications that enable consumers to view their own health
information online, but also now, the next step is that they
are going to automate it so that I, as a consumer, can decide
that I want an automatic feed anytime there is new data, and I
can say I would like you to also send it to my primary care
doctor. So when we talk about care coordination, which is so
essential to consumers, this is a great innovation and they
have held more than 20 code-a-thons where application
developers and entrepreneurs and different communities have
come together to create applications in real time using HHS
health data that are really making a difference. U.S. News and
World Reports uses it in their health insurance, their best
health insurance plans. Health Grade uses it to help consumers
pick the best health care providers out there. So there is
really no limit to the innovation that I think can occur,
because of the collaboration with the Federal Government and
entrepreneurial innovators.
Mr. Pallone. Thank you.
Mr. Pitts. Chair thanks the gentleman and now recognizes
the vice chairman, Dr. Burgess, for 5 minutes for questions.
Mr. Burgess. Thank you, Mr. Chairman. Well, it begs the
question then, is there going to be an app for the regulatory
apps, and I guess that is what we are here to answer today.
Dr. Smith, you brought up an intriguing issue about--when
speaking about electronic health records and I guess Meaningful
Use and where outcomes, not location actually ought to be
considered. I had a physician in the office this morning, a
gastroenterologist who said look, I got a problem. I have got
an EHR in my office, I use it and it meets all the criteria for
Meaningful Use. I go to the ambulatory surgery center. I access
the same record online and use it, but because I am in an
ambulatory surgery center, it does not count toward Meaningful
Use, and in fact, if I spend more than 50.01 percent of my time
in the surgery center, which is where I spend my time because I
am doing procedures on patients who need them, then suddenly I
fall out of the criteria to meet the criteria for Meaningful
Use. Is that what you were referring to where you said outcome,
not location?
Dr. Smith. It is in part that. It is also the notion that
until we realize that it is all about the outcome and really
irrelevant about how we get to that outcome, we will drive
rather bizarre behavior, and so when one thinks about
telemedicine and the opportunity to----
Mr. Burgess. He is a gastroenterologist. Bizarre behavior
goes with the territory. I am sorry, go ahead.
Dr. Smith. So I am a cardiologist, and I resemble that
remark.
Until we focus entirely on the outcome, we will drive--
first incentive will drive instead of taking care of patients
at a distance and keeping them on the straight and narrow, we
will facilitate the system we have had, which is one of really
emergency rescue as opposed to health care.
And so I think with respect to information flow, it has to
be seamless. With respect to the burden of chronic disease that
we have in this country, the notion that we are best off taking
care of folks only when they show up in the emergency room or
in the doctor's office is clearly wrong-headed when those
patients need the kind of day-to-day iterative care that some
of these remote technologies and integrated interoperable
systems can provide. And so that is really the point of that
comment.
Mr. Burgess. Now there is a difference between what a lot
of us would consider traditional medical advice, and an app. I
mean, an intercardiac defibrillator, a traditional medical
device, can you sort of delineate the difference there for us?
Dr. Smith. Oh, absolutely. So, I spent much of my life in
either the implementation or even design of implantable
defibrillators, and the company I was working for at the time
kind of led a charge in making sure that that information that
is resonant in those devices could get back to doctors wherever
they were when it was most needed, instead of using the patient
as a vehicle for bringing that information back to see you in
the office. And so there is a huge difference between the one-
to-one patient encounter that you can have--and I will point
out that you can now have technology mediated encounter versus
the information that you can get on the web. I mean, so whether
it is an app or whether it is the web, those are really quite
different things. And so I think as a physician yourself, you
would realize the important differences.
Mr. Burgess. Well, and the ownership of that data is
important as well, and when we talk about an HHS Web site, but
that is, at least in theory, the identified data, but you are
talking about data that is specific to that patient, specific
to that patient encounter.
Dr. Smith. Absolutely.
Mr. Burgess. Dr. Mitus, I was fascinated by your testimony.
I remember a few years ago in the middle of the chaos of the
Haitian earthquake, it was either on CNN or reading a Time
magazine article where a doctor who was not an OB doctor was
helping take care of a pregnant woman after the earthquake. She
had a hypertensive crisis. His reflex action was to reach for
an angiotensin converting enzyme inhibitor, but he looked it up
on his mobile app and found that that was contraindicated in
pregnancy and used something else. I think the story had a
happy outcome, but it certainly underscores the power of having
that medical information at your fingertips, and you just go
into the app store--even as we sat--not that I wasn't paying
rapt attention to all of the testimony, but you can download
Harrison's Principles of Internal Medicine. You can download
the Merck Manual. You can download the Washington Manual, and
have that literally at your fingertips in as odd a place as a
congressional hearing.
So how does the regulatory environment affect that?
Dr. Mitus. I completely concur that health IT has really
revolutionized our ability to provide timely and safe care to
patients in ways that that we could never have envisioned even
10 years ago. The power of technology enables us and is very
different than a medical device. I believe, though, there is an
important distinction, to return to your prior question. A
device, in our mind, sits directly connected to a patient and
has automation that allows it to independently act upon that
patient. It is really replacing that human judgment. Whereas a
physician who intervenes and accesses medical guidelines, such
as a textbook online or receives an alert to potentially
prevent a fatal drug interaction is allowed to use their own
common sense and judgment, and that is fundamentally different
than a device.
Mr. Burgess. But the FDA looks at it as decision support,
so therefore, it is open to regulation. Is that correct?
Dr. Mitus. That is our understanding, and we believe a
risk.
Mr. Burgess. Thank you, Mr. Chairman. I will yield back.
Mr. Pitts. Chair thanks the gentleman and now recognizes
the ranking member of the full committee, Mr. Waxman, for 5
minutes for questions.
Mr. Waxman. Thank you very much, Mr. Chairman.
Dr. Mitus, as I understand, you are a hematologist/
oncologist. Is that right?
Dr. Mitus. Correct.
Mr. Waxman. OK. So let's say you had software that could--
claims to diagnose a mole and whether it is melanoma or not. Do
you think the FDA ought to regulate that?
Dr. Mitus. That is a very interesting question, and one
that I pondered last night after you asked that yesterday. I
actually looked up Dr. Mole online to understand, as I was not
familiar with that technology. I think that really delineates
the challenge that we have before us. What a wonderful piece of
technology----
Mr. Waxman. Excuse me. I really have a limited time. Do you
think it ought to be regulated by the FDA or FDA ought to
review it before it is widely used? Yes or no.
