American Health Information Community

EHR Workgroup Meeting

March 22, 2006

1 p.m. EDT

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\>\> JONATHAN PERLIN: Dr. Brailer, would you like to start with some
opening remarks?

\>\> DAVID BRAILER: Sure. Thank you. Let me thank everyone for
participating in the Workgroup discussion today and step back and more
broadly thank chairs and the members of the Workgroup and the staff, the
National Coordinator, and HSR for their very hard work in getting us to
this point. Those of you who heard or participated in the discussion of
the Health Information Community on March 7 know that we\'ve begun in
earnest the discussion and delving into the topics that the workgroups
are charged with. There was a very good and healthy discussion. I think
there\'s a great appetite to have more depth and more specificity as we
move forward.

My comments today are in the spirit of guidance and charge to the
Workgroup to make sure that everyone recognizes that the time between
now and 60 days from now, when the Workgroup goes back to the American
Health Information Community to report on its progress, is a critical,
critical time in the life of health information technology. We\'ve set
these very specific short-term breakthroughs with an eye towards getting
something done early next year, sometime in the spring of 2007 in each
of the areas. And that means that the recommendations that come forward
in May are going to be critical, because it takes months for the
government to work through those recommendations and to be able to make
determinations about what policies could change or what other actions it
could take.

So I just encourage you all to be as specific as possible and to
certainly make sure that as you go forward, you\'re not only thinking
about what advice you want to give the Secretary, but also what other
parties and industry \-- what industry segments you should be calling
out to to give them advice about what they should be doing to be able to
accomplish the goals that you\'ve got laid out, whether it\'s
physicians, the laboratory industry, payers, consumers, etc.

So I hope that you\'re able to make these recommendations about who
should do what and you\'re able to really bring that kind of
specificity, because I assure you, we\'re quite thirsty and hungry to
have this advice come in and to be able to really start turning the
wheels to have these translated into real results whenever we see that
we can do that. There is a short amount of time. I know it\'s incredibly
frustrating, because we\'ve got discovery going on at the same time
we\'re trying to shape, and at the same time that we\'re able to start
formulating these recommendations. But I think the key word that I would
use here is leverage, which is, "Don\'t get caught in the weeds. Don\'t
get caught in technology discussions." We let the market sort those
things out. Let \-- you keep focused on the key leverage points about
what the principles are and the governing ideas and about how it is that
we should go forward.

I know in your discussions one of these very, very key issues is going
to be, "Do you recommend that the world that you want to see be more
person-centric information or more doctor centric or more lab centric?
As you go forward with that discussion, that\'s going to set the tone
for everything else that you do.

Again, thank you all very much. We are very happy and thankful to have
you participating with us, and we are very eager to hear the discussion
and begin acting on the recommendations as the community brings those
forward to us. Thank you very much.

\>\> JONATHAN PERLIN: Thanks, David. Good afternoon, everybody. This is
Jon Perlin. Pleasure to welcome everybody to today\'s Electronic Health
records workshop meeting.

Lillee Gelinas will be joining us in about an hour. She is presently
using the wonders of technology to speak to about 16,000 constituents
throughout the HVA, Inc. family, and we look forward to her joining us.
We want to thank each of you for not only your participation today but
the participation throughout this process.

As David said, let me again thank Dr. David Brailer for your exceptional
leadership; your clarity of your charge; the passion with which you, the
Secretary, and indeed the President address the task before us to
realize not only the President\'s objective, making electronic health
records available to most Americans by 2014, but the immediate objective
we all share: developing breakthroughs in this coming year, which, as
you reminded us, require us to have our recommendations available
coherently, concretely, specifically to the Secretary in May to allow
for the mechanisms of government, all the associated regulatory and
simple communications processes to transpire. We had, I believe, a very
successful AHIC meeting a couple of weeks ago. I will come back to that.
But today, we have a very full agenda with a number of presentations.

And I think the ear that we have to listen to these presentations with
achieves two things. One, it answers the President's point that David
Brailer just raised, which is, who needs to do what to achieve these
breakthroughs? We need to be listening carefully to these presentations
with that in mind and with an ear towards being able to provide a degree
of specificity in terms of both what government and private-sector and
clinical and standard-setting entities need to do to be able to achieve
these breakthroughs.

And secondly, we need to be listening to the presentations \-- I\'ll
come back to this after we go through our basic introductory material
for today \-- with an eye towards what are the leverage points to
achieve success with the models that this Workgroup endorsed previously
and that were discussed at the last AHIC.

I will come back and set the stage for that momentarily, but I want to
turn now to Dr. Karen Bell to review the call-in procedures and the FACA
guidelines and allow full introduction after all members of the
Workgroup who now joined and are online. Karen?

\>\> KAREN BELL: Thank you very much, Jonathan. Before we go into the
call-in procedures and the introductions, in order to allow for a few
more people who might be joining us, I do want to first just go over
some of the guidelines. So everyone is aware that as far as the call-in
is concerned, it is only the Workgroup members or their designees who
can participate in today\'s meeting.

There are a number of invited presenters as well, as you know. And they
will be participating. The public will participate at the end when we
have our public comment period.

Secondly, I would like to address the publicly posted materials. These
include the summaries, transcripts, copies of the presentation slides,
and any recommendations or papers that have been developed and signed
off by the entire Workgroup for presentation to the AHIC, American
Health Information Community. The site also includes some publicly
available articles and references that were requested by the Workgroup.

There are materials that are available online to the Workgroup members
only while they are work in progress. And these include any preliminary
reports developed by small group members for work internally prior to
final vetting and prior to public availability. These can include the
recommendation documents that we\'ll be talking about shortly.

And lastly, I also wanted to address the fact that Workgroup members
very frequently may be asked to speak in various public settings. Please
be aware about two things. Number one, the workgroups do not and cannot
provide advice or recommendation to anyone, including the Secretary, the
Department, or any Federal official outside of a Community meeting. So
that all work here goes directly to the AHIC.

Secondly, when presenting in public forums, Workgroup members must
acknowledge that any comments outside of those that are currently
publicly available cannot be attributed to the Workgroup or to the work
that has been done within its context, so that in a public presentation,
only that information that is publicly available can be used in those
particular settings. So again, I just wanted to clarify that as a
background.

Now we\'ll go back to the call-in procedures and the introduction of the
participants, which I believe Matt McCoy will be doing for us.

\>\> MATT McCOY: Yes, Karen. The biggest difference with the call-in
procedures for this meeting as opposed to what we\'ve done in the past,
as Workgroup members already know: We\'re not using a queuing feature to
do the speaking today. So everybody has an open line, and you can speak
when you feel, when you see fit. We just ask that you keep your phones
muted on your end when you\'re not speaking to cut down on the
background noise.

And since you won\'t be introduced before you make a comment now, we ask
that you introduce yourself just in case we don\'t recognize voices. We
like to know who to attribute comments to. That goes for members
participating over the phone and in the room.

The other thing: if you are logged into the Webcast interface, please
don\'t touch the controls because all those changes will be streamed
live across the Web.

As Dr. Karen Bell already mentioned, we will have time set aside for
public comment at the end of this meeting. When it\'s time to receive
public comments, we will put instructions on to the Webcast.

I\'ll do a quick introduction of everybody who is on the phone and then
let members who are present in the Humphrey Building do the same.

On the call, we have Connie Laubenthal, who is sitting in for John
Tooker today; Dr. Blackford Middleton; Alan Mertz; Chip Kahn; Bart
Harmon; Dr. David Brailer; Pam Peer; and our Co-chairs, Lillee Gelinas
and Jonathan Perlin.

And if members in the Workgroup in the Humphrey Building would like to
introduce themselves?

\>\> JASON DuBOIS: Jason DuBois with the American Clinical Lab
Association.

\>\> CHANTAL WORZALA: Chantal Worzala, American Hospital Association.

\>\> MATT McCOY: Okay, Karen; I\'ll turn it back over to you.

\>\> KAREN BELL: Actually, I believe now it goes back to Dr. Perlin.

\>\> JONATHAN PERLIN: Thank you, Karen, and good afternoon again. Let\'s
dispense first with some of the pro forma meeting requirements. I trust
everyone has had a chance to take a look at the minutes. I know that
Karen \-- and thank you and the staff \-- I know you received some
comments from us and others.

Let me take a 10-second pause here to see if anyone has any immediate
comments, members of the Workgroup specifically, on the minutes.

CONNIE LAUBENTHAL: Yes, this is Connie Laubenthal. I just wanted to
point out that my name was misspelled in the minutes. It\'s
L-a-u-b-e-n-t-h-a-l.

\>\> JONATHAN PERLIN: Thank you very much. We\'ll make sure that\'s
corrected. I appreciate the staff\'s help with that. Anyone else?
\[There is no audible response.\] I will confess that there is one typo
that we picked up. John Houston, not John Tooker, providing a
presentation last week.

Hearing no other comments, we will keep the minutes open for 24 hours.
If there are any other corrections or technical corrections to the
minutes, please communicate those to either Dr. Bell or Alicia Bradford
or other staff and we\'ll move forward with the meetings provisionally
accepted and to be fully accepted in 24 hours.

Let me turn to our first item of business for today, which is Agenda
Item 5, the brief summaries of previous Workgroup and Community
meetings. I think Dr. Brailer so well set the stage in terms of the
history and the responsibility that both the Workgroup and the Community
have. It\'s hard to imagine, but over a third of the year, nearly a
half, has gone by. The first meeting of the full Community was in
October of 2005. The Community met again in November, January, and
March.

I note this with recognition that not all members of the Workgroup are
on the Community and that not necessarily everyone is able to tune in. I
offer this in the spirit of identifying and saying thank you for how
much has been accomplished. I really appreciate the work and
collaboration of this group specifically in allowing us to bring forward
a set of visions for how we from the Electronic Health Record Workgroup
believe we can offer some actions to meet both the broad and specific
charge; that is, real-world implementation, advancement of electronic
health record within a year.

I would note that we presented the report that we all reviewed at our
last meeting and proceedings at the Community meeting. There was broad
discussion and enthusiasm for advancing the electronic health record as
oriented around laboratory function using three models: the standardized
peer-to-peer; the Web-based portal; and, of course, the RHIO, as the
group had discussed.

I know Dr. Brailer, in his introductory comments, really reinforced the
impact that our discussions on input could potentially have in the
gestation of national electronic health records. I think this group has
really wrestled with the relationship of the different models to the
person centricity, the doctor centricity, health systems centricity, lab
data centricity of the different types of data elements and their
relationship, again, back to the model. And it\'s really in that vein
that I return to my earlier comments that we have to listen to today\'s
input in terms of what do we need to know to actually make
recommendations to the Secretary for specific individuals or entities to
take actions to make this real.

I should note to you that the Secretary at the Community meeting did
give us an additional charge. I think it\'s important to recognize that
some of this came about because our activity occurs not in isolation,
not only in the global context, but in the context of three additional
peer workgroups, the Biosurveillance, the Chronic Care, and the Consumer
Empowerment Workgroup.

And the issue \-- particularly as we focused on the challenges of the
contemporary world, manmade as well as natural, and we received very
moving, compelling presentation from Katrina Recovery Workgroup \--
meant that the Secretary was emphatic that electronic health records, as
they came forward, should be able to support first responders in terms
of having adequate information to be able to serve patients and, in
fact, populations in emergency situations. I think, again, you know,
from the parochial perspective of the Department of Veterans Affairs, I
think we realized how compelling that can be in the wake of Katrina when
health data were able to be available to patients who were displaced and
moved. But I believe we best honor the Secretary\'s specific charge if
we really move forward on our broad and specific charge, which is the
advancement of health records and the determining mechanisms to support
and advance the three models.

Let me ask if Dr. David Brailer wants to make any comments as to the
additional charges we heard from the Secretary with respect to \--

\[Beep.\]

\>\> JONATHAN PERLIN: David?

\>\> DAVID BRAILER: Jon, I\'m sorry; you just cut out the last piece of
it. You want to give me my assignment again?

\>\> JONATHAN PERLIN: I\'m sorry. In short, I was recapitulating the
discussion at the Community meeting and, in fact, that we took away as
an additional charge that the electronic health record would have a set
of critical elements needed in emergency situations and suggesting that
we can best support what we heard as guidance from the Secretary by
really being effective in our recommendations to support both broad and
specific charge of this Workgroup for deployment of electronic health
record perhaps around its most aerodynamic form, the lab data, as a
backbone for meeting the emergency intent. I wonder if you have any
additional comments on the emergency data elements and the Secretary\'s
desires there.

\>\> DAVID BRAILER: Yes, that\'s right, Jon. And the discussion, I
think, at the Community was very well-received because of the internal
dialogues that you and others know about how do we make sure that we are
ready to respond the next time.

We specifically charged the task force that was created by the Southern
Governors Association for the Gulf Coast to look at what\'s happened in
the Gulf Coast and to make recommendations, if you would, from the field
about what would have worked there and what their advice is for
electronic health records. We want to filter that through workgroups,
this Workgroup and into the AHIC.

So I hope that over the course of the next several weeks to couple of
months that we are able to take that input and to bring that back to the
Community.

So it\'s definitely an added charge that is reflecting that urgent
request and not in any way a substitute for the charge of figuring out
how we can get really portable lab data to begin becoming one of the key
assets that EHR brings to doctors.

\>\> JONATHAN PERLIN: Thank you very much for that, David. That
reinforces the salience of our original charge and our attention to it.
I think one of the things that is going to be so important as we come to
today\'s presentation is, as we specify who needs to do what, we also
need to make sure we specify how we interoperate for, as a broader
community, not just the industry-specific or entity-specific leverage
point but how that leverage point is best realized as part of a broader
community \-- not in the big C sense, but the sense of entities which
have to, in fact, interoperate together to deliver health care.

I want to come back to this point, Karen, and provide some introduction
to the scheduled presentations. But I think \-- as we move to that, I
think this would be a good point for you to review with clarity the
timeline for recommendations and the expectations just so we\'re all on
the same chronological framework.

Karen?

\>\> KAREN BELL: I\'ll do that. Thank you very much. As David said
earlier, the recommendations that this Workgroup will be putting
together in essentially letter format by the 1st of May really focus
around who exactly \-- and the "who" can be Federal as well as in the
private sector \-- needs to do a very specific action in order to move
the entire agenda forward. The letter will also need to include why that
particular action is critical.

My two slides that I have right now show those three objectives: the
responsible entity, the detailed action, and why \-- are the critical
things to keep in mind.

Our time frame is very short. No later than April 14, we will need some
draft initial high-level recommendations and have identified the
outstanding issues and have developed a plan for resolution. That\'s not
that far away. The week of the 17th, we will be drafting detailed
recommendations in the letter format, including these three objectives.

The week of the 24th, the entire Workgroup will be asked to review and
edit in a very timely way the document as it becomes closer to its final
stage, so that by May 1st, we will have finalized recommendations
available for distribution to the members of the health community \--
Health Information Community.

We will be working with you very, very closely. We will be also working
with the Co-chairs to determine what is the best way to get this first
draft done. Perhaps we will be pulling together a small group as we go
aside and take a day or half day to essentially flesh out the first
draft. But we will be, as I say, working on this very closely with you
as soon as this round of Workgroup meetings has finished.

My second slide, which I am not going to go to in any detail at the
moment, basically is for discussion. It is a framework on which your
discussion of the recommendations can occur after the \[inaudible\] I
would say that these group of about 10 possible items for discussion has
come through reading all of the notes from the various workgroups as
well as from some other workgroups that projected similar ideas. They
were outlined for you here again not as recommends from ONC to the
Workgroup, but basically pulling together a list of possible
recommendations for you to discuss and make decisions about.

The only one that I will take a moment to discuss is the very first one,
because that I think is critical to your thoughts as we move forward,
not only with the recommendations but also with the scheduled
presentations. We did a lot of excellent work thinking about the various
models. But what I would like to suggest is that the first
recommendation really focused on the direction that this Workgroup would
like to see this very specific charge go with respect to the flow of
electronic laboratory information. And I do underline electronic.

We have the possibility of a patient-centric model, a lab-centric model,
or a physician- or provider-centric model for the electronic exchange.
And let me just take a moment to describe each of those to you so that
everyone has a consistent picture of what these three things may be.

The patient-centric model essentially collects information or lab
results from multiple labs wherever a patient may be and makes that
historical and complete set of laboratory results available to any
provider that is authorized to have that patient information. There can
be many ways that this model can play out. We\'ve discussed some of them
at the last Workgroup meeting.

The second model, the lab-centric model, is actually one that is fairly
common right now. A single laboratory, generally as part of a large
integrated delivery system or a very large clinic, will make its lab
results available in a person-centric way to selected physicians. Those
physicians can access this information from a specific portal or an
encrypted portal, and all of the information related to a patient for
whom he or she is caring can be made available. However, for physicians
who are not part of that integrated delivery system or do not have an
agreement or some sort of formal arrangement with that delivery system,
the standard approach of paper fax results being transmitted to whoever
orders a lab is in place.

The third model, the physician-centric model, basically recognizes \--
and again, this is for electronic information only \-- that a physician
with an electronic health record will have patients who seek testing at
multiple labs. This could be because they happen to live next door to a
local laboratory. It could be because their payer only allows
reimbursement if certain labs are accessed. Or it may be that it\'s a
laboratory that a physician uses quite frequently. Either way, each one
of those laboratories in our current system requires a very specific and
separate interface right now. However, it is the physician who controls
the ordering, and the physician only receives the result for which he
has placed the order. So in this particular physician-centric model, the
historic lab data is not available, and lab data is not available
electronically from any lab that that physician has not created an
interface with.

So I hope that this has been \-- this has clarified the three different
models, because we will be asking, again, you to focus and make a
recommendation on one of these three. And just to make it a little bit
easier, I will offer a final example of each three. Patient centric: A
diabetic patient is found comatose and has a blood sugar drawn at the
local hospital emergency room. He or she then is seen 3 days later in
followup by the endocrinologist, who is actually based at the hospital
across town. Thirdly, he\'s back with his own primary care physician,
who uses the local lab. In the patient-centric lab, all three providers
would have access to all three blood sugars, all of the testing that has
been done.

That same patient in the lab-centric model essentially would not have
information flowing to any of the providers. However, if both the
endocrinologist and the primary care physician were associated with the
hospital where he was initially seen, where the emergency room had, and
there were agreements between those physicians and the hospitals, then
the information would then flow to those physicians. But clearly, since
they were in the hospital across town and using the local lab, in this
situation, it did not.

In the third model, the local physician actually does have a
relationship with the local laboratory, and he uses that laboratory
quite a bit. So they exchange information back and forth through a
single interface. So the only information that would flow in this
situation electronically would be the blood sugar test that was ordered
by the primary care physician and done at the local lab and transmitted
back to him.

So I hope those examples really underline the difference between the
three models and will be helpful in making your discussion a little bit
further. We can come back to this slide when you actually get into the
discussion about the recommendations and decide where you would like to
take this. But I just wanted to tee it up for you now and to tee up the
discussion about the three different approaches that will be key \--
your key recommendation or your keystone recommendation and can then
lead to the others.

\>\> BLACKFORD MIDDLETON: Karen, question? Blackford Middleton here. I
wondered if \-- I think the debankrature\*\* \-- as you have gone
through it, these labels are very useful for these different kinds of
options. I wonder, though, if you can map them back to the four options
we considered on the last call.

