[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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                                Pensions
                                
                                
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming             PATTY MURRAY, Washington
RICHARD BURR, North Carolina         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

                              ----------                              

                               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.]

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