```

[Senate Hearing 114-641]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 114-641

 HEALTH INFORMATION EXCHANGE: A PATH TOWARDS IMPROVING THE QUALITY AND 
                   VALUE OF HEALTH CARE FOR PATIENTS

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                                   ON

   EXAMINING HEALTH INFORMATION EXCHANGE, FOCUSING ON A PATH TOWARDS 
      IMPROVING THE QUALITY AND VALUE OF HEALTH CARE FOR PATIENTS

                               __________

                             JUNE 10, 2015

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
                                
 [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                               

      Available via the World Wide Web: http://www.gpo.gov/fdsys/
      
      
      
                  U.S. GOVERNMENT PUBLISHING OFFICE                    
25-971 PDF                  WASHINGTON : 2017                     
          
----------------------------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Publishing Office, 
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, 
U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). 
E-mail, gpo@custhelp.com. 
                 

          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman

MICHAEL B. ENZI, Wyoming		PATTY MURRAY, Washington
RICHARD BURR, North Carolina		BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia			BERNARD SANDERS (I), Vermont
RAND PAUL, Kentucky			ROBERT P. CASEY, JR., Pennsylvania
SUSAN COLLINS, Maine			AL FRANKEN, Minnesota
LISA MURKOWSKI, Alaska			MICHAEL F. BENNET, Colorado
MARK KIRK, Illinois			SHELDON WHITEHOUSE, Rhode Island
TIM SCOTT, South Carolina		TAMMY BALDWIN, Wisconsin	
ORRIN G. HATCH, Utah			CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas			 ELIZABETH WARREN, Massachusetts
BILL CASSIDY, M.D., Louisiana

                                   

               David P. Cleary, Republican Staff Director

                  Evan Schatz, Minority Staff Director

              John Righter, Minority Deputy Staff Director

                                  (ii)

                            C O N T E N T S

                               __________

                               STATEMENTS

                        WEDNESDAY, JUNE 10, 2015

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Murray, Hon. Patty, a U.S. Senator from the State of Washington, 
  opening statement..............................................     3
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina.......................................................     5
Warren, Hon. Elizabeth, a U.S. Senator from the State of 
  Massachusetts..................................................    33
Cassidy, Hon. Bill, a U.S. Senator from the State of Louisiana...    35
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of 
  Pennsylvania...................................................    37
Franken, Hon. Al, a U.S. Senator from the State of Minnesota.....    39
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode 
  Island.........................................................    40

                               Witnesses

Payne, Thomas H., M.D., FACP, FACMI, Board Chair-Elect, American 
  Medical Informatics Association, Medical Director, IT Services, 
  UW Medicine, University of Washington School of Medicine, 
  Seattle, WA....................................................     6
    Prepared statement...........................................     8
Richardville, Craig D., MBA, FACHE, Senior Vice President and 
  Chief Information Officer, Carolinas HealthCare System, Chair, 
  Premier Healthcare Alliance Member Technology Improvement 
  Committee, Charlotte, NC.......................................    13
    Prepared statement...........................................    15
Bechtel, Christine, M.A., Advisor, National Partnership For Women 
  and Families, Chair, Health IT Policy Committee Consumer 
  Workgroup, President, Bechtel Health, Olney, MD................    19
    Prepared statement...........................................    20
Patterson, Neal L., MBA, Co-Founder, Chairman, Chief Executive 
  Officer, Cerner Corporation, Kansas City, MO...................    24
    Prepared statement...........................................    26

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    AMIA, Jeffrey Smith, Vice President of Public Policy, memo...    47
    Response by Thomas H. Payne, M.D., FACP, FACMI to questions 
      of:
        Senator Alexander........................................    48
        Senator Murray...........................................    52
    Response by Craig D. Richardville, MBA, FACHE to questions 
      of:
        Senator Alexander........................................    55
        Senator Murray...........................................    59
    Response by Christine Bechtel to questions of Senator Murray.    60
    Response by Neal L. Patterson to questions of:
        Senator Alexander........................................    62
        Senator Hatch............................................    64
        Senator Baldwin..........................................    65

                                 (iii)

  

 
 HEALTH INFORMATION EXCHANGE: A PATH TOWARDS IMPROVING THE QUALITY AND 
                   VALUE OF HEALTH CARE FOR PATIENTS

                              ----------                              

                        WEDNESDAY, JUNE 10, 2015

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:09 a.m., in 
room SD-430, Dirksen Senate Office Building, Hon. Lamar 
Alexander, chairman of the committee, presiding.
    Present: Senators Alexander, Roberts, Burr, Scott, Cassidy, 
Murray, Casey, Whitehouse, Warren, Franken, Bennet, and Murphy.

                 Opening Statement of Senator Alexander

    The Chairman. The Senate Committee on Health, Education, 
Labor, and Pensions will please come to order. Our hearing 
today is on how to improve the exchange of health information. 
Senator Murray and I will each have an opening statement. Then 
we'll introduce our panel of witnesses. After our witness 
testimony, Senators will have 5 minutes of questions for the 
witnesses.
    We're here today to outline our plans to conduct an 
intensive review of electronic health records. To save a little 
time, I'm going to summarize my comments and put my entire 
statement in the record.
    I have these things I'd like to say as we begin. There is a 
great deal of bipartisan interest in this subject. Senator 
Murray's staff and my staff have been meeting with experts 
almost every day, the staff of our committee members have been 
meeting once a week, and Senator Murray and I have been working 
with Secretary Burwell and other members of the Administration 
on this. They understand the importance of it.
    Here's what we're talking about. The Meaningful Use 
Program, as it's called, began in 2009 to encourage 491,000 
physicians who serve Medicaid and Medicare patients and almost 
4,500 hospitals to begin to adopt and use electronic health 
records systems, and 456,000 of those physicians have received 
some sort of Medicare or Medicaid incentive payment.
    All hospitals and most physicians that tried were able to 
meet the early requirements. So far, the government has paid 
out about $30 billion in these incentive payments. The stage 2 
requirements have been so complex that only about 11 percent of 
eligible physicians have been able to comply so far, and just 
about 42 percent of eligible hospitals.
    The next step in the program is penalties for doctors and 
hospitals that don't comply. This year, according to a CMS 
statement recently, 257,000 physicians who serve Medicare and 
Medicaid patients have already begun losing 1 percent of their 
Medicaid reimbursements, and 200 hospitals may be losing more 
than that.
    Our committee's goal is to identify the five or six steps 
that we can take, working with the Administration, to improve 
electronic health records. It is a technology that has great 
promise, but through bad policy and bad incentives has run off 
track.
    To put it bluntly, physicians and hospitals have said to me 
that they are literally terrified of the next implementation 
stage of electronic health records, called Meaningful Use 3, 
because of the complexity and because of the fines that will be 
levied. Our goal is--my goal, anyway, is before that phase is 
implemented, we can work with physicians and hospitals and the 
Administration to get the system back on track and make it a 
tool that hospitals and physicians can look forward to using to 
help their patients instead of something they dread.
    Today we will start a series of hearings that we will hold 
this summer to address various possible solutions. Senator 
Murray and I are announcing the next two hearings in the 
series, which will be chaired by different members of our 
committee, to examine solutions to the problems we identify.
    The first hearing is on the burden physicians face with 
these systems. I have asked Senator Cassidy, who is a physician 
himself, to chair that hearing.
    The second hearing is on the question of whether you and I 
control information about our healthcare, and I have asked 
Senator Collins to chair that hearing.
    The full committee held its first hearing on Meaningful Use 
on March 17. Today, we'll set the table for this series of 
hearings by discussing how we can solve problems. 
    The Precision Medicine Initiative that President Obama has 
proposed, which we are working on and which I strongly support, 
will only work the way it's supposed to work if electronic 
health record systems work the way they're supposed to work. 
The systems can help to assemble and understand the genomes of 
the 1 million individuals required for the Precision Medicine 
Initiative. And, second, if we want to make genetic information 
useful to doctors when they write prescriptions, we'll need to 
get things in order.
    According to medical economic surveys recently published, 
about 70 percent of physicians say their electronic healthcare 
record system hasn't been worth it. They are spending more time 
taking notes than taking care of patients, and they are 
spending a lot of their own money on systems that have to 
comply with government requirements.
    Today we have invited experts representing various 
perspectives--medical informatics, a records system vendor, a 
health system chief information officer, and the perspective of 
the patient--so we can hear these recommendations. I am 
especially interested to hear from our witnesses the 
recommendations they have to improve the system.
    We're fortunate that a report was published in late May by 
the American Medical Informatics Association offering several 
strategies. They include simplifying and speeding 
documentation, refocusing regulation, increasing transparency, 
fostering innovation, and supporting person-centered care 
delivery.
    I look forward to our witnesses' recommendations, their 
thoughts on the report I just mentioned, and also specific 
advice on how we can make improvements as rapidly as possible.
    Senator Murray.

                  Opening Statement of Senator Murray

    Senator Murray. Well, thank you very much, Chairman 
Alexander. Thank you to all of our witnesses for being here 
today. I'm especially pleased to have a thought leader from 
Washington State with us, Dr. Payne, who I'll introduce 
shortly.
    Thank you for taking the trip today and for everything you 
are doing in Washington State to make our healthcare system 
work better for families and patients.
    As I've said before, I really believe strongly that when it 
comes to our healthcare system, we really need to keep building 
on the progress we've made so far. We need policies that 
continue to make healthcare more affordable, not less; expand 
coverage to more families instead of taking coverage away; and 
improve the quality of care patients receive.
    I'm really pleased our committee is focusing on improving 
our Nation's health IT infrastructure, because effective health 
information technology is essential to improving quality and 
cost of care. I'm especially pleased that this is a shared, 
bipartisan priority.
    Members on both sides of the aisle have some great ideas 
for ways we can move forward on these issues. I know that 
Acting Assistant Secretary Dr. Karen DeSalvo also sees this as 
a top priority as she moves into her new role.
    I'm very hopeful we will be able to reach an agreement on 
some ways to strengthen health IT in our country, because while 
we have come a long way in a short time, there is a lot more to 
do.
    Over the last few years, our healthcare system has made 
significant gains in terms of adopting electronic healthcare 
records. Today, 78 percent of physicians use some form of 
electronic health records, compared to just 18 percent in 2001.
    The HITECH Act that passed in 2009 was a big part of that 
transformation. I truly appreciate the work that so many 
doctors and hospitals have done to bring our healthcare system 
into the 21st century and improve the value and quality of care 
patients receive. This is really making a difference.
    In my home State of Washington, for example, Virginia Mason 
Medical Center now has more than 100,000 patients who are able 
to look up their own health information through Virginia 
Mason's medical record. Virginia Mason is also helping patients 
and their doctors keep in touch in more efficient ways.
    Every week, doctors at Virginia Mason exchange more than 
15,000 secure emails with their patients. That means patients 
can get more of their questions answered without making an 
appointment or being put on hold. It means they are more 
empowered to work with their doctors to find the treatment that 
is best for them.
    Without question, there is a lot more we need to do to 
build on this progress. Many physicians across the country are 
facing a Medicare payment reduction this year because they are 
struggling to meet requirements for the use of electronic 
health records.
    I'm very interested in speaking with our witnesses today 
about the major gaps that still exist when it comes to 
interoperability, because this problem is preventing doctors 
from sharing information in a secure, efficient way. As we find 
ways to help doctors share information across systems developed 
by different vendors, we also need to continue helping patients 
stay informed about and involved in their own care.
    During our last hearing on health IT, Dr. Angela Kennedy of 
Louisiana Tech University shared a story that really showed how 
big a difference electronic health records can make for 
patients. She explained that when she takes her adopted 
daughter Grace to the doctor, she is always quick to note that 
she does not know her daughter's biological family medical 
history.
    Last year, the importance of having these kinds of records 
became very clear when, after Grace failed to respond to 
allergy treatment, genetic testing revealed that she had a rare 
form of cystic fibrosis. Without access to accurate, thorough 
medical records or the ability to correct errors in medical 
records, Grace's illness, one that is usually identified right 
after birth, was not diagnosed until she was 11 years old.
    As Dr. Kennedy's story makes clear, strengthening our 
health IT system is absolutely critical to making sure patients 
get the care they need. There are a few steps I will be 
especially interested in looking at as we continue this effort.
    I know the Meaningful Use provision has caused a lot of 
frustration among physicians. We need to do more to both set 
high standards and ensure providers have the support and 
flexibility they need to reach them.
    We should make sure that systems developed by different 
vendors and used by different doctors are able to speak to each 
other. That way, families like Dr. Kennedy's will not have to 
spend countless hours tracking down and comparing documents 
from different sources. Providers will have quick, easy access 
to information about patients' unique medical needs.
    We also need to continue supporting the development of a 
network of networks so providers have many options for 
trustworthy information sharing, and they don't have to 
reinvent the wheel every time they need to exchange information 
with a new facility. Similarly, we should look for ways to make 
it easier for providers to shop for electronic records systems 
and vote with their feet when one isn't working.
    And, finally, as electronic health records become more 
integral to our healthcare system, we need to look at ways to 
ensure security that stands up to our 21st century challenges.
    These and other steps would go a long way toward improving 
our health IT infrastructure and making our health care system 
work better for the patients and families we serve.
    As I said before, I've been truly pleased by the great 
ideas and interest that we have seen so far in this, and I want 
to thank all of our committee members who are so willing to 
work with us on this and for the hard work that everyone has 
already put in.
    I look forward to our efforts on this, Mr. Chairman, and 
I'm hopeful that we can reach some bipartisan agreements on 
this really critical topic.
    The Chairman. Thank you, Senator Murray.
    I'm pleased to welcome our witnesses, and I'll ask Senator 
Murray and Senator Burr to introduce the first two.

                       Statement of Senator Burr

    Senator Burr. Thank you, Mr. Chairman. I thank you and the 
Ranking Member for holding this hearing, and I want to welcome 
Craig Richardville from Carolinas HealthCare System in 
Charlotte, NC.
    Craig, thank you for being here and sharing your expertise 
with us today.
    Mr. Richardville is the vice president and chief 
information officer overseeing all of the systems for 
information services and strategies for the Carolinas 
HealthCare System, a network of more than 900 healthcare 
locations. Mr. Richardville also lends his expertise to a 
number of organizations focused on health IT, including serving 
as a Fellow with the Healthcare Information Management System 
Society and the American College of Healthcare Executives, as 
well as chairman of the Premier Healthcare Alliance Member 
Technology Improvement Committee.
    Prior to joining Carolinas Healthcare System in 1997, Mr. 
Richardville spent 12 years with Promedica Health Systems.
    I want to thank Craig for being here and lending his 
expertise to this very, very important hearing.
    Senator Murray. Mr. Chairman, thank you. I'm really pleased 
to have a witness today who has come all the way across the 
country from Washington State. Dr. Thomas Payne is the medical 
director of IT Services for UW Medicine at the University of 
Washington. He's an Associate Professor of Medicine, an Adjunct 
Associate Professor in Health Services, Biomedical Information, 
and Medical Education at the University.
    He's also an attending physician in general internal 
medicine at the University of Washington Medical Center and 
Harborview Medical Center. Prior to his current position, he 
led the installation of the Veterans Administration CPRS 
electronic medical record at VA Puget Sound in Seattle, and 
he's also the author of over 60 articles in this field, 
including the recent EHR 2020 Task Force report which he wrote 
as board chair-elect of the American Medical Information 
Association.
    Dr. Payne, thank you so much for all you've done. We really 
look forward to the information you have to share with us 
today.
    The Chairman. Thank you, Senator Murray.
    Our third witness will be Ms. Christine Bechtel from Olney, 
MD. She's a long-time consumer advocate and the president of 
Bechtel Health, a mission-driven organization focused on 
accelerating innovation in patient and family engagement and 
patient-centered care. She serves as chair of the Consumer 
Workgroup of the Health IT Policy Committee, a Federal advisory 
committee.
    Our final witness is Mr. Neal Patterson from Kansas City, 
MO. Senator Roberts was here to introduce him to me, so I'll 
introduce him to the other Senators. Mr. Patterson is Chairman 
of the Board and CEO of the Cerner Corporation, a company he 
co-founded in 1979. He has led Cerner to invest more than $4 
billion in the research and development of health information 
technology. Today, Cerner's systems are in use at more than 
18,000 healthcare facilities in over 30 countries.
    Dr. Payne, why don't we begin with you and go down the 
line. If each of you could summarize your remarks in 5 minutes, 
we have lots of Senators who would like to ask you questions.
    Dr. Payne.

 STATEMENT OF THOMAS H. PAYNE, M.D., FACP, FACMI, BOARD CHAIR-
   ELECT, AMERICAN MEDICAL INFORMATICS ASSOCIATION, MEDICAL 
 DIRECTOR, IT SERVICES, UW MEDICINE, UNIVERSITY OF WASHINGTON 
                SCHOOL OF MEDICINE, SEATTLE, WA

    Dr. Payne. Good morning, Chairman Alexander, Ranking Member 
Murray, and distinguished members of the committee.
    My name is Dr. Thomas Payne. I am the medical director of 
IT Services at UW Medicine and the University of Washington 
School of Medicine, and I am chair-elect of the AMIA board of 
directors. The American Medical Informatics Association 
represents more than 5,000 doctors, nurses, clinicians, 
researchers, and other informatics professionals who develop, 
implement, and study ways to manage information for patients, 
professionals in their clinical practice, public health, and in 
clinical research.
    It is an honor to appear before you this morning alongside 
this distinguished panel. My comments will focus on positive, 
near-term action items policymakers can take to capitalize on 
the increased adoption of electronic health records and utilize 
an expanding trove of health data to improve the quality and 
the value of healthcare for Americans.
    Recommendations, which I will describe in my comments, are 
derived from a recent report published by a multidisciplinary 
task force chartered by the AMIA board of directors. The EHR 
2020 Task Force was established to develop recommendations on 
how we, as a Nation, can resolve challenges related to EHRs, 
challenges this committee has examined and will continue to 
examine through a host of recent hearings. This report was 
developed over the course of 12 months by a very diverse group 
of informatics professionals representing a broad range of 
perspectives.
    Broadly, the report's 10 recommendations fall into four 
categories, which I will briefly summarize as a need to, first, 
improve documentation requirements and functionality to empower 
patients so that all members of the care team can contribute 
their perspectives and information; second, refocus regulations 
so that patients and their caregivers can derive the most 
benefit from a networked healthcare ecosystem; third, increase 
transparency to improve usability and safety of EHRs; and, 
fourth, foster innovation so that we can build toward the next 
generation of EHRs and realize the benefits of the learning 
healthcare system.
    Congress can and should play a vital role toward 
encouraging better EHR usability, improved interoperability, 
and more meaningful patient engagement. For example, relatively 
simple steps could be taken to improve documentation 
requirements, such as encouraging regulatory guidance that 
clearly delineates who is and who is not eligible to enter data 
into the record for compliance and reimbursement purposes.
    A more impactful and coordinated undertaking would be to 
include the refinement and adoption of standards meant to 
integrate clinical data from patients, medical devices, and 
other sources into the EHR. Longer term, Congress should 
develop policies that require CMS to revisit the entire billing 
and coding system that drives documentation for reimbursement 
and compliance purposes.
    Congress should also continue to promote broad adoption of 
alternative payment models, such as value-based purchasing, so 
that reimbursement is contingent on outcome-oriented measures, 
supported by less prescriptive and more flexible requirements 
for documentation.
    Documentation and the burdens associated with it are only 
one piece of a larger, more complex puzzle. The EHR 2020 Task 
Force also recommended that policymakers refocus the varied set 
of regulations and policies shaping the development of the 
health IT market and its use within healthcare.
    The simple message resonating among the Tasks Force's 
recommendations: slow down regulation to accelerate progress. 
Ensuring CMS does not rush to get to the next stage of 
Meaningful Use, but rather works to help the private sector 
accelerate optimization of the tools and regulations that are 
already in place; reorienting ONC's certification program to 
test true interoperability by testing how systems both send and 
receive information are among the key steps HHS should take in 
the near term. Should the regulatory pressure continue, 
stakeholders may look to Congress to intervene.
    While these steps will help the private sector make 
advancements toward more interoperable, safer health IT 
systems, Congress would engender genuine and lasting impact by 
enabling all patients to have their medical record, not just a 
summary of their record, available in standardized, machine-
readable formats. It is unconscionable that in 2015, with the 
widespread adoption of electronic health records, a patient 
must still print and scan their medical record when they change 
to a new physician.
    The future of healthcare will be characterized by an 
electronic, transportable record of care that provides 
customized views depending on what the care team needs to 
deliver and according to patient preference. The record will 
have the ability to incorporate data from different sources, 
including patient-generated data, population data, and 
community context, into an EHR.
    Should this committee take up legislation during this or 
the next Congress, you should focus on the areas described in 
the EHR 2020 Task Force report. If so, I am confident that we 
can turn the page from frustrations of today's technology to 
realize the promise of a truly integrated, modern healthcare 
experience for all patients and their care providers.
    A more detailed explanation of the recommendations and a 
copy of the EHR 2020 Task Force report will be submitted as 
part of the written record.
    Thank you.
    [The prepared statement of Dr. Payne follows:]
        Prepared Statement of Thomas H. Payne, M.D., FACP, FACMI
                                summary
    Recommendations, which I will describe in my oral and written 
comments, are derived from a recent report published by a 
multidisciplinary Task Force chartered by the AMIA board of directors. 
The EHR 2020 Task Force was established to develop recommendations on 
how we, as a Nation, can resolve challenges related to EHRs--challenges 
this committee has examined through a host of recent hearings. This 
report was developed over the course of 12 months by a diverse group of 
informatics professionals representing a wide range of perspectives.
    Broadly, the report's 10 recommendations fall into four categories, 
which are briefly summarized as a need to:

    1. Improve documentation requirements and functionality to empower 
patients so that all members of the care team can contribute their 
perspectives and information;
    2. Refocus regulations so that patients and their caregivers can 
derive the most benefit from a networked healthcare ecosystem;
    3. Increase transparency to improve usability and safety of EHRs; 
and
    4. Foster innovation so that we can build toward the next 
generation of EHRs and realize the benefits of the ``learning health 
system.''

    The steps Congress should take to help encourage better EHR 
usability, improved interoperability and meaningful patient engagement 
should focus near-term activities on Reducing documentation burdens for 
clinicians by clarifying regulatory ambiguity and supporting adoption 
of standards meant to integrate clinical data from patients, medical 
devices and other external sources of data with the EHR. Second, 
Congress should unleash the potential for every patient to enrich the 
learning health system by requiring vendors to give patients an 
electronic copy of their entire record, not just a summary, and require 
that such information is available in machine-readable formats. Policy 
development in this area will leverage existing requirements of HIPAA 
and generate a host of positive externalities to facilitate health 
information exchange among patients and their caregivers while fueling 
an ecosystem of modern applications and research. Third, Congress 
should streamline the Federal health IT certification program so that 
the process is more flexible, more transparent, focuses on clinically 
relevant functionality, and tests for true interoperability.
    Finally, Congress should embrace the notion of slowing down 
regulation to accelerate progress on EHR usability, interoperability 
and innovation. Federal regulators should not rush to get to the next 
stage of meaningful use, but should instead work to help the private 
sector accelerate optimization of the tools and regulations that are 
already in place.
    The recommendations developed by AMIA's 2020 Task Force are 
inclusive of a diverse group of informatics professionals and we think 
they are sensible, feasible and will capitalize on the progress made 
to-date. In combination, these recommendations represent the most 
important work Congress can engage to help turn the page from our 
current State problems. Lawmakers have a vital role in determining the 
next evolution in EHRs, and AMIA stands ready to support Congress in 
this important work.
                                 ______
                                 
    Good afternoon, Chairman Alexander, Ranking Member Murray, and 
distinguished members of the committee. My name is Dr. Thomas Payne. I 
am medical director of IT Services at UW Medicine and the University of 
Washington School of Medicine, and I am chair-elect of the AMIA board 
of directors. The American Medical Informatics Association represents 
more than 5,000 doctors, nurses, clinicians, researchers and other 
informatics professionals, who develop, implement and study ways to 
manage information for patients, professionals in their clinical 
practice, public health and clinical research.
    It is an honor to appear before you today, alongside this 
distinguished panel. My comments will focus on positive, near-term 
action items policymakers can take to capitalize on the increased 
adoption of electronic health records, and utilize a burgeoning trove 
of health data to improve the quality and value of healthcare for 
Americans.
    Recommendations, which I will describe in my comments, are derived 
from a recent report published by a multidisciplinary Task Force 
chartered by the AMIA board of directors. The EHR 2020 Task Force was 
established to develop recommendations on how we, as a Nation, can 
resolve challenges related to EHRs--challenges this committee has 
examined through a host of recent hearings. This report was developed 
over the course of 12 months by a diverse group of informatics 
professionals representing a wide range of perspectives.
    Broadly, the report's 10 recommendations fall into four categories, 
which I will briefly summarize as a need to:

    1. Improve documentation requirements and functionality to empower 
patients so that all members of the care team can contribute their 
perspectives and information;
    2. Refocus regulations so that patients and their caregivers can 
derive the most benefit from a networked healthcare ecosystem;
    3. Increase transparency to improve usability and safety of EHRs; 
and
    4. Foster innovation so that we can build toward the next 
generation of EHRs and realize the benefits of the ``learning health 
system.''