\>\> KAREN BELL: I think the peer-to-peer one would be the
physician-centered model. The patient-centric model would include a
RHIO-based situation. Could also include a hospital-based situation if
that hospital had access to laboratory results from multiple other
laboratories as well. The laboratory-centric model is the \--
essentially the current hospital-based model that we have at the moment,
where most hospitals do not acquire a laboratory results from other
laboratories and only have what they have tested themselves.

\>\> DAVID BRAILER: Karen?

\>\> KAREN BELL: Yes.

\>\> DAVID BRAILER: It\'s David. Could I just contribute to that answer
as well?

\>\> KAREN BELL: Please.

\>\> DAVID BRAILER: Blackford, I think that\'s a great question, and
part of the reason that we came forward with this way of organizing this
information was \-- in terms of person, lab, or provider centric, was
because of some of the discussion at the Community meeting on the 7th,
evidence that we kind of mixed some apples and oranges in terms of some
forms of deployment, like peer-to-peer with the conceptual way of
organizing the information. And it was our sense \-- and obviously the
Workgroup has to decide itself \-- that we first probably had to get
clarity at these conceptual levels, because peer-to-peer could be a way
to map really any of these, although it would be a really inefficient
way to accomplish a more transactional world of laboratory data from a
lab-centric origin.

So this conceptual level is able to be mapped into a variety of
deployment schemes. On the other hand, I think the Workgroup would need
to discuss how far towards these deployment schemes should it go. I
don\'t think there\'s a very clear mapping overall. But I think the
question is, are these the right conceptual forms? Are they NICI, and do
they start guiding where all the other recommendations flow accordingly,
including how much depth you want to get into some of the technology
forms?

\>\> BLACKFORD MIDDLETON: Thank you, David. Karen, I think that\'s
useful.

\[Beep.\]

\>\> JONATHAN PERLIN: Okay, this is Jon Perlin. Let me ask if there are
other clarifying questions or comments from the Workgroup members that
you would like to offer?

\>\> KAREN BELL: Yes, we have a comment here.

\>\> JONATHAN PERLIN: Please identify yourself. I heard someone join us.
If there are any other Community members, please let us know that
you\'ve joined. That is Workgroup members. I remind people, when you are
not making a comment, please turn your phones to mute so that there is
little background noise. Thanks.

Go ahead.

\>\> JASON DuBOIS: Yes, it\'s Jason DuBois with ACLA. My question is the
following: At the end of the EHR presentation at the last AHIC meeting,
Secretary Leavitt \-- I think there was a little confusion that ensued
at the presentation, but ultimately he did kind of make the statement
that he thought we needed to drill down and facilitate the peer-to-peer
relationship before we can move on to more of the pure vision of, you
know, the RHIO example. I wanted to see, you know, what staff or other
people\'s impressions were of how that might affect where we\'re going
on this.

\>\> DAVID BRAILER: Jon, could I comment on that?

\>\> JONATHAN PERLIN: Yes, absolutely. Thanks, David.

\>\> DAVID BRAILER: I think that\'s a fair interpretation of that
discussion. He and I have talked a number of times about this since. And
you know, I think, again, what we\'ve come back to here with these three
paradigms, these three conceptual ways of thinking about the
information, is where both he and I think the discussion needs to start.
I say that not trying to guide the Workgroup towards an answer, but we
got kind of in the weeds in terms of some of these models. I think what
some people meant when they talked about peer-to-peer or RHIO or
something else was not what other people meant. Because I think some
people were using them as proxies for conceptualization in terms of
integration of information. Other people were talking about technical
forms. So I think we are \-- the government, the Secretary, myself, the
other agencies, HHS \-- are not trying to exhibit a technology
preference. We are not trying to steer towards products that are
peer-to-peer based towards ones that are more hub and spoke based. We
are not trying to switch, not trying to steer towards or away from
transactional pieces.

I think the question is, what is our goal for laboratory information in
this challenge? I think if the Workgroup can make a good decision on
which of these three forms as amended \-- or maybe there\'s another form
that needs to be considered. I think all the other pieces that really
came up in that discussion that we cared about will fall into place.

Does that help, Jason?

\>\> JASON DuBOIS: Yeah, I think so. Thank you.

\[Beep.\]

\>\> JONATHAN PERLIN: Quick clarification there, David. I appreciate
that. Let me ask \-- I hear someone trying to ring in. If you would like
to make a comment, please identify yourself and proceed. \[There is no
audible response.\] Okay, then, hearing no additional comments and
clarifications at this point, let me thank Karen Bell and David Brailer
for keying up the recommendations, and Dr. Brailer especially for the
very useful clarification that we need to come to really a conceptual
model of how we want \-- how we envision things working rather than a
specific technology recommendation to achieve that philosophical desire.
I think if we do that, we\'ll find that we can also honor the
Secretary\'s request that we have the critical data elements for
emergency responses as well.

We are about to go to four presentations. The first one will be a report
on RHIOs from Dr. Scott Young at AHRQ; the second one, John Houston and
Chip Kahn on privacy and security; the third, Judith Yost from CMS on
CLIA; and a final slide or presentation, HIPAA discussion from Susan
McAndrew.

Before we go to those, I want to tie together now essentially Karen and
David\'s comments and particularly the very helpful clarification that
we think about what sort of conceptual model do we want in terms of
being able to achieve timely implementation of a very usable, desirable
form of electronic health records, not the underlying technology, with
the really a charge to ourselves that as we hear these presentations we
think about the question, "Who, in the broad sense \-- what entities,
which individuals, what groups need to do what to achieve the vision?"

Let me tee up some sorts of questions that I think are the sorts that we
really need to be grappling with. For example, as we hear the
presentation from AHRQ, we look forward to understanding what conveys
sustainable business model; what allows early transcending traditional
clinician, conceptual, or cultural barriers to the health record; ditto
on a patient. That\'s a bit of a derivative issue. From a financial or
business or value proposition, what sorts of incentives specifically \--
what sorts of alignments \-- what creates the value proposition for lab
and electronic health records adoption?

And then what sort of data need to come forward to determine if adoption
results in process efficiencies or quality improvement? And particularly
interesting and relevant in an era of pay for performance, how will \--
what sorts of data or pathways should become available to deal with
emergency situations or, in fact, their prevention, the sort of
biosurveillance that Judy Gerling presented a vision for at her last
Workgroup report at the last Community meeting. What sort of
biosurveillance are available from clinical information? With respect to
the sort of subcharge that the Secretary brought forward, there are
policy issues that, further along, we\'ll have to identify, you know,
potentially issues in \-- around HIPAA as relates to authorizing release
of information in emergency situations. And I think the Southern
Governors Association report found that one could actually have a fair
degree of insight mapping certain clinical information with FEMA zip
codes of affected areas in order to both make specific identifications
and associations with pharmaceuticals, as an example, for displaced
individuals or, operating in the other direction, learning about some of
the health needs of displaced or affected individuals.

I think there will be entities, perhaps National Library of Medicine,
that we should be considering, whether they are the Good Housekeeping
Stamp of Approval for clinical-terminology mappings, very
technical-level mapping discrepancies, inserts, errors.

But ultimately this process will give way as HITSP terminologies become
available and, in terms of the standards and HITSP, asking questions
about what sorts of standards will need to be evaluated for our efforts.
I think we already made a recommendation \-- at least have the basis for
a recommendation that ELINCS should be something that HITSP would need
to evaluate among other standards, and ultimately implications for
certification commission for health information technologies and what
they might need to do.

The reason I\'m teeing these up: There are a number \-- as we go through
these questions, we need to be asking \-- we need to be clarifying in
our own minds why or why not we support certain vision for payer
centricity and provider centricity. What information do we need to know?
What questions do we need to have answered? What can we take away from
these presentations to be able to translate into specific
recommendations that in turn may not support a single technological
platform but may support multiple? And how do we align \-- how do we
suggest that there may be better ways to align incentives and regulatory
policy for timely adoption that takes us right back to our charge?

So with that, let me turn to Dr. Scott Young for the Agency for Health
Care Research and Quality to really tell us a little bit about what you
learned, not only about RHIOs, but also about the broader questions,
about business models, sustainability, clinician cultural barriers, etc.
Scott?

\>\> SCOTT YOUNG: Thank you, Jonathan, and thank you for the Workgroup
for having us in today to learn a little bit about our SRD projects, our
State and regional demonstrations of health IP. As usual, I\'m a doctor,
so I crammed too much information into a 7-minute office visit. We are
going to go fairly quickly through our slides.

If I could have the next slide? Today we are going to really focus on
three of our six State and regional projects: Utah, which is in some of
the early planning and implementations efforts around lab exchange;
Tennessee, their initial implementations; and a very experienced player
in this realm, Indiana.

Next slide. Just a little level-setting today. We are going to talk
about some of our exchange experiences, discuss some of the complexities
and challenges that confronted our participants, and tell us \-- and
tell you a little bit about what we view about how SRDs laboratory
exchange experiences may help the recommendations of the Community and
specifically this Workgroup.

Next slide. Just some background on these projects. AHRQ and our health
IT portfolio fund about 122 individual projects across the country.
We\'re in 41 States. Our footprint is around 40 million Americans. This
is six of those discrete projects. These are 5-year State-based
contracts to really help States secure statewide networks to use health
IT to provide care. One charge is to ensure the privacy of the health
information and to make individuals\' health information more available
to health care providers.

We started the SRD projects in Fiscal Year \'04 with five initial
projects. They are a million dollars for each project over 5 years. Over
five projects, that\'s \$25 million all in 2005. We awarded a sixth
project, Delaware Health Information Network, for 4.7 over 5 years.

The initial five are Colorado, Indiana, Rhode Island, Tennessee, and
Utah. And each of those is attempting to exchange data a little bit
differently. They are each trying a different tack on this, but each of
our six projects are required to exchange laboratory data, and
prescribing pharmaceutical data, medication data, as a baseline. They
can, in fact, exchange other data, but that\'s the baseline.

Next slide. Let me see. Waiting on somebody \-- whoops, there we go.
Very quickly, the project goals are to enable information and
communication technologies to allow clinician access to patient
information at the point of care; to develop health information exchange
that connects systems of various health care providers for better steer
coordination; the third one, plan, develop, and implement and evaluate a
patient indexing system. This is very important in our Rhode Island
project, which is really pioneering a master index and the peculiarities
within that. To build and evaluate a State-based regional data sharing
and interoperability service that links health care organizations across
counties, a county-by-county strategy. Tennessee is leading the charge
on that one.

Expand and refine existing statewide networks that convey patient
information electronically. That\'s really Utah.

Next slide? Let me jump right into it. Utah's Utah Health Information
Network was founded in 1993 out of one of the original CHINS. It\'s a
nonprofit, self-sustaining \-- by that, I mean "in the black," not
dependent on open grants or other funding. It\'s a member-based
organization of approximately 2,000 members, 50 million administrative
transactions per year. And really, the primary mission is to reduce the
cost of health care by using electronic data interchange and
standardized transactions.

Next slide. It is really a value-based network. It\'s a trusted neutral
third party. It\'s the post office, if you will, for data exchange in
Utah. They develop products at the request of their community, and the
goal is to reduce the costs of health care for UHIN members, bringing
value to those members, and they are singularly focused on that. They
are deeply involved in standards development, both nationally and at the
local level.

In 2003, Governor Leavitt convened the communities to explore exchanging
clinical transactions. UHIN was chosen to be the highway, a low-cost
trusted authority, if you will, and they evolved from there. They view
clinical and administrative exchanges in the same venue. Personalized
health information is personalized health information is personalized
health information: no matter what, the same assurances across each of
those exchanges. The goal is to move health care into EDI. They \-- in
fact, you\'ll recognize that a majority of health care still uses paper
and there is a need for formatted messaging.

UHIN is now resolved to create an easy, low-cost, and effective way to
\[inaudible\] physicians and other entities. They really developed a
tool for this, the UHIN tool that can pick up a standardized HL7 file or
a PDF file and mail it, if you will, from one entity to another. And it
allows anyone to send the lab result in that way.

Next slide. At the same time, you can receive an easy, low-cost,
effective lab result in either HL7 or PDF tool, which allows people to
receive them in such a way. This can be for clinical purposes or a
claims attachment.

Next slide. With this, the users with an EMR can send and receive
formatted or PDF messages. Users without an EMR can send PDFs and
receive formatted or PDF messages. Really, it allows people to focus on
the workflow issues and move past whether lab results can be sent or
not.

Next slide. Let me move on to Tennessee. They are in their initial
throes \--

\>\> BLACKFORD MIDDLETON: Hey, Scott? You mind a question along the way?

\>\> SCOTT YOUNG: No.

\>\> BLACKFORD MIDDLETON: Blackford Middleton here. How are you? I want
to ask you, of the message content being shipped in the UHIN, can you
give an idea of the breakdown of the PDF versus an HL7 message? What
percents?

\>\> SCOTT YOUNG: I can\'t give you that now. I don\'t have that
information now. I think there may be some UHIN folks on the line. If
there are, let me see if they can respond to that.

\[Pause.\]

\>\> SCOTT YOUNG: Hearing none, Blackford, can I get back to you with
that information?

\>\> BLACKFORD MIDDLETON: Certainly; thank you.

\>\> CHANTAL WORZALA: Can I also clarify? Can the \-- sorry; this is
Chantal Worzala. Do the data go just where they would normally?

\>\> SCOTT YOUNG: Uh-huh.

\>\> CHANTAL WORZALA: There\'s no search capability or laboratory
capability?

\>\> SCOTT YOUNG: No, not at all. UHIN is set up literally that way. Has
that neutral third-party; they are the post office. So you have to know
I want to send a letter from Point A to Point B.

\>\> JASON DuBOIS: Is it \-- This is Jason DuBois. Is it one laboratory
that is providing the results for all these different providers at all
these numerous hospital laboratories?

\>\> SCOTT YOUNG: It\'s any laboratory that is \--

\>\> JASON DuBOIS: Independent hospitals? Physician office laboratories?

\>\> SCOTT YOUNG: Independent hospitals, yes.

\>\> JASON DuBOIS: What is the agreed-upon way that they\'ve decided to
send and receive this information, since a lot is talked about how
there\'s all these disparate systems and at least one of the things we
tried to work on, this ELINCS project that provides the kind of Rosetta
stone or implementation guide for sending and receiving that
information? What is this agreed-upon standard that everyone is working
with?

\>\> SCOTT YOUNG: One of the unique things around Utah \-- we\'ll get
you additional information on standards. One of the unique abilities
that they have: They have virtually everybody in the room. They really
work through how are we in Utah going to agree, what standards are we
going to agree in our State to exchanging data. They are, you know,
painstakingly meticulous in getting consensus agreement on that before
they go forward.

\>\> JASON DuBOIS: It started with HL7, and everything is nailed down
underneath that?

\>\> SCOTT YOUNG: Exactly right.

\>\> JASON DuBOIS: Just putting everybody in one room and working it out
that way?

\>\> SCOTT YOUNG: It is an arduous, day-to-day, "We are going to knock
it out one at a time" process. At the end of the day, you have consensus
across the Board.

\>\> JASON DuBOIS: Sure.

\>\> SCOTT YOUNG: I think they would tell you that that bottoms-up
approach keeps everybody at the table and, at the end of the day, drives
value for those consumers and for participants.

\>\> JASON DuBOIS: Thanks, Scott.

\>\> SCOTT YOUNG: Okay. Let me move through Tennessee quickly. Tennessee
is a hospital-based initiative designed to create a utility to inform
clinical practices to exchange hospital-based information initially with
not only hospitals but practices. It\'s a live system. Twelve hospitals
are in the data. Initially, it\'s a county-by-county approach. Right
now, it\'s in three counties, a million people with 250,000 from
adjacent States. As you can see, it\'s a highly uninsured Medicaid
population, complex delivery in an insured climate.

Next slide. There we go. Right now, consumers can see the clinical
providers and receive some laboratory tests. They can log onto a
provider system and review the results within hours. The view for
tomorrow or the hope for tomorrow is, consumers may receive their tests
at a wider range of clinical settings; e.g., rural pharmacies that can
log on or bank systems and see the results, interpretations, and
charges. And in the future, we hope to see organizationally specific
approaches from that.

Next slide. The charges to the Tennessee program were really to explore
HI hospital-based opportunities; to explore the governance and financing
approaches; to identify key components of a patient-driven, easy-to-use,
secure authorization process; and to consider these very crucial opt-in,
opt-out patient choices.

Next slide. Some of the opportunities. The hospital data feeds are
fairly easy to acquire and develop. The primary challenges were around
translating the data into appropriate standardized forms and formats.
And also, if you look at that fourth bullet, standardizing some core
elements have to be essential for comparison and use, going back to
Jason\'s comments earlier; and standardizing all lab values initially
which were determined by the scope to not be cost effective prior to
demonstrating value with the select set.

Next slide. Some early lessons learned on the governance and financial
models is that the ROI on laboratory exchange may be put on the margins,
some of the more peripheral savings. It\'s not just financial, but it\'s
the ROI on quality and the ROI on efficiency, the so-called nonfiscal
ROI.

And here is a paradox. In the announcement, when Tennessee found that
they were announcing to go to the county-by-county route, it actually
accelerated some issues. It sort of took off, establishing a formal
governance in relationship potential and needs to be an early
deliverable. And distribution of fees relative to value conferred is
expected to be low.

Next slide. Technology data sharing and the opt-out. This is a hybrid
technology. It\'s logically decentralized but fiscally centralized
databases. Data sharing agreement is based on data connecting for health
framework. Patients will initially be able to opt out at the
institutional level and creating infrastructure that allows scaling
through practitioners is found to be essential.

Next slide. Some early lessons learned from Tennessee. Position of
patient data should not confer a competitive advantage to institutions
and entities. Data exchange can be evolutionary. It does not have to be
expensive. Technologies can be inclusive and actually will help to
create and drive markets. Some examples of addressing major impediments
to reach the data exchanged are listed below: trust and confidentiality
issues, limitations and specifications of government the governance
issues, federated identity management and authorization approaches.

Some next steps for Tennessee is laboratory check emulating the
commission for the CSI-efficient prescription drug histories; standard
approaches for patient identification to allow reliable integration of
data; standard approaches to information representation; and a means of
identifying, authenticating, and authorizing access. That will be
crucial. I know Mark Frisse and company are working on that day to day.
Also public safeguards for inevitable errors and lab acquisition issues.
You can see the governance issues are really ones that Tennessee is just
focused on on a day-to-day basis.

Indiana \--

\>\> JONATHAN PERLIN: Scott, before you go to Indiana, these are complex
enough we should see if there are any questions or points of
clarification.

\>\> SCOTT YOUNG: I know I have some Tennessee folks on the phone.

\>\> JONATHAN PERLIN: Let me throw it open to the Workgroup members if
there\'s anyone who wants to ask any clarifying questions or comments on
the Tennessee model before we go on to Indiana.

\>\> BLACKFORD MIDDLETON: Hi, Scott. Blackford Middleton again. The
question I have: In the physically centralized logically distributed
model, is there actually data aggregation across any hospital for any
model for any particular data type?

\>\> MARK FRISSE: Hi, Blackford. Mark Frisse. The answer to that is not
at the storage space. In essence, if you were a contributor and your
information was never used by any participant, you could flush it out.
You keep control until it\'s accessed by another member, at which point
it becomes part of the audit log and you no longer have exclusive
ownership of that. So the aggregation all comes at the receiving end
through record locator service \-- record access service aggregation
function.

\>\> SCOTT YOUNG: Okay, thank you.

