[This Transcript is Unedited]

NATIONAL COMMITTEE AND VITAL HEALTH STATISTICS

EXECUTIVE SUBCOMMITTEE

Hearing on “Meaningful Use” of Health Information
Technology

April 29, 2009

Marriott Wardman Park Hotel
2660 Woodley Road, NW
Washington, D.C.

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 352-0091

Table of Contents

P R O C E E D I N G S (9:00 a.m.)

Agenda Item: Welcome, Roll Call and Introductory Remarks

MR. REYNOLDS: Let’s go ahead and get started please. Good morning. I would
like to call this meeting to order. This is the second day of hearings of the
National Committee on Vital and Health Statistics, the Executive Subcommittee,
focusing on meaningful use of health information technology. The National
Committee is the main public advisory committee to HHS on national health
information policy.

I am Harry Reynolds, chair of the committee. I work at Blue Cross/Blue
Shield, North Carolina.

I want to welcome committee members, HHS staff, and others here in person.
As we did yesterday, again I welcome Dr. David Blumenthal, as the head of the
Office of the National Coordinator. I would also like to welcome everybody who
is on the Internet. Yesterday I know we had a lot of listeners.

I would like to remind everyone, because of that, as well as the smallness
of this room, anyone moving around or anything might make it harder to hear, so
if we could keep that to a minimum, that would be good.

I would ask anybody on any of the panels and the committee to speak clearly
into the microphone, so that it does project. I know some people had some
trouble hearing a little bit yesterday, based on people’s distance away from
it.

I would like to now have introductions around the table and then around the
room. For those on the National Committee, I would ask, if you have any
conflicts of interested related to any issues coming before us today, would you
please so publicly indicate during your introduction.

I have no conflicts.

MR. J. SCANLON: Good morning. I’m Jim Scanlon. I’m the acting assistant
secretary for planning and evaluation at HHS and I’m the executive director of
the NCVHS.

MR. BLAIR: Jeff Blair, director of health informatics at Lovelace Clinic
Foundation, member of the committee. I’m not aware of any conflicts.

MS. TRUDEL: Good morning. Karen Trudel. I’m the deputy director of the
Office of E-Health Standards and Services in CMS and liaison to the full
committee.

DR. WARREN: Judy Warren, University of Kansas School of Nursing. I’m a
member of the committee. No conflicts.

DR. W. SCANLON: Bill Scanlon, Health Policy R&D, member of the
committee. No conflicts.

DR. FERRER: Jorge Ferrer, Veterans Health Administration.

DR. FRIEDMAN: Charles Friedman, deputy national coordinator for health
information technology.

DR. SUAREZ: Good morning, everyone. I’m Walter Suarez. I’m with the
Institute for HIPAA/HIT Education and Research, a member of the committee. No
conflicts.

MR. TRENKLE: Good morning. Tommy Trenkle from CMS.

DR. BLUMENTHAL: David Blumenthal, national coordinator for health
information technology.

DR. MIDDLETON: Blackford Middleton, Partners Healthcare and member of the
full committee. No conflicts.

DR. STEINWACHS: Don Steinwachs, Johns Hopkins University, member of the
committee. No conflicts.

DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the committee.
No conflicts.

DR. CARR: Justine Carr, Caritas Christi Healthcare, member of the committee.
No conflicts.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and
Quality, liaison to the committee.

DR. FRANCIS: Leslie Francis, University of Utah, member of the committee. No
conflicts.

DR. OVERHAGE: Marc Overhage, Regenstrief Institute, Indiana Health
Information Exchange, member of the committee. No conflicts.

MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member
of the committee. I have no conflicts.

MS. AMATAYAKUL: Margret Amatayakul, contractor to the committee.

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics,
CDC, and executive secretary to the committee.

MS. BUENNING: Denise Buenning, senior adviser, CMS Office of E-Health
Standards and lead staff for the NCVHS Standards Subcommittee.

MR. REYNOLDS: For those of you who are usually at our meetings, we usually
introduce the audience, but we usually don’t have this many friends that join
us, so we are not going to put you through that today.

Again, one thing I mentioned yesterday. I would really like to once again
thank Chuck Friedman, Karen Trudel, Denise Buenning, and all of the NCVHS
support staff. Those of you who were here yesterday, they have put on a magical
opportunity in a very short time. I would again like to make sure that
everybody clearly recognizes that. We showed up to do it; they made it happen.
So I thank all of them again on behalf of the committee.

As I said yesterday, we have 40-percenters in two days. We did 24 yesterday,
so 16, I guess, would be “Meeting Light.” We heard a little bit about
“light” yesterday. So it seems a little more surmountable than
yesterday. But I appreciate everybody staying on time.

We will have again a limited open mike, on a first-come/first-served basis.
We will, in fact, start from the list yesterday. I know that one of the people
who was here yesterday is not back today, but, in fact, did confirm that they
are submitting written comments. Again, the most important thing is, whether
you get to speak or not, whether you are on the list or not, we will be
adjudicating all of the written testimony. You will hear how we are going to do
that and how we are thinking about that as we wrap up later today. You will be
heard, either with your keyboard, your pen, or your voice. We look forward to
it.

There is information on the table as to how you submit the testimony.

Again, I would like to reiterate to the panels, please be ready to start on
time. Respect those after you. We really need to hear from everyone. I think
that’s key.

We will prepare a meeting and a written comments summary over the next
two-plus weeks and send it to ONC and post it on our Web site. It will be a
public record.

Media inquiries need to contact Nick Pappas at 202-690-6343 at HHS. They
will coordinate any requests and use members of the committee or government
officials, as needed. I know yesterday we had some. Those are handled by HHS,
not by the committee. I think that’s good.

As we think through what we heard yesterday, the information was excellent.
It was a really diverse panel, diverse thinking, diverse opportunities. But as
we look at today, one of the things that I would ask members of the committee
and that I would ask those that are testifying — I know you have prepared your
testimony. Nobody is asking you to think any differently about your testimony,
because we do want to hear exactly what you prepared. We want to hear that
clearly.

But we heard some themes yesterday that, as we go through them and as we
look at — in other words, whatever we hear here is what we will write up. So
it’s important for us to hear, maybe a little more in-depth, as we ask
questions and you cover things — we heard things like a discussion of light
EHRs. What would be the difference between a light, moderate, sophisticated?
Then, if you can, be specific about functionality, standards, level of
adoption, outcomes, and so on. Again, in the end, we are talking about how we
can pragmatically approach this, especially when you start talking about
incentives and other things. We will have to get to a pragmatic level at some
point. So any help you can be in answering the questions, any help you can be
in moving forward would be good.

We heard the need for registries and registry functionality. What’s the
difference between those? How does a registry fit into things like the EHRs?
What exactly does that mean?

The next thing to consider is equating data exchange with the existence of
an HIE. As HIEs are going to continue to expand — some are in place; some are
going to continue to expand — if you are looking at a provider and it’s their
responsibility to show the ability to do data exchange, the ability to exchange
information, and there is not an HIE by 2011 or so in their area, what would
they need to do to be able to say that they, in fact, have meaningful use — if
they don’t have partners and they don’t have an HIE and they don’t have some of
these other things that need to occur?

I think that’s another thinking that we need to all come up with now or will
have to be thought of at a different time.

If you were responsible for distributing incentive money, what are the three
to five ways you could document meaningful use to satisfy those requirements?
What are the kinds of things that you would think about?

We also heard that the majority of standards for interoperability were
available. Assuming this is true, what is preventing their full-blown adoption
by vendors in a product or by providers in their RFPs and other things? Again,
how do we move this?

Again, if the goal by 2014 is to significantly improve outcomes, health, and
all the things we heard yesterday — and everybody kind of played that theme
throughout the day — what functionality is missing today and where would you
see the bar for functionality as we take this journey? We have 2011, 2012,
2013, 2014. How do you see that journey?

I think we heard clearly from the vendors yesterday the possibility of a
need for a 24-month cycle — what they were saying as far as how they would
roll out changes. That means, if you are in 2009 now, you have, probably, three
major delivery cycles between now and the end of 2014. That is, again, why it’s
so important to back up to today and think about how you play it out. If those
cycles stay, then you really only have a couple of shots to start making sure
that things happen as they should.

Again, we are not doing this to change your testimony. We are just trying to
drill down. We heard a lot of information from 24 different people, plus a lot
of others yesterday in questions and so on. Now, as we move it forward, I would
like you, after you do your prepared remarks — and maybe I’ll give the panel a
moment after each time before we start asking questions, if you want to weigh
in on any of these things. If not, then we may drive the questioning to that a
little bit to try to get some more insight from you. That might be key to do.

Again, we want to be able to move forward to ONC, move forward to CMS, HHS a
document based on the input from you — that is, you who are in here talking to
us. That’s an important thing. That was our charge, and that’s what we would
like to try to be able to deliver. You are the experts that can deliver it for
us. So we look forward to hearing that from you.

Unless there are any other comments from anybody, we will proceed with our
normal thing. We will be ahead of schedule, and that will be a good thing,
especially since we gave people a bunch of new things to answer — probably not
a bad place to be.

So if the first panel would come up, I would appreciate it. That would be
Meaningful Use and Population/Public Health.

I am seeing a number of new faces up there on the panel, so I would like to
go through our process. You each have 10 minutes. There’s a light box on your
table. At the end of eight, it will turn yellow. When it turns red, we need you
to close, please. Again, we need to hear from everyone, and we want to make
sure that we have enough time in this period to do that. So if you will help us
with that, that would be a good thing.

As I’m going to ask each panel today — I know that for some of the others,
it matters — is there any order that you would want to go in? You are listed
here as Carol Diamond, Dr. Hacker, Dr. Lenert, and Dr. LaVenture. Are you
satisfied with that list?

After deliberation, it appears we are going in order — after appropriate
deliberation, which we always like. Carol, please.

Agenda Item: Panel 7: Meaningful Use and
Population/Public Health

DR. DIAMOND: Thank you. Members of the committee, Dr. Blumenthal, thank you
for the opportunity to testify today.

This is a really critical moment. I think we are sitting at a really
unprecedented opportunity to jumpstart health IT in the right direction, and
that is to improve health, to slow growth in costs, and to protect privacy.

At the Markle Foundation, in our Connecting for Health Collaborative, we
have been working with a very broad group of health-care leaders over the last
few months to develop views and strategies that are critical to achieving the
objectives of this public investment under ARRA. We have really been focused on
three critical areas: trying to think about what meaningful use is and how it
should be defined; trying to outline a forward-looking strategy for standards
and certification; and third, really describing a technology approach that will
stimulate much-needed innovation.

Tomorrow we are going to host a forum where experts in health-care
information technology will sit down with political and policy leaders to talk
about how the new law will impact ongoing health-care reform and the best ways
to ensure that the money improves health-care outcome, secures privacy, and
reduces growth in health costs.

The forum dialogue will center on a document that is strongly supported by a
wide array of health-care leaders. Many of them are here today or have
testified over the last few days, and we’ll make it public tomorrow and share
it with the committee for your future deliberations.

What I would like to do today is really make some comments about some issues
that were outlined in the opening remarks and that I think will be critical to
some of the deliberations that you are going to have.

I think it’s an understatement for us to say that the landscape has changed
for health IT. This opportunity was borne out of the economic crisis. The role
of government shifted overnight from trying to motivate private-sector adoption
of standards and technologies to an environment where there is significant
public-sector investment in health IT. That will bring new scrutiny and demands
for accountability, and rightly so. I don’t need to tell anyone here that the
stakes are very high.

This may seem a desire to really try to develop rigid requirements or
detailed technology specifications to ensure that the money is well spent. I
think, given the nascent state of the health IT industry, it’s important to
resist this impulse. What we need are crystal-clear goals, crystal-clear goals
for what the technology is to accomplish. To create the right market innovation
and spur innovation, both in care delivery and in technology, we should not
over-specify specific technology at this juncture. People will respond with
better and more functional products if we introduce a new driver, and that
driver should be a definition of meaningful use pointed to health improvement,
not specific features and functions of technology.

We really have to shape this around what those goals are. We need IT to
improve health-care quality and to control growth in costs and to protect
privacy. These expectations have to be set from the start. If the goals are not
set from the start, it really will be very difficult to offer the kinds of
results that government is seeking after technology has been commissioned and
incentives have been offered. The government risks wasting its valuable
resources and losing support, quite frankly, from both providers and the
public. So this is a critical moment, and the goals are not the purchase of
technology, they are not the installation of technology.

To that end, the definition of meaningful use means to center on improving
patient outcomes, improving health status, improving the delivery of care, and
controlling growth in costs.

Where do we focus in the near term? I heard some of the discussion
yesterday, and certainly in our own deliberations people are very concerned
about what’s possible today, what’s possible in the near term. This leads you
to say, let’s focus on two things: What has the highest potential for impact in
health improvement and reduction in growth in costs now? What information can
be made available to point of care in electronic format in the near term?

Based on these criteria, there are at least a handful of areas that offer
near-term opportunities. There is mediation management and care coordination.
These goals are broadly applicable, and they will have a strong impact on
health improvement and controlling growth in costs. They rely on information
that is available electronically, including some of the information that was
discussed yesterday. They fit and are very consistent with the meaningful-use
framework outlined in the law and with the new national quality priorities. The
definition should over time, as the law states, expand to include additional
things. But there does need to be a clear and focused starting point.

How do we know if we have achieved meaningful use? We distinguish two terms
and have distinguished two terms in our work. I will explain that, because I
think it’s helpful.

Certification is about demonstrating whether or not a system has the
capability to be used to achieve these objectives of meaningful use.
Validation, on the other hand, is being able to demonstrate that it was, in
fact, used to achieve meaningful use.

There has been a lot of mixing of those terms. I would just caution against
using “certification” as a proxy for the goal. The goal is health
improvement. I want to be clear about that distinction.

The law envisions an evolving set of requirements. The requirements have to
enable a broad range of providers to participate, through a variety of
mechanisms. As you know, providers are on a wide spectrum of levels of adoption
and readiness for adoption. So there will have to be flexibility in this
approach.

There has to be something demonstrable in the near term. The validation
requirements or the metrics have to be simple and achievable to demonstrate,
preferably automatically from technology.

There does have to be a clear motivation in these goals to use and share
information to improve health-care quality, but there does not need to be an
over-specification about all the things and technology features and functions
that need to be specified on how to get there.

We hope what this can also do is stimulate innovation, again, both in
health-care delivery, finding new ways of delivering better and improved care,
and in technology. There are lots of studies that show that even in small
practices, where there is no IT help desk to call, there is no department to
call when a system doesn’t boot up, costs can be very significant, innovation,
especially in that marketplace, for new tools that offer near-term value and
can achieve the objectives of meaningful use is very much necessary.

We also would like to say that meaningful use should dictate the technology
approach, the approach to standards and certification, and not vice versa.

I think we envision certified or qualified technologies accommodating a wide
array of health IT tools. We must reward the meaningful use of these tools, and
not the specific purchase of hardware or software products.

Let me spend a minute on standards — not to belabor the issue. I have said
many times to this committee and in the Health Affairs paper, standards
are not created through committee consensus. Standards are created through
adoption. There are protocols that are created, but they become standards when
they are widely adopted and used. This law has the opportunity to create that
motivation for adoption.

Similarly, certification is critical to prevent fraud, to prevent faulty
products, or reward superficial uses of technology, and clearly, whether or not
the technology can achieve the objectives of meaningful use and meet the
technical privacy and security requirements of both HIPAA and the new law. But
it should be open to a broad range of applications. The question we should be
asking today about certification criteria is, will they enable providers to
achieve the health improvements and cost-control growth objectives of
meaningful use? That’s what we should focus on.

In terms of certification, let me just say that it is very clear that there
should be clear testing criteria for interoperability, for transport and
security protocols, which have to be defined, and they could be validated using
Web-enabled testing environments. We encourage a pluralistic approach to
applications, not a narrow definition of what an EHR should be, and also a
pluralistic approach to certification. If the requirements are clear and
specified, then innovation can take place from the marketplace to help
purchasers find value in different products.

Let me make a comment about the population health objectives, from my
Health Affairs paper. The latest issue is here. Suffice it to say that
the opportunity to use health IT to improve population health goals is not lost
on any of us. This is clearly something everyone is interested in.

The urge that I would make the committee is to really think about ways in
which the paradigm for how population health is measured and analyzed and
achieved is shifting and changing in very important ways, from centralized
structures and centralized data-collection efforts, where the people who
generate the data and who are in a position to make the decision using that
information are separate and removed from that process. It has not served us
well.

In fact, health care is not unique. This process of trying to create large,
centralized, or big-bang approaches to efforts is true in the FAA and the IRS
and other large-scale failures, like government IT projects.

I think what’s critical to think about are distributed ways of analyzing and
measuring population health goals. There are a few examples I will just mention
briefly.

One is the DiSTRIBuTE model for flu surveillance, which does not collect
detailed, identified, or de-identified data, for that matter. It just collects
summary statistics. That project is spearheaded out of the New York City
Department of Public Health; also the New York City Department of Public
Health’s approach, the PCIP project, for quality measurement, where the quality
measures were embedded in EHRs and the provider is able to assess in real time
and see where they are in terms of performing on the indicators that are
necessary, but centrally only summary statistics are collected. Again, my paper
here, which is available, offers a more elaborated view.

Thank you.

MR. REYNOLDS: Thank you. Appreciate it. I’m sorry I did not recognize you as
Dr. Diamond, excuse me.

Dr. Hacker, please.

DR. HACKER: Thank you very much, Mr. Chairman, members of the committee, Dr.
Blumenthal.

I’m William Hacker. I’m the commissioner of public health for the State of
Kentucky. I’m the chair of ASTHO’s Informatics Committee. I’m taking this
opportunity to address the committee from ASTHO’s point of view and the state
health officer’s point of view, in regard to the term “meaningful
use.”

The nation’s public health community is united in the belief that meaningful
use of electronic health record systems must include bidirectional exchange of
data between public health departments and private providers. I will focus my
remarks to try to address the issues related to cities, counties, states, and
territories in the United States and how we can improve health across the
country.

Public health is an essential component of successful health reform, to
transform the United States health system. It is a system that prioritizes
prevention, supports healthy environments and lifestyles, provides at a minimum
preventive and primary health care for every person, eliminates inequities in
health status, and protects the people in communities from existing and
emerging health threats. We should work to build a health system, one that is
oriented toward health rather than sickness and is able to effectively address
known determinants of health, whether they be environmental, social,
behavioral, or medical.

Public health enables this kind of health-system transformation. Public
health agencies already touch the lives of every American to promote health,
prevent disease, and to protect us from health threats. The public health needs
to be strengthened and empowered as a significant foundation for health-system
reform.

In public health, we recognize that electronic health records and
health-information exchange are essential tools that can help us to be more
effective at carrying out our jobs and fulfilling public health’s mission to
improve the health and well-being of all Americans. Public health practice will
significantly transform, if we are able to fully leverage EHRs to enhance our
data-collection needs to support disease surveillance and population health
improvement.

Don’t forget that we are also providers of health care. Many of the
vulnerable populations in our communities, women and children, seek health
services through the local health departments.

With the use of electronic health records, we can strengthen our efforts to
ensure that children appropriately receive their immunizations. We are better
able to manage chronic conditions and coordinate care, while employing
community-based methods to support individual self-care. We can fortify our
alliance with medical-care providers and ensure that we conduct screenings for
newborns. We can better assist our medical-care colleagues to more rapidly
translate evidence-based medicine — what works — to inform an effective
clinical practice. And with electronic health records, we are better equipped
to promote healthy behaviors and healthy lifestyles.

Public health seeks a future where it can easily consolidate and integrate
information from a variety of disparate systems, sources, across multiple
settings, across clinical and business domains, and across technologies. To
serve the public well, the governmental public health agencies must be linked
to inpatient, outpatient, home, and industrial settings. We must be able to
receive data from clinical settings, as well as provide information and
decision support to clinicians.

That is a vision for a transformed health system operating in an environment
where the use of electronic health records and health-information exchange is a
standard way of practice, not the rarity, and where public health agencies work
in close partnership with clinicians to promote and protect the health of all
citizens.

There are three high-priority and high-impact public health data needs that
can be advanced through electronic health records: immunizations, electronic
data reporting, and notifiable and non-reportable disease data. Let’s start
with immunizations.

Vaccinations are a proven public health tool to prevent and reduce disease.
If all providers collected immunization information electronically on each of
their patients and were able to send the data to public health, we would be
better able to identify poorly immunized populations and groups, targeting
interventions and evaluating program efforts. We would be able to use the
information to control outbreaks of vaccine-preventable diseases and would be
better able to measure progress toward goals of vaccine coverage and disease
control.

In addition, we would be able to assure accountability for effective vaccine
use.

Immunizations are mouse-ready. Technology is available. Data are currently
being captured by some providers electronically today. But immunization data
need to be part of all electronic health records. Capturing this information
needs to be part of the provider’s standard practice, not something that is
collected on a separate registry or something that is not an expectation for
medical practice.

I am aware that certified electronic health records have adopted core
immunization information. We need to assure that electronic health records
seeking certification are interoperable with public health immunization
information system national standards. At the same, public health agencies need
support in maintaining public health systems to be interoperable, through the
standards, back to the private sector.

Public health labs are also mouse-ready. Our nation’s public health
laboratories have worked diligently to implement the laboratory
information-management systems needed to exchange data with many stakeholders.
The interoperability standards for electronic reporting of laboratory data
exist today. Being able to receive electronic requests from specimen analysis
and report results, we will be better able to enable public health to monitor
communicable disease and control or contain their spread.

Communicable disease reporting has been largely paper-based, relying on
faxing, telephones, and mail. We are vulnerable to public health threats on a
daily basis — for example, the swine flu issue we are dealing with today. How
can we quickly and effectively protect the public from acquiring preventable
communicable disease when we are dealing with a slow paper process today?

Electronic lab reporting from clinical providers to public health can
significantly improve the handling of high-volume, time-sensitive diseases and
enable public health to quickly conduct assessments of complicated cases and
determine the best course of action to efficiently and effectively respond.

Third is the notifiable diseases, as well as non-reportable disease data.
Electronic reporting of notifiable diseases — infectious diseases,
communicable diseases — can significantly be more rapid and accurate.

I believe you understand all that process, so I’m going to skip my words in
your handout to save some time.

But in addition, electronically capturing non-reportable disease
information, like diabetes, heart disease, and asthma, will better enable
public health to develop and target health-promotion interventions to improve
population health. This is putting the power of prevention, linked to clinical
care. I can say with great confidence that public health agencies are good at
this. Public health is effective in studying the data, designing community
interventions, communicating the message, and working with their local
colleagues to make sure we impact individual health, as well as population
health.

The public health community commits itself to linking its shovel-ready — to
use the older term — components of electronic health records and
health-information exchanges by 2011. Specifically, I would like to suggest
that as part of the definition of meaningful electronic health record use,
immunizations, electronic lab reporting, and electronic reporting of notifiable
and non-reportable diseases be included. Real-time public health reporting and
bidirectional data exchange should be an expectation in standard practice, if
we are to achieve health-system transformation and a healthier America. With
bidirectional exchange, we mean clinical reporting to public health and public
health exchange with clinical care.

I would like to offer some implementation considerations with respect to the
inclusion of the high-priority data needs in the definition of meaningful
electronic health use.

As I mentioned previously, immunizations, electronic lab reporting are
mouse-ready and could be captured electronically. These should be required by
2011. Electronic reporting of notifiable and non-reportable diseases may be
phased in over time.

Electronic health record systems use different methods to capture data
today. Some are diagnosis codes, procedure codes, or even medications. The use
of different approaches to capture data requires manual review to filter
erroneous or non-relevant information, making electronic reporting more
ineffective than usual. Efforts are necessary to standardize how disease data
will be captured in electronic health records to make it less burdensome to
collect and analyze. Electronic reporting of notifiable, non-reportable
diseases will be prioritized diseases. Non-reportable diseases should be
considered as part of those that are listed and supported by the Prevention and
Wellness Fund.

Public health wants a seat at the table as these priorities of diseases are
fleshed out in the national debate.

In closing, I would like to point out that incentives for provider adoption
of electronic health records and inclusion of public-health-data capture are
significant, but still only initial steps. Public health, to be truly
strengthened, requires a transformation of its own to be ready to receive,
filter through, and effectively translate and utilize the massive amounts of
data from clinical systems. We will need support for this transformation, given
the limited staff and funding resources available for state and local public
health.

We stand ready and willing, however, to work with the committee and our
federal partners to assure the successful implementation of the HITECH act and
continue the consideration of public health’s role and value in
health-information exchange and health-information technology.

Thank you.

MR. REYNOLDS: Thank you. I am sure the vernacular of “mouse-ready”
will now be ingrained in the conversation going forward. We appreciate that.

Dr. Lenert, please.

DR. LENERT: This is testimony from the National Health Center for Public
Health Informatics, NHCPHI, one of 11 centers at the Centers for Disease
Control and Prevention in Atlanta, Georgia. NCHPHI protects the public’s
health, promotes health equity, and transforms public health practice to
advance the science of biomedical informatics and public health practice and
collaborative development of information systems for public health.

Our vision is to promote innovation and provide leadership on a national and
global level to transform the public health system to informatics.

NHCPHI is heavily engaged in the design and development and testing of
systems that use the national health information network standards and
infrastructure to promote collaboration between the clinical care system and
public health. Programs funded by NHCPHI that are focused on this collaboration
include BioSense, the National Notifiable Diseases System, and the Public
Health Information Network.

I will review these programs briefly as I go on, but I’ll cover them in more
detail in the written testimony.

BioSense is a program designed to provide real-time situational awareness or
national monitoring of health through data generated in emergency rooms
throughout the United States. Approximately 12 percent of emergency-room visits
to — hospitals and 100 percent of those to governmental hospitals in the
United States are monitored through BioSense.

The National Notifiable Diseases System provides support to states for
linkages to public health reporting for notifiable diseases to clinical care,
notifiable conditions or diseases where there is a statutory reporting
requirement within a state for providers, for laboratories, for the purposes of
prevention of the spread of disease. Notifiable diseases are typically
infectious diseases. Each state has its own list of notifiable conditions and
diagnostic criteria that are active. CDC is informed of states of a case that
has been investigated and confirmed.

The NNDS program supports state health departments through direct adjunct
funding, through development of software systems for managing notifiable
conditions, and through software programs that link clinical care sites and
laboratory systems to public health.

The Public Health Information Network is a set of programs designed to
produce interoperability between public health departments and state, local,
and national-level protection, intervention, and notification. The PHIN program
promotes beset practices for interoperability through communities of practice
for selected issues.

NCHPHI is highly involved in the standards process, participating in the
AHIC subcommittees in HITSP, in standards development with HL7 (phonetic), and
in promulgation of standards through PHIN. Our philosophy is that standards
development is essential but not sufficient for public health capabilities.
Standards are the link between clinical and public health infrastructure.
However, without investments in public health infrastructure, there is no
capability for collaboration.

An example of the type of collaboration between clinical care systems and
the public health department is work on public health alerting and
decision-support systems for electronic health records, performed in
collaboration with our centers of excellence within the Integrating the
Healthcare Enterprise organization. Working with participants in the IHE, we
developed a standards-based approach to notify clinicians of public health
alerts on their desktops, through publication to a centralized database.

This approach notifies clinicians when they are seeing a patient who resides
in a zip code with an ongoing public health problem and has demographics and
symptoms potentially consistent with the alert. It also informs clinicians of
the types of actions they should take — restricting food handling, culture,
other types of interventions that are frequently ignored in clinical practice.

This type of system demonstrates the degree of collaboration between the
clinical care system and the public health system that is inherent in the term
“meaningful use” of electronic health records.

Responses to the committee’s specific questions follow below.

With regard to the vision for public health practice in an era when all
Americans have electronic health records and the priorities for functioning:
NHCPHI’s vision for population health practice in an era where all Americans’
health care is supported by EHRs focuses on two areas: public health-clinical
care collaboration, and public health empowerment through access to clinical
data.

Broadly speaking, the goals of the clinical care-public health system
collaboration fall into five areas:

Systems that assure that every clinician in the community is an astute
clinician, one that recognizes public health notifiable conditions, reports
unexplained illnesses, follows public health recommendations for outbreak
control, and is assisted by decision support at the point of care in order to
make this happen.

Second, the infrastructure must be in place for rapid two-way communications
with public health about notifiable diseases. Diagnostic laboratories should be
able to report conditions to public health departments, all EHRs reporting of
public health notifiable conditions to state health departments, helping
providers fulfill their statutory obligations.

Public health should work with the clinical care system to help ensure
appropriate care for all. Registries should monitor patients with serious
illnesses to make sure they receive appropriate care and that none with serious
illness, especially those with infectious illness, are lost to follow-up.

Alerts should notify clinicians when individuals with untreated, contagious
illnesses come in casual contact with the health care system, so that
appropriate action can be taken.

Public health can work with clinicians to manage the growing problem of
antimicrobial resistance in communities. It is our vision for resistance to be
actively managed through surveillance of resistance patterns and improved
prescribing practice delivered through or advised at the point of care.

