[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

May 21, 2008

Renaissance Washington Hotel
999 9th Street
Washington, D.C.

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030

Table of Contents

P R O C E E D I N G S (9:06 a.m.)

Agenda Item: Call to Order, Welcome and Introductions of New Members

DR. COHN: Good morning everyone. I want to call this meeting to order. This
is the first day of meetings for the National Committee on Vital and Health
Statistics. The National Committee is the main public advisory committee to the
U.S. Department of Health and Human Services and National Health Information
Policy.

I’m Simon Cohn, I’m Associate Executive Director for Health Information
Policy, for Kaiser Permanente and Chair of the Committee. I want to welcome
committee members, new committee members, HHS staff, and others here in person
as well as those listening in on the Internet. I would also as always, remind
everybody to please mute their cell phones, just in case of a call, because
everybody just grabs their cell phones. I would remind everybody to speak
clearly and into the microphone.

Let’s now have introductions around the table and then around the room.
Those on the National Committee, I would ask if you have any issues, any
conflict, any conflicts of interests related to any issues coming forth today,
would you so publicly indicate during your introduction.

MR. J. SCANLON: Good morning everyone. I’m Jim Scanlon, Deputy Assistant
Secretary for Planning and Evaluation at HHS, and I’m the Executive Staff
Director for the Full Committee.

DR. WARREN: I’m Judy Warren from the University of Kansas, School of
Nursing. I’m a member of the Committee, and I have no conflicts.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention and
liaison to the Full Committee.

DR. GREEN: Larry Green, University of Colorado, member of the Committee. No
conflicts.

DR. OVERHAGE: Marc Overhage, member of the Committee Regenstrief Institute,
and Indiana Health Information Exchange.

MS. MILAM: Sally Milam. I understand I’m here on a consultant capacity, not
yet a member of the committee, soon to be one. I’m the Chief Privacy Officer
for West Virginia’s Executive Branch, and I’m also the Executive Director of
West Virginia’s Health Information Network. I’m glad to be here.

MR. LAND: I’m Garland Land with National Association for Public Health
Statistics and Information Systems, member of the Committee. No conflicts.

DR. SUAREZ: Good morning everyone. My name is Walter Suarez with the
Institute for HIPAA/HIT Education and Research and the Public Health Data
Standards Consortium. I am a new member of the committee and I am very pleased
to be here.

DR. MIDDLETON: Good morning. My name is Blackford Middleton. I’m from
Partners Healthcare in and Brigham and Women’s Hospital Harvard Medical School.
I think this is the orientation session I was supposed to be at. New member of
the committee, I guess beginning next month.

MR. HOUSTON: I’m John Houston from the University of Pittsburg Medical
Center. I’m a member of the Committee. I don’t have any conflicts, but I
believe there is a conflict between Judy and Harry over something about Kansas.

(LAUGHTER)

MS. MCCALL: I’m Carol McCall. I’m with Humana. I’m, Vice President of
Research and Development, and I head our Health Services Research Center. No
known conflicts.

MR. ROTHSTEIN: I’m Mark Rothstein from the University of Louisville School
of Medicine. I’m a member of the committee for today —

(LAUGHTER)

DR. FRANCIS: I’m Leslie Francis. I’m Professor of Philosophy and Law at the
University of Utah and a member of the Committee without I hope, conflicts.

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

DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center, member of the
Committee. No conflicts.

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

MR. REYNOLDS: Harry Reynolds with Blue Cross, Blue Shield of North Carolina.
Member of the Committee and no conflicts, but I do have to congratulate the
Kansas basketball team for winning a national championship. I have been
reminded by Judy and Denise quite heavily this morning that they do do
something in Kansas.

(LAUGHTER)

MS. GREENBERG: I’m Marjorie Greenberg from the National Center for Health
Statistics, CDC, and the Executive Secretary to the Committee. I want to
especially welcome the new members and thank you for filling out all your
paperwork so you will become members of the committee.

(Introductions around room)

DR. COHN: Well, welcome everyone and I also want to comment that I actually
have no conflicts of interest for any of these issues coming before us today,
either.

This is a time of change and transition for the National Committee. I think
as you all know when one would of course reflect with the election season upon
us, which is also a time for transition for the country as a whole which we
will reflect on today and tomorrow.

I want to thank each of you on the committee, both our current and departing
members, for your dedication, hard work, and leadership. The achievements of
the last few years at least in my view have been nothing short of spectacular.
I just wanted to reflect on them for a moment.

We are guided the HIPAA implementation, including privacy and
confidentiality. Administrative and financial transactions, and of course the
issues of moving to current standards, which I’m sure we will talk about a
little later on today. Of course the other interesting issue having to do with
identifiers, the NPI, which will also be a topic today as we continue our
discussions.

We have recommended initial e-prescribing standards that since our last
meeting have become part of Federal regulation. We should congratulate
ourselves for that. We have developed the initial vision for the Nationwide
Health Information Network and from that actually moved a step below income
specificity, identifying practical next steps that we have been able to be very
helpful with in terms of advising HHS on.

Things like functional requirements for the NHIN, finalization for
publication of our recent report on Enhanced Protections for Uses of Health
Data. The impressive set of letters of recommendations on Privacy and
Confidentiality and the developing NHIN. And of course our report on personal
health records. These are just to name a few.

We obviously have letters and reports on key population, vital statistics
and quality issues including our 21st century vision, which I know
we’ll also talk about some today, and our recent reports on quality measurement
and public reporting and promotion of a hybrid strategy. This is obviously just
to name a few areas that we have touched on and provided leadership to in the
past few years.

There is a lot to be proud of, and I want to take a moment to recognize and
celebrate the contributions of our departing members. There’s Mark Rothstein,
he and I are the only ones that are departing. We’ll comment about some of the
others.

Mark is Professor of Law and Medicine and Director of the Institute for
Bioethics Health Policy and Law at the University of Louisville School of
Medicine.

Mark with this meeting, will complete a second term on the NCVHS. Mark, we
appreciate your contribution and participating. You’ve been a very capable
chair of the Subcommittee on Privacy and Confidentiality. In addition, I think
it is noteworthy that he has played a major role in our Secondary Uses and
Enhanced Protections Report, and sat on the Executive Subcommittee. We will
certainly miss you and talk more about you this evening.

We also want to acknowledge Gene Steuerle, who is not here, though we may
see him later on today or this evening. Gene is a former Deputy Assistant
Secretary for the Treasury and now a Senior Fellow at the Urban Institute and
with this meeting, he completes his first term on the NCVHS. He has been,
obviously actively involved on the Full Committee, he has also been a member of
the Population Subcommittee.

I think we have all appreciated his helpful insights and perspectives on the
issues that have come before us and even sort of the unique insights given that
he not really a health economists – he is just an economist. We will talk
more about that this evening.

Kevin Vigilante is another retiring member. He is a principal at Booz Allen
Hamilton, and is not able to join us today. He is actually on international
travels, I understand. We want to thank him for his involvement in the
Population sub-group, Quality Work Group, the NHII Work Group, as well as his
participation on the Secondary Uses Work Group, and his input into the recent
report.

You will all be missed and we will of course, celebrate your contributions
this evening.

Before the new committee members and the committee, there’s obviously much
to be done and new challenges to face. We the committee, have guided the
initial HIPAA implementation. From my view now comes sort of the hard part
which is this issue of turning the initial standards and work into products
that really are helpful to the industry and healthcare and help actually
achieve that vision of administrative simplification.

We also have the issue of beginning to institutionalize the Change
Management Process. Obviously it is one thing to identify standards and it’s
another thing to be able to successfully update them and keep them updated in
an environment. Once again is an issue and hopefully we’ll be reflecting on
later on today.

For the NHII, we need to further flesh out the vision and continue to
provide the advice as we have been, on a variety of the NHII and NHIN issues,
going forward. For population and quality, important questions need to be
explored relating to health information needs for the 21st Century.
Especially as health reform emerges as a key issue for the next Administration
and Congress. I think we can provide some great help there.

For Privacy, there is continuing to provide thought leadership on the NHII
and the developing NHIN. These are just a few of the issues and challenges for
the NCVHS, going forward and there’ll be certainly more for the current and the
new members coming on.

With that I obviously want to spend a moment welcoming the new members. Now
they each somewhat introduced themselves, so I don’t have to go through their
CV to extensively. I do want to acknowledge the appointment of Mark Hornbrook,
who is a Senior Investigator and Senior Healthcare Economist with the Center
for Health Research for Kaiser Permanente in our Northwest region. He’s out in
Portland, Oregon. He sends his regrets that he is unable to attend today, but
will be here in September. He obviously brings a strong research and economics
background, which I think everyone may find helpful and continue deliberations.

I’m also pleased to welcome Sally Milam. I’ll get it eventually and
congratulations on your recent marriage.

(Applause.)

MS. GREENBERG: We’re like family here.

DR. COHN: She is a practicing lawyer with 17 years experience in the field.
I should comment, I looked at the mailing address and I think I mentioned to
here briefly that I actually have a history in relationship to West Virginia,
including a medical license there. I just recognized that she works above the
State Medical Bureau or across the street from it. She is very close to where I
send my check every couple of years.

(LAUGHTER)

MS. MILAM: Across the parking lot.

DR. COHN: Across the parking lot.

DR. STEINWACHS: Simon, how many licenses do you maintain?

DR. COHN: Just a couple. Blackford Middleton has introduced himself.
Blackford, obviously you bring a strong healthcare informatics expertise to the
NCVHS. We are glad to have you join. He spoke of some of his current
activities. I actually was thinking about when I first met you back in the mid
80s when you were a medical director for Information Management and Technology
at Stanford University. I’ve obviously known you for many years and we are
absolutely delighted to have your expertise on the committee.

Finally in terms of our new members, Walter, we are delighted to have you
join us. He mentioned I think some of his work and obviously you’re activity as
President and CEO at the Institute for HIPAA/HIT Education and Research. You
bring very significant expertise in HIPAA and health data standards to the
Committee and I think that will be very helpful as we move forward. Thank you
for joining and we look forward to your participation.

All the new members, at least in my view, joining an elite group. The NCVHS
is known within the federal government as one of the most productive and
hardest working Federal Advisory Committees. As you know, we all have important
day jobs. The reason we have taken on this additional responsibility is our
commitment to a better health care system and a better America. We have all had
the satisfaction of having your deliberations and recommendations make a
difference.

I also want to acknowledge the following members who will be entering their
second term. Justine Carr, who is Director of Clinical Research Management at
Beth Israel Deaconess Medical Center. She is Chair of the Quality Work Group,
which may change at the end of today. The status of the committee, and a member
of the Executive Subcommittee. She also provided exceptional leadership during
our work on the Enhanced Protections for Uses of Health Data report. We do want
to thank her.

Also, Judy Warren who is reappointed to a second term, Professor of Nursing
Informatics at the University of Kansas, and a member of our Standards
Subcommittee.

Finally, as you know, I am the outgoing Chair. After 12 years on the
Committee – Leslie has her mouth open. I don’t think she realizes how much
of a history I have here.

Leslie, just to give you a view of how long I have been around. I actually
came on the committee within three months after the passage of HIPAA and the
rechartering of the NCVHS. Obviously, I have a lot of institutional memory.
With my departure, Jeff Blair who is almost, actually I think 11 years on the
Committee, will become sort of the Dean of History when Marjorie isn’t around
and somewhat of the institutional memory.

It has obviously been a terrific experience, being here both as a Committee
member and a Chair for the last four years but I leave the Committee, I
believe, in good hands. I’m pleased to publicly announce and I think you all
know, that Harry Reynold, Vice President of Blue Cross Blue Shield in North
Carolina has been the named the new Chair of the NCVHS beginning June 1.

(Applause.)

DR. COHN: I want to point out that it is June 1st that this is
yours.

MR. REYNOLDS: That would be whatever year I decided that it is?

DR. COHN: Harry, congratulations. Thank you. I really can’t think of a
better person to take on this responsibility. It’s obviously a difficult and
demanding, but at least in my view an ultimately satisfying role. Harry will be
talking later today about some of the appointments and reorganization that will
occur with this transition. That will be a conversation this afternoon.

I also want to thank the members of the Executive Subcommittee who have been
working closely with Harry and me on this transition. I just want to take a
moment to acknowledge our skilled and dedicated staff. Obviously without their
support, none of the reports would happen. Our meetings wouldn’t even occur, so
we really do want to appreciate their dedication and skill and activity.

We also want to especially acknowledge our Executive Director and Executive
Secretary for their tireless devotion and commitment to the success of the
committee. I will also take a moment to acknowledge our liaisons and I think —
do we have any here? There is Steve, okay. I’m looking for Steve. We want to
include Steve Steindel who is here. Thank you for joining us today Steve, also
Karen Trudel, Mike Fitzmaurice, Ed Sondik, and Jorge Ferrer, who provided
advice and guidance over the years.

As the outgoing Chair, my intent was to get everyone a breather at this
meeting. However, this is not to be. As I mentioned earlier, the NCVHS is known
as one of the most productive and hardest working advisory committees, and that
seems to apply whether we are in the midst of transition or not. We have a full
meeting today and tomorrow, and actually a pretty full agenda, especially
today.

Agenda Item: Review of Agenda

DR. COHN: So let’s review the agenda and noting that there have been I think
some changes since the printing of the agenda.

This morning we begin an update and we’ll actually will be initially
starting an update from CMS and Stewart Streimer who is the director of
provider billing group from CMS, talking about probably a variety of related
issues, I would anticipate. This will be followed by an update from Jim
Scanlon, our Executive Director, on the current status of the department.

After the break, we will consider a letter from the Standards and Security
Subcommittee on e-Prescribing standards, and long term care for discussion and
possible action at this meeting. Now, I do just want to point out that we do
have a new version. I reviewed the version in your books on the way out
yesterday, and noticed that the second recommendation had a four line sentence
that I didn’t understand. It has been somehow shortened and made a lot more
intelligible and I thank Harry and Denise for the quick response to my question
about what this recommendation meant. It is on the table as opposed to in the
packet.

Then this morning, we had an update from Ron Kolodner, National Coordinator
for Health Information Technology, talking about the NHIN progress as well as
plans for AHIC successor organization.

After lunch, Justine brings forward a very interesting document for
discussions, sponsored by the Quality Workgroup, looking at the progress of the
last several years, related to health data and quality. This is followed by an
update from Betsy Humphreys on health terminologies and the activities of the
National Library of Medicine. As you will remember, this sort of follows on
from previous conversations we had last meeting, that include Christian
Copyright ICD 11 and HIMA, talking about their work and projects around health
terminologies.

At 3 p.m., we have time to talk about transition and planned changes to
committee structure. This will be led by Harry Reynolds, our incoming chair. At
4 o’clock, we will break into subcommittees, and I believe there is a meeting
of Standards and Security as well as Populations, this afternoon.

The NCVHS, as I think you all know has a committee dinner and a celebration
at Maggiano’s.

Now, tomorrow’s subcommittees and workgroups meet early in the morning with
full committee sessions beginning at about 10 a.m. We will talk more about
tomorrow’s agenda before breaking for the subcommittee sessions this afternoon.

With that, why don’t we begin with our first sessions? Now, is Stewart on
the phone?

MR. STREIMER: Yes I am. Can you hear me?

DR. COHN: Yes, Stewart. Listen, thank you so much for joining us. I have
given a brief introduction in terms of your role as being director of the
provider billing group. We are actually very pleased to have you join us, and
we’re sorry we can’t see you hear in person.

Agenda Item: CMS Update

MR. STREIMER: Thank you and I appreciate you allowing me to do this
remotely. I just want to double check that you can hear me clearly. Okay,
great. First of all, I do also remember when the committee was first
established way back when, Simon, and your induction as the head of it. I have
to tell you it sounds like you guys have a lot more fun now than you did 12
years ago, and that’s really nice to hear.

I’m also in addition to the Director of provider billings group, the CMS
coordinator for NPI implementations so I can bring some different perspectives
to my remarks. I will be speaking very quickly so we can leave some time for
some questions.

I do want to express Karen Trudel’s apology for not being able to attend but
I am happy to stand in her place to the best that I can. I do want to point out
that I do have a different role in the agency from Karen. I want to just point
out that difference because it is a very important difference. As the Deputy
Director of the Office of the e-Health Standards and Services, Karen’s
responsibility is basically overseeing the national implementations for HIPAA
for the most part, and I think today we are speaking about the National
Provider Identifiers specifically. Her role is more industry wide, national
implementation of HIPAA, as well as the enforcement arm of HIPAA standards.

My role conversely is focused on CMS’s implementation of the National
Provider Identifiers. Very different, very separate and I want to make sure
that the separation is made very clear to those listening in. What I would like
to do is give you sort of an update on where we are with NPI implementation,
hoping that everyone is aware that Friday, May 23rd, is the final
deadline for full implementation as the National Provider Identifier.

I am happy to say that for the most part, CMS is quite ready for full
implementation. I would like to go through some of our metrics and some of the
things that we have been doing to track our readiness. As I go through my
remarks, I want to point out that I will use the term providers in a very
generic sense. I don’t want to, you know, insult anybody. I just want to –
so I can get through very quickly, that when I use the word providers I
certainly mean physicians, other practitioners, ambulance companies, labs, and
all the institutional providers with whom we deal. I just wanted to make that
very clear at the outset.

As far as CMS is concerned, we have over 100 systems internal to the agency
that are ready for the NPI, whether it’s to exchange the information that
contains an NPI, or whether it’s just to receive an NPI during various parts of
the programs that we administer. I think most interest to date as you can
imagine has been with Medicare readiness for NPI. I want to speak pretty
quickly about Medicare Fee-for-Service if I may, since that has been a primary
focus but not the total focus.

On May 23rd Medicare Fee-for-Service will implement those HIPAA
transactions that require a NPI. We have as you know, implemented the
transactions themselves, but in terms of the NPI itself, all of our electronic
and paper transactions, whether it’s a claim or a remittance advice, an
eligibility inquiry, or a status inquiry almost have just the NPI on those
transaction.

As you may know, up until May 23rd we have implemented the dual
use strategy that much of the industry has adopted and that is we have been
accepting NPI or NPI Legacy payor throughout the course of the past many, many
months. Not until I guess it was January 1, 2008 did we mandate NPI or NPI
Legacy payer on all institutional claims.

On March 1, 2008, we mandated the NPI or NPI Legacy payer on all
professional claims. For the past several months, we have been operating the
Medicare program pretty much requiring the NPI on our claims. At this point in
time, we sustain the 99 percent compliance rate with Medicare claims coming in
with NPI’s and of course, I want to just emphasize, that NPI only or NPI Legacy
payers.

As we’ve been watching the compliance rate, certainly CMS has been prepared,
but we are also very concerned about the readiness of our partners. Whether
it’s the providers, whether it’s the clearinghouses, whether it’s our other
trading partners, commercial and Medicaid state agencies. We’ve have been
monitoring that very closely. We also have been having regular calls with
industries. We have been through over telephone with the AMA, the MGMA, the
HBMA, I’m hoping you know what all the acronyms stand for. We also have
periodic calls with other industry representatives just to basically exchange
information, let those folks know where we are and get information from them in
terms of what their hearing from their constituents.

We are being very aggressive in doing that. we are being very aggressive in
terms of reaching out to the healthcare industry to make sure that they
understand what our expectations are for May 23rd so that there will
be no surprises. You may also know that we, or may not, that we have daily
calls with our Medicare contractors. The Medicare contractors are the ones who
are at the frontline and get all of the calls or most of the calls from the
provider industry and have the largest interaction with the provider industry.
We have daily calls with them to find out exactly what is going on, what they
are experiencing in terms of the prior day claims submissions, what they are
hearing in terms of their call volumes, what their providers are saying, and we
exchange information everyday along those lines. We will continue those calls
for several weeks following the May 23rd deadline.

The next milestone as I mentioned, will be Friday, at which time we will
accept NPI only. I wanted you to all know if you don’t know this, that on April
7th, we actually started issuing our remittance licenses with NPI
only. We are pretty much at 100 percent compliance in terms of remittance
advices. At this point in time, we have not heard many concerns in regard to
our use of NPI only on Medicare remittances advices but I will be certainly be
open to hearing any concerns you may have heard.

At this point in time, here we are two days away and we are like I said,
tracking numerous metrics in terms of CMS and provider readiness in terms of
NPI only. We have seen great progress in terms of the growth of claims with NPI
only. We had been concerned with I guess maybe at the end of April, where the
numbers seemed to sort of stabilize in terms of NPI claims and we were
wondering and confirmed whether it was due to clearinghouses, and the
clearinghouses actually being the avenue for sending most Medicare claims to
the program. Sixty to 80 percent of the Medicare claims come in through
clearinghouses or billing services. That is a real key statistic for us,
because what we have learned is that most providers that use clearinghouses at
the provider level are able to submit claims to their clearinghouses one way,
or they choose to send it one way so they don’t have to program their systems
differently.

A provider may say, okay, not all of my plans or payers are ready, so I am
going to submit NPI Legacy payers to my clearinghouse and count on them to make
sure that on May 23rd they send to my various plans whatever they
need to process my claims. They program their systems one way and generally
with NPI Legacy payers. We have spoken to a lot of providers about this and we
have confirmed that assumption and we have also talked to the clearinghouse
industry.

We actually have been working very closely with the Healthcare Information
and Management System Society which represents clearinghouses across the
country. As a result of what we were hearing in collaboration with HIMSS, we
set up on May 7th, what we called Legacy free day. For one day only,
we asked those clearinghouses that handled Medicare claims if they could strip
off legacy numbers from those claims that are coming in with NPI legacy payers.

Not all clearinghouses were able to participate, and quite frankly we don’t
know how many were able to participate. But through HIMSS and through their
messaging to their memberships, they got that word out and on May
7th what we experienced was a very positive outcome in support of
NPI only on May 23rd. We saw a tremendous number of spikes all
across the country for NPI only. We saw some contractors reporting as high as
75 percent – 80 percent of their claims coming in on May 7th with
NPI only.

That wasn’t to be unexpected. Clearly we were expecting spikes and we were
glad to see that. More importantly, there were two metrics that we were looking
at very closely. One was the number of claims that were coming in that were
rejected at the front end. That would have been an indication to us that a lot
of those NPI only claims couldn’t be found on the Medicare NPI Crosswalk. Had
that been the case, we would have been very concerned with the Crosswalks
capability of handling the workload on May 23rd.

Fortunately, we had very few rejections across the country. In fact, our
rejection rates on May 7th actually declined somewhat from the prior
days and weeks. We were very happy to see that the claims were coming in and
the NPI was on the claim or being found on the Medicare NPI Crosswalk. I
emphasize Medicare NPI Crosswalk because I read a number of articles, and a
number of press articles, where there seems to be some misunderstanding that
there is one National Crosswalk that is being used by health plans across the
country. I just want to make sure that folks understand that that is not the
case. Medicare Fee-for-Service has its own NPI Crosswalk that we use just for
Medicare Fee-for-Service.

The other statistic that I wanted to mention that was very encouraging is
the number of suspensions we saw as a result of NPI only claims coming in on
May 7th. The number of suspensions were relatively few as well.
There were a couple of spikes in very few places across the country. What a
suspended claim means, for those of you who are practicing physicians you may
have seen some of these, a claim would come in with an NPI only Crosswalk and
we have some systems logic that will take the NPI and the information on a
claim and try to match that NPI to exactly one Legacy number on the Crosswalk.

In many cases you would get one NPI to multiple Legacy numbers because as we
all know over the course of time especially Medicare Fee-for-Service, providers
were assigned various pins or Legacy numbers depending upon their various
practice locations. It was very important for us to be able to Crosswalk the
incoming NPI and claim to the precise legacy number to be used for processing
that claim, internal to our systems.

We did like I say, have logic that would take the NPI, go to the Crosswalk,
identify the multiple pins or legacy numbers that may exist, and then use other
information on the claim. For example, the service location on the claim but
there are quite a few criteria that we use to narrow down the exact legacy
number for that NPI and for that claim. If per chance we couldn’t narrow it
down, we call this a one to many situation, you may have heard that expression.
We would suspend the claim, and send a letter or have the contractor call the
provider to nail down the exact legacy number to use for processing that claim.

