Congressional Hearings
IMPLEMENTATION OF THE 21ST CENTURY CURES ACT: ACHIEVING THE PROMISE OF HEALTH INFORMATION TECHNOLOGY
Congressional Hearings
SuDoc ClassNumber: Y 4.L 11/4
Congress: Senate
CHRG-115shrg27492
| AUTHORITYID | CHAMBER | TYPE | COMMITTEENAME |
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| sshr00 | S | S | Committee on Health, Education, Labor, and Pensions |
[Senate Hearing 115-658]
[From the U.S. Government Publishing Office]
S. Hrg. 115-658
IMPLEMENTATION OF THE
21ST CENTURY CURES ACT:
ACHIEVING THE PROMISE OF
HEALTH INFORMATION TECHNOLOGY
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED FIFTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING THE IMPLEMENTATION OF THE 21ST CENTURY CURES ACT: FOCUSING ON
ACHIEVING THE PROMISE OF HEALTH INFORMATION TECHNOLOGY
__________
OCTOBER 31, 2017
__________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont
JOHNNY ISAKSON, Georgia ROBERT P. CASEY, JR., Pennsylvania
RAND PAUL, Kentucky AL FRANKEN, Minnesota
SUSAN M. COLLINS, Maine MICHAEL F. BENNET, Colorado
BILL CASSIDY, M.D., Louisiana SHELDON WHITEHOUSE, Rhode Island
TODD YOUNG, Indiana TAMMY BALDWIN, Wisconsin
ORRIN G. HATCH, Utah CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska TIM KAINE, Virginia
TIM SCOTT, South Carolina MAGGIE WOOD HASSAN, New Hampshire
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Democratic Staff Director
John Righter, Democratic Deputy Staff Director
(ii)
C O N T E N T S
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STATEMENTS
TUESDAY, OCTOBER 31, 2017
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 1
Murray, Hon. Patty, Ranking Member, Committee on Health,
Education, Labor, and Pensions, opening statement.............. 3
Witnesses
Statement of Jon White, M.D., Deputy National Coordinator for
Health Information Technology, Office of the National
Coordinator, U.S. Department of Health and Human Services,
Washington, DC................................................. 6
Prepared statement........................................... 7
Statement of Kate Goodrich, M.D., Director of the Center for
Clinical Standards and Quality and Chief Medical Officer,
Center for Medicare and Medicaid Services, Baltimore, MD....... 11
Prepared statement........................................... 12
Statement of James A. Cannatti III, Senior Counselor for Health
Information Technology, Office of Inspector General, U.S.
Department of Health and Human Services, Washington, DC........ 16
Prepared statement........................................... 17
Summary statement............................................ 19
(iii)
IMPLEMENTATION OF THE
21ST CENTURY CURES ACT:
ACHIEVING THE PROMISE OF
HEALTH INFORMATION TECHNOLOGY
----------
TUESDAY, OCTOBER 31, 2017
U.S. Senate,
Committee on Health, Education, Labor, and Pensions
Washington, DC
The Committee met, pursuant to notice, at 2:34 p.m., in
room 430, Dirksen Senate Office Building, Hon. Lamar Alexander,
Chairman of the Committee, presiding.
Present: Senators Alexander [presiding], Cassidy, Young,
Murray, Casey, Franken, Bennet, Baldwin, Murphy, Warren, Kaine,
and Hassan.
Opening Statement of Senator Alexander
The Chairman. The Senate Committee on Health, Education,
Labor, and Pensions will please come to order.
I want to congratulate my Democratic colleagues for being
on time. I've issued reprimands to the Republicans, but
probably with no effect.
This afternoon we're holding a hearing entitled,
`Implementation of the 21st Century Cures Act: Achieving the
Promise of Health Information Technology'. Senator Murray and I
will each have an opening statement, then we'll introduce our
panel of witnesses. After our witnesses, Senators will each
have 5 minutes of questions.
Last December I said that, for the second consecutive year,
President Obama has signed a `Christmas miracle' into law. That
was his term for what we did in 2015. It was the Every Student
Succeeds Act, the law fixing No Child Left Behind. Last year,
it was the 21st Century Cures Act, which Majority Leader
McConnell called `the most important legislation Congress
passed last year'.
This is the first hearing on the implementation of what we
call Cures, which this Committee worked hard on and almost
every single member contributed to. We hope it will help
virtually every American family by taking advantage of
breathtaking advances in biomedical research.
But as I have often said when we began hearings on the
Every Student Succeeds Act, a law is not worth the paper it's
printed on if it is not implemented properly. I intend to
ensure that Cures is also implemented properly, the way
Congress wrote it, and today is the start of that oversight.
This hearing is focused on the health IT provisions in
Cures. We will have additional implementation hearings in
December on the sections of Cures dealing with research,
development, and approval of innovative treatments, cures and
medical devices, and on the reforms to the mental health
programs.
As we worked on Cures, we learned that in order for most
areas of the bill to succeed, it was essential that electronic
health care records systems work properly.
For example, the precision medicine initiative that was so
important to President Obama aims to assemble 1 million genomes
to help doctors tailor treatment to patients. But most of that
information the head of the National Institutes of Health, Dr.
Francis Collins, is trying to collect, will flow through
electronic health care records.
The more we looked into these systems, the more we realized
our Nation's system of electronic health care records was in a
ditch.
Since 2011, we have spent $37 billion incentivizing doctors
and hospitals to install electronic health care records systems
through the meaningful use program in Medicare and Medicaid.
A well-respected hospital told me that Meaningful Use Stage
I was helpful, Stage II was difficult, Stage III was
terrifying, in their words. On top of that, doctors and
hospitals were being asked to adjust to a new system of
Medicare and Medicaid reimbursements.
So I recommended slowing down the implementation of Stage
III to get it right, and working with doctors and hospitals to
get it right, which the previous administration declined to do.
In 2015, a family doctor in Kingsport, Tennessee explained
to the New York Times the problems that he and others face with
electronic health records systems saying, ``We have electronic
records at our clinic, but the hospital, which I can see from
my window, has a separate system from a different vendor. The
two don't communicate. When I admit patients to the hospital, I
have to print out my notes and send a copy to the hospital so
they can be incorporated into the hospital's electronic
records.''
The exchange of information between electronic health
records systems is called interoperability. In the case of the
doctor from Kingsport, and many others, this exchange of
information does not always happen easily, or at all.
This Committee eventually held six hearings in 2015. We
didn't set out to do that, but when we stumbled into the
problem with electronic records we found ourselves holding six
hearings looking at ways to improve electronic health records
and formed a bipartisan working group that made recommendations
that were included in the final Cures legislation.
The goal of the health IT provisions in Cures was to make
it easier for patients to access their health records and for
doctors and hospitals to get the information they need to treat
patients.
The law set clear deadlines for the Administration to meet,
and today I would like to hear how implementation of those
provisions is going.
Are doctors spending less time on administrative tasks and
more time with patients?
Are doctors and hospitals better able to understand before
purchasing an electronic health records system how well it
shares information with other systems?
What has been done to discourage information blocking,
which is when there is some obstacle getting in the way of
health records being sent to another medical provider, like one
clinic refusing to send information to another, or one record
system not exchanging information with another?
What tools have been given to local provider networks,
hospitals, and doctors to help them achieve interoperability
with other health providers?
What has been done to ensure patients know they have a
right to access their own health care records?
What steps have been taken to help doctors ensure they are
looking at the record of the patient in front of them and not
another patient's record?
There is also a role for the private sector to play. In a
country where 2 million people fly every day, taking for
granted how easy it is to make and change flight reservations
on different airlines, we should be able to use the genius of
our private sector to make sure electronic health records are
working.
While some regulations are useful, we should be careful to
leave plenty of room for the game-changing innovation in
electronic health records that we've seen in so many other
sectors of our economy.
One such effort is the Center for Medical Interoperability,
a group of non-profit, for-profit, and university-based
hospitals that is headquartered in Nashville.
Their idea is that, all together, they have a large enough
purchasing power to tell the makers of electronic health record
systems they want systems that work properly and that are able
to communicate with each other. If the systems don't work
properly and communicate with each other, these purchasers will
find products that do.
In February 2016, former CMS Administrator Andy Slavitt
joined me at the Center for Medical Interoperability in
Nashville. Both of us were impressed with what we saw. I was
glad to see these hospitals coming together to work out a
solution in the private sector to help with interoperability.
Electronic health records are a critical piece to the
success of the 21st Century Cures legislation. I look forward
to hearing what steps the Administration has taken to implement
the provisions this Committee helped to enact into law.
Senator Murray.
Opening Statement of Senator Murray
Senator Murray. Thank you very much, Chairman Alexander. I,
too, am very glad we are continuing our work on ways to improve
the health and well-being of families across the country.
Today's discussion really picks up on a series of hearings
that we held last Congress to improve health IT for patients
and families, doctors and hospitals, and for our Nation's
larger health care infrastructure.
This is an area where I am very glad we found common
ground, explored common sense steps, and built on some of the
great work that has already been done.
Here's why this is so important, and here's why we are here
today.
Whether it's coordinating care between providers, being
able to look up your own health care information online, or
using patients medical records to catch a dangerous interaction
between medicines, a strong health IT infrastructure is
critical to building a health care system that works for
patients and families and puts their needs first.
Now, as we've talked about, we have made some progress.
Hospitals and providers have made great strides over the
last few years when it comes to adopting health IT.
Today, physicians use electronic health records more than
ever before. Health care organizations are continuing to share
and use electronic health information.
But we do have more work to do. Fortunately, because of
your efforts, Mr. Chairman, Members on this Committee, and the
overwhelming majority of the Senate, we now have an important
tool at our disposal to better advance this work. Of course,
that is the 21st Century Cures Act, something I know we all are
proud of.
Along with all Cures does to tackle our hardest-to-treat
diseases, confront the opioid epidemic, strengthen mental
health care, and advance medical innovation, this legislation
helps make improvements to help empower patients and providers
with more and better information to help drive treatment and
improve health outcomes.
So, I look forward to talking today about this and how we
can best utilize and build on Cures.
First of all, that means making sure this Administration is
implementing Cures in the way Congress intended, and that
includes strong investments so that patients and families
actually see the benefits of this law.
Quite frankly, that has been an issue with this
Administration. I won't go into all of the reasons why, but I
am concerned, for one, that President Trump has asked Congress
to slash ONC's operating budget. That certainly will not help
our efforts today.
I am also concerned the President didn't include anything
in his proposed budget for information blocking, requested by
ONC and the Office of the Inspector General, which helps
certify and protect health information.
So those are two examples, but it does speak to a larger
concern.
I hope that, just as we came together to pass Cures, we can
work across the aisle to make sure the agencies involved have
access to the funding they need in order to make this a
success.
Now, to be clear, we have seen this Administration continue
the work started by the Obama administration to support the
development of a framework for trusted exchange of health
information, which Senators Baldwin and Hatch worked together
to include in Cures. That will help make sure that providers
and networks don't have to reinvent the wheel every time they
need to exchange information with a new facility.
That is very encouraging, and I want to make sure they keep
at it and that we keep moving in the right direction so that we
continue to engage stakeholders to find the best path forward
and implement critical new conditions for certification of
health information technology.
Fortunately, we have great witnesses here today, and we
appreciate all of you coming today. I look forward to all of
you sharing your expertise with us.
Last, I would just acknowledge all the work our colleagues
on both sides have done and are doing when it comes to health
IT.
Like all of you, I am very hopeful we can do more to ensure
electronic health records are accessible to patients and
families so they are able to stay engaged in this effort.
I will have questions for the witnesses, but thank you very
much, Mr. Chairman.
The Chairman. Thank you, Senator Murray, and thank you for
your leadership in passing the 21st Century Cures Bill, which
the Majority Leader called the most important bill last year.
I would say to the witnesses before they begin what I said
to the witnesses from the Obama administration. We have our
differences on this Committee, but in this area we've got a lot
of common goals, and our purpose is to create an environment in
which you can succeed toward those goals. So I would encourage
you not to think of us as adversaries, and we won't always
agree, but think of us as wanting to create an environment in
which you can succeed, and if during the hearing or afterwards
with our staff you think of ways that we can do that, I hope
you'll be specific about it.
The first witness is Dr. Jon White. He is the Deputy
National Coordinator for Health Information Technology in the
Office of National Coordinator for Health Information
Technology--that's a pretty big title--also known as ONC.
That's the lead entity within the Department of Health and
Human Services on issues related to health information
technology. He's provided leadership over all those programs.
Next we'll hear from Dr. Kate Goodrich. She is from the
Center for Medicare and Medicaid Services. She's Director of
the Center for Clinical Standards and Quality and Chief Medical
Officer at CMS. She oversees the implementation of the
Electronic Health Record Incentive program, also known as
meaningful use, and the implementation of the quality
provisions of the Medicare and CHIP Reauthorization Act.
Last we will hear from Mr. James Cannatti. Mr. Cannatti
serves as Senior Counselor for Health Information Technology in
the Office of the Inspector General at Health and Human
Services. In the Cures Act, the Office of Inspector General was
given new authorities to investigate and take enforcement
actions against acts of information blocking or the blocking of
the flow of patient data or electronic health information.
We welcome, again, our witnesses. If you could summarize
your remarks in 5 minutes, that will leave more time for
questions from the Senators.
Dr. White, let's begin with you. Welcome.
STATEMENT OF JON WHITE
Dr. White. Thank you very much. Good afternoon, Chairman
Alexander, Ranking Member Murray, and distinguished Committee
Members. I appreciate the opportunity to speak with you today
about the Office of the National Coordinator for Health
Information Technology's progress in implementing provisions of
the 21st Century Cures Act.
I am grateful to Congress and particularly to this
Committee for your vision and your thoughtful leadership in
passing this important and bipartisan law. We agree with
Congress that health IT must be more interoperable, that it
should be easier to use for everyone, and that information must
flow seamlessly and without unreasonable blocking, and I know
the National Coordinator, Dr. Don Rucker, shares this view.
I've worked with health IT as a family physician and as a
public servant for a long time, so I'm familiar with a variety
of health IT perspectives. While the Nation has made
significant progress in digitizing health information,
important work remains, particularly around interoperability,
clinician burden, and information blocking.
Indeed, ONC has been concerned with these issues in recent
years, and I'd like to share with you some of the work that we
led in the years prior to the passage of the Cures Act.
In 2015, ONC outlined a 10-year plan for interoperability
in the Shared Nationwide Interoperability Roadmap. We released
the Federal Health IT Strategic Plan, developed in partnership
with over 35 Federal entities, and we submitted a report to
Congress on information blocking. We included application
programming interfaces, or APIs, as part of the 2015 edition
Health IT Certification Criteria, and we partnered with the
innovation community through various prize competitions to
advance patient matching, patient privacy, and API security.