Public health should also work to promote health in the community. Public
health systems should ensure that tailored health-promotion and prevention
programs are available to all persons in the community, regardless of insurance
and socioeconomic status.

Public health activities and public health departments will be transformed
through enhanced access to data from the clinical care system. Routine
activities that are now slow and inefficient will be automated. Activities
include integration of vital registration tasks with clinical care, 100 percent
situational awareness, with appropriate sharing of detail across levels of
government, creating an infrastructure that allows the national to rapidly
characterize outbreaks and precisely control efforts in pandemics.

Data should be automatically from the clinical care system to automate
public health practice. Disease-control programs should spend the majority of
their time on management of cases rather than data collection. The clinical
care system will also generate data on communities at a highly detailed level
that is not practical to obtain with survey methods. This will allow public
health officials to identify needs and target health disparities.

Communities will have capabilities to assess the risks of local
environmental threats and to monitor health in conjunction with those threats.

There will be widespread automatic surveillance for adverse effects of
pharmaceuticals and other therapies. Systems will ensure the first million
patients receiving a drug will have special monitoring, and active surveillance
to ensure overall efficacy and safety.

The support for monitoring rates of hospital infections will ensure that
infections are accurately tracked and data are widely available to the public.

Specifically, what do EHRs have to do to achieve meaningful use to allow
this to happen?

In short, we believe that clinicians should put all their patients into an
EHR system and should use that for routine care. In addition, they have to
collaborate on exchange of information for patient and population care.
Information should be delivered through links to the clinical care system and
should impact patients’ care. Meaningful use should include a requirement for
clinicians to respond to specific notifications about a patient or requests for
incoming information into their EHRs, including medication issues and errors,
abnormal lab results, public health alerts, and requests for medical records
from authorized institutions, including public health-oriented requests.

Meaningful use should also include sharing of health information in the EHR
for collaboration on patients’ care, particularly information that is mandated
by state statues for public health reporting. If a patient using an EHR has not
implemented features that allow sharing of information, he or she cannot be
using that EHR in a meaningful way.

To sum up, how can public and population health needs and requirements
translate into meaningful-use criteria for 2011? I think if we look underneath
the hood of the NHIN, we will find that there are serious threats to the
validity of all operations and that public health practice is as far along as
any other activity in the NHIN. What’s needed is investment simultaneously in
public health infrastructure, as well as the infrastructure for information
exchange for clinical purposes. If we do these things simultaneously, we can
achieve meaningful goals for 2011 with public health practice. It is a matter
of will, not a matter of ability. But if all the resources are committed to
clinical care, this will not happen.

What I urge this committee to do is to recognize that meaningful use should
include public health practice, and particularly collaboration between public
health and clinical care. This collaboration will open a new window and world
for public health operations and for ensuring the health security of the United
States.

Today, as we face the threat of pandemics in this world, we can see more
clearly than ever the need for investments to enhance our health security.
Without these investments, the efforts in 2011 or in 2016 will not produce the
type of system that we need.

Thank you very much.

MR. REYNOLDS: Thank you. Dr. LaVenture.

DR. LAVENTURE: Thank you and good morning, Chairman Reynolds, Executive
Subcommittee members, and Dr. Blumenthal.

Thank you very much for holding this important hearing and allowing us the
opportunity to provide a perspective on the Minnesota e-Health Initiative and
on the definition of meaningful use, and specifically how it relates to
population health.

My name is Marty LaVenture. I’m the director of the Center for Health
Informatics and e-Health at the Minnesota Department of Health. I’m pleased to
join you today.

The example of the statewide collaboration in Minnesota is reflected by a
public-private collaborative that was legislatively chartered in 2004. It
reflects the health community’s strong commitment to act in a coordinated,
systematic, and focused way. It’s unique in some aspects, in that it’s
comprehensive by way of its broad settings and broad definition of providers.
Of particular note for this committee and this panel today is that population
health and public health has been included some the inception of the
initiative, and it is really part of both the vision statement and one of the
four major domains as reflected in the circles on the Minnesota e-health
conceptual figure, public health, clinical care, consumers, and policy being
the major domains for the focus of the initiative.

In 2007, the State of Minnesota legislature passed a mandate that required
all providers to have interoperable electronic health records by 2015. As part
of that legislation, a plan was required for how we would meet the 2015
mandate. The plan was published this past June at our e-health summit. You have
a copy of the plan, both electronically and the paper copy before you.

Of particular note for this plan is that population health and public health
issues are addressed in it, in its comprehensive approach for providers
statewide. Along with the legislative action was a grants and loan program to
focus on underserved and rural settings in Minnesota.

One of the challenges in looking at 87 counties and nearly 2,000 different
diverse settings in the implementation of electronic health records was
communications. We developed an approach — sort of a visual way to communicate
this process of how we are going to move forward around getting adoption,
effective use or utilization of electronic health records, and then exchange of
information across this.

This diagram that you see reflects that approach, where all providers and
settings, whether it be clinics, hospitals, public health labs, find themselves
at some stage, either beginning or more advanced. With that comes a plan,
tools, tips, and resources to support them in advancing in that particular
stage.

Of note to this committee is the center section, referring to the utilized
area, where effective use is discussed. We’ll spend a little bit of time
talking about that.

Of note in Minnesota, since the effort, nearly 60 percent of the primary
care clinics in Minnesota have reported adoption of electronic health records,
and we are moving them through more effective use and exchange capabilities.

In terms of the initiative, meaningful use is seen as a broader part of a
framework for effective use of electronic health records. We would encourage
you to think of it in the broader sense of where we are heading with regard to
effective use of electronic health-information technology to improve care, and
really recognizing the real value that is associated with that effective use.

The initiative engaged a workgroup this past year to define “effective
use” and is developing a guide to effective use of electronic health
records that will be published at our June 2009 summit that you all are welcome
to attend.

The model that is reflected so far in the work of this workgroup is as shown
in the next slide. The four key components are identified as elements of
effective use, recognizing that, pre-going-live, organizational issues are
important, but also that post-live, organizational issues are essential, that
smart use of clinical support systems is essential, as well as
quality-improvement reporting, and, fourthly, health status, including
population health and public health, which is of note for our work today.

In Minnesota, we follow a definition of population health similar to the
AHIC’s definition, where population health is looked at as really improving the
health of the entire population. If you will, it’s all of our responsibilities
— everyone’s responsibility — with public health being the governmental
responsibility. It provides the backbone of public health infrastructure and
carries out the legal responsibilities associated with particular geographical
areas. Both are important and both are included as part of the thinking and
focus on meaningful use and effective use in Minnesota.

As we have talked about effective use in the workgroup and the advisory
committee, several key principles for meaningful use were identified. They
include that population and public health really is essential to the definition
of meaningful use, that the criteria for certification of electronic health
records need to contain elements associated with population and public health,
and bidirectional exchange is essential. Given that notion, we also recognize
that the first year must be achievable in its core components of what is
expected for meaningful use, and that a broader set of components and the goals
of where we are going need to increase over time.

We also suggest the approach of progressive implementation relative to the
first year, so that late starters aren’t necessarily penalized.

Similarly, the resources for filling the gaps: If we are expecting to do
exchange, we need to make sure that both sides of that digital handshake are
completed, and the gaps in the capital funding and the knowledge gaps for
informatics are filled in several areas. I’ll comment on that in a moment.

The meaningful use should include two key components:

  • Electronic health record functions for population health, such as lists of
    patients with chronic conditions and risk factors, lists for case management,
    referral, and follow-up of particular files, and an ability to produce summary
    tables and analysis. You have heard a number of comments. These have been well
    documented in other settings. Many of these are sometimes classified as
    registry-type functionalities.
  • Also bidirectional exchange and a list of key categories that aren’t
    necessarily in priority, but really operational priority. In Minnesota, we feel
    these are very close to business-ready — mouse-ready, if you will — to move
    forward.

Being pragmatic in Minnesota, we tried to answer the four questions that
were given us. We have outlined, in summary here, some responses to the key
questions.

The first one is the vision. Clearly, the vision in the initiative for five
years now has been for healthier communities. We strongly believe that
certified electronic health records can help really complete the — they need
to have complete population health functions in order to do that. We need
near-real-time bidirectional electronic communications with the public health
authorities, at a high level of interoperability. We are defining that in
Minnesota to combine technical, semantic, and process components for
interoperability, as well as a highly integrated population and public health
network.

Second, the priority data needs are listed here, similar to what you saw on
the previous slide. We would be happy to go into whatever detail you would
like. Some of those are outlined, including the standards that have been
adopted. The commissioner of health in Minnesota has the ability to require
that and require the use of those standards. We are moving forward with
adoption of those, based on a number of national efforts.

The third area is the requirements for use. We believe that certified EHRs
have the function to support population health. They require schedule for
exchange that, as we mentioned, is achievable. It increases over time and
provides relatively first-year qualification as a meaningful user.

What’s our path to 2016, starting at 2011? We boil it down into two key
areas. One is to fill the gap in essential capital funding resources, and a
second is to fill the gap in knowledge.

The capital resources clearly are modernizing our public health and
population health systems to be more effective and support exchange, including
reporting the requirements and completing the interoperability of standards
that are so essential.

The gap in knowledge is several key areas that you are familiar with that
are critical to success in Minnesota, because it will involve the technical
support centers being as close to the community as possible:

  • The closer they are to the community, the more effectively will
    on-the-ground operations advance activities.
  • Ensure that the RFPs that are issued reflect population and public health
    expectations.
  • Support the CDC and NHCPHI in their applied research and evaluation, a
    critical area in public health informatics.
  • To expand the workforce competencies, adopting the public health
    information competences that have been developed.
  • Develop a plan similar to the spectrum recommended by AMIA.

I want to just recognize as I close the advisory committee co-chairs, Dr.
Jennifer Lundbard and Walt Cooney (phonetic), who have been providing great
leadership, and the workgroup members who are participants. Literally thousands
of hours have been volunteered in a collaborative approach to move Minnesota,
statewide, for example.

Thank you very much, Mr. Chairman.

MR. REYNOLDS: Thank you very much.

Based on the comments I made earlier, thank you. I think this panel laid
some things out. I heard that immunizations were a must. I heard bidirectional.
I heard reporting of notifiable diseases, and that public health infrastructure
needs some upgrades.

A lot of our friends around the table have questions. We will begin with
Karen Trudel.

MS. TRUDEL: Thank you very much. I would like to dig a little deeper into
the capabilities for 2011, 2012, in the short term, being mindful of the fact
that an eligible professional or a hospital sending data has to have someone
that you send it to who can do something with it and a means to get it from
point A to point B. Realistically, when we are trying to make sure that
meaningful use is set in such a way that many providers will be able to meet
the goals, what do you think are the reasonable goals for 2011 and 2012? I know
you mentioned immunizations and labs. But in terms of the ready receiver and
the means to get it there, how reasonable are those expectations across the
country, as opposed to in certain areas of excellence?

DR. LENERT: The issue with immunization registries is primarily the level of
funding for the registries to upgrade so that they can receive messages from
the provider systems. We have two years to get them ready for the receipt of
that. If there was funding available for them to embark on a program to upgrade
it, then they would be able to receive the messages as structured in the
existing format.

The point is that we can’t have the infrastructure without the investment.
Standards are not enough.

DR. HACKER: I would add in Kentucky we are hoping to tap into some of the
stimulus dollars to connect several data sets in public health, including
immunizations, newborn registries, and so forth, to be able to feed that back
out. The technology is there. It’s just, what do we have the money for?

The ongoing concern is, what happens after our stimulus dollars are spent?
Where’s the funding for the ongoing support? I think all of us are saying that
public health has to be included in any national approach to health-system
reform and transformation, and it takes capital investment to do that.

But in terms of the technology, that’s available today and it can be done.
We are doing it in limited places around Kentucky.

DR. LENERT: I wanted to comment on laboratories, as the next level. What
public health needs is all the laboratories in the country on the NHIN in
communication with physicians electronically. If that happened, it would be
relatively low-cost for us to support the infrastructure to have them transmit
laboratory reports to state. But as it stands right now, in the NHIN and ARRA
legislation, there is not a specific investment, except for the provisions to
states, to bring laboratories onto the network. Without those laboratories, the
vast majority of which are not on the network — without bring them up on
there, physicians won’t have anything to talk to for their meaningful use.

Let’s make communications with laboratories for order entries and results
reporting and for alerting when there are abnormal results part of meaningful
use. When you do that, you are going to enhance public health practice.

The third thing I would say is that there are certain select pieces of
infrastructure we could build right now — build once, one way, correctly, and
deploy, and have meaningful impact. I believe that public health alerts to
clinicians’ desktops, using standards like Key 81 and RFD, is something that we
could get done right away. It’s very important, because those things are
largely ignored. If we make a decision on one way to do this and make that part
of how we are building things out, we can get public health capabilities out
now.

But again, we have to make the decision to do this.

So I really see three different things:

  • Things where if you just do what’s right — that will be the labs 
    everything will come along for public health. You have to provide the
    infrastructure to get them on.
  • The immunization registries, where we have to actually support the
    registries to be ready to interoperate. It will be cheaper than to pay
    manufacturers to build 57 interfaces to different registries.
  • The third thing is where we choose to build critical infrastructure right
    now, concurrent with the process of rolling these things out, based on existing
    standards. There, if we do that, we can get amazing capabilities into the NHIN
    by 2011.

MR. REYNOLDS: Judy Warren.

DR. WARREN: I have become concerned, in looking at some of the testimony
from yesterday and then with testimonials today — both Dr. Lenert and Dr.
LaVenture mentioned that you were doing chronic illness follow-up and that you
were interested in looking at behavioral changes. Yet none of the data that
people are saying need to be transmitted will transmit that information,
because you are only looking at physician orders, you are looking at labs, you
are looking at immunizations, and you are looking at problem lists. You are not
really looking at assessments of patients.

The same thing could be said of some of the quality indicators. We are
looking at quality data being transmitted, but never the baseline data or the
assessments of those.

Do you have any comments on where you see those data coming from or if it’s
just implicit in what you are talking about, or whatever?

DR. LAVENTURE: I will start. This is Marty LaVenture.

Certainly we see the chronic disease issues as being an important part of
the menu of where we are headed. It may not be available, certainly, in 2011.
But unless we plan for that immediately, we won’t get there. So that’s where
the issue, I think, alluded to in the previous question, too, of the
collaborative development of the standards and the specifications, is so
essential, and it will be built into what is expected from an electronic health
record. That includes standardization of the data in uniform ways and
collecting and coding of the data in the electronic health record.

We would love to expand the surveillance related to asthma, related to
cardiovascular disease and stroke, and a number of areas. There are a lot of
interesting projects with the health plans that are doing population health.
The standards certainly would be welcome in order to update their particular
information systems, so we could then share across the health plans. Right now
we have a good set of data being collected in a number of different health
plans, but not in uniform ways. That would be a first critical step to
achieving that, and then hopefully the exchange, for true meaningful use.

DR. WARREN: Just to clarify, you said data was coming from health plans, not
providers?

DR. LAVENTURE: Health systems, the large systems that cover a big portion of
the population in Minnesota. They are doing terrific population health work,
but to really make that effective across true populations, we will need,
obviously, uniformity.

DR. LENERT: I would like to suggest that we take something that we can
already do, like a CCD, and use that as a way of tailoring health information
for people. We take an existing capability, we push that out using NHIN
services, and then we try to bring back the health information that is most
relevant to people to change their health behaviors. That’s a first step.

It’s something that could be done, again, relatively quickly, because it’s
based on existing standards, if we had investments in tailoring technologies
that are necessary. We have a lot of investments in tailoring technologies
already, through the MCI and other places. But we have not tried to bring
together tailoring and the CCD and existing ways of doing electronic reporting.

Again, I see this as being closer than we think. It’s just a question of
whether we are able to engineer what we are doing now to reach the cause of
individual health promotion. I think we can. We just need to think about doing
it.

MR. REYNOLDS: Justine.

DR. CARR: Thank you. Thank you for your presentations. We have covered a
huge landscape. One of the themes that we heard yesterday was, from the EHR
perspective, EHR Light, thinking about the vast numbers of people who are just
getting started and where we can go with the EHR Light.

I want to reconfigure a bit of what we have heard today and say a couple of
things.

The goals seem to be to promote health and prevent harm. The sources of data
could be the EHR, could be system administrative data, could be direct lab
feeds, and then, I guess, e-prescribing information.

But I would like to bring it down to — if we had three pieces of data or
four sources of data, what would they be? And by having them, what would get
better, either in terms of promoting health or preventing harm? I just want a
real simple thing of what we could do.

DR. HACKER: I mentioned that three –immunization registry, laboratory data,
and then reportable disease — are available, doable, and are being done in
some places right now. It’s the lack of resources in the public health system,
as well as the incentives for the private sector to do that.

DR. CARR: But we have that, and we get that information, and then what gets
better? How does it get better? It goes back to the EHR with decision support
or it’s a public program? What happens?

DR. HACKER: Several, I think, are fairly obvious. You prevent duplication,
giving the same immunization twice to the child, if you have immunization
feeds, both for private sector and public sector. Dad takes the child to the
public health department or a private doctor; mother takes him to the health
department. They don’t know — yes, he got a shot, but they don’t know which,
and so people go ahead and administer it.

Secondly, we are able to identify those populations that are not adequately
immunized. Then we can go after those folks to increase their targeting, both
the private provider world and to the public health world.

Thirdly, if we have an outbreak and we know we have — say, pertussis — we
have pockets where we knew we had inadequate immunization. We could focus our
public health resources. That’s more effective use of our dollars and our staff
time, as well as achieving a public health goal of decreasing the presence of
communicable disease.

The immunization piece out there is, I think — I can’t see anyone debating
the issues of why that’s not a good idea. That’s a classic one.

The others I think are self-evident, and I would be happy to speak in more
detail, but I suspect there are other questions.

DR. LENERT: When we talk about EHR Light, if you are willing to send out
small pieces of anonymized data to centralized services for decision support,
like an immunization registry, you can get back meaningful recommendations on
what the physician should do next. That’s the same way our public health
alerting technology that we tested in IHE this year works. The chief complaint,
the zip code, age — that goes out to a centralized server. It comes back with
what the doctor should be able to do.

A simple addition to an EHR Light can add a lot of capability, if we are
willing to change the architecture a little bit and get things that are
practical on the clinician’s desktop. We think that when the clinician is using
the electronic record, they have to get something back from the environment,
from the community, for it to be worthwhile. This type of system, where you are
sending data, anonymized, getting it back, which is relevant just to your
patient at the point of care, that’s what is really going to drive adoption in
this particular setting.

DR. DIAMOND: I just want to respond and say that I think the end of your
question is the crux of the issue: What is the public health goal that we are
after and need to achieve, rather than what data is available? The goal changes
how you pursue the information, and it changes what you really need. That
discipline, in our work anyway, is outlined by a set of information principles.
But, for instance, to take flu surveillance as an example, the old way of doing
flu surveillance was to try to derive all the underlying data and basically
derive who in that population might have the flu and then look at trends.

The model that I mentioned in DiSTRIBuTE is actually low-tech. It turns out
that to do good flu surveillance in a timely manner, you don’t have to
standardize all the underlying data and all the data definitions. You can
tolerate some noise there and still develop meaningful trends that enable
public health officials to do what they need to do, simply by collecting
summary statistics in a robust and comprehensive way, even if that means faxing
in those summary statistics on a weekly basis. It is better than sometimes
waiting for all the data that’s necessary to become available or for everybody
to comply with those requirements.

MR. REYNOLDS: John Houston.

MR. HOUSTON: Thank you. This is for Martin LaVenture. I was reading through
the document that you provided, the manual. I guess I have one question. Based
upon the Minnesota mandate, has the state been able to establish specific
measurement criteria for what is described in the manual as “effective
use,” which, I’m assuming, would equate to the same thing as
“meaningful use,” what we are here to discuss today?

DR. LAVENTURE: The workgroup of the e-Health Advisory Committee is working
on effective use as a second stage. We worked first on adoption this past. They
are working on effective use. In developing some criteria for measurement of
effective use, we see “effective use” as broader than the
“meaningful use,” in the sense that meaningful use may increase over
time or change over time, whereas we see effective use as being fairly
comprehensive, in a sense a part of best practices that needs to be achieved
overall for your practice. It may vary a bit by community or region as well.

The group is looking at a number of indicators in each of those areas,
clearly more related to outcomes, on decision support, for example, as well as
public health indicators. We have not published any yet, but will be, as part
of the ongoing development of that plan. The plan will be updated based on the
requirements coming out of ARRA.

MR. HOUSTON: Is there a timeframe for those?

DR. LAVENTURE: We hope to be updating the plan in the third quarter of this
year.

MR. REYNOLDS: I’d like to go to Marjorie next.

MS. GREENBERG: Thank you, and thank you to all of you.

This is not so much a 2011 question. But when we are talking about
population health, we are obviously talking about the health status and
functioning and condition of people who aren’t in the clinical system. We are
talking about the entire population. There are obviously a lot of things that
we can do in relationship to sharing information about people in clinical care.
But just thinking more down the road — I think someone yesterday someone
mentioned, and today at least one of you mentioned, that there is a potential
of getting a lot more depth of information than you can get in surveys. But,
obviously, it’s only for those people who have the electronic health record.

Have any of you thought about the potential for the personal health record,
as tethered or not to the electronic health record, and the potential of that
to collect information — with, obviously, the person’s consent — that could
perhaps, if not replace, then supplement the data that we get through surveys?

DR. LENERT: Marjorie, like NCHS, we embrace the idea of sentinel citizens
and hope that people will start to contribute their personal health records to
research, to population health, and to quality purposes for the country. It’s a
great thing.

But I would say, let’s not miss the other infrastructure that we need here
to really do public health. Vital registration has to be tied to clinical care.
And you know what? Vital registration needs to be tied to master patient
indexes for regions. This is an infrastructure piece. It doesn’t come out of an
EHR. It’s something we need to build that says, when somebody is born, for the
region that they are in, there is an MPI index created for that person, and
when they die, we note that so that we can prevent fraud. These activities that
are tied to the MPI for health-information exchange are an integral part of
vital registration processes as well. They need to be all brought together.

MR. REYNOLDS: Jim Scanlon.

MR. J. SCANLON: First of all, I thank all the panel members for your
insights.

Virtually all of the core services relating to public health that you are
discussing today have the dimension of health-information exchange. What do you
see, leading into 2011 and beyond — you talked about various options for how
to support that health-information exchange — what do you see as the
options? Are you viewing a public information network as sort of the vehicle
for supporting the public health exchanges? Are you looking at commercial
services? Are you looking at local health-information exchanges? What do you do
when the areas where a local health-information exchange, in the context we
have been discussing, is unlikely to form or be sustained?

DR. HACKER: In Kentucky we have an e-Health Board. Our lieutenant governor
was instrumental in passing legislation four years ago establishing an e-Health
Board in the state, which is trying to develop a statewide vision. We have
released an RFP, which is now being reviewed, to respond as a respondent. We
are on the road to contracting with an entity to establish electronic health
exchange in Kentucky, basically a pipeline across the state, with Web-based
portals, and different providers being able to connect into that, with, of
course, all the security and privacy, and all the other bells and whistles that
go along with that, with a long-term vision of being able, then, to tap in this
pipeline statewide information flow.

Of course, this is still evolving. This is a complicated process. Certainly
Indianapolis has a much more robust and more mature system, with Regenstrief,
for several years. Marty has a great program in Minnesota. I think other states
have the problem, essentially, that Kentucky has. We have a good vision. We
know where we want to go. We need resources. The technology is not the issue.
It’s the relationship issues, the legal issues, and the funding issues. But we
are on the road.

I think I’m answering your question there, Mr. Scanlon.

DR. LENERT: I wanted to throw another alternative for you that hasn’t been
considered enough. It’s verticals for health-information exchange. We have seen
tremendous success with Kaiser Permanente. One piece of health information we
exchange is a vertical at Inland Northwest Health. They provide all the
services to the participants, both hospital and individual EHRs for systems.

It would make a lot of sense to me that vendors would get into the business
of hooking up all the systems that they put together. Why not have Wal-Mart
hook up all the commission offices to that?

What do you need for that to work, if we were to do verticals? We again need
to go back to this idea of state infrastructure — master patient indexes,
facility indexes, physician and other provider indexes — that would allow the
health-information exchanges to exist as a vertical, based on product lines or
other things, without necessarily having regional coverage.

I think we would move to that. I think you would see a huge acceleration if
you changed this to exchanges that were organized along similar products. Why
not hook up all the labs together in one big system? These things might work
much faster than trying to do this on a region-by-region basis. We don’t know
this with Visa anymore by regions. We don’t buy things by region on the
Internet. We buy them by functions.

MR. REYNOLDS: Tony Trenkle.

MR. TRENKLE: I have a question for the two state representatives. One of our
incentive programs is going to be for the Medicaid incentive. I want to know
how that would best support your public health goals in your states.

DR. HACKER: Thank you. In Kentucky, I’m part of a mega-cabinet, the cabinet
for health and family services, Secretary Miller — of course, governor this
year. Within our cabinet we have Medicaid, mental health, public health, and
social services. Our IT folks have gone through the process of interviewing
each of our divisions, each of our functions within all four of those major
groups to see where the commonality is, where the shared interests are.

Certainly, the Medicaid piece and the public health piece are self-evident.
But there is also a lot of social service issues out there — WIC, food stamps
— that cross over with USDA, with public health’s involvement.

The mental health world is not adequately supported with the stimulus
dollars right now as it stands, but we are still trying to find out how we make
sure we don’t leave it behind.

The vision we are trying to build for, then, and give it different clinical
example — the Department of Public Health and the Division of Medicaid
Services within the cabinet are talking about local public health helping to
provide disease management for people with diabetes who are Medicaid
recipients. We have the Medicaid list of diabetics. We identify those. We have
lots of severe problems, a lot of ER visits, a lot of hospitalizations,
moderate, mild, different levels of interventions. The Public Health Department
identifies and works with local physicians at the community level and the
patient, with patient education and so forth.

Having that link of data and using it in the electronic health record, we
will be much more effective in sharing information back and forth, from the
clinician — if they send the patient to an ophthalmologist, did they get to
the ophthalmologist or did they get to the Health Department?

There are a lot of opportunities for improving clinical care more
efficiently and doing it in a team way, while still maintaining a patient home,
a medical home, with one person — primarily, the primary care physician —
responsible. That’s the vision we have in Kentucky, and we are pursuing that.

DR. LAVENTURE: In Minnesota Medicaid is part of a separate agency from the
state Health Department, but we work very closely on the e-health initiative.
We see the Medicaid portion as being a very important incentive to support
activities in Minnesota. The Medicaid efforts and funding will support the
Minnesota statewide health-information exchange, but also the outreach things,
as Dr. Hacker mentioned as well. In Minnesota there are a couple initiatives
related to health reform and medical homes. We see leveraging the efforts there
to make sure that whatever we are doing in support of these incentives, it
supports those initiatives also.

One of the challenges that I think we all have and that in Minnesota we face
is the whole issue of assessment. How do we target resources to those who need
it the most? We think that trying to leverage both the state grants and,
hopefully, the Medicaid funding to make sure that we are doing assessment that
allows us to differentiate adequately the subtleties of where people are at on
a spectrum and what they need to be doing — then we can target the grants and
the loans which are going to be so important for Minnesota. Our loan program —
it doesn’t have the money now, but we did, and it has been very popular — has
really been effective at leveraging to the rural and underserved community
areas. That, we feel, is important to continue in the process.

So wherever we can more fine-tune the focus of the public efforts and make
sure they are in concert with the private — many great private efforts going
on around the country, in Minnesota, around the state, are so essential to make
sure that we can sort of use a scalpel and not a hammer to how we apply some of
the resources, in particular the Medicaid funding.

MR. REYNOLDS: Dr. Blumenthal.

DR. BLUMENTHAL: I want to thank you all for very informative comments. I
want to ask a fairly simple question, just to be sure that I understand it. It
strikes me that most of what you are hoping to get as part of meaningful use
depends on most clinicians participating in electronic information collection
and exchange. Is that correct?

(Nods from panel)

And since we know that maybe 17 percent of physicians and 10 percent of
hospitals are now IT-enabled in any sense, we are starting from a very basic
level at the current time. To have the capacities that you are interested in
for bidirectional exchange, does it become useful at some level of adoption or
is it useful at every level of adoption? That’s a question, in some ways, about
timing. If you had 20 percent of clinicians or 30 percent of clinicians with
electronic records in 2011, would it be as important to have bidirectional
exchange at that point as it would be when you have 50 percent or 70 percent?

DR. HACKER: I will take the first stab and then I’ll let Leslie respond.

In Kentucky, I would love to have 20 percent exchange of information between
the providers in the private sector and the public sector. My concern is, if
it’s allowed to be developed without the exchange capabilities, we will end up
with a system that never gets caught up, and we will end up with a
private-sector system and private vendors having invested so much in technology
and purchased so much in technology that when we say, “Well, now let’s go
with the exchange,” they will say, “How do we afford that?”