Clearly that is a workload for providers, that is a workload for the
Medicare contractors, and that is a workload we are very concerned about. Just
getting back to our legacy free day on May 7th, I’m happy to report
that the number of suspensions were relatively small compared to the volume of
claims coming in. That was another piece of encouraging news that allowed us to
feel more comfortable about May 23rd rapidly approaching.

Another piece of information I would like to share with you is that during
that week, over eight million claims with NPI only came into the Medicare
program from all over the country. That is not an insignificant number to look
at and see that the majority of those claims were processed and paid
successfully. With that said, I am actually very optimistic about May
23rd, and what will happen. I’m cautiously optimistic, if I may but
I am optimistic that the majority of Medicare claims will go through process
and paid correctly.

Having said that, I don’t want to underestimate the concerns that we do have
and we share with many providers across the country whether it’s a solo
practitioner or a large hospital system, who do still have some difficulties in
terms of making sure that their NPI matches the enrollment information that
Medicare retains in its systems.

We do know that there are some concerns out there. We are actually doing a
lot of casework, one on one across the country both here in central office, in
our regional offices, and through our contractors, to try and address these
questions and fix whatever we can before May 23rd.

Some of the things we are doing I wanted to mention very briefly. We have
established NPI coordination teams that every single contractor site, should a
provider problem arise we can address those problems as quickly as possible and
we are prioritizing those issues.

We are having the contractors you know address their resources a bit so they
can put more towards enrollment backlogs that exist in some places. We
understand that these enrollment applications that are pending for NPI
corrections are diminishing greatly and we are confident that most will be
resolved by May 23rd in terms of the backlogs of enrollment
corrections. We are diverting resources of contractors to help staff up the
phone lines in case questions are coming in. We have issued guidance to the
Medicare contractors so that they may expedite their review and processing of
enrollment applications. As I mentioned, we do have daily calls with the
contractors to continue to get their progress and insights.

The last thing that I wanted to mention is that while I have been focusing
on the Medicare Fee-for-Service, we also are very much involved with other
payors across the country. We, most Medicare beneficiaries have supplemental
insurance. We have over 550 commercial insures with which we have crossover
claims. We have trading partners agreement with them, so we are very concerned
about our ability to electronically cross over claims with NPI only. We are
being told by these commercial insures that they will be ready. All but one of
these commercial insurers have reported to us that they will be ready to accept
our NPI only crossover transactions on May 23rd. The one that won’t
be ready is a very, very small health plan.

As far as the Medicaid State Agencies, all but a handful report to us that
they will be ready. We have gone out very recently with a letter to the State
Agencies asking for their contingency plans and what they are doing to ensure
that patient access continues, and their reporting back to us that we don’t
have all of the results yet, but they do have contingency plans in place to pay
for the secondary claims.

Unfortunately, some of these contingency plans are maybe somewhat difficult
for the providers, in some cases they may have to submit claims on paper
separately to their Medicaid State Agency. Fortunately, that’s not like I said,
pervasive across the country, but in a couple of states, that’s what will
happen. Other states have their own plans in terms of how they are working with
providers to make sure they get their claims paid, and get paid promptly.

With that, I know I spoke very quickly. I did want to get all that in before
my time was up which is in ten minutes. I wanted to give you the opportunity to
ask any questions that you may have. With that, I am going to turn it back to
you. Okay, Simon?

DR. COHN: Yes, and Stewart, thank you very much for the sort of the clear
and obviously extensive outreach you are doing on all of this stuff. I actually
want to start with a question, and I think I’ll let Harry and I’m sure,
probably has other questions but, just to clarify the scope of the, I guess of
the rule as of May 23rd.

My understanding obviously is that CMS as a payer has the right to end
contingency. My understanding also is that private payers at their discretion
continue to accept this sort of double in maintaining both the legacy and the
new NPI as they choose. I guess I was a little more confused by your comments
about State Medicaid Agencies, and others. Are they also being held to the CMS
requirements or do they have some discretion based on their capabilities and
competency?

MR. STREIMER: It’s unfortunate that Karen is not here. What I can say is
that at this point in time, and I even had this conversation as recently as
yesterday with Tony Trankel(?) who is the Director of LESS and is responsible
for monitoring and enforcement of the nation.

We are on target for national implementation on May 23rd, and all
covered entities named in the statute are required to come into compliance on
May 23rd. I think Tony or Karen can speak more eloquently in terms
of the enforcement aspect of it, but I think most people know that the
enforcement provisions of HIPAA will be grounded in a complaint driven process.
Whereby, of course, if a provider or a clearinghouse or a health plan is
dissatisfied with one of their trading partners, they have the option to file a
complaint with the agency.

I can’t really speak much more to that. I was speaking more to the fact that
sort of as far as Medicare’s readiness is concerned, you know. Just because
Medicare’s Fee-for-Service itself is ready, does not mean that we don’t have
substantial impact on other health plan, clearinghouses, and providers,
especially those whom we cross over claims. That was my point of mentioning of
Medicaid and other commercial plans.

They are ready to take, for the most part our NPI only claims. How they deal
with the rest of their provider base is a question that I can’t answer but
hopefully they will be able to answer. I think Medicaid is a good example. The
Medicaid receives claims from providers which are not covered under HIPAA. How
they deal with them is I’m sure an important concern and I can’t answer because
each state could be handling that very differently.

MR. REYNOLDS: Stewart, thank you. I have been part of HIPAA ever since it
came out. The transition that CMS has gone through as a leader in making this
happen has been absolutely monumental from my standpoint. When it started I
think you struggled–

MR. STREIMER: Well, thank you. I appreciate that.

MR. REYNOLDS: You struggled some to be understand what visibility was, and
now you’re making daily calls and weekly calls and you are available, and I
think more importantly, the fact that you stood by the May 23rd,
2008 I think is also important. As we move into this next realm of 5010, ICD 10
attachments and other things, people realizing that the dates really are
important, the dates really do mean something and I do agree with the idea that
most of the issues are dealt with when people complain. Having been on the side
of one of those complaints a few times, I think you guys do that process quite
well and nicely to. I commend you for that.

Thanks from the standpoint, as Simon mentioned earlier as we try to get to
administrative simplification, some kind of structure and order is really key,
and I think that CMS has really changed their focus on making sure that that
structure is there, it means something and the dates are important and people
are going to have to line up to those dates. I commend you for that.

MR. STREIMER: Thank you.

DR. COHN: Other questions or comments? Walter, please.

DR. SUAREZ: Thank you. I really appreciate it. Being a new member of the
committee, and jumping into– it’s a little scary to tell the truth.

(Laughter)

I could not let this pass. Having been involved in the NPI since before the
NPI existed, and having worked on the NPI for the last three intense years as
one of the Chair’s of WEDI National Implementation Workgroup, I have to bring
in some additional perspectives if you don’t mind.

Stuart I want to say also that I have nothing but praise to the amount of
work that CMS both the regulatory side as well as certainly the Medicare
operations side, has done in preparing for this.

I think a lot of people have actually argued that the May 23rd
might be known as the second or the next Y2K, which has two connotations. One
is nothing might happen, like nothing happened really with Y2K, or this might
be the real Y2K.

(Laughter)

The reality is I think one of the realities, maybe there’s more than one
certainly, is that there are a lot more complexities in the implementation of
this transition. I think you referred to Stuart, that as NPI-only
transactions– and I think it’s important to distinguish within each of the
transactions the fact that there are what is known as primary providers in the
transactions and secondary providers in the transactions.

What is being seen more and more is that indeed the primary providers in the
transactions are showing up with an NPI-only. Where a lot of the problems are
happening, which could, and in many cases according to the HIPAA regulations,
would require a suspension of the claim, or a rejection of the claim for not
being compliant.

The secondary provider in a transaction, and the secondary provider, to give
you an example, is in an A37 professional claim, you know the traditional
professional healthcare claim, would be a referring provider, a person that
would refer a patient to another provider.

The requirement is that the NPI be the one used to identify that referring
provider, and the NPI be the only number to be used to identify that referring
provider.

Whereas the primary provider in this claim which is the rendering provider,
could be and certainly is more and more being identified with a unique ID, with
the NPI itself and only the NPI.

The secondary provider is not near that. Most if not a very large number of
transactions are still lacking the NPI-only on the secondary providers, which
again would cause the transaction to be dropped.

There is that first distinction. I think the industry overall has seen and
also raised the concern that there is really a major gap between the fact that
today, over 90 percent of the transactions might be NPI plus Legacy – a dual
transaction. Whereas, less than, in some latest surveys, 15 percent of the
transactions are NPI-only. You can see a major gap, and it has been sort of
documented over the last three or four months that, you know, rapidly the
industry adopted a dual use of the NPI plus Legacy, and rapidly the
transactions ramped up. But then the transition from the NPI plus Legacy to the
NPI-only really saw, or has seen, a very low adoption, and so we are at the
verge of this transition two days before the final deadline.

In many cases there is only a fraction of transactions that have the
NPI-only, which creates a major problem.

The third issue I wanted to raise is certainly we’re talking of one of the
six transactions that require the use of the NPI. Two basically, claims and
claims payment. There are other transactions eligibility referrals which have
even less of an adoption of NPI-only. That’s the kind of places where we might
see a lot of problems, starting May 24th.

The very last item, very quickly, is I think the issue that we have faced
with NPI is an unfortunate issue of what I’m calling, a customized enumeration
done by providers because in order for them to make sure that they will not be
challenged by payers, and payers will not be necessarily rejecting their claims
because they don’t enumerate their providers– their providers choose not to
enumerate the way the pay had enumerated them. Many providers have seen the
need to enumerate customize their enumeration — their NPI enumeration, based
on different payers.

What we’re seeing is, rather than a single unique NPI ID, identifying one
provider, we’re seeing providers actually having to get more than one NPI to
accommodate for the expectations that payers have. I just want to raise those
four points. Thank you.

DR COHN: Stewart, how long do we have you for now?

MR. STREIMER: Well I was actually handed a note that my ten o’clock is now
ten fifteen.

Dr. COHN: Oh good. Okay.

Mr. STREIMER: I’m going to try to walk through these if everybody would like
me to. I can try to talk to some of these issues from a Medicare perspective,
and maybe a broader perspective.

The first you raised had to do with the secondary identifier. I share that
concern about its use nationwide. In Medicare, per se, the secondary identifier
is often required as part of our payment policy.

For example, as you made the point of the referring ordering physician being
required on a number of Medicare claims. Certainly lab claims require that.

We actually are very sensitive to the fact that some referring ordering
providers may not have NPIs because they are not HIPAA covered entities for one
reason or another.

We have built in, at least in Medicare, a way so that any billing provider
can submit an NPI in that secondary field. That is, our guidance says, that to
the extent possible if a secondary identifier is required, the billing provider
must try to seek out that secondary provider’s NPI. The NPI registry is
available. They can pick up the phone and call the provider.

We certainly know that there could be some circumstances where even after
all of that, they cannot guess an NPI for that secondary provider. uq

We have implemented a temporary measure that will allow a billing provider
to use his or her own NPI in that field. We’ve issued that instruction so that
anybody who bills Medicare can fill out that field without a problem.

As far as Medicare is concerned, I think we should be okay. If a claim is
rejected because a secondary field does not have an NPI in it when it should,
it should be a quick fix for the billing providers so they don’t have to wait
too long to resubmit their claim. They can resubmit their claim virtually
immediately.

There is also a frequently asked question that I think is posted on the CMS
website that gets at this issue and provides some flexibility that I would turn
your attention to. You might want to take a look at that. It deals with– it
actually came up with regard to the Part D program, where sometimes billing
pharmacies are unable to get a prescriber’s NPI.

There is an FAQ out there that provides some flexibility, but it is payer
dependent. If the payer allows some flexibility, I think it would be allowed.
If the payer does not allow flexibility, then it’s up to the payer to enforce
that. In Medicare’s case we are enforcing that and NPI-only must exist in those
fields.

Your comment about low NPI-only compliance is a concern. Your analogy to Y2K
is on point because we have learned, as I have mentioned earlier, that most, at
least with Medicare, most of our claims come in through clearing houses. As
providers continue to deploy the dual use strategy, which is being encouraged
across the industry, one would expect a low NPI-only rate.

One would expect that until May 23rd when the switches flip that
clearinghouses and they send on to payers NPI-only claims.

The only option that I would have seen is that if other payers across the
country would have done what we have done, and that is have some sort of Legacy
Free Day, where they could ask the clearinghouses to strip legacy numbers to
see what would happen.

I am very concerned about relatively low NPI-only claim rates but to me
that’s not an indication of providers not being ready, as much as it is an
indication of how providers use billing services and clearinghouses. They were
really left with no choice which is unfortunate.

Since they often deal with tens if not hundreds of payers, they really only
have a choice of sending NPI/legacy payers to their clearinghouses.
Clearinghouses have been telling us that they send on to the plans, what they
get from the providers. It’s not until May 23rd that they would
strip legacy numbers to be in compliance with HIPAA.

I am concerned again about the low NPI-only rate, but I think that is a
product of the system we have in working through clearinghouses.

I too am very much aware as I mentioned earlier, about other transactions
besides the claims, as I mentioned the remittance advice, CMS is pretty much
one hundred percent in compliance as of April seventh.

I am told that 74 percent of our eligibility inquiries are NPI-only, which
is a very encouraging statistic. I don’t have data on our claim status
inquiries, but I understand that they are very low, in terms of what comes into
Medicare because most providers use our telephone system for claim status
inquiries.

That’s not to diminish what may be going on elsewhere around the industry,
but I think if we step back and look at the millions of providers that we have,
and the thousands of other trading partners, whether it’s clearing houses or
plans that we have, there will be issues. I don’t think we’re saying there
won’t be issues.

We’re just looking to the industry to resolve those issues. Health plans
have to be working closely with their providers to make sure cash flow
continues and what needs to be done is done, to not only be in compliant with
HIPAA, but to facilitate their providers readiness and to make sure that that
cash flow continues.

The last thing you mentioned is customized enumeration. Yes. We’ve seen that
in Medicare as well as elsewhere. You may recall, it may have been back in
January, I don’t remember the exact point in time. Even Medicare posted
something on our website that was encouraging. For example institutional
providers with subparts, to enumerate those subparts to make sure that claims
got processed correctly.

That is unfortunate that there are some places where we have to have
customized enumeration. Clearly the goal of HIPAA was to have one NPI that
would be used by a provider for all its practice locations, for all its
subparts, for all its lines of business, and you know, that didn’t quite
happen.

For the most part, what we’re seeing in Medicare, there is a tremendous
reduction in the number of legacy numbers that will be used. Clearly when a
provider joins the program, and whether they have subparts, or whether they
have fifteen practice locations, the NPI has gone very far at this point in
time to reduce the number of legacy numbers that those providers had to use.

I agree that customized enumeration exists, it’s unfortunate in some cases,
but I think we’re a lot better off than we were prior to deploying the NPI.

DR. COHN: Okay, Leslie?

DR. FRANCIS: This may be a question from complete ignorance, but I would at
least like reassurance that there is some kind of data monitoring in place if
there’s a risk that certain groups of patients are likely to be disadvantaged
by the fact that their physicians have trouble getting reimbursed, or that
their providers have trouble getting reimbursed. I’m particularly worried, say,
about dual eligibles? I don’t know if that’s a risk but–

MR. STREIMER: Well, I think that’s one of the primary concerns we have, and
that is to make sure that deployment of the NPI does not adversely affect
patient access to care. We have not heard that providers are threatening to
deny access, which is good of course.

In many cases providers continue to see patients even if difficulty exists,
they are either holding their claims, until such time as issues are resolved,
or they’re sending their claims in, learning what specific issues are, and then
resolving them.

I will say this, we are watching the metrics everyday, contractor calls
everyday, and we have contingencies in place. We are not unprepared for
whatever may happen on May 23rd to take immediate action, to make
sure that Medicare continues to see patients, and process and pay claims. We do
have contingencies in place at the local level, at each contractor.

We are ready for May 23rd, we are cautiously optimistic that the
majority of claims will get processed and paid correctly. We are also well
prepared to take whatever steps might need to be taken if things don’t play out
as positively as we think they will.

DR. COHN: Well Stewart, thank you very much for the update. Obviously, as
you know the committee– and I’m sure that you are going to hear lots of
concerns. I am delighted obviously, that you’re monitoring this as closely as
you are.

I would I think, also ask the Subcommittee on Standards, which our Chair
also Chair’s, since they will meet this afternoon, to sort of ponder this as
well as obviously letters we have received from the industry about this, just
to see if there’s anything we need to be doing at this point. Clearly we
realize you are in a very advanced state of implementation.

I think our biggest concern is obviously this issue, which I think you’re
doing, which is close monitoring, being aware of all the vulnerabilities, and
being prepared to take quick action as needed. That’s obviously the most
important piece. We will obviously talk about it later on today.

Thank you very much. We really appreciate your participation. Sorry we can’t
see you in person, and hopefully we’ll connect over the next while.

MR. STREIMER: Well thank you very much. I wish the committee, and its new
members, and the departing members a lot of luck. Simon you’ve been a wonderful
Chair of this group, and I’m sure your presence will be missed.

I will be available. Karen will be available for future meetings if you
would like further updates. Again I appreciate the opportunity to present to
you, and I appreciate your willingness to allow me to do it from my desk.

Thank you everybody. Have a great rest of meeting.

DR. COHN: Okay. Stewart, thank you.

MR. STREIMER: Sure, bye-bye.

DR. COHN: I realize we’re running a little bit behind schedule, and this
morning is going to be pretty packed. As the day moves on we’ll obviously make
adjustments as we go.

What we’ll do is have the HHS update from Jim which will be a little bit
abbreviated. We will take a break and then hopefully have some conversations
about that letter, which may also continue into the afternoon. Jim?

Agenda Item: Department Update – Data Council

MR. J. SCANLON: Thank you Simon and good morning everyone. Let me again
welcome all of the new members, and thank you for your willingness to serve,
and of course to thank again all of the current members and the retiring
members for a wonderful service.

I think as Simon said, I think Stewart and Marjorie and I were present at
the reincarnation when the old NCVHS was expanded to include a much broader
function. This was 1995 or 1996 I guess. We were teenagers obviously at the
time but the leadership of HHS asked us to take advantage of what we’re seeing
as the opportunities and Health IT, and of course HIPAA was enacted at that
point as well, to really kind of make the committee into a mechanism which we
would get the best advice from the public, and from the public health and
research community, and from the industry itself.

We started then– Simon I think you were actually a member of the original
class and Mark joined in a few years later.

I think everyone agrees that this has worked actually tremendously, and the
committee, as everyone has said, is well known in HHS leadership for very
thoughtful, nauance, recommendations, substantive reports, and we have hundreds
of advisory committees.

I don’t think any of the committees can match the NCVHS in terms of
substance, productivity, and giving us recommendations where there usually is a
client to listen, and there’s some thoughtful recommendations which we can act
on.

It’s not unusual for us to get recommendations from advisory committees
where basically it says HHS should do everything and pay for everything. While
we do many of those, we can’t always act on that.

Again, the committee has been a tremendous asset to HHS. I hope it’s been an
asset the industry and the public health and research community as well. We
look forward to another 50 years– 60 years actually, for the committee.

I am going to abbreviate my report, I wanted to give a sort of an overview
of a couple of things. As Simon said, the thing here is change and looking
forward.

I wanted to give you a brief report on what we see as potential developments
in Congress. I’m going to go through some overall HHS policy issues which I’ve
briefed you on before, just to remind you and a little bit about the HHS
strategic plan.

Then there some initiatives which the department has put into place. Many of
which this committee provided intellectual fire power and ideas about how to
get these underway. Again it shows the progress we’re making, and it also shows
how difficult making progress on some of these areas is.

Before I do, Simon, if I may take the opportunity, since you and Mark are
here, the Secretary has given you, this is not a monetary award–

(Laughter)

–but the Secretary has written letters of appreciation to the four members
who are retiring, and two of them who are here. Let me start with Mark.

Dear Dr. Rothstein, It gives me great pleasure to award you this Certificate
of Appreciation for your eight years of service to the Department of Health and
Human Services, of a member of the National Committee on Vital and Health
Statistics.

The Committee is one of the oldest and most prestigious advisory groups
serving the department. Its recommendations have helped shape healthcare,
health data standards and epidemiology for our nation, and have had a
significant impact on national health information policy.

Your knowledge, leadership, and expertise have contributed greatly to the
excellent work of the Committee. We wish to commend you particularly for the
time, effort, leadership, and counsel you have provided. And I am going to list
the various roles you played.

As the Chairman of the Privacy and Confidentiality Subcommittee, member of
the Executive Committee, and of the Ad Hoc Work Group on Secondary Uses. There
are probably additional roles as well.

The Secretary concludes, only the very best are asked to serve, and we are
proud to have had the opportunity to associate with you in this endeavor.
Should the occasion arise, we would like to call upon you for additional
advice.

(Laughter)

MR. ROTHSTEIN: I think Marjorie had it that way.

(Applause)

MS. GREENBERG: I should note that Barbara Starfield, who was one of the
longest serving members, until Simon beat everyone’s record– Simon and Jeff.
She did testify yesterday to the Populations Subcommittee, and I noted there is
no such real thing as retirement from thie Committee.

(Laughter)

MR. J. SCANLON: No that’s true. That’s true. Simon, a similar letter. Your
certificate was even longer – it went up to two pages.

(Laughter)

I think we have had very few members who have been able to serve three full
terms. In fact you may be the only one the Secretary made an exception, for the
last round to ask Simon to continue as Chair, so we’re very pleased.

Dear Dr. Cohn, It gives me great pleasure to award you this certificate of
appreciation for your 12 years of service to The Department of Health and Human
Services as a member of the National Committee on Vital and Health Statistics.

I won’t repeat the idea about the Committee as the oldest and prestigious,
in terms of its influence and impact on health information, policy, and
privacy.

Let me go right to the part of the letter where your leadership, expertise,
and experience have contributed greatly to the excellent work of the committee.

I wish to commend you particularly for the time, effort, leadership, and
counsel you provided as the Chair of the Committee, the Chairperson of the
Executive Committee, Chairperson of the NHIN Ad Hoc Work Group, Co-Chair for
the Standards Subcommittee, Chairperson for the Ad Hoc Work Group on Secondary
Uses, and Chairperson of the NHI Work Group, and a member of the Privacy and
Confidentiality Subcommittee.

Again, only the very best are asked to serve and we are proud to have had
the opportunity to associate with you in this endeavor. Should the occasion
arise we would like to feel free to call upon you for further assistance.
Sincerely, Michael Leavitt, Secretary of the Health and Human Services.

(Applause)

Oh, Gene’s here. For Eugene Steurle.

Dear Dr. Steurle, Again it gives me pleasure to award you this Certificate
of Appreciation for your four years of service to the Department of Health and
Human Services as a member of the National Committee on Vital and Health
Statistics. The Committee is one of the oldest and most prestigious advisory
group serving HHS, and its recommendations have helped shape health statistics,
data standards, public health for our nation, and have had a significant impact
on national health information policy.

Your knowledge, expertise, and experience, have contributed greatly to the
excellent work of the Committee. We wish to commend you specifically for the
time, effort, leadership, counsel and advice you’ve provided as a member of the
Populations Subcommittee.

Only the very best are asked to serve, and we are proud to have had the
opportunity to associate with you in this endeavor. Again should the occasion
arise, we would like to feel free to call upon you for further assistance.
Sincerely, Michael Leavitt, Secretary of Health and Human Services.

(Applause)

Okay. Simon, let me take about five to ten minutes to update. Again there’s
a lot of activities underway, some of them dealing with transition and change.

Let me start — I think you have copies of the HHS policy priority areas.
There are nine of them in your briefing book, and I’ve talked about these
before.

The only thing I would add is virtually all of them involve reliance on
health information technology, and on the data and so on to help them move
forward.