    Congress can and should play a vital role toward encouraging better 
EHR usability, improved interoperability and more meaningful patient 
engagement. For example, relatively simple steps could be taken to 
improve documentation requirements, such as encouraging regulatory 
guidance that clearly delineates who is and who is not eligible to 
enter data into the record for compliance and reimbursement purposes. A 
more impactful and coordinated undertaking would include the refinement 
and adoption of standards meant to integrate clinical data from 
patients, medical devices and other external sources into the EHR. 
Longer term, Congress should develop policies that require CMS to 
revisit the entire billing and coding system that drives documentation 
for reimbursement and compliance purposes. Congress should also 
continue to promote broad adoption of alternative payment models, such 
as value-based purchasing, so that reimbursement is contingent on 
outcome-oriented measures, supported by less prescriptive and more 
flexible requirements for documentation.
    Documentation--and the burdens associated with it--are only one 
piece of a larger, more complex puzzle. The EHR 2020 Task Force also 
recommended that policymakers refocus the varied set of regulations and 
policies shaping the development of the health IT market and its use 
within healthcare. The simple message resonating among the Tasks 
Force's recommendations: slow down regulation to accelerate progress. 
Ensuring CMS does not rush to get to the next stage of meaningful use, 
but rather works to help the private sector accelerate optimization of 
the tools and regulations that are already in place; reorienting ONC's 
certification program to test true interoperability by testing how 
systems both send AND receive information are among the key steps HHS 
should take in the near-term. Should the regulatory pressure continue, 
stakeholders may look to Congress to intervene.
    While these steps will help the private sector make advancements 
toward more interoperable, safer health IT systems, Congress would 
engender genuine and lasting impact by enabling all patients to have 
their medical record, not just a summary of their record, available in 
standardized, machine-readable formats. It is unconscionable that in 
2015, with the widespread adoption of electronic health records, a 
patient must still print and scan their medical record when they change 
to a new physician. The future of healthcare will be characterized by 
an electronic, transportable record of care that provides customizable 
views and varied amounts of context depending on what the care team 
needs to deliver care, and according to patient preference. The record 
will have the ability to incorporate data from different sources, 
including patient generated data, population data and community context 
into an EHR. Once the complete medical record is available in an 
electronic form, patients can more fully participate in clinical 
research, precision medicine, and other activities in which they 
control who can use their data. The first step toward this future is to 
enable patients to have access to their entire record in a computable, 
electronic form, not just a summary of their record. The electronic 
standards are ready, and this is perhaps the single, most important 
work Congress can engage to help turn the page from our current State 
problems.
    Should this committee take up legislation during this or the next 
Congress, and should you focus on the areas described in the AMIA EHR 
2020 Task Force report, I am confident that we can turn the page from 
the frustrations of today's technology to realize the promise of a 
truly integrated, modern healthcare experience for all patients and 
their care providers.
    A more detailed explanation of recommendations and a copy of the 
EHR 2020 Task Force report will be submitted as part of the written 
record.
    Thank you.
                                 ______
                                 
    The remainder of my comments will detail the action items 
policymakers can take to improve the quality and efficiency of care 
delivery, optimize patient safety, and improve interoperability of 
health IT.
Recommendation 1: Improve documentation requirements and functionality 
        to empower patients so that all members of the care team can 
        contribute their perspectives and information.
    For the last two decades, documentation requirements for 
reimbursement and compliance purposes have increased dramatically in 
healthcare. Rather than diminish the burdens associated with 
documentation, as information technology has done for countless other 
industries, EHRs have magnified the amount of time physicians and 
nurses spend away from the bedside, increasing their workload and 
contributing to worsened professional satisfaction. Because EHRs are 
expected to serve the dual purpose of capturing data for clinical and 
billing purposes, as well as envisioned to fulfill a myriad of quality 
reporting requirements, EHRs do not inherently promote sensible 
workflows. Quite the contrary, in many cases EHRs dictate workflows to 
users in order to generate reports and satisfy documentation 
requirements, creating a classic ``tail wagging the dog'' situation.
    The EHR 2020 Task Force concluded that much of the information 
relevant to the diagnosis and treatment of a patient could more 
effectively be entered by other members of the care team, captured 
automatically by devices or other information systems or captured and 
entered by patients themselves. Further, the Task Force noted that 
moving away from the current evaluation and management (E/M) billing 
structure would free EHR developers to support more novel methods to 
collect important data. In order to help the care team get back to the 
bedside, Congress should:

     Encourage regulatory guidance clearly delineating who is 
and who is not eligible to enter data into the record for compliance 
and reimbursement purposes;
     Adopt standards meant to integrate clinical data from 
patients, medical devices and other external sources with the EHR;
     Encourage and support Federal agencies, such as AHRQ, NIH, 
NLM, NSF and NIST to study alternative approaches to documentation 
using different media and data sources to identify more efficient 
documentation;
     Finally, Congress should support and encourage further 
adoption of alternative payment models, such as value-based purchasing, 
so that reimbursement is contingent on outcome-oriented measures, 
supported by less prescriptive and more flexible requirements for 
documentation. This will focus attention on documenting outcomes and 
clinically relevant information (rather than processes and procedures), 
and will speed the adoption of better ways of capturing and documenting 
clinical care.
Recommendation 2: Refocus regulations so that patients and their 
        caregivers can derive the most benefit from a networked 
        healthcare ecosystem.
    Over the last 5 years, the Federal Government has been much more 
proactive in shaping the market for health IT and informatics. The 
Federal Government's centerpiece legislation, the HITECH Act, has 
driven significant efforts by public and private stakeholders, 
resulting in undeniable gains for the public good. The CMS EHR 
Incentive Program has enabled a remarkable rise in the adoption of EHRs 
and ONC's certification program has provided a long-overdue framework 
to identify, harmonize and drive the adoption of health IT standards 
across the fractured healthcare landscape. The impact of HITECH is 
undeniable, but so too are the burdens associated with compliance--and 
not just to meaningful use, but a host of other programs dependent on 
the use of IT and informatics tools. The growth in adoption and use of 
health IT has not been without its challenges.
    Following completion of meaningful use Stage 1 and adoption of the 
2011 Edition of Certified EHR Technology, many developers struggled to 
produce upgraded versions--2014 Edition CEHRT--and many providers 
struggled to meet Stage 2--more rigorous--requirements for meaningful 
use. Seeing these challenges, policymakers turned to a flurry of 
regulatory responses with exceptions, flexibility, and extended 
attestation periods. The challenges faced by healthcare stakeholders 
has also led to proposed legislation to increase flexibility in the 
program. These changes suggest that the EHR incentive programs should 
take a different approach to leverage the gains already made and 
prevent further erosion of the program. Further, the Federal Government 
needs to refocus the wider set of health IT and informatics policies 
across agencies and programs.
    The EHR 2020 Task Force recommended Federal health IT regulations 
focus on (1) clarifying and simplifying MU regulations for providers 
and vendors; (2) improving data exchange and interoperability; and (3) 
Reducing duplicative quality measurement while prioritizing patient 
outcomes over new functional measures.
     clarify and simplify mu regulations for providers and vendors
    In order to provide vendors with clarity on how to meet the MU 
certification criteria, ONC provides precise instructions for each MU 
functional objective. The advantage of this approach is that vendors 
know with certainty how to qualify for MU certification. An unintended 
consequence is that vendors believe their customers must follow the 
workflow they programmed into the certified function and built into the 
automated calculation of the MU threshold determination. This 
predetermined workflow built into EHR products significantly affects 
usability of the products, often in a negative way. The goal of 
certification should be to assure that standards are consistently used 
in vendor products, in how systems interact with each other, and how 
quality is measured. Properly used, standards can lead to more 
flexibility as best of breed and modular products allow customization. 
The certification program, however, has led to preprogrammed workflows 
that are intended only to meet the conditions of certification, and not 
the needs of health care providers. Near-term action items for Congress 
include:

     Ensuring CMS does not rush to get to the next stage of MU, 
but rather works to help the private sector accelerate optimization of 
the tools and regulations that are already in place;
     Create flexibility in the certification program by 
encouraging vendors to develop testing methods that focus on 
demonstrating a functional capability instead of adherence to a 
predetermined, prescriptive test procedures.
               improve data exchange and interoperability
    New certification requirements should focus on technical 
requirements that will improve interoperability and data exchange, 
support better quality measures, and provide for safer and more secure 
care. To do this Congress should:

     Engage with HHS to ensure that ONC's certification program 
tests not just conformance to the standards, but true interoperability. 
This means testing both how systems send information and making sure 
that they are flexible in how they receive information.
     Require that health IT vendors provide all patients with 
their entire medical record in a standards-based computable format.
      reducing duplicative quality measurement while prioritizing 
                            patient outcomes
    Quality measurement and reporting has become the primary focus of 
many FTEs within any given healthcare system due to a proliferation of 
quality reporting programs, such as the Physician Quality Reporting 
System (PQRS) Program, Inpatient Quality Reporting (IQR) Program, 
meaningful use quality reporting requirements and a host of quality 
reporting regimes applied by State-level health officials or 
private-sector insurers and accreditation bodies. Many, if not most of 
these quality reporting requirements befall providers simultaneously 
and call for slightly different specifications of quality measures, 
rendering multiple uses of the same measures impossible. As Federal 
legislators look to quality measures as the basis for future 
reimbursement models and consumer comparison efforts, Federal 
regulators are looking to require submission of electronic clinical 
quality measures, which are incomplete and inaccurate without the 
addition of manual abstraction with current EHR systems.
    The EHR 2020 Task Force recommended that quality measurement should 
focus on outcomes that are consistent with national priorities while 
also being relevant to patients, their communities and clinicians' 
specialties. And, again, working with payers and other stakeholders to 
develop payment alternatives that depend less on documentation and more 
on quality and value is likely to promote EHR innovation and uses that 
support these goals. In order to reduce duplicative quality measurement 
and prioritize patient outcomes over functional measures, Congress 
should:

     Develop a special committee dedicated to harmonizing 
quality measurement across Federal, State and private sector 
stakeholders.
     Encourage development of accurate, complete and reusable 
electronically specified electronic CQMs, by building quality measures 
from a consistent set of data ``building blocks''.
     Study the value of complex versus simple quality measures, 
and use the results of those studies to simplify data collection and 
quality measure calculations. Complex quality measures will lead to 
complex data collection requirements, and simple, high quality measures 
may achieve the same goal at a lower cost.
Recommendation 3: Increase transparency to improve usability and safety 
        of EHRs.
    Currently, purchasers of EHRs often do not have visibility into how 
applications work. This lack of transparency inhibits an effective, 
competitive marketplace. Those choosing EHRs need clear knowledge of 
what commercial EHR systems offer and, importantly, what workflows are 
incorporated into their use for frequent tasks such as creating notes, 
entering data, reconciling medications, responding to decision support, 
and extracting data for reports or research--so they can make more 
informed choices.
    However, transparency in how EHRs perform during certification 
conformance testing is only one aspect of transparency. Users of health 
IT also need transparency in how systems perform after they're deployed 
in a live environment. Moreover, patients and their care providers 
should have a clear understanding of the safety performance of health 
IT and informatics tools. In order to improve usability and safety and 
to foster innovation, health care organizations, providers and vendors 
should be fully transparent about unintended consequences and new 
safety risks introduced by health information technology systems, 
including EHRs, as well as best practices for mitigating these risks. 
In order to create the most transparent market for health IT, Congress 
should:

     Encourage ONC to modify its certification program to 
streamline the certification process--as outlined previously in my 
comments--and better convey the process by which developers program 
common functionality and frequent tasks;
     Make all the results of testing and how each vendor 
satisfies the certification requirements open to the public for review. 
This should include not just summaries, but videos, screen shots and 
details of the workflow used to satisfy the certification requirements;
     Move forward with recent Food and Drug Administration 
Safety and Innovation Act (FDASIA) report recommendations to develop a 
public-private Health IT Safety Center that would promote health IT as 
an integral part of patient safety with the ultimate goal of assisting 
in the creation of a sustainable, integrated health IT learning system; 
and
     Encourage a more inclusive ``culture of safety,'' by 
affording similar safe harbors to vendors that are afforded to 
providers that participate with Patient Safety Organizations (PSOs).
Recommendation 4: Foster innovation so that we can build toward the 
        next generation of EHRs and realize the benefits of the 
        ``learning health system.''
    Given the complexity of our healthcare system, the incomplete State 
of several national efforts to modernize care, harness health data and 
empower patients, a clinician could be forgiven for being overwhelmed. 
But the future is bright and the possibilities are great. As a Nation, 
we are closer than any other point in history where every patient 
encounter could present an opportunity for patients and clinicians 
alike to contribute to our understanding of health care and participate 
in research and clinical trials. This is the essence of the learning 
health system.
    In addition to enabling the incorporation of research knowledge 
into practice to support evidence-based medicine, EHRs can enable 
evidence generating medicine thereby creating a virtuous cycle of rapid 
evidence generation and evidence-based care delivery, an essential 
element needed to create a learning health system and to advance 
precision medicine.
    Although we don't know what the next generation EHR will look like, 
we know that it will likely be very different than the systems that we 
have now. If we want to have the same successes that we've seen in the 
internet, we need a stable base of standard building blocks that allows 
us to create new technology to benefit patients. Unfortunately, there 
is a disconnect between the promise of what we can do and the real-
world infrastructure required to actually make it operational and 
scalable.
    In order to foster innovation so that we can build toward the next 
generation of EHRs and realize the benefits of the learning health 
system, Congress should:

     Support the adoption of standards for connecting different 
systems together, such as Application Program Interfaces (APIs),
     Require standards that allow patients to have a copy of 
their entire medical record, not just a summary as previously 
described;
     Fund research on how to best capture data, integrate data 
and design new user interfaces utilizing the best computer and human-
computer interaction science available; and
     Support innovation in precision medicine by making it 
easier to get information out of the electronic health records and into 
the hands of patients who wish to participate in precision medicine.

    We know that the IT sector has in many other domains driving 
significant economic development and job growth. We believe the same is 
possible in Health IT, but we must create the innovation ecosystem that 
will allow everyone, not just the largest companies thrive in the 
expanding marketplace.
    Together, we are confident these recommendations will improve the 
landscape for better, more usable EHRs that will lead to greater 
interoperability, more engaged patients and improved clinical outcomes. 
Congress can take tangible steps toward the improved future of health 
IT by reducing documentation burden, requiring vendors to give patients 
an electronic copy of their entire record, and by streamlining 
certification so the process is more flexible and transparent. These 
actions will enable advances in population health, precision medicine 
and capitalize on the progress made to-date.
    Lawmakers have a vital role in determining the next evolution in 
EHRs, and AMIA stands ready to support Congress in this important work.

    The Chairman. Thank you, Dr. Payne.
    Mr. Richardville.

  STATEMENT OF CRAIG D. RICHARDVILLE, MBA, FACHE, SENIOR VICE 
 PRESIDENT AND CHIEF INFORMATION OFFICER, CAROLINAS HEALTHCARE 
 SYSTEM, CHAIR, PREMIER HEALTHCARE ALLIANCE MEMBER TECHNOLOGY 
              IMPROVEMENT COMMITTEE, CHARLOTTE, NC

    Mr. Richardville. Thank you, Chairman Alexander, Ranking 
Member Murray, and the members of this committee, for your 
leadership in holding this hearing today, and to you, Senator 
Burr, for your gracious introduction.
    I appreciate the opportunity to testify today on behalf of 
Carolinas HealthCare System and the Premier Healthcare 
Alliance, where I serve as chair of Premier's Member Technology 
Improvement Committee.
    Carolinas HealthCare System is one of the largest health 
systems in the country. We have a diverse network that includes 
more than 900 care locations, 3,000 physicians and ACPs, 39 
hospitals, behavioral health centers, home healthcare, nursing 
homes, hospice, and palliative care. In 2014, we touched the 
lives of 11 million patients living throughout North Carolina, 
South Carolina, and northeast Georgia.
    Premier is a leading healthcare improvement company, 
uniting an alliance of approximately 3,400 hospitals and 
110,000 other providers to transform healthcare.
    Improving health information exchange and achieving true 
interoperability is one of the key challenges of our time, 
especially given the drive from volume-based care to value-
based care, to increase the quality, efficiency, safety, and 
well-being of our citizens. As this committee has heard earlier 
this year, the current HIT ecosystem continues to be 
challenging for healthcare providers due to the lack of 
interoperability among various HIT systems.
    Efficient, easy to use, and the integration of health 
information is foundational to advancing and providing 
excellent care in this country. The cost to build, test, and 
maintain those integrations and interfaces is significant. At 
Carolinas HealthCare System, we have had success in these 
integrations. To date, we've integrated more than 125 different 
systems into our EMR.
    More than the impact on providers and hospitals is the 
impact on the patients that we serve. In order to truly engage 
our patients in the management of their care and to give them 
the tools that they need to manage and understand their health 
status, we must provide them with this clinical information.
    Take, for example, a patient who has diabetes and other 
chronic conditions. This patient may be receiving care from 
multiple providers who are documenting their care in multiple 
systems. In order that the care be coordinated, up-to-date, and 
based on reliable current information, providers need to have 
the information readily available.
    The lack of easy exchange of this data amongst all 
providers and patients is the challenge. The goal should be to 
design and implement a secure HIT ecosystem that enables an 
easy exchange of health information.
    To accomplish this, we ask for a combination of 
congressional leadership and administrative actions that 
promote policy principles that further open health IT 
infrastructures. These include:

    Governance: Private-public partnership on HIT 
interoperability governance should be established to provide 
clear rules of the road.
    Functional standards: The governance mechanism should focus 
on the development of functional data and transport standards 
in key areas including patient identifiers, terminologies, 
clinical data query language, security, open APIs, and clinical 
decision support algorithms as well as business practices and 
policies.
    Measures: Transparent and public measures of 
interoperability should be developed in collaboration with the 
Federal Government.
    Transparency: Secure data should flow freely and easily.
    Compliance enforcement: The Federal Government should be 
enabled to enhance its enforcement tools to ensure functional 
data and transport standards and measures are compliant in 
vendor partners through its certified technology programs.

    The impact of having true interoperability achieved through 
the functional standards, metrics, and innovative technologies, 
such as open and secure APIs, would be transformative in terms 
of care, efficiency, safety, and patient engagement.
    Let's go back to our patient with diabetes. With a more 
robust and open system, the patient could securely send to his 
or her provider daily glucose readings from a mobile device. 
Those readings would be easily posted and translated to a care 
management system where a coordinator is monitoring for 
fluctuations.
    During the visit, either in person or a virtual visit, the 
physician sees all the data from the patient and the various 
clinical systems. This allows the provider to understand not 
only today's clinical data, but also the information that the 
patient voluntarily shares from outside the office.
    Thank you again on behalf of the providers at Carolinas 
HealthCare System and Premier Healthcare Alliance members and 
the patients that we serve for this considerable transformative 
work that you are doing for the benefit of the communities that 
we serve.
    [The prepared statement of Mr. Richardville follows:]
        Prepared Statement of Craig D. Richardville, MBA, FACHE
                                summary
    Chairman Alexander, Ranking Member Murray and members of the Senate 
Health, Education, Labor, and Pensions (HELP) Committee, I appreciate 
the opportunity to testify today on behalf of Carolinas HealthCare 
System and the Premier healthcare alliance, where I serve as the chair 
of Premier's Member Technology Improvement Committee (MTIC), which 
consists of member CIOs that advise Premier's leadership and the Board 
on health information technology (HIT) matters.
  hit interoperability is foundational to improving quality and value 
                       of healthcare to patients
    As this committee heard earlier this year, the current market 
incentives are not aligned with open exchange of necessary healthcare 
data in cost-effective ways. The sharing of data that sits in software 
systems across the care continuum is not only technically complex, it 
also is expensive. Data resides in many systems, not just electronic 
medical records. Registration, billing, lab, pathology systems, medical 
devices, sensors and monitors, to name just a few, all have vital data 
that can and should be integrated and accessible across the care 
spectrum, no matter what the underlying software system is.
    More than the impact on providers and hospitals is the impact on 
the patients we serve. In order to truly engage our patients in the 
management of their care and to give them the tools they need to manage 
and understand their health status, we must provide them with this 
clinical information.
                 pathway to achieving interoperability
    The goal should be to design and implement a secure HIT ecosystem 
that enables an easy exchange of health information in timely and cost-
effective ways. To accomplish these goals, we ask for a combination of 
congressional leadership and administrative actions that promote policy 
principles that further open health IT infrastructures. In creating 
these structures, we need clear rules of the road for providers and 
vendors alike through establishment of functional data and transport 
standards and methods to measure and test functionalities, with 
enhanced enforcement tools for regulatory bodies to drive compliance in 
the marketplace.

     Governance: Private-public partnership on HIT 
interoperability governance should be established to provide clear 
rules of the road on interoperability. This should be done in 
consultation and coordination with Federal agencies, such as HHS and 
ONC, and the private sector. Providers, vendors, patients and payers 
should be consulted. The government entities should provide regular 
reports to Congress and the Administration on current standards 
development status as well as ready to market timelines and assessments 
for their applications.
     Functional data and transport standards that promote 
interoperability and innovation: The governance mechanisms should focus 
on the development of functional data and transport standards in key 
areas including: patient matching, terminologies, clinical data query 
language, security, open application program interfaces (APIs), and 
clinical decision support algorithms as well as business practices and 
policies.
     Public interoperability and cost efficiency measures: 
Transparent and public measures of interoperability should be developed 
in collaboration with the Federal Government, including HHS and ONC, 
and standard-setting bodies in consultation with the private sector and 
be required as part of ONC's certified technology program.

          These measures should be validated and tested in 
        terms of functional standards, processes, and their maturity 
        for application in the marketplace in a timely way, and within 
        specific use case scenarios.
          Measures should include business and implementation 
        approaches that deliver functional interoperability outcomes 
        and include operational processes and implementation practices.
          Measures should also include assessment of cost 
        efficiency metrics achieved through incorporating innovative 
        technologies, such as existing API, which is an open source 
        code that enables third party applications to exchange data.

     Transparency: Data should flow freely and easily. 
Determinants of transparency should include:

          Availability of ``free'' (no cost) export of 
        publishable EHR domains.
          Prohibition of specific fees for access to necessary 
        data through API or other functional standard callable methods.
          Publication of technical instructions on how to 
        interact with APIs, interface standards or other callable 
        methods. These should be published either publicly or broadly 
        to any authorized third party.
          Technology and devices that generate health 
        information be required to publish clinical data to any other 
        authorized consuming applications, including EHR/EMRs, to 
        create interoperability. Consuming applications' ability to 
        develop methods to ingest information from other HIT assets, 
        including devices, should adhere to current and future medical 
        device interoperability standards.

     Enforcement of functional data and transport standards and 
measures of HIT interoperability: The Federal Government should be 
enabled to enhance its enforcement tools to ensure functional data and 
transport standards and measures compliance of vendors through its 
certified technology program.
                                 ______
                                 
    Chairman Alexander, Ranking Member Murray and members of the Senate 
Health, Education, Labor, and Pensions (HELP) Committee, I appreciate 
the opportunity to testify today on behalf of Carolinas HealthCare 
System and the Premier healthcare alliance, where I serve as the chair 
of Premier's Member Technology Improvement Committee (MTIC), which 
consists of member CIOs that advise Premier's leadership and the Board 
on health information technology (HIT) matters.
    To start, I applaud the leadership of Chairman Alexander and 
Ranking Member Murray for holding this important hearing today. This is 
a vital topic, important to the well-being of our citizens and our 
Nation.
    Carolinas HealthCare System is one of the largest health systems in 
the country. We have a diverse network that includes more than 900 care 
locations, 3,000 physicians and advanced clinical practitioners, 39 
hospitals, behavioral health centers, home health care, nursing homes, 
hospice and palliative care. For 11 consecutive years, we have been 
named one of America's Most Wired Hospitals by Modern Healthcare. We 
are the only health system in North or South Carolina to have received 
HIMSS Analytics Stage 7, the highest level, for adoptions of electronic 
medical record (EMR) technologies in both outpatient and inpatient 
settings. We also are a member of Healtheway, a founding member of 
Carequality and being certified for the national eHealth Exchange. Just 
last month, Carolinas was named by Forbes magazine as one of the 
Nation's best employers.
    Our mission is clear--to create and operate a comprehensive system 
to provide healthcare and related services, including education and 
research opportunities, for the benefit of the people we serve. In 
2014, we had more than 11 million patient encounters, touching the 
lives of those that live throughout North and South Carolina and 
northeast Georgia. Each day, our 60,000 teammates dedicate themselves 
to providing the best medical care possible. Much of the care they 
deliver each day is extended, buttressed and enhanced by the advances 
in technology.
    Premier, Inc. is a leading healthcare improvement company, uniting 
an alliance of approximately 3,400 U.S. hospitals and 110,000 other 
providers to transform healthcare. With integrated data and analytics, 
collaboratives, supply chain solutions, advisory and other services, 
Premier enables better care and outcomes at a lower cost. Premier, a 
Malcolm Baldrige National Quality Award recipient, plays a critical 
role in the rapidly evolving healthcare industry, collaborating with 
members to co-develop long-term innovations that reinvent and improve 
the way care is delivered to patients nationwide.
  hit interoperability is foundational to improving quality and value 
                       of healthcare to patients
    Despite its potential, the current HIT ecosystem continues to be 
challenging for healthcare providers because of a lack of 
interoperability between systems. Cost-effective, efficient, and easy 
to use and integrate health information is foundational to advancing 
and providing excellent care in this country. Patients and care 
providers are missing opportunities to improve people's health and 
welfare when information about care or health status is not easily 
available. It is critical for us, all of us, to fully use and leverage 
the health data that is vital to improving patient care. Doing so will 
help us discover and develop better treatments while improving safety 
and quality in the delivery of that care.