If we are going to do it, let’s do it right. We don’t have to do it all at
once, but let’s make sure that what we do do has that functionality and
capability of bidirectional exchange between those two sectors going forward.

DR. LAVENTURE: I would definitely agree with that. I think it’s essential to
get started. It may not be bidirectional everywhere, but those first
bidirectional efforts are going to really, in Minnesota, lead the way to assure
a more rapid adoption. Collaborating on best practices, developing some
consensus and implementation guides will help, I think, really distribute that
to others in the practice.

There’s nothing like colleagues adopting something and seeing the value and
demonstrating the value of that effort and contribution to accelerating the
further adoption. So getting started is very important, and a reasonable step.
It may not be bidirectional, first stage, of everything. Certainly something
like the immunization makes a lot of sense.

DR. LENERT: What does that really mean to invert it? Physicians need to know
what the history of the immunization is. It takes time. We are actually seeing
that the first steps are incentives for adoption. They are not obstacles. They
are things that will promote it. Bring up all the laboratories on to the
Internet so people can order tests electronically and get them back. That’s an
incentive for meaningful use. It’s part of your definition of what a functional
electronic record is. That supports public health. When physicians have to
track down the immunizations, that takes time. But if they can get that
electronically, that’s a feature of the system; it’s not a barrier to it. It’s
something you put in right now.

If they could get public health alerts on their desktops by typing in the
chief complaint — I wish I had time to show you the demo of what we did in IHE
— that’s a feature. It gives them an incentive for adoption.

So I think that calling what we are proposing a barrier to adoption is just
backwards. We are proposing the types of tools that will make physicians want
to use it, by basic communication with outside channels, which makes this a
meaningful experience to them.

DR. HACKER: I’d like to add one short thing. I practiced primary-care
pediatrics in southeast Kentucky for 18 years. I wish I had known then what I
know now about what public health had to offer. Public health has a tremendous
amount of data and information and resources that can facilitate private
practice. We have not been doing that because we don’t have the bidirectional
exchange of information. It’s too burdensome and too cumbersome.

I have made presentations to the e-Health Alliance for the NGA. I was asked
to talk about what public health is getting out of playing in this arena, and
my presentation was on what we can contribute to it. But until it’s there,
primary physicians may never appreciate the value public health can add to the
health-care system, the efficiency of their practice, and the optimum outcome
of the entire country.

MR. REYNOLDS: One clarification on that. Dr. Lenert, you mentioned the CCD.
There are standards out there right now. Are those standards the packages that
you would see some of that being done in or do we have to come up with new
standards to do it?

DR. LENERT: To the extent that we can use existing standards, we should. CCD
is a great thing. If I’m trying to figure out a flu investigation and whether
this is striking people who have preexisting conditions or not, and I’m trying
to contain it, what information do I need to be able to do that? I need to be
able to retrieve the CCD from an EHR to do that and say what the patient’s
problem is and what the basic issues are that are going on there. That type of
capability is the type of functioning that we are talking about.

The immunization registry activity — there are existing standards for
transmitting that information that are just fine. But the trouble is, our
registries can’t accept the information. They have old hardware. They have no
money to upgrade. They have no infrastructure to do that. They would be happy
to be able to work on that, but we need to be able to get them the resources to
shift that.

So the basic standards work has been done. They are at the same level, I
think, as the rest of the National Health Information Network.

MR. REYNOLDS: With that, I would like to thank the panel. A 15-minute break.
We’ll be back at 10:45. Thank you.

(Brief recess)

MR. REYNOLDS: Our next panel is going to be talking The Glide Path to
Meaningful Use for 2011 and Beyond for Other Stakeholders — a tall order. We
are excited for them to begin.

Is there any special order you want to go in, other than what’s on the
agenda?

I would like to introduce Henry Chao first. Henry, thank you.

Agenda Item: Panel 8: The Glide Path to Meaningful Use
for 2011 and Beyond for Other Stakeholders

DR. CHAO: Good morning. Thank you for inviting me to share my perspectives
with this distinguished panel, as well as the Executive Subcommittee, Dr.
Blumenthal, and the participants that are here in the room, as well as
listening on the broadcast.

My name is Henry Chao. I am the chief technology officer for CMS. I’m here
today to discussion some of the challenges, concerns, and recommendations
regarding meaningful use from the policy and operations perspectives.

I have had the pleasure of being part of several teams of very committed and
talented people, both internal and external to CMS, working to implement the
Medicare prescription drug program. It was a tremendous challenge to integrate
the systems and processes for Medicare, Medicaid programs, health plans, the
pharmacy industry, and third parties. I would characterize the experience as
extreme systems development. Even though it was an environment of intense and
rapid development to meet the deadline, CMS strived to follow as closely as
possible the discipline of the lifecycle process.

The vision and the major goal were both very clear for MMA: Implement a
prescription drug program so that Medicare beneficiaries are able to receive
prescription drug coverage by January 1, 2006. The requirements and business
processes, however, were less clear, and the operational requirements and
increases in scale and capacity were even less clear.

CMS had to quickly adapt to acclimate itself to key requirements for a
24-by-7-by-365 real-time pharmacy transaction processing model and to gain
enough knowledge and understanding of the business process before it could
choose best alternatives, given the requirements and constraints.

Public agencies often are given large, complex programs to implement, and
generally we do not start from scratch because of the necessary integration and
accounting for multiple touch points to legacy and new systems and processes.
Almost never are there clean slates which CMS can start from, and I’m certain
the rest of the world is not like that either.

Implementing the IT systems infrastructure for a complex program taught CMS
many lessons about the operational realities of a massive initial program
startup and the effort it takes to stabilize over a short period of time.

Also there were important lessons learned about implementing systems that
have program performance metrics and data-quality checks built in as part of
the design rather than extrapolating the metrics and quality checks from
transactional production data. As we discuss and plan execution of the
incentive program, we have to give some thought as to how to build in
performance metrics and quality data indicators that help determine, at the
lowest level, if there are operational performance issues and, at a higher
level, if the data coming in and out of the systems are being processed and
representing issues at the program-performance level.

What the incentive program under HITECH indicates to the health-care
industry and public agencies is that great change is needed, and a starting
place for this particular cycle of change begins with incentivizing physicians
and hospitals to increase their adoption rate and meaningful use of EHRs and
health-information technology in general. By comparison to what we all have
been discussing about improving outcomes in health care and increasing
effectiveness and efficiencies, meaningful use of EHRs represents connecting
only a few pieces of a vastly larger health-care puzzle.

Incentives for the meaningful use of EHRs are a good, if not great, change
for health care, but do they address a solution for the entire puzzle? I think
not. The mere presence of HIT and EHRs alone do not speak to how meaningfully
it’s being used. We have to examine the entire puzzle and acknowledge and make
all the pieces visible and reasonably accounted before we apply technology to
business problems at the local and the national level.

But do we have to absolutely know everything up front? Not necessarily, but
we do need to be smart and proactive in working on the present-day change,
while always maintaining a line of sight to the larger vision and common goals.
Strong and sustained leadership, common vision and goals will ensure that an
initial good enough roadmap is defined, while helping to navigate to a more
mature state over time. Without leadership and vision, it is exponentially more
difficult to define and measure operational successes.

There are many perspectives from the major stakeholder domains. Patients,
providers, payers, vendors, and the government all move at different rates of
change, and health-care strategies, policies, business models, modes of
interaction, requirements, and technical implementation of systems and data are
still somewhat fragment, even within each domain.

There is an overabundance of variability and randomness in health care
because, while we all share the desired outcomes, we choose to operationalize
and attempt to make real the shared vision in our respective ways, which is
somewhat understandable, and not necessarily viable as we desire to move
towards greater levels of HIT adoption, interoperability, and meaningful use.
Obviously, something is lost in translation if we mostly agree at the vision
level and not at the implementation level.

What about the vision for security framework needed to support data
exchanges and measures of reporting meaningful use at the HIE level, across
HIEs, and nationwide? As major federal health-care agencies strive to create
the workable and implementable security framework of public-to-public and
private-to-public health-information exchanges, how can we come up with a
workable model that keeps data secure yet borderless when needed, private but
shared when the proper permissions and approvals are granted, while at the same
time, comply with the Federal Information Security Management Act and other
laws applicable to federal agencies?

Operationally, the authentication piece of identity management is daunting
within the Medicare data-communications universe. How do we operationalize and
create efficiencies in authentication identity management for an entire network
of millions of individuals and entities needing to send information, receive
information, request reports, provide reports, give consent, revoke consent,
and the list of functions requiring the application of information security
controls and applicable privacy protections as data exchanges scale in tandem
with the vision for the interoperable health-care enterprise?

I’m going to talk a little bit about the operational challenges. I have a
couple of slides for that, as well as policy.

What are the challenges associated with coordinating meaningful-use policy
and operations across Medicare and Medicaid in 2011 and as requirements become
more robust over time?

Number one is provider identification. When providers enroll and register
for meaningful use in reporting and incentive payments, how do we know who they
are?

It requires an increased level of granularity to account for relationships
and association between the eligible professional, with practice settings in
use of EHR, and yet maintain integrity of incentive payments.

Medicare and Medicaid must coordinate across the continuums of time,
location, program participation in order to pay accurately.

Factor in provider workflow and patterns of practice to operate a measures
collection incentive payment program that is unobtrusive.

Factor in the integration points between Medicare and Medicaid for policy
and operations, accounting for overall industry readiness in coordinating
robustness of meaningful use with stakeholders, an ongoing integration of
legacy processes, operations, systems, and data with new requirements,
incentivizing the use of EHRs as an initial step in payer programs to conduct
greater levels of integration between the business process of paying bills and
measuring quality.

Medicare and Medicaid IT capabilities and capacities require increased
scaling to meet growth in data and data-integration requirements.

The entire health-care industry, along with Medicare and Medicaid, is faced
with resource challenges in just maintaining day-to-day operations and planning
for major changes already in the works. Examples are 5010 and ICD 10.

CMS must implement Recovery Act provisions without adversely affecting our
current operations and programs. Attention to security and privacy rules,
regulations, and requirements, and how they may change over time, is critical
to successful operations and policy development.

Let’s move into the most important policy issues associated with
implementing the incentive program.

  • First, we have to define meaningful use and measures. That has been talked
    about quite a bit.
  • Balancing greater rates of adoption with the rate of improvement in
    standard measures of meaningful use.
  • Building a clear roadmap for desired sets of outcomes.
  • Measuring policy effectiveness.
  • Ensure that policies for an incentive program influence greater rates of
    adoption, and also adoption and meaningful-use use is sustained to 2015 and
    beyond.
  • Establishing privacy policies for the ethical sharing of health
    information.
  • Creating a robust security policy framework to address HIEs where source
    data are from EHRs.
  • Establishing policies that harmonize payer-centric, provider-centric, and
    patient-centric health-care domains.
  • Policy coordination among all the stakeholders.
  • Education, outreach, and communication.
  • Using EHR incentives to further link payment to quality.

In closing, I ask the NCVHS, the Executive Subcommittee, to consider how
sets of constructs and strategies may be established to focus on common aspects
of health-care effectiveness and efficiency that will drastically reduce the
risk of incongruous and inefficient health-care operations. The sets of
constructs and strategies may be able to establish core common vision and
goals, a common information architecture for health care, where participants
know respective and collective starting and end points and the progression
roadmap of converging on the common goals, account for respective needs and
uniqueness for tolerance for rates of change, and identify the logical
integration points between the administrative and clinical domains.

Through what I have discussed above, CMS and others will be able to
adequately and successfully iterate towards an operational model and meet the
intent and spirit of the incentive program, and also be poised to play its role
in transforming health care.

Thank you.

MR. REYNOLDS: Thank you. Mr. Kelly.

MR. KELLY: Good morning. I’d like to thank the committee for this
opportunity to speak here today on behalf to the payer community. May name is
John Kelly. I’m the director of e-business architecture for Harvard Pilgrim
Health Care in Wellesley, Massachusetts.

E-business architecture means that I’m the person responsible for getting
machines to talk to machines. I do this so that those whose primary
responsibility is to improve the general health and well-being of a large
number of people can do that as effectively and efficiently as possible.

In truth, I have spent the past 10 years at Harvard Pilgrim and the payer
community in New England dealing with the question of meaningful use and
technology. In addition to my role at Harvard Pilgrim, I sit on the governing
boards of NEHEN, the New England Health Care EDI Network and MA-SHARE, a
subsidiary of the Massachusetts Health Data Consortium. In essence, MA-SHARE is
a health-information exchange.

The first important thing to understand about the relationship between these
two organizations is that they use the same train tracks to deliver two types
of cargo. The network that delivers HIPAA transactions also handles discharge
summaries, medication histories, and planned formularies. The provider and
payer members at these collaborative organizations have jointly developed
standards, software, and processes that meaningfully improve health-care
delivery in our region.

The second important thing to understand about these organizations and
meaningful use is that the tools and methods we use in New England can be
replicated and scaled nationally. Harvard Pilgrim Health Care has been named
for the fourth consecutive year by U.S. News and World Report and NCQA
as the number-one commercial health plan in America.

Beyond just shameless self-promotion, I mention this because the
capabilities we have developed and the culture we have sustained, which has
helped us achieve that recognition, have very much to do with the
information-exchange relationships we have established between Harvard Pilgrim
and our network of providers. Most of those exchanges are electronic. Some are
still paper-based. But our lesson learned is that we continue to strive as a
process community to electronically share more and better information from all
of our systems in order to get better outcomes for our members.

So meaningful use: Health care is a process community — providers, members,
patients, plans, vendors, facilities, on and on. As the delivery and financing
of care has become increasingly complex, so has the web of interactions that
take place between all the participants. It has been said that what makes a
community is that you have to need each other, willingly or otherwise. The
parties in our community certainly meet that criterion, despite the public
perception to the contrary. What we need most from each other is information
exchange.

As a group, we have and will continue to work steadily on administrative
simplification. Delivery-system simplification is a much more challenging task.
Can HIT really simplify the delivery system? The Federal Reserve might call it
“decomplexification.”

What I can say from my experience with technology is that even if I can’t
make a complex problem simple, I can use smart systems to mitigate risk at
potential points of failure. From the payer point of view, this is meaningful
use.

It’s a cliché in other industries, but right information, right
place, right time, is how smart systems improve outcomes. In health care, the
stakes might be higher, but the principles are the same, from the patient’s
point of view.

So payer meaningful use has to be about outcomes. The validity of using
claims data to measure quality is challenged on a regular basis. There are two
reasons usually cited. Claims data is not a true representation of what
happened in the exam room, since the codes are chosen for billing purposes.
More importantly, claims data really can only be used to measure process, not
outcomes.

I don’t disagree with either of these assertions, but I will add my voice to
others and say that right now it’s the best data we have. I’ll further add that
a lot of good has come from smart people using claims data to develop programs
that have improved the lives of literally millions of Americans, both sick and
well. In addition, those programs have clearly shown that the meaning of
quality differs very much depending on whether you are generally well or
chronically ill. Claims data delivers fairly good process measures about
whether or not healthy people are receiving the procedures that demonstrate and
benchmark the best standards of care. Did they get a mammogram? Did they get a
colonoscopy? Have they got a flu shot?

For chronically ill people, however, claims data at best determines only
that the patient probably needs more attention than they are currently
receiving.

Meaningful use of the EHR should necessarily lead to the compiling of data
from multiple sources so that the quality and value of delivered care can be
measured in a way that can be accepted as valid by all the constituencies.
Without the HIT money right around the corner, one might take the position that
it’s time to thank the payers very much for all their good work on disease
management, health and wellness programs, centers of excellence, development of
discharge coordination programs, et cetera. Maybe between EHRs and medical home
providers, we will be ready, willing, and able to reclaim the role of
end-to-end caretaker. Maybe meaningful use will mean that payers aren’t needed
anymore, and therefore are no longer part of the process community.

I was a recent HIMS (phonetic) event in Chicago, where Dr. Wesley Wong, the
regional vice president and national medical director for Anthem Blue
Cross/Blue Shield, was speaking on a panel with two physicians who were
advocating for a diminished role for payers once EHRs are broadly adopted. Dr.
Wong observed that size matters. Payers can leverage economies of scale,
capital investment in data-analysis systems, and access to large repositories
of data to partner with providers in the best interests of the patient. Payers
can also put together programs that cover patients across spectrums of care
that are beyond the control of all but the largest integrated delivery systems.

I agree with Dr. Wong and believe that payers do have an important role to
play in the future process community that is saturated with electronic medical
records.

What our regional experience in New England has shown is that not only
payers important suppliers to and consumers of a merged clinical and
administrative data stream, payers and large delivery systems provide critical
leadership in efforts to put together communication networks that will form the
basis of regional health-information exchanges. Without the thought leadership
and capital investment resulting from the collaboration of payers and large
provider systems, the build-out of the communication grids necessary to support
meaningful use will be difficult to sustain.

If you accept that payers do indeed have a role, then, with regard to
meaningful use, payers need to be considered when determining the baseline
certification standards to be established for EHR data-exchange capabilities.
EHRs must be able to exchange data with everybody in the process community. I
strongly support making CAQH/CORE level 1 and 2 vendor certification a
requirement for subsidy consideration.

As an example, if you buy a PC today, there’s a baseline assumption that you
get Outlook loaded at the factory. Without it, you couldn’t do email. Vendor
EHR systems should have such a requirement.

The CAQH/CORE standards have been developed on a national basis, similar to
the work done in New England with NEHEN and MA-SHARE. While the current
data-content standards address only eligibility in claims status transactions,
they will rapidly evolve with the goal of automating the entire payer-provider
revenue cycle.

What we have proven at Harvard Pilgrim, however, is that we can use the
current core connectivity protocols to deliver any payload the two trading
partners agree to exchange. Using the core 2 Web services standard, which is
secure and free, I could, with equal ease, exchange a HIPAA 270-271, a CCR
document, a medication history, or even today’s Red Sox box scores.

With such capability broadly available, the forces of market innovation will
quickly yield desktop workflows that will create real value in the health-care
delivery system. I can confidently assert this because it’s a phenomenon we see
repeated over and over when any industry fully embraces the Internet. John
Wilkey (phonetic), formerly at Warrick (phonetic), now with SAP, once said the
Internet is all about connectivity, collaboration, and self-service. That
Internet effect begins the minute lots of point As can connect with lots of
point Bs.

Important work being done by HCSFIG, IHC, and others to harmonize standards
for semantic interoperability will be greatly accelerated if every machine
comes ready to talk to each other.

I know that, to some degree, this committee is faced with refereeing a food
fight between those that recommend setting the meaningful-use bar low so as to
mitigate the risk of adoption failure and those that want the bar set high so
as to ensure the realization of the ultimate goals of increased quality, lower
cost, and overall value for every health-care dollar spent. I have also grown
to believe over time that the fundamental principle of management science is to
measure what’s easy, not necessary what’s important. Increasing quality,
lowering cost, ensuring value are all functions of our ability to assess the
collective outcomes of a series of complex processes. This is true in any
industry.

Within our regional health-care community, as payers and providers, we have
begun to view our transactions and efforts as a supply chain-integration
challenge. We question the notion that everything we do is proprietary, that
sharing information reduces our competitive advantage. We have found that the
more we know about each other’s interactions, internal and external, the better
we can integrate our activities to jointly create an improved product for the
customer we all share — the patient.

As I understand the scope of this hearing, the committee is gathering input
to support the requirement under the HIT stimulus program to define the term
“meaningful use.” Payers, as stakeholders in this discussion, believe
that the standards should be established such that they strike a balance
between aggressive support of outcomes management and broad-based provider
adoption. We also support progressively higher standards being promulgated
beyond the timeline of the recovery package. We believe strongly that there
will be an inevitable convergence of clinical and administrative data in
support of both quality and efficiency and as the PMS and ERH vendors
consolidate their product offerings. The national payer community will support
the CAQH/CORE efforts to supply better and more information that could be
integrated with provider systems to automate manual processes, increase
reliability of information, and drive down the costs associated with the
coordination of responsibilities between payers and providers.

We look forward to the provider community reciprocating our commitment to
information integration, under a wisely crafted definition of meaningful use.

As an active member of AHIP, Harvard Pilgrim and other member plans stand
ready to work with providers as they take steps to take advantage of the new
EHR incentive program. We will ensure that our quality-improvement initiatives,
such as disease management, care coordination, quality management, value-based
purchasing, and streamlined administrative processes, are complementary to
Medicare incentives. We also stand ready to work with providers to leverage
existing data sources, like claims and personal health records, to aid the
transition to meaningful use of EHRs.

Again, I want to thank the committee for its time and for this valuable
opportunity. I welcome any questions.

MR. REYNOLDS: Thank you. Anthony Rodgers, please.

MR. RODGERS: Thank you.

I’m here to represent the 61 million members that Medicaid serves today —
our vision for health information technology and how Medicaid is going to be a
partner and a driver of health information technology for Medicaid networks.

The vision of Medicaid, I think, is summed up in this slide. We see this
transformation of the Medicaid system as creating an informed and activated
patient and a prepared and informed clinical team. We see that this productive
interaction has been broken down by the lack of information, both on the
patient side and on the clinical team side. Our goal is to use electronic
health information, the ability to share and exchange data, to provide not only
the clinical practice with information, but also to extend that to the patient
through personal health records.

Our problem is that we don’t have the infrastructure. We have to overcome
the infrastructure barrier and get widespread adoption. We have to come up with
rapid adoption strategies. The good part about being in Medicaid today is that
we are probably the fastest-growing market share of beneficiaries and members,
especially today, and so we have a lot of market leverage. That being said, we
need to use the dollars and capital wisely and work with our public health
partners and our private partners to overcome the infrastructure barrier. But
Medicaid has a real stake in this.

Moving beyond the infrastructure barrier, we have to get to the level of
performing systems and the competencies to create high-performing systems,
systems that use the data to improve performance. But beyond that, once we can
get to that level, there is the optimized system. The optimized system is the
advanced medical practice or the advanced medical home. It’s the broader use of
technology for population health management and for community quality
improvement.

So what we are talking about here is an upgrade of our health-care system.
Right now we are at Health-Care System 1.0. We want to use the technology to
upgrade the system, but that’s going to take leadership. I’m not a
technologist. I am a Medicaid director. My job is to lead and drive the
technology in a direction that helps us upgrade the system to a system that can
manage performance in a much more comprehensive and coordinated way. But again,
the goal is to eventually get to an optimizing system, one that is
self-correcting and is capable of extending itself into the community, of
identifying root causes to disease, including environmental issues that are
causing diseases, and to have an advanced medical-home capability at the
physician office.

If we do that, we have to have certain performance measures. That means that
we have to look at the wide range of performance measures that we overlay
across the system, from medical-cost management to the manpower capabilities we
have, the quality-improvement practices, the system-capacity issues, the
operational issues, and then the compliance. This is our performance focus in
Medicaid. We drive this through our provider communities and through our
various networks of programs.

That’s the challenge today. We believe that electronic health records will
provide us with the tool to help drive those new performance levels. But it’s
going to require both public and private working together to assure widespread
adoption.

So what’s our glide path to meaningful use? At the first level, we know that
we have to build infrastructure. Between now and 2011, one of our focuses as
Medicaid — and we have a multistate collaboration that’s looking at these very
issues — is, how do we get the acquisition, installation, and adoption of
electronic health records that have e-prescribing capabilities, computerized
order entry, quality reporting capabilities, clinical decision support
capabilities into our hospitals, et cetera? How do we get that information
exchange, and then, from there, using that data, create the continuity-of-care
documents that can be shared at the point of care?

This is going to require clinical data repositories. Right now many of us
have administrative data repositories. We see ourselves as adding the clinical
data and then providing that back in terms of a continuity-of-care record.

We also have to look at the practices. One of the realities is that, unlike
Kaiser or the VA, we don’t have many staff models. We have systems that are not
integrated. We are trying to integrate them with the data. It’s going to take a
significant amount of effort to support those practices and reengineer the
practice to be able to achieve that next level of performance management. So we
realize that our role is going to be going out and supporting practices and
helping them reengineer their processes.

The structural requirements: We need to develop a strategic plan, which many
of the Medicaid programs are in the process of doing, that will establish the
approaches, look at health-information infrastructure that is required, be able
to do the environmental assessment of where we are today and where we need to
go, and then we will be able to invest the dollars from the federal government
and other dollars wisely.

We also have to then assist physicians with the acquisition, upgrade, and
integration of their technology through health-information exchanges. Many of
our Medicaid provider networks are in communities that are not well connected
and that are going to need an infusion of capital to do this.

We also need to provide ongoing technical support and assure that physicians
are able to get the technical support quickly, and, as I mentioned, practice
reengineering.

Building the interfaces with public health and with our case-management
systems and our managed-care organizations and the integration of patient
decision support tools that we believe can be an extension of electronic health
records — this will raise health literacy in our population, which is so
important to reducing health disparities.

It’s also going to require creating new relationships between hospitals and
providers. The one thing about Medicaid is that we can be the honest broker
that facilitates, through contracts, through regulations, and other
expectations, these relationships to form. As a payer, but also as a regulator,
we have that ability to say, you shall our data, and you shall share it through
these EHRs, et cetera. So we can create these partnerships and relationships.

Beyond that phase, we have the initial phase. I call it the burn-in phase.
Every new system in a provider’s office or a hospital has a burn-in phase. This
is where systems fail. So we are going to have to make sure there is the
technical support, beyond just the installation, providing the physicians and
practices on how to use the system, how to integrate the system, to focus on
productivity improvement. That’s one thing we know we are going to lose. We
will lose productivity improvement initially. We have to focus on bringing that
productivity improvement back, by taking out some of the administrative hassle
factors, whether it’s prior authorization requirements, et cetera, and
installing those and integrating those with the EHR.

Again, we also have to give the physicians a sense that we are there to help
reduce risk of failure.

Connecting those systems to the external sources, including public health,
including behavioral health, including all the other program sources — the
benefit of us doing this is that many of our physicians practice with private
patients as well. As we develop these resources, they will be available to the
private sector.

As we look at it, we are driving our physician practices to the first level
of medical home, which is a physician that can e-prescribe, that can develop
individual patient-care plans, that can do care coordination, by using the
electronic health record, which has multiple sources of data, as the
coordinating tool and integrating tool. In that way, we can use the physician
practice as kind of the command center for how that patient’s services will be
provided.

Getting beyond that:

  • We have to get to the managed performance phase, where we have physicians
    together in quality networks.
  • We consider the clinical decision support tools that give references that
    are specific to Medicaid requirements and Medicaid expectations, so that we
    actually have proactive clinical decision support tools that are providing
    information to the physician — referral information, et cetera.
  • The Web connectivity to the patients to improve patient compliance —
    electronic reminders, messaging, et cetera.
  • E-learning tools as well.
  • Finally, supporting disease registries and performance reporting.

This diagram kind of illustrates the transparency that we want to see. We
want to see that episode of care at every step along the way. We want to see
the cost outcome of that episode of care.

To do this, we need a system that is self-correcting, that is cost- and
quality-transparent, that is vertically and horizontally integrated, and that
is patient-centered.

This is the diagram of Medical Home 2.0 after we have had that burn-in
period.

Getting beyond that is the optimized system. We have to really look at all
the areas where we need to optimize patient care and overcome, especially in
chronic care management, the problems we see today.

This is a diagram of how we see integrating the entire system around our
e-health, within our Medicaid organization.

The core competencies that Medicaid is going to need to have in the future
are described on this slide.

Finally, the information technology environment, which will be much more
complicated for Medicaid, but it’s going to be important. That is going to get
us to the advanced medical home.

This is a description of our optimized system:

  • It’s a fully integrated, coordinated patient-care system.
  • Performance focused on the individual family and population.
  • Health networks that have the resources designed and organized around the
    individual.
  • The ability to exchange electronic health information.
  • The optimized system efficiency, the transparency, that we would see in
    the episode of care.

Thank you.

MR. REYNOLDS: Thank you to all of you. I just want to ask one clarification,
Mr. Rodgers. It lists you as the state of Arizona, but are you talking about
all Medicaids.

MR. RODGERS: It is Arizona and all the other Medicaids. We have a multistate
collaboration, and this is the vision that we have been working on over the
last two years, since we got the Medicaid transformation grants.

MR. REYNOLDS: Okay, good. Thank you. First is Jeff Blair.

MR. BLAIR: Mr. Kelly, you introduced a new perspective here in terms of
meaningful use — that meaningful use also be applied for preventive care and
wellness, for disease management. When we were listening to providers before,
they mentioned priorities in terms of registries or interoperability or
decision support or quality measurement. What are your priorities with respect
to any of those items as a focus for meaningful use?

MR. KELLY: We all ready have a number of programs in place around things
such as registries and clinical management and disease management. I think that
our priority is that we be included in the information-sharing infrastructure,
so that we can augment the data that we have with more, better data that is
more reflective of what’s happening in the clinical domain.