\>\> JIM SCIROCCI: By the way, this is Jim Scirocci. Dr. Barry Straub
asked me to represent CMS. He extends his regrets.

\>\> JONATHAN PERLIN: Thanks for being there. Other questions on the
Tennessee model?

\>\> CHANTAL WORZALA: Yeah, this is Chantal Worzala. When you say it\'s
hospital based, is it only the labs that the hospital themselves are
performing, or are they bringing in data from other labs as well?

\>\> MARK FRISSE: This is Mark again. We are bringing the labs from any
outside clinical labs as well. We really want to support so very much
the process you are in the middle of, because we think that broader
standards are required. So we anticipate a time when we\'ll get
information directly from clinical labs and from the hospitals on the
same item and have to worry about duplicates, but we are essentially
getting only hospital feeds right now, because it was felt by the
Governor that getting the hospitals primarily as the engine to start
this thing would inform the rural practitioner.

And the paradox was just simply \-- it\'s very interesting. When you
first announce one of these declarations for the greater good, there are
always individual partnerships who want to accelerate the point-to-point
solutions in essence to strengthen what they perceive to be a position,
but after a while, they understand that\'s where they want to compete
anyway.

\>\> KAREN BELL: This is Karen Bell. Mark, could you give us an idea of
the degree of usage that the system has outside of the individual
hospitals?

\>\> MARK FRISSE: Karen, it\'s not being used at all. It\'s capable of
being used; it\'s quite remarkable to see it. It\'s not being used
because until we can be absolutely sure that we can unambiguously
authorize the use by an individual practitioner, we are \-- the
generalized identity management problem \-- we are still fine-tuning
that. We will be deploying this in selected emergency departments in
May.

Our long-term goal is not to have a Web-based interface as a stand-alone
but rather to create a utility, if you will, in the spirit of and in
concert with places like Scripps and Arts Hub to become yet another
aggregator and help the region and what the right market is so they can
make independent solutions in the future.

The answer is \-- it knocks your socks off, but we are not using it yet
because we are very, very conservative about patient confidentiality.

\>\> SCOTT YOUNG: That\'s going to be a significant problem for Mark. At
some point, I\'ve gone down and looked at the system, and at some point,
there is going to be clamoring for it from individual physician offices
and things like that. He\'s wise, and we think we\'re wise to make sure
that all our ducks are in a row for secure acquisition within the
system, within the hospital matrix, before we move outside of that.

\>\> JASON DuBOIS: This is Jason again. What is the solution that you
guys proposed? I think one of the documents that was circulated to the
Workgroup provided by \-- I think it was John Lewis, but don\'t hold me
to that \-- was about the privacy issue. I think developing a type of
algorithm system to address the issue.

Is that basically the way that the Tennessee demo is going to go about
it, Mark?

\>\> MARK FRISSE: Well, first and foremost, we have a strong
not-for-profit organization with an interinstitutional data sharing
agreement along the lines of Markle. We set the organizational framework
correctly, and Vicki Estron is here to talk about that if you wish.

Secondly, the technical model for knowledge is basically a secure token
ID, which is not scalable. Until we can get some energy into this, then,
we will work with selective clients on a federated identity model.
That\'s for the identification. For the authorization, we see no better
recourse than a retrospective one, although in some settings, you can
take registration messages, in a sense, to identify that.

We think that\'s one of the areas of research that the AHRQ program has
really brought to the public mind to a degree that I certainly did not
realize its importance a year ago. We are very open to any suggestions
and recommendations or decrees you would like to make.

\>\> CHANTAL WORZALA: Can I ask one more question, please? Sorry. This
is a bullet that was skipped over, maybe two bullets that were skipped
over.

One was the best accomplished if one doesn\'t expect the hospital to do
the programming. And I think that\'s kind of an interesting point. And
then I just wanted to understand what it meant to, say, problems
simplified because the associations with patient identifiers are
straightforward. Just didn\'t understand that. These are on a slide
entitled Hospital-based Opportunities.

\>\> MARK FRISSE: Mark, it\'s relative to the clinical lab problem. That
is to say that we have identified duplicate IDs in individual hospitals
publishing data and the like, but I\'m not saying patient identification
is straightforward, although actually our ROC analysis of probabilistic
matches is pretty darned good. Relative to the problems you\'re taking
on today with the clinical problems where the identification problem is
the primary issue in terms of not going through the practitioner, it\'s
relatively simple. It\'s only a matter of degree, not an absolute.

\>\> CHANTAL WORZALA: And you\'re saying that because there\'s more
information available in a hospital system to identify the patient? Is
that the issue?

\>\> MARK FRISSE: It\'s easier for us to get a uniform set if you can
arrive at any of your three models with a uniform set of patient
identifiers. At least there\'s a technical possibility of new business
opportunities and markets. We would certainly welcome that, which is
separate from the business issue for the clinical labs. I\'m just saying
that many of the clinical labs from the outside require a mapping back
to the person who originated the test in order to get enough information
to accurately merge that data with the correct patient.

\>\> CHANTAL WORZALA: Got it. Thank you.

\>\> JONATHAN PERLIN: Good, good discussion there. I appreciate the
clarifying. We will have opportunity again for discussion at the end.

Let\'s move on, Scott, to Indiana and the State and regional demo.

\>\> SCOTT YOUNG: Right. Indiana evolved from \-- the Indiana SRD
Project evolved from the Indiana Network for Patient Care. Another
evolved from a federally funded program and \-- in operation about 10
years, created within Regenstrief.

Some of the numbers here are impressive. Out of a population base of 1.7
million and 150 HL7 message beads, almost a billion structured
observations \-- lab results for vital signs per year, 80 million
results are added annually. Over 30,000 clinical results are delivered
daily. And all data is coded using one code.

Next slide. This is a federated data model. The data is standardized as
received. It\'s deterministic. Patient matching is utilized.

Next slide. And just to give you a sense for the fragmentation of the
laboratories of Indiana. Just looking at this, statewide and within the
Indianapolis MSA, you know, 31 hospital peaks, 24 regional peaks, on
national peak, three reference labs, four public lab sites, just within
Indianapolis. Expand that out, you know, nationwide, that gets you 214
hospital feeds, 102 regional, and so forth and so on.

So, you know, this is kind of the information resources that the
Indianapolis folks and Indiana folks are trying to corral, if you will,
to try to bring it to line.

Next slide. Again some more of the complexities. Fragmentation of the
market, no surprises there. Significant number of important labs
performed in physician offices. Typical lab, what Mark Overhage has
found, has 5,000 unique results. These are poorly structured. Result
messages, test catalogs don\'t contain enough information to map them to
standard codes. No two laboratories use the same code. Laboratories
change codes frequently. Laboratories often don\'t retain results online
for more than 60 days. This varies significantly. And the complexity of
the mapping to a single laboratory requires approximately 6
person-months.

Jonathan, I don\'t know if your shoulders just got heavier there.

\>\> JONATHAN PERLIN: I\'m going through that, but that\'s the Indiana
approach.

\>\> SCOTT YOUNG: So what Indiana has, their workaround to these
complexities, is as follows: accumulate a large sample of laboratory
result messages; to build a database; to clean up those units; to
evaluate lab terms; to analyze name words, if you will; to use GRLMA to
generate first paths and edits and error checks; and that\'s an edited
review, both at the specimen and the unit level.

Some of the lessons learned on that is to limit the efforts to one lab
section at a time and to limit the focus expertise. And also just an
observation that chemistry and hematology are easiest and microbiology
and blood bank are difficult. No surprises there as well. Here is the
good news: nearly every laboratory can be automated. That\'s what
Indiana\'s experience has been.

Essentially, every laboratory system can generate an outbound HL7
message. LOINC is in fact fairly comprehensive. GRLMA facilitates the
mapping process, and centralized mapping works; decentralized does not.

Let me just point out the product that has come out of Indiana as part
of their efforts: the Docs4Docs clinical messaging system. It\'s an
inexpensive bridge, if you will, to an EMR. Delivers clinical results in
real time. By that, we mean within minutes. Routing is based on
providers listed in a message. Every data source uses their own provider
IDs, so they could be mapped to a single identifier.

Consistent reports formats across all sources. Replaces all other
delivery systems where it can. It accommodates paper-based practices, so
it doesn\'t really blow up a workflow just by utilizing this. Three
delivery options exist for Docs4Docs: either a secure inbox requiring an
Internet connection, a PC, and browser in a providers\' office \-- we
know that most physicians have this; greater than 90 percent of
physicians have got at least this connection \-- it can be delivered
into a provider\'s electronic medical record; or it can be faxed to a
physician or a provider.

That is the \-- let me just pause there on Indiana. Indiana, as you can
see from the last presentation, is our more mature SRD as far as
laboratory exchange.

Questions? Comments? I think we have Mark Overhage on the phone here to
comment.

\>\> JASON DuBOIS: This is Jason. I have just a question, really. I
think, obviously, this is the model by which all others should probably
look to follow. I remember \-- first of all, I think they had a lot of
success. It was developed at the Regenstrief Institute but something
that is not mentioned here that I think drove adoption, and Clem
McDonald addressed MedPAC a year and a half or 2 years ago about this.
He said the way to facilitate the adoption of laboratories into their
network was by incentivizing laboratories and creating some type of an
add-on payment so that they do transmit their results and transmit it
into a format that they can use readily. And he said, you know, by not
doing that, it\'s essentially like one hand clapping.

I wonder if Mark could talk a little bit about that.

\>\> MARK OVERHAGE: This is Mark Overhage; thank you. I\'m not sure
exactly what you are remembering Clem McDonald talking about at that
meeting. I wonder if maybe what he was describing is for the Docs4Docs
clinical messages, essentially what we do, as Scott Young pointed out:
we replace their existing delivery processes. They quit printing; they
quit faxing; they quit providing a portal to the physicians to deliver
their results, which cost the laboratories in the hospital, for example,
an average \$0.81 to do. In other words, if they generate a result in
the lab, to get it to the physician\'s hand cost \$0.81.

So we charged them to deliver that to the physician, but we charged them
a lot less than \$0.81. They end up saving on every result that they are
generating. That has been a very powerful influence in engaging
laboratories and radiology centers and so on that we might not otherwise
have been able to engage because we are providing a service that they
value. So we are not actually \-- we are incenting them by providing a
lower-cost option or lower-cost service for them than they could
generate themselves, not incenting them by paying them a fee or
something like that.

\>\> SCOTT YOUNG: Mark, I think we are taking this away as an important
point. I appreciate the discussion between you and Jason on this that
there is a value proposition; there is alignment of incentives in terms
of the ability to not have to ship out paper based or something that is
a one-off, laborious process we\'re sending out to a laboratory. You
estimate that the value proposition is in a cost that is less than
\$0.81, correct?

\>\> MARK OVERHAGE: Correct, although I will say the \$0.81 is for
hospital results. We find a lot of the commercial laboratories are more
efficient, have focused more on driving the costs out of those
deliveries. I think Connie Laubenthal, for example, would probably say
that their costs for delivering results are less than that. She may not
want to share that publicly, what their numbers are. I didn\'t mean to
imply that she should.

We do find that there\'s a spectrum there that ranges from around \$0.25
to around \$0.81 for \-- well, actually \$0.21 to \$1.20 for different
sources. So there\'s quite a range, but there is, as you say, a value
proposition and something they have to do for their business today.

\>\> JIM SCIROCCI: Mark, this is Jim Scirocci. I\'m curious: do you have
any experience with the physician office lab?

\>\> MARK OVERHAGE: We do, and there\'s two flavors of those. One is the
larger practice, the 10-physician internal medicine practice that in
fact has a very sophisticated lab and they work just like everybody
else. They\'ve got a laboratory information system; they submit
messages; everything is fine.

The other one, which is trickier \-- and we find this \-- it may be
different in other markets, only in primary care, certain tests like
cholesterols, INRs, and glycosylated hemoglobins as well as a smattering
of others that are done in physician offices that might be nice to have
your hands on, and it\'s hard to get a hold of them, because they are
generated on these desktop devices which maybe have a thermal printer
output, maybe have a RS32 port on the back.

It\'s not so much capturing the data but the problem of linking the data
up with the patient identifier. There\'s nothing in the device that
identifies the patient. You just get this number: "Glycosylated
hemoglobin, 7.4."

And so those are tough. It\'s an area where we\'re doing a lot of work
right now. If we find any magic, we will be happy to share it with the
Workgroup.

\>\> JONATHAN PERLIN: This is Jon Perlin again. I wanted to complete the
thought that beyond the value proposition, though, it\'s not \-- it is
not absolutely necessary for it to be a centralized database. In fact,
other models could sustain this as well. Value proposition would remain
intact.

\>\> MARK OVERHAGE: Right, and we\'re a federated model but centrally
managed, which I think supports that. And that particular value
proposition of clinical messaging or results delivery doesn\'t
necessarily mandate that anything be stored in the middle. Although we
find that the providers want us to store it on their behalf when they
receive it into, say, a secure inbox that they access over the Internet.
They need a place to keep it.

\>\> JONATHAN PERLIN: Great; I appreciate that clarification. Other
questions, comments on the Indiana model?

\>\> CHANTAL WORZALA: Yes, this is Chantal Worzala. I guess I saw one
thing that I thought was troubling given our desire to move folks into
using standards. This point that centralized mapping works and
decentralized mapping does not work?

Can you just expound on that a little bit, why you think it doesn\'t
work? Presumably we want to get to a point where everyone is doing their
own mapping when they generate results.

\>\> SCOTT YOUNG: Mark?

\>\> CHANTAL WORZALA: Hello? Hello?

\>\> JONATHAN PERLIN: Chantal, we got your question. Mark, are you still
there? \[There is no audible response.\] Okay. We\'re having a technical
issue. Let\'s try one more time for Mark Overhage. \[There is no audible
response.\] Okay, let\'s try for Scott Young.

\>\> SCOTT YOUNG: At least from my discussions, it\'s just the
operational, you know, work that\'s involved in this, from my
understanding. Mark would need to expand on it much more. We can get
those answers back to you \-- more precisely, get the written responses
back to you. From what I understand, it\'s operationally how to get this
done anyway. We\'ll get a response back. All right. Jonathan, I have a
few more slides here to finish up, and then we can finish up here, if
that\'s fine with you.

\>\> JONATHAN PERLIN: Scott, that would be great. Go ahead.

\>\> SCOTT YOUNG: Just a few trends and recommended options that came
from this team that put this presentation together. That would be, you
know, our National Resource Center, Utah, Indiana and Tennessee. One is,
paper-based offices are going to continue to constitute a significant
portion of the health care landscape. No surprise there. That\'s just a
realization that our team, you know, wanted to face and take on in all
of their projects. Recommendations are:

-   Adopt policy leverage to promote electronic exchange of lab orders
    and results. You know, that may seem obvious to this group, but they
    wanted to say it explicitly.

-   Formally adopt a standardized image format, whatever that is, you
    know, PDF or others.

-   Promote the creation \-- adoption of standardized (by that we mean
    inexpensive) tools for physicians to securely send and receive
    standardized labs electronically. We said less than \$100. That\'s
    just a number that we threw out that we thought would be \-- that
    had appetite for physicians and that it not be faxed and not
    e-mailed, but something like the Docs4Docs example that you saw from
    Mark. The achievement of this exchange will result in offices
    reorganizing workflows around EDI instead of phone, fax, mail, et
    cetera. This is often an underrated step, and we think it\'s a very,
    really critical step towards your ultimate goal of HR adoption.

-   Next, we realize that there\'s a lack of standardized \-- standards
    for format and messages. And we \-- I know that this discussion
    occurred in here before, but consider adopting ELINCS as the
    standard for lab order and results messages. The current version
    Mark Overhage pointed out may not be adequate for health information
    exchange. But I think there\'s ongoing work within ELINCS to add to,
    to develop more modernized versions which will allow HIE.

-   Promote assistance for creating crosswalks between the plethora of
    proprietary lab codes and appropriate LOINC codes; e.g., the work
    that Indiana has done.

-   Assist LOINC in developing appropriate codes and with developing
    workshops to help the health care community learn how to use these
    codes correctly and uniformly.

-   Next one: interoperability. There\'s a lack of health information
    exchange standards. Convene and/or recognize a core group of HIEs or
    RHIOs as we have here, preferably entities who are actually in the
    production and operation at this time to discuss and adopt a suite
    of HIE standardized messages.

-   Recognize the lab exchange is not exclusively clinical. It can be
    administrative, public health, so forth and so on. As a matter of
    fact, in Utah, they are now capable of exchanging rods data with
    their public health departments.

-   And recognize the need to exchange labs using identical formats and
    codes regardless of how the destination is going to use them.

-   Some enabling factors are \-- we have an old slide here. Reduce the
    number of proprietary \-- that impede the effective flow of
    information.

-   Drive adoption of LOINC and adopt a federated authentication model
    for providers.

-   Finally and in summary, Health Information Exchanges are a viable
    strategy option to promote electronic exchange of lab results and
    data. That \-- AHRQ is supporting a core group of Health Information
    Exchanges, initiatives currently exchanging lab data. A series of
    policy discussions and decisions need to ensue to fully realize the
    capability within this arena. Health Information Exchange
    initiatives, we believe, can bridge the gap between a distrustful
    public \-- I would say a suspicious public \-- and health care
    entities. People are wondering where is my information going, and we
    think these entities provide an assurance to them or can provide
    real assurance to them. We think that our SRDs offer an opportunity
    to evaluate alternative strategies where consensus has not yet
    emerged.

And I thank you for your time, and we\'ll entertain any questions or
comments.

\>\> WOMAN: Come in. I need to ask you what all this \--

\>\> JONATHAN PERLIN: Let me interrupt. Scott Young, you\'re finishing a
great presentation. Let me remind everyone that all microphones are
live. I believe we have an open mic.

\>\> WOMAN: He wants that in there.

\>\> MAN: No, we took it out.

\>\> JONATHAN PERLIN: Hello! Whoever has an open mic \-- okay, good,
much better. I remind people that all lines are active today and please
mute your phone unless you\'re contributing a comment.

Scott, you were, it sounded like, just at the last comment. Let me turn
back to you.

\>\> SCOTT: I\'m done. I just entertain any questions or comments.

\>\> JONATHAN PERLIN: Great. Let\'s open the floor for comments. Thank
you for an excellent presentation.

\>\> HOWARD EISENSTEIN: This is Howard Eisenstein with Chip Kahn. I have
a question on Indiana, which is, now that you\'re rolling it out
statewide, I mean, do the Indianapolis docs \-- I mean, what if you made
your life so easy that they are not trying to sell this statewide to get
adoption? In other words, how much have you created incentives for them
to adopt it, and to what extent are they doing so?

\>\> SCOTT YOUNG: I think Indiana \-- I mean, I don\'t know if we have
Mark Overhage on the phone yet. I would ask him to jump in if he is.
Essentially, you know, the Indiana project is taking the work that\'s
gone on in Indianapolis and putting it on steroids, if you will, and
taking it border to border.

I believe that there was sufficient buy-in from Indianapolis, and I
don\'t think that they are running across any great barriers from the
physician community from the provider community in \-- you know, in
adoption or participation at this point. I don\'t know that there are
specifically incentives out there other than those, you know, nonfiscal
incentives that we had talked about earlier. I don\'t know if there\'s
any dollars on the table for participation, if you will.

\>\> MARK OVERHAGE: This is Mark. I am back on the call after hanging
myself up. This technology overwhelms me sometimes. Sorry.

