[This Transcript is Unedited]




November 18, 2008

Radisson Hotel Reagan National Airport
2020 Jefferson Davis Highway
Washington, DC

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

List of Participants:

  • Harry L. Reynolds, Jr., Chair
  • James Scanlon
  • Marjorie S. Greenberg
  • Jeffrey Blair
  • Justine M. Carr, M.D.
  • Leslie Pickering Francis, Ph.D
  • Larry A. Green, M.D.
  • Mark C. Hornbrook, Ph.D
  • John P. Houston, J.D.
  • Garland Land
  • Carol J. McCall
  • Blackford Middleton, M.D.
  • Sallie Milam, J.D.
  • J. Marc Overage, Ph.D
  • William J. Scanlon, Ph.D
  • Donald M. Steinwachs, Ph.D
  • Paul C. Tang, M.D.
  • Walter G. Suarez, M.D.
  • Judith Warren, Ph.D


P R O C E E D I N G S (9:10 a.m.)

Agenda Item: Call to Order and Welcome

MR. REYNOLDS: Good morning. I’d like to call this meeting to order. This is
the first of two days of meetings of the National Committee on Vital and Health
Statistics. The National Committee is the main health policy advisory committee
to HHS on national health information policy.

I am Harry Reynolds from Blue Cross Blue Shield of North Carolina and Chair
of the committee. I want to welcome committee members, HHS staff and others
here in person, and also welcome those listening in on the Internet. I would
like to remind everyone to speak clearly and into the microphone.

Let’s now have introductions around the table and then around the room. For
those on the National Committee, I would ask if you have any conflicts of
interest related to any issues coming before us today, could you please so
publicly indicate during your introduction. I have no conflicts.

MR. J. SCANLON: Good morning, everyone. I am Jim Scanlon. I am the
Assistant Secretary for Planning and Evaluation Office at HHS, and I am the
Executive Staff Director of the full committee.

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

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

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

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

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

MR. LAND: Garland Land, National Association for Public Health Systems and
Information Systems, member of the committee. No conflicts.

DR. MIDDLETON: Blackford Middleton, Partners Healthcare, Brigham and
Women’s Hospital, member of the committee, and no conflicts.

MS. MILAM: Sallie Milam, West Virginia Health Information Network and the
West Virginia Health Care Authority, member of the committee, and no conflicts.

DR. HORNBROOK: Mark Hornbrook, Kaiser Permanente Northwest, member of the
committee. No conflicts.

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

MR. BLAIR: Jeff Blair, Lovelace Clinic Foundation, no conflicts, member of
the committee.

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

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

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

MS. GREENBERG: Good morning. I am Marjorie Greenberg from the National
Center for Health Statistics, CDC, and the Executive Secretary to the
committee. I have returned from India with our poster. It is up there on the

MS. JONES: Catherine Jones, CDC, National Center for Health Statistics.

MS. GILL: Alison Gill, American Health Information and Management

MR. DI CARLO: Mike DiCarlo, Blue Cross Blue Shield Association.

MR. KYLE: Frank Kyle, American Dental Association.

MR. NEWMAN: Mike Newman, Health Resources and Services Administration.

MS. SING: Medhi Sing, Health Resources and Services Administration.

MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC,
committee staff.

MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics,

MS. KAHN: Heddy Kahn, National Center for Health Statistics, CDC.

MS. SACHS: Jody Sachs, National Center for Research Resources at NIH.

MR. REYNOLDS: Each of you should have a copy of the agenda in front of you.
One piece of housekeeping before we get going is, in front of you you have some
pages about what is around here for lunch. There is a bistro that, if you fill
out the form you can have lunch delivered here for you, so if you would do that
before the end of the break, that would be a wonderful thing. If not, then get
your coats and go find it, and be back by one, please. I’ll leave that up to

With that, the first item on the agenda is an update from Jim Scanlon on
the Department.

Agenda Item: Department Update – Data Council

MR. J. SCANLON: Thank you, Harry, and good morning, everyone. I am going to
update everyone on some of the detail and some of the developments since we
last met in September

Obviously, the biggest event is the national elections with a new
President, largely a new Congress in January. I hope everyone got the word. If
you haven’t, see me later.

MS. GREENBERG: Even in India we were all aware of it.

MR. J. SCANLON: I understand even in other countries it was well known and
well celebrated.

MS. GREENBERG: Absolutely.

MR. J. SCANLON: Let me just update a couple of things. I think we are going
to get a report later today from CMS on where we are with a couple of HIPAA
proposed rules. I think Karen is going to report on that.

On the AHIC front, I think Chuck Friedman will be reporting. The originally
AHIC had its last meeting within the past few weeks, so they are basically
closing out activities. The new AHIC, the AHIC Successor group, had its initial
meeting today after the last meeting of the AHIC. So the board met, and they
are planning how they will operate.

On the board of directors of the AHIC Successor organization, we have a
current member, Paul, and we have Simon Cohn, a previous member. So they can
carry forward all of the good thinking from the NCVHS as well.

On the Hill, obviously there is now a lame duck underway, probably a week
or two. The focus seems to be on the economy and stimulus packages. In January
with the new Congress, everyone is reading the crystal ball and basically
looking at what is likely. Clearly some health reform. Well, economic measures
first of all probably, and some security measures.

The thinking seems to be that there will be great interest in health IT.
Whether there is a bill right away, or whether it is part of a larger health
reform bill or whether it is later in the session, there clearly is interest in
health IT, much of the way we have been thinking about it here. But again, we
will have to see what bills actually emerge. But it is clearly expected to be a
priority in the 111th Congress.

On the budget front for HHS and for most federal agencies, most federal
agencies have what is called a continuing resolution that basically allows us
to spend at the same level as last year, basically can’t undertake any new
projects. That continuing resolution continues until March 6. After that, it is
up to the new Congress on how they will handle the remainder of fiscal year

Fiscal year 2010 is in the hands of the new President, President-elect. So
that will be his first budget. It will be a policy budget. We have prepared in
essence a current services budget that has all of the accounting budget lines
for HHS. Other federal agencies have done this as well. So the new President’s
team could come in and decide whether they want to increase, decrease or add
new things. That will be a very compressed process, but at any rate it will be
probably in January, February, March.

On the continuing resolution, that does create some uncertainties for some
of our population statistics, for some of our surveys for MEPS and for the
Medicare survey and for SAMHSA surveys. We are basically continuing those at
the same level, which is an accomplishment. But for NCHS, unfortunately, NCHS
was slated for an $11 million increase, and it was meant to get the Center’s
level up to a level that everyone believes necessary.

Well, the continuing resolution just delays all of that. All it does is
create some uncertainty until March at least. So NCHS as they have said
previously, is having to look at what is the best strategy for getting through
these first four or five months, and we are uncertain as to what will happen
after March. Otherwise, we are operating at the current levels.

Remember, for HHS our total is about $737 billion, but only ten percent of
that is discussed here. The rest of that is associated with Medicare/Medicaid,
the TANF programs and so on, so it is that ten percent that we have some
leeway. So anyway, we are still unsure about what the next half of the year
will bring.

What we have been doing in HHS and the Data Council, I will say a little
bit about that and then some of the projects we have initiated.

We have begun as we normally do, we are looking at what the impact is of
the budget on our various population statistics programs. Again, I think the
NCHS issue is probably the most concerning. We are hoping that NCHS will — I
don’t know if Ed is going to be reporting, but whatever action they take,
minimize the effect on other programs and keep the options open as much as we
can. This will be a year where it is quite possible we will get the increase,
and you wouldn’t want to take steps that are unreversible in March.

What we have been doing on the Data Council for example in addition to
that, we have begun a review, much like the Population Subcommittee will be
doing today or tomorrow, on the likelihood of some sort of health reform
measures or public health reform measures, how we are positioned with our own
data sources, our own surveys, our own modeling, our own actuarial capability
to marshal those in support of whatever development might be needed as well as
what analysis and evaluation might be needed.

In the past two months, the Data Council has been focusing on what data
resources and where are we with all of them in terms of health insurance
coverage, access to care, cost of care and related matters like that, as well
as where are we with our actuarial support capabilities, as well as our
modeling capabilities.

At the previous two meetings we have gone through pretty much what we have.
We have a few more to look at, but we are looking at where we are and what
might be needed. Again, the Population Subcommittee will be doing this on a
much broader scale, involving other members of the policy research community
beginning tomorrow, so all that should come in very handy.

Obviously we are dealing in a situation of not knowing what all of the
details would be. I think the economy clearly has taken much of the oxygen away
from a lot of the other reform efforts, but that will probably have to be dealt
with first. But you could argue that health reform is part of an economic
stimulus package, anyway.

We do have as a result of the executive branch transition — as you know,
the transition starts on Election Day and goes forward until January 20, until
Inauguration Day at noon. So we already have in HHS — so do all other federal
agencies — we have begun a transition process. It is fairly organized,
systematized and centralized. All agencies were asked to do some of the same
things. So we have prepared briefing books. We have prepared space for the
transition team, and we have had every agency designate a senior career deputy
who would be in charge of the agency when other folks are leaving so that there
will be no interruption in continuity of operations or business.

In addition, our transition team has begun to arrive. You can see all of
the latest news on the Presidents transition on the Change.gov website. So it
is very transparent and very open. You will see all the members of the
transition team, how it is structured and so on.

There is a large comprehensive of the President-elect’s transition team
that is focusing on agency reviews. They are looking at all of the federal
Cabinet agencies and all of the Departments. They will report back to their
full working group.

We have had our group arrive already, at least some of them. Many of them
are folks that previously worked in HHS and in the health community, and they
are very familiar with some of the issues. They certainly know the health IT
area as well. So we will be briefing them, providing the information they will
need, and then they will do their reviews. They are on a pretty quick time
line. By mid-December I think they would like to be able to report back to the
home transition team. Then that will help to prepare nominees and other folks
who will be coming in in January.

A couple of projects. I think I reported previously that we have undertaken
evaluations and demonstrations in the PHR area. One of those is an evaluation,
well, a pilot study of electronic PHRs in South Carolina, in the Medicare fee
for service area. We have the pilot underway. We also have an evaluation
underway. So we are learning a lot of how this actually operates in the
Medicare program, for example, the fee for service program.

We also have announced a project that will involve two Western states,
Arizona and Utah, where we will offer four PHR products to Medicare fee for
service beneficiaries. So they will have their choice of any one of the four,
and then we will do an evaluation of how that works as well.

It will be everything from to what extent do folks enroll, to what extent
do they use, how do they use, what are outcomes to the extent we can define
outcomes, and what are the features of those as well in the functionality. So
we use a variety of methods to try to get at this, including outcomes and
satisfaction and so on.