As I pointed out, we can do a pretty good job around healthy people, HEDIS
measures, things like that — yes, I know that you’re 40 years old and you got
your mammogram. That’s great. What I can’t do is tell if the chronically ill or
cancer patients is getting everything that they really could be getting, things
that we might cover as benefits that the doctor may be aware of, programs that
we may have negotiated with a broad agency in the community that would serve as
our population, and we need to be able to connect that up to the doctor. A lot
of that we can’t do if we don’t have a fuller picture.

I think we have looked at this as a two-way street, though. What we have
done within our community in Massachusetts, to a great degree, is to look at
flopping all the information we have back and forth, so that we can really look
at it as a patient-centered process and we can coordinate. We are getting
better. It’s a rather new idea, but the notion that a doctor might actually
recommend to their patient, “You’re going to get a call from Harvard
Pilgrim, because they have this great discharge processing program that they
have put together. I work with them. I talk with them. My nurse is in contact
with them.”

If we could do that, with our size and leverage, we could actually work as a
team member with the physician as part of the process community.

MR. REYNOLDS: Tony Trenkle.

MR. TRENKLE: I have a question about readiness. This is for Henry and for
Anthony.

Henry, you talked about the Part D program and the tradeoffs you needed to
make because of a short deadline. My question for you is, with this short
deadline we have here — and there will be some tradeoffs operationally — how
can you avoid getting in a situation where you are just trying to make a
deadline as opposed to building a platform for the future?

Tied to that, Anthony, what do you see in terms of the states’ readiness for
2011 and the challenges you are going to need to face between now and 2011 to
get there?

MR. CHAO: In my testimony I mentioned getting the good enough roadmap done,
recognizing that it’s connected to a larger vision of exactly what you have to
trade off in order to make the deadline. You have to get the program started.
You have to get docs taking on this cultural shift. They are getting some
assistance and funding for use of EHRs, acquisition of HIT. But then what will
they do with it? How do we measure it?

We need to first take care of making sure the program gets off the ground.
So we can’t make the program start out with the standard so high that we
actually have a lot of folks sitting on the fence.

But we do have to know what’s going to be happening in 2015. What does that
vision look like? If you don’t have that, then you don’t know what you are
trading off.

MR. RODGERS: In terms of Medicaid, we do have 50 different Medicaid programs
that typically have 50 different solutions. What we are going to try to do is
to work together to come up with some common solutions. Each state has a
different type of network. In our state, we contract with community doctors and
most of the hospitals. In some states, they have primarily FQHCs and safety-net
hospitals. So the solutions will be slightly different on rapid adoption.

The biggest challenges that we are hearing are regulatory challenges in
terms of the role that Medicaid will play. In some cases, the legislature and
the governor have to facilitate that this role is appropriate. The incentive
program that is anticipated, in some cases, will require legislative authority.
So those are the kinds of things that will have to be done.

What we are doing to get ready for this is, we are encouraging states to
start their strategic planning process. You want to get the return on
investment. Our analysis of our return on investment, if we get widespread
adoption by 2011, is $248 million. That’s a lot of money to have on the table.
This is from the level of duplication in the lab and x-rays and pharmacy, the
overuse of emergency room, et cetera, that we believe this technology can help
us resolve. That immediately comes back to the state. In terms of
sustainability, I think that’s where the state will see the benefit of
supporting sustainability of these systems as well.

The FQACs, the federally qualified health centers, community clinics, IHS
facilities, and some of the hospitals that we work with are already getting
grants and have already moved with electronic health records. So we have that
to build from. Some states are actually operating, as in the case in Arizona,
their own health-information exchange. So we have that to build from as well.

MR. REYNOLDS: Judy Warren.

DR. WARREN: This is for Anthony Rodgers. You are the first person who has
talked about patient education and family. What I would like for you to talk
about is, what would meaningful use of the EHR look like for patient education
and family? Where do you see that on the timeline that we are working with?

MR. RODGERS: I appreciate that. We see that as very important. Many of our
programs are family-centered. Engaging our family members and empowering them
to make choices that are beneficial to them — and then to understand the
impact of their choices, et cetera — is so important.

We see the technology as helping us do that, if we use it as an extension of
the electronic health record. Many of the beneficiaries today have connectivity
to the Web. They don’t have any product. We have to develop product for them.
We have to bring that product so that it’s e-learning products for diabetes
education, et cetera.

But the other place where we have missed the opportunity is in the doctor’s
office. We have to provide an e-learning center for our patients in the clinic,
in the doctor’s office, very similar what you see with ATMs. They used to be
all at the banks and then they were everywhere. We want to see e-learning
opportunities for our patients everywhere that they can go.

The issue is, the younger people have no problem with the technology. Our
older beneficiaries we are going to have to help overcome some of the initial
fear of the technology. But once we do that, we believe they will be active
users of e-learning, personal health record information, and become active
communicators with their practitioner team.

DR. WARREN: The nurse in me just has to say, thank you for mentioning both
of those things.

MR. REYNOLDS: As I mentioned to the group, it is all about nurses.

DR. WARREN: It is.

MR. REYNOLDS: Leslie?

DR. FRANCIS: There have been a number of comments made about the investment
issues with respect to achieving meaningful use for underserved populations,
the need for extra support, training, and so on of providers. I would like to
ask all of you whether you see any substantive issues about how we should
understand meaningful use. Should we be thinking about it differently with
respect to the kinds of standards rather than just indicating that we need lots
of money to make sure that it can happen?

I have in mind things like problems with mobile populations, with patient
trust, questions about identification, fear of being identified, or other
issues such as that. Do any of them play into how you think we ought to
understand standards for meaningful use? Or are there other issues that you
see?

MR. CHAO: I mentioned something about — and Tony addressed this as well —
what will be the tradeoffs? Often, when we are kind of squeezed for time, to
get something across the finish line we look at what we have and we reuse it.
Often data is repurposed — the classic example of using claims-based billing
information to determine quality outcomes. It’s what’s available. It’s common
and it’s accessible. We use it. It does have value.

But if you want to run a quality outcomes program, what data are you really
after? The same goes for — if you want to collect meaningful use, and
meaningful use changes over time and depends on the practice setting and the
type of provider, how do you define that set, instead of going after the
low-hanging fruit, because the low-hanging fruit may not suffice to cover your
needs three, four, five years out.

MR. KELLY: I think another way to look at the issue is that — I have had a
number of conversations with Marilyn Daly (phonetic), who is the CIO at
Neighborhood Health Plan in Boston. They do some very innovative programs with
the disadvantaged. The tenor of our conversation essentially is, if you can get
good at managing a difficult population, then you should be able to do a
crackerjack job with the rest of the world.

So I think the meaningful-use piece of the EHR that gets very relevant here
is, how do you stop the ball from getting dropped? When patients move from
place to place, setting to setting, physician to physician, program to program,
especially programs out in the community where the responsibility and the baton
is being handed off, that is a perfect opportunity for a smart system. That’s
not to say it’s easy. But the tools that would be part of meaningful use in an
ERH that really address the management of the continuum of care, I believe,
would be the tools that you would exercise more effectively with a difficult
population.

MR. RODGERS: In the Medicaid program, I think to maximize our return on
investment at the provider level is to bend two curves — the quality curve up
and the cost curve down. What we want to do is take out the need for
duplication in medical errors, et cetera, due to a lack of information. So
meaningful use means that they have an integrated source of data that they can
see at the point of care. The patient’s health history has the information they
need to provide the continuity of care.

Our role, as Medicaid, is to assure that that happens and that our
investments assure that that happens. It’s not just the physician’s
responsibility. The incentive program will help with that, but also the
infrastructure we create around that.

At the patient level, it is the activation of the patient through the
information, to communicate to the patient in a way that they would receive the
communication through the telecommunication tools that we have today and
through the technology and the Web tools that we have today, e-learning tools,
so that they become activated and users of the system.

To validate that, we are asking our members what’s valuable to them that
they will use this in terms of their health care, in terms of their knowledge.
What typically is valuable to them is knowing where to go, knowing what to do
about specific situations, knowing where the community program is that they can
go to to get assistance. That’s where you start. That’s what they want. Then
you build form there into building their medical knowledge about diabetes or
about asthma, et cetera. But you start, as a product, with the questions they
have today. That’s what we see using the Web for. We can do that. We have many
systems that can actually project that out.

The other thing we have to capture the member is, we now have Web-based
applications for Medicaid, where you can go online and do your own application,
with someone’s help. That’s introducing them to the technology as well.

MR. REYNOLDS: Mike.

DR. FITZMAURICE: My question is, are there any additional or different basic
functions needed for electronic health records to support the Medicaid program
goals of CMS and of the states? For example, will existing standards and
functions examined by CCHIT suffice to prepare EHR products for Medicaid
provider meaningful use and for your vision of what HIT should do for Medicaid
patients, as a starting place?

MR. RODGERS: From my perspective, the one thing that is not in the standards
is the case-management activities that are so important, and the
care-coordination activities. It can be developed and it can be formatted. But
the health plans we contract with need to be part of that data flow, so that
the physician knows what that case manager is managing that patient for.

We see that. We see EPSDT and the EPSDT forms and referral processes as part
of the clinical decision support tools that we need to configure in, and then
the eligibility. We see that Medicaid eligibility in the provider office or the
point of care — if we can have a simple way for people to keep themselves
eligible in the provider’s office, without hassle, and assist that member by
giving them connectivity back in to change their information as necessary, this
will help us.

Those are things that I think are important in terms of Medicaid.

MR. REYNOLDS: Jim Scanlon.

MR. J. SCANLON: I think several of you mentioned that, in essence, the same
electronic rails that transmit claims and administrative data for HIPAA are the
rails that will transmit clinical and electronic health record data.
Presumably, the HIPAA information-exchange capability is ubiquitous, it’s
nationwide, in virtually every state and every locality, and has the capacity
to do that? How would that fit in? How would it support health-information
exchange capabilities for EHR?

MR. KELLY: I think — and this is my view on it — that a lot of the work we
have done we did by looking at other industries, telecom and banking, to see
how they integrated the supply chain.

If you look at the Internet, when most of us in this room started using it,
it was a green screen and all you could do was push text. The important thing
about it, though, is that it connected point A and point B. Just the connection
of point A and point B led to an explosion of innovation, where now you are
sending documents and then you are sending music downloads, then you are
sending videos, and now you have Facebook and Web 2.0.

If you start by connecting — and the lesson we learned with NEHEN is that
just by starting with simple frame relays — I’ll even go back further than
that. We started our connecting with Partners Healthcare, putting a tape of
claims in a cab and sending it up the street. That led to collaboration, in and
of itself.

Once you connect the points and the dots, innovation starts to happen.

I think the key thing, though, right now is that the Web is available
everywhere. There is still competition, to some degree, around standards. What
CORE and CAQH have done is to come up with a consensus model for creating Web
services, which I’ll call “haloed light.” On the other side, you have
the IHE, which has crafted a standard that they call XDS — and the NHIN is
essentially based on that — for exchanging much more complicated payloads.

I have been brokering conversations between CAQH and the IHE, with the idea
that we can’t have two email standards; we have to have one. The standards that
exist between CORE and CAQH were built with a lot of talk between the two of
them. Our position right now is, a lot of the systems in the doctors’ offices
aren’t ready to do the complicated exchange that is needed with the IHE
standard, so starting with the CAQH standard, which is a fairly low lift for
anyone with some decent technology tools — it’s free. It’s just a standard.
Then you start getting people connected.

The other thing that we have realized in our experience in the last 10 years
is that there is a lot of low-hanging fruit around administrative transactions
that save a lot of money. We have used that money to fund further projects and
to increase capabilities, to the point where now we are using a gateway for
ERX.

We eliminated WebMD. I pay no transaction charges for exchanging claims,
eligibility, anything like that. I don’t want to say no WebMD. Sorry about that

We believe that the Internet is about this intermediation; it’s about
connecting people point to point. We look at ERX right now. We have built the
MA-SHARE ERX gateway. So I have the option — and providers and vendor systems
now have the option — of not necessarily going through an intermediary to get
my formulary, my medication history. That’s all real hard dollars you can pull
out of the system, just leveraging tools that exist today and using the
Internet.

I getting to the real meaningful use, all it would take would be a
commitment to have the IHE and CAQH sit down for six months and reconcile the
standards and come up with essentially one email protocol for health care. We
don’t need to go develop anything more.

MR. RODGERS: I just want to point something out that’s very interesting. We
use the MA-SHARE open-source software as well. As we develop functionality or
as Massachusetts develops functionality, we can share that. That’s one of the
benefits of having some common standards and some open-source software
applications in terms of the health-information exchange.

MR. CHAO: If I heard portions of your question correctly, you were talking
about whether we could reuse underlying infrastructure. I have to make the
comment that a lot of the underlying infrastructure is point-to-point
negotiated exchanges. What we need is to elevate that up to a level — the
Internet certainly helps a great bit. But then how do we impose the security
model that I mentioned on top of that, so that the point-to-point is
multi-point-to-point and the network takes care of that for you? How do we
authenticate individuals on that entity? How do we trust domains?

Granted, NEHEN and lots of the health-information exchanges are beginning to
have some answers for the larger question of how you do it at the nationwide
level. But we have to be careful. From an infrastructure perspective,
repurpose/reuse is great, but we would not use your water system for an oil
pipeline. You know what I’m saying?

MR. KELLY: One follow-up on that. The standards that CAQH and IHE have put
into place are based on the same kinds of standards that secure the banking
industry and the telecom industry — X.509 certificates, Web Services. Those
are open, free, and all that is required to really make a national network
would be some centralized authority — one or two or three — that manage
certificates, the same way we have a couple of authorities that manage Internet
domains.

MR. REYNOLDS: I’ve got a question. Mr. Rodgers, this committee has done a
lot of work on privacy, data stewardship, secondary uses of health data, and so
on. We have put forward this philosophy of a data steward.

You made a statement, “They share our data.” It appears to me that
that’s a wonderful step towards you establishing that you guys are the data
stewards of the information for your members, which then puts it at a
significantly higher and more structured level than every single person that
deals with it. Then you are responsible. If people are sharing your data, they
are sharing it under your auspices, under your control, and under your
evaluation, which I think is a lot of the philosophy that we were looking for
and a lot of the thinking, which starts to take this.

If you have fewer entities that step up to be larger stewards, you start
driving privacy and you start driving all these other things down, a little bit
like Business Associates was originally set up under HIPAA. Is that a fair
statement? I don’t want to jump too far.

MR. RODGERS: That’s a fair statement. It goes beyond that. For that purpose,
we want to drive the research agenda. We want to be part of that
priority-setting process that says, we would like to see more research in this
area — Native Americans and diabetes.

Within our state, we have an agreement where, to use our data, it has to
have value back to society as a whole. What the electronic health record allows
us to do is actually push down the consent and open up the door for individuals
who want to participate to have other information and to allow community
physicians at federally qualified health centers to participate in a much more
efficient way, so that we can reduce the cycle time between discovery and
practice. That’s really our ultimate goal.

MR. REYNOLDS: Then you are also assuring the Native American diabetics or
whomever you put in the population that you are the steward, and you know that
wherever it goes, it’s being handled appropriately.

MR. RODGERS: That is correct, because they are part of our advisory
councils. They are the ones that give us that authority. We report back to
them.

MR. REYNOLDS: Again, that starts to bridge the gap between the individual
and the common good.

Jorge, you have a comment.

DR. FERRER: I have a question for Mr. Chao. Today health services research
is predominantly done off Medicare/Medicaid claims-based analyses. How do you
foresee, as we move into deeper clinical information, CMS facilitating health
services research in that area? How would you envision that? Payment reform
really can’t happen without having the ability to go to that level. Today you
provide a great service by providing that claims base. It’s limited, but it at
least provides a good service to the health researcher. Can you comment on
that?

MR. CHAO: There is obviously a need for a business vision that drives the
technology vision. I mentioned that the challenge for large operations, such as
Medicare, which processes so many claims and eligibility transactions and is
trying to send terabytes of data to hundreds of partners — you can’t really
disturb that overnight. You are threatening a program that is in operations for
45 million individuals on the Medicare side, probably 12 million to 15 million
people that are duly eligible on the Medicaid side. So you have to gradually do
that. The business vision has to be created before we apply the technology
vision.

I don’t know if I’m exactly answering your question. We have to wait and
see. We have to discuss this among HRSA and all the other operating divisions
under HHS, about how to work on this together under the leadership of the new
Secretary and the Office of the National Coordinator.

MR. REYNOLDS: Okay, I am going to have to end the panel now. I thank you
very much. Excellent job.

We are going to move to open public comments. I would like you to queue up
back there, please, since we only have two minutes per. First is, I believe —
I believe Jack Callahan was the one who came up yesterday and told me he was
not here today. Unless he stands up, I will take that as a fact. We have
Michael McCoy, Michael Mitzak (phonetic), and Arthur Gasch.

Again, it’s just like yesterday. It’s two minutes per, please. We would like
you to stick with that, if you would. Mr. McCoy.

Agenda Item: Open Public Comments

DR. MCCOY: Thank you, Dr. Blumenthal, distinguished committee members. I’m
Dr. Michael McCoy. I’m an obstetrician by training. I’m the co-chair of the IG
Patient Care Coordination Committee. I have served on various things for both
HITSP and for CCHIT.

This committee has heard a lot about meaningful use over the last couple of
days, but little has been said yet on hospital departmental systems and how
meaningful applies to those, as opposed to the enterprise-wide systems. Often
the departmental systems are from different vendors than those of the
enterprise-wide. Thus, certification currently exists for enterprise-wide
systems, but not for the departmental systems, except for the emergency
department.

How will the meaningful use apply to people who are using those other
systems? If there is going to be a requirement for individual certification for
those departmental systems, how does that go about coordinating with the
enterprise systems?

I think the interoperability between the departmental systems and the
primary system needs to be considered. That’s something where direction needs
to be given to address those concerns. It causes fear, uncertainty, and doubt
in both the hospital vendors and the users as to what’s going to happen. So I
would urge the committee to consider those aspects.

Thank you.

MR. REYNOLDS: Thank you.

Mr. Mitzak.

(Not in attendance)

MR. REYNOLDS: Then we will go on to Arthur Gasch.

MR. GASCH: Hi. I’m Arthur Gash, with Medical Strategic Planning. We do
surveys of electronic medical records companies.

As I was thinking about meaningful use, it occurred to me, meaningful use
for whom? In the last day or two, the notion of meaningful use for the
physician, meaningful use for the patient came up. It was noted several years
ago, when Dr. Baylor was the coordinator, that 50 percent of the systems
deployed failed. It has been noted more recently by work at the Institute —
Tupper (phonetic) — that 20 percent fail to live up to the expectations of
those who deploy them. A recent article in the New England Journal noted
that the reason for this is that many of the systems are very difficult to
operate and, in some cases, too complex.

I think if we are going to have the second part of the national health
agenda, which puts 46 million people under medical coverage, they have to be
able to see somebody, and most of the small practices that have not yet adopted
are closed to new patient admits.

So the question becomes — I think the first meaningful-use requirement is,
how does it become meaningful to the physician who uses it and improves his
office efficiency so that we create the capacity necessary to see these new
patients under the system?

I think we could be careful not to leverage so many third-party requirements
onto the meaningful-use agenda that we balk down the actual performance of
health-care delivery by the physician to the patient in their office, by
encumbering the system with all of these other requirements.

So I would just encourage you to take that into consideration.

I think also that standards exist already. For example, a number of vendors
point to the fact that they could accept LOINC codes. We could enforce those
with CLIA regulations and then get the laboratories to support them.

Thank you.

MR. REYNOLDS: Thank you. I’ll apologize ahead of time for not pronouncing
the next name correctly. If you would please introduce yourself —

MR. CALLAHAN: I’m the first one you called, Mr. Chairman.

MR. REYNOLDS: Jack Callahan?

MR. CALLAHAN: Yes, sir.

MR. REYNOLDS: Then you are ready to go.

MR. REYNOLDS: Thank you very much. Dr. Blumenthal, Chairman Reynolds,
members of the committee, my name is Jack Callahan. I’m executive vice
president with SRS in Montvale, New Jersey. We have over 4,000 high-volume
specialists as EMR clients.

First, I would like to applaud this committee on behalf of all of us
health-care consumers and providers, who are depending upon you to get all the
perfect answers for all stakeholders.

Our focus yesterday and today has been on outcomes, meaningful use as to
what data is to gathered, reported on, networked, how it’s all brought together
to show evidence of meaningful use. We have also heard how the data will
improve our health care, reduce our costs, and result in fewer medical errors,
and even enable patient rights and access to the data — all the hard work of
many people, to be applauded.

But what about all this data being gathered? What about those who have to
gather it — the physicians, the providers themselves, the ones that give the
care? The more discrete data we ask doctors to gather, the more burden we are
placing on them in their jobs as physicians and caregivers at the point of
care. We have to keep in mind the physicians themselves.

A couple of questions need to be answered: Why is the EMR adoption rate, as
Dr. Blumenthal mentioned earlier today and as evidenced in the New England
Journal of Medicine — why is it so low? Why has the adoption rate of EMR
up to this point had such a high failure rate — in many studies, in excess of
50 percent. Why is that?

All the hard work of this group in bringing these incentives into play —
will that change that whole curve going forward?

Providers, up to this point, have used as the number-one reason for not
adopting it as, it’s too costly. That has two components: one, the upfront
cost; and two, the ongoing productivity costs operationally going forward, in
protracted training, long learning curves, fewer patients that they have to
see. Many doctors suffer this, especially the ones we serve, the high-volume
doctors.

I urge the committee not to ignore the provider in this equation in defining
what meaningful use is and the data that is to be gathered.

I make two recommendations:

One, that you include in your thinking usability principles. I know that Dr.
Blumenthal has already said he is including this. Include metrics for
usability. That allows a comparative sense between methods of gathering it.

Second, I urge the committee to allow providers to choose how they provide
the data required. You are measuring outcomes, and those outcomes are the
essential part of the equation. Allow doctors to choose.

Look for answers to those “why” questions.

MR. REYNOLDS: Thank you, sir.

Mr. Jagannathan, please. Then it will be Dana Green, then Sandra Fuller.

MS. GREEN: If I am cutting in line, I apologize. My name is Dana Green. I’m
with the Altarum Institute.

One of the things that you are intending to do is to predict the future, and
so I’m going to quote Dr. Phil, the most accurate predictor of the future, as
well as past experience. There are a couple from my past that I would like to
bring up. I am no longer the project director for the HSPIC (phonetic) project
in Michigan. However, from my experience wit the HSPIC project — no one has
mentioned it before — there is significant overlap to what the HSPIC project
did. I found them handy and cheap. So I thought I would at least mention that
this is a resource that you may want to consider for field staff in the field.
They have already been designated by their governors. They already have
steering committees that have multi-stakeholders. They have already canvassed
the projects that are in their state. They have developed proposals and
implementation plans. So they are handy and very inexpensive.

The other thing from my past is that I used to work for Disney, and one of
the things I found out about Disney was that they are great at traffic control.
How they do it is, for example, to get in the Magic Kingdom, there is no way to
just drive up, park, and walk in. You have to go through the Disney
transportation center in order to get to the Magic Kingdom. That is how they do
crowd control getting into the parks.

Your definition of meaningful use will define how much stress you put on the
system. It’s the only thing you have. I would recommend that you be ambitious.
What we have learned from HIPAA is that you have the right to change your mind.
If you need to move deadlines back, you have that option as well.

MR. REYNOLDS: Thank you.

Sandra Fuller, then Gavin Lew.

MS. FULLER: Thank you, Mr. Reynolds. On behalf of the American Health
Information Management Association and its 63,000 members, I thank you for your
attention to this topic and welcome Dr. Blumenthal to his job and thank not
only the committee members, but the committee staff and the staff of the Office
of the National Coordinator, who have done a fine job and will continue to be
challenged by this work.

We will submit written testimony, but I would like to make three main points
for the committee’s consideration.

First, we clearly agree that this is no simple IT project. The goal of this
is to improve health care. Like our vision, we believe in quality health care
through quality information.

We challenge you first with the adoption of certified standards-based
electronic health records, widespread adoption. Somebody said yesterday, let’s
raise all ships. We think that’s the first goal.

Second, consistency. We would challenge you that the definition of
meaningful use has to be certain that it doesn’t have the unintended
consequences of incenting behavior based on a single payer, a single provider
type, or a single type of patient. No patients left on the shelf, please.

Third, an incremental path that takes two forks, if you will. The first is
to maximize the benefits of electronic health records for continuity and
coordination of care. There are some low-hanging-fruit projects there that we
have heard about. But second, we should also continue to work on the
relationship between the primary use of data and the secondary use for quality
reporting, public health reporting. In fact, when you get to the fork in the
road, we have to take both paths.

Thank you very much.

MR. REYNOLDS: Thank you. We will take Gavin Lew, and then we will just have
two left, as the sign-up is right now, for this afternoon. Mr. Lew.

MR. LEW: I’d like to thank the Committee for this opportunity. My name is
Gavin Lew, from User Centric.

I and my colleagues are behavioral scientists, expert in human interaction
with technology. I share the vision of improved quality of care through
improvement in HIT. I agree with the panelists on the future benefits. However,
the key assumption is that clinicians actually embrace EHRs. To quote Dr.
Blumenthal in the NEJM article, many certified EHRs are neither
user-friendly nor designed to meet HITECH’s ambitious goal of improving quality
and efficiency in the health-care system.

My question to this distinguished committee is simple: Shouldn’t meaningful
use address the problem that poor usability is one of the key barriers to EHR
adoption? In short, if doctors don’t use it, it doesn’t work. Poor usability
and adoption issues are universally recognized points today. How will this
change if meaningful use and certification do not address usability?

Yes, clinicians can be forced to use EHRs. But if EHRs continue to be
difficult to use, the result will only be a bare minimum interaction. Even
worse, poor design induces error. When it comes to improving quality of care,
it starts with the clinician experience with EHRs. Meaningful use must have a
behavioral component, one that measures clinical interactions. EHR clinician
performance can be measured. Outcomes can be reliably reported. Criteria can be
established. Setting criteria by clinical specialty and measuring
post-implementation will make user performance relevant and drive technical
innovation from vendors.

Technical aspects have been broadly and thoroughly discussed. I urge the
subcommittee to understand the human aspects of meaningful use, how to measure
how well EHRs really work to make the stimulus package realize the benefits now
and for the future.

A more descriptive written statement will be submitted by User Centric to
provide a roadmap for implementing these measures.

Thank you.

MR. REYNOLDS: Thank you. With that, we are adjourned until 1:15. Thank you,
everybody.

(Whereupon, a luncheon recess was taken at 12:00 p.m.)

A F T E R N O O N S E S S I O N (1:15 P.M.)

MR. REYNOLDS: We are back for this afternoon. Panel number 9, Certification
and Meaningful Use. I would like to know what order you would like to go. I
would like to introduce Dr. Leavitt.

Agenda Item: Panel 9: Certification and Meaningful Use –
EHR Product Certification

DR. LEAVITT: Thank you, Chairman Reynolds, members of the committee, and
distinguished guest. My name is Mark Leavitt, I am chair of the Certification
Commission for Health Information Technology, or CCHIT. I hope you will spell
it and not pronounce it.

We are a non-profit 501C3. I have a new side job as a lightening rod and it
singed all the hair on my head.

Over the past three and a half years, we have worked under a contract from
ONC to develop and validate certification criteria and inspection processes for
EHRs and other forms of health IT. We have been the federally recognized
certifying body since 2006.

I found your questions thoughtful and provocative. So instead of delivering
a standard presentation, I’m going to answer your questions. In the course of
that, I’ll share some information. If you want more, the end of the slide
presentation has an appendix with some supporting details. So let’s go right
into your questions.

The first was, what role does certification play in meaningful use? Let’s
look at the usual role of certification. The usual role of certification is to
reduce risk, whether it’s electrical appliances, cars, aircraft. Certification
ensures that some type of technology complies with some type of standard.

Certifying bodies may be in the private sector, as in the case of UL
Laboratories, purely government, such as the FAA, which certifies planes, or
kind of hybrids, quasi-governmental. The funding model varies. That’s probably
not all that important. But what is important is that certification is very
valuable when the risks are high or when the technology buyer can’t really
evaluate the product’s quality and suitability.

Think of the one-doctor office and think of EHRs, and I think you will all
agree that that applies. Think of the risks that we are taking here of making a
mistake — not just patient safety, but just the wrong route to adoption. The
risks are high.

So I think certification has an important role to play.

However, even though during our initial years certification served as a
confidence builder for providers who were reluctant to buy EHRs, they were
worried they wouldn’t have the functionality or the security or the
interoperability that was needed. That role is changing, because financial
incentives started emerging. Before the Recovery Act, we found $700 million in
incentives, and we were already feeling that increased responsibility. But the
Recovery Act has taken us to a whole new level. Now we are all engaged in a
very challenging journey together.

You have seen 40 different slides about how to describe the roadmap. I’m not
going to go through it. I think of it as three parallel tracks rather than
sequential. Adopting ERHs is one, developing and sustaining health-information
exchange is the second, and ultimately the system reform and transformation.
But I don’t think they are sequential. I think they all three go on at once and
they are interdependent.