Last month we provided administrative flexibility for
certification, which has downstream benefits to the clinicians
using EHRs.
To provide focus and clarity for ONC stakeholders around
our interoperability goals, we're concentrating on three
framing questions. The first is about the patient. Can patients
access their medical data in a secure, straightforward, and
consumer-friendly way?
The second is about institutional accountability. Can
payers assess the quality and value of the care they purchased,
and can clinicians provide outstanding care for entire
populations?
The third guiding question is how do we operationally
define an openly published API that makes information available
to the right people without special effort, language that may
be familiar to you?
Today, under the National Coordinator's leadership, ONC is
deeply engaged in supporting the implementation of the Cures
Act, specifically the provisions in Title 4. ONC will work with
the HHS Secretary to establish a goal, a strategy, and
recommendations to reduce regulatory or administrative burden.
We understand that clinicians face real challenges in using
health IT, and it's a priority to get that right.
We work closely with CMS on this effort and have engaged
with dozens of stakeholders to identify the important issues.
We've also met with stakeholders representing medical
specialties to better understand how health IT can best help
them meet the needs of their patients. ONC has begun to
implement the trusted exchange provisions outlined in the Cures
Act. The resulting Trusted Exchange Framework and Common
Agreement, or TEFCA, will be a critical component of
nationwide, network-to-network exchange of health data and our
charge to support nationwide interoperability.
We've held two to three initial public meetings on the
TEFCA and had one round of public comments, and we intend to
release a draft of the TEFCA for public comment by the end of
the year.
We have already closed the previous two Federal Health IT
advisory committees, and we'll open that new health IT advisory
committee established by the Cures Act, holding our first
meeting this winter.
We're also working to implement the information blocking
provisions in Title 4. Information blocking is a complex issue
with significant implications for patients and the industry.
It's important to distinguish inappropriate practices for
information blocking from appropriate ones like protecting
patient privacy and security. So we're working closely with our
Federal colleagues, including the HHS Office of the Inspector
General. We're also working with the Agency for Health Care
Research and Quality to include health IT developers as
protected participants in patient safety organizations, and
with the HHS Office for Civil Rights to support patient access
to their health information.
As we look ahead, effortless access to and use of their
medical data will improve the ability of patients to shop for
their care. As authorized by the Cures Act, we're working to
support a modern information economy and a competitive
marketplace by improving the ease with which clinicians,
patients, and their caregivers can securely send and receive
medical information. These pro-competitive steps will allow new
business models and software applications to flourish.
Importantly, we believe that computational ownership or
access to and use of electronic data by patients and payers,
not just clinicians, can set a floor for increased market
competition in health care. ONC will use the tools provided by
Congress through the Cures Act to tackle today's challenges of
interoperability, usability, and information blocking.
We look forward to working with you to achieve our shared
vision. Thank you again for the opportunity to speak before you
today, and I look forward to your questions.
[The prepared statement of Dr. White follows:]
prepared statement of jon white
Chairman Alexander, Ranking Member Murray, and
distinguished Committee Members, thank you for the opportunity
to appear today. My name is Dr. Jon White, and I am the Deputy
National Coordinator for Health Information Technology. On
behalf of Dr. Rucker, the National Coordinator, I appreciate
your invitation to discuss our progress with the implementation
of 21st Century Cures Act (Cures Act).
The Office of the National Coordinator for Health
Information Technology (ONC) was established by Executive Order
in 2004. Today our mission is to improve the health and well-
being of individuals and communities through the use of
technology and health information that is accessible when and
where it matters most. In 2009, ONC was statutorily established
by the Health Information Technology for Economic and Clinical
Health (HITECH) Act as part of the American Recovery and
Reinvestment Act, or ``Stimulus Bill.''
The HITECH Act provided important resources and
infrastructure needed to stimulate rapid nationwide adoption
and use of electronic health record (EHR) systems. In the 8
years since the HITECH Act was enacted, we have seen dramatic
progress in the use and adoption of health IT. Today, 97
percent of hospitals and three-quarters of office-based
physicians use health information technology (health IT) \1\
that has been certified under the ONC Health IT Certification
Program (Certification Program).
---------------------------------------------------------------------------
\1\ Office of the National Coordinator for Health Information
Technology (December 2016). 2016 Report to Congress on Health IT
Adoption.https://www.healthit.gov/sites/default/files/2016--report--
to--congress--on--healthit--progress.pdf. Accessed October 2017
---------------------------------------------------------------------------
ONC initiatives like the Regional Extension Centers, the
Certification Program, and terminology standardization, as well
as the Centers for Medicare & Medicaid Services (CMS) Medicare
and Medicaid EHR Incentive Programs under the HITECH Act, and
the Quality Payment Program (QPP) under the Medicare Access and
CHIP Reauthorization Act of 2015 (MACRA), have accelerated
health IT adoption across many care settings. As ONC stated to
this Committee in 2015, the Nation is on the path to a digital
healthcare information system. We thank the Committee for its
leadership in the enactment of the bipartisan Cures Act and
look forward to implementing the Act's health IT provisions.
My career has been dedicated to improving health and
healthcare quality through the use and sharing of electronic
health information. In my 15 years as a family physician, I
have worked in a variety of settings with multiple health IT
systems. At ONC, I advance key National Coordinator and
Administration priorities, and provide executive direction and
leadership for all ONC programs and policies. Before my service
at ONC, I was Director of Health IT at the Agency for
Healthcare Research and Quality (AHRQ) where we established
hundreds of health IT projects in 48 states. These included
research, demonstration, and implementation projects on a
variety of applications such as telemedicine and e-prescribing.
I have worked with Federal partners, including CMS and the
Department of Veterans Affairs, and state and local government,
as well as key clinician, patient, and policy stakeholders to
advance health IT progress.
Despite gains in health IT adoption, important work
remains. ONC's highest priorities improving interoperability,
reducing clinician burden, and addressing information
blocking--are central to recasting our healthcare system. In
recent years, ONC has focused on advancing data liquidity among
clinicians, patients, and their caregivers; addressing
information blocking; and advancing developers' move to
interoperable systems that are easy to use for clinicians. In
2015, ONC outlined a 10-year plan to achieve nationwide
interoperability, ``Connecting Health and Care for the Nation:
A Shared Nationwide Interoperability Roadmap.''
That year we also released the Federal Health IT Strategic
Plan 2015-2020, developed in partnership with over 35 Federal
entities that use and support the use of electronic health
information and designed to support and align important changes
across the Federal health landscape. In April 2015, we
submitted a report to Congress, ``Report on Information
Blocking,'' \2\ which was the first time the government issued
a formal report on the problem of information blocking.
Information blocking is the act of providers and EHR vendors
knowingly and unreasonably engaging in business practices that
interfere with electronic health information exchange (HIE).
Since we submitted the Report, additional studies and
experience have confirmed that information blocking persists
and is a serious impediment to interoperability. \3\
Recognizing these concerns, Congress included provisions in the
Cures Act that provide a robust response to the information
blocking problem. We are working closely with our Federal
partners to implement these provisions.
---------------------------------------------------------------------------
\2\ ONC, Report to Congress on Health Information Blocking (Apr.
2015), https://www.healthit.gov/sites/default/files/reports/info--
blocking--040915.pdf[hereinafter ``congressional Report'']
\3\ See, e.g., Julia Adler-Milstein and Eric Pfeifer, Information
Blocking: Is It Occurring And What Policy Strategies Can Address It?,
95 Milbank Quarterly 117, 124-25 (Mar. 2017), available at:http://
onlinelibrary.wiley.com/doi/10.1111/1468-0009.12247/full; Martin
Gaynor, Farzad Mostashari, and Paul B. Ginsberg , Making Health Care
Markets Work: Competition Policy for Health Care, 16-17 (Apr. 2017),
available at:http://heinz.cmu.edu/news/news-detail/index.aspx'nid=3930;
Diego A. Martinez et al., A Strategic Gaming Model For Health
Information Exchange Markets, Health Care Mgmt. Science (Sept. 2016).
---------------------------------------------------------------------------
We have also kept pace with the specific needs of the
health IT community and the clinicians and patients they serve.
In support of industry innovation and requests, we updated our
Certification Program to support greater transparency around
developer product capabilities and even the types of costs
users can incur. We have considered industry developments
around technology in our work and included application
programming interface (API) capabilities as part of the 2015
Edition Health IT Certification Criteria. Published APIs, or
doorways to the data, are a critical component of our connected
future. Mobile applications use APIs to connect us with the
life tasks we complete each day--from seamlessly banking
online, to ordering dinner and rides on our smartphones. APIs,
when securely linked with health IT, hold the same promise for
patients and clinicians with regards to their ability to
readily access health information without special effort.
ONC works closely with the health IT community in a number
of ways and looks forward to expanding these types of
engagements. For example, we have partnered with the innovation
community through various prize competitions under the America
COMPETES Act \4\ to better understand patient matching, patient
privacy, API security, and how information can flow to the
patient. 1A\5\ We also approved two alternative testing methods
administered by stakeholders in the private sector \6\, \7\.
---------------------------------------------------------------------------
\4\ America Creating Opportunities to Meaningfully Promote
Excellence in Technology, Education, and Science (COMPETES) Act
\5\ https://www.oncprojectracking.healthit.gov/wiki/display/
TechLabI/ONC+Challenges+and+Winners
\6\ https://www.healthit.gov/buzz-blog/healthit-certification/step-
diversify-certification-programs-testing-portfolio/
\7\ https://www.healthit.gov/buzz-blog/interoperability/onc-health-
certification-program-approves-himssimmunization-integration-program-
iip-testing-method/
---------------------------------------------------------------------------
Today, under the National Coordinator's leadership, ONC is
deeply engaged in supporting the implementation of the Cures
Act, specifically the provisions in Title IV. Looking ahead,
ONC is committed to the critical role we play to advance health
IT usability and interoperability that supports coordinated
care and reduces clinician burden. We continue to engage with
our Federal partners, including CMS, and with external
stakeholders to better understand and find ways to address the
regulatory and administrative burdens identified by
stakeholders related to the use of EHRs. I would like to
express particular gratitude for my colleagues at CMS who have
taken several concrete steps to address clinician burden in
their programs head-on. As outlined in section 4001(a) of the
Cures Act, ONC will establish a goal, develop a strategy, and
provide recommendations with respect to the reduction of
regulatory or administrative burdens, such as documentation
requirements, relating to the use of electronic health records.
With CMS, we have established four working groups which address
(1) EHR Reporting; (2) Documentation, Administrative, and
Reimbursement Models; (3) Health IT and User-Centered Design;
and (4) Non-Federal Payers (State/Private) and other Government
Requirements, and are engaging with relevant stakeholders in
each area.
We also have other efforts underway to reduce the
regulatory burden on health IT developers. ONC now allows
health IT developers to self-attest to certain functionality-
oriented certification criteria to which most had previously
been tested in the past in order to focus more on
interoperability testing. Additionally, we allow ONC-Authorized
Certification Bodies to use discretion in their randomized
surveillance of certified health IT in the field, thus reducing
the potential of unnecessary productivity impacts on
clinicians. These two steps preserve the integrity of the
Certification Program while at the same time improving its
efficiency and overall impact on the industry.
We have met with stakeholders representing medical
specialties, including pediatrics and long-term care, to better
understand how health IT can best help them meet the needs of
their patients, as outlined in section 4001(b) of the Cures
Act. We are working to implement the conditions of
certification and maintenance in section 4002. We are also
working with AHRQ regarding the treatment of health IT
developers as providers with respect to patient safety
organizations, as outlined in section 4005(c), and with the HHS
Office for Civil Rights (OCR) to identify effective means to,
for example, promote convenient patient access to health
information, as outlined in section 4006. We are also working
to implement the information blocking provisions in Title IV,
in close coordination with all of our Federal partners,
including the HHS Office of the Inspector General (OIG), CMS,
OCR, and the Federal Trade Commission (FTC).
We agree with Congress that health IT must be more
interoperable, that it should be easier to use for everyone,
and that information must flow seamlessly--that is, without
unreasonable impediment--while still respecting individual
privacy rights and applying strong security protections to the
information. Transaction costs to move health information
within Federal programs alone are considerable. For example, in
FY'2016 the Social Security Administration Office of Disability
Determination received medical records from healthcare
organizations costing about $180 million and consultative exams
costing about $391 million for a total cost of about $571
million.
Frictionless access to and use of medical data will
increasingly improve the ability of patients to shop for care.
As authorized by the Cures Act, we are working to support a
competitive marketplace by improving the ease with which
clinicians, patients, and their caregivers can securely send
and receive medical information. These pro-competitive steps
include combating information blocking and will allow new
business models and software applications to flourish.
It should be noted that increased interoperability is also
important to the payers who purchase most of our medical care
and who often have difficulty accessing data they need for
reimbursement decisions. Computationally open APIs provide the
data liquidity that artificial intelligence and machine
learning are dependent upon to realize their full potential in
healthcare (that can be used consistent with the privacy and
security requirements of the Health Insurance Portability and
Accountability Act of 1996 regulations).
There are many potential avenues for us to work to advance
interoperability. To provide focus and clarity for ONC
stakeholders, we are concentrating on three framing questions.
The first is about the patient: can patients access their
medical data in a secure, straight-forward, and consumer-
friendly way? The second is about institutional accountability:
can payers efficiently assess the quality and value of the care
purchased, and can clinicians efficiently and effectively
provide care for entire populations? The third guiding question
is how to operationally define an open API without special
effort.
Most patient data is held by clinicians and EHR vendors, so
what do open APIs at the clinician and at the vendor level look
like? The Cures Act requires that the use of these APIs be
``without special effort,'' so we are looking at advancements
in the health IT community to help understand the full
opportunities presented by APIs. ONC is leading efforts to
bring these modern data standards to healthcare working with
the Health Level Seven standards organization and key
developers of Fast Healthcare Interoperability Resources (also
known as FHIR) interface technology.
APIs provide one avenue to interoperability, especially for
patients and payers. Regional and commercially initiated
interoperability networks provide another route to
interoperability. To date, these have focused exclusively on
facilitating communications between certain groups of
clinicians for the purpose of treatment (though often
behavioral health and substance use treatment information is
not exchanged) but not payment or healthcare operations
purposes. ONC has initiated efforts to implement the ``trusted
exchange'' frameworks and common agreement provisions outlined
in section 4003(b) of the Cures Act. We held two public
listening sessions with stakeholders across the health IT
spectrum and completed one round of public comment to gain
insight from stakeholders on the policies and practices the
Trusted Exchange Framework and Common Agreement (TEFCA) should
address. The TEFCA will be an integral component of nationwide
network-to-network exchange of health data and a critical part
of our charge to support nationwide interoperability. ONC will
hold one more listening session before we release draft
materials for public comment.