    As this committee heard earlier this year, the current market 
incentives are not aligned with open exchange of necessary healthcare 
data in cost-effective ways. The sharing of data that sits in software 
systems across the care continuum is not only technically complex, it 
also is expensive. Data resides in many systems, not just electronic 
medical records. Registration, billing, lab, pathology systems, medical 
devices, sensors and monitors, to name just a few, all have vital data 
that can and should be integrated and accessible across the care 
spectrum, no matter what the underlying software system is. The 
difficulty in achieving this has an impact not only in care quality but 
also in cost.
    The cost to build interfaces and test and maintain those interfaces 
is not insignificant. At Carolinas HealthCare System, we have been 
successful with many of these integrations. In order to meet the needs 
of our patients across our geographies and throughout the care 
continuum, we have interfaced with more than 125 systems to get data 
into our EMRs. One critical factor to our success has been with our 
patient matching biometric program which uses palm vein scanning. 
Patients scan their palms, and we are able to match them to the data in 
many of our systems, ensuring that the right information about the 
right patient is available. Using this system, which 99 percent of our 
patients do voluntarily, results in less than .11 percent failure rate. 
That means 99.9 percent of our patients are correctly matched in our 
systems. The national average for this is 8 to 10 percent, while a best 
practice is 5 percent.
    Achieving this integration has not been easy or inexpensive. Today, 
in order to build the bridges that connect disparate data sets 
necessary to provide comprehensive and informed decisions or care, 
providers must either pay their original system vendors thousands and 
sometimes millions of dollars to custom code linkages so they can 
``talk'' to other systems, or they often find paper-based workarounds 
that are fraught with potential for both errors and wasted resources 
and expense.
    The costs of sharing this critical data among other health systems 
is not just in dollars. It creates an environment of inefficient use of 
some our most valuable resources, our people. Having care providers 
faxing or mailing information to other providers is not the best use of 
these highly skilled clinical people.
    More than the impact on providers and hospitals is the impact on 
the patients we serve. In order to truly engage our patients in the 
management of their care and to give them the tools they need to manage 
and understand their health status, we must provide them with this 
clinical information. Take for instance a patient who has diabetes and 
other chronic conditions. This patient may be receiving care from 
multiple physicians who are documenting their care in multiple systems. 
In order that the care be coordinated, up to date and based on reliable 
current information, those physicians need to have the information 
readily available when they are making clinical decisions. The lack of 
easy exchange of these data amongst all providers and the patient is 
the challenge.
                 pathway to achieving interoperability
    The goal should be to design and implement a secure HIT ecosystem 
that enables an easy exchange of health information in timely and cost-
effective ways. The system should promote collaboration among all 
stakeholders, from patients to providers to vendor partners and payers. 
We need a system of standards that focuses on improving healthcare 
quality, efficiency, safety, affordability and access through 
government and market incentives, while encouraging innovation and 
competition.
    At Carolinas, for instance, we care for more than 60,000 people 
with diabetes. Continuing to manage their care through today's methods 
is not optimal. The shift from volume-based care, where we are paid for 
the numbers of things we do or the number of patients we see, to value-
based care where we are compensated for the quality of the care, leads 
us to this new care delivery model. Population health programs like we 
are implementing at Carolinas will advance the delivery of this value-
based care where providers and patients are linked and partners in the 
care.
    To accomplish these goals, we ask for a combination of 
congressional leadership and Administrative actions that promote policy 
principles that further open health IT infrastructures. In creating 
those structures, we need clear rules of the road for providers and 
vendors alike through establishment of functional data and transport 
standards, and methods to measure and test functionalities, with 
enhanced enforcement tools for regulatory bodies to drive compliance in 
the marketplace. These include:

     Governance: Private-public partnership on HIT 
interoperability governance should be established to provide clear 
rules of the road on interoperability. This should be done in 
consultation and coordination with Federal agencies, such as HHS and 
ONC, and the private sector. Providers, vendors, patients and payers 
should be consulted. The government entities should provide regular 
reports to Congress and the Administration on current standards 
development status as well as ready-to-market timelines and assessments 
for their applications.
     Functional data and transport standards that promote 
interoperability and innovation: The governance mechanisms should focus 
on the development of functional data and transport standards in key 
areas including: patient matching, terminologies, clinical data query 
language, security, open application program interfaces (APIs), and 
clinical decision support algorithms as well as business practices and 
policies.
     Public interoperability and cost efficiency measures: 
Transparent and public measures of interoperability should be developed 
in collaboration with the Federal Government, including HHS and ONC, 
and standard-setting bodies in consultation with the private sector and 
be required as part of ONC's certified technology program.

          These measures should be validated and tested in 
        terms of functional standards, processes, and their maturity 
        for application in the marketplace in a timely way, and within 
        specific use case scenarios.
          Measures should include business and implementation 
        approaches that deliver functional interoperability outcomes 
        and include operational processes and implementation practices.
          Measures should also include assessment of cost 
        efficiency metrics achieved through incorporating innovative 
        technologies, such as existing API, which is an open source 
        code that enables third party applications to exchange data.

     Transparency: Data should flow freely and easily. 
Determinants of transparency should include:

          Availability of ``free'' (no cost) export of 
        publishable EHR domains.
          Prohibition of specific fees for access to necessary 
        data through API or other functional standard callable methods.
          Publication of technical instructions on how to 
        interact with APIs, interface standards or other callable 
        methods. These should be published either publicly or broadly 
        to any authorized third party.
          Technology and devices that generate health 
        information be required to publish clinical data to any other 
        authorized consuming applications, including EHR/EMRs, to 
        create interoperability. Consuming applications' ability to 
        develop methods to ingest information from other HIT assets, 
        including devices, should adhere to current and future medical 
        device interoperability standards.

     Enforcement of functional data and transport standards and 
measures of HIT: The Federal Government should be enabled to enhance 
its enforcement tools to ensure functional data and transport standards 
and measures compliance of vendors through its certified technology 
program.

    Let's go back to our patients with diabetes. With a more robust and 
open system, the patient could send to his or her care provider, their 
daily glucose readings from their mobile device. At Carolinas, they 
soon will do that through MyCarolinas Tracker, which integrates data 
from 60 consumer-based medical devices. Those readings would be easily 
posted and translated in a care management system, where a coordinator 
is monitoring for fluctuations. In the meantime, the coordinator is 
scheduling the patient for a check-up with the physician. Before the 
patient goes in for the visit, they log in to look at the latest lab 
and test results on them. During the visit, the physician sees all the 
data from the patient and all the data from the clinical systems in the 
EMR. The physician can also view when the patient had an ER visit at 
another hospital while on vacation. This allows the physician to 
understand not only today's clinical data, but also the life of the 
patient outside of the office visit.
    The technology is now available to realize the goals of what the 
Institute of Healthcare Improvement calls the Triple AIM--improve the 
health of the population served, improve the experience of each 
patient, and improve the affordability of the care.
    Thank you again for the opportunity to testify today. As this 
committee continues its work on improving HIT infrastructure and data 
exchange, we urge the Members to require HIT interoperability as 
foundational to facilitate research, storage and use of health data to 
advance patient care, quality and safety, while reducing costs. Thank 
you on behalf of the providers at Carolinas HealthCare System and 
Premier healthcare alliance and the patients we serve for this 
considerable transformative work you are doing for the benefit of the 
communities we serve.

    The Chairman. Thank you, Mr. Richardville.
    Ms. Bechtel.

    STATEMENT OF CHRISTINE BECHTEL, M.A., ADVISOR, NATIONAL 
  PARTNERSHIP FOR WOMEN AND FAMILIES, CHAIR, HEALTH IT POLICY 
COMMITTEE CONSUMER WORKGROUP, PRESIDENT, BECHTEL HEALTH, OLNEY, 
                               MD

    Ms. Bechtel. Good morning, Mr. Chairman, Ranking Member 
Murray, and distinguished committee members. I'm Christine 
Bechtel. I'm a consumer advocate, and I'm an advisor to the 
National Partnership for Women and Families. Thank you for 
having me here today.
    As you've just heard, the healthcare system is struggling 
to foster the kind of exchange that will drive better care and 
smarter spending. We're making progress, but many organizations 
still treat health data as a close-hold business asset when it 
should be treated as a public good.
    I'm here to talk about how consumers can be a force for 
change. The role of consumers in healthcare is changing 
rapidly, thanks to emerging information technologies, evolving 
economic incentives, and rising consumer expectations.
    If we harness these forces, consumers can play a major role 
in beginning to dramatically reshape the way we share 
information in healthcare today. Simply put, if I can gather my 
data electronically from all of my healthcare entities that 
hold it, use a safe and secure app to store it, then I could 
share it with any one of my healthcare providers for my care or 
for other purposes, like precision medical research.
    As the only one present at all of my healthcare encounters, 
I can potentially amass more data more quickly and more 
comprehensively than any single healthcare entity can today, 
because I know where it is, and I have a legal right to it.
    We're close to achieving this vision. Both the policies and 
the technologies exist, but we aren't there yet, and my 
personal experience demonstrates that we have work to do.
    Eight weeks ago, I tried to gather my health records from 
the patchwork of providers that hold it, and I started with my 
primary care practice. Because the practice participates in 
Meaningful Use, I should have been able to download my data 
directly from the patient portal. Unfortunately, the portal was 
broken, and the practice had no plan to fix it.
    Instead, I asked for an electronic copy of my record, which 
I now have a legal right to under HIPAA. The practice was 
unaware of my right, and they had no established process for 
complying. I had to drop off a copy of the Federal register to 
demonstrate my right, and then the staff had to work through 
how to meet my request.
    After a lot of back and forth, they put two files on this 
lovely CD-ROM, and I physically went to the office to pick it 
up. The process took about 2 weeks, and then once I looked at 
the CD's contents, I learned that the files alone aren't very 
useful. I researched and I downloaded an app, as anybody would, 
to display my medical record in a way that I could understand.
    This simple medical records request was a lot of work. Most 
consumers will not have the resources or the expertise to 
persist as I did. They should, because my experience produced 
results. My doctor's office is now changing their process so 
that all patients can have an electronic option when they want 
it.
    If consumers writ large can do what I did, if they can 
really ask for and demand their health information right now, 
then I believe that this can enable systematic change. To do 
that, there are several actions that we need to take in the 
next 12 months to make this process easy, private, and secure.
    Good news--none require legislation, but a little nudge 
from Congress would certainly help. There's more detail in my 
written testimony. In summary, we need to start by raising 
consumer awareness and provider awareness about our rights to 
our electronic health information and the use of patient 
portals for downloading health data. HHS has many mechanisms 
for doing this.
    We should also use the Federal EHR certification program to 
create the capacity for EHRs to receive consumer-generated data 
and make it easy for providers to analyze it and act on it.
    Next, we need to preserve the Meaningful Use patient access 
requirement, including the requirement that a small percentage 
of patients use their online access at least once. We can argue 
over the exact percentage, but the fact remains that CMS's 
proposal to drop this threshold to just a single patient will 
completely undermine efforts to make consumer access to 
healthcare data the norm.
    Finally, we do need advancements in consumer privacy. 
Consumers don't realize that once they download their data from 
a provider into an app, most often, HIPAA no longer protects 
them.
    We need to do three things in the short term. One is to 
encourage HHS to finalize best practice guidance for app 
developers on privacy and security. The Federal Trade 
Commission can enforce voluntary best practices for those who 
adopt them.
    Second, we need to incentivize more app developers to use 
ONC's model PHR notice for consumers. That's a Personal Health 
Record notice, and it enables quick and easy comparison of 
otherwise complex privacy policies.
    Finally, we should shorten the timeframe for meeting 
medical records requests under HIPAA to less than 30 days. When 
the data is digitally available, the law should not give us a 
basis for delay.
    The challenge before us is simple and straightforward, and 
success, I believe, is within reach. The steps I outlined will 
move us toward the day when consumers no longer have to use the 
sneaker net, where we walk our medical records around from 
doctor to doctor, and instead leverage the internet to drive 
quality, value, and patient-centered care.
    Thank you.
    [The prepared statement of Ms. Bechtel follows:]
             Prepared Statement of Christine Bechtel, M.A.
    Our health care system is struggling to foster the kind of exchange 
that will truly drive better care and spending. But consumers can be a 
force for change. Namely--if consumers could leverage their legal 
rights and gather data electronically from all of the health care 
entities that hold it, then use a safe and secure app to store it, it 
would enable us to share that data with health care providers and give 
them a much better view of health and care. Yet my own personal 
experience does not bear this out. My simple medical records request 
required multiple trips to the doctor, several aggravating phone calls, 
legal and technical knowledge, and persistence. Most consumers won't 
have the resources to persist and succeed. My case is not unique; it 
illustrates the challenges of our current system.
    There are a range of actions we can take over the next 24 months to 
achieve change. A little nudge from Congress can help:

     Better educate consumers about their legal rights and 
about the use of patient portals for downloading and using health data. 
HHS has many mechanisms for doing so, including the Office of Civil 
Rights (OCR).
     Develop and disseminate tools to help consumers understand 
how/where/what and what format to request, what to do with the data, 
where to securely store it, and how to navigate roadblocks along the 
way. Make the data request process frictionless for consumers.
     Work through HHS to educate providers about how to meet 
the demand for digital health information.
     Use the Federal EHR certification program to create the 
capacity for EHRs to incorporate consumer-generated data and make it 
easy for providers to analyze and act on.
     Finalize the proposal to include open Application 
Programming Interfaces (APIs) in the Federal EHR Certification program. 
APIs will help break down information silos in health care.
     Preserve the Meaningful Use view/download/transmit 
requirement: both the requirement that the technology is in place, and 
the requirement that a percentage of patients use it at least one time 
during the reporting period. Regardless of whether the number is 5 
percent or something else, CMS's recent proposal to drop this threshold 
to just a single patient will completely undermine efforts by consumers 
who want to have and use their data. Requiring providers to actively 
engage with a percentage of patients is an essential mechanism for 
changing consumer expectations and enabling consumers as a force for 
change.
     Privacy protection--consumers want and support greater 
online access, and consumers also care about privacy. We must encourage 
ONC, FTC and OCR to finalize best practice guidance on protecting 
privacy and security for app developers (most of whom are not covered 
by HIPAA). The FTC can enforce voluntary best practices for those who 
adopt them.
     Incentivize more app developers to use ONC's model PHR 
notice for consumers. It enables consumers to quickly and easily 
compare privacy policies across apps, including whether or not the 
developer sells consumer data for marketing or to employers and/or 
insurance companies.
     Shorten the timeframe for meeting records requests under 
HIPAA from 30 days. Patients should have the data as soon as doctors 
do, and where digital records make that possible, the law should not 
provide a basis for delay.
     Require providers to offer an ongoing data feed so 
patients don't have to submit requests again and again. There are 
technical standards that already enable this.
     Establish that it is willful neglect to deny a patient 
access (or even claim HIPAA precludes it), unless the provider in good 
faith is relying on one of HIPAA's exemptions.
                                 ______
                                 
    Good morning Mr. Chairman, Ranking Member Murray and distinguished 
committee members. I'm delighted to be with you today to talk about 
driving progress toward quality and value through health information 
exchange.
    The notion of ``health information exchange'' has been around for 
decades, and we have tried many approaches. Yet our health care system 
is struggling to foster the kind of exchange that will truly drive 
better care and smarter spending. Entrenched payment policies that do 
not reward better health outcomes or coordinated care continue to hold 
us back. We are making progress, but many health care organizations 
today still treat health data as a close-hold business asset, when it 
should be treated as a public good.
    I'm here to talk about how consumers can be a force for change.
    We know that consumers want health information technology (IT). 
According to a nationwide survey released by the National Partnership 
in December, patients overwhelmingly believe that electronic health 
records (EHRs) are essential to making sure providers have timely 
access to information that can help avoid medical errors and repeat 
tests.\1\ Consumers also want and use online access to their own health 
information, largely through patient portals. Almost 9 in 10 patients 
who have such access use it, and it has a significantly positive impact 
on patient engagement, better care and improved outcomes. Notably, 
individuals who use patient portals with some frequency are 
dramatically more likely to say it motivates them to improve their 
health.
---------------------------------------------------------------------------
    \1\ Engaging Patients and Families: How Consumers Value and Use 
Health IT. National Partnership for Women & Families, December 2014. 
www.nationalpartnership.org/patientsspeak.
---------------------------------------------------------------------------
    We also know that the role of consumers in health care is changing 
rapidly, facilitated in part by these emerging technologies, along with 
evolving economic incentives and rising consumer expectations.
    These forces are converging, positioning consumers as a potentially 
potent force for change that can dramatically reshape the way we share 
and use information in health care--if we can make the process of 
downloading, managing and sharing health information easy, private and 
secure.
    What does it take to unleash this consumer potential? Let's look at 
how our system works today. In my case, I have a primary care physician 
(PCP) who uses an EHR. I also have a high-deductible health plan, which 
means that I often seek out care from places that have published price 
lists and are convenient--like a web-based service that, earlier this 
year, allowed me to ``see'' a doctor online on a Sunday morning for 
just $49. As a result, health care data about me exists in several 
different places--with my doctors, my health insurer, MinuteClinic, my 
web-based doctor service, and more. This is not usual for most 
Americans--all of us have data spread across a patchwork of providers 
and systems.
    Few if any of these systems talk to each other, which means that no 
single provider can see a complete picture of my care. So how can I, 
and the millions of consumers like me, become a force for change that 
drives health information exchange in the marketplace?
    If I could gather my data electronically from all of the health 
care entities that hold it, and use a safe and secure app to store it, 
then I could share it with any one of my health care providers, giving 
them a much better view of my health and my care.
    The fact is, as the patient, I am the only one present at all of my 
health care encounters--so I can potentially amass more data, more 
quickly and more comprehensively than any single health care entity can 
today, because I know where it all is. And, in theory, I know how to 
get it. If I have the data, I can spot errors, avoid repeat tests, 
detect fraud, help facilitate coordinated care, and much more. I can be 
the curator of my own health record, sharing it where and when it is 
needed to improve my care, and for other important purposes like 
research into precision medicine.
    We are close to achieving this vision; both the policies and the 
technologies exist. But we aren't there yet. I learned this the hard 
way when I requested my data from my PCP 8 weeks ago. Because the 
practice participates in Meaningful Use, I should have been able to 
download my data directly from the patient portal. That is due to an 
important Federal requirement that stipulates patients must be offered 
online access to view, download or transmit their health information to 
a third party. Unfortunately, the patient portal was broken and the 
practice had no plan to fix it.
    I decided on another approach that few consumers--and it turns out, 
few providers--know about. Under the HIPAA amendments made by the 
HITECH law, I now have a legal right to an electronic copy of my health 
information. I can exercise this right with any covered entity that 
holds data about me, as long as they can produce the data 
electronically. And if they have a Meaningful Use-certified EHR, they 
can. So I asked my PCP's office for an electronic copy of my health 
record.
    After convincing them that I wasn't trying to change doctors and 
just wanted my record electronically, they told me they ``don't do 
that;'' they only offer paper copies. I told them about my legal right 
to an electronic copy since they have a certified EHR, and they again 
simply said they don't do that.
    I returned a few days later with a copy of the Federal Register, 
demonstrating my legal right under HIPAA to an electronic copy. Over 
the course the following week, and many phone calls back and forth, the 
practice staff figured out how to meet my request. They created a text 
file, and a second file in a format called CCR, which stands for 
Continuity of Care Record, and placed both files on a CD-ROM that they 
left at the front desk for me to pick up.
    I quickly learned that having my record on a CD--ROM wasn't very 
useful. I could read the text file (once I bought an external CD-ROM 
drive), but text files aren't very actionable. So I did what anyone 
would when faced with a problem--I downloaded an app. The app used the 
CCR file to summarize and display my medical record in an organized way 
that I can understand.
    This simple medical records request was a big hassle--it caused a 
lot of friction even though I was simply requesting information to 
which I am legally entitled--information that is an essential part of 
my health and care. It required multiple trips to the doctor, several 
aggravating phone calls, legal and technical knowledge, and 
persistence. Most consumers won't have the resources to persist and 
eventually succeed.
    My case is not unique, and it illustrates the many challenges of 
our current system:

     Many providers and their staff members don't know we have 
a right to an electronic version of our records.
     They don't have workflows to accommodate it--for example, 
their medical records request forms don't ask if the patient wants 
paper or an electronic copy.
     Consumers don't know about this right. And if we do, we 
don't know the best ways to ask for the data--that we should avoid PDFs 
in favor of structured data, and what our options are to get structured 
data. Many also don't know about their ability to download data via 
their portals.
     Most of us don't know what to do with the data once we get 
it. Which app should we use? What are that app's policies and practices 
on privacy and security? We also don't know that once we download data 
from my doctor, hospital or other covered entity, and upload it into an 
app like a Personal Health Record (PHR), that data is no longer covered 
by HIPAA unless the app developer is itself a covered entity. That 
means the developer could sell my identifiable health information.
     And finally, to drive heath information exchange, EHRs 
need to be capable of ingesting data from consumers, and making it 
actionable.

    These are challenges, to be sure, but they can be addressed in the 
very near term. And if we overcome them, the potential of consumers to 
unravel the knot that binds our health data in silos is enormous. If 
consumers can make a concentrated tug on the rope and demand their 
data, starting right now, it can enable systemic change.
    To do that, we need to take the friction out of the process for 
consumers. There are a range of actions we can take in three broad 
areas over the next 24 months to achieve change. The good news is that 
none require legislation. They can all be done by administrative 
action, by the private sector or with public-private collaboration. 
However, a little nudge from Congress can help:

    1. Equip consumers with the tools and awareness they need to 
exercise their rights to their digital health data.

     Better educate consumers about their legal rights, and 
about the use of patient portals for downloading and using health data. 
The U.S. Department of Health and Human Services (HHS) has many 
mechanisms for doing so, one of which is the Office of Civil Rights 
(OCR). OCR has a Web page to help consumers understand and exercise 
their privacy rights. Content should be updated to emphasize electronic 
requests over paper-based ones.
     Develop and disseminate tools to help consumers understand 
how/where/what and what format to request, what to do with the data, 
where to securely store it, and how to navigate roadblocks along the 
way.
     Make the process of requesting data easier. How can we 
automate it? A small group of leading experts, consumer advocates and 
former policymakers are catalyzing action in this area right now. 
Developers are working on tools such as the Vocatus tool, which enables 
consumers to request their health data online. Others are working to 
fix problems with patient portal download features.

    2. Give providers the tools and incentives to make consumer use of 
digital data the norm in health care.

     Work through HHS to educate providers about how to meet 
the demand for digital health information--through patient portals and 
through other means of downloading data such as Blue Button (which 
Medicare and the Veterans Administration already use), or the Direct 
protocol--a secure email link between patients and providers.
     Use the Federal EHR certification program to create the 
capacity for EHRs to incorporate consumer-generated data and make it 
easy for providers to analyze and act on.

    3. Advance Federal policies that enable consumers to routinely 
request, download and use their own health data in private, secure and 
valuable ways. Focus on two areas.

    1. First, support policies that drive more information sharing by:

          Finalizing the proposal to include open Application 
        Programming Interfaces (APIs) in the Federal EHR Certification 
        program. APIs will help break down information silos in health 
        care.
          Preserving and strengthening the Meaningful Use view/
        download/transmit requirement, most commonly met by offering 
        patient portals which deliver functions patients want like 
        secure messaging with their providers, online medication 
        refills and data downloads. We must preserve both the 
        requirement that the technology is in place, and the 
        requirement that a percentage of patients use it at least one 
        time during the reporting period. Regardless of whether the 
        number is 5 percent or something else, CMS's recent proposal to 
        drop this threshold to just a single patient will completely 
        undermine efforts by consumers who want to have and use their 
        data. Requiring providers to actively engage with a percentage 
        of patients is an essential mechanism for changing consumer 
        expectations and enabling consumers as a force for change.

    2. Second, privacy protection--there is no question consumers want 
and support greater online access to their own health information. 
Consumers also care about privacy. Now that health data is increasingly 
accessible in digital form, an app market is rapidly emerging, bringing 
with it both benefits and risks. We need to enable the market and 
protect consumers who are using apps to manage their data.
    To do so, we should:

          Encourage the Office of the National Coordinator 
        (ONC), the Federal Trade Commission (FTC) and OCR to finalize 
        and widely disseminate best practice guidance on protecting 
        privacy and security for app developers. Under its existing 
        authority, the FTC can enforce voluntary best practices for 
        those who adopt them.
          Ask the public and private sectors to come together 
        and explore how to evaluate apps on a range of aspects, 
        including privacy, security and usability. My own research into 
        the privacy policies and data sharing practices of the apps I 
        considered for my record required hours of reading and the 
        ability to decipher a lot of legalese. We should incentivize 
        more app developers to use ONC's model PHR notice for 
        consumers. It enables consumers to quickly and easily compare 
        privacy policies across apps, including whether or not the 
        developer sells consumer data for marketing or to employers 
        and/or insurance companies. But it should be promoted much more 
        aggressively by the Federal Government.