As I said previously, the Medicare ambulatory EHR demonstration program,
that is getting underway. ASPE is working with CMS on the evaluation of that
program as well. So we will get a lot of good information hopefully from these

I think I mentioned previously, we are also working with the National
Center for Health Statistics. We are trying to get a better sense of to what
extent do consumers actually use health IT to get health information. So we
have added a few questions to the National Health Interview Survey to try to
get a sense of when do they use computers and health IT, where else do they go
for health information, when do they go, why do they go, and how does it relate
to their overall health status and overall household economic status and so on.
So we are adding a few questions.

There have been other surveys. I think all of you have seen a survey like
this periodically to look at how people use the Internet, but it doesn’t relate
any of those findings to health status or any of the other health information.
So hopefully we will have that as well.

MR. HOUSTON: What is the time when these surveys are done, and how often?
What is the lag in getting data?

MR. J. SCANLON: The National Health Interview Survey is continuing, so
these questions will be asked in January.

MR. HOUSTON: And what would be the time when you would get data on health
information back?

MR. J. SCANLON: It could be up to a year, or if NCHS were willing, we could
ask — each two weeks of the survey is a national sample, but that wouldn’t be
enough cases. So possibly within six months we could get some tabulations.

MR. HOUSTON: I think it would be helpful to some of what we are doing to
understand the answers to those questions sooner rather than later, even if it
was simpler short term.

MR. J. SCANLON: We will try to do that. At full strength it is about a
40,000-household survey, so you really get to see a lot of differentiation and
a lot of different health statuses and a lot of different circumstances. So
maybe we can look at maybe a quarter of data or even a half year of data.

DR. SUAREZ: A quick question. You mentioned PHR projects and the
evaluations you are conducting. You mentioned several dimensions you are
looking at evaluating functionality and some of the usability. Are you going to
be looking at the privacy issues related to personal health records, electronic
health records? Is there an evaluation component around privacy?

MR. J. SCANLON: Well, for the one we have underway, the South Carolina PHR,
privacy is covered through the — in essence it is a business associate
agreement with the PHR. So there is no variation.

But for the Arizona and Utah project, there are actually four vendors. They
probably do vary on what they actually say on their websites in terms of
privacy. It is a minimum privacy level to begin with. So it could be part of
it. I think we could look at to what extent privacy was a factor in choosing
one or another.

DR. SUAREZ: I was looking at both the questions from the perspective of the
offering entity, as well as questions around how the product is going to be
handling consent and disclosure issues in the product itself.

MR. J. SCANLON: And the perception as well.

DR. HORNBROOK: Jim, the National Health Interview Survey of course is the
gold standard. Is there any possibility you could do a supply side survey of
vendors and managed care systems? So you would talk to Kaiser and get an
estimate of how many people who are Kaiser members are using their health
record information systems.

MR. J. SCANLON: We have actually thought about that, to get some — we have
brought this idea as well. When we first brought this idea up, it was based
largely on the NCVHS early assessment of where we stand with PHRs. The
conclusion then seemed to be that this was a very evolving and developing
field. We were encouraged not to try to ask standardized questions, but to
monitor this on an industry basis.

Since then, there have been a couple of other — as you know Mark,
evaluations of what is happening. A lot of these PHR products are largely
marketing, as you know. It is largely press releases and things like that.

So we are probably thinking, and we will see where this leads us, that we
may want to do a more systematic review of who is offering, what is being
offered and the functionalities of the various systems. That is a systematic
kind of thing, so that would require a fairly long lead time. It would require
OMB clearance and that sort of thing. But I think we may want to do that as
well. It is a good idea.

DR. FRANCIS: What I wanted to say is in response to the question that was
asked. The Privacy Subcommittee is going to be planning hearings on PHRs
probably in January and in coordination with the Quality Subcommittee. One of
the topics in that hearing is going to be exactly the question you asked.

DR. TANG: Since person centered health data is one of the main topics of
the full committee and all the subcommittees, is there a possibility to tag
onto the evaluation of the two state pilots, to add the quality of the data
coming from or housed in those PHRs?

For example, if one of them is populated by claims information, how does
that compare to what the patient thinks? is there a way we can assess the
accuracy, compared either to the medical record or to the person’s own —

MR. J. SCANLON: That is a good question. You don’t mean from the point of
view of the perspective of the patient or consumer. You mean some actual
validity or accuracy kind of assessment?

DR. TANG: Yes. The person can judge the accuracy of what has been populated
in the PHRs. We can also look at it from a medical records point of view. What
is really important is, can the PHR be a source of information for our new
population health surveillance report. This might be a really good opportunity
to go look at that.

MR. J. SCANLON: We are just beginning this. We are just putting together a
proposed evaluation design. So we can certainly try to add that in as well. It
sounds, Paul, like that would be more an expert judgment. We would have to have
people review the sources and how it was displayed, and it would be an expert
judgment conclusion about validity.

Yes, we can do that. We are just starting the evaluation design now, so we
can certainly factor that in.

DR. CARR: This is for Jim, following up on knowing where people go for
their health information. I was just wondering if you would tie it in at all
with the recent Google reports of the fact that Google was able to anticipate
the flu outbreaks based on the inquiries. I think that is an interesting flip
side to take into account as well.

MR. J. SCANLON: It may or may not, but it was reported that it did. Clearly
we all admit that we will probably see the flu outbreak on CNN before we see it
reported epidemiologically. But that is all right, that is media, and the smart
folks in public health and health care use that, as you say.

Under the emergency preparedness and public health preparedness side of the
office, we are starting to look at non-traditional sources of health
information. Again, this is an analogy. You have a National Security Agency and
a CIA for all the security information. You really have a lot of information
like this that could help the health side as well. You don’t always know what
it means, it may mean nothing, but there is a whole analytic side that you
could look at non-traditional sources, including Google, search terms and other
things like that, to try to see if there are patterns emerging.

So we are starting off on that as well with our emergency preparedness

DR. FRANCIS: Could I just make a quick quantitative? About what Justine
mentioned, there was a very — I don’t know whether it is good or bad, but
there was the following privacy point that was raised. Because the way Google
gets that information is, if a consumer clicks on information about the flu, so
they figure that people might be worried about having the flu and getting the
flu if they click on information, Google will record the ID of the computer
that clicks on that, so you will know the source of the click.

Now, the potentially scary thing is, suppose we aren’t data mining or
identifying people from their PHRs, but they are in their PHR and then they
click on a Google ad. They are out of the PHR, and suddenly their computer
identification is identifiable.

As I said, I don’t know if for good or for bad, but there is a really
interesting potentially questionnaire for consumers about what they might
unwittingly do, moving back and forth between the protected environment of a
Google privacy policy on PHRs, and then surfing the Web for info.

MR. BLAIR: Since our discussion has been on personal health record systems,
if we do wind up having some hearings about this, there are two studies that
have been very helpful for me in this last month to be able to have a better
understanding of a very complex and dynamic marketplace.

For one of them — you have to close your ears, Blackford — is from CITL,
which looks at PHRs from a value standpoint. The other one, I ran into in July.
There was testimony to AHIC, and one of the testifiers was John Moore from
Chilmark. That is a marketing study, in terms of the different market segments
of PHRs and how they interrelate with each other. So those are two sources of
information that I think could be very helpful to help the committee have a
better understanding of the PHR system marketplace evolution, values, privacy

DR. MIDDLETON: Thank you for the reference, Jeff. I would be happy to fill
in the committee on that study when the time is appropriate.

I think we are bleeding into the PHR conversation from the NCHS update, but
it strikes me that the idea of additional surveying of Americans regarding
their web habits and practices and their use of PHRs really is of paramount

I am just going to offer two data points. One, we find when a patient has
access to their medication list in a study underway at Partners Healthcare, we
find the patient is able to identify discrepancies in the meds they are taking
approximately two-thirds of the time. So the physician has one idea of what the
patient is doing and the patient of course knows what the patient is doing,
usually, and can offer an update to the physician two-thirds of the time.

Secondly, when that update does occur, it has significant impact on the
physician. At least in the care of diabetes care management, more often than
not, in a randomized control trial we found physicians more likely to adjust
more aggressively diabetic medication management if they were aware from the
patients themselves what the patient was doing in taking with respect to their

So I think we are going to be increasingly seeing the patient entering into
clinical decision making in conjunction with the provider as well as on their
own behalf, as is the case and should be increasingly the case.

So it strikes me that thinking about the recurrent studies and survey work
done by NAMCS, the National Ambulatory Medicare Care Survey, that certainly
does take a marker of EHR use in the provider office. There is interest in
perhaps augmenting that survey instrument to understand better how physicians
are using ambulatory EMR, to what degree and what level of sophistication, et

So I would like to suggest that some instrument be defined, and maybe we
can co-opt other instruments in use that allow us to better survey Americans
about their web practices beyond just the PHR, but be sure to address both;
what are the web practices with respect to health in a very objective and
quantifiable rigorous way, as well as what they do with PHRs, because I’m sure
the same findings will arise. Some patients will use PHRs in a very
sophisticated manner, and most probably will not.

MR. J. SCANLON: The questions we will be adding to the health interview
survey, they are broader than the PHR. We are really trying to find — they are
based on questions others have asked, but it asks under what circumstances they
have used the computer, why they did it. So it could have been their own health
or referred by a doctor or a family member and so on, what they used it for. It
could have been simply going to a health finder or NLM or WebMD, or it could
have been making an appointment or using a PHR.

DR. MIDDLETON: I forgot one feature I meant to mention. It is the issue
which pertains to privacy, this issue of proxy management. Might I give you
access to my ailing grandmother’s record and to serve as her care manager, what
have you.

MR. REYNOLDS: You became your own breakout session.

MR. J. SCANLON: I know.

MR. REYNOLDS: You obviously got the group’s attention. That is a good
thing. That means we are all interested in the same kind of stuff, so that is

Tony, are you on?

DR. TRENKLE: I’ve got a few additional comments I can make on the PHR
pilots, as well as reporting on some of the CMS activities. So whenever you’re

MR. REYNOLDS: Yes, please, go ahead.

Agenda Item: CMS Update

MR. TRENKLE: Just a couple of comments in addition to what Jim had said.

We put some very specific privacy requirements, actually Meridian did, in
the PHR pilot for Arizona and Utah. All of the vendors who participate are
required to sign a data use agreement with CMS, in which we lay out very
specific security and privacy requirements.

The beneficiaries also have to sign a consent form to agree to allow their
data to be transferred from the CMS contractor to the PHR vendor.

