**AMERICAN HEALTH INFORMATION**

####### COMMUNITY MEETING

**APRIL 24, 2007**

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## Hubert H. Humphrey Building

## 200 Independence Avenue, SW, Room 800

## Washington, DC 20201

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### List of Participants:

### 

> **[Members:]{.underline}**
>
> ** **

-   Secretary Michael Leavitt, Chair

-   David Brailer, M.D., Ph.D., Vice-Chair

-   Robert Kolodner, M.D.

-   Craig Barrett (also represented by Colin Evans)

-   S. Ward Casscells (also represented by Stephen Jones and Ron Pace)

-   Robert Cresanti

-   Nancy Davenport-Ennis (did not attend)

-   Julie Gerberding. M.D. (also represented by Steven Solomon)

-   Gail Graham (also represented by Linda Fischetti)

-   Douglas Henley, M.D.

-   Kevin Hutchinson (represented by Paul Uhrig)

-   Charles Kahn, III

-   John Menzer (represented by Steve Lampkin)

-   Leslie Norwalk (also represented by Tony Trenkle)

-   E. Mitch Roob (represented by Jeff Wells)

-   Scott Serota (represented by Justine Handelman)

-   Linda Springer (represented by Daniel Green)

-   Lillee Smith Gelinas, R.N.

-   Phillip Swagel (represented by Adele Morris)

# Presenters:

-   Karen Bell

-   Jodi Daniel

-   Gregory Downing

-   John Loonsk

-   Kathleen Nolan

-   Virginia Riehl

-   John Thomasian

#### TABLE OF CONTENTS

-   Call to Order: Secretary Leavitt

-   Introductory Comments: Secretary Leavitt

-   Comments: Dr. Brailer

-   Comments: Dr. Kolodner

-   Report on the First Year of the NHIN Initiative

    -   John Loonsk and Virginia Riehl

-   National Governors Association -- State Alliance for e-Health

    -   Jodi Daniel, John Thomasian, and Kathleen Nolan,

-   Personalized Healthcare Workgroup Update

    -   Gregory Downing and Douglas Henley

-   Break

-   AHIC Successor

##### Secretary Leavitt and David Brailer

-   Electronic Health Records Workgroup

    -   Karen Bell and Lillee Gelinas

-   Public Input

**PROCEEDINGS (8:00 am EST)**

SECRETARY LEAVITT: Good morning everyone, and thank you for coming for a
bright and early start this morning. We're anticipating the arrival, has
been snagged in traffic, of Ward Casscells, who is going to be the \--
is the new assistant Secretary for Defense for Health Affairs.

Ron, we welcome you momentarily in his stead. We have a lot of work to
do, and there is no time to lose. I would like to acknowledge that,
regrettably, I'm going to have to slip out a couple of times, just
briefly during our meeting; and I ask Dr. Brailer, as vice chairman, to
take my place. I will be back. I have to go to the White House for a
meeting with the one person for whom I would leave AHIC for.

I know that all of you understand the urgency of what we're
accomplishing here. This morning on my urgency meter, it says 637 days.
I feel that every morning. You know why it matters, and your monumental
efforts between these meetings are a testament to the dedication that
you are showing to make this work.

The AHIC has taken great strides in enabling the success of health IT.
We're identifying areas that can offer near term breakthroughs. We have
begun to process harmonizing standards. We called the development of \--
we have called for, and seen the reality of a certification process,
that is now entering its second phase.

We have called on the Office of National Coordinator to contract the
development of prototypes of a nationwide health information network.
That effort is now in its second phase. We have put in place the
Workgroups that are necessary to help AHIC advance recommendations on
other aspects of this as a priority. We've also identified a long list
of issues we need to consider to continue our progress. I'm not going to
go through that list now, but I have reached the point where I believe
we need to take another look at that list.

We need to prioritize the topics. We need to talk about the various
partners, and find out what their capacity is. And we need to urge their
accomplishments to be as expeditious as we possibly can. And I'm acutely
aware, as I said, of the way that the time begins to focus and needs to
focus us.

Today, we also have a hope of making real and sustainable improvement to
healthcare in this country, and I've come to HHS with that hope, and
since then, I think we have begun to see the department organize its
focus, and focus all of its efforts on accomplishing what we can.

Now, obviously this effort continues on after 637 days, but I think we
have all concluded that that's an important moment, because when a new
administration takes over, whichever party controls the administration,
there will be a break in the action. And it will take some time. And our
objective here has been to clearly establish a pattern, to have it
moving forward with a battle rhythm, and clearly establish this process
as the means by which standards are set. And I believe we can bring that
to fruition.

By doing that, it will not only make the hope of a better healthcare
system for the American people, but we will have made tangible and
irreversible progress. The result will be a healthcare system that
provides better health at lower costs, and for all Americans. I see
health IT as one of the initiatives that is absolutely crucial in making
that a reality, and I know that I'll \-- that all of you are focused on
it as well.

First of all, before we go too far, I'd like to congratulate Dr.
Kolodner. He has very ably been serving as the interim national
coordinator for health IT. I'm very appreciative of the experience and
the thoughtfulness that he's brought to HHS, and I'd like to thank the
VA \[Veterans Administration\] for allowing him to come and help us
during \-- on a detail, but now I look forward to his sustainable and
ongoing leadership of ONC. Having him as a permanent leader there will
obviously be very important. But we still have to ensure that AHIC's
work can be continued regardless of what happens in the future, and so
let's get about that.

As you all understand, in order for our organization to be successful in
the private sector, it has to have a business model, so today, HHS has
been establishing contracts to develop business models for AHIC's
successor. I've asked Rob to manage these contracts, and we'll talk more
about that later.

Now I want to know about the \-- I want to go on with the full agenda,
which is robust. Good morning, Chip. And I'd like to ask the vice
chairman to offer comments, and then we'll get on to the business. Dr.
Brailer.

DR. BRAILER: Great. Thank you, Mr. Secretary, and let me join you in
congratulating Rob Kolodner for his very hard work, and for his
willingness to take on this role that I know so well. It's something
that is both demanding and important. I certainly believe that we're at
a turning point, and Rob's ability to oversee this effort for the next
several years, in a career slot, will be a critical part of making sure
that we continue the progress that we've made. And I know that Rob
brings the right tone and approach to this. So Rob, thank you very much
for taking this critical role.

This is the 13^th^ meeting of the American Health Information Community.
And I think it's important to note that we now have the full complement
of our work before us, and our focus is on execution, and on results and
being able to deliver the promise that so many people expect from health
information technology. And you'll see this reflected in the agenda.
You'll see it reflected in the activities of the Workgroups, and in the
quickening of the pace that we have.

Let me, before we move forward, turn to tab two, which are the minutes
of the March 13^th^ meeting, and ask for any comments on this. Motion to
accept? Second? Any opposed? The minutes of March 13^th^ are accepted.
With that, let me turn to Rob Kolodner for comments. Rob?

DR. KOLODNER: Thank you very much, David, and Mr. Secretary. It's a
pleasure to be here with you in my new role, and look forward to working
with you over this next period of time.

There are a few things that I wanted to catch up on. There are,
obviously, a number of things that the Office of National Coordinator
are doing to support your efforts, and to move forward on advancing the
health IT agenda.

One of the things that we were charged with, when the President issued
his Executive Order back in April of 2004, was to deliver a strategic
plan, and we, in fact, are now working to do that. And this will be
something that you will see a couple of times, so we are currently doing
the internal staffing and some clearance. We will be presenting it to
you at the June meeting, and putting it out for public comment.

After processing those comments, and your input, we'll bring it back for
a final review, by you, with more detail in terms of the some of the
actions that we have; and then we'll plan to submit it to the department
for the usual clearance process.

This will be a national strategic plan for the health IT, as we were
charged, and should reflect input from multiple different federal
agencies, and look forward to your guidance in that when we present it
to you in June.

Next thing is that there have been a lot of recommendations, as you
know, that you have provided to us to advance the national agenda, and
in doing that, we have actually a total of 35 recommendations that you
made in 2006, and 58 that we have advanced in the last couple of
meetings in 2007. We are in the process of reviewing those and
indicating what actions have been taken in response to those, so that we
can show you what our current status is.

There are a lot of things on that. I suspect that we are going to be
coming back to you, as the Secretary alluded to, and setting some
priorities, and figuring out which ones do we want to push forward and
make sure we accomplish, and which ones, in retrospect, do we decide are
a lower priority and we'll get to if we do, or some that we actually
say, this is not the time to put the emphasis on that.

The key is for you to see what the status is, and we'll be working with
the Workgroups when their recommendations should end, and get them
involved in looking at the evaluations. We'll be bringing that to you,
and giving you a more detailed list at our next meeting in June.

A couple of things that we are also seeing some progress on. One, as you
know, we have been doing a lot of emphasis on the standards, and then
\-- including certification. Certification as you heard at the last
meeting, has been going extremely well, and has really been adopted by
the vendor community, and by the provider community, as a means of
verification of the quality of software. And that's taken off a lot
faster than I think many of us thought it might in the first year.

In addition to the national standards, I wanted to mention that we have
been working, as \-- HHS has been working with the international
community, and there are international standards activities that are
progressing, and we should expect an announcement later in the week
about a development that should promote the international adoption of
SNOMED CT. So we look forward to that announcement, and HHS and the U.S.
are part of that activity as well.

And then finally, with regard to one of the key areas that we need to
make progress on, that of privacy, we are working to put together a set
of privacy principles. We will be working with the Confidentiality
Privacy Security Workgroup to review those, to shape those, and to bring
those to you, as well as a roadmap of how we will plan to proceed in
this area.

So a number of things that are going on. These are in support of the
priorities that you're setting, and we will work with you to continue to
move forward and to advance the agenda, as you guide us and recommend.
Thank you.

DR. BRAILER: Thank you, Rob. I appreciate the update. With that, let's
turn to tab three, and I will ask John Loonsk and Virginia Riehl to come
forward. As you all know, we have had a significant amount of activity,
in the coordinator's office, around framing the architecture for the
Nationwide Health Information Network, and this is a synopsis report on
the experience that's occurred over the last year. It can't give justice
to the incredible depth of work that's been done. And there will be a
focus on where it goes from here.

And as Virginia and John come up, I just want to call out and thank
somebody that's not sitting at the table there, who is Wes Rishel from
Gartner, who I think is in the audience someplace. Wes is the person
that \-- often when you read something in the newspaper about health
information technology, he has that one sentence, incisive comment that
seems to summarize it also well. But Wes has been one of the great
thought leaders behind this as well.

So with that, let me turn it to John, and thank Virginia for coming
today.

DR. LOONSK: Thank you David. Good morning Mr. Secretary, members of the
AHIC. We're here to talk about the status of the Nationwide Health
Information Network. We're going to talk a little bit about the Gartner
report, and Virginia is going to give some findings of the Gartner
report on the 2006 prototype architecture work, and particularly on the
common services aspect of those. And then we're going to talk a little
bit about plans for the 2007 trial implementations of the NHIN.

So to begin with, we're talking about the Nationwide Health Information
Network \[NHIN\], and that's really about mobilizing data, making data
move. Not just between jurisdictions, but between providers, between
providers and consumers, and essentially, trying to make sure that the
different parts and pieces of the health information infrastructure can
work together and move information.

The assumptions we're making in moving forward with the NHIN, some of
which are listed on the screen. First, that this will be a network of
networks. It's not going to have a central data store, or even
centralized systems at the national level. It's going to be constructed
out of shared architecture, standard services and requirements, some of
which you're going to hear today. Gartner has been working on helping to
specify some of those requirements.

The concept here is a network of networks, a system of systems that work
together securely to provide information and share it as necessary. To
do this, to talk about this for the purposes of this discussion, we do
have to have some definitions, and the first one to allude to here is
just health information exchange \[HIE\].

And there are varying definitions of health information exchanges, but
for the purposes of this discussion, we're describing it as a
multi-stakeholder entity that enables a movement of data. This is
something within a state, regional or non-jurisdictional participant
groups.

We're adding to that definition, the definition of a NHIE, a Nationwide
Health Information Network Health Information Exchange, because we need
to define the group of health information exchanges that will work
together to come together to provide this network of networks. So an
NHIE is an HIE that implements the NHIN architecture, including the
services, standards, and requirements, processes and procedures; and
participates in a new activity that we'll be starting this year, which
is the NHIN cooperative, where these HIEs will come together to work
together, to form this network of networks.

Visually, it looks something like this. If you envision the different
HIEs, those that meet the standards, specifications, processes and
procedures, will form a ring of enabled HIEs that will be able to share
data, that will allow for the connection of information between EHRs,
PHRs, and importantly, between each other.

And we're going to be talking about those different interfaces. So
thinking about how an HIE connects to an EHR, as well as how an HIE
connects with another HIE.

Eventually, we anticipate that there could be other networks that are
participating in this cooperative. But in the first year, in this next
year of trial implementations, these NHIE's will form the core of
connected networks that will make the NHIN.

The specifics of the requirements, the processes and procedures, and the
standards that will form the needs for these HIEs are listed on the
screen. This represents a lot of the work that has been initiated by the
Community. Up there are now seven use cases. So the use cases that were
initiated last year, as well as the new four for this year, are fodder,
if you will, for the guidelines for next year's NHIN activities.

We have three sets of HITSP standards. We have functional requirements
that were developed in conjunction with the National Committee on Vital
and Health Statistics. We have public input from three public fora,
there were comments, and suggestions were made on advancing the
Nationwide Health Information Network. We have the privacy and security
work of both the National Committee on Vital and Health Statistics and
the Confidentiality and Privacy and Security Workgroup. We have the
technical expertise that was developed in the prototype architectures.
And we very much anticipate that that technical expertise, that was
visualized for you at a previous AHIC meeting, will contribute to this
next round of trial implementations as well.

And what we're going to be talking about today are some core services
and capabilities that are at a business level, at a business operational
level, but which will have detailed interfaces, and this is the work of
the Gartner report, to specify exactly the way in which each HIE has to
connect with each other HIE to make this network of networks work
together, and form the NHIN.

So with that, I'll turn over to Virginia Riehl, who will talk about some
of the Gartner summary findings, and also talk about some of the
operational needs, the services that we expect from NHIEs.

MS. RIEHL: Thank you, John. I want to, on behalf of Gartner, tell you
that we are pleased to be here today, and appreciate the opportunity to
present the findings of our analysis to this Group. And before I jump
into the slides, I wanted to talk one level up, about what I think are
more global perspectives that we developed as part of this analysis.

Many of these findings confirm or expand on the working framework
developed in response to the challenges set by the national health IT
agenda, and the AHIC. So as you go through these, you may say, that all
sounds very familiar to me, but the importance of that is that we found
that those familiar things actually could be validated in the process of
the prototypes.

The prototypes provided validation and refinement to those working
models. And I think for this reason, we can say that the prototypes have
made an important contribution to advancing the national health IT
agenda, and support the next steps towards implementing the NHIN.

Another point that I'll probably allude to, again, but there was a
significant amount of consistency across the prototypes, in terms of
what they did and what they wrote about. So we're seeing a good deal of
coherence that is behind these findings from each of the prototypes.

So I'm going to talk about architecture right now, and this was an area
of almost \-- I would say universal consistency here. The prototypes
confirmed that the NHIN can be a network of networks, does not require a
central hub, and does not need a central repository.

With respect to standards, the prototypes concluded that the NHIE should
be fully standardized in their interactions with other NHIEs. The
importance of that is that there needs to be a very high degree of rigor
in those interactions, and standards compliance. These standards would
be the target standards for EHRs, and PHRs, but probably as everyone
knows, this is \-- this was an evolutionary and a migratory process, for
all of those systems to reach the very high rigorous standard that we
are implying for the NHIEs.

And in that transitional process, the NHIEs can help bridge and support
PHRs, and EHRs, in complying with those standards by taking their less
standardized transactions and making them \-- bringing them to the
rigorous level, so they can access the NHIN.

In the area of secondary use, again, the prototypes confirmed that this
is very important to the NHIN. For the purpose of our analysis, we did
expand our focus to include public health quality monitoring
organizations and researchers, and at least from an analytic standpoint,
tested the findings against those. Those were not necessarily all
represented in the prototypes, but conceptually, we tried to examine
that as a possibility, because we knew you were headed there.

The NHI \-- all of the prototypes agreed that the NHIEs can greatly
facilitate appropriate secondary use of data, including forwarding the
data to appropriate secondary users, and enabling anonymization of data,
where a source system is not able to do that. Not every EHR and PHR is
going to be able to anonymize, so an NHIE can do the anonymization, and
enable the data from those systems to be used by secondary users.

Most prototypes demonstrated how secondary use could be supported, and
most saw this as an important aspect of sustainability, so this is not a
secondary service, it is a very core service, from their perspective.

The prototypes also identified common services that the NHIEs must
provide to participate in the NHIN, and that is what I'm going to talk
about on the next two slides.

The services fall into four areas: date of delivery, user and identity
management, management in general, and then there will be another slide
on the consumer services.

With respect to data delivery, the NHIEs are \-- have the \-- provide
the service of getting the data to EHRs and PHRs, and doing that in a
secure manner. They also provide the service of locating where data is,
again doing that in a secure manner, so that they can send data in
response to requests or for other needs.

The NHIEs also ensure that the individuals, who are interacting through
them, and through the NHIN, are appropriate \-- should be there, are
validated by identity proofing, authentication or attestation to their
identities.

The NHIEs also arbitrate identities between entities, and this is a
service that is critical, given that there is no national identifier.
And each of the prototypes demonstrated methods for linking patient
records together in the absence of a national patient identifier.

They suggested approaches to appropriately linking data to the correct
patient in the environment, and I would also say that they were all very
conservative in how this should be done. Each of the prototypes
indicated that this needs to be done in a way that we do not falsely
match patients, and suggested how that could be done.

With respect to management services, again, another area of security,
making sure that the partners, system partners in the NHIE are trusted
partners, and that the communications among them occur in a secure
fashion. And then, finally, in this area of management services, there
are needs for emergency access to data, and the prototypes, again,
discuss the circumstances where this would be needed, at both the
individual and community levels.

Consumer services, both the AHIC and ONC, emphasize looking at consumer
services, and what can be done to advance the role of consumers. The
prototypes had ideas about how to do this, and implemented approaches to
providing these services. Based on their efforts, they identified the
following consumer services that the NHIE should be able to support.

Identifying a personal record home for the consumer, supporting the
consumer and getting data into their PHR, searching for places where
data about the consumer exists, controlling who has access to the
consumer's records, their personal health records; and then being able
to determine who has access to their personal health record, or had
actions going through the NHIE, either for lookups, or other actions
that may have involved disclosures of their information that the NHIE
was engaged in. They can also send change requests to data providers, if
they think there is an error in their data, and they can choose not to
participate in the network.

DR. LOONSK: Thank you, Virginia. So as you can well imagine, there are
several levels to these services, and what Gartner has done is produce a
report that details, at a very high technical level, the specifics of
implementation to support these activities.

You'll note the consumer services, I think, are key in moving forward
with some of the areas that the AHIC has prioritized. This idea of a
consumer being able to identify where their personal health record is,
and being supported in getting data to that personal health record. And
the other enabling technologies that are here, don't dictate policy, but
describe an infrastructure for how the next steps in consumer
empowerment can be advanced.

What we're going to do with these capabilities is bring them to bear on
the next procurement, and we have a request for contracts that is with
our contracts office now, in its final stages of being refined, before
it is put out onto the street.

It takes the 2006 architecture products that I alluded to. So the
requirements, the standards, et cetera, and uses them as guidance;
targeting state and regional health information exchanges, as the next
leads for the consortia that will move forward with this next step
activity.

So in 2006, we had prototype architectures that were led by systems
integrators, each of which was expected to have several markets
participating in their consortia. In 2007, we anticipate having state,
regional, and potentially non-geographic health information exchanges be
the leads of new consortia, that will bring to bear technical expertise,
business and operational expertise, as well as open governance, and
trust and buy in from that appropriate health information exchange
jurisdictional community, to more forward with those efforts.

We're going to focus on the services and interfaces, so we're not going
to spend a lot of time dictating how these health information exchanges
are architected on the inside. We're going to focus on how they connect
to others, which is necessary in terms of pulling this all together.

We're going to establish a cooperative of awardees, and this cooperative
will be charged with and responsible for moving forward with the next
step of developing interoperability. A key deliverable of this next
round of trial implementations will be when we bring all the NHIE HIEs
together, at the end of the year, in one place, and have them
demonstrate that they can connect up with each other, as well as with
the central services necessary to support this exchange.

