[This Transcript is Unedited]



January 30, 2008

Hubert Humphrey Building
200 Independence Avenue, SW
Washington, D.C.

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030


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

Agenda Item: Call to Order

MR. REYNOLDS: Good morning. I would like to welcome you to the Standards and
Security Subcommittee of the National Committee on Vital and Health Statistics.
I am Harry Reynolds, Co-chair along with Jeff Blair the other Co-chair. NCVHS
serves as a statutory advisory, a public advisory body of the Secretary of
Health and Human Services. In that capacity, the committee provides advice and
assistance to the department and serves as a form interaction with interested
private sector groups on a variety of key health data issues.

I would like to mention to everyone that we are on the Internet. We are
being recorded. Those at the table keep your Blackberries away from the
microphone to keep the static down. In general, we do not want to have to take
them away. We do not want to confiscate anything. If each of you as presenters
will speak clearly into the microphone since we are on the Internet, people
will be anxious to hear what you have to say.

I will now like to go through introductions and have each member of the
committee mention whether or not they have any conflicts. I do not have any

[Introductions around the room.]

MR. REYNOLDS: Thank you everyone. Our agenda for today starts off with the
HITSP overview and then our panel on upcoming issues. As I mentioned a bit ago,
the important thing to us today is to learn more about you because as we plan
our schedule for the rest of 2008 and then looking at 2009 and so on, we make
sure we are also doing the things we need to make sure we keep our eye on the
ball to help all of this wonderful momentum that is going on continue forward.
That is what we are really looking for. Starting at about 11:15, the committee
will be going back into some discussion and touching a little bit on what we
did yesterday plus a few of the other things we have listed here. With no
further ado, John, welcome. We always look forward to your comments.

Agenda Item: HITSP Overview

DR. HALAMKA: Well, thank you. Thanks certainly for inviting me. These are
friends around the table. It is very good to see you all.

In my previous presentations to the committee, I have described HITSP as an
organization of over 300 groups coming together to harmonize standards through
an open transparent public private process. Today, I will be describing what
have we done in 2006-2007. What are we doing in 2008 and planning for 2009? I
certainly look forward to your questions and discussion.

Importantly to start with, the first slide is an overview of the process of
getting us to acceptance and recognition of standards. These are very, very
important terms that I will be using throughout the presentation today.
Recognize that AHIC serves as the body that sets priorities, sets the use cases
and the breakthroughs for HITSP to work on. HITSP then with those use cases
goes through a process that takes between six and nine months and results
interoperability specifications. Interoperability specifications are delivered
to AHIC. AHIC then recommends to the Secretary the acceptance of the standards
where acceptance then triggers a one-year period of implementation and review.
Presuming that the standards are deemed appropriate course in that period of
review, there may be technical adjustments and clarifications made. Then the
secretary recognizes these interoperability standards.

As we will talk about today, we have our first body of work for 2006, body
of work that has been officially recognized and published in the Federal
Register. Once published, then that triggers both federal systems and health
care contracts and executive order 13410 as part of procurement to require
these interoperability standards. They feed into the NHIN project, and CCHIT
now will look at these as possible certification criteria. The end result of
the process going from AHIC’s initial use case for breakthrough to final
incorporation to CCHIT functional criteria and recognition by the Secretary
with regard to federal procurement and it takes about two to three years, as
you will hear about. We have done this now for three use cases end to end, and
we are well along the way on additional four use cases. In 2008, we will be
going through six use cases.

Here are the rounds. As Secretary Leavitt calls these, these are the terms
of the crank for HITSP. Round 1, we were given the challenge to do laboratory
exchange, both documents and messages between constituents, bio surveillance,
and consumer empowerment. That body of work has been completed all the way
through recognition. There are two exceptions. The first exception was that in
order to achieve harmony on the lab standard, HL7 itself needed to come
together with a variety of stakeholders and create the HL7251 message standard.
That was fully ratified, passed by all appropriate HL7 processes in December of
2007. Therefore, recognizing that there did have to be appropriate time between
the official work products of HL7 and the Secretary recognizing this. It will
be recognized in June of 2008.

Also, there is the HAVE standard on hospital availability. In the case of a
mass casualty incident, certainly many stakeholders would like to know are
hospital beds available. What resources are available to deal with such an
issue? That standard has been fully balloted by Oasis and we will have its
final resolution of comments done by the first quarter. So, again, we are
looking at the June timeframe for recognition by the Secretary. All of that
Round 1 has gone through the HITSP process, and all of the stakeholders have
accepted these HITSP standards by consensus without objection. We recognize of
course that implementation of these standards such as unifying all of the labs
in this country cannot over night change to HL7251. So CCHIT and the federal
government procurement agencies will recognize this will be a process that will
probably be about two years to ration as these standards are now baked into
vendor-based systems and systems that are home-grown.

Round 2, three use cases and security and privacy. Now, let me start with
security and privacy. We know that security is foundational to everything that
we do. All healthcare information exchange must have robust security. We worked
hard as a HITSP organization to come up with a security framework. Of course
the challenge is, we do not have a national privacy policy. Of course we have
HIPAA. That is a floor, but to suggest that we have one uniform set of privacy
practices in every locality in this country, not yet. Therefore, we had to
devise security standards, technology standards in the absence of unified
privacy policy. This means the security standards need to be robust enough such
that any local privacy policy, whatever it may be, can be supported by these
technical standards. I will give you some more details on what we did there in
a moment.

Also, in round 2, we have done some additional consumer empowerment work. We
have worked on medication management, although we will be finishing up some
aspects of medication management by March of 2008. We have done a very
challenging use case, which I will tell you about, called the Emergency First
Responder. We call it the Katrina Use Case. What do you do in a mass casualty
incident to exchange information? We had some work that is truly
multidisciplinary with folks at MQF, NCAQ, AMA, and AHRQ on quality standards.
I will go through those. That body of round 2 work, the quality, the EHR for
emergency first responders and the work that has been done to expand consumer
empowerment all has been presented to AHIC. AHIC has unanimously forwarded that
to the Secretary for acceptance. We expect that the Secretary will be accepting
those shortly.

Round 3, six draft use cases that have been circulated for their public
comment, and I will detail those and show you the roadmap in a moment.

So, I recognize this slide is very challenging to read. It does summarize a
number of the issues that I have described that in 2006 we finished consumer
empowerment, comprising registration and medication history. The lab standards,
which was result reporting, and that covered both a document and a messaging
standard and bio surveillance, which include visit utilization data for
emergency departments, registration information, clinical data exchange
including lab and radiology reports. In 2007, consumer accessed information was
expanded to include not only registration and medication history, but also
problem lists visit history.

Importantly in 2007, that use case not only describes exchange of personal
healthcare information over a network, but also transportable media. So, should
you want to carry around your lifetime medical record on a thumb drive, you
can. I thought it would be interesting for the committee just to actually see
what that looks like in reality, so this is my lifetime medical record in the
continuity of care document format that I have brought to the committee on
transportable media. What is great about this is it is human readable and
computable. Underneath this, this is a CDA document all created in XML that has
both tabular data, vocabulary controlled, and narrative data. So, if you will
look – by the way, I am releasing this to you with my full consent. There
are no issues with HIPAA. You will see that it includes co-defined information
about my payer and my coverage, advance directives. Problem lists and current
status of the problem, active are resolved. You will see my problem list
includes I have had lime disease twice. I have had a corneal abrasion. Being
vegan is an active problem. I accept that. My family history is displayed,
including the relationships of all of those individuals to me and their medical
history. By the way, all living relatives have consented for me to disclose
this information. Again, we are fine. Social history, you will see that I have
absolutely social history of any interest. I am allergic to amoxicillin. I get
a rash. I take medications of a multi-vitamin and vitamin D because in my vegan
diet I cannot get B12 and I do not drink milk that is supplemented with vitamin
D. I have a lifelong immunization history. There is co-defined tabulized vital
signs trended over time, vocabulary controlled so that a computer or a provider
can understand what is my pulse and what is my blood pressure. All of my
laboratory results trended over time and normals versus abnormals. The only
thing I have in this entire trended tabular data that is abnormal is my vitamin
D level is low, hence why I am now taking vitamin D. Here is an example of
narrative text on procedure results. Bone density and exercise treadmill. As a
procedure, I have implanted RFID with my medical records on them.

Now, this in contrast is a highly structured transportable, computable
record. In fact, if I were to just show you the source of this – I
recognize this is far more than anyone would really want to digest in the
committee, but what you see is it has been very human readable, but underneath
it is the full codification of all the controlled vocabularies that describe in
a computable way my entire record. So, this one CCD document can be used as a
personal health record can be used to transfer to a doctor’s EHR and can be
used for quality measurement, used for bio surveillance, and in some future
state should be given the use case could be used for clinical trials or
research. So, it is very nice that this one standard is highly repurposable.

This, of course, compares to – this is actually what my doctor produced
for me. This is a leading nationally provided electronic health record system.
I said, can you please me my entire personal lifelong history in a
transportable way? It is a 77-page PDF that mixes administrative and clinical
data. It has no vocabulary control. It is not searchable. If you just go
through it, it would take the average doctor about three hours to get anything
out of this because there is no sense of what my active problems are. There are
labs scattered over dates. There are huge amounts of boilerplate that are
repeated. This is of course the state of most electronic health records today.
So, I am very excited by the notion that vendors, over the course of the next
two years will begin to adopt that continuity of care document standard.
Therefore, emit from vendor-based systems that codified consumer centric, but
as well interoperable with other EHR summaries of my entire lifelong medical

Let us go back to the slides. Also in 2007, the emergency first responder
use case I described, they are a challenging use case because this one requires
that if an emergency first responder finds a patient in the field may be able
to find medical information about this patient from wherever it may be, a
clinic or a hospital. As well, as the patient receives medical care that may be
a nursing note, a triage note, a physician note, all of those need to be
recorded in electronic format. The reason this one was so challenging is if you
look at the workflow that exists today, ambulances have paper-based run sheets
and no interoperability. Although these standards are extraordinarily important
for the future, the current workflow between healthcare providers and hospitals
and clinics and ambulances today does not incorporate a lot of technology. In
some ways, we were really pushing the envelope on even finding the standards to
make this possible.