So we believe that we have certain safeguards in place to make sure that
the data is protected. Obviously nothing is 100 percent foolproof or safe, but
we have done a lot of due diligence in this area, and have certainly worked
with the Office for Civil Rights and others in terms of looking at the PHR area
and some of the privacy considerations.

We are also separately looking at our entire data use. CMS does thousands
of data use agreements each year. One of the things that we want to look at is
how can we strengthen them for future data use agreements, working not only
within CMS, but also with ASPE and other parts of the Department.

The South Carolina pilot has expanded in recent months to include an
agreement with the Department of Defense to send tricare data on active
medications. We signed an agreement with them several months ago, and that
should begin early next year. Both the South Carolina pilot and the Utah and
Arizona pilot are scheduled to continue until the end of 2009. Of course, the
Utah and Arizona pilot won’t begin until January; the South Carolina pilot has
been in effect since April of this year.

Turning to the reg front, we have as you know put out the — NPRM has
gotten the comment period closed October 21. We received about 3,105 comments
on IC-10, and I believe about 150 on 50-10. Currently the staff is going
through those comments, looking at things such as the implementation date where
most of the comments were addressed to other key areas that people had concerns
about, some of the cost-benefit data, and a number of technical issues
regarding the X-12 transactions under 50-10.

So we are in the process now of trying to go through the comments and move
towards a final rule. Whether that will come out during this Administration is
something that is going to have to be decided at the Department and OMB. But we
are certainly working as quickly as possible to revise the reg based on the
comments received.

A side area related to the IC-10. We have the AHIMA report on the internal
operations of the CMS, how they will be impacted by ICD-10. We have posted an
executive summary up on the website about four weeks ago. We are now in the
process of doing an internal clearance on the entire report, which we will then
try to post before the end of the calendar year.

We have signed a contract with Noblis to continue the work beyond what
AHIMA did. AHIMA did an initial impact analysis on the CMS operations, and now
Noblis will take that work and give us some more specific details on the
different components of business processes within CMS.

In the e-prescribing area, there is a lot going on with that. The
physicians’ fee schedule rate was published on October 30. Despite the Federal
Register it will be published tomorrow. That contains several things related to
e-prescribing. One was the revision once again of the computer generated fax
exemption. If you recall, that was the exemption we put in the initial MMA
e-prescribing foundation standards, where we exempt computer generated faxes
from the use of the script standard, organizations that use computer generated

We have subsequently gone through a couple of rulemaking exercises, where
we have attempted to lift that exemption at least partially. Finally, this year
we have decided that we will not lift it until 2012, when the MIPA, which is
the Medicare Improvement Act that just passed a few months ago, begins to offer
disincentives for providers that do not use e-prescribing.

That is the other major part of the physicians fee schedule that relates to
e-prescribing. The MIPA incentives program for e-prescribing begins January 1.
There are specific instructions in the regulations about that, but basically
starting January 1 running through calendar year 2009 and then changing in the
coming years, there will be an incentive offered to providers who do
e-prescribing under the Medicare Part D program. Very specific information is
in the regulation, and also we have a website that has a lot of additional
guidance and specific details of how the incentive program will work.

The other major thing we are doing within the e-prescribing area for
standards. We are continuing to look at RxNorm and codified sig. We have signed
a contract with the RAND Corporation in September, where we once again are
partnering with AHRQ, and will do some additional pilot testing on the RxNorm
codified sig, and also using the script standard 10.5.

We expect that pilot test to begin next month, run through September of
next year. This would involve much more extensive testing of those standards
than we did in the original pilot testing in 2006. Of course, there has also
been some additional feedback we received from both the initial pilot testing
and from industry that we will use in terms of this pilot testing. So we are
hopeful these can be — as a result of pilot testing, we can then move on the
rulemaking for these two standards.

The other major standard that was not adopted out of the last pilot testing
was prior authorization. We are also working with AHRQ and industry on that,
and we will probably be doing a separate effort in that area, since apparently
it requires much more of an extensive look at the business processes around
prior authorization.

We had a conference call last week with AHRQ and some of the industry
players. We have to move ahead with some work in that area.

The final thing with e-prescribing. The Drug Enforcement Administration as
you know put out a notice of proposed rulemaking that closed in September. I
have been working along with Jim Scanlon and others on a HHS team that has been
meeting with DEA. We have both a leadership team and a working group team that
have been working with the DEA staff to go through the comments, to work on
looking at what are some of the key areas of concern that were expressed by the
commenters as far as the technical requirements for the regulation.

We have gotten some progress in working with the DEA. We are hopefully
optimistic or cautiously optimistic maybe is the better word. We have a number
of areas we still need to work through, but I feel much more confident that we
will have a final rule out within the next year. I can’t say whether it will be
within the next several months or the next 12 months, but I do believe DEA is
committed to getting out a final regulation, and we will continue to work with
them on that.

Just a couple of other things real quickly. You probably saw we did get an
OIG report on our HIPAA security enforcement function on the fact that we were
not doing compliance reviews.

We had actually started the process of doing compliance reviews before the
OIG came in and audited us, but we have continued to do that. Last year we
conducted ten compliance reviews and we expect to conduct an equal or even
greater number of compliance reviews this coming fiscal year.

One of the things that we pointed out to OIG was the fact that in order to
do an effective compliance program or an enforcement program, compliance
reviews are only one piece of that. Also you have to work closely with industry
on outreach education, not only doing the compliance reviews, but also insuring
that industry is aware of some of the things we pick up in the compliance
reviews so that we can work together as partners in making sure that the
security aspects or the enforcement and the implementation of the security rule
is done in a way that is very — what shall we say, continues to improve over

Our biggest concern with the OIG is the fact that we felt that given the
resources we have, or even expanded resources, the only way you could use
compliance review solely as an effective weapon would be to do compliance
reviews of thousands of covered entities, which of course is basically
impossible with the resources we have now or that we could get to. So a more
effective program would employ a large number of other tools in addition to
compliance reviews. But we will continue to work with the OIG on that.

I guess that pretty much sums up the major work that we have been doing at
this point. I can open it up now to any questions.

MR. REYNOLDS: Okay, Tony, thanks, that was excellent.

DR. FITZMAURICE: Tony, this is Michael Fitzmaurice. I wanted to ask you
about the ICD-10. I think I read somewhere that AHIMA originally was asking for
two years for implementing ICD-10, and I think they have moved to three years.
That may or may not be right. I think I only saw it in one place. But it seems
that in order to implement it, we don’t want to go down the path of, let’s have
a date, let’s extend it, let’s have more compliance time, unless the industry
is serious about it.

I wonder if Medicare is planning to develop pilots on 50-10 once we
get there, pilots on ICD-10, after we get through 50-10, and put out lessons
learned for the industry, so that CMS continues to be a partner with industry
in showing the way and some tips on how to make it work better.

DR. TRENKLE: You made a couple of points. The first is, AHIMA’s official
comment was that they wanted the ICD-10 implementation to occur on 10-1-2012.
We received a variety of comments from people, anywhere from 2011 to 2015, and
we are looking through those comments, trying to strike a balance between
moving quickly towards ICD-10 to recognize the benefits, but also understanding
the challenges and the operational implementation issues that were raised by a
large number of our commenters who came in.

In terms of pilot testing, that is certainly something we need to take a
look at. However, one of our concerns with pilot testing is, unless you do it
on a large scale, pilot testing for ICD-10 could actually detract from the
overall implementation rather than adding to the implementation.

But that is certainly something that once the final rules are out on both
the regulations, we will sit down with our industry partners to work through

MR. BLAIR: Harry, from the standpoint of time, is there time for me to do
two questions or only one?

MR. REYNOLDS: No, you can do two, since you were quick on your last one.

MR. BLAIR: First of all, Tony, I really want to compliment CMS for all of
the areas where it has active, proactive, in trying to facilitate, encourage
and accelerate health information technology and health information technology
standards. I was just listening to your review, and being aware of all of the
areas that you are struggling to move the ball forward on.

The first question is with respect to negotiations with the Drug
Enforcement Administration. I understand you can’t necessarily tell us
everything that is involved in that, but maybe you could just verify that this
is one of the topics on the agenda which would be the ability of clinicians to
seamlessly include prescriptions for controlled substances, along with other
prescriptions over the current e-prescribing networks, like ShareScripts and
R-Sub. Is that part of the seamless use?

MR. TRENKLE: Yes, Jeff, that is correct. One of the things that that we
have been pushing with the DEA is that we want this to be something that
integrates with the current networks and does not impose an undue burden on
industry. So that has been one of the pillars that we have had.

We have had three pillars. One is that it can integrate with the industry,
the current e-prescribing systems and practices. Second, that it is scalable,
and third, that is promotes e-prescribing adoption and does not inhibit
e-prescribing adoption. So with those three pillars in mind, that is how we
have been looking at each of the requirements that DEA has put on the table.

One final thing on the DEA. One of the things that we have been asking DEA
is to try to tie back the technical requirements to specific risks that they
are trying to mitigate. There may be certain instances where they are trying to
mitigate a single risk with multiple technical requirements.

So these are the kind of things we have been looking at with them, is this
the best way to mitigate a risk, or are there alternatives out there, both the
current practices or other ways that are less burdensome that you could adopt
instead. So that is the kind of thinking we are approaching this with.

MR. BLAIR: Best wishes. Good luck.

MR. TRENKLE: We are constantly optimistic. I think Jim would echo that as
well. But we recognize we have a ways to go still.

MR. BLAIR: I am very glad that you are working on this.

The other area. You are looking at some of the areas of health information
technology. This is just to maybe add one for the future, so that it is at
least on your list.

From the perspective of health information exchanges, and I am speaking
from personal — full disclosure, this is from personal experience with the
health information exchange, whereby there seems to be support among health
plans and Medicaid to work together in a community to be able to support health
information exchange based on the value for continuity of care, for reducing
redundant lab tests and radiology tests, where the CITL study for example
showed that there was value to a community.

There is one player that is not at the table, and that has been Medicare on
those, Medicare benefits as well as Medicaid and the private health plans. So
as everybody sits down at the table and says how do we equitably divide this up
to support the benefits of state and regional health information exchange
networks, Medicare is not there.

So I just wanted to mention that so that you would have that on your list.

MR. TRENKLE: Well, Jeff, it is on our list. We actually have been active,
working with the Office of the National Coordinator, not publicly but
privately. But we do have some issues we need to work through with them. That
doesn’t mean we are not supportive, but we need to be supportive in a way that
it also supports applications that are being done.

Without getting into more detail, just suffice to say that we are working
with them and will continue to work with them, but we need to have a longer
conversation on this, because it is something that is evolving and will
certainly evolve under the new Administration.