We will be putting out roughly 22 million, in seven to ten contracts. We
anticipate having each of the awardees perform the core services that
Virginia alluded to, so they will each be working on those core
services, as well as doing two breakthroughs. So we're going to expect
and work to try to get coverage of all the AHIC breakthroughs that have
been put forward to this point, a total of seven use cases, and seek to
have at least two awardees working on each of the breakthrough areas.
And we expect that this request for contracts will be available in the
coming month.

So we think this represents substantial progress in taking the work that
was done last year, and moving forward with trial implementations for
2007. And we appreciate the work that Gartner has done in developing
this high level of specification to \-- as a lead in for that work, and
for the NHIN cooperative in the coming year.

DR. BRAILER: Thank you, John. We now have time for discussion. Any
questions of either John or Virginia? The floor is open to members of
the Community.

John, let me go ahead and start, just to ask you, let's think about this
next wave that's going to be started with the RFCs in May. When they
conclude, could you give a sense to the Community about where the NHIN
effort should be at that point, what \-- how far along will this next
phase take us? And discuss, perhaps, kind of what might look, in a
conceptual way, flowing from there?

DR. LOONSK: At the end of that first year, we should have a cadre of
health information exchanges that can work together and exchange data.
They should be able to reconcile identities across each other so not
that we will have a common national identifier, but when data does need
to flow, it can be accurately associated with the appropriate patient.
And we should have initial implementations of all of the breakthrough
areas that the AHIC has advanced. That will include connecting up with
other networks and services, as well as the HIEs.

DR. BRAILER: Julie?

DR. GERBERDING: I know this has been discussed, but I just wanted, one
more time, to kind of revisit the issue of the national identifier,
since, you know, other federal agencies have national identifiers for a
large market share, what we're talking about.

Is this a transition phase between we're not doing that now, because
we're trying to bring a lot of systems together, or do we ultimately
want to end up where we have a national identifier?

DR. LOONSK: We \-- we are \-- in the work in the prototype
architectures, we were asking the contractors to look at how you could
do this, without a national identifier. We are precluded from advancing
a national identifier. And the next round, the trial implementations,
does not advance a national identifier.

That being said, each of the prototype architectures looked at the
issues associated with matching patients to their data, and have come up
with approaches for doing that within a jurisdictional area, in a
regional health exchange, for example. So a regional health exchange may
use an identifier for the purposes of indexing patients in that
exchange. What we're advancing is a network of those different health
exchanges, without a common identifier across them, but where those
different health exchanges can do the appropriate adjudication of
identities, so that when necessary, and data move from one HIE to
another, they can do the match up.

The truth will be \-- the end result will be in the product. I was at
the airport the other day, and I put my credit card in, and it suggested
that I was Hannah Loonsky who was flying to San Francisco. Well, I
wasn't, at least not that day. \[laughter\] And that level of mistake is
not going to be tolerable in this setting.

Virginia identified the fact that each of the prototype architectures
was conservative in their approach as well, so what they opted for were
few false positives, and the \-- the issue is, to some extent, is that
the right balance, and if we have a lot of false negatives, in other
words, if we fail to get data, associated with a patient, how does that
manifest itself, and what are the outcomes? I think that's part of what
the trial implementations will hopefully help us work through.

DR. GERBERDING: Just from a consumer perspective, it's daunting to feel
like you might have different numbers in different exchanges or
different systems, if you move from place to place.

DR. LOONSK: It is an issue. I think that the idea of having a consumer
\-- a personal health record home where you could say, this is my
network address, or this is where my data are, and expecting that to be
managed by the HIEs, which is what we're talking about here, so that you
would say, this is my personal health record home, I am saying this is
where my data are, this is my identity, and having that appropriately
identity proofed and authenticated, et cetera, can help. Whether it
solves all the issues is another question.

DR. BRAILER: Doug Henley.

DR. HENLEY: Great presentation. Thanks, John and Virginia. Question
relative to EHRs. Do you foresee the day, understanding where we are now
with a great diversity of the capabilities of electronic health records,
even with the certification process, do you foresee the day where, if
I'm a doc in practice using an EHR, and I want to transmit data from my
office to somewhere else in the healthcare system, that I will not have
to use an NHIE, or will I always have to go through an NHIE, kind of
like an Internet service provider?

DR. LOONSK: We've been trying to articulate the NHIE as a role, not
necessarily establishing it as an organization. And I think that when
you look at the industry, and you see some of the very interesting new
products where there \-- it's a networked EHR, where they can easily
access data that's on the network, and provide it in a way that's
somewhat \-- increasingly coherent for a provider.

I think the networked activity is going to continue, is going to
persist. We probably will need to have the role of an NHIE to advance
this, although it could be applied to a number of different
organizations, and eventually it could be the fact \-- what we're
leaving open here, is that an NHIE could do other services. It could
provide EHRs. It could provide PHRs. It's not necessarily precluding
those other networked activities or those other activities. But as we've
structured this now, we do anticipate that there will be some
requirements, some standards, some processes and procedures to bring
these networks together to make this coherent and workable.

DR. BRAILER: John, let me just ask a variant of Doug's question. There
has been a great deal of interest in the so called broker free NHIN,
where there is a peer to peer play, not unlike Natella or Napster would
have been in days gone by, or maybe still today. Based on the work of
the NHIN contractors, did they \-- and Virginia, you can please comment
on this as well. Is that a feasible solution? Is that in the realm of
sets that are still being examined?

DR. LOONSK: I think it's not technically inconceivable, but one of the
key things that's lacking is a \-- what we would call a trust model,
wherein if it's totally peer to peer, you know that that's \-- that's an
EHR and not a dog that's on the other end of that, to \-- so how do you
know who you're sharing data with?

And one of the key services here that is suggested for NHIE, is that
they would, as Virginia suggested, attest for or play a role in
attestation for the identity and the capabilities of that other group.

The Internet doesn't have that at the level it operates, so you don't
know necessarily who's on that other end. It's critical for this
activity, that we do have that. And while it's not inconceivable that
you could have more peer to peer nature to this, that trust process, and
having someone who can help ensure that the other EHR, or PHR, is who
they say they are, is a critical part that really, at least for the time
being, suggests that there needs to be some semi centralized trust
model. In this case, at an HIE level is what we're talking about. We're
not talking about a national trust model, we're talking about a trust
model where the HIEs play an important role in assuring that those who
are participating are who they say they are.

DR. BRAILER: Is there not also, again, in a peer to peer model, a
computational and tractability problem where essentially every node
would have to interrogate every other node for data availability about
the request? Becomes incredibly high in overhead.

DR. LOONSK: That's absolutely true. And we see that at another level,
wherein if you're doing a \-- if you're looking to get \-- if it's a
consumer, looking for where their patient information is, or a provider
looking up where data is on a particular patient, if it has to query too
many different registries, it can become a very complicated issue. So
part of it is to balance this goal to not have a \-- an onramp that is
obstructive to \-- and not have a gateway, but to try to, indeed,
enhance those connections to this network of networks. And try to
encourage connection to the network of networks, while still trying to
make sure that you have it in a reasonable trust model, and can make
sure that the data are secure.

DR. BRAILER: Thank you. Chip?

MR. KAHN: I guess I have two questions, one that \-- and I hope this
isn't a naïve question, that comes from what David just asked. If you
don't go to every place, how do you know that you've got all the
information? Wasn't that \-- I mean when you talk about going \-- when
\--

DR. BRAILER: That's what happens.

MR. KAHN: The request goes out.

DR. BRAILER: Yeah. And when there is no \-- nothing in sight. I think
the question maybe is how much \-- how heavy is the index in the middle?
How much does it know about how much is on the perimeter?

MR. KAHN: Right.

DR. LOONSK: How many places do you have to go to to try to get a sense
that you've looked across the board? So it's the number of queries, so
are the NHIEs \-- are those a thousand? Are they a hundred? Are they 50,
or are they ten? That's the issue.

When working through the scenarios relative to the prototype
architectures, there was also a scaling activity, that most of the time
when you're looking for data on a patient, you have a sense for where
they \-- those data would be. Although at a starting point, people think
about a world global query, and there definitely needs to be capability
for that.

A lot of the queries for information \-- I know they came from Florida.
I can do a query to the Florida HIE to retrieve that information. So
there is an opportunity to have a scaling, where you say I'm looking
locally, in my HIE. Then maybe I'm looking in a particular jurisdiction
that's been identified, like I'm querying for the Florida HIE, because I
know that that \-- that's where they came from.

And then there is a need for a global query. But that global query is
not exercised every time you do a look up. And from a practical scenario
standpoint, that's how it seems to play out.

MR. KAHN: The second \-- and I hope this isn't a naïve question, too. On
the 22 million, begins to, I guess, to support some of this activity,
and I guess the question I have is sort of over time, what's the
business model for these different entities that is going to keep them
going, once you sort of know what kind of linkage we want to have?

DR. LOONSK: It is something that we're working on, struggling with in a
number of different settings, because sustainability of these HIEs is
critical to this activity, as well as many of the other parts of the
national agenda.

Each of the prototype architectures and prototype consortia, were asked
to look at sustainability, and each of them thought that they could
project out, having a sustainable system approach in a roughly five to
seven year timeframe. Many of them were heavily dependent on secondary
use data as a potential source for how that would be sustainable.

And I think that Virginia alluded to that in her comments, that they \--
there is a great capability for HIEs to support secondary use of data.
Many of the consortia thought that that was a critical factor in
sustainability.

MR. KAHN: So who would be paying them, then? I mean when you say
secondary, so just who would be paying?

DR. LOONSK: There are a number of different possibilities. I think that
it's not \-- some look at it as an opportunity to \-- for research data
to be advanced from the standpoint of whether it be on drugs, or on
other activities inside those domains. Some of it is potentially other
uses of \-- secondary uses of data, but the details of those are still
sketchy.

MR. KAHN: Because that sort of touches on Julie's question in a
different way, it seems to me, which is are the incentives \-- I mean
it's not just having a business model, it's the question of whether the
incentives in the business model are right, from the standpoint of the
consumer that wants their information protected.

And even if all of this stuff is blinded, the question still comes back
to what's the motivation of the people who are running these entities,
in terms of survival. I mean you can't blame them. But on the other hand
\-- I mean it just seems to me whether it's \-- if they're a public
good, it seems to me we sort of need to go through a process of if
they're a public good, should we shield them in some way from having to
earn their keep, day in and day out, where the earning the keep may
become the priority, not the running of the kind of system we want. I
just throw that out.

DR. BRAILER: If I could just comment on that. I know that a number of
\-- you're going to comment, too, Rob? A number of states have, as
governors or state governments, have gotten involved in health
information exchange, have made it known that they do view the business
model not being a value realized model, in terms of secondary use of
data, or, hopefully, primary use of data, which is that the actual
sharing of data that has value to providers and plans and others, such
that the model can support itself on its merits. But that they do view
this as a public utility that shouldn't be subjected to a business case.

And so, you know, my sense is, this is going to be very heterogeneous
for a while. I think the question before us, not today, but at some
point will be, what boundaries do we want to put on that? What kinds of
principles or operating rules about how it could happen? And I could
easily see health information exchange paying part of their bills
through the public health support, paying part of their bills through
perhaps some general non value added public support, through secondary
uses of data, and hopefully, through end stage user subscriptions,
doctors, hospitals, plans, because they see that this is cheaper than
sharing data another way, which is through paper.

And, you know, this is really yet to be told. But this is really part of
the question that we have to build a lot of this, to be able to then
understand how the economics can work.

MR. KAHN: I'd also like to throw out an idea which is more \-- maybe a
non starter. But I would like us to think about, through this, that this
is similar to water, or telephone, or anything else, so that the
consumer ought to pay for it.

And I think that if we get to a point where everyone understands the
importance to their healthcare, of having this record work the way we
want it to, with the interoperability, it's really the ultimate
consumer. And obviously, there are some who can't afford it, and we
should deal with that.

But it seems to me that one thing that's lacking in the discussion is
figuring out how to make the person, who actually is going to ultimately
benefit the most from having the record, be involved in making sure this
runs. I mean all of us have water. All of us buy power. And it seems to
me that this is something on that level, that we ought to think about.
Just throwing that out as an idea.

DR. BRAILER: I think it's clear that the consumer ultimately pays for
it, regardless. I think it's a question of whose hands it goes through
to get to the consumer.

MR. KAHN: Right. The question of hands, though, affects the incentives
of those who are operating the system. And so I think in terms of
records, and ownership of the records and paying for the records, if
we're too convoluted in the type of system we have, in terms of how the
people running these systems and the records make their money, and they
have to jump through all the hoops that everybody else in the healthcare
system has to jump through, to make something happen, I think we need to
\-- we may end up setting up a system that is either perverse, or has
incentives that the consumer, at some stage, may question.

And I just want to put on the table, for future thought, that maybe we
ought to break through that and just as many, when they talk about
coverage, talk about individual responsibility and individual mandate,
we ought to think about the same thing here, albeit that there are some
Americans that would need help with it.

But I think it's one area I haven't heard much discussion about, and at
the end of the day, it's not the provider who benefits from the record.
I mean in doing their work, it does, but it's the individual patient.
And I think we sort of kid ourselves if we're going to jump through all
the hoops to make this work, and then pay drug companies and other \--
insurance companies, and other kinds of end users.

I understand at the end of the day it's the consumer, whether it's the
premium dollar, or the prescription dollar that pays, but all this
indirect cross subsidy, I think, is a problem. In other areas of the
healthcare system, as we're thing thinking this, why do we want to
invent it here, too? I'm just throwing that out as an idea.

DR. BRAILER: Good. Thanks. Rob?

DR. KOLODNER: Chip, I think you raised an important issue. It really
isn't so much the NHIN issue, but it's really the health information
exchanges, and we have activities going on where we're examining,
looking at best practices, communicating with the states, and the
regions and the health information exchanges. And I think we can bring
that back, you know, in the future, because certainly there are
different health exchanges that are looking at different ways to support
themselves. And I think we're really in a learning mode to see which of
these, in fact, is \-- can be self-sustaining.

A number of, as David indicated, either are looking at kind of splitting
the support, and some are actually looking at self-staining, based
simply on the dollars that are in the current healthcare system. I mean,
remember that right now, as a country, we're still paying twice as much
of our GDP as any other country, and yet not getting the value out.

So if just a small amount of that can cover the infrastructure, and we
can find a way of doing that from what we expect will be efficiencies
and savings, then, you know, the question is can we get to that point?

But the good thing is that we do have quite a number of experiments
going on, explorations going on at the local and regional levels, and
what we need to do is to learn from them. I think one of the things I'm
hearing you say is let's bring some of that learning back.

DR. LOONSK: It is a very good issue for the AHIC to be considering. This
is not easy to do. It's \-- you can see from the services, and as you
see the Gartner report and the technical details, this is a challenge,
to do this well. Health information exchange is a challenge. To do it
securely is even more of a challenge. So it's a high bar in terms of the
kind of participation, and it needs to be considered, how to net support
it.

DR. BRAILER: Steve?

MR. LAMPKIN: This may be an oversimplification, but in the spirit of a
public utility model, you know what comes to my mind is, Chip, you're
talking is the telephone system that we have now.

There \-- most Americans \-- let me say it this way. Most Americans have
a phone, cell phone or some type of PDA. And there is a price that goes
with that, whether you use one company or another, and how much of a
device you buy.

So my question is, if you took the public utility model, and suggested
that folks who buy a phone, or buy a trio, or some device like that,
that they're going to carry with them to get information, that perhaps
that be built into that model, if you will. I don't know what all we pay
for when we buy a cell phone, and we use it for personal reasons or
business. But I know that it's all calculated in, and I wonder if we
could take that approach and say that as part of the information
exchange for all Americans, that ought to be part of it.

DR. BRAILER: There are many models of public and private finance, I
think that's fair to say, and, you know, I think there is clearly a
difference we should tease out here between a consumer pay model and a
public model, you know.

Even the utility model is different than national parks, where you
obligatorily pay it through tax payments. And you may not even choose to
use it, but you do pay for it. And there is a very large spectrum here,
and, you know, we have an enormous amount of investigation going on
about not really the theory of economics here, but I think the
practicality.

Because to me the question starts ultimately from where does value get
realized in these exchanges, which I think tells us what tools we have
economically to work with for sustaining their finance.

But I was surprised, and actually pleased along the way, again, that
several governors and others have seen this as a public model. And so
this is going to feed directly into that. And this AHIC will talk about
more about over the next year, because we certainly have this on the
list of decisions to make, before we turn out the lights at the end of
this administration.

MR. LAMPKIN: The other thing I would add, David, John and Virginia, to
your presentation, thank you, is that one of the things that we've
learned in our company at Wal-Mart is to not let perfect get between
doing good. And so to the question about can we access everything, maybe
not initially, but I'll bet we'll have access to a whole lot more than
we do today, providers.

So if we could move in that direction, perfection can come later, if at
all. But I think we shouldn't let that get in the way of us doing some
really good things to advance the cause, so to speak.

DR. LOONSK: That's a very helpful comment, and I think one of the things
we didn't touch upon is the importance of a summary record in moving
some of this forward, because it is not necessarily a question of
getting all the data all the time. And a summary record, and now that
there is a harmonized standard for that, I think that can play a
critical role in getting some of the good.

DR. BRAILER: Providers have said many, many times that just knowing who
has data on a patient is not quite as important, but pretty useful,
compared to not knowing at all.

With that, I think we are finished. John, Virginia, thank you very much.
Thank you members of the AHIC for a great discussion.

Before we move on to the next agenda item, I would like to welcome a new
member of the American Health Information Community, it's Dr. Ward
Casscells. Dr. Casscells is a \-- many of you know, is the new Assistant
Secretary for Health Affairs at the Department of Defense. In his prior
life, he is a distinguished professor at medicine at UT Houston. He is
an expert and leader in disaster and pandemic preparedness, and one of
the most ardent advocates for patient-centered care that I know. Ward,
thank you so much for joining us and for coming into service in the
government.

DR. CASSCELLS: \[inaudible\] on behalf of Secretary Gates, I want to say
it's an honor for us at DOD to be included. We are not in a bomb
shelter. We're actually part of the world. Our beneficiaries, our
patients interact as reservists, as retirees. We interact with Dr.
Gerberding and others, and other heroes of mine, in humanitarian
efforts. So we're delighted to have a seat at the table.

Certainly, I want to continue what Dr. Winkenwerder has been doing in
pressing forward with electronic health records, and particularly
patient empowerment of personal records. So we're delighted to be here,
and look forward to learning from this distinguished group. Thanks very
much.

DR. BRAILER: Thank you very much. With that, we're going to now turn to
tab four, and have an update on the State Alliance for e-Health. This is
a very important project that's grown out of a collaboration between ONC
and the National Governors Association; and presenting this is Jodi
Daniel from ONC, John Thomasian, and Kathleen Nolan from NGA.

And you will see many of the themes that have happened in the past in
this area come together with this presentation. And with that, I will
turn it to Jodi. Thank you.

MS. DANIEL: Thank you, David. Good morning members of the Community. Can
we get the slides? Great. We got it.

I'm just going to talk for a few minutes, and give some context for why
we started this State Alliance for e-Health and engaged the National
Governors Association in this important work, how it fits in with some
of the other activities, including some of recommendations that are
coming out of this Community. And then I'm going to turn it over to John
Thomasian and Kathleen Nolan, from the National Governors Association
Center for Best Practices, who will talk to you in detail about the
State Alliance for e-Health and the important work that they're doing.

So the State Alliance for e-Health was really created with the vision of
having an advisory body by and for states, about state government \--
state governor and government level issues that were regarding health
IT. We had many issues identified, through the American Health
Information Community, through some of our other activities that we are
working on, and other projects we're working on, that really highlighted
the fact that this is not \-- this really needs to be a partnership
between federal government and state governments, as well as with the
private sector, because a lot of the laws, a lot of the policies, and a
lot of the drivers really are going to happen at a state level, and not
just at a federal or national level.

So we realized that there was this important need, and last fall, we
engaged the National Governors Association Center for Best Practices,
and contracted with them to form the State Alliance for e-Health.

The State Alliance had its first meeting in January. It's comprised of
governors, legislators, insurance commissioners, and attorneys general,
so we tried to engage all of the different \-- the different entities
within the state government to look at some of these issues. We also
have technical advisers that have expertise, and can advise these high
level executives at a state level to address some of these health IT
issues.