As a theme, and I did mention this to Secretary Leavitt when I testified to
AHIC last week, as we go to AHIC 2.0, I really look forward to business cases
that cover domains as opposed to use cases that cover very narrowly defined
while cross sections of data transfer. If you were to say, what is the workflow
that is necessary in a doctor’s office, in a pharmacy, or a patient at home? It
may be actually quite different than a use case, which is quite specific in
this case. Electronic data exchange to a first responder only a microcosm of
everything that actually goes on in a mass casualty incident.

Quality – let me describe the quality use case. The challenge we have
with quality measurement in this country, and all of you I know have certainly
done aggregate data analysis and are familiar with some of these issues.
Quality measures are often based on experts looking at the best evidence, not
what data is actually is available and the quality of the data that is
available electronically. This implies there are armies of chart abstractors
going through paper-based records trying to extract subtle impressions of
patient care because even though we are 85 percent electronic, we do not
necessarily record in a vocabulary controlled way the patient has comfort, care
measures only. Yet, a quality measure may say, congestive heart failure must
have ACE inhibitors given except in patients on comfort care measures only.
Hence, the measure becomes instantly incomputable for us. Therefore, it may
take months and 20 dollars a chart for us to abstract the data into a measure
that we report back whether that is whatever entity desiring such a measure.

This quality use case was very important because it brought together the
National Quality Forum and its Healthcare Information Technology Expert Panel
(HITEP) to begin to start looking at the entire ecosystem of those groups that
generate quality measures and metrics, those that have to generate the data,
and then other stakeholders such as the AMA and the NCQA who may be consumers
of the data that is resulting and said, can we revise the entire mechanism by
which quality measures are generated such that first experts would gather
evidence and quality measures would be proposed. Then the NQF and its
Healthcare Information Technology Expert Panel would be able to look at what
data elements would actually be needed to make that quality measure more
automatic. Then HITSP would be involved to determine what standards would be
most appropriate to populate those particular data elements and also identify
gaps such as, you have required here that we identify comfort care measures
only. There is a standard, however no one has ever used it, therefore this
would be a very challenging measure to require if you wished electronic near
real-time dashboards with this quality measure. NQF would then feedback to the
metric’s authors, AQA and others, those limitations and gaps, and the resulting
quality measures would be revised to eliminate, we hope, many of the
exclusionary criteria, which are not computable.

Folks may argue that will create a measure that is less than perfect. True.
One would hope, assuming that comfort care measures are equally distributed
across all providers in the country that it will be imperfect equally for
everyone. The advantage, however, is that we can have a computable measure in
near real-time giving feedback about the quality of care, and I would much
rather have an imperfect measure in near real-time quality than a perfect
measure six months after I delivered poor quality care to a patient.

So, what we have done in this quality use case is working with NQF we have
taken the Institute of Medicine’s 13 priority disease states. We have examined
all of the quality measures that were currently AQA, HQA measures around those
disease states and identified the data types and data classes that were
necessary to compute these quality measures and then provide all the standards
necessary to populate those automatically. This is work that is ongoing.
Caroline Clancy has really Sheppard quite a lot of this work along. I do
believe as we see the next year to two what I have outlined as a new mechanism
for defining quality metrics will really empower these HITSP standards now and
into the future to be very usable for real-time dash boarding of quality
measure from EHR’s and hospital information systems.

Medication management – I did mention that we are continuing work on
that through March is just refining a lot of the e-prescribing standards.
E-prescribing standards are very good and very rich and certainly millions of
transactions are already being done, but we also recognize there are certain
elements that are still in evolution, such as RxNorm as a mechanism of
describing the actual medication itself. Fill status, as a transaction still
evolving. So, HITSP has worked closely with NCPDP and others to make sure that
we have got a very crisp and best description of how to fill some of the gaps
in these transactions that are still evolving.

In 2008, we have been given six use cases. I have read all of these use
cases. They are still up for public comment. One impression I have is that
these are six use cases that really represent about eight or ten. One
frightening thing to me as the Chair of HITSP is the body of work that will be
required in 2008 is extraordinary. We have done 2006 and 2007 without a lot of
volunteer burnout, but of course this is all volunteer work. We had 20,000
hours in 2006, and 40,000 hours in 2007. Looking at the use cases, it is 80,000
hours in 2008. So, we obviously have to be very careful about this. I suspect
we will work very closely with AHIC 2.0 as these use cases are further refined
to make sure we are delivering business cases that are useful to everyone and
that we do not have volunteer burnout because these use cases are quite broad.

The use cases include remote monitoring. I call this bench to bedside to
sofa. That is, if you are caring for a patient at home who has a blood pressure
cuff, a gloucometer, or an electronic scale, how is that data transmitted to a
PHR or an EHR from the patient’s home? Presuming that is done, there may be
desire for a clinician to interact with the patient remotely for
tele-consultation. There may be secure e-mail. There may be alerts and
reminders to go back and forth from provider to patient. So, remote
consultation includes all those standards that are necessary to support those
workflows and that messaging.

Referrals and transfer of care as patient goes from outpatient to in-patient
to outpatient again, long-term acute care, or SNIP. How do we ensure that a
summary of the patient’s problems, medications, what has been done in the last
sight of care, current labs, dietary restrictions, et cetera are transmitted
from caregiver to caregiver. Of course, we will repurpose all of the continuity
of care documented clinical summary work we have already done for that set of

Personalized healthcare will include family history and the genome. This is
quite interesting because there has been some work done in HL7 to date around
the standards of representing family history, relationships, et cetera and some
work on the genome, but these are very evolving standards. So, this is a good
example of, yes, this it is necessary. Yes, it is forward thinking, but the
standards are very embryonic. This will be a challenging body of work for us in
2008. Folks who know me on the committee know that I really do try to be as
helpful as I can, so in addition to contributing my lifelong medical record for
the CCD, I am the fourth person who have been fully sequenced in my genome will
be the basis for some of the work to look at how it might be represented in
these genomic standards.

Just to give you the fun capsule summary of this, two aspects of my genome
have been sequenced. First, a set of aprometric chips have been processed into
SNIP’s. So, I have all of the SNIP analysis of 500,000 pieces of my genome
which indicate that I have a higher than normal risk of obesity and
cardiovascular disease, which is very good because if I would have known that,
I would have become vegan far earlier than I did at age 40. I did lose 70
pounds between seven years ago and today. I think that yes, that SNIP analysis
may have some credence.

What will be happening between now in February is 60 million based pairs
will be fully sequenced and made public through the personal genome project in
addition to all of my phenotypic data, three dimensional photographs, and cell
lines made available. This will be a rich set of data that will help us as we
progress towards standardizing and protecting genomic information.

Public health case reporting, of course as a clinician, I always want to
report disease to public health departments regional, local, and national as
necessary. Today, it is a very manual process. How do we make sure that
workflow is automated?

Response management – the important key on this particular use case is
lifelong immunization, vaccination histories transportable across a community.
There are also a variety because this does have some pandemic – what if
czars happens? How do you figure out who in the population needs resources?
What are the vaccination statuses and what is the electronic health record
data? Immunization is key here.

In 2009 and beyond, you will see a vast number of potential use cases.
Things that are in there include clinical trials and clinical research and
long-term care. Many things that have been proposed during the HITSP process
over the last three years as gaps in the use cases because they were not
domain-wide business cases. We look forward to working with AHIC 2.0 on
prioritizing those in 2009 and beyond.

The overall timeline in this slide is really more diagrammatic. This just
shows you between the introduction of the use case and its final CCHIT
certification inclusion in the implementations goes two to three years in
duration. So, I have promised to Secretary Leavitt because he now has 359 days
left in office that we will have of course ensured that our 2007 standards are
fully ready for recognition and that we will have the 2008 work to the extent
that we have all of the use cases finalized and ready for acceptance by the
time that he does leave office. We will have finished the three turns of the
crank, which is Secretary Leavitt’s desire.

To give you a sense of what was involved in doing this and to give you a
sense of how we have achieved parsimony of interoperability standards. In round
1, we were given these use cases. Initially, we looked at all the standards
that might be most appropriate for those three use cases. We found over 700
standards that were candidate standards. Through committees, Lynne Gilbertson
for example, chaired our Harmonization Readiness Committee. We developed
objective criteria to filter those standards based on such things as, how were
they developed? Is this an SDO that has got an open transparent process that is
sustainable that will maintain these standards? Are they appropriate for the
business needs, et cetera? We were able to dwindle those 700 standards to 30.
Those 30, of course I mentioned, are now completed.

We got a little better in 2007 as we were given the four use cases. We were
looking at just 200 candidate standards. We were able to dwindle that down to
20, but recognized that the 20 standards that we picked for 2007 had an 80
percent overlap with the 30 standards from round 1. So, we are really trying to
repurpose and reuse our interoperability specifications by repurposing base
standards and transaction packages which may be collections of these name
standards wherever possible.

Let me talk a bit about our security and privacy work in 2007. I did mention
that this has to be a set of security standards that are flexible enough to
support any privacy policy. Just as a description of variation in privacy
policy that gives you a context for this. So, I practiced in Boston,
Massachusetts. I practiced on the south side of the Charles River. On the south
side of the Charles River, we believe that in the interest of continuity of
care, sharing patient data with an opt-in consent with any provider related to
providing patient care is a good thing. On the north side of the Charles River,
they want those providers to be credentialed and controlled should there be any
violation of patient privacy therefore there are sanctions that are possible
because you credential the provider, you can fire them. That is on two sides of
the Charles River, the privacy policy on record disclosure varies. This is the
challenge. It is not a region. It is not a state. It is not a country. It is
two sides of a river.

Let me give you a sense of what those privacy and technical standards
include. We wish a robust audit trial to be standardized across all
applications that informs us as to who looked at what and why and where they
work. We have a standard for that. For legal purposes, we need consistent time.
When was a record modified? When was a record examined? For transmission of
records, we use secure communication channel. In 2006, HITSP was criticized
because we came up with standards for representing the data but not for sending
them from place to place in a secure and audited fashion. This security and
privacy technical note now fixes that. We have gone back by the way to the 2006
initial interoperable specifications and retrofitted them with all of these
security standards. So, those are now intact. All future work will have these
standards as a foundation.