          Shorten the timeframe for meeting records requests 
        under HIPAA from 30 days. Patients should have the data as soon 
        as doctors do, and where digital records make that possible, 
        the law should not provide a basis for delay.
          Require providers to offer an ongoing data feed, at 
        least where it is feasible, so patients don't have to submit 
        requests again and again. There are technical standards that 
        already enable this.
          Establish that it is willful neglect to deny a 
        patient access (or even claim HIPAA precludes it), unless the 
        provider in good faith is relying on one of HIPAA's exemptions.

    If all that sounds technical, the challenge before us really is 
quite simple and straightforward. More than that, success is within 
reach. By taking some of the steps I have outlined, we can make it 
possible for consumers to finally stop being the ``sneaker net''--
patients who have to walk our records around to different doctors--and 
start leveraging the Internet to drive quality, value and patient-
centered care.

    The Chairman. Thank you, Ms. Bechtel.
    Mr. Patterson.

STATEMENT OF NEAL L. PATTERSON, MBA, COFOUNDER, CHAIRMAN, CHIEF 
     EXECUTIVE OFFICER, CERNER CORPORATION, KANSAS CITY, MO

    Mr. Patterson. Thank you, Senator Alexander and Senator 
Murray. This is a privilege and a pleasure, and I was told 
yesterday it would be fun to testify. This is my first.
    Just to give you a quick thumbnail of Cerner, there's about 
21,000 Cerner associates around the world. I had the privilege 
of being the co-founder of it in 1979. The first thing I want 
to do is thank you for the opportunity to be born in such a 
great country that a poor farm boy from Oklahoma that went to a 
land-grant college actually could go and create something that 
is significant.
    It was pure fortune that I found the intersection of 
healthcare and IT. That is the world I live in. I wake up every 
morning and I go to sleep thinking about that. I think it is 
the most--I think information technology is the greatest lever 
we have to change our healthcare system. I also have the 
privilege of basically agreeing almost wholeheartedly with 
everything that has been said here today.
    My lift is relatively small. My biggest challenge as an 
entrepreneur is to talk within 5 minutes, and the clock is 
running.
    We have a huge opportunity. We've invested as a country to 
digitize the entire content of the most important and largest 
sector of our economy. That's healthcare. Information 
technology is the biggest lever to create change.
    We are, I believe, at the dawn of a new era, and I think 
there is huge opportunity for it to be a golden era. There are 
significant things, though, in front of us that are barriers to 
realizing all of those benefits, and the fact that you are 
having these hearings, the fact that you are as informed as you 
are about the issues, I think is a very, very good deal.
    One thing that we say at Cerner about healthcare is that 
healthcare is too important not to change, and also healthcare 
ultimately becomes personal. My wife has stage 4 cancer since 
2007. I have my version. My version of this with Jeanne are 
bags and bags, and you continuously update these. You do go to 
see doctors that are outside of the organization, and you need 
all that information in those bags.
    I think it is a crime. I think that--I shouldn't say crime 
here. I think it is a failure of all of us to have in 2015 the 
fact that Jeanne carries bags to her doctors' appointments 
where she's going to see a new doctor or a specialist if she 
wants specific opinions. We have to fix that.
    Interoperability is high on my list, both professionally 
and personally, to fix. From the role, I guess--what's your 
role as government in interoperability? I hold up this card. 
This is my ATM card. I'm old enough to basically remember when 
that was issued by my bank, and I had to use the bank's 
machine.
    I'm old enough to remember that I was so excited when I 
could go to other banks in other cities. As long as I had a 
network--my card had the network that was on the machine--I 
could get money out of it, and today, we go--my youngest son 
just flew last night to Sri Lanka, and he will get currency out 
of an ATM machine there.
    We, as an industry, are behind around access to 
information, enabling the person, the patient, to have that. I 
believe industry should solve that. I think all of my 
associates up here believe that, too. It takes, frankly, my 
part of the industry to solve that, and we have to work 
together to do that.
    That has not happened to date. I'm moderately optimistic it 
will happen. I commit--I will do everything I can to make that 
happen so that we collaborate as an industry, and our networks 
that we build as companies, where we have our clients 
connected--that those private networks connect, and it will 
work like the ATM, I hope, by the end of this decade, so that 
you can expect to go to any physician anywhere in the country, 
and they can push one button and the relevant part of your 
lifetime record would appear on that screen.
    I think what you--one other quick thought on your role. 
Make sure when you do regulations and you do legislation that 
you put rounded edges on it. One of the issues with Meaningful 
Use is it was defined specifically, and physicians felt like 
they had to follow the specifics every time for every patient, 
and, in reality, that was not--and they felt like they had to 
do it, and their assistants could not do it.
    We need thoughtful regulations coming from here. Thank you 
very much.
    [The prepared statement of Mr. Patterson follows:]
              Prepared Statement of Neal L. Patterson, MBA
    Dear Chairman Alexander, Senator Murray, and members of the HELP 
Committee, thank you for inviting me to share my ideas about how to 
improve health information exchange for the benefit of every American. 
I appreciate your openness to ideas and action from the private sector 
as well as administrative and legislative change.
    My name is Neal Patterson. I am co-founder, chairman and CEO of 
Cerner. We are a leading health information technology company with a 
projected $4.7 billion in revenues in 2015. We will spend more than 
$650 million on research and development in 2015. We employ 21,000 
associates who operate in more than 30 countries worldwide.
    The intersection of health care and IT is one of the most important 
in modern society. Every citizen touches and depends on both.
    I appreciate the opportunity to share Cerner's perspective on what 
can be done to create a more interoperable health system. We believe 
that every individual has a right to access their complete health 
record, regardless of where it's located or what system contains the 
data. It is immoral for any organization to block the flow of 
information that could help individuals--and their providers--make 
better-informed decisions about their care.
    In other industries beyond health care, from retail and 
entertainment to banking to manufacturing and distribution, information 
technology has wrought massive change and materially improved our 
lives. It is not simply the efficiencies of IT. When things are 
digitized, they change.
    Digitizing content drives transformation. Digital music recording 
paved the way for file sharing and iPods to change our music 
collections. The movement of news online changed how quickly we receive 
the news. ATM cards changed how we bank. Social media has enabled 
political mobilization against dictatorships. The second-order effects 
of content digitization are profound.
    You don't always see these effects coming. They happen when data 
liquidity allows innovators to use information in new ways.
    In health care, HITECH and Meaningful Use are not perfect, but they 
are helping move health care onto a digital platform. As a society, we 
may be closer than we think to a golden era when science, intelligence 
and insights from big data can become a natural, unforced part of 
health care.
    Two qualities are important to enable this type of transformation. 
Health IT platforms must be open, and they must be interoperable.
    The quality of being open is what allows independent developers to 
build ``apps'' and extensions that work with existing health IT 
platforms. After years of little movement, our industry is finally 
making real progress toward being open to outside development. It will 
fuel an entrepreneurial wave of novel health IT apps and services that 
will address particular needs of providers and patients.
    For all the progress and promise, however, our current efforts are 
insufficient if they still serve a bunch of disconnected digital silos. 
Current health IT systems lack true interoperability, and the lack of 
true interoperability is failing patients. Without it, we risk missing 
the moonshot transformation that has positively changed other 
industries and lives.
    My wife has been fighting breast cancer since 2007. I have her 
permission to share her story. She has had procedures in the last 8 
years ranging from mastectomy, radiation and chemo to brain surgery and 
genome sequencing. Her diagnostic and treatment journey has taken her 
to multiple providers, and her records have wound up in more than 20 
different health organizations' EHRs. Everyone has a piece of Jeanne's 
record, but no one has the whole picture.
    Because there is not widespread interoperability, Jeanne carries 
printed copies of her records around in shopping bags. Each record she 
carries represents a phone call, a wait in a line at a records desk, a 
fax or a photocopy. The burden of assembling those records is what she 
calls the ``train wreck.''
    It's, of course, not just cancer patients who live this reality. 
It's almost all people with chronic conditions who have to see 
specialists--and people who move--and people who rely on emergency 
rooms for their care. In reality, everyone in the chamber today has 
experienced this issue. In the United States, the average person has 
seen 18 different doctors. If you're over 65, the number increases to 
28.\1\ It doesn't matter if the records are across the country or 
across the street. If the systems are not interoperable, the result is 
the same.
---------------------------------------------------------------------------
    \1\ Practice Fusion survey conducted by GfK Roper, 2010.
---------------------------------------------------------------------------
    Here is my litmus test and vision for real, patient-centered, true 
interoperability. It is when you as a patient can go to a new doctor 
who hasn't seen you, sign your name electronically giving your consent, 
and then the doctor can click a button in the EHR and compile what is 
most relevant from your lifetime record that you want to be shared, 
pulling information from many places. We actually are quite close to 
being able to realize this vision, and the issues in realizing it are 
largely not technical ones.
    Over the past decade, there has been some good progress on 
interoperability. Standards have progressed that define how and what 
information is shared to whom and when. Governance and privacy 
standards are also progressing. We are members of Carequality, an 
industry coalition focused on governance. I think Congress's recent 
focus and sensitivity to the behavior of data blocking (intentional or 
inadvertent) is a good thing. There are current efforts to create the 
concept of ``semantic interoperability,'' which is extremely powerful 
and has the potential to unleash enormous innovation that will interact 
with the EHR platforms. But it is my testimony that, while this 
progress is good and necessary, it will not realize the vision I shared 
above. I want Jeanne's doctors to have access to her full lifetime 
record. That vision requires a system for national patient 
identification, for record location tracking and for patient-driven 
consent.
    There is a tendency to use isolated interoperability success 
stories as the poster children for progress and defense of the status 
quo. Some regard largely single-vendor networks or ``intra''-
operability as equivalent to interoperability. It's a form of progress, 
but it's not the same, because your records and Jeanne's records are 
not all on one vendor's system. They're spread out across every vendor 
in the industry. It's just not enough. If we remain satisfied with this 
progress, patients could wait decades to see real interoperability. It 
will leave too many patients carrying too many bags for too long.
    As a health IT industry, the electronic health record community has 
grown up alongside each other--Meditech, Cerner, Epic, McKesson, 
Allscripts and many others. We were out conquering the map. Each of us 
has had our own version of building our core capabilities. Competition 
has been healthy, and it has driven a lot of innovation. But too often 
these competitive instincts led to technological silos.
    Outside of health care, there are plenty of examples where 
competing business interests, spurred by consumer pressure, came 
together to solve interoperability problems. Apple and Android phones 
can talk nationwide. The Verizon network connects with the Sprint 
Network. My Microsoft Outlook email communicates seamlessly to Google 
Gmail. My ATM card works at nearly every machine worldwide. Government 
may have helped, but industry played the biggest role.
    In 2013, in an effort to augment the standards and governance work 
playing out in Washington, our industry sought to take on a set of big 
issues that are impeding true interoperability and data liquidity. 
Along with some other vendors, we created a non-profit called 
CommonWell with an eye toward addressing three barrier issues to true 
patient-centered interoperability: patient identification, record 
location and patient-driven consent. CommonWell invited all electronic 
health record vendors to come together.
    To solve for the needs of patients, we wanted an approach that was 
national in scale. The service it offered had to be available at a very 
low, utility-like cost to providers. And it goes without saying that it 
had to safeguard privacy and the trust of individuals and providers.
    Achieving this level of interoperability in health care requires a 
virtuous cycle of product innovation and standards development and 
evolution. It also requires all the players in the industry to agree 
that patient-centered interoperability needs shared networks between 
vendors, not just a trickle of individually negotiated connections. 
Waiting around to fulfill the next request to connect two hospitals to 
each other or to a local HIE meets the letter of the law. But getting 
to full interoperability requires active cooperation among all the 
vendors, and their acceptance that once technological silos are 
eliminated, they will have to compete on innovation, quality and cost. 
We do not have this yet in health IT, but this kind of dialog at the 
national level has a chance of creating real change.
    What we do have is CommonWell, a non-profit vendor-to-vendor 
network, national in approach, which providers and hospitals can access 
on behalf of individual patients. It is open to the entire industry, 
and its members include Allscripts, Athenahealth, Brightree, Cerner, 
Evident (formerly CPSI), Greenway, McKesson, Medhost, Meditech, Merge 
Healthcare, Sunquest, and other companies--which includes every major 
acute care EHR company in the industry with the exception of one. 
Cerner is committed to any effort to advance true interoperability, and 
the CommonWell network is in my opinion our industry's best cooperative 
effort so far. I have made it clear that if someone establishes another 
open network that has a reliable method of patient identity management, 
record location tracking and patient-driven consent, it will also have 
my support and participation.
    As for Washington's role, it must be clear to all that the policy 
of this country is true interoperability. The Office of the National 
Coordinator (ONC) must continue pressing its framework for 
interoperability, convening, facilitating and evolving important 
standards work. Vendors and providers must enable sufficient 
transparency around data sharing to allow keeping a watchful eye on 
behaviors in our industry. Congress should not be afraid to act. 
Whether intentional or unintentional, behaviors that restrict patient 
choice, throw up roadblocks to true interoperability, or use control 
over data to further market share should be challenged. None of us have 
a perfect record, and we can all do better.
    The subject of interoperability can quickly become blurred into an 
alphabet soup of acronyms, nomenclature, standards, governance and use 
cases--so much so that we lose the point. In the end, you will know it 
when you see it. It's when you can go to your doctor and they can push 
a button and assemble the relevant parts of your lifetime record that 
you want to be shared with your doctor.
    We all can cite how the rising cost of health care is consuming 
more of our resources as a family, community and country. I am 
convinced that information technology is the single greatest lever for 
creating value in health care by eliminating waste, variance, error, 
delay and friction. It can put a system into health care.
    We have a chance to deliver a golden era of health care. It's a 
system where consumers not only have a right to their data, but also 
have the ability and the financial incentives to mobilize it in pursuit 
of better health.
    We have a chance to make Jeanne's shopping bags a thing of the 
past.
    I look forward to working with the industry, as well as members of 
the committee, to advance that vision.

    The Chairman. Thank you, Mr. Patterson, and thanks to all 
the witnesses. We'll now begin a round of questions. I'll call 
on the Senators in the order they were here at 10 a.m. Senator 
Murray after me, and then Senator Burr, Senator Warren, Scott, 
Casey, Cassidy, Bennet, Franken is the order that I have.
    Dr. Payne, in March, the department released proposed rules 
for Stage 3 of Meaningful Use and the 2015 edition of the 
Certification Program for Electronic Health Record Technology. 
The comment period ended in May, and we expect the 
Administration to release the final rules this fall. Meaningful 
Use 3 will go into effect in 2018. Parts of 2015 certification 
could go into effect later this year.
    A hospital that should know what it's doing has told me 
it's terrified by Meaningful Use 3. Do you think that it would 
be a good idea to delay some or all of these proposed rules 
until Congress and the Administration have a chance to work on 
the five or six things that seem to be the biggest impediments 
to making our electronic healthcare records something people 
look forward to instead of dreading?
    Dr. Payne. Thank you for the question. The answer is yes. 
We think Stage 3 needs some improvements. There are many 
elements to it. A good example of an improvement would be that 
it tests whether a vendor conforms to a standard, but it 
doesn't test whether the vendor systems are truly 
interoperable.
    We should be sure that the record can be sent and that it 
can be received and used. The certification program also needs 
to be improved so it can make certain that both the sending and 
receiving is possible. Some of the standards in it are in a 
draft state.
    The Chairman. My question is do you think it should be 
delayed or not, in part or in whole?
    Dr. Payne. We think it should be delayed until it's 
improved.
    The Chairman. Mr. Patterson, in your comments earlier, you 
seem to think that physicians are being asked to do some 
things, or they think they're being asked to do some things 
that's not necessary for them to do. Senator Cassidy is going 
to chair a special hearing on physician documentation.
    As I understand your position, you feel that physicians--
there is some documentation that physicians certainly should 
do. There are other things that an aid could do. To some 
extent, the billing system has gotten mixed up with the 
electronic healthcare records and made it even more onerous on 
physicians. Is that a fair summary?
    Mr. Patterson. I would agree with your summary.
    The Chairman. Would you be able to suggest to us or perhaps 
to Senator Cassidy's work the specific things that you think 
doctors should do and other things that others shouldn't do--or 
aren't necessary for them to do, and how we might change the 
regulations or the law to make that clear?
    Mr. Patterson. Yes. We certainly can provide some followup 
to that in writing.
    To give you an example, meds reconciliation, I think, as 
written and the intent of the regulation is that the physician 
is to do the meds reconciliation. I think that's appropriate in 
many cases, but that was--but I think in many cases, that 
function could be done by a nurse or an aid to the physician 
under their supervision. They review the work and basically 
accept it. That's the, if you will, rounded corners, rounded 
edges on the regulation.
    The physician's time is one of and if not the most critical 
resource inside of the healthcare system, and then the person 
they're serving--the patient's time is the other part of that. 
We need to preserve the physician's time with the patient, and 
I think, current state, we have impacted that amount of time 
that they can spend negatively.
    The Chairman. Mr. Richardville, all of you have mentioned 
the importance of having agreed upon standards by the various 
participants in healthcare, and it's critical to enabling real 
interoperability, the kind of ATM card that Mr. Patterson 
talked about. To what extent would you propose that the Federal 
Government get involved in mandating or otherwise requiring 
health information technology standards to be adopted?
    Mr. Richardville. A couple of points, and thank you for the 
question. There are current initiatives out there today that 
help promote--that are trying to promote some of this 
interoperability--Carequality, CommonWell, Epic Care 
Everywhere, Argonaut--and there are successful----
    The Chairman. My question is on standards. To what extent 
should the Federal Government get involved?
    Mr. Richardville. Well, I think what the Federal Government 
needs to do is to come in from a governance perspective and 
help define what those rules of the road are so that these 
organizations can all abide by those rules. I think, as Senator 
Murray talked about, that the ability for the network of 
networks, which is similar to Neal's point, like the Cirrus 
network that connects the ATMs, would be a viable opportunity 
for the healthcare industry.
    If those rules are set up----
    The Chairman. Do you want the Federal Government figuring 
out the standards?
    Mr. Richardville. No.
    The Chairman. Or do you want it encouraging the development 
of standards developed by private industry?
    Mr. Richardville. Encouraging the development of--I think 
it's a multidisciplinary team of payers, patients, vendor 
partners, and providers that should get together and develop 
what those standards are. We do need regulation to help define 
what the timelines are, the aspects of defining what those 
rules of the road are that we all need to play into so we can 
participate in a very multidisciplinary approach and allow that 
network of networks to develop.
    The Chairman. Thank you.
    Senator Murray.
    Senator Murray. Thank you. Our hearing today is focused on 
health IT because of its potential to improve the quality and 
value of healthcare for our patients. Health IT can support 
research that unlocks innovative new treatments. It can support 
better coordinated care at critical times like when a patient 
is being discharged from a hospital. To achieve any of those 
objectives, patients themselves need to be engaged in this 
work.
    Ms. Bechtel, I want to ask you: How does health IT enable 
better partnerships between patients and families and their 
doctors?
    Ms. Bechtel. Health IT does quite a lot to enable those 
partnerships. It lends a lot of transparency, so I can see 
what's in my medical record. I can correct errors. I can add to 
it and complete information. It also helps me engage more in 
not just managing my care, but in managing my own health. 
There's a lot of data that shows us the many ways, from reading 
my physician's notes to looking at lab results, that health IT 
really supports and enables that.
    I think the one thing that is essential to also think 
about--and this is going to point back to Senator Alexander's 
question about delaying Stage 3. There are aspects of patient 
engagement that we would give up if we delayed Stage 3 
wholesale. I just want to note that we would also, ironically, 
give up requiring a greater percentage of doctors to share 
information electronically, not just with patients but with 
other doctors.
    We would also lose a technical fix that would help us to 
unlock the data that is currently siloed in patient portals. 
It's called an API, an application programing interface, where 
we would be able to download that. We would give up some gains 
on patient-generated health data.
    I just want to recognize that wholesale delay of Meaningful 
Use Stage 3 should be very thoughtfully considered in light of 
the items that we would impact, give up, that I know we all 
support.
    Senator Murray. OK. Great.
    Dr. Payne, in your testimony, you talked about enabling 
patients to receive an electronic copy of their entire medical 
record, that that would have the most genuine and lasting 
impact on smoothing the flow of electronic health information. 
I'm really proud that in our home State of Washington, 
including the University of Washington, we are pioneering the 
Open Notes Project, which is working to give patients access to 
the visit notes written by the doctors and nurses that Ms. 
Bechtel just talked about.
    Talk a little bit about how enabling patients to access and 
download their entire electronic record would improve the flow 
of information.
    Dr. Payne. Well, just as the Open Notes Project makes 
sense, we think that providing access to the entire record also 
makes sense, and it's the right thing to do. The notes are very 
important, but elsewhere in the record are also pieces of 
information that are very important and that are still today 
very difficult for people to access.
    If we set the standard that the record that is truly the 
right of the person to see is available to them, they will have 
other benefits beyond just reading the notes. We think there 
will be innovation that will be based on having access to the 
entire record that we don't see today. We think it is the 
logical next step, now that we have a good deal of the Nation's 
health record in electronic form, that the person who owns it 
has a right to see it.
    Senator Murray. Well, in order to make sure that patients 
and clinicians have better access to electronic health 
information, we need to make sure that no one is deliberately 
blocking it.
    Mr. Patterson, I'm glad that in your written testimony you 
agree. We need to prohibit data blocking. HHS tells us that it 
can be difficult to distinguish between contract terms and 
pricing policies that are normal business practices and those 
that are designed to deliberately block information.
    In your view, can you share with us how vendors and 
providers deliberately block data?
    Mr. Patterson. The word, deliberate, is a bit caustic from 
the way I think it actually happens today. I think their 
historic practice is we're not to share data. I think business 
strategies get in the way, and business models get in the way, 
saying, ``I'm better off if I don't share it.''
    In my written testimony, I frankly, if it's you or your 
loved ones, and that information is vital, I consider it 
immoral for people to block that data and force us to carry it 
in bags. I think we're just crossing over into a new era. I 
think, as I said earlier in my oral comments, your asking that 
question, is extraordinarily powerful, and I think you should 
continue to talk about it.
    We individuals, the citizens, the people who are served by 
the health system--those are our records, and I think you 
should pass a law that says we should have a copyright to 
that--we should have a legal standing in that information, 
because too many times, healthcare thinks it's theirs. They 
should have a copy, too. They produced it. It's a part of 
their--they have all kinds of reasons for that record.
    But when it's digital, I can have my copy, too. I think it 
happens. It happens from a historical practice point of view. 
We need to change those practices or we're never going to get 
rid of the bags.
    Senator Murray. Thank you very much.
    Thank you, Mr. Chairman.
    The Chairman. I should repeat that one of our next hearings 
this summer is on precisely the subject of who controls my data 
and how do I get hold of it. Senator Collins is going to chair 
that hearing for the committee.
    Senator Burr.
    Senator Burr. Mr. Richardville, why is this so hard?
    Mr. Richardville. Great question. There are actually 
multiple factors that makes interoperability difficult. First 
and foremost, it's technically complex. You have a varied 
amount of different systems that have different rules of the 
road that they're participating in, and we're expected to try 
to connect that information that they're producing together.
    Second, in terms of prioritization, when you look at the 
incentives, especially those that came out through Meaningful 
Use, a lot of the investments that healthcare providers had to 
make--it was not one of the top incentives. When you have 
limited resources, looking to try to achieve things that you 
need to have done--those are things that kind of fall a little 
bit more down to the bottom of the list.
    Senator Burr. What's your definition of interoperability, 
and is your definition different than anybody else on this 
panel?
    Mr. Richardville. I hope it's not different. My definition 
of interoperability is the open, free exchange of secured data 
between providers and patients, utilizing health information 
technology systems as the road to provide that kind of 
activity.
    Senator Burr. Let me throw it out to any of you. Why would 
a provider not want to make a patient's information available 
to a patient?
    Ms. Bechtel. Well, I can tell you that when I asked for my 
health record electronically, I first had to convince them that 
I wasn't trying to leave the practice. They have real endowed 
business reasons, because of the way we pay for healthcare in a 
fee-for-service environment, to try to hold my data as a 
business asset so it's not as easy for me to actually go get an 
office visit somewhere else.
    From a consumer perspective, it makes it much more 
challenging for me. Yet every piece of data says that if you 
give me my data, and you give me access to it, it actually 
increases my loyalty to the practice. Other folks may have 
comments.
    Mr. Richardville. You know, at Carolinas HealthCare System, 
our motto is patient first always. For us to engage and involve 
the patient in everything that we do is part of how we are able 
to move forward and progress.
    The only thing that I would say in addition to what Ms. 
Bechtel has said is that sometimes some of the language and 
some of the data structures that are put in place may be 
difficult for a patient or a consumer to digest without some 
easier way to translate that into meaningful pieces that they 
can then absorb.
    Senator Burr. Dr. Payne.
    Dr. Payne. One friendly amendment to Craig's definition--I 
would add that interoperability includes the ability to use the 
information when it is exchanged. There are many ways to 
exchange information, some of which leave it dormant. If we 
make the exchange occur in a way that it's useful for its 
intended use, that's an important element of interoperability.
    Senator Burr. Mr. Patterson.
    Mr. Patterson. To have true interoperability nationally or 
get close to the ATM card functionality, there's really three 
things that have to be in place. One is there has to be an 
identification. When you're going to send Neal Patterson's 
record from physician to physician, provider to provider, there 
has to be an identifier of Neal. We do not have a national 
identification system in this country. It's a subject that's 
been discussed a lot, and it's one that's basically been 
tabled.