I\'m not sure that I heard the whole question, but I heard you talk
about incentives for the users \-- physicians in their practices, for
example. There are a lot of incentives for them, as Scott said, that are
not financial. For example, the savings in staff time organizing and
processing results is very substantial, especially for larger groups.
But even for smaller groups, there are a lot of savings in that.

For the physician \-- this may sound trivial for those of you who
haven\'t struggled through this, but you get a stack of 45 lab results
at the end of the day and the fact that the patient\'s name is in the
same place on every page and the abnormals are highlighted in the same
fashion and things of that nature make your lives so much easier. We
have tremendous acceptance by the clinicians.

The only real barrier at the clinician practice level that we run into
is that they are very busy and any time you talk to them about a
potential change of any kind, you know, even if it\'s a change in the
color of the paper in the fax machine \-- we don\'t do that, but
anything at all \-- they get nervous about it. But as soon as you get
over that anxiety about, well, this is something different; they are
tremendously happy.

I don\'t know if you want to or not, but as I hung myself up, there was
a question about the mapping. You want to go back to that for a moment?

\>\> SCOTT YOUNG: Mark, there was a question on \-- yeah, on the
mapping.

\>\> MARK OVERHAGE: I think the question was centralized versus
decentralized map.

\>\> SCOTT YOUNG: Right, right. One is acceptable, and one is not.
Centralized mapping works; decentralized does not. Can you expand on
that?

\>\> MARK OVERHAGE: Absolutely. We, as others \-- Santa Barbara, for
example, I believe \-- tried to do this decentralized mapping. We have
many other examples of folks who tried to this, where you say to the
laboratory or the radiology center, "Okay, here is the set of standard
codes. We would like you to take your local codes or terminology and
tell us what standard codes correspond to that." What we find is that,
for one, they don\'t have the understanding and expertise in the
standardized coding sets in order to make intelligent choices, so they
pick the wrong codes a lot of times.

Second of all, they are not terribly motivated to maintain them. So what
happens is, you start getting these codes coming across which are
perfectly legal, legitimate LOINC codes but are not the right codes for
the things that they are sending. So I think Santa Barbara had this
experience. We tried many times, and we keep coming back to \-- you need
a group of folks with specialized knowledge of the standard coding
systems, and then as well as the knowledge of, for example,
laboratories, in order to make that translation.

And you do need help, though, from the labs and radiology centers and so
on. You come up with questions. There is not enough content in the
message or in the result that you receive for you to confidently
understand what it is. You have to go back to the laboratory and get
additional information about how do you do this test, when do you do it,
those sorts of things.

\>\> MARK FRISSE: Mark Frisse here, too. Someone asked about the bullet
about best \-- if you don\'t expect the hospital or other publisher to
do all the work. That was exactly the point we have found in Tennessee,
too. That you need a strong centralized group to address that issue.

\>\> JON PERLIN: Comments?

\>\> BART HARMON: This is Bart Harmon with the Department of Defense.
Our experience has been identical. We initially tried to get the local
facilities to do the mapping. We asked them to do the first draft, but
that requires the centralized expertise of people that really understand
the terminology with some depth.

\>\> ROB KOLODNER: This is Rob Kolodner from VA with Dr. Perlin. One of
questions I have \-- if we think about the expertise that\'s needed and
the number of institutions and sites and labs that you are out there,
the question is, as you scale it up, how many people we would have to
have with that expertise or whether, at some point, it\'s better to go
back to the vendor community for the lab tests, the reagents and other
things and see whether we can, whether there\'s a way of at least doing
an 80-20, whether you can pick up and say if you have this test with
these reagents, here is the LOINC code. You go out from the purveyor of
the test rather than trying to do it the way we are doing it right now.

\>\> MARK FRISSE: Mark Frisse here. We have found even our Chief
Executive Officers to start to understand that exact business dynamic.
As is the case with security and privacy we are starting to see that in
standards, too. They\'re asking those fairly sophisticated questions of
their CIOs who in turn are asking it of their vendors. I think we are
going to see an iterative process of exactly that. Without the vendor
coherence this will not be scalable across the Nation in my view.

\>\> JONATHAN PERLIN: That\'s a very useful dialogue. That\'s starting
to take the form with \-- of a recommendation with some specificity that
allows us to serve the Secretary\'s request in terms of what sorts of
things need to happen for this to move forward. And I think the part
that is so enticing is that the value proposition is also very
compelling.

Go to any other questions? Let\'s move away from the specific technical
questions on the individual initiatives and move it up to any other
comments or observations on the programs evaluated in Scott Young\'s
presentation, particularly as relate to our charge?

\>\> JASON DuBOIS: Jonathan, this is Jason DuBois again. I would add to
the last point we were discussing that I think the problems experienced
by the VA, Santa Barbara, Indiana, Tennessee will all be ameliorated
with the implementation guide if I\'m not mistaken through \-- we kind
of put this off, but it has to be approved, standard like ELINCS or
whatever else decides to be approved will help make everybody\'s job
easier in those areas. I just would like to hear from the two Marks if
that, in fact, wouldn\'t be the case.

\>\> MARK OVERHAGE: This is Mark Overhage. I think it does help,
although there\'s a trade-off with how much you ask the institutions to
do. But it doesn\'t really help the implementation guide. It leaves the
LOINC mapping issue on the table. That\'s where the vast majority of the
work is. The message reformatting is important, but it is the minority
of the work.

\>\> VICKIE ESTRON: This is Vickie Estron for Mark, who had to step out.
We would concur and agree with what Mark Overhage has just said from
Tennessee.

\>\> JONATHAN PERLIN: I want to thank everyone for the very good
dialogue around this. I think we will make a dovetail back, but I am
also trying to pay attention to time and note that we have three
additional presentations. Let\'s take note of what we just discussed as
really format for recommendation. Let\'s also note the business process
alignment for value proposition that makes sense and take note of that,
again, endorsement of HITSP as ultimately arbiter for some of these
standards.

I want to mention that Lillee Gelinas has now joined us. I mentioned at
the outset that she was speaking to a mere 16,000 of our constituents on
a national broadcast. Lile, great to have you back with us.

\>\> LILLEE GELINAS: Thanks, Jon, very much.

\>\> JONATHAN PERLIN: We completed one of our four scheduled
presentations. Let\'s go now to the privacy and security report with
John Houston and Chip Kahn.

Chip Kahn, are you here?

\>\> CHIP KAHN: Yes, I\'m here.

\>\> JONATHAN PERLIN: Great. We\'ll turn to you and John Houston for
your report, your presentation on privacy and security.

\>\> HOWARD EISENSTEIN: Is John on the line? I spoke with John
yesterday.

\>\> CHIP KAHN: This is Howard talking.

\>\> HOWARD EISENSTEIN: This is Howard. I spoke with John yesterday.
You\'ll see in your packet his submission, I think, to the office in the
coordinators sometime ago. This wrestles with the issue of privacy in
terms of HIPAA versus some other mechanism. Basically, you know, our
kind of default policy is HIPAA should be the standard, but given the
kind of time constraints that we have with this Workgroup and the AHIC
in general, it just doesn\'t seem feasible in terms of what Congress is
up to.

So John offered his solution, which is sort of \-- does not have to be
legislated, which is basically patient authorization, which we basically
have signed on to. We had that discussion briefly, and I think Blackford
briefly discussed it with John, but you know, in terms of the short run,
that\'s the only thing that seems viable given the very aggressive time
line of this Workgroup an AHIC in general.

\>\> CHIP KAHN: This is Chip again. There\'s no way we are going to
amend anything having to do with HIPAA that will help us here. So
assuming that we could avoid the HIPAA problem by sort of allowing
people to opt into this with permission, we don\'t see any other
solution in the short run.

\>\> JONATHAN PERLIN: Okay. Let\'s stop there for any comments because
this is a fairly provocative statement that we have a tight timeline
towards implementation. There are certain opportunities afforded by the
regulatory and legislative process. There are also certain challenges.
And you\'re suggesting that these can be circumvented by simply moving
to an opt-in approach.

Let me throw the floor open for questions.

\>\> ALAN MERTZ: This is Alan Mertz with ACLA.

\>\> JONATHAN PERLIN: Alan, go ahead.

\>\> ALAN MERTZ: Hi, Chip. This issue came up actually at this Energy
and Commerce Committee hearing last week on preemption. And the problem
\-- the problem for the labs is \-- and with the State privacy laws
require ordering and reporting lab results \-- is that some of the
States don\'t even allow reporting of results to anyone other than the
ordering physician, even with \-- there\'s no provision for consent of
the patient allowing it. So other than \-- the physician would have to
report all the results.

The labs and \-- in many States cannot even \-- we couldn\'t send lab
results to anyone other than ordering physicians, even with the
patients\' opt-in. But I understand the difficulty, obviously, of
amending.

\>\> CHIP KAHN: In terms of those kinds of laws, once the physician
receives the materials or the documents, does the physician \-- what are
the physician\'s prerogatives?

\>\> ALAN MERTZ: The physician could \-- actually, I can\'t speak for
the physicians, because I don\'t know all the rules. All I know is the
rules that apply to the rules. Jason, you\'re there. Could the physician
then disclose the lab results to another entity?

\>\> KAREN BELL: Jason just stepped out of the room for a moment. This
is Karen Bell. Oh, he\'s back. Okay. But I also wanted to point out that
we have Susan McAndrew in the room.

\>\> CHIP KAHN: Susan would probably know, yes.

\>\> KAREN BELL: Our resident specialist on everything related to HIPAA.
Those on the line with respect to our \-- everything related to CLIA,
I\'m going to give the microphone to Susan right now.

\>\> SUSAN McANDREW: And I don\'t know \-- do you want me to do the
HIPAA run-through at this point? Would that help clarify this \-- put
some context for possibly Jon\'s recommendation?

\>\> KAREN BELL: I think it might at this point, yes.

\>\> SUSAN McANDREW: Okay.

\>\> JONATHAN PERLIN: Well, let\'s just orient now to what we\'re doing.
I appreciate Susan McAndrew being with us. In fact, the HIPAA
run-through that is being referred to is one of our scheduled
presentations.

So in fact, let\'s with \-- if Judith Yost \-- if you\'re amenable,
let\'s flip the order here and take HIPAA and then CLIA and perhaps
discuss these in bulk in terms of how we move forward. I think that
would be a good approach.

\>\> SUSAN McANDREW: Okay. What I wanted to do was to briefly run
through some basic "who," "whats," and "hows" of the HIPAA privacy rules
and then try to provide some context in terms of some eight or nine
questions that were posed in terms of how HIPAA may interact with this
particular initiative. Just briefly, in terms of \-- and I do have a
slide set, and I apologize; I didn\'t get it online, and \--

\>\> OPERATOR: Pardon the interruption \-- \[Lost audio.\]

\>\> SUSAN McANDREW: It\'s important in this context to note that the
standardization that has been talked about in terms of how to transmit
the clinical information from provider to provider is not a HIPAA
standard, and so engaging in that kind of standardized electronic
transaction would not make an entity a covered entity for HIPAA
purposes. By the same token, we are expecting that most providers are
already HIPAA-covered entities, because many of them \-- in addition to
whatever clinical information they are exchanging electronically, they
are currently engaged in electronic billing or other kinds of
eligibility inquiries with plans that would make them a HIPAA covered
entity.

All health plans except for a small carve-out for small-group health
plans are also HIPAA-covered entities, and we also cover clearinghouses,
which are entities that help exchange information between providers and
payers and make sure that the information is in standard format.

So we can assume for purposes here that most if not all of the labs and
the doctors will be covered by HIPAA, but that may not be 100 percent.
So some of these entities may not need to bother about the HIPAA privacy
rules. But there are many people with health information that HIPAA does
not cover, including employers; other types of insurers who are not
dealing with health insurance, such as life insurers or worker\'s comp;
and other entities that may hold medical information banks. And credit
companies may have medical information, and they have their own
protections under other laws. Government entities such as public health
and many of the State oversight entities, both on the plan side and on
the provider side, would not usually be HIPAA-covered entities, even
though they also maintain health information.

There is also a category that may come up in this context in terms of
business associates. We recognize that in carrying out many of their
functions, a covered entity may engage a third-party \-- may hire a
third-party to do these functions for them, where to carry out that
business function on behalf of the covered entity, this third-party
needs protected health information. We call them business associates,
and it needs to be a business associate agreement between the covered
entity and this third-party.

The purpose of the agreement is so that the third-party that obtains the
health information in order to carry out this business function is
providing adequate assurances that that information will be protected
and properly safeguarded. Their receipt of protected health information
and the assurances that they make pursuant to their business associate
contact do not make these business associates covered entities. And
I\'ll come back to that in just a second.

\>\> ALAN MERTZ: Susan, this is Alan Mertz. Could I ask you one question
there?

\>\> SUSAN McANDREW: Sure.

\>\> ALAN MERTZ: One of the things that some folks have brought up is
that the \-- let\'s say that a lab, for instance, if they were to give
information to a disclosed PHI to a RHIO, and the \-- that you couldn\'t
necessarily have a business associate, that the RHIO couldn\'t be a
business associate, because they would not be performing a function that
otherwise would be performed by a lab.

\>\> SUSAN McANDREW: It depends on how you conceptualize what the RHIO
is doing on behalf of the lab.

\>\> ALAN MERTZ: Isn\'t that a business requirement of a business
associate \-- it has to be performing a function that would otherwise be
performed by the covered entity?

\>\> SUSAN McANDREW: Right. I mean, not every vendor needs to be a
business associate of the covered entity. I think one of the primary
examples \-- excuse me \-- is banks with whom you do financial
transactions. Banks are not business associates of the payers or
providers who are handling their banking accounts that are doing their
business and the entity is doing its business. So it depends on what you
view the RHIO as doing. Certainly, to the extent a RHIO is engaged in
any kind of data aggregation or is the gateway for a disclosure activity
by the entity, you can conceive of that RHIO as carrying out that
disclosure function on behalf of all of the membership in that RHIO.
Conceivably, you could look at that RHIO as a business associate of all
of its members. And it is kind of the, the hub-hub in the hub-and-spoke
scenarios. Each of those examples \-- you could look at that as a
business associate agreement.

There are other scenarios where it\'s more like a cinematic switch. In
those kinds of situations, it\'s a little more questionable about what
functions are being performed by that kind of intermediary, both in
terms of whether to perform that function, they actually need to, as
they say in the banking industry, open the envelope or have access to
the protected health information, or they are just reading the address
on the outside of the envelope, whether they actually need to have
access to PHI in order to perform that function. That kind of question
may come into question, as well as whether this is one of those
functions that the entity would otherwise be allowed to do. Most of them
don\'t \-- health care operation or essential component of their
business to run an Internet switching operation.

\>\> JONATHAN PERLIN: Does that help? The question on the table is in
\-- there is a law that doesn\'t allow release of information from the
laboratory to other than the clinician \-- physician in many instances.
The subsequent question is, "What, then, are the rights, and what are
the rights or limitations for that clinician in terms of subsequently
sharing that information?" And a solution that I think you proposed is
that if a RHIO exists, potentially, RHIO members could be business
associates, if I got that right so far.

\>\> ALAN MERTZ: This is a State law that prohibits us from disclosing
results. The other is a Federal law. It \-- HIPAA\'s close construct,
two different issues. One is a HIPAA problem, and the other is a State
law problem. The other one is the CLIA problem.

\>\> SUSAN McANDREW: You have a whole ball of wax. To park that a little
bit before we move on, from the HIPAA perspective, the State law that
says a lab can only report to ordering doc with the results. HIPAA would
look at that and say, you know, "Fine." HIPAA doesn\'t mandate
disclosures. It permits it. If a State law is more stringent in terms of
what it doesn\'t allow to be disclosed or limits to whom that disclosure
may be made, that State law, that more stringent State law, continues in
force and effect under HIPAA. We are in Florida, and those State laws
continue to operate.

\>\> JOHN HOUSTON: This is John Houston. I apologize.

\>\> SUSAN McANDREW: Hi, John.

\>\> JOHN HOUSTON: I hung the phone up when I took it off of mute, and
unfortunately, it took me 10 minutes to get back in the conference call.
I\'m just \--

\>\> JONATHAN PERLIN: Welcome back, John. We are having a discussion now
of HIPAA with \-- Susan McAndrew is presenting and offering clarifying
questions. After we go from this discussion, let\'s circle back after
you kind of regained contact.

\>\> JOHN HOUSTON: My point is that this is part of the reason why the
gentleman\'s question about State law and CLIA \-- that\'s one of the
reasons why I think we have to investigate whether authorizations are
the mechanism.

\>\> SUSAN McANDREW: Okay. But once \-- \[Lost audio.\]

\>\> SUSAN McANDREW: That doc can disclose it as HIPAA would require or
permit, including to the \-- you know, unto the individual, because
HIPAA allows that. He can tell another provider, because HIPAA allows
exchanges of information between providers for treatment purposes. He
can share it with public health if that is required and the lab hasn\'t
already done so. There are a variety of other purposes for which that
information can be disclosed once the doctor obtains it, so that HIPAA
doesn\'t present a problem at that stage.

\>\> JOHN HOUSTON: Well, that\'s assuming this business associate issue
is not a problem. \[Lost audio.\]

\>\>: It is not an issue if you rely on the physician to give the RHIO
the lab data. If you want the labs to transmit it to the RHIO, they
can\'t, even with patient consent in some States.

\>\>: I don\'t understand. From my reading of everything I have been
able to find about State law, you know, if there\'s a patient consent
that\'s appropriately constructed, that provides the basis for any HIPAA
disclosure that\'s provided with the consent.

\>\>: Not \-- we looked at Florida and Georgia, and clearly, in Florida
and in \-- maybe in other States, there\'s no provision for consent. It
says we\'re flatly prohibited from giving the results to anybody other
than the doctor. There\'s no out tore us with consent.

\>\> SUSAN McANDREW: With regard \-- there may also \-- and in addition
to those kinds of laws, which I believe relate to CLIA, and who is \--

\>\> MAN: But CLIA is trumped by the State laws.

\>\> SUSAN McANDREW: The State has been given under CLIA the right to
define that for CLIA purposes.

\>\>: But the States have given no provision for us to give it to
anybody else, even with consent.

\>\> SUSAN McANDREW: Right.

\>\> JUDITH YOST: This is Judy Yost. I thought we would jump in. We
finally did get in the call from CMS, the CLIA program. I can hardly
wait.

\>\> JONATHAN PERLIN: Judy, hang tight for just a minute. We are trying
\--

\[Overlapping speakers.\]

\>\> JUDITH YOST: Absolutely.

\>\> JONATHAN PERLIN: \-- with the HIPAA discussion.

\>\> JUDITH YOST: Sure; go ahead.

\>\> JONATHAN PERLIN: Let me remind participants we have open lines
today. Let\'s pause after statements, and please state your name so that
everyone knows who is saying what. And let\'s come back to Susan
McAndrew. You were addressing a set of comments and, I think, a very
important discussion about HIPAA and the concept of State law as might
relate to a doc who in turn wants to release information to a RHIO.

\>\> SUSAN McANDREW: It would seem to me that for HIPAA purposes, the
release to the RHIO would need to assume that the RHIO is the business
associate of that doctor, he\'s a member of the RHIO, and the RHIO has
given over the responsibilities of some portion of the data management
of the various members.

That could justify the release of this information into the RHIO. As a
business associate, that \-- the RHIO would only be allowed to use and
disclose the information as necessary to carry out whatever business
associate functions they had been contacted for, and they would also not
be permitted to use and disclose that information in any way that any of
its members could not themselves do.