How do we authenticate individuals? Now, let me explain this one because
there are hundreds of ways you could authenticate an individual from secure ID
to biometrics to user name and password to voice recognition, et cetera. Rather
than specify, the one best way to authenticate is iris scan. We said, no. There
will be many ways to authenticate, but we have to represent who is the user,
how were they authenticated, and it is up to the implementer of the application
whether or not to trust that mechanism of authentication. It may be for an
internal user, standard user name and password on a corporate intranet is
sufficient. If they are coming from an external site, they need something
additional like two factor authentication. This set of standards allows us to
represent the authentication method of who you are, but not specifically
specifying the means of authentication that must be used.

Once an individual is identified, then the question of access control. Who
can see what under what circumstances? In this case, for example, as a
clinician in the emergency department, I may be given right to see the
psychiatric notes of an individual. Now, a psychiatric note may have a special
lock box that I have to specifically get into by justifying why I am opening,
but this set of standards allow us to lock down portions of the record with
access controls and have a workflow such that individuals with certain
credentials and qualifications can look at pieces of the record under specific

Non-repatriation of records, where did they come from? Who created them?
When were they created? They were signed at the level of entries into the
record. Managing patient consent, now this was a challenging one. HL7 has come
up with a consent standard. We obviously want to represent, was this a consent
opt-in or opt-out? What specifically did the patient specify as their consent?
Sharing of documents among entities, how in the context of transmitting a
record from place to place do we know it is being sent from and being sent to?

That is the security and privacy technical note. Note it is not called the
interoperability specification. It is a set of constructs that are so
foundational, it is cross cutting every use case in every interoperability

Just to give you the final description of the standards that we actually
picked. There were some 249 standards evaluated. The final selection were 8
composite standards and 20 base standards including some that are already in
existence in our previous interoperability specifications. Note that these
standards are many of them foundational web standards. So, we are using SSL,
Secure Socket Layers. We have tried to adopt the web 2.0 XML driven standard
IETF mediated standards wherever possible. We obviously do not want to reinvent
the wheel. Let us leverage the security of the Internet where you can, but
clearly there were such standards such as Oasis, access control, and HL7
consent that were unique to healthcare that needed to be added in.

A brief overview of the other 2007 use cases. The emergency first responder
I described already, but this gives you a granular sense of some of the
standards that we include. Encounter summaries, the patient summary with a
continuity of care document, summary documents, triage notes, nursing notes,
physician notes, and data exchange in a messaging level. This does allow all of
those stakeholders, ambulances, hospitals, and clinics to exchange data.
Secretary Leavitt commented in my AHIC testimony, if you would imagine a
Katrina use case with this that an individual now without having an electronic
record could show up for care in the Super Dome and have with them a CD or a
have with them a thumb drive which would have the representation of the patient
summary like the one I showed you. Or, assuming that there was network
connectivity and that hospital information systems such as the Veteran’s
Administration highly distributed clinical information system were available
that providers in the Super Dome could query the VA and get records on an
individual using these standards.

In these standards, the CCD has now fully included the medication history,
allergies, encounters, problems and conditions, immunizations, and key
laboratory test results just as the one that I showed you. It is a much richer
CCD than the original one they came up with in 2006. This does include the
continuity of care record within it. Just so folks understand that HL7 and ASTM
truly came together. How could you take the richest of the continuity of care
record in its XML representation of tabular data with the richness of the
clinical document architecture and its representation of narrative data and put
these together in one container? That is really what the CCD is. It really
represents HL7 and ASTM coming together and harmonizing.

Comments about consumer empowerments use case, there are many new vendor
products that you have heard about and will hear about in upcoming months such
as the Microsoft Health Vault and the rumored Google Health Activities. All of
these have a workflow that enable a patient to be the steward of their own
data. A patient registers on these vendor based websites, connects securely
with their consent to sources of data such as clinics, hospitals, labs, or
pharmacies and then transfers data into these secure areas where presumably the
patient can apply privacy flags and exchange data with other providers or care
givers as appropriate for the patient’s desire. This set of standards, the
updated consumer empowerment standards really do support that kind of workflow.
I really look forward to 2008 as more and more of these vendor products come
online to see these continuity of care document standards used more
ubiquitously between payers, providers, and patients.

On the consumer empowerment, just to reemphasize that this is media as well
as network. So, should there truly be absence of a network, you do have a
physical means of carrying your record with you.

Quality I described in some detail already, but just to reemphasize that
this does now give us the capacity to represent what our 28 different data
types and 11 data classes, and let me just describe what a difference between a
class and a type might be. A type, very specific, might be allergy to
penicillin. A class may be adverse reactions in general. When you looked at all
of the IOM disease states and the AQA measures, we were able to define these
data classes and data types and represent them using both documents and
messaging standards as we had done for some of the other use cases I had

Where we are on – January 22nd we presented a security and
privacy technical note, emergency first responder, consumer empowerment, both
our networks, media, and quality to AHIC. Unanimously AHIC recommended these to
the Secretary. The Secretary noted that he would process these rapidly for
acceptance, and also on that date published in the Federal Register were all
the initial 2006 initial work recognizing those standards. So, to date 2006
done, 2007 nearly done, and 2008 beginning. Our committees are already
gathering to look at the use cases and begin the process of standards

I look forward to your questions, but that is where we have been in our
roadmap for the future. I look forward to working with you.

MR. REYNOLDS: Exciting. Questions from the committee?

DR. STEINDEL: John, thank you very much. I am glad Harry let me jump in
front of the line because I actually have to go down in a few minutes and chair
one of those goals on the next use cases. Yes, this is a very ambitious time. I
am going to put on my NCVHS hat right now, and you will see some of this
resulting in comments coming in on the various use cases. What we are finding,
and I think the first real instance of this was in the quality use case last
year. We are definitely seeing in the two population health use cases on case
reporting and immunizations that on the ONC use cases are extremely broad. What
we are getting are extremely broad, and they do not tend to respect what is
going on in the community today in the way of workflows. They are difficult to
parse out for standards, for harmonization, to make actual sense of what they
are doing.

Is there anything that can be done to try to get initial, more focused work
products into HICSP because if we do that, it is going to reduce the work loads
to all of the volunteers. In many of those use cases, like we saw this with the
quality use case, we are seeing it with the population health use cases. There
are people coming in who want to contribute on that process that haven’t
contributed before. So, there is ingoing and outgoing volunteer flow. I am not
that concerned about volunteer burnout except for the few crazy people who hang
around a lot, like me. We are very concerned and unless we have more focused
products, there is going to be a lot of burnout really due to frustration more
than anything else. Could you have any comments on what you would focus?

DR. HALAMKA: Sure. You are speaking with AHIC 2.0 individuals at Brookings.
I really do believe we are going to see a revision of this process to be
business case domain focused rather than use case focused. I think that there
has been enough input both for individuals involved in the HITSP process and
the NHIN processes, but also lessons learned from other countries. If you
actually look at what Canada has done. Well, first recognize that HITSP has
been funded by about $5 million dollars for all of its work over the last two
years. Canada has put $100 million dollars into these same standards,
harmonization efforts. But what they did with that $100 million dollars was
they specified why the domains around workflow and business case. That has
seemed to work quite well.

They said we are going to take the medication domain. The medication domain
will be everything from the supply chain to e-prescription and the patient and
it is really a whole ecosystem of all the stakeholders in the pharmaceutical

I think the short answer to your question is, AHIC 2.0 realizes this. I do
think that the future use cases will be quite different.

DR. STEINDEL: That is very encouraging. Thank you.

DR. FITZMAURICE: A couple of questions. Let me just run through the
questions, and then I can repeat them. The first one is a matter of resources.
In 2008, we have six new use cases. We have gaps in some of the existing use
cases. We have some permanezation of data elements across the use cases and
across some of the CDA or CCD documents. We have the NHIN cooperative, which is
looking through them and finding their own gaps and will come to HITSP with a
fast track to expand some of the existing use cases to meet their use cases.
All of which, I think these are all good things, but the concern is over
resources. That is the first question.

Secondly, can we have a copy of your slides? Good.

Third, where do you anticipate the resources in the future to come? In the
immediate future, will they come through ONC or will they come from AHIC 2.0?
Is that just a matter of discussion, and we will find out when the future hits

Fourth and final, the CCR is codified you said, but you also said at Beth
Israel you have vocabulary control. Some people wish that there were more
vocabulary control across these things and realize that people who adopt them
will have their own sets of vocabularies and code sets. I would like to see a
target or a map able code set and vocabulary so people who use the use cases
can talk with each other through their own language by mapping and eventually,
by talking the same language with each other. Can HITSPY help move us toward
that direction if you think that was a good direction?

DR. HALAMKA: Those were all excellent questions. With the first, recognizing
this issue of scaling HITSPY was a real challenge as we have more and more
work. We have taken what were three technical committees and now created six
committees specifically charging three committees with maintaining existing
HITSP interoperability specifications and now giving three other committees
more strategic ability to look at such things as urgent issues that the NHIN
may raise. Issus of harmonization that are crosscutting across use cases, so by
creating this new structure which has just been put in place. We do believe we
will be scalable, and we are getting now more volunteers in to populate those
six committees.

With regard to my slides, all of my presentation materials are on the laptop
here. It is fine with me if the NCVHS wishes to use the CCD and my printed PDF
medical record as examples. Certainly feel free to repurpose those.

With regard to the resources in the future, the AHIC 2.0 organization I have
been told will include funding for standards harmonization support. Obviously,
I cannot predict the future, but my experience in the past has been when we
looked at the business viability of standards harmonization, it is a public
good and there are few folks who will pay for a public good. So, we could offer
educational seminars. That certainly would give us some funding. We could
conceivably charge for some of our work products. It still will not cover the
cost of administrating all the program management at HITSPY. Even though we are
a volunteer organization, it still does cost to organize meetings and keep all
of this harmonization running. I believe AHIC 2.0 will fund that.