As in the past, ONC is committed to serving as a
coordinator and convener of most participants in the health IT
field. As part of our implementation of the Cures Act, ONC has
worked closely with the HHS Secretary's office to wind down the
previous two health IT Federal advisory committees and to stand
up the new Health IT Advisory Committee called out in the Cures
Act, as outlined in section 4003(e). To select new committee
members, we have worked closely with Members of Congress and
the Government Accountability Office. The new charter has been
finalized and we anticipate meetings will commence this winter.
We are excited about our work underway to advance
Congress's goals in the Cures Act, however it is important for
me to share with you what ONC has not been able to advance at
this time. Due to competing priorities, at this time ONC is
unable to move forward with implementation of Section 4002(c),
which calls for a transparent process to develop reporting
criteria as part of an ``EHR Reporting Program'' for certified
health IT.
ONC recognizes the importance of working with our Federal
partners, Members of Congress this Committee included and
external stakeholders such as patients, clinicians, health IT
developers, and payers. ONC has a primary role in implementing
the health IT provisions in the Cures Act. We are excited to
work with Congress and our stakeholders to make health
information more accessible, decrease documentation burden, and
support EHR usability while simultaneously accelerating
innovation and competitive healthcare markets.
Health IT holds great promise to increase more effective
and efficient care. Importantly, we believe that computational
ownership, or access to and use of, electronic data by patients
and payers (not just clinicians) can set a floor for increased
market competition. The Cures Act encourages new approaches and
business models for healthcare, and ONC will use the tools
provided by Congress through the Cures Act to tackle today's
challenges of interoperability, usability, and information
blocking. We look forward to working with you to achieve our
shared vision. Thank you again for the opportunity to speak
before you today and I look forward to your questions.
------
The Chairman. Thank you, Dr. White.
Dr. Goodrich, welcome.
STATEMENT OF KATE GOODRICH
Dr. Goodrich. Thank you. Chairman Alexander, Ranking Member
Murray, and Members of the Committee, thank you for the
opportunity to discuss the Centers for Medicare and Medicaid
Services efforts to implement the health information technology
provisions of the 21st Century Cures Act. We appreciate your
leadership in enacting this important law, and CMS is working
closely with our colleagues in the Office of the National
Coordinator and HHS Office of Inspector General on its
implementation.
In addition to my roles at CMS as the Director of the
Center for Clinical Standards and Quality and Chief Medical
Officer, I continue to practice medicine as a hospitalist on
weekends. This gives me an on-the-ground perspective of how the
work we do at CMS is succeeding or failing. From this vantage
point I see both the promises and the pitfalls of health IT and
electronic health records.
I regularly see anywhere from 20 to 30 patients on a
weekend. Prior to the adoption of health IT, I spent at least 2
hours writing out, by hand, separate orders for each patient.
Today, with just a few clicks, I can complete that same work in
less than one-quarter of the time, which allows me to spend
more time with my patients.
At the same time, though, I can tell you that there are
still too many burdens on clinicians, and we are a long way
from true interoperability. Far too often, I still need to
call, fax, copy, or manually enter information into a health
record, a process which could and should be much more
efficient.
Additionally, as the caregiver for my mother, an 80-year-
old Medicare beneficiary, I've been with her when her
geriatrician doesn't have access to her records from an
appointment with a specialist that we saw just a few weeks or
months ago. I use these perspectives to help guide me and my
CMS colleagues as we implement recent laws that encourage the
adoption of health IT.
CMS, by law, has implemented two key programs to encourage
hospitals and clinicians to adopt and effectively use certified
EHR technology, the Medicare and Medicaid EHR Incentive
Program, and the Advancing Care Information component of the
Quality Payment Program, or MACRA. Congress created these
programs to encourage hospitals and clinicians to adopt and
meaningfully use EHRs. While these programs have helped
clinicians to procure and begin to use these technologies, we
are far from the goal of interoperability.
As we travel the country and meet with doctors and nurses
on the front lines, CMS leadership is hearing similar concerns
from these stakeholders. The implementation of the 21st Century
Cures Act provides an opportunity to look at what's working,
what's not working with regard to policies surrounding health
IT, and at CMS we are taking a hard look to make sure we are
meeting the needs of clinicians and patients.
For example, as directed or required by the 21st Century
Cures Act, CMS has adopted and proposed for clinicians a
specific hardship exception for hospitals and clinicians whose
EHR technology becomes decertified, to recognize the difficulty
health care providers face when the software that they have
invested in becomes decertified.
Earlier this year CMS implemented and proposed for
clinicians an exception to the 2017 and 2018 Medicare payment
adjustments for clinicians who furnish 75 percent or more of
their covered professional services in an ambulatory surgical
center. We've clarified our policies so that a physician may
now delegate some of the EHR documentation requirements to
another person as long as the physician signs and verifies the
documentation, which gives physicians more time facing their
patients and less time facing the computer. CMS is publicly
hosting data that shows the percentage of hospitals and
eligible professionals delineated by state who have
demonstrated meaningful use of certified technology in the EHR
incentive programs.
Like the situations with my mother and with my patients
demonstrate, health information should be available and
securely and effectively shared when and where it is needed.
CMS anticipates referring any cases of information blocking it
becomes aware of to the OIG for further investigation, as
required by law.
In addition, CMS now requires clinicians to attest that
they have not knowingly and willfully limited or restricted the
compatibility or interoperability of their certified EHR
technology as part of the quality payment program.
As a practicing physician, every time I meet with patients,
I want to be able to give them the best care efficiently and
effectively. However, far too often, I still encounter
obstacles to achieving true interoperability and the full
promise of health IT.
CMS is looking to drive patient-centered care in all of our
programs. We are listening to stakeholders and committed to
using data-driven insights, meaningful quality measures, and
technology that empowers patients and their clinicians to make
decisions about their health care.
The enactment of the 21st Century Cures Act has provided
CMS with another opportunity to pursue flexibility and reduce
burden on providers and patients while helping to spur the
adoption of promising technologies. We appreciate the
Committee's ongoing interest and commitment to this important
work, and look forward to continuing to work with you. Thank
you.
[The prepared statement of Dr. Goodrich follows:]
prepared statement of kate goodrich
Chairman Alexander, Ranking Member Murray, and Members of
the Committee, thank you for the opportunity to discuss the
Centers for Medicare & Medicaid Services' (CMS) efforts to
implement the health information technology (health IT)
provisions of the 21st Century Cures Act.\1\ CMS is committed
to partnering with healthcare providers and stakeholders to
harness the potential of health IT, while reducing burden on
providers and ensuring high-quality care for their patients.
CMS is working closely with our colleagues in the Office of the
National Coordinator for Health Information Technology (ONC)
and the Department of Health and Human Services Office of
Inspector General (HHS-OIG) to implement this important law.
---------------------------------------------------------------------------
\1\ Public Law No. 114-255: https://www.Congress.gov/114/plaws/
publ255/PLAW-114publ255.pdf
---------------------------------------------------------------------------
While health IT holds promise in helping clinicians
communicate and in empowering patients with access to their
health information, as a practicing physician, I can personally
attest to the work that remains before we fully meet this
promise. Electronic Health Records (EHRs) can be an important
source of information and data, but the need to input data can
interrupt the face-to-face time I have with my patients. CMS is
hearing similar concerns from clinicians across the country. We
have heard that there are too many quality programs, technology
requirements, and other measures, like meaningful use measures,
that get between the clinician and the patient. Clinicians have
difficulty getting the data they need for reporting quality
measures directly from the EHR, which should be a seamless
process. Some patients struggle to access their information
online. In my experience, everyone practicing medicine wants to
provide the best care possible for patients, and far too often
it seems the on-the-ground reality of EHRs fall short of what
was envisioned. We have a long way to go before EHRs are truly
interoperable, allowing clinicians, like me, to easily access
health information about our patients when other providers they
see use different systems.
CMS, by law has implemented two key programs to encourage
hospitals and clinicians to adopt and effectively use certified
EHRs: the Medicare and Medicaid EHR Incentive Programs (as
established by the American Recovery and Reinvestment Act of
2009 \2\) (for clinicians and hospitals) and the Quality
Payment Program and its Advancing Care Information category (as
established by the Medicare Access and CHIP Reauthorization Act
of 2015 \3\ (MACRA)) (for clinicians). These programs are
intended to encourage hospitals and clinicians to adopt and
meaningfully use EHRs. While these programs have helped
clinicians procure and begin to use these technologies, we are
far away from the goal of interoperability, in which these
systems can effectively communicate.
---------------------------------------------------------------------------
\2\ Public Law No. 111-5: https://www.Congress.gov/111/plaws/
publ5/PLAW-111publ5.pdf
\3\ Public Law No. 114-10: https://www.Congress.gov/114/plaws/
publ10/PLAW-114publ10.pdf
---------------------------------------------------------------------------
At CMS, we are taking a hard look at what is working and
what is not working, as well as what is duplicative, and what
we may be missing to help us move in the right direction and
more fully realize the promise of EHRs without placing
unnecessary requirements on clinicians. CMS is committed to
simplifying our programs, especially for small, independent,
and rural practices, while ensuring fiscal sustainability and
high-quality care.
CMS is reducing burden and increasing flexibility for
hospitals and clinicians through our payment policies,
rulemaking, and other interactions with providers. CMS has
included Requests for Information (RFIs) as part of our annual
Medicare payment rulemaking process to obtain feedback on
positive solutions to better achieve transparency, flexibility,
program simplification, and innovation. This feedback will
inform the discussion of ways to reduce burden in program
requirements. Through these RFIs, CMS is starting a national
conversation about improving the healthcare delivery system,
how Medicare can contribute to making the delivery system less
bureaucratic and complex, and how CMS can reduce burden for
clinicians, providers, and patients in a way that increases
quality of care and decreases costs--thereby making the
healthcare system more effective, simple, and accessible while
maintaining program integrity.
Promoting Health IT with the 21st Century Cures Act
Congress has helped to further streamline EHR adoption and
use efforts with the enactment of the 21st Century Cures Act,
which charges HHS with addressing some of the obstacles to
realizing the promise of health IT. The implementation of this
law will help to continue the adoption and use of health IT,
while eliminating unnecessary requirements, and making it
easier for clinicians to do what they do best: care for
patients. CMS is supporting ONC's work to establish a goal for
the reduction of regulatory or administrative burdens relating
to the use of EHRs as well as a strategy and recommendations
for meeting the goal, as required by the 21st Century Cures
Act. Working closely with the ONC, CMS is looking at
opportunities for improvement, particularly related to
timelines, flexibility, decreased burden, and clearly defined
requirements.
Electronic health information should be available and
securely and efficiently shared, when and where it is needed,
to support patient-centered care, enhance health care quality
and efficiency, and advance research and public health. To
implement the 21st Century Cures requirement for the Office of
the Inspector General to investigate claims of information
blocking by health information technology vendors, health
information exchanges or networks, or health care providers,
CMS anticipates referring any cases of information blocking it
becomes aware of to the OIG. In addition, MACRA required
clinicians to show that they have not knowingly and willfully
limited or restricted the compatibility or interoperability of
their certified EHR technology when they attest to how they
used EHR technology for the purpose of the Quality Payment
Program. CMS issued a rule that implemented this requirement
for all clinicians in November 2016. \4\
---------------------------------------------------------------------------
\4\ Merit-Based Incentive Payment System (MIPS) and Alternative
Payment Model (APM) Incentive Under the Physician Fee Schedule, and
Criteria for Physician Focused Payment Models Final Rule (CMS--5517--
FC)--https://www.gpo.gov/fdsys/pkg/FR-2016-11-04/pdf/2016-25240.pdf
---------------------------------------------------------------------------
CMS is also examining the opportunities presented by
telehealth and telemedicine technology. CMS will produce a
report on the populations of Medicare beneficiaries who would
most benefit from expansion of telehealth and other information
that can help inform future congressional policymaking on the
future of telehealth in Medicare as requested by the 21st
Century Cures Act.
CMS has also begun work to establish a provider digital
contact information index, another requirement of the 21st
Century Cures Act, which will provide digital contact
information for health professionals and facilities. This index
is intended to improve the exchange of electronic health
information between different providers and facilities and CMS
is working with our colleagues at the ONC to ensure that this
directory is useful to providers who want to contact each other
and stakeholders.
Promoting Health IT though Flexibility and Alignment
In addition to implementing important provisions of the
21st Century Cures Act, CMS is using the opportunity presented
by the creation of the Quality Payment Program to help reduce
burden on clinicians using EHRs. The Quality Payment Program
\5\ includes certain aspects of three separate programs,
including the Medicare EHR Incentive Program (often called
``meaningful use'') for physicians, into one program designed
to reward clinicians for providing high quality care. The
Quality Payment Program brings significant changes to how
clinicians are paid within Medicare, so CMS is continuing to
take implementation slowly to ensure that clinicians can easily
participate and that patients are put first. CMS is using
stakeholder feedback to find ways to streamline the programs to
reduce clinician burden. For example, we proposed to implement
a variety of participation options, including a virtual group
participation option. CMS is carefully reviewing the comments
we received on the Quality Payment Program proposed rule
released in June 2017 \6\, and this Administration will
continue to listen to stakeholders and take steps to support
clinicians and patients by alleviating burdens and allowing
them to focus on improving health outcomes.
---------------------------------------------------------------------------
\5\ https://qpp.cms.gov/
\6\ CY 2018 Updates to the Quality Payment Program Proposed Rule
(CMS--5522--P)--https://www.gpo.gov/fdsys/pkg/FR-2017-06-30/pdf/2017-
13010.pdf
---------------------------------------------------------------------------
In addition, CMS has taken the following specific steps in
the last year to reduce burden and improve flexibility through
our proposed and final policies related to EHRs.
. Improved Flexibility. For the EHR Incentive Program, CMS
adopted for the 2018 reporting period \7\, and for the Quality
Payment Program, it proposed for clinicians for the 2018 \8\
performance period, policies that allow hospitals and
clinicians to use various versions of certified EHR technology.
For example, some clinicians may use the 2014 Edition while
others may use the 2015 Edition, or a combination of the two.
This increased flexibility encourages hospitals and clinicians
to participate in the programs even if they haven't upgraded
their software to the latest certified version. CMS continues
to encourage clinicians and hospitals to migrate to the
implementation and use of EHR technology certified to the 2015
Edition so they may take advantage of improved functionalities,
but we recognize that depending on their circumstances, some
hospitals or clinicians may need more time to make these
updates.