MR. BLAIR: Thank you.

DR. FRANCIS: This is a comment with respect to the compliance issue. One of
the questions that has been on the table, it is not quite off the table of the
Privacy and Security Subcommittee, is the question of — I will put it in
John’s words, because he was out of the room when the discussion happened, the
question of governance, what kinds of structures are in place to be sure that
people can feel appropriately reassured that data protection practices are in

Obviously one piece of that is compliance. Your point was that that is of
course not the only piece, but the more there is openness and discussion about
for example education as a complementary strategy, as well as oversight to make
sure that complementary strategies are in place and working, the better.

So that question may come up. I just wanted to flag it for people.

MR. TRENKLE: I absolutely agree with you. One of the things that I want to
talk to the Department about is the fact that as I mentioned, we want to do
some things to strengthen our BUA surveillance.

The agency itself, Medicare, does thousands of data use agreements each
year, and we found that a large number of these data use agreements we do are
with organizations that have federal contracts or grants with other HHS
operating divisions, and also other federal agencies such as VA, DoD and SSA,
the Social Security Administration.

One of the things that I want to talk to the Department about is how can we
better utilize — there are federal dollars involved to do a better job in
terms of privacy and security as we give out this data.

Now, in terms of overall privacy and security, I agree with you, education
and outreach is a part of it. But the compliance reviews are certainly a tool
that we need to look at as well as governance. There is a lot of work to be
done in those areas.

One of the things that I have stressed with the OIG of course is that the
security rule itself did not go into effect until 2005, 2006 for the small
plans, and the enforcement rule itself did not go into effect until 2006.

So there is still a lot of work that needs to be done in those areas. I
look at it as an interative and evolving process, but obviously we would be
interested in hearing what the subcommittee has to say on the subject, too,
based on testimony that comes in.

DR. TANG: Hi, Tony. Paul Tang.

MR. TRENKLE: Hi, Paul.

DR. TANG: Thanks for your update. May I clarify something on the
e-prescribing rules? At one point, electronic faxing was going to not be
considered electronic prescribing as of January. I think that is what has been
pushed back to 2012.

MR. TRENKLE: That’s correct, yes.

DR. TANG: How does that interact with the MIPA incentive program for
electronic prescribing? In other words, is electronic faxing of prescriptions
going to qualify as electronic prescribing for the incentive purposes?

MR. TRENKLE: No, Paul, it won’t. Actually, under MIPA what they do is base
an e-prescribing system based on core functionalities that they spell out in
the regulation. We do not consider for purposes of the incentive payments —
computer-generated faxes are not considered electronic prescribing.

DR. TANG: So in a sense, the prohibition has been delayed, but the
incentive has not changed?

MR. TRENKLE: The lifting of the exemption was originally supposed to occur
January 2009. Last year we proposed lifting it in all cases, except for the
network issues for use on an emergency basis.

After we went out with that rule last year, we received comments primarily
from the pharmacy industry that said that would create a problem with
prescription refills that they fax to providers. They said that would create an
issue, where they would be forced to go back to paper if we took away the

So we went out this year with a proposal to include the refill as part of
the exemption, but then with MIPA passing and also with the comments we
received, we decided to keep the exemption on until 2012.

Now, in terms of the incentive program, that is correct, they were not
going to include faxing as part of it. And I don’t expect this to change. But
the Secretary does have the ability to modify the requirements for the
incentive program each year. So things could be modified slightly, depending on
the response. But at this point, we don’t expect to change that.

In fact, last year there was actually an e-prescribing measure in the
physicians quality reporting initiative that was similar in a way to what the
program is for next year, except for the fact that now, instead of being one
measure is part of physicians quality reporting. The e-prescribing measure is
actually a separate incentive payment. But that particular measure also did not
include computer generated faxing as part of e-prescribing.

MR. REYNOLDS: Tony, thanks again. I would like to echo what Jeff had to say
to both you and to Jim. CMS and the Department are both really taking a lead in
helping these things move forward. A lot of the answers aren’t completely clear
yet, but you are not shying away from subjects, and you are absolutely making a
difference. So I congratulate both of those entities. A lot of us on the street
get to see it, and you are really making a difference. Thanks for your time
today. You guys are wide open up there.

With no other comments, we will take a break and be back at 10:30.

MR. TRENKLE: Thank you, Harry, and thank you for the committee’s support as
well, and your personal support for the efforts.

(Brief recess.)

Agenda Item: Update from Executive Subcommittee
Retreat – Framework for Committee

MR. REYNOLDS: Let’s get back to business here. The next portion of the
program is an update. I will start off the update, but then I will ask each of
the co-chairs of the committee to give a quick update on their plans for the
upcoming year. Then we will have the breakout sessions this afternoon and
tomorrow morning to add to that.

On October 14 and 15, we had an offsite of the Executive Subcommittee
liaisons and staff. We had had a brief preliminary planning meeting on
September 17 after our last hearings to begin what we were thinking.

If you look at the slide on the projector, we have had some situations in
the past where we have had subjects that we had individual committees deal
with, and then we had ad hoc committees, we tried that on some things, which
meant that you pulled certain people out, got them all together and did

As we looked at the subject up there, which is patient centered health, and
you will hear a lot more about that as we go through this today, we decided to
approach this a little different. It is really cross cutting and it is really
something that is foundational for everything that is going to be going

So all the picture is trying to depict up there, when we talk about person
centered health, what the picture is trying to do, maybe not in an elegant way,
but is to say as it says at the bottom, we want continuous learning by NCVHS
from its committees and others. So every time somebody holds a hearing and it
relates to this subject, it needs to be reported back to everyone. We need to
do this on a continuous basis.

This is a subject very much like the PHR discussion. You notice Jim started
off and everybody jumped in, then Tony started off and everybody jumped in,
because it is based on the same kind of premise that we are talking about. So
this is not about individual subcommittees or full committees or other
entities. This is really about continuous learning and continuous building on
this subject as a basis for everything that we are doing.

So that is a little different than we have approached it before, so I ask
everyone in full committee and others, as we do this to continually share your
thoughts, ideas, through the subcommittees, through the full committee. Then as
we need to, we will pull in other entities, and you will hear about some of
that today. So that is the way we wanted to approach it.

Also, we had representatives with NCHS and its Board of Scientific
Counselors, political for collaborations with AHIC 2, the National Quality
Forum, and national priority partnerships and other bodies. So continuing to
look at the things that are out there that will continue to help us with this
subject as we create it.

Some of the highlights were, all of the subcommittees will work on
dimensions of person centered health, with quality taking the lead. You will
hear a little more briefly about that. I want to thank Paul and Justine for
being the thought leaders in that whole committee for doing that, and for
Populations kicking it off when we first had the medical home discussion.

The Subcommittees on Population Health, Standards and Privacy and Security
also planned additional activities, so you will hear a little bit about those
between now and 12:00, so you will understand what else is going on. Then
tomorrow you will see the revised subcommittee charges. We would like everybody
to be able to look through those.

So in the breakout sessions today, make sure that you clean those up, make
sure that is what your charge is, and you bring it back tomorrow ready for
serious review.

Also, we may still continue the follow up project on the person centered
medical home in spring of 2009 in the context of the person centered health
project, not assuming that the medical home will be the model; assuming that it
may be one of the ways that person centered health gets delivered and/or dealt
with. Paul, is that a fair way of saying it? Okay, good. Paul wasn’t listening
but he shook his head anyway, so we will go from there.

Special projects and assignments were approved on data stewardship which I
will cover more on, revising the vision for the 21st century, and the 60th

I am not going to spend a lot more time on person centered health, because
I would like Justine and Paul as they give their overview and discussion of
their upcoming hearing, and how we are going to kick it off for the whole
committee, to go ahead and do that. Some other things that occurred in the —
and I will let Dawn talk about the person centered medical home.

The data stewardship compendium. If you remember, when we had the full
committee discussion that we really didn’t believe that data stewardship was
going to be a cross-cutting subject that we would hold hearings on. But more,
it was going to be dealt with more as a lens or a filter.

I think we have had some of those discussions today about data stewardship
as we talked about personal health records. So Justine and I will be working
probably with Susan Canaan to put together a framework for that that lays that
out as far as a lot of the things that NCVHS has already done and decided, as
well as some other work that has gone on, to put this together as a document
only to use as a filter, not something that is prescriptive, but something that
you can continue to use as a filter.

The work that we did on that was quite horizontal and broad reaching, but
then if we overlay that on something like person centered health, you can
really start making sure that we bring the ideas and concepts to life. So that
is kind of what we are trying to do with that, so I think that will be good.

There was some discussion at the Executive Subcommittee about a data
steward. We heard testimony when we were doing some of the other meetings about
whether there should be a data steward. However, the group agreed to complete
our document, complete our filter, not necessarily weigh in at this moment
about whether or not there should or should not be a data steward or anything
related to that. So that is where we came out there.

A couple of other things, and then I will turn it over for some open
discussion on what I just had to say. Then we will go through each of the
subcommittees and have full discussion on the subject.

On collaborations with NCHS and the Board of Scientific Counselors, we had
Jim Lapkowski make a presentation to us. He expressed interest in the
committee’s new person centered health initiative, and offering the BSC as a
resource. So we have other entities, and listed a few up there. Obviously BSC
and others could do that as they think about it.

Also, as Jim Scanlon spoke earlier about some concerns about vital
statistics and so on, he said the BSC may make a specific request of the
committee to weigh in on certain issues related to that. To date I have not
seen any yet, but that was discussed.

Marjorie, why don’t you take a minute on the revising the vision of the
21st century health statistics, again, just a couple of comments.

MS. GREENBERG: I wonder if Debbie might want to come up on that. I think it
is on the agenda for tomorrow. We might as well do it now because I know
tomorrow will be rushing to end so we can go to the hearing over at the
Humphrey Building.

Debbie and I did have a teleconference with Gib Parrish and Dan Friedman,
our former member, last week. I think we have got a plan. We have obviously
also been in communication with Harry and Don and Bill. Do you want to tell us
where we are on this?

MS. JACKSON: Yes. I think in looking at the proposals that were submitted
and looking at where the committee is in what your ideas were for 21st century,
we have been trying to walk that line of what can be accomplished.

Dan Friedman was so instrumental in the original 21st century materials.
You will recall that that was built up on coordination with the Department,
with the Data Council and with the committees and NCHS. So so much groundwork
had been laid, and we mentioned your name, Carol, as a real ambassador and
strong person who has kept the report up front and center along with Dan at the
Subcommittee on Populations level.