The charge for the State Alliance was two-fold: to identify, assess, and
through consensus solutions, map ways to resolve state health IT issues
that affect multiple states and pose challenges to interoperable
electronic health information exchange.

So we have representatives from various different states, both at the
State Alliance level, as well as the task force levels, and Kathleen
will talk to you more about the task forces, to try to engage as many
states as possible. And we'll have rotating membership to bring in as
many states as possible to this process.

The second charge, besides the consensus solutions on some of these
policy issues, was really to provide a forum in which states may
collaborate to increase the efficiency and effectiveness of health IT
initiatives that they may develop or be involved in.

So how \-- I wanted to just spend a little bit of time talking about
where we see the role of the State Alliance for e-Health and how it
links with some of the other activities that we have. As I mentioned,
this really is about state government consensus across jurisdictions. So
there's a lot of activity going on within particular states. What we
really saw was a need for collaboration across states, and consensus
building across states, on some of these really important policy issues.
And you see the bridge across the nation working with states, but
working with them nationwide.

The goal is to look at state government policies and roles that state
government may have, or state programs may have, in health information
exchange and health IT. The goal here was to take some of the ideas and
issues that were raised through some of our state initiatives, and some
of our federal initiatives, and bring them to the State Alliance for
discussion and consensus.

So for example, we have the health information security and privacy
collaboration, and they presented at the last meeting to talk about the
important work that's being done at the state level on privacy and
security issues.

Many of the issues that have come up at the national meeting, at the
regional meetings, and just within the states, is that this really isn't
a state by state issue, but there is a lot of need for cross-state
collaboration, regional collaboration, and the like, on privacy and
security issues. And so that's one of the areas where the State Alliance
is taking a look, and focusing its efforts, to look at some of those
privacy and security issues that really do cut across states, and are
necessary for interstate sharing of health information.

Similarly, the American Health Information Community has made
recommendations about engaging states in some specific state level
issues, like licensure, like the clinical laboratory improvement
amendments, and Kathleen will talk more about the work that the State
Alliance is doing in these areas.

But those recommendations really helped to us to realize that there was
a need to work with states in a collaborative way to try to address some
of those issues. So some of the work both at the state and the federal
level really have driven the \-- this project and some of the issues,
the important issues that the State Alliance is focusing on.

And before I turn it over to John Thomasian, I just wanted to talk a
little bit about some of the various state level activities that we
have. We've heard that there is some confusion or need for clarification
on how some of these different state level initiatives are working
together, and what roles they're playing. And I just wanted to take this
opportunity to put the State Alliance for e-Health in context with some
of those other state level activities that we are engaged \-- that we're
engaged in.

So first, the State Alliance. The focus is really on the state
government role. so state government role as policy maker, as the
manager of different state programs like the Medicaid program, public
health programs, and the like. As well as, you know, just as we are
taking on a role as a leader in health IT nationwide, many of the states
are trying to take on a role as leading health information exchange and
health information technology adoption within their states. So it's
really focusing on the state government role.

The composition of the State Alliance is, as I mentioned, governors,
legislators, and other high level executives, as well as some technical
experts that are looking at these issues, and the products that they
hope to come up with and they anticipate coming up with are sort of
action-oriented recommendations to the state government to spur health
information exchange and adoption within and across states, as well as
policy recommendations that may help to enable health information
technology and health information exchange.

We also have a project, state level health information exchange
initiative that's being managed by AHIMA, and they're looking at state
level health information exchange practices in, I believe it's with
representatives from 12 states. These are \-- the folks that are
involved in this project are state health information exchange leaders,
both public and private sector, that are looking at best practices for
\-- in very important areas for health information exchange, for
governance, funding, and data exchange practices. Some of this may
overlap. They may be looking at some practices related to privacy and
security, for example.

They're \-- some of the funding mechanisms may need to be coordinated
with the State Alliance, as far as what is the state government role or
state program role in funding for HIEs and things like that. So there is
a need for collaboration among those \-- these two groups, although they
do have very different roles. So we're working on figuring out how best
to capitalize on the expertise from both of these groups, and to bridge
them, where appropriate.

And then the third project that we are working on at the state level is
the health information security privacy collaboration. As I mentioned,
our contractor, RTI, had presented on this at the last AHIC meeting. The
focus here is on state territory and organizational privacy and security
practices and laws. So this one is really focused on a particular topic
area, albeit one of the most important policy issues that we're facing,
with respect to health information technology and health information
exchange.

Again, the stakeholders here are 34 states and territories, and they
have both public and private sector representation. Some of the leaders
at the state level are governmental, some of them are private sector.
All of them have been \-- have been endorsed by the state governors as
representing that state in this project.

The product, from the Health Information and Security and Privacy
Collaboration \[HISPC\], which we should have in June of this year, is
an assessment of organizational practices and state laws, solutions and
specific implementation plans to enable health information exchange
while preserving privacy and security of the health information.

Each of the 34 states are working on their own implementation plans,
identifying opportunities for cross state collaboration, and again,
there is a need to collaborate with the State Alliance, the specific
task force that's looking at privacy and security, to help out and come
up with some consensus in areas related to cross jurisdictional privacy
and security issues.

With that, I'm going to turn it over to John Thomasian to \-- and
Kathleen Nolan to talk specifically about the State Alliance for
e-Health.

MR. THOMASIAN: Thank you. Good morning. The State Alliance, I view the
State Alliance as a first and major opportunity to begin to connect the
head to the body of all this. The body being the large, the panoply of
private, public activities in health information exchange that are
ongoing out there, that in some ways have been built up from the
grassroots, have been influenced, of course, by a lot of support from
the federal government, and are moving forward.

The head being, however, those individuals at the state level for which
all of this needs to make sense. The health information exchange has to
make sense to providers, has to make sense to patients, but it also has
to make sense to those individuals that are in charge of the regulation
oversight of healthcare in the states, and also those that are in charge
of enforcing patient protections.

So the Alliance is an effort to bring those individuals together to
begin to develop the capacity, and to begin to focus on some of the
issues that are bubbling up from the large amount of actives that are
ongoing. States play a key role, again, in the regulation oversight and
shaping of healthcare, and they do protect patient privacies. They're
also major market participants. They're major market participants
through the public programs in Medicaid, and they're major market
participants through just their own employee benefit plans. So they have
a major stake in ensuring that health information exchange works, and it
works for everyone, it's portable, and it also works for those that
leave their state or come into their state under different
circumstances.

Now, one of the reasons we're involved in the Alliance is that we have a
longstanding role in working with governors, in working with our sister
organizations such as National Conference of State Legislators, National
Association of Attorney Generals, to help organize interstate issues
from time to time, and spur cooperation. We've done this in our
so-called interstate tax project. We've done this in pandemic
preparedness planning. Right now, we have been doing this for some time
in the sharing of best practices, which is the unit that I oversee.

Now, there are major state activities ongoing in health information
exchange. I'd say so much that the state activity is moving so rapidly,
that it's hard to keep tabs on it. Right now, at least half the states
are developing or implementing plans that deal with the deployment of
health information technology, but policies, bills, and proposals are
moving monthly, if not weekly.

We're in the thick, of course, of a legislative session out there and
we'll be seeing, we believe, a whole new host of bills that have come
out or proposed from the states, many of which will be enacted.

So a large motivation for this interest in the states is the desire to
improve the quality, safety, and productivity of the healthcare system.
I say that because when we formed the Alliance, it was interesting to
note that immediately, they viewed health information exchange not just
as an end to itself, but they immediately viewed the connection, the
connection to patient safety, the connection to improving quality, and
the connection to also improving the productivity and efficiency of the
healthcare system. I would say to you that they view the health
information exchange as the backbone, if not the connective tissue, of
healthcare reform.

There is a great deal of health reform, as you know, out there in the
states today. They are, in a sense, fulfilling their role as
laboratories of democracy, and they're experimenting not just in health
information exchange, but in greater forms of coverage, exploring
changes to benefit plans, exploring ways to \-- for states to serve as
brokers, to bring people into the healthcare system.

Now, the goals of the Alliance. They're fairly simple. Thank you. We're
to provide state decision makers with realistic and practical options to
enable adoption of health IT and allow its utilization within and across
states. And I would say that the group we're working with, of course, is
very practical oriented. Several elected officials, governors. Governors
are very pragmatic. They see things in terms of a four-year, eight-year
timeframe. So they are very impatient. Attorney generals are very
impatient. Insurance commissioners are elected, many of them as well,
are very impatient. So we are, in essence, being driven to be much more
pragmatic and provide them practical solution. It has to make sense to
them.

We're appropriate. We're probably going to be identifying model laws and
consensus solutions for states to adopt or consider adopting.

Our membership, Jodi touched on this. We have two governors, former
governors, attorney generals, state insurance commissioners,
legislators, and, you know, we have an advisor group as well. We're very
blessed with this initial membership.

We have assembled a distinguished and engaged group of leaders.
Governors Bredesen and Douglas are very active in our health reform
efforts at NGA. Attorneys General Carter and Myers were appointed
because of their expertise in healthcare legal issues, and insurance
commissioners Klein and Prager have strong national reputation in their
association, overseeing \-- on healthcare issues and overseeing the
healthcare market.

The state legislators are viewed as some of the strongest national
leaders and leaders in their state on healthcare information technology.
They're extremely knowledgeable. I would point out that \-- and they
bring a great perspective to this. They have to see how this works for
them in their constituency.

I would say that, for example, Assemblyman Conaway, from New Jersey, is
both a practicing physician and legislator, as well as a lawyer. So he
brings a very unique perspective. I told him, I said, Assemblyman, you
scare me. He said, sometimes I scare myself. \[laughter\]

To support the Alliance, we've also assembled some nationally noted
subject matter experts as listed. They have been helping \-- they serve
on the Alliance as resources, but they are nonvoting members. We have
created the Alliance, so that issues regarding model laws, statements,
proposals to the states, will be voted on by the elected membership.

Now our timeline, in access, our timeline is short. Three years, which
is in some ways the long term for some of these members. And we are
going to have some turnover, purposely. We're holding our meetings in a
transparent fashion. We are \-- our inaugural meeting was January
26^th^. I would say that meeting was about getting their arms around the
issue and beginning to carve out the work products.

We held our second meeting in March, and our third meetings are
scheduled for July and August. Ownership is very clear, has been very
clearly created on the alliance. By our second meeting, there was a very
strong effort to carve out specific work products, and call for rapid
delivery of them. And I'm going to let Kathleen talk about some of the
efforts that have been passed down to the task force on the work product
charge.

MS. NOLAN: Thank you. There are three task forces that exist under the
State Alliance configuration, two of which have been formed in February,
and have had several meetings. The third is being formed right now and
will have its inaugural meeting in May.

The task forces are the Health Information Protection Task Force,
Healthcare Practice, and Health Information Communication and Data
Exchange. Before I talk about specifically the roles and activities of
these task forces, I wanted to give you a sense of how they're formed.

Although the State Alliance is primarily state government, the task
forces, themselves, are a blend of public and private individuals. We've
attempted to really bring together, and to make almost even, the balance
between those that represent public programs, public aspects of the
issues, as well as the private sector. So the mix is between sort of
public health, Medicaid, health plans, providers, and then a number of
other stakeholders. We're also working very hard to ensure consumer
representation. And that came up, actually, at our second meeting of the
Alliance. We've really worked on the issue to have consumers, and we are
working hard to do that. Consumers are seated at the table for each of
these task forces.

But we are also really looking for other opportunities to engage with
the consumer public. There are a lot of challenges with having consumer
representation on groups that can have a level of expertise, and buy in
to contribute. But also really getting a sense of what your average
consumer really wants to get out of the process, and to get out of these
activities. And so we're going to be exploring additional issues, as
well as placing consumers on each one of these task forces.

The roles, as John said, is really to feed up into the Alliance process,
to carry out assigned tasks, but we've also given each of the task
forces some freedom and some flexibility to do some work on their own,
if that is a pathway they choose to follow. So that's the setup for the
task forces.

And I'm going to walk through each one of these task forces, but I'm
going to keep my detail very brief. These are not going to be surprising
issues for you. They're ones you've spoken of yourself as a group, and
I'm just going to sort of outline those, and would be open to a lot of
interaction and questions.

The first is the health information protection task force, as we
mentioned, that is privacy and security focused. Clearly, a major issue
for everybody in this arena, but since much of this exists at the state
level, we really are focused on those issues.

As Jodi said, we're really beginning to build upon what has happened in
HISPC. That project really did outline a number of interstate needs, and
intrastate needs. And so we're really going to be working to further
those, to gather them together to have some interaction between those
two projects, that we can move those agenda items forward. The other
main work product at this time for this task force is to begin to
outline some of the rationale for the original privacy and security laws
and regulations that have been developed at the state level. Lots of
those are arcane, older, not \-- no longer rational in a current
environment.

But several of them are, and we want to make sure that we don't simply
rewrite the books. So we're going to be looking at some certain aspects
of protected health information through a lens of those classes that
have been identified as special, whether that be HIV, mental health, or
other kinds of special protected classes of information, using that as a
lens to look at our rationale, and to analyze opportunities for making
changes in a way that will bring them more in align with the current
environment. So that is really the overall basis for this task force,
and they will be forwarding their recommendations.

The second task force is the Healthcare Practice Task Force. Clearly,
states don't regulate the delivery of healthcare services, but they do
have a number of places where they do interact with those aspects, and
those are clearly under licensure, particularly for the health
professionals. There are issues around malpractice and liability that
come forward in all of these discussions, as well as, as Jodi mentioned,
the laboratory information access and some of those issues.

So the \-- this task force really tried to take a look at how they could
concretely move progress in some of these issue areas. The first that
bubbled up clearly was state licensure laws. And this was less really
about state licensure laws, and their impact on the exchange of
information, as it was about that secondary step, where that information
is acted on.

So what we have begun to describe is e-health, what has traditionally
been described as Telehealth, the idea that just the exchange of
information probably doesn't have any licensure impacts that we can
identify. But as soon as you begin to act on it, and there is action
across state lines, we have that issue here, in the DC metro area. You
can have providers in four or five different states, patients as well.
How do those things interact when you're talking about the delivery of
e-health services?

And so the first work product for this task force will be to look at the
current environment for state licensure, and how that's impacting these
issues in the promotion of health information exchange, and therefore,
e-health.

There are also two additional items that they have identified as being
sort of second-generation approaches for them. These are having to do
with liability and malpractice issues, in terms of what is the
precedent, what are the opportunities for looking at malpractice and
liability in this environment?

It's really challenging. There are five or six cases that really set the
stage, and they don't set the stage very well. So we've sort of put this
as a second-generation issue that we'll get to, sort of after resolving
some of the licensure concerns.

And then a third issue came up in our most recent meeting of this task
force, having to do with the availability of malpractice insurance
coverage for these kinds of interactions, for health information
exchange and, therefore, e-health, and so really beginning to break
down, what are the issues that are there having to do with the
availability of coverage for providers participating in those kinds of
services.

So those are the three aspects for that task force to take up. As I
said, the licensure is first, and these two will be later this year or
next year.

As I mentioned, the third task force, the Health Information
Communication and Data Exchange Task Force has not yet met. We are
forming that at this time. We are really looking to be sure we were
coordinating well, as Jodi mentioned, with the other efforts that have
been underway, to take a look at this issue, and so have come up with
this as a charge to really look at publicly funded programs, and their
interaction with health information exchange, specifically Medicaid and
SCHIP, public health programs, and also state employees. As John
mentioned, this is increasingly a major issue for states, is to look at
their own uncovered populations.

And so when this group meets in May, they've already got two charges for
work products in front of them, so they've got their work cut out for
them. Again, the primary will be to look at those publicly funded
programs, and then also to begin to look at the current landscape. As
John said, there is a lot of activity going on. We've got a separate
project to begin to survey states about what they are doing, and try to
really get our arms around that. That's happening outside of the State
Alliance, but certainly think it will feed into, particularly, this task
force on what states are doing in this arena.

So those are the task forces. And I wanted to move back up to the
Alliance level, for some of those issues. And it was wonderful to hear
Chip Kahn and others talking about exactly this issue. As everybody
else, we are also interested, at the state level, in what is going on in
the business model discussion, and in the sustainability issues.

Clearly, there are some components that go beyond sort of the
interaction of publicly funded programs, but what are the needs of state
government action in the arenas particularly? Are there options for a
public utility model? Are there public good activities that need to be
considered that way, funded that way? And sort of where does state
government come to fit into this business model and sustainability
discussion?

And so we really looked to build on, as we've talked about, all of those
other efforts that are going on to analyze the opportunities, and to
refocus that for the state government activities that might contribute
to those, as the dialogue goes forward. And that is something that the
Alliance is well aware of, a lot of the other activities, and wants to
build on those and focus in on these issues.

As I said, there will be recommendations. We expect recommendations from
the task forces to flow during the next two meetings. The first one,
licensure, as I mentioned from the Healthcare Practice Task Force, we
expect those recommendations to come from the task force to the Alliance
at their August meeting. We will also be moving forward with the other
two major products for those other two task forces, particularly the
privacy recommendations, and then as I mentioned, the publicly funded
programs. Those will be flowing to the Alliance in the October meeting
that we're working on scheduling right now. So as those bubble up, we
really look for those to begin to move back into the states.

And then finally, the last issue that came up at our second meeting of
the Alliance was really this issue of really building on, and not
duplicating, and not reinventing the wheel, but how do we get our hands
around, and really encourage, as states, the kind of integration and
collaboration that you all are looking for. And how can the states sort
of further that agenda? So that's really where the State Alliance is
right now. Jodi, did you...

MS. DANIEL: Before turning it over for questions, I just wanted to
highlight a couple of the issues that Kathleen had noted the State
Alliance has taken on, that the American \-- come directly from American
Health Information Community recommendations. Four of the Workgroups had
proposed recommendations related to state level activities over the
course of the last year, and all four of those are being considered and
incorporated into the work of the State Alliance.

Specifically, the EHR Workgroup had recommended that we engage the
National Governors Association, which was the initial impetus for this,
particularly in the area of CLIA, the Clinical Laboratory Improvements
Act, which has both the federal and the state legal component. And it is
something that the Healthcare Practice Task Force is going to hear
testimony on at their next meeting, so it is something that is directly
feeding their work.

The new \-- the Biosurveillance Workgroup, now renamed as the Population
Health and I'm not going to remember \-- Coordination Group \-- I'm sure
I didn't get that right, had made a recommendation to \-- for the State
Alliance for e-Health \-- to look at the role of public health agencies
in developing a business case for public health being incorporated into
health information exchange.

And again, this is an issue that the State Alliance has talked about at
their last meeting, talking about the business models related to public
health and health information exchange. So again, it is feeding the
agenda for the State Alliance.

The Consumer Empowerment Workgroup had brought a recommendation to the
Community, which was accepted, about looking at state privacy laws, and
personal health records. Again, the Health Information Protection Task
Force is looking at the rationale behind some state privacy laws, and it
may incorporate some laws that are related to personal health records,
and how they impact personal health records.

And finally, the Chronic Care Workgroup is the Workgroup that proposed
recommendations regarding developing, adopting licensing alternatives,
to enable electronic care delivery across state boundaries, and as
Kathleen had noted, this is one of the primary focuses at this point of
the healthcare practice task force, and looking at how to address the
licensure issues across state lines, and how it impacts e-health and
Telehealth.

So I just wanted to share that a lot of the recommendations that are
coming out of the Community that are really state level issues are being
taken seriously, and looked at carefully by the State Alliance. And I
think it's a really great opportunity for this Workgroup and the State
Alliance to coordinate on some of these issues, and we anticipate that
it may go the other way. The State Alliance may have some
recommendations as they come up, as they look at some of these issues,
for things that really do need to be considered at a federal level, and
may come back and provide some of that to you as well.

We anticipate that there will be some specific deliverables, later this
year, and that we would welcome an opportunity to come back in the
November, December timeframe to provide some more input on some of those
work products and recommendations. Thank you.

DR. BRAILER: Thank you, Jodi, and thanks, John and Kathleen. This is
very important project that's had several years of background work as
it's come to fruition, and this is clearly a very important tool in the
nation's effort to achieve the goals that we have.

We do have time for discussion, and I just want to start with a
question. I think it's mostly aimed at Jodi, although I think \-- I
appreciate John and Kathleen's comments on this as well.