\7\ Merit-Based Incentive Payment System (MIPS) and Alternative
Payment Model (APM) Incentive Under the Physician Fee Schedule, and
Criteria for Physician Focused Payment Models Final Rule (CMS--5517--
FC)--https://www.gpo.gov/fdsys/pkg/FR-2016-11-04/pdf/2016-25240.pdf
\8\ CY 2018 Updates to the Quality Payment Program Proposed Rule
(CMS--5522--P)-https://www.gpo.gov/fdsys/pkg/FR-2017-06-30/pdf/2017-
13010.pdf
---------------------------------------------------------------------------
LIncreased Alignment Between Programs. It can be
challenging for hospitals and clinicians to comply with the
differing requirements of multiple programs. Whenever possible,
CMS has looked for ways to align the programs relevant to EHRs,
including aligning the clinical quality measure requirements.
As an example, under the Quality Payment Program, the Medicare
clinical quality measure requirements have been aligned to
eliminate any duplication in reporting. Clinicians can choose
to report quality measures through their EHR system; however,
if another reporting mechanism better meets their needs for
reporting measures, such as a qualified clinical data registry,
they can choose that mechanism to report. \11\
\11\ Merit-Based Incentive Payment System (MIPS) and Alternative
Payment Model (APM) Incentive Under the Physician Fee Schedule, and
Criteria for Physician Focused Payment Models Final Rule (CMS--5517--
FC)--https://www.gpo.gov/fdsys/pkg/FR-2016-11-04/pdf/2016-25240.pdf
---------------------------------------------------------------------------
LException for clinicians in small practices.
Additionally, in response to concerns raised by small and rural
providers, CMS has also proposed a new category of hardship
exceptions for small practices (15 or fewer clinicians). \12\
\12\ CY 2018 Updates to the Quality Payment Program Proposed Rule
(CMS--5522--P)-https://www.gpo.gov/fdsys/pkg/FR-2017-06-30/pdf/2017-
13010.pdf
---------------------------------------------------------------------------
LClarifying Documentation Requirements. CMS has also
implemented 21st Century Cures requirements by clarifying our
policy that a physician may delegate some of the EHR
documentation requirements to another person as long as the
physician signs and verifies the documentation. \13\ This
allows physicians to spend more time with patients and less
time in front of a computer.
\13\ For more information see: https://questions.cms.gov/faq.php--
faqId=20477
---------------------------------------------------------------------------
LHardship Exceptions for Decertified EHR Technology.
CMS has granted timely requests for hardship exceptions from
the Medicare EHR Incentive Program for hospitals and clinicians
with EHR vendor issues. As directed by the 21st Century Cures
Act, this year we adopted \14\ (and proposed for clinicians
\15\) a specific hardship exception for hospitals and
clinicians whose EHR technology becomes decertified to
recognize the difficulty health care providers face when the
software they have invested in becomes decertified.
\14\ Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals and the Long-Term Care Hospital Prospective Payment System
and Policy Changes and Fiscal Year 2018 Rates--Final Rule (CMS--1677--
F)--https://www.gpo.gov/fdsys/pkg/FR-2017-08-14/pdf/2017-16434.pdf
\15\ CY 2018 Updates to the Quality Payment Program Proposed Rule
(CMS--5522--P)-https://www.gpo.gov/fdsys/pkg/FR-2017-06-30/pdf/2017-
13010.pdf
---------------------------------------------------------------------------
LNew Advancing Care Information (ACI) Exception for
Clinicians Who are ASC-Based. CMS has implemented the 21st
Century Cures Act provisions requiring an exception to the 2017
and 2018 Medicare payment adjustments for clinicians who
furnish 75 percent or more of their covered professional
services in an ambulatory surgical center \16\.
---------------------------------------------------------------------------
\16\ Hospital Inpatient Prospective Payment Systems for Acute Care
Hospitals and the Long-Term Care Hospital Prospective Payment System
and Policy Changes and Fiscal Year 2018 Rates--Final Rule (CMS--1677--
F)--https://www.gpo.gov/fdsys/pkg/FR-2017-08-14/pdf/2017-16434.pdf
---------------------------------------------------------------------------
LPromote Transparency. CMS has implemented the 21st
Century Cures Act provision by publicly posting data online
that shows the percentage of hospitals \17\ and eligible
professionals \18\, delineated by state, who have demonstrated
meaningful use of certified EHR technology in the Medicare and
Medicaid EHR Incentive Programs.
\17\ https://dashboard.healthit.gov/quickstats/pages/FIG-
Hospitals-EHR-Incentive-Programs.php
\18\ https://dashboard.healthit.gov/quickstats/pages/FIG-Health-
Care-Professionals-EHR-Incentive-Programs.php
---------------------------------------------------------------------------
Looking Forward
As CMS looks to drive patient-centered care in all of our
programs, we are listening to stakeholders and committed to
using data driven insights and meaningful quality measures and
technology that empowers patients and clinicians to make
decisions about their healthcare. While recognizing that we
have a long way to go to make health IT truly interoperable,
the enactment of the 21st Century Cures Act has provided CMS
with another opportunity to pursue flexibility and reduce
burden on providers and patients, while helping to spur the
adoption of promising technologies. We appreciate the
Committee's ongoing interest and commitment to this important
work, and look forward to continuing to work with you.
------
The Chairman. Thank you, Dr. Goodrich.
Mr. Cannatti, welcome.
STATEMENT OF JAMES A. CANNATTI, III
Mr. Cannatti. Thank you. Good afternoon, Chairman
Alexander, Ranking Member Murray, and other distinguished
Members of the Committee. Thank you for the opportunity to
appear before you today. I am pleased to be able to discuss
OIG's role in the implementation of the health IT provisions of
the 21st Century Cures Act. My testimony today will focus on
OIG's new information blocking authorities provided under
Section 4004 of the Cures Act.
In general terms, information blocking is a practice that
inappropriately impedes the flow or use of information. The
availability of information when and where it is needed is a
critical element of a high-functioning health care system.
OIG's mission is to protect the integrity of HHS programs
and the health and welfare of program beneficiaries.
Information blocking can pose a threat to patient safety and
undermine efforts by providers, payers, and others to make our
health care system more efficient and effective.
For example, when pertinent information is not available in
a patient's record, a physician may inadvertently prescribe a
contraindicated drug. Although an area of concern for some
time, OIG historically had no authority that allowed us to
investigate or take enforcement action based solely on acts of
information blocking. Rather, we looked to leverage existing
authorities, where possible, to hold wrongdoers accountable.
With the passage of the Cures Act in December 2016,
Congress empowered OIG to directly address the problem of
information blocking. The statute requires rulemaking to carve
out certain reasonable and necessary activities that do not
constitute information blocking for purposes of the law. Within
the Department, ONC has been tasked with that rulemaking.
ONC's final rule will provide a legal basis that OIG will
use to assess conduct during our investigations and our
enforcement activities. In the meantime, OIG has been preparing
for effective, efficient, and fair enforcement. Our goal is to
protect patients and the health care system by stopping
information blocking. We aim to leverage our new authorities to
change behaviors in the industry. We believe that this can best
be accomplished through a combination of clear rules of the
road for those who want to comply with the law and targeted
enforcement against those who choose to break it.
The Cures Act information blocking prohibition covers a
broad spectrum of conduct and arrangements. It covers everyone
from large electronic health IT providers and developers to
individual physicians, and the information blocking landscape
is complex. It combines highly technical issues with a breadth
of business arrangements. Stakeholder engagement is critical to
developing a deep understanding of this complex landscape.
To date, we have held more than a dozen stakeholder
meetings with representatives from a wide cross-section of the
health care and technology communities. The insights gained
from stakeholders will help us as we begin enforcement.
We have also engaged with our partners, including ONC, CMS,
the HHS Office for Civil Rights, and the Federal Trade
Commission. We have provided and will continue to provide
technical assistance to ONC, and we are working to formalize
processes for sharing complaints, referrals, and other
information within HHS.
The Cures Act provided important new authorities that
enhanced the government's ability to address the problem of
information blocking. OIG is working diligently, alongside our
HHS partners, and with input from stakeholders, to prepare to
enforce. We aim to deter information blocking, hold wrongdoers
accountable, promote the integrity of HHS programs, and benefit
the public.
Thank you for the opportunity to testify on this important
issue. I look forward to answering your questions.
[The prepared statement of Mr. Cannatti follows:]
prepared statement of james a. cannatti, iii
Good afternoon, Chairman Alexander, Ranking Member Murray,
and other distinguished Members of the Committee. I am James
Cannatti, Senior Counselor for Health Information Technology
for the Office of Inspector General (OIG), U.S. Department of
Health and Human Services (HHS or Department). Thank you for
the opportunity to appear before you to discuss OIG's role in
the implementation of the health information technology (health
IT) provisions of the 21st Century Cures Act (the Cures Act).
My testimony today will focus on our new information blocking
investigative and enforcement authorities provided under
Section 4004 of the Cures Act.
Information Blocking Harms Patient Care and Our Health Care System
In general terms, information blocking is a practice that
inappropriately impedes the flow or use of information. \1\ The
availability of information when and where it is needed is a
critical element of a high-functioning health care system.
---------------------------------------------------------------------------
\1\ Section 4004 of the Cures Act added a specific definition of
information blocking for purposes of the statute. That definition is
codified at Section 3022(a) of the Public Health Services Act, 42
U.S.C. 300jj-52(a).
---------------------------------------------------------------------------
OIG has long acknowledged the importance of the appropriate
flow of information, subject, of course, to privacy and
security protections. In fact, OIG has highlighted the issue
for the past several years in our annual list of Top Management
and Performance Challenges facing the Department. \2\
Addressing the negative impacts of information blocking is
consistent with OIG's mission to protect the integrity of HHS
programs, as well as the health and welfare of program
beneficiaries.
---------------------------------------------------------------------------
\2\ For 2016, OIG identified 10 top management and performance
challenges, including one entitled ``Health Information Technology and
the Meaningful and Secure Exchange and Use of Electronic Information.''
OIG's 2016 Top Management and Performance Challenges Facing HHS is
available at:https://oig.hhs.gov/reports-and-publications/top-
challenges/2016/.
---------------------------------------------------------------------------
Information blocking can pose a threat to patient safety
and undermine efforts by providers, payors, and others to make
our health care system more efficient and effective. For
example, when pertinent information is not available in a
patient's record, a physician may inadvertently prescribe a
contraindicated drug causing the patient to become ill.
Further, when results are not shared between providers,
patients may be subjected to duplicate tests. Beyond
unnecessarily exposing patients to risks associated with the
tests, \3\ payors and patients incur unnecessary costs for the
duplicative services. Information blocking also threatens the
significant investment taxpayers have made in encouraging the
adoption and use of technologies like electronic health records
(EHRs).
---------------------------------------------------------------------------
\3\ Some tests pose greater risks than others; for example, some
tests may be more invasive or expose the patient to higher levels of
radiation than other tests.
---------------------------------------------------------------------------
OIG's Approach to Information Blocking Before the Cures Act
Historically, OIG had no authority to investigate or take
enforcement action based solely on acts of information
blocking. Rather, the concept arose for us in the context of
the application of the Federal anti-kickback statute (the Anti-
Kickback Statute) \4\ to arrangements in which one party, such
as a hospital, provides an EHR system to another party, such as
a physician group practice. These ``donation'' arrangements
were designed to facilitate and promote broad adoption of EHRs.
Questions arose about the need for safe harbor protection for
some of these donation arrangements. In 2006, OIG issued a
final rule establishing a safe harbor that protected certain
EHR donation arrangements and required, among other conditions,
that donated EHR software be interoperable (the EHR safe
harbor). \5\ Our goal was to ``promot[e] the adoption of
interoperable [EHR] technology that benefits patient care while
reducing the likelihood that the safe harbor [would] be misused
by donors to secure referrals'' from those receiving the
technology. \6\ As with all safe harbors, we attempted to
strike a balance--endeavoring to include safeguards that
minimize potential fraud and abuse risks, without impacting the
positive benefits of the underlying arrangements. In the case
of the EHR safe harbor, one of the key safeguards prohibited
donors and certain other parties from taking actions to limit
or restrict the use, compatibility, or interoperability of
donated EHR systems.
---------------------------------------------------------------------------
\4\ 42 U.S.C. 1320a-7b(b).
\5\ 71 Fed. Reg. 45110 (Aug. 8, 2006); 42 C.F.R. 1001.952(y). We
most recently modified the EHR safe harbor at the end of 2013. 78 Fed.
Reg. 79208 (Dec. 27, 2013).
\6\ 78 Fed. Reg. 79208 (Dec. 27, 2013).
---------------------------------------------------------------------------
Although we did not use the term ``information blocking''
at the time, the EHR safe harbor conditions included concepts
that align closely with the Cures Act prohibition on
information blocking. We were concerned that information
blocking would serve as a method of locking in or steering
referrals, conduct prohibited by the Anti-Kickback Statute.
Over time, our concerns about this risk grew. Moreover,
Congress, HHS, and other stakeholders began raising additional
concerns about information blocking. Accordingly, we issued a
policy reminder in 2015 to again warn the industry about the
impact of information blocking on potential safe harbor
protection, and we went so far as to restate our position that
EHR donation arrangements involving information blocking would
be suspect under the Anti-Kickback Statute. \7\
---------------------------------------------------------------------------
\7\ OIG Alert, OIG Policy Reminder: Information Blocking and the
Federal Anti-Kickback Statute (Oct. 6, 2015), available at:https://
oig.hhs.gov/compliance/alerts/guidance/policy-reminder-100615.pdf.
---------------------------------------------------------------------------
The Cures Act Empowers OIG to Directly Address Information Blocking
With the passage of the Cures Act in December 2016,
Congress gave OIG new authorities that will allow us to address
the issue of information blocking more directly--beyond those
limited circumstances in which the conduct is a part of a
larger kickback scheme. The Cures Act added section 3022(b)(1)
of the Public Health Services Act, \8\ which granted OIG
specific authority to investigate claims that certain parties
(health information technology developers, health care
providers, and others) engaged in information blocking as
defined in section 3022(a). Further, subsection (b)(2)
established penalties for those engaged in information
blocking. For developers and certain other parties, the
penalties take the form of civil monetary penalties not to
exceed 1 million dollars per violation. \9\ For health care
providers, the Cures Act directs OIG to refer such parties to
``the appropriate agency to be subject to appropriate
disincentives. . . .'' \10\
---------------------------------------------------------------------------
\8\ 42 U.S.C. 300jj-52.