So much work had been done in developing that document that we felt that —
what are the things that can be done to bring the basic issues to the forefront
and updating it, keeping in mind, so much has been developed over the last four
or five years in health IT.

One of the exciting things I saw in what Marjorie’s poster is, this is one
of the first places we had with the NHII as well as the 21st century graphics
where put together in one place. Usually you had to go to one document or the
other and take a look aT them. But we are in a place now, a neat synergistic
place, to pull it all together. So that is where in talking to Skip and Dan who
were there from the very onset, that we think we can pull this off in a couple
of years to do an update.

MS. GREENBERG: Thanks, Debbie. What we are doing is two phases. As you will
hear, all the subcommittees have plans for this coming year, yet also as you
have heard, we have some budget constraints, too.

This phase one, which will be in this fiscal year, will be Dan and Gib
pulling together all the information that has happened, and the reports of the
committee and others that have happened since the vision was published, and
bringing a lot of that information together and bouncing it back. I think the
Population Subcommittee will be the focal point, but also the Executive
Subcommittee and of course the full committee.

Then in the following fiscal year, probably a year from now, may be a few
hearings or workshops looking at a revised vision based on the changes that
have happened with health IT, and looking broadly as Sondik has encouraged us,
on how the whole organization of health statistics might change.

I have to share this with you. Bill told us to think broadly, and he sent a
great e-mail suggesting how things could dramatically change. Then he asked me
if this was more hallucination than a vision. I wrote back and said, no, I was
hallucinating with him.

When we talked to Dan, just to bring this down to the human level, he said
he appreciated that so much. When his late mother, may she rest in peace, she
was in her ’90s, I think, when he was coming down to CDC to present this 21st
century vision for health statistics, he went to visit her in the hospital. He
told her what he was going to be doing, she said, I hope your hallucination
goes well.

So you weren’t the only one, Bill, who was thinking that way.

So anyway, we hope to vision and hallucinate into the 21st century and have
something that we can chew on over the next year and a half and then present at
the 60th anniversary in 2010.

MS. JACKSON: We are planning on having Dan for the February meeting.

MS. GREENBERG: Yes, that’s right, Dan and Gib. At that point they don’t
want to get too far down the road without talking with all of you. So we have
proposed to them that the come down for the February meeting.

MR. REYNOLDS: The last item I will cover, and then we will go through the
subcommittees. Mike Fitzmaurice had some up with an idea of possibly a letter
to the new Secretary as to what was going on. I was playing off of Jim
Scanlon’s discussion earlier, where the Departments have done the same thing,
pretty well put a plan together.

It was taken by the Executive Subcommittee that if a letter like that were
going to be prepared, it would be prepared about the full committee. So myself
and Jim and Marjorie with contributions from anybody on the subcommittees that
want to put input, will be working on it.

I think something like the chart is a great visual that I appreciate
personally now. People ask you about the committee, and I think that has done a
good thing. But we have to do this with the appropriate protocol at the
appropriate timing, for the appropriate reasons. This is a major change in this
country, and you want to make sure you are introducing yourself in an
appropriate way, not just being another letter saying, hey, we are here. That
will be the art. We write letters, but that will be the art of the letter.

So any of you that would have any insights to that, we would appreciate
that now as we begin that journey. So that is where we are headed with that.

With that, I would like to first kick it off with the Quality Subcommittee
since they are going to lead the way. Then after they are finished, let’s open
some discussion on the person centered, and then we will move down the rest of
the committees.

But before I do that, I would like to publicly thank Don Steinwachs and
Debbie Jackson. Don physically chaired the Executive Subcommittee retreat due
to my surgery. I truly appreciate that. He did a masterful job of doing that.
He did a great job in working through that with me, and Don, I thank you very,
very much for that. That was very appreciated.

DR. STEINWACHS: Harry, I heard it was because you didn’t want me to do
surgery on you.

MR. REYNOLDS: That was absolutely a fact. That is why I didn’t let you know
until afterwards. But I really appreciate that. He did a very, very good job.
Both of them pulled it together, so thank you to all of you that did that.

With that, I would like to turn it over to whichever of the spokespersons
from the Quality Committee.

DR. CARR: Thanks, Harry. I will read from what Paul has written, so we will
do a combined effort.

This is just our overview on the upcoming hearing that we are planning.
Just as way of background, every ten years HHS leverages scientific insights
and lessons learned from the past decade along with knowledge of current data,
trends and innovations. Healthy People 2020 will reflect assessments of major
risks to health and wellness, changes in public health priorities and emerging
issues related to our nation’s health preparedness and prevention.

The importance of empowering and engaging individual Americans in their
health and health care represents an increasingly significant way to achieve
improvement in national health outcomes. Such programs as the National Quality
Forum’s national priority partners initiative set forth clear rules and goals
for people in improving their health and health care.

By way of background, the next generation of health surveillance data set,
which is what we are looking toward, should seek to meet the emerging health
data needs of the nation by improving the accuracy, the timeliness and the
comprehensiveness of national health information with new sources of data.

While electronic health records hold promise in improving the ability of
clinicians to improve the quality, safety and efficiency of care that they
provide, the emergence of person centric health information technology
applications, like personal health records, provide individuals with the
ability, often in concert with their health care professionals, to track and
improve their care.

PHRs and other person centric tools evolving from outside traditional
health care delivery models represent the new and potentially significant
sources of data for delivering, monitoring and improving the nation’s health
and health care.

The goals are as follows. NCVHS seeks to better understand the emerging
data needs for measuring and tracking population health in the 21st century and
to inform HHS policy, decision making and projects by three things. One,
determining the applicability, use and limitations of PHRs and other personal
health tools and applications, either alone or in combination with EHRs and
other provider systems as vehicles for capturing needed national population
health information.

Two, assessing current and proposed certification standards for taxonomy,
standards, security, authentication for PHRs and other personal health
applications. Three, providing recommendations to support person centered and
population health functionality in PHRs and other personal health IT systems.

So I will stop there. Do you want to add anything, Paul?

DR. TANG: I think the goals we had for the hearings or the activity were
what Justine just enumerated. That would be getting information from other
peoples’ experiences without doing a roust formal evaluation, sort of consensus
expert opinion.

It would be nice, where you are having three states who are doing a PHR
pilot, two of which are yet to begin, is there any way to bake in an evaluation
that addressees some of these goals in a real live implementation. I think that
would be much more primary data to bear on the policies that we are trying to
recommend. I don’t know what kinds of resources we can put on that, because I
know that wasn’t necessarily baked into the original blueprint.

DR. FRANCIS: This is one of the examples where it is wonderful to get
together for coordination purposes. The Privacy and Security Subcommittee was
looking towards hearings in January. Part of what we were looking towards
virtually paralleled the structure of what you all were looking towards for
hearings with questions about what are the privacy and security practices,
issues, what needs to be thought about from that perspective so that the
benefits of PHRs can be harnessed in ways that patients don’t find threatening.

One of the things that we are going to need to work through with the
schedule of committee meetings, hopefully it will all work out so that we can
jointly meet in maybe the second half of the afternoon today.

Maybe Quality can join us after they have been with Population. I am
serious about that. I know that funds are tight and time is tight for hearings.
You can’t have two days of hearings and then have us have two days of hearings,
having the same people come. So we have got to figure out how to make all that
work, and how to integrate it.

DR. TANG: The proposed draft hearing schedule that we had offered
incorporates that thinking. The first day would be about the data and the
standards and coded sets that apply to getting information from patients that
might satisfy the population reporting. The second half day was about PHR
specifically and the certification standards related to privacy.

So we thought that second half day could be a joint meeting that would go
from PHR’s data and migrate into the privacy aspects of those. That was the

DR. FRANCIS: We shouldn’t be taking up the general committee, but to figure
out for example if Google comes and tells us one thing on the first day but
doesn’t tell us about privacy, we are going to have to work through all that.

DR. WARREN: I would just like to say ditto to what Leslie just said. When
you start talking about code sets and transmission standards and stuff, then
the Standards Committee wants to get in that. I shared that at our conference
call, where I joined Quality.

So if there is a dance card, Standards would like to meet with you guys
tomorrow morning. The only thing you have is the last half of your meeting,
because you are meeting with everybody else.

So I think we need to look at — this is a perfect example of, most of if
not all of the subcommittees are interested in the same set of hearings. So
when does it become a set of hearings and when does it become a full meeting?

MR. REYNOLDS: That would be the reason that we used to do ad hoc
committees. We pulled people together and we did them.

The picture is real. That is the thing we are going to have to do. But we
have got a lot of names up there of subcommittees, but we have got to figure
out what we are doing.

Again, remember, we have got an hour and a half today. We left an hour and
a half today and some tomorrow to have this discussion, because we want the
full committee to buy in, because everybody is on subcommittees and so on. So
before we change what Quality is doing, I would like to make sure that we hear
from Privacy and Standards and Populations before we all of a sudden take this
hearing — I asked them to go first to introduce the subject, but now all of a
sudden we are changing it. Let’s hear from everybody. That is why we are having
this discussion.

MR. BLAIR: There are probably several ways to do coordination, but I would
like to suggest one for consideration that might be easy and straightforward.

That is, as each of the subcommittees winds up developing questions it
needs to get answered, if we share those questions with each other, that is I
think the most efficient way. If the Standards Subcommittee is asking the same
question of a testifier that Quality or Privacy is, then bingo, you could wind
up saying, we don’t have to do that twice. We can wind up having that done in
one and just share the answers with the other subcommittee.

DR. TANG: We did have a planning call that involved Privacy and Standards.
The original design of this was to do the juxtaposition of the three groups.

So one way is, day one has overlap with Standards. That is the way this
proposal is designed. Day two overlaps with Privacy. So that is one approach,
is to have the overlaps constructed so that it maximizes peoples’ individual
committee work.

The other option is what Justine just mentioned. We could just have the
full committee at the hearing because it clearly involves Population.
Population is almost going to be part of Quality in this. But that might turn
out to be the most useful and efficient way to getting the information to all
relevant parties.

MR. REYNOLDS: So after we hear from everybody, we will consider that.

DR. WARREN: I just want to reply that what I find fascinating with this,
because I was on the phone call with Quality when they looked at this, you are
looking at a piece of what Quality is interested in. As it turns out, that
piece everybody is interested in.

So it shifts it away from the way we have always done things with
subcommittees, Quality is interested in quality and only looking at that. Now
all of a sudden they are getting into an area where yes, they are interested in
quality, but it cuts through everything else, which is the way life is, and
should be run.

So while I think each subcommittee needs to report, this particular project
may be unique in a way that we are going forward. It may be the successor of
the task force idea that we have had before.