This is really drilling down on the importance that you identified,
Jodi, of the recommendations that are coming out of the HISPC about
privacy, and information portability, and the significant amount of work
that would flow from that in terms of changing state or potentially
federal laws, to bring them into this digital era. How would you
envision that body of material, those findings, moving forward? Do they
go over to the State e-Health Alliance? And then does it become more of
an action discussion? And then does it go out to the states from there?
What is the thinking about process, and how we make sure that we keep
this moving at the fastest pace possible, given the very broad nature of
the debates that they're going to ensue?

MS. DANIEL: The HISPC projects, the states have identified both
implementation plans and solutions within their state, where they've
identified there is some law in their state, for instance, that may be a
barrier to health IT, and those are incorporated in there. Those are
really interstate \-- I'm sorry, intrastate issues.

But they've also identified some interstate issues, and needs for
regional coordination or national coordination. And so where there are
those types of solutions that are being recommended, they would have an
opportunity to communicate directly with the Health Information
Protection task force that's looking at some of these issues, helping
them identify where there is a need for cross state discussion and
solutions on some of these policies; and for the Health Information
Protection Task Force to recommend solutions up to the State Alliance.

We have also talked with some folks at the National Conference on
Commissioners for Uniform State Laws. They are very interested in
potentially being engaged to look at the opportunity for either model
laws or uniform laws that could be developed based on recommendations
from the State Alliance. So that's one option. As John had mentioned,
that's something the State Alliance would be interested in looking at,
so I think there is a couple of different approaches.

We also hope, in the future, that the HISPC project, as it goes into
next iterations, will not only focus on the state by state issues, which
was really the focus of the first year, but start looking at some more
collaborative issues as well. And we'll have to figure out the best way
to coordinate that, but it may be that they take on some of the
recommendations that are coming out of the State Alliance. So I see this
as a sort of an iterative process.

The other thing, and I'll turn it to John and Kathleen to talk more
about, but they have engaged the National Council on State Legislators,
and National Association of Attorneys General, to help promote some of
the consensus recommendations across the states. And I'll let John and
Kathleen talk a little bit more about how they see these recommendations
being shared with \-- across all of the states and territories.

MR. THOMASIAN: I think the Alliance would like to take the privacy and
security issues on and try to make it actionable. I mean it's \-- some
of the information that's bubbling up, for example, is making it clear
that there is \-- there are differences among states, and states want to
preserve those differences in terms of privacy protections.

But among the differences, there may be iconic approaches that are out
there. And if we can get some more \-- if the states can move towards
more conforming to some of the iconic approaches, we might have
situations where there is seven to ten switches, on a particular issue,
and a state or information exchange from one state to another would say,
aha, you fall in switch six, so that's being blocked. So I think the
Alliance sees a value in them sorting this out, and then offering up
some consensus solutions.

DR. BRAILER: Is there an equivalent, John, or Kathleen, that you draw
from another NGA experience, where this level of complexity, both in
terms of the policy issues, as well as the operational issues, and the
degree of variation and complexity in the states, has worked through
that we could look to as a model in terms of how this could happen?

MR. THOMASIAN: There is. There is indeed one, that actually \-- one of
the governors actually saw the analogy right away. Governor Douglas \--
we call it the interstate streamline sales tax project. In short order,
in the '90s, there was a Supreme Court decision that said that retailers
in other states could not be compelled, by the state for which you were
buying something from, to collect sales tax, although their liability
did not go away.

So the states came together under NGA's auspices as well as others, the
interstate multistate tax commission, et cetera, to try to simplify
sales taxes across the state. And that was no easy matter. Orange juice
is defined one way in one state, and another way in another state. And
that's just \-- one example. And so this was a \-- an effort to try to
bring together, among the differences, to get some consistency of how we
define products, et cetera, knowing that if we did that, and made it
easier for the retailers to collect sales tax through an electronic
means, for example, through common categories, they might do so.

In doing so, we brought together, I think approximately 22 states have
joined in this. We're moving forward to try to create a compact that
would allow this to happen in all states, but more importantly, by
moving this and simplifying this process, a number of retailers have
voluntarily come to the table, and are now collecting sales tax from
remote sales for us.

So that is one example. Right now we're engaged in pandemic flu
preparedness where we're trying to get consistent approaches within
regions on how states, for example, may choose to close schools, et
cetera. So we have a number of analogies. I think there is a point where
we will come up with, I think, consensus solutions, maybe model laws,
and then we'll probably engage in a process to encourage other states to
adopt these.

DR. BRAILER: Thank you very much. The floor is open. Lillee?

MS. GELINAS: Thank you for your terrific presentation. I greatly
appreciate that rapid action on the EHR Workgroup Recommendation. Thank
you for that.

Two quick questions. First is, on one of your slides you talk about the
status of those that are represented, but it appears that not all 100
percent of the states are represented in this group. They are not?
That's just something that was really transparent to me. It's a little
bit of that tolerating insanity. We don't have everybody at the table,
how are we going to be effective?

MR. THOMASIAN: We do plan some rotation to do as much as possible.

MS. GELINAS: But the real practical issue here is what would give you a
sense of urgency to get better cooperation, more at the table, faster,
quicker? I don't know why it is in this country that it takes a tragedy
to either help us overcome barriers or address critical issues.

I was really struck by the Katrina after-action report. I'm struck by
the stories out of our hospitals that received patients out of that
whole Gulf States region after Katrina, and the loss of life because
there was no medical record at all, didn't even know allergies, didn't
know anything. So \-- and just struck with the Virginia Tech issue last
week where these kids hit ERs, and the docs know nothing about them.

So I think you've got a great plan in place. I want to applaud you for
what you're trying to accomplish. But in a practical sense, is there
something we as an AHIC can do, that would address some of the issues
that you're trying to address and bring a greater sense of urgency,
because I'm very respectful of your timeline and timeframe here, but
again, on a very practical sense, we really need the e-health initiative
across the states to get on steroids. I don't know.

MS. NOLAN: We have been talking quite a bit about the dissemination
approach to this. First of all, between the task forces and the State
Alliance, itself, as I said, there are public sector folks on the task
forces. We do have \-- I won't say every state, but we do have a lot of
states, because we have attempted to be very broad in our approach, so
that we can get as many states involved. And then with turnover, we
think even within the next year we'll be pretty close to all of them
playing at least some role.

We have done a lot of dissemination already and are continuing to focus
on that. When I say dissemination, I don't mean just an outpouring of
information, but a true engagement. And that is really the goal of our
work, both within NCSL, NAG. We've also had conversations with the
National Association of Insurance Commissioners, the Association of
State and Territorial Health Officials, and others, to make sure that
there is buy in, that there is participation, whether \-- if it's not in
membership, then it is engagement, so that we can really actively go out
and make sure if the task force is considering X, Y, Z, we bring in
states to testify so that we're getting even broader representation. And
that we also really make sure that if there is a written product, we
want reaction and feedback. So I agree that it's not everybody at the
table all the time, however, we are looking very seriously at how we
engage, not just disseminate, engage all the other states.

MR. THOMASIAN: Just a quick note. The urgency is out there. I don't
think any of us can deny that. I can't \-- I would suggest to you that
there is no governor out there that is satisfied with the current
healthcare system.

The urgency is out there. What we're dealing with is a very large jigsaw
puzzle, so let's be realistic, putting the pieces together at the same
time, solving this simultaneous equation simultaneously is very
difficult. But one of the purposes of this alliance is to bring together
a group of individuals that have to confront these type of decisions,
and let them sort out what gets solved first, or what gets solved
together. And they're seeing that. They're already seeing that there's
just too many pilots out there. Why don't we take advantage of this and
make it all fit together?

So the urgency is there. The Alliance is \-- we're building capacity in
the Alliance to be able to understand that decisions have to be made. I
think we will be soon offering up potential solutions. But again, this
is a big jigsaw puzzle. They've just started playing with it. I think
we'll get to some conclusions fairly shortly, though.

MS. GELINAS: So is there any one thing that AHIC can do to speed your
work?

MR. THOMASIAN: Well, I think they're very appreciative of the
standardization efforts. They don't want to play in that realm. They
want that adopted. I think all the work that you're doing and feeding
into this is important, because that's one less thing that they need to
work on.

MS. NOLAN: I think that gets to the coordination issue that did really
emerge at the last meeting, is they do not want \-- again, they don't
want to start from ground zero. That's not the desire at all. And so it
really is about trying to build.

And so we've had ONC come to each meeting so far, both of them, to
really try to represent and to get the best sense we can of what is
going on out there, what is being taken care of, and that's been one of
their first questions. So I think that as much as possible, the AHIC and
others can represent what's being done, so that we can move from there,
rather than try to sort that out for the first three meetings.

MS. DANIEL: Thank you.

DR. BRAILER: Other questions or comments from members of the AHIC?

John and Kathleen, there are \-- have been in the past, I know, perhaps,
the most recent significant effort was in the late 1980s, efforts to
standardize or harmonize state licensure, the National Conference of
State Medical Board's effort is one that is notable.

What has changed in the calculus of states as they look at this
question? Is it the presence of health IT, telemedicine? Is there
something else that's going on, as they look out and ask, what is the
compelling public interest to take a look at licensure laws that \-- or
licensure rules?

MR. THOMASIAN: I'll mention a couple things. Part of it is the health IT
clearly, but also I would say that the \-- our experience recently, in
some natural disasters, et cetera, have made it very clear the
importance of being able to move people rapidly into different areas,
allow them to practice. And in so doing, I think we've built up some
experience, knowing that there wasn't \-- there weren't a great deal of
major problems around doing that. So I would suggest that that \-- that
does play a role.

MS. NOLAN: And the business model has changed. That's what we have been
hearing as well. It's sort of the approach is that it's \-- it's more
open to a dialogue at the very least, and maybe even ready for motion.
That was our latest testimony, that there may be a readiness for change,
in part because of those kinds of issues, in part just because I think
there is a difference in how they're viewing, potentially, their book of
business. And so I think that that's a slightly different approach.

Now, that's saying that's how the \-- potentially the medical arenas and
the professionals feel. How the boards feel is a different issue, and
some we're \-- sorry, stating the obvious. But I do think they've also
exhibited, particularly the medical boards, and the nursing boards as
well, have their own compact process and other things like that, that I
think have changed since ten years ago, that maybe we have a different
dialogue going on.

We have also been looking, in addition to the requirements for
licensure, the process by which people obtain licensure, and could we,
at the very least, streamline that. If we weren't able to get to the
issues around what is required to be a licensed physician or nurse in
different states, could we at least look at how you go about getting
licensed, and making sure that that process is as simplified as it can
be while still protecting the public's health. And so that's another set
of issues beyond just the requirements for licensure that we want to get
to.

DR. BRAILER: And is there a way that the state medical boards engage in
this process? I mean they're not on the list, so is there a dialogue, is
it informal, is it formal?

MS. NOLAN: It's very formal, and we have been working with them. It's
mostly been from the testimony perspective, but we're also working with
them on the work product itself, to ensure that we've got a viable
approach.

I think the bottom line issue is that they're very different, state by
state. Their authorities vary, the way that they're appointed, the way
that they interact with government differs. Some of them are in health
departments, some of them are free standing, those kinds of things very
much play out. So we're working with them, I would say more as a
technical expertise and consultant, as well as a testimony approach, so
that we can make sure that this is a viable approach.

DR. BRAILER: So that, just as an example, if there are some states that
may want to move forward and begin piloting or collaborating with other
states, in a more porous licensing process for health IT collaboration,
or telemedicine, it's in the realm of possibility that they could
orchestrate that together without having everyone else necessarily come
along. It's not an all or nothing phenomenon?

MS. NOLAN: Absolutely. Absolutely. And that's true, pretty much, of all
of this, is that we don't expect an all or nothing approach in many of
these areas. We expect a wave of states to take on these issues and see
how they work.

DR. BRAILER: Okay, great. Thank you. Other comments, questions,
discussion, related to the State e-Health Alliance? You'll certainly
hear more about the HISPC and the privacy recommendations at the July
meeting, Jodi, is that correct?

MS. DANIEL: I'm not sure when it's scheduled, but we are planning to
have them come back after their reports are due. Absolutely.

DR. BRAILER: Okay. At this point we will take a break. We will resume at
about 10:15 or a few minutes after. Thank you all for your time this
morning, and we look forward to discussion in the mid-morning.

\[break\]

DR. BRAILER: Thank you. The Secretary is still indisposed, and so we are
going to turn to Tab Seven and discuss the Personalized Healthcare
Workgroup update. And with us we have Greg Downing from the Office of
the Secretary and the Office of the National Coordinator, and Doug
Henley. John Glaser was to join us via phone, and because of the
schedule change, he's not going to be able to be with us, so with that,
I turn this to \-- who is going to lead the discussion? Greg. Greg.

DR. HENLEY: Well, actually I'll take the lead \--

DR. BRAILER: Oh, Doug.

DR. HENLEY: Thank you very much. And on behalf of the Personalized
Healthcare Workgroup, it's my honor to make our first initial
presentation to the Community. We appreciate that time very much.

I would be remiss if I did not recognize my co-chair, John Glaser,
Partners Health in Boston. John brings a huge amount of expertise to
this co-chair work, and I sincerely appreciate his working with me on
this. Also, I want to make note of our excellent staff, Greg Downing, as
well as Kristin Brinner, and the excellent work they do on our behalf to
move forward this important agenda.

Let me quickly show to the Community, the Workgroup members, as they
exist, if a measure of success of our Workgroup is the ability to
surround ourselves with a whole bunch of good people that are smarter
than the co-chairs, then we should declare victory and go home, because
indeed, these folks represent a huge diversity of expertise in this area
of medical genomics, and health information technology, and the vendor
community, et cetera, and again, in helping us move forward on this
important task that we have before us.

I have been asked, David, by several people on several occasions, what
the heck does personal healthcare have to do with the American Health
Information Community? And I know the Secretary's passion for this, and
John and I, and Greg, and Kristin share that passion; and I would just
simply make four points in making that connection, that you will see
shortly, in terms of the priorities that we intend to focus on as a
Workgroup.

First, clearly, the evolving science of genetic tests and genomic tests
clearly demand attention to the necessary common data standards to embed
that information in EHRs, and PHRs, and to assure the interoperability
of that data. So that's an important connection that clearly relates to
the work of the Community.

Secondly, one of the biggest tools in this realm of personalized
healthcare that's been around forever is the family medical history. And
clearly, the structured \-- a more structured approach to family medical
history and standardization of that nomenclature, including that
information in EHRs and PHRs, is clearly another important connection to
the Community.

Thirdly, the need for clinical decision support \[CDS\] tools, delivered
just in time, evidence based at the point of care, via the use of health
information technology, is another connection directly to the work of
the Community, and a focus of the important nature of clinical decision
support as it relates to this type of personal healthcare information,
particularly as it relates to the interpretation, clinical utility of
genetic and genomic test information.

And finally, as this evolving science moves forward, the concerns of
both consumers and clinicians in terms of the confidential nature of
this information and its use in that regard, and how we keep it private
and secure, via health information technology, also makes an important
connection back to the American Health Information Community. So I am
very pleased that we are moving forward with this great work.

Let me next focus on the two charges of our Workgroup. As you can see
from the broad charge, we are focusing, in the long term, on what are
the necessary common data standards that will facilitate the
incorporation in an interoperable fashion of clinically useful genomic
and genetic test data and information, and importantly, the analytical
tools that facilitate the clinical decision making process through
electronic health record technology. And importantly, that will be to
the benefit of not only the clinician, but the consumer, as well.

As to our more specific charge, in the short term, we intend to focus
again on what are those common data standards that we should be most
concerned about, as it relates to genetic and genomic test data, and
family medical history, and how that can lead to use case development,
work through the health IT standards panel, and the certification
commission so that EHRs can effectively capture and embed that
information to improve healthcare. And importantly, through the health
information community, how can we use the leverage of the federal
government to move forward the adoption of those important standards?

Now, the Workgroup has met on several occasions by telephone conference
calls, but we've had one in-person meeting on March the 12^th^ that
constituted our visioning exercise, as we assessed the current status of
personalized healthcare, but also as we looked to an envisioned future.
And we approached that from the perspective of four constituencies: the
consumer, the clinician, the researcher, and the payer or the health
plan.

The Workgroup, after a lot of discussion, views personal healthcare as a
system which, indeed, should be consumer centric, but where such a
system allows the clinician, be it a physician or other healthcare
provider, to customize, indeed, personalize their approach to the
individual patient as it relates to diagnostic treatment and medical
management. Clearly, an important future that we have to improve the
quality of care.

Now, everybody is unique in terms of their genomic makeup, but that
uniqueness is influenced by a variety of other factors that are
important in the realm of personal healthcare, be it the culture in
which the patient finds him or herself, their own personal behavior,
their own personal preferences, their family medical history, their
environment in which they live and work. The list is lengthy, in terms
of other factors that affect one's personal healthcare, current and
future, beyond just their genomic makeup, and all those factors need to
come into play.

And we think the time is current and now, when we should begin to
address this important issue, because of the confluence of advances in
health information technology, as well as a better understanding of the
human genome, and the various factors which affect that, which I've
already spoken to.

Now, as we look to these four constituencies and envision a desired
future, let me look at the consumer perspective first and discuss that
briefly. I won't dwell much on the current status, but rather focus,
again, on an envisioned and desired future.

Clearly, we feel as a Workgroup, that personal health records, as we
look to the future, should capture this information in a much more
complete and organized fashion, especially as it relates to family
medical history, to, again, improve the quality of care for the
individual consumer or patient.

That there should be greater access of this information to the consumer
that includes information about the risks involved in choosing to engage
or undergo these particular tests, what the various treatment options of
those choices might be as a result of that testing.

And ultimately, as personalized healthcare moves forward, based upon a
greater array of genetic information being available, in different
treatment options and so forth, as to diagnosis and management as well,
higher quality of care, we think, is in fact achievable, as it relates
to the individual patient rather than just simply populations of
patient, based on the idea of making diagnosis and treatment options
more personal and more customized in their nature.

From the clinician perspective, again, looking primarily at the desired
future, again, personalized healthcare will allow clinicians to better
combine both genetic and genomic test information, with family medical
history, to enrich the medical decision making process for an
individual. Hopefully, this will move medical practice from a current
reactive position to a position which is more preventive in its focus,
more proactive in its nature, and again, can lead to higher quality of
care and better management of an early intervention of disease, and in
fact, even prevention of disease with time. And clearly, the necessity
to embed in EHRs robust clinical decision support tools is part of this
overall equation, from the clinician perspective.

From the researcher perspective, again, an envisioned future would
include continued understanding of the impact of the genetic basis of
disease as it relates to populations of people, as well as individuals.
We see a time where such resources for this type of research will be
more robust and more wildly available, including continued federal
funding for same.

And importantly, we see an envisioned future where truly translational
research can thrive in moving this type of research from the bench to
the bedside, but more importantly, moving the information from the
bedside back to the bench in a cyclical fashion to inform future
research, based upon clinical utility and clinical information.

Finally, from the perspective of the payer and the health plans, we
would see a future where, in fact, new reimbursement strategies might
exist to facilitate and incentivize the appropriate use of these types
of technologies, and a better understanding of their clinical validity,
their analytical validity, and, indeed, the clinical utility of these
tests. It will allow, we think, more focused attention on prevention and
chronic disease management, as well as health maintenance, and perhaps
this information can be used in the future in better benefit design and
disease management focused on the individuals, rather than just
populations.

Now, let's go to the priorities that I mentioned just a few minutes ago
in my introductory remarks. And the first priority of the Workgroup in
the near term is focused, again, on the current science of genetic and
genomic testing.

It is important, again, that we focus in the near term on what are the
common data standards that can be utilized to capture this information,
embed it in both EHRs and PHRs to move forward on this agenda.
Importantly, some of those standards may have to be harmonized in order
to better submit more specific data, such as state mandated newborn
screens, as well as clinical pharmacogenetic information which currently
is available and needs to be addressed.

I've mentioned previously, the need to better understand and have
information, both at the clinician and consumer level, of all these
tests that are out there, and others that will be developed in the
future. What is there \-- how do we determine that they are valid tests,
and that they do have clinical utility in a given situation? And what is
the information that will be utilized and provided at the point of care
to inform that decision making process?

We do think that there will need to be incentives to move forward in
developing new genetic tests, as appropriate, and importantly, what is
the necessary consumer education and information that should be
available that shows the potential risks and benefits of choosing to
undergo these tests, and how they may apply in the real world.

A second area of focus, in the near term, is family medical history has
been around forever, but the need to empower both clinicians and
consumers to include this information in EHRs and PHRs in a more
structured format is clearly necessary, and thus the standards to
achieve that. And importantly, a standardization of a nomenclature that
we all use to capture that important family medical history information
as we move forward.