\9\ Section 3022(b)(2)(A) of the Public Health Services Act, 42
U.S.C. 300jj-52(b)(2)(A).
\10\ Section 3022(b)(2)(B) of the Public Health Services Act, 42
U.S.C. 300jj-52(b)(2)(B).
---------------------------------------------------------------------------
OIG's information blocking authorities under the statute
are directly tied to the definition of information blocking in
Section 3022(a). That definition contemplates rulemaking to
identify ``reasonable and necessary'' activities that would not
constitute information blocking for purposes of the Cures Act.
Within the Department, our colleagues at the Office of the
National Coordinator for Health Information Technology (ONC)
have been tasked with that rulemaking, which will address the
definition of information blocking within the meaning of
Section 3022 and will provide the legal basis that OIG will use
to assess conduct during our investigations and enforcement
actions.
OIG Is Preparing for Effective, Efficient, and Fair Enforcement
OIG has been readying for effective, efficient, and fair
enforcement. Our goal is to protect patients and the health
care system by stopping information blocking. We aim to
leverage our new authorities to change behaviors in the
industry. We believe this can best be accomplished through a
combination of clear rules of the road for those who want to
comply with the law and targeted enforcement against those who
choose to break it.
The Cures Act information blocking prohibition covers a
broad spectrum of conduct and arrangements. It covers everyone
from large electronic health IT developers to individual
physicians. The information blocking landscape is complex. It
combines highly technical issues and a breadth of business
arrangements and scenarios. Stakeholder engagement is critical
to developing a deep understanding of this complex landscape.
That is why we began engaging with industry and other private
stakeholders that expressed an interest in sharing their unique
perspectives on information blocking. To date, we have held
more than a dozen stakeholder meetings with representatives
from a wide cross-section of the health care and technology
communities. We have included our colleagues from ONC in these
meetings to further coordination on this topic within HHS. The
insights gained from stakeholders will help us as we implement
an effective, efficient, and fair enforcement approach to the
issue of information blocking.
We have also engaged with our Federal partners, including
ONC, the Centers for Medicare & Medicaid Services, the HHS
Office for Civil Rights, and the Federal Trade Commission. For
example, we have provided technical assistance to ONC on
enforcement-related issues in order to inform its policy
formulation efforts. Additionally, we are working to formalize
processes for sharing complaints, referrals, and other
information relevant to information blocking enforcement
efforts within HHS that build on existing efforts, where
possible. These efforts are intended to ensure that we are
prepared to leverage the new tools to curb information
blocking.
Conclusion
Stopping information blocking is important for patients and
the broader health care system. The Cures Act provides
important new authorities that enhance the Government's ability
to address this problem. OIG is working diligently, alongside
our HHS partners and with substantial input from private
stakeholders, to implement an enforcement approach that deters
information blocking, holds wrongdoers accountable, promotes
the integrity of HHS programs, helps protect the health and
welfare of program beneficiaries, and benefits the American
public.
Thank you for the opportunity to testify on this important
issue. I look forward to answering questions.
[summary statement of james a. cannatti, iii]
Information Blocking Harms Patient Care and Our Health Care System
In general terms, information blocking is a practice that
inappropriately impedes the flow or use of information. It can
pose a threat to patient safety and undermine efforts by
providers, payors, and others to make our health care system
more efficient and effective. Information blocking also
threatens the significant investment taxpayers have made in
encouraging the adoption and use of technologies like
electronic health records (EHRs). Historically, OIG had no
authority to investigate or take enforcement action based
solely on acts of information blocking.
The Cures Act Empowers OIG to Directly Address Information Blocking
Through the Cures Act, Congress gave OIG new investigative
and enforcement authorities that will allow us to address the
issue of information blocking directly. OIG's new authorities
are tied to the definition of information blocking in the
statute. That definition contemplates rulemaking to identify
``reasonable and necessary'' activities that would not
constitute information blocking for purposes of the Cures Act.
Within the Department, our colleagues at the Office of the
National Coordinator for Health Information Technology (ONC)
have been tasked with that rulemaking, which will address the
definition of information blocking within the meaning the law
and will provide the legal basis that OIG will use to assess
conduct during our investigations and enforcement actions.
OIG Is Preparing for Effective, Efficient, and Fair Enforcement
OIG has been readying for effective, efficient, and fair
enforcement. Our goal is to protect patients and the health
care system by stopping information blocking. We aim to
leverage our new authorities to change behaviors in the
industry. We believe this can best be accomplished through a
combination of clear rules of the road for those who want to
comply with the law and targeted enforcement against those who
choose to break it. We have engaged industry and other private
stakeholders that expressed an interest in sharing their unique
perspectives on information blocking, holding more than a dozen
meetings to date. We have also engaged with our Federal
partners, including ONC, the Centers for Medicare & Medicaid
Services, the HHS Office for Civil Rights, and the Federal
Trade Commission. We have provided, and will continue to
provide, technical assistance to ONC, and we are working to
formalize processes for sharing complaints, referrals, and
other information relevant to information blocking enforcement
efforts within HHS. The Cures Act provides important new
authorities that enhance the government's ability to address
the problem of information blocking. OIG is working diligently,
alongside our HHS partners and with substantial input from
private stakeholders, to implement an enforcement approach that
deters information blocking, holds wrongdoers accountable,
promotes the integrity of HHS programs, helps protect the
health and welfare of program beneficiaries, and benefits the
American public.
------
The Chairman. Thanks to all three of you.
We'll now begin a 5-minute round of questions.
Let me start with Dr. White and Dr. Goodrich on a subject
that I expect you'll get some more sophisticated questioning
about from Dr. Cassidy, but this is the subject of physician
documentation.
There are about, I believe, 900,000 doctors in the country,
and about 500,000 who use Medicare. Am I correct that the
doctors who use Medicare are subject to the meaningful use
rules and regulations that involve electronic health care
records? Is that correct? It's about 500,000 doctors.
According to a 2016 study funded by the American Medical
Association, for every hour a doctor spends with a patient, two
additional hours are spent on electronic health records and
desk work. According to a 2013 study by the Rand Corporation,
electronic health records are the leading cause of physician
dissatisfaction.
Does that sound right to you, Dr. Goodrich?
Dr. Goodrich. I have read the same studies, and that is
what we have certainly heard from the clinicians that we engage
with through the implementation of our programs.
The Chairman. Dr. White, what about you? Do you think it's
true that for every hour a doctor spends with a patient, two
additional hours are spent on electronic health records and
desk work?
Dr. White. Not to be smart, but when they find out my job,
usually that's the first thing they complain to me about. I
will say that it is certainly an issue that we hear about
frequently. When you consider studies like that, it's worth
taking a look at the full breadth of the administrative tasks
that any provider has to go through. Some of that is
documentation. Some of that is other things, as well.
The Chairman. Let me keep going, since I've got 5 minutes.
That's two-thirds of a doctor's time spent on electronic
records and desk work. If two-thirds is too much, what would be
a reasonable goal? Do you have one in mind? Did some
independent group ever set one? Did they say it should be 30 or
40, or not more than 50 percent?
Dr. White. I'm not aware of a number specifically, myself.
The Chairman. Dr. Goodrich, have you ever heard of a
number?
Dr. Goodrich. I haven't heard of a number. I think the
point here is that two-thirds is way too much time and we need
to reduce that.
The Chairman. Well, I had a suggestion last year. Let me
make it to you. In fact, as a result of this suggestion, we put
it in the law, or I put it in the law, we all did, and that was
that the Secretary is to set a goal by December 13 of 2017, a
year after the President signed it, of reducing physician
documentation.
Now, part of reducing physician documentation is reducing
it, and part of it is causing the 500,000 doctors who are
subject to meaningful use to believe it's been reduced. I
remember that Secretary Burwell, I kept complaining to her, as
did other Senators, that the patient satisfaction surveys in
hospitals were providing incentives for opioid prescriptions,
and all the evidence she had said that wasn't true. But
everybody believed it was true, and so she changed the
procedures because she said perception has become reality.
It seemed to me an important part of reducing physician
documentation and causing doctors to believe it has actually
been reduced is to involve them in the process, which is why I
suggested that meaningful use be delayed and that they be
involved in coming to a conclusion.
Here is a suggestion I made. It may sound very simple.
There may be a better one. But you're supposed to come up with
a goal, or the Secretary is, by December 13. That's not very
far away. My suggestion was that you say we read your report,
the AMA report, that said you're spending two-thirds of your
time on electronic health records and desk work. If that's
true, then either we're not doing our job or you're not doing
your job right, and let's work together to reduce that goal to
X. That's the goal I was hoping the Secretary would set by
December 13, and then involve the physicians in a collaborative
process, taking a whole lot of steps to say what can we do to
reduce the goal.
Now, you mentioned, Dr. Goodrich, that you've taken some
steps, and you work on weekends, and you know what you're
talking about. But don't you think it would be a good idea to
involve the physicians in that way and say we're going to go
from two-thirds to 40 percent over the next 3 years, or 50
percent, or 25 percent, and let them join you in doing that?
Dr. White. This is such an important issue, and we really
do hear about it frequently. So we agree with you completely
that it's critical to address it, and we want to get it right.
We are very closely partnered with CMS. We work very
tightly on this because it's such an important issue. We found
four areas of focus that we think are high priorities to
address. One is Federal reporting requirements for quality. A
second is Federal documentation requirements, including
billing. A third is issues of technology, including usability
of the software and things like that. The final piece is other
requirements like state-level requirements, public health
requirements, and other third-party requirements.
We are meeting on a regular basis with key stakeholders,
including physician groups, including hospital groups.
The Chairman. I'm going to cut myself off here or I'll be
in trouble with my colleagues. But to me, a goal--those are the
steps you're taking, but toward what goal? I think it helps to
have a goal. If everybody thinks it's two-thirds and it ought
to be something less, I think it would be wise to pick a number
and then say join us in doing all these various things to reach
that goal, and let us have hearings to see how you're doing.
Senator Murray.
Senator Murray. Thank you very much.
Dr. White, let me start with you. Your team is working to
engage stakeholders in the implementation of the 21st Century
Cures Act, which asks the Office of National Coordinator to
develop or support a framework for trusted exchange of
electronic health information across networks, and to develop
new conditions for certification of health information
technology. We had a number of Senators--Baldwin, Whitehouse,
Cassidy, Hatch--who worked very hard on those policies, and
those will advance interoperability so providers can provide
more coordinated care and give patients access to their health
information.
Both of those policies are due within the next year. Could
you give the Committee an update on how those two priorities
are proceeding, and also what you're hearing from stakeholders?
Dr. White. Sure. We appreciate the chance to work on both
of those situations. We both think they're very important.
On the trusted exchange framework and common agreement, we
believe that ONC can act as a neutral party to work
collaboratively with all the stakeholders and ensure that
everyone who requires interoperability has a voice in that
agreement. We've held two initial public meetings. We have a
third one planned. We've had a round of public comments on the
trusted exchange framework and common agreement. We're looking
forward to getting their feedback. We are committed to getting
a draft of that out by the end of the year for public review.
On the conditions of certification, again, there are a lot
of important things to work on. We mentioned some of them
earlier. That involves rulemaking, so I'm not at liberty to say
where we are on that, but we have been busily addressing those,
and we look forward to working with your staff and keeping you
updated.
Senator Murray. So you'll meet the timeline.
I'm curious what you mean by what you're hearing from
stakeholders as you go through it.
Dr. White. Well, as you all know, there are several
nationwide networks that address or try to achieve
interoperability, and there are a number of frameworks and
agreements between them, and all these folks are, again,
working hard at this and have set up their frameworks and their
agreements in certain ways. We've been working hard to
understand the variation across those different approaches.
They're often there for good reasons, but we sometimes find
that some of the variations cause those networks to not be
interoperable with each other, which is a challenge. So that's
something that we're working hard to understand.
Senator Murray. Okay, thank you.
Mr. Cannatti, while you're here I wanted to ask you, last
month the Office of the Inspector General reported that
Medicare spent over $1.5 billion on just seven medical devices
that were either recalled or failed prematurely, but it took
the IG years to complete the report because providers are not
required to document which device they use when they file a
claim. So after a procedure there may be no way to find out
what device was used, which can lead to waste in the health
system and pose a serious threat to people's safety.
This is especially frustrating because FDA requires each
device to carry what is called a unique device identifier, put
in place to help us better track safety performance of medical
devices. ONC has begun to address this by requiring medical
records to include information on what device was used. But
wouldn't it be easier to know which devices have safety issues
if the device identifier was also in the claims data?
Mr. Cannatti. Yes. Based on our work, without that
information you could not rely solely on the claims data.
Senator Murray. Your report recommended that the device
identifier be included in the next version of the CMS claims
form. My staff's investigation into outbreaks of superbug
infections linked to duodenoscopes recommended inclusion in the
claims form to improve patient safety. Do you still think
that's the right course of action?
Mr. Cannatti. I do.
Senator Murray. Okay. Thank you. I really hope that CMS
will work with the organization that develops the claims form
and push it to include in the next edition. I think that's
really important.
I just have a few seconds left. But, Dr. White, I wanted to
ask you, the President's 2018 budget requested $38 million in
budget authority for ONC's operating budget. That is a pretty
significant cut from the $60 million you ultimately received in
2017. Given the work you have to do to implement Cures, what
provisions of the bill will you not be able to carry out if
this budget cut is enacted?
Dr. White. So, under the current budget proposal, we are
expected to meet all the requirements of the Cures Act, with
the exception of the EHR reporting program and Section 4002. As
you all know, there was $15 million that was authorized in the
Cures Act but not appropriated for that.
Senator Murray. So what will you cut?
Dr. White. So at this point, right now, we expect to be
able to meet all the requirements of the Cures Act, but we will
not be able to implement the EHR reporting program.
Senator Murray. Okay. Thank you.
The Chairman. Thank you, Senator Murray.
Senator Young.
Senator Young. Thank you, Chairman.
Dr. White, I'm going to pick up on the Chairman's line of
questioning about establishing goals. I spent a couple of years
as a management consultant, and as you likely know, you have
your techies who are system experts oftentimes, and you have
those who do business process redesign and help tease out
system requirements and try to come up with organizational
efficiencies.
I don't intend to be prescriptive with respect to your
project work, but I'll just say that it might be helpful to
this Committee and to other stakeholders, as you establish
clearer goals, to assign probabilities to achieving a certain
amount of work by a certain amount of time. You have that hard
aspirational goal out there, but that would give us I think a
richer sense of how likely you are to accomplish this
monumental task by certain dates. That's one thought from
someone who has done a little of that.