And this is permissions only with regard to HIPAA. So, for instance, you
can\'t contract with the business associates to make what would \-- what
HIPAA would consider to be an impermissible disclosure of the
information. If the covered entity, if it would be impermissible for the
covered entity to do it, they cannot contract with an agent and permit
the agent to do it.

But in general, we would look at that business associate as limiting its
handling of that information as necessary only to carry out whatever
business functions had been delegated to it by the covered entity. In
general, under HIPAA, it is the covered entity, then, that is the \--
that is liable for both the criminal and the civil sanctions under the
statute. The business associate is not a covered entity and is not
directly liable under the statute for either civil monetary penalties or
criminal sanctions.

And the covered entity is also not necessarily liable for any violations
by its business associate.

\>\> JONATHAN PERLIN: Okay, let me ask that we go on to the CLIA
presentation, because we are wrestling with three threads here. I think
your presentation was excellent and, I think, provided the basis for
recommendations for, potentially, ways in which information might be
effectively and appropriately shared with the appropriate prohibitions
stated as well. You\'ve added another important piece to the puzzle and
a thread to allow the information sharing. I think what also is fairly
clear \-- that there are a number of, if not competing \-- I want to say
"complementary" \-- regulatory and legal processes and one of those,
with respect to our specific charge of laboratory data, is, of course,
CLIA. We were fortunate to have Judy Yost join us on the call.

Before I turn to that, I want to thank everyone for your work today.
I\'m going to leave the VA site in the hands of Rob Kolodner and Linda
Freschetti and ask Lillee Gelinas to continue chairing the remainder of
the call. I have to be on the Hill with the Deputy Secretary shortly.
Let me apologize and step out. Thanks. And Judy, Lillee, go ahead.

\>\> LILLEE GELINAS: Thank you, Jon, so much. Good luck on the Hill as
always.

Judith Yost, are you ready?

\>\> JUDITH YOST: Sure.

\>\> LILLEE GELINAS: Are there any handouts we should be referring to on
the Web?

\>\> JUDITH YOST: I apologize. I have been out of town. I just wasn\'t
able to prepare anything. Perhaps I can send you something at a later
date, at least to have as a reference so you have a summary of the
current requirements. Or actually, I could refer to you a Web site where
you could download that piece of information. I could send that to you,
and you can forward it to the group, and they can do that at their
leisure.

\>\> LILLEE GELINAS: One thing that is \-- I think we are seeing that
from the RHIO privacy and HIPAA presentations already is implications
for us. And having experts at the table here in each of these topics,
it\'s important to understand both of the scope of the regulations but
also the "so what," for us. I think you can be most helpful to us with
that.

\>\> JUDITH YOST: We\'ll do our very best. We are very excited about
your project and hope you are able to \-- you have a lot of challenging
items in front of you. We are hoping that perhaps we can be as much help
as possible and provide you some flexibility where we can within the
scope of the regulations, or if we feel that there\'s no other way but
to make changes, we\'ll see, you know, what we can do about that, but we
would hope we can work through policies rather than having to do any
complex type of regulatory changes at this point. What I thought I would
do is \-- I know it might be slightly boring, but \-- at least give you
a summary of some of the regulations that apply to the processes that
you\'re all discussing. That\'s really on the front end of the process,
where we have a provider ordering a test, and then on the back end of
the process, the postanalytic where the result is being reported to as
you were talking about, the authorized person.

And then we can take the discussion from there. This is actually fairly
short. The way that \-- just for your general information, the way that
the regulations are aligned is that they actually follow the process of
the testing specimen through the laboratory so that all the requirements
that would apply to the phase where the specimen is \-- the test is
ordered; the specimen is collected and processed \-- are in one area.
Then, where the actual analysis takes place, they\'re in another area.
And lastly, when the results are reported, all the applicable
requirements are compiled again in a separate section. So it\'s very
easy to follow it through the laboratory as well as to identify what the
particular requirements are for those areas. Should you have the time or
a desire to actually read the regulations, you\'ll know where to look
then.

What we have also done \-- since CLIA\'s intent is to assure accurate
and timely and reliable test results, we\'ve also interspersed quality
assurance, which is what \-- applicable to some of the things you\'re
talking about, because we\'re talking \-- because you\'re talking about
transfer of information through various means.

CLIA was written in a very broad stroke as far as the regulations. So it
allows for any kinds of information gathering and results transmission.
It doesn\'t specify that it has to be on paper or that it has to be
electronic. It can be, you know, whatever means the laboratory needs to
use to get the information to the provider in a timely fashion.

So just to start out, we\'re talking about the test request, which is
the test order. The laboratory in \-- ordered to a test obviously must
have a written or electronic request for the patient testing from an
authorized person, and this segues from the conversation that we had
that it defines the authorized person as the individual that is
authorized under the State law to order tests or to receive results or
both. If a State law does not address who may order tests or receive
results, then anyone may order those tests or receive those results.

However, the laboratory must follow the requirements of the Social
Security Act also if it wishes to be reimbursed under Medicare for test
ordering. I believe that does require a physician order a test to assure
that only the authorized person is the individual ordering the test. The
laboratory needs to have some sort of security levels to ensure that
they in fact are getting that information from that individual.

As far as the test request, the laboratory must ensure that the test
requisitions solicit certain information: the name and address or other
suitable identifiers of the authorized person requesting the test and,
if appropriate, the individual responsible for using the test results;
or the name and address of the laboratory submitting the specimen,
including a contact person to receive any life-threatening or
critical-value types of results.

What the requisition is select\-- collecting is the patient\'s name or a
unique patient identifier, the sex and age or date of birth of the
patient, tests that are to be performed, the source of the specimen if
it\'s appropriate for the types of the particular test, the date or time
of the specimen collection. For PAP smears, they also need to correct
the patient\'s last menstrual period, and then it says any additional
information relevant and necessary for a particular type of test for
force and genetic tests, you need additional information. The test
request also says if the laboratory transcribes or enters test
requisition or authorization information into a record system or
laboratory computer system, the laboratory must ensure the information
is entered accurately. Pretty straightforward stuff.

And then the laboratory, if our policy \-- in our guidelines, we say the
laboratory has to have an ongoing mechanism to ensure the accuracy of
manual entries by personnel into a laboratory information system. The
regulations also talk about when a test is referred to another lab to
perform that testing as well, that there has to be certain information
provided to the clients about where the test is performed. And then we
go to the postanalytic or the reporting section of the regulations.

And this talks about the laboratory having a process to monitor and
evaluate the overall quality of the systems that they have in place and
how they correct any identified problems for each type of testing that
the laboratory performs. And then under the test report, the laboratory
needs to have an adequate manual or electronic system in place to ensure
that test results and other patient-specific data are accurately and
reliably sent from the point of data entry, whether it\'s interfaced or
whether it\'s entered manually, to final report designation in a timely
manner.

And then under our policy, we indicate that the regulations apply to
manual as well as automated record systems or laboratory information
systems. However, the regulations do not specify the mechanism or
frequency for which a laboratory should evaluate its record storage and
retrieval systems, but it is basically enforcing a QA type of approach
in which any time you receive or transmit information, you have to check
the system or process that you have in some place to ensure that you are
receiving correct information, and that you\'re also transmitting
correct information as well, and that you have security measures
instituted to ensure that the reports go directly to the device sending
reports only to the authorized individual.

Under the test report, there\'s a number of items that also have to be
included. That includes results reported from calculated data. Sometimes
the test system the lab uses actually does some calculations, or the lab
does some calculations and that \-- in that data as well and then
results in patient-specific data electronically reported to network or
interface systems or that is manually transcribed or electronically
transmitted results and patient-specific information reported directly
or upon receipt from an outside referral laboratory, satellite, or
point-of-care testing locations.

And then the policy indicates that manually transcribed or
electronically transmitted results from an outside referral laboratory
or from within the laboratory system that is another site that may be
testing \-- must be periodically verified for accuracy and timely
reporting. That\'s what I just talked about before, that you need to
check what's coming in and what\'s going out of the laboratory
periodically, but we leave it up to the lab to determine how frequently
and how extensive they do that. But they need to be sure that those
results going it are timely and accurate. The test report further says
that information needs to be maintained as part of the patient\'s chart
or medical record must be readily available to the laboratory and to CMS
upon request.

Test report information (this is pretty much common sense) should be
legible, understandable, and complete. The test report must include the
following types of information: positive patient\'s identification;
either the patient\'s name and identification must be \-- or a unique
patient identifier and identification number; then, of course, the test
report date \-- that\'s the date that the results were actually
generated as a final report \-- the test that was actually performed;
again, a specimen source where it\'s appropriate; and then further, the
test result and any units of measurement or interpretation of the test
results or both.

And then the policy indicates that the laboratory prints the test's
normal ranges on the patient report. They need to verify that they are
printed by the laboratory information system on that patient test
report. Again, we talk about \-- normal values must be available to the
authorized person. They can be on the report or available to the
authorized person who ordered the test or the individual who is
responsible for using the test results.

Test results must be released only to the authorized person \-- this is
the regulation saying that \-- and, if applicable, the individual
responsible for using the test results and, if it\'s a referral test,
the laboratory that initially requested the test. The laboratory must
immediately alert the individual or entity requesting the test or the
individual responsible for using the test results when any test results
indicate an imminently life-threatening condition or alert value.

When the laboratory cannot report patient test results within an
established time frame, the regulation says the laboratory must
determine, based on the urgency of the patient test results, the need to
notify appropriate individuals of the delayed testing.

I\'m just kind of pointing out all the nuances that are included in the
regulation. Again, if the laboratory refers patient specimens for
testing, the referring laboratory must not revise results or information
directly related to the interpretation of the results provided by the
laboratory that performed the testing. So that\'s a very important point
for the large reference laboratories. The referring reference laboratory
may permit each testing laboratory to send the test results directly to
the authorized person who initially requested the test. The referring
laboratory must retain or be able to reproduce an exact duplicate of
each testing laboratory\'s report. And an exact duplicate is an exact
copy of the information sent to the individual requesting the test or
using the test results and includes the name and address of the
laboratory performing the test.

And then it talks about \-- we talk about preliminary and partial
reports as well, because CLIA requires that each type of result that is
produced by the laboratory throughout the testing process need to be
transmitted and retained by the laboratory and sent to the authorized
person. The authorized person who orders a test must be notified by the
referring laboratory of the name and address of each laboratory location
where testing is performed.

That can be done by a coding system. It doesn\'t necessarily have to be
the actual name and address on the report. All test reports or records
of the information on the test reports must be maintained by the
laboratory in a manner that allows ready identification and timely
accessibility.

Then the regulation speaks to when test results errors are detected and
you have to send a corrected report, that the authorized person needs to
be notified. A corrected report needs to be issued promptly to the
authorized person and, if applicable, the individual using the results
corrected, and the reports must indicate that they are corrected
reports. And then the laboratory needs to keep a copy of both the
original report that they sent out as well as the corrected report.

\>\> KAREN BELL: Judy, I\'m wondering if, by any chance, there may be a
way to take the original of what you\'re sharing with everyone and have
an offline discussion about how the Workgroup might be able to craft
some recommendations for either CLIA guidance or maybe even long-term
changes to CLIA or perhaps even recommendations on \-- to the National
Governors Association or someone else about the State laws piece,
because clearly, you\'re articulating that there are concerns, and the
group has articulated there are concerns, with the ability for us to
move forward with making historical data available. But I\'m thinking
that from the Workgroup\'s perspective, this might be a good offline
discussion with, particularly with the folks who are very interested in
the privacy and security so that the group can make the recommendations
to the AHIC that ultimately could lead to some change. Is that something
you would be amenable to?

\>\> JUDITH YOST: Sure.

\>\> LILLEE GELINAS: That\'s a great recommendation, Karen. As I was
sitting here trying to take notes \-- and as for a lay person like me,
this is very new \-- I immediately went to the CMS Web site for CLIA and
didn\'t even understand that CLIA covers 189,000 lab entities.

\>\> MAN: One hundred thousand of those are physician office
laboratories. Don\'t be disillusioned here.

\>\> LILLEE GELINAS: No, but still, it\'s big, so the experience is
broad. I was also intrigued how the proficiency testing in the areas
affected by Hurricane Katrina were suspended, so I know that there are
ways to address very difficult and complex scenarios. The piece that I
also thought was intriguing that we might, Karen, consider is, since the
regulations are aligned, with how the specimen is ordered, collected,
processed, analyzed \--

\>\> KAREN BELL: Mirror image, right.

\>\> LILLEE GELINAS: If we were just to make sure that our
recommendations are aligned with the process here, because the process
is very clear and I know there\'s a lot of nano details under each
aspect of the process, but it would seem to me, I think it\'s a great
suggestion, Karen: go offline. This gets to what I asked for in the very
beginning, and that is the so with a. We all know that CLIA is in place,
we all know it\'s very complex, but we also know why it exists and why
it was put into place. So given the charge of our Workgroup that we\'ve
got to make a recommendation fairly quickly, and having heard the
previous conversations around HIPAA and privacy, I don\'t know whether
our work will be any easier, but we certainly do have the issues at hand
on the table.

\>\> CHIP KAHN: This is Chip Kahn. I guess I\'m curious. I understand on
the \-- Katrina that State officials were willing to waive things. But
my assumption is both for CLIA and for HIPAA and whatever kind of State
requirements are, if you\'re talking about something permanent that
certain consumer groups and others will get their backup immediately and
try to prevent any change.

\>\> SUSAN McANDREW: I don\'t think \-- Chip, I don\'t think it\'s
permanent at all. But if you go to the front page of the CMS Web site on
CLIA, you\'ll see it just says, "In these very difficult times, we have
no wish to make things for \-- complex for labs affected by Katrina\'s
wrath. Therefore, we have decided that until further notice, PT for the
laboratories that no longer exist, may have to relocate, or where the
infrastructure has been destroyed should be suspended. And it doesn\'t
give a time frame.

\>\> CONNIE LAUBENTHAL: This is Connie Laubenthal with the American
College of Physicians. I happen to run one of the proficiency programs
that that applied to.

\>\> SUSAN McANDREW: Great.

\>\> CONNIE LAUBENTHAL: Everything is back to normal now.

\>\> SUSAN McANDREW: How long was it suspended?

\>\> CONNIE LAUBENTHAL: There was just one event. There\'s three testing
events a year that we send out. It was really just one event that was
affected. It was the fall event. And frankly, you know, out of all of
the labs that we serve, there were only two labs that weren\'t able to
reopen.

\>\> JUDITH YOST: This is Judy Yost. This was a very, very unique
circumstance that, again, will never happen again in our lifetimes.
Clearly, where there are no roads or no laboratory in existence, up
can\'t send samples that could potentially be infectious out into the
world and just let them float. I mean, this \-- the suspension of
proficiency testing was a very unique circumstance and not something
that we would consider doing under routine circumstances. I had plenty
of people evaluating that, but it was clearly something that needed to
be done very quickly and for a very short period of time, as Connie
indicated, until the laboratories were either back in operation or had
moved to or relocated or whatever they needed to do to reopen.

So I would not use that as an example in this circumstance, since we are
\-- I would assume you\'re planning for a long-term future.

\>\> SUSAN McANDREW: Absolutely. So Karen, just in terms of more on the
presentations, we really do need to have some good Workgroup discussion
around how these presentations inform our decisions around the
recommendations.

\>\> KAREN: I think that\'s very true. And we may not be at a point
where we can come to a recommendation, particularly today, either CLIA
or HIPAA. But clearly if we take something offline and add to what John
and Chip have already started, we may be able to circulate some
recommendations over time of the next several weeks and everyone can
chime in online on those.

\>\> LILLEE GELINAS: I was sorry that I had to join you late. Did you
\-- on Agenda Number 6 on the timeline for recommendations, did you talk
about calendars anymore? Is that something we\'ll do at the end of the
call?

\>\> KAREN BELL: No, that will be at the end of the call. We did not
actually talk about the recommendations at all. That was \-- that would
be Number 8 on the agenda. Before we move on, we do have more questions
in the room for Judith.

\>\> CHANTAL WORZALA: Yes, this is Chantal. Briefly, I do support the
notion of moving this offline. I wanted to make sure I hear the question
correctly. The question to CLIA sounds to me that it allows the release
of the information to the individual person or the individual
responsible for the test or the referring lab. Is that blanket, or could
a lab release that data under CLIA \-- forget about State law \-- to
something like a RHIO or central data repository if the individual
consented?

\>\> JUDITH YOST: What is the \--

\>\> CHANTAL WORZALA: What is the rule under CLIA?

\>\> JUDITH YOST: Clearly, since CLIA was written in 1992, I don\'t
think it considered a RHIO. So I think, again, we would have to
understand what all that \-- I mean, we have your lovely graphic here,
but we would have to understand exactly what that is comprised of,
because again, this certainly wasn\'t contemplated previously. I mean,
recently, release of information also have to do with that individual\'s
consent.

\>\> JOHN HOUSTON: This is John Houston. I think that\'s central to the
issue \-- is \-- I\'ve always understood that CLIA allowed things to be
released as long as there was patient consent or authorization, as under
HIPAA.

\>\> JUDITH YOST: Actually, we don\'t actually speak to that at all.
What I talk to here \-- and I apologize that I was not able to send you
anything. I will send you a Web site where you can go look this stuff
up. But essentially, all CLIA says is to the authorized person. Where it
goes from there, we really have no control over it. That\'s not within
our purview. And HIPAA does refer to \-- or does defer its authority to
CLIA very specifically, and in its requirements. In the preamble, it
even discusses that.

\>\> CONNIE LAUBENTHAL: Judy, this is Connie Laubenthal. Isn\'t it true
that the CLIA regulation in that particular area is really kind of tied
to State law, and if there is no State law saying who the authorized
person is, then you could release it to whoever, you know, the patient
wanted you to under that circumstance?

\>\> JUDITH YOST: Under that circumstance, if there is no State law,
yes. That speaks to that, but where there is, that\'s what I was
referring to.

\>\> ALAN MERTZ: Judy, this is Alan Mertz. But under CLIA, to any
authorized person, what is the range of people who could be the
authorized person?

\>\> JUDITH YOST: It depends on the particular States.

\>\> ALAN MERTZ: No, but I mean, if there is no State law, then who is
the authorized person?

\>\> JUDITH YOST: We do not define it at all.

\>\> ALAN MERTZ: And the labs, haven\'t they traditionally defined that
narrowly to mean that \-- someone basically in the ordering physician\'s
office? Isn\'t that \--

\>\> JUDITH YOST: Usually it is because of Medicare requirements,
because Medicare pretty clearly says only a physician can order a test.

\>\> ALAN MERTZ: I wanted to bring that up. We basically interpret that
to mean someone in the physician\'s office, not a RHIO. The other thing
I would encourage you all to look at \-- owe on I\'m not sure. I\'m glad
to participate in a subgroup, but if you look at the document that was
submitted with States requirements on tests \-- look at Hawaii, look at
Illinois, Kentucky, look at Maryland \-- in these states, test results
may not be reported to anyone other than the person requesting the test,
period.

\>\> JUDITH YOST: Right.

\>\> ALAN MERTZ: In Hawaii \-- there are States where you can\'t even
report it to the patient even with the patient\'s consent; the lab
can\'t give it to the patient.

So I\'m going to argue strongly for preemption here, because this just
isn\'t going to work without some pretty strong preemptive language.

\>\> LILLEE GELINAS: I did hear consensus, and group, tell me if I\'m
wrong here, but Chip, when you talked about the recommendation for
opt-in, I didn\'t hear any counter to that at all.