    In today's world, we can solve that as an industry without 
you doing anything. But it has prohibited, because to curate 
who I am on the other receiving side is a lot of work. We lack 
a functionality around identification.
    We lack a functionality--there's no place that knows where 
my records are, other than me, and, frankly, that's--you know, 
Jeanne has been to 35 different places. I can figure it out, 
but it's a--so we don't have a system that says where my 
records are.
    And third, we really need a consent--everybody is very 
afraid--providers are very cautious of letting records out 
because HIPAA has some very stringent penalties in there around 
sharing information, patient information. We need a consent 
system.
    Senator Burr. It's a shared feeling. We're scared about 
opening up HIPAA to try to tweak it, because it may become more 
cumbersome and more onerous.
    Let me just say this to all of you. If you will think 
about, when you leave here, anything else that we might need to 
look at from a provider's standpoint that's a disincentive to 
sharing information, so that we know what we're up against as 
we begin to look at legislation, as regulators begin to look at 
regulations, I think therein holds the key.
    If we're just down to an economic decision, Ms. Bechtel, I 
think we can find a trigger for that.
    I've got to believe that there's more than that, and I 
think it revolves around interoperability in some way, shape, 
or form. It may be what they chose to put their electronic 
medical records in and their inability to merge that into 
something else.
    I think that we're going to find things that are out there 
that maybe, by themselves, you wouldn't look at and say, 
``Here's the problem,'' but, collectively, they probably 
contribute greatly to this inability.
    I thank the chair.
    The Chairman. Thank you, Senator Burr.
    Senator Warren.

                      Statement of Senator Warren

    Senator Warren. Thank you, Mr. Chairman. So far, the 
Federal Government has invested $30 billion in electronic 
health records, in part because sharing health information 
between doctors can improve patient care. It's still the case 
that the health record systems can't always match a particular 
scan or test result to the right person, and mismatches can be 
very dangerous. As more patient information is stored 
electronically and as doctors exchange more health records with 
other doctors, the risk of mismatching patient information goes 
up.
    We've got at least two studies that I know about on this. A 
2008 Rand Corporation study estimated that even with database 
management software and personnel that were dedicated to 
preventing such mistakes, hospitals mismatch patient 
information about 8 percent of the time. A 2012 study conducted 
by the Council of Health Information Management Executives 
found that one in five physicians encountered mismatched 
information that put a patient at risk during the previous 
years.
    I would like to start--Mr. Richardville, can you explain to 
us what tools Carolinas HealthCare used to solve this problem?
    Mr. Richardville. Yes. CHS on many pieces are on the 
forefront of innovation. What we looked at several years ago 
and was the first, actually, to bring into the country was a 
biometric palm vein scanning system. It actually scans the 
veins in the palm. It's not a palm print, but it's the veins, 
like a snowflake, in the palm. We have that at all of our 
locations. We've had that for many years.
    Since then, when you quantify like the 8 percent, our 
medical record number duplicator error rate is .11, which is 80 
times better than the average that you talked about. At least 
within our system, we've been able to mitigate that issue.
    As we try to match across the systems, I'm not saying that 
that is the answer for others. I think there's probably other 
successes in the country, and we need to put those heads 
together and see if there is a way that we can expand that 
across.
    Senator Warren. Let me ask the question about, then, among 
systems. Mr. Patterson, in your written testimony, you 
discussed CommonWell, an alliance of health IT companies that 
connects health records that are managed by different vendors. 
What has CommonWell done to avoid the mismatches? We've got 
between systems here.
    Mr. Patterson. Right. In broad terms, CommonWell allows you 
to create an account that is used for--and you, as an 
individual, create it. You say, ``Here's what consent I give to 
share my information, and here is my identification.'' It's 
like having your Google email account, and you are controlling 
that account as the person.
    Senator Warren. This is done patient by patient.
    Mr. Patterson. Patient by patient at enrollment. Once you 
have that account--obviously, to start your first email 
account, there's a process to it. Once you have your 
identification, then information can be sent and moved. 
CommonWell has solved the identification problem on a voluntary 
basis.
    Craig's solution is much more precise and elegant, but I do 
not think we can implement that nationally. I'm not going to--
you'll have to have a hearing on that. That's much more 
precise.
    Also CommonWell basically provides the software--we have 
near 30 members of CommonWell. All of us as software companies 
agree to also--when we record the fact that there is 
information about a person under that ID in our records at 
these locations. We solve the record location issue.
    Senator Warren. Carolinas HealthCare and CommonWell and 
others around the country are all working to prevent patient 
matching errors within their own systems. There are obviously 
limitations on what you can do alone.
    Mr. Patterson, I'd like to ask you: What can Congress or 
the Office of the National Coordinator of Health IT do to help 
scale individual efforts to reduce matching errors and at the 
same time to protect patient privacy?
    Mr. Patterson. The ability to have an identifier that we 
all share would be an enormous help in reducing the risk and 
improving the value to patients. If it were possible for it to 
be simple to do and accurate, then it would happen more often, 
and I think patients would benefit enormously from that.
    In the absence of such an identifier, algorithms that help 
us do the next best thing, which is to use existing information 
to make sure that we know who the person is when the 
information is sent or received, would also be very helpful. 
Much work has already been conducted in this arena.
    It is a complex and very important question, and I'm glad 
that you are focusing on it. We also have people who come to us 
in our trauma center who are unconscious, unable to tell us who 
they are. It is a risk to them and requires enormous effort on 
the part of our staff to be sure we know who this is as we 
provide care to them in the safest way we can.
    Senator Warren. Thank you. You know, accurately matching 
health information to the correct patient record is critical 
for the safety and the effectiveness of electronic health 
records. I look forward to seeing more research in this area. I 
hope that industry and government can work together to find a 
solution that keeps patients safe and that protects their 
private health information.
    Thank you very much.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Warren.
    Senator Cassidy, I've already noted that you'll be chairing 
a hearing for the full committee. I think Senator Whitehouse 
may serve as the ranking member for that hearing on physician 
documentation. We appreciate your willingness to do that.

                      Statement of Senator Cassidy

    Senator Cassidy. Thank you.
    Mr. Patterson, you mentioned in your testimony semantic 
interoperability. Is that a challenge? Because it sounds like 
once you go through CommonWell, and you have this kind of ID 
that I volunteer and it goes to others, that there should be 
some sort of way to communicate. How much of an issue is that?
    Mr. Patterson. Dr. Payne would be probably the subject 
matter expert on it. I'm very impressed--so there is work on 
standards to create the next level of interoperability. In my 
testimony, I call that semantic interoperability. It's one 
thing to move safely information about ourselves. For it to be 
consumed by the physician, if we can understand what's in that 
record and it can be worked into the----
    Senator Cassidy. Simply, as Ms. Bechtel said, not 
necessarily as a pdf but rather structured so I can follow 
blood pressure over time with some chart relative to medicine.
    Mr. Patterson. Right.
    Senator Cassidy. That would somehow structure it between 
records.
    Mr. Patterson. Yes, you've got it near--you are perfect on 
that.
    Senator Cassidy. Thank you.
    Mr. Patterson. And that's a huge deal.
    Senator Cassidy. Will you talk to my wife about that and 
extrapolate the other things?
    [Laughter.]
    CommonWell, you mentioned in your testimony that all major 
players except one are participating in CommonWell. Who is the 
major player not participating in CommonWell?
    Mr. Patterson. Epic is not participating in CommonWell.
    Senator Cassidy. Senator Murray asked about business 
practices, or somehow that developed in the conversation--is it 
deliberate or is it business practices. The effect is the same, 
that data is not--I feel like Epic is the elephant in the room.
    It was implied in your testimony that a business practice 
which does not allow sharing somehow furthers their business 
model. If you want to share data with another Epic hospital, 
you have to have Epic, and they have such a market share that 
people will migrate. That's my opinion, but is that a fair 
opinion? Is that defensible?
    Mr. Patterson. That would be my experience, that they would 
use that as a marketing technique.
    Senator Cassidy. Again, as Senator Murray----
    Mr. Patterson. I might add that I believe--and I hope Epic 
will join CommonWell and that we work together as an industry. 
The only way this is going to get solved is that we work 
together.
    Senator Cassidy. I accept that totally. On the other hand, 
sometimes we set this up--I say Congress--giving billions of 
dollars, and now a major player is not participating in a 
common effort to create the sort of structured data that Ms. 
Bechtel would find so useful and that you agree would be a nice 
way to do it. We need to have them come to say it.
    But that is a problem, and I say that as a physician who 
shakes my fist at the computer because I can't get the data 
that I need as I am seeing a patient. Let me ask, and I'll open 
this up. What can we legislate that would--if people don't want 
to come forward voluntarily--we can say you've got to--it's 
hard to say you have to participate in CommonWell, because 
CommonWell may become something different.
    Mr. Patterson. Right.
    Senator Cassidy. Yet I have a sense that you prefer the 
private sector to be the setter of the standards as opposed to 
a Federal agency. Really, it may be that we have to have a 
Federal agency that says, ``We shall solve these problems by 
this deadline or else we shall prescribe.'' Do you have 
opinions on that? Is that what's required?
    Dr. Payne?
    Dr. Payne. I think one move that we as a nation and 
Congress could take is to move toward reimbursement for value, 
for quality. If that movement accelerates, there will be a big 
drive for interoperability.
    Senator Cassidy. That just may be a big drive to continue 
business practices which say,

          ``Listen, if you want to play, you've got to play 
        with me because I'm the big guy on the block, and so, 
        therefore, I'm the only person that can give you 
        everything.''

    Dr. Payne. I think it would also be a strong incentive for 
industry, but also provider organizations, to use standards 
that exist now for interoperability. We should do a better job 
with interoperability----
    Senator Cassidy. I'm not sure you're answering my question. 
My question is: Do we have to be more coercive than we are now 
in order to crack it open?
    Mr. Richardville.
    Mr. Richardville. I would say, Senator Cassidy, several 
things. One is I do think congressional action is needed so we 
can set up what I would call functional standards that we can 
all play by. I also think that the measures of the outcomes 
that was referred to needs to be part of it. Most importantly, 
is the enforcement. Make sure that compliance takes place as we 
start doing this.
    In addition to what Neal Patterson talked about and with 
CommonWell, I do think there are a handful of other integrative 
efforts that are going on in play. We at Carolinas HealthCare 
System actually--one of the unique systems that we actually 
have--Cerner, Epic, McKesson, Allscripts within our system, and 
we've built a core competency of interoperability with our 
health information exchange to actually change information 
within our system with different vendor partners that we work 
with.
    Senator Cassidy. Does it cost you per transaction, or can 
you do that without charge?
    Mr. Richardville. It is not per transaction. It's per 
member. We pay based upon the number of people who actually 
participate in it. For us, as we have more physicians come into 
that, we actually pay based upon the people that consume and 
participate in our health information----
    Senator Cassidy. That's interoperability with a charge.
    Mr. Richardville. It's interoperability with a charge based 
upon usage.
    Senator Cassidy. OK. I yield back. Thank you.
    The Chairman. Thanks, Senator Cassidy.
    Senator Casey.

                       Statement of Senator Casey

    Senator Casey. Thank you, Mr. Chairman.
    I want to thank the panel for your testimony and for 
helping us to better understand and, we hope, figure out a 
complex problem.
    I wanted to start this morning with children. We have over 
many years developed programs that enhance children's health 
insurance, whether it's in the Children's Health Insurance 
Program or Medicaid or otherwise. We often don't ask, I think, 
an essential question, which is--just as we do in the context 
of protecting the environment, we say, ``What's the 
environmental impact of a particular policy?'' or the 
environmental impact, more particularly, on a project.
    We should ask the same question in the context of children: 
What will be the impact on a child or children if we take this 
step with regard to healthcare and, in this case, with regard 
to healthcare records? I wanted to start in a very particular 
way.
    Dr. Payne, you've heard child advocates say for a long time 
that children are not small adults. We need to make sure that 
we have strategies and approaches to children's health 
insurance that may not be applicable or transferable from the 
strategies for adults.
    In particular, I wanted to highlight immunizations, so 
critical to pediatric healthcare and also providing a great 
public health benefit. Access to immunization records is 
necessary to ensure that children receive the recommended 
vaccinations at the appropriate time.
    What can you tell us in the context of this discussion with 
regard to the fundamental question, which is ways that having 
electronic health records that are interoperable--how can that 
improve access to immunizations?
    Dr. Payne. That's a great question and a great example of 
the benefit of interoperability. In our report, we addressed 
just that issue, that there are a growing number of registries 
for children's immunizations, because children, as do adults, 
move from city to city, and those registries contain the record 
of their immunizations. Most importantly, the record tells us 
what they have not received so that we can make sure that they 
do receive it.
    The challenge here is that the information in those 
registries is not flowing seamlessly into the electronic health 
records that the pediatrician or family doctor would use to 
look to see what's needed next. That's an example of where 
improved use of existing standards or refined standards would 
help children in a very direct way. This is an important 
preventative care measure, and we should make sure we use it 
every time it is appropriate for a child's health.
    Senator Casey. I want to open it up to the panel, if anyone 
else has any comments on this, and I'll have a followup for Dr. 
Payne. Anyone on the panel?
    Ms. Bechtel. Sure. I think this is a terrific use case for 
the kind of consumer demand for their health information that I 
was describing earlier. I think as moms and caregivers can 
begin to get and request an electronic copy of their health 
information from their doctor, they can begin to catalog those 
things, and, at least, until we fix the standards and fix the 
registries, I can build a comprehensive list of my 
immunizations. I can share that with my provider. I can manage 
that. I can set alerts when things are due.
    It really enables me as a caregiver to have a much more 
complete picture of my child's health, including immunizations. 
Enabling that kind of consumer demand, that pulling on the rope 
right now, would be a really essential strategy to make very 
quick progress in the short term.
    Senator Casey. I appreciate that.
    Mr. Patterson. I might add that immunizations is a very 
good example of something where IT creates a lot of value. 
Immunizations at birth--you know for the next 7 years when, 
approximately, immunizations need to be done. The systems 
should know what--not just help document what is happening. It 
should know what isn't happening, and it should be able to then 
report back to the pediatrician, report to the family that 
these events need to happen.
    There's just too much reliance on well-intended--and the 
systems are increasingly getting smarter--would need to get 
smarter. That's a great example of population health.
    Senator Casey. I appreciate that. I'm almost out of time. 
Maybe for a fuller answer to this question, I'll start with Dr. 
Payne--or I should say a fuller answer from everyone. It might 
be better just to put it in the record.
    I wanted to ask, in the context of transparency, what can 
we do more broadly now--not just with regard to children, but 
more broadly--to increase transparency as it relates to 
electronic health records? If you can give a short answer, and 
everyone else can put it in writing if that's all right so I 
don't get the chairman upset.
    Dr. Payne. I think you can highlight its importance and its 
value and encourage other regulatory bodies to embrace it.
    Senator Casey. Thanks very much.
    The Chairman. Thanks, Senator Casey.
    Senator Franken.

                      Statement of Senator Franken

    Senator Franken. Thank you, Mr. Chairman.
    I'm co-chair of the bipartisan Senate Rural Health Caucus, 
and I've had a lot of roundtables around Minnesota--I think 
about 30 between me and my staff having roundtables. At 
practically every roundtable, they bring up this issue of 
health records, electronic health records. In rural America, we 
have a lot of small providers, and one of the issues is the up 
front cost.
    I guess this is for Mr. Patterson, since you're in this 
business. Even those who can afford the initial investment are 
often sort of--end up with the most basic out-of-box product 
because they don't have the resources or the influence to 
demand a custom tailored solution from vendors.
    Are there ways that EHR vendors like Cerner can structure 
their sales models to help lower or eliminate the up front cost 
of implementing a new EHR system?
    Mr. Patterson. You're talking to an old farm boy, and rural 
health is actually on my, if you will, professional bucket list 
to fundamentally make a difference in. We have been very 
aggressive in using kind of shared services and shared domains 
to create as low price points as we can to get out into 
critical access in smaller facilities. It's been, frankly, 
fairly successful, both from the client side and from our side. 
Yes, they're on very thin budgets, and I started that--they get 
advantages of very sophisticated technologies.
    My wife's brother, who is still the farmer down there in 
Oklahoma, unnecessarily died from sepsis. I went to the local 
healthcare community and said that didn't need to happen, and 
sepsis is a predictable condition. That community now has an 
intelligent set of algorithms looking over the entire community 
and identifying the people that look like they're on a path to 
become septic, and it has fired over 60 times this year. It 
would have saved his life.
    They need, really, everything we talk about. You've got to 
create business models and get low price points.
    Ms. Bechtel. Senator, if I might, I think one of the things 
we haven't really addressed--yet it plays a huge role in all of 
the challenges that clinicians and other providers are facing--
is the fact that we don't actually pay for and reward the kind 
of care that clinicians can deliver when they're enabled by 
health IT and by an interoperable system.
    Senator Franken. Sure.
    Ms. Bechtel. The up front costs would be worth it, as they 
were for the banking industry, right? If we were able to start 
paying for coordinated care, paying for health outcomes, paying 
for better patient experiences, I think it would drive this 
discussion in a far different direction. The banks didn't 
struggle with standards for 30 and 40 years as we have in 
healthcare, right? We didn't actually talk ever about bank IT.
    Senator Franken. Well, this is supposed to lead to savings. 
This is supposed to lead to coordinated care. This is supposed 
to lead to value. I think the next questioner has some thoughts 
about that. Senator Whitehouse does.
    I want to talk about interoperability. Why, why, why can't 
the VA and the Defense Department become interoperable? This is 
just a mystery to me. A lot of resources have been spent trying 
to do this. Does anybody have any thoughts on that?
    Mr. Richardville. Senator, if I could just make a couple of 
comments, I do think that the lack of the standards, functional 
standards, in place that allows this transport of data back and 
forth between systems is difficult. It is expensive. You talked 
about the EHR with the rural facilities. We look at 
interoperability. It's just as expensive and complex to try to 
connect them to other care providers when they do referrals 
back to other complex organizations. Until we actually have the 
government action in place to help us to have the functional 
standards, the measures, and the compliance to take place, 
we're going to have this difficulty in this country.
    Senator Franken. These are two government entities that are 
dealing with the same population. If they can't get it 
together, I don't understand how we're supposed to be 
optimistic about us setting standards. I'm out of time.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Franken.
    Senator Whitehouse.

                    Statement of Senator Whitehouse

    Senator Whitehouse. Thank you, Chairman.
    This is such an important issue, and Chairman Alexander and 
Ranking Member Murray have embarked on a committee-wide process 
to take a look at health information technology and information 
exchange. I would invite each of you, in terms of what a law 
student would call issue spotting, to feel free to send in to 
us the list of issues you think our process should be sure to 
be addressing, even if you haven't had the chance to get to it 
in this hearing. I know that we would be interested in that.
    My particular concern comes from my Rhode Island 
experience. Many years ago when I was the attorney general in 
Rhode Island, I established an organization called the Rhode 
Island Quality Institute, and we embarked on, first, electronic 
prescribing and then electronic health records, and now full-on 
health information exchange through a nonprofit organization 
called CurrentCare which has been very effective in terms of 
how broadly it has reached out and connected all the providers, 
connected with the Epic system in both of our major hospital 
chains. It's been quite good.
    Here's my concern. We've spent an enormous amount of money 
on Meaningful Use. Most of that has gone to end users, 
subsidizing the machinery on the doctors' desks. We kind of 
take a bank shot off of that back into the information exchange 
piece by defining Meaningful Use in ways that require things to 
happen.
    For a lot of those providers, the healthcare providers, 
they don't really have a big say in whether or not there's a 
statewide health information exchange in their State. They just 
have to sort of live with the consequences of whatever their 
world is.
    Rhode Island has worked really hard to get the health 
information exchange up and going. I think they've done a 
terrific job. I believe that they've won every available grant 
every single time that there's been one available. Even with 
all of that, they've had such a heavy load to carry. It's like 
this little donkey trying so hard at the head of the pack with 
all these burdens of solutions that have to be achieved, and 
the Federal Government kind of over there in the next field 
throwing billions at Meaningful Use and not paying as much 
attention as it should to those States and those localities--
it's not always a full State--that are really trying to get the 
exchange piece right.
    If you're going to have health information exchange, I 
think there has to be an exchange. Maybe it can happen in the 
cloud. I think it works a lot better if there's actually an 
exchange, and I'd love to hear your thoughts on how, as we 
reconsider a Meaningful Use 2.0 or try to reboot this issue--
how should we be focusing on exchange?
    The easy way to do it is to give money to big systems, and 
then they exchange data within the system, and a CEO gives a 
rule, and everybody complies. It gets harder when you're doing 
it by State, and you've got a whole bunch of people together. I 
think that's where we have to end up, is with cross-corporate 
exchange, and it seems to me that that is something that needs 
direct attention, not just the attention of conditions being 
put on Meaningful Use.
    If you could take that right down the line, starting with 
Dr. Payne, I'd appreciate it.
    Dr. Payne. I agree with your premise that we're really 
after health information for its being used, and exchange makes 
that happen. I think one element that would really help with 
exchange would be to include the patient in that so that they 
get the entire record, because we will not be able to 
anticipate all the uses they might have for that.
    I think also that for critically ill patients who need 
exchange of information, such exchanges as you described in 
your region would be incredibly helpful. There are other 
solutions, also. I'll be brief. We have much more information 
we can provide because we agree with you that that is really 
how we're going to get the best use out of these systems that 
we've invested so much in.
    Senator Whitehouse. Mr. Richardville.
    Mr. Richardville. Yes, thank you. I would make two points. 
One is we talked earlier about the patient match or the patient 
ID. We have to solve that problem. It's a foundational 
component of exchanging information back and forth in between 
providers.
    And second is how we do it. We have to do it in a very 
cost-effective way. Today, it's onerous and it's very 
expensive, and many cannot afford to do what some other systems 
have been able to do. For me, it would be kind of moving toward 
the open API, a more innovative type of technology, to allow 
you to freely share information back and forth.
    Also, it allows innovation from other companies who 
actually have access to that as well, and they can start 
generating apps and other things for patients and others, but 
it can also consume the data from the different EMRs that we've 
all installed and put together. Those would be the two 
components.
    Senator Whitehouse. Ms. Bechtel.
    Ms. Bechtel. I couldn't agree more. Far as I understand it, 
ONC has invested about $570 million in State health information 
exchanges, so that pales in comparison to the Meaningful Use 
price tag. No question about it. They have tested a couple of 
different models, one, of course, that looks a lot like--
suspiciously like Rhode Island's.
    Also is consumer-mediated exchanges I testified to earlier. 
This is certainly an area where I think Congress could help 
invest in developing the infrastructure further.
    Senator Whitehouse. Mr. Patterson.
    Mr. Patterson. Finally, I might be a bit contraire in here, 
but I think you all pioneered some real meaningful work in 
Rhode Island. You implied, though, in your statements there's 
not a fundamental business model for the exchange. It has to 
either be financed through grants and/or through the healthcare 
providers that are exchanging information.
    The people that are actually benefiting from the 
information aren't actually funding that. It did not solve all 
of the fundamental--so you still are curating an 
identification--identification is still an issue, and it's part 
of the cost of you running it.
    What we're saying is through standards--and then get the 
software manufacturers--people who make software and sell into 
these marketplaces--and if CommonWell is not the answer, show 
it--I think we need a national system, because you've got 
boundaries. You've got water on one side but you've got 
boundaries on the other side, and people are transient. We need 
a national approach to this and one that is sustainable.
    Senator Whitehouse. Chairman, thank you for the hearing. I 
think this is very helpful and constructive, and we clearly--I 
think one thing that the witnesses will all agree on is that we 
have work to do.
    The Chairman. Well, thank you, Senator Whitehouse. I 
mentioned earlier that I thank Senator Cassidy, who I've 
asked--and you, who Senator Murray has asked, who will chair a 
hearing on physician documentation later, and that will be an 
important part of what we do.
    Senator Murray, do you have any final comments?
    Senator Murray. I don't have any additional questions. I 
just want to thank all of our witnesses for being here today. I 
think this is really a critically important conversation. I 
think we all know that effective health information technology 
is really essential to improving quality and the cost of care.
    We've got to find a way, and the best way, for providers 
and patients to share information securely and efficiently in 
order to get people the best care possible. I'm really glad 
that we're making this a bipartisan priority on this committee 
and doing the work that I think is so important to get us to a 
better place. Thank you.
    The Chairman. Thank you, Senator Murray. This has been very 
helpful. I think you can see that we're pretty committed to 
this, given the amount of time we're spending on it, and that 
we're working in a bipartisan way, not just among ourselves, 
but with the Administration.
    Of course, the best way to solve whatever problems exist 
are, first, for the community to do it itself, for the industry 
to do it itself; second, for the Administration to be able to 
do it; and, third, we might have to pass a law. In my view, 
those are the steps of preference.
    Just so I can get it clear, Mr. Patterson, you held up an 
ATM card. Would you say this is the goal, that a patient-
centered electronic medical system--that the goal is that I 
would have the ability to have all my medical information on a 
card? If we started from there and worked back to where we are 
today, would that be the way to think about this? Or am I 
simplifying it too much?
    Mr. Patterson. I think it is the goal, but it's the fact 
that the real information about what my bank account is isn't 
on that card. We have to have a way of identifying ourselves in 
accessing highly critical information at almost any point, any 
time.