DR. FITZMAURICE: The last question was about the CCR codification vocabulary

DR. HALAMKA: Right. Obviously, we try to whenever possible in the HITSPY
data standards describe not only content but actually the vocabularies used.
So, this is SNOMED. Units of measure will be standardized. Typically what we
have done because we recognize you cannot adopt new standards and vocabulary
controls over night is that we will have a triplet in the standard. The triplet
will be first, use what you are using now. It may be non-vocabulary controlled,
but it allows you a soft path to transition. Second to the triplet is, here is
the standard that is vocabulary controlled and therefore it will be
interoperable. It will be computable. The third is human readable. It means
that an individual can actually understand that G-3 means milligrams. I use
that example because in standardizing labs, we actually had to come up with
standardized units of measure using the vocabulary, which in a sense is very
metric like. Will a doctor who is use to seeing mg now seeing G-3 understand
that to mean milligrams? Hence, you might imagine the standard shows us for
this transitional period all three of those and the application consuming it
can elect to use the visual display for the doctors, where the G-3 where it is
interoperable comparisons or decision support.

We do try to be quite specific. We do allow transition to the future. I
share your thoughts. We want to get as controlled of vocabularies as much as

DR. FITZMAURICE: I want to thank you and HITSPY and all of the volunteers
for the great work you have been doing.

DR. HALAMKA: Thank you.

MR. REYNOLDS: I have got a question. The question I have is we did a lot of
planning yesterday as part of our session about where we see this committee
making the difference and the things we aught to be looking at. So, with the
good stuff you have going on, what can we do to help in your eyes?

DR. HALAMKA: Well, sure. A couple of thoughts. The first, as we have talked
about, is this theme of let us look at domains and workflow and business cases.
That is really quite important to me. Second, implementation is really the
measure of our success. So, how do we go from what has been a wonderful body of
harmonization work in the interoperability specifications to products that are
actually using it? Certainly, one thing that we have started with is
communication and education quite importantly. We just started a new committee,
and that new committee will be how do we get the word out. Here is what the
standards here. Actually, CCD is not that scary. It is not that hard. We hope
that over the next two years, implementation will then result in many more
opportunities for personal health records, electronic health records, and
decision support because we are speaking in a common vocabulary. Anything you
can do to foster an implementation would be wonderful.


MR. BLAIR: Let me echo everyone else’s comments on how impressed we are with
how much you have achieved by leveraging the private sectors for all of these
voluntary efforts and pulling it together into something that has moved quickly
and effectively. My questions really are along the same path as Harry’s. You
mentioned that you thought NCVHS could help in domains and business cases and
implementation. Could you elaborate a little bit what you mean by domains and
what you mean by business cases?

DR. HALAMKA: Sure. When we get a use case, typically it has not taken into
account all of the workflow that is necessary to accomplish a specific task.
So, if we look for example at the NHIN implementations, we would say, we have a
community that needs to actually insure continuity of care for good quality,
and therefore we actually need is all of the standards appropriate for sending
data from emergency departments to provider and then from provider to patient.
It is more than just a very discreet set of use cases. It is a business flow
that takes place in a community. So, I worry that because we have attacked this
problem like Swiss cheese, there are going to be a lot of holes that need to be
filled. Presumably, NCVHS, you will have some sense of what are the most urgent
business needs. As a representative from the NHIN project you, I am sure, will
be articulating those as well. By domain, what I mean is, instead of just
focusing on e-prescribing, it is the whole of medications from supply chain to
delivery to the patient to post market pharmacy surveillance. What you will see
is that since we just looked at pieces of this, we may have done good work, but
we are getting medications into the patients’ hands that have no idea if they
are doing harm to them.

MR. BLAIR: Let me add one other area. This prompting a little bit with my
own thinking here. HITSPY has taken these cases, which are an indication of
where the nation has high priority things that it wants to achieve and improve
in health care. So, you are very directed and very focused. One of the topics
on our agenda that I sort of want to run by you for your reaction to this is
that as we look at things over a period of time, we look at the evolution of
standards. ICD9, ICD10, ICD11, SNOMED, LOINC, RxNorm, that transition, the
process seems to take so long to be able to move forward. Is this an area where
you think we can be helpful either directly or indirectly to HITSPY or to the

DR. HALAMKA: If I look at the last couple of years, the work that we have
done at HITSPY I think has created an acceleration to harmonization. I believe
there is a pace of change that is acceptable to stakeholders. I think what has
been interesting about this process is you look end to end at the entire
process of going from use case definition to HITSPY to acceptance to
recognition of three years. Maybe there are some elements of that process that
could be shortened, the hand offs, the periods that seem to be being used for a
year of review, et cetera. The actual harmonization activities, those six to
nine months, seem to be going about as quick as they can go. Now, I do hope
that because we have fought some difficult battles, we actually have now got a
record summary standard that maybe the future use cases are simply repurposing
the work of the past, so it will go even faster than the six to nine months. I
believe the Office of National Coordinator is looking at the end to end
process, asking where they can skinny it down, and certainly, your role if
there are ways to help prioritize and focus the work further so that we get
those things that are necessary to empower connectivity first. That would
probably get us there sooner than by just trying to fill in every potential use
case and eventually get to a business case.

MR. REYNOLDS: Jorge and Judy, if you have a specific question on something
that HITSP is doing, we can hold that. Maybe talk to John. If you have a
question on how it affects us, then we can move forward.

DR. FERRER: Very quickly, when you move from the use case to the business
case, are you using the use cases to drive the parameters for that business?
The business case can be very large long-term care. Why do you think based on
use case development you will draw those arbitrary primers initially before you
get to —

DR. HALAMKA: Sure. What is most concerning to me about the use case approach
is it leaves whole gaps. It gets you part of the way there, but then you have
missed what you actually need to accomplish the workflow. So, what I guess I
would hope is – again, I see this sometimes from a doctor’s perspective.
From a doctor’s perspective, I would have said if we can get to a really well
codified problem list, medication list, allergy list, a very brief summary of
the current care, and the laboratories. That would empower quite a lot of
workflow, but of course if you look, we did some surveillance over here and
some consumer empowerment over there. We eventually got to that clinical
summary, but we would have been better to start with the clinical summaries the
very first thing that we did. What I just hope is that looking at the business
case would inform you in not a completely broad fashion but in a constrained
way to get those things done that were just sufficient to empower the workflow
of the clinician or the stakeholders rather than highly detail here, there, and
over here but not getting the whole workflow done.

DR. WARREN: This is why I couldn’t figure out whether or not my question
qualified. I noticed that on the standards you pushed forward you had some IHE
profiles. We had a discussion yesterday on whether or not IHE was standards
development organization. What I am wanting to hear from you why those were
selected, and are they selected as standards – I think it was the next
slide down.

DR. HALAMKA: There are a number of IHE constructs.

DR. WARREN: Then you had the emergency responders.

DR. HALAMKA: Let me just talk about what is a standard. Here is the slide
that I wanted to emphasize. Okay, if you look, a standard – when we think
of a standards development organization, specifically ANSI may certify certain
standards development organizations like your HL7’s, your NCPDP, but what HITSP
wishes to do because HITSP is not a SDO, is to repurpose standards, but also
code sets, terminologies, and integration profiles that may be created by
organizations that are adopting the standards and then doing very good
implementation guides from them. Is IHE and SDO ANSI certified? No. Is it a
consensus-based organization that comes up with profiles and implementation
guides that are highly useful? Yes. We will leverage those.

DR. WARREN: That helps. That helps put a perspective on this continuum of
the word standards, which has wide meaning.

MR. REYNOLDS: It is also helpful as we say the word standards from now on
around the room. It gives us a little different view. John, thank you.
Outstanding. Excellent work. We appreciate it. Are you leaving.

DR. HALAMKA: Well, I will be in the building for the next three hours on a
joint commission phone call.

MR. REYNOLDS: All right, moving to our next panel. We are going to hear from
John Quinn from HL7, Robert Barbour from WEDI, and Alix here?

Agenda Item: Panel Discussion on Upcoming Issues

MR. QUINN: First of all, can I ask the chair for some guidance on how much
time we have here?

MR. REYNOLDS: We are shooting for each of you to have about ten minutes to
give us an overview. Again, you can see the questions. We are trying to look
forward. What are you doing, and how can we help make a difference, and how can
we understand it better? So, rather than everything you are doing, if you could
really focus there, that would be great. Thank you.

MR. QUINN: I will try to skip around then. Let me – you have a copy of
my comments, and I am going to skip right along to first of all I am John
Quinn. I am the Chief Technology Officer of HL7. While I have been with the
organization for 21 years, this is a new position. I started this by last
September’s meeting.

First, HL7, what is it now? This is a standards development organization.

MR. REYNOLDS: Again, on some of these things we know what it is.

MR. QUINN: We have 31 affiliates as this point. Here is the affiliates. You
can see they come from all over the world. We have a couple more coming online
right now.

Let me skip to what has happened recently. We have reorganized on the CTO.
Chuck Jaffe is the CEO. The board was restructured to include outside board
members, specifically Dr. Kemlon from the NHS, Dennis Giekas the CTO of Canada
Health Info Way and Doctor Don Simborg, our three outside board members. Some
of you are probably aware of some of these individuals and brings interesting
advice into the board.

Let me skip ahead to the reorganization. We reorganized HL7. This is a
three-year process. The Robert Wood Johnson funded a process where we went
through. This is the first significant reorganization of HL7 that has occurred
since we started our previous which was 1988 I believe. You can see on the
slide that it was a CEO, CTO potential for COO in the future. The most
important part of this slide is the lower left pieces, the technical steering
committee. We have reorganized the entire working group that is 50 some
committees into four steering divisions, under technical steering committee.
What is important to understand is the running of the development of a standard
now is a responsibility of the technical steering committee. It is not an issue
that is consuming board meanings. The board is now focused towards the strategy
and business of HL7. The technical steering committee, which meets weekly on
conference calls, managing the day-to-day running of the development of the

You asked about our vision. Here it is, to create the best and most widely
used standards and healthcare. We revisited our vision and our mission
statement both last July at our board retreat. This is relatively current. Here
is our mission statement. HL7 provides standards for interoperability that
improve care delivery, improve care optimize workflow, reduce ambiguity, and
enhance knowledge transfer among all of our stakeholders, including healthcare
providers, government agencies, the vendor community, fellow SDOs and patients.
In all of our process we exhibit timeliness, scientific rigor and technical
expertise without compromising transparency, account-ability, practicality, or
our willingness to put the needs of our stakeholders first. So, we are going to
be talking a little more about stakeholders as well.