MR. REYNOLDS: Justine and Paul, one comment. As I went through your
document, one of the reasons I think we went to person centered health was to
talk about the person, not the medical home which was a model, and not the
person being a patient only, just a patient.

Personal involvement, personal responsibility and personal accountability
didn’t jump out. I think it is there, but what other kinds of things are going
to be available? I know at home when we take health risk assessments, we are
not patients, we are employees taking a health risk assessment. As you order
lunch today you are not a patient. So whether or not we are talking about the
full person, not just the person when they are with the doctor.

DR. TANG: They all talk about population health, and that is deliberate to
not mean health care.

MR. REYNOLDS: But I am just saying, about each person’s individual — what
tools are we going to give each person to do that.

So I think it is there. I’m just saying, maybe at more a layman’s — just
think about it.

DR. CARR: I didn’t go through the planned agenda for the hearing, but —

MR. REYNOLDS: I’m saying in the first couple of pages. I believe that the
hearing does — you are right, up in front doesn’t necessarily pull out what we
had talked about. Just add a couple of words, but maybe nobody else agrees.

MS. MC CALL: I do agree. You tell me whether or not this comment aligns
with what you are saying.

I think that we talk a lot about data. I think we talk a lot about what we
mean. But data is an exhaust off a process that meets a need of a person. So if
we want the data then we need to make sure that the data is coming from
something that the person finds valuable, in terms of what they can learn, what
they can know, what they can do around the pursuit of their own health.

So I think that we need to add something to the dialogue that investigates
and explores what it is that people would actually be doing that would generate
that data. So it is not about the data first, it is about the personal use.

MR. REYNOLDS: These aren’t criticisms, these are just — it didn’t jump out
at me.

DR. TANG: Actually that is my day job. The reason that this was a bit more
slanted toward population health and reporting is because I thought that was
the scope for NCVHS. So we can use clarity there.

My particular professional interest in my day job is in managing health and
wellness. So it is slanted a bit towards the reporting side, but please clarify

MS. MC CALL: One clarifying comment then. I would say that if we want to
continue to focus around data and population health, that we simply don’t
assume that we have the can opener, that we confirm that there is going to be
some sort of tool or mechanism or capability that a person will have that would
generate the data. Don’t assume that it is going to naturally be embraced by a
person, that that be a confirmation conversation that we have.

DR. CARR: I think we perhaps have not fully enriched the — recapped the
conversation that we had at the hearing. But we were talking a lot about
individual tools and techniques for a variety of things, weight management,
exercise management, as well as diabetes management, blood pressure management.

I am happy to recount them now if you would like. I didn’t know if — but I
think that is where it began. The focus are mechanisms that empower an
individual’s focus on their health. The NCVHS has as its mandate the data; we
are focusing on the data. So I think we are linking these two things, but our
hearing takes on a data focus so that we stay within our charge.

DR. TANG: Let me give you a concrete example. Steps might be a very useful
thing to manage individual health, but fitness is the publicly reported data.
So I am still looking at this side of the table to say what is the scope of
NCVHS and how do we incorporate the ideas about the wellness that Caroline and
Harry brought up.

MR. J. SCANLON: You have a fairly broad set of parameters here, but you are
not the health policy board or the public health board, so your focus is on
measures, metrics, data, systems that would meet the needs and the gaps that
you identify in those areas — prevention, promotion. Some of it is clinically
based, some of it is population-based, some of it is employer based. But yours
is the data perspective.

MS. GREENBERG: When we were talking in September when we started
conceptualizing this, part of it was talking about what is really important to
people about not just how can providers or statisticians or agencies or
whatever get more information from these people, but what is really important
to people about their health and their well-being, and a broad view of health
that might never — some aspects of it would never be part of the health care
system, the WHO definition of health, which includes well-being and also
aspects of society and the environment, facilitating the type of health and
well-being that is important to people.

So I think that probably requires maybe hearing from some consumer groups.
I don’t know if I am being clear about this, but not just what the health care
system or even the health statistics system wants to know, but what is really
important to people.

Larry isn’t here now, wasn’t able to come today, but the idea of why people
— if it has to do with the health care system, why they are seeking care, or
what people care about from the point of view of their health and well-being. I
think we want to make sure we have that voice, too.

DR. CARR: It might perhaps be helpful if I just gave you a couple of
bullets about what we are intending for the hearing. We thank Matt Quinn for
his help on this.

The first topic, overview of current population and health measurement
strategies and data sources. Next, understanding and assessing emerging needs
for measuring and tracking population health, so evaluating gaps and needs for
measurement of person centered goals, supporting Healthy People surveys. Next,
identifying current data standards and their gaps, so ICF, SF-12, SF-36, LOINC,
SNOMED, et cetera, and then summarizing that.

Then moving on, determining the applicability, use and limitations of PHRs
and other personal health tools as vehicles for capturing needed national
population health information. So this is patient centered health information,
but actually this should have been person centered visions and tools, PHRs,
stand-alones, aggregators.

Moving on, assessing current and proposed certification standards, and
summary and action items to support population health.

Some of the folks that we are looking to be hearing from on the PHR front
include Cleveland Clinic and Care Group, but also PHR platforms from Google and
Microsoft, stand-alone and commercial websites, WebMD. That is the idea. The
purpose of our work today would be to flesh that out.

DR. MIDDLETON: I think the primary objective on the table is to figure out
some scheduling, which is complicated enough. But it does to my mind perhaps
also raise some framing questions about NCVHS scope and purview and orienting

What I am struck with in this conversation is thinking back to Larry
Green’s observations in the NAJM article, where he talked about the premature
determinants of mortality, and identified behavior and the environment and
genetics as being much more important frankly than health care.

So I wonder if that doesn’t help us think about a broader scope with data
and data acquisition to assess the broader set of impacts on what are
determinants of health and mortality. So that is number one.

I think the second thing is, even in this conversation, we are struggling a
little bit in framing who to talk to and whatnot, because we are not explicitly
addressing the value proposition. This is a CITL favorite topic, but do we want
to introduce business and/or value considerations into our hearings process and
our determinations, because it is ambiguous still, and because the data we need
to assess determined value might be very important to the marketplace.

I might suggest that taking a value perspective on these hearings would be
useful. That involves both patient and community perspectives as has been
highlighted, certainly the traditional provider perspectives from any number of
strata of provider organizations, and then payor perspectives both public and
private is the natural set there. But then that value perspective can help
define further data and measures.

DR. STEINWACHS: I just had a couple of thoughts. It strikes me it is an
interesting environment. You are probably starting into the process soon of the
2020 health objectives. That generates I would think a huge list of what people
would like to see, and that is matched against what data are available, what
can be looked at, what are the goals. It would be interesting to think about
how one could tap into at least some of that developmental process and thinking
about what would be wanted possibly in terms of data and information if it were

Carol’s point, which I thought was excellent, was saying what would I be
motivated to actually do. It always strikes me when you talk about health risk
appraisals, at least my experience is, if they are just offered to people,
there aren’t that many that are filled out. So others are providing an
incentive. So that brings in the third group, which is who are the stakeholders
who are invest resources, energy or incentives to us, who want to provide that
kind of information that would be helpful to us more broadly.

The last was what Blackford was getting at. When we were talking about data
linkages and the framework that we are trying to update for NCVHS, it talks
about bringing together such things as environmental data, law enforcement. We
have some studies going on at Hopkins that are looking at bringing together
information about the structure of neighborhoods, sidewalks, other things,
where you begin to understand what people can and can’t do in the place that
they live.

So it seems to me it would be interesting to lay out those elements and
then figure out how do we at least touch on them, trying to understand what
motivates what we get, and more broadly talk about what people could benefit

MS. GREENBERG: This would be for discussion in the breakouts, but I look at
1:30 to 2:15, overview of current population health measurement strategies and
data sources. I see CDC there, too.

I think this is going to have to be very focused as to what you want people
to report on, or I would suggest that is not really enough time to set the
stage or the background for the types of measures, the types of information.

It very much relates actually to the 21st century vision, but you knew I
would say that, that whole influences on health which Blackford was mentioning.
So you don’t just want to hear about all the surveys obviously. So I think this
needs some fleshing out.

DR. CARR: Will you be joining us? This was just the product of one phone
call. All of this input is very — we are just trying to keep the process
moving so that we have some straw man thing for us to respond to. I think all
of the input today has been very helpful.

MS. GREENBERG: I am kind of wondering, with everything that is hanging on
this, why the schedule is the way it is. It looks to me like only a half day
and a half day. Maybe I am missing something. Particularly if we include the
interests of the other subcommittees, we might want to think of a bit more
robust schedule.

DR. CARR: That is a great suggestion, thank you.

MR. REYNOLDS: Again, the purpose of today — and as soon as we say cross
cutting, that means we are going to be tripping over each other in the early
discussions. So I just ask that we not be too — they put out a straw person
for us to start working with in the waterfall, so they are the first trip over
the waterfall. So I want to make sure that we continue to build off of that.

Again, we have got the breakouts, so I want to get as much discussion as I
can right now during this time, so we understand what we are thinking about as
a group. Then when you do your breakout, what you may want to do is consider
moving one of your people from your breakout session, and think about how to do

I have asked them to go first, because they are our first waterfall, but I
don’t want them to be the lightening rod for every — we have got to figure
this thing out. We are making part of this up. Nobody else has got this thing.
So I ask everybody to play at that level that we are making it up. Then in the
end, once we figure out what it is, we will debate whether or not we did the
right thing, and whether or not we have got the right stuff in place.

MR. BLAIR: A lot of times we study areas where we know there is improvement
in quality and improvement in privacy and improvement in health or improvement
in health care, and they have tremendous value. But if there is a piece of that
as we do that, which can pick up Blackford’s comments — he said value, and in
my mind when I hear value, my mind replaces it with quantification of the

Even though so many of the other studies have tremendous importance, I am
finding that if you can’t quantify that value, if you can’t quantify the
benefits, very often everybody intuitively agrees to that, but it doesn’t get
funded and implemented.

So I would just say that as we do our work, if there is a piece of that
where we could quantify the benefits or it could lead to quantification of the
benefits, I would wind up saying that is the piece we ought to put a high
priority on.

MR. REYNOLDS: I’ve got Mark, Paul and Carol. Then I am going to move
Quality out of the spotlight and I am going to give the other three
subcommittees the opportunity to move to the forefront.

DR. HORNBROOK: We have been doing some strategic planning in Kaiser. One of
the things that is glaringly missing out of all our efforts to build an IT
system is a measure of output. There is nothing in any of our information
systems that tells us how much health we have produced.