I would add that there is a great deal of focus as well now, on drug safety
and food safety relating to the activities of the FDA, as another priority
area.

I won’t go through those, but we’ve discussed those before. I might also
take the opportunity to– HHS actually received some credit for the HHS
Strategic Plan. I think we’ve talked about this before. There are overall
goals, a number of objectives, and virtually every one of them rely on health
information technology.

Some of the objectives actually include progress on health information
technology to support public health as well as healthcare quality and
transparency.

Actually, HHS moved up from what had previously been 19th – we
moved up 19 places among all federal agencies counting one of the biggest
improvements with the strategic plan.

We are now ranked number five out of all of the federal agencies. These are
rankings from organizations that look at strategic plans in terms of
transparency, public benefit, readability, and outcomes in accountability and
so on.

This is about the highest or the best that HHS has ever done. It’s not
completing the strategic plan, or the outcome but it is the rating is on the
quality of the planning process than the plan itself, but we’ll take credit for
that.

Let me turn quickly to some potential developments on the Hill, and I think
all of you are following these.

There is again interest on the Hill and several health IT bills in the
Senate. There is a current version of the Wired for Health Care Act, which
actually looks like it may, at least according to public reports, it may
actually get some legs and possibly move.

Though again I caution, no one is going to make any money betting on, or
making predictions about what’s going to happen this year particularly on the
Hill.

The Wired for Health Care Act, you’ll remember, would codify The Office of
the National Court Order For Health IT, it would codify some form of an AHIC in
a partnership kind of an arrangement.

There is possibly inclusion of grant and loan programs, and initially
remember, there were some privacy concerns that held up progress. Apparently
now, there are some public service announcements, from Senator Leahy has
offered some improvements to be considered that may find a way to move this
forward.

We’ll follow this and we’ll see what happens. There is a great deal of
interest, bipartisan interest really, in moving along health IT and on the
privacy side as well.

Later today, we’ll hear a report from Rob Kolodner the Head of The Office of
the National Coordinator. There too, a transition is in the works.

HHS has awarded a cooperative agreement to basically create an AHIC
successor organization. A number of work groups have been formed. Several of
you are on those work groups. The timeline is such that on June 4th at a public
meeting, the reports of the work groups in terms of what the options are, for
an AHIC successor organization will be presented.

The concept here is that the AHIC, you’ll remember, is a FACA like this
Committee. The intent was to create more of a public private partnership.
Probably some sort of a corporation that would include the public and private
participants to carry forward the work that was initiated within the AHIC.

There are a number of proposals that will be coming forward then. We awarded
this cooperative agreement to the Brookings Institution and a contractor LMI,
and the work is proceeding. It’s at a fairly rapid pace. The goal is to have
the recommendations from all of the various work groups come forward at the
June 4th meeting.

The idea would be, next to set up the organization. It is in envisioned as a
membership organization. There would be a board of directors, obviously, there
would be a staff and executives, and then there would be a membership. The
membership process is being thought about now.

The ideas that the AHIC success organization would carry forward, not all,
but some of the activities that the AHIC want is underway. Focus on some core
activities for moving forward.

It’s thought that after the organization is formed, and it’s moving along,
then they could look at other possibilities, and other activities that they may
want to undertake.

Again, this would affect many of you. Many of you probably would end up
being members, or otherwise participating as you have participated in the work
groups now. Rob will give you more of a detail there as well.

On the budget, I wish I could be more optimistic, but we are two thirds of
the way through our 2008 fiscal year, and we did reasonably well on Health IT,
and on some of the population data and health statistics programs.

The President’s budget for 2009 actually has some increases in these areas,
particularly for The National Center for Health Statistics. I think we were
requesting an $11 million increase. Hopefully that will all play out, but I
think we’re a little uncertain what will happen now in the fiscal year 2009.

Hopefully our request will be met and we’ll be able to move forward. The
idea was to at least protect our basic health data, public health data, health
statistics programs, and hopefully provide a little bit of growth where we
could, so we can get everything on a stable footing.

Again, the budget process is such that we won’t really know what the 2009
budget will bring, which is October 1st.

We won’t know for awhile longer. We have to do some contingency planning
within our statistics programs and data programs. As you remember, many of our
statistics activities have long lead times. You can’t change these all that
easily.

The 2010 budget will be the next precedence budget. The planning activity
there will probably take place in the fall, in terms of what the new policy
budget will be.

There are a couple of projects I wanted to mention too, quickly. I think I
mentioned to you briefly, and it’s certainly moving along well now. The
Medicare EHR Ambulatory Care Demonstration Project is moving along. This is a
vision that’s a five year demo for about 1200 small to medium size physician
practices, in 12 communities across the country. There would be a comparison
control group as well, and the focus would be on demonstrating and hopefully
evaluating how it is done and what the outcomes may be.

My office, the Office of Planning and Evaluation is sponsoring the
evaluation part of this, and we have an evaluation contract in place. I’m
pleased to say that we have received about 33 applications from community
partners. These would be organizations and communities, that would sort of be
willing to organize the physician practices in that area, to participate in the
demo.

I think next month probably we’ll be announcing this selection of 12 of
them. Four of them will then begin in the fall with the actual implementation
of the demo, and then the other eight would be later.

A lot of the ideas here, would have to be certified EHRs. There would have
to be other conditions met. There is a fairly structured evaluation part of
this, so we can see exactly what’s happening, and we can learn from it.

Usually on these kinds of demos, the first year is where you learn the most
and then you move along.

Similarly in the PHR area, there are a couple of demonstrations and
evaluations. Our office is working with the Medicare. One of them deals with an
evaluation of an electronic personal health record – the broad – the
majority of Medicare beneficiaries for in the fee for service program. The PHR
has been — the contractor is conducting outreach. I think we have about 500
folks, Medicare enrollees in the state of South Carolina participating.

We’ll be evaluating how this works. How do people use it, how do clinicians
use it, what’s the usability, and so on. On the managed care side, we have
another evaluation of several health plans and PHRs. Again, these are the kinds
of ideas that the committee advanced in concept and in specifics.

We have also done an analysis of Health IT workforce needs which we would
probably want to brief the committee on at some point in the future.

As we look ahead– let me mention one other-— we’ve also started an
evaluation of Health IT, EHRs and health information exchange and the safety
net basically, largely focusing on community health centers and the networks in
which they participate. That’s going along very nicely as well.

We are also looking at, in the spirit of transition, and so on, some of the
capabilities we have with an HHS for policy research and health statistics and
data, including our modeling capabilities. Let me stop there and answer
questions.

DR. MIDDLETON: I guess my first question Simon, is how many naïve and
silly questions am I allowed?

(Laughter)

Jim, I’m very interested actually, in the EMR demo and the PHR demo
activities. I wonder if the committee has considered, or what our role would
be, in consideration or reviewing guidance on specifically the IT performance
measures.

Clearly there’s a lot of interest on how to measure the implementation of
IT, not only structurally, but also perhaps measuring its effective use, and of
course assessing the use on outcomes and the like.

Certainly other activities are underway across the country. The NQF
Structural Measures Committee – I happen to Co-chair, has been thinking about
this. Clearly there’s a set of activities about IT measurement. I wonder if you
could comment or Chair my comment on where NCVHS sits with respect to that
activity.

MR. J. SCANLON: What I think we’d want to do is schedule a briefing on the
demo to the Committee as sort of the first step. We’re in the formative stage
here. This is going to be a fairly difficult demo. I’m just pleased to see we
have a number of communities that are interested. I think we would be very
receptive to any thoughts the Committee had about variables that we might want
to–I think both process and outcomes of the variables that we might want to
focus on that would be readily obtained.

I don’t think we want to create a lot of new measurement and data systems to
some extent, because this would be difficult enough to do.

I think we in HHS would be receptive to ideas that the committee might have.
Again, remember this is a five year demonstration. We’ll get the first four of
the communities going this fall probably.

As you know how these demos go, it takes a fair amount of effort and
activity. It never is easy as anyone thinks, just to get the basic operation
going.

These would be certified EHRs. We sort of have the general framework for
what we would measure conceptually and generally we’re starting with– you may
remember the docket physician survey.

As a baseline we will probably be using that survey as a measure of
functionality in those offices.

DR. COHN: Are those both your questions?

DR. MIDDLETON: Just by way of follow-up, being familiar with the docket
office system survey instrument, I wonder to what extent do we feel, or will
there be an opportunity to go further in really assessing not only the
structural adoption but again, this notion of effective use, which is very
different than what the office systems survey gets at, and in correlation of
effective use without—

MR. J. SCANLON: We’d be very receptive. I think we could use any advice we
can get from the Committee we would factor right into our measures.

DR. COHN: It sounds like that briefing will be September

MR. J. SCANLON: It will be September. Yes. It will be far enough along to
have more meetings.

DR. CARR: Yes. I think this dovetails very beautifully with the hearings
that we’ve had in the last two days on the medical home. The themes that came
through yesterday, were very much about the attributes of care that are
delivered by an IT infrastructure.

I think that incorporating those attributes into the assessment, that at the
end of the day if it worked, did it contribute to continuity, and
comprehensiveness?

In fact, one of the things we heard yesterday, is the importance of
registries and how there are EHRs that allow you to deliver care but don’t
include as part of the package, a registry of the population, say with
diabetes, or with a condition, and that’s extra.

There was a lot of discussion yesterday and concern about the fact that,
making an investment in EHR but not being able to pull the data out and assess
performance of a population of people was a true concern.

I think it would be great to hear more about this in September.

MR. J. SCANLON: We’d be very receptive to the ways of measuring –
defining the criteria and then measuring them. We’re trying to build on sort of
what would happen generally in the ambulatory practices as well, so we’re not
trying to add a lot of new data points, but this would help very much in terms
of outcomes and process managements.

DR. COHN: Blackford, did you have a follow up. No?

DR. MIDDLETON: Very quick follow-up because of the last question. Actually
the NQF Committee on structural measures for HIT has received from CMS two
measures on registries and there will be an open period for commentary. The
measures actually reflect both the local presence of a repository for local
disease population recording if you will, but also pushing the field a bit, the
notion of a remote reporting capability through a national repository not
inclined could be anyone’s, but two registry measures will be put forward for
public comment.

DR. COHN: Okay, any other comments or questions? Marc it looks like you have
something you want to ask.

DR. OVERHAGE: I did have a question. A have a question about the PHR
demonstration that you mentioned.

I’m just curious because if I remember, Medicare did a PHR project back in
2004, 2005, which the little bit of follow-up I did individually was that it
was actually quite well adopted and the beneficiaries were quite happy with us.

I’m kind of curious about– didn’t really hear sort of a push or rollout of
that, and I wasn’t exactly sure how this PHR demonstration in South Carolina
differed from that, or was similar. I have some vague notions but I’d love to
understand better.

MR. J. SCANLON: I’m not as familiar with the earlier work other than the
Medicare portal. If you remember it wasn’t exactly a– what we would think of a
PHR. As you know, the nature of the functionality of PHR products is really
moving fairly quickly. I understand that the CCHIT is thinking about certifying
these.

There’s the other side of the coin, which has sort of says let the market
develop here before you start certifying.

Some of these are really press release initiatives. There’s no substance
yet. There’s really a lot of change occurring. The demos that we are evaluating
now are fairly—-there are specific products in South Carolina for example,
you can actually see on the Web what’s being offered and where.

I don’t think we’re trying to evaluate that product specifically as much as
the – do people find these sort of things useful? In what way do clinicians
find them useful? I’m not sure they actually use them? So we’ll be measuring
both attitudes as well as behavior.

The plan of PHRs-the number of plans have PHRs that they offer, so this is
sort of evaluating, in that group how much people use and what the use is.

DR. COHN: Paul I think I see your hand going up.

DR. TANG: One of the questions when our plan pre-populates let say,
diagnosis with a claims data, is to understand the accuracy of that and the
implications of that. Is that part of the evaluation?

MR. J. SCANLON: Yes, and this comes up a lot. This comes up frequently
actually. You have clinical information of a PHR and even current medication
information for example. As Simon as already said, it was probably true at the
time it was entered, but you know, how much now?

I don’t know any way– some of these PHRs are sort of linked to the
clinician reporting and others are not so much. I don’t know how we’re going to
overcome that Paul, but that’s something you see mentioned whenever PHRs are
discussed, that a clinician might not want to rely on some of the information
there.

DR. TANG: Actually I was assuming that since it was Medicare demonstration
project that would be pre-populated with claims information and that would
include the meds but also the encountered diagnosis. To understand the role and
the implications of using claim diagnosis would be very useful.

MR. J. SCANLON: We will see. We are envisioning at least in both of the
evaluations that we would not just look at process and use and so on, but can
we actually base it on records. Look at maybe validity is what is there.

DR. COHN: Certainly I sense a great deal of interest by the Committee in
this area. A think a session in September makes a lot of sense. I am also
reminded, and maybe this is my long history on the Committee, there was a PHR
report we produced a couple of years ago. From my view on this one, I may be
alone, but I– the area is obviously getting very full of multiple players with
many– its beyond different business models, it’s actually different conceptual
models of what’s going on.

Some people are having personal information, others are trying to collect
all the medical records in a single source. I’m trying to figure out what this
is, becomes as much of a question as anything else.

It may be something this Committee may want to think about, sort of
revisiting this issue and even updating the report given all of the new things
that are going on in here.

Sort of as a placeholder, it’s always great to gear things toward a new
Chair, in case he was wondering what he might be doing anyway.

It ought to be something the Committee ought to consider.

DR. FRANCIS: Could I just put on the agenda for things to look at the
privacy and confidentiality issues?

DR. COHN: Absolutely. I think that was a big piece of that report. Much of
which was sort of tabled because you didn’t quite know exactly how this area
was going to evolve.

I think there are a lot of issues here, and even more than issues, a lot of
activity that probably merits some review.

Now obviously we’re a little behind time. We’re redoing the schedule as we
go. What was planned this morning was some updates and I think it has been very
useful to hear-— given that NPI is a very hot issue, and now obviously
this CMS update, usually it’s a very constrained update. We don’t really have
time to talk about it. But it was nice to have an opportunity to engage around
it.

We obviously are having Rob Kolodner coming in around eleven, so we don’t
really have time this morning to talk about the letter, but I am going to
suggest that we, and Justine I am hoping that you don’t kill me but what we’ll
do is consider that letter as a one o’clock item.

Depending on how long it takes, we will get to the quality letter or we
actually have time tomorrow morning first thing, that we could also bring it up
and discuss it.

We have a fair amount of flexibility in the agenda today to try and make
things reasonable. I’m always really appreciative of new members when they
speak up during our first meeting.

I think it’s always a very good sign for the incoming class. Given that we
engaged really, all of you in conversations even at this very first session, I
did want to congratulate Jim and Marjorie for recruiting such a good new class
coming in.

MR. REYNOLDS: We’re going to have trouble with this group?

(Laughter)

DR. COHN: Not me. Not me.

(Laughter)

Why don’t we take about a fifteen minute break and we will reconvene at
eleven o’clock.

(Break)

Agenda Item: AHIC Successor, NHIN

DR. COHN: Okay, everyone seems to be seated. We are going to get started
with our next session.

Okay, we are very pleased to welcome Rob Kolodner joining us. Rob is,
I think you all know, is the National Coordinator of Health Information
Technology for HHS. Speaking for myself, I think he’s being doing a perfect job
in his roles so we want to congratulate him on that.

We’re also very pleased obviously to have you here today with us for a
briefing basically on recent activities of the office, as well as what’s going
on with AHIC’s successor and the NHIN grants and all of that.

I guess I should — at least I don’t think I need to recuse myself, but I
should comment I think that I’m probably on one of his slides.

(Laughter)

We are really getting money from the federal government. Okay my own big
success from the federal government I don’t think — I think I’m able to ask
questions about that.

I do want to just remind everybody that obviously we are very appreciative
of the close and cordial and collaborative relationship that we’ve had with the
Office of the National Coordinator and with Rob.

We obviously knew — we have some distant memories of the committee.
Remember when Rob was actually working with us as a staff just under some
security, when he was with the DA around issues related to HIPAA and clinical
data standards work that we did in the early part of this decade. Rob thank you
for joining us.

DR. KOLODNER: Thank you very much. It’s a real pleasure to be with you and
look forward to the active questions and comments.

What I’m going to do is briefly just remind you of the five different areas
that we are working in. I’m going to concentrate on talking about three
specific things.

One is the strategic plan, the next is AHIC successor of AHIC 2.0 or A2
whatever its names, still not branded.

The third area is about the current status of the Nationwide Health
Information Network, then divide the remaining conventions(?)in other areas.

Just to remind you in terms of the construct that we used, that there are
five general areas that summarize the activities that we are doing.

One, has to do with an area of governance, whether that’s the AHIC,
which secretary AHIC successor or things like the strategic plan.

There is an area of policies, particularly privacy and security policies,
but there are other policies as well, that relate to the health information
exchange.

The third area is interoperability standards in products. It’s identifying
the harmonization of the standards and certifying of them being products and
services. The fourth area is the area of adoption of the various solutions. The
fifth is in terms of networking to connect these isolated islands of
standardized information.

In the first area, talking about the strategic plan, we expect that that
will be released within the next few weeks, a long time in coming. At this
point, it’s in its final clearance stages.

It will have two goals. One in an area of kind of patient-focused or the
health care arena. The other being an area of population health. A variety of
things covered there, public health measurements, and reporting quality by
medical research, readiness and preparedness.

Under each goal, there will be a structure that has four different
objectives that are applicable to those two different goals. While they have
the same headings, they obviously have a very different way of applying within
those — under the two different goals.

You have a privacy security area, you have interoperability in standards
and networking, an area for the adoption and stimulating the adoption of the
technologies, and then a collaborative governance and decision making objective
as well.

There are policies that are in fact laced, through out all four of those
objectives. Where, as I mentioned policies in addition to privacy and security,
they are spread throughout that.

The plan itself will have a preamble and a laying out of the plan at a high
level, and more detail in its appendices.

A key part of this is that, as a strategic plan, it’s not an ONC strategic
plan. It’s not an HHS strategic plan. We are actually laying out all of the
activities and engaging across federal government and showing how a variety of
agencies across the federal government contribute to that strategic plan. Now,
in doing the strategic plan, I couldn’t lay out those things that the private
sector — they aren’t quite within the realm of our purview.

The idea is, that this is a nationwide plan because it is intended to — as
to how the federal government is going to play its role, to encourage, attract
and move forward the national agenda, and to in fact help the nation to have
that secure interoperable nationwide health IT infrastructure.

Our focus then, in contrast to those of you who knew me when I was at VA,
instead of focusing on solutions it’s really about focusing on the
infrastructure and on enabling the exchange of information in a secure way, a
way that honors the privacy of individuals and can build trust, so that we can
meet these multiple needs of the nation.

Again it’s not about technology it’s about having safer, higher quality, a
more cost-effective care also about having — it’s about the health and well
being of our population and the communities as well.

Hopefully you will see that coming out within the next few weeks and look
forward to being able to talk in more detail, once it is.

Next area under governance that I want to touch on very briefly is about the
AHIC successor. As you probably recall and have heard multiple times, when the
AHIC, the American Health Information Community, was set up as a federal
advisory body, through HHS, the message even at the beginning was, that this
was time limited, that it was meant to ultimately move out, and there’s
functions — the non-governmental functions meant to move out into a different
realm.

Secretary Leavitt has been very articulate in the public meetings about why
this move needs to be made. We have been able to get started. It’s in the first
stage of the rocket — to get momentum, across the nation.

For those of you who have been at this for awhile and I think most of you
have and ultimately get on to this committee, you know that we’ve tried many
times to jump start this. Going back at least in my memory into the early
1990’s, probably so much even before that. It wasn’t until 2004 that we seemed
to actually get some traction and get some momentum, moving forward.

That said, there is only so much that we believe can be done within the
confines of the government. There are certain inherent challenges, one of which
is if you are laying out the plans that you want, your financial projections
are dependent on the budget you have. Which means that in the federal terms,
you planned it 18 months in advance and you find it out, either when you are
supposed to start your fiscal year or sometime thereafter, and may or may not
have the dollars there and that’s been one of the challenges that, in terms of
an ability to project out what we are doing and how fast we can move.

The other is that because of the very nature of government, that every two
or every four years, there is potential for change in leadership and in
direction.

During that change, there is a pause or the potential for a pause, in the
momentum. Right now, while we’ve been very lucky in the last couple of HHS
Secretaries that had people who were very committed to moving forward in health
IT.

Certainly Secretary Leavitt’s been extremely admirable in terms of his
commitment to the fact that the one factor that he would actually chair, is
this one having to do with IT when he has 230 others across the Department, is
a testimony to how central he sees this to being able to accomplish all of the
other kinds of missions of the Department.

As he puts it, there is no guarantee that the next Secretary will have that
same commitment that’s in leadership. Therefore, he feels that it’s important
to move the controls, the priority setting and momentum to a public-private
entity in the private sector. We are not privatizing, the government is very
much there.

Our government as you know accounts for at least 40 percent of either paying
for or delivering health care in the nation.

It’s also one of the major advocates, if not the major advocate, for
multiple areas in population health such as public health and research, whether
it be in terms of its advocacy or even in its funding. Those are reasons why
the government has to be very much involved in whatever activities move forward
in terms of interoperability.

By moving it out of a FACA — as you know, you have been appointed to this
committee. To say that you then have all the input from the sectors and the
interests that you represent may be stretching it just a bit.

What we have talked about doing the way the AHIC successor or A2 as they now
refer themselves is moving this, it will actually have a membership type
structure for each of the sectors. All of the interested healthcare parties and
sectors will be at the table and part of the governance and done so in a very
deliberative way, that none can control it but all can be a part of it. Yet
that be done in a way that will not be organized or setup in its bylaws for
stalemate but actually to move forward and really driving progress forward for
interoperability.

The process was that we let a grant to a collaborative, which was led by
management group, LMI, teamed up with the Brookings and Mark McClellan in
particular has been the person at Brookings who’s been exercising the
leadership there.

It’s been a very collaborative process, where they formed planning groups in
four different areas and the planning groups are working through the variety of
recommendations in the areas of the governance and how it’s structured, and how
the bylaws might be structured to provide that equitable balance of membership
and management.

In terms of a membership committee, what are those different sectors and
how might they move forward, and how do they select their representatives, or
how are their representatives appointed? An area having to do with business
sustainability. What is it that this group is going to do to be able to
generate the incumbent needs to accomplish its work?

The fourth is focusing on the transition and the activities that are going
on in the current AHIC that need to move out into this AHIC successor. Looking
at what’s the rate, what are the best ways to do that, what work groups need to
be formed?

These groups have been meeting together on a very aggressive time schedule
on a regular basis. They will be making recommendations. They’ve had a couple
of public meetings. You can find more information on their website at
www.AHICsuccessor.org. They’ll have links to those public
meetings. I believe they were webcast and you can get the links so that you can
watch those and see the materials if you like.

The next meeting is scheduled for Wednesday June 4th and that’s when the
three of the groups, not the transition group but the governance membership and
business sustainability will be presenting their recommendations. That’s the
day after the next AHIC meeting, which is Tuesday June 3rd. Because
of the fact that the groups haven’t posted their information,there is not a lot
more that I can say about substance there.

That’s what they want to bring forth in particular at the June 4th meeting
and the way forward, how to get from those recommendations to the next phase,
which is really establishing the A2 as a new entity and beginning to develop
those bylaws and recruiting staff, board members, leadership and other things.
That’s the A2 or AHIC successor.

The third area that I wanted to talk about is the NHIN and you have heard
about this. In fact we really appreciate the input that you had in the phases
for the NHIN, including the evaluation of the prototype architectures, where
you were able to provide guidance in terms of what are those core activities or
functions that are needed?

Since the last meeting, which was in February, by John Louis, we ended with
a number of participants as Simon alluded to. You see here on this slide, the
list of initial contractors on the left side. Those involved a number of —
actually those who are all geographically based health information exchanges,
or RIOs. The one exception being the federal group which consists really —
this only shows three but there is another one and that is Indian Health
Service will be participating also in December. We have four federal agencies
or departments that are participating in this trial implementation phase.