\>\> CHIP KAHN: Opt-in doesn\'t work at all. There is no provision for
opt-in.

\>\> LILLEE GELINAS: At this time.

\>\> CHIP KAHN: No, under State law that doesn\'t allow for \-- consent
doesn\'t help. You have to preempt the actual State law itself.

\>\> MAN: There\'s another way to approach it, which is to have an
opt-in policy. And there\'s opt-in policy, and there are a number of
States it won\'t work in.

\[Overlapping speakers.\]

\>\> ALAN MERTZ: Doesn\'t work with CLIA at all.

\>\> CHIP KAHN: But at the Federal level.

\>\> ALAN MERTZ: Opt-in wouldn\'t work under CLIA either.

\>\> LILLEE GELINAS: Why wouldn\'t it work under CLIA?

\>\> ALAN MERTZ: I thought Judy just explained there is no provision for
consent. It has to go to the ordering physician or their authorized
person, which generally is interpreted to mean, I think \-- I guess,
Judy, the only way would be some guidelines that would expand the
definition of authorized person and that would work in the States that
couldn\'t have a rule on that.

\>\> JUDITH YOST: The definition is in our regulation for authorized
person. That\'s the difficulty here.

\>\> ALAN MERTZ: Yes, that\'s right.

\>\> JUDITH YOST: I realize what you\'re saying and of course we have
the circumstances where \-- one of the reasons I think CLIA was so
specific about this piece (because, as you saw, some of the other stuff
is not) was the idea that sometimes results need interpretation. It\'s
important that that authorized individual explains that to the patient.
The process, I think, is meant for us, for CLIA, to stay out the
practice of medicine, which is clearly the ordering of tests and the
interpretation and use of that information, and so we are always kind of
like the middle pieces, where that involved directly the laboratory per
se, because it\'s really intended to not get involved in clinical
practices. And that\'s partly why CLIA is so narrow.

\>\> LILLEE GELINAS: Well, you know, part of our charge \-- and Karen,
please weigh in here, but part of our charge is to identify the policy
and law regulation, that whole arena that we need to make
recommendations for change.

\>\> KAREN BELL: Absolutely.

\>\> LILLEE GELINAS: This is a fabulous discussion.

\>\> JOHN HOUSTON: This is John Houston. I agree with that. The one
thing we need to be very cautious of \-- we need to look at the path of
least resistance with regard to our recommendation.

\>\> LILLEE GELINAS: Which would be?

\>\> JOHN HOUSTON: We need to be careful that we don\'t shoot for pie in
the sky and look at things that we think have the most opportunity to
get passed in the time frame that we are talking about, trying to get
them passed.

So we \--

\[Overlapping speakers.\]

\>\>: I\'m sorry to interrupt, John, but can\'t we don\'t both? Even
Secretary Leavitt has kind of put it in the parameters of the AHIC as
both the pure vision, and then there\'s the breakthrough area, which can
be accomplished in 1 year. We can get recommendations from the Workgroup
say something to the extent of \-- about pie in the sky or the pure
vision would be for Federal preemption of State privacy laws with the
idea that we can only get so far, that maybe something that would be
more appropriate and fast track would be preaching out to the National
Governors Association to see how you can streamline these privacy laws
at that level.

\>\> JOHN HOUSTON: I agree with that. We can look at it as a two-pronged
approach, but I think we need to make sure that we\'re maximally
practical in what we ask for, at least ought out of the gate
recommendation, because I think it\'s going to be a real challenge to
get accomplished here. I just think we have to be very practical about
this.

\>\> CHIP KAHN: This is Chip. I don\'t think there\'s any way \-- we
cannot make any assumption that Congress could do anything. Whether or
not a regulation \-- a definition and regulation could be changed if
something gets really dictated by the legislative language, I suppose
that\'s a possibility and the Secretary has power to reconsider how he
defines things as long as the general council would rule that you still
have that flexibility in the way the law is written. But I think that we
just have to assume that if Congress hasn\'t allowed it at this point,
it ain\'t going \-- it is not going to change what it does, because
Congress just moves too slowly and some of these issues are too
politically packed. It\'s impractical to assume any recommendation that
assumes changing law in my mind.

\>\> LILLEE GELINAS: Karen, I\'m mindful of the time and ask you for
your counsel on this as well. As you can see, we have other pieces of
the agenda to consider. But if \-- what I would like to get help from
the Workgroup around is some conclusion around this part of the agenda.
But I came in the middle of the RHIO discussion. However, one of the
pieces that was really enlightening is that some trends are clear and
there are some successes: the Indiana experience is clearly a success.
So we know a little bit more today than we knew yesterday.

Under the privacy piece, we need an opt-in scenario. Under HIPAA and
CLIA, clearly, State-level regulations are the barrier, if I\'m hearing
that correctly.

\>\> JOHN HOUSTON: Certain States.

\>\> LILLEE GELINAS: Certain States, okay. So help me with summarizing
what we\'ve gleaned from this portion of the agenda.

\>\> KAREN BELL: I\'ll jump in a little bit here, and then I\'m going to
rely on everyone else as well. I think \-- taking a part of RHIO
discussion, but really concentrating on this particular piece, with the
exception of the RHIO report, I think that clearly, there is opportunity
for guidance from both our HIPAA colleagues and from the CLIA colleagues
in terms of how we may make some recommendations with respect to pushing
the envelope just a little bit, moving forward. And I think we\'ll need
to go offline and have those discussions in greater detail. I would hope
that Chip and John would be willing to do that with us, if that\'s \--
and anyone else who is interested.

\>\> JOHN HOUSTON: I\'ll help out; that\'s fine.

\>\> CHIP KAHN: Sure.

\>\> KAREN BELL: And anyone else who is interested in defining the issue
where CLIA and HIPAA guidelines would be helpful. I also agree that we
can\'t assume that we can change Federal law at this point, but clearly,
we could certainly point out where it limits the ability for electronic
health information to really be used to its fullest potential. I think
we could certainly make those sorts of comments offline as well.

So I would basically sum up by saying that there are opportunities for
guidance in both of these areas and we\'ll need to explore them in
greater detail before we can make them into robust recommendations.

With respect to the RHIO report \-- and Scott is no longer with us, and
I\'m not sure if we have anyone on the line \-- so I think that the RHIO
presentation certainly gave us an understanding that there clearly are
patient-centric approaches that are being developed and are in use right
now that we could explore in greater detail. And while that doesn\'t
mean that we have to make a recommendation for a patient-centric
approach, the basic concept that they do exist and they are robust in
many parts of the country, I think, was brought forth today by John\--
I\'m sorry, by Scott\'s discussion and everyone else who chimed into
that.

So that \-- as we move forward and start thinking about the kinds of
recommendations that will need to be made and will need to go into the
letter to the Secretary by May 1, where we are really talking about who
needs to do what, I think we can \-- we have a much better understanding
of how to shape those recommendations moving forward for the last part
of this call.

Is that helpful, Lillee?

\>\> LILLEE GELINAS: Yes, I would ask anyone else to weigh in. If not,
we\'ll move to the next item on the agenda.

\>\> CHANTAL WORZALA: This is Chantal. I guess I want to challenge a
little bit. I don\'t want to get caught up too much in the labels, but
in the three case studies that we went through, in Utah, they are
basically making electronic the point-to-point result reporting so that
it sounds to me a lot like a peer-to-peer model in Utah.

In Tennessee, no data is actually being moved at the moment, although I
think that is very much a, you know, RHIO kind of approach where you
have hub-and-spoke kind of access to data.

And then in Indiana, it\'s again \-- I don\'t know exactly how I would
characterize that, but certainly the place where they seem to have made
a good business case, which is the Docs4Docs portion of what they did in
Indiana \-- it is again sort of, point to point, automating the release
of results from the person who did the test to the person who ordered
the test.

So I just wanted to push back on that a little bit before we get into
this discussion of what model we really are looking toward.

\>\> CONNIE LAUBENTHAL: This is Connie Laubenthal. One other thing we
might need to think about is if you have a peer-to-peer, you can work
around with patient authorization, because the physician controls the
result. And if the physician then feeds it either to a RHIO with the
patient\'s permission or feeds it to another physician, you done have
those CLIA or State regulatory issues. That\'s something that would
certainly work in the short-term more than \-- you know, because you
wouldn\'t have to do all the changes of State laws or even look at any
of that.

\>\> HOWARD EISENSTEIN: This is Howard. I was thinking of that idea. I
mean, there could be some kind of programming function such that if
there\'s prior operate-in, it waits 1 millisecond after it goes \--
after the physician receives it to the RHIO or some other patient or
whatever entity the patient has indicated.

\>\> MARK OVERHAGE: Mark is Mark Overhage. Just a clarification on
Docs4Docs. It is not really point-to-point delivery. It\'s delivery from
the source to the health information change, which then delivers it to
all designated recipients that might be the ordering physician, the
"copy-to" physician, or the others on behalf of the generating data
source.

And the other comment I can\'t resist interjecting is that if you think
of trying to deliver it to the physician and have the physician to send
it somewhere, the physicians don\'t have the ability to do that, by and
large. They don\'t have EHR. The data doesn\'t get delivered into a form
that they can deliver it to anybody.

\>\> KAREN BELL: Is Mark still on the line, Mark Frisse from Tennessee?

\>\> MARK FRISSE: Yes.

\>\> KAREN BELL: Could you comment about the nature of your exchange? I
know that you haven\'t started up yet, but my understanding of it is
that it was more from the patient-centric point of view and that
information from multiple labs would be available to the clinicians
caring for the patient or other authorized clinicians.

\>\> MARK FRISSE: Yes, that is true. I would say data is being moved.
They are not being used again because of the rather stringent issues or
concerns we have about confidentiality. But I think that, again, I see a
physician both as a necessary safeguard in the current regulatory
environment, but frankly a bottleneck in the long-term delivery of the
health information, the information I want about my health. When we
look, for example, at opt-out strategies in our institution and other
things, we let the partnership within the delivery organization and the
patient make that decree.

So while I think that a physician-centric model is the \-- is always an
appropriate model, I don\'t think it should be an exclusively model. I
don\'t think it will meet our long-term needs, but I have no evidence to
suggest that other than, I think, if you want to have true data exchange
and help the million-plus people in the region we\'re serving to wait
for a physicians to automate, it will slow things down a bit. I hope we
can find alternative solutions.

\>\> ROB KOLODNER: This is Rob Kolodner from VA. I think one of the
things \-- and in keeping with what I think I heard from David, what we
might want to do is endorse a principle rather than a solution.

\>\> DAVID BRAILER: Right.

\>\> ROB KOLODNER: Because, for example, I could conceive of \-- I
don\'t know that it\'s necessarily going to be delivered, but the
patient convenience tri actually supports either the RHIO or an
aggregating Web portal, which was one of the other options that we had.

So if we make sure we are clear about what we are endorsing rather than
the technical solution of how it\'s there, I think we will be able to
advance this forward and it may be what would be most helpful to the
AHIC.

\>\> MARK FRISSE: Rob, this is Mark Frisse here. I would endorse that as
well. We are endorsing principles and trying solutions, but we are not
sure it\'s the right solution or the exclusive solution. We want to make
sure that the technical and regulatory barriers are such that people can
make choice over time as people get comfortable with various means of
health care delivery.

\>\> JASON DUBOIS: This is Jason Dubois. I would double with what you
said three and wholeheartedly agree. That\'s what I got from Dr.
Brailer. He wasn\'t looking to have us drill down on a particular focus
but instead of principles that would drive all of these, be it
peer-to-peer or a patient-centric focus.

\>\> KAREN BELL: But I think one of the critical piece \-- this is Karen
Bell \-- among the principles include a recommendation on the direction
that this Workgroup would like to go. Do we like \-- would we like to
move forward with a patient-centric approach, where data from multiple
labs is available to multiple authorized physicians; a lab-centric
approach, where we can \-- we\'re really talking about one lab, no
matter how big it is, and the multiple physicians that it may have a
relationship with to share patient information; or a patient-centric
approach, which is really limited to what can come into the physician\'s
EHR? I think those are really \-- that recommendation does need to come
from this group and the principles around that.

\>\> CHANTAL WORZALA: It seems to me from our discussion at the last
meeting that we saw it as a staged approach where we have to move
through a lot of things. Of course we all want the data to follow the
patient and the whole history to be available at the point of care. But
how do we get there and what can we do the next 12 months, I think, is
the question.

\>\> KAREN BELL: I absolutely agree. Again, the whole RHIO discussion
was around the fact that there are technologies in place and there are
businesses and programs in place in some RHIOs that can allow the
patient-centric approach. While there may be a few more privacy and
security issues in Tennessee, it is there; it has been built. It\'s
working in Indiana. So the concern that was articulated a little bit
earlier, that RHIOs aren\'t ready yet, I think, is true for many other
parts of the country, but there are some parts of the country where the
RHIO approach can be used and the patient-centric model is in place and
can be supported.

So while ultimately we probably needed to do things in an iterative
fashion, I think it\'s important that the Workgroup recognize that the
RHIO-based approach is in fact something that is alive and well at the
moment.

\>\> ROB KOLODNER: This is Rob Kolodner again. I think, again, I want to
be very careful about \-- if we\'re saying that we \-- and it\'s an "if"
right now, but hopefully we can drive this to conclusion as to what
we\'re saying. If we are saying that we want patient centric, I would
not necessarily tie that to RHIO. If there are other technical ways of
delivering it, I think that\'s what Mark and Jason also agreed with.

I think when we went in and said \-- and gave what was perceived by the
AHIC to be a wish-wash answer, that we didn\'t choose anything and we
are going to stage it and therefore you do this and do that, that\'s
where we lost them. What we may want to do, if people are in agreement,
is to make a very clear statement that this, X, is the direction we
should be doing and we should achieve that if at all possible. And I
think the concern about the stage is that that\'s where we seem to
confuse the Secretary and other members of AHIC.

\>\> JASON DuBOIS: Can I interject with what I think is maybe the way
the recommendation could go? Looking back, and as \-- this is Jason
DuBois. Looking back at the specific charge, I note it says, "Make
recommendations to the Community so that within 1 year, standardized,
widely available, and secure solutions for accessing current and lab
results and interpretations are deployed." I\'m kind of focusing in here
on the "widely available" concept. I don\'t know whether \-- while \--
there are RHIOs that are established in the country and could be a model
for others to adopt, and I don\'t know that that\'s the widely available
piece that might be the best way to come at the specific charge. So
maybe the recommendation could come about to say that, you know, the
initial widely available solution would be to help drive peer-to-peer
relationships with the pure vision that ultimately a more widely
patient-centric focus with would hone in on, be it an RxHub-type
relationship or more appropriately a RHIO-type relationship.

So we\'ve addressed both this continuum idea that, I think, everybody
expressed of kind of moving from peer-to-peer to patient focus, and we
addressed both the idea of the immediacy of achieving the widely
available portion of this and kind of the pure vision that Secretary
Leavitt had.

\>\> ROB KOLODNER: This is Rob again. I would like to ask the AHRQ staff
to weigh in a little bit here. Certainly, as we talked with the
Secretary and the league also, since you were a part of that, my sense
in talking with the Secretary was that while we had the widely
available, he actually wanted to make sure we were moving towards the
end goal, and that \-- certainly, that was one of the things we wrestled
with on our last call, but my sense both from the premeeting with the
Secretary and then at the AHIC was the \-- that the widely available
wasn\'t to drive it out as broadly as possible in something that wasn\'t
where we\'re going. So if Karen or Lillee or others want to weigh in \--

\>\> LILLEE GELINAS: No, I think that\'s an accurate interpretation.

\>\> ROB KOLODNER: That was Lillee?

\>\> LILLEE GELINAS: Yes; I\'m sorry.

\>\> ROB KOLODNER: So Jason, I think in light of that and the fact that
there are some aggregating peer-to-peer that might also be other ways
that the laboratories, even in those places where you don\'t have a
RHIO, could advance forward \-- that, you know, again, there\'s no
perfect answer here, but it\'s what we are recommending to the AHIC, and
I\'m wondering whether we have enough consensus at least to do a straw
\-- a quick straw poll to see whether there is agreement or consensus
forming around the endorsement of the patient-centric approach as the
recommendation, knowing that we\'re not recommending a technical
solution. We\'re recommending the direction that in fact the solution
should be driving towards.

\>\> LILLEE GELINAS: Karen, I\'m not at liberty to do a consensus poll,
because I\'m not quite sure who\'s on the phone. It is a good idea. It
is how we move forward if we have consensus that would allow us to move
forward.

\>\> KAREN BELL: Would it be possible for us to get through a roll call
for who is on the phone and just ask for comments? This is a very
important first step.

\>\> MATT McCOY: Karen, this is Matt. If you like, I could read down the
names. When they are called, Workgroup members could speak up one way or
the other on it.

\>\> LILLEE GELINAS: Good idea. Thanks, Matt.

\>\> KAREN BELL: If you feel you\'re not comfortable making an absolute
recommendation and would just like to make some comments, that\'s fine,
too.

\>\> LILLEE GELINAS: Absolutely. No pressure here. We want to see if we
have consensus.

\>\> ROB KOLODNER: We may want to state what we are talking about as far
as consensus rather than just a phrase. Karen, I\'m wondering when we go
back to your description of that patient centric which seemed to be
where multiple providers could get to the multiple labs or multiple
entities. We\'re focusing on this, on the providers, to get to multiple
labs on a patient.

\>\> KAREN BELL: That is absolutely correct. It would provide us
ultimately with the ability to gather information from multiple labs and
to present that to an authorized provider of care. And that essentially
is the patient-centric model, because the information comes to the
patient and it includes historical information.

\>\> LILLEE GELINAS: Okay.

\>\> MATT McCOY: Okay. So I\'ll read you the names on the phone. If
there\'s a Workgroup member I miss in the shuffle for some reason, jump
in at the end. When we finish the names on the phone, we can have those
members present in the Humphrey Building state their opinions. Connie
Laubenthal?

\>\> CONNIE LAUBENTHAL: Yes, I would be in favor of the patient-centric
model, with the understanding that the RHIO isn\'t the only model that
would support that. I don\'t care how many big things that you have \--
big networks that you have. If there\'s not a computer in the individual
physician\'s office, they are not going to get that result. And that\'s
where we need to start is to get the EHRs in the physician offices so
that they can have connectivity. And so I think that that\'s an
important first step. Definitely the patient-centric model is what I
think we need to aim towards.

\>\> LILLEE GELINAS: Did we ever establish how many physician practices
are not automated? Do we even know that?

\>\> CONNIE LAUBENTHAL: Some of the material that was sent out for this
meeting included numbers like about 30 percent that were. So that would
be 70 percent that weren\'t.

\>\> KAREN BELL: In fact, those depend on the methodology. Think there
are 43 different studies out there, 42, that have looked at this, and
the range is from 5 to about 25, 30 percent. But that 30 percent
probably includes anyone who has anything that looks like an electronic
health record and is using it for at least one function.

\>\> CONNIE LAUBENTHAL: So did I hear the answer is 70 percent?

\>\> LILLEE GELINAS: Probably closer to 80 or 90 percent that don\'t.

\>\> KAREN BELL: The average around 17 percent is what we\'re going with
in the absence of any better data at the moment.

\>\>: I\'m sure every physician\'s office has a fax machine. Even though
I\'m a strong advocate of EHR, there is another way of distributing the
data.