So we are pushing and trying to figure out how in the world you can pay for
regular health and related quality of life surveys that have utility scores, so
you can get to a single global measure and deal with resource allocation
issues, which of course is a key issue of the high cost of our health system

So electronic medical records are really great measures of input. Surveys
of health behaviors are necessary, but they are still measures of inputs, not

Then on the 21st century thing, I have been looking at Hawaii, and they
seem to be having some really important early warning issues. The population is
getting older. The physicians are getting older. Physicians are not able to
sell their practices, because their practices aren’t worth much. They aren’t
hiring people to replace themselves in the Islands, so they are feeling like
the physician shortage is down on them very, very fast.

So I would say that we need today to think about detecting the implosion of
the health care system in our data system design, not thinking about the 21st
century. We have got to get there first. We are going to go through a huge
chasm before we get to the other side.

MS. MC CALL: I love the comments that have come forward. I think that the
way this is structured, giving what Justine read, the little bit more
background was very helpful.

I think it is possible to link three concepts as we go into these hearings.
One is around our 21st century vision. Another is around the determinants of
health, and the third is around the concept of value.

The 21st century vision says we have a point of view, not complete, we are
still learning, but we do have a point of view around the things that we need
to better understand to push forward on population health and the context of
that in the environment and the community. So I think we can put that out

I also think that we can ask some of these testifiers what are they doing
to capture data about those, either directly or indirectly, and what are they
also doing to bring the concept of value that makes the person using this
thing, whatever it is, want to do that and to explain that. So we can go in and
link those concepts.

We are looking to learn, but we are also looking for gaps, which I think
was a very important thing that you guys read off. What is going to come out of
this is a sense of gap. We have a point of view. We are fleshing it out even
more around 21st century, but we are going to find gaps to say, with all this
good work that is great, but we have more to do, and we are going to have shone
a big light on that.

So I think it is well framed out to do those things.

MR. REYNOLDS: You said 21st century vision?


MR. REYNOLDS: Determinants of health, and what was your third one?

MS. MC CALL: The concept of value. It is the idea that any proposition
whose value relies essentially on externalities or the idea that we can begin,
once I have ten million people signed up and I have exhausted all that, it has
a problem because it hasn’t addressed the fundamental issue of how do you

MR. BLAIR: Could I ask a clarification question?


MR. BLAIR: When you say value, in my mind that means the ability to
quantify the value. Is that what you mean when you say value?

MS. MC CALL: For me, I think there are different values. I should pluralize
it. The value to me as an individual person on some of the tools that may be
there, I may not be able to quantify, but I will recognize the value because it
gives me an ability to do something that I never could have before. Maybe it
will be quantified someday, but that is not my primary goal. I seek to orient
myself on the Map of Health Life, I seek to help my family, I need resources, I
need knowledge, I need new things.

The value to the system needs to be quantified, I would agree with that.

DR. MIDDLETON: This is such a great thread. It is very exciting. In a way,
Jeff, following up on Carol’s comments, I think we do have to address the
values of the system, that is, what are we aiming to purchase or produce, as
Mark had alluded to, too, which is different and perhaps not well understood or
not fully analyzed, and of course requires data to do so at a variety of

That is a very large policy question, as to what we are going to do with
our increasingly scarce health care dollars, what are we going to pursue. So we
need information which may be based on data to inform those values.

Secondarily though, I think there is then the fundamental value question,
which is to objectify the value at some level, but also to appreciate what Mark
also alluded to, is a patient’s personal preferences and utilities. That is
increasingly going to be important as the value metrics shift toward more out
of pocket or consumer expenditure in health care.

We already know that two-thirds of health care dollars spent are not into
the traditional health care delivery system, they are spent on everything else.
So I think there are both dimensions that we have to address.

DR. TANG: This is a possible process of procedural suggestion. We have had
a very similar discussion probably three times already. I am wondering whether
it would be wise to start out our breakouts almost as a full committee, meaning
representatives of all the subcommittees, in a working session to try to
enumerate all the concepts, find out where the overlaps are, and assign a
detailed agenda to the work groups that would follow.

So let’s say an hour working session together, and then the next three
hours or whatever time remaining schedule so that we can each meet in our
subgroups, just to try to get a bit of — put us all on the same page, and have
clearer or crisper subgroup —

MR. REYNOLDS: I like the idea. We can use conference calls for individual
subcommittees which we have done in the past. Face to face on these kind of
subjects is almost priceless, when we struggle to get everybody together and
look across the table.

So we will think about how to do that. Maybe that will be a good lunch
discussion, figure out how we actually do that and how do we construct it, and
what does it look like.

Before I turn it over to the next subcommittee which will be Population,
back to one of the points. Jim, you were mentioning incentives. I can
comfortably tell you that — and I just went through the surgery and everything
else, but the health risk assessment that we went through in our company, and
also the ability to meet with a nutritionist, has dramatically changed the way
I look at things.

Now, I have seen a lot of doctors. I have had a lot of other stuff. But
knowing that and seeing trend lines and seeing things that I do, so when I
order this, I do that, I think different. But when I went in the hospital, they
didn’t care about my personal blood pressure, they cared about their charts,
and we had an ongoing fight. They told me I was fine, and I wasn’t at my number

So back to the person thing, I was not at my number. So they are telling me
I am okay and I am going, no, because my chart says I am not okay, the one I
have from this entity. So those are the kinds of things.

Now, take people less prepared to do that than some of us. We talk about
personal accountability and we talk about personal responsibility and so on; if
we can make any difference there — in our company right now, we have got an
incredible percent of people that are obese. We have got to make a difference.
So those are the kinds of things that we are all trying to think about.

So that is just personal from somebody who is in it, but that alone
dramatically changed what I do and don’t do, dramatically changed it, and that
is kind of fun.

So with that, Populations.

DR. STEINWACHS: So Harry, can I change my lunch order now?

MR. REYNOLDS: No, I actually did not order well today, but I did it

DR. STEINWACHS: Bill and I will try and do this. I will lead off and Bill
will fill in all the things I don’t say.

I think, Harry, when you went through what we covered in the Executive
Subcommittee, you laid out the things that we have underway. So the follow up
to the patient centered medical home hearings on the Populations Subcommittee,
we see what Quality is leading off with as the next step.

Then we have been going some work and Matt Quinn has been helping on a use
case. If we focus back on this idea of some sort of enriched primary care,
medical home, whatever you want to call it, the medical home is the words that
people are using, how could we explore a manageable piece of that in the use
case idea.

So we will be talking this afternoon about that use case idea as a way to
explore it. But we are waiting until after the January hearings on the person
centered health to see where this fits in, so that we are coordinating this. We
were talking about doing something in the springtime, I think was the plan.

We put the patient centered medical home at least in the subcommittee’s
concept under looking at information and issues that support health policy and
health reform, and this being one direction, namely, trying to strengthen
primary care coordination and continuity functions.

The other, which we are going to have hearings tomorrow afternoon and then
we are talking about subsequent hearings, and these have also already been
discussed, but just to say them quickly, was to look at data sources available
and used within the government data collection systems related to insurance
coverage and access to care. That will be the hearing for tomorrow afternoon.

We are then looking forward to doing another hearing particularly around
modeling and the opportunity to use the data in models that look at policy
options. The discussion has been to have both modeling that is done in the
government and the different models that are used in different parts of the
government for insurance coverage and some of the implications there, and on
access, and also to include some of the academics who are involved in modeling,
so that we get a sense of what is going on dynamically in both areas, and what
are the tools that may be most useful for different kinds of questions or most
useful more broadly, as health reform issues are raised, and the government and
others are responding to trying to understand policy options.

The other activity that came out of discussions, and Mark Hornbrook brought
this forward in the Population Subcommittee, was the interest in what kind of
synergy might exist between health statistics and collection of health
information and what the CTSAs are doing by providing funding and bridging
commitments that talk about linking what is going on in research into
communities and tracking what is happening in communities.

So the first step in that is, today we will have a person coming in to the
full committee meeting here to talk about what the CTSAs are expected to do,
what they are doing, and begin to get a sense of where we might find this kind
of synergy, which sounds exiting.

DR. W. SCANLON: They are already sitting in the back.

DR. STEINWACHS: Okay. So I better watch what I say about the CTSAs.

We were hoping that out of that there would come greater clarity as to what
the next steps were, and looking forward to this idea that there might be some
potential here to develop community level, very dense kinds of information that
are not available at the national level, and then to begin to think about how
statistically would you bridge that. If you had 40 or 60 communities around the
country and then you could relate that to national health statistics in a depth
and dynamic way.

You have already heard about the updating process for the vision for health
statistics in the 21st century. Certainly this is a great part of the whole
committee activity, but the Population Subcommittee is seeing itself as trying
to facilitate that and move that along.

Let me turn to Bill about the discussions on vital statistics and what has
been going on between the BSC and ourselves. And Garland may have something to
add to that, I don’t know.

DR. W. SCANLON: Sure. I guess our principal issue in vital statistics is
the adequacy of funding and the consequences of the inadequacy of the funding
and what it is going to mean in terms of the kinds of statistics we are going
to have available.

It has been a continuing concern of the BSC. They have written a letter to
the Secretary, expressing that concern. They have created a work group to look
into it further. We have agreed that as that work group proceeds that we are
going to coordinate with them in terms of looking at the issue.

This is one where when you think about resources, sometimes you say, how
can we change the process to conserve resources and be more efficient. I don’t
think that is really on the table at this point, because there has already been
some changes that may have done that.

The issue right now is, we are at a level of resources that is falling
below what one might think of as a desirable level in terms of the kinds of
data that we will have available. Garland knows this in much more detail than
I, but I think that is the overall assessment.

DR. STEINWACHS: Garland, did you want to say something before I knock over
the microphone here?

MR. LAND: Yes. I think there are two critical issues going on. One is, the
proposal is to reduce the number of data elements that are being collected on
the birth and death certificate. Particularly on the birth certificate they are
going to reduce it by about 75 percent of the data elements.

The other issue is that there is a proposal to cut the funding to the
states that provide the data to the National Center between 30 to 50 percent,
at least 30 percent, and who knows, it may be even higher than that. So that is
going to affect the quality and timeliness of the data that is being submitted
to the National Center. So we are quite concerned about the ramifications from
the national perspective and from the state perspective.

DR. HORNBROOK: Can you be a little disclosing about whether this is the
best decision or a political decision? It sounds like a Washington Monument

MR. LAND: I would say that there are other alternatives.

DR. MIDDLETON: I know as a second or third meeting attendee, I am not
allowed any more naive questions, but I am going to try one.