With respect to information blocking, I thought Mr.
Cannatti put it pretty concisely, ``the practice of some
providers electronic health record vendors of inappropriately
impeding information flow or use.'' So 21st Century Cures Act
defines information blocking with respect to electronic health
information. The Secretary, in fact, under that law is directed
to identify practices that are not information blocking so that
he or she can provide safe harbors and give clarity over the
issue.
Mr. Cannatti, you directly mention this in your testimony,
that the Cures definition of information blocking contemplates
rulemaking to identify reasonable and necessary activities that
would not constitute information blocking, but there's been no
rulemaking. So why hasn't there been a rulemaking, and when do
you anticipate this rulemaking taking place, sir?
Mr. Cannatti. So, we have been working closely with our
colleagues at ONC. They are tasked with that, as you indicated.
I would have to defer to them in terms of timing.
Dr. White. First, thank you for the advice. They didn't
teach me project management in medical school, but I've been
learning it in the government.
Regarding rulemaking, the Cures Act----
Senator Young. Thank you for your service.
Dr. White. My pleasure, absolutely.
The Cures Act asks us to define what is not information
blocking, and we're looking forward to doing that through
rulemaking. As I said previously, because it's before the
issuance of a Notice of Proposed Rulemaking, I can't say when.
We're working very closely with stakeholders across the
spectrum that will be affected by information blocking to
understand instances in which it might be appropriate and in
which it might not be appropriate.
Senator Young. I appreciate maybe if you huddle up with the
team and try to give us some estimate of when we can expect the
rulemaking to begin.
Dr. White. In general, we are always delighted to follow-up
on a regular basis with staff, so I'm happy to.
Senator Young. Thank you.
There's been some discussion of steps that are being
taken--all of you have talked about steps you're taking to
improve interoperability, reduce the clinical burden, and
address information blocking. But what flexibilities are needed
to be built into our health IT system so we can keep up with
the latest technology developments?
We'll start with Mr. Cannatti.
Mr. Cannatti. I think you raise a very important point.
From an enforcement perspective, one of the things that's
really important for that rulemaking, for the contours that
ultimately set out the rules of the road, is to have sufficient
flexibility to allow for adaptation to emerging trends or
emerging technology. At the same time, it's important to have
enough clarity so that both the regulated industry and the
enforcers understand what it is that is prohibited and is not.
I know it can be a challenge, but it's really important to
kind of strike that balance.
Senator Young. Dr. Goodrich.
Dr. Goodrich. The provisions around interoperability are
primarily under the purview of my colleagues at ONC, but what I
will say is that as a clinician it is very frustrating not to
be able to see all the information that I need to see when I
have a patient right in front of me that I'm trying to take
care of, especially in this day and age. So we are strongly
supportive of the new tools and flexibilities that Cures has
given the Department to be able to move forward on that.
Dr. White. On the technological side, I'd offer the thought
that really the industry has said application programming
interfaces are the technical way to get at your data, and that
includes both the standards for the data as well as the
business rules under which that data can be accessed and by
whom it can be accessed. So that's the technical side of
things.
Then there's the business practice and policy side of
things. This is an instance where the exchange framework and
common agreement is not going to be something in a regulation.
It's a voluntary agreement. So that's the kind of thing that
moves fast enough, and business practice moves fast enough that
you shouldn't commit that to a regulation. So again, we're
looking forward to having that be a voluntary agreement.
Senator Young. Well, thank you for your work. It's really
important we get this right from my constituents perspective.
Their ability to shop for health care is really going to be
enhanced once this process plays out, so I really appreciate
it.
The Chairman. Thank you, Senator Young.
Senator Bennet, if you'll excuse me, Senator Murray and I
were talking and asking staff where is there a rule that says
you can't tell us when you're going to start making that rule
and when you're going to finish? We hadn't heard of that.
Dr. White. Oh, I'm sorry. My counsel has told me that when
we're engaged in rulemaking and we've already started, the
official----
The Chairman. I thought there was a blackout period for
comments, after you were waiting for comments.
Dr. White. Right. So--and you may be able to help me out on
this one.
[Laughter.]
Dr. White. We started staff discussions about potential
rules. That's been ongoing----
The Chairman. Why don't you go back to the counsel and say
that we, in a bipartisan way, we'd like to know when you're
going to start and when you're going to finish. If there's some
law or rule that prohibits our knowing that, we'd like to know
what it is.
Senator Murray. Is there a law?
Mr. Cannatti. I'm not the expert on that. I don't know.
We'll ask our counsels, too.
The Chairman. Thank you.
Senator Bennet.
Senator Bennet. Thank you, Mr. Chairman.
Let's say you started making a rule 60 days--no, I'm just
kidding.
[Laughter.]
Senator Bennet. Thank you for having the panel, and it's a
privilege to be on a Committee that actually passes
legislation. I think we should be passing Alexander-Murray
right now. That's not in front of us today.
In the discussion that we're having around interoperability
and linking different electronic medical health records, it's
important to focus on prescription drug monitoring programs. As
all of you know, these data bases help physicians and other
providers to monitor opioid use by seeing a patient's
prescription history.
When I visited the University of Colorado emergency room
not long ago in Colorado, actually the Commissioner of the FDA
was with me when I went this past August. Their physicians
demonstrated a new tool where the prescription records and the
PDMP were tied into the hospital's patient records. Now that
those two records speak to each other, that ER has the
information it needs in one click, which means that 3 years ago
about 20 percent of the patients were leaving the ER with a
prescription for pain medication and that percentage has since
dropped to 12 percent, and they believe that the advancement
can drive that number even lower.
So I wonder--and I'll start, Dr. Goodrich, with you--how we
can speed up interoperability between electronic health records
and PDMPs as another tool to address the opioid crisis, and
anybody else who would like to speak to it, I'm happy to have
you do that.
Dr. Goodrich. Absolutely. Thank you for the question.
Interestingly, that is also a functionality that has recently
been made possible in the health system that I work in, as
well, and it has proven to have incredible benefit to be able
to have that information at your fingertips about your
patients.
We definitely believe--first of all, the opioid epidemic
overall is a top priority of the Administration. In both the
QPP, or the quality payment program--excuse me--and the EHR
incentive program, we do require that clinicians and hospitals
report on their prescribing practices. In addition, under the
quality payment program, one of the things that we've put in
place is that we can give clinicians credit under the
improvement activity category if they access their state's PDMP
when considering opioids for their patients or when working
with patients who are already on opioids.
So again, we strongly support the work that ONC will be
doing with stakeholders around enhancing interoperability. In
terms of the actual activities under those sections, I would
certainly defer to my colleague, but we're very supportive of
that work.
Senator Bennet. Dr. White.
Dr. White. Senator Bennet, thank you for the question. One
of the ways in which health IT has become ubiquitous for those
of us who get health care that you may have noticed is
electronic prescribing. A large number of prescriptions are
sent electronically now.
ONC's efforts in this area are focused on two things. One
of them has been what you just mentioned, which is harmonizing
the technical standards so that data that's in a prescription
drug monitoring data base and in an EHR are one and the same
and can be shared between them. That's work that we've
undertaken for the past 2 years, and you're starting to see the
fruits of that.
The other thing that we've done is we've worked with our
colleagues at the CDC to translate their prescribing guidelines
for responsible prescribing into clinical decision support that
can be implemented in information systems so that when Dr.
Goodrich goes to prescribe something, she's got the guidelines
at her fingertips.
Senator Bennet. Thank you.
Dr. Goodrich, I have one other question. I only have about
a minute left. In your written testimony you indicated that CMS
is examining opportunities that telehealth presents, and you
also noted that CMS is working on a report to describe which
Medicare beneficiaries can benefit the most from expansion of
telehealth. In Colorado, over 700,000 people live in rural
areas, and by 2018 about 40 percent of them will be over the
age of 65 and presumably covered by Medicare. So expanded
telehealth and remote patient monitoring may be important tools
for these Coloradans that have to travel long distances.
I wonder if you could give us what you're looking at in
that regard.
Dr. Goodrich. Absolutely, happy to. First of all,
telehealth is very important to us, and we hear all the time
from consumers and patients and providers how they would like
to see telehealth expanded. We are working actively on the
report, as is directed by Cures. We know it's a priority for
this Committee, so we're working hard on that. We're looking at
which types of patients may benefit from telehealth. We are, of
course, looking at innovation center models that are utilizing
telehealth and future models that could utilize telehealth.
We're also looking at high-volume procedures and codes and
diagnoses that may be well suited for telehealth, and also
barriers to expansion of telehealth.
So we're excited to be doing this work and working hard to
get the Committee the report that you've asked for.
Senator Bennet. Thank you.
Thanks, Mr. Chairman.
The Chairman. Thank you, Senator Bennet.
Senator Cassidy.
Senator Cassidy. Hey, you all, thank you for what you do.
As a guy who occasionally still uses an electronic medical
record, and as one of those people who if I caught you in the
doctor's dining room would wear you out, thank you all for
doing it.
I think I gather from what you're saying, though, that
information blocking persists. Is that correct?
Dr. White. Yes.
Senator Cassidy. If it persists, it begs the question what
are we doing about those who are persisting in blocking
information. What are we doing? Do you have the tools? Because
I thought we gave you those tools. If we did, are we using
those tools to stop this?
Dr. White. It does remain an issue of concern for us, and
we do appreciate you giving us the tools to be able to address
that. The process is laid out in the law. It starts with saying
what is not information blocking, and we're going to work to do
that. We're working very closely with our colleagues at OIG and
the stakeholders, as I mentioned. Then once we've gone through
that process--James, I'll let you speak about what you all
might be doing.
Mr. Cannatti. Absolutely. So, first, just to be clear,
while we are not anticipating imposing penalties under the new
authorities until after that rulemaking, we are looking at and
assessing complaints that we receive, whether referred by ONC
or through a hotline, to determine whether there might be other
authorities to hold people who are engaging in prohibited
conduct accountable.
We are currently engaged in preparing so that when the
rulemaking is complete, we'll be ready to enforce. Once we're
in the enforcement phase, we will go about that the same way we
would with any CMP. We would investigate. We would leverage our
investigators. We would issue subpoenas, gather information,
weigh the evidence, and in the event that the evidence
supported a violation, we would move through the penalty
process.
Senator Cassidy. So we're in a little bit of a holding
pattern until all these rules are done, although you hope you
have things that could otherwise encourage folks to comply.
Mr. Cannatti. That's correct.
Senator Cassidy. Now, in terms of publishing APIs, I
actually read some very positive things about how this is
progressing. A person who does third-party APIs said, ``You've
got to be kidding, I'm totally blocked out.'' There's a woman
back home who sees patients but goes home and spends 4 hours
every evening typing up her notes. I go to four different
hospitals, I have four different interfaces. Why can't I have
the same interface which made me so much more efficient when I
was there? I wouldn't have to go home and type up notes for 4
hours. So that seems fairly straightforward.
Are the vendors publishing their APIs?
Dr. White. One of the recent enhancements we made to the
ONC website is the terms of developers' APIs. So right now you
can go to healthIT.gov, pull up what's called the Certified
Health IT Product List, and there is actually an API Terms
button. You click on it and pick your vendor and you can take a
look at the terms of use for that API.
Senator Cassidy. Now, I didn't quite follow that, the terms
of use. Usually that's something I click I agree to, and I
would have no clue what it says.
[Laughter.]
Senator Cassidy. Does the terms of use have adequate
technical information so that I, as a programmer, could take my
own widget or whatever it's called and, using this, be able to
plug it in and take it between vendors products?
Dr. White. Yes, if you're a programmer. Not if you're Dr.
Cassidy, but if you're a programmer. That is under the 2015
additional certification rules. Of course, this passed after
the 2015 edition was finalized. So we are taking a look at the
new provisions and specifically talking about published APIs
that make information available without special offer, and
trying to figure out how best to implement that so exactly what
you're talking about does not happen.
Senator Cassidy. So, if I'm a programmer--I'm going to be
dense. If I'm a programmer, I could log on, and I could see the
terms of use, and I would be able to program to that terms of
use to come up with something that my friend the neurologist,
the pediatric neurologist could then somehow use to go between
vendor and vendor and have the exact same form that she was
filling out to improve her efficiency, yes or no?
Dr. White. That's an approximate description, yes.
Senator Cassidy. Okay. Dr. Goodrich, perhaps you'll weigh
in on this. Whatever the advantages, one of the specific things
that people complain about, physicians complain about EHRs, is
the narrative. I mean, instead of the chief complaint is ``my
leg hurts,'' and the history of the present illness is ``fell
out of a tree,'' it's now just gobs and gobs of information,
oftentimes people cutting and pasting.
Similarly for review of systems, and the importance of this
is that you bill for this. If you do a review of systems of the
whole body, you just billed a lot more, and that's going to be
done automatically, and oftentimes I find people are cutting
and pasting review of systems, cutting and pasting physical
exams when they've not done them. Frankly, it's Medicare fraud,
I think. I don't know if there's been an audit to this.
You are a person who has become quite facile with these
EHRs. You feel good about it. But do you find this is a
problem, the absence of a narrative, the cutting and the
pasting, the bloating of notes, and frankly, the over-billing
to payers? If so, what do we do?
Dr. Goodrich. Thank you for the question. This is
definitely something that I have experienced in my clinical
life, where you have essentially the same text day after day
after day. So you can't really tell what's happening with the
patient, if the care plan has been updated----
Senator Cassidy. Because of cutting and pasting.
Dr. Goodrich. Because of cutting and pasting.
Senator Cassidy. It takes so long to do it. People are
cutting and pasting because it takes so long to do it.
Dr. Goodrich. Right, and I think what you're getting to are
some of the issues I know my colleagues and I think a lot
about, which is around the safety of health IT. I know ONC has
done a lot of work in that area. So this is definitely
something we're worried about.
As it relates to Medicare fraud, that is obviously
something that's a high priority for us at CMS, to guard
against Medicare fraud. So it's something that I think we
definitely need to keep an eye on and work with our colleagues
at ONC to get to a better way to be able to do documentation
just generally, and also at an EHR.
Senator Cassidy. I think that directly feeds into what
Senator Alexander said, which is that you've got to make this
so that physicians aren't so crunched for time that we're
cutting and pasting.
Dr. Goodrich. Yes.
Senator Cassidy. Because even though you're good at it, for
most physicians it's still a productivity killer. So you don't
get the integral change, you just get a cut and paste, which is
bad on several measures.
Dr. Goodrich. Documentation is one of the things that we
are taking a comprehensive look at, at CMS, as part of our
burden reduction initiative for clinicians.
Senator Cassidy. Thank you.
The Chairman. Thank you, Senator Cassidy.