Dr. Mitus. I believe that there is risk and there is
intelligence in that application, as I understand it, and it
is--should be considered a high risk piece of software, and we
believe in a risk-based system and it could potentially be
regulated by the FDA, much the way mammography software is
today.
Mr. Waxman. OK. Now you raised a bunch of points in your
testimony, and you pose a number of questions. Should an iPad
application that helps track the number of steps you walk per
day be regulated as a medical device, and FDA says no in their
guidance. You asked if it is a reminder time to refill a
prescription. FDA's guidance said no, that is not a medical
device. You asked a question whether digital versions of a
physician's desk reference would be subject to regulation, and
FDA says no. Those are not going to be subject to regulation.
So I found it puzzling, because FDA addressed them specifically
in their draft guidance, a specific list of these examples of
what should not be regulated. Is your concern that FDA is going
to change its mind and regulate it?
Dr. Mitus. My concern is that there is a spectrum of
capabilities that is increasingly delivered through technology,
whether on a mobile app or on a desktop, and that gray area as
we just described, the ability for a doctor to receive an alert
or a warning is not something in my mind that should be
regulated as a medical device.
Mr. Waxman. Well, I can understand that point of view but
you would see the point of view that some things ought to be
regulated as a medical device, wouldn't you?
Dr. Mitus. Medical devices certainly should be regulated as
medical devices.
Mr. Waxman. Well, there is a judgment to be drawn. My
colleague said well, that judgment ought to be up to Congress.
Do you think Congress should make those distinctions, or should
it be the FDA or some government regulatory agency that has
some expertise on these kinds of issues? There is a line to be
drawn. Who should draw that line?
Dr. Mitus. It is a difficult line to be drawn. I am not--I
won't presume to be able to tell you who should draw that line.
What we would like to point out----
Mr. Waxman. Well, knowing that it is difficult doesn't
help. Who should draw the line? There is some that should be
regulated as medical devices and some shouldn't. I agreed with
your testimony. Those things that are informational based
shouldn't be regulated, and FDA agrees with that, but there are
some that ought to be diagnosed.
Mr. Bialick, there is a device that remotely monitors
infants with congenital heart defects using a pulse oximeter.
Pulse oximeters monitor the oxygen saturation of a patient's
blood, and especially in the case of newborns with congenital
heart defects, they are a critical tool to monitor cardiac
health. This is obviously a sensitive and important device. If
the device provides the wrong reading or provides faulty
information, it can lead to disastrous results. Do you believe
that FDA should play a role in ensuring that these types of
devices are safe and effective?
Mr. Bialick. That is why FDA does evaluate pulse oximeters.
Mr. Waxman. And you think that is appropriate?
Mr. Bialick. Pulse oximeters as medical devices, yes. The
app that has the potential to connect to a covered device, that
is a different story because it is not a traditional medical
device. You are talking about medical software at that point.
So I would like to talk about drawing the delineation here.
That is the delineation I would like to make.
Mr. Waxman. Well, the app transmits the information, but
the information is based on this pulse oximeter.
Mr. Bialick. Right, and----
Mr. Waxman. And the pulse oximeter ought to be reviewed by
the FDA because if it is giving false information, it can have
serious consequences, right?
Mr. Bialick. I agree. Medical devices should be evaluated
by the FDA.
Mr. Waxman. So say, Dr. Mitus----
Mr. Bialick. I am sorry.
Mr. Waxman. I am switching to Dr. Mitus. If somebody takes
a picture of a mole and they say don't worry, you don't have
cancer, and they are wrong, that is a serious disaster waiting
to happen. We need somebody other than members of Congress to
say that ought to be regulated, and the law requires, I think,
FDA appropriately to regulate it.
My point to all of you is there is a distinction that has
to be made, and the points you raised, Dr. Mitus, were all
scary things that just aren't being considered for regulation,
and FDA has been very explicit about it. So I am somewhat
disappointed that you would say these things are going to be
regulated when FDA says they have no intention of regulating
them, and so that is why I asked do you think FDA is going to
reverse its stand. Is that what you are worried about?
Mr. Pitts. You may respond.
Mr. Waxman. To Dr. Mitus, are you worried the FDA is going
to change its mind and suddenly regulate those things?
Dr. Mitus. We are worried that there is a large gray area
of medical health IT that could be subject to regulation.
Mr. Pitts. Mr. Bialick, you wanted to say something?
Mr. Bialick. To your point, Mr. Waxman, you said is this
Congress's decision to make this or is this FDA's decision or
is this another agency? I would like to say that this is such a
big issue and such a dynamic market that no one entity should
be making these decisions. There is a clear need for a
framework of experts to convene to talk about what is going on
at FDA, what is going on at ONC, what is going at FCC,
especially as these things consider mobile apps, as well as
what Congress's role is in regulating that? So the framework,
absolutely Congress has a role. Congress has a role to develop
this framework.
Mr. Waxman. Well, FDA is required to bring in a group like
that and give them guidance, but if you are giving an amorphous
group to look at it with nobody having clear responsibility,
nothing is going to happen and that is a very dangerous thing
if a device can do harm.
My time is expired.
Mr. Pitts. The chair thanks the gentleman and recognizes
the gentleman from Illinois, Mr. Shimkus, for 5 minutes.
Mr. Shimkus. Thank you, Mr. Chairman. I enjoy following Mr.
Waxman, who is obviously very thoughtful. We had part of this
debate yesterday in the other hearing, and I think--and I am
going to go off script just because Mr. Bialick, on this pulse
oximeter--I am not a health care guy but I did read it in your
testimony--your point is that that device is a taxed and
monitoring. So as I was trying--you are trying to say that data
is being formed by the medical device as certified. The
transmission of that data to a handheld device is a concern,
especially if it gets classified as a Tier III medical device.
Mr. Bialick. Absolutely.
Mr. Shimkus. What happens if it gets classified as a Tier
III medical device?
Mr. Bialick. It would be evaluated as such through the FDA
process.
Mr. Shimkus. And what else happens to it?
Mr. Bialick. It gets pulled off the market. It has to go
through the entire process. I mean----
Mr. Shimkus. And what else happens to it? It gets a big
freaking tax on it, a gross tax, not a net tax. So anyway, it
is always exciting to be on this committee with my friend from
California.