That means certification has, I think, a much broader strategic role. In
this case, we need to be a coupling mechanism between policies, which are
constantly advancing as we learn, and the real-world marketplace of developers
and people buying them and people implementing them. That very messy world
often doesn’t interface well with policy proclamations. So we are a coupling
mechanism. We send signals ahead of time. We figure how you ramp into things
and how you motivate the marketplace to move.

Let’s go to the second question: What are the strengths and weaknesses of
current CCHIT processes, and how do these need to change under the Recovery
Act?

I’m going to start with the strengths. Since we were founded, we have
recognized that a critical factor for success was credibility among
stakeholders. We are a nonprofit, so we don’t have stock. That’s our
stock-in-trade. If we are not trusted and credible, then we really can’t
deliver what’s needed. So we developed both our criteria-development processes
and our inspection processes to serve that need. The development is
transparent. It is done with volunteers. There are three cycles of public
comment. There is pilot testing.

The inspection process, which is firewalled from the development processes,
uses juror volunteers and staff, but no one is permitted to have any financial
interest in the vendor, meeting the federal standards, basically, for
non-conflict of interest.

As a result, we have had really great industry engagement. This year we had
640 volunteers come to us. That was probably two to three times as many as we
can take. That has increased every year. The 10 largest professional
organizations have all endorsed CCHIT.

We have strong compliance by vendors. We started with ambulatory EHRs,
followed by hospital or inpatient EHRs. But once it became clear that
certification was having an impact, other domains of care came to us, urging us
to bring certification to them, so they could see more rapid adoption. So we
added emergency department, child health, cardiovascular medicine. This year we
will launch personal health record certification and standalone e-prescribing
certification. For next year, we have committed to eight new programs.
Long-term care is one of those, advanced clinical decision support, and a half
a dozen others.

We have also earned the confidence of payers. Put aside the Recovery Act for
a second. Certification by CCHIT was the gating mechanism for incentives in the
Medicare EHR demo, the Stark law safe harbor, several state EHR initiatives,
private-sector pay-for-performance programs, like Bridges to Excellence, and
even discounts on liability insurance, malpractice insurance, for physicians.

All of those accomplishments are a credit to the work of our volunteers.

Nevertheless, it’s all the more reason why we have to listen to our critics
as well and strive to improve our processes. Let’s just have a frank discussion
about it.

I think the number-one issue is the one that Dr. Classen talked about on the
first day: Buying a certified EHR is not a guarantee of successful
implementation. There is a wide variation in success. Although we got started
just by testing products, we know now that we need to go beyond it. The
Commission has approved moving beyond that. We are already beginning
investigation into how to measure and rate things like usability, correct
implementation and training, literally all the way to success rates and user
satisfaction and patient satisfaction as part of that, once products are in the
field. I think the Recovery Act gives us the context to get out of our box and
start asking these harder questions and measuring them and reporting and rating
them.

The second issue — you heard one speaker yesterday from Open Source. Their
licensing model is really different from the licensing model of commercial
products, and our policies are not really fully compatible. We think we can
change them. We see what the issues are. They have to do with versioning. With
a commercial product, you want a stable version. With Open Source, the more
dynamic and more quickly the versions are changing, probably the more viable
the product. We can fix that, and we are committed to fixing that and updating
our policies this summer.

We also know that our fees can be a barrier for, for example, nonprofit
developers, for EHRs that serve vulnerable populations. We are looking for some
grant funding so that we can use that to defray the cost of certification for
them.

Finally, what about the next Thomas Edison? Maybe they are not working in
their garage; maybe they are working in their consultation room developing the
next great breakthrough. We don’t want to be the barrier. We think we can find
a way to certify experimental EHRs that are going to be used in a few sites or
one site that aren’t yet broadly commercially sold, and have lower cost and
fewer hurdles for them to jump over, to let those innovations be tested in the
real world.

Just to sum up our answer to your question, we understand the higher
expectations. We will rise to meet them on all of these parameters —
accountability, transparency, focus, scale, and speed.

Let me get to the next question: How should certification work in 2011? How
should it develop over time?

Let’s talk about how we get to defining meaningful use. Now I’m going to
take off my CCHIT hat and just keep on my EHR wounded-veteran hat.

First of all, I feel strongly that meaningful use should be documented
electronically. Of all the places not to use paper processes, this is one of
them. The risk of fraud would be high — not to mention it sort of proves that
you are not really trying to get electronic when you file paper forms to prove
that you have computers. Let’s let that one go.

But here’s something that may be news to some of you. Current certified EHRs
are inherently capable of collecting many meaningful-use measures. They are
required to have an audit trail. It records every transaction — a log-in, a
view of a chart, a prescription, a review of a lab result. If these audit
trails can be used properly, I think we are halfway there.

So the concept I’m suggesting is that all certified EHRs in the near future,
and probably for 2011, would need to be able to register their existence with
an authority, saying, “Here I am. This is this EHR, and it’s
certified,” generate and display a meaningful-use dashboard to the user,
display that basically on demand — this is Carolyn Clancy’s “press
F7” — and then sign and securely submit the dashboard statistics to a
designated entity when they apply for their incentives, and retain an audit
trail for verification.

The dashboard would look something like the dashboards you see in many other
cases. It would have different practice models, different years. The provider
sees it. The goal is to get it up to green, get your money.

I won’t go into this slide about timeline concepts. I agree with the
two-year cycle that the vendors — I think that’s probably the right pulse.

I’ll stop there and look forward to your questions.

MR. REYNOLDS: Thank you. Mr. Ratliff.

MR. RATLIFF: Thank you very much. I want to thank the NCVHS Executive
Subcommittee for the opportunity to testify today.

I am Rick Ratliff. I’m the president of the Virginia division of
Surescripts. It is Surescripts now. As most of you, we are the result of a
merger of Surescripts and RxHub in 2008. I am also a commissioner on the
Certification Commission for Health Information Technology and work with Mark
and his team on the certification processes he just described.

My comments today are going to focus on Surescripts’ practical experience
with regard to electronic prescribing and the application of this experience to
standards development, certification, and the definition of meaningful use.

As most of you know, we do operate the country’s largest electronic
prescribing network. It’s used every day by thousands of physicians,
prescribers, pharmacies, and other stakeholders in the health-care system,
across all 50 states, including the District of Columbia. Our network connects
prescribers, through their choice of electronic prescribing software, to the
nation’s major chain pharmacies, independent pharmacies, and the leading payers
across the country. The network is the backbone that facilitates the electronic
prescribing. We enable this by providing prescribers with secure access to
prescription benefit information, prescription history information, and by
allowing prescribers to electronically transmit prescriptions to the patient’s
choice of pharmacy.

What’s real important and relates to the comments that you just heard from
Mark Leavitt is that in order to utilize the network, whether you are a
pharmacy, a prescriber, a payer, you must use software that is certified on our
network. That certification is a process that we manage, that we have been
managing for a number of years, that is to ensure, as Mark was describing, that
the different systems connected to our network adhere to the industry
standards. So everything that we do within the network is all based on industry
standards. I’ll talk a little bit more about that.

I want to emphasize that from our perspective — and this really starts to
get to where we would like to see the definition of meaningful use go —
electronic prescribing includes not just the usage of a standalone electronic
prescribing system or electronic medical records system, but the use of
prescription benefit information, prescription history information, and, again,
the routing of that prescription to the patient’s choice of pharmacy, whether
that is a retail pharmacy or a mail-order pharmacy.

Essentially, electronic prescribing occurs when a prescriber uses a
certified system that allows them to access the patient’s prescription benefit
information, with the patient’s consent, allows them to access prescription
history information — these are prescriptions that could have been written by
other physicians for that patient — to help enhance clinical decision support,
and then electronically route that prescription to the patient’s choice of
pharmacy.

It’s only through the use of these three components within the standalone
system or an EMR with electronic prescribing that you can realize the full
benefits of electronic prescribing. I’ll comment on that in a minute.

First, just to hit some highlights. I know there have been some comments
about where we are with electronic prescribing, what the status is. We released
a report last week called The 2008 National Progress Report on
E-Prescribing. This will provide additional details on exactly where we are
with these different services I just described. But just to hit, again, some of
the highlights:

We have seen significant momentum. From 2007 to 2008, we doubled the volume
of the messages I just mentioned. Again, these are standard NCPDP SCRIPT
messages, NCX12 messages over our network — over 240 million messages
processed in 2008.

We also have seen a tremendous growth, due to many individuals’ efforts in
this room, and working collaboratively with our organization in pharmacies and
payers, in driving physician growth in the network. We currently have almost
110,000 physicians that are actively prescribing on the network. It’s important
to note that these are physicians that are using electronic medical records,
that have been certified for electronic prescribing to the NCPDP SCRIPT
standards, working in conjunction with CCHIT to certify those according to the
e-prescribing interoperability requirements, et cetera.

About 70 percent of those 110,000 users are using an electronic medical
record system. The other 30 percent are using a standalone electronic
prescribing system. We continue to see growth across both.

Electronic requests for prescription benefit information grew from 37
million in 2007 to 78 million in 2008. Prescription histories delivered to
prescribers went from 6 million to 16 million in 2008. Prescriptions routed
electronically went from 29 million in 2007 to 68 million in 2008. We have
already processed over 134 million transactions in the first quarter of this
year, and we have added over 30,000 physicians in the first quarter of this
year to the network. Again, these are real users of electronic prescribing and
real users of systems that have been certified.

The reason for the success has to do with a number of different factors that
are coming into alignment, such as the broad-based support for industry
standards. The Medicare Modernization Act put forth the NCPDP SCRIPT standard,
and we are certifying against that, as is CCHIT. We are seeing the new
incentives start to have an impact as well. The Medicare incentives have really
driven a significant amount of activity towards the end of 2008 and
particularly, as I have just described, in 2009.

We have over 130 very large physician groups that are primarily associated
with large health-care systems across the country that are connected to the
Surescripts network. I’m going to name a few of them — I might leave out a
couple, so please excuse me — just so you have some idea of the reality of
where we are: Sutter Healthcare system, Cleveland Clinic, Geisinger, UPMC,
Baylor, Partners Healthcare system, the Care Group, et cetera, et cetera. They
all have users on our network. They are electronically prescribing to
pharmacies, sending prescriptions fully electronically. Those are primarily
electronic medical record systems.

In addition, we are seeing applications from Allscripts, their e-prescribed
application, DrFirst, RxNTm MedPlus, and others that have standalone systems.
We are still seeing growth in that area. I think a lot of that has to do with
the fact that CCHIT has moving towards certification of standalone systems and
the fact that small and medium-sized practices need a way to easily get into
this area.

In our experience, the underpinning of all the success in building this
national, open, and neutral network is about working with these agreed-upon and
non-proprietary standards and moving through the certification process. Once
the standards are in place, we have to have a proven certification process, as
was described by Mark.

I’ll move on, in the interest of time.

We certify applications, as I mentioned, across all three different
services. We have completed over 450 certifications and recertifications of
prescriber, pharmacy, and PBM systems. Nineteen of these systems are standalone
systems, 165 EMR products. I mention that, again, because of the fact that we
are moving into the electronic medical record world.

There are 135 products that are in active use, with users across the
network. So we are seeing tremendous growth in this area.

I would say the certification process has been a very collaborative process.
It’s very critical that it is a collaborative process, as Mark describes. We
have to continue in that direction. Certification is important, but I would
have to say certification is not enough. That is what Mark was alluding to.

Of the 135 products that actually have active users in our network, many of
those are EMR systems, as I described. They are not all certified on
prescription benefit, prescription history, and prescription routing. Even with
those that are, there is not consistent deployment of all those services into
the user base, for a variety of reasons that are outlined in the written
testimony.

I think it’s very important, when you think about meaningful use, that it is
the use of those three services. If you are not looking at benefit data and the
history data and the routing component, you don’t get the full advantages of
electronic prescribing — selecting the right economical alternative, the right
clinical alternative, and then routing efficiently to the patient’s choice of
pharmacy. I think it’s extremely important that certification considers that,
but you have to go to go a step further, as Mark was describing, and look at
implementation, deployment, look at support, and look at utilization.

If you look at our national progress report on electronic prescribing, you
will see some of the details of the real utilization. We can measure usage. We
can measure meaningful use.

I’ll leave it at that.

MR. REYNOLDS: Thank you. Next, Dr. Lansky.

DR. LANSKY: Thank you, Chairman Reynolds. Thank you, Dr. Blumenthal. I
appreciate the opportunity to be with you.

I do have some slides.

I have been with you before. This time I have the pleasure to be with you on
behalf of purchasers of health care. I work for the Pacific Business Group on
Health, which is a large coalition of employers and public purchasers in
California and the nation. I want to share with you our views of meaningful use
and how that might pertain to the question of certification and validation that
we are discussing today.

I appreciate the opportunity in these hearings to bring other perspectives
— that we don’t go too quickly to a narrow definition of EHR or of meaningful
use or of qualified EHR. I hope you will take this opportunity to think more
broadly about the health system as a whole and our objectives.

Our members certainly are concerned about improving health and improving
affordability of health care. Meaningful use ultimately needs to serve those
two objectives to be of particular value to the purchasers in the country.
While we certainly support the broad applications that we are talking about in
these two days, I want to raise some other issues in the course of my
presentation today and really highlight the opportunity to evaluate whether the
products and services that we are talking about deliver health and
affordability improvements to the health-care system.

Purchasers’ expectations for the clinical IT infrastructure that we are all
laboring to build come from a slightly a different angle than simply and only
improving bedside care. Purchasers have a particular interest in some of the
drivers of cost in the health-care system and of overuse and misuse in the
health-care system, which we have all talked about for 10 years. Here may be an
opportunity to take some action, by evaluating and monitoring new technologies,
planning and evaluating changes in payment systems, changes in workflow,
changes in practice design.

We are particularly interested right now in implementing recognition and
payment programs that reward high-quality care, whether through
pay-for-performance, pay-for-outcomes, bridges of excellence in other programs.
We are looking at how to measure the performance of individual providers, how
to create financial rewards for high performers, how to aggregate data that may
be derived from the systems we are talking about here to support bundling and
other payment mechanisms.

Ultimately, we want to support a flow of information that, as we said
before, is not only two-way, but multi-way across the network. We want feedback
to clinicians, to patients, to families. We want to capture data from patients
in terms of symptoms and outcomes, functional status, and so on, and fully
engage all of us in our health care and our health.

So we have fairly broad objectives for this health-care system. I would just
highlight that the provisions of the stimulus bill are primarily — Congress
really gave specific attention to these public-interest uses of the
information. The definition of meaningful use, in my mind, has to reflect
Congress’ insistence that information sharing and clinical quality reporting
are primary reasons that public money is being invested in what is essentially
a private good. So for us to capture the value as purchasers, both public and
private, we want to see that meaningful uses are being demonstrated along these
lines.

In the short term, that means that we have to be able to measure and
document individual physician performance. We have to be very attentive to the
differences and similarities between what Medicare, Medicaid, and commercial
payers may be looking for in terms of information sharing and measurement.

From a purchaser point of view, I think a very high priority for us — and
I’ll talk some more about this   are the quality deficits in our
system, in our ability to provide feedback and improvement tools that will
allow us to ameliorate some of the problems, both in terms of cost drivers and
quality failures that we see. So the areas of high variation, inappropriate
utilization, high cost, which may be different across different payer groups,
need to be accessible to this information infrastructure that we are all trying
to build.

A caution, obviously, that we have heard about in these two days is, we are
particularly sensitive to the fact that over 20 years we have certified a lot
of things in health care, and not always seen performance improve as a result.
So we can certify something and still see mediocre performance.

Just to Rick’s comment a moment ago, I flag one comparator statistic he
mentioned that I know Surescripts has been concerned about for a while. There
may be only 10 percent or so of doctors who are transacting a prescription
across the network who are retrieving the medical history, and therefore,
capable of looking up potential interactions and risks that are afforded by the
new prescription. So here’s a case where, in rough numbers, a large number of
the transactions are not being associated with the use that we think is really
essential. For us, we need to be able to test performance in order value.

As Carol suggested this morning, your ability to stipulate what the goals of
this investment of public funds are and then assign objectives to those goals
and measure whether those objectives are being reached is really vital.
Certification is one important step in a cycle of activity, which I will
simplify to say, we need to certify that a product can do what we want it to do
to meet the goals of the public. We have to validate that it is doing it. We
have to measure whether the uses are being satisfied, provide feedback to
everyone involved, and reward that high performer, so there is a virtuous
circle of improving the products, improving the services, and documenting it.

I want to do a little sidetrack here on a cardiology example of our concern.
Purchasers, when they look at interventional cardiology in particular, are
concerned right now about the appropriate use of imaging studies, or the
inappropriate use of such studies, whether stress tests are being used
appropriately prior to interventions, the use of diagnostic catheterizations,
when they are indicated, and if they are being used when they are not
indicated, and certainly the use of interventions in the cath lab. We are very
interested in the outcomes of these services in terms of symptom relief,
functional improvement, survival gains of course.

Right now, if we look at the PQRI measures, which are going to be an
underpinning for this clinical quality reporting that we are talking about as
part of meaningful use, they are inadequate to tell us what we need to know as
purchasers about whether the health-care system is performing in ways that we
are particularly concerned about, in terms of improving health or reducing and
managing cost.

The National Priority Partners, mentioned earlier today, have identified
20-odd categories of overuse as a national priority. I would ask the committee
to give some thought to whether the meaningful-use definitions that you
ultimately promulgate can address these 25 or so areas of overuse. This would
be a very great value to society as a whole, to begin to get a measurement and
improvement cycle to intervene in some of these areas. I highlighted some of
them that we are particularly concerned about. They come out of this area of
cardiologic intervention.

As an example of percutaneous interventions in cardiology, we just had a
recent paper showing that 55 percent of the cath-lab interventions in the
country apparently have not been preceded by a stress test to document
ischemia. We would like to know more about that. We would like a data system
emerging from meaningful which will tell us whether these treatments are
actually indicated or whether they are being overused.

Fortunately, the American College of Cardiology has published a list of
indications for these particular treatments, and they have done us the favor of
telling us what data is needed to document the appropriateness of these
cath-lab interventions. I would ask again, as we look at the certification
criteria that Mark and others may be developing, are we able to evaluate and
tell everyone — the practitioner, the patient, and the purchaser — that these
extremely expensive and frequent interventions are or are not being used
appropriately in our society.

In general, I would say meaningful use is to satisfy the needs of the
purchaser and payer community for information about not only routine
primary-care services, as important as they are, but also the very expensive
and highly variable interventions that are happening in the operating room, in
the cath lab, and elsewhere. I would suggest for you to consider that where
there are significant quality, safety, and cost variations in procedural and
specialty care, we do not omit those from the data network; we do not define
meaningful use and the use of public money in such a way that 60 percent of
doctors and an enormous amount of American health care is not captured and
documented on this electronic network. The incentives that we are all working
with need to bring those clinical registries and other data systems into the
fold.

As we look at certification today and the current CCHIT ambulatory
certification criteria, they would, generally speaking, not reach into some of
the data areas that we have great concern for. In the areas of cancer,
orthopedics, maternity, behavioral medicine, cardiology, I hope we could take a
special look at how we tailor meaningful-use definitions to capture critical
indicators of high public value in those other areas.

Finally, certification is needed to inspect the capability of product to
deliver value. Then the product and services and users must then be validated
after installation to ensure that the capabilities have been enabled. I hope we
will consider a tailoring, or picking-and-choosing strategy, here, where —
Carol and others have mentioned the importance of innovation — we allow the
certification criteria and the meaningful-use definitions to be tailorable
enough that we can allow innovative products and services that bundle in a
different way than may be a fully functional EHR to satisfy the meaningful-use
criteria, if they are adding to the public good.

Markle will be issuing a report tomorrow that Carol mentioned. That report
will identify a number of criteria for certification that I hope you will take
a more careful look at. Some of them are summarized here.

Finally, just to represent a purchaser perspective on this, our key question
is, is the information being used to increase appropriate use of expensive,
dangerous, and variable technology? Certification criteria need to address
these kinds of requirements that are relevant to public-interest concerns,
outcomes, appropriateness, and efficiency. I think the meaningful-use
definition should be construed to capture the use of clinical registries that
CMS and others might designate, which have high public value in the eyes of
Congress and certainly private purchasers.

Certification can verify that EHRs, as both Mark and Rick have just said,
capture and audit the documentation that will allow us to inspect whether the
uses are being performed.

Ultimately, this is a virtuous circle. Improving the data will permit better
measures. Better measures will drive payment. Payment and feedback will drive
improvement. The HIT incentives by themselves will not be the only driver of
this mechanism. We have to engage the full payment cycle.

Thank you.

MR. REYNOLD: Mr. Findlay, you would appear to be next.

MR. FINDLAY: Hi. Thanks very much for the opportunity to testify today. You
are coming to the end of a long two days, so I want to be brief. I’m at the end
of this panel, so I have sliced a few things out here. If you will indulge me,
I’ll read a statement. It will take three or four minutes. Then I’ll be
available for questions.

My name is Steve Findlay. I’m here today representing Consumers Union and
the consumer-patient perspective on this issue.

In full disclosure, I’m a registered federal lobbyist. I do not have any
investments in any HIT companies, outside mutual fund accounts. I’m also on the
board of the National E-Health Collaborative, the AHIC successor entity.

Certification has played a really critical role in the advance of HIT so
far. It was reasonable in 2004, when CCHIT — and you have heard an update on
that today — was launched and it is reasonable now, as specified under ARRA,
to look to certification as one of the foundational pillars of promoting an HIT
marketplace which meets certain standards. In compelling certification in ARRA,
Congress aimed to build on work over the past five years. That’s good. However,
it is now time to pause and reflect on the future role of certification in the
context of the changes ARRA calls for, but also in light of the plain fact that
EHR certification has not been particularly successful to date at driving
adoption.

But I won’t waste time on the past. Your mission is to help envision the
future use of HIT and the best and fastest way to get there.

So cutting to the chase and being responsive to the formal questions asked
of the panel:

First and foremost, certification of EHRs and PHRs should be redirected and
adjusted to explicitly promote better-quality and safer care, more efficient
care, and new models of care that over time will save money. That’s the
meaningful use you have been hearing about for the last two days. Technology
for technology’s sake is just not the point.

But we also believe that meaningful use of HIT should enhance consumer and
patient engagement in care and make consumers’ access to accurate medical
information and data about themselves and their care easy to obtain,
understand, use, and act on. Thus, meaningful use for consumers will require
some mechanism to present things like lab, blood, and imaging results,
diagnosis and clinical status, medication history, and other relevant
information to consumers in a way they can evaluate and understand and that
permits them to track changes over time.

As you all aware, ARRA grants the consumers the right to get an e-copy of
their medical record if it’s kept in EHR.

We believe this kind of patient-centered meaningful use should indeed be a
criterion for EHRs, as well as PHRs. Obviously, this is a given for PHRs, but
it has not been for EHRs. So we are talking about an evolution in certification
that would reward EHR systems that translate and contextual part of the content
of an EHR for the consumer and the patient. We believe ARRA intended that.

In this regard, some experts, including committee member Paul Tang, have
talked about PHRs that are integrated with EHRs. That is one way to go, and it
is already being deployed in various settings and creates an attractive model.

We also believe that EHR data and information should be easily transferable
to a secure standalone PHR or other e-health tool set up by a consumer. Of
course, that’s in large part the model of the PHR vendors today.

Either way, integrated or standalone, it’s critical that data integrity and
accuracy be a key component of both EHR and PHR certification. There can be no
meaningful use of medical information that is wrong. Clearly, billing data, as
we have learned with a recent case, won’t do.

That is why we think EHRs simply must be open to patient input, and
certification around the ease of that is essential. A patient’s input can come
in a variety of ways. It can come from a PHR or it may simply come from a
patient asking to see their EHR and reviewing that.

There are two reasons for such patient input — two main reasons; there are
hundreds of reasons. The first is accuracy, as I just mentioned. As everyone
knows, medical records are hardly infallible as a source of truth. There has
been a flurry of discussion recently about the garbage-in/garbage-out problem
stemming from a patient’s detailed account on a Web blog and in the Boston
Globe of finding errors and misleading information when their data was
transferred from an EHR into a PHR.

The second reason EHRs need patient input is that, as we all know, most of
the stuff that impacts our health and may influence the treatments we are
prescribed happens outside the clinical setting. The self-care revolution is
alive and well, and a growing number of people are actively engaged in using
e-tools, Web sites, and creative software to track their medical lives, whether
that’s their weight, their symptoms, the OTC medicines they take, the course of
their chronic illness, whatever.

We think that organized notes from a patient can be every bit as valuable as
notes from the doctor. We think every EHR should accommodate patient notes if
the patient so chooses.

So certification around meaningful use must promote two goals: transfer of
information from an EHR to the consumer, and transfer from the consumer into an
EHR. It’s a two-way street. This has a vast potential to improve a lot of
things, not the least of which the doctor-patient relationship.

Again, to repeat, most of us now think of this integration, this two-way
street, in terms of PHRs and EHRs. But it’s not hard these days to imagine new
platforms of such information to flow into the consumer’s hands. Is an iPhone
or another PDA app that allows you to organize your top-line registry,
insurance, and medical information far away? I doubt it. Should that be
certified? I don’t know.

Indeed, guidance on meaningful use being released tomorrow by the Markle
Foundation, which you are now well aware of, notes that the definition of
certified or qualified EHR technology should not be narrowly construed within
the confines of EHRs and HIEs. Such tools, the report will point out, are not
the only way to get to meaningful use for doctors or, more importantly from my
perspective, for patients and consumers. Rather, the Markle Foundation report
will note, a broad view of HIT and certification of HIT tools would and should
feed innovation and not lock in today’s technology. Certification must evolve
and be adaptive.

Two final quick points. ARRA has propelled us into a new world when it comes
to the privacy and confidentiality of medical information. I’m confident that
vendors and CCHIT will know that stricter standards must evolve abetted by new
technology.

But I would still urge this committee, which has deliberated on this issue
in the past, to develop clear guidelines on privacy in the context of the ARRA
legislation. For example — just one example — audit trails must now clearly
be a larger part of certification.

Finally, you posed a question to us about additional EHR certifiers
recognized formally by the HHS Secretary. In a word, yes. We do think that
would be advisable, though we do think CCHIT ought to be among those groups.

Thanks for your attention.

MR. REYNOLDS: Excellent. Walter?

DR. SUAREZ: Thank you. Thank you for this panel. This is one of the panels
that I think everybody was waiting for.

We heard over the last two days a lot about certification. We heard that
certification is a key element of meaningful use. We heard that certification
is not enough, as has been mentioned a few times today and during this panel.
We heard that certification defines a series of capabilities that a product can
have, but after installation, there is no assurance of whether those
capabilities have been actually enabled or turned on, if you will.

My question goes into that part. It seems that we are now talking about one
level of certification or one aspect of certification, which is the product,
and then another, which I wouldn’t necessarily call certification, but the
verification, the monitoring, the assurance process of the fact that after the
implementation and installation of a product, a series of those capabilities,
which is the heart and soul, in my view, of the definition of meaningful use,
now turn on and enable and are actually being used.

So my question is, who should be conducting those types of evaluations of
assurance that the types of capabilities that are part of meaningful use are
actually enabled? Is that a role of the certification body? Is that a role of
an accreditation body, for example? Is that a role of a government body?

DR. LEAVITT: We will all probably take a crack at it. It’s a great question.
I think one of the important things is to think of the scale of this. We talk
about the number of doctors in the United States, the number of offices. I
don’t believe we are going to be able to send inspectors into all of those
offices and accredit every office in their use of the EHR. I think we are going
to have to measure it using technical tools. That may be within the EHR, which
— in order to be a medical legal record, it has to have the audit trail. We
require it. It’s very rigorous, actually. The number-one cause of systems
flunking our test was not having an adequate audit trail. So I think you want
to use that data.

Some of it you can’t get from within the office. You need a system view. I
think it’s going to take a good dialogue and probably a combination of efforts.

I think we could help. We can make sure that the EHR has an accurate
self-instrumentation system that can’t be played with. We can make sure that
that is submitted in a secure way and it’s coming from who you think it is.

But the system measurements — to get those, you have to reach outside the
office. That’s what you are trying to do, integrate care. So all we can really
make sure of is that the EHR can submit not just the quality data, but the data
about what is happening to the patients, to health-information exchanges or
other repositories or registries. That’s where you begin to measure these
larger things.

I think it’s important to realize that those won’t exist tomorrow. If you
want to write checks in 2011, those doctors and nurses need to be buying these
systems this year. So I think you are going to have to start from where we are.
Where we are is not so bad. But I absolutely acknowledge it’s not perfect, and
we need to do better.

That’s my answer. I think it’s going to be a combination of standard
certification plus some new concepts about how we measure quality in
accountable care-delivery organizations or networks.

MR. RATLIFF: From our perspective we can actually measure, at least to some
level, what we call utilization. To Mark’s point, there are certain aspects of
the system that we can see in the network related to prescription routing, as
an example. We can see which prescriptions go electronically. We can determine
when an eligibility check is done and when it’s received.