Senator Warren.
Senator Warren. Thank you, Mr. Chairman.
Electronic health records are a valuable resource to help
healthcare providers share information about patients in real
time, improve the quality of the data, and empower patients to
be able to understand and track their own health care needs.
But we all know that there are errors. A health record system
doesn't always match the patient's health records to the right
person. For example, when somebody has the same name and the
same birth date, they may get switched. Or human error in a lab
might mean that they end up assigned to the wrong patient
record. I understand these mismatches can be dangerous. They
also can be very expensive.
Dr. Goodrich, you oversee efforts at CMS to ensure the
quality in health care settings, and quality means, at least in
part, accurate patient matching. So can you just say a word
about what the dangers are to a patient when their medical
records are not accurately matched in a medical setting, when
there's a patient misidentification?
Dr. Goodrich. Yes, absolutely. Unfortunately, I have
witnessed actual harm to patients in my clinical practice that
has been as a result of patient mismatching. So, as you point
out, when one patient is mistaken for another because of an
identical or similar name, we know this does happen. Patient
mismatching can result in the wrong patient getting the wrong
treatment at the wrong time, and that, of course, can lead to
actual harm to patients and, of course, medical error.
It also can result, though, in inefficient care when
incorrect tests or diagnostics are performed and the patient
then needs a duplicative test later on once the mismatching is
identified. So that, of course, can contribute to increased
cost to the health care system.
Senator Warren. So money and the fact that people can
actually get hurt from this.
Dr. Goodrich. Yes.
Senator Warren. A 2012 survey found that 1 in 5 physicians
encountered mismatched information that led to illness or
injury at least once during the preceding year. Then a recent
report showed that medical error, including patient
misidentification, was the third leading cause of death in the
United States.
Dr. White, you work on patient matching issues at the
Office of the National Coordinator. Why is it that the health
IT systems used by hospitals and doctors don't always
accurately match patient records?
Dr. White. You actually outlined two of the reasons that
might happen. There might be a lot of Jon Whites that go to a
given hospital, or Jon White might have mistakenly had more
than one medical record number assigned to my name. So my CAT
scan wasn't in the same place as my blood test.
Even though a hospital uses the same system, that doesn't
always preclude you from having patient matching issues. We're
actually quite encouraged by some of the modern approaches to
matching people to their information. We're certainly taking a
look at approaches like biometric identifiers and a couple of
other different approaches. There is actually a very robust
interest in the private sector. This is an issue that they
really want to see solved. We've been very closely following
the CHIME patient matching challenge with great interest, and
we think there are going to be some good approaches on the near
horizon to address the issue.
Senator Warren. I'm very glad to hear this, that we're
working on ways to address the shortcomings in the current
system. It's part of the reason, though, that Senator Cassidy
and I worked, along with Senator Hatch and Senator Whitehouse
and Senator Baldwin, on a provision in the 21st Century Cures
Act that requires the GAO to produce a study on patient
matching, and that's why all five of us sent a follow-up letter
to GAO earlier this month reminding them of the urgency of this
issue and requesting that they produce some clear
recommendations for improving patient matching methods in their
final report.
So I look forward to working with both of you to improve
the safety and quality of our health information systems so
patients can get the care they need. Thank you very much for
your work, and let's get this done.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Warren.
Senator Hassan.
Senator Hassan. Thank you, Mr. Chair and Ranking Member
Murray, for holding this hearing. Thank you to our witnesses
for being here today.
I was very glad to see the topic of this hearing. I'm
blessed with two children, one of whom happens to have very
complicated medical needs, and at various times we've had as
many as nine doctors and 20 medications. Ben is now 29, but
especially early on in his life, I really felt like I was the
walking medical record and that if I wasn't there with him, all
sorts of heck could break loose just because there was a lot to
keep track of and everybody had their own recordkeeping system,
and sometimes the records made it to the next doctor in time,
and sometimes they didn't, for the meeting. So I have seen the
benefits as we have moved into the electronic age. I tried as
Governor of New Hampshire to help move the process along, but
clearly we have some work to do.
So I just wanted to explore really how we are going about
implementing the charge in the 2015 Medicare Access and CHIP
Reauthorization Act, which instructed HHS to develop metrics to
measure the degree to which health providers across the country
are able to achieve the widespread interoperable exchange and
use of electronic health information.
Dr. Goodrich, I wonder if you can help walk us through
this. What metrics did you adopt, and how are you using them to
measure interoperability?
Dr. Goodrich. I can speak to a couple of ways we're doing
that. First of all, we do track the adoption of EHRs by rural
providers and non-rural providers. I think what we have found
is that the adoption rates by rural and non-rural are actually
quite similar. So adoption rates have been fairly good for
rural providers.
Having said that, we know that there are certainly still
significant barriers to adoption by small practices and rural
providers.
We also, in the meaningful use program, as well as part of
the quality payment program, we have focused the measures on
EHR use to really be about interoperability. So about 70 to 80
percent of the measures that clinicians must report on in
hospitals really are focused on that exchange of health
information from one person to another. We anticipate learning
a lot more as those measures are implemented to understand
where people are with interoperability.
The other thing I would note is that under MACRA, Congress
gave CMS resources to have technical assistance provided
specifically to rural providers and those in underserved areas
and small practices. We awarded those contracts in February of
this year, and as our contractors are going out into the field
and working with these providers to help them with the quality
payment program, what they're hearing is I definitely need some
help in figuring out what the best EHR is for my practice that
is affordable and that is going to meet my needs.
So I think we're also able to give those types of providers
who may have increased barriers assistance to help them to get
what they need so that they can really see the benefits of
EHRs.
Senator Hassan. Thank you. I'll echo the other Senators on
the panel, it sounds like we have plans in place for making
progress with metrics. We all want to get to the even better
use of this. Coming from a state with a lot of rural providers
and small providers, I know that they understand the potential
benefits but, yes, they really do need this technical
assistance to truly adopt.
Last--and in a second I'll yield back the remainder of my
time--I just want to echo what Senator Bennet raised about the
importance of prescription drug monitoring for all of us, but
particularly in states that have been particularly hard hit by
the opioid crisis and the need to make sure that we're sharing
that information but also protecting patient privacy, as
appropriate. I know you're all working on it, but I'll just add
my voice to the chorus on that.
Thank you, and I yield the remainder of my time.
The Chairman. Thank you, Senator Hassan.
Senator Baldwin.
Senator Baldwin. Thank you.
I'm encouraged that we're continuing to focus on bipartisan
work that can improve health care through the interoperability
of electronic health records. Last year I worked with my
colleague, Senator Hatch, to advance the development of a
national structure for all health IT exchange networks to share
at the basic level patient information with each other. Just
like calling someone on a cell phone with a different network,
it shouldn't matter what network your doctor belongs to in
order to share basic data.
But we shouldn't reinvent the wheel. Much of the work has
already been done for us, and the industry has made significant
progress in creating a blueprint for this exchange. For one,
Carequality is a network-to-network framework with a common
agreement developed by a large coalition of stakeholders,
nearly 300,000 providers over 23 vendors, including EPIC, which
is based in my home State of Wisconsin. That number are using
Carequality today. In fact, EPIC has exchanged nearly 3 million
records with other networks through Carequality.
Dr. White, the 21st Century Cures Act requires the Office
of the National Coordinator to develop or support a voluntary
framework and agreement for the exchange of health information
across networks. Importantly, the Office of the National
Coordinator is also required to take into account and leverage
the work of existing frameworks to avoid disruption. This means
that we should not create an entirely new framework.
Can you please discuss how the Office of the National
Coordinator plans to support the advancement of a trusted
framework by partnering with and utilizing industry's work in
this space? Can you assure me that you will not be duplicating
existing agreements?
Dr. White. Senator, thank you for the question. The great
news is that progress has been clearly made by the networks and
the industry. There has been an acceleration of the work in the
past 2 years with your and our focus on improving
interoperability, and they've made great progress. I'm very
glad to be able to report that.
That's why, as I said earlier, we've been focused on the
areas of variation that exist between these networks and
frameworks that we're finding can limit the ability of those
organizations to connect with each other and support that
nationwide interoperability that we all want and that we know
we're trying to get at. We want to build on that great work.
Just to give you a quick example, when I say what are
variations, one example is different policies on to what level
users must be identity-proofed and authenticated in order to be
able to access. So it's one thing if I have my iris scanned and
give you a pint of my blood. It's a whole other thing if I've
got a handwritten card that says ``Dr. White''. You need to
have some agreement across those trust frameworks and common
agreements to be able to trust each other, really is what it
comes down to.
There are some areas where we believe we can provide some
minimum requirements that enable and build trust between these
organizations, and we think that we can be a neutral
coordinator of the industry efforts to help ensure that no
particular group is disenfranchised.
Senator Baldwin. Input from a diverse set of health IT
stakeholders, from vendors to patients during the development
of this legislation, was truly invaluable in our process and to
our bipartisan work, and I think it should continue to be
integral to the Office of the National Coordinator's
implementation. I've heard some frustrations from stakeholders
in this process that the Office of the National Coordinator has
not always followed the recommendations from its Health IT
Stakeholder Advisory Committees and does not usually provide
insight when the guidance isn't followed as to why that's the
case.
Our legislation streamlined the work of these committees
into one Health IT Advisory Committee and included specific
areas of focus for its recommendation, and I'm running out of
time. So maybe as a follow-up, in writing, Dr. White, can you
please describe how the Office of the National Coordinator
plans to increase transparency and how it utilizes stakeholder
input, including sharing why or why not recommendations from
this advisory committee are implemented?
Dr. White. Would you like a brief answer, or would you
rather I follow-up later?
The Chairman. Why don't you give her a brief answer and
follow-up?
Dr. White. Belts and suspenders.
We really appreciate and value the input of our advisory
committees, and I'm pleased to tell you that I was the Chair of
the Standards Committee for a couple of years. They're good
folks and they give us great advice. We often do take their
advice. They were actually integral for us for our response to
the Zika crisis and a number of other situations.
On our website, healthIT.gov, in addition to making sure
that our meetings are publicly open, that we webcast them so
anybody can listen in to them and offer public comment, we're
also working to ensure that our website, healthIT.gov, has full
transparency of all the proceedings and all the recommendations
that have been made. So we look forward to working with you and
your staff.
The Chairman. Thank you, Senator Baldwin.
Senator Franken.
Senator Franken. Thank you, Mr. Chairman. I apologize for
missing so much of this hearing. I was just in a Judiciary
hearing right now.
In 2015, the Government Accountability Office put out a
report highlighting areas that would need to be addressed to
advance efforts at nationwide interoperability. The report
states that interoperability would move forward if providers
saw value in their systems being interoperable, and
specifically highlighted efforts to tie payments to quality and
value rather than volume as a potential catalyst for more
information sharing across providers. Basically, there hasn't
been a strong business case for interoperability, but new
payment reforms, including those focused on care coordination,
offer a path forward.
Dr. Goodrich, in recent years the Department of Health and
Human Services has advanced a number of policy reforms aimed at
implementing these types of payment reforms, including
accountable care organizations and bundled payments. Can you
describe the specific way in which CMS is leveraging these new
policy reforms which are focused on value rather than volume to
promote the timely exchange of health information?
Dr. Goodrich. Yes, thank you for the question. Over the
last several years we've seen a fairly significant expansion of
payments from Medicare coming through what we call alternative
payment models, so these value-based payment arrangements that
are directly tied to quality and value of care. We now have
about 30 percent of payments from Medicare coming through these
types of arrangements. As required under the MACRA legislation,
for example, advanced alternative payment models that
clinicians can participate in to basically reap extra rewards
from the Medicare program if they perform well on these
measures does require the use of certified EHR technology.
In addition, many of these payment models do directly
incentivize those types of activities that are most important
to patients like care coordination, like communication across
providers. So there are direct incentives for those types of
activities that are built into these models.
Senator Franken. Does that seem to be helping?
Dr. Goodrich. With interoperability itself?
Senator Franken. Yes.
Dr. Goodrich. I think it's probably a contributor. I think
the problems with lack of interoperability are complex and
multifactorial, and if it was just one thing we would have
solved it by now. So I also believe that the Cures Act gives us
as a department, and ONC in particular, some new tools to
really move forward on that. So I think value-based
arrangements are an important piece of it, but they're not by
themselves probably sufficient.
Senator Franken. My State of Minnesota is working to
develop a multi-level system of health information exchange.
The state wants to move beyond the system that enables just the
basic flow of health information for an individual payment for
purposes of care coordination to a more expansive health
information system that simultaneously allows for the flow of
information for a larger patient population. The goal of this
more expansive system would be to connect data to support
community health and enable community advisors, social
services, and other public health actors to use the data to
address community health needs.
Dr. White, ONC is working to develop a national trusted
exchange framework. From the conversations you've held thus
far, would this framework be focused on promoting the flow of
information solely at the individual level, or do you envision
a framework that is expansive enough to allow for the exchange
of information for entire patient panels as piloted in my
state?
Dr. White. This is about interoperability for all,
interoperability for everybody. That's important for me as an
individual, for the people for whom I care, for the people in
my family, but it's also important for my community. So it's
for both. You really have to be able to enable it for
individuals, and every individual. But you've also got to be
able to enable interoperability across a population for the
right purposes.
Senator Franken. In what ways do you think a national
trusted exchange framework that provides clearer policies,
standards, and services to stakeholders can better support
communities' focus on solving community-level problems like the
opioid epidemic?
Dr. White. Well, it helps you set the rules of the road.
It's everybody who agrees that they're operating from the same
play book, essentially. Kate mentioned that this is
complicated, so I'm not going to get into a lot of the
details----
The Chairman. Another opportunity for a brief answer and a
written follow-up.
[Laughter.]
Dr. White. ----but it allows you to address some of that
complexity in the agreement. If folks are voluntarily signing
on to it, it helps them pull them to address those issues.
Senator Franken. I look forward to the written follow-up.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Franken.
We have votes at 4. I think some Senators may want to ask
additional questions. Before they do, let me just say, Dr.
White, in addition to Senator Murray and me, the Congressional
Research Service has never heard of a prohibition in the
Administrative Procedures Act that would keep you from telling
us when you're going to have a rule that defines what is
information blocking and what isn't. So after you consult with
your counsel, we would appreciate your letting us know when
that rule is coming out.
Dr. White. I'll have my counsel talk to your counsel.
The Chairman. Thank you. No, just give us the answer.
[Laughter.]
The Chairman. Now, Senator Murray, do you have additional
questions?
Senator Murray. I just want to thank you for having this
hearing. I think Senator Warren had one additional question.