Because we talked about the chips and the shoes, too.
Obviously for general fitness, just measuring steps, no, but
what if that is a device that has been prescribed?
Mr. Bialick. Another case.
Mr. Shimkus. And my friend, Mr. Pallone, mentioned HHS
health and one app. Good for them. How many apps are there?
Ninety-seven thousand apps. How are the other 96,999 developed?
By the private sector, by individual capital, by people
assuming risk. I pulled this up--pull up your page. How many
new apps are there to change your app? Notifications, you got
to update your app. What happens if this whole process falls
into that? So now you have an app, it has had technical
problems, maybe it is a Tier II and now you want to update the
app. Does that have to go back through the entire process
again? These are very, very important--they belittle--the fact
that we are having these questions, but the fact that we are
having these questions means that we don't have answers.
So what does FDA do when they go to the Institute of
Medicine, right, they commission a report, which they did on
MDUFA, and they kind of follow that a lot of times. Well, what
did the Institute of Medicine just come out on this? Well, one
member disagrees with the committee and would immediately
regulate health IT as a Class III medical device as outlined in
Appendix E. So they are saying all health IT--or this guy, this
one respondent says this should be, and there is a fear about
that, is there not, because of the things we issued before.
So Mr. Bialick, if FDA regulated health IT as medical
devices, would they be subject to the device tax as written in
law?
Mr. Bialick. I default to Congress on that.
Mr. Shimkus. I already asked that. The answer is yes. What
could this mean for patients, especially for telemedicine and
other advancements that are starting to improve the quality and
access to care for patients in rural areas, like my district,
who are sometimes hours away from the care they need?
Mr. Bialick. It is a very important question. I think that
as telemedicine develops, we are starting to also see a
development of our networks of care. So it is not just we go to
the one rural doctor that we have access to----
Mr. Shimkus. Right.
Mr. Bialick [continuing]. But rather, we have access to
many professionals.
Mr. Shimkus. Anybody else want to jump in real quick on
this?
Dr. Mitus. I believe it could significantly delay and put
at risk the deployment----
Mr. Shimkus. Here is what I observed in my district. I have
a large rural district. There are 102 counties in the State of
Illinois. I represent 33. Where a lot of hospitals are moving
to is obviously nurses on site, doctors at computer screens
monitoring the real data, and also what they can do is--so the
nurse says doc, calls him up, Doc, check this patient X. So
they go into the room, the patient is laying there and he will
have the nurse open up the eyelid and the camera will zoom in
on the eye to make a determination. Now if you follow this
debate, now you have got data flowing over in a picture form,
i.e., like the mole debate, but it is a camera in essence
taking a real time picture. How does that get regulated? And if
it, as my colleague from California said, if that should be a
Tier III because then do I not have the access to real time
picture of the pupil of a patient, and an immediate doctor
intervention, versus calling one from 20 miles away?
My time is expired. I thank you all and I yield back my
time.
Mr. Pitts. Chair thanks the gentleman, and now recognizes
the gentlelady from Virgin Islands, Dr. Christensen, for 5
minutes for questions.
Mrs. Christensen. Thank you, Mr. Chairman, and thank you to
the panelists for being here this morning. I am sorry I missed
yesterday's hearing.
But this hearing--this series of hearings is centered on
the relationship between innovation and public--and patient
safety, and I think the Meaningful Use EHR program is a great
example of how government can promote technological innovation
that has the potential to significantly improve patient care.
Phase one of the program already enables providers to
maintain up-to-date electronic lists of the health conditions,
diagnoses, medication, and medication allergies. They can
automatically check for drug interactions and drug allergies,
as we have heard, and have the ability to send prescriptions
electronically to a patient's pharmacy, reducing wait time and
eliminating handwriting errors.
Ms. Bechtel, can you give us some information about--some
more information about how electronic health records are
already helping to improve patient care, and how future phases
of Meaningful Use advance our ability to improve that care, and
would you add into your answer how it--how HIT--the role it can
play in eliminating health disparities?
Ms. Bechtel. Absolutely. So let me start with health
disparities, because I actually think that that is one of the
ways that the Meaningful Use Program is making a real
difference for patients and families.
In the first stage of Meaningful Use, there were a couple
of things that were really important to help disparities. One
was collecting better and more granular data about race,
ethnicity, language, and gender, because those are categories
where we see vulnerable populations and the greatest amount of
health disparities, as you know. And so we have now created the
ability to collect information like that in a standardized way,
and when you do that in a computer system, you can then
stratify other information by those data types to identify
disparities, and the first step in eliminating them has to be
identifying them. We also created a capability for electronic
health records to report quality measurement, and which is key
to payment later, and so the ability to look at the kind of
care that you are providing for different populations that you
are serving is really instrumental, and that was not
standardized prior to Meaningful Use.
In future stages as well, we are going to see things like a
population health dashboard that is going to allow you to look
at multiple populations. My hope is that, well into the future
we will see things like more advanced intelligence systems that
will look for disparities that we didn't even know to look for,
for example. So there are some really terrific things.
I think I would say that in terms of what is happening
today already right now, the Commonwealth Fund, an independent
organization, looked at several different hospitals and they
concluded that health IT adoption has led to faster, more
accurate communications, streamlined responses that have
improved patient flow. It has reduced duplicative testing and
sped up responses to patient inquiries, and that has been
really phenomenal.
Yesterday there was a study released by the Quest
Collaborative, which Premiere reads, and it is really an
indication of what can happen when you blend not just the
health IT infrastructure that the Quest hospitals have, but the
quality measurement and the public reporting and the payment
and all of these things that have bipartisan support, they
saved 92,000 lives and $9.1 billion over 4\1/2\ years.
Mrs. Christensen. Let me try to get another question in.
You sat on the Federal HIT Policy Committee and you reported
that 70 percent, I think, of physicians are utilizing HIT, but
have you seen the adoption in minority practices, practices in
rural and poor communities, and if so, if not, is that a
concern and is the committee doing anything to address that?
Ms. Bechtel. Yes, and I think that is also a great question
for federal officials tomorrow as well. But yes, we are. So 40
percent of rural primary care providers are working with
regional extension centers and are therefore more likely to
achieve Meaningful Use, so that is really good news. In terms
of providers serving vulnerable populations, many of them will
receive payments under the Medicaid program, and every State
has, in fact, designed and has begun to implement their
programs, and that is really the first step to make sure.