That brings us to the industry advisory board. HL7 routinely seeks advice
from an outside group of advisors from the healthcare industry. This is a
diverse group that represents the business of healthcare both in this country
and from our major affiliates. The scope of industry represented here includes
all of our major stakeholders, the IAB meets with HL7 officers and staff once a
month by conference calling once each year face to face at our annual board
retreat. From this has come a road map that is now in the process of
development. We had a two-day meeting with an extended group of stakeholders
last October. From that the board is now coming up with a business strategy for
HL7 based on the roadmap suggestions.

The easiest way to try and understand what HL7’s scope is to look at the
titles associated with our various committees. This is what is buried in those
boxes called steering divisions on that orange chart you saw. Each one of these
are individual committees with co-chairs that have their own meeting schedules.
We have typically 30 or so committees meeting in parallel in HL7 meetings. This
list gives you a good idea of what the scope of things we are working on. For
instance, clinical genomics was something that Doctor Halamka was something he
spoke about in his presentation. That committee has been meeting for about six
years as well.

Major recent developments, in order to deal with this, I went to the HL7 web
page. I took the last five headlines off the page, copied it onto the slide and
that is pretty much where to go to find out what is going on recently in HL7.
Most specifically ongoing work with OMG and SOA. The new board members,
personal health record, this has to do a lot with CCHIT and the work of RAHRS
Committee, and a collaboration between HL7 and America’s health insurance plans
for their PHR, which unfortunately has the same acronym with the one we are
working on as well with CCHIT. So, some harmonization, some collaboration, and
some better understanding of what is going on with personal health records is a
big focus right now within our EHR Committee.

Our formal collaborations, here is the list of all the organizations that we
have formal agreements with. This means there is a signed agreement. It is
reviewed every year. It is resigned typically every three to five years, and
there is somebody within HL7 that has point responsibility to be the liaison
with each one of these organizations. Okay? I will just leave it at that.

Let us talk a little bit about X12 and WEDI and what we have been doing with
them. We can let them talk about it later with what they are doing. I guess I
got first shot, not that I believe there will be any disagreement here because
the folks that wrote this are the joint group.

Our attachment special interest group is showing volunteer fatigue. After 12
years of work on HIPAA 275 attachments without yet seeing final rules
publishing, you might imagine it is getting a little difficult to find people
to step up for leadership in this group. You asked what you could do, and
things we feel are out of our control, and this clearly falls into that

You will hear about this later. We have done a pilot on the adoption of 275
using the HL7 CEA based attachment transactions. This is another implementation
guide for CEA just like CCD was. They have seen as much as 30 days faster
turnaround. By the way, the pilot is over, but they are continuing to use it
because it has been that successful for them. We would love to see the rest of
the country get that benefit as well.

Education about HIPAA, its transactions and its other rules is becoming a
more urgent need. This really has to do with the 12 years that it has taken to
get us to this point. Some of us are retiring. Some of us are finding other
things to do. The group that so enthusiastically started working on this 12
years ago, you have to expect there is going to be some attrition. There is not
– without the obvious use, it is hard to get people to say they want to
come to a meeting, to volunteer to run all these projects, and take the
responsibilities of being at all these meetings. That is important.

HL7 along with Blue Cross Blue Shield Association and America’s Health
Insurance Plans are working together to leverage the HIPAA 275 transaction with
the Continuity of Care Document to move member information between plans when
an individual changes health plans. This same implementation guide is the focus
of what AHIP wants to do with the movement of PHR information. That is the
basis. You can understand that there is repurposing going on of the
implementation guides that we are creating that are being used.

We need, and you will see specific questions at the end of this
presentations, but the HIPAA legislation and the existing processes for
updating and revising rules are cumbersome, expensive, and slow. You will see
that as a formal request at the end of this. Vendors will not implement without
published final rules. We really end up with the reality that once final rules
are announced, then we start getting pushed back. It is too quick. We need
this. We need that. So, they wont implement HL7 until we publish a ballot, at
least as an HL7 standard if not as an ANSI standard. Those all have timelines
associated with them further on. There is a certain amount of time required for
uptake afterwards, so even as we approach hopeful publication of 275 final
rules, we still have to deal with the time that will occur after that.

CDISC, the Clinical Data Interchange Standards Consortium, this is a pretty
active group of HL7, specifically focusing on what does it take to get HL7 and
its artifacts used in the area of clinical research, or how do we connect DHRs
to clinical research. There is a lot of activity going on in that area. There
is very substantial presence of pharmaceutical companies in this particular
committee. The FDA has clearly strong involvement as well.

The roadmap, I have taken a few of the most general and most clearly
emphasized principles that came out of our meetings. The current board is a
current Board of Initiative. It is based on our recommendations from the
stakeholders in our meetings. Some samples, we have to measure our success by
the use of our standards. It is not an issue of how many documents that we
publish, how many dollar cycles a year we go through, it is an issue of how
many people will use it. When we talk about things like HL7 version 2, we know
it is somewhere north of 90 percent of the organizations and the authority
diagnostic centers and reference labs that in some version use the HL7 version

Our standards and technologies are founded and managed by a set of
architecture principles. In other words, an architectural review board that has
leadership as opposed to being passive, we want a more active ARB. We have
created that. They had their first meeting two weeks ago in San Antonio. They
are having weekly status calls at this point. I co-chair that group.

The continued development of the Standards, implementation guides, and other
technologies of the V2 are critical. A loud clear message from our
stakeholders. Do not think for a minute that V2 is going away. It makes
absolutely no business sense to work out a working Version 2 interface and
replace it with anything whether it is a Version 3 interface or a newer version
2. It makes no sense at all. That is a loud and clear message. What we are
seeing is, V3 is being back fitted into V2. Things we have developed for V3
that were not in V2 are now being back fitted in, giving V2 a lot more
normalization across the standard.

What should NCVHS do? Do all you can to revitalize HIPAA, its rules, and its
processes and to finish what has not be done. Help the Department of Health and
Human Services and Congress see the importance of more streamlined maintenance
process. One of the points I make in my prepared notes is, just imagine what
has changed in technology since 1996 that nobody even considered when the
legislation was written or when we first took a look at our initial rules. Try
to figure out some way to get HIPAA and other standards and implementation
guides like it on a timeline that starts to resemble the rate of change we see
of technology. It is a standard that dictates how we use technology. If it does
not at least approximate that same timeline, we are going to have just
increasing gaps.

Recognize and report that although the US’s Healthcare Finance system maybe
different than other countries. The science and medicine, clinical processes,
practice and healthcare information technology used in the US are also largely
the same in other countries. We see that a lot with those 31 affiliates. Okay?
None of them use HIPAA transactions. There is a claims transaction in the HL7
for use outside the United States, but they specifically asked us to put it
inside of HL7. More importantly, the vocabularies, the workflow processes, the
use cases, those are all very, very similar. I travel to a lot of these
countries. No two health care systems in any two countries looks exactly the
same, but there is far more similarity than difference. When we look at the
clinical side of this, this is especially true.

With 30 participating affiliates, we see and manage to this commonality
every day. Nevertheless, cooperation and leadership from the US Government
working with other countries would allow all to achieve our goals with much
less difficulty. One of the interesting things I read just last night in
researching is an announcement from our Turkish affiliate that they are
probably the most active group right now mapping version 2 interfaces to
version 3. That would not have been my first choice where to look. The use of
HL7 continues to surprise me. We had over 100 individuals certified in the use
of HL7 from India last year. Okay?

That is the short version of the prepared comments, so any questions?

MR. REYNOLDS: Robert, we will move on to you. I want to make sure that
– I want to make sure you introduce yourself and say whether you have any
conflicts. I want to have on the record that you were here.

DR. CARR: Yes, I am Justine Carr from Beth Israel Deaconess Medical Center.
I have no conflicts.

MR. REYNOLDS: Okay. Thank you. We are glad to have you with us. Robert?

MR. BARBOUR: Actually, my first name is John. I am wondering if I could use
this. For those of you who can only hear, I was putting Dr. Halamka’s sign up
in front of me since he is just an excellent speaker. He is a tough act to
follow. I am here to give you a brief overview of what WEDI is going to be
doing over 2008. We structured our slide presentation just to be what we are
going to be doing in 2008. I am actually quite pleased to hear that the areas
we overlap with HL7, the message is identical. That should give this committee
some comfort that the industry is seeing some of the issues and concerns in a
likeminded fashion.

We have six items that we wanted to bring to your attention. The health
industry timeline, and it is implications with the 5010 new X12 transaction
that needs to be implemented, the standardization of a new transaction called
the acknowledgement process. What we think may be the most exciting thing that
will actually make all of this work is a concept of real time transactions. It
may be the hidden place where the elusive ROI of all of these transactions will
come together and actually make the end dream we all share actually create
value for us. The claims attachments, we are going to support what was told
before. New ideas around standardizing health care identification card, and to
let you know what WEDI is going to be doing in its continuing role in the
National Provider Identifier Outreach Initiative.

The first thing we would like to bring to your attention is the constant and
always troubling realization that the process to move standards forward is a
long protracted process. The North Carolina group, NCHICA has been working on
that for a while. They vouch only forces with WEDI to get a broader industry
consensus on it. Their particular timeline that they have developed and now
publishing is based on the idea that it will be furthering the upgrade to the
5010 series that X12 is now finishing. The concern we all have is this is a
realistic timeline that shows it is going to take maybe 6 years to do that.
That is bringing us out to date 2014. Unfortunately that number is on the list
serves. Everyone is now saying exactly what we heard from the other presenters
that nobody is planning to do anything now to 2014.