    The way the ATM system works--that card does not have your 
bank balance on it. That bank balance is somewhere--I don't 
want to say in the cloud, but it is on a database. If you're in 
France, you're not going to get----
    The Chairman. If the card works, the bank needs to know my 
bank balance.
    Mr. Patterson. That's what I'm saying. I'm just saying your 
bank balance isn't on the card.
    The Chairman. What I'm really trying to get at is there are 
different ways to approach this. One way to approach it is from 
the point of view of what you do, or the point of view of what 
each of you do. The other way to think about the whole thing, 
it seems to me, would be to start with this and work back to 
all the other issues that there are.
    Mr. Patterson. I don't disagree with that. At least, it 
should work as simple as that.
    The Chairman. As I'm hearing you, what you're saying--and I 
think Senator Cassidy's comment was an important one, and I 
haven't made my mind up about this yet. Do we need to do 
something to cause to happen here what needs to happen, for 
example, standards for all the people who do what Mr. Patterson 
does, to work together?
    My very strong bias is that the less we have to do, the 
more efficient it will work. The ATM card probably doesn't work 
because of a law that Congress passed. The terrific airplane 
reservation system that we enjoy every day probably doesn't 
work because of anything we did, and if we had done it, it 
probably wouldn't work as well.
    What we need to know from you is what are the things that 
we have to do to get you to do it? That is the question, and we 
don't have to know that today. It sounds like standards is one 
of those. My bias is that we are better as enablers rather than 
mandaters--the government is, and that the more we have to 
mandate, the less successful we're likely to be.
    Senator Whitehouse. Mr. Chairman.
    The Chairman. Yes, Senator Whitehouse.
    Senator Whitehouse. Can I address your point just for one 
moment?
    The Chairman. Sure.
    Senator Whitehouse. I think that having the card and having 
a mechanism by which the individual patient has access to their 
data is one of the important goals that we need to achieve. I 
think we also need to achieve the goal for the patient who is 
unconscious, who is very elderly and perhaps at the end of 
their life, who is perhaps not at their full mental capacity, 
to have the data system work, even when the patient is not a 
participant.
    I think we've all had the experience, either ourselves or 
with loved ones, of being in a hospital and having to be there 
at the bedside to help manage what's going on just in that 
hospital, just for that patient. I think there are two goals. 
One is the ownership and command of information by the patient 
themselves, and the other is a system whose information support 
will take care of that patient even when they are alone and 
incapable and eliminates a lot of the confusion and 
misinformation that bedevils modern complex practice.
    The Chairman. Dr. Payne mentioned that example, and I see 
what--Ms. Bechtel, I wonder if you are thinking something.
    Ms. Bechtel. I am, always. How did you know? I think that, 
conceptually, you're right. The challenge is I have two ATM 
cards and three credit cards in my purse. My bank card isn't 
linked across the data systems. What is, though, is Mint, 
right, Mint.com, where I can connect it to all of my accounts. 
We still do need the electronic--the systems to connect to each 
other.
    I think you're fundamentally right, which is this is my 
electronic health record right now, and I can add to it in this 
particular version. It's not particularly secure. You saw Neal 
grabbing it earlier, and I hope I don't lose it today. The 
concept that I described around how consumers can ask for, 
aggregate, and hold their health information, at least in the 
near term, would start to unlock that data and enable me to 
share it with the providers who do need it and who can rightly 
have access to it.
    Mr. Richardville. Senator, if I could add to the comment, I 
do think that where we're moving toward, or where we'd like to 
move toward, is truly changing the culture of how health and 
care is looked at by the patients and by other consumers, and 
really move that to be part of your daily life. One aspect of 
doing that, like we've all done with our smart phones and with 
apps, for those that have those--and it keeps growing and 
growing--is that open API infrastructure that allows people 
like Mint.com and others to grab that information and present 
it back to the patient or back to the provider.
    The action that we need is to help support us to move this 
so this becomes part of the rhythm of life. You wake up every 
day. You check your email. You check your texts. You check your 
Facebook. You need to check your health status, and this is 
part of what we want to try to incorporate as we continue to 
move toward the value-based system of prevention.
    The Chairman. Dr. Payne, everyone else has had a last word. 
Would you like to?
    Dr. Payne. I would just add that innovation can help in 
coming up with ways to solve this problem. I agree with your 
approach that we want to have something we can work toward 
that's practical, and the way to come up with that is probably 
to leverage the ideas of people who are not at this table and 
maybe not even a health IT at the moment, but are clever people 
who can help us solve that problem. Our report encourages the 
development of innovation to help solve some of these problems.
    The Chairman. Senator Murray, anything else?
    Senator Murray. No.
    The Chairman. Thanks to all of you. It seems to me a couple 
of unresolved questions that I'll be looking for answers to 
are, No. 1, to followup on Senator Cassidy's point, to what 
extent do we need to use coercion to cause things to happen so 
that you can do what needs to be done? And, No. 2, I take the 
point about delay of the Meaningful Use 3 regulations. There's 
probably some downside to that.
    For something that seems to have as much resistance right 
now and as much need to improve, human nature tells me that it 
may be better to step back a little bit on at least some parts 
of the rules and work with physicians and vendors and hospitals 
and take some advice about how to improve things, and then once 
they're better, to accept and go forward. We want to do this as 
rapidly as we can. We don't want to lose the impulse to cause 
people to do this.
    At the same time, the more important thing, I would think, 
is to make sure that we get it done in a way that causes 
patients, doctors and hospitals to look forward to the 
experience of this system rather than to dread it. If you have, 
after you leave, specific suggestions about these parts of the 
regulations that absolutely not be delayed, these parts might 
be delayed while we continue to work together to try to improve 
them, that would be very helpful.
    The hearing record will remain open for 10 days. Members 
may submit additional information if they would like.
    The next hearing will be Achieving the Promise of Health 
Information Technology: What Can Providers and the U.S. 
Department of Health and Human Services Do To Improve the 
Electronic Health Record User Experience? That's the one which 
the shorthand name would be physician documentation, and 
Senator Cassidy and Senator Whitehouse will chair that. Senator 
Whitehouse will be the ranking member on that hearing.
    Thank you for being here today. The committee will stand 
adjourned.
    [Additional Material follows.]

                          ADDITIONAL MATERIAL

                                             July 14, 2015.

To:  Alicia Hennie, Health Policy Advisor, Sen. Alexander (R-Tenn.); 
Colin Goldfinch, Health Policy Advisor, Sen. Murray (D-Wash.)

From:  Jeffery Smith, Vice President Public Policy, AMIA

Re:  Strategies to improve interoperability of health IT through 
changes to certification and adoption incentives

    This memo outlines ways to amend and enhance Federal health IT 
policy to further widespread interoperability. Recommendations focus on 
ONC's Health IT Certification Program and potential changes to CMS's 
incentive structure for meaningful use and other value-based 
reimbursement programs.
                  onc health it certification program
    As part of the HITECH Act, the Office of the National Coordinator 
(ONC) for Health IT established a health IT certification program to 
help ``ensure that health IT conforms to the standards and 
certification criteria adopted by the Secretary of Health and Human 
Services.'' \11\ The Federal health IT certification program is meant 
to provide assurances to users that the technology meets certain 
capability, functionality and security requirements adopted by HHS, and 
provides assurance that the products are interoperable (the systems can 
exchange information and use that information for a specific purpose 
once it's received). As the Federal Government's only policy lever to 
impact the technical development of information technology in 
healthcare, ONC's Certification Program should be seen as vital pathway 
to improve interoperability, usability and patient safety.
---------------------------------------------------------------------------
    \11\ ONC Health IT Certification Program, ``About the ONC Health IT 
Certification Program,'' http://bit.ly/1FLG7ip accessed June 11, 2015.
---------------------------------------------------------------------------
Recommendations
     Improve interoperability through more robust testing.

          Require interoperability testing on both the sending 
        and receiving of data.
          Incorporate exception handling into EHR 
        certification.
          Develop C-CDA guidance and tests to support exchange.

     Contract for--or otherwise solicit--testing methods from 
developers and other stakeholders.

          This is a current policy option, but ONC has had 
        limited success engaging with others to help develop testing 
        methods.
          Without more ``skin in the game'' vendors may 
        continue to ``develop to the tests'' that government 
        policymakers design.

     Force transparency into obfuscated market.

          Require additional information to be submitted for, 
        or captured during, certification testing, and make these 
        publicly available. This includes:

                  Establish greater transparency and uniformity 
                on UCD testing and process results.
                  Screen shots and/or video of workflow 
                configurations.
                  Screen shots and/or video of exception 
                handling with data provided by testing body, not the 
                developer.
                  Participation in on-going interoperability 
                testing with an ONC-ACB or other entity, as designated 
                by the HHS Secretary.

          Require ONC-ACBs to conduct post-market surveillance 
        through in situ testing.

                  This will require resources and agreement on 
                how to test, which will require stakeholder buy-in.
                  This is in keeping with anti-information 
                blocking efforts.

          Promote pathways and protocols for users of certified 
        technology to report information blocking.

     Provide regulatory clarity and certainty to an emerging 
market.

          Support ONC efforts around the Standards Advisory and 
        regular updates to Certified Health IT Editions.

                  This supports policies already underway at 
                ONC, but will require on-going leadership when the 
                inevitable pushback comes.

          Make ONC develop a multiyear--3- or even 5-year--
        Edition development plan.

                  This would be similar to a vendor's product 
                development plan and it would help vendors know what to 
                expect long before its officially proposed as part of a 
                regulation.
                  An example might be a certification for LTPAC 
                or behavior health, improvements to quality measure 
                report generation, etc.

          Limit the scope of ONC certification to areas with a 
        ``demonstrated need''.

                  This will help assuage fears that ONC will 
                start certifying everything in health IT and it would 
                create an opportunity to define some kind of rationale 
                identifying circumstances when certification would be 
                more harmful than helpful.

     cms incentives: meaningful use and other value-based payments
    Should ONC make substantive improvements to its certification 
program, it will not have the intended impact unless there are 
continued incentives (positive and negative) to drive further adoption 
of health IT and to compel continued upgrades of certified health IT 
technology. While we acknowledge that financial incentives are not the 
domain of Senate HELP, we felt it was important to complete the logic 
model of how to improve interoperability from a policy and program 
perspective.
Recommendations
     Provide relief to a highly regulated sector of the 
economy.

          Prohibit CMS from issuing a final Stage 3 rule until 
        at least 60 percent of EHs and EPs are successfully 
        demonstrating Stage 2 (as defined in an upcoming rule--expected 
        August 2015).

     Provide incentives rather than deadlines.

          Sunset MU penalties and make CMS incorporate MU 
        ``status'' as part of reimbursement updates ala MACRA/MIPS.

                  This provides long-term sustainability in 
                incentive to participate in the program; without which 
                all other policy levers are substantially weakened.
                  Hospitals are not impacted by MACRA and so 
                their market basket update would be a good candidate to 
                make this happen.
                                 ______
                                 
    Response by Thomas H. Payne, M.D., FACP, FACMI, to Questions of 
                  Senator Alexander and Senator Murray
                           senator alexander
    Question 1a. Many stakeholders have suggested that the health 
information technology industry could come up with many solutions to 
the problem of interoperability on its own. However, so far, we are 
stuck with a system that does not work even though the government has 
spent over $30 billion.
    What areas would be best determined by private industry? What areas 
should the government decide, if any?
    Answer 1a. Overview: Americans benefit when their health 
information is available when and where needed. To get there, the 
private sector should be responsible for developing technical standards 
to support interoperability that have consensus across stakeholders. 
The government should help convene stakeholders, support pilots and 
enforce adherence to standards--their use in certified products, their 
implementation in provider settings and their application toward the 
widespread use of ``open'' EHRs.\1\ The government should also continue 
to create and integrate incentives for use of health IT as part of 
evolving alternative payment models. Further, the government should 
conduct a full review of Federal and State privacy laws, harmonizing 
legal inconsistencies, correcting misinterpretations and prosecuting 
bad actors who inhibit exchange or improperly disclose information.
---------------------------------------------------------------------------
    \1\ Sittig DF, Wright A, J Am Med Inform Assoc 2015;0:1-3. 
doi:10.1093/jamia/ocv060.
---------------------------------------------------------------------------
    Detail: The current state of interoperability cannot be addressed 
solely by the health information technology (health IT) industry. As 
you and your committee have heard, the lack of interoperability--the 
ability of two or more systems to exchange data and use that data to 
care for patients once exchanged--is a multifaceted problem. Numerous 
technical, business and cultural barriers have converged to inhibit the 
free flow of information in healthcare and nothing short of on-going 
public-private collaboration will change this current State of 
challenges.
    Policymakers should focus their efforts on refining the mechanisms 
and policy levers already at their disposal and consider augmenting 
those levers with new ones. Specifically, the Federal Government's 
primary policy lever when it comes to interoperability is the Federal 
Health IT Certification Program and health IT adoption incentives. 
Certification has the potential to produce harmonized technology that 
conforms to foundational standards upon which developers can innovate 
and augment technology for their customer's needs. This has always been 
the goal of the Federal certification program, but only recently has it 
been possible.
    Prior to 2012, there was no national conversation, nor agreement, 
on standards prerequisite for interoperability: namely, content 
standards, vocabulary standards and transport standards. Prior to 2014, 
and perhaps even true to this date, the technology bundle containing 
these standards--the 2014 Edition of Certified EHR Technology (CEHRT)--
had not been widely adopted, as required for Stage 2 of meaningful use 
(MU). Also, prior to 2014, no hospital or physician had met the 
objectives for Stage 2, which included process requirements to exchange 
health information across care delivery settings and technology 
platforms. According to the most recent data available from the Centers 
for Medicare & Medicaid Services (CMS) only 36 percent of hospitals and 
10 percent of eligible professionals have met the requirements of Stage 
2, using the 2014 Edition of CEHRT.\2\ Moreover, 91 percent of 
hospitals and 82 percent of professionals chose to defer the 
requirement to send a summary of care record at transitions of care, 
which is the process requirement in MU Stage 1, preceding the most 
straightforward ``interoperability requirement'' in Stage 2 to 
electronically send a summary of care record at transitions of care.\3\ 
In other words, the ecosystem of technology and processes which would 
demonstrate interoperability to a degree worthy of $30 billion in 
taxpayer investment is highly underdeveloped and the vast majority of 
providers do not even practice the processes laid out in regulation 
that would move data from place to place. This is true even without 
considering the business and policy barriers that inhibit 
interoperability.
---------------------------------------------------------------------------
    \2\ Centers for Medicare & Medicaid Services, ``May 2015 CMS HITPC 
Report,'' http://go.cms.gov/1MhJ924 (accessed July 9, 2015).
    \3\ Ibid.
---------------------------------------------------------------------------
    I will not go into detail here, but as it pertains to your 
question, Congress should continue efforts to change Medicare & 
Medicaid fee-for-service reimbursement by helping CMS develop, evaluate 
and scale alternative payment models. Changing how we pay for care can 
lead to great advances in interoperability. Congress should also 
reassess Federal & State privacy laws--with broad input from patients, 
providers, researchers and the informaticians who support them.
    In my testimony, I mentioned the need to,

          ``streamline the Federal health IT certification program so 
        that the process is more flexible, more transparent, focuses on 
        clinically relevant functionality, and tests for true 
        interoperability.''

    The practical application of this phrase is provided in a memo 
developed by AMIA staff, and included as an enclosure to this response, 
but I would reinforce the notion that to improve interoperability, 
Congress should focus on improving ONC's certification program, 
especially as it relates to testing for interoperability, and 
reconsider ways to incentivize further adoption and continued upgrade 
of certified health IT technology.
    Finally, Congress should embrace the notion of ``slowing down 
regulation to accelerate progress on EHR usability, interoperability 
and innovation.'' Federal regulators should not rush to get to the next 
stage of meaningful use, but should instead work to help the private 
sector accelerate optimization of the tools and regulations that are 
already in place. Again, the enclosed memo goes into more detail, but I 
reiterate my previous statement that Stage 3 rules not be finalized in 
haste. I believe it is imperative that Congress keep MU requirements, 
with penalties for noncompliance, in place over the near and mid-term. 
The forthcoming ``meaningful use modifications'' rule has proposed a 
number of changes to help streamline and simplify participation.\4\ 
These changes would apply to the current program year through to 2018 
and they will give providers a stationary set of requirements while 
technology optimization and workflow enhancements occur.
---------------------------------------------------------------------------
    \4\ Centers for Medicare & Medicaid Services, Notice of Proposed 
Rulemaking (CMS 3311P) http://go.cms.gov/1HqJNqV.

    Question 1b. Does the government need to set deadlines or otherwise 
encourage industry to make decisions?
    Answer 1b. Overview: Deadlines are not as impactful as providing 
strong incentives.
    Detail: Both positive and negative government incentive programs 
have been successful in converting health information from paper to 
electronic form. This was necessary for interoperability, but not 
sufficient. There have also been encouraging efforts for greater 
interoperability in the private sector, such as CommonWell Health 
Alliance,\5\ the Sequoia Project\6\ and others. However, the vast 
majority of work--and all of the regulatory consequences--of exchanging 
and using healthcare data falls to hospitals, physicians, clinics, and 
other providers. And few are happy with the result we've achieved to-
date. Today, the best way to ensure data can be used at the point of 
care across settings is to have a single EHR vendor across all 
settings. This single-system approach is counter to prevailing trends 
in technology, which allow for substitutability and modularity. The 
most successful utilizers of information technology know that diversity 
is far preferable than expecting one system to do all functions well. 
But adherence to common standards is prerequisite for a diverse 
ecosystem to work.
---------------------------------------------------------------------------
    \5\ http://www.commonwellalliance.org/.
    \6\ http://sequoiaproject.org/.
---------------------------------------------------------------------------
    As an example of the current state, there are enormous national 
meetings for customers of EHR vendors. There is no comparable meeting 
devoted to interoperability across EHR vendor products, or in caring 
for patients whose health records are dispersed. The unspoken message 
is that the simplest route to interoperability is to use one vendor, 
but this does not fit how Americans live and receive health care.
    And this is where government can help.
    Incentives should be changed so all government-certified EHR 
vendors whose products are used to care for Medicare/Medicaid 
beneficiaries work together to have the same rapid advance in 
interoperability that we have seen in EHR adoption. This doesn't mean 
government creates interoperability. It means government moves the 
market toward rapid rise in interoperability.
    New incentives are not needed, nor are heavy-handed penalties. The 
recently passed MACRA may provide a template for incentives that can be 
long-lasting and impactful. For physicians participating in the Merit-
based Incentive Program System (MIPS) meaningful use penalties will 
sunset in 2018, and participation in MU will constitute \1/4\ of a 
composite score that will determine a physician's reimbursement rate. 
This dynamic provides a pay increase for successful participation in 
MU, which is significant because there are very few--if any--incentive 
dollars left from the HITECH Act in 2018. For physicians participating 
in MIPS who fail to meet meaningful use requirements, they forego the 
possibility of obtaining a full increase in payment, but it does not 
necessarily translate to a penalty, or a negative payment adjustment.
    Congress should look at this model and determine if a similar 
approach can be used with hospitals and clinicians not participating in 
MIPS. Increases to hospitals' market basket update, or additional funds 
for ACOs, bundled payments, et cetera, could be leveraged to encourage 
participation. Nonparticipation will not be penalized, yet money will 
be ``left on the table,'' so to speak. Key to this recommendation is 
adjusting the meaningful use ``all or nothing'' paradigm where 
providers must meet all requirements or receive no incentives/full 
penalties. Such flexibility will be needed to keep providers engaged in 
the only Federal Government program that dictates use of modern 
information and communication technology in healthcare.
    Likewise, Congress needs to examine ways to incentivize--or 
compel--interoperability between and among competing EHR developers as 
a business imperative, rather than just pressuring providers and care 
delivery system.

    Question 2a. If you could change all or parts of the rules for 
Stage 2 and 3 of Meaningful Use and the 2015 certification rule, what 
would you change?
    Are there particular parts that should be delayed and others that 
should go forward? What changes would you make to them?
    Answer 2a. On the macropolicy level, the ``Stage 2 modifications'' 
rule, issued by CMS April 10, 2015, should be finalized as soon as 
possible and it should be finalized largely as proposed. The 
certification rule, likewise should be finalized on schedule and 
according to general consensus received through the open commenting 
process. Stage 3 meaningful use rules should not be finalized until 
2018--at the earliest--or until 60 percent of EHs and EPs are 
demonstrating Stage 2 as modified. This dynamic keeps provider 
requirements set for a time where technology and workflows can be 
optimized to deliver on the promise of modern communication and 
information technology. It also allows for ONC to move forward with 
updates to certified technology to incorporate fixes to known ``bugs'' 
or to accommodate emerging national standards.
    On the program design-level, participation in meaningful use cannot 
continue 365-days per year ad infinitum. Much-needed downtime for 
upgrades, bug fixes and workflow re-design is necessary during any, and 
most likely every, year. For this reason, and for related reasons of 
patient safety, CMS should not require 365-day EHR reporting periods, 
but something closer to 180-days or 270-days. Likewise, more 
flexibility needs to be built into the program by removing the ``all or 
nothing'' construct. Especially as the program is integrated into MIPS, 
there are rational policy changes that could allow for this to happen 
because meaningful use becomes part of a composite score dictating 
reimbursement. A rudimental example could be that if a physician meets 
80 percent of MU objectives, they receive 80 percent of the available 
meaningful use points that are part of the composite score.
    On the program content-level, it will be difficult for various 
stakeholders to agree on all the necessary program components. 
Meaningful use was developed with broad input from various stakeholders 
and because of this, it has requirements important to many groups of 
health professionals and patient advocates. The problematic areas of 
the program are well-documented--patient action requirements, such as 
patient portals and secure messaging and summary of care requirements 
for transitions of care are among the most often cited. Despite the 
challenges associated with these objectives, they have strong support 
from different segments of the stakeholder community, and they have 
illuminated technical, cultural and business barriers that are signals 
of progress. We would not be as cognizant of our ``interoperability 
problem'' without the requirement that data be exchanged and used after 
transitions of care--or at least we would not know the extent of the 
challenge.

    Question 2b. Do you think that the proposed rules will make health 
information technology better? If so, which parts?
    Answer 2b. The degree to which MU and the Federal health IT 
certification program have advanced the ecosystem for health IT cannot 
be overstated. The regulations have served as an important catalyst and 
the work to develop and implement them has enabled the entire sector to 
evolve at an incredibly fast rate. We can't exchange health information 
electronically if it is on paper. The proposals in question will 
undoubtedly have a positive impact on the health IT landscape, but they 
will also engender more disdain unless they are implemented properly--
at a pace the industry can handle and with flexibility to accommodate a 
dynamic system.
    Specifically, the Stage 2 modifications rule will make several 
changes to remove topped-out measures and provide a single definition 
for all providers beginning 2015. Keeping the requirements steady for a 
period of 3 to 5 years will give providers time to optimize the 
technology they have and developers the time to innovate on the 
versions already deployed. Lowering the patient action thresholds, 
while controversial, is the right step absent a more nuanced 
conversation over how to encourage--and measure--patient engagement.
    ONC's 2015 Edition Certification rule contains many proposals that 
should improve the State of health IT, including:

     A proposal to expand the ONC Health IT Certification 
Program to additional types of care and practice settings;
     An expansion of existing surveillance efforts of health IT 
under the ONC Health IT Certification Program, where ONC-ACBs 
(authorized certification bodies) would conduct annual randomized in-
the-field surveillance;
     A significant expansion of health IT developer 
transparency and disclosure requirements for certified health IT;
     Expansion on the 2014 Edition transitions of care 
criterion by using updated C-CDA standard and requiring capabilities to 
detect valid and invalid C-CDA documents;
     Enhanced requirements for data portability to facilitate 
the accessibility and exchange of data; and
     A new requirement that health IT would have to demonstrate 
that an API responds to data requests for any one, and for all, of the 
data referenced in the Common Clinical Data Set (CCDS). This criterion 
would rigorously assess a product's C-CDA creation performance (for 
both C-CDA version 1.1 and 2.0) when presented for certification for 
exchange capabilities.

    The net-effect of these changes should be more usable, safer and 
more interoperable health IT. However, passing a regulation with these 
changes does not ensure these outcomes. Developers must build 
technology that performs these functions in a way that corresponds with 
how care is delivered; providers must adopt, implement, test, train and 
use the technology as its intended and a large share of providers must 
do this before the impacts will be noticeable.

    Question 2c. Are there any parts of the proposed rules that you 
think would make health information technology worse? If so, which 
parts?
    It may be premature to know which parts of the proposed rules will 
make HIT worse, but there are a number of proposals that necessitate 
close watch; that will be very difficult to operationalize and scale; 
or that will create stress on an already-stressed system. For example, 
the Stage 3 proposed requirements to incorporate patient-generated 
health data and requirements related to ``clinical information 
reconciliation'' fall across several of the aforementioned categories. 
There are well-documented use cases where PGHD or reconciliation have 
added value and safety to care, but these are domains with little 
experience and immature standards.
                             senator murray
    In your testimony, you suggest that in order to,

        ``see the same success that we've seen in the internet, we need 
        a stable base of standard building blocks that allows us to 
        create new technology to benefit patients.''

    You also note that these ``building blocks'' will support the 
development of new electronically specified clinical quality measures 
to help streamline and improve Medicare's quality incentive programs.