To Mark’s point, though, we can’t tell if the formulary was used to
determine the right economic alternative. That is in the practice. That’s in
the four walls of the practice. That would be in the audit process in the tool
itself, in the EMR. Medication history would be the same way. We can see if
medication information is pulled into the system. However, you have to have the
local view in order to know whether that information was reviewed as the
prescription was being written.

So has to be within the certification process — it does have to evolve to
the point that you have the right audit capabilities and the right capabilities
to report out, if that’s the approach that you go through, to demonstrate real
use, at least in the context of prescribing as we have been describing it, in
medication-information sharing, as an example.

Who does that? There are certain capabilities that an organization like
Surescripts has. Certification bodies could do that. There are accreditation
bodies out there as well that would have that ability, with the right
definitions.

DR. LANSKY: I think parsimony is important. That is, the criteria that will
be used for this kind of inspection should be very limited and focused on
high-value considerations for the definition of meaningful use and for the
public interest. It should be electronic, as Mark said, at the outset, not
through some other mechanism. Some of it may be done through attestation or
other certification techniques.

The design questions I hope this committee can take up and assure that the
certification criteria permit the discernment of meaningful use. Maybe the
audit trail is sufficient. Maybe there’s some other kind of data capture that,
as Rick suggested, has to happen. That’s part of the definition of meaningful
use. But the execution might happen through independent parties and so on. At
least the design piece, I think, is a critical feature here.

MR. FINDLAY: I would only add one point, and that is that there would seem
to be an important role for some applied research here, as the health research
community gears up to track this stuff. I think that’s going to be important.

MR. REYNOLDS: Jorge, you have a follow-up?

DR. FERRER: Mark, do you think the certification should reside under a
federal agency? Would that help or hinder your efforts?

DR. LEAVITT: I think it is best placed in the private sector, but with
federal funding. We have to move pretty fast. We have to be able to do outreach
very effectively and quickly when new standards come through. I think people
would mostly agree that we have moved very fast. One of the number-one
complaints is, you move too fast. We are moving faster than the vendors can
keep up.

So I think the private sector is good because of the speed and the
connection to the market. If what we do doesn’t match the market, we fail. So
we have to have a very good market sense.

But I think it needs a core of federal funding. If our contract runs out —
and it’s in extension right now   so that all of our revenue as a
nonprofit comes from the fees we charge vendors to certify, then even if we do
our best to avoid vendor influence, there will be a perception that the vendors
who are paying the fees have undue influence.

So I think it should be federally funded and operated in a public-private
partnership.

MR. REYNOLDS: Blackford.

DR. MIDDLEFORD: Thanks for a great panel. Nice to see you all again. I have
a question for David and Mark.

Interestingly, we seem to struggle still with certification between
functionality and feature sets, if you will, versus the overall objective of
our HIT adoption, et cetera, in terms of value in reducing inappropriate use
and misuse and increasing appropriate use, et cetera.

My question is, should we reorient certification around value clusters of a
kind that actually are more targeted toward the payer’s objective, whether it’s
public or private? If we had this orientation, what might those value clusters
be, in your mind? Do we consider this kind of certification both within a
product — so the Cerner suite of products, if you will, might allow
certification of value clusters within a set of products, so it’s not
inconsistent with the physician adopting a technology — and could we consider
certification of value clusters across products?

It’s a fundamental kind of relook at certification around value as opposed
to feature function.

DR. LANSKY: I like that idea, Blackford, and I like the terminology. I think
it also helps to support this pathway toward innovation that many of us have
talked about. We could imagine a new player introducing a radiation therapy
management technology EHR, which is a value cluster for a certain application
and discipline that is very high-value and could be hypothetically certifiable,
but doesn’t have all the capabilities that a contemporary ambulatory EHR might
have. The same in oncology or other disciplines.

So I think the opportunity to think through — I don’t know the answer
offhand, what those buckets are. But I have been thinking, for example, about
the Medicaid meaningful-use application and how different it may be, given the
difference in PQRI measurement philosophy in a Medicaid population, for
example. We do need to think about classes or value cases of patient
requirements, as well as clinical settings, that will accommodate more
diversity in the product mix that we try to certify.

DR. LEAVITT: I would respond as well. I think there is actually a role for
both. One of the reasons that I think you still need to be certifying products
is that it’s a long leap to get to that quality improvement. I think we can see
that providers don’t know how to get there. So you say, you have to get a tool
that you know will get you there. It’s 10 steps to this quality level. When you
do step 1, you don’t know enough to pick the right tool. So we’ll make sure you
are not going to get a tool that — like a ladder that won’t reach as high as
you need to go.

So you need to certify the product, but you can’t stop forever on that,
absolutely not.

If you look at programs like Bridges to Excellence, they sort of phase out
that pay-for-adoption into a pay-for-measurement and, finally,
pay-for-performance. I think we need the same model here.

MR. REYNOLDS: Justine.

DR. CARR: Thank you. Thanks for a great presentation.

I would like to go back to the e-prescribing experience and what we can
learn from there, in the context of how much of that is transferable to EHR.
With e-prescribing, we identified a tremendous patient safety opportunity. We
also identified that there was efficiency for the provider. We had standards,
developed certification, and then the incentives.

As we look now at EHR, are we going to have a doubling of use? If you look
at how quickly e-prescribing doubled and tripled in a year, what is the piece
that made it happen? Was it just the incentives or are there fewer obstacles in
e-prescribing than in EHR? Can we somehow capture that experience to get the
same level of success?

MR. RATLIFF: Let me clarify a couple of things. One is, the significant
growth that we saw last year was with e-prescribing in the context of the
electronic medical record. What happened was, there are a large number of users
of existing electronic medical record systems that are writing prescriptions
electronically in the system, and they are printing that prescription or faxing
it. So the way that you can get very fast adoption is to certify those systems,
make sure the practice upgrades to that certified system that is connected to
the network. Those prescriptions that were printed and faxed to pharmacies, as
an example, are now routed electronically.

That was the low-hanging fruit, if you will. There is significant uptake, if
you will, within existing EMR usage.

The challenge at this point, going forward, is, as new EMR systems are
deployed, we still have the same challenges and complexities of the change
management, et cetera, involved in implementing the electronic medical record
system. There is the cost and the complexity. What you can do with electronic
prescribing is, as a first step, put in place the medication-management
component. You already have connectivity and the interoperability.

The key is that, as we do that, we need to make sure it’s not just
prescription routing. We saw growth across all different types of transactions,
but you are not going to get to the outcomes and the value-cluster kind of
approach unless the electronic medical record systems are installed with all
the functionality. So every new system that goes in needs to have that
capability.

What I will tell you is that, at least for small physician practices, there
is a question: Do they need a fully functional EMR? I suspect there’s —
unfortunately, I haven’t been able to participate in all the discussions. But
is there something short of that that you could implement in the practice,
particularly a single-doctor, small doctor practice? That’s where we see a
great deal of success with standalone electronic prescribing. There are a few
of those systems that went out last year. That automates the prescribing
process. But you need to move towards lab information delivery and sharing of
other information, towards something that looks more like an electronic medical
record.

I don’t know if that happens.

DR. LEAVITT: Can I add to that for a moment? That brings us to the concept
of Light EHR, which was discussed. It’s very valid to give people an easy first
step. You don’t eat the whole cow at the same time when you install an EHR.
What’s critically important is that that first step isn’t a dead end or a trap.
I will also tell you right now, it has been, in some cases.

But if it’s a first step, so that it just whets their appetite for more —
and then, when they want to move past it, they are not locked in. One of our
requirements in certifying a standalone is that you have to have a migration
path to a more complete EHR. You have to have interoperability.

MR. REYNOLDS: Before I let Blackford follow up, I think another thing that
would be helpful is that we have a definition of e-prescribing. People that are
buying it a lot of times think one thing and people that are selling it think
another thing. I think, as we get a clear definition of what that really means
to the industry — I’m not asking a question. I’m making a statement.

Blackford, your follow-up, please.

DR. MIDDLETON: A new topic, if I may, briefly. I’m going to ask you to put
on your crystal-ball hats — to mix a bunch of metaphors. I sort of wonder
where does certification end and regulation begin? There is some concern that
medical-device regulation types of policies and procedures may eventually apply
to medical software. This hasn’t been the case historically, for lots of good
reasons. Is there a scenario in the future, as we think not only to 2011, 2014,
but beyond, where certification runs out of gas and we need to think about
regulation of the medical-device type?

DR. LEAVITT: Regulation is needed if certification is not sufficiently
rigorous. So if you have cases where it’s a sham and you have a risk to the
public or to the country, then it’s really appropriate to have it be a
government function. But I think, in the absence of that, if it can run well in
the private sector, because of various factors, then I think you probably get a
little bit more for your money and probably more responsiveness by having it on
the edge of private sector or a public-private quasi-governmental function.

MR. REYNOLDS: Leslie.

MR. FINDLAY: Can I respond to that?

MR. REYNOLDS: Yes, sir.

MR. FINDLAY: Just very briefly. That brings to mind the JCAHO issue. I don’t
think any of us think JCAHO got us where we wanted to go. I’m not sure
certification will either. I think at some point we are going to deal with your
question.

ARRA sets up a lot of regulatory teases. I think we are going to be
grappling with it in the not-too-distant future.

MR. REYNOLDS: Leslie?

DR. FRANCIS: Steven, in your closing comments about privacy, you used the
example of audit trails for the protection of privacy. Audit trails are a way
of identifying when records have been accessed, giving the potential of notice
to patients, for example. Could you comment on whether you see other directions
— for example, a consent process — as also necessary for the protection of
privacy, and thus functionality for this to be included in certification?

I noted, for example, that in Rick’s written testimony — although you
didn’t mention this in your discussion — that there was mention of “with
patient consent” to access to medication history in the Surescripts
process.

I would like to hear all of you comment a little bit more on whether audit
notice or something more is what you see in the certification.

MR. FINDLAY: Clearly it could be other things. ARRA just made a huge leap in
the privacy space, more than many of us thought was going to be possible. It
was really dynamic and great. There are no fewer than 15 or 16 specific
privacy, confidentiality, and security measures in ARRA. Not all of those are
going to be amenable to certification, but probably half a dozen or so will.
That’s going to take some think-through that I haven’t done about how those get
incorporated in EHR certification.

But I’m sure Mark has done some thinking in that area.

DR. LEAVITT: No. We asked our legal counsel to do some thinking. It’s
sufficiently complex.

MR. RATLIFF: Relative to patient consent, we actually do require
contractually that vendors have a process in place, not only contractually with
their customers, but technically, to capture patient consent before a
medication history is pulled out of our network for that particular patient, to
be used in the context of delivering care. So we not only require it
contractually, we do certify against it. Then the technical standard actually
has a flag in the transaction that says whether patient consent has been
captured or not, which is another audit trail.

We feel that’s very important. At the time we actually implemented this
process, HIPAA did not require us to do that, because it was for treatment
purposes. However, we thought it was an appropriate approach to take, in
anticipation of the future, such as we have just described.

MR. REYNOLDS: Last comment.

MR. FINDLAY: I would just add to what I just said. You asked for another
example. One would be that ARRA specifies that patients have the right to edit
their record as it’s released from one physician to a health plan, if there is
a business-associated relationship there. I think that’s an area that would be
very important for certification around, as an element of EHR.

MR. REYNOLDS: With that, that ends this panel.

If the next panel will please come forward, we would appreciate it.

(Pause)

MR. REYNOLDS: Our panel is on measuring meaningful use. Dr. Eisenberg,
welcome.

Agenda Item: Panel 10: Measuring Meaningful Use

DR. EISENBERG: Thank you. I am Floyd Eisenberg. I want to thank Chairman
Reynolds and members of the committee.

I am senior vice president at Health Information Technology at the National
Quality Forum. I also do wear two other hats. I’m a co-chair of the HITSP
Population Health, now Quality Tiger Team Committee, and also of an IAG
Integrating the Health Care Enterprise Quality Research and Public Health
Technical Committee.

Just to get started, I want to give a short background on NQF, National
Quality Forum. We are a nonprofit, with the mission of setting national
priorities and goals for performance improvement, endorsing national consensus
standards and measures, and education and outreach concerning the priorities
and consensus standards.

We were pleased to convene the National Priorities Partnerships, which is
the first dimension of two areas of significance that we look at. This was a
28-multi-stakeholder group looking at priorities for care in the U.S., which
includes engaging patients and families, well-coordinated care, improving
health, improving safety, guaranteeing appropriateness of care and
compassionate care, and eliminating waste.

Our other dimension has been to look at high-impact conditions — an example
provided here for acute MI care, trying to look at episode care across
different settings of care and across the continuum, the example here given
with acute myocardial infarction, showing care across acute, post-acute, and
secondary prevention settings.

We also do not develop our own measures. We put out a call for measures,
based on these priorities and based on these high-impact areas. We have fairly
strict evaluation criteria for the measures that we evaluate. What I want to
really focus on here is the fourth one, which is feasibility. Note that all of
these evaluation criteria have been updated as of August 2008. Much of the
reason for the update was the result of work we did to identify information
required to address data captured within electronic data sources, including
electronic health records. So we have strict criteria.

The concept is to try to connect information across clinical guidelines,
physician support, and quality measures, using Paul Tang’s example that the
sweet spot is where all of these connect in the middle. That’s often with the
data flow and the data set that creates the connection. So that’s where much of
our attention has been.

Addressing your questions, you start with limitations of various
methodologies. What I want to address are the essential components of the EHR
used to improve to care as it’s delivered.

In 2008, chaired by another member of your panel, Blackford Middleton, we
pulled together a panel to look at consensus standards for health-information
technology structural measures. As was said many times in these presentations,
certification is necessary but not sufficient. As presented by Dr. Classen
yesterday, many of the certified components were not necessarily implemented.
The intent of this group was to identify the measures of implementation that
need to be addressed to see that the components could be effectively used.

In such, there were five basic areas: e-prescribing, EHR interoperability,
care management, quality reporting, including registry reporting, and
addressing the medical home.

Much of the output of this group dealt with attestation by a practice that
each of these was implemented. That was a good first step. Attestation is
helpful, but, like certification, not sufficient. The intent of the group was
really to look for the fact that key functions are actually implemented at
individual sites. But the first was attesting they are there.

Where CCHIT certification had not been identified, the key areas to be
attested to were use of essential components of the record for good medical
care, including medication lists, problem lists, laboratory results, privacy
and security, key elements for direct patient care, and making sure they are
utilized. Those are key elements as a start for identifying that it’s being
implemented.

The next step, as in your next question, is, how do we implement the F7 key?
Thanks to Carolyn Clancy for coining the “F7 key.”

Our current process, as we look at this area from NQF, is that we do endorse
measures based on standard specifications and standard endorsement criteria. We
have a group called the Health Care Information Technology Expert Panel, which
is now in its second iteration, looking at developing a quality data set. We
developed some of the framework in our first iteration. Now we are identifying
a set of data to be used for measurement. It could also be used for decision
support and direct care.

That information moves to HITSP, where health IT standards are selected to
address the areas of the quality data set. Based on work already performed in
HITSP, some of that data set can easily be addressed using existing standards.
Those standards are approved by the CCHIT and then that enables new standards
to help us create a new measure-authoring tool so that quality measures, as we
move forward, will be able to be authored using the components identified
within EHRs, in the same format, in the same terminologies, in the same
vocabulary.

To do that, that means taking the source of the measure in a standard
format, which is progressing now to be developed, making sure the data are
collected, and receiving the report on the other end. The two ends are orange
because these are the new pieces being worked on this year, through the
National Quality Forum, through HITSP, and through IHE.

What’s very important is the collaboration of many industry groups to make
this happen. One alone is not sufficient. All of the groups together can make
this occur.

Our next question is based on various methodologies for use. As we
identified in the structural measures, some of the areas of concern that can be
identified for measures of meaningful use are use of problem lists for every
patient, allergy lists, medication lists, orders, prescriptions, medical
summaries, and creating a continuity-of-care document — many of these already
certified in systems, so now measuring that they are used; using some of the
audit capabilities discussed in the past panel, to be able to determine that
they have occurred.

To give an example, a measure of tracking medication interactions for
patients with a history of falls, to see if they are receiving drugs that may
make them more confused, dementia, drugs for confusion — basically, to measure
the process. Is there success for decision support? No treatment over the
number of prompts. What is the outcome? How many ADEs were there? So you look
at the process and the outcome together.

In summary:

  • Use existing consensus process to expand measures, looking at providing
    effective care, removing waste, eliminating harm, eradicating disparities.
  • Start with structural measures that exist today.
  • Enhance to add use of problem lists, allergy lists, and key functions of
    EHR, like e-prescribing.

Thank you very much.

MR. REYNOLDS: Thank you. Dr. Rapp, please.

DR. RAPP: I’m Michael Rapp. I’m director of the Quality Measurement Health
Assessment Group at CMS. I’m involved in developing, helping measures get
endorsed, and implementing programs using quality measures in a variety of
settings, including being involved in the Physician Quality Reporting
Initiative, the Electronic Prescribing Reporting Initiative, and measures for
the hospital programs.

We have some questions that we were presented. Floyd has already gone over
the basic questions.

The first one is about the strengths and limitations of methodologies for
demonstrating meaningful use. This is the “how” of meaningful use and
what is most opportune.

There are several statutory options that were provided, including
attestation, claims, survey, reporting quality measures, and, of course, other.
The statute gives the Department a lot of options in terms of how to approach
this.

In terms of demonstrating being a meaningful user, there are basic
requirements. The first is the “how.” This is the “what,”
which is what this discussion is about. What is a meaningful user? Electronic
prescribing, being connected, and quality-measure submission, when the
Secretary can accept those. It becomes a policy question of what should be a
meaningful use at any particular year. We have heard a lot about that.

But in terms of the mechanism, how the professional or the hospital will
give that information, those are the options that we are going to talk about.

One of the things that’s important to note is, it’s not only what they
assert, it’s not only how they do it, but it’s the fact that you have to tie it
to an individual, ultimately, and make a payment based upon that.

So when you think about attestation, survey, or other, it would be fairly
easy for one to certify or attest that they are doing a certain type of use of
an electronic health record and get that information. Then you could even tie
that to the individual. But what’s missing in that is that you have to end up
tying it to a sum of money that will be distributed to the party to whom that
money is owed. Within the statute, we have statutory maximums required to
coordinate the incentive, limitations among the practices, and a requirement
that no incentive will go to hospital-based eligible professionals.

So how do you bring that all together? As I mentioned, basically you have to
make that determination at the individual level and ultimately tie it to
claims. We do have existing structural measures that are used in the PQRI
program and the e-prescribing program. They are basically collected using
claims. As I say, the attestation survey and other would make it possible to
make that determination at the individual level. Then, however, one would have
to go to the claims to deal with the 75 percent.

Many of these things we have in our current programs work through the
Physician Quality Reporting Initiative and the Electronic Prescribing Reporting
Initiative, in particular. Things that we have not yet worked through are how
to apply these maximums. In the PQRI program, the electronic prescriber
incentive program, there are no maximums. So that adds some complexities to
this.

So our current structural measures — a structural measure, I would say, is
a vehicle, and one would plug into that structural measure, if one decided to
use something of this sort, the various items of meaningful use. So it’s really
a plug-and-play option. Claims are one vehicle where that structural measure
could be used.

The elements of a structural measure: If one talks about attestation or
survey, you get a qualitative determination, but you don’t get a quantitative
determination. If one used claim codes, one would get that quantitative
determination, both on the things that one might require for meaningful use and
for the things that aren’t required, but one wants to track over time in terms
of seeing the bar being raised and where one might want to go.

The second main piece in the requirement for meaningful use is reporting
quality measures from EHRs. Here are a variety of ways that we collect quality
measures at CMS: from claims, from augmented claims, like in PQRI, chart
abstraction measures from patient-assessment instruments. In PQRI, we also use
clinical registries and have 31 of them that participate in that.

There are considerable advantages to quality measures being collected from
EHRs. We have looked forward to the possibility of this in terms of trying to
develop this in our existing programs, the Physician Quality Reporting
Initiative in particular, and looking for it with hospitals. It’s
primary-source data. It doesn’t have to be segmented by pair. There are
standardized data elements, much more timely data available. We have talked
about audit output files that would be available, an improved relationship
between population measures, which have been discussed as being highly
important, and accountability measures at the various payment settings or
provider settings, potential to aggregate clinical and claims information, the
potential to use that data as an element to consider in payment.

So clinical quality measures — again, HITECH makes that one element, but
only if the Secretary can receive that information.

In terms of what is in a measure, Floyd that — numerators and denominators,
the specifications, the certified systems, and, of course, the transmission of
the data, getting back to that point that the Secretary has to be able to
receive that data.

So we have looked to see how we might work to develop that, not for this
program, but for our other programs, the Physician Quality Reporting Initiative
and the hospital. There are two basic ways. EHR could produce an output file,
and you just take that information. It does come from the electronic health
record. You have to have the elements in the electronic health record. But it’s
basically a file output. It’s not the same as direct data-element transmission,
which we have talked about, such as through health-information exchange.

Those are two basic approaches. But certainly, as one looks to the future,
the possibility and the promise of being able to query data elements from this
health-information exchange, as opposed to just pushing it out from a system,
is something that we have significant interest in, as we look toward these
other programs that I mentioned.

To show you that this is not something that only ARRA or HITECH has
stimulated interest in, CMS, back in the PQRI program in 2007 — even though
that was initially a claims-based system and is today for reporting — we
announced our plan to test EHR submission. We posted the electronic
specifications for 10 physician quality measures. We coordinated this with the
HITEP panel that Floyd was talking about. We have worked to make sure that we
follow standards. Now we are looking toward carrying out this testing, and in
so doing, to not just look for an output file, some way to get the data to CMS,
but look to see how we can pay attention to the transmission using
health-exchange standards that exist. We have the potential, possibly, to
implement this in PQRI as early as 2010, which could provide a foundation for
what might be implemented in the HITECH legislation.

Again, we would look to expand over time the measures. Part of that is
thinking in terms of having them be able to be collected in the electronic
health record.

As far as hospitals, in our hospital reporting program we have stated an
interest in moving to EHR reporting. We have had quite a limitation on our
abilities to expand this because of the chart abstract and nature of measures.
We have worked with HITSP to get sets of measures that have not been
implemented yet in the hospital program specified in a way that we could have
them collected in the electronic health record and ultimately move toward that.

There are a variety of challenges for use of EHRs for clinical quality
measure in terms of the unstructured data, the dynamic development of quality
measures. You have heard people about existing quality measures and what they
would hope to see in quality measures. One has to think about the physical
quality data set. We have talked about initial measures set, the inpatient
quality data set. There is a care data set that we have been working on as
well. There is a process needed for regular update of EHR certification
requirements that would help these data elements be captured and then used for
the reporting of quality data. We have heard about the two-year cycle for that.

We believe that, at least for our other programs, it’s important to pay
attention to health-information exchange and not to have the quality measures
reporting be something separate from that, but have something where these two
items work synchronously, at least as far as our testing. There is a
significant relationship, we believe, to interoperability.

Several conclusions here for you:

• Quality measurement can support measurement of meaningful use
progressing from structural measures to clinical quality measurement.

• On the clinical side, once CMS has the ability to collect the quality
measures, then those audit output trails we talked about could come with it.

• Structural measures are based on claims submission.

• Clinical quality measures require the Secretary to receive the data.

• I have talked about a number of these advantages, standards, and
existing structural measures that could provide a foundation for EHR
submission.

That’s a quick overview of a few things. I’ll stop at that point.

MR. REYNOLDS: Thank you. Dr. Tripathi.

DR. TRIPATHI: Thank you, Chairman Reynolds and the committee, for inviting
me to be here today. I really appreciate the opportunity.

I would also like to thank you for not going in alphabetical order, so that
it’s Phyllis and not me who has the distinct honor of being the very last
person to testify after these two long days. I’m very grateful for that.

MR. REYNOLDS: If you make her late, we will hold it against you. (Laughter)

DR. TRIPATHI: The clock hasn’t even started yet. I’m very happy to see that,
too.

Let me just dive in and talk about measuring meaningful use. I’m going to
have somewhat of a different take than some of the previous speakers and very
much welcome the discussion afterward on this.

The first thing I would like to talk about is just to point out that the
government has very high expectations for the Medicare and Medicaid incentives
that are being rolled out. What I have done here is just graphically depict the
CBO scoring of the incentives and the money that’s flowing, to just point out
that the expectation is that we are going to spend something on the order of
$35 billion — $33 billion in direct incentives, $2 billion discretionary that
Dr. Blumenthal and the ONC team are going to be deciding — with an expectation
of a financial benefit of something on the order of $16 billion.

The reason I like to point that out is that that is a pretty high standard
that we all need to hit here. I think, as all of us have been hearing over the
last couple of days, this stuff doesn’t just happen; it gets done. In
particular, my concern about this is that too little, I think, is being
invested on the infrastructure needed to meet those high expectations.

I think in two slides, I’ll come to how this relates to measuring meaningful
use, which you may be wondering.

But as you can see here — this is just blowing up that $33 billion versus
$2 billion — you have the vast majority of it going into direct payments to
individual providers to just take technology and put it in their offices, and
very little money dedicated to all of the support infrastructure that is really
needed to make that happen. I think it’s wildly disproportionate with the need
there.

As I said, meaningful use doesn’t happen; it gets done. In the current
approach, just to put a fine point on it, it funds the pieces, but it doesn’t
connect them. So we have money for incentives, as I pointed out, we have money
for RHITECs, the regional health IT extension centers, we have money for the
health-information exchanges, which is all good. I would argue that there is
too little money given to the support infrastructure. But they are completely
disconnected in the law — completely disconnected. There’s no connection
between those incentives and the HIEs and the regional health IT extension
centers. What we need is that connection, I would argue.

So why am I talking about this? Because how you have to measure depends on
what it is you need to measure. Assuming that meaningful use is going to have
some of the following core elements — and as I went through this — and I
think probably other speakers went through this as well — how do you talk
about measuring it without talking about what meaningful use is supposed to be?
That was panel, and I didn’t want to dive into what they are doing.

But certainly it’s about interoperability. We know it’s about electronic
prescribing, assuming now that it’s about electronic laboratory and radiology
results and order entry, assuming that some type of clinical summary document
exchange will be a part of that, and then quality data reporting.

I think one question to ask is, what is the best way to measure these use
elements, with an eye toward trying to make sure that the cost of monitoring
and enforcement doesn’t exceed the benefits of higher compliance?

Just to get to this point now, the reason I mention that is that I think
that the depth of meaningful use is actually going to depend on our ability to
connect the support infrastructure with the incentives. I think if we don’t do
that, we are actually going to have to set a very low bar on meaningful use,
because the vast majority of physicians won’t be able to accomplish it. They
won’t be able to accomplish just getting the implementation to have the
structure data elements that Floyd was talking about to get out the door. The
example that he used on adverse medical events, I would argue, is actually a
very, very high bar for the vast majority of practices out there, even the
practices that have been on EPIC for 15 years. I would argue that that exact
measure that he was talking about would be a very high bar. So when you talk
about the onesie/twosie physicians who are 80 percent of the physicians out in
the ambulatory space now, that’s really going to be a big challenge.

In thinking about this, what I did was to sort of say, if we set that low
bar, these are the things you could probably cross off the chart, I would
argue. If you don’t have robust regional health IT extension centers connected
to those incentives and implementation, and if you don’t have
health-information exchanges that are trying to lower the cost and raise the
effectiveness of interoperability, you can probably cross off order entry as a
meaningful-use standard, because most people aren’t going to get there. You can
also probably cross off clinical summary document exchange as a meaningful-use
standard, again because most people won’t get there. Finally, I would argue
that you can probably cross off electronic quality data reporting — not
process measures, like PQRI, but actual outcome data. I would argue you can
probably cross that off, again because most physicians aren’t going to get
there.

One thing I would like to point out is how we do it at the Mass eHealth
Collaborative. The Mass eHealth Collaborative was founded in 2004. We
implemented roughly 550 physicians across three communities. We implemented
them on electronic health record systems, created three health-information
exchanges. We have a quality data center that sits on top of that that extracts
quality information out of the health-information exchanges, and we use that
for outcomes analysis and benchmarking.

Where we measure our version of meaningful use — and we can argue about
whether that’s a good way to measure  we actually measure down here.
I’ll show you this in a second. We measure it down at the EHR level to see how
physicians are using the individual EHRs, and we measure up here, up at the
quality data center level.

What I’m going to argue, actually, is that I think the vision ought to be to
have interoperable systems where we measure up at this level, on the assumption
that if you are getting robust reporting up here, you don’t have to worry about
what they are doing down here, because they must be doing it right.

But, obviously, there is a lot that has to happen between where we are now
and being able to get to a ubiquitous, uniform system that has this kind of
infrastructure in place.

Just to give you a sense of what we are able to measure, down at the
practice level, what this shows is one of our usage reports, from January 2007.
Every bar is a practice. We actually are able to see for what percent of the
encounters that they documented in their system did they actually enter
something on the clinical portion of the chart — not just use it for billing
and scheduling, but for what proportion of the time they actually used the
clinical portion of the chart — which is one indication that they are actually
doing something meaningful in the chart. They could just be entering a text
blob in the review of systems. So there is still that second question: Is it
structured data? But we at least know that they are using the clinical side of
the chart.