On a much \-- in a bit longer term focus of the Workgroup will be in two
areas: clinical decision support and confidentiality, privacy, and
security. First, related to clinical decision support. Again, we see in
a bit longer term, that the importance of understanding and using health
information technology to better inform, again, the clinician, at the
point of care of the clinical utility of these tests that are available
that now number in the thousands, and in the future, will clearly be in
multiples of that in very important ways.

Perhaps we can develop predictive algorithms that can be best utilized
in clinical practice to inform that medical decision making process. And
again, clinical decision support tools will be critical to that in
embedding those in electronic health record systems, as well as to some
extent PHRs.

And finally, again, on a longer term horizon, relative to
confidentiality, privacy and security, I'll simply say that we feel
strongly that there probably need to be both technical and policy
decisions and solutions to guide this process, and that we understand
that the Community is addressing that already through the separate
Workgroup on CPS; but importantly, as has already been discussed, we
need to determine how best we can de-identify, and yet aggregate that
data to further inform a research agenda in this area, as we look
forward in the future.

Now, in terms of the immediate next steps of our Workgroup, again, we'd
subdivide those into short term and long term. As it relates to the
short term, we have formed two subgroups of the personalized healthcare
Workgroup. One is looking at genetic and genomic tests in particular,
and the second relative to family medical history, and again, what are
the common data standards and structured formats that need \-- these
need to be looked at, from the standpoint of embedding those into
electronic health records. How can the standards lead to use case
development, and then referral to the HIT Standards Panel, and
eventually become part of the certification process for health
information technology. We hope to have those recommendations to you at
the time of the Community meeting in late July.

And then on a longer term, again, we hope to be involved with a subgroup
of our Workgroup dealing with issues of confidentiality, privacy, and
security, as they specifically relate to issues of personalized
healthcare and genomic and genetic information, and what are important
recommendations that need to be considered there that then can be
referred to the larger AHIC Workgroup on CPS.

And finally, we were involved as a group, and some of our members, three
of our members, I believe, are involved in the evolving AHIC ad hoc
Workgroup dealing with the important need for clinical decision support
tools that become part of electronic health records in the future.

So with that, David, I'll see if Greg has any additional comments, and
then we'll open it up for Q and A.

DR. DOWNING: I think we're fine, David. As you know, this is a component
of the Secretary's initiative on personalized healthcare and a number of
other Workgroup activities that we have been working hard for this
Workgroup to interface with. Included amongst them are the Secretary's
Advisory Committee on Genetics, Health and Society that also has a
member participating in the CPS Workgroup.

So we have been doing a great deal of effort behind the scenes to
facilitate the integration of this Workgroup, along with others; and the
participation by this group of experts has been absolutely fabulous, and
the amount of input that we've received from the Community thus far has
been very substantive, so thank you very much for taking this on.

DR. BRAILER: Great. Thank you, Greg and Doug. Thank you for spending so
much time on these AHIC topics, that I'm sure you might have some time
left for your day job. But I appreciate it very much.

With that, we'll open it up for questions. This is a budding area that's
playing out, as Greg said, with respect to the Secretary's broader
agenda with the direct interface here with health IT. We certainly want
to keep a narrow scope to this within the AHIC, because it has so many
other tentacles that touch other things, and we have many other
priorities.

But this is an area that is quite important for us, because unlike many
of the things that we deal with today, where we're trying to get the
horse back in the barn, this is a chance to get it right from the
beginning. And we're certainly taking advantage of that.

So with that, the floor is open for discussion, and I ask anyone that
has comments or questions for the Workgroup or more broadly to raise
them. Lillee.

MS. GELINAS: Great report, and I also want to commend you with \-- the
back of the materials is the actual visioning summary, which I thought
was outstanding. It might be helpful, in the future, if you could give
us a report on how personalized healthcare is viewed by the Department
of Defense and the Veterans Administration.

I recalled when some of us saw the MyHealth*e*Vet \-- am I saying that
right, Gail \-- on how the veterans have their own website to view their
own personal health information, I hope I'm not misrepresenting that,
but I remember being highly impressed by that. And so I just wonder if
there is some learning we could learn about. I know I would like to know
a whole lot more about how personalized healthcare is viewed in the VA
and DoD. And that could inform our thoughts as well.

DR. HENLEY: I think that's a good point, Lillee, and we certainly can, I
think we can get that information.

MS. GELINAS: That would be great.

DR. DOWNING: I'd just like to add that after a series of our Workgroup
meetings on the phone, we've had presentations, meetings with the VA and
also recently with DoD, and will be continuing to support the
Workigroup's activities with additional supplemental information about
the readiness for these.

DR. BRAILER: Jeff.

MR. WELLS: Just for my educational benefit, I was trying to understand,
I guess maybe from a definition standpoint, what types of tests fall
under genetic or genomic tests. Does that include things such as
proteins and biomarkers, or is this strictly limited to specific gene
tests? Any further education would be great.

DR. DOWNING: The definition of genomics and genetics is a fairly broad
one, and it's a definition that we've adopted for this Working Group
activity from the National Human Genome Research Institute. And I don't
have it memorized, but it does adopt those components that are sort of
downstream components of genetics, meaning proteins, metabolites
epi-genomics. As we see those parts of the research frontier start to
open up in clinical practice, those may be \-- follow in the same
pathway that's established for more common genetic tests that are
currently used today.

DR. BRAILER: Greg, I was struck by an article that was published in
JAMA, I think two weeks ago, that showed a somewhat surprising study of
85 known cardiovascular genomic risks; and upon subjecting to a large,
thousand person trial, demonstrated that in fact none of those, with
maybe the exception of one, had a very small \-- or very large P value,
was borderline significant, actually invalidated these other trials, I
think showing the amount of knowledge turnover and where we are with
respect to this. Was that shocking to you? Was that something that we
should expect to continue to happen, and how does that translate into
the work that this Workgroup will have, as it begins helping physicians
understand how this becomes part of decision support?

DR. DOWNING: I think that's a very good question. We've had a lot of
discussion around that, those lines, and Doug, I think, paraphrased that
somewhat in the context of the clinical utility of these tests.

Consummate with the discussions that occurred this morning about the
information exchange aspects, that the ability to gather the right kinds
of information, understand where these tests play a role in healthcare
decision-making, is really a frontier that's supported by the kinds of
efforts that AHIC is working here.

We just don't have the capabilities of doing large clinical trials for
thousands and thousands of patients for one test. And so looking at the
appropriate ways to gather information, analyze it, and structure better
trials in the future, better informed, the complex variance of
environmental and genetic factors that come into play here are probably
the explanations as to why small, focused studies around homogenous
populations don't yield the same information we see in larger studies.
And I think that the study \-- the reporters that report in JAMA, I
think alluded to that fact. We need better information systems to really
construct better designs.

DR. BRAILER: And just one other \-- it's more of a comment than a
question. I noticed that in the membership of the Workgroup, FDA's
represented, but I didn't see a CMS representative. And I know that
there is some discussion about where the locus of regulation of genomics
exists, if it's an FDA or if it's in CMS.

I wonder if this is across the Workgroup, and if it would be valuable to
have a CMS participant on that Workgroup. Not that this group is going
to be directly speaking to that question, but I think there is certainly
\-- unless there is another way to get that input, I'm sure that that's
a dialogue that could be held.

MR. DOWNING: Yes, thank you, David. The \-- as you recall, our
membership was capped at a two-dozen figure that you limited us to
\[laughter\]. So using the creative skills that our chairs have brought
to the committee or the Workgroup, we have adopted a nomenclature of
senior advisors, and we do have a member from CMS now that's been
participating in the last two Workgroup meetings.

DR. BRAILER: Good. Great. Any other discussion on this topic? Adele.

MS. MORRIS: Doug, I think you mentioned that down the road, these were
issues that would end up in the lap of the certification \-- was it the
certification process? And because some of these tests and data items
are so new, is it possible in this field to avoid some of the legacy
vocabulary problems we had for some of the other standardizing clinical
issues in the past, since we \-- we kind of know we're going towards
standardization already, to, from the get go, kind of develop systematic
nomenclatures and data approaches?

DR. HENLEY: I think there is the potential for that. Certainly the
people who have volunteered on the two subgroups that I mentioned, one
about genetic and genomic tests, and one about family medical history,
they see a desperate need to standardize not only the architecture and
structure of how who you enter the data, but the nomenclature as well.
And so we \-- I think we have every intent of trying to address that, as
we also address the issue of common data standards that would then feed
into the CCHIT process. We're going to take a stab at it.

DR. BRAILER: Any other comments or discussion? Thank you all very much.
Appreciate the hard work. We look forward to hearing back from you.

With that we will turn to Tab Five, and welcome back, Secretary Leavitt.
This topic is the planning for the long-term succession and
sustainability of the American Health Information Community.

And you will recall that the charter of the Community called out when it
was established for this to be a group that is sunset, and to explore
its own sustainability. And we've waited to have this process launched
until we have a repertoire of work, and some success, and certainly many
processes under way.

But now we're at the point where we want to begin this dialogue. And
I'll ask the Secretary to start with his introductory comments, and then
we'll unfold with some slides.

SECRETARY LEAVITT: I foreshadowed this earlier today. Our purpose is to
create a sustainable process that is widely understood to be the means
by which standards are established in health information technology.

The goal has not \-- when it comes to standards, there really are only
three ways standards are created. One is for someone, in government,
usually, to arbitrarily stand up and say, this is the standard. We
typically don't have a good record of getting them right when that
occurs, nor do we have a universal record of people agreeing to them.

The second option is what I call the last, or \-- the last vendor
standing, which is for the marketplace to compete until one standard
emerges. That generally doesn't work in a market like this, because
there are various ways in which problems can be solved and people
maintain a proprietary interest in their standard.

The third way is what we're doing, which is a collaborative process that
most significant players in the market adopt, and then we drive it
forward. It is slower than we'd like it to be. It is hard. It is a
little messy. But it's the only alternative that works, and yet it's not
well conducted always by government, because it needs continuity.

So our goal from the very beginning has been to give a process birth, to
give it substance, to create a battle rhythm about the way it operates,
connect it with the other parts that need to be, and then fund it, give
it a sense of momentum, and government will continue to participate in
it. Our purpose, now, is to begin to examine the business models that
can be utilized to perpetuate this. So with that, David, let's proceed.

DR. BRAILER: Let me turn you to slide two, and just to remind you that
the AHIC charter was established under the Federal Advisory Committee
Act Authorities that are held in the department to be able to create a
public/private collaborative, and it has two functions. And you know
this well, but just as a capstone: to advise the Secretary and make
specific recommendations. This is an inherently governmental function.
And secondly, to serve as a forum for discussion, participation, and
decision-making, which I think is more of a filling the void function,
an effort to have one place where these discussions are held.

There's been a lot of discussion, turning to the next slide, about what
things an AHIC successor would do. And I think it's fair to say that the
inherently governmental functions that it could take on are not the
things that are under debate. Said another way, it's very likely that
when this collaborative stakeholder governance function, that the AHIC
does so well, moves out to the private sector, the government will still
need a mechanism for getting consensus input from industry, perhaps from
that new AHIC successor itself.

So it's not that component that's being discussed, but the roles that
are being discussed here, for example, are continuing to be a
public/private workplace with broad, multistakeholder representation.
Being able to set priorities based on the information that's determined;
being able to guide many stakeholders, based on the collaborative
priority setting; being able to continue a governance model, certainly
not a corporate governance model, but a public governance model, to make
sure that issues are arbitrated and discussed and decided. To set
guidelines, for example, related to the NHIN. To work on behalf of the
voluntary participants, to give guidelines or standards where they're
needed or necessary. To provide principles that could guide regional or
state efforts in health sharing policies. To support advice on a
roadmap, to make sure that there is a reality check on the functions
that government have with respect to where this effort will play out and
how. To stay on top of market trends, economic models. To look at what's
working and what isn't. To be able to make corrective actions or to be
able to make sure that the parties who can take corrective actions do
so. And finally, to coordinate federal and state relationships in
governance activities. Again, this is something that is on the
borderline of the other functions.

So this is a very broad brush of the kinds of things that an entity
could have. This discussion is really surfaced from the perspective of,
is there even something for an AHIC successor to do? And our answer is,
our work is not done. And therefore, there is work to continue, and
therefore, we need an entity to continue doing this that can really be
accountable to the broad public.

Next slide shows a timetable for how we envision this process playing
out. The Secretary has been emphatic that we need to have this process
done so that there is a solid year of effort under his leadership to be
able to make sure that we have an established, firmly rooted,
sustainable, financed successor in place.

Therefore, we have urgent work to do over the next seven months, and
that includes being able to develop business models, so we can
understand how this public function is supported sustainably, develop
decisions on what \-- not just the options are, but what the model will
be; being able to understand what entities could be created or could be
shared to be able to provide the organizational framework for an AHIC
successor, being able to have that entity actually contracted and under
way, and working simultaneously with us so it's not a hard handover on
some fixed date, but it's a collaborative transitional process, as we're
able to do this over time.

The key step in the short term, next slide, is determining the business
model; and to this end, the plan had been to have three contractors who
would actually go off and independently do work, understanding business
models. Come back not unlike we did with the NHIN, and say we have three
different worldviews, derived independently, with independent decision
making. They could come back and inform our thinking about the broad
range of opportunities, what the role of government is, what the short
term, long term goals of the entity could be. What mechanisms could
ensure broad representation, how we would transition, and how this would
become sustainable, without interfering in the core function that the
AHIC and its successor would provide.

And to this end, I'm going to turn it to Rob to have an announcement to
show where we are with this, and to discuss the first steps that have
been taken towards it. Rob?

DR. KOLODNER: Thank you, David. What we have done in the last few days
is we have issued three contracts to three different firms. The
representatives from those firms are in the audience, so that they'll be
able to hear the discussion that you have. And then they will be
developing the various business models, three different business models,
to bring back; which we will then use as the starting points for the
discussions that we'll proceed with. And David will go back into how
we're going to proceed on this. But they serve as alternatives that we
can consider, as we look at the business model that ultimately will be
the one that's recommended.

The three contractors are Booz Allen Hamilton, Avalere, and Alchemy, and
so those are the three groups that now have the contracts.

If we could ask the representatives from those three firms to stand up,
please? And so they will be coming back with the product, according to
the timetable in June, for us to consider.

DR. BRAILER: Turning to the next slide, so the AHIC will oversee this
effort. The Secretary will chair a committee of the whole or perhaps a
subcommittee as needed, to be able to make sure this process stays on
target. This will become a standing agenda item of the AHIC, between now
and the end of the year, hopefully not occupying a great deal of time,
but very important time, nonetheless.

The AHIC will set the criteria by which these models will be evaluated.
It's your decision to make about how these things get filtered. The
contractors are in an idea generation mode, to make sure that we have
the broad representation. We will hear other testimony and have other
information collection, again following the model that we've done with
NHIN, and the RFIs and things that followed that.

And then recommendations will come around the end of July. That's the
timetable we're functioning on about governance structure and business
model \-- how the government interacts with this, what residual
government functions are left, transition plan, and a path to
sustainability. And then we have months to implement this and begin the
transition process.

This is a very serious undertaking that we hope will set a trajectory
for at least the next five years to work and oversee this effort, and
it's something that we expect and hope that all of you, let alone all
the people that are not around the table, will support and continue to
invest a large amount of energy in, so we can continue the progress
made.

So with that, let me stop with the slides, and open the floor to
discussion. And the discussion can be broad ranging, as much as you want
it to be, but I also want it to be specific, so that this first step
with any input that the contractors need to have about issues or
thoughts that you have, or constraints or boundaries they can take, so
we can be expeditious in the work they're going to follow.

Thank you. Chip, do you want to go first?

MR. KAHN: Well, I think this is a great idea, and I'm very supportive of
it. Let me say that the model that we have out there for it, which I've
been involved with some, is a frustrating one, and that's the National
Quality Forum \[NQF\]. Frustrating because it doesn't have sufficient
funding to be doing the kind of priority setting it needs to do, and
frustrating because even though it has a dues base, it receives most of
its funding to consider endorsements of measures from those who want to
get their measures endorsed.

The body works very effectively and is obviously careful, and only
endorses measures they think are worthy of endorsement. But their agenda
is driven, and it gets to the same issue that I raised earlier today,
about we need to be careful that we don't have a business model that has
an agenda driven by its business model.

And that's why I think broad based financing of some type, and whatever
it is, is really fundamental here to make this work. If the head of the
new \-- of the private \-- public/private partnership, AHIC, has to
worry about where the money is coming from every day, it's not going to
work. And then issues over time of conflict of interest and other
concerns will arise, I can assure you.

So I think we need to think broad based, not dictating necessarily, you
know, a grant from the government, necessarily, although that's
obviously an option. But it's got to be broad based. And the one sort of
problem here is that if it does require significant funds from the
government, then that obviously would have to be legislated. But I
assume we're talking 30 to 50 million dollars minimum here, just for the
operations, before you get to whether they're going to be funding
demonstrations and other kinds of activities that might be extensions of
the mission you laid out.

DR. BRAILER: I think the business model question is clearly linked to
the scope of the AHIC, and how broad it goes beyond this core charge
that we've had here, and that's one of the issues that's going to be
discussed, to get a decentralized business model that has to have a
decentralized scope of work. And so that's a tradeoff, that I think
you're going to see very clearly coming back to you, in terms of how
broad do you think this should be, and how much touching really
operational things should it be versus staying back at the very abstract
layers of what these standards are. So you'll hear more about that.
Other discussion? Craig?

MR. BARRETT: Following on that, is there \-- are there one or two
examples that you could give of this sort of successful implementation?
Not trying to presuppose the output of the three groups, but just in the
existing private/public partnership type of activity. Are there one or
two examples you could reference where the movement has moved out of the
public sector into more of a private?

MR. LAMPKIN: Yeah, I can share one, that from a retail standpoint,
Craig, that we have found very helpful, and that's GS1, Global Standards
One. And the elements that I think for the contractors that we ought to
tee up, among other things, are things like \-- that we found to be
successful in that space, is one, it needs to be user driven. It needs
to be absolutely driven by those end users, not by technology companies
or others who have a proprietary interest.

It needs to be, if at all possible, a public/private initiative that is
nonprofit and independent, so there is not political things going on, if
you will, so it's really something that stands alone, and that a variety
of players can engage in without feeling like their personal interests
or their companies are at risk.

So those are some things, user friendly, nonprofit, independent, and
public/private, that we found very helpful with GS1, to create standards
for interoperability or data exchange, said simply, in the retail
business. And they actually have a users group, a help users group that
they've established, so\...

DR. BRAILER: Craig, any echoes of Semitic in what you're asking?

MR. BARRETT: I'm not quite sure the parallels of something like Semitic
with the charter of AHIC or the direction of AHIC has been. The reason I
ask the question is just to get a \-- an idea of the direction \-- there
are lots of standards setting bodies around, obviously, and they come in
different flavors and different formats, and when you say it's user
driven, then you get to the definition, well, who is the user, and who
is the consumer, and who are you benefiting, et cetera, et cetera. I was
just trying to get a feel, if you've given this thought, what direction
you might want to model this after, because of the wide variety of
options that you have.

SECRETARY LEAVITT: I think there is no question that there is a wide
variety. I also think that there's a little question that it's somewhat
unusual for a government to undertake the proposition of let's create
something and spend it out of government. Government isn't accustomed to
doing that.

MR. BARRETT: Most of us are aware of that, Mr. Secretary.

\[laughter\]

SECRETARY LEAVITT: So to some extent where there is uniqueness here, but
it's the right thing to do, and I think one of the jobs of the
contractors will be to go out and analyze every possible model and say,
where are the applicable experiences that we can learn from?

We likely have to invent some things along the way. If this was easy, it
would have happened a long time ago. Heaven knows the need is there. But
I suspect that will come out of the various proposals.

MR. CRESANTI: I think one of the important challenges that we I think
would all confront in this process is how do you know maintain the
involvement of senior government officials in a situation like this,
because our conflicts of interest, ethics, rules, and so forth and so
on; we've been working on international bodies and similar areas where
US government officials are senior participants, but there are still
ethics challenges being actually on a board of one of these
organizations, or helping \-- being in a decision making process.

And if we spin it out, I foresee significant work having to be done, and
maybe even some legislative changes which will be very difficult to keep
involvement from a government official's perspective, particularly if
it's at a senior level.