    Question 1. How would these building blocks allow for the 
development of better measures and streamlined processes for reporting 
electronically specified measures? Could they help align reporting 
requirements across quality reporting programs and accelerate 
interoperability between electronic health records and registries?
    Overview: Congress is well-positioned to help advance quality 
measurement in healthcare by moving toward outcomes-based clinical 
quality measures (CQMs) and by supporting technical improvements to 
CQMs produced in the digital age. Given Federal plans to accelerate 
toward reimbursement based on value and outcomes, rather than volume, 
now is the right time to think systematically about quality 
measurement. This means simplifying the process, streamlining the 
number, and harmonizing the types of CQMs required for public 
reporting. Alignment of CQMs across programs is largely a policy issue; 
whereas the need to generate accurate and complete CQMs, and accelerate 
interoperability between EHRs and registries is a technical one.
    In order to accelerate development of quality measures to improve 
Medicare's quality incentive programs, and to improve interoperability 
between EHRs and registries, policymakers must take three important 
steps: (1) review and adopt a national format standard for common data 
elements (CDEs) used to generate CQMs; (2) simplify quality measures by 
rethinking exclusion criteria for CQMs and (3) improve the quality of 
data in CQMs by encouraging broader adoption of up-to-date EHRs.
    Detail: Similar to the internet, there are foundational ``building 
blocks'' that support flexible, standards-based interoperability. For 
health IT there are five building blocks that we need to facilitate 
standards-based exchange of information and streamlined 
interoperability:

    1. Standardized Meaning
    2. Standardized Format (or structure)
    3. Standardized Transport
    4. Standardized Security
    5. Standardized APIs or services
Standardized meaning
    Standardized vocabularies and terminologies like SNOMED and ICD-10 
allow a computer to understand that ``heart attack'' and ``myocardial 
infarction'' are the same concept, because they have the same 
standardized code. MU provides for four major vocabularies--LOINC for 
lab tests, RxNorm for medications, SNOMED for problem and symptom 
descriptions and ICD-10 for billing diagnoses. These should be used for 
all quality measures and registries so that the vocabularies are the 
same as those used in EHRs.
Standardized Format
    MU has adopted a number of document-centric ways to standardize 
information that include a patient care summary or a transitions of 
care document. However, two additional standardized formats are needed: 
(1) A standardized format for granular data that can be used to build 
quality measures and new kinds of documents; and (2) a standardized 
format for unstructured data so that patients can share their entire 
medical record in an electronic format. Both of these play an important 
role in improving quality reporting.
Standardized Transport and Security
    These standards are typically drawn from fundamental building 
blocks that support the internet and the WWW. In healthcare, we should 
leverage these mechanisms like email and Web page interactions, or 
secure ways to encrypt data or authenticate users, but not develop 
specific transport or security standards .
Standardized Services, such as Application Programming Interfaces 
        (APIs)
    APIs provide very specific channels or connections between two 
systems. These are useful to connect systems, but cannot substitute for 
a full export of a medical record for a patient to access their 
information.
    By focusing development on format standards that are more data-
centric and less document-centric, different pieces of medical data can 
be used in modular ways. Perhaps no better example of this is quality 
measurement. Development of granular data standards would most 
certainly yield positive benefits for quality measurement reporting, 
measure specification alignment and facilitate interoperability of EHRs 
and registries.
    Quality measures are made up of three kinds of information: (1) 
Meta-data; (2) a data value; and (3) a formula. The meta-data describes 
what the quality measure is, when it was developed, who developed it, 
and other provenance data. Data value, includes the actual values for 
things like lab test result, medication, or problem list, for example. 
Finally a formula is needed to calculate the quality measure; for 
example a formula to identify all patients with diabetes who have an 
elevated HbA1C.
    If one had a granular data element that defined diabetes (all 
patients with a problem list that had a SNOMED code for diabetes) and 
defined what an ``elevated HbA1C level'' is, one could identify those 
patients who need more help caring for their diabetes. In the diagram 
below, each of the boxes represents a granular data building block that 
are reusable.

    This approach is generalizable. If there was a national common data 
element structure that used standardized vocabularies, the same 
structure could be used to describe the data values in a quality 
measure, the data values in a registry, and the data values in the 
electronic health records. This common format would accelerate 
interoperability for granular data elements, and provide a fundamental 
building block for other initiatives such as precision medicine and 
decision support.
    Candidate standards for common data elements (CDE) currently exist. 
For example, a CDE standard was developed through the standards and 
interoperability framework at ONC (http://hl7.org/fhir/2015May/
sdc.html), and has been balloted through HL7 as a FHIR resource; 
however the standards has yet to be adopted by Federal agencies. Such a 
format standard, if adopted nationally, would be an important step 
toward accelerating quality reporting programs, registry and EHR 
interoperability.
    Once there was a common format standard for granular data elements, 
additional work to agree on the standardized meaning would be greatly 
accelerated. Domain experts in medicine and quality assessment can 
focus on reaching agreement on the definitions of data elements, 
knowing that once an agreement is reached on the definitions, the 
technical format will allow for rapid adoption and use for quality 
measures, registries, and EHRs.
    Last, I would urge Congress to use the upcoming development of the 
MIPS as an opportunity to focus more work toward simplifying quality 
measures in healthcare. Many measures have tens of hundreds of data 
elements that are of dubious quality and that complicate the user 
interface and documentation requirements for clinicians. Each 
additional data element creates additional cost and complexity while 
adding only marginal value. One source for this problem is a 
proliferation of exclusion criteria, which are highly variable across 
programs and CQM specifications. We would do better to have quality 
measures with simple, but high-quality data.

    Question 2. How would you recommend that clinicians and HHS 
identify these building blocks, and what process should be used to 
translate them into quality measures?
    Answer 2. The Federal Government has a process to develop and 
maintain quality measures, and this process has gone through several 
evolutions since EHRs were used to generate quality measures. The 
unfortunate truth is that the current process is still new and still 
evolving, and I fear that it will need further modification and 
improvement before it will yield the intended results. This means 
dedicated resources are needed and the process must include individuals 
with deep clinical and technical expertise.
    Generally speaking, the National Quality Forum (NQF) and CMS have 
worked to ``regularize'' a process to identify areas of quality 
measurement and update those quality measures over time. Through the 
Measure Applications Partnership (MAP) HHS has convened multiple 
stakeholders to guide ``the selection of performance measures for 
Federal health programs,'' to provide ``a coordinated look across 
Federal programs at performance measures being considered.'' \7\ This 
effort has been developing recommendations since 2011 and has played an 
important role in helping define core measures for Medicaid 
populations, including adults, children and dual eligible 
beneficiaries. However, work related to eMeasures or eCQMs (measures 
generated by EHRs) is still on-going with little demonstrable success, 
due to a lack of aforementioned building blocks. The original notion 
was to ``retool'' paper-based measures as electronically generated 
measures. This approach has been largely abandoned and now most eCQMs 
are de novo, or newly constructed. The foundational problem is that 
some data needed to complete eCQM specifications are not currently 
captured by EHRs, or not captured in a way that can be used to generate 
quality measure reports.\8\ \9\
---------------------------------------------------------------------------
    \7\ National Quality Forum, Measure Applications Partnership, 
http://bit.ly/1dW7VJq (accessed July 10).
    \8\ Amster A., Jentzsch J., Pasupuleti H., Subramanian K 
``Completeness, accuracy, and computability of National Quality Forum-
specified eMeasures,'' J Am Med Inform Assoc, http://dx.doi.org/
10.1136/amiajnl-2014-002865 409-16, October 2014.
    \9\ Garrido T., Kumar S., Lekas J., et al, ``e-Measures: insight 
into the challenges and opportunities of automating publicly reported 
quality measures'' J Am Med Inform Assoc, http://dx.doi.org/10.1136/
amiajnl-2013-001789 181-84 Jan. 2014.
---------------------------------------------------------------------------
    As is often the case in the regulator-regulated relationship, 
requirements developed by the regulators are often incomplete because 
regulators have little direct exposure to the regulations they develop. 
In this instance, measure developers, technology developers and 
government regulators are not required to gather/input data necessary 
to generate eCQMs--clinicians gather these data at the point of care, 
often in ways unreflective or disjointed from clinical workflows. This 
has contributed to poor usability in EHRs and incomplete quality 
measures.\10\
---------------------------------------------------------------------------
    \10\ Parsons A., McCullough C., Wang J., Shih S., ``Validity of 
electronic health record-derived quality measurement for performance 
monitoring,'' J Am Med Inform Assoc, July 2012 http://bit.ly/1HqDUtK.
---------------------------------------------------------------------------
    One potential approach would provide dedicated resources to quality 
measure experts, inside and outside government, developers and 
clinicians to develop measures consistent with realistic clinical 
workflows. Bringing together clinical and technical expertise could 
then help inform the process already developed by CMS and the NQF MAP. 
Stated simply, measure developers and EHR developers must incorporate 
the views of practicing clinicians and their workflows. However, 
without a granular data standard, as outlined above, we will continue 
to have little success measuring quality as a ``byproduct'' of care 
delivery.

                                 ______
                                 
                               Carolinas HealthCare System,
                                                     July 13, 2015.
Hon. Lamar Alexander, Chairman,
Health, Education, Labor, & Pensions Committee,
U.S. Senate,
Washington DC, 20510.

Hon. Patty Murray, Ranking Member,
Health, Education, Labor, & Pensions Committee,
U.S. Senate,
Washington DC, 20510.

    Dear Chairman Alexander and Ranking Member Murray: Thank you for 
the opportunity to testify on behalf of Carolinas HealthCare System and 
the Premier healthcare alliance at the ``Health Information Exchange: A 
Path Toward Improving the Quality and Value of Health Care for 
Patients'' hearing on June 10, 2015. Attached are my responses to the 
Questions for the Record posed by the Chairman and the Ranking Member.
            Sincerely,
                                        Craig Richardville,
                 Senior Vice President & Chief Information Officer,
                                       Carolinas HealthCare System,
                                Chair, Premier Healthcare Alliance,
                          Member, Technology Improvement Committee.
                                 ______
                                 
    Response by Craig D. Richardville, MBA, FACHE, to Questions of 
                  Senator Alexander and Senator Murray
                           senator alexander
    Question 1. Many stakeholders have suggested that the health 
information technology industry could come up with many solutions to 
the problem of interoperability on its own. However, so far, we are 
stuck with a system that does not work even though the government has 
spent over $30 billion.
    What areas would be best determined by private industry? What areas 
should the government decide, if any?
    Does the government need to set deadlines or otherwise encourage 
industry to make decisions?
    Answer 1. Despite its potential, the current HIT ecosystem 
continues to be challenging for healthcare providers because of a lack 
of interoperability between systems. Cost-effective, efficient, and 
easy to use and integrate health information is foundational to 
advancing and providing excellent care in this country.
    As this committee heard earlier this year, the current market 
incentives are not aligned with open exchange of necessary healthcare 
data in cost-effective ways. The sharing of data that sits in software 
systems across the care continuum is not only technically complex, it 
is also expensive and time-consuming to integrate. Data resides in many 
systems, not just electronic medical records. Registration, billing, 
lab, pathology systems, medical devices, sensors and monitors, to name 
just a few, all have vital data that can and should be integrated and 
accessible across the care spectrum, no matter what the underlying 
software system is. The difficulty in achieving this has an impact not 
only in care quality but also in cost.
    Despite the challenges, significant strides have been made with 
digitizing health information in the last 6 years. More than 80 percent 
of eligible providers and more than 90 percent of hospitals have begun 
the work to digitize their patient health data. Still, achieving 
necessary data integration to move forward has not been easy or 
inexpensive. Today, in order to build the bridges that connect 
disparate data sets necessary to provide comprehensive and informed 
decisions or care, providers must either pay their original system 
vendors thousands and sometimes millions of dollars to custom code 
linkages so they can ``talk'' to other systems, or they often find 
paper-based workarounds that are fraught with potential for both errors 
and wasted resources and expense.
    In order to achieve the goal of having data that is secure, 
accessible and actionable by providers and patients, one of the key 
prerequisites is creation of patient matching systems. It is imperative 
that for the patient data to be interoperable we have a rational and 
effective method to match the right data to the right patient. A 
patient matching system is also foundational to interoperability. This 
goal of a secure HIT ecosystem that enables an easy exchange of health 
information in timely and cost-effective ways could be achieved with 
foundational work in patient matching.
    To accomplish these goals, we ask for a combination of 
congressional and administrative actions that promote policy principles 
that further open health IT infrastructures. In creating those 
structures, we need clear rules of the road for providers and vendors 
alike through establishment of functional data and transport standards, 
and methods to measure and test functionalities, with enhanced 
enforcement tools for regulatory bodies to drive compliance in the 
marketplace. These include:

     Establishing governance: A private-public partnership on 
HIT interoperability governance should be established to provide clear 
rules of the road on interoperability. This should be done in 
consultation and coordination with Federal agencies, such as HHS and 
ONC, and the private sector. Providers, vendors, patients and payers 
should be consulted. The government entities should provide regular 
reports to Congress and the Administration on current standards 
development status as well as ready to market timelines and assessments 
for their applications.
     Identifying functional data and transport standards that 
promote interoperability and innovation: The governance mechanisms 
should focus on identifying and setting the development of functional 
data and transport standards in key areas including: patient matching, 
terminologies, clinical data query language, security, open application 
program interfaces (APIs), and clinical decisions that support 
algorithms as well as business practices and policies.
     Focusing on public interoperability, cost and quality: 
Transparent and public measures of interoperability should be developed 
in collaboration with the Federal Government, including HHS and ONC, 
and standard-setting bodies in consultation with the private sector and 
be required as part of ONC's certified technology program.

          These measures should be validated and tested in 
        terms of functional standards, processes, and their maturity 
        for application in the marketplace in a timely way, and within 
        specific use case scenarios.
          Measures should include business and implementation 
        approaches that deliver functional interoperability outcomes 
        and include operational processes and implementation practices.
          Measures should also include assessment of clinical 
        quality and cost efficiency metrics achieved through 
        incorporating innovative technologies, such as existing APIs, 
        which are open source codes that enable third-party 
        applications to exchange data.

     Encouraging transparency: Data should flow freely and 
easily. Determinants of transparency should include:

          Availability of ``free'' (no cost) export of 
        publishable EHR domains.
          Prohibition of specific fees for access to necessary 
        data through API or other functional standard callable methods.
          Publication of technical instructions on how to 
        interact with APIs, interface standards or other callable 
        methods. These should be published either publicly or broadly 
        to any authorized third party.
          Requiring technology and devices that generate health 
        information to publish clinical data to any other authorized 
        consuming applications, including EHR/EMRs, to create 
        interoperability. Consuming applications' ability to develop 
        methods to ingest information from other HIT assets, including 
        devices, should adhere to current and future medical device 
        interoperability standards.

     Enforcing functional data and transport standards and 
measures of HIT: The Federal Government should be enabled to enhance 
its enforcement tools to ensure functional data and transport standards 
and to measure compliance of vendors through its certified technology 
program. Enforcement also can be encouraged through measurement and 
adherence to Meaningful Use standards.

    Question 2. If you could change all or parts of the proposed rules 
for Stage 2 and 3 of Meaningful Use and the 2015 certification rule, 
what would you change?
    Are there particular parts that should be delayed and others that 
should go forward? What changes would you make to them?
    Do you think that the proposed rules will make health information 
technology better? If so, which parts?
    Are there any parts of the proposed rules that you think would make 
health information technology worse? If so, which parts?
    Answer 2. Given the complexity of the objectives proposed under 
Stage 3, we believe meaningful use of EHRs can only be achieved if and 
when data captured in various EHRs and other data systems are 
interoperable. Being able to fully leverage the robust clinical and 
health data in various disparate systems is essential not only to 
deliver efficient, high-quality, and patient-centered care but also to 
provide patient access and engagement. The data is digitized. Now it 
needs to be shared freely and easily. The HIT assets within the current 
ecosystem continue to be challenging for healthcare providers; however, 
due to the lack of interoperable HIT infrastructure as market 
incentives are not aligned with the open exchange of necessary 
healthcare data in cost-effective ways. As a result, data is locked in 
proprietary software systems.
    As we have commented to CMS on the proposed rules for Stage 3, 
without an interoperable HIT infrastructure in place first, the 
increased thresholds for the various objectives proposed under Stage 3 
will be challenging for providers. While we applaud the optional 
measures utilizing APIs to meet some of the objectives proposed, we 
have requested that CMS minimize and keep consistent the baseline 
compliance thresholds when it comes to most of the objectives and 
patient access and engagement provisions in particular. More 
specifically:

     Calendar Year Reporting Period for 2015 CEHRT. Under the 
CMS proposed rule, the EHR reporting period for all providers, 
including eligible professionals (EPs), eligible hospitals and critical 
access hospitals (CAHs), would be a full calendar year, beginning with 
calendar year (CY) 2017. In particular, for the first year in which the 
2015 edition of certified EHR technology (CEHRT) must be used and Stage 
3 meaningful use requirements met, providers would have a full CY 2018 
EHR reporting period.
    We strongly oppose requiring a full calendar year reporting 
requirement for the first year of Stage 3, whether that first year 
occurs in 2017 (by a provider's choice) or in 2018 (as required under 
the proposed rule). It is unrealistic to expect all providers to adopt 
a new edition of CEHRT and initially meet the full array of Stage 3 
meaningful use requirements for an entire year, whether or not they 
have previously been able to satisfy Stage 1 or Stage 2 EHR meaningful 
use requirements. We, therefore, urge CMS to allow for a 90-day 
reporting period for the first year. We argued for similar treatment 
for 2015 and CMS has recently, and somewhat belatedly, proposed to 
provide this recommendation. We believe it would be a serious mistake 
to fail to give providers the flexibility to use a 90-day reporting 
period for the first year in which they adopt the 2015 Edition of CEHRT 
to meet Stage 3 requirements.
     Objective 4: Computerized Order Entry. Objective 4 focuses 
on computerized provider order entry (CPOE) for medication orders, 
laboratory orders, and diagnostic imaging orders. The proposed 
objective calls for such orders to be directly entered by any licensed 
healthcare professional, credentialed medical assistant, or a medical 
staff member credentialed to and performing the equivalent duties of a 
credentialed medical assistant who can enter orders into the medical 
record per State, local, and professional guidelines. CMS emphasizes 
that a layperson is not qualified to perform functions associated with 
order entry, and that medical staff whose organizational or job title, 
or the title of their credential, is other than medical assistant may 
enter orders if these staff are credentialed to perform the equivalent 
duties of a credentialed medical assistant by a credentialing body 
other than their employer.
    Providers' primary concern with this proposed objective is the 
demand that medical staff member credentialing be conducted by an 
entity other than the staff person's employer. In the case of 
providers, that would mean that a hospital would be unable to 
credential such individuals, even though hospitals are in the regular 
business of credentialing members of their medical staff. We see no 
additive value to imposing such external credentialing costs and 
burdens on the Nation's hospitals and we strongly oppose this aspect of 
the CMS' proposal.
     Objective 5: Patient Electronic Access to Health 
Information. Objective 5 focuses on providing access for patients to 
view online, download and transmit their health information (e.g., 
through a portal), or retrieve their health information through an API, 
within 24 hours of its availability.
    Provider's primary concern with this proposed objective is the 
unrealistic timeframe for making the information accessible, moving 
from the current Stage 2 requirements of 4 business days for EPs and 36 
hours post discharge for hospitals to 24 hours for all providers. We 
believe this is unrealistic from a workflow perspective and also risks 
forcing information to become accessible before its content can be 
adequately assessed for accuracy and before actions can be taken by the 
provider to educate or prepare the patient, if this is necessary. Since 
the thresholds for the objective are being increased and since CMS is 
interested in having near-identical requirements for both EPs and 
hospitals, we urge adoption of the same four business day timeframe for 
all providers.
    In contrast to our concerns regarding timeframe, we heartily 
endorse CMS' proposal to offer providers the option to use an API-based 
mechanism to provide patient access to their health information, in 
addition to the existing option of viewing online, downloading and 
transmitting such information. To enable this option, however, it will 
be essential for CEHRT vendors be required to provide open and 
functional standard APIs that will enable secure applications to 
facilitate the exchange of information. We encourage CMS to look beyond 
data in EHRs and also consider the growing usage by patients and 
consumers of tools where they store, track and can share their own 
health data with providers.
     Objective 6: Coordination of Care through Patient 
Engagement. Objective 6 focuses on provider use of the communication 
functions of CEHRT to engage with patients and their authorized 
representatives about the patient's care. For this objective, providers 
would be expected to attest to the numerator and denominator of all 
three proposed measures and successfully meet the threshold for two of 
these three measures. Proposed measure 1 would, for example, require 
that more than 25 percent of all unique patients discharged from the 
hospital inpatient or emergency department during the EHR reporting 
period view, download or transmit to a third party their health 
information or access their health information through the use of an 
ONC-certified API that can be used by third-party applications or 
devices. Similarly, proposed measure 2 would require hospitals to send 
a secure message using the electronic messaging function of CEHRT to 
more than 35 percent of such unique patients. Proposed measure 3 would 
also require hospitals to incorporate into the CEHRT patient-generated 
health data or data from ``a non-clinical setting'' for more than 15 
percent of such unique patients.
    We have concerns with Objective 6, especially its proposed increase 
in percentage thresholds. First, in the case of measure 1, we believe 
it would be unfair to providers to hold them accountable for patients' 
ability and willingness to electronically access their health 
information, especially given the proposed 25 percent threshold. CMS 
itself notes that median hospital performance for Stage 2 (for a 
related measure) is only 11 percent. Additionally, CMS has recently 
proposed to change the Stage 2 threshold for this measure so that 
providers would be able to meet the measure if at least one patient 
views, downloads or transmits his or her health information to a third 
party.
    Given all the other changes being contemplated for Stage 3, and 
given CMS' proposed change for Stage 2, we urged CMS to adopt a 5 
percent threshold for Stage 3, which is the threshold previously 
finalized under Stage 2 for the comparable measure. This would more 
realistically recognize that the patient populations served by 
providers vary widely in terms of their medical literacy, their access 
to computers and other technologies, their desire to access their 
health information under various scenarios, and even their interest in 
doing something they have never done before: electronically access 
their health information (that is, be early adopters of a new option). 
We would also note that the current broadband availability exclusion is 
inadequate, especially as measure thresholds increase; some providers 
have indicated that the current exclusion does not apply to their 
locale even though a significant proportion of their patient population 
do not have ready access to computers and/or the Internet. In addition, 
CMS also needs to recognize that some patients with multiple chronic 
conditions who are receiving care from multiple providers during an EHR 
reporting period may have no interest or need to access information 
from all of these providers. For all of these reasons, a 25 percent 
threshold for measure 1 would be unrealistic. Providers need more 
experience with electronic patient access to health information to 
better understand which patients take advantage of and value such 
accessibility before being able to provide advice regarding a threshold 
greater than 5 percent.
    We also consider proposed measures 2 and 3 for this objective to be 
extremely problematic. We do not believe these measures should apply to 
hospital inpatients or to individuals presenting themselves to hospital 
emergency departments. We do not understand CMS' objective in requiring 
emails to be sent to patients after their discharge from the hospital 
or emergency departments. The issue with hospital-based providers being 
held accountable for sending secure messages is that it does not 
acknowledge how that care differs from an ambulatory setting and how 
care is delivered through hospitals. Patients often are cared for by 
hospitalists and then when the patient is discharged, care is returned 
to the patient's primary care provider. Oversight and coordination of 
care happens with the primary provider.
    Further, a 35 percent threshold for measure 2, which is a new 
measure, is unrealistic. Similarly, we do not believe that hospitals 
should be expected to incorporate patient-generated data or information 
from ``non-clinical'' settings for patients' post-discharge from the 
hospital inpatient setting or emergency department. Thus, for 
hospitals, we believe that only measure 1 should apply and only if a 5 
percent threshold is adopted. Even for EPs, we believe that measure 3 
would be challenging, as this is a brand new concept and fails to 
recognize the diversity of patient health literacy and willingness or 
need to furnish patient-generated data.
     Objective 7: Health Information Exchange. Objective 7 
focuses on the provision of a summary of care record when providers 
transition or refer their patients to another setting of care, 
retrieval of a summary of care record by providers receiving a 
transitioning or referred patient (or upon the first encounter with a 
new patient), and incorporation into the EHR of summary of care 
information from other providers using the functions of CEHRT. For this 
objective, providers would be expected to meet two of the three 
proposed measures. Measure 1 focuses on the creation and electronic 
exchange of summary of care records by the providers initiating a 
transfer or referral. Measure 2 focuses on the incorporation of 
electronic summary of care documents by the receiving providers (or 
those seeing a new patient for the first time). And measure 3 would, 
for example, require hospitals to perform clinical information 
reconciliation for more than 80 percent of transitions or referrals 
received and for new patient encounters. This reconciliation could, for 
example, address the reconciliation of medication, medication allergy 
or patient problem lists.
    We have significant concerns with Objective 7. For measure 1, our 
primary concern is the lack of adequate infrastructure for 
electronically exchanging summary of care documents with many providers 
likely to be on the receiving end of transitions of care or referrals, 
such as post-acute care providers. We do not believe it would be 
reasonable to hold hospitals accountable for other providers' inability 
to electronically accept a document. Thus, at minimum, the 50 percent 
threshold for measure 1 is unrealistically high.