So I think there is very good news, but it is something we
must continue to monitor.
Mrs. Christensen. OK, thank you. I guess I will yield back
the balance of my time. I don't----
Mr. Pitts. Chair thanks the gentlelady and now recognizes
the gentleman from Texas, Mr. Hall, 5 minutes for questions.
Mr. Hall. Mr. Chairman, I would like to use part of my time
thanking you for bringing this up. It is something I am very,
very interested in. I would ask Mr. Bialick, I guess--I hope I
pronounced it right. I don't believe anyone has got around to
the newborns. If they have, I will wait and write--and ask for
written testimony.
But if not, Mr. Bialick, a lot of us remember the sleepless
nights and exhausting routines that go along with a newborn at
home, and if we are blessed with a child without medical
problems, we have sleepless nights also but not like others.
Can you share with the committee the additional challenges and/
or stresses of medical problems and how technology can be
utilized to make their lives better, or--let me shorten it. How
do you envision mobile medical technology devices being used to
improve care for newborns, and if these technologies are
subject to a lengthy bureaucratic approval process, how will
that impact patients and families? Because if they apply or
register when their newborns are newly born, they won't be
newborns when they get around to them.
Mr. Bialick. Sure. Thank you for that question. Babies with
congenital heart defects are super users of the health care
system. They are not only going to be using imaging services
very early, they are going to need, in critical cases, either
immediate intervention, maybe surgically, and then follow-up
care with additional imaging throughout their lives.
Now, it happens to be that, like I said, not all babies are
born in advance cardiac care centers. They are not all born in
coordinated care environments. Half of births in many States
are Medicaid births as well, so care can often be fragmented.
Right now, the way the health care system has developed, really
to stay at the center of your care, you have to be the one that
is coordinating it yourself, and mobile apps have allowed us to
do that. We are able to hold in our hand the electronic record
now, because of something like the Meaningful Use Program of
Medicaid providers and maybe several different hospitals,
several different specialists. And that not only is comforting
to know that you have access to this information, but it is
also very valuable because sometimes when you go back into a
care situation, it is for a very critical reason, and having
this information will help you and your provider and your care
team get to answers much faster.
Mr. Hall. I thank you for that. I was a father to three
boys, three sons, and I was amazed because they were so
intelligent. They could count. If they didn't count four eyes,
they wouldn't go back to sleep.
Thank you. I yield back my time.
Mr. Pitts. Chair thanks the gentleman, and now recognizes
the gentleman from Virginia, Mr. Griffith, 5 minutes for
questions.
Mr. Griffith. Thank you, Mr. Chairman. I appreciate that
very much.
I have gotten a sense from some of the questions that
somehow this is a partisan thing, and I don't think it is, and
so I am taking a step back. I am not sure really where that is
coming from, but I think it is very interesting as a lawyer and
I am learning all this medical stuff, and I thank you all for
educating me. But it seems to me that the real question is, and
what everybody seems to have agreed on is that we as Congress
need to make sure there is a framework that then you can put
the complicated does this fit, does that not fit, into that
framework. Am I correct in that, Dr. Mitus?
Dr. Mitus. Absolutely.
Mr. Griffith. Dr. Smith?
Dr. Smith. I might add, if you would let me. I think that
we if we whisk overprescribing this framework, and I think at
some point there is a role for not drawing the sharpest of
line, but to give latitude to the bedside where the patient and
physician can decide whether technology is appropriate in use,
as opposed to trying to draw one line for the broad population.
Mr. Griffith. And I think we all want to see this
technology being used. It is great stuff and whatever we can do
to encourage folks to use it, but I do think there is a
difference if--in the case of a picture of a mole, if the
mobile app is actually running it through a computer and
telling you it is cancerous or not cancerous, then yes, I want
the FDA looking at that. If the mobile app is getting that to
an expert doctor to take a look at it, I don't see that as
being a medical device, and if there is a problem with the
diagnosis--and I would think that Mr. Waxman would appreciate
this--there are a slew of trial lawyers who would be more than
happy to help you figure out what you need to do next if there
is a misdiagnosis. So I think we go from there.
I am concerned that the FDA sometimes tends to be slow, and
if we have got something that doesn't fit the norm, obviously
if it is something serious like the app is making the decision
on whether or not that mole is cancerous, yes, then I want that
top thing and I kind of like the framework that you pointed
out, Dr. Mitus. If we don't have that kind of a framework and
they decide to review everything, wouldn't you all--and I guess
I will ask Dr. Mitus and Dr. Smith this question, and Mr.
Bialick and others can chime in if they wish. But isn't there a
real concern that the slowness of the FDA, particularly if you
are looking at something that just transmits the data, can
actually slow down innovation in this area where we really want
the innovation to go forward? Dr. Smith?
Dr. Smith. So you know, as a practicing cardiologist, I
would often get records to make decisions based on transmission
through a fax machine, and at that time, it was difficult to
tell the difference between a three, a five, and an eight. And
so one could make wildly different decisions based on that
communication transfer, which no one regulates. Now that we
make it so crisp and so clear and so error-free, now I don't
believe is necessarily the time to regulate that particular
flow of information. I think the market has served the need in
this case, and so if it is really just about transmission of
information, it is difficult to see even though that
information may be clinically relevant, that that is
necessarily something that requires FDA oversight.
Mr. Griffith. It is funny how sometimes people can
interpret old rules with new technology and get it wrong or get
a different answer. In my law practice, if I had a book, I got
taxed on it. If it was a disc, it didn't get taxed. If I could
subscribe to an online site, it didn't get taxed. But if it was
a book, by golly, I had to pay tax on that book.
Let me ask this about the smaller creative entrepreneurs,
Mr. Bialick.
Mr. Bialick. Bialick.
Mr. Griffith. Bialick, thank you. In your opinion, if the
FDA is successful in classifying all these medical apps, those
particularly that I know we are talking about data are
essential data's medical devices, do you think that might
discourage some of the app makers to go into something that is
easier to get their capital back out, or a quicker return on
their investment?
Mr. Bialick. Absolutely. The threshold for a blockbuster
app is gigantic now. I mean, it is millions of dollars, and so
even to get the investment now to--let's say you are going to
develop it beyond just in your garage and have a large scale
launch. The concern that you will have the potential for or if
it is known that you will have additional regulation on top of
that cuts out the bottom line, so there is an investment side
to it, too.