We desperately need your help to get the word out that we need to figure out
ways not only to shorten the timeframe, but whatever that timeframe is, it is
not serial. It is not A follow B follow C. We need to think about how we can do
things in parallel, otherwise that is how we will end up in a never-ending
repetitive process of the industry is not ready for something. The most
important thing we can ask NCVHS to do is to encourage CMS to move the industry
forward in parallel and not wait for a final rule, but whatever the final rule
is, we have to shorten that process. The timeframe from the NPRM publication to
the final rule itself needs to be shortened. Again, we want you to encourage
CMS to quickly publish the NPRM and to do whatever it can to shorten the
ensuing period to the final rule.

The other thing that this all brings together, and it is another way of
saying the same thing we have heard from others is there is a number of other
things happening in parallel. We have the new NCPDP standards coming out. The
claims attachments standards will hopefully be adopted. CAQH, the core
initiative is getting ready to do phase 2, and probably in the same period as
phase 3 and phase 4 because they have a much faster cycle. ICD10 is looming.
E-prescribing is going to have a lot of work to be done. Real time adjudication
will consume resources. All of these will take technical support. Guess what,
at least in my shop and most of the people I talk with, it is the same people,
the same technology experts that are being asked to do this. We do not have
this huge backlog of IT geeks waiting to address each of these projects
independently. We need some sense of where the priorities are, and we would
really, really hope that the NCVHS could reach out and get some sense of how
these things not only should be prioritized, but where they integrate and will
create the best synergistic response to all of the concerns that we all share
together in this process. The timeline and its implications are very important,
and it is very important for us to make sure the industry does not adopt a wait
and see approach.

Acknowledgements are a very important piece that escapes most people on its
face as to why. Right now, there are a myriad of different proprietary ways
that payers will let us know where in the spectrum they received a claim or
another transaction. A number of payers do not even tell us anything. Why is
that important to the provider community and to the people who are trying to
develop this? For a very practical reason, if we cannot agree where something
is, we cannot agree that it ever occurred. So, from a very practical viewpoint
from providers, we are constantly in a conversation battle with payers. Did you
get my claim? Where is it in the process? If we could have a standard that
actually tracks every step of the way where a transaction is in a federal
express model that we all seem to quote. That would be a major step forward. We
urge NCVHS to work with WEDI on approving voluntary standards that support for
this kind of transaction and to develop pilot projects for it.

Real time transactions are an activity that has brought together both WEDI
and X12. What is driving it is that most of us that are involved in it really
think the concept of real time is missing glue that brings all the transactions
to a meaningful basis foundation and something that will generate an ROI. The
easiest way to describe it is in the position with the new experiments we are
trying to do with consumer-directed healthcare. We are talking about how do we
go about getting patients to participate in the cost of healthcare, what
treatment modalities they should use, and be true consumers. How ca we ever be
a consumer of anything in healthcare if we only know the cost of it after it
was done? How are we going to know whether we should do process A versus
process B based on the ability of resources one has if we only know about that
after it is done. Being able to have transactions transmit information either
contemporaneously or before they are done opens up all kinds of opportunities
we could never have without it.

For example, if a provider sends a transaction that basically says to the
payer, I am thinking of doing A, B, and C for this patient who has this
condition. From a provider’s perspective, they are really saying how much you
are going to pay for it. From the consumer’s first impression, they are going
to be told, if we do this, this is how much you are going to have to pay for
it. The payers already at the table said, you are telling me this before you
are going to do it. That gives me the opportunity to come back and say here is
best practices, here is pay for performance criteria, and patient here are your
alternatives that you may want to consider. The patient now has become a
consumer. For this, an endless list of other reasons we want to get NCVHS’s
support to encourage CMS explore both Medicare and Medicaid who can take
advantage of this to move forward. You can imagine we cannot do real time
transactions without the full spectrum of the payer systems supporting it.

Claims attachments, likewise we are here at WEDI supporting the need to go
forward. We have held a number of meetings on that. We worked with NCHICA and
WEDI and incorporated it into our timelines. We have developed a whole series
of white papers, and we continue to go forward on that. We are going to be
opening up a website to have an area for people to post issues and other
conversation son it and be able to talk to those of us who were involved in the
pilot project. I can on the side put my Monty hat back on and say claims
attachments are a great idea. We encourage and urge NCVHS to encourage CMS to
expedite the publication of the final rule as quickly as possible particularly
in light of the extremely positive results for early implementers so far.

WEDI has also gotten involved in developing a health identification card
standard. Again, the best way to explain why it is important is to tell it
again from a provider’s perspective. When we try to train our employees how to
take information off an ID card, we show them almost countless different
examples of where that information is. The good cards have it somewhere. All
too often, many of the cards have part of the information and the people are
looking for more, and it is not there. Unfortunately, if it is not there, we
may invent it. There is a blank on the screen that the employee has to fill
out. God knows what is going to go in there. If we could have a standard of
what goes on a card and more importantly, we see the card as a triggering
event. One concept may be the start of real time. If it triggers the
transaction, goes out to the payer, we get the information back, it minimizes
the employee input. It is a wonderful thing. As you can imagine, we want your
support to encourage CMS to consider something like this for the Medicare and
Medicaid operations as well.

Finally, the area of NPI, which is coming rapidly to a closure, WEDI will
continue its educational efforts there. There are some initial concerns that
are bubbling. Suffice it to say that it will not be as smooth a transition as
most of us would like it to be. Most of the problems will occur in the payer
systems for trying to figure out how to cross map this new NPI to legacy
numbers. The biggest area we see will be a problem is where providers had
multiple legacy ID’s. How did they take one number and cross map it to many?
That would be our biggest problems. There are others on the phone along with me
that would be delighted to take your questions.

MR. REYNOLDS: Thank you. Alix?

MS. GOSS: It is a pleasure for me to be able to say Amen to the remarks of
HL7 and WEDI. We very much support their remarks and are very much inline with
the spirit of the comments. I have tried to design this presentation to stay
within the ten minutes that we were allowed. Hopefully I will achieve that goal
knowing that the larger context of the issue has already been discussed.

I should probably introduce myself. I am Alix Goss of the Payformance
Corporation. I am here today as the chair of the Insurance Subcommittee. We are
very glad to be here, anticipating in this important discussion.

Just to give you some background for those of you who are not familiar with
X12 —

MR. REYNOLDS: We are very familiar.

MS. GOSS: Moving on, if you would like us to discuss any more of our mission
and our efforts I would be welcome to come back and talk to you about our
strategic cleaning effort, our focus over the next several years in meeting our
stakeholders’ needs. I will move on from there.

Okay, let us talk about a problem you are probably all too well aware of. It
is a narrative of healthcare initiatives that occurring today. These
initiatives focus on proving patient safety, insuring efficient and reliable
data exchange of clinical, financial, and administrative data and establishing
a national health information structure based on interoperability standards. It
is a very complex landscape and it is hard for the industry participants and
consumers to understand how all of the pieces of the puzzle fit together.

Many of today’s initiatives of building on cornerstones are in place. For
instance, the HIPAA law of 1996 provided us with administrative simplification
codes to set standards, privacy, security, and identifiers. CHI is an integral
part of the federal health architecture program. For today’s health information
and technology standards panel, effort is mindful of that HIPAA work and high
efforts among others.

A simple example it is easy to see how the interrelatedness and progress
being made can be difficult to understand, follow, and influence. A road map is
needed to enable the various parties to the process to be informed and promote
a festive collaboration. The current process for adoption and transactions
adopted under HIPAA is problematic. Operating in the regulatory environment,
the ability of the standards development organizations to be responsive, to be
evolving and changing industry needs is greatly impaired resulting in
stakeholders waiting a minimum of five years to be able to implement new
specification adopted under the current regulatory infrastructure.

Most concerning are the underlined industry assumptions. They are
assumptions on when to participate in the process, when they can make comments
on the process, and the skepticism of the adoption timing and enforcement of
mandated standards. Although we are not under a regulatory environment with
HITSP, we have a related conundrum including widespread adoption of the current
focus, which is based on use cases to achieve patient safety and national
health information infrastructure. We may not have robust use cases nor enough
support to bring the current initiative to pass.

The key to interoperability is being able to trust and rely upon the word,
language and values we use to exchange data. The goal is to be able to know
that when I say the value of X, the receiver knows what X means and can then
determine the appropriate uses of X in their world. For instance, it is more
specific than saying we are talking apples to apples. It is known we are
talking about a red delicious apple grown in Adams County, Pennsylvania near
historic Gettysburg, not a red delicious apply grown in Yakama Valley in the
southern part of Washington state.

X12, NCPDP, HL7 among others are collaborating in the HITSP form to tackle
this vocabulary issue. We must create a dictionary that is very detailed in
defining the terms and values used to describe every piece of data exchanged
within the healthcare industry to support data exchanges across multiple
standards and platforms resulting in having a high degree of trust and use of
data. The dictionary becomes the foundation for normalizing and harmonizing
standards, which leads to interoperability. Vocabulary, dictionary normalizing
efforts underway, we fully supported he who understood, incorporating the
existing processes, and compile by entities adhering to a universal healthcare
dictionary as a foundation for interoperability of parts and data exchanges
regardless of the things we use and support the national initiative. This week
leads to the role of NCVHS.

NCVHS has a critical role in carrying various viewpoints and articulating to
the secretary at HHS with balance while making recommendations. NCVHS should
support and advocacy for efficient adoption, an education of the processes is
very important. We need to learn from our experiences under HIPAA and the need
for standards that involve business needs. We have many competing priorities,
and we need to support businesses. We need to be agile in today’s marketplace.
Data is the lowest common denominator across all of the entity types in
healthcare. We need to enable businesses to have predictability and have
limited resources effectively. We need to have regulatory government
involvement in the process to be an enabler.