    In the case of measures 2 and 3, we oppose the application of these 
measures to patients who are not the subject of a transition of care or 
referral. We believe it is unrealistic, for example, to apply this 
requirement to first patient encounters in hospital emergency 
departments. In many cases, there will be no referring physician or 
even a physician of record, and no clinical information available to 
reconcile. Further, we believe that any such requirements would be 
extremely disruptive to emergency department workflows. These measures 
also presume the existence of an infrastructure that is capable of 
efficiently exchanging available information and such infrastructure 
does not currently exist in many or most cases.
    In sum, for Objective 7, we believe that only measure 1 should 
apply to hospitals for Stage 3 purposes and only if a much more 
reasonable measure threshold is adopted. As infrastructure 
interoperability capabilities improve, we believe it would then be 
reasonable to reconsider the appropriateness of applying measures 2 
and/or 3 in the hospital context for specified patient populations.
     Objective 8: Public Health and Clinical Data Registry 
Reporting. Objective 8 focuses on active provider engagement with a 
wide range of public health agencies (PHAs) and/or clinical data 
registries (CDRs). As proposed, this objective would require EPs to 
meet three of five possible measures (with two of these measures able 
to count more than once if more than one PHA or CDR were involved), 
while hospitals would be required to meet four of six possible measures 
(with measure 6 focusing on electronic reportable laboratory result 
reporting).
    With respect to Objective 8 and its many associated measures, we 
believe that the number of measures that need to be met by providers 
should be uniformly set at two, rather than the proposed three for EPs 
and the proposed four for hospitals. We recognize that the proposed 
rule includes a number of exclusions that would have the effect of 
reducing the number of measures that a given EP or hospital would need 
to meet, in some cases below the required three or four, but we believe 
that the proposed thresholds of three and four are too high given the 
current state of readiness and the lack of provider experience. While 
we understand that CMS views Stage 3 as the final stage, CMS also 
acknowledges that future changes to the objectives and measures are 
likely to be warranted for a variety of reasons. Therefore, we believe 
that additional experience with provider reporting to PHAs and CDRs 
should precede any decision about the reasonableness of requiring 
provider reporting to three or more PHAs or CDRs.
                             senator murray
    Question 1. The private sector is beginning to make progress toward 
standards, including the development of Fast Healthcare 
Interoperability Resources (FHIR) that will promote the 
interoperability of health information technology. In your testimony, 
you note that, ``the Federal Government should be enabled to enhance 
its enforcement tools to ensure functional data and transport 
standards.'' What enforcement mechanisms should be enhanced?
    Answer 1. As this committee heard during the hearing, the current 
market incentives are not aligned with open exchange of necessary 
healthcare data in cost-effective ways. The sharing of data that sits 
in software systems across the care continuum is not only technically 
complex, it is also expensive.
    The costs of sharing this critical data among other health systems 
is not just in dollars. It also results in inefficiently using some of 
our most valuable resources--our people. Having care providers faxing 
or mailing information to other providers is not the best use of these 
highly skilled clinical people.
    Thus, the reform goals should be to design and implement a secure 
HIT ecosystem that enables an easy exchange of health information in 
timely and cost-effective ways. The system should promote collaboration 
among all stakeholders, from patients to providers to vendor partners 
and payers. We need a system of standards that focuses on improving 
healthcare quality, efficiency, safety, affordability and access 
through government and market incentives, while encouraging innovation 
and competition.
    To accomplish these goals, we ask for a combination of 
congressional and Administrative actions that promote policy principles 
that further open health IT infrastructures. In creating those 
structures, we need a combination of clear rules of the road for 
providers and vendors alike through establishment of functional data 
and transport standards, and methods to measure and test 
functionalities, with enhanced enforcement tools for regulatory bodies 
to drive compliance in the marketplace. More specifically:

     On standards, we need functional data and transport 
standards with a focus on key areas including: patient matching, 
terminologies, clinical data query language, security, open application 
program interfaces (APIs), and clinical decision support algorithms as 
well as business practices and policies. Although FHIR is promising, we 
need government leadership to prioritize the need for functional data 
and transport standards that are necessary within a care context to 
enable adoption as they become market-ready.
     On the enhancement of enforcement tools, enforcement 
should focus on compliance by technology vendors and entities who 
choose to do business in the CEHRT marketplace. Through the ONC 
certified technology program, they should be required to demonstrate 
through testing results that they meet functional data and transport 
standards to validate that they meet the metrics for interoperability.
    The Federal Government should be enabled to use its existing 
enforcement tools as well as be provided with additional tools to 
ensure compliance through the ONC certified technology program with 
impactful consequences for noncompliance. The provider consumers who 
suffer the consequences and disruption due to technology vendors or 
entities who fail to comply with the standards and metrics of 
interoperability should be provided with hardship exemptions from 
meaningful use penalties.
      response by christine bechtel to questions of senator murray
    Question 1. How would you recommend that the Department of Health 
and Human Services (HHS) leverage rulemaking to enhance patient 
engagement in health information technology products?
    Answer 1. Thank you for the opportunity to expand on this essential 
issue. There are several ways in which rulemaking can advance patient 
and family engagement in health IT, as well as in their own care.
    We recently launched the GetMyHealthData campaign, spearheaded by 
the National Partnership for Women & Families, in collaboration with 
Amida Technology Solutions; Code for America; Genetic Alliance; Health 
Data Consortium; and NATE.
    What we have learned so far, unequivocally, is that most patients 
and most providers don't know about patients' right to an electronic 
copy of their records under HIPAA--an important provision of the HITECH 
law. What's more, many providers often don't refer patients to their 
own portal, which should be capable of permitting downloads of records 
if the provider participates in Meaningful Use. These problems are not 
caused by ill-intentioned or bad actors; these providers and their 
staff are simply unaware of the law and do not have a workflow designed 
to produce e-Copies.
    To remedy this, and facilitate broader patient engagement, 
rulemaking can help:

     Guidance from the Office of Civil Rights regarding the 
HIPAA right of access. OCR should strengthen its guidance around this 
right, and conduct significant outreach and education efforts to 
providers and consumers.
     The Meaningful Use program has been and continues to be a 
powerful lever for patient and family engagement. Its power lies in the 
requirement to genuinely engage patients in using online access to 
their health data, as well as in new proposed requirements that 
facilitate care coordination. Specifically:

          Stage 3 would also increase the percentage of 
        patients, or authorized family caregivers, that use online 
        access and secure messaging. Nationally representative data 
        demonstrate beyond any doubt that electronic access to health 
        information is a significant catalyst for engaging patients and 
        families in their care: Almost 9 in 10 patients who have such 
        access use it, and it has a significantly positive impact on 
        better care, better communication with providers and improved 
        outcomes.\1\
---------------------------------------------------------------------------
    \1\ National Partnership for Women & Families. (2014, December). 
Engaging Patients and Families: How Consumers Value and Use Health IT, 
from http://www.nationalpartnership.org/research-library/health-care/
HIT/engaging-patients-and-families.pdf.
---------------------------------------------------------------------------
          However, many patients today do not know that they 
        have online access and can download their records, because they 
        are not told by their providers. The requirement implemented in 
        Stage 2 and continued in Stage 3 for providers to actively 
        engage a percentage of patients to use their data is mission-
        critical in addressing these challenges and making consumers' 
        use of their own data a reality.
          Stage 3 would also introduce Application Programming 
        Interfaces (APIs) into Meaningful Use for the first time. 
        These, and the health applications they make possible, could be 
        a significant benefit to many patients and providers. APIs 
        could give patients the ability to more easily download the 
        data they need, in ways they find more useful, and incorporate 
        the data into their comprehensive record, to be shared and used 
        by primary care providers and others involved in the patient's 
        care on an ongoing basis.
          A new requirement would also enable providers to not 
        only send patients' health data electronically, but also to 
        incorporate patients' health data sent by other providers.
          New abilities would also enable patients and 
        caregivers to contribute information to their medical record 
        that is specific and material to their care, including 
        correcting errors in doctors' records.

    Therefore, measures of patient electronic access and health 
information exchange must be left intact for Stage 3, and these aspects 
of Stage 3 cannot be delayed. Further, CMS's proposal for Stage 2 to 
reduce the required threshold for patients accessing their health data 
to just a single patient should not be finalized.
     The EHR Certification rule also offers an important 
opportunity to create the necessary technical ability to deliver on the 
policy promises outlined above. Through the Certification rule, the 
ability to download and transmit patients' own data, as well as the 
additional Stage 3 proposed requirements described above, will become 
feasible for providers using certified systems.
     Alternative Payment Model (APM) rules also offer an 
important opportunity to advance patient and family engagement via 
health IT. APMs should require the use of certified EHRs, as well as 
include at least Stage 2 of Meaningful Use as a basic requirement of 
qualification for participation in APMs.

    Question 2. What would you identify as key short- and long-term 
objectives for patient engagement in the Health Information Technology 
for Economic and Clinical Health (HITECH) Act.
    Answer 2. Short-term patient engagement objectives:

     Accelerating health data access for consumers. HITECH 
established in law the policies, technology standards and education 
outreach that permit and encourage patient electronic access to and use 
of health data. HITECH not only created the Meaningful Use program, but 
also created a new right of access to an electronic copy of one's 
health record. Also included in the Act was an education campaign 
focusing on health IT, privacy and this new right of access.
     Reducing health disparities. HITECH included a provision 
to advance standardized ways of collecting data on race, ethnicity, 
language and gender so these data may be used to reduce health 
disparities in the short term, and advance health equity in the long 
term.
     Giving consumers a voice. HITECH also established 
important Federal advisory committees with specifically designated 
consumer seats, in recognition of the essential role consumers and 
their advocates should play in Federal policymaking. Meaningful Use may 
not have had a priority focus on patient engagement without these 
consumer voices, and more consumer voices are needed as current 
policymakers consider the future of health IT policy, including 
interoperability and Meaningful Use.

    Long-term patient engagement objectives: Based on the short-term 
objectives laid out in the HITECH law, it is clear that long-term 
objectives for patient engagement include:

     Making consumer access to data ubiquitous, seamless and 
easy to use.

         Advancing health equity, including equal access to 
        health information for all individuals, in languages of their 
        choice, as well as measures of quality that are stratified by 
        disparity variables (specifically race, ethnicity, language, 
        gender, sexual orientation and gender identity).

     Achieving patient- and family-centered care, including 
care that is coordinated, affordable, planned, effective and efficient.

    Thank you again for the opportunity to provide input. Please don't 
hesitate to contact me with any questions.
                                 ______
                                 
                                            Cerner,
                                     Kansas City, MO 64117,
                                                     July 13, 2015.

Hon. Lamar Alexander, Chairman,
Senate HELP Committee,
428 Dirksen Senate Office Building,
Washington, DC 20510.

Hon. Patty Murray, Ranking Member,
Senate HELP Committee,
428 Dirksen Senate Office Building,
Washington, DC 20510.

Hon. Orrin Hatch,
Senate HELP Committee,
428 Dirksen Senate Office Building,
Washington, DC 20510.

Hon. Tammy Baldwin,
Senate HELP Committee,
428 Dirksen Senate Office Building,
Washington, DC 20510.

    Dear Chairman Alexander, Ranking Member Murray, Senator Hatch and 
Senator Baldwin: Thank you for the opportunity to testify at the June 
10, 2015, HELP Committee Hearing entitled, ``Health Information 
Exchange: A Path Toward Improving the Quality and Value of Health Care 
for Patients.''
    Please find attached my responses to your Questions for the Record.
    I welcome any opportunity to discuss these questions or any others 
as you continue your very important work.
            Respectfully yours,
                                         Neal L. Patterson,
                                                  Chairman and CEO.
                                 ______
                                 
   Response of Neal L. Patterson to Questions of Senator Alexander, 
                   Senator Hatch and Senator Baldwin
                           senator alexander
    Question 1. You have mentioned that there are four specific things 
that physicians complain about the most relating to the burden of 
documentation. You've also said that three of those four things could 
be shifted to other members of the care team to free up more physician 
time.
    What do you think providers should continue to document and what do 
you think could be shifted to other members of the care team?
    Answer 1. Capturing the patient's health history, present illness, 
and course of treatment through observations, evidence of medical 
decisionmaking, treatment plans and outcomes is critical for 
facilitating treatment and continuity of care, driving accurate coding 
to maximize revenue, and calculating a facility's quality of care 
indicators. These needs are not new--they existed in the paper world 
and are deeply embedded in the Fee-For-Service model.
    Further confounding the automation of the clinical workflow through 
electronic health records is the effect of narrowly interpreting 
prescriptive regulatory requirements, resulting in workflows that have 
driven physicians to become highly trained, highly specialized data 
entry experts.
    State licensure, State boards governing specific professions, 
Medicare conditions of participation, and hospital or practice policies 
dictate patient care activities dependent on physician involvement, as 
well as permitted activities for non-physicians, such as physician 
assistants and advanced practice nurses. Specific to Meaningful Use 
requirements, according to CMS FAQ10071, computerized physician order 
entry (CPOE) is the only Meaningful Use objective that has limitations 
on who can perform the activities necessary for that particular 
objective to meet the measure--it must be performed by a licensed or 
certified provider with clinical knowledge.
    What we have seen implemented at hospitals and physician practices, 
however, are complicated physician workflows that go beyond traditional 
approaches and attempt to address multiple objectives: e-prescribing 
(eRx), medication reconciliation, clinical summary, patient education, 
transition of care summaries (for which the physician must verify that 
the summary contains a problem list, medication list and medication 
allergy list), and patient portal.
    I believe that government needs to ``round the corners and smooth 
the edges'' of regulations and provide guidance so that critical data 
can still be captured as part of the patient's record, yet care team 
members--including nurses and physician assistants--are able to proxy 
for physicians, particularly in the areas of medication reconciliation, 
orders, clinical documentation and discharge planning, where exclusive 
physician responsibility for these activities is not required.
    The shift away from the Fee-For-Service payment model is a major 
step in the right direction. CMS could speed this process by relaxing 
the complex evaluation and management (E/M) documentation guidelines or 
by expressly allowing non-physicians to complete the aspects of that 
work that do not require physician judgment, but with physician final 
review. Further, Meaningful Use must not impose any additional 
requirements--either actual or perceived--that hospitals and physician 
offices should presume physicians must perform when State licensure and 
State medical and health professional board regulations allow non-
physician roles to do so.

    Question 2. Many stakeholders have suggested that the health 
information technology industry could come up with many solutions to 
the problem of interoperability on its own. However, so far, we are 
stuck with a system that does not work even though the government has 
spent over $30 billion.
    What areas would be best determined by private industry? What areas 
should the government decide, if any?
    Does the government need to set deadlines or otherwise encourage 
industry to make decisions?
    Answer 2. EHRs should be built to be interoperable--to exchange 
critical information with providers and organizations across the 
patient's entire continuum of care. Clinical data should always flow 
unimpeded to wherever it is needed for direct clinical care of the 
patient.
    It is true the industry has not yet ``solved interoperability'' for 
seamless exchange, yet we have made significant strides and learned 
valuable lessons.

     Standards alone will not create interoperability. 
Standards must be developed and tested by the private industry based on 
real-word use cases. Deployment and use of the standards must be to 
achieve a business purpose. Government should continue to facilitate 
emergence of appropriate business drivers through changes in provider 
payment that reward managing care over a continuum, and perhaps other 
regulatory pressures if market forces prove to be inadequate. 
Government could also play a role in funding pilots and demonstrations 
of up-and-coming standards. Government should facilitate transparency 
around the degree of actual data sharing so that ``data blockers'' will 
be exposed to market scrutiny.
     Nationwide interoperability requires an open network that 
has a reliable method of patient identity management, record location 
tracking and patient-driven consent.

          The network must manage contractual and legal 
        arrangements necessary to share health data, as well as deploy 
        a governance mechanism to ensure the arrangements are followed. 
        Government could play a role in ``blessing'' material elements 
        of such arrangements to reduce the amount of time needed to 
        negotiate new relationships and to ensure that participants are 
        comfortable that such an arrangement complies with appropriate 
        regulations. The government could encourage and/or require 
        public transparency of business practices, and provide 
        enforcement mechanisms when a business entity falls short of 
        its obligations.
          These networks require the active engagement and 
        collaboration of their participating entities. They cannot be 
        simply created by a legislative vehicle.
          CommonWell Health Alliance is such a network.

    The government should define the ``what'' and ``when''--the U.S. 
health care stakeholders should define and achieve the ``how.''

    Question 3. If you could change all or parts of the proposed rules 
for Stage 2 and 3 of Meaningful Use and the 2015 certification rule, 
what would you change?
    Are there particular parts that should be delayed and others that 
should go forward? What changes would you make to them?
    Do you think that the proposed rules will make health information 
technology better? If so, which parts?
    Are there any parts of the proposed rules that you think would make 
health information technology worse? If so, which parts?
    Answer 3. For more detailed responses to your questions, I have 
attached Cerner's responses to each respective proposed rule: 
Modification of Stage 2, Stage 3 and 2015 CEHRT.*
---------------------------------------------------------------------------
    * Due to the high cost of printing, the attachment referred to have 
been retained in committee files.
---------------------------------------------------------------------------
    Two key points:

    1. A wholesale delay of the Stage 3 timeline could create a major 
disruption in momentum of health IT adoption that could interfere with 
payment reform and advanced initiatives such as precision medicine. 
January 1, 2018, should remain as the start date for Stage 3; however, 
the final rules should proceed with a purposeful focus on requirements 
that advance interoperability and increase patient engagement.
    2. ONC should propose certification criteria beyond what is 
necessary for Meaningful Use only at the point in time they are 
required by other Federal program requirements, and not presume a 
market role absent a Federal policy interest.
                             senator hatch
    An HIT vendor change brings with it new challenges, including data 
collection and reporting, which are both part of Meaningful Use 
requirements, as well as patient safety issues. One hospital system in 
my State estimated that it could take as long as 19 months to safely 
transition EHRs.
    Question 1. From your experience, can you tell us how long 
installing an EHR takes and give us a sense of all of the steps 
required? Please describe the timing and the complexity of the problem 
for a physician office, for a hospital, and for a multi-hospital 
system.
    Answer 1. The answer varies based on organization size and profile. 
For example, we can have a stand-alone physician office live in 3 
months. A single hospital system typically requires 14 months, as is 
our standard recommendation for a community-based health system; 
however, a larger, multi-facility health system could reasonably expect 
18-24 months.
    Most EHRs are highly configurable so they can meet the needs of a 
variety of different kinds of provider organizations. At a high level, 
steps accomplished in the implementation timeframe include:

     Planning: Project governance, organizational change 
management, resource allocation, current State assessment, definition 
of measurable project outcome.
     Execution: Executing the plan, defining future State 
(people, process, technology), building the configurable parts of the 
EHR, testing and training.
     Conversion/System Adoption: Includes post conversion 
assessment, adoption confirmation, outcomes measurements.

    Question 2. In what ways would transitioning to a new HIT vendor 
interfere with a provider's ability to comply with Meaningful Use 
requirements? What considerations would ease the burden on providers 
looking to transition from one vendor to another? What are the merits 
of a hardship exemption from Meaningful Use penalties for such 
circumstances, and what other options would you suggest? What would be 
an appropriate amount of time for a hardship exception from Meaningful 
Use penalties for providers who transition vendors?
    Answer 2. Even with a fairly seamless transition to a new system, 
the provider or hospital must be live on this new system for some time 
to reach productive use in the same (or improved) mode and manner 
experienced before. Expecting immediate par level results with a new 
conversion may not be realistic for at least a period of months.
    The challenge of transitioning to a new technology is much greater 
than simple data migration--the provider/hospital must essentially re-
implement and roll out all features. This likely requires process and 
workflow changes, database customiza-
tion, education, and so on. Post implementation, a client may 
experience a re-adoption curve where performance levels may dip, or a 
dual system period with multiple reporting approaches.
    Some measures allow for consideration of activity that occurs 
before, during or after the reporting period. That data may not be 
available to the new system, as the old system's mechanism may not be 
``translatable'' for how the new system recognizes numerator credit, 
the data that was the basis of proof in the old may not be able to be 
converted, or it simply may be a process not available to the new. To 
that extent, any such functional measures need time to build that 
history for the activity data, which may require more than simple data 
conversation but actual new rounds of seeing existing patients to 
establish or re-establish that history.
    In Cerner's experience dealing with technology transitions, one of 
our clients' biggest issues is related to the patient reminders 
objective for Stage 2 Eligible Providers (EPs). Fortunately, this issue 
would be addressed under the proposed Stage 2 Modification Rule. As way 
of example, however, on that measure, there is a requirement that the 
provider send patient reminders to 10 percent of patients that have had 
two or more encounters in the 24 months prior to the reporting period. 
If the provider switched vendors, pulling relevant data could be a 
potentially expensive and time-consuming process for that one measure.
    Public health reporting may create another issue. If a provider/
hospital is submitting on an ongoing basis for public health and then 
switches technologies, the rule is not clear as to whether there will 
be a new time to enter into ``active engagement'' again.
    To help facilitate a technology transition, we suggest, at a 
minimum, a hardship exemption that avoids penalties. To support ongoing 
incentives, and/or in lieu of a hardship exemption, allowing the 
provider/hospital the ability to attest in good faith--without being 
judged strictly on measurement achievement--may also be a helpful 
option. So would allowing a temporary break in reporting, focusing on 
attestation when the provider is fully operational on the new system, 
but not necessarily the entire year. In general, regulatory measures 
that focus on ``process'' rather than ``outcome'' will be harder to 
transition to a new system. This is one reason why we favor focus on 
the ``what'' rather than the ``how.'' If a new system has a better 
approach to certain processes, then those process changes should not 
adversely effect achievement of incentives.
                            senator baldwin
    Question 1. I am encouraged by progress made on vendor-developed 
exchanged networks, such as Epic's Carequality and Cerner's CommonWell. 
How many patients have opted in to CommonWell as of the date of this 
hearing? What percentage of hospitals and clinics using Cerner's EHR 
software are currently connected to CommonWell?
    Answer 1. CommonWell Health Alliance, an open, industry-driven, 
vendor-led Alliance consisting of 29 health IT organizations including 
Cerner, concluded its year-long pilot testing and began nationwide 
rollout of services in January 2015. Seventy-three facilities were 
connected and live on CommonWell services as of June 10 (the date of my 
testimony), with 5,000 facilities anticipated to be enrolled by years' 
end.
    While CommonWell is in early deployment across the country, we are 
reporting promising patient adoption. As of June 10th, over 30,000 
patients were actively enrolled in CommonWell, and active data exchange 
was occurring nationwide. We fully anticipate that growth in these 
numbers will accelerate as the national rollout expands, as new members 
extend services, and as provider utilization increases.
    Specific to Cerner, 336 acute facilities using Cerner's EHR are 
currently enrolled in CommonWell services. This represents 
approximately 10 percent of Cerner's acute client base.
    Of course, even as CommonWell adoption grows, we continue to 
support a number of interoperability activities, including connections 
to more than 130 HIEs and numerous point-to-point connections, many 
facilitated by Cerner's open, standards-based exchange network. All 
told, last month (June), we generated more than 7.7 million CCD records 
across our client base. Most were for consumption by non-Cerner 
systems.
    If you have additional questions specific to CommonWell, I 
encourage you to contact: Jitin Asnaani, Executive Director, CommonWell 
Health Alliance. 617.396.4009; jitin@commonwellalliance.org, 
commonwellalliance.org.

    Question 2. It is important that we support putting into place a 
national structure to enhance and connect existing networks so they can 
seamlessly and securely share patient records with each other. 
Therefore, it is critical to identify any barriers to participation in 
networks, as well as barriers that may inhibit connecting of networks. 
Do you see potential drawbacks in charging for the licensing or use of 
interoperability software? Does this create any barriers for 
participation?
    Answer 2. The pricing of interoperability services is a great 
concern, particularly as we try to encourage a State of true nationwide 
interoperability. Point-to-point interfacing has traditionally been 
very labor intensive and costly, and that is one of the reasons we saw 
a need for CommonWell. Interoperability should be free for patients, 
and priced like a public utility (like water or electricity) for 
provider organizations. As the beneficiary of all the public investment 
in health IT, it doesn't bother me if the industry/vendors have to pay 
a little more to make this happen.
    It is Cerner's goal to provide interoperability services at a low 
cost to health care providers, and to engage in fair practices that do 
not financially penalize connections that flow outside of our own 
network to other vendors or other networks. We endeavor to embrace the 
notion of FRAND (fair, reasonable and non-discriminatory) pricing. A 
good example of FRAND pricing at work: when a Cerner client signs up 
for CommonWell, they pay a low, one-time setup fee, and that covers all 
their standards-based connections, whether those connections are to the 
CommonWell network or to organizations using non-CommonWell vendors 
such as Epic. Right now we don't have direct bridging between 
CommonWell and the entire Care Everywhere network, but we support 
unlimited connections to points inside that network. We believe that 
direct bridging of networks will follow. When that happens, our work 
will be easier, not harder.
    Countless dollars have been spent as a nation on health information 
exchange networks, yet they rarely scale to all the venues where any 
given patient actually receives care. I believe the greatest barriers 
to participation in networks are associated to the creation of the 
networks themselves, not a result of connecting them. These are the 
exact frustrations--governance and data sharing agreements, patient 
identification, record location and consent management--that sparked 
the need for CommonWell to provide more services than simply bridging 
limited network infrastructures. In other words, problems within the 
networks themselves must be addressed--not just the efforts--and 
costs--necessary to connect them.

    [Whereupon, at 11:45 a.m., the hearing was adjourned.]

                                   [all]
```