\>\> CONNIE LAUBENTHAL: Believe it: I have laboratories in my database
that do not have fax machines.

\>\> KAREN BELL: Really!

\>\> MATT McCOY: Continuing on, Alan Mertz?

\>\>: I think he dropped off.

\>\> JASON DuBOIS: I\'m happy to chime in. This is Jason DuBois here in
Washington.

\>\> ALAN MERTZ: I\'m sorry; I was on mute.

\>\> LILLEE GELINAS: You both can chime in. Alan?

\>\> ALAN MERTZ: Hello? Yes.

\>\> LILLEE GELINAS: Go ahead.

\>\> ALAN MERTZ: Go ahead, Jason. I just was on mute.

\>\> JASON DuBOIS: All I would say is, I hate to be the squeaky wheel
here, but I don\'t think \-- I\'m not against the patient-centered
focus. I\'m looking at it in terms of both the widely available concept
and also, you know, what can be accomplished in the next 12 months. In
both of those, I think we need to stick to this continuum approach of
hoping to incentivize the peer-to-peer relationship with the ultimate
pure vision again, to use Secretary Leavitt\'s words, with the
patient-centric focus, be it a RHIO or some other means.

\>\> LILLEE GELINAS: You\'re saying stick to the continuum focus first
and move to patient centered?

\>\>: What is the end of the continuum?

\>\> JASON DuBOIS: That\'s the end of the continuum really, that
patient-centric focus \-- to use John Houston\'s words, pie in the sky.

\>\> LILLEE GELINAS: Yes.

\>\> JASON DuBOIS: For everybody.

\>\>: We will get there.

\>\> KAREN BELL: However \-- I\'m just throwing this out; this is Karen
Bell \-- however, if we were to adopt a patient-centric approach and
then recognizing that that will require us looking at maybe a dozen
other recommendations that could support not only the patient-centric
approach but can also help with the peer-to-peer piece, then as long as
we have consistent recommendations with patient centric, that might be
something that will move the continuum.

\>\> JASON DuBOIS: It might, Dr. Bell, but it\'s kind of like putting
the cart in front of the horse. We just got done talking about \-- there
are 80 to 90 percent of the physicians who haven\'t adopted this type of
technology. The question is, wouldn\'t you have a broader participation
with any kind of RHIO concept if there were more physicians who already
adopted the technology and already had some type of electronic health
record or health information technology product at their disposal that
you can get more people to plug in and play than those that don\'t
today?

\>\> KAREN BELL: Well, I guess the question, then, is whether or not
physicians without an electronic health record will find it easier to go
to a RHIO to get information than they will going to five different
labs. So I think that that \-- again, I think it\'s just a way of how we
think about the recommendations, and we could craft further
recommendations to support a continuum, the movement along the
continuum, recognizing where we are right now.

\>\> JASON DuBOIS: You make it sound good.

\>\> KAREN BELL: I\'m not being \--

\[Overlapping speakers.\]

\>\> JASON DuBOIS: You make it sound good.

\>\> LILLEE GELINAS: Karen, were you just saying that it\'s easier for
physicians to adopt if there was a RHIO?

\>\> KAREN BELL: If physicians only have to go to one place to access
laboratory information, then I\'m talking about those that don\'t have
an electronic health record. Then that would certainly be easier for
them.

Right now, they are getting faxes from multiple labs, and they are all
coming into the office. So that\'s the current state. But if we\'re
talking about electronic information, then electronic information can
come in in a much more efficient and easy way if it\'s coming from one
source as opposed to multiple sources.

\>\> ALAN MERTZ: This is Alan Mertz. Let me correct it a little bit.
They are not coming on fax. I give the example on the Hill of Quest
Diagnostics. Sixty percent of the results are going back to physicians
electronically today. They are already more than halfway there for some
of the national labs.

\>\> JASON DuBOIS: And 40 percent of their orders.

\>\> ALAN MERTZ: And 40 percent of the orders.

\>\> JASON DuBOIS: Maybe the better thing to look at: What is the
biggest dividend that the patient and the physician are going to get out
of it? Obviously, the big dividend \-- is it going to come from the RHIO
concept or more peer-to-peer to the patient for the physician?

\>\> CONNIE LAUBENTHAL: This is Connie Laubenthal. You also have to
remember: if there\'s a single electronic standard for transmitting
these results, then they will end up getting the result from multiple
places the sale way so they don\'t have to have separate interfaces.

\>\> JASON DuBOIS: That\'s part of the way I think \-- I mean, part of,
I hope, what I think our recommendation would be. It\'s kind of inherent
that HITSP is working within each of the breakthrough groups. That\'s
one of our recommendations, that there is breakthrough standard that
will drive the peer-to-peer relationship so you are getting all of this
information in one format. Presumably whether they have a relationship
with Quest, LabCorp, Mt. Sinai Medical Center, whoever, the data streams
will be the same, providing a uniform standard \-- clinical standard and
messaging system.

\>\> JIM SCIROCCI: Is \-- this is Dr. Scirocci for CMS. That\'s a very
important point. It\'s a very simple one, but this is a standard that
applies and is useful in basically all settings, all technical
solutions.

\>\> KAREN BELL: So the standard would essentially help the patient
centric propose as well as the peer-to-peer or lab based?

\>\> JIM SCIROCCI: From our point of view here, we are going through an
effort to try to get several thousand physician offices to adopt EHRs.
In many cases, you know, they will only have an option of having a
direct connection with one or perhaps a few limited labs. And there\'s
no mature RHIO for them to turn to. But it does help them substantially
reduce the costs and barriers of implementation. But in virtually all
these other settings, you need that standard, too. It has to be CLIA
compliant nationally in some way.

So I mean, it just is a rising tide that helps all possible technical
implementations out there. How the system develops may be clearer, may
be hard to understand right now in terms of some of the choices people
are trying to select on the phone currently with our available
information, but I think this is one that generally helps and has to be
one that clearly \-- and has to be forcefully recommended.

\>\> KAREN BELL: So essentially, Jim, you\'re talking about a second
recommendation that would support whatever the Workgroup chooses as a
basic recommendation, either patient, lab or physician centered?

\>\> JIM SCIROCCI: I guess what I\'m throwing out on the table is just a
standard similar to what Jason just said that allows results to be
reported back to the ordering physician through whatever mechanism one
\-- that always has to occur, right? I mean in whatever setting or
whatever technical solution or whether it\'s patient centric or what
not. We always have to get the result back to the health care provider
that requested it.

\>\> JASON DuBOIS: It can be the means, Dr. Bell, to help drive
increases in that \-- physician adoption of EMRs from 10 or 20 percent
to 30, 40, 50 percent, and then you, again \-- getting back to this
continuum idea that I talked about and Chantal touched on, is the more
physicians you have to plug and play into the \-- into a RHIO concept, I
think, that would be the next step. If I\'m a physician, okay, I\'ve got
this tool; I\'ve got an EMR; I have some type of health IP hardware or
software. Now I would like to go to the next step and see about, okay, I
want to get the historical data for new and existing patients. And say I
have a patient who is a snowbird and spends half their time in Florida.
I want to see what work they had done in the last 6 months.

\>\> WOMAN: Can they get information ordered by other physicians?

\>\> JASON DuBOIS: In a peer-to-peer relationship right now? I think
that\'s only possible in RHIOs, frankly.

\>\> KAREN BELL: That\'s why we\'re having the difficulty in the
conversation, because the charge basically says historical as well as
widespread. So I think we\'re dealing with a charge that is difficult to
come to terms with around where we need to be.

\>\> LILLEE GELINAS: Does anyone have any other thoughts about the
recommendation at this point?

\>\> JOHN HOUSTON: Yes. This is John Houston.

\>\> BART HARMON: I would like to make one comment. One thing we found
within the Department of Defense is different models serve different
purposes. It may be that we have a collection of models here that are
all valid and useful, but it would be hard to argue that as an end-state
vision, the patient-centered model isn\'t probably the best one on the
table at this point. We want \-- wherever the patient shows up for
health care, we would like for all of their historic and current lab
results to be available for review. That doesn\'t mean that some of the
other models aren\'t perfectly valid and helpful as useful steps toward
that end-state vision, if we keep that as an end-state vision and maybe
accept all of the models and identify barriers to any of the models.
Barriers to any of the models are barriers to getting to that end-state
vision. Identify and suggest ways to deal with those barriers. I think
we\'ll be accomplishing what we need to accomplish in this setting.
That\'s just one suggestion.

\>\> CHIP KAHN: But if at the same time, you\'ve done a lot to foster
HIT adoption by people in States that, for legal reasons, can\'t support
this patient-centric model \-- say they are just able to come online
faster once those issues are addressed.

\>\> BART HARMON: I suggest that any of models you\'re talking about are
components of and progress toward the ultimate patient-centered model.
It\'s not like they are exclusive of each other.

\>\> ROB KOLODNER: This is Rob Kolodner again. I know that we still have
some territory to cover, and this is a very important one. I\'m just
wondering whether \-- what I\'m thinking, I understand, is that this
will be very important, this discussion, to inform the ONC staff. But
our role is to make a recommendation knowing the way it\'s carried out
\-- the details will be carried out by HHS and others. What we are
really doing is drilling down into some specifics that would support a
patient-centric model and moving the Nation towards that.

I\'m wondering whether we heard from everybody all the members or
whether we stopped partway down the list.

\>\> BLACKFORD MIDDLETON: Blackford Middleton here, Rob. I haven\'t had
the chance to chime in. It\'s been a fascinating conversation. I think
my sentiments lie within the spectrum that\'s been alluded to.

Bart Harmon\'s comments, I thought, were insightful. One of the
problems, I think, is that the technology adoption path has to be
evolutionary necessarily, given the penetration of various technologies.
I wouldn\'t want to lose sight of the fact, though, that browsers and
fax machines could be pretty much omnipresent in short order if
necessary. I\'m strongly in favor of the patient-centric approach, but I
might suggest that there could be an evolutionary path towards a more
RHIO-like model, as has been alluded to. I think failure to get all the
way towards kind of the patient-centric approach with some amount of
client side or other virtual data aggregation fails to deliver on the
full value proposition for clinical decision support and quality
management.

\>\> KAREN BELL: Was that Blackford? I didn\'t hear.

\>\> BLACKFORD MIDDLETON: Yes.

\>\> LILLEE GELINAS: Matt, help me a little bit. We heard from Connie
Laubenthal, Jason DuBois \--

\>\> MATT McCOY: You want me to go down the list?

\>\> KAREN BELL: Carolyn Clancy has just joined us here in Washington.

\>\> JOHN HOUSTON: This is John Houston. I haven\'t spoken yet.

\>\> LILLEE GELINAS: Matt, let me ask you to bring some order here.
Let\'s go down the roll call like we were doing. If we could have brief
comments but we are just \-- I\'m trying to bring us back up to the
30,000-foot level. We are trying to get consensus around this approach.

\>\> MATT McCOY: Very good. Continuing on, Chip Kahn? Chip, are you
still on with us?

\>\> HOWARD EISENSTEIN: This is Howard. Chip just stepped out. I think
Chip would favor the patient-centric approach in general. What we want,
the gold standard to me and to Chip, I think, is the Indianapolis and
now Indiana RHIO. There\'s a lot of people who are not going to be able
to play in that space for a long time. There\'s going to be some who
will in the next 12 months, and in order to get any consumers to buy in
and to support, I think you have to have something that really does
maximize the value proposition to them and to the doc. I think that the
patient-centric one is one that does that best.

\>\> LILLEE GELINAS: Thank you.

\>\> MATT McCOY: John Houston?

\>\> JOHN HOUSTON: Thank you. I tend to focus towards the
patient-centric model. I think that\'s really the end goal, but I talked
about having an offline or another discussion regarding some of the
State law issues related to CLIA and other issues related to trying to
provide access to this information.

I think that, ultimately, in my mind, is going to \-- is a discussion
that has to occur before, I guess, I provide a final opinion.

\>\> LILLEE GELINAS: Okay, thank you.

\>\> MATT McCOY: Before we turn to Workgroup members in the Hubert
Humphrey Building, are there Workgroup members on the phone who felt
like they haven\'t had a chance to weigh in on this yet? \[There is no
audible response.\]

\>\> MATT McCOY: I turn it over to Karen or somebody sitting in the
Humphrey Building to guide us through whoever is sitting there live.

\>\> KAREN BELL: Jason commented, and Chantal is here from VHA.

\>\> CHANTAL WORZALA: Sure, I\'ll be brief. The notion of an
evolutionary model with the goal of the patient-centric approach makes
sense to me. I\'m focusing very much on the short term and what are the
things we can do to get there. And focusing on standards and how to
standardize and really getting guidance for how to standardize and
thinking about the incentives that you need to put out there in order to
get people to standardize are all needed.

You know, I don\'t think that we can have an approach \-- and the reason
I was drilling down on a little bit of the Indianapolis and Tennessee
experience \-- I don\'t think we can have an approach where the coding
is done centrally. I think we need to get to a world where things are
done standardized in the place where the data is generated, and it\'s
going to take a lot of thought and probably some incentives and a lot of
direction building the standards and building the implementation guides
to make that happen.

And I wouldn\'t want to lose sight of those very practical kinds of
recommendations that we can make for short-term progress with our
end-stage goal.

\>\> KAREN BELL: Thank you, Chantal. And Carolyn Clancy, as I mentioned
earlier, has just joined us.

\>\> CAROLYN CLANCY: And with the benefit of 5 minutes' participation, I
would be happy to weigh in.

Blackford, just keying off your comments, it struck me in the last 5
minutes, but also in preparing with Scott and some of our grantees for
the RHIO conversation: there is a real strategic call here, and I don\'t
know what the right answer is. I\'m looking at Kelly and Karen, who
might be able to give us some advice here.

If we choose a path, first of all, you have to recognize this is going
to be evolutionary, and I think the message that patient or consumer
centric is the way to go came across to me loud and clear at the last
Community meeting. That is the disruptive in a very positive way force
that I think is going to make a lot of this happen.

The question is recognizing \-- if you recognize an evolutionary path,
are we coming up with one recommendation that everybody can get on
board, in which case we are heading for the really late part of the
diffusion curve? Or can we have several suggestions that will help us
recognize that people are on various places along the path? I mean, I\'m
speaking as the funder of six of these State demos. We can put a lot
into place, and I am a little more agnostic than Chantal about whether
centralized coding is a sort of transitional scheme or one that might
actually be quite viable in Indiana now and 20 years from now. I simply
can\'t say. I think there\'s a lot of market activity that is personally
hard for me to predict.

But I actually think we would be better served making recommendations to
the Community that are staged in some fashion. I don\'t know if that
quite fits the model. That\'s really the question I\'m asking.

\>\> KAREN BELL: Thank you, Carolyn. Is there anyone else to comment?
Because I think maybe one of the things that we can do is to recognize
that if, ultimately, our goal is a patient-centric model and we focus on
that, as we go through other recommends, we can bum them up against all
three focuses and make sure they are at least supportive of patient
centric and hopefully along \-- of some the other steps along the
evolutionary path as well.

Does that make sense to everyone?

\[Overlapping speakers.\]

\>\> LILLEE GELINAS: I think I heard consensus around an evolutionary
approach. Carolyn, I really like what you just said. You\'re absolutely
right, the adoption curve. What we are heading for is the late part of
the diffusion curve with the consumer-centric approach, and we certainly
need the purposeful and planful path to get there.

Thank you all. That might have been a little bit painful to everyone,
but we needed to see with all of the discussion if we were landing on
some rough decision here.

Karen, the next part of the agenda is around review of recommendations.

\>\> KAREN BELL: That\'s correct, and everyone received some listing of
possible recommendations to discuss. What I would just like to underline
again, because you were not on the call a little bit earlier, Lillee,
and for Carolyn as well \-- we culled through various notes from ought
not only these groups but others as well to help think through some very
basic concepts. Again, they are simply concepts. These are not
recommendations. These are only designed to get information flowing, to
get discussion flowing among the Workgroup members in terms of whether
or not these could be crafted in a logical way to make the evolution
happen so that a very clear entity is responsible for making a very
clear action occur with some very strong rationale, which is why the
very first one after the focus labeled HITSP right on and basically says
that HITSP should make as one of its top priorities standards for live
vocabulary transmission and implementation of lab result data.

If we move forward with that, again, we would extend a lot of time over
the next month making sure that the language was just right and flesh it
out in a way that it could be included in a letter to the Secretary. But
I think the basic concept is whether or not there\'s, again, agreement
in the group as to whether that should be a recommendation in terms of
concept, and we can move forward with including that in the work that
will happen offline later. Maybe on this one, because it\'s pretty easy,
if anyone believes that isn\'t the representation, that would be the
best way for us to get input.

\>\> JASON DuBOIS: Opt out of the recommendation?

\>\> KAREN BELL: Yes, opt out of the recommendation. We\'re opting out.

\>\> LILLEE GELINAS: Good. Proceed.

\>\> ROB KOLODNER: This is Rob. One clarification we may want to do,
although it may be obvious and innate, is that particular one \-- goes
along with the HITSP as the mechanism for identifying those standards as
set up through the whole process that ONC has put in place.

\>\> KAREN BELL: That\'s correct. So this group has the option of
perhaps not saying it is HITSP, but right now, we do have a contract in
place with them to move forward to the adult standards. Our
recommendation would be that they make labs the top priority. It\'s a
vocabulary transmission and implementation guidelines.

\>\>: I guess we should point out, this recommendation to HITSP doesn\'t
necessarily suggest that they develop new standards because for all
three of those components, it\'s a matter of harmonizing existing
standards.

\>\> LILLEE GELINAS: Good clarification.

\>\> JASON DuBOIS: In the absence of any other or all of those,
obviously, I talked about ELINCS being part of the answer here, but in
the absence of them, does that mean that HITSP comes back without a
recommendation because there is no standard that addresses the
transmission issue of the data?

\>\> JIM SCIROCCI: This is Jim. I also think you need to think about the
CLIA thing. I\'m not sure that there\'s an HL7 standard that has
formally addressed that set of requirements.

\>\> KAREN BELL: Well, again, if HITSP, if they are not there, it is top
priority for HITSP that those recommendations that they be developed. So
this question is on the table, it seems to me, are:

-   Do we focus on HITSP because that\'s the standard-making body that
    the government has contracted with?

-   Secondly, do we request that it make these standards, whether it\'s
    harmonization \-- suggest they be developed, but as soon as
    possible, they have endorsed \-- developed and/or endorsed or seen
    that there would be development of a set of standards? Again, the
    language here \-- we will spend a whole month clarifying the
    language.

The question is, is this concept important? Chantal?

\>\> CHANTAL WORZALA: I agree with the concept, and it\'s a great
recommendation. I actually \-- and this is something we should probably
address \-- I have been wondering how the use cases the contractors are
working on intersect with the work of the workgroups, because I believe
their use case is exactly this, one of the use cases. I would like to
understand that.

\>\> ROB KOLODNER: This is Rob. Is that something that the whole group
would like to hear? Is that something you might be able to take offline
after the call?

\>\> KAREN BELL: One thing: Just yesterday, the use cases that were sent
back to the contractors became available, and they will be available to
you online. So anyone who is interested in seeing those will be able to
do so.

\>\> CHANTAL WORZALA: I was thinking about a process question: How do we
factor that into our work? Because there\'s staff assigned to these
things already.

\>\> KAREN BELL: The question is, how can we make this happen? I do know
that we are talking about making this happen, about having an
opportunity for the contractors to discuss the use cases with a number
of will workgroups. We don\'t have date or time set up for that yet, but
that is one of the agendas. I believe that will be the mechanism to do
it. I don\'t know that we can do it before May 1.