I wonder, the severity of the impact of some of these decisions on data
gathering for assessing the country’s health and wellness strikes me as beyond
the pale. I wonder, when does the NCVHS take it upon itself to actually assume
within the appropriate boundaries a stronger advocacy position with respect to
some of these decisions?

MR. REYNOLDS: One of the comments as I was going through the Executive
Subcommittee discussion where the BSC may give us an assignment, I think that
was one of the subjects, where they were going to ask us to consider doing some

MR. J. SCANLON: On the committee you can’t really lobby or advocate
obviously with Congress. But the committee is free to make an assessment of
what they think the impact is and to send that letter forward with some
recommendations to the Secretary.

Again, the irony unfortunately is that everyone has requested increased
funds for NCHS for the past two years, and it just got caught in the budget
process. So literally everyone supported a fairly large increase that would
have at least helped with some of the situation that Garland has described.
What it just got caught up with this compliance resolution and what happens

But you are certainly free to provide an assessment of the impact and
concern and recommendation for the Secretary, of any kind.

MR. REYNOLDS: Also, out of this initiative, as we consider such things, it
might be a good time to make it part of the subject also, so that we talk about
the continued importance of that to drive this to the end.

Don or Bill, anything else?

DR. STEINWACHS: I think that’s it.

MR. REYNOLDS: Let’s move next to Privacy and Security.

DR. WARREN: We have put together something like a briefing book that is
what has been said to date and what are the resources available about the kind
of information and use of that information in PHRs.

So starting with that, what we were planning to be doing with respect to
PHRs, and this will require some integration obviously that we need to work
through today, first of all, what are the privacy practices that the various
PHR vendors are currently using. So we would want to know that. Some of them
are available on websites and so on. There are also typically reservations
about the possibility of change, too.

Then where are these PHRs being put into effect, and what are the examples
with respect to employer use of them in wellness programs. What are the privacy
issues that come up in these settings? In many cases, the old idea of a PHR
was, it was on a little stick and it was mine, and it was my own little silo.

The kind of things that are being talked about, about data flow in the
current use of PHRs as part of a more general health practice is not siloed, it
is much more integrated. So what are the kinds of privacy issues and security
issues that that raises?

What are the concerns that are being raised by patients and patient
advocates about this kind of use that might make this way of transmitting,
using and so on data less useful than we think it ought to be? So that is a

The other piece that we thought that we could have something quite focused
and immediate to say is, what is happening in the Medicare demonstration
projects is adequate, is it a model, or is it not. We haven’t had an
opportunity to look at that.

Finally, what kinds of governance structures if any are there in place for
PHRs as their use is evolving? There are some private certification proposals.
There are questions about whether the use of business associate models is an
appropriate on, whether it is inadequate, issues like that.

So that is the territory that we have scoped out in an outline for
hearings. I think John may want to add to that. And obviously we need to do a
lot of coordinating.

MR. HOUSTON: To expand on what Leslie said last, I think the one area that
I personally am very interested in, and that we have talked a good bit about is
not just governance of the PHRs, but overall governance as it extends to the
EHRs as well.

I think you can almost look at that as one governance structure, or at
least try to form a new governance structure, because you have everything from
the tethered and untethered PHRs and how do you deal with data as it moves in
different types of environments, such that that data may or may not be
commingled within an EHR.

I am just very concerned that the ship is leaving the dock, and I don’t
know how much governance people have really thought of in a macro sense. I
really think that is going to be a showstopper if somebody doesn’t try to
address that soon.

MR. BLAIR: Could you just clarify what you are thinking? When you use the
word governance, could you say what you are thinking about?

MR. HOUSTON: Sure. As we talked about in the Executive Subcommittee a
little bit, I think there has to be everything from a central mechanism whereby
privacy issues are addressed at a macro level to how does one participate in
whatever is formed.

We continue to talk about the NHIN. The NHIN is made up of many, many
entities that need to participate, but how does one decide who is worthy of
participation, and what happens if there is an issue? How do you try to address
— especially on the privacy side, how do you address patient issues associated
with passing between these entities that make up the NHIN?

I think there are going to be profound issues. Let’s put it this way; in
order to get public trust there has to be that in place.

MR. BLAIR: Are you thinking of governance at a national level, or are you
thinking of governance at a local level?

MR. HOUSTON: I think it is a national level, because I think there is
already governance at a local level. But the problem is, once data start to
cross borders and boundaries of RIOs and states, all of a sudden I think you
have a class of problems that don’t necessarily occur at the local level.

As I said, ultimately at the end of the day you are going to have thousands
upon thousands of entities making up an NHIN, or the NHIN, I should say. How do
you deal with somebody who is not a good actor or somebody who is a bad actor?
How do you deal with reasonable patient concerns, where a patient may be
situated in Florida and they have records in three or four other states, and
there are concerns that maybe a provider in some of the localities is
improperly accessing that data? How do you deal with that?

So I think there needs to be some thought put into this. I’m not overlaying
an architecture, but I think these are questions that remain unanswered today.

DR. FRANCIS: Let me just add to that. Fragmentation is an enormous problem.

MR. REYNOLDS: What is?

DR. FRANCIS: Fragmentation in this whole area. It is not clear to us
whether taking up this question with respect to PHRs is — that might itself be
in some of the fragmentation, but it is clearly a question that underlies the

DR. HORNBROOK: Just being selfish, I remind you that I sit inside an
integrated health care system with complete automated medical records. I have
already had three e-mails with my doctor this morning. So it is a whole
different world that I live in.

MR. HOUSTON: One of the things that we should be aware of when we talk
about PHRs is, there is a whole different kind of informatics approach that we
are finding is very important, and that is panel support.

We have taken the medical records system now, it is set up for each
individual patient, but when you have physicians who have to manage their
panels you can provide informatics support for them to make decisions about how
to allocate their time across patients.

So obviously preventive service are very important, but chronic disease
management is extremely important in trying to keep track of what the priority
is for each patient in terms of outreach, but also in-reach when that patient
shows up at the door, are you doing the right things for that patient that day.

A counsel support tool requires you to manage all your data for a physician
across multiple people, integrate it and put it through an analytic engine.
That is a whole different process than simply linear separation of each
person’s private records.

So I just want to remind us all to think about the fact that when the
people are coming into a physician, the best way to use that physician is for
that physician to have all the different for all their patients in some sort of
analytic engine to help them practice medicine.

MS. MILAM: I would like to give some context around the PHR situation in
the NHIN. When you look at where most of the health information exchanges are
across the country, most of them are getting started. So to frame where they
are in terms of building out their own activities versus joining the NHIN, you
may see numbers of exchanges not yet joining the NHIN, focusing on building out
all the different communities within their purview.

So I would suggest that we look at the PHR at the NHIN level, but also at
additional levels, so that in the interim, maybe the next five to eight years
we don’t have a lot of people slipping through the cracks.

MS. MC CALL: I’d like to go back to John’s point. I know that if I heard
you correctly there are some concerns about governance at a high level. Yet, I
don’t think we have taken or anybody else has taken a point of view about
whether or not there should be such a mechanism. Is that accurate?

MR. HOUSTON: I think that is one of the questions we need to explore.

MS. MC CALL: Right. So before we talk about how, I think a relevant
question would be whether, and what is the expectation.

Also, outside of health care, is there some sort of analogy? What are the
expectations of the citizens of this country? It would be very difficult I
think to put together and it would be very time consuming. Whatever we did
needs to be something that embraces what people would find valuable. I was just
looking for whether or not there was an analogy outside of health care.

MR. HOUSTON: There is probably only one analogy outside of health care that
I can immediately think of. It is in a much more controlled environment, which
is banking, because banking data flies all over the United States. We have an
expectation that when I —

MR. BLAIR: It is supposed to. We are trying to make it do that again.

MR. HOUSTON: Banking information I think in large measure is easy, because
we are dealing with numbers, we are dealing with passing — you pay somebody a
hundred dollars or there is a credit or a transaction, there is a certain
amount of money and it is quantifiable data. I think health care is
fundamentally a different animal. It is qualitative, it is quantitative, it is
a lot of different things.

MS. MC CALL: I think you are right. The question is whether to have one,
and if so is there an analogy. We will find one.

MR. HOUSTON: This is predominantly from — my view is from a privacy and
security perspective. I think you can ask that question at a couple of
different levels. You may need one for privacy and security. You might say we
don’t need one for the management of the NIHN. We don’t need to have somebody
out there adjudicating transactions for the purposes of efficiency or whatever.
This very well could be a phenomenon that is unique to privacy, primarily
privacy, but I guess there is a security component to it as well.

MR. REYNOLDS: If you took privacy, security and data stewardship, it would
also fit in the same category.

MR. HOUSTON: Yes, linked together. You may argue that NHIN doesn’t require
some centralized infrastructure to otherwise operate.

MS. MC CALL: I guess my only point is twofold. I am going to go back to
something Mark said. Around all of these topics we are entering into a space
that nobody has ever been before. So to wrestle with the questions, I think it
is important to find a way to have a discussion that is familiar, not
identical, but a way to have it that is familiar. I think that is something we
should actively look to do.

I think it also applies to the nature of the technologies. One thing is
going to be for sure: Whatever paradigms we hold around what technology is
going to be able to do, we in this room are going to be way behind. So for us
to think about and talk about specific kinds of technologies, there are so many
more than we will ever know about, let alone be able to grasp, and they are
coming faster and faster all the time.

I think both of those things should inform how we have the discussions, the
types of questions we ask, the types of recommendations we put out.

MR. REYNOLDS: Don, and then I would like to move on to Standards.

DR. STEINWACHS: Just a small thing that you made me think about. There is a
sense that medical records live on forever and EHRs will live on forever, in
the sense that you die and it still goes on.

But PHRs, it strikes me, is a very different kind of territory. When I
leave Paul’s health plan I may want to have a clear expectation that he
destroys his version of my PHR but he keeps my EHR. When I die, maybe I want
all of my PHR records somehow destroyed.

So it added a twist to governance I hadn’t really thought about too much.
There are different record expectations possibly here in those two domains,
even though we keep thinking of them as interlinked; but not totally.

DR. FRANCIS: Can I just make a comment on that? It seems to me that is one
of the really interesting questions. The whole concept of what a PHR is has
been changing.

MR. HOUSTON: Carol said something about how fast technology is moving. One
of the concerns I think we also need to have here is, another analogy towards a
national system is air traffic control.

One of the biggest problems we have in the universities is, we can’t seem
to ever upgrade the damn system because it is so complex. It is mission
critical, it can’t be brought down for even a second. We have to be very
careful though that when we design our environment, we do it in a way that it
is technology neutral. It recognizes the fact that we