We are also able to dig down into the various elements of the clinical side
of the chart. This shows it for a community perspective, but obviously this is
a roll-up, so we are able to see it physician by physician. We get monthly
reports send electronically via FTP. Then we process the data and then we
deliver these reports back to physicians, so they can benchmark themselves
against how other physicians are using the chart.

Some of the noisiness of that kind of data — you can see here that it’s
hard to know what the denominator ought to be. For example, for medical history
here, 45.9 percent of the time, that’s 45.9 percent of all of the encounters
that occurred in these practices. We don’t know if it should be 100 percent.
It’s not clear that you should have taken a medical history 100 percent of the
time or documented it — if it was a quick follow-up visit, for example. So
that’s some of the messiness you get into with this.

The other thing I want to show is, just in the quality data center, we
measure it at the highest level as well. We can see the data that’s flowing
through all the way to the quality data center. That’s a good representation to
us that the physicians are actually using the system. If they actually are
entering data in structured fields and then appropriately triggering the data
so that it goes through the interface and is then delivered to the quality data
center, we will see the data up here, and we will see it in a pretty robust and
uniform way, physician by physician. That allows us to identify gaps. Then we
do go back to individual practices and try to identify, how come we are not
getting anything on smoking status from you? We should be getting measures from
you as a primary-care physician. Then we will walk through that a little bit.

One of the things that I tried to do here is just think about, what is the
spectrum of measurement approaches that we might think about? That can go all
the way from out-of-station and audit to HIE activity measurement. I would
argue that unless we are going to raise the bar on meaningful use, we can just
get away with some of these easier ones — out-of-station and audit and surveys
— because, frankly, if all you are going to be doing is looking at
e-prescribing and lab results delivery point to point into a practice, we are
not going to get a whole lot of value out of that anyway. So why spend a whole
lot of money on monitoring it? That would be my argument.

But if we do have this vision of a robust infrastructure for it, we can
start getting into what I would argue is the HIE activity measurement piece of
this, which I think would be the best. Let me just quickly flip through.

What I did was to try to look at some criteria of valuation that you might
use for each one of those measurement approaches. I’ll quickly go through my
little bubble chart here.

Basically, what I would argue is that the goal of getting up to this HIE
activity measurement is actually a very good goal to have and that ought to be
the vision that we have. It would suggest that the focus of ONC discretionary
spending really ought to be on making these HIEs and quality data aggregation
points more accessible now, sooner, and also more geographically available.
That really ought to be a primary focus.

I’ll just make this my last slide.

The notion that I would propose is that HHS actually contract with three
sets of organizations to get this done:

• The regional health IT extension centers, so that they are actually
implementing according to meaningful use to begin with, so they have a clear
vision of what meaningful use is and they are actually required, as part of the
contractual obligation, to facilitate implementation at the practice level, so
that they are able to certify that a practice got off on the right foot.

• Next would be the nationwide health information network nodes, which
would be the nationwide health-information exchange, which is able to monitor
and enforce data exchange according to HITSP-approved exchange standards and a
particular reporting physician-level use of the HIE exchange.

• Finally, having quality data entities and public health entities.

All of these could be wrapped up in a single organization that allows you to
start looking at the semantic standards. Are physicians actually entering
codified data into structured fields so that we are able to measure things,
and, by implication, they are able to use decision support as well?

Thank you very much.

MR. REYNOLDS: Thank you. Since this is playoff time in a lot of sports, you
get the last shot.

MS. TORDA: I am very cognizant of getting the last word here.

I’m going to try to use my time to both reinforce some points that I think
you have heard from many speakers over the last couple of days and also to
focus a bit on the specific experience that NCQA has that we think is relevant
to your considerations today.

NCQA, the National Committee for Quality Assurance, is a private, nonprofit
organization. Historically, we have been best known for accrediting health
plans. We also have a growing business recognizing physicians and physician
practices, including medical homes. We develop and maintain the HEDIS set of
performance measures, which has accompanying audit and certification programs
that we think are relevant here.

Our program, physician practice connections, the patient-centered medical
home version, was really the first program to very explicitly link the use of
HIT to what is required to delivering high-value care. That’s where we think
the most relevant experience is. The requirements for that program are very
deliberate about when HIT is needed and how it is related to delivering quality
care. I’m going to focus on that.

I would also say that, thanks to Mike, we are a recognized PQRI registry. We
received 560 submissions in 2008 — a number which surprised us, frankly.

To reinforce some of the themes that I know you have heard already from many
of the speakers over the last two days, let me start by saying that we envision
that one of the important tasks related to the Recovery Act and to the
meaningful-use provision is, at least for 2016, defining a set of measures of
meaningful use, specific measures that relate to the overall objectives of
health reform. We envision in the measure set for 2016. That measure set needs
to be very deliberate about what they are going to do to improve the quality of
the nation’s health, the safety, and reduce unnecessary costs.

We recommend, strongly, working backward from that vision, recognizing that
what we are going to be able to measure and report and pay on in 2011 is very
different than what we are going to be pay on in 2016 and beyond, but that
everybody needs to see that trajectory in those relationships.

Multi-stakeholder input into what that measurement set should look like is
needed, as you have heard over the last couple of days. There are very
important perspectives from the different stakeholders.

The phase-in strategy needs to be realistic.

Individual practices need support, and that support ranges from financial
support to thinking about how to redesign their programs, what systems to buy,
how to use those systems, and how to engage in quality-improvement activity.

Federal leverage is needed for standardization and progress at a faster rate
than we have had so far.

Let me turn specifically to our experience with the medical home program. We
have recognized through that program to date 370 practices of 4,000 physicians.

The first point is that the link between HIT capabilities and practice
design must be made clear. One of the most common reactions that we get to our
requirements from practices trying to meet them is, “I didn’t realize that
I could use my EMR to count across patients and come up with a performance
measure.” Really making clear what it is that HIT can do that goes beyond
taking paper records and replicating them in electronic form is needed.

Our own published research shows that the presence or absence of an EMR per
se correlates only weakly with clinical measures. Again, practices need help
with thinking through how it is that HIT can bring them into the
21st century and lead to improved care.

Implementation is disruptive and takes time. We know this through much of
the feedback that we get. But also simply the time between when a practice
purchases our standards and then submits them for our review can often be long.
We get lots of phone calls during that period about what’s going on.

Small practices need assistance. We have recognized a lot of small
practices, and we don’t think a lot of this is impossible for small practices.
Sometimes it’s more possible, frankly, than in big practices, where you have a
bureaucracy of one sort of another to deal with. But it certainly helps to be
able to provide external assistance.

Financial support: Practices don’t go through our programs unless they
believe that there will be financial support of some kind or another, or
financial rewards or recognition for doing so. It takes money. Particularly
primary-care practices don’t necessarily have that disposable income.

Getting to your questions about attestation and surveys, we absolutely
believe that documentation of some sort is necessary, but that the reporting
effort, of course, should be minimized. Again, our own published research shows
that practice self-report is not reliable as a way of getting information.
There are a number of reasons for that that we can go into if you want to.

There are many aspects of current EHRs that do not support the kind of
reporting that we are talking about now, even for basic sets of clinical
measures. So there is a pathway that is needed to get from here to there.

I just want to give you a few examples of some of the measures in our
medical home program that might be, quote/unquote, shovel-ready, if you will,
or will show at least some measures currently in use. They get at some of the
areas anticipated by the Recovery Act.

We have a measure that is percent of patients seen in the last three months,
with seven specified data fields entered. I think that builds on some of the
ideas that you have heard here. It goes a little bit beyond just looking at
whether one cell is filled in. It has to be searchable information. There are
specified types of information that count towards the measure.

Moving up from that, use of registry functions: Does the practice use
electronic data to generate lists of patients needing specified services? You
are moving from, did they simply enter the data in a searchable form, to
showing that they used it to reach out to patients.

Test tracking, electronic systems for lab and imaging we have talked about.

Use of e-prescribing: There is a progression here. We reward along that
progression, going from standalone all the way to linked-to-patient-formulary,
for all the reasons that you have heard about.

We do look at whether the practice can electronically report on nationally
approved measures, a small subset.

Let me talk about what we would call validation. Our understanding of the
use of the term would be, in Recovery Act terms, are the eligible professionals
actually making meaningful use of the system? I’m going to describe how we
currently do it and then where we hope we might be able to get, with the input
of everyone over the last couple of days and the leverage and incentives
offered in the Recovery Act.

Under our current process, we have an electronic, Web-based data-collection
tool. That data-collection tool allows the practice to attach documentation,
just like you attach a document to an email. But the practice has to create
that documentation. It can range from a screen shot to a report, to having to
physically abstract data from individual charts. There is no F7 key to push and
get the reports that we need to document the measures that I talked about. We
certainly hope that we could get there in the future.

So the practice creates the documentation. Our trained reviewers review that
documentation. We go further. For a sample of practices, we do a physical audit
onsite, whether the federal government requires that or not. We can talk about
why it might or might not need it.

So we are hoping to get where others have described, that certified
electronic health record technologies would be able to generate standardized
reports, that that capability would be certified. We envision that the eligible
professional would then authorize electronic submission of that report to CMS
or whatever branch of the federal government is appropriate, through something
like the registry function that we have now for PQRI.

We could talk about whether the federal government wants the assurance that
comes with doing some random audits onsite. We hope that you would consider
whether practices that are meeting the medical home standards — once we know
what the measures of meaningful use are going to be, look at the overlap with
our current medical home requirements or our future medical home requirements,
and whether there might be some kind of deeming that would be appropriate.

I’m not going to talk too much about electronic quality measurement, because
Floyd and Mike have already talked about that.

I think, in summary, we have laid a good foundation for standardized
reporting directly from electronic health records of clinical quality results.
We are not there yet. Most systems can’t do it yet. But hopefully we can get
there a little faster than maybe we anticipated before the Recovery Act.

Just to reiterate, our recommendations would be to:

  • Establish a broad vision linked to health reform and define an endpoint,
    at least as far ahead as 2016, if not further, for it to be eligible for the
    incentives, what we want to the reported measure set to look like.
  • To create that measurement set with a multi-stakeholder advisory committee
    or input.
  • To have a realistic phase-in strategy. That phase-in strategy might start
    with the use of basic functionality — are the cells being filled in? —
    progress toward clinical processes — is the searchable data being used to
    contact patients, to deliver patient care? — and then move towards outcomes,
    which would be the quality measures.

Important considerations — the practical considerations:

  • What are the implications for legacy systems? We would recommend that the
    measures of meaningful use be to the maximum extent possible —

MR. REYNOLDS: We’ll need to wrap up, please.

MS. TORDA: — specified to be reported through the EHRs.

  • Consider the PQRI registry precedent as an option for data collection and
    validation.
  • Begin now to provide support for practices and to the larger support
    organizations that Mickey mentioned.

With that, I’ll stop and turn it over to you.

MR. REYNOLDS: Judy Warren.

DR. WARREN: This is for Phyllis Torda. On one of your slides, you said that
current EHRs do not generally support reporting. My concern is that most EHRs
have reporting functions that are fairly robust. Are you talking about the EHR
software not supporting reporting or the implementation of that EHR that cannot
populate reporting of the details of the elements of your indicators?

MS. TORDA: That specific statement referred to the kinds of reports that
would be necessary to document the measures on my next slide. Percent of
patients seen in the last three months, with seven specified data fields
entered — that’s our measure. But those kinds of reports and certainly any
standardized reports — some can do it, to some degree, but most of it is
pretty ad hoc across the different systems. The same goes for actually
reporting standardized clinical quality measures.

DR. WARREN: So it’s the implementation of the EHR that doesn’t support the
reporting.

MS. TORDA: I think it’s both.

MR. REYNOLDS: Marjorie.

MS. GREENBERG: I wondered if you had any thoughts on how the general public
might receive information about progress being made towards meaningful use of
electronic health records, either in the aggregate or physician-specific, in
the context of the transparency about how funds are being spent under the
stimulus bill.

DR. RAPP: I believe the statute requires the Secretary to publish the names
of the individuals who are qualifying for the incentives. That’s something that
is required in the statute. It’s required in the Physician Quality Reporting
Initiative, in the electronic prescribing, and in the HITECH Act.

There are two authorities. One is at the individual level and the other is
at the group level. Depending on whether the Secretary would implement the
group level, then — but that would come out.

As far as so-called performance — in other words, if there was reporting on
this function, that function, that function, which ones those particular
doctors are using or not using — I don’t believe that’s in the statute
specifically.

DR. EISENBERG: Can I take a stab at that, at some risk, having been a
vendor, about six months ago? Vendors are often very attuned to something
called KLAS rating, K-L-A-S. I could see that if there are measures of use
which their customers are required to report on, perhaps KLAS rating could
collect that information, at least for vendors and public reporting of use of
vendor systems. That could be another mechanism to say how these systems have
been used in practice.

DR. TRIPATHI: I would certainly agree with that. You could imagine all sorts
of other kinds of ways to market this that would raise the visibility, I think.

But the other piece that we haven’t really talked about is whether
patient-facing applications ought to be a part of meaningful use, and that
physicians use systems to populate patient-facing applications. It would
certainly raise the visibility of it, if all physicians are going to be
required to do that at some level.

MS. TORDA: Let me add my two cents. One of our research findings, actually,
is that positive patient reports of experience do not correlate well, for
whatever reason, with EHR use. There are a lot of potential explanations of
that. But I think that there is room, in the sense of public education, to make
for the public the connection — and this goes to having the broad vision —
the connection between improved quality, improved safety and use of the EHR.
Why is my doctor using this? How can the doctor make it a more patient-friendly
experience?

But there is really room to make that case better. I think there is also
evidence that the public doesn’t understand why this is in part of the Recovery
Act and how this money is really going to benefit them, so that there is an
opportunity to do that.

We do know that the systems that are patient-facing — and certainly the
most well publicized is the Kaiser system, which is wildly popular with Kaiser
members. Certain key functionalities of that system, which allow patients to
make their appointments and see their results, are really wildly popular. I
would certainly recommend that those features be given and consideration.

MR. REYNOLDS: Blackford.

DR. MIDDLETON: Thanks for a terrific panel and for your endurance.

For my question, maybe Micky would start, then Michael and Phyllis might
pick up the second half.

Micky, I was impressed with your vision, the notion that from a disparate
set of EMRs, potentially we might gather data into a reporting resource of some
kind and from that, then, meet reporting needs of a variety of forms across a
region or across a state, as you have described. My question for you is, how
much variance do you see in the report types that might be expected from such a
resource, given the needs of NCQA or PTE or PQRI or meaningful use, et cetera?
How much variance or overlap is there in those sets of data requirements?

Then, Michael and Phyllis, if we see a way to actually gather these data
into a reporting environment, how can we clean up the front end, if you will,
where the data comes from, into the EMR? Can we actually design standardized
documentation templates or minimal structure documentation requirements that
make the backend reporting work so much better?

DR. TRIPATHI: That’s a great question. I’m completely going to punt on it.
On my slide I said a report on a national core set. Mike and Floyd and Phyllis,
I think — not to be so flip. I think that’s a big part of the conversation, to
say what we would start with as a core set of measures that are going to apply
to everyone. I think that’s the unique opportunity we have with raising the
national consciousness around meaningful use. Perhaps the federal government
can at least start that conversation, to say there surely has to be a small set
that all of us can agree on that will apply to all primary care and none of us
will be surprised around what those things are — get a common definition of
those so that, as you said, then we can roll those out into training, as well
as the kinds of templates and the implementations to at least make that happen.

That would be a start, just a start.

For some of those — for example, if you are doing diabetes and you are
collecting glycosylated hemoglobins, it isn’t as if someone is going to set up
a lab interface to just collect those. Once you have that, you know they have a
lab interface set up. Similarly, if you have a measure that has something
around prescription history, again, that means they are getting all the
prescription histories; they are not just getting it just for that measure.

So I think that can go a long way, if those are carefully selected.

DR. RAPP: I am not sure which of the two issues you are raising, whether
it’s the clinical data elements or the data elements that relate to so-called
meaningful use, functionalities in the EHR itself.

DR. MIDDLETON: Yes.

DR. RAPP: Both. Going to the clinical data elements, I think the hospitals
are one area where I think, at least in this area, it’s not as challenging as
for physicians. In the hospitals, most hospitals are pretty general, and so we
have a set of three measures — emergency department throughput, stroke
measures, venous thromboembolism — that basically all hospitals take part in.
We have worked actively to try to see if we can get those data elements in an
electronic health record at the inpatient level for the certification and so on
and so forth. So that, I think, we can get to, and we will have at least a
start.

One would to then go to all of the other measures that one is interested in
at the hospital level. But I think once you get to the point that you can put
these in the electronic health record, then things are just a lot easier and we
are not limited to the measure set that we have for hospitals now, which is
really held back by the fact that these are chart-abstracted.

Somebody said that you can’t get outcome measures from claims. I disagree
with that, because we have quite a few outcome measures that we, in fact, get
from claims. But that’s the one thing. On the doctor’s side, this is a
completely different kettle of fish. This was our challenge in the Physician
Quality Reporting Initiative. Congress wanted all doctors — and not only
doctors, but every other kind of practitioner, from therapists — and they even
added audiologists at the last legislative go-round in MIPPA.

When you deal with that, there is no single data set that would apply to all
doctors. So the way we have tried to tackle this is to start with a set of
measures, 10 of them, that apply to primary care, prevention, chronic care,
that will hit a lot of doctors and the issues that you are interested in.

What PQRI has been successful with is getting a lot of measures developed.
The problem is, these measures are not really those that we have had a lot of
experience with.

I think we can get somewhere — we work with Floyd and others to get this
basic set of data elements in the certified products, and that way we can start
with collecting these measures, whether you do it through some output file or
we try to take advantage of the health exchanges, which I think would be the
best way, as I have indicated.

So that’s the clinical aspects of it.

As far as the EHR itself and the use of the EHR, as we heard about the audit
trails and so forth, if and when the Secretary has the capability of collecting
data elements from EHRs, presumably those same audit trails would be able to be
collected as well.

I’m not techie enough to understand the ins and outs of this higher level,
probably. But certainly if that was a vehicle to do that, then that would be
good, too. It has to be in the EHR first, though, before you can pull it out of
it.

MR. REYNOLDS: One last comment.

MS. TORDA: Let me just put in my two cents. The short answer is yes. The
cacophony that exists today exists, I think, for two reasons. One, fools rush
in where angels fear to tread, and we are all fools that have rushed in. But we
are certainly, I think, willing to harmonize our activities, particularly in
the face of strong national leverage. That’s what has really been a missing
piece. I think the Recovery Act provides the potential of that national
leverage to bring us all to the table and do it.

Just a word about the audit trails. Maybe this gets at the earlier question.
My experience in working with some of the systems and the audit trails is that
they are really hard to get to. They are very deeply in the structure. To get
reports out, the document to use is a pretty difficult task at this point. So
it’s not just that you have an audit trail, but how easy it is to get to it and
generate a report.

MR. REYNOLDS: First I would like to apologize to Jeff Blair. I have had to
cut off the conversation the last two times. Sorry, Jeff.

That ends our last panel. Thank you very much. We’ll take a 15-minute break
and then we will be back to hear public comment and then wrap up. Thank you
very much.

(Brief recess)

Agenda Item: Open Public Comments

MR. REYNOLDS: Let’s go ahead and get started. Let me tell you the order.
I’ll apologize again. Mr. Jagannathan and then I would like Mr. Nayak, Dr.
Rose, Robin Raiford, and then Tony Schueth. Two-minute limit, please. We’ll get
everybody in, and that will be a wonderful thing.

MR. JAGANNATHAN: Thank you for giving me the opportunity to provide some
comments. My name is Juggy Jagannathan. I head up research at MedQuist, a
transcription company. Hopefully, I will bring a unique perspective to this
august group here.

Contrary to popular belief, we are not Luddites. We transcribe 35 million
documents annually. We have about 1,000 computers in our data center. We do a
lot of high-tech work in providing a solution.

One of the points I wanted to get across here in this audience — I want you
to do a thought experiment. What is the vision you have for what the physician
interaction with an EHR should be or needs to be? Just think: Do you want to
use a mouse-ready system to interact with an EHR or would you rather have a
voice-ready system which would allow the system to interact with the system
with speech?

Now think of the context of what’s happening around you — Google; IBM just
released the Watson system, which can play Jeopardy. Look at where technology
is going.

I also want to underscore that natural language is probably one of the best
ways to document clinical care. It is arguably the best way, and it also passes
the smell test that 100 years down the road, people can actually understand
what was said.

I hope I have convinced you that it’s an efficient way of documenting care.
Now I will also go into why it is also one of the most effective ways of
documenting care.

All of the transcription companies who are in the forefront of the
transcription systems — and I represent about 100,000 transcriptionists, who
are actually editing speech-recognized documents. We are using speech
recognition. We are using natural-language processing technologies —

MR. REYNOLDS: Sir, you need to summarize, please.

MR. JAGANNATHAN: We can create CDA now. We can create CCD now. We are using
a combination of speech recognition, NLP, and human oversight in our role.
Physician adoption of EHR should not preclude creating documentation, creating
CDA content for distribution to EHR or HIE or PHR. That is one of the best and
most effective ways, and the technology and the industry is ready to be part of
the solution and not part of the problem.

Thank you.

MR. REYNOLDS: Thank you, sir. Mr. Nayak, please.

(No response)

MR. REYNOLDS: Dr. Rose.

DR. ROSE: Hello. I appreciate the NCVHS holding these hearings and the
opportunity to comment on the meaningful-use issue.

My name is Eric Rose. I’m the product manager for McKesson’s Practice
Partner EHR. I’m also a practicing family physician and have been a CCHIT
volunteer since its inception. I have co-chaired the CCHIT Ambulatory Workgroup
for the last two years.

I have two very focused suggestions regarding the development of a
meaningful-use definition.

First, the definition should not presuppose system capabilities beyond those
reflected in the certification criteria for a qualified EHR. This may seem
obvious, but since to do so would create situations where a physician who
invested in a certified EHR system might be unable to use it in a manner deemed
meaningful to HHS, unless the utmost care is taken to ensure harmonization of
the meaningful-use definition, with certification criteria, there is a good
chance that some subtle inconsistency could make it into the final version.

My second suggestion is that ONC, in defining meaningful use, consider the
full spectrum of providers and avoid requirements that would compel any
provider to use technology not relevant to his or her practice. For instance,
while the value of immunization data flow between EHRs and public health
systems is beyond question, it makes little sense to require a podiatrist who
doesn’t even stock immunizations in her office to invest the time and money to
implement the technology required for such data exchange.

These sorts of considerations could be handled either through a
lowest-common-denominator approach, where only those requirements appropriate
to all Medicare providers are implemented, or a segmented approach, where the
requirements vary by practice characteristics. But they must be addressed.
After over four years of developing and refining HR certification criteria,
these issues are at the forefront. The CCHIT volunteer community should be kept
in mind as an expert resource to draw on in the development of the definition
of meaningful use.

MR. REYNOLDS: Thank you, sir. Robin Raiford, then Tony Schueth, and then
Rodney Peele, and then that ends the list.

MS. RAIFORD: Hi I am Robin Raiford. I’m on the HITSP Education Committee.

At the urging of Walter, I share with you the largest single-page submission
to NCVHS. It’s a summary of the 7,000 pages of HITSP. It’s three feet by five
feet that I’m holding up in front of you. I’ll send it to you electronically.
It’s all the components of HITSP, much of which is the continuity-of-care
document and those pieces.

I just want to point out that a silent voice that has kind of been here is
that of a consumer. In the HITSP webinar series, there is a story called
“Steve’s Story,” which is, what would it be in an interoperable world
from a consumer perspective? I wrote “Steve’s Story.” It’s the story
of my nephew, with a brain tumor, who has to repeat his history over and over
and over again, who has had numerous CAT scans and whatever. His grandmother
died, who was my mother, because they couldn’t trend her lab results across
visits, across doctors, which is a sad way to lose your mother.

I would just encourage you, when you come up with meaningful use, even
though it’s tough for the doctor, it’s nothing like for these consumers. I read
letters at the White House for a year and a half in the Clinton Administration
— how these people get trapped in the system and get dropped. It’s a
preexisting condition. Then they are Medicaid. Then they get disability. Then
they make too much money in disability, and now all of a sudden they have to
wait for Medicare. Whatever a doctor goes through to get to meaningful use,
it’s nothing — nothing — to what these very sick people go through in
Medicaid to get through this. Who holds their hands? There’s a nurse out there
somewhere listening to them and going through that.

So I urge you to strongly consider the continuity-of-care document, even if
it’s just level 1 and a summary, so these poor people do not have to repeat
their problems, their meds, their allergies, and their past medical history to
the one of 20 doctors they see in the course of a year.

Thank you very much.

MR. REYNOLDS: Thank you. Appreciate it. Tony Schueth.

MR. SCHUETH: Hello, everybody. My name is Tony Schueth. I’m the CEO and
managing partner of Point-of-Care Partners, which is an HIT consulting company.

I have testified to the NCVHS in the past. You know me as an expert on
electronic prescribing and electronic prior authorization.

I want to bring two thing to your attention. First of all, I’m not an
attorney, but as I understand it, if a physician accepts MIPPA money, they are
statutorily unable to accept ARRA Medicare incentives. But there will be
documented-care pay(?) beginning in 2012, if I understand this correct. I
checked with a few attorneys and a few others.

As someone who has his ear to the ground, I can tell you that there are a
large number of physicians that are considering that the bucket for ARRA is
much bigger than that for MIPPA. Despite what you might have heard yesterday,
EHR purchasing is slowing right now. We are predicting that the rapid growth in
e-prescribing that Rick talked about this morning is going to sort of level off
as some of these physicians wait for the ARRA money.

So what’s the implication of this? 2011 is going to be a big year for EHR
adoption and electronic prescribing. Also the nation’s largest payer, CMS, is
not going to realize the kinds of savings that they might have realized as the
adoption levels off, in my view. I’m not sure if this has been communicated to
you, but in SEMI, where I’m the project manager, the autos have found a savings
per prescription of $3 to $5. So that’s a meaningful amount of money to CMS.

I have been here before. I know you don’t want me to just raise problems.
You want me to sort of mention solutions.

One of the things that I would like to suggest is, if the bar were to be
raised on electronic prescribing so that it’s —

MR. REYNOLDS: Tony, you’ll need to summarize, please.

MR. SCHUETH: — higher than Medicare, possibly the statutes could be
changed. Some of the bar raising would include some of the things that Rick
talked about earlier. I guess I can’t go into detail. I’ll send it to you
electronically.

The other thing I really want to talk about and mention is, I’m not sure if
you are aware, but Surescripts right now is asking for activity reporting from
its EMR and e-prescribing vendors. This activity reporting would be very
similar to sort of meaningful use. They have a format for the submission. It
goes electronically to Surescripts and then on to the payer, who can then see
this information. There is a certain level that can be seen at Surescripts as
well.

So the point is that activity reporting can happen today. It is happening.
You may want to actually –it’s too bad Rick didn’t talk about that or isn’t
around to give you a little more detail on that. But that is happening today.
It’s happening through an intermediary. It could also go directly to some sort
of data repository.

Thank you for your time.

MR. REYNOLDS: Thank you. Rodney Peele.

MR. PEELE: Good afternoon. I’m Rodney Peele. I work for the American
Optometric Association. I’m making these comments also for the American Academy
of Ophthalmology and the American Society of Cataract and Refractive Surgery.
We represent more than 50,000 optometrists and ophthalmologists, and we have
tens of millions of patients.

We are concerned that we will be shut out of this process, no matter how
meaningful our use is, because there is no certification available yet for
eye-care EHRs. We continue to pledge our support to help develop a
certification process for eye-care EHRs in 2010, so that our members can be
using certified products. We ask that you recognize the limits of product
certification on meaningful use and to assist us with rectifying the situation
so more physicians qualify for recognition of their meaningful use that
benefits our patients.

We’ll submit more extensive comments in writing. Thank you.

MR. REYNOLDS: Thank you. That completes everybody who signed up for public
testimony. The time limit was good.

Again, we would recommend that anyone who wants to submit written comments
for us.

With that, that ends the prepared portion of the program. Now we have to
figure out what we do.

Agenda Item: Subcommittee Discussion

MR. REYNOLDS: Since Dr. Blumenthal is here, I asked Chuck Friedman whether
or not they want to make any comments, and I think he want to make a couple
brief ones. Then we’ll continue on.

MR. FRIEDMAN: Sure, Harry. Thank you.

Very, very briefly, on behalf of David Blumenthal and myself and the entire
staff of the Office of the National Coordinator, I want to issue a great deal
of thanks to a great many people for these wonderful two days. I have to say,
thinking back on a very long time, this has to be the most informative two days
I can ever remember. Even though this is on paper, it is an extremely valuable
collection for us as we go forward.