But I think this is a really important discussion. We have to
focus on this if we want our health care system to work better.
I'm going to keep focused on making sure this
Administration is implementing the 21st Century Cures Act as
intended, and that the agencies involved have the resources
they need to actually carry this out. So there's much work
ahead of us, and I look forward to working with you on that.
The Chairman. Thank you, Senator Murray.
Senator Warren.
Senator Warren. Thank you, Mr. Chairman. I appreciate a
chance to ask another question.
I want to talk about medical devices. As you know, millions
of people are living with some kind of medical device implanted
in their bodies. Every year, about a third of a million
Americans have surgery to get a pacemaker implanted. About a
million hip or knee replacements are performed every year.
We're talking about things like cardiac stents and IUDs and
artificial disks and screws and defibrillators.
Patients going under the knife need to have confidence that
they're getting a product that isn't likely to fail or get
recalled and force them to have to have a second operation. But
right now, doctors don't have the information available to tell
which pacemaker has a failure rate of, say, one-tenth of 1
percent and which one has a failure rate that is ten times or
even a hundred times higher.
So I want to follow-up on a question that Senator Murray
asked about unique device identifiers. Mr. Cannatti, you work
at the Office of the Inspector General for HHS, which recently
released a report about Medicare's ability to track the
performance of medical devices. What did you find about the
cost to patients and to taxpayers when these devices fail
prematurely?
Mr. Cannatti. We found that CMS could not, from the claims
form or information alone, determine that amount. In doing
really advanced audit techniques, we were able to determine
that over a 10-year period approximately $1.5 billion were paid
for Medicare services related to the replacements, and that
accorded to about $140 million in beneficiary, co-pay, and
deductible liability.
Senator Warren. That was just on one kind of product,
right? Just cardiac devices, just seven of them.
Mr. Cannatti. That's correct.
Senator Warren. It was $1.5 billion, and another $140
million out of the pockets of the patients themselves.
So it seems that figuring out how to use safer devices and
sorting out the safer devices from the less safe devices could
save Medicare a lot of money and save consumers a lot of money
and a lot of pain. That's why, back in 2007, Congress required
that all medical devices be labeled with what's called a unique
device identifier, basically a string of numbers and characters
that tell the specific model and the specific manufacturer.
But, of course, those data are valuable only if we actually
collect them.
So, Mr. Cannatti, does the Medicare claim form that
hospitals currently fill out include a line for the device
identifier information that tells us what model of device
failed and who made that device?
Mr. Cannatti. No, it does not.
Senator Warren. Does the HHS Inspector General support
adding such a line to the claim form?
Mr. Cannatti. We do.
Senator Warren. All right. I was glad to see that the
standards group in charge of updating the claim form added this
line to the draft that it released a few months ago. So it
looked like everybody was on board and this was about to
happen. Last year, CMS also supported adding the device
information to claims. But when the OIG report came out a few
weeks ago, CMS said they were reviewing the policy. Then a few
days later CMS put out a new statement saying the device
identifiers on the claim form would ``reduce Medicare costs by
identifying poorly performing devices more quickly''--true--
``and protect beneficiaries from unnecessary cost''--also true.
So, great. It looked like everybody was back on board. But
then a few days after that, CMS put out another statement
saying the policy is still under review and that the earlier
statement was wrong.
So, Dr. Goodrich--you're the Chief Medical Officer at CMS--
I'm hoping you can clear this up. Do you agree with the
Inspector General's recommendation that adding device
identifiers to the claim form would help reduce Medicare costs
and protect beneficiaries from unnecessary cost and pain?
Dr. Goodrich. First I want to say that we very much
appreciate the work of the OIG and this Committee's interest in
this issue. Patient safety as it relates to the devices is
obviously very important to CMS. However, at this time, I don't
have anything else to offer besides that because, as is
customary for new administrations, we are still reviewing this
policy.
Senator Warren. So, all right. Let me just say, this should
be a no-brainer. Your agency's own watchdog says you should do
it. MedPAC says you should do it. Organizations that represent
orthopedic surgeons, cardiac surgeons, thoracic surgeons, all
say you should do this. Adding device identifiers to claim
forms has bipartisan support in Congress. Senator Grassley and
I have been pushing this now for years, and I'll be blunt,
we're going to keep pushing on this. It is time for CMS to step
up to protect patients and to protect the Medicare system.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Warren.
Senator Baldwin, do you have other questions?
Senator Baldwin. I have a remaining question. Thank you.
The Chairman. Sure.
Senator Baldwin. I wanted to share a story about the La
Crosse area of Wisconsin. La Crosse, Wisconsin has, I think, a
unique story that illustrates the importance of provider and
patient access to electronic health records. In that community,
an astounding 99.4 percent of patients at the end of life have
an advanced care plan that's easily accessible in their medical
records thanks to an innovative program pioneered by Gundersen
Health System. Easy access and usability of electronic health
records for both patients and providers is essential to that
program's success and helps ensure that the most appropriate
care is delivered at the right time.
But as we know, providers and patients continue to face
some barriers such as navigating various standards, from
meaningful use to patient privacy requirements, and also how to
access your own medical record from your doctor.
So I want to ask both Dr. Goodrich and Dr. White if you
could please update us on how ONC and CMS are working together
to help reduce provider reporter burdens across programs and
how you're educating providers to better share medical record
data with patients.
Dr. White. You know, it really starts with talking to
doctors. We do that regularly and often. We're pleased to say
we engage on a regular basis with representing doctors,
representing hospitals, representing patients, representing
communities, representing other users of health information. It
really informs what we do, and it really helps us drive where
we go.
They have said to us we clearly think this is important,
that we need to have access to this information, and we've
clearly heard some of the issues which have been well described
here today.
I mentioned earlier I don't want to rehash some of the ways
in which Dr. Goodrich's team and my team are taking a look at
provider burden. We recognize that it's absolutely essential,
whether it's the reporting burden, whether it's billing
documentation, whether it's usability of software, whether it's
other requirements that are being placed on providers. We need
to identify what those issues are and drill down on them and
make them better.
Dr. Goodrich. So I would just add that reduction of burden
on providers and beneficiaries is a top priority for CMS. We
actually launched last week our Patients Over Paperwork
initiative. So we are taking a very comprehensive and holistic
look across CMS at our administrative requirements certainly as
it relates to meaningful use, as it relates to quality measure
reporting. Like Jon said, we are also spending a huge amount of
time just listening to clinicians, listening to patients.
Patients want to be at the table. They want to be part of the
solutions.
We've been traveling the country, going into physicians'
offices and talking to them so that we can really understand in
a specific way their pain points and how our requirements
impact their daily lives. We are taking this approach across
all providers.
I will say we do have a particular focus on clinicians, as
well as a focus on beneficiaries, because I would say, again as
a caregiver for a Medicare beneficiary, it is a burden on
patients when their doctors are facing away from them at the
computer and when they cannot access their health care
information.
So this is definitely a top priority for both of us.
The Chairman. Thank you, Senator Baldwin.
Thanks to all three witnesses.
I have two quick questions. Dr. Goodrich, Dr. White, this,
according to Tom Friedman's new book, was invented in 2007 when
Steve Jobs showed it to John Dore at a soccer game out in
California, and it has transformed the world. It caused a lot
of trouble, too. But that was 2007, 10 years ago. The
electronic health care records law was passed 2 years later, in
2009. In my view, we spent $37 billion on it, and Meaningful
Use I was helpful, Meaningful Use II was difficult, and
Meaningful Use III, people at Vanderbilt and Mayo, two of the
biggest users of that kind of thing, say they're terrified by
it, it was a big problem.
Now, we've talked about all that, but I wanted to make sure
that in all of our regulatory and legal efforts we left plenty
of room for the kind of genius that created this to solve the
problems with electronic health care records. If 2 million of
us can fly every day and we can use these things and all the
things that Amazon and Google and those people do, we try to do
this in the law.
I tried to resist putting too many mandates in the law
about electronic health care records and interoperability
specifically. That's why we're so pleased to see the Center for
Interoperability in Nashville--and Andy Slavitt went down
there. Dr. Goodrich, you were there when he went with me, and
we were both surprised, actually, and impressed by what $100
million a year purchasing power might be able to do in terms of
getting a common platform where everybody could talk to each
other, both with devices and with data.
So my question is, do you share the same hope or zeal that
I do in trying to make sure that we allow within our regulatory
framework the opportunity for game-changing technology to solve
many of these problems for us and make electronic medical
devices work better for providers, doctors and patients?
Dr. Goodrich. Absolutely. I think that's exactly what we
would like to see happening. That's a great example. You're
right, the Center for Interoperability, it's just amazing what
they've done. So I think there are lessons to be learned from
them and other stakeholders who have done some really
innovative work in this space.
The Chairman. Dr. White.
Dr. White. You know, I was in the room with you when you
got the terrifying comment, and I didn't like it any better
than you did. It haunts me to this day.
But here's what I'll say. I think you've given us the right
tools, I really do. There was a really thoughtful process that
went into the passage of this law. I think that what you've
done is you've given us the ability to introduce the right
amount of regulatory focus and reform, as well as the right
amount of non-regulatory--for example, the trusted exchange
framework and common agreement--that's going to allow us to
work both with the developers in the private sector and the
folks who need access to this information.
One of my children just started their second year of
college halfway across the country, and they've got a medical
condition. Ten years ago I couldn't have had access to their
information on my device. Now, as soon as my child is seen, the
note is there, the record is there. I can log in, I can talk
with him, I can talk and make sure he's taking his medications.
As a parent, it's made a world of difference. That's what I
want to see across the health care delivery system.
The Chairman. My last words are more of a suggestion than a
question, but I'm going to make it again, and it's redundant.
Someone gave me a book when I was elected Governor about
presidential leadership or executive leadership. There are
three parts to it. One, you see an urgent need. You develop a
strategy to meet the need. Then you persuade at least half the
people you're right. I found that to be very useful.
In the case of physician documentation, we would say the
urgent need is that you've got two-thirds of the doctors who
say they're spending two-thirds of their time on electronic
health care records and desk work.
Now, you've listed a number of strategies that you've
developed to try to change that. But the third part of
executive leadership is persuading at least half the people
you're right. If they don't believe that and you actually
change it, you haven't made as much progress as you should.
If I were doing it--and I hate to say it that way, but I
believe this. If I were doing it, I would call in the American
Medical Association and the other physician groups and say we
read your report, it says two-thirds of the time is being spent
on this, what do you think it should be? Let's see if we can
agree on a number. Just like a football field is 100 yards
long, and a basketball goes this way, let's agree that over the
next 3 years we ought to try to get it down to 50 percent, or
45 percent, and then let's work together to identify all the
things that would do that, and let's announce on a quarterly
basis or every 6 months what progress we've made, or lack of
progress we've made. So then you actually do it, and they
believe you're doing it. Or probably, if it's like most things,
it's partly the fault of the regulators and partly the fault of
the physicians who may not understand all the things they need
to do.
So I guess what I'm urging you to do is set a number. I
mean, if they think two-thirds of their time is being spent on
that, pick another number and say let's get to that goal, and
get there. What's wrong with that sort of executive leadership?
Dr. Goodrich. I don't think anything is wrong with it. Our
experience has absolutely been that when you want to improve,
for example, quality of care, the way you do that is you set a
goal, a time-bound goal, you get everybody to buy into it, and
then you move toward it, and you're much more likely to achieve
it.
So we'll certainly take that advice back as we are working
with the clinician community on implementing that section of
care around setting a goal and a strategy to meet the goal.
We'll take that back.
The Chairman. Dr. White, any comment? We'll wrap up.
Dr. White. I think it's sound advice. I look forward to
taking it.
The Chairman. Well, I don't want your job, let me make that
clear.
[Laughter.]
The Chairman. I think you've got a tough job, but I'd like
for you to succeed. I think a clear goal for a period of time
would be a helpful aspiration and would help.
The hearing record will remain open for 10 days. Members
may submit additional information for the record within that
time if they would like.
Thank you for being here.
The Committee will stand adjourned.
[Whereupon, at 4:11 p.m., the hearing was adjourned.]
[all]
| MEMBERNAME | BIOGUIDEID | GPOID | CHAMBER | PARTY | ROLE | STATE | CONGRESS | AUTHORITYID |
|---|---|---|---|---|---|---|---|---|
| Sanders, Bernard | S000033 | 8270 | S | I | COMMMEMBER | VT | 115 | 1010 |
| Hatch, Orrin G. | H000338 | 8314 | S | R | COMMMEMBER | UT | 115 | 1351 |
| Murray, Patty | M001111 | 8237 | S | D | COMMMEMBER | WA | 115 | 1409 |
| Burr, Richard | B001135 | 8286 | S | R | COMMMEMBER | NC | 115 | 153 |
| Collins, Susan M. | C001035 | 8291 | S | R | COMMMEMBER | ME | 115 | 1541 |
| Enzi, Michael B. | E000285 | 8328 | S | R | COMMMEMBER | WY | 115 | 1542 |
| Baldwin, Tammy | B001230 | 8215 | S | D | COMMMEMBER | WI | 115 | 1558 |
| Isakson, Johnny | I000055 | 8323 | S | R | COMMMEMBER | GA | 115 | 1608 |
| Murkowski, Lisa | M001153 | 8234 | S | R | COMMMEMBER | AK | 115 | 1694 |
| Alexander, Lamar | A000360 | 8304 | S | R | COMMMEMBER | TN | 115 | 1695 |
| Whitehouse, Sheldon | W000802 | 8264 | S | D | COMMMEMBER | RI | 115 | 1823 |
| Murphy, Christopher | M001169 | 7870 | S | D | COMMMEMBER | CT | 115 | 1837 |
| Bennet, Michael F. | B001267 | 8302 | S | D | COMMMEMBER | CO | 115 | 1965 |
| Franken, Al | F000457 | 8339 | S | D | COMMMEMBER | MN | 115 | 1969 |
| Young, Todd | Y000064 | 7948 | S | R | COMMMEMBER | IN | 115 | 2019 |
| Scott, Tim | S001184 | 8141 | S | R | COMMMEMBER | SC | 115 | 2056 |
| Paul, Rand | P000603 | 8308 | S | R | COMMMEMBER | KY | 115 | 2082 |
| Kaine, Tim | K000384 | S | D | COMMMEMBER | VA | 115 | 2176 | |
| Warren, Elizabeth | W000817 | S | D | COMMMEMBER | MA | 115 | 2182 | |
| Hassan, Margaret Wood | H001076 | S | D | COMMMEMBER | NH | 115 | 2302 | |
| Roberts, Pat | R000307 | 8275 | S | R | COMMMEMBER | KS | 115 | 968 |
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