\>\> ROB KOLODNER: In answer to your question, Karen, are there any
other opt-outs, or do we have consensus on this?

\>\> KAREN BELL: With lots of words missing over the next month.

\>\> ROB KOLODNER: Lots of words missing.

\>\> LILLEE GELINAS: Keep going. I\'m very mindful of time, Karen.

\>\> KAREN BELL: Another one could be the degree to which \-- again, the
"who" and "what" exactly would be the mechanism here that the
laboratories will adopt HITSP standards. What is it that will make that
happen, and who would be the engaging party so we can move forward with
the recommendation that all labs are adopting \-- or labs are adopting
HITSP standards?

\>\> JASON DuBOIS: This is Jason. A couple of comments. First of all, as
you have written it here, it says "must adopt HITSP standards."

\>\> KAREN BELL: I\'ve taken that out.

\>\> JASON DuBOIS: It was. I respectfully request to revise and extend
my remarks here.

\>\> KAREN BELL: I\'ve taken that out. That was a misprint.

\>\> JASON DuBOIS: Another way to drive adoption here through the use of
the HITSP standards would be incorporation into the consolidated health
informatics initiative that the government has all agreed to exchange
their information. They used LOINC and SMCP as part of that, and the
government is already a large purchaser already. That may be a means to
help drive adoption from the national labs. That might be a means to
help move them in that direction.

\>\> KAREN BELL: Again, with words missing that will have to be offline
\-- and I apologize to everyone, but \-- the concept of finding some way
to incent labs to adopt HITSP standards is something we might choose to
use in a recommendation once we decide who needs to do what.

\>\> CHANTAL WORZALA: I think detailing this will require a lot of
information and discovery of who is it that provides lab tests and how
likely are they going to be able to do this and over what time frame.
I\'m thinking about transition time frames and that sort of thing, if
you think about all the labs that are actually performed in physicians\'
offices, as we were hearing earlier, and the notion that a lab result is
actually popping out of a machine that is made by, you know, a
manufacturer and can\'t necessarily be programmed by the provider.

I just think we need a lot of pretty significant understanding of the
current state of how lab reports are generated and what it would
actually take to adopt the standard. That\'s the end goal, but I want to
make sure that we all understand the state of play and what\'s actually
needed to get from where we are today to that goal.

\>\> KAREN BELL: So that if we were to move forward with this, it
clearly would also have within either some timelines or some
prioritizations, and that would be part of the discussion as to why and
how this would roll out?

\>\> CHANTAL WORZALA: Yes, whether it\'s physician lab, the hospital
lab, the clinical lab, referral lab, and what it really requires for
each of those settings.

\>\> KAREN BELL: We\'ll take them all at the moment and leave labs
there, and we\'ll wordsmith that one a little bit. If we do that, are
there any opt-outs? \[There is no audible response.\]

\>\> CHANTAL WORZALA: It\'s getting rid of the "must adopt."

\>\> KAREN BELL: Yes, absolutely. The next item is something that was
talked about a little earlier. This will probably require quite a bit of
discussion before we come to agreement. And that is whether or not there
could be a recommendation which would allow for a central hub where
laboratory data comes together, much the same way that medication
information comes together in the RxHub model or in some of the other
models that are out there. This discussion has come up in a couple of
places, and I put it down here just to open it up as a discussion
amongst the Workgroup members.

\>\> ROB KOLODNER: Rob, this is Rob Kolodner again. I\'m wondering if
this is actually at a lower level of detail than what we are charged
with as a Workgroup in terms of drilling down to a solution as opposed
to what is the, what is the nature of the solution we are getting down
into what is the solution? You know, I certainly agree we could be doing
this. I wanted to put it on the table. It\'s something that bubbled up.
I\'m happy to put it down into the second level of work down the line,
not as a basic recommendation.

\>\> JASON DuBOIS: I think \-- this is Jason with ACI. I think there\'s
still some extenuating circumstances about this particular model. Dr.
Brailer made reference to it at the last AHIC meeting, in the respect
that there\'s so much more consolidation, in terms of the purveyors of
prescription drug information through RxHub, than there are on in the
laboratory industry. We already made light of the fact that there are
100,000 physician office labs. I\'ll add onto that the 13,000 hospital
and independent reference laboratories.

So when you take into account also the proprietary interests at heart
here, I think that you know are some of the reasons that this particular
piece \--

\[Lost audio.\]

\>\> KAREN BELL: We have two opt-outs on this go-around. Any others?

\>\> JOHN HOUSTON: This is John Houston. I tend to agree.

\>\> BLACKFORD MIDDLETON: This is Blackford Middleton. I agree with Rob.
It\'s probably at a solution detail that we don\'t have to specify now.
I suggest, though, if we do the rest of the principles and tenets
correctly, that the market will produce a solution of this nature.

\>\> JASON DuBOIS: If that\'s opting out, I agree with that last
statement. I don\'t think we want to prescribe that.

\>\> KAREN BELL: Yes, okay. The next two are quite related. We heard
from at least three of the AHRQ contractors today that as they have been
moving forward trying to exchange historical data, they identified a
number of barriers. Clearly, we may want to have a recommendation that
we get more of these multiple markets not just from RHIOs. What are the
true barriers to patient-centric exchange of historical data and what
necessary actions might be taken to enable it?

Again this isn\'t necessarily the RHIOs. You may want to look at other
entities as well. Is this something that we could have agreement on?

Anyone having particular concerns around identifying an NC to really
describe for us what the barriers are foyer historical data exchange?

\>\> JASON DuBOIS: I don\'t think so. This is Jason again. You\'re right
to talk about \-- it\'s not just a RHIO focus, because Quest, LabCorp,
ARUP Lab in Utah, all of these have different mandates in terms of how
long they store data online. You might be surprised to know I don\'t
think it\'s any more than 6 to 12 months that it\'s stored online, and
any information they hold on patients is usually first archived onto a
disk and later to a tape and stored, you know, remotely.

So in terms of the historical \-- how far back you want to go to find
it, that could certainly present problems, although again, much like
Howard referred to earlier, I think that with the right incentives,
anything is possible. Whether you\'re asking \-- I won\'t provide an
example, but again, just leave it at that.

\>\> KAREN BELL: Okay, again, a lot further fleshing out on this one.
The next one is around guidance or regulatory changes to CLIA and/or
HIPAA that will facilitate clinician access to lab data. I think we
agreed we will have offline discussion on that.

So is everyone comfortable with leaving this here for a concept?

\>\> JASON DuBOIS: The CLIA issue might lead back to the HITSP approved
standards as well. But Dr. Scirocci, a pathologist himself, made
reference to it and I think it is important.

\>\> CHANTAL WORZALA: Just a quick clarification. That is access to
current and historical lab date data, right?

\>\> KAREN BELL: Yes, that\'s correct; thank you.

\>\> ROB KOLODNER: This is Rob. Do we also want to say something about
exploring the preemption or patient opt-in?

\>\>\> KAREN BELL: Okay. We can certainly do this on the first go-round.
As they say, this will get wordsmithed to death. We can put that in and
see how it flies over the course of the next month.

The next one is \-- actually, I\'ll direct mostly to Bart and to Rob.
What about the possibility of suggesting that the federally owned and
operated care delivery labs include actions with respect to policies,
technologies, and HITSP standards that will support the use of
patient-centric exchanges historical data? Is it premature to make a
recommendation about our own delivery systems right now, moving in this
direction?

\>\> ROB KOLODNER: This is Rob. My sense is that\'s the direction that
we\'re moving, but I think to reinforce it, so don\'t throw me in the
briar patch.

\>\> KAREN BELL: Okay. How does DOD feel, Bart? Are you still with us?

\>\> BART HARMON: This is Bart. I\'m having a little trouble
understanding the intent of the statement. The DOD and VA are probably a
couple of the biggest health enterprises, sharing large volumes of
health data already with each other. I think we\'re \-- certainly part
of the reason we\'re part of this is that we are interested in extending
that on a more national level, but we need all of these rules to sort
themselves more out to make that feasible. I\'m having trouble
understanding the intent of the statement.

\>\> KAREN BELL: If HITSP standards become available, it means that the
DOD, the VA, HRSA, Indian Health Services, etc., would be adopting the
HITSP standards for interoperability.

\>\> BART HARMON: That\'s generally a goal for us. That doesn\'t mean
that if a standard is adopted 1 day, we won\'t rip out 20 years of work
in 6 months and rebuild it all. It depends on what we mean. Certainly,
we have every intent of aligning with declared standards and moving
towards them as our natural system migrations support moves towards
them.

\>\> KAREN BELL: What I\'ll do, then: I\'ll keep this in here, and I\'ll
focus on the alignment part of this. And again, we can always leave it
on the line, but we can leave it on the table for the first go-round.

There\'s another one that involves the Federal Government. Federal
procurement could possibly support use of the HITSP standard for
interoperability for its purchasing power. That could come in multiple
different ways. And so I\'m putting that on the table as well as
something we might want to flesh out a little bit more.

\>\> CHANTAL WORZALA: I\'ll signal a concern that that not be the back
doorway to reinsert "must adopt."

\>\> KAREN BELL: Yup, yup. Exactly. Now, there\'s one other one that I
would just throw out for discussion. We may or may not want to get
there. At some point in time, would we want to consider the use of the
HITSP standards as a condition of reimbursement in the future?

\>\> LILLEE GELINAS: Boy, that\'s really going where the heart of it is,
isn\'t it?

\>\> KAREN BELL: I thought I would put it on the table.

\>\> JOHN HOUSTON: This is John Houston. That sounds a bit draconian.
Obviously, if everything is successful, it will be a natural; people
will want to adopt it anyway. To put it out there in this light, it begs
for some type of challenge.

\>\> JASON DuBOIS: They\'re not doing that for the prescription drug
standards, are they?

\>\> KAREN BELL: Not that I know of.

\>\> CHANTAL WORZALA: What if you actually reworded this and came up
with a few options that would be informed by what we\'ve done before?
For example, I do believe that electronic billing was stimulated by
people getting faster reimbursements. Faster is an incentive. Mandating
is a mandate. So you know, I think coming up with a couple different
approaches there would be more even handed than mandating. I don\'t see
that going too far.

\>\> KAREN BELL: It may very well be that it will come up when we are
talking about incentives to adopt HITSP standards. We will develop a
whole bunch more of that, and somewhere along the line, we will either
include something like this or take it off the table under the HITSP
adoption standards.

\>\> CHANTAL WORZALA: The other reason to worry about this: You are
actually going to remove some revenue from a lot of those physician
offices. This starts to be like a slightly complicated calculus here.

\>\> KAREN BELL: Those are the only ones that I could find as I went
through all of our discussions. There\'s whole section of other. If
anyone else can think of recommendations, I know it\'s late, but let us
know as soon as possible, and I\'ll include them in the e-mails that
will be circulating.

\>\> JASON DuBOIS: I can add one now.

\>\> KAREN BELL: Good; Jason\'s got one.

\>\> JASON DuBOIS: You have the guidance or regulatory changes to CLIA
to facilitate clinician access to historical lab data. I thought it
would behoove us today, since Susan McAndrew did come today to give us a
presentation on HIPAA, to the extent possible changes, regulatory or
other, with HIPAA or State privacy laws and just use the same language.

\>\> KAREN BELL: Right, okay. Thank you. I think we have it, Lillee, at
least enough to start and work with.

\>\> LILLEE GELINAS: It is enough to start. I thank everyone for your
honesty and robust discussion, because it\'s the only way we will get
where we need to go earlier.

The next piece is the timeline discussion. Knowing that Jon was going to
have to leave early, he and I talked this morning about some issues.
First of all, I want to commend everyone, because as you can see, the
January-to-March 2006 outcomes that we were being asked to produce \--
you can see \-- I would really like to see this word \"complete\" after
these tasks. So many thanks to the group and to the staff for getting us
to the point.

Now, when we are down to March activities, as you know, Jon and I did
present recommendations at our recent meeting, and we truly began this
policy and privacy issue discussion during this call. And I want to
thank you for that. We put it on the agenda and in the time frames,
knowing that it really was going to be one the issues we were going to
have to tackle head on.

Now, as we look at the timeline for deliverables and recommendations, no
later than April 14, we have to have the draft initial high-level
recommendations with some of the outstanding issues and plan for
resolution. And the reason I point out the April 14, week of April 17,
and week of April 24 timeline \-- and that\'s on my agenda I\'m looking
at; those are under Agenda Item Number 6. We do not have an AHIC meeting
in April. Nor do we have a scheduled AHIC conference call.

And so what Jon and I talked about this morning is, we as a work team
need to really have some consensus about how we are going to achieve
those types of deliverables, and I want you to think about the robust
discussion we had today and what it was taking to get to just some
consensus today, what our recommendations would be in order to assure
that we are going to help the staff meet the guidelines that are \-- the
deadlines that are in front of us.

Karen, have y\'all \-- has staff had a chance to talk about that that
witness that could inform this part of the discussion?

\>\> KAREN BELL: The best we have been able to do is consider having
several people from the various Workgroups to spend some time, either
virtually or here in Washington with us, to really go over fleshing out
this first piece so that by the 14th, a small group of people have
created \-- includes Workgroup people obviously \-- that first go-around
document. Is that something that some of the folks either on the call or
on your team might be willing to do?

\>\> MAN: Can you just restate the request? I didn\'t quite understand
that.

\>\> LILLEE GELINAS: I want you to look at the very aggressive time
frames we have for April with no later than May 1 our finalized
recommendations available for distribution. We have no AHIC meeting and
no conference calls for this Workgroup on the calendar in April.

So what I heard Karen say \-- because in April, we have the challenges
of multiple religious holidays and spring break, which is probably the
reason that an AHIC meeting which was originally planned because we
couldn\'t find a day that was not interfering in those important events
\--

\>\> JASON DuBOIS: Can\'t we try to set up a Workgroup meeting?

\>\> KAREN BELL: We could certainly set up a Workgroup meeting if
everyone is interested.

\>\> CHANTAL WORZALA: I think most of the workgroups are going to meet,
if not the third week because of holidays, then the fourth week. What we
talked about yesterday in consumer retirement \-- the last week in
April, maybe the earlier part of the week, as a full working meeting \--
draft the recommendation letter immediately following with just a few
people who are willing to participate, and then have \[lost audio\]
during the scheduled Workgroup meeting the first weekend in May to make
sure everybody is comfortable with the meeting before it gets
communicated to the Secretary.

\>\> HOWARD EISENSTEIN: That makes sense. I guess a few people have
blocked their calendar for the previously scheduled meeting.

\>\> KAREN BELL: For the AHIC on the 23rd?

\>\> LILLEE GELINAS: I wouldn\'t assume that.

\>\> KAREN BELL: Is it the week of the 24th that we were thinking we
would be able to have some extra meeting?

\>\> CHANTAL WORZALA: Yes, unless people are willing to meet on the
21st.

\>\> KAREN BELL: You know, what we probably should do is just poll the
Workgroup members, Lillee, and find out if one day is better than
another and go with the majority. How is that?

\>\> LILLEE GELINAS: Okay.

\>\> KAREN BELL: We\'ll do some work offline \-- and again, we\'ll have
not only the work with Judy on CLIA and Susan on HIPAA, but we\'ll also
do some work offline with some of these high-level recommendations and
run those by everybody via e-mail or else keep it on the Web site until
we get to the point where we can really pull everybody together well for
a robust discussion. Okay?

\>\> LILLEE GELINAS: Okay.

\>\> MATT McCOY: Do we want to go through members?

\>\> LILLEE GELINAS: I think that\'s what I heard.

\>\> MATT McCOY: Okay. Blackford Middleton?

\>\> BLACKFORD MIDDLETON: So the question is about the week of the 21st?

\>\> KAREN BELL: No, no, we\'re going to do that offline. A lot of
people are no longer on the call.

\>\> LILLEE GELINAS: Okay.

\>\> KAREN BELL: Take that offline and we\'ll get a day that works for
everybody \-- most people.

\>\> MATT McCOY: Okay.

\>\> KAREN BELL: Thank you.

\>\> LILLEE GELINAS: Okay. So what else? Do we need to talk about
second-quarter outcomes at all, Karen?

\>\> KAREN BELL: At this point, probably not, because we are going to
have to make some changes and some adjustments to that as we bring in
more information from the use cases, for instance, and for the policy
council. So I think at this point, if we can just get to the point where
we can get a letter to the Secretary by May 1, because that\'s when it
has to get out \--

\>\> LILLEE GELINAS: Okay.

\>\> KAREN BELL: You will have a huge deliverable.

\>\> LILLEE GELINAS: Okay. So I think we\'re clear on next steps in
terms of calendar query. Are we ready to move to public input?

Hearing no objection, let\'s move to public input.

\>\> MATT McCOY: If there are members of the public on the call already
and you want to make a comment, press star-1 on your telephone. If
you\'re following along on the Webcast, I\'ve just put instructions
occupy a slide, you can follow those and make a comment.

Looks like we have our first one. Operator, would you please open the
line for Ash Goggle?

\>\> ASH GOGGLE: Yes, this is Ash with DeLoitte. We are a major player
in the industry. And I wanted to mention that we do favor the patient
centric model as the end state. Thanks.

\>\> LILLEE GELINAS: Thank you very much.

\>\> MATT McCOY: Looks like that\'s it for now. We might want to wait a
few more minutes to see if people get through the operators. I\'ll give
you an update to see if anybody else would like to comment.

\>\> LILLEE GELINAS: That would be great. Karen is there anything else
we need for next steps that we want the group to consider?

\>\> KAREN BELL: Not at this point. I think we have the followup for how
we\'ll work through these recommendations and that was the most
important. So thank you.

\>\> LILLEE GELINAS: Although all may not be here, I really want to
thank Scott Young, Susan McAndrew, John Houston, Judy Yost, and others
who really helped us with our scheduled presentations today so that we
could charge ahead thoughtfully and planfully. Without understanding
AHRQ\'s work around RHIOs, HIPAA, the privacy and security issues in
CLIA, we just weren\'t able to get to that recommendations piece.

So many thanks. And to those who did not submit presentations but would
like to give us \-- Karen, that would be one thing I asked. Judy Yost
said she had a Web site with succinct CLIA requirements. I was on the
CMS Web site and did not find that that was easy to get. If we can
please follow up with that and post that on the Web site in an easily
readable way, that would be greatly appreciated.

\>\> KAREN BELL: Okay, thank you.

\>\> CHANTAL WORZALA: I had one other question. The slide that had the
more specific recommendations \-- is that on the Web site right now?

\>\> MATT McCOY: It got e-mailed out. I just sent it out.

\>\> KAREN BELL: You will be having it very shortly in the latest
iteration.

\>\> CHANTAL WORZALA: Okay. Thank you.

\>\> LILLEE GELINAS: Matt, do we have any other callers?

\>\> MATT McCOY: It doesn\'t look like we do, Lillee.

\>\> LILLEE GELINAS: I just want to make sure we give everyone ample
time.

With that, I think we have drawn to a conclusion that our Tuesday, the
21st of March, meeting of the American Health Information Community
Electronic Health Record Work Group has completed its charge for the
day. I would like to thank all of you who participated so robustly. We
greatly appreciate your interest, time, attention, and most importantly
your sincerity at getting this job done.

With that, I wish everyone a good day. Goodbye.

\[The meeting ended at 4:50 p.m. Eastern time.\]