I would like to thank you, Harry, the NCVHS members, the NCVHS staff, who
worked so hard in preparation for this, the 39 panelists, who gave us wonderful
material, everyone who attended, and among those who attended, those who
provided public input. This was marvelous. Thank you so much.

We received information, knowledge, and wisdom over these past two days that
will be of enormous value, as I said to us going forward. We will use this
material in very, very important ways. Again, I can’t thank all of you enough.

MR. REYNOLDS: Thank you. Tony.

MR. TRENKLE: I want to echo Chuck’s thanks to the committee, to you, Harry,
and to all the staff who helped support this effort and to the speakers, who
came in on short notice, as well as the people in the audience, both here and
those who listened remotely.

I think we have made a lot of strides over the past couple of days. I was
sitting next to Dr. Blumenthal, and I know it was very helpful to him. It gave
him some insights that brought some different perspectives that he hadn’t,
probably, totally thought through before, as did all of us.

I think it also shows the value of the NCVHS that you can bring experts
together on very short notice and come up with some hearings that are
meaningful and useful to us. We look forward to moving forward and working with
the committee as we begin to figure out how to actually implement this over the
next several years.

MR. REYNOLDS: Thanks to all of you.

Before we start the deliberation, I want to thank the committee and the
staff around the table. You kept the energy the whole time. There was plenty of
opportunity to lose that.

The other thing is, what I’m excited about is that every seat participated.
That’s what has always been good about our committee. That’s what has always
been good, and that’s why we have such a strong group. Everybody played. We got
a lot of great perspectives, and that’s one of the things we try to do.

With that, I’m going to give you an update on what we are going to be doing.
I’ll reiterate to everyone that our goal is, within the next two-plus weeks, to
make sure that we have a document that clearly describes what went on here. We
have not been asked to give specific recommendations. However, we will be.
Margaret Amatayakul is already working on a set of draft categories that we
want to kind of think about.

Back to Chuck picking up the paper, if we just give him the paper, that
wouldn’t be very helpful. We’re not going to go there.

We are actually going to go through, and a number of us have touched base at
different times about some possible categories of how to think about this. So
Margaret is going to produce those. By the end of the day Monday, we will have
a draft out to the full committee on what that would look like.

In the meantime, when we open it for discussion here in a few minutes, I
would like you to talk about categories that you might have heard that you want
to make sure are included. Understand, it’s not directing the conversation.
It’s grouping the conversation. That’s what we were asked to do, to report out,
not to push it in one way or the other and not to add any value-add, until such
time as we would be asked that, possibly. That’s part of the whole process as
we move forward.

So that will be happening.

We will get copies of all the submitted comments to the committee as soon as
possible. We will communicate with you quickly as to how fast that would be out
to everybody. It will be out on the Web site. You won’t get a UPS package. It
won’t fit in your front door. We’ll make sure you know where they are and you
will have access to look at them — all the written comments from the people
that didn’t testify, because we want to go through those.

I will be requesting — and some of you have already stepped up — a member
and/or a staff lead on each of the categories that we come up with, so that we
make sure, as we look through it, we are calling out the right things that we
need to add to the extensive testimony that we have heard. I will ask each of
you to step up in those ways. If we have a category, as we start putting it
together, if you read something different in the written testimony or something
that adds further clarity to it, then that’s how we would adjust it. So we will
look at all of it, but again, we are doing a readout by category, making sure
that we make the points that we heard, clearly, in there.

With that, let me open it up for any comments or any discussion by the
committee. Again, the purpose today is to gather as much as we can from each
other as to what we thought, what we heard. Again, it’s not that that’s going
to be exactly what we do, but it’s very important that, if you have anything to
add to the thinking that we are going to do as we put these categories
together, you are able to say it while we are together. Then, obviously, we
will start our process.

Again, to those of you in the audience, our document, when it is completed,
will, in fact, be posted to the Web site and it will be delivered to ONC. So it
will be returned to the public environment, as it should be and as is always
our practice.

With that, let me open the floor for discussion. Paul and then Justine.

DR. TANG: As the committee’s lumper —

MR. REYNOLDS: Yes, we ought to get clearly divergent views over the next two
comments. Go ahead, please, Paul. You first.

DR. TANG: I thought it was a really good two days. Thank you to the staff
for organizing this all and for bringing so many people together, and for the
clear presentations.

I thought of three categories to look at meaningful use. I’ll just throw
this out.

One is to have the system that interacts with the human professionals and
the human patients be meaningfully usable. That’s very broadly encompassing.
That’s the feature set, the way it presents itself — i.e., the user interface
— to the humans interacting with it, et cetera, the coding. It’s the
meaningful usability.

Then there is the sort of adoption, which is the meaningfully used. That
speaks to the adoption and getting it in, getting people interacting with it.

I think the endgame, which I heard the strongest from these two days, is
meaningfully useful.

That’s a bit of a play on words, but there are different ways of
characterizing what we are looking at. Then we have to decide what is the most
important. One of the things that struck me about Micky Tripathi’s — near the
end, where he talked about if you get the meaningfully useful part right, then
the other two probably happened, and you don’t have to micromanage those
pieces, or even to instrument them very finely, which all costs money.

At any rate, that’s one suggestion.

MR. REYNOLDS: Justine.

DR. CARR: I echo what everyone said. It was an amazing two days.

I actually agree with everything that you just said. But I wanted to add
some granularity to it. I think that there are just a couple of things that are
probably worth — kind of as background information.

We heard a lot about, meaningful to whom? I think, as we put these things
together, we want to think about what’s meaningful to the patient, the
provider, the payer, to public health, and, really, to the nation.

A second area, again sort of in the category of definitions, is starting
with exchange. I think I understood something that I didn’t understand before.
There are large groups, like Partners or Kaiser, that unto themselves they
exchange, but they don’t exchange, let’s say, across the street to another
entity —

MR. REYNOLDS: Only using them as examples, correct?

DR. CARR: Only as an example.

So understanding what the meaning of exchanging is — and I think the fact
that Amazon doesn’t exchange regionally — one Amazon, one exchange — I
thought that was important.

The second thing, of course, is, what is EHR? I think we need to pay close
attention to the concept of “EHR Light,” in the context of meaningful
use. We heard a bit about the fact that an EHR Light can have a big return
early on — thinking about that and sort of getting everybody engaged.

I’ll stop with that.

MR. REYNOLDS: Could I add one thing to that comment on EHR Light? Would you
take the amendment that maybe it’s “EHR, the Journey”? If we just use
one word, it starts to —

DR. CARR: Right.

MR. REYNOLDS: I think, as Paul said, we have heard the endgame. The endgame
is much more than EHR Light.

DR. CARR: Right, but I think we need to define it in terms of the endgame
and where we start.

MR. REYNOLDS: Yes, right. But it’s within the journey.

DR. CARR: Absolutely.

MR. REYNOLDS: Good.

We have a list. We’re going to get everybody, I promise. Paul is playing off
that one, and we have everybody else on the list.

DR. TANG: I think this was an important point, what you just said. I think
what Justine is saying is, the concepts should no longer be tethered to the old
labels. EHR isn’t a thing; it’s a set of data that is useful in care or health.
Similarly, we may have come into the meeting thinking of HIE as either an
organization or a set of operations, but it’s really an exchange of data in a
meaningful way.

I think Les Lenert mentioned a vertical exchange. That’s just as valid when
that’s where the data has to go to support health and health care. We need to
recognize meaningful exchange. The whole “meaningfully useful” is the
bigger term. I think that’s a big thing we learned in the past couple of days.

MR. REYNOLDS: All right, we’ve got Marc.

DR. OVERHAGE: This kind of plays off of the lumpers and splitters a little
bit here. I’m a lumper. In some ways, as I listened to what we heard, we heard
a lot about where we need to end up — too much about where we need to end up.
I think some of the things about meaningful use from multiple aspects and so on
belong there. That’s where we need to go.

We heard some about our current state, what some of the constraints and
limitations are. We heard vendors says, two years to get the next version out;
we don’t have two years. So there is some current-state information.

Then, in between, we have to navigate a path. To me anyway, there are three
major categories of that navigation:

• One is the data evolution that we heard about, starting with targeted
things, evolving onward.

• I couldn’t come up with a great word for this — sort of “value
realization,” the EHR journey that you just described. That’s somewhat
orthogonal. It’s related. There are certain functions you can’t do until you
have certain data, but it’s somewhat orthogonal.

• Then measures and measuring. How do you identify and report progress
along that continuum?

Those seem to me the three buckets of the journey.

MR. REYNOLDS: Good. Blackford.

DR. MIDDLETON: I will resist the temptation to be categorize myself as a
lumper or a splitter. But just to add on to the comments so far, I guess if I
was to distill what arise in my mind as kind of the essential buckets for
thinking about the testimony, they sort of revolve around system capabilities
and functionalities, which was the focus of a lot of our conversation:

  • Within that, we heard a lot about data access and knowledge access,
    decision support and quality reporting. That’s a bucket of stuff.
  • The second is this notion of the exchange and interoperability of
    information, those sorts of issues there.
  • It’s already been commented on a couple of times, usefulness and
    usability. It’s an important bucket as well.
  • Finally, the measurement or the attestation, or otherwise the
    documentation and proof, of meaningful use as a set of independent criteria
    with which to organize the testimony.

There were a couple of other thoughts, just to go on for a second, if I may.

I wonder if it would be useful to organize the testimony, what we have
heard, as sort of a cross-tab of stakeholder and goals by stakeholder, by
criteria or features or capacities or functions of EMR. In my own mind, I would
love to see that, because I think it will help us analyze the great array of
testimony that we heard and see where there are clusters of related concepts
that we may not be able to get to in any other way.

I think we heard a little bit about value and utility as well. Once we have
a list, how do we actually prioritize or rank it in a way that’s meaningful, so
that our assessment or the interpretation of these testimonies is not only
accurate, but also useful itself? I think we have to do some work there. Part
of that work might be to suggest to the national coordinator that, possibly,
testimony is not going to be sufficient, that testimony needs to be
substantiated with a careful review of the evidence to substantiate the
testimony so that we have a clear idea and a defensible position going forward
— or they do.

I think part of that evidence review might suggest also these value
clusters, this idea that we came up with, that might help us organize or
prioritize these criteria.

Lastly, I would just suggest that the “light, medium, and heavy”
discussion of the technology — we have to be very careful that that doesn’t
become a distraction. All of this needs to be technology-independent at a
level. There will be various forms of light, medium, and heavy each and every
time, if you will. I would almost propose that we avoid that language. While we
are thinking about technology independence, if you will, that’s one of these
overarching principles that I also suggest we try to arrive at. There may be a
small number of them — utility, usability, value, and then these process ideas
— to sort of rank the testimonies.

MR. REYNOLDS: Leslie?

DR. FRANCIS: I want to raise a couple of additional or different overarching
themes.

One, given that John and I are co-chairs of the Privacy and Security
Subcommittee —

MR. REYNOLDS: We would be disappointed if you didn’t.

DR. FRANCIS: Yes, you would be disappointed if I didn’t mention it. I do
think we should simply pay attention to what was said about the role of privacy
and security in facilitating all of this, what needs to be done and so on.
There were suggestions, for example, about standards.

The second thing is that a theme that went along in a number of points was
whether the question about how to address underserved populations is
essentially a resource question. So getting more in the way of knowledge,
getting more in the way of funding out to Medicaid providers, safety-net
providers, providers who serve the underserved — whether that’s really just a
matter of getting more money to them or something else — paying attention, for
example, to what certification ought to look like for varying practice
situations.

My third observation — and I don’t quite know what to do with it, but it’s
an observation — I think there is a fundamental divide between people who
think that the way this is going to need to be approached is basically in the
private sector, with federal support of money, or whether the way this is going
to need to be approached is much more in the public sector, and what that would
look like. I think we are going to need to pay attention to — maybe this is
borrowing a word from John — the governance and whether that’s really a
public-sector issue or public/private, and exactly how that will look.

MR. REYNOLDS: Jeffrey.

MR. BLAIR: Those of you who know me recognize me from my engineering
background, where I always, typically, wind up structuring things. I’m going to
do exactly the opposite this time.

MR. REYNOLDS: We won’t recognize you.

MR. BLAIR: I know. I’ll have to have a different name.

There were several things that came up where I feel like, as Margaret begins
to structure the information for us, we really need to give her the freedom and
latitude to be able to modify that structure, to incorporate, for example, the
fact that if we look at certain data elements for meaningful use — and I’ll
just give an example here, fill notifications in e-prescribing. Is that a
measurement of the health-care provider, the clinician, or the pharmacist or
the patient? It may be all three. I could start to think of many, but time
won’t let me list those.

But those are really important, because this gives us the chance to begin to
move beyond just simply saying meaningful use from the standpoint of the
clinician to meaningful use getting closer to the patient. I don’t think we
want to lose those.

So I just want to make sure that Margaret has the flexibility to recognize
areas where data have multiple use. That same data element may have use for
better patient care, but it may have use for public health or clinical
research.

MR. REYNOLDS: Jeff, one of the testimonies talked about acceptance of new
responsibilities by clinicians, payers, patients, et cetera. I think what you
are saying falls into that category.

MR. BLAIR: Let me add one other piece here. Some of the people that spoke at
the open mike — there are some outliers there, and I don’t want to lose those
either. One of those that kind of wasn’t in our framework really struck me as
something that I don’t think we want to lose. Somebody wound up saying that of
all the areas of meaningful use, we never included a measure of having more
accurate and complete diagnosis. EHRs and CCDs absolutely will contribute to
that. That is a huge area for savings in health care. Those are the types of
things that I just think — we need to make sure we don’t lose those.

MR. REYNOLDS: Good. Marjorie.

MS. GREENBERG: I want to thank everyone as well. Particularly — always at
risk of not mentioning somebody — I want to thank Denise and Karen, who just,
I thought, did an amazing job in their lead staff role, and, of course, working
with Chuck and the ONC group as well, and then also the NCVHS team. We keep
referring to them, but I would like to mention by name those who are here

MR. REYNOLDS: Please do.

MS. GREENBERG: Debbie Jackson and Katherine Jones and Marietta Squires and
Cynthia Sydney and Jeannine Christiani.

I want that on the record. The presentations just kept appearing on the
slides and we just kept getting copies of things, and everything was amazingly
smooth. I really appreciated that.

My reaction to this whole buildup was to leave the country for 10 days. So I
really take no credit, except that, hopefully, maybe in the past for something
I have done. But I really am very grateful to the all the professionals who
helped put this together.

As is my wont, I sort of agree with what everybody said. But I was really
attracted to Blackford’s suggestion as one of the ways of looking at the
information, because I’m confident that Margaret will not feel bound by what
people have said, but will be enriched by it, and then we will be able to react
to her drafts.

I think there are several different ways you are going to want to cut it.
But the idea of looking at the stakeholders as one cut and what would be
meaningful to each of those categories — I think we heard a lot of interesting
things from employers. We just received a few presentations on that, but it
definitely had some different things, and I think it’s important that we not
lose that.

The consumers — just in the last panel, I guess, we had an official
consumer representative. We are all consumers in some regards. Because we
didn’t have a lot of consumers, I think we should look back, possibly, at the
hearings we had on medical home and just what all those features of meaningful
care are that we have been talking about. Our theme for this past year and the
coming year, without knowing that this was going to be on our agenda, is the
person-centered health. I think we did hear a lot of people referring to that.
It was perhaps most eloquently captured by one of our last public speakers.
What really would be meaningful to patients and to people with a lot of chronic
conditions, et cetera?

I think, although we will summarize the hearings and the data from the
hearings, there are some other areas that we can draw on that the committee has
been looking at and discussing probably over the last 60 years, but I would
say, more over the last year. I just want to suggest that.

Also the provider perspective that we heard in public comment — the whole
issue that if this doesn’t make workflow better, if it makes it worse, then we
are probably not going to get meaningful use either.

Although there seemed to be a lot of consistency across a lot of the
testimony, I think there were some really different stakeholder perspectives. I
just want to endorse that concept.

MR. REYNOLDS: Walter.

DR. SUAREZ: Thank you. I think we heard a lot during these two days, as
everybody has said, and I think we heard a lot from things that were much
broader than the actual focus of trying to figure out what to include in a
definition of meaningful use, which was great. I think what we heard were a lot
of innovative and more challenging things about health-information technology
in general.

I want to make a few comments.

The first one is the definitional issue and the scope. We started with a
hearing on meaningful use of health IT. What is health IT in that respect? Is
it EHRs only? Is it EHRs and PHRs? Is it EHRs and e-prescribing? Is it HIEs and
EHRs? We have to really, at the end of the day, concentrate and focus the
scope. It seems to me that we were mostly talking about EHRs and how EHRs
relate to e-prescribing functions or relate to HIE connectivity or relate to
PHR interoperability or things like that.

So that’s one issue we have to start with.

I would group the things that I heard in four areas. The first one is the
purpose. I think we heard a lot of reasons about meaningful use around the four
or five major things that we always talk about — quality, safety, access
issues, cost and efficiency issues, and value, ultimately, the concept of
value. All those were kind of the framework for the purposes of meaningful use.

But I think we heard more specifically about — and this is a second element
— the features and capabilities. I would separate internal features and
capabilities from external features and capabilities, internal features meaning
the internal characteristics of EHRs and the things that need to be enabled,
not just that the system is capable of. Those include things that we heard from
the very beginning — registries, clinical decision support, privacy and
security elements, and specific applications of internal features.

For external features and capabilities, we heard about interoperability and
being able to exchange messages, comply with interoperable standards, quality
data collection and reporting — that is the second one we heard — and a
number of other features and capabilities related to external characteristics
of an EHR.

The third element I heard is the application areas. Here what I heard is
that there are differences, of course, between meaningful use in hospital EHRs,
ambulatory EHRs, EHRs implemented by others. Then there are also the
application areas for specific sectors of the industry, like public health,
Medicaid, the medical homes model, the underserved. What are the elements that,
in a meaningful-use definition, we should consider recommending to be included
in order for the EHR to communicate public health messages or Medicaid —

MR. REYNOLDS: Let me jump in. We will not be recommending.

DR. SUAREZ: Oh, I’m sorry.

MR. REYNOLDS: Since this is a public record, I just want to continue to
remind everyone —

DR. SUAREZ: I used the wrong word.

MR. REYNOLDS: I’m not worried at all that you used the wrong word. I’m
bringing it back to make sure that it’s a public record — you don’t need to
apologize. That’s my job, to make sure that the record sticks as it should be.

DR. SUAREZ: So noted, then.

The last area I wanted to highlight is operational issues. Here is where we
started to hear about the idea of what the requirements are that we would
include in a definition of meaningful use — the requirements in terms of going
beyond the certification of “capable of” to actually expecting that
the system will have this or that   and then balancing the bar
between setting it too low and making it useless or setting it too high and
making it discouraging for the adoption of EHRs, and the metrics that we would
need to use in order to assess and ensure that systems and organizations are
implementing EHRs and actually are complying with this meaningful-use
expectation.

Another very critical element was scalability and the ability for those
measures and metrics to be scalable. When we talk about EHRs in a
single-doc/solo-practitioner clinic, like in New York City connecting to public
health, versus a very large system implementation, we are talking about
different levels of implementation of the metrics. So scalability in those
metrics is something important.

Then we talk about three other things inside the operational issues:
Assurance and the way we can look at assuring the meeting of those;
enforcement, as potentially the next level of this assurance; and then the
timeliness and the timeline itself of the transition. There are a lot of
questions and challenges about being able to do all this in the timeframe
between now and 2011. Many of the things that need to be done between now and
2011 have to happen in the next few months in order to get a system and be able
to, by 2011, demonstrate that it is meeting the meaningful use.

So that’s my summary. I’ll stop there. I have a number of other comments,
but I’m sure we will be able to exchange more offline. Thank you.

MR. REYNOLDS: Judy.

DR. WARREN: As I thought back about the testimony we heard, it seems to me
— I’m almost with Marc about lumping here — that there were two issues that
we really heard about. One was about the technology and its ability and
readiness to serve the purpose, and the other, which to me is probably a more
important function, is trying to get the clinicians to exhibit behavior of
meaningful use. It really is a person thing — and not only the clinicians, but
patients and families as well.

So it’s the behavior of people using the system to be sure it’s meaningfully
used and it’s the behavior of the systems to make sure that technically they
can support that use.

MR. REYNOLDS: Jorge.

DR. FERRER: My observation is very global, but I think there are themes that
we heard. It is a phased approach. It is not a one-fit model; it’s really
phased.

Then there is also the progression path. A lot of the testimony also is
progression path, based on the sector which the testifier is coming from. As
fragmented as the testimony is, when you really delve into it, you still are
going to view a very centric view of what that individual has given testimony
on. So you have to be sensitive to that, because if they are testifying from a
provider’s standpoint versus a plan, their testimony will really reflect that
doctors want to provide great clinical care, but plans really want to evaluate
the cost-effectiveness of that care.

MR. REYNOLDS: Chuck.

MR. FRIEDMAN: Thank you, Harry. I’m really hesitant to say anything, but I
feel like I should make a comment along these lines. It’s a comment in the
direction of conservatism in preparing the summary. This comes from a couple of
perspectives.

The first would be a conservatism in the sense of suggesting that you might
want to stay close to the structure of the law, because that’s going to be our
foundation as we move forward. The closer the structure of your summary is to
the structure of the law itself, all other things being equal, the more helpful
I think it will be.

This is sort of derivative from that first comment. I think it was that kind
of conservatism to stay close to the structure of the law that suggested the
structure of the panels for the session. So derivative, then, from my first
statement is a suggestion that you might want to be sure your summary preserves
some of the constructs that were implicit or maybe even explicit in the
structure of the panels themselves.

The three things that a meaningful user has to do: make meaningful use of a
certified product, exchange health information, and report quality measures.

Another construct along those same lines would be what we called the glide
path. It was used in the names of the panels. I realize the “glide
path” is a bit unfortunate terminology, in the sense that a glide path is
a way down, and I think we are talking about a way up. So we are open to
suggestions. But “glide path” is a good metaphor for other reasons,
and I think we introduced it into the structure of these sessions for those
reasons. It would be good if that were preserved in the summary as well.

MR. REYNOLDS: Good. Paul.

DR. TANG: This comment is to follow up Marjorie’s comment and Judy’s about
the patient. Just to remind ourselves — I know it’s in the transcript, but I
want to make sure it gets in the summary — the first panel responded to the
direct question, “Should patient access to and use of be part of the
definition,” and they unanimously said yes.

MR. REYNOLDS: Mike.

DR. FITZMAURICE: On the definition of meaningful use, a lot of what I heard,
on the one side, could be the characteristics of the definition itself versus
the expected impact of the definition. I was pleased to hear that several of
the speakers prioritized what they wanted to see. They prioritized the
electronic health record functional priorities and the public health functional
priorities. I think that could be a great help.

I heard, “Avoid provider burden.” That, I guess, falls under
characteristics of the definition.

Look at the difference between capabilities and our vision — that was
guiding a lot of comments — versus comments on the other side, “Look at
what we have in actual practice today, and don’t push it too hard.”

The use of structured data came through strongly. even when people didn’t
use the term “structured data,” they talked about the need to get the
data elements, the picture of the data elements, for labs, for example.

I thought they really did us a good service by giving us some criteria for
what the definition of meaningful use should have. What are the properties of a
good definition of meaningful use?

Also there was comment on how to move from a claims data focus to a clinical
data focus for measuring the same things. That is, how are we improving patient
outcomes? How do we move — and it’s very hard to move from a claims data
focus, which we have, to a clinical data focus. Do we do it piecemeal? Do we
build that piecemeal into the definition of meaningful use or not?

The importance of connectivity as a part of interoperability keeps coming
back. Many places aren’t connected to do something, whether it’s rural areas or
not. We have to be aware of that. The Department has to be aware of that when
we come out with definitions of meaningful use.

I didn’t hear any comments — or maybe I just wasn’t listening at the time
— on different requirements for different kinds or categories of providers,
except for ophthalmologists, and that was through the benefit of a public
comment. I don’t know if public comments would guide us not to try to
categorize priorities and give different definitions of meaningful use for them
or to make it as general as possible and leave it to the implementation.

DR. REYNOLDS: Okay.

DR. FITZMAURICE: I guess I could make one more comment, if I may. That is, I
didn’t hear how ARRA constrains us, constrains HHS, in developing an incentive
reward system for providers over time, how it affects the timing of what we can
do, how it affects the amounts that we can do, and how it affects the
relationships of the timing and the amounts to the functions and the outcomes
that we seek. That might have been a good conversation to have.

MR. REYNOLDS: Okay, excellent.

Again, playing off of Chuck’s comments, we want to be very pragmatic. We
want to tell the story of everything we heard. We want it to match pragmatic,
and then we may have some other things that we put in there that are other
things we heard that may need to be considered, whether they be other aspects
of what we do or others do. They could be things that we consider doing as we
do this.

Marjorie?

MS. GREENBERG: I got at least one e mail sort of asking, what next? Of
course, we know what we are going to be doing next, with the report. But what
is the kind of timeline for the Department to process all of this, to begin to
identify how this is going to play out?

I just wonder, since this is a public meeting, if there is anything that
anybody can say about that. We know that the first incentive payments are —
what? — 2011. So sometime between now and 2011, this is going to be worked
out. Is there anything more specific or are there milestones in particular that
people might be aware of? If not, that’s fine. I’m just trying to be responsive
to questions I have received.

MR. REYNOLDS: If there is a comment on this, I would rather it not be from
NCVHS.

MS. GREENBERG: No, I don’t think it could be from NCVHS.

MR. FRIEDMAN: I was going to say, I don’t think there are any specifics.

MR. REYNOLDS: Okay. We have been asked to produce our document, and we will
do that.

DR. SUAREZ: Could you explain to me a little bit more about the process we
are going to follow as a committee?

MR. REYNOLDS: I just went through that.

DR. SUAREZ: I might have missed it, I’m sorry.

MS. BERNSTEIN: Margaret A. is going to produce a summary and then?

DR. REYNOLDS: We are going to produce a summary and, as I have said six
times in the two days, it will, in fact, be put out on our Web site and it will
be delivered to ONC.

MS. BERNSTEIN: In between those two things, I think there is some — is the
committee required to meet again in order for that to —

DR. REYNOLDS: No, we are not. We are not required to meet again. We are
doing nothing more than summarizing it. We are just coming up with ways to
summarize it.

DR. SUAREZ: So this is not a position statement where the committee approves
—

MR. REYNOLDS: We are not making — we are reading this out in a way other
than taking this stack of paper and handing it to them and going, “Thank
you very much. We had a great hearing. Use it.”

MS. BERNSTEIN: There will be some review process.

MS. GREENBERG: The Executive Subcommittee essentially will be the review
group.

MR. REYNOLDS: That is exactly correct.

MS. GREENBERG: And so there will be —

MR. REYNOLDS: I will go through it again. I’m tired of going through it.
After two days, I’m tired of going through it, but I will go through it again.

Here is the point. By the end of the day Monday, we will have some idea of
the categories we are going to use. Each of you, by Tuesday, will be asked to
pick a group that you will be involved in and help go through the testimony and
make sure that you call out any things related to these things. We hope to have
some kind of summary document by the end of next week. It gives us part of the
following week to review it and turn it in to ONC.

Again, we are not making magic. We are not taking it to the committee and
having arguments over our position or anything else. We are trying to tell the
story of the two days in a meaningful way that goes against meaningful use and
the ARRA, period.

The other thing is, we have never done this before. We have never had this
much information to do in this fast period of time. If anyone wants specifics,
get over it. We’re going to work this out in the next few days and we’re going
to make this happen.

DR. SUAREZ: Harry, will you define “meaningful way”?

(Laughter)

MR. REYNOLDS: At this late date, if you walk out with me, I’ll explain
“meaningful way.” It has been a long two days, guys.

Leslie, the last comment.

DR. FRANCIS: This is just a process question. When will the submitted
documents be available for us to look at?

MR. REYNOLDS: They will be on the Web site by the end of tomorrow. We have
announced that over and over again. They have to be in to us, and they are
submitted to the Web site by the end of the day tomorrow. That’s it.

DR. FRANCIS: So they will be up on the Web site —

MS. GREENBERG: They won’t be posted by the end of the day tomorrow.

DR. FRANCIS: That’s the question I had.

MR. REYNOLDS: I don’t know. You have to tell me that.

MS. GREENBERG: People have until the end of the day tomorrow to submit them
to us.

MR. REYNOLDS: That is correct.

MS. GREENBERG: Then we will have them all posted on the Web site within,
hopefully, 24 hours after that.

MR. REYNOLDS: We should all have access to those by the end of the week.

DR. FRANCIS: And I take it those will be included in our summary.

MR. REYNOLDS: Those are absolutely equal to anybody that spoke to us, in any
way, shape, or form.

Again, we are making this up. I ask you to play. We played the two days. I
ask you to play hard between now and then. We may redo, we may rethink, but I’m
asking you to play. We have never done this — fast-track, hang on. If they
could pull the hearing together this fast, we ought to be able to put a
document together.

Thank you very much. I appreciate everybody. We are adjourned.

(Whereupon, the meeting adjourned at 4:30 p.m.)