Mr. Griffith. So they are more likely to try to find the
next Angry Bird as opposed to finding the next Angry Mole?
Mr. Bialick. Well said.
Mr. Griffith. And last--and I only have a couple of seconds
left. I am just going to make a statement. I think a lot of us
on this committee feel that the FDA is not only risk averse,
but they are at the point of no risk. We don't want to approve
something if there is any risk, and obviously every human being
is a little bit different and whatever you do, there is going
to be at least some risk. And so I would just encourage the FDA
to work with you all and hopefully we will pass that framework
that you want and get it done.
Thank you, sir, and I yield back.
Mr. Pitts. Chair thanks the gentleman, and now recognizes
the gentleman from Texas, Mr. Green, for 5 minutes for
questions.
Mr. Green. Thank you, Mr. Chairman. I would like to thank
our witnesses for appearing today.
As mobile technology has gotten more sophisticated,
applications relating to health have become more complex, but
also hold more potential. The possibilities of innovation are
tremendous, but there is potential risk to health safety as
well. Mobile applications such as glucose monitors are being
sold as a way to monitor critical health issues, or other
applications having direct effect on health should be regulated
in a way that ensures their effectiveness and trustworthiness.
Regulation through the FDA comes with challenges. The
agency is oftentimes far too slow. Obtaining approval can be
costly. I worry about stifling innovation and bringing in
unnecessary levels of regulation onto clever people with
limited startup capital, but unlimited potential. However, even
big companies have made high profit mistakes developing mobile
apps. Had the recent mishap with a mapping software been a
glucose monitor, there could have been serious consequences.
But we must protect patient and consumer safety at all costs,
but properly determining what poses as a safety risk may prove
difficult.
Dr. Mitus, the Bipartisan Center framework focuses on
clinical and nonclinical software. It also recognizes the role
for FDA oversight for medical device software. Do you agree
with that approach and that FDA does have a role for the
oversight of riskier MMAs?
Dr. Mitus. Yes, absolutely.
Mr. Green. OK. In what ways can the FDA regulate mobile
medical applications as mobile devices without slowing
innovation?
Dr. Mitus. We believe that if a device, again, is defined
as something that directly touches a patient or independently
acts on a patient, that is a medical device and the software
that runs that device would be considered a medical device, and
subject to the current regulatory process. I think it is very
important to distinguish that from the vast bulk of health IT,
which is really not best categorized as a medical device.
Mr. Green. OK. Dr. Classen, a lot has been discussed about
risk-based framework for regulation. As I read it, there are a
lot of similarities between FDA's and the Bipartisan Policy
Center's approaches. In what ways do the BPC recommendations
differ from the draft guidance issued by the FDA?
Dr. Classen. The guidance that we focused on in our report
at the Institute of Medicine, a lot of the FDA guidance
excluded what we were focused on there from their oversight on
mobile medical apps, and we had recommended that a new
framework be created for oversight of these areas. So we would
agree with BPC Center approach and framework as a next step,
creating more specificity around a future framework as we have
outlined.
Mr. Green. I do have concerns about the capacity of the FDA
to properly and efficiently regulate mobile apps. This is a
topic that deserves more scrutiny by Congress and the FDA. We
must find a way to ensure that the safety and effectiveness of
the applications regulate only the application that posed a
risk, and do so in a way that is efficient and effective.
Mr. Chairman, members of Congress always doesn't do things
that are efficient and effective, but in this case, because it
affects the health care and how we can deliver and monitor
health care in the future, it is so important not only for our
subcommittee, but the full committee and Congress.
Thank you, Mr. Chairman. I yield back my time.
Mr. Pitts. Chair thanks the gentleman and now recognizes
the gentleman from New Jersey, Mr. Lance, for 5 minutes for
questions.
Mr. Lance. Thank you, Mr. Chairman, and good morning to you
all.
I have heard from at least one app developer in my district
who has been attempting to work with the FDA to approve the
medical app. This involves a smartphone and corresponding app
that helps patients with diabetes monitor the diabetes and so
they can track their glucose levels. It is my understanding
that while the procedure is currently under review at the FDA,
the approval process is slow moving and there are some levels
of uncertainty as to how the agency can address or regulate the
technology. Your testimony this morning has involved this type
of discussion. Do you believe that the experience of companies
such as the one with whom I have been speaking in my district
are common experiences that companies have, and should we be
concerned about the FDA as it goes forward to regulate mobile
apps as medical devices? To whoever wishes to respond to the
question.
Dr. Smith. So I do believe it is about clarity and speed,
and I think we are in part here today because it was in the
middle of 2011 when draft guidance was issued in this space,
and we still don't have the clarity and certainty of even that
guidance, which by itself, still has elements in it which
maintains some vaguery. And so, I believe we are suffering the
confusion of successive clarification, as opposed to enjoying
the speed of appropriate regulatory efforts. And so I think it
is both slow for the folks who are engaged, but perhaps even
slower for those who are hesitating to engage and are finding
other things to do with their time, treasure, and talent. And
so I think it is fundamentally about clarity and speed, and at
times, even willing to accept the imperfect now as opposed to
waiting interminably for some other perfected notion of
regulation.
Mr. Lance. Of course.
Mr. Bialick. I would like also just to say, I won't comment
on the frequency with which that is a common occurrence, but I
would like to say that that viewpoint and the experience of a
developer like that is critical to this process. We talk about
large apps, we talked about the apps that are being developed
in a garage or a basement or an attic. We want to also make
sure that those that are going to be engaging in this process
and those that have made this market so dynamic, their
viewpoint and their experience is brought into the process as
well.
Mr. Lance. It is clear to me that this would be helpful to
those who have the condition of diabetes, and this is a well-
respected group and wants to move forward in a medically
responsible way. What would you suggest that we as the
legislative branch do to help the FDA move through this
situation to benefit the American people, particularly as it
relates to such health concerns as diabetes?
Dr. Mitus. We would like to reiterate what you have just
articulated so well. There is a risk, barriers to entry and to
this important space, the delay of important advances into
health care, and really we support a risk-based approach where
we continue to manage devices as they are today, and then
develop other mechanisms for the important oversight of health
IT that is not a device.
Mr. Lance. Yes, Dr. Smith?
Dr. Smith. I would like to draw attention to the impact
that the delay between draft guidance and formal, permanent
guidance provides. So it goes well beyond the current issue.