DR. BRAILER: I think it's a helpful comment, and one that we will look
into. And there is some precedent for that in healthcare, for example,
with the National Quality Forum, where a significant number of the
boards \-- I'm looking to Carolyn for the number, are just that, senior
government officials. But we can discover, through the contractors, how
that came to be and what the conditions for that would be.

SECRETARY LEAVITT: One of the most important aspects will be assuring
that government purchasing power is committed to the outcome of AHIC. We
have an executive order right now. Part of the executive order that both
creates AHIC and also that requires government departments and agencies
to adhere to it is what drives a lot of the change.

We've talked about this, but one of the most significant changes we've
already seen as a result of this, is the commitment on the part of the
VA and the DoD to begin to upgrade their systems together. I think there
is no question that would not have occurred, absent this convening. And
that alone will begin to drive it.

We may have to find a unique way for that to happen. It may be \-- I can
think of several different alternatives on how that should be or could
be done. I won't take the time today to articulate.

DR. BRAILER: Craig?

MR. BARRETT: The charter to the three groups to come back with three
distinctly unique formulations such \-- I'm just interested from a
consideration standpoint. Do you get to choose from three different
recipes here, or is it likely they come back with three very similar
approaches, which only have very minor differences?

DR. BRAILER: I learned from the Secretary early on that he follows a
process called design and build, where you get different contractors to
work on ideas. They're not being told to do things differently, but they
are being asked to work independently, and they come from very different
vantage points in terms of the industry.

And I think part of the challenge of the AHIC will be to take the best
of each, and figure out how they fit together in something that we want
it to be, as opposed to just endorsing one of the three solutions. It's
possible one would be superior, but I think it's unlikely.

SECRETARY LEAVITT: While I was governor, it became evident that we
needed to rebuild all of the freeways within the heart of our capital
city, 17 miles, that both serve as I-15 and I-80. It's the intersection,
and it's the most traveled part of the interstate highway system, and
\-- one of the most traveled.

And the prospect was we would have \-- we would have nine-and-a-half
years of construction under the traditional contracting process. We
concluded that we would adopt a different strategy we referred to as
"design-build," but it never had been applied to highways before.

And we called the series of contractors in and said we want to pay you
to think through the best way to do this, and at the end of the day, we
want to own a lot of your ideas, because we may, in fact, want to take
bits and pieces, and construct a truly unique proposal from this. And we
went through the process; I won't detail the whole thing. It was a new
way of approaching it. Instead of nine-and-a-half years, it took a
little over four years; and we \-- the original proposal, once we got
the bids, was six months ahead of schedule and about \$100 million under
cost. That's not usual in government contracting.

I'd like to see us deploy some of the same ideas here. Let's put a lot
of smart people thinking about this, use their best ideas, and come up
with a new model that will allow us to perpetuate the best of private
sector thinking connected to government purchasing power. And I believe
this is the way to go about it. We're pioneering here in many respects.
But it's a good process, in my judgment.

MR. KAHN: From reading the mission that's envisioned here, the actual
standard setting would be a separate function, and in a sense, it has to
find its own way in terms of supporting itself over time. That's \-- I
think it's a good idea, but I want to make sure \--

SECRETARY LEAVITT: This is the process by which \-- this is a formalized
collaboration that has to be hooked to a whole series of other
functions, such as certification, standards harmonization, et cetera.
And it also needs to be integrated, I might add, with the whole process
of quality.

There are a number of pieces we're inventing at the same time here, and
all of these have to be integrated, and \-- for that to occur, this has
got to be part of larger vision than simply health IT standards.

DR. KOLODNER: I think one of the things is that the relationship of this
entity and its governance to the standards process, to the HITSP, to the
certification process, and even to the governance of the NHIN is still
something that is up in the air, and I think those are things for us to
consider, to see what's the best way, how might those fit together; and
to consider not necessarily ruling those pieces out, but not also \--
also not assuming that those are part of the organization or the
governance.

DR. BRAILER: Lillee?

MS. GELINAS: I'm thoroughly enjoying this conversation, but I just
wanted to perhaps have a reflection, and that is, we need to call out
why AHIC has been successful, Mr. Secretary, and that's been your
leadership. And the leadership of this new entity needs to be very
strongly considered by the contractors, and what that will mean, because
through leadership, much gets done. Lack of leadership, nothing gets
done. And I would say that you have allowed the Workgroups to face
really tough questions, and you've also stepped up to the plate when
you've had to step up to the plate.

I really liked Craig's question as to where are the examples of this
type of entity working that we can use as a beacon of light going
forward?

Many times, at least in the EHR Workgroup, we've talked about the fact
that health IT is a bipartisan issue. It's not a Republican issue, it's
not a Democratic issue. It is one of the bipartisan issues. And so I
would just ask the simple question, why not keep AHIC? I just want to
put that ugly elephant on the table. It may not be possible.

But I would not, in the process, want to lose the fact that health IT,
and the charge that we have, is for the public good. And the public good
cannot be underestimated, and at the end of the day, what we're doing is
in the pursuit of quality and reduction of cost, this is not health IT
for health IT. It's for the greater good of increasing quality in the
United States and lowering the cost burden at the same time. So I just
want to make sure the contractors hear that and it doesn't get lost.

SECRETARY LEAVITT: We ought not to take any option off the table. I mean
if you look around at various standards bodies, you look at the Internet
itself, was there a government function in the development of the
Internet? Absolutely. Was it government who ultimately formed it up? I
don't think so. It evolved in a different way.

You look at some private models like \-- you take Visa. Rob and I have
taken \-- spent a lot of time talking about \-- Visa isn't an \-- it's
an association of a lot of people who have developed a set of standards
that now work very, very well. It was a model that didn't exist before,
and now it does.

We can learn from all \-- we can be informed by all of these. You look
at \-- what's the \-- I triple E? \[IEEE\] Is that the \-- that's
another standards organization that really developed, in some respects,
out of a competition of the last vendor standing. I mean they \-- there
was a lot of \-- ultimately, the vendors got together and developed a
set of standards. All of these standards bodies have a different
genesis, but they all end up the same place, and that's an organized
collaborative that have the major players at the table who have adopted
and agreed to subordinate their going forward strategy to a group of
common standards, and \-- or open standards that they meet, and they may
meet them in different ways. That's the vision here. We've got to invent
the right way to establish this.

There may be an ongoing role for ONCHIT, clearly will be for ONCHIT.
There may be for AHIC. That may become the way in which you harness up
the power of the public payers to the process of standards setting.

DR. BRAILER: Tony?

MR. TRENKLE: I think I'd agree with what you were just saying, Mr.
Secretary. The financial services area certainly offers a lot of good
examples. It seems like where they've been most successful is when they
have been looking at developing common business rules and overall
standards that run the various mechanisms that make the financial
service industry go. So it seems to me, as I'm looking down this list,
that those are the areas that would make this group the most successful,
as opposed to looking at things like evaluating market trends and things
of that sort.

DR. BRAILER: Any other discussion on this topic? You will hear more
about this a lot over the next several months. Okay. Thank you.

With that, we will turn back to tab \-- I'm sorry, forward to Tab Six,
and this is our final work for today, which is the Electronic Health
Records Workgroup, and we'll be hearing from Lillee Gelinas, as well as
from John Perlin, who many of you know, sat with us before in his role
at the Department of Veterans Affairs. Oh. But you'll put him on TV,
right?

DR. BELL: Good morning Mr. Secretary. I'll just take a few moments to
state the fact that Dr. Perlin very much wanted to be here this morning,
could not, and extends his sincere apologies for his absence. And I'm
extending his greetings for him. I'd also just take a few moments to
introduce the fact that the EHR Workgroup has basically been very active
for the past year, since you first heard its set of recommendations
relating to making historical laboratory information available.

Under the very strong leadership of both Lillee and Jonathan, the group
has set forth a set of three very specific actionable recommendations,
and one that is more overarching that is here for discussion. But I want
to share with you that this group very easily could have come forth with
about another 30 different recommendations. So as I turn this over to
Lillee, I do want to commend both her efforts and Jonathan's efforts to
keep everything on track, and as you say, crisp and actionable. Thank
you.

MS. GELINAS: Thank you, Karen. Karen has been just wonderful counsel. I
want to acknowledge her as well. And I do want to extend, on behalf of
John Perlin, the fact that he wishes he could be here, but trust me, he
is here in spirit.

And as Karen said, I would say that in the leadership of our Workgroup,
we said that we did not want initiative overload to get in the way of
focus. And I'll say that again. We didn't want initiative overload to
get in the way of focus. This was tough stuff, in order to bring to you
just a few recommendations, when it would have been much easier to have
brought you 15 and let you sort them out.

So when you look at the Workgroup member list, I want to acknowledge the
tremendous work that this Workgroup has done to bring us to a short list
of recommendations. And you can see the members of our Workgroup. I have
really not worked with such a talented group of folks in a really long
time. I want to commend them for our goal of getting to focus.

Let's review just quickly, I know there is always new members present.
The Electronic Health Records Workgroup overview, our broad charge and
our specific charge \-- I'll try to get this advanced, there we go. Our
broad charge was to make recommendations to the Community on ways to
achieve widespread adoption of certified EHRs, minimizing gaps in
adoption among providers.

And our specific charge, to make recommendations so that within one
year, standardized, widely available and secure solutions for assessing
current and historical laboratory results and interpretations is
deployed for clinical care by authorized parties. It's hard to believe
that it was a year ago when the EHR Workgroup was making its
recommendations, and much has been done in that period of time.

We moved to the broad charge in June 2006, just so you know that. We
have been concentrating since that time on issues related to EHR
adoption and physician practices. And then let me also point out that
following, I hope, our robust discussions today, that this Workgroup is
now moving to EHR adoption in the hospital setting. Our next Workgroup
meeting will begin to tackle the issues related to EHR adoption in the
hospital setting.

But just to review what we put in front of you in May 2006, there were
seven recommendations from the EHR Workgroup; and once again, let me
emphasize, this related to the laboratory. We have been results-oriented
in our work, and have tried to hold recommendations at a minimum. And as
you see, I will not read these for the sake of time, but Mr. Secretary,
the fact that seven recommendations have gone forward, acted on, and are
in place, I also would like to commend the EHR Workgroup for their
leadership in calling out some recommendations such as we needed a
Privacy and Security Workgroup on its own.

And that we did need to move rapidly on the Secretary's desire to see an
interoperable first responder EHR. The HITSP interoperability standards
for exchange of lab results presented to you in October, done. So I hope
that when we're presenting to you the hospital recommendations, that
rather than having all the words on this slide, we can just have done,
done, done, done, done. Let's hope.

Our next slide really refers you to how we focused, because this entire
area of electronic health records is huge. So we used much of the
testimony that we had seen in the past, and addressed the most pressing
issues in order to move these issues forward. And the five key areas of
focus are business case alignment, workflow and cultural concerns,
medical-legal issues, privacy and security, and state of the technology.

We have heard extensive testimony in the areas of financial and business
case barriers, organizational issues such as workflow, work design,
human resources, and culture; Medical-legal concerns, privacy and
security concerns. And of course we've heard many speak on technical
issues.

Today's recommendations, I'd like to bring to your attention, are going
to focus on the first three areas that we believe are critical to
furthering the adoption of EHRs. The other two areas we will continue to
consider, but remember that we now have a Privacy and Security and
Confidentiality Workgroup that will be focusing on that area, and we
also know that continuing advances in interoperability and usability
will address the state of the technology.

The first of these in the business case alignment area pertains to the
financial arena. Recent studies suggest that the EHR adoption rate is
still very low, about ten percent, due in part to the misaligned
business case for physician adoption. EHR systems are costly, but the
return on investment is directly, primarily to the entity that holds
financial risk for the cost of care. So once again, let me emphasize
misalignment of incentives.

The executive order, I remind you, promoting quality and efficient
healthcare and federal government administered or sponsored healthcare
programs, which was released in August of 2006, directed the Federal
Government, in its contracts with commercial health plans and insurers,
to include language that promoted the adoption of HITSP interoperability
specifications. This provides an opportunity for the Federal Government
to guide commercial health plans towards programs that are likely to
accomplish this goal.

In the ambulatory care sector, adoption of HITSP standards is most
effectively accomplished by the adoption of certified EHRs. Which, I
know we're all proud of the fact that there are now 55 certified, almost
25 percent of the marketplace. When we first began here at AHIC, we
couldn't have said that.

Pay for performance plans can be strong motivators for physician
behavior, and this has been a key topic of our Workgroup testimony. Most
pay for performance programs are based on process and outcomes measures,
which favor those who have already adopted EHRs.

We now know, and please remember this, that it takes about three years
to demonstrate improvements in clinical outcomes after EHR
implementation. It takes three years. Many times faster, sometimes
slower.

Structural measures have been defined by the Medicare payment advisory
commission and include, for example, things like patient registry
systems to monitor and track patients, evidence based clinical decision
support at the point of care, and medication safety checks.

We heard testimony from both Bridges to Excellence and the Pacific
Business Group on Health. In conjunction with the healthcare \--
Integrated Healthcare Association, which have offered programs that pay
for structure, as well as process and outcomes, in a way that is
weighted towards moving practices along the path of adoption, and the
path of better outcomes.

We learned that physicians who implement certified EHRs, and those whose
care is supported by these types of structures, can be rewarded, at
least in part, on these measures, until their systems have matured to
the point of improved outcomes. Remember, I said it takes a while for us
to really see improved outcomes as a result of implementation.

So before I ask you to discuss the Recommendation 1.0, let me just read
that Recommendation 1.0; and I'm going to ask you, I would like to read
Recommendation 1.1 so we can take both recommendations in concert.

But our Recommendation 1.0 to you, as the Federal Government develops
language in its contracts with health plans and insurers to support the
widespread adoption of HITSP interoperability standards, this language
should foster the use of pay for performance programs for physicians
that include structural measures to incent the adoption and effective
utilization of certified EHRs. This emphasis on structural measures may
be limited to a specific timeframe, with the ultimate goal of using
process and outcomes measures to assess performance.

With that, let's turn to Recommendation 1.1, and we will come back to
1.0. In addition to the March 2005 MedPAC report to Congress, which
recommended the use of structural measures in pay for performance, the
Tax Relief and Healthcare Act of 2006, which became public law on
December 20, 2006, recognized the value of structural measures in 2008
pay for performance programs. Such structural measures can be validly
and reliably assessed by using either the National Committee for Quality
Assurances, or NCQA proprietary physician practice connections
assessment tool, or using the publicly available office systems survey
developed by CMS for use by its QIOs.

Therefore, Recommendation 1.1, these pay for performance programs should
use reliable, standardized, and validated tools which are currently
available to us as structural measures, as defined by MedPAC, such as
NCQA's physician practice connections, or CMS's publicly available
office systems survey. And once again, our Workgroups saw demonstrations
of both.

So with that \-- those are our Recommendation 1.0 and 1.1, and we open
the floor for discussion.

DR. BRAILER: Okay. Chip?

MR. KAHN: I'm not sure where to start, and let me start off by saying I
really apologize for being asleep at the switch here. I have two issues
that will go through each of the recommendations. One is a thematic
issue of how you use pay for performance. The other is a structural
issue of how you apply it.

And let me start with the second, because it's more relevant here in
terms of Recommendation 1.1. I think we have the wrong bodies here. We
have the National Quality Forum, which is the entity that endorses
measures, endorses safety practices, and ought to be endorsing here, and
it plays that role in government policy, and it really should be here
rather than MedPAC.

MedPAC is not the right entity here. It doesn't play this kind of role.
It does make policy recommendations. It does advise Congress on an
ongoing basis regarding payment policy for Medicare, but this is the
wrong track. And what we are all seeking, I think all the stakeholders,
generally, is to try to have NQF play this role as the ultimate filter.

And so \-- and not that it's \-- and so this is a structural measure, in
a sense, that's not dissimilar from many of the safety measures, or from
computerized prescription order entry. And I think that's the proper
entity to play the role.

Second, I think it's very important to instill in this that NQF, and
then ultimately, the AQA on the physician's side, and the Hospital
Quality Alliance on the hospital side, are the filters in terms of the
\-- in determining practicality of what is set of requirements, whether
they be clinical measures or structural measures. The HQA is already
playing this role in the clinical side, but it's also playing it on the
quasi structural side, by being an entity that approved H caps, which is
the survey done of consumer expectations or patient expectations.

So I think that the route here and the sort of guardianship by the
stakeholders of what the "it" is, is not really present. That's the
first thing.

The second thing is, I think when we, in the first recommendation
overarching, make recommendations about pay for performance, we need to
be awfully careful about what the "it" is and what we're talking about.
One person's pay for performance is not another person's pay for
performance. And I think that \-- I'm not \-- I can't be against pay for
performance, I mean it's the fad of the moment; but I think we have to
be very careful to say that we want to provide some incentive. But I
would almost step back and say, why do we even need to get into the
current term of art, and just simply say, financial incentives of some
type ought to be included.

Now, I have some problems when we get later on with Medicare, in later
parts of the recommendation, but those are \-- I probably said enough
for that right now.

DR. BRAILER: Doug.

DR. HENLEY: Well, in speaking in general about both 1.0 and 1.1, I'll
just simply quickly say, let the congregation say a big amen. This is
finally putting, in general, a financial incentive on the table to move
the adoption of electronic health record technology in a meaningful way,
a positive financial incentive, and so I applaud the Workgroup in moving
this direction.

I share some of Chip's concerns about semantics, and the groups that we
referred to such as MedPAC. MedPAC is not the right entity as compared
to NCQA, and some of the others that Chip referred to. But I consider
that more semantic than the guts of the recommendation.

So with those qualifications, I think both of these recommendations are
on target, but let's modify them so that we get it right in terms of the
entities involved, as well as the \-- I view this as pay for use rather
than pay for performance. I mean that's another term that one might use,
or just simply the term, let's build in positive incentives for the
adoption of certified EHRs, and leave it at that. But the goal is the
same.

DR. BRAILER: Justine, do you want to speak, and then I'd like to turn it
back to Lillee and Karen for comment.

MS. HANDELMAN: Sure, and I'll be brief. I want to echo what Doug had
said as well. We think this is a great starting point. I just also
comment on what Chip had said, that there are many things that are going
on, pay for performance is evolving, and I think it's important that we
recognize \-- maybe we don't use the term of art pay for performance, or
we add in, or other incentives, because there are things that we're
doing, and we don't want to shut down where there may be some real
innovative ideas.

And for example, one thing I know Doug is involved that we're doing is
the advanced medical home. And how can we do things in that area and
continue to incent? So we just want to make sure that we don't limit it,
that we allow incentives that are appropriate.

DR. BRAILER: And just to make sure that I have a synopsis of this, I'm
not hearing opposition to incorporation of EHR in a pay for performance.
It is that it should be written more broadly. Is that fair, Chip? I'm
not going to putting words in your mouth.

MR. KAHN: It is fair. I think later on you get into \--

DR. BRAILER: I understand that.

MR. KAHN: \-- a recommendation that's very specific, and I have concerns
there. But, yeah, I am supportive of the notion \-- I just \-- I guess
what I'm most concerned about is that we are careful in terms of not
tying ourselves to something, and be broader; and then structurally,
that we respect the current structure that has grown up on the measure
side, because it's there, and we ought to use it. And if we set up some
other structure or set some other kind of thing, we begin to undermine
the credibility in other things of a structure that we need.

DR. BRAILER: So Lillee and Karen, if you could just speak to the
question of how intentional was the limitation here with respect to pay
for performance, and to the specific players that were enumerated in
1.1?

MS. GELINAS: Let me just say \-- and if John Perlin were here \-- I wish
I could read the script for him, but I want to just absolutely make sure
you understand that tough problems take tough conversations, and I
appreciate that very much. And that's why you have the recommendation in
front of you.

It was not meant to be limiting, and Doug, thank you, because I really
believe that the conversations in the Workgroup were around pay for use
or pay for adoption. That was the more common language that was used. So
I thank you for bringing that up. And if you use that pay for use or pay
for adoption frame of reference, then, Chip, I don't know if that
satisfies what you're \--

MR. KAHN: \[inaudible\]

MS. HANDELMAN: If I could just add, the one thing that we thinks
important in the short term, certainly we agree pay per use, and it's
something our plans are doing; but it needs to be tied to, and I know
the recommendation's there, eventually when we're ready, getting to
paying for outcomes. That's very important.

MS. GELINAS: Right. We greatly appreciated the testimony we had, though,
from several physician practices that have adopted EHR, that talked
about the amount of time it took to adopt that EHR, get it wholly
interoperable, have all their staff know how to use it, and then be able
to start seeing clinical outcomes improve as a result. It's not
automatic and didn't happen in 24 hours.