Also in the last few weeks, we let a grant and ordered a grant to six
entities and you see them on the right hand side. Those include Cleveland
Clinic and Kaiser Permanente, two large health care entities and integrated
delivery systems, and several other geographic health information exchanges, as
well.

Let me go through a couple of slides. You see now, depending on how you
count these, there are either 16 or 19 participants for the activities that are
going to be occurring this fall.

You see on this next slide, just a summary of some of the four different
areas, for those who were at the Nationwide Health Information Network meeting
that was held a few weeks ago. Actually it was held in conjunction with some of
our other collaborators, the ones from the HISPC, the privacy security
collaborative at the state level, as well as the state level health information
exchange groups. I think we were able to get some good synergy across those
various activities.

We have four areas where — these represent these core functions that we
need to get a dial tone, to be able to connect up.

One has to do with the patient look-p and information retrieval. That’s
when a provider has a patient but doesn’t have the record needs to find – okay
where do I get that record, another being, how do you update the health data
where it’s needed. There’s an information routing and delivery component. When
the patient wants or doesn’t want information be released electronically to an
entity, to a provider, or to others. That’s having to do with consumer
preferences and we are having methods to exchange those consumer preferences
among the participating entities.

How do you provide the best care in protecting the population so we have
the support for the population data uses well, which I would expect would be of
particular interest to this committee?

We will be doing some testing, testing specific data and terms and the
envelope that hold the data, and making sure that the communications back and
forth, and the protocols for query and response are working. Also to
fundamentals, making sure that there is both a transport layer — but the
security of moving this information, only when it should be moved, to whom
should it be moved, in a secure manner.

One way of representing it, then is — this next slide — the AHIC
successor and the Nationwide Health Information Network, represent taking
several of the activities that have been going on for the last few years and
bringing together, merging them so that you then have real activity, real
product, whether it’s real governance as opposed to advice which is what a FACA
provides, or whether it’s really being able to mobilize the data nationwide.

We have talked about there being communities, I mean these that have
multiple different entities that connect and share information in those
communities. I also mentioned some of the entities that serve as integrated
delivery systems, whether they be within one community or across communities.

In light of the announcements in the last few months and especially the last
stage, there are entities that are either serving as health banks, or as OHR
support organizations, providing places where individuals can keep their
information that is under their control.

We need health centers. We need to make sure, it is very important that as
we move forward in all of this, we not increase the disparities that occur
there. We have to make sure we are paying attention to the needs of the
underserved and the disadvantaged.

I mentioned the federal entities, whether they be in public health or
whether they be in payer area, indirect care is there – Social Security is
there, Social Security being a non HIPAA entity, and some new challenges of the
federal entity that is outside of the HIPAA coverage.

It spends a half a billion dollars a year getting records, paying for
records, in order to do disability determination. That’s a lot of money. We
know how inefficient that must be, on paper and the long delays in terms of
making that stay with the local governments.

Healthcare is both — because of Medicaid but also because this — because
health care is local and these entities need to be a part of the activities,
also laboratories, pharmacies, and a variety of others.

What you see here is unlike what I think when some people had early on, of a
view of, everything is going to be one way, everything is going to be
geographic or have a single way of connecting across the nation. It’s a hybrid.
It’s going to be a hybrid. Whatever solutions we deploy have to be able to
support this very diverse community of entities that are sharing and need to
share or should share, information in order to improve the health and well
being of individuals and of communities.

Now, you know that we have the Internet so we could just connect them with
the Internet. Except you and I would make sure that our data never flows on
that because it is inherently insecure by itself.

To mobilize that health information nationwide, the NHIN is about putting in
standards, specifications, various agreements, for secure connections and for
the secure exchange. Riding over the Internet, we’re not put in any wires, but
using this as the means to move forward.

It’s really using these activities and what you see with NHIN is getting
these 19 different entities around the table, eah of whom has a different
internal architecture, different needs, different requirements for privacy and
release of information, and allowing them to work together in the areas so that
the kinds of specifications, the kinds of agreements that are laid out, in fact
are broad enough to be able to support the diverse needs. Whether that be as
simple as whether one entity does opt-in and another does opt-out. Or a variety
of much more complex things that a number of you around the table can probably
tell me better then I can recite.

We need to be able to do this. The way of doing this isn’t a top down
government telling entities how to do it. It is in fact the government creating
the opportunity, bringing to the table these multiple entities to help
identify, move forward, and as you know, that means we are going to get it
mostly right the first time. Through the trial of limitations and the testing,
we would continue to refine it.

Even when we go operational, we expect that it will start as it should, in a
very responsible way. Start with a few connections among a few entities, grow
the number of connections, increase the volume, until we are sure that this
really is scalable and we have been able to address and detect the kinds of
things that we thought we had right but need to be tweaked as they go forward.

This next slide, just lays out for you the timetable for the trial of
limitations. In May, we will have the initial core specifications all except
for one or two. We’ll be getting those very shortly. We are moving forward on a
test data use agreement that is being reviewed by all the participants and
cleared on that.

In July we will be doing some updates on the used cases and in August, we
will be testing the core services, these core dial-tone types of things,
including being able to move a summary record, a CCD and a particular subset of
the CCD as the first step.

In September, we are actually going to demonstrate the exchange of that
information, both pushing and pulling among the 19 entities, as a demonstration
of these core services and being able to move that information, identify where
information is and to move it back and forth.

In December, we demonstrate not only the core services and an enhancement of
some of those, but also, the seven different priority areas or use cases that
were first approved by the AHIC and recommended to the Secretary.

The standards for the first three are already recognized. The standards for
the next four have been accepted by the Secretary. All the participating
entities will be kind of choosing the area of the use cases that they want
share and being able to move that back and forth. Also at that time, we want to
move from a test data use agreement to the identification and approval of a
production level data use agreement.

The intention then is that, at some point and it may be before the end of
this calendar year or in the first quarter of 2009, of calendar year 2009, if
all proceeds as planned we expect that there will be a number of the entities
that will say that they are ready to actually begin to exchange information for
day to day operations, again starting small and increasing and doing it
collaboratively using the various standards and specifications that are part of
this activity.

With that, let me stop and see what kinds of questions you might have? What
areas you would like to know more about? I look forward to the conversation.
Thank you.

DR. KOLODNER: Okay. John Paul, then Mark Rothstein and then Leslie.

MR. HOUSTON: Very interesting. I — toward — on your slide regarding the
common network dial tone, one of the things that you maybe — I know you spoke
very briefly about it. It seems like there is a lack of discussion about any
real structure fabric for privacy and security specifically. I understand
everybody talked about, this is going to be a secure infrastructure, but I
can’t see how that can’t occur, no matter how I try to look at it without some
type of essential authority, or for something that has to oversee how you
manage credentials, to how do you grant even organization level access, to how
you do things like auditing and management of that type of data.

Where do we stand with regards to that? What’s your view on that? Where do
we stand with regards to developing infrastructure to support that?

DR. KOLODNER: That’s an excellent point and thank you for bringing it up.

We do agree that there needs to be governance. Whether that governance comes
out of the participants themselves as they grow and have a trust across the
growing number of participants, or as some of us have been advocating, whether
that in fact is one of the roles of the AHIC successor, which then has all the
participants around the table and can make sure that the interests of all the
parties are properly addressed and protected.

Right now, the AHIC successor recognizes that it is trying to get
established. It’s trying to say how it functions and how it supports itself the
first few years, because they notice that — and you notice as well — if you
look at those five different areas that I have talked about, the two most
immature areas are the governance and the networking.

Unlike the standards and the harmonization in the certification which they
can take over as a process gets started, they’ll want to refine it, they’ll
want to improve it, which is great, but at least keep the process going.

They see the NHIN as still being, is it there yet? It’s not going to
be a place where there’s going to be monies from their point of view. I think
that that step into, how did we get into that place, it may be that what
happens is that the first participants establish an interim governance, because
again that’s going to be a smaller number that are working together and using
the same standards and things where the number of participants is not going to
be huge. If they then are able to show that it is working, then A2, because it
will now have a board in place, that those discussions can go on. It’s better
earlier then late.

MR. HOUSTON: One real quick comment. I think that that’s fine except that
I’m a little concerned about scalability and what works small for limited
membership doesn’t necessarily scale the way I think it needs to, nor do we
necessarily have — this is maybe one of those areas where you have to have
standards.

Yes you can have different opt-in versus opt out then you have some
localized differences. This is an area where I really think it has to a fairly
rigid set of standards.

DR. KOLODNER: We agree, and I don’t see that –I’m not saying that this
governance, this interim governance isn’t scalable.

I’m saying, I think what it basically does, is that it really is working
–you ought to have a board, to help re-transition this. I think that with
these two things in motion, it’s very difficult right now to definitively say
how that’s going to occur, but that it needs to occur if everybody is in
agreement.

DR. KOLODNER: Thank you. Mark Rothstein?

MR. ROTHSTEIN: Rob, I want to follow up on John’s question and with a
comment as well, on privacy issues.

Personally I think it would be mistake to entrust the AHIC successor group
with too much responsibility in the privacy area, if for no other reason, than
it’s going to take that group to get a while to get geared up and get
organized.

As you know in 2006, we submitted, that is NCVHS submitted to the Secretary
a list of 26 recommendations that needed to be considered in the context of
privacy and confidentiality in the NHIN. Of those I think the most important
one is the need for central organizing privacy principles to govern the NHIN.

ONC and first incarnation of AHIC has taken up various issues related to
privacy and security, but we are still waiting for this framework and that, of
course, was part of well main part of the criticism of the GIO in 2007.

In February of this year, NCVHS dumped another set of recommendations on
the department dealing with sensitive information, which certainly those of us
around this table know is very complicated and would take a great commitment of
resources and time to get all the parties and stakeholders to get something
workable.

What I’m concerned about mostly is that privacy which I think we all felt
was behind the technical developments, is falling farther and farther behind. I
think we are going to reach a point where it’s not going to be possible to
catch up, because the systems are going to be in place. I think we have got a
window of opportunity and I see the technology is Big Brown and privacy is just
red. Unless we do something, we are never going to be able to catch up. I
wonder if you could comment on that.

MR. KOLODNER: First of all, if you remember, Big Brown wasn’t in the lead
for most of the race.

(Laughter)

It may very well be that, privacy and security is Big Brown. It will come
forward like a big burst. To get to the actual activities, we have — we’ve
said multiple times, and I know you are probably tired of hearing it. We are
working on the privacy and security framework. The Secretary is committed to
releasing the privacy and security framework this year and so you will be
having that, before the NHIN goes operational.

The activities that we are doing, the investments that we are making, we are
certainly very cognizant of the fact that, the privacy and security boundaries
and the framework is not out there, and yet when we are putting together the
various technologies and requirements for the NHIN, we are building in the
capabilities to be able to support a variety of policies. For example the
DERSA(?) or the way the NHIN is being rolled out, has to support both the
opt-in and opt-out.

We are not letting the technology make a decision. We know that we need to
support both. Having had the experience in VA and DOD when we were first
working out what eventually became a health information exchange, it’s morphed
into more things, we were designing that at the time before the HIPAA privacy
and security rules were published. We ended up building a lot of capabilities
into the system because we didn’t know which way the policy would go.

I think that there are things that we are doing in the way that the NHIN is
being conceived of, being architected, and the various specifications that are
in fact laying the foundation for being able to support the framework when it
is released.

MR. REYNOLDS: Leslie you are next.

DR. FRANCIS: You actually — you have a privacy row here. Let me just follow
up quite specifically. One of the concerns that has affected the
recommendations that were in the letter in February, was that design shouldn’t
be just opt in or opt out, that there should be additional ways to consider
privacy protection.

I guess my quite specific question is, how can we, who have worked very hard
and have a history of expertise on privacy, have a seat at the table while
those recommendations are being formulated so that privacy expertise from this
committee is not just reactive but actually active in that process?

DR. KOLODNER: Good question. I’m not sure I’m going to be the one who can
answer that. Obviously that is a Department decision and ultimately at the
Secretary’s level in terms of where those activities occur, because the nature
of the government activities — there are some deliberations that occur inside
the Department. The idea is then to begin the conversation, put something out,
so that we can have that dialogue back and forth and move forward.

Those of us who also have a long standing commitment to the privacy and to
needs of individuals, but balancing that also with the fact that how do we also
support the community, and how do we find that right level that doesn’t violate
privacy that allows us to help the public health and advance the public good?

I look forward to engaging you in that, when the internal activities are
completed.

DR. FRANCIS: It won’t be until after the first draft is out?

DR. COHN: Yes. I also want to clarify the role of a FACA committee. Our role
is to provide advice and guidance to the government. I just want to
congratulate everybody in this area. We actually have provided a significant
amount of input. The Secretary a couple of years ago asked us to specifically
look at this area and I think we have more than fulfilled this phase one of
that activity.

There is a difference in providing advice and a guidance hopefully in the
advance of need, so it is valuable now, versus having a seat at the actual
decision making table. Jim did you want to say something?

MR. J. SCANLON: I just might add that the sort of the first step is the
recommendations of the NCVHS have been made available to the deliberations, and
clearly that is part of the formulation.

I don’t think Rob or I could predict exactly how it will turn out but the
intellectual thinking, the formulation, the framework and the recommendations
of the NCVHS have been made available to that process.

DR. COHN: Already I would say, part of the NHIN may I assume will be
referenced into the NHIN work. I think you probably we mean that. I just wanted
to frame that in a way that it sort of makes sense for a FACA conversation.
Larry you are next.

DR. GREEN: I want to add my appreciation to your doing what you do and
sharing your time with us this morning. Several of us have had the privilege
over the last couple of days of sitting in hearings that were focused on this
thing called the patients in a medical home, a system that care that is trying
to engineer itself into providing modernized primary care and outstanding
chronic disease management.

A recurring message we heard from multiple parties, multiple sectors,
multiple directions, over the last two days, was frustration with the tension.
The tension between controlling the flow of information in order to create
business opportunities that are profitable versus interoperability, to have the
information available at the point of care when it’s needed.

Could you just update us about the current thinking about how that tension
is being considered and could possibly be managed?

DR. KOLODNER: As we move forward, I think it’s been striking to me,
patrially because I spend my life in the public sector, the tension that’s
there — whether we are talking about, do standards that have been recognized,
been put into products? Or whether, do those products get adopted by providers,
or whether it’s whether entities in the community have a reason to share
information among one another or not share? Or whether communities that are
struggling to make that work, have any reason to share across that? This
recurring theme of, is there a business justification, comes up again and
again.

It is understandable that an entity that has to pay its bills, that has to
pay its staff, that has to stay in business, needs to answer that question and
needs to be able to answer that question.

One of the things, when we talk about the interoperability, and certainly
this committee in its deliberations and its areas of interest, know that many
times that interoperability is something that helps the entire community, helps
the population, helps the cost of care across the country. It’s in the public
good, it’s the right thing to do.

But from a financial point of view, there are many times that the public
good is something that it’s very difficult for business that is trying to make
it on the margin, in order to find a way to say, oh, I’ll do it for the public
good. It doesn’t mean there aren’t many businesses that do the right thing and
do public good, but when you are trying to do this for a business case and
moving forward, it costs money.

We need to figure out a way to address those things. We have all the
answers? No, I think that’s why there hasn’t been much progress before now.
Right now, those are some of the very difficult challenges. We’ll be talking
about it more at the AHIC on the June 3rd meeting.

The issue of A2 coming together and what is the business reason for coming,
if you have to pay, especially the first few years? Or what is the reason if we
do have entities sharing in a trial implementation? What is the business
reason? Where do we find it? It is a tension. It’s one that we have to keep
firmly in front of us and it is one that we have to work together to find the
ways. Whether it is access to certain information if you do, federal data,
whether it’s increased payments, that’s probably not going to be the primary,
whether it’s recognition or comparison or publishing who’s doing the best job.

We need to — so that you kind of want to do better job and you get — there
is a competitive edge for doing better because somebody is going to want to
know that or want to do it. Like right, now there is a competitive edge if you
have better quality.

We are struggling for that and we are engaging with a variety of people at
all these levels to address that. I can say that, we’ve recognized it as an
issue. It’s still — until you get a critical mass, you have that. Right now,
we are starting without that critical mass and how do we get to a point where
you reach the tipping point and it takes off.

In some ways, in thinking of analogies, I understand that when television
first came out you had the issue of, the chicken and egg. do you have enough
sets to broadcast? Do you invest in broadcasting before there are receiving
sets? There were some very difficult decisions that needed to be made within —
when they went from black and white to color.

These were industries of struggles that had to occur. Right now we have
something that has to do with our health and that as a nation we are struggling
to get it right.

DR. STEUERLE: As I listened to the questions around the table I realize that
all of us are coming from a particular vantage point whether it’s people who
work on standards or privacy or something. I might wonder on the committee as
an economist is to try to think about incentives. The day we set standards they
are outdated and the day we ask for more information, we obviously increase
the probability of a privacy error.

This is a kind of a statistical fact of life. I am always curious, when we
think there is inadequate progress, there is always this question, what are the
incentives and the disincentives in the system?

I really like the way you started up by talking about trying to improve
processes. This is an ongoing — this not something where we are trying to find
a vaccine to cure something — this is — only the positive side, this is more
like chronic care only unlike chronic care because things are getting worse,
because opportunities are getting better and better. There’s a continuum of the
things that we want to do.

I’m curious where — within your office — maybe this is for Jim too, from
his previous discussion. Where is there a discussion of how to actually change
the incentives which include by the way, a message you recommended to this
committee, including, even and where necessary going to Congress.

If you say and you’ve just decided we are far enough along, we can pay more
for prescriptions that are electronically filed or that are e-prescribed versus
those that are not or pay less for those that are not, or do we want to change
the incentives for identifying certain groups. I think there are certain groups
for instance, who would gladly abandon any opportunity to worry about privacy.
I’m thinking of, for instance, parents of autistic children, who would probably
love to have their information shared and probably would abandon all the —
they would be willing to give up any opportunity to sue if some of their
privacy is violated.

I am just curious. I’m not asking you to identify specific incentives, but
who is really working on putting forward sets of incentives that might actually
try to use the word jump start, but really try to push this agenda a little
further and moving over some of these hurdles?

DR. KOLODNER: I think that is an excellent question. There are a number of
activities that are underway. They is kind of a step-wise approach.

One by the things that I would point out is that, if we had the prefect
incentives, if we had the right products and everything was ready to go, we
would be in deep trouble. The reason why we would be in deep trouble is, we
don’t have the work force properly implemented and support the systems. We have
to grow into that.

If you remember in the late 1990’s and when the explosion in electronics and
you get the latest new gizmo and something didn’t work and you picked up the
phone to call for help. Maybe you didn’t get an answer on the other end, or you
got an answer and you were put on hold, or you got an answer and you got to
somebody where you had to get the third level help before you had somebody who
wasn’t reading from the screen.

Right now, we do not have the trained individuals, informaticists, as well
as individuals who can help work with individual providers to help them redo
their work flow and get things together.

We need to incrementally move forward. A couple of those increments that
we’ve put in place, one was a very simple one and that was, we created an
exception to the self-referral rules that started again to hit back and said
that, large entities could provide up to 85 percent of the cost of a record to
their referring physicians, as long as it was interoperable, as long as you
didn’t do a log(?).

The products had to use the interoperability standards, and the easiest way
rather than going and measuring each one is, if it’s certified, it needs to be
interoperable.

That’s starting to take off because a lot of the larger providers that seem
to have this slew of paper coming in and are able to more than cover their
costs, by making these donations and beginning to cede their missions(?).

Another is we are working with malpractice insurers and some have already
started to offer a reduction in malpractice premiums for practices that are
using electronic health records that meet certain standards and the kind of pay
for performance activities that have been going on within the context of
quality.

The next step of that is the program the Secretary has been advocating now
for about the last six months. We now have applications from a variety of
communities and shortly, we’ll be selecting 12 communities across the country
and providing a Medicare demo.

This is where we collect the information say, is it cost effective, is it
cost neutral or is it cost beneficial to provide incentives, to provide bonuses
to providers who use electronic health records to achieve certain things?

It isn’t just a straight, here’s a grant, take the money and go. It will
give you bonuses each year. First year, if you can do some simple reporting.
Second year, if you can do some reporting on quality measures. Third, fourth
and fifth years, if you attain certain quality benchmarks and are able to use
certified electronic health records.

That’s another activity that’s going on. The most recent that’s now playing
in Congress, the reason why we try not to go to Congress for many things is
because, that is a process that often takes a number of years.

Right now, the Secretary, as you know, has been asking for the authority,
which he doesn’t right now have, to require the use of e-prescribing for
Medicare providers. Not to pull the strings, he just wants to have the
authority which right now he doesn’t have. Then there then can be some
incentives and targets and timetables for moving that forward. Those are a
number of the activities to provide the incentives.

Regarding privacy, and you mentioned the idea that there are entities,
groups of individuals, who will gladly trade that privacy. That is the issue
that in fact, we all fall somewhere on a spectrum from risk takers to risk
averse, if you believe the usual statistics, you have got 20 percent of us who
tend to be risk takers and about 80 percent tend to the risk averse. Some
things like having a condition or having a family member who has a condition,
can move us from one to another.

Probably the most dramatic, for those who aren’t aware, the now web 2.0 and
Facebook and others where people tend to participate. There is a health row(?)
that’s emerging and one example is a group called Patients Like Me. Or patients
with ALS are actually posting their own data. Not only the health care data but
their own reports of side effects, of other things that they’re doing, some of
which most of us would not post, up on a web. They have largest database now of
patients with that condition. We are looking and finding patterns of levels of
medication, levels of side effects and they are forming a self-organizing
community.

As with privacy, as with the Internet, we all chose when we wanted to put a
credit card, or use our credit card over the Internet. Probably none of us did
when the World Wide Web first came out in 1995. There are few who are really
the innovators out here but at some point we found, if the trust is there and
could choose when we wanted to move that information or join using the credit
card. Maybe some around here, there is certainly some out there who still
won’t.

That choice, the question is, how do we in fact provide that capability and
that choice? What’s the right way of doing that within the movement of the
health information, so that people can get comfortable and can choose whether
they want to participate? How they want to participate? Whether they turn the
on or off switch, which is a pretty coarse way of doing it.

Whether they are able to select and say they don’t want data going to
certain places, or they don’t want certain places to release their data, or
they don’t want certain types of information to flow.

Those latter are much more complicated because you still have issues, for
example of, I don’t want my psychiatric hospitalization to be released, when I
go into that hospital and I want to have information released to them and that
entity, that hospital goes and says, I want the information on John smith. The
place releasing it is going to want to know where they are releasing it to, and
we don’t yet have ways of anonymizing that in a reliable or trustable fashion,
so that the releasing entity is going to want to let go of it. Those are things
— that’s where personal health records that may or may not serve or new
entities that may arise that have or haven’t yet arisen.

If you think about the Internet, most of us probably all of us around the
table here, did not envision search engines, whether they be AltaVista or
Googles, eBays, Facebooks. All of those entities came afterwards. These are
issues that need to be addressed but the idea of how we do that, can be very
complicated.

What we need to do is get started, take a little step, make sure that we
know where we want to go to and know the capabilities we want to get to, but
start with the entities and with the type of data that are willing to get there
and allow that trust to grow.

Those are some of the tensions we have. Some people for example feel that
out of the gate, we have to make sure we do it in population health or moving
anonymized data. That may keep people from participating.

Others think we should just start with health care. Well, how do we make
sure that it meets the needs of population health?

These are some of the kinds of issues that, as we move into operations, we
need to be working at together, or at least the participants need to work at
together.

We need to make sure that we allow individuals to be able to grow and allow
their trust to grow so they can participate more. Lots of very difficult
problems, very challenging things but ones that I am sure we will be able to
address, we will be able to move forward on.

DR. COHN: There are a couple more questions but let me just do a time check.
Since it is 12 noon, do you have time for a couple of more questions? Harry.

MR. REYNOLDS: Ralph, thank you and since we will be losing Simon, and you
are friends with Simon, we hope you don’t lose your friendship.