The next draft guidance offered, if there is a doubt that that
will become final, you will have no movement based on the
draft. No companies will engage based on those recommendations,
for fear that that process will be again derailed. And so
imperfect as it may be, I think there is a value proposition
that says fulfill that draft promise, or else we risk the
notion that the regulatory cloud becomes even larger. And so I
think there is a calculus to be performed here, but one that
has implications well beyond the current discussion.
Mr. Lance. Thank you. Let me say, I do not view this as a
partisan issue, and I want to work in a bipartisan capacity
with colleagues on the other side of the aisle, as well as with
those on this side of the aisle which I am involved, because we
want to do this in a responsible way, making sure that the
American people can have access to these marvelous new portions
of improving the health of the Nation.
Thank you, Mr. Chairman. I yield back the balance of my
time.
Mr. Pitts. Chair thanks the gentleman and now recognizes
the gentleman from Maryland, Mr. Sarbanes, for 5 minutes for
questions.
Mr. Sarbanes. Thank you, Mr. Chairman. This is a
fascinating hearing.
When we were doing the health care reform effort here,
which resulted in the Affordable Care Act, one of the things
that I was most excited about was this turn in the direction of
prevention with our health care system and trying to come up
with a system that is a health care system, rather than a sick
care system, which in many ways is what we had until now. But
the promise of it is that patients can become full partners in
their care, and at a time when we worry about whether there is
going to be enough caregivers to provide the services out
there, if you begin to identify the patient themselves as a
potential caregiver, you get a little less anxious. Now, you
have to approach that in a sensible way, but if we are focused
on so the acute care side of things, I can't help my surgeon
perform surgery on me, but I can certainly help my primary care
physician make me more sensible about prevention. So I really
become a partner in that, and this technology holds that real
promise.
There was--Dr. Francis Collins, who is the director of NIH,
recently highlighted the results of a mobile health clinical
trial in his personal blog, and this was a trial conducted over
a year by University of Maryland School of Medicine, which
utilized a diabetes mobile health technology of a company that
I am very familiar with called WellDoc, which is based in
Baltimore. And they showed that these patients were able to
demonstrate a reduction in terms of the percentage result on
their blood sugar test that they would take on a regular basis,
and the same system was studied in a demonstration project of
Medicaid patients, where patients used this diabetes self-
management system, with the result of reducing the number of
diabetes-related hospital admissions and emergency room visits
among that population that was using it by approximately 57
percent, which is really incredible. And a lot of times people
do end up in the hospital because they have missed some basic
precaution they need to be taking in their own self-management,
so it just shows how important these opportunities to use
technology are in terms of self-management by patients, and you
have all spoken to that.
My question, and I offer it to anyone here on the panel, is
as we continue this effort to reduce our health care costs, and
there is real potential using this technology to do that, can
you point to instances where federal programs are beginning to
adopt these validated technologies across the spectrum of
government health care? And you can--if you want to point to
Medicaid and Medicare, please do, to the Federal Employees'
Health Benefits Program, TRICARE, Veterans' Affairs, what have
you, because obviously we are very interested in that, given
the cost and scope of those programs.
Ms. Bechtel. So I will start, and I say that I think it is
a terrific question, and my testimony really focused on the
Meaningful Use Program in Medicare and Medicaid, because of the
work that it is doing to make patients full partners in their
health. Giving patients access to electronic tools is really
making them members of the care team now. We are moving from a
point where we used to do things to patients and for patients
to now doing things with patients, and that is essential to
lowering costs and making care better for them. And the online
tools are really facilitating important things like shared
decision making, population health outreach so that we can get
reminders about being overdue for a mammography screening or
immunization or--whether it is pneumonia or flu shot or
something like that. And it is also facilitating the provision
of education resources for patients that are very specific to
their needs. So we are moving to a health care system that is
much more customized and personalized and engaging for patients
and families, and so that is why I think that it is essential
as we move forward in the Meaningful Use Program to really keep
up the pace. In the next phase, we are going to give patients
online access that they can download their health information
and transmit it to other care providers who need it. We are
going to give them the ability to securely send an e-mail to
their doctor. I mean, there are some really important
advancements that are coming down the pike if we just keep our
foot on the gas pedal.
Mr. Sarbanes. Mr. Chairman, would you indulge one more
response from Dr. Smith?
Mr. Pitts. Go ahead.
Dr. Smith. So I point to the VA here. Adam Darkins runs the
VA telehealth program. In 2012, I think there were 1.5 million
telehealth visits. The net impact of that at 150 VA medical
centers is to drop emergency room visits by 40 percent,
hospital admissions by 63 percent. Patients experienced a 60
percent reduction in hospital days. Nursing home admissions
dropped by 63 percent, and patients reported a 95 percent
satisfaction rate with their care. And that is the largest
functioning telehealth program that we have in the country, and
it is run by the Veterans' Administration. I think it is one of
the best kept secrets of excellence inside the Veterans'
Administration, and it speak to the potent opportunity that
this has when we align the incentives system so that this
technology is fully realized.
Mr. Sarbanes. Thank you. Those are powerful statistics. I
yield back.
Mr. Pitts. Chair thanks the gentleman and now recognizes
the gentlelady from North Carolina, Mrs. Ellmers, for 5 minutes
for questions.
Mrs. Ellmers. Thank you, Mr. Chairman, and thank you to all
of our panelists today for this very important subcommittee
hearing.
First I would like to just say that across the board,
health IT is so important. We have got to do everything we can
to make it move forward quickly for our patients. As you all
have pointed out, the very helpful information that we are
gaining from it and how this truly will improve upon health
care in this country, with all the hurdles that it has faced.
However, having said that, I think it is incumbent upon myself
to point out that it isn't quite the nirvana that has been
discussed here. For instance, when we are talking about the
Meaningful Use, as Ms. Bechtel, you had cited some of the
statistics, the number of physicians, the number of hospitals,
however, we do have to remember that this is a mandate that was
put forward and physicians are participating in it because if
they do not, they will receive a Medicare reimbursement cut. So
it is not only very beneficial and very important; however, it
is very costly and at a time in this economy when you see what
we are faced with, physicians being small business owners
themselves, hospitals having difficulty functioning,
physicians--tens of thousands of dollars that they are having
to incur to put this into place, hospitals, millions of
dollars. It is a challenge. And again, the importance being
duly noted, however, very difficult for many physicians to be
incurring this cost.