X12 project and focus is in mind with the goals of interoperability. We
undertook related projects before HITSP and will continue to actively
participate, contribute, and seek ways to meet the healthcare industry needs.
We strongly believe we must use industry resources widely that result in being
adopted and will make a difference. We will continue to develop our Health Care
Implementation Guide or develop a new guide to meet the needs and support
interoperability. I hope I made that time, Harry.

MR. REYNOLDS: You get the star. That is great. Thank you. That is very
comprehensive and a wonderful message, as were all of them. Now, I would like
to open it up to the committee for any questions.

DR. FERRER: John, I have a question. As HITSP now moves into a different
scope, if you will, from a business standpoint, how does that influence the
ongoing work of HITSP? Is it disruptive for HL7? Does it help? Prior to HITSP,
HL7 by and large was the leader, if you will, in exchange of clinical data,
standards, and so forth. If you had to do it over, would you suggest that HITSP
have a different mechanism by which they worked with you guys?

MR. QUINN: On the record, let me start out by saying, we produce a standard.
I like to tell folks in my class that standards are framework of possibilities.
An implementation guide is a very specific recipe. An implementation guide, I
should be able to write software that can take an implementation guide and
produce a message or consume a message. Whereas a standard is just like saying
English. That doesn’t help me very much decide it is going to be this book
versus that book. I think there are those issues. Would we do it differently?
Well, HL7 is evolving. It clearly moves slower. Right now, my ballot has far
more implementation guides in it that are being balloted. We have three ballot
cycles a year. The pages of implementation guides that are being produced most
of them structure documents CDA implementation guides is becoming substantial
for us. It is pretty obvious that the group is becoming far more focused on
implementation guides.

There is an element that was brought up of what we refer to as the dynamic
model. The dynamic model really refers to this use case or process. Very broad
use cases for us, we have complained that the use cases as AHIC had produced
them were just too broad for us to create any sort of implementation guides off
of it. It has taken a tremendous amount of work by HITSP in order to be able to
get them down to a point where implementation guides could be created. So yes,
far more focused use cases are an advantage.

When we talk about that term semantic interoperability, really we talk about
the context. The context of who is doing what, where, when, and why. As we move
to more real time messages including in the provider organizations, it is
important that context by understood by both systems, both the sender and the
receiver because if we take a look at getting really interactive with things
like lab tests or ordering procedures, you realize there needs to be something
to tie this all together. That has to be in context. Not just what am I
sending, but why am I sending it, and who is it going to?

DR. FITZMAURICE: Let me start with John. HL7 first started –

MR. QUINN: Which John?

DR. FITZMAURICE: John Quinn. HL7 started to develop messages for within
hospital use, sent from the laboratory to the patient or to the pharmacy. When
you installed HL7 version 2, each hospital had its own code sets for
laboratories. As HL7 grew and the demands for HL7 standards grew more and more,
there was a demand for exchange of information across hospitals. Then you ran
into the problem of, hospitals have all these different code sets, so we need a
version 3. I guess I am asking, where is HL7 going with regard to a vocabulary
controlled and code set harmonization? Does it take version 3 to get that? How
do we solve the problem of across hospital communication? It goes beyond

MR. QUINN: Correct. In my script, I talk about green fields like RIO’s or
NHIN’s or NHS or these type of projects where you are integrating already
existing organizations. NHS is a great example in a sense that they make huge
use of version 2. All of their institutions use version 2 inside their
organization just like we do here, yet both in Canada and in the UK when it
came to saying, how are we going to integrate them across organizations –
for that very reason you just gave, which is vocabulary along with an ability
to become quite formal in my definition of exactly what that implementation
guide looks like based on modeling that we see almost universally in other
countries when I get to a green field, they want to go to version 3. Why? For
the same reason I said that we have a problem with HIPAA because it was
developed in 1996. Technology has moved so much since 1987 when we started HL7
that you cannot really look at it and say, I do not want to use XML. I do not
want to use model-based methodologies for creating these messages. I do not
want to tie them and bind them to vocabularies on a day to type by day to type
basis. That is why the version 3 is important.

What happens the most now is we map where you cannot throw out the existing
interface. You take that interface and you map it to the version 3
implementation guide that you are going to use. That is what we have seen
happen successfully.

DR. FITZMAURICE: For Robert, is WEDI looking at what is required for
generating claims from electronic health records? That is, if you look down the
road, what would it take to generate a claim from an electronic health record
that followed the HITSP standards, or are those so far down the road and we
have enough problems here that that is all WEDI can handle at this point?

MR. BARBOUR: WEDI itself is not looking at the messaging standards that
would create that, but WEDI in its workgroups recognizes that is where it is
going to start. Again, if we are putting it in conjunction with real time, we
are focusing in the physician environment means if we look at it from the point
of view of starting with charges that should be a by product of documenting in
the medical record that a real time transaction or message will flow from the
medical record to the billing side of the process, go out in real time to a
payer, come back and the way we try to put it is that the entire revenue
process ideally should occur before the patient finishes getting dressed so
that by the time they come out from the front desk, we know what they owe. More
ironically, we know why the payer does not want to pay the claim just yet, and
we have both the provider and the patient right there to address the denial
process, and we can close even the denial process before the patient leaves the
office. The point you are talking about is the most critical part of the
process. WEDI acknowledges that it is a critical part of it, but we ourselves
are not looking to address it other than to say it is a necessary component.

DR. FITZMAURICE: I love it. You jumped right in to real time, which is the
business case for the return on investment and what the consumer gets out of

MR. BARBOUR: That is correct.

DR. FITZMAURICE: Alix, I have a question for you. How does the vocabulary of
the X12 standards correspond A with the vocabulary of clinical data, and then B
will the vocabulary of the other non-health insurance data? I know X12 has to
be concerned about fitting in with all the other insurance uses, but
standardizing the things like patient demographics for example would seem to be
a no-brainer. Yet, if we standardize differently in health than we do in other
insurance areas, it will cause problems outside of the health arena. How does
the vocabulary of X12 correspond with the vocabulary of clinical data, and with
the vocabulary of the other health insurance partners?

MS. GOSS: That is a great question because demographics is something HL7 and
X12 started working on a while ago. So, it is harmonizing those. What we have
found is that we not only have our non-healthcare insurance partners to worry
about within the X12 arena, but we have our other cost industries here like
finance, transportation, supply chain, government where we have – X12 is a
big standard. That is usable by anybody in any of the industries that is doing
X12 development. So, we have the data elements, and it can be used across
multiple transactions. The data elements, when you maintenance them, it is not
just getting an approval process of the insurance subcommittee, it is also
getting the buy off of finance, which is used globally. X12 has been focused on
these vocabulary issues in creating a common dictionary and understanding the
interplay of our industry with the other industries and how we can work
together to expand our data element total values. When you say gender, we know
it is male, female, and unknown that we work with the other industry
organizations to say, what is the common denominator that we need to put in
place? Then we go back to our organizations and modify those SDO specific
values in the data elements, and that that process is going to be somewhat
complex because we have got to negotiate consensus across multiple industries
to enable everybody to have the flexibility of what they do. There are a lot of
implications about how we bring this whole process together and work when we
have got standards that are used in multiple industries.

From a clinical perspective, you asked about the data content I believe of
an X12 set of transactions. Let us just say the claim and how that works in the
clinical world. Where there are two pieces to that. There is the basic that we
have in the initial transactions for supporting the payment processes that need
to happen. People need to be paid for their services. We need to move that
data, which contains not only the value of who we are talking about and who has
responsibility in this process, the payers and the patients, but we also have
the information that enables claim adjudication determinations to be made.
There is a fairly robust set of values within the X12 transactions, but when we
get down to a clinical domain that goes along with the final nuances of the
medical policy determination, we actually have patterned with HL7 and
encouraged in various ways today –

You heard about the Patient Health Record Initiative that HL7 was talking
about. That HL7 initiative is actually the clinical part of the CDA that goes
into the X12 transaction for portability among the entities. So, we are
leveraging our infrastructure. Although in X12 we have a lot of clinical
values, the very detailed specificity that goes into the clinical nuances of
lab reports, et cetera is not our domain. We partner with HL7 to provide that.
It is transported in a 275 world of X12 transactions so we can provide that
service with the information.

DR. FITZMAURICE: Alix, let me interrupt for one final quick question.

MR. REYNOLDS: We have time constraints. Justine, I haven’t had a chance to
call on you.

DR. CARR: I do not have a question at this time.

MS. GREENBERG: I have a short question. Just going back to the very
beginning of your slides, John Quinn. When you had the mission of HL7, and I
guess this is a soapbox, but you had on it that you wanted to develop the best
standards possible for healthcare. I wondered if everyone was on board with
that, nobody had any questions, or whether anyone raise the point that I would
like to raise which is, what about population health and public health? The
health, as we know, of the American people and of the global population is
affected by a lot more than healthcare. I think I know that HL7 is clinical,
people who are trying to do electronic messaging and are looking to use HL7 and
certainly I know CDC and others in population and public health participate
actively in the HL7 process and not just to facilitate exchange of data from
healthcare to public health or vice versa, but within public health. The whole
movement that is afoot now to develop electronic birth and death registration
and messaging is an example. This may sound that I am just being picky, but my
concern is that people in public health and population health are much less
likely to get on board with standard – we have looked at using X12 or
should we use HL7? I think we have come to the conclusion that we should use
HL7, and that is the way we are moving. If they see HL7 as being healthcare,
then they are going to say, where do we fit in? Particularly with all of your
international affiliates where there is often a more organic relationship in
their countries between population health and healthcare. If you are only
looking at healthcare, you are cutting out a lot of people who aren’t even
getting healthcare in the traditional way of transactions. Did anyone else
raise this?

MR. QUINN: Well, the CDC is such a large participant in HL7 for such a long
time. Going back to one of our standards on immunization registry that we are
quite comfortable with it. I do not think for a minute in our discussions that
we weren’t considering public health when we said healthcare because of the
long established relationship we have had with the Center of Disease Control.
When it comes to other countries, the NHS for instance had about 80 public
registry databases that basically are already integrated into their program of
creating public health information. Their ability to actually automate and have
almost up to date information through the web in their environment of public
health metrics is actually already organic to their environment. As far as this
country goes, I do not think we felt uncomfortable because it is hard for me to
have a conversation in a board meeting that the CDC doesn’t come up.

MS. GREENBERG: I guess what I am asking is, do you recognize that that is
more limiting by saying standards for healthcare? Would you consider referring
to standards for health and healthcare or something like that? Healthcare
really doesn’t mean health.

MR. QUINN: I understand and I will take that message back to our board. We
have another board retreat this July, so we typically revisit it. So, I may be
hearing it in the next board meeting as well.

MR. REYNOLDS: To close the panel, I will make one last comment. First of
all, I want to thank everybody for exactly what we needed. One of our plans was
to start having standards be adopted faster and implemented faster because I
think it is important to remember HIPAA took a long time implement MPI, which
is kind of the easiest one. When it is done, it will be four years and four
months. You will be a target rich group for us to pull in as we do these
deliberations on how to do this better because you as others are talking about
doing more faster. We accept. You heard one time frame from WEDI. We as a group
have set forward and we felt three years – there is a difference from
parallel and maybe a more appropriate sequencing where you have a little
overlap and not necessarily a complete overlap. Your point was well made. You
only have X amount of people doing the key things. All of you have helped us
with the planning, but you have also helped us see the road map, and then we
will ask you to join us because as you mention the education and everything

May of 2008 is four years and four months and we still may not have
crosswalks right now. Those are the things that we have to figure out as an
entire group and an industry, and maybe we can help lead that on how do we
really get to everybody sooner? It is who all we get to and whether they do it.
So, thank you very much. You have given us exactly what we wanted. We covered
it within five minutes of the timeframe. I think it allows us to plan. All of
you are regular testifiers. Thank you to everyone.


Agenda Item: Subcommittee Discussion

MR. REYNOLDS: Let’s get started. I just want to touch base on a couple of
things that we have listed here. The AHIC letter, what that means in
terminology is there has been a suggestion by the AHIC members to the Secretary
that there be consideration made to having e-prescribing mandatory, possibly
around the 2010 timeframe. That has been discussed. The only reason we wanted
to bring that up here is if that were to occur, I believe we would have some
kind of involvement. We talk about process and we talk about the other things
we heard this morning on how you implement it and how you make it happen. I
think that would be a subject that if it occurs would be one that we would
probably want to weigh in on and make sure it is on the list of this group to
in fact do this. There is an actual letter that has come out about this.

The second thing is, just so we can kind of wrap this up. We heard a number
of different streamlining proposals on the whole process of HIPAA. We heard a
little bit about that this morning. We have taken that as a possible letter to
the full committee twice for approval and moving forward. We felt that we, from
good process, owed a comment back out of this subcommittee as to exactly where
we are. What we realized as we went forward was that there is a firm belief by
the testifiers or else we would not have written a draft letter in context that
there should be a way. There needs to be a way to streamline the process. As we
got to the full committee, and you had a much more diverse set of thinking
going on, there were enough questions about what does that really mean? What
does it really change? How does it really look? What does it really happen? We
never were able to quite sell ourselves through that even if we had multiple
discussions about it and wanted to go forward. We felt that we owed that to
everyone that had presented to us that it is not something that we let drift
off into the past. We truly took a forward – I felt that their input is
why this is a good committee. In context, everyone that knew the process and
understood what was going on was fine, but when you had other people who step
back from it and said, so what are you really doing? What is the real
difference? If anyone else can more eloquently say that please jump in and do
so. If not, that would be – we want to make sure we at least brought that
forward to close it.

One other thing I wanted to mention and then we can wrap up our planning.
Yesterday there was the discussion – we heard from the long-term group and
from the NCPDP and so on the idea of things they want us to move forward. So,
we felt that there were probably two letters that came out of yesterday as far
as what we need to do. We felt that we probably try to work those letters
through conference calls and other things rather than having that. Again, with
the makeup of the committee right now, again, since there may be some
significant change, we really need to close that before the May full committee
meeting so that we have all the right players in place to get that done and
make sure that letter is done. Jeff and I will be working with Denise to put
that together, and we will move forward accordingly about that.

The other question I have, based on everything we talked about and based on
the current knowledge of the committee, is there anything that we should
adjudicate prior to May that would require us or have us to have a desire to
have another meeting prior to May to close that subject since we will move
forward through letters – I am talking about face to face, making a
difference on something that we could close out. Again, starting something now
when there is going to be a change in some of the players in the committee, we
won’t be really excited when they have to drop back and figure it out again. I
want to open that to the floor as to whether or not there is anything that any
of you have heard or felt should be adjudicated at another meeting prior so
that we could take it to the full committee in May?

MS. GIBERTSON: You mentioned yesterday needing to hear testimony on the post
adjudication standard coming forward. Since that is tied into the other
standards with the HIPAA, that probably would have a timeliness as well.

MR. REYNOLDS: Denise, why don’t you make a comment on that please.

MS. BUENNING: We relayed the information last evening to the OASS, and they
are taking under consideration the information that you gave us trying to
determine where it fits in in terms of timelines and what information we need
to move forward in terms of, we know we had some survey results, but we also
needed to get more input from the industry as to the value of this and how it
will be used and the other information that we need to develop any kind of a
impact analysis.

MR. REYNOLDS: What we are going to do is we obviously need to wait in here
some more from CMS and others as to exactly how this would fit in and what
process. Yes?

DR. STEINDEL: Harry, can we presume from what Denise just said that the look
that CMS gave to this last night says it is under the purview of HIPAA? Since
you have been asking for details regarding moving on with the HIPAA process.

MS. BUENNING: Again, we got this information late yesterday, and our
analysts haven’t had a chance to really fully vet this, but the initial
impression that we have is that this is HIPAA and that it is a new transaction
and new standard.

MR. REYNOLDS: If that is the case that may be something that would generate
that. Lynn, we will make sure that we adjudicate that quickly with CMS on what
it is.

The last thing, we have had a lot of good discussion and I want to see if we
have anymore. We did a lot on the planning yesterday. We kind of hoped that
today would give us a further look at it, and I think it did. We had a lot of
discussion yesterday and had a lot of different individual items. Today, they
talked about almost the same subjects, but they crystallized a lot of them as
to why they were or were not a problem. Also, I appreciated that they made it
clear where we could play and what were some of the other subjects that we felt
we could play in and make a difference as a group. I think we are all seeing
that there are a lot of standards that are coming out. There are a lot of
committees and a lot of efforts. Is there anything that anybody heard today
that they thought was dramatically different than yesterday? I believe
everything we heard today, we will incorporate into the document that we put
together as to how we think we need to approach it and the categories we talked
about last night on what is strategic and what are things moving forward, and
what are the tactical things that we tend to have to do. Personally, I think it
will all fit together nicely. We need to sit back and look at the data a little
closer. We have a lot of great stuff today that maybe helps tell a story

MR. BLAIR: I don’t have any comments.

MR. REYNOLDS: Is there anybody else that has something they want to add or
any other comments in general? Our plan is that we will begin working on the
two letters. We figure we should be able to handle those by conference call.
Those are on the long-term care, and the second one is on some of the changes
that came through yesterday for the NCPDP. We did discuss earlier that there
was one new transaction, and that is being vetted now by CMS as to exactly
where they see that fitting in the process. If it is a part of HIPAA as it may
be indicated, then we may have to go over that and have hearings to go over
that and move that forward.

MS. GREENBERG: I am sorry, so is the letter related to the current exemption
for long-term care and there is a letter related to 10.0 or 0.1 or 0.2?

MR. REYNOLDS: Don’t worry about that.

MS. BUENNING: That would probably be covered in the same letter.

MS. GREENBERG: I would think that. What is the other letter?

MR. REYNOLDS: If you will remember, Lynn and others presented a litany of
changes and so on. Most of those would probably just be a letter from us
recommending that they be accepted. However, the other one that is a new
transaction is where we are trying to decide exactly how to do it.

DR. COHN: I guess I just I want to remind everyone that there are actually
three pieces. One was the long-term care. It actually had two pieces to it. One
was miscellaneous stuff and then there was actually some things that directly
effected the dental community. I think given that we did not hear anything from
the DSMO representative that represents the dental perspective on this one, nor
from dentistry in general, we probably need to get some way – we need to
hear something from them to make sure they are comfortable and agreeable with
the changes that were sort of brought forward.

MR. REYNOLDS: I appreciate it. We will hear soon in a final position on
whether or not the other thing Lynn brought forward fits into HIPAA and so on.
I know the recommendation is to try to move that forward before this committee
significantly changes possibly. We can put the two of them into a hearing prior
to and try to have it to the May. That is what we are doing. I am just telling
you the process that we are going through. We do not have all the answers yet,
but I am telling you the process that we are thinking through. Again, we got it
yesterday. It went to CMS last night. We are working in a 24-hour window trying
to make sure we understand exactly what fits where. They have all of the
documentation from yesterday and can help us and figure out exactly how to go
about it.

DR. STEINDEL: Given those comments, can I ask that we get enough information
to make a go/no-go decision on a meeting between now and the May full committee
meeting before the executive committee meeting next week?

MR. REYNOLDS: That would be good. I think we can do that. I do not think
there is any question.

DR. STEINDEL: I think that gives CMS a few days to get their information

MR. REYNOLDS: Okay. That is perfect. Again, we want to understand what our
charge is, but we do not want to leap ahead with our charge until we do. We are
trying to do some planning right now. We will put this document together and
make sure we get that out to everyone. We will probably use the substance of it
in next week’s executive subcommittee planning discussion as to how it should
be. Unless there is anything else, Simon?

DR. COHN: I apologize because you were probably ready to adjourn. I just
wanted to observe very briefly that I was sort of struck in the testimony
today. I was reminded about streamlining.

MR. REYNOLDS: I covered streamlining. That is why we had it on the agenda.
Absolutely, as to why we had taken it forward a couple times and where it was
and this whole approach again. Great question. I want everyone to be
comfortable. With that, I am not trying to rush it, but I don’t want to hold
anyone longer than we have business. With that, the meeting is adjourned.

[Whereupon as of 11:38 am the meeting was adjourned.]