(Laughter)

We have many friends who have left the committee and we look very forward to
working with them. I think one of the things that would continue to be helpful
for us is, as we are going to be talking about going forward as a committee, we
are going to be looking at some items that are visionary, some items that are
near term, and some items that are the kind of things that we have to keep an
eye on. This morning, it’s almost all three of those — over the last couple of
days.

We did the HIPAA NPI today, which is something we have got to keep an eye
on, on what’s going on. E-prescribing came up today, which to a lot of us,
playing back to Gene’s comment and others, because the way it was set up, is
actually bringing incentives to the table in local communities, that are
fascinating, that I know in my day job we never would have thought of under any
circumstance.

The fact that it is a standard now, the fact that it has proven to be real,
the fact that it is making a difference — and for example Karen used some of
our data in a presentation she made today.

Those are the things that, once it is proven to be real, once it is proven
to be horizontal rather than just a vertical single answer, it’s amazing how
people line up in ways that are strange and different.

I’m getting to meet with people now that I never even knew we would know.
That’s been a great -– that vision of — if it is a use case, it’s of
horizontal use case. If it’s a use case that really makes a difference across
multiple venues rather than individual, I think it is going to be key for us as
we help you deliberate some of these things.

Then, having sat through the whole presentation yesterday on the medical
home and I haven’t come through it after a day and a half, whether or not you
actually believe in a thing called a medical home or you believe in a vision of
a medical home. The vision of a medical home is going to take an awful lot of
these things that we have a chance to help build you, or actually doing some
things with.

Keeping that vision clear and using ourselves — and many times to make sure
that we continue to discuss the vision, continue to discuss the make-up of the
vision, work with you on what you are doing, then I think that is how these
things can maybe start to happen.

We welcome that involvement with you. We really welcome it on multiple
levels and I think as you said, you’ve given us assignments, so the NHI is a
big picture, but oh by the way, tell us what the functional requirements should
be.

I think we can play on all these venues and so we are very anxious to
continue that with you. The reason I say it in those three venues, is for you
to think of us as we work with you in those three different distinct
environments, because I think we can play a prominent role in making a
difference, probably at all three levels. Whereas some of the others that you
deal with, might not be able to traverse all three of those with what we try to
get done, and the openness of our process.

DR. KOLODNER: I can tell you the contributions that you’ve made, the reports
that you’ve provided, even though sometimes it feels as if we haven’t fully
embraced them, I can tell you we actually have.

Sometimes it isn’t as timely as we would like it, as we were hoping, but in
fact all of the things that you have done have significantly guided and
influenced the approach we’ve taken, and the kinds of activities and directions
that we’ve pursued. I look forward to continuing to work with the committee in
that.

The areas that you cited, Harry, e-prescribing, is an example of one where
you have that whole spectrum again of people saying, we can’t do it until all
these other things are addressed.

Whether it is controlled substances, or whether it is the rest of the
standards for e-prescribing and yet you have other people who are starting to
make progress and seeing that it already creates a synergy.

We are going to have that spectrum of opinions that are there. That means
that, as with almost everything that we have, at least in the last ten years in
the Internet Age, now getting started, sooner – and it’s something that is
not quite perfect. It is more important than waiting for perfect and engaging
those who are ready to use the not-yet-perfect, to help it move it along.

The issue of privacy is certainly one. We know that every technology that we
use, at some point or another, hurts. Whether it is cars that kill or other
things, there is a balance. There is no perfect.

When you put these out, there will be breaches. We will do everything we can
possibly do, to decrease those. But that means that earlier on, the people who
participate and the communities that participate, are a little more
risk-taking, doing everything possible but they still don’t know all the things
that need to be done. We are still discovering that. Yet we need to move
forward. Whether it’s standards or whether it’s the other things.

We need to do it deliberately with our eyes open and understanding what the
risks are so that we don’t minimize those for the people at any given point. We
also allow the progress to move forward.

DR. COHN: Blackford, and Sallie, you finish up and then we’ll break for
lunch.

DR. MIDDLETON: I just wanted to add my thanks and congratulations to you for
continuing to carry on the good fight and you know I share the passions with
you deeply. I am concerned, however, that we are going to build it and no one
will come.

My own CEO, Jim Randen(?), who is a pretty smart guy despite the following
comment, will say, there is no contribution to the margin for information
exchange.

If I transfer a patient from the Brigham across the street to the BI, one
of the world’s most sophisticated clinical information system, to another one
of the world’s great clinical information systems, the patients carry a paper
record. A paper jacket.

I am concerned that we are doing the somewhat typical IT or informatics kind
of error, that is creating a technology infrastructure and envisioning that and
implementing it, without clearly articulating a business case or identifying a
business sponsor who will put money on the table to make things happen — for
example in information exchange. So I only have three ideas.

(Laughter)

And I look forward to sharinf, because all the other good ideas have already
been said.

We sort of danced around the idea that NHIN is being a critical information
infrastructure. st-World War II, we certainly were able to do the highways in a
way that was federally driven, federally mandated, as a public good absent the
road side gas stations and service centers that grew up to use it.

I wonder if we are not actually getting enough MBAs, enough CEOs, enough
politicians interested in this. We have infomaticians who can design this kind
of stuff but the CEOs aren’t talking about it. They aren’t talking about as the
thing they have to do, to keep their hospitals alive.

As you know, I believe actually, if we fail to do information exchange and
decision support and a number of other things, that health care will go broke.
This country will suffer calamities things that we have difficulty envisioning
in fact.

The second thing is, if their information is actually the asset, have we
actually thought through how to monetize the asset, so we can apply a property
framework, and I’m not a legal scholar, but apply a property framework that
will allow it to be used, exchanged and rewarded in its exchange, to those who
created it and or use it or modify it.

Right now, the complexity of our information exchange environment is that
the providers really don’t want to exchange information because it is a
disincentive for doing the next CT or the next blood work or what have you.

The payers actually benefit most from information exchange, but they are not
been asked to foot the bill at all with respect to HIT investments, largely.

I think there is the issue of information assets or how do we monetize or
apply property rights to data, so we can monetize it.

I think the last thing has already mentioned about the incentives. They are
complicated and they are cyclical in some ways because of our complicated
health care reimbursement. We actually have to address not only the incentives
for the providers, but disincentives for the providers too. I’m thinking of the
never care kind of CMS policy, which won’t pay for medical error. Why should we
pay for a repeat lab test if one was done last week across town and it was
available?

The provider incentives, may have both carrot- and-stick components. The
payer though should be strongly engaged to pay for information for technology
infrastructure. I think there will be transaction costs that can be marketized,
if you will, or commoditized to find the right level of the market that will
allow the other players who weren’t central stakeholders.

DR. KOLODNER: That was an excellent articulation Blackford. As we were
talking about business justification, that those are the kind of things that we
are certainly talking about.

For example, the first one that, whether it is critical in what happens with
CEOs. It’s a matter how short that burning platform needs to be, before
entities come.

Remember that right now, the employers are paying a good chunk of the
private sector bill, and it’s going up and up.

The big payer is Medicare and so things like the CMS EHR demo is an example
of a first step to be able to collect the data to say, yes we should do it
everywhere.

You can’t take that first step without getting the data, at least that’s the
review and the reason to do the demo.

In fact, for those CMS EHR demos, the idea, and the Secretary has been very
clear, although we can’t sit down and gather a group of private sector payers
together, he has been very vocal that the communities that will be favored are
the ones where the payers are also there and contributing as well in a similar
manner, however they choose to do that. We have actually got good response from
a number of payers.

Remember, too, there are a some payers, such as the ones in Massachusetts,
that have put money in, significant dollars, to do the demonstrations and to
light up communities with these things.

As with the disincentives, the never-care kinds of events, is a start that
hadn’t been there before. That’s a start now. What do you do about the repeat
tests, but as you know, that can get into the, you’ve now not paid for this.
What that particular test needed because there is an event in between, and you
get into battles.

None of these are easy but they absolutely do need to be — we need to make
progress in them. Thank you.

DR. COHN: Okay. Sallie?

DR. MILAM: I wanted to offer some reflections just to John’s question and
others about privacy and NIN-2(?).

West Virginia is a NIN-2 participant and it has been a good learning
laboratory for us. We come from a broad base of HIPAA experience. We have
adopted our own privacy principles in the executive branch.

We thought it would be a matter of simple application and I can tell you, we
have learned and we are learning through NIN-2, that’s it not and these
different HIPAA requirements and privacy laws as well as the really dependent
on an analysis of your organization structure as well as others, the legal
organization and governance structure, as well as the specific functionality
that you are providing.

So when we talk about consent, for us, that is just one of six principles.
You need to look at all of the different principles and the laws that are
attached to each principle and think of it in much more granular terms, which
is something that we are just starting to do.

I think the others in NIN-2 are learning this along with us. I would suggest
that getting into this level of granularity is really a new conversation.

It is, for those of us participating in NIN-2 and I know we are not ready to
say in West Virginia that we know the answers and I don’t think yet we know the
answers to NIN-2. It has been a real eye-opener for us.

DR. COHN: Point well made. Mark Overhage had actually put his hand up and
wanted to ask a question. Just as he had — he left the room. Mark did you want
to ask the final question? — Fine. Okay.

DR. KOLODNER: Simon, I was worried that Mark was quiet and hadn’t asked
questions.

DR. COHN: He had raised his hand. Sallie, a very good point. I want to thank
everybody. I think it has been a very interesting session. Rob, thanks for
sticking around — especially it actually went a little longer than you had
anticipated, but it is a good opportunity to engage and talk about the real
issues.

Now we are going to adjourn for lunch; we’ll come back at 1:15 p.m. We’ll be
gone a little less than an hour but we’ll come back and talk about the letter
and the other items on the agenda.

(Whereupon, a luncheon recess was taken)

 

A F T E R N O O N S E S S I O N

DR. COHN: Okay. Now what we are going to do at this time is to take up our
letter on e-Prescribing Standards and Long Term Care for I guess review and
consideration, as we comment that this is a letter being brought forward by
Standards and Security, for action at this meeting.

Following that rest, we are delighted to have Betty Humphreys who will be
providing an update on what’s going on with health care terminology with the
National Library of Medicine. Also, I think she is going to talk about the
HTSPL(?).

MR. REYNOLDS: Yes, and before I do that, since you haven’t given anybody a
chance to speak take a mic since you started this morning. A number of us, or
at least I would like to make a couple of comments. We are going to make some
comments at dinner tonight, but I thought it would be good. No, I think it
would be good — The roast is tonight. This is on the record, so I’ll speak
only as the chair of Standards and Security at this point. Since you were on
that subcommittee, I can use that as part of the committee.

You know as all of us have worked with Simon, when you think of a leader, a
mentor, a sounding board, a collaborator, a debater, a subject matter expert,
and more importantly a friend, you know Simon’s name comes to mind for those of
us that have worked directly with him, and we really appreciate that.

He is no longer going to be chair and I’m not sure what happens to people
after that.

(LAUGHTER)

I think some of us were really lucky, we wish you had met Simon Cohn early
in your career because it would have probably made us even better than we are,
but when you meet him towards the late stages of your career it just
revitalizes you to make a difference. I think all of us feel that way. Simon,
we greatly underestimated his numbing travel and stage ops(?). Any of you who
go to the West Coast at all and come back you usually get a couple of days to
get over it and he’s been undaunting on that so we’ll say some more on that
tonight.

Simon, I did just want to on behalf of an awful lot of people just recognize
that there are people, you read about leaders, and then there are some you get
to meet, and then there are some you get to know, and there are some that get
to make a difference in your life. I think you have done a lot for us, so thank
you.

(Applause)

Agenda Item: Standards and Security Letter on:
e-Prescribing Standards and Long Term Care

Okay, and now moving on to the last letter — You will get plenty of
opportunity tonight, and it won’t be one word. The letter that we are writing,
and again since we have some new players around the table and in the room, the
Standards and Security Subcommittee has been responsible for following along
all of the standards, and we have been in here numerous of times talking about
e-prescribing.

The letter that we have right now really relates to long term care, and so
we are going to be discussing just the fact that we believe long term care
ought to be included in the regulations going forward and they ought to be able
to use the e-prescribing that’s out there and you’ll see in the letter what
that means.

The other thing that I think is really neat and Simon you can take credit
for this as you’re making your list of things that you did. We talk about, you
hear a lot of times standard streamlining and how long standards take and
everything else. When we get the recommendation one, we talk about a standard
that’s not available yet, but as soon as it is voted on, we would like it to be
enacted by the industry is a significant difference in, for example if you talk
about the NPI that’s been taking four years and then people are still talking
about not quite being done. We are talking about a part of the industry, back
to our earlier discussion today that has stepped up on e-prescribing. They are
continuing to say here is what we want to do and we are ready to do it, and we
will take it and we will run with it. As we look at the different things it is
easy sometimes focus on pieces of it, but there are others where everybody has
behaved in a different way.

Through the committee and through some of the things that Simon has helped
us with to make sure that they look at, this is a great example of it,
e-prescribing, and so as you listen to the two recommendations, it kind of
brings it home. We are going to start with the letter and start with our
regarding, and it’s NCPAP Script Standard version 10.0 for use in Medicare D
E-prescribing in Long Term Care settings.

Dear Secretary Leavitt,

The National Committee on Vital and Health Statistics (NCVHS) is directed by
Medicare Prescription Drug Improvement and Modernization Act of 2003(MMA) to
develop recommendations for uniform standards to enable electronic prescribing
(e-prescribing) in ambulatory care. This letter will specifically address the
current exemption for long-term care facilities from use of the adopted
e-prescribing standards, the progress that has been made in modifying these
standards to make them workable in long-term care, and our recommendations
regarding the adoption of e-prescribing standards for use in long-term care
settings.

Background — The Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA) established a voluntary prescription drug benefit program for
Medicare Part D. Prescription Drug Plan (PDP) sponsors a Medicare Advantage
(MA) organizations offering Medicare Advantage-Prescription Drug Plans (MA-PD),
are required to establish electronic prescription drug programs to provide for
electronic transmittal of certain information to the prescribing provider and
dispensing pharmacy and pharmacist.

There is no requirement that prescribers or dispensers implement
e-prescribing. However, prescribers and dispensers who electronically transmit
prescription and certain other information for covered drugs prescribed for
Medicare Part D eligible beneficiaries, directly or through an intermediary,
would be required to comply with any applicable final standards in effect for
e-prescribing.

The November 2005 regulation that adopted foundation standards for
e-prescribing contained three exemptions from the requirement to use the
standards. One was based on comments that indicated that the proposed
standards, while well-accepted in the ambulatory setting, were not proven to
sufficiently support the workflows and legal responsibilities in the long-term
care setting. Therefore, long term care facilities were exempted from the
requirement to use NCPDP SCRIPT standard.

Healthcare delivery in long term care (LTC) settings is unique for several
reasons. Nurses are frequently the primary caregivers, with offsite physicians
who monitor care. Specialized long-term care pharmacies are located off-site
with drugs being delivered to the facility. Given these unique factors, the
calendar year 2006 pilot project tested use of the foundation standards within
LTC facilities in “three-way prescribing communications” between the
LTC facility, physician, and pharmacy. This pilot setting provided us a special
opportunity for understanding e-prescribing’s impact and use of both foundation
and initial standards on an entirely different patient population, provider
type, and prescription delivery system.

In long-term care, a prescription order typically remains an open order with
no end date or with an end date far in the future. A prescriber may need to
modify this order and notify the pharmacy. Changes might include dose, form,
strength, route, modifications of the frequency, or a minor change related to
the order. Also, in the long-term care environment, there is a need to send a
refill request from a facility to a pharmacy. An example is when a medication
supply for a resident is running low, two to three doses remaining, and a new
supply is needed from the pharmacy. The facility needs a way to notify the
pharmacy that a refill for the medication is needed. E-prescribing was
evaluated within the unique context of long-term care workflow from facility to
pharmacy.

The long-term care pilot site grantee tested the NCPDP SCRIPT 8.1 Standard
in long-term care setting, and upon demonstrating that the standard was not
feasible for use in long-term care setting, used workarounds (modifications)to
test the standard as required to ensure complete prescription data was
transmitted and received appropriately. On completion of the LTC pilot, the
proposed modifications that were identified and tested by the grantees were
formally submitted to NCPDP to modify the standard as follows.

1. Adding identification for facility unit, room and board, for medication
delivery.

2. Census update transaction to notify the pharmacy about census events such
as a new resident, change to a patient’s demographic information; or patient
discharge;

3. A new transaction type of “Resupply Request”;

4. Change of prescription status flag added for discontinuance or
cancellations in the request segment.

5. Fields for needed no later than with a date and time.

These requests have been fully incorporated under NCPDP SCRIPT 10.2, and
approved by the NCPDP Board of Trustees in July 2007. According to the feedback
received from the industry testimony to the NCVHS, NCPDP SCRIPT 10.2 meets the
basic needs of long-term-care industry relative to e-prescribing. Since these
changes to NCPDP has further advanced the SCRIPT standard in other areas to
achieve version 10.5, preserving all the needs of LTC e-prescribing.

The long-term care industry expressed its readiness to NCVHS to embrace
e-prescribing so that it can enjoy the potential workflow and patient care
benefits.

Recommendations

Recommendation 1:

Once NCPDP SCRIPT Version 10.5 is balloted and approved, NCVHS recommends
that it be considered for voluntary adoption under the streamlined process for
backward compatible standards. This would provide the functionality needed in
long-term-care settings to communicate information about prescription drugs
that have been dispensed to a patient among facility, physician, and pharmacy,
and would provide direction to vendors developing e-prescribing products for
long-term-care. It would also allow for the voluntary use of the most recent
version of the SCRIPT standard in ambulatory settings.

Recommendation 2:

NCVHS also recommends lifting the current exemption on the requirement to
use the NCPDP SCRIPT for non-prescribing providers in long term care settings.
The exemption currently applies to prescribers when they are required by law to
issue a prescription for a patient to a non-prescribing provider (such as a
nursing facility) that in turn forwards it to a dispenser. While long-term care
facilities will be able to voluntarily use NCPDP SCRIPT 10.5 standard even
while the exemption is in place, we believe lifting the exemptions sends a
clear message to the industry of the desirability of e-prescribing and
long-term care.

Sincerely, Simon Cohn.

Comments, questions, adjustments?

DR. COHN: I want to compliment you, I think and as well as Jeff obviously
who is co-chair, for what I think was a very clear and very well written
letter. As he said we obviously requested changes directly to Recommendation 2,
but I think they have come out beautifully.

MR. REYNOLDS: We would thank Denise and others quite nicely, and the rest of
the committee for that — Jeff, do you have a comment?

MR. BLAIR: May I make a motion that we adopt this recommendation letter
regarding long term care?

MR. REYNOLDS: Leslie, you had your hand up. Is there any discussion
question?

DR. FRANCIS: I just had a question that you might inform me whether there
was any need to consider or any consideration of the fact that a lot of folks
in long term care facilities will have surrogate decision makers, and any
notice to surrogate decision makers about prescriptions? I don’t know whether
that is relevant to this but it is a special feature of long term care that I
didn’t see in the letter?

MR. REYNOLDS: I’ll give you my personal feeling. I don’t believe we are
changing the process at all. We are not deciding whether somebody can write a
prescription, whether somebody can get a prescription, whether they understand
how to do it, or whether we are changing the mechanism of how the data flows
and so on. That would be my response. A good question. Jim?

MR. J. SCANLON: Just a question, do we have a sense of the timing on when
the Version 10.5 would be validated and approved?

MR. REYNOLDS: Yes, July. Is what we understand.

MR. J. SCANLON: A couple months from now?

MR. REYNOLDS: So there is a motion and a second?

DR. COHN: All in favor?

(A chorus of ayes)

DR. COHN: Opposed? Abstentions?

MR. REYNOLDS: Again, so when you get down, any moment that you get down and
think that we can’t make a difference, think about we’ve already recommended a
standard that’s not completely validated, the industry wants it, the industry
tested it, the industry is going and it’s not four years, and it’s not ten
years. The vendors are going to then note to go ahead and move. That’s pretty
fun stuff to look at, so thank you.

Agenda Item: Classification Briefing on Healthcare
Terminology – Update

DR. COHN: Well, congratulations obviously the motions passed and thank you.
Well, with that, why don’t we move into the discussion, I’ll let Betsy sort of
take the floor. Obviously, we are very pleased to have Betsy Humphreys joining
us.

Betsy is I think one of the key people that has believe in over the years
moving forward the whole concept and reality of health care terminologies, and
bringing us to a place where, despite that I don’t think we are completely
there the progress that has been made over the last 10, 15 years, I think is
phenomenal, and she has been behind a lot of it.

I was reminded, actually I remember a strategic document a two-pager that
she produced in 1991. She has actually continued to perform against that
strategic document keeping up until the present. We can grade strategic
planning, but to have a two-page strategic document that will hold you well for
20 years is really quite a compliment and a phenomenon.

DR. HUMPHREYS: I have to say that that doesn’t speak to well does it, to
what Harry was talking about, making a difference. I have to really say, since
I am not going to have the pleasure of being able to roast Simon tonight, he
has just made a tremendous difference and he has done an outstanding job, and
he has actually stuck with some incredibly difficult and knotty issues over all
of these years and has really moved the ball forward. I really don’t like to
think what wouldn’t have happened if he hadn’t stuck with this for that amount
of time. I really appreciate it.

DR. COHN: Thank you.

DR. HUMPHREYS: Okay. I am, I had a very strange title, or at least it seems
strange to me on your agenda. I decided to use some of those words on the title
of my presentation. I was guessing what you might be interested in, and I have
to tell you that it is actually in this particular six to eight month period,
it is kind of a welcome change for me not to be talking to committees or policy
groups about either the NIH Public Access Policy, or the recently passed FDA
Amendments Act with amazing provisions related to the expanded registration of
clinical trials and deposit of their results, summary results data probably
prior to publication the way the deadlines and this law are set. I actually
think that on that latter one the NCVHS may deserve a break(?) in the future.

At any rate, the Secretary of HHS, as recommended by the NCVHS, designated
NLM as the central coordinating body for clinical terminologies standards a few
years ago. I am going to be talking about some of the things that we have been
doing in that area, sort of across the board. I am going to go through a bunch
of stuff and relatively quickly. I am very happy to be interrupted with
questions about any of this. If I didn’t put your favorite thing on the slide,
ask me about that one too.

You could say that what we generally do in this area can be summarized in
these few things. They cover a multitude of sins. The first one is the one we
consider to be the thing that we would do last before the lights went out,
supporting licensing, developing, coordinating, and distributed standard
clinical vocabularies, LOINC, SNOMED, RxNorm, being the principle ones, UMLS
and also supporting your distribution in your native formats.

We have worked with the FDA to be the distribution point for structured
product labels by the daily Med Service. I checked this morning and there are
now more than 3,800 labels there. This is getting to be about a lot of the ones
that are generally used, but of course as new labels are approved or as old
labels are reviewed and changed, they are automatically put up there.

We also recommended many times by the NCVHS our attempting to direct efforts
to map clinical terminologies to HIPAA administrative code sets. I’ll be
updating you on that. We direct the contract activity with HL7, which uur
purpose in doing it was to support work within HL7 to get to the point where
HL7 was more closely aligned and connected to standard vocabularies. When we
awarded the contract, we did it more broadly to also support work that was
being funded by the Department in terms of getting further with EDA in exchange
of electronic health record information.

I should say that we are just about to issue a new, our current contract is
running out. We are about to award or develop a new contract action, and we are
talking to Rob and John Lunsk(?) and others last week, because we will once
again make this statement of work broad enough to handle tasks from other
government agencies that may have issues to deal with in terms of HL7.

We are also, over the last several years working with NIH to promote the use
of standards in clinical research, and trying to avoid the development of
clinical research standards that bear no relationship to the standards that are
used in health care. That is kind of our mission, to make sure that that
doesn’t happen anymore than it has to.

It is true that they exchange data that doesn’t come up routinely in regular
health care so those things have to be accommodated obviously.