With that, I do have a question. Ms. Bechtel, you had
mentioned that this situation--that we are moving forward and
it is very important, and that there are many of these
physicians, but you do acknowledge the fact that it is a
mandate?
Ms. Bechtel. Absolutely, and I think it points to the
problem that we have in the larger system, which is a complete
lack of payment, that really drives quality and the
development----
Mrs. Ellmers. Absolutely.
Ms. Bechtel [continuing]. Of functionality, as you well
know, and I know you are a big supporter of health IT, when we
have fee-for-service, of course we are going to see the
proliferation of billing systems, and we have no problems in
interoperability or adoption rates of billing systems that are
designed to really focus on services.
Mrs. Ellmers. And two, this is my next question. We had
also discussed the fact--and I think you had mentioned that at
some point in the future, patients will be able to download
their own information. Now, there again, I see a big problem
and this feeds into the reason that we are having this
subcommittee hearing, which is the future, where are we going
to go, how is FDA regulation going to affect these things, how
is medical device tax going to keep technology from innovating
and moving forward?
One of the issues that I continuously hear about is the
fact that communication or software is different, the different
systems that physicians, hospitals, and others use, so there
really is a communication problem right now. What timeline do
you--number one, do you acknowledge that, and two, what
timeline do you see that happening for patients to be able to
download information on their own so that they can be partners
in this?
Ms. Bechtel. So you can do this if you are a veteran
through the VA right now, or through the Medicare program. The
ability to do it through the Meaningful Use Program, which will
be from the EHRs, is going to start in October of this year for
hospitals, and in January for physicians.
Mrs. Ellmers. But do you--have you also heard that there is
a communication problem between different facilities, physician
offices and hospitals, different health care----
Ms. Bechtel. Yes. It is one of the most common complaints
we hear from consumers is the lack of coordination and the lack
of communication. They say over and over again, I just want my
doctors to talk to each other. The problem is they are not paid
to talk to each other, so Meaningful Use has done a couple of
things. One is there is an open standard now called the Direct
Protocol, which is essentially like secured g-mail. Physicians
and soon patients can actually use it right now to talk to each
other, so you can have a hospital send a care summary to a
primary care clinician----
Mrs. Ellmers. OK. Can I just--I need--I only have 30
seconds left here, and I do have a question for Dr. Mitus. Now,
you had mentioned that doctors are not paid to talk to each
other. How do you describe that?
Ms. Bechtel. Because they are not paid for care
coordination, they are paid on volume for services and
procedures. So my doctor doesn't get reimbursed for picking up
the phone and calling my cardiologist and coordinating----
Mrs. Ellmers. So you are basing that on payment?
Ms. Bechtel. Under fee-for-service.
Mrs. Ellmers. OK, fee-for-service, oK.
Dr. Mitus, and again, I apologize because this is such an
important issue for me. The Commonwealth Alliance that you put
together, what do you see Meaningful Use not doing that you
feel is an issue that needs to be addressed? In other words,
where are your areas of concern and the Commonwealth Alliance's
concern?
Dr. Mitus. May I take a few moments to answer?
Mr. Pitts. You may proceed.
Mrs. Ellmers. Thank you.
Dr. Mitus. Thank you for raising an issue that we are very
proud of, that we announced with an intention to launch, led by
McKesson, Athena Health, Allscripts, Cerna, and Greenway. We
are really trying to create to solve the very difficult problem
of disparate health systems and the ability to communicate
across those health systems. It is one thing to gather data
from an electronic medical record within an individual
physician's office, but that ability to aggregate information
from all the sites of care is a tremendous problem. We are
attempting to solve that and create interoperability and
seamless communication by setting standards and creating an
infrastructure to support those important processes.
Mrs. Ellmers. Is there a government HHS or any other agency
that is hampering this availability that you are aware of?
Dr. Mitus. Not that I am aware of.
Mrs. Ellmers. OK. Thank you so much, and again, thank you,
Mr. Chairman, for indulging me for a few moments.
Mr. Pitts. Chair thanks the gentlelady and now recognizes
the gentleman from Georgia, Dr. Gingrey, for 5 minutes for
questions.
Mr. Gingrey. Mr. Chairman, thank you very much.
This is really for all of the panelists. Some have
suggested that the mobile apps may be a game changer for health
care delivery and consumer engagement. Do you agree with that
statement, or do you believe they have already changed? Why
don't we start at the end and----
Dr. Smith. It would be sad if where we are is where we are
going, and so I have to believe that we are looking at the
front end--on the cusp of a transformation in health care where
engaged consumers work with a coordinated and integrated health
care system, and so we can realize the important benefits of
having ambient health care as opposed to having the model of
health care delivery that we have been living with since my
grandparents.
Mr. Gingrey. Sure, thank you.
Mr. Bialick. I 100 percent agree with that, absolutely
agree with that.
Dr. Mitus. I support the comments of my colleagues.
Dr. Classen. And I would agree.
Mr. Gingrey. All right. Excuse me, I didn't realize my
phone was alive. I apologize for that, panelists.
Dr. Smith, who makes mobile apps? It is sophisticated, big
developers or are we talking about the little developer working
out of the garage, the entrepreneur types, or is it both
engaged in this activity?
Dr. Smith. So over the last 3 years, I have probably met
with 1,000 companies that are interested in this space, all
small, all largely unaware or incompletely aware of the
regulatory framework that they are kind of naively entering,
and find a bit of frustration as they realize that there is
this other burden that they are not yet aware of. It is not
enough to solve the problem; one must then engage a system with
its own set of rules. And so it is often a fresh graduate out
of graduate school, or even an undergrad who identified a
problem in his family, the health care that they see, and are
trying to figure out a way to solve it.
Mr. Gingrey. The next question is for Mr. Bialick. Today,
there are roughly 97,000--I can't believe that, but this is a
statistic that I have. Today, there are roughly 97,000 medical
apps in the Apple app store, 97,000. These apps have generated
more than three million free downloads. If the FDA regulates
medical apps as medical devices and these products have to go
through regulatory review at the agency and then they become
subject to the 2.3 percent medical device tax, how likely do
you believe it is that these apps will remain free to the
public?