DR. BRAILER: Dan, and then Doug.

MR. GREEN: I have a practical question to do with the first part of the
recommendation. The recommendation is aimed at the Federal Government
that contracts with health plans and carriers to promote this, and being
a representative of one of those government entities, I have a practical
concern about how to implement.

And first a question. Currently, we're operating under an executive
order that has us implementing HIT standards through the \-- among other
things, through the contract mechanism. And there is a section in that
contract, in that executive order that says that your efforts shall not
increase costs.

Well, just on the face of it, pay for performance is a method of
transferring cost from the contract payer to the provider. And was that
discussed in your \--

MS. GELINAS: Budget neutrality absolutely underpins everything that we
did.

DR. BELL: Perhaps I could address that as well. There are many plans who
are already doing pay for performance. Not that many are using
structural measures. So if moneys are already going into pay for
performance programs, our hope is that there would be an opportunity,
for at least a limited period of time, to use structural measures.

And the reason that we outlined MedPACs structural measures is because
they are based, essentially, on the ones that were developed by NCQA,
and many people aren't really aware of what a structural measure
actually is. So by referring to the public, very public access of
definitions of what could the examples of structural measures, MedPAC
provides that. So that was the reason we outlined \--

DR. BRAILER: So just to be clear here, you're not calling for the
adoption of pay for performance measures, per se. You're calling for if
they're going to be used, that they include some kind of an incentive or
a bonus within that, for the use of an EHR to improve quality. Is that
\--

DR. BELL: That's correct.

MR. GREEN: I think that would be real helpful if that was captured in
the recommendation.

DR. BRAILER: I think we have some semantics to do here, and this is
consistent with, I know, testimony you've gotten where large pay for
performance programs have seen, that those doctors that use electronic
health records actually perform consistently better, but it is a zero
sum gain where those incentives come out of the overall pool that are
using the pay for performance. Chip?

MR. KAHN: I have a real problem with that. I mean it's not here, the
word budget neutrality is not here. When Lillee described it, she said
it takes three years. I mean we know that the capital investment, the
workflow issues, the development and the effect on care of records is
not an immediate thing.

So for us to say we're going to budget neutrally, take from some people
and give to other physicians, is, I think, problematic. And part of the
semantics of talking about financial incentives, in my mind, is not
necessarily saying that this body is qualified to say it ought to be
done in a budget neutral fashion.

I mean it just doesn't \-- it doesn't work for me, because the very, you
know, the very fact that this is not something that has an effect
overnight, I mean it's not like a clinical measure where you say if
you're not given the aspirin, you know, maybe when somebody comes to the
emergency room, they ought to be burned for it.

Well, I can live with that, probably, because it's a question of
standard of care. Here we know it will have a positive effect, we're
confident of that, but it's not a standard of care, at this point. It
may become one eventually.

And I think to imply that people should be \-- somebody should be
penalized, and somebody else rewarded, I think is a problem. As soon as
you say budget neutrality, you're dealing with penalties. And I think
this body is not the right one to adjudicate that, for one. And two, I
just find it troublesome.

MS. GELINAS: And Chip, I would just ask that in future Workgroup
meetings, because I want to honor the number of Workgroup members that
showed up for all of our meetings that vetted this recommendation. And
we had those tough conversations. But it all boiled down to the
testimony that we heard from those payers that had remarkable, higher,
better clinical quality and lower cost, and the use of health IT was the
railroad track that got them there. It was very powerful. And it was
very compelling. And really was part of what informed the recommendation
as it is.

MR. KAHN: I'm not disagreeing with that, and I'm all for \-- I'm all for
even the requirement over time. But at least in the short run, to talk
about budget neutrality implies that you're going to penalize someone.
It's great to say we're going to have an incentive program, but when you
say budget neutrality, you immediately say we're going to penalize some
and reward others. And I'm just not sure for a clinical process, that
doesn't have an overnight effect, to say we're going to do that is
unfair. I guess I'll look to Doug, I mean I'll stop now, but \--

DR. BRAILER: I just want to make sure we have a discussion on using the
same words. Let's assume, and tell me if this is right, and then you can
decide if you still disagree with this. We're not discussing whether or
not money gets put out of some form of reimbursement, whether it's bonus
dollars or some other dollars into pay for performance. We're assuming
that there is money in a pay for performance pool.

MS. GELINAS: That's correct.

DR. BRAILER: And the question is, is that money allocated purely on the
basis of their outcome measures, or in many programs, simply the
reporting of outcome data; or is some of that earmarked such that the
money that is either allocated to outcomes or to data, reporting is
given preferentially to people who do it with electronic health records.
So we're not talking about a penalty, we might be talking about a
smaller incentive, if you do it manually. Now, I know this becomes
semantic, but I'm not \-- I'm not trying to steer the conversation. I
just want to make sure we're all talking about the same thing.

MR. KAHN: The problem is that this level of 30,000 feet with this
recommendation, it's probably vague enough that it's not clear. When you
get to the further recommendation about Medicare later on, that's where
the rubber hits the road.

DR. BRAILER: I can tell you're already going to talk about that one,
Chip. \[laughter\] Okay. Doug, did you have comments? I'm going to come
back to Steve.

DR. HENLEY: I think your last example, David, may have clarified it for
me. As I read 1.0 and 1.1, that the intent was that within a health
plan, you've got a fee schedule where the docs are being paid according
to a fee schedule that's usually RBRBS based, with one or more
conversion factors, and that's the standard fee schedule. To the extent
that any of those programs have an additional pool of dollars, as you
described it, David, for pay for performance, then typically in the
current environment, most of those are usually process measures that
people are reporting, more so even than outcome measures. But very few
of them, there are some exceptions, but very few of them have structural
measures.

So what we're trying to achieve here is that structural measures should
become part of those programs so that that pool of dollars, people \--
physicians and other providers, to the extent they implement EHR,
certified EHRs, can have access to that pool of money. Not the basic fee
schedule pool, that stays the way it's always been. But the incentive,
the positive incentive for pay for performance becomes pay for use, in
addition to pay for performance.

And you can still stay in the paper world, if you want to, and report
process or outcomes measures, and you might get some financial incentive
for that as well. Or you can do an EHR, plus the other, with your EHR,
and get more access to that money.

DR. BRAILER: If you look at this on a purely economic basis, it
recognizes that, in fact, as ironic as this sounds, it's actually more
expensive to do these things in the short term, with electronic health
records, because the systems aren't set up. Someone always has to push
F7 and report the data.

So this is, in a sense, trying to keep a level incentive for those who
are using the tools, so that there is not a disincentive for the
electronic health record to be put in place.

But regardless of the semantics, I think, you know, the main thing is we
define it the same way. And I'm reminded by Gary, that, you know, budget
neutrality, can be defined not necessarily in the same budget year. It
could be a five-year budget neutrality.

MR. KAHN: Yes, it could be. And \-- but experience with the government
is that budget neutrality means that generally there is less spent,
overall; unless you're Maryland, unless you're Maryland, and your budget
neutrality is over so many years, then that you can pull the wool over
the federal government's eyes and make a lot of money on their hospital
side.

But I mean \-- I just think it's a very difficult concept, and I guess
I'm just saying we should avoid it. But \-- and there are, you know,
Leap Frog does this right now with computerized prescription order
entry, and that's really problematic. It's problematic because, you
know, you just can't say, go do CPOE, you know. You've got to get a lot
of people to buy in, so these things are very complicated. I'm just
saying we've got to be real careful.

MS. GELINAS: David, I do want to say that the way Doug framed that was
the intention of the Workgroup, I believe. The way he worded that.

DR. BRAILER: Steve, and then Dan.

MR. LAMPKIN: This is a very \-- what we would call spirited discussion,
and it's kind of fun to watch this happen. Let me frame it a little
differently and go back to the terms, forgetting, for a moment, the
bucket that the money comes out of.

I really do like the idea of pay for adoption or pay for use, because I
think it's broader, and I think the broader we can be to envelop or at
least to enable us to look at a broader array of possibilities would be
good; because the common ground here is that I think we all have agreed,
and many, many others outside this room have agreed, that the technology
is not the end game, it's the enabler. It's what's going to help us to
improve quality, safety, effectiveness, efficiency, all of those things
in the healthcare field.

Having been in that field for 27 years before I joined our company, I
can tell you, I have been there, done that. And so I do have that
appreciation of the provider side.

My point being, that I think we're going to have to look for new, very
innovative ways to think about paying for adoption, and so I think as
large employers, as the government, we should be looking at everything
\-- not just electronic health records, but electronic consultations,
electronic messaging, phone calls to the office that perhaps will save
the patient and the system a whole lot of money over time. Electronic
clinical decision support. All those things that work together to drive
quality, and safety, and effectiveness, and efficiency.

So I think we ought to look at that very broadly. One of the things that
Doug's group has talked about is, if you will, e-coordination of care,
especially on chronic diseases. So I hope that we can frame it broadly,
not narrowly, and that we can keep a very open mind to the
possibilities.

DR. BRAILER: Thank you. Dan.

MR. GREEN: Along the same lines, and to risk getting into the weeds a
little bit again, one more semantic point. I would like to see the
language broadened to get away from contract itself. For what we're
talking about now, at least in my program, the contract is not
necessarily the correct vehicle to accomplish this. And so I would
recommend additional language that gets at promoting adoption, and
incentives and such things, but not necessarily \-- not restricted to a
contracting vehicle.

DR. BRAILER: And Dan, you can supply, through further work with the
Workgroup, what that might look like?

MR. GREEN: Yes.

MS. GELINAS: Help us with the language with that.

MR. GREEN: Sure.

DR. BRAILER: Okay. I would suggest, based on our discussion, that I
think I hear three things. First, there is significant enough concerns
with the scope and wording of this that it requires some more work.

Secondly, that there is a general thrust of support for what this is
intended to be; and therefore, the Workgroup should recognize that we
are going to send this back to them for that kind of a tune up and
expansion.

And thirdly, that the AHIC stands ready to approve this when it comes
back, if it's in that form.

So with that, let's move on, Lillee, and thanks. This was a very healthy
discussion.

MR. KAHN: I would like to qualify that, depending on later, where we
stand on later recommendations.

\[laughter\]

DR. BRAILER: I've got you first in line on number four, Chip.
\[laughter\] Okay. Let's turn to number two. Let's go through these
quickly so we can get to number four, right?

MS. GELINAS: That's right. If you think this discussion was good, for
all of you that thought you were getting out at noon, no. Okay.

Recommendation 2.0, and let me just frame it in this way. That as a
Workgroup, we heard much testimony that helped us understand what
physician offices had to do to reorganize work flow processes, train
employees, minimize disruption and patient care during the EHR process.

We absolutely understood that effective adoption of an EHR, with minimal
disruption, poses an additional and unique challenge, especially for
small practices with limited resources. In addition, CMS has supported
the creation of doctors' office quality information technology
university or DOQ-IT U, a publicly available CME supported web based set
of learning modules that can guide a clinician's office, through the
steps necessary, to successfully and efficiently choose, contract for,
and implement an EHR that best meets the needs of that practice.

It's based on the learning and experience of the DOQ-IT program, which
is currently supporting the effective adoption and use of EHRs in over
5,000 small physician practices. I have to admit, I was extremely
impressed with it when I saw it.

Early experience suggests that this tool provides physicians with the
needed information they need to effectively move across the adoption
process. At present, however, DOQ-IT is in need of upgrades to its
web-based learning platform, and needs continued funding for
maintenance, further module development, and content enhancement.

Therefore, coming to you as Recommendation 2.0, HHS should provide
continued support to DOQ-IT U for new module development, upgrades,
maintenance, and CME credit management, beyond the eighth scope of work
currently funded by CMS. The program should be supported by a learning
management system that is user friendly, has search functionality, and
provides links to other key sites.

Back to you for comment.

DR. BRAILER: Thank you, Lillee. The floor is open. Doug?

DR. HENLEY: Well, in \-- I don't know a whole lot about this specific
aspect of DOQ-IT. And I suspect that the information the Workgroup has
gotten is pertinent to the recommendation.

My only request or question is, do we have data from the user community,
those 5,000 practices or whatever, that, in fact, this tool has been
useful? I know at some point in time, there was supposed to be an
evaluation of the program. I'm not aware that the evaluation, from the
user perspective, has occurred. And so if \-- obviously, if that
evaluation from the user perspective was glowing about this program, and
the need for constant upgrades and whatnot, wonderful. Let's make that
happen.

But if the user community said this wasn't worth a toot, then why are we
continuing to put money into it? So I don't have that information to
make this determination at this time.

DR. BRAILER: Thanks, Doug. Lillee, what did you discover?

MS. GELINAS: The presentations, we did have some users, and the notion
here is that we needed to give especially small physician practices
tools that were free, and that worked. And certainly the testimony we
heard was that they worked.

Our concern with just bringing this to you and saying, we need to
continue with DOQ-IT, is that its funding ends with the eighth scope of
work. And therefore, if we're going to move with a tool that will enable
physician practice adoption, there are two things that have to happen:
the funding, and then the upgrading in order to meet current needs.

DR. HENLEY: My only point, Lillee, would be that in a group of 5,000
users, you can always find somebody who's had a good experience to make
testimony versus a full evaluation instrument that gives you the
diversity of opinions of all 5,000.

MS. GELINAS: Well taken.

DR. BRAILER: Rob.

DR. KOLODNER: I want to make sure that we're separating the DOQ-IT U,
which is the educational module, from DOQ-IT as the program. I think
this specifically is talking about this educational tool for helping
doctors to understand how to choose electronic health records, not the
entire DOQ-IT program.

MS. GELINAS: Right.

DR. BELL: Thank you very much, Rob. I'd also just like to add that this
particular tool has been used by folks outside of the DOQ-IT program
itself. So they've not actually worked within DOQ-IT, but they've used
the tool and have found it very, very helpful. In fact, there is even a
university that has used it as a teaching module in its programs, and
has been very successful in that arena as well. It certainly is just
fairly new. It's just taking off now. But those who have used it have
given very, very positive feedback.

DR. BRAILER: Other comments here?

MALE SPEAKER: Out of curiosity, what sort of dollar sum are we talking
about?

DR. BRAILER: Tony?

MR. TRENKLE: I don't have that number in front of me for the actual
DOQ-IT U.

DR. BRAILER: Do you know the budget of all of DOQ-IT is \-- anyone know?
Karen?

MS. BELL: The original funding for the development of the DOQ-IT
University was about \$3 million. Ongoing funding would be certainly
much, much less than that.

DR. BRAILER: Craig, you wonder why we're talking about it?

\[laughter\]

MS. GELINAS: Are you going to write the check, Craig?

DR. BRAILER: Okay. I would suggest \--

MR. BARRETT: Prioritizing the discussion, David \--

DR. BRAILER: Thank you, Craig. The message is well taken, sir.
\[laughter\] With that, I would just suggest, and I hope the Workgroup
wouldn't be offended by a \-- just a notation here that calls for the
ongoing evaluation of the program.

I think it's clear, whether it's been evaluated or not, people need to
know the successes and the failures, and so let's just make sure that we
note that. I hear no objection to this, so I would say by acclamation,
let's accept this, and we'll move on to 3.0 and 3.1.

MS. GELINAS: Thank you. As we move to the medical-legal area, let me
just note that we did hear quite a bit of testimony, as well as
conversation, around the fact that physicians are concerned about the
accuracy of information coming from multiple other sources.

They are also concerned about responsibility for large amounts of
electronic health information that were not anticipated, and increasing
demands for personal health information to be made available for
purposes not related to direct patient care such as quality, public
health reporting, research, et cetera.

Clear, focused, easy to find documentation of health information
decreases overall cost of claims paid by malpractice coverage entities,
and some have decreased premium rates for those physicians with specific
CCHIT certified EHRs. Let me say that again. Some have decreased their
premium rates for those physicians who have adopted specific CCHIT
certified EHRs.

HHS should, therefore, encourage the Certification Commission to assure
that its criteria include approaches to mitigate malpractice risk.

It was interesting, hearing the medical-legal testimony, and hearing
that in one insurer, that 70 percent of their claims are settled due to
a lack of documentation. 70 percent of their claims are settled due to a
lack of documentation.

With that, I'd like to just move to 3.1, so that we can take this
medical-legal arena together in our conversations. We heard, again from
those malpractice carriers, that lower the cost of malpractice premiums
to providers. And I know that most of our information is posted online.
That may be an area of great information for you. It certainly was for
me.

We really, as a Workgroup, wanted to encourage HHS to influence
malpractice carriers to consider the similar premium reductions that we
had seen in these prototype groups that testified in front of our
Workgroup.

So if we can go back, Recommendation 3.0 was HHS should encourage the
CCHIT to obtain medical-legal counsel, which would assure that its
functional criteria include documentation, security, and other
approaches that will mitigate malpractice risk.

We pulled out 3.1 for a reason, because it was another specific action,
that HHS should work with malpractice insurers throughout the country to
encourage premium reductions by those physicians who have adopted
certified EHRs.

These two recommendations, in no way, fully represent the amount of
discussion and the presentations that we had in this entire
medical-legal area.

DR. BRAILER: Thanks, Lillee. The floor is open for discussion. I have a
quick question, which is about 3.0. I know that one of the key issues
with defensibility in these cases is about attribution, which is the
ability to have a positive identification of who did what at what time,
which is potentially quite disruptive to physician workload, to have to
potentially sign on every time a certain prescription is given or add a
new password.

Has this been discussed in terms of \-- or let me ask a different way.
You're calling for the CCHIT to make those kinds of tradeoffs about its
work flow requirements for doctors versus these kind of protections. Is
that fair?

MS. GELINAS: That was my understanding, but we really didn't go into
this particular aspect about attribution, single sign on, that kind of
thing in depth.

DR. BELL: And I would just add that that is one of the reasons that we
would like to encourage the Certification Commission, itself, to work
with the medical-legal lawyers to determine what's the best way to move
that forward.

DR. BRAILER: Oh, very good. Okay.

MS. GELINAS: You get into legal language, it's a different ball game.

DR. BRAILER: Tell me about it. Okay. 3.0 and 3.1, is there any dissent
to either of these? They stand adopted. Let's turn to 4. Chip, do you
want to start now, or do you want them to read it? \[laughter\] Do you
want them to read it first?

MS. GELINAS: Do I really need to read it?

DR. BRAILER: Yeah, go ahead. Might as well get it over with.
\[laughter\]

MS. GELINAS: And I would just publicly like to commend the Workgroup for
their leadership in bringing this forward, and the vetting process that
we went through. We had quite a bit of wordsmithing. We are aware that
CMS is bound to provide services in a budget-neutral environment. And as
payment updates are considered and acted upon by Congress, CMS has the
unique opportunity to support the adoption of EHRs, by differentially
reimbursing those who have adopted certified EHRs at a higher rate than
those who have not adopted any form of health information technical
support.

While the Workgroup has concentrated on physician EHR adoption for the
past year, it was made very clear to me by the Workgroup, that when I
read this recommendation to you, that it was clear that this
recommendation may apply to other settings in the future, and remember
that with our next Workgroup meeting, we will begin to consider hospital
EHRs.

With the completion of this set of recommendations, and as we turn to
the adoption of hospital EHRs, your discussion today is going to be
critical as we begin to delve into this next major area of deliberation.

So the overarching Recommendation 4.0, HHS should develop a schedule for
implementing differential reimbursement to Medicare physicians for use
or nonuse of certified EHRs. While we would defer to departmental
expertise, we note that this might be achieved by paying full Medicare
rates and market basket updates, and possibly an EHR premium, to
physicians using certified EHRs, while physicians using paper based
records are paid at discounted rates, achieved by nonqualification for
full market basket updates or other measures. Back do you, David, for
discussion.

DR. BRAILER: Okay. Is there any discussion on this? \[laughter\] Chip
Kahn?

MR. KAHN: Okay. I have two levels. One level is easy and I'll dispense
with it, which is this needs to been rewritten even in its current form,
because the market basket is a hospital side term, and all this is done
under the sustainable growth rate \[SGR\].

And I'm nervous to even say the words sustainable growth rate, because I
committed many sins when I worked on the Hill in my work on physician
payment reform that ultimately led to the sustainable growth rate we
have right now, is one of my embarrassments.

The fact that physicians are going to get a ten percent cut on January
1, unless Congress acts, and the likelihood is they will act, but I mean
in that kind of environment, where you have a \-- this gets into the
thematic side, a destabilized payment system, I think you've got to be
very careful when you start talking about using money, whether it's
budget neutral or not, in this way.

So one, I think you're treading on \-- regardless of other providers
that Medicare may pay, this is a very dangerous area to tread on,
because we have an SGR that is broken, and we have a physician payment
system that's broken; and even though Congress did, in the last
Congress, pass some differential update, ultimately, I guess, in the
middle of the year, based on reporting, which is problematic on its
face; I think it's very difficult to get into this area of Medicare on
physician payment.

Second, I guess going back to the whole point that the results of this
are not overnight, and if the results are good, that actually, over
time, will play \-- will reduce physician or hospital or provider
revenue.

I think as a theme, one of the things that this group needs to recognize
is that the big loser in better care, more efficiently provided, with
better outcomes, is the revenue of doctors and hospitals and other
healthcare providers.

Now, they ought to make less revenue, if we can get better care. But the
point is that all these things that make things more efficient, one,
frequently cost capital, capitalization and ongoing operating expense;
and two, you're taking money out of the people who are ultimately going
to lose because of what you're doing.

Now, that's great, and we ought to be doing that, but I think that this
kind of change \-- we ought to recognize that we want to move the
providers in a positive way. But we also got to recognize that it is \--
if we design it as a zero sum gain, ultimately you're just going to get
dissidence from the providers, because all they're going to see is that
you're imposing things on them, without any kind of return on equity
that \-- to them, that you can really rely on. And \-- so the business
case isn't there.

But now, Government can do it. Government does it all the time.
Government did the SGR. But I think this group ought to recognize that
the return on investment on IT for providers isn't there.

And if it's a good thing, if it's for the public good, we ought to be
\-- we ought to be providing an incentive for it, but in terms of ROI,
in terms of return on investment, it's not there. Anyway, that's my two
cents.

DR. BRAILER: Doug, and then Jeff.

DR. HENLEY: Well, I remember those days ten years ago when I was
battling Chip about the SGRs, so I'm glad he's recognized his mistake.
\[laughter\] I, too, believe that Recommendation 4 is not ready for
prime time and goes too far.

1.0 and 1.1 is where we should have started and stopped in terms of,
again, providing a positive financial incentive for the adoption of
electronic health records, whatever the final semantics are that we
reach at our next meeting.

Adopting this recommendation enters into the Medicare fee schedule and
paying \-- creating a negative disincentive, if you don't adopt an EHR.
And I just think that sends entirely the wrong message in terms of
trying to raise all boats. And that's what quality improvement should be
about. And this would create a negative incentive for that.

The other concern I have is that to me, this recommendation implies that
an electronic health record is all about the business side of medicine.
And I would assert that EHRs \-- that's the practice management system
that's the business side of medicine.

This is as important a technology to improve medical care as a CT scan
is, as an MRI scan is, as the next ultrasound scan is. And when we
create CPT codes for those, we include what the cost of that business
is, and that new technology is. The current resource based relative
value system does not include the cost of this medical technology,
called an EHR, in the practice expense equation of ENM codes or anything
else. We would have to go back and totally, in my view, totally
reevaluate all those codes, as this being a new technology.

I don't think CMS or anybody else wants to do that. So I think we should
stick with 1.0 and 1.1 as a positive incentive, as part of structural
measures for pay per view, et cetera, and not adopt this recommendation.

DR. BRAILER: Craig.

MR. BARRETT: Could I have my endless voice for the consumer up again.
You guys are talking about the system. You're not talking about the
consumer. You're not talking about benefit to the end user of the
system. You're talking about benefit to the system. I don't think we're
about benefit to the system. If you are, then I'd like HHS to subsidize
the semiconductor industry as well as the medical industry.

We make investments, because we have to make investments to satisfy our
consumers, our customers. And I'd really like to have the conversation
always about return on investment for the consumer, return on investment
for the customer.

We sit here and debate, and debate, and debate about EHRs, and how do we
get these put in place. And every time we come up with a motivation to
do that, we come back to the system doesn't like it.

I just find objection to that. The customer likes it. I just came from a
conference across the street which basically, how do we get the consumer
involved. How do we get the consumer with his electronic medical record?
How do we service the customer better?

And this whole discussion is how do we service the system, not how do we
service the customer? And are we really interested in providing better
capability to the individual, to the patient, or are we worried about
does the hospital make more money? There is a fundamental difference of
opinion, I think, on what we're trying to accomplish.

DR. BRAILER: Jeff?

MR. WELLS: Let me just echo some of Craig's comments. I think on one
piece, I have just a question about sort of the pay for use model. I
think in reality, tons of providers are going to adopt EHRs, some of
which will implement them, and change their business practice in a way
that will improve outcomes; and some, unfortunately won't at the outset,
and maybe ever, be able to implement them in a way that improves
outcomes.

The question is are we going to be subsidizing the adoption of these,
knowing that many of those may not go well? So you may want to add on to
it you know, the adoption and some \-- excuse me, some demonstration of
an implementation that resulted in a positive outcome.

And I know that that's challenging, and you guys have likely addressed
that, but I would want to throw that out there.

And I guess the second piece is just touching on the reimbursement
structure. I know that this group has discussed that in the past. But I
think on a going forward basis, there will have to be a change in
reimbursement to be more aligned with value for the patient, as opposed
to, you know, reimbursements for hospitals and physicians, for just
doing more stuff.

DR. BRAILER: Lillee, could I turn to you and ask about the discussion in
the Workgroup, and as it's framed by what you've heard here today? I
think, you know, very different worldviews that are ultimately trying to
be reconciled with respect to where we go with healthcare.

Did the Workgroup have that same diversity of views, and what was the
nature of the dialogue that brought to this reconciliation, and what you
put before us?

MS. GELINAS: I wish I could play the tape of the conference call for
you; I think you would hear the same debate played out, which I think is
enormously important that we do hear both sides. And at the end of the
of the day, though, it's literally going around the Workgroup saying go
or no go, because we knew we had to sit in front of you today. And we
never would have brought this to you if there wasn't Workgroup
consensus.

Was there dissent? You bet. Was there concern? Absolutely. Did the
conversation need to be held? Yes. And I want to emphasize what I said
to Mr. Secretary right before he left, and that was, and I want to
underscore that the conversation was around, at the end of the day,
quality and cost. Not about the health IT system, as it was. And I just
want to make sure we represent that.

Carolyn Clancy sits on our Workgroup. She does a great job bringing the
quality piece, as well as the quality Workgroup perspective into our
Workgroup. CMS is on our Workgroup. We have a broad range of
stakeholders who had input.

I would also say that last year, around the May 2006 recommendation that
I sent you, perhaps after a Workgroup meeting, the e-mails are going
and, you know, there is behind the scenes conversations that are going
that would give you a real sense that perhaps there was going to be some
controversy.

When our Workgroup conference call ended, this conversation ended.
Neither Jon nor I had a lot of background conversation or future
concerns or anything that came forward. And so we viewed that as
consensus around the recommendation coming forward. I find that
conversational or lack thereof interesting as well, but Karen, you were
in that meeting. Would you represent it any other way?

DR. BELL: No, I think you've done an excellent job, Lillee. As you
indicated, we recognized this would be controversial. And one of the
reasons it is listed as an overarching recommendation is that we really
did believe the conversation here was critical, and that's why we
brought it \-- that's why the Workgroup chose to bring it here.

DR. BRAILER: And was the view of the Workgroup to bring it here for
general guidance, subject to the kind of nature of the discussion, or is
the Workgroup prepared to have the AHIC act at this point?

MS. GELINAS: I certainly got a sense that they wanted us to act. I
didn't hear that it was \-- because it was just going to be a
discussion. We could have brought it forward as an update or a
discussion point, but it passed the Workgroup as a recommendation to
come forward to you.

DR. BRAILER: And was there discussion of or testimony given that \--
about the question of the department's authority to do this under
current statute? Tony, maybe you could comment on \--

MS. GELINAS: I do recall \-- I can't remember who was on our call, but
we did talk about the regulatory and statutory implications of this, and
needed to talk more about that. But I know the CMS representative did
bring that issue up.

MR. TRENKLE: Yeah, we've had similar questions in the Chronic Care
Workgroup, and have brought in some CMS people from the Medicare
operations side of the house, and there certainly are legal and
regulatory constraints that need to be considered when you look at these
types of issues. So...

DR. BRAILER: Was it the goal of the Workgroup, Lillee, that \-- it's not
to seek statutory changes, to act with an existing authority?

MS. GELINAS: I do believe that would be correct.

DR. BRAILER: Okay. Justine?

MS. HANDELMAN: I just had a question. In any of the discussions, was
there discussion on how you would define the term of use or nonuse of an
EHR? Because I know that there was a report brought to the AHIC that HHS
had done, sometime last year, on adoption rates on EHR, and what was
interesting in that report is while the adoption rate might have been
around 20 or 25 percent, when you actually looked at those that were
using the full capability, and not turning off clinical decision support
in some of those important features, e-prescribing, that we see real
benefit, we were probably down to about nine percent. So they were
really only putting their records in an electronic form, not using the
features.

So one question is, has that use or nonuse been defined; and then
another challenge \-- I think there are issues here that probably do
need to be worked out, is how do you go about tracking which providers
are using and not using these in order to move forward? So I think there
is questions, and I don't know if that was discussed or how that would
be fleshed out.

MS. GELINAS: I do not believe we defined use or nonuse. However, and as
I noted earlier, that we did have \-- the conversations around the
adoption was only ten percent. At the end of the day, you couldn't use
all of the adoption data. We're talking fully implemented and used is
only ten percent.

And at the end of the day you just sat back and said, what other
industry would be tolerating this? So I think that's good counsel, and
we should go back and define use and nonuse, especially as we get into
hospital EHRs, because that aspect can be all over the board.

DR. BRAILER: Any comments here otherwise? Hearing the discussion, I
would suggest that we do the following, and then ask for anyone to
disagree or suggest an alternative pathway. I would suggest that the
Workgroup take this back, after hearing this discussion, and focus on
three efforts.

First, to clarify some of the nonsemantic issues within this. Chip has
raised issues about definitionally, we're really mixing metaphors
between end patient and ambulatory care. I think this question about use
is going to be an important question that goes just beyond the words.
It's how do we metric that, and I'm thinking kind of the preregulatory
dance that would happen with that.

Secondly, I think we do seek input on what minds can tell us we have
authority to do within the department, and what boundaries that would be
put on this, and the degree of feasibility that comes from that.

And thirdly, I would suggest just given the importance of this, and the
nature of the kinds of conflicts that ultimately are the ones that I
think are the very heart of where our healthcare system is today, that
the Workgroup have some form of substantial public input through a town
hall or through an open hearing, something where we can have more of
this debate to make sure that when you come back to us again, not only
do we have a more precisely written recommendation, but you can
represent, I think, the broader debate and be able to tell us either
that you could reconcile it or you couldn't. I think it would make it
just a more powerful ingredient in our discussion, and I hope you can do
that, if not by the next meeting, the one thereafter.

Does that sound like a reasonable plan to go forward? Craig? I know,
just do it.

MR. BARRETT: I just found wanted to add one other suggestion, that \--
the earlier discussion about the follow on to AHIC. This may be a
wonderful type of test case to put before those possible structures,
because I think these are the sort of issues that you're going to come
up with, and these are the issues of what are you trying to accomplish?
Are you trying to promote higher quality, lower cost healthcare to the
end user, or are you trying to protect the system? And I said that in an
inflammatory way, Chip, so don't get angry at me.

Because the extreme arguments are kind of useful sometimes to couch the
discussion, and so the three contractors that you have may want to look
at this type of a situation to see exactly how you could structure
something which would give you the full bodied and healthy debate that
we're having on this topic.

DR. BRAILER: And I'm sure that the contractors have heard this. Steve?

MR. LAMPKIN: I'd like to go back to something, Craig, you said earlier,
and it was about thinking about this entire discussion around
sustainability of the system. And what I thought you meant by that was
the healthcare system, all the providers and so forth. I think another
angle that we probably ought to have the Workgroup think through, in the
spirit of Consumer Empowerment, how do we not only incent appropriately
providers for adoption, but how do we incent the consumer? How do we
incent the patient?

One example might be, for this discussion, is, let's say that we incent
patients, your employees, our employees, government employees, to use
physicians who use e-prescribing, through some type of a discount on
e-prescribed medications, as opposed to paper medications.

What are those things that we can do, thinking outside of the box, of
our usual and customary mental mindset in healthcare, what are the
things that we can do as organizations, as large employers, to incent,
at the end of the day, the consumer? Because I think, Craig, you're
right. I think the thing that's been missing today, most of all, is what
is the voice of the consumer? The folks who are out there every day
trying to make good decisions about their own healthcare and that of
their family.

So I'm not sure what all that \-- what all the possibilities are, but I
think we ought to go back to that and ask ourselves, are we solving for
sustainable healthcare or a sustainable healthcare system for the
current model that we've known in the past?

DR. BRAILER: Okay. Any other discussion?

MS. GELINAS: I would say, as I said in the beginning, aren't you glad we
didn't bring a lot of recommendations to you? \[laughter\] And I want to
\--

DR. BRAILER: Could have had a fistfight.

MS. GELINAS: We truly wanted to focus where we would get the biggest
bang for our buck in moving this agenda forward, so I want to thank you
all for that.

DR. BRAILER: Thank you, it was excellent work. I appreciate it very
much, and thank you all for a healthy discussion.

At this point, the mics are open for any public input, and again, I
would caution to keep your comments brief. If you have materials to
distribute, we would be happy to take them, to share with the members of
the Community, and we will not allow any commercial solicitations or
endorsements.

Please.

MR. KEELER: Thank you. I just wanted to relay a word of thanks to the
Community because what you do does not go unnoticed out in the field. I
work for a PHR vendor, and in implementing strategies and tactics that
people are willing to pay for, the impetus that you have provided, in
terms of raising awareness, as far as how technology can save companies
money and improve individuals' lives is of tremendous value.

So in spite of the perhaps sometimes rocky road that you go through in
your discussions, certainly out in the field I can't thank you enough,
because it gives us tools to say this is where it's going.

And as you \-- and as solutions are being created, I want to give you a
sense of hope, too, from the company whose 80 percent of its assets are
involved in truck drivers to deliver propane gas in trucks, that there
are tools and they're adopting methodologies to get a hold of how many
are diabetics; capturing their glucose level remotely, to send them
alerts, to reduce their liability in the eyes of the state, that their
blood sugar levels are not so low that they're causing accidents on the
road. I mean powerful, powerful rubber meets the road sort of impact.
That what you're doing cannot be discounted in any way.

Secondly, on the issue of sustainability, I think that goes across
several fronts from what to do about the AHIC successor, to even
touching EHRs and physician adoption.

There is a couple of different models to Mr. Barrett's question, what is
people looking at as models, something that you, perhaps, might not have
thought of before, but obviously there is the subscription model where
consumers or employers or payers are using on a subscription basis, to
the fee for as you go basis.

And I kid you not, some of these discussions have looked at the TSA as a
national model that people are not necessarily frustrated with, but
there is a certain element that \-- when you look at communities and
regional RHIOs, it's a model that might have some legs to it.

And, of course, when you develop these residual streams of revenue,
going back to whoever sponsored the operation, that can pay for
physician adoption. So just to share some of these with you, you know,
you're doing great work, and thank you.

DR. BRAILER: Thank you, and just identify yourself for the record.

MR. KEELER: My name is Stephen Keeler, and I'm with the CapMED PHR.

DR. BRAILER: Thank you, Stephen. Ross Martin.

MR. MARTIN: Thank you, David. Ross Martin, with Director of Healthcare
Information Convergence at BearingPoint. I know many of you from my time
at Pfizer for the last six years, but I've recently taken a new role.

Two points. One of them is about the conversation that happened around
the National Governor's Association and the state initiatives. There are
\-- there is an ANSI-accredited standards organization MedBiquitous; I
serve on their executive committee. And they deal with medical education
standards, but they also deal with physician credentials, demonstrations
of competence, and the exchange of state license information. The
members include entities like the Federation for State Medical Boards,
the AAMC for medical college representation, the National Board of
Medical Examiners; and they have been working on pilots for exchanging
that type of information already.

So I'd just like to encourage you to include that conversation and
dialogue. Their website address is www.medbiq.org, but an important
place to look for work that's already ongoing in that.

And the second is just a comment about the AHIC successor, and the
potential roles. I did not hear a discussion about the global input in
both directions of what AHIC could have, or the son of AHIC could have,
in the global conversation about standards development. There are many
entities that represent, in different ways, the standards development
and also how we're going to do this on a global scale.

But I do think that there is \-- there has been a general \-- I have
been observing this whole process since its inception, and only
occasionally do we talk about the role of the global standards effort,
and how the stuff has to connect globally. And the future role of the
AHIC should, I believe, include either representation into that, or a
stronger level of feedback from that, so that we can coordinate on that
global level. Not just for issues around things like biosurveillance and
pandemics, but also to learn from those entities. Thank you.

DR. BRAILER: Thank you.

MS. SERKS: Good afternoon. I'm Catherine Serks, speaking on behalf of
the Association of American Physicians and Surgeons. I'm also, as I've
spoken before, I also sit on the HHS task force of Alex \[spelled
phonetically\] State Legislators Group, their Health Information
Technology Committee, and also on the Patient Privacy Coalition. And I'm
going to be putting something into the record for the Patient Privacy
Coalition as well.

But first, for my brief comments for AAPS. First of all, I heard the
very last speaker was talking about more public input, and we would
absolutely support that. I have found that attending the Workgroup
sessions of AHIC have been extremely valuable to me. And I've gotten
more information there in a useable form, and for discussion points for
me to take back to my physicians.

So I think that some of the \-- it's to open up some of the workings,
would be a very, very valuable process not just for you, but for the
constituency, the stakeholders. So I'd like to encourage that.

In January, I spoke \-- I made comments about concerns that I'd heard
about the state consent and privacy laws being perceived as a barrier to
implementation of HIT, and I'd like to take a moment to speak about that
again, because \-- and at the last meeting of the e-health alliance.
Again, that was \-- some of the discussion was positioned that way
again, that they're examining the existing state and consent,
particularly the consent laws, consent and privacy laws that are a
barrier, that pose problems for implementation of NHIN.

And I would like to, again, to offer the \-- our concern that instead of
thinking about these consent and privacy laws as being barriers to HIN,
to NHIN, that we need to remember to take a look at how NHIN would be a
barrier to privacy and consent, flip that equation around and start
thinking about it that way. And I brought with me some of my comments to
the NGA and to the e-Health Alliance, so I'd like to leave for the
record.

Now, on to the \-- there was one another thing that was mentioned today,
that I'd specifically like to address, and that is that in the
presentation on the personalized health records, the doctor raised the
issue of the embedding of the clinical decision support tools. This
always raises red flags for physicians.

I remind you that AAPS is the largest national organization of
physicians in private practice. The embedding of the clinical decision
support tools raises red flags and causes concern to the individual
physicians. That starts to sound to them like the cookbook medicine, and
concerns over pay for performance. So I'd like you to be \-- as you have
discussions about embedding those tools into HIT, that you remember
that.

Now, for briefly \-- to get into the record, the Patient Privacy
Coalition is a nonpartisan coalition of more than 40 organizations,
non\-- and as I said, nonpartisan; from the Christian Coalition, to the
ACLU, to the Family Research Council who have signed on. The coalition
has now issued its patient privacy rights, principles for 2007; and the
highlights of this that I think would be of interest, and I will \--
these electronic versions of this can be \-- these can be circulated to
the Community; is that patients have the right to opt in and opt out of
electronic services, that health information disclosed for one purpose
may not be used for another purpose without informed consent, and audit
trails be included in the design of any system so that any information
could be tracked. And that patients be notified of any breaches, and
that we have strong measures for meaningful enforcement mechanisms for
violations.

Now \-- and then the other issue has come up with the states, so in the
privacy principles now is preserved stronger privacy protections and
state laws, and that there should be no secret health databases; as New
York, New Jersey are looking at developing their system with their
cooperative patient identifier. We'd like full disclosure on any states
that are doing that.

So I will give these to you to submit for the record, and we sure
appreciate the time, again.

DR. BRAILER: Thank you. Please make sure that staff have those. Are
there any other comments? At this point, I want to thank you all for a
very, very healthy discussion, and very important work today, and we
stand adjourned.

[\[Whereupon the meeting was adjourned at 12:30 pm EST\]]{.underline}