Here are some of our recent priorities. I think the last time that I spoke
to this group was about a year ago when I was telling you about how we had been
involved in establishing the International Health Terminologies Standards
Development Organization, the IHTSDO. This organization was established a year
ago, March and they actually purchased the Intellectual Property and SNOMED CT
on April 26, 2007, so it is about a year later and sort of behind the scenes
although some of the people in the room, Judy for example and Steve saw some of
that behind the scenes work.

There have been a number of things to sort of get that organization up and
running. One of the things that occupied my colleague, Vivian Altshear?), and a
number of other people at NLM longer than we hoped, was to actually put a
contract in place so that we could pay for the US membership. I may have
mentioned to you before it is kind of a trick to establish a large US
Government contract with a Danish association that was just formed two months
before you’re trying to award the contract to them.

It was all done and we had a tremendous amount of goodwill which overcame
the total culture clash, not only US-Danish but organization of that type
versus the US government. I applaud that everyone did it. The STO has elected
committees that Steve and Judy are members. Do we have any other members here,
I don’t think so, of elected committees? Now there are established open working
groups that are many of them are continuations that existed within the CAP
prior to the transference and new license and so forth.

A lot of international participation in those groups more perhaps than there
was before, which is good. This is a heads up because you will be seeing
announcements going out because half of the committee members elected last year
had one year terms, and half had two year terms so that they would sort of have
staggered rotation. We will be once again soliciting US potential nominees for
these slots and putting forward a slate of potential US candidates for them.

There are four committees, they each have twelve members and half of those
twelve members are rotating off and perhaps a couple of a few others may resign
because of changes in responsibilities or inability to actually participate.
We’ll see, I hope, and I think the STO hopes the reelection of the US people
already serving, but I’m sure we’ll have some new slots in there too.

PARTICIPANT: I heard Simon Cohn is looking for some work.

(LAUGHTER)

MR. BLAIR: He wants to fly to Denmark.

DR. HUMPHREYS: Yes, right. He thinks that that will be even a neater trip
regularly from —

Simon is actually an alternate for Andy Wiesenthal on the management board
which is an even higher level of responsibility than this organization.

That was sort of the background of activities, and there was more in terms
of assisting them with recruitment for their key positions and so forth. The
thing we’ve been really focusing on at NLM is trying to move forward the
establishing a framework for solid collaboration between LOINC and SNOMED and
particularly a division of labor. Prospective division of labor so that each
would know what the other was working on and there would be a method of either
the ability to distribute these things together or for them to work together in
some prescribed way. I think we are making very good progress on that, in that
there was a sort of a position paper developed on the LOINC side which was then
reviewed and approved by the management board of the FDO and we’re now down to
making the next steps of establishing a joint group.

It’s interesting because this group. originally in their bylaws or whatever
they referred to all of the connections between standards groups as boards.
Like we were going to have a harmonization board. I think that they are
thinking that they are going to rename this and call it a partnership, which I
think I like better. I’m really hoping that this can move forward.

The US didn’t have a huge amount of input except to say what we thought made
sense. They have come up with what I think is a very useful definition of the
boundaries for medication terminology and information on SNOMED CT. There had
been proposals on the table for actually integrating within SNOMED CT, what we
might call more drug knowledge based information, and they have pretty much
decided they wont go that far, which I think is good.

Then there has been a lot of activity to attempt to set up a really strong
harmonization activity between the SDO and WHO. Marjorie Greenberg has been
very helpful in terms of also providing US perspective and input on a lot of
questions that arose here. It seems to be moving along. Just to say that if you
look at this collaboration from the SDO’s perspective, their priorities are as
you see them here in this order, except it’s supposed to say ICD-10. Sorry
about that. I’ll correct it so we won’t have more confusion than we already
have.

As you can imagine, and as you know, most countries of the world are heavily
into ICD-10 for morbidity, as well as mortality, except for the United States.
It is a high priority with the other eight countries in the SDO to move ahead
with this. Their second priority really is to do mapping from SNOMED CT to ICF,
and their third priority is the development of ICD-11, and the interest in the
WHO’s proposed new approach to ICD-11, building it more in an integrated
fashion with the clinical terminology.

I think that based on after their recent meetings in April, the SDO sent a
letter to the WHO and basically said these were their priorities and they did
not think that it was probably too feasible to do a huge amount of parallel
work on these things given the resources available. I know that from their end
where they are going to put their emphasis is on map to ICD-10. As far as I
know, the next meeting between WHO and the SDO people is scheduled for June
2nd, and they have gone through a couple of iterations about exactly
how they will establish this and what will be the terms in the agreement of how
the collaboration will go. I know that the SDO is very anxious to move this
forward, and I think WHO is, too.

DR. COHN: Betsy, can you comment for a second — One of the conversations
we’ve had for many years now both on the committee and you and I have this
whole issue of mapping. What seemed to be sort of a simple activity many years
ago that you could just sort of do —

DR. HUMPHREYS: Simon, I never thought it was simple.

DR. COHN: Okay. A doable and a reasonable contract. How does that sound?

DR. COHN: I guess I’m sort of — do you have any comments to make about —
there just seems to be myriad difficulties in doing these things.

DR. HUMPHREYS: Yes there is, and I will get into some of them in just a
minute in terms of the ones we’ve been trying to push. I think that there are a
lot of issues and problems associated with them. I think everyone has the same
notion that they wish to be able to capture data at a more granular level and
then meet their statistical reporting and obligations.

I think that it’s possible to do this in a better way than we’ve already
done it. A lot of the issue does relate to getting the appropriate resources
lined up to do this on both sides and the time tables aligned. It is a priority
for everybody at the same moment. I think that is what they are trying to take
care of up front if they can in these arrangements. Also obviously the
governance of the WHO is very different from the governance structure of the
SDO. They have to deal with those cross cultural issues.

One thing that I think amazed many people, I’m sure Marjorie as well as all
of us, was that there was a huge significance between the words board and panel
on the WHO side. We kind of wondered why but there seems to be. My own view of
the ICD-11, I know you had a presentation at one of your first meetings. it is
obviously this idea of building ICD-11 as an aggregation layer if you want to
say it that way. It is known as CT, is very attractive.

I believe and I think that Marjorie is in agreement and a lot of people are
in agreement, that getting some sort of a robust mapping from the current
version of SNOWMED, or at least trying to create one through ICD-10 is sort of
a necessary prerequisite to figure out how easy or hard it’s going to be to do
this aggregation. I have a feeling that probably this thing is going to work
very well in some areas, and it is going to be painful in others. We may need
to do the evaluation of whether if we have a robust mapping of a certain kind
in some areas, whether that really is a step forward in and of itself and
whether it has to be 100 percent for it to be useful. I don’t know, but we’ll
have to see this.

At the meeting that Simon referred to, I think everyone who was there from
the US side was convinced that it was going to be very helpful to do some pilot
testing of this proposed, very attractive methodology in several different
areas and figure out what’s really involved in doing it. How would you most
effectively keep it up to date? All of these things, try to get some more
specifics around this. At least the timetable that’s been shared with us is
very ambitious.

Marjorie and I were discussing this earlier, and I think that she could fill
us in if she hasn’t already filled you in on plans. I think the idea is that
there’s going to be forward motion on updating the content of ICD-10,
irrespective of this structural approach. Some of that will probably directly
feed into the 10 CM and 10 Modifications, maybe. Have I got that about right,
Marjorie?

In addition, we have been attempting to advance the US mapping project.
There are three, and you see two of them here. We have been focused on two maps
to CPT, SNOMED CT to CPT, and LOINC to CPT. You can see the status of these
now. In the case of the SNOMED CT to CPT map which was originally created by
CAT, and it’s under review and validation by the AMA. They expect to have a
draft available for testing this summer. This is very recent information as of
a phone call last week. I think it is probably pretty good. In terms of LOINC
to CPT we released an initial draft in 2006 that was of the high frequency used
LOINC codes collected from a variety of different places.

The original map was created by InterMountain Healthcare and the second
edition of the map or revision of this map has been done by 3M, and NLM is
paying for this. They are sort of subcontracting LOINC to IHC to 3M, but this
one is also under review by the AMA. We might even shake this one loose at the
beginning of the summer of 2008, because they have said that they think it is
in very fine shape, the AMA has.

There is one for radiology. This is also under review by the AMA but they
really haven’t done much review of this one yet. You notice the AMA is involved
in all of these reviews. Maybe everything is coming out this summer. This is
one of the issues with these things. Who’s going to do what and how you get
them maintained over time.

I am happy that I think the AMA has agreed to get together with LOINC at an
upcoming meeting and I think they will really focus on how this is going to go
forward. That map from LOINC to CPT as you would imagine is much more sensibly
maintained on the LOINC side because that has much more turn over and so forth.
I actually think we may come up with a reasonable way to keep this thing up to
date and going.

When we started talking about these maps lo these many years ago, we had an
initial meeting that involved some people from CMS. In the end we want the CMS
to be comfortable to help us with testing and evaluation of these maps, look at
the impact it has on billing data, et cetera. Come up with some ways of testing
this that makes sense and then have them in a way that the process to the
ongoing maintenance of this because it’s obviously not going to work if they
have to deal with technical review of everyone. By the time the review is
through, the map will no longer be valid because we will be on to the second
year.

I think that as we now see that we are really going to get more robust
examples of these soon that we are now going to go back to CMS and find out who
we should be talking to now and really start engaging on this testing. Off the
top of my head it seems to me that you obviously need to take some
retrospective set of data and see what happens, in terms of what really was
submitted versus what happens if you rely to some extent on these maps.

There is always going to be a set of human judgment involved in a number of
these cases. The idea is maybe to reduce the number of cases and make it easier
by narrowing down the choices for the human beings, all remains to be tested
and seen.

The one that seems to have been around longer than anyone else, and yet you
have still not been handed anything to test, is the one that goes from SNOMED
CT to ICD-9 CM. A map was created, we were sort of unable to reach an
acceptable level of concurrence, in terms of the review of certain cases within
this map in order to feel comfortable that we could distribute is it as a test.

We decided to change the approach, and we are now focusing on a subset of
heavily used SNOMED CT things that in effect handle problems or diagnosis for
98 percent of the patients seen by Kaiser and University of Nebraska Health
System. Just take those 5,000 which we suspect are going to be easier cases
than some of other esoteric ones which caused a lot of disconnect between — we
couldn’t even get much inter-rater reliability in some of these areas. This
5,000 now — we generated the subset based on some data that Kaiser and
Nebraska sent us. It’s been sent off to a AHIMA, who is reviewing it on behalf
of the National Center for Health Statistics. They designated a AHIMA as a
group that could do this validation. We live in hope that we’ll have the draft
available for testing by October.

We have a number of other priorities that we’ve been pushing. The first two
of these relate to the AHIC and the Secretary’s personalized health care
agenda. NLM and LOINC have been heavily involved in expanding coverage of
genetic tests and also been heavily involved in what has been a very productive
discussion among a large number of players about how we can end up sooner
rather than later, with sort of standardized value sets that across different
clinical standards that collectively represent what should be sent back and
forth on a newborn’s screening. To get very robust reporting and testing of
newborn screening.

In both of these cases, one of the big issues, which I know has come up in
this group and before, is the fact that you want to improve or you want the
data that the laboratory actually has to be transmitted, not just the clinical
interpretation of the data. The clinical interpretation is necessary and useful
in a variety of things. You would actually like the values to come to and then
that particularly in newborn screening would support a huge amount of very
necessary research and testing and evaluation, because of state variations in
the actual definition of the clinical interpretation, in terms of whether this
child has this problem or doesn’t have this problem, and the issue of having
any base line data in the testing so that if you are following children in
registry that you would sort of know what the real values were and we could get
to the point of maybe doing better quality control.

I think that the AHIC personalized workgroup has really done a very nice job
of pushing this agenda along. There have been a lot of excellent people
involved in that. Partners Healthcare and Steve Downs at Indiana, and it’s been
people at Intermountain Healthcare and University of Utah, some really good
work there. I think this is going to be very valuable.

One of the things that we have been engaged in discussing with HITSP and
with various other places is how do we get to a sustainable approach or
defining and distributing specific terminology value sets or HITSP
specifications or in fact for other purposes like the one I was just talking
about. I have been interested in trying to set up, we are in the early stages
of this but we are trying to figure out a sustainable way of dealing with this
issue with HITSP. How can we come up with a practical and feasible way of
having vocabulary and clinical experts who would be needed to define these
value sets, engaged at the appropriate time to do it with enough background to
do it well, without having to start back at use case development and run all
the way through?

We have a very limited set of these experts and when they are any number of
use cases being worked on or any number of things, we just can’t get these
people in rooms for the entire process. We need to figure out — I talked to
Lee Jones about this and I’m going to be having phone calls with the
Foundation’s people about it, too. I just received an email about that. We’ll
have to come up with something about how to do this.

In the meantime there has been a huge amount of expansion and assignment of
RxNorm that is going along well. There also has been some interesting work
going on related to RxNorm and use in standards in health information
interchange and so forth, combined activities I guess also at Indiana and with
Vanderbilt and the Memphis crowd. We are excited and happy about that. I
mentioned DHL-7 contract before.

One of the issues of course is what has come up and is a high priority for
example, when polled, the US committee members of the SDO. That is basically
establishing an appropriate mechanism for people to provide input and advice
and assist with priorities of these terminology coordination efforts. I have
been in discussions with ONC and this is something that is directly relevant to
the NCVHS and to the AHIC and have come up with some ideas of strategies for
moving this forward in a way that will migrate well across administrations.

I will be glad to come back and talk to you about that in the future when we
have some specific proposals or ideas on the ground for that. I am going to
stop there but I would be happy to answer questions about this or anything
else.

DR. COHN: Well, Betsy, I’ll start with one question before Justine, and
Blackford, and Harry. I guess your last comment which made me wonder. How much
at risk is a lot of the pieces you are talking about in relationship to
transitions in administrations, in Congress, and all that?

DR. HUMPHREYS: I think that basically NLM has used the NLH doubling to build
into its base activities support of the ongoing maintenance and dissemination
of these basic vocabularies. That’s something that we will protect. If I go all
the way back to the beginning of this, you see that in the development stages
or the early stages a few years ago, we got some very nice support from ASPE
and from AHRQ for getting going, for example getting setup with daily med,
which we can sustain at the level we are at. That also helped with scaling up
RxNorm, and so forth.

Some of this basic activity we can sustain. To be frank, some of the dollars
that are being spent this year on these mapping efforts, are dollars that were
obligated in previous fiscal years because all of these organizational efforts
and other problems that came up made it that you couldn’t move ahead as quickly
as we would have liked to do. I have to say that these mapping efforts of
course are affected by anything happening in either organization at either end
of the map. Of course in the middle of some of these things involving SNOMED we
had these major changes in the ownership of it and then you have key people who
leave or do something else at any of these organizations. It takes a while to
re-up them.

We have to get this on a better footing and we really do have to get the
process and the initial responsibility worked out so that in my view it belongs
at one end or the other. The other one has input vested in the process and we
can’t be passing these things around, you do everything and you look at it and
somebody else looks at it, and somebody else looks at it. We never get them out
the door in time to be useful for anyone.

However, we have to do that the first time so that we can all believe that
it can be done and it’s technically good, so that’s what’s going on. I don’t
know. We still don’t have a situation, well let me just say that in my view we
don’t have the level of funding that would give us greater confidence that
these things could be developed and maintained at the rate that over time we
would want to see them happen.

DR. COHN: Justine?

DR. CARR: Well, I think I was asking something along the same lines. What
would it take to make us look like one of the European countries that does this
successfully?

DR. HUMPHREYS: It would take the United States being an entirely different
country. It would take us having a health system instead of a lack of one. It’s
just a whole different approach. I think that they are not dealing with this at
the same level. Yet of course, let’s face it, they are taking advantage in
their system of these important and very useful vocabulary standards that were
developed in our lack of system.

DR. CARR: Is there anything that NCVHS could or should do, or say that
increases support for as you said the clarification of the responsibility and
the ongoing support of this activity?

DR. HUMPHREYS: Well I do think that one of the things that should not be
forgotten as we’re driving towards adoption, which is of course the end goal
and real use, and getting real feedback. We are going to find that some of
these standards that have no yet been heavily used across the whole spectrum of
healthcare in the United States need changes and improvements, and enhancements
and whatever based on what we now know on how people really use them in those
environments.

I think that we need to, we’ll be better off if we support that adequately
because we need to make the changes that real use will show are needed. In the
case of LOINC, LOINC gets a lot of real use, and there we know exactly where
the new stuff is coming from. It’s coming from Genomics and it’s coming from
the next test, and the next thing and we know that this is a continuing
trajectory and in the case of RxNorm, I think we have built a pretty good
process there because we are headed towards a place where we can feed RxNorm
development. We are already there to a certain extent, but we are going to get
there more. It can be driven coming off the drug approval process. That becomes
quite an effective and efficient way of moving forward there. I do think that
we have to remember that these things don’t maintain themselves and they don’t
need billions, but they need support going forward.

DR. COHN: Blackford?

DR. MIDDLETON: Thank you, Betsy. Great update. Great to see you again and
learn about all that’s going on. One question that I had though, I guess was
about the aggregation layer you described. I’m not familiar with the
terminology. I wonder if you could —

DR. HUMPHREYS: I’m sorry. I shouldn’t have said that. I should have just
pointed you back to however Chris Shute(?) describes this. It’s just in my mind
it’s the notion tat the view that ICD-11 should be built on top of a clinical
terminology and there should be a defined set of relationships and paths that
get you from down here up to the appropriate ICD for that aggregation of
clinical facts encoded in SNOMED somewhere. Some of it is hierarchical and some
of it not quite. I should refer you back to his presentations. This is perhaps
my strange terminology for his idea.

DR. MIDDLETON: That means I would actually have to talk to Chris?

DR. MIDDLETON: If I could follow up. One of the things we are struggling
with I think is as we implement terminologies in clinical systems and what not
is that there is something in between sort of the ontology representation and
its utility. Of course the root terminologies that express different concepts,
what not. Specifically, we run into the problem of classification services or
classification concepts that are in between you know kind of ontology
representation and terminology.

We are actually building classification services that say based upon a set
of data or attributes of patient, he or she is a diabetic or have you. Is there
a role for development of such classification?

DR. HUMPHREYS: I think this is kind of what — you know the issue is if you
get the terminologists working on this just from a terminology perspective, you
can only go so far with it. What you really need to figure out is okay, the
terminology is here, it is used in this way in the clinical data. Given that I
have the clinical data and the use of this terminology, how can I aggregate up
to this thing? That’s why it is a very appealing idea and I don’t believe that
it can be built like this notion that ICD-11 would work.

It seems to me that it absolutely has to be built and tested and get
information from real clinical record systems. Which is why I say the sort of
ongoing maintenance and change more so in SNOMED than in the other two that
have RxNorm and which have in some ways a more limited used case, and more
experience on how that would work over time. I think that’s why we need to
expect that we are going to make changes to the terminology that we are going
to find other layers that we are going to figure you know work like such as
you’re doing and is being done in other places. Is going to figure out what we
really need to do here.

MS. GREENBERG: I just wanted to mention that in the minutes of the February
meeting are in your agenda books and I think actually on pages 12, 13, and 14,
there is a summary of the discussions, the presentations and then the
discussions with Chris Shute. We probably have also posted the slides, so you
don’t have to go far, just go to the NCVHS website.

DR. COHN: Okay, Harry?

MR. REYNOLDS: Betsy, thank you. Prior to, about a month ago, SNOMED was
something that Judy and Steve would just talk about when they didn’t want me to
understand what we were doing but I ran in to it on my day job. Based on what
Justine said, and some of the privacy stuff we had this morning, I had a chance
to look at a website the other day that somebody is developing and they use
SNOMED to take a lot of the data that they need to use.

They used SNOMED to put it into terminology so that when the patient wanted
to select data that wouldn’t, sensitive data and other things, it was put in
those categories using SNOMED. As we think of these things, and again as we
implement during the day, when you think about it, if we are ever going to get
down to passing this data and actually putting it on the street everyday for
normal use, it’s going to have to be something in play. You sure don’t want
each entity going at it themselves and trying to figure out and know what it
means.

Justine back to your point. If we are talking about more information,
letting the patient be involved more on this and doing that, as we move to
ICD-10 and other things, ICD-10 doesn’t work with real people on real streets
as far as exactly what is meant.

MS. GREENBERG: Neither does SNOMED.

MR. REYNOLDS: The way they were able to use it, they were able to use it in
a way that made it pragmatic.

DR. HUMPHREYS: I think that in many environments and for many reasons it
does help tremendously. There are a lot of people for example who are after the
fact using SNOMED to encode clinical data in warehouses so they can display it
more. There is more going in, in restricted, certain environments. Partners has
a big thing going coming out in a month or two, right, in terms of problem list
using and so forth.

Just do me a favor. When you get to doing that, please don’t invent another
vocabulary.

MR. REYNOLDS: No, just using it as an example where a lot of us, well I’ve
heard a lot of you talk about it but I haven’t seen it in practical use in the
environment that we are all trying to go to. This is very timely, and it
relates to a lot of stuff we are thinking about because it did answer some of
the privacy stuff and some of the other things that were with the way that
vendor was using it. I don’t know if they were using it good, bad, or
indifferent because I still don’t know a lot about it.

DR. COHN: Yes, and this is partially in administrative data?

DR. HUMPHREYS: I’m really delighted to hear this. I’ve spent a certain
amount of time trying to make this available in the US so I’m delighted that
people can find it useful.

DR. COHN: A question on this one, or did you? Jorge has a question.

DR. FERRER: Just two observations. In retrospect, would you say that use
cases of AHIC 2.0 shaped under that terminology, national efforts? Looking at
the future of AHIC 2.0 what do you think the role should be regarding the
national efforts. Oftentimes I cringe when I hear volunteer consistent standard
body(?) and 2.0 use at the same time. I still have scars on my back that I’m
trying to heal.

DR. HUMPHREYS: I have to say that I think that — I’m on the HITSP board so
I will give that as my conflict of interest statement. I really do think that
the combination of the AHIC use cases, and then the work of HITSP, has really
made a big difference in driving forward some standards activities, similar to
what Harry was saying about decisions made here and so forth.

Some of these things where heads were knocked together about you know the
CCD and the CDA and all of the other stuff. Some of the work that Steve and
others have done to try to move these things forward. I really do sort of feel
that if there hadn’t been this whole process, how many more months or years
would it have taken to move some of those things ahead. I also think that, and
this is work that has come out of Indiana, that sometimes the massive
standardization approach, standardize everything may not be the way forward.

If you have a group of people who say we are going to exchange these data
and you can get to standardize that set of data, then of course the systems
have to deal with that vocabulary. Maybe they only have to deal with it in this
particular way but they get familiar with it they start using it. I think it’s
been helpful and I guess, is there another way, was there a better way, maybe?
It is always easy to say that, but I think it really has moved things forward.

I am concerned about AHIC 2, the same way everyone is, which is they come up
with a structure and an approach that will allow a legal process for government
agencies to take on board and pay attention to the advice coming from that
group one way or another.

MS. MCCALL: First, I wanted to thank you for your comments. This is I know
is sometimes things are rather arcane and very detailed technical discussion,
yet the concepts are really important. First, thank you for coming and sharing.

As I listen to you, it seems to me that one of the fundamental problems here
is that of speeding. Trying to speed up in fact a lot of the mapping work so
that it is not only done, but made available so it can be made relevant. The
relevancy is I think back to some of Harry’s comments, not just the relevance
of the existence, but its use in making somebody’s life different.

I think on this issue of speed, it is not just mere frustration that it’s
slow although I’m sure that that’s ever present. It is more than just a missed
opportunity. I actually see it as an emerging kind of threat. It is a threat
of, if it’s not sped up, it will be marginalized. The reason for that is that
there are a lot of things happening in the whole personal health space. Just
even in the announcement on Monday, that Google has now in fact launched free
data. It doesn’t matter, they are there. People will begin to hook to it and to
begin to build off it at a speed that I think will begin to accelerate for good
or for bad.

Something will happen. To not keep pace with that, to synchronize, to
synchronize means to accelerate makes that third element an issue kind of a
quasi threat of being marginalized. With that as a backdrop, I would recommend
that you find ways to harness kind of a wisdom of crowds approach, a many eyes
approach, in ways that have been made delightfully rigorous in other forums,
witness Linux.

Who is the red hat of clinical taxonomies? Not just who is the organizing
body, but how to exploit some of those same mechanisms that are both
delightfully open and delightfully rigorous and have governance and decision
around this as a final answer. Not in just producing the answer but once it’s
done, also the mechanisms that help created itself.

DR. HUMPHREYS: Yes, I think that there is great deal of interest in movement
in a lot of these areas toward more ability to have distributed input and
comment, if still some centralized approach to making sure that in the end it
was done with real understanding of what is the meaning on both ends.

MS. MCCALL: I have to tell you that I actually think that personal health
records situation in terms of standardized terminology may be easier to crack.
A lot of our problem in dealing with mapping and every other thing is the
existing systems and the training and whatever of the people who are used to
using them. Now my colleague, Clay McDonald, is focused on the notion of
personal health record data entry for capture, which kind of standardizes it
for you under the hood. It’s pretty impressive actually. I’m sure that others
are working on similar things.

If you are dealing with somebody who is in some ways now starting in an
electronic way to capture data about their family, and get input from a variety
of places and whatever, you have a much more blank slate that you might be able
to draw nicely on than you do when you are attempting to deal with large
installed healthcare organizations and many physicians trained different ways
and so forth, but your points are well taken.

DR. HUMPHREYS: Just as a coda. When I talk about personal health, it’s not
necessarily with a simply a personal health record as you often think about it.
My intent is to think about something much broader than that. I do think there
is an opportunity for those worlds to truly mesh. For example, Mediconnect is
something that will populate, I think they announced with Google Health.
Basically it would scan whatever is out there for you and then put it into your
PHR.

What it’s going to snag are all the vocabularies and taxonomies that you’re
talking about, that people work so hard to figure out how to get in.

I really do think that the development of personal health records has a
potentially very strong standardization. It can drive standardization. It can
really drive it. If I am expecting that wherever I go somebody is going to send
me and electronic message that my PHR is going to be able to absorb, that means
something in conjunction with the rest of them in terms of my latest lab tests
or whatever it is. I think if people are very interested in that, they will in
the end get it. That will drive standardization. Your points are very well
taken.

DR. TANG: Thanks again, Betsy, for all the long hours and years of work on
this. One quick question? Did you say that HIMA was going to be validating in
the mapping scheme in SNOMED and ICM, and did you say in October?

DR. HUMPHREYS: No, they have this heavily-used subset, and they are going to
— the approach we’re taking is as follows.

They are going to do an initial validation of this. We are then going to
have a meeting. They’re going to send around their results. We’re going to
bring in the CAP people also, excellent people who know a lot about medical
records and coding or whatever.

We’re going to bring them into a meeting. We’re going to see what are the
differences and whether there are reasons behind them and whether we can
adjudicate, you know, if there’s one way to do it or not.

We’ve invited Jim Campbell. He’s going to come if they can’t absolutely
agree. He’s going to decide.

We really just need to get to a place where we can get a feel that we have
quite defensible inter-rater reliability on this issue, and I think we can get
it by this mechanism.

Our hope is that all of what I’ve just described will take place. In
October, we will actually be able to say to people, well here is a test version
of this.

Now we have the next thing which is, will it be useful to anyone? We need to
get that out of the way, too. It’s just been one of these things where we have
felt that there were significant enough questions from the experts about the
technical accuracy of the mapping.

We think in some of the more esoteric corners of it, and so we just decided,
why don’t we just go for the stuff that people use the most? If we can get that
in a really good way and move on from there, I hope we can.

DR. TANG: The other question, I was very sympathetic to your comment that
the world doesn’t invent or at least the United States doesn’t invent more
vocabularies. Clearly the time window has created private sector, filling the
gap kinds of activities. Just thoughts on that?

DR. HUMPHREYS: Well I really think that what the FTO(?) is really about and
what I think is already there with LOINC is really strong input of people who
are trying to implement things. I think we’re moving in that direction.

The issue is that you need to see what people have done, and what they’ve
thought was necessary in order to make this useable.

As I’m sure this group has discussed before, and maybe will again, and I
know you have, there is the whole issue of, do we actually know the structure
of the record that we want the controlled vocabulary to work in? That is, and
there is an interaction between the way you divide up the world in your record,
and the terminology you need to go in it.

I suppose you discuss this all the time, and everybody knows this as well as
I, but I mean if you put the person’s family history in the problem list, then
you have to have terminology that deals with the mother’s breast cancer. That
has to be a connected term in there.

If on the other hand you have a family history and you have a mother slot
over there, and you can put down the types of diseases the mother had, then
hey, you don’t need to attach mother to every vocabulary thing that the mother
could have had.

It’s therefore very difficult for any terminology to be exactly what every
medical record vendor wanted if they’re all designing the structure of their
record differently. The problem is we don’t have hundreds of years of excellent
experience on which to tell everybody that we’ve already proven that this way
works better than that way. We all have our ideas and some of them probably we
do have, and that’s the issue.

If somebody says, well just standardize the way the record looks, and I —
that bothers me incredibly because I don’t know that we have any heavy use of
any of these records really as much as we would want. How do we know that we’ve
even invented the structure that will really make these things take off and be
most useful?

It just is a — obviously I don’t think this is insoluble reason not to do
anything, otherwise I’d be in another line of work. But it does mean that it
isn’t so simple.

Anyone going to implement a vocabulary, depending on how they have
structured the electronic record that they’re putting it in, may find that a
given vocabulary just doesn’t have everything they need.

DR. COHN: Final questions?

DR. GREEN: Betsy, thanks again. During the last couple of days some of us
have sat through hearings about patients that are in medical homes. In a
segment of that, in discussions about data models and data flows, an old idea
resurfaced that I would like your opinion about.

The old idea was that we still don’t really seem to have a mechanism to
capture why people here become patients. Why is it that people enter the health
care delivery system as they do when they do, where they do?

Captured, I think by one — may have been Michael Clinton(?) that said you
know, just capture in the patient’s own concepts and words, why they’re there,
as opposed to a process that suggests and explanation that says well it’s
diabetes. That was an example that was used yesterday.

What’s your opinion of how full or how blank the slate is, related to
terminologies about why people enter the health care system?

DR. HUMPHREYS: You know, I don’t know the answer to that. I suspect that
it’s definitely not blank.

My guess would be usually when we start on any of these things, it’s
somewhere between 60 and 70 percent of it is there, and can be found.

I also think that you don’t — that the use of standardized vocabulary is
not — I’m absolutely not in favor of using it to the exclusion of capturing
people’s own words, whether they’re, you know, the clinicians or the patients.

I think it’s just the issue of certain things, if standardized in the
record, will make decision support more accurate, will allow you to detect
conditions that are difficult, will get the person faster to the place they
need to go, et cetera.

I myself feel the most effective electronic record is going to combine coded
information or information that’s in controlled vocabulary and numbers, and
some pretext information.

DR. COHN: Okay, well with that Betsy we want to thank you. I think it’s been
a great briefing and you have given the committee a fair amount to think about,
especially when it comes to their future directions, and sort of next steps.

What I’d like to do is give everybody about a fifteen minute break before we
come back for a discussion, so that the next steps for the committee.

(Brief recess)

DR. COHN: Well you know it’s Harry’s turn now.

MR. REYNOLDS: In the spirit of technology, if you would follow the wire from
— and notice it’s not connected to the back of the system that I have, you
would find out who put that up there.

(Laughter)

In a moment for me to get connected, someone will have to go near their PC
and bring it down. I have nothing else to add to the discussion.

(Laughter)

MR. HOUSTON: I’m going to tell you what this is all about. In 1938 Wendell
Wilkie, when he was running against FDR, had a button that said, no man’s worth
three terms or something like that, or no man is good for three terms.

When Dewey ran against FDR in 1942, he had a button that said, no fourth
term either. We just thought we’d put that on the same rhetorical purposes.

(Laughter)

Simon that has nothing to do with the fact that you have been here for three
terms as a leader.

(Laughter)

DR. GREENBERG: I didn’t realize that John was that old.

(Laughter)

DR. STEUERLE: Dewey after he lost the election, said he felt like a man who
had woken up in a grave, and said to himself, now if I’m alive then why am I
here?

(Laughter)

If I’m dead, why do I have to go to the bathroom?

(Laughter)

Dr. COHN: I just want to remind everybody to look at Leslie’s face when she
realized that I’ve actually been here for 12 years.

(Laughter)

Anyway, Harry, it’s all yours.

Agenda Item: Committee Structure and Work Alignment
Considerations NCVHS in Transition

Mr. REYNOLDS: Okay. This is a presentation we put together out of
discussions that we had in the Executive Subcommittee on the structure of the
committee going forward and the subcommittees.

I’d like to especially thank Simon and Justine for helping me through these
slides and moving forward.

First thing we wanted to do is just to remind everybody of what our mission
is as we advise on the shaping of national information strategy for improving
the population’s health.

I think that really came up yesterday as we heard the whole thing about the
medical home and just this idea of coordinated care and making a difference
with individual people.

We’re charged by Congress with advising the federal government on
information needs underlying health policy. I know a lot of times a number of
you glaze over when we mention HIPAA, but we do have a HIPAA charge straight
from Congress that we do. We do have to keep an eye on it, we do have to
respond, and we do have to comment, we do have to stay close to it as a
subject.

We need to really provide a bridge between government and to help industry
and research, and the public health communities as well as connections to those
working on health information policy in other countries.

Everything we do is either affected by others or many of what they’re doing
affects us. Just to remind us of the things we need to keep in mind as we do
what we do.

What we’ve come up with, and are going to move forward with, is a bit of a
change. The names of some of the subcommittees and also what Simon had
recommended, I guess maybe in his first term or second term or third term, is
something about that we ought to have maybe a little different leadership
structure. We actually listen. Next meeting maybe when he’s not here, we’ll go
back to the way it was.

(Laughter)

We want him to feel good that we kind of listen a little bit. Don’t get
excited about this little idea —

(Laughter)

If you remember, Standards used to be Standards and Security. It’s just
going to be Standards now. It’s going to be co-chaired by Jeff Blair and Judy
Warren.

The interesting thing about the fact that we’re mentioning Co-chairs is if
you look in the book, we have many — everybody has a term. As those terms
change, then we would more than likely change. In this case, if Jeff has been
here, probably longer than Simon — I think at the end of next year, Jeff’s
term runs out, then obviously Judy would still stay involved and then we would
probably have somebody else step up to the co-chair.

What we found, and I know you’ve heard us all kidding about the Ad Hoc
Subcommittee, we found that having more than one person working on these
things, from a leadership role, really enriches what’s going on, and takes a
lot of pressure off.

I’ve watched what Mark Rothstein and others have to go through just being
the chair themselves. It is tough because some of these subjects are broader,
wider, and deeper than things in the past, especially as we’re trying to
coordinate these things. We’re starting off there with that.

Privacy, which was Privacy and Confidentiality is going to be Privacy and
Security. That’s going to be John Houston and Leslie Francis. They’re going to
be coordinating that for us.

Under Populations, Don Steinwachs and Bill Scanlon are going to be working
with us on that.

We used to have a Quality Workgroup, which was a subgroup of the Populations
Subcommittee. Based on what we did with the secondary uses and looking forward
at the things that are going to be happening, we’re actually now recommending a
full subcommittee called Quality and Data.

If you remember, a lot of the things that came out of our Secondary Uses,
the de-identified data, the data stewardship. We heard a lot about quality
yesterday, and the day before. Focusing that — that’s going to be Justine Carr
and Paul Tang. I’ll obviously remain as the chair of the Executive
Subcommittee.

This is the slate that we plan to go forward with, but again, any of you
that are interested in leadership roles continue to remind us.

As we go to the next one, to show you, we used to have an NHII Workgroup and
subcommittee and we decided that since — we realized that many — we may be
running into more and more subjects that could include things like the NHII,
could include things like the secondary uses or other things. There are going
to be subjects that are going to be really horizontal across everything we’re
doing that we basically just decided to set up an un-chartered work group for
flexibility, which is really an ad hoc, instituted when necessary.

I would be the chair, Debbie would be our initial administrative support,
but then based on the subject, possibly pick a couple of vice chairs and
members, and the vice chairs in my opinion, would not necessarily have to be
people that chaired subcommittee. We got somebody that’s really interested in a
subject, really interested in what’s going on they could vice chair this
committee on a subject.

The other thing we’ll do is as we select staff, we would be stuck in lead
staff, based on what they did, and what the issue was. We’ve had that happen in
a few of the different meetings that have gone on.

We don’t know the specific subject, but this gives us the ability to
mobilize pretty quickly when it doesn’t fit nicely.

I’m going to make some more comments about how maybe we can also work
together a little differently as committees, than we have in the past where we
just got really vertical and said what it did. I’m going to touch base on those
two in a moment right now.

Some things we’re going to want you to consider as you do your subcommittee
breakouts and — so if you take everything we learned, and some of us learned
since Monday, and then you take some of the things that came up today, when you
have your breakouts later this afternoon and tomorrow morning, we’re going to
ask you to put together what do you think you ought to be doing? What does that
look like? What does that feel like? What are those subjects? Which ones go
this way?

You have some things — like the medical home we heard yesterday — if we
just wanted to use it — call it coordinated care rather than a medical home,
if anybody ever got fired up about not liking the name of it.

The point is when you talk about coordinated care, maybe everybody should be
looking that up and maybe somebody like Populations has a lead on it, when the
whole thing together — not necessarily that you’d set up a work group for
that.

The other thing to always remember is, who is our customer and audience of
our efforts? It’s very important that we make a difference for others, and make
a difference, for the Department, and make a difference for the industry, and
not just get overly excited that we did it for us. We have to be really
cautious that we understand who that is.

However, if we have a subject that’s visionary or self-generated, how will
it make a difference? As we would look at each of these subjects that would
come up, these are the kind of questions we ought to be asking ourselves,
because if we don’t know that it’s going to make a marked difference moving
something forward, and then possibly after we do the initial discussion of it
— like the secondary uses is a good example — we had an assignment, but now
that we’ve done it, it’s going to break off some other things that we ought to
keep going on, and those wouldn’t be under an ad hoc committee, a couple of
them would probably fall under Data and Quality.

We’re working how a subject can move around and we’re not going to just get
overly myopic about who’s on what committee, and what exactly does that mean?
How do we tailor our letter or product to appropriate audiences?

One of the things we realized as an Executive Subcommittee, is — and it’s
covered in the next one too — is we need to make sure that after we finish our
product, that we package it, market it and format it in a way that it makes the
most sense.

Some of you have seen the document today that you have in your packet on the
secondary uses that’s being produced now, and it was written and reformatted in
a way that it can now be used by people that are thinking about policy and
other things in a different form than the voluminous document that we put
together, through the many, many Sunday nights, and other nights that we did
doing that.

As I said, what format, and who authors each NCVHS product? Do we have an
NCVHS document style? All of you know Susan Kanaan, and what you come to find
is, no matter what we’re saying more and more, it has to play in all audiences.

As Simon said he called yesterday, and wanted some things adjusted in that
paragraph and after I adjusted it, I let Susan look at it, and she looked at it
totally different than I did, and actually made it much better.

Having somebody that basically is not stuck in the detail, not stuck in the
subject, and really stuck in how we really project what we’re doing and how
we’re doing it to the outside audience, can make us dramatically more effective
on certain cases, because it’s just a different way to look at it. We have to
consider that as we do our things going forward.

When subjects span the expertise of more than one committee there are
several approaches. Supplemental selected members. In other words, if there’s a
subject going on in one of the committees and it would be good to know that
there’s going to be some privacy involved, you don’t have to invite the whole
Privacy Committee.

Maybe if you talk to John and Leslie, and maybe somebody comes to your next
two hearings to make sure that we’re asking the right privacy questions without
making it a whole subject for the whole Privacy Committee, and let the
committee that tends to have the lion’s share of the discussion, still carry
the ball.

It’s not then brought in to the full committee, and that’s the first time
you start hearing about any significant issues that may come up or things that
should have been considered as part of the initial deliberation, and part of
the initial discussions.

We can obviously create an Ad Hoc Workgroup, but again that needs to be
something that’s cross-cutting enough that that’s important to do that. We can
divide the work and hearings between two committees to cover different parts of
the subjects.

For example, I’ll show you in a minute when I put up what we had put
together awhile back for Standards and Security. I think you’ll be amazed at
some of the things that came up in the medical home yesterday, were already on
the list of items to develop by the Standards group. It played perfectly
together.

Standards could take those pieces, and I think you’ll see what they are in a
minute. Even if Populations continues forward with the whole idea of the
medical home and keeps that as the general subject, maybe wanting Standards to
develop and push forward some of the individual pieces that would play into
that as a subject.

This idea of subject and then pieces and those things — so that we don’t
just get hung up on very vertical thinking about who’s who, and what does that
committee do, and how do they do it?

More and more, I think from all the testimony that we all hear, and I know
all the sessions that we have, the more horizontal we can be about a subject,
and inclusionary of the things that consider in that subject, I think that’s
how we can take these.

There are many individual groups out there meeting on individual pieces of a
subject. We sometimes are the best at pulling the subject itself and making
sure that people see how that subject would work together, and I think that’s
— take the NHIN requirements, take the 21st century look, take some
of the other things that we’ve already done with many of you on the committee
here.

The other thing that you need to take a look at as your looking at the
committee is — I use the word a lot at home called undertow, you can get —
for example, Standards can get pulled into the quiet undertow of HIPAA.

You could have a hearing every hour and half on something related to the
next HIPAA thing and standards, but that’s not the only standards we need to be
thinking about.

We’ve got to be careful that we have a good balanced thinking, so that every
committee is looking at some visionary type items, some near term things that
we need to deal with, and then obviously there are appropriate follow-up to
previous things that we’ve done.

For example, if I took the Privacy Subcommittee —Mark and I and others
have talked continually — we put out the larger letter. We’ve gone back and
looked at each of those recommendations again to see if we should be the ones
that drill down to the next level on those things.

If we just throw them out there at the higher level, and they’re out there,
but then we need to decide the ones that we think we can make a further
difference in, and drill down on. You could take one that was more of a
visionary look, and then you could actually play on all three of these, as we
would develop it.

Again that’s what you have to decide as a member of the subcommittees, as to
how we’re going to make a difference and what that actually looks and feels
like. Those are the things we’re likely to think about.

Also subcommittee considerations and for the breakouts you’re going to have
this afternoon and tomorrow morning, we really need you to make a work plan for
the next twelve months. Obviously we’re in a transition right now and we’re
losing a lot of really good thinking and a lot of skill off of the committee.

We’ve got to reconstitute, and we’ve got to pick up where we go, and make
sure we do the next best things. Think about what we can get done in roughly
six to eight months.

In planning a hearing — and I’ll have to tell you I’ve been in a number of
hearings, and I thought that the structure of the Populations hearing the other
day was actually almost mind bogglingly well done. Credible number of speakers,
credible amount of data, done precisely, done quickly. The speakers —
obviously somebody scared the speakers to death because they stayed on time,
stayed on message period. It was amazing, I mean, it was really well done. We
got a wealth of information from them and it was well done. Still plenty of
time for questions and I don’t think anybody walked out thinking that they
couldn’t.

Making sure that you plan it, making sure that you understand what you’re
trying to get to. Put the right people in the right order so we get somebody
that’s coming in and giving the big picture, let’s let them first and then
drill down on it.

Just some things to think about, that again, a lot of us were taught
individually by the Simons and the Jeffs, and the Marks, but make sure that we
keep these things in mind so you can have this as a document for you.

The next thing — and I’ll go to the next one first and then I’ll come back
to show you what we’re thinking about. What we’ve been doing with Standards all
along is to try to — because what always hit me, as we all mention, we all
have a day job. Every once in awhile somebody would call me and say, what’s
Standards doing? You then kind of hem and haw and make some things up as you
go, till you get your feet under and you go, oh yeah that one, we were doing
that one.

What this does, is this allows us — personally, and Simon and I were
talking about it, every once in awhile we give speeches about the committee.
Marjorie may be doing the same, or somebody else might, four or five individual
pages that says what the committee is thinking about, near term, short term,
and what are the things we do, and who do we deal with, makes it a whole lot
better.

Each time you meet, you ought to be looking at this, because if you’re not,
then I’m not sure we doing the next right thing. That’s how we’ve been managing
what we were doing, because we had to keep in mind, what we should be thinking
about, then each of you would have that.

For example, the interesting thing on subjects to develop, the third one
down is terminology for primary care — ICPC(?), which came up the other day. I
didn’t touch this document before that. Then you got, for example, under
evolutions to new standards, you got the third one down as evolution to SNOMED,
LOINC and so on. Some of these things were already on a list, as things we know
that we’re going to have to help move forward even though those presentations
came in today, they’ve been on our radar for a while, and it’s just, how do we
get to them?

If you went over to the current hot issues on this one, which is for
Standards, we could absolutely spend forever and ever hallelujah, on those
particular items right now, because there’s going to be some big new standards
coming out — 50-10 ICD-10, claims attachments, and so on. That’s not the only
thing we’re here for, and I don’t think everybody signed up here just to do the
thing on the chart today. It’s to try to make a difference going forward.

Going back, I’d like each of you to take that kind of thing and as you have
your subcommittee breakouts, put it together and then some of the requirements
that we have for you to do this is to keep it current, use it regularly to
update the full committees. If you’re sitting, and you come in trying to talk
to the full committee, when we give our readouts, you ought to be able to go
straight to that, and we ought to be able to see.

The other thing you should be able to do with it, is when you talk about
subjects, you could say, oh, by the way, I would like Standards to consider
doing this as part of what we’re doing or something this, or I think we ought
to do something ad hoc.

The point is, it allows us — everybody walking around all day every day,
ought to be able to know what we’re doing as a group. Not have to call
somebody, not have to say, well, don’t check with me I don’t know. We ought to
all know what we’re doing.

If it’s not on the list, we maybe shouldn’t be doing it, but until we
collectively put it on a list and the committee feels it’s something worth
doing. That’s what we talked about doing.

It’s also great for NCVHS speaking engagements, which was one of Simon’s
gifts to me on his way out, another one of them.

(Laughter)

No, but because what happens is, you know that they’re really interesting
things going on, but you don’t see it, and you’ve got your day job, you can’t
grab them again. This is a great way to grab all that available.

Most of us that have been in leadership roles can speak about all these, not
as good as individuals, but you can sure talk about — at a level where you’ll
be doing a speaking engagement — you can talk about all these subjects just by
having these four, five pages right in front of you, and maybe call somebody on
one or two of them. Not make it up every time, not try to chase somebody down
and do it.

It really insures the visibility of NCVHS inventory to all members, staff,
and audiences. We’ve got a lot of audiences. We asked Rob today, what should we
be doing? We ought to make — that’s a little more obvious, and if somebody
says a little more on that or as we’re talking to anybody at our large
constituents.

For example, if I were to sit down with Rob and show him all these and say,
here’s where we’re headed, is there anything else that we can be doing that you
think can move you guys along forward? ‘s a different discussion, than sitting
there with a slate in his head, and our slate in my head, and trying to connect
it. It’s a little more — and again, I can’t replace the experience that
Simon’s taking away. We need to do a little process to catch up.

A lot of that stuff that a lot of you, you know the Jeffs, and the Mark
Rothsteins, that have had in your head — I want to make it a lot more
pragmatic for a lot of us. We’ve got four new members that I’m working with,
and it immediately puts everybody at least on the same discussion page even if
we don’t agree, and we don’t think that’s exactly what we ought to be doing. At
least we can have that discussion at a little different level.

It was kind of automatic. I’ve learned this kind of automatic. A lot of
people that we’re losing were really good at it, and they could bring us along,
so I’m going to play it at a little different level there.

With that, we’ve got a number of other things that came out at the Executive
Subcommittee. I’m not going to go through them, but I’m just going to give you
an example.

There were a number of other areas that were listed at the Executive
Subcommittee — as we had other people that joined us at the Executive
Subcommittee on some of the other things that we ought to think about — . Uses
and adoption of EHR, data stewardship — most of Americans have, and again,
I’m not pushing any of these, I’m just — they’re just attached for your
breakout.

You can see some of the other items that came out at the executive
subcommittee discussion that related to things that people mentioned at the
Executive Subcommittee meeting that might be worth us taking a look at.

Again, put it against the filters we talked about. Make sure you’ve got a
list, decide how many hearings you think you’re going to have. We’ve got to
work with Marjorie and others on a budget to do that, and let’s figure out how
we’re going to make a difference, moving from now forward and not just make it
up each time we go.

With that I’ll open it up for discussion, comments, anything else anybody
wants to have related to it. Questions or comments? If you have any questions
you need to ask them now, because when we break up you’re going to have to go
do it.

DR. MIDDLETON: We have this handout?

MR. REYNOLDS: Yes. That handout should have been given to everyone, correct?
Yes, everybody has this. Don?

DR. STEINWACHS: I like your idea about how you could split things up across
committees potentially, and so on. Have you thought about it, or have some
advice for us on how you’d coordinate across, when we split things up, is the
coordination here at the full committee, or is it committee co-chairs or?

MR. REYNOLDS: No, I don’t have the answer. I don’t want to be prescriptive.
If you gave me the subject, then I might be able to give you a specific on it.

The thing — ad hoc is there when it gets — when it’s really sideways, we
might as well accept that we may have to go ad hoc.

The minute we have something — like I said, you could invite members from
another subcommittee, because the important thing I know that happens a lot of
times, and I know I’ve found myself in the same situation. When the letter
finally hits the full committee, all of a sudden we start hearing a discussion
from a segment of the group that really changes the discussion.

As Standards, we’ve got a lot of letters passed, and we’ve got a lot of
letters put back in our face. Not negatively, positively, because we hadn’t
necessarily — there wasn’t full agreement on the committee as exactly how we
approach this. I don’t know the exact one.

DR. STEINWACHS: It may be fine to talk on the hearings we had on the medical
home. You’ve already identified, I thought it came out as sort of three areas
that might be split up. One would be around security and protection of privacy,
was one of the things — Leslie was there raising some of those issues.

The last sessions dealt very much with how health information technology
could support medical home and some of the complexities of that. The idea of
sort of a — I’m thinking of the structure of the core data set that it would
underpin. The medical home was something that came out of that, and Populations
might be another place to pursue that.

You had me thinking about, well if you take something and you split it up,
which makes a lot of sense, then what are some kinds of mechanisms we might use
or forms in which, to sort of keep bringing back together.

MR. HOUSTON: Two points. The first being, if you look in Tab 7 of your
distributed book, about halfway through it, there was this Committee Operations
and Processes document and I thought it would be valuable, especially for the
members to take a look at it.

When we had the breakout session a year or so ago, we came up with these
principles to try and facilitate the production of recommendations and letters
and things.

Now being the co-chair of the Privacy Subcommittee, I’m going to make one
plea, and I say this to a lot of people and I’ll say it in open session as
well, if you’re not involved in Standards and some of these other workgroups,
you typically don’t have an opinion about them.

I don’t have an opinion on HL7, ICD-10 or whatever, but I think that privacy
is a different animal. Whether you’re an expert on it, you’re involved heavily
in it or not, you always have an opinion.

I don’t mean that negatively, because I think this course is very important.
What it does do, is unless we do it in a structured fashion, it slows down the
pace in which we can get the letters through. It is absolutely vital that,
especially if it relates to something like privacy — we have an early letter
that’s coming out for review, it’s really important to get feedback early.

We’ll try to address everybody’s feedback in a way that — if it’s written,
we’ll try to provide back written comments and see how we handled it in the
letter, if somebody had a specific objection. Or if it was just a generalized
objection, we’ll try to do the same.

We can’t wait until the eleventh hour, to really have a letter that’s really
ready for prime time and then somebody coming up and for the first time listing
a concern. It’s too disruptive in my mind.

Again, we want to hear the feedback, and everybody has an opinion on
privacy, but we just have to get in a way that allows us to move these things
forward.

MR. REYNOLDS: Simon, do you have a comment on that?

DR. COHN: I agree with what you’re saying. I guess I was reminded of a
previous meeting where Bill Scanlon talked about certain issues being value
driven, as opposed to more technical, and I think that’s what he talked.
Certainly I think that that almost speaks of a certainly different mechanism
would bring in a committee discussion also, which I think Privacy and
Confidentiality has done a really good job trying to gauge people.

MR. HOUSTON: An engagement has to be early and substantive, I guess is my
point. If we wait until where we have a letter that’s ready, and that’s come
forward on a number of occasions, where it’s been out there for review.

I think we’d all agree it’s very frustrating at the end to start getting
comments de novo, to just get philosophical concerns with the letter. We want
to hear them. We need to hear them early so that we can structure the letter
and try to move it forward.

To Harry’s point, a six to eight month timeframe to try to get a letter
through, where we struggle with that in Privacy because it really takes a long
time to flesh these out just based upon the volume of comments that we have to
deal with.

MR. REYNOLDS: The other thing I thought we could use — like our charter,
what we’re doing is as we start something new, and I think Privacy and Security
is a great example, as we start something new, having it even before we start
the hearings, having it presented, maybe by the Co-chairs as to what the
subject is, what are the issues we think are going to be involved, Simon’s word
of values is great. Does it really start pushing on the core values of
individuals in the United States or is this really about a technical situation
or some kind of thing that we’re dealing with?

I think that would get the committee notified and then make sure that we get
people to play a little earlier than when we bring a letter in and then people
get involved. Yes, Carol?

MS. MCCALL: Thank you John for sharing your microphone with me.

(Laughter)

First my question — so the subcommittees are going to go off and we’re
going to do these assignments, and we’re all going to essentially try to fill
in the template that you’ve laid out. I think that can be a great organizing
mechanism.

What I have is kind of a process question. First is how to have you guys
talk about how to best synthesize, and then also communicate this. Because what
we’re going to get is a whole bunch of stuff organized and aspirational and all
those things, and yet it may be more than as a group we want to take on. Point
number one.

It’s really a question of how we decide and how we synthesize. That’s a
process question.

The second part of that, Part B, is have you guys discussed any organizing
themes? If you think about some of this cross-cutting work, there may be some
topic that cuts across different groups, is really important. It may involve a
lot more value type questions. It’s also something worth branding ourselves
with.

You may not have an answer now, but I didn’t know if any of those topics had
already surfaced and if they had, if that’s something that is your desire or
intent to try to do.

DR. GREENBERG: In regards to what Cheryl just said, maybe it was my
enthusiasm over the Dan Heath hearing on medical home, though I think it was
more than medical home. The Dan Heath hearing that we just had or maybe it was
my level of exhaustion — but I actually thought, Harry, that when you said at
the end of yesterday’s meeting, that you were going to present what you’ve
presented, and ask every subcommittee to kind of look at this, you asked and I
said, oh we’ve never had and organizing theme for the whole committee.

I actually thought what you were suggesting was that as we went through all
these issues related to the integration of care, but it also related to
population health data. It related to Standards, of course there were privacy
issues.

As we kept raising all these issues and saying, well we’ve got to bring this
subcommittee and that subcommittee, maybe this could be a theme, on not
necessarily the medical home, not necessarily using those words, but what we
were talking about yesterday, could maybe be a theme that could cut across the
entire committee.

I reacted really positively because I liked the idea of — that doesn’t mean
that’s the only thing, that the subcommittees would do or work on, and then we
have the issue of how do we synthesize it or bring it together.

I did think that that was a really nice suggestion. It’s hard to ask people
to do that now when we haven’t reported back to them, those who weren’t there,
what the discussion was the last day and half.

I just wanted to mention that because Carol asking was —

MR. REYNOLDS: My hope is that as every committee goes of thinking this way,
I would hope the Populations based on yesterday, would come back and say, we’ve
got a cross-cutting subject. We’ve got a theme.

We’ve got something we think is going to make a difference in a lot of
things. An, oh by the way, here’s how we think it affects each of the groups
that we currently have in place and what it is.

I haven’t had a chance to meet with all the co-chairs. I didn’t want to come
in here today and start saying, oh congratulations, I don’t know what I’m doing
yet as chair but I’ve got the answers.

The whole reason for the breakouts is, we’re giving you something — a way
to think about it, we’re asking you to go off and do it, we’re asking you to
come back tomorrow in a way you could synthesize — playing off on what Carol
said and some of the other things. We’ve got readout time tomorrow from all of
the subcommittees.

We don’t have any letters outstanding — we don’t have — so we’re kind of
getting going again. We’ve got six months at the end of this year to make a
difference, and so that’s what I’m hoping is going to happen tomorrow, and what
you come back with tomorrow from your subcommittee may get adjusted by what
somebody else brings in.

At least you have the sense as to what you’re putting it against, not that
you’re just being told to go off and all of a sudden become the prophets of the
medical home without a discussion for this whole group.

Those of us who were in the hearings may feel different. I see — Paul is
your hand next? We’re going to go down the line. Mark, are you up? I can’t see
your hand.

MR. ROTHSTEIN: Yes. I just want to recommend to the subcommittees as they
meet this afternoon and tomorrow, please keep in mind the political calendar.

I think it would be a mistake, if the subcommittees over-committed
themselves to long-term projects. The overall committee’s agenda is likely to
change after the first of the year.

With a new Secretary, new Congress, and so on, if we’re knee deep in some
big projects, we may not be able to be nimble enough to respond to some new
requests made of us. What I would suggest, unless there’s some compelling
reason, is to schedule a series of more modest projects. There’s no shortage of
projects long, short and long, just to keep some powder dry.

DR. FRANCIS: This is prompted in part by switching Security from Standards
over to Privacy, and also by the title Quality and Data.

I want to be sure I’ve got a good handle on what the responsibilities are of
the different subcommittees. Maybe I could try out, and you could correct me if
I’m wrong, that Standards has had to have good data.

Privacy and Security had to protect that. Populations is what do we want,
and how do we use it to look at the health of the populations and subgroups.
Quality is the same thing about what kind of data do we want, and how do we use
it to look at quality of care?

MR. BLAIR: Could you repeat those so that we could digest it?

DR. FRANCIS: Well just try it, because this has been my crude understanding
I want to correct it if it’s wrong. Basically Standards is about how to have
good data. Privacy and Security is about how to protect data. Populations is
about what data do we want, and how do we use it with respect to health and
populations, or population health?

Quality is about the same thing but, with respect to the quality of care
that people receive. If I’m way off?

MR. BLAIR: I like the fact that you have put forth, that thinking where you
try to distill down the roles to a single word or two. It sort of challenges
us. I started to think, are the things we’ve looked at in stages today fit into
quality of data? Quality of data is I think, one of the dimensions. Maybe let
me just step back from going into a discussion with you.

As we begin to have discussions in the future, we could elaborate on that
more. It’s a useful exercise.

DR. STEINDEL: Leslie, I would replace the word — we use standards and
quality in the same definition — I would replace quality with a word like
uniform.

What we’re talking about in quality, when we put data in there, is how to
validate that the data that we’re getting was collected against those uniform
standards.

The other piece, since we’re still on this discussion a little bit, I almost
look at the standards subcommittee as the committee that looks at data as an
enabler. Is it an enabler to communicate? Is it an enabler to define? Is it an
enabler for clinical specificity?

It seems like the standardization is a tool related to data to achieve
goals.

MS. MCCALL: I would then just like to add, I think it’s a great idea. I
would recommend that every subcommittee take on the task of a short English
description of what they intend it to mean and bring that back as part of the
assignment.

MR. REYNOLDS: Simon you have a comment and then Justine.

DR. COHN: When there are changes in subcommittee structures, it’s actually a
charge document for each subcommittee, and those need to also be updated.

DR. TANG: I’m purpose-driven and a lumper.

I like to try to create a sense of purpose and then lump sort of how to get
there. This sense of purpose, I got out of yesterdays hearings, which has to do
with, what would a patient want? A patient would want to be able answer in the
affirmative one of the questions that I’m modifying from one of the testifiers
yesterday is, do you have a personal doctor to go to, to address your health
and healthcare needs in a timely way while protecting your privacy? That would
be what I’d like to ask someone, and we would have gotten there if everyone
could say, yes.

The second thing then is, for the provider, the professional provider, do
you have a way of delivering timely, appropriate, and efficient care in ways
that protect the health information of the patient? They should be able to say
yes.

The third point is the reason we’re here. Can we create the information
infrastructure that allows the first two to be answered in the affirmative?

That talks about the data and information needs, and the ways to deliver
efficiently to the people. That whole health care team includes the
professional health care providers as well as the patient and their caregivers.

Our challenge — and it does fit — the work then splits out into these
workgroups. I wonder if we need to think about, before we split up, what is our
mission? What’s our general purpose, and where do we fit in that hierarchy that
I proposed.

DR. COHN: Justine you’ve been patient with your hand —

MR. ROTHSTEIN: Can I comment on that for just a second? I think that’s
valuable Paul but I think that’s a narrow view of what we’re all about. Because
it doesn’t take into account — I mean it’s really clinically focused. There
are all these other uses that we have to be concerned about. The public health
implications and what do law enforcement people get — when you think of all
the exceptions under the HIPAA privacy rule.

We are concerned about the issues you raised, but we’re concerned about many
other things as well, marketing and so on.

DR. TANG: Let me expand then on that a little bit. In the ideal world, this
is sort of what I tried to describe, all of these other things, if you did the
data, and data systems right, would be byproducts.

DR. GREENBERG: They can’t all be byproducts.

You wouldn’t have any surveys, you wouldn’t have vital records. All data
that we need in this country to be healthy isn’t going to come out of the
clinical encounter.

DR. TANG: It’s going to come out of the fact that we interact — we capture
clinical information in systems.

Maybe the two questions I’m getting are more tethered to the way things are,
than what I’m trying to present as far as the future vision.

If patients didn’t have to just enter data when they were in the four walls
of a hospital, or the clinic, and they constantly fed information into a — let
me just use the term PHR to — if we are constantly instrumenting and
monitoring our activities of data living in the sense that we knew, we
patients, consumers, knew what we were doing and how it impacted our health,
then that would be a system by which you could derive a lot of information,
including health surveys, including potentially — if we were smart enough to
have the right way of capturing data and stored them in a coded fashion. Does
that make any sense?

DR. GREENBERG: We’ll continue this. I’m thinking, Harry, that in June 2009
we might want to have another full committee retreat.

MR. REYNOLDS: Yes. Justine?

DR. CARR: Now this is not as loftyas my previous speakers, but just getting
back to the details — you’re a lumper, I’m a splitter —

(Laughter)

–that’s why we’re going to be co-chairs.

Jut some house-keeping things. First let me say again, in terms of the model
in the last two days on the medical home hearing, I think it was great Leslie
was there, it was great Harry was there.

I think even though at the outset they might not — well maybe Harry might
not have seen why he would want to be there. There were things that were very
clearly mapped to Standards that he didn’t understand before.

I think that setting up the hearings, it’s a good idea to invite someone who
would not naturally be in that particular group.

The second thing is, the idea about the draft – I think we had some
success when we brought preliminary drafts forward, so we’re not always on the
eleventh hour.

Harry, one thing I’m concerned about, I think when the committees meet, if
you’re on more than one subcommittee, you run the risk of not being able to go
to that other subcommittee. As people get more involved — I think we already
have some conflicts now.

I don’t know how we want to deal with that. I think that’s all I’m going to
say.

MR. REYNOLDS: The other thing I’d like everyone to remember is we’ve had
committees all along. I know the breakout Standards is not going to be anything
necessarily magic and mystic that jumps — we’ve got a pretty good list. I look
over this list, and even though I’ve heard some different things over the last
few days, it doesn’t change dramatically.

I know we had a quality agenda, we had a populations agenda, we had a
privacy agenda. Asking you to build off what you had, some of the discussions
about restructuring is going to take us a little while to get to. You can bring
those things in.

I want to remind everybody, that everybody already had work at hand in one
way or the other. I’m not saying just go back and wipe the whole slate clean,
no.

Obviously the vision yesterday of coordinated care, and I use that term
because whether or not people like it as a medical home or whatever they end up
saying it is, starts to make you think at a higher level, and starts to make
you un-dependent in a different way than just doing a specific thing.

Leslie one thing I would comment back to yours, you use data and you took it
across all of our committees. I would say that you could take interoperability,
you could take adoption of things, you could take a lot of things across all of
those committees. I think data is a good one, but it’s one of many that can go
across there as to what we’re doing.

When you mention standards, standards is a lot more than just the data. It’s
the interoperability, it’s the willingness of vendors to do things so that we
can get more adoption by people. It’s a whole lot of stuff, not just data. I
think that was a great example, but I think it’s one of many, many examples
quality can go across all these things.

Right now, populations goes across — one of the things that I did bring up
in the meeting is if you don’t capture it up front, and you want to use it at
the end for population, have a nice day, it’s not there. Those are some of the
things that we have to keep in mind.

Again, we’re not going to fix this in an hour and a half, and I don’t expect
everybody to come back with a chart. I’m talking about how do we move forward?

The other thing we’ve realized is there were two large groups of members
come in at the same time. We lose some good skill this year, we lose some
strong skill — we’ve got to get ourselves in order as to what difference we’re
going to make. I didn’t say for everybody to go off in an hour and a half and
have the magic answer.

We’ve got a six month hold here where we’ve got not a lot of hearing
scheduled. Not a lot of difference we’re going to make. I know there are
standards that are going to happen, so if the NPRM comes out for 50-10, we’re
all just going to react.

That’s all I ask you to keep in mind as we look at these and go forward.
Jeff?

MR. BLAIR: Usually I am not this open. I get attention that way. This seems
to be the afternoon for being philosophical. Standards, is really a very humble
Subcommittee.

Here you wind up having these perspectives of a population perspective, and
a quality perspective, and a privacy perspective, and then standards comes in
afterwards and standard — you could see, Judy and I feel like everything
revolves around standards. No, but seriously, the standards are an enabler but
it’s not the originator. In many cases it will be the populations or the
quality Subcommittee or the privacy that will really be the creators.

The standards really look to having you enable and facilitate some of these
constructs that are moving forward. It’s like the apples and oranges because of
the standards. The others you can’t refer to. I don’t think you think of them
as enablers. You think of them as perspectives. I was actually serious when I
said we are a little bit more humble.

MR. REYNOLDS: Simon, I see your hand’s up and then I’ll make one last
comment and then —

DR. COHN: Make the last comment then because I’m —

MR. REYNOLDS: The other thing for example, that I know as I look at the list
for standards — we just sat through again today a discussion on NPI. There was
a lot of good discussion on where it is, whether it is done, and whether we
ought to extend it again, or whether something ought to happen. There is an
overriding thing that we all have to do and no matter what we are talking about
is, how do we get this group of industry players to adopt something? How do we
get them to do it in a time frame that is reasonable?

The next three sets of standards that are coming out and things are going
to happen are big and different and they are not — NPI being an implementer
was the easiest one we’ll do. It took four years and we still have people that
are struggling to get it done. We have to make sure we get the rest of this
really good. We have to figure out how to group people up out. We’ve got to
figure out how to do outreach differently.

Those are some of the things also that we can consider and do as a group and
it’s the same thing whether it’s on privacy for personal health records or any
of this other stuff. These are the kinds of things that we can think about that
there aren’t groups out there that do this. I think that’s one other way that
we can differentiate ourselves to help with that in every way that we can, and
make some recommendations forward on how to do that because that is part of our
period here. Simon.

DR. COHN: Thank you. Very good timing. Obviously I think a very interesting
conversation and we certainly have engaged the committee in the organization.

You know you’ve engaged them. I think the good news is that the
recommendations from the executive committee which I think you’ve shepherded
through in terms of the reorganization, seems to fit very well with the vision
of the committee, so congratulations.

Now what I wanted to do is take a minute and talk about the break outs —

MS. GREENBERG: Say something about the dinner

DR. COHN: Marjorie talks about dinner, and then I’ll talk a little bit about
tomorrow morning and the plans, and then we’ll take hopefully a couple minutes
break and we will be able to get back together in subcommittees.

We obviously have subcommittees that start around 4:15 or so. The Standards,
not Standards and Security, but Standards is going to be here. Populations is
in Room 16. We will be meeting probably till around five thirty, and then
Marjorie, please.

(Administrative comments about dinner plans)

DR. COHN: Yes. I was going to go through that next. What’s happening for
tomorrow morning is that the break outs start at eight-thirty. Privacy is here,
and then Quality is back in Room 16 again. Hopefully we’ll figure out where
that is by tomorrow morning.

Now the preliminary sessions convenes around ten o’clock in the morning.
What we are going to do is to start out with the sort of the item from
yesterday which is the quality document. I am going to ask Justine to sort of
lead off with the discussion of that, which may help also begin to frame the
discussions and the report outs from the Subcommittees which will be in the
work we’ll be doing tomorrow morning.

Following that really, it is a conversation which I think which Harry will
lead beginning to try to put together Subcommittee plans. It will be
interesting to hear from people, exactly what people are thinking of for the
remainder of the year and then to early next.

I do to mention that we had had a presentation scheduled from the CDC on
their Health Information Technology contracts and that’s been rescheduled
probably until September or November. There is an occasion for a fairly
extensive conversation around sort of views of what Subcommittee activities are
and obviously help to engage the members. What we will do is to finish with a
conversation around the 60th anniversary which Marjorie will I think
probably begin to lay out some of her thoughts.

I am reminded and I should do a little bit of looking at the history of the
NCVHS. The interesting story is, the best I understand, which maybe Marjorie
can clarify for us either tonight or tomorrow morning, it’s unclear to me
whether actually the committee started in 1948 or 1949?

MS. GREENBERG: 1949.

DR. COHN: If you look back there, there is actually some suggestion. We’ll
ask her maybe at one point to make reference that looking through earlier
documents.

MR. BLAIR: It’s important. We’ve got to get this right.

DR. COHN: That’s right. Maybe if we are celebrating it this year we’re just
giving up?

MS. GREENBERG: Susan, you’re the historian.

DR. COHN: You guys can think about it and maybe enlighten me.

MS. GREENBERG: It came out of a recommendation from the World Health
Organization, which is observing its 60th anniversary this year. I
think it took them a little while to make the recommendation. They made the
recommendation. The main thing is they couldn’t have made it before ’48 because
that’s when the World Health Organization was established. We already have one
in ’49.

DR. COHN: It could have been 1950 or 1951 in fact? I didn’t mean to get the
answer right now, I just maybe wanted to bring up the question.

MS. GREENBERG: Can I say something to the new members? You are almost new
members. First of all, you are more than welcome of course to sit in, and maybe
I already told you this, on any of the subcommittee meetings. Generally I think
our practice has been, and our new chair may have other thoughts on this. This
meeting and at the end of September meeting, we’ll probably ask people to
commit to at least one Subcommittee.

You can visit different ones and see where you think you would fit in best.
There are people like Simon who serves on everything. I think he wasn’t on
Population. We just got the paperwork even executed, but you were appointed and
that you were accepted. We haven’t had time to have an orientation session. I
know Chairs have been in touch with you and I think Debbie Jackson has been. I
sent you a bunch of paperwork.

We will be having an orientation session probably in June by conference
call. We’ll schedule that. If we have any subcommittee meetings in the summer,
other than the Executive Subcommittee which we are talking about trying to have
something for them, if we do have any then you will be welcome to come to those
as well.

MR. REYNOLDS: I have gotten each of them committed to at least one over the
phone. We are working it.

MS. GREENBERG: Some of them are obvious. Like if you are a privacy officer,
we have some ideas of where.

MR. REYNOLDS: Even the new hair could figure that one out.

DR. COHN: Well, with that, what do we think, about ten minutes for break and
then we convene? Okay.

(Whereupon, the Full Committee adjourned)