Mr. Bialick. I would just say that any additional costs
added to the development process is going to change the
marketing approach for them. This is a very capitalist market
that we have created in health care apps. I would say that if
you are going to increase the startup cost, if you are going to
recoup that cost within a reasonable amount of time, you are
likely going to have to change how money is coming in, and so
that is either going to be to stop offering them for free, or
require that end users pay for additional functionality within
the app itself.
Mr. Gingrey. Well sure, exactly, and I will stay with you,
Mr. Bialick. The death toll for chronic conditions is a
staggering number. More than 10,000 people die every day
because of chronic conditions. Not only is the human toll
large, but of course, the economics behind it are driving up
health care costs, they are harming our household and national
finances, and as these costs for health care go up, more money
is diverted from other programs. It is diverted from job
creation, indeed, from consumers' pockets. How can health
information technologies such as medical apps or electronic
health records, if not classified by the FDA as medical
devices, how can they address these problems and how do we
accelerate their use?
Mr. Bialick. So to address the--let's look at a really high
cost problem specifically to get to your question, which would
be something like dually eligible beneficiaries between
Medicare and Medicaid programs. Even if you target a specific
issue like using these mobile apps to provide very high touch
care, so we are not talking about managed care, but rather, we
are talking about a direct way for the patient to be reminded
for something, like imagine, taking their medication, some of
these issues that could avoid the number of costly returns to
the hospital. That is a very direct and tangible way that
people can interact with their health care. That is what should
be accelerated.
Mr. Gingrey. Well, and that is the point I wanted to make
to the witnesses and to my colleagues on the subcommittee.
These devices, these medical apps, they don't draw blood. They
don't take a biopsy. They are not invasive. They are just
giving information to people in a timely fashion, and if
permitted, to members of their family so that they know what is
going on with mom or dad who 5,000 miles away and maybe very
elderly, or maybe even in a nursing home. I mean, this is a
hugely important subject and I commend the chairman for
assembling this panel of witnesses and discussing this subject.
So Mr. Chairman, I thank you for letting me go over a
little bit, but I appreciate it and I yield back.
Mr. Pitts. Chair thanks the gentleman, and now recognizes
the gentleman from Florida, Mr. Bilirakis, for 5 minutes for
questions.
Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it
very much. Thank you to the panel for their testimony. I was
over in VA. I apologize, but that is very important as well.
I want to--question to Mr. Smith. You mentioned in your
testimony the potential cost savings benefits of telehealth. Do
you believe it is feasible to expand the use of telehealth to
Medicare to effectively lower its costs?
Dr. Smith. It is a simple word, absolutely. I could go on,
but we have seen the impact of telehealth and telemedicine--New
England, the Health Care Institute, the VA program, there is a
rich history of information, some of which I provided in my
written testimony, about the beneficial impacts not only on
outcome but also on costs. And so it seems obvious that we can
extend that to patients struggling with chronic disease,
independent of how their health care bills are paid.
Mr. Bilirakis. Very good, thank you.
Follow up again to Mr. Smith. With doctors showing an
increase of reluctance to accept new Medicare patients, for
obvious reasons, do you believe that allowing doctors to use
telehealth will enable them to expand their reach in not only
treating existing patients, but also increase access by
enabling them to treat new beneficiaries? If you could
elaborate a little bit.
Dr. Smith. Sure. I think the technology obviously enables
that notion of care at a distance in ways that are much more
efficient than, say, in addition to the costs associated with
travel, say, many of the costs associated with--in unnecessary
or untimely ER visits or doctor's office visits. But I think it
is not enough to have the technology enabled, we also have to
have payment mechanisms that provide appropriate incentives for
use. And so I was talking to a colleague who is a dermatologist
and I asked about this--the world of teledermatology. And he
says, it is never going to take off because I don't get paid
for it. I think that is an unfortunate, but rational,
statement.
Mr. Bilirakis. Very good. Anyone else on the panel wish to
comment?
Mr. Bialick. I would like to just specifically on that
point about taking on more Medicare providers. I think that
when we talk about telemedicine, we think about it in a
traditionally rural setting, so it is the idea of someone that
lives in the country that doesn't have access to advanced care
facility that is using telemedicine to connect to that. But
especially from what we have learned from the VA around
telestroke interventions as well as a number of other
occupational therapy style interventions that you are able to
do via telemedicine, this is absolutely something that can be
leveraged to not only increase--improve outcomes, but save
money in the urban setting as well.
So we shouldn't be thinking about this as a purely rural
situation, but this is also something that can be done in an
urban situation as well, and still much like we are talking
about with the idea of regulation of apps, there are major
regulatory barriers in place that are limiting the amount that
Medicare providers are able to do that.
Mr. Bilirakis. Thank you. Anyone else?
Thank you very much. I yield back, Mr. Chairman. I
appreciate it.
Mr. Pitts. Chair thanks the gentleman. That concludes the
questioning.
At this time, I would like unanimous consent to place two
documents into the record. The first is a letter from Kevin
McCarthy, the second is a statement from the Bipartisan Policy
Center. I think you have seen these. So without objection, so
ordered.
[The information appears at the conclusion of the hearing.]
Mr. Pitts. This has been a very interesting hearing, very
important issue, very informative. We would like to thank all
the witnesses for taking time and presenting testimony and
answering all the questions. Members may have follow-up
questions. I will remind members they have 10 business days to
submit questions for the record, and I ask the witnesses to
respond to the questions promptly.
With that--and members should submit their questions by the
close of business on Wednesday, April 3. With that, thank you
very much. Without objection, the subcommittee is adjourned.
[Whereupon, at 12:00 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Phil Gingrey
Mr. Chairman, Thank you for calling this hearing today, and
I commend the committee looking at the benefits that health
information technologies can provide to the practice of
medicine. The possibility that these emerging technologies may
encourage higher patient engagement and ultimately better
health outcome is impossible to ignore.
An impediment to innovation continues to be the uncertainty
regarding the regulation of these technologies. We must seek a
balance between patient safety and innovation. An overly
restrictive regulatory process will stifle innovation and
ultimately lead to erosion in the quality of care that a
patient may receive. We need to work together to develop a
framework that minimizes risk to a patient, but limits the
regulatory hurdles so that future innovation will continue to
change health care delivery and a patient's access to their
health information.
Mr. Chairman, I look forward to working with the Committee
to develop this framework. I still believe in the amazing
potential that health information technologies will have on the
practice of medicine, and I will continue to work to allow the
market to develop breakthroughs to the benefit of patients.
Thank you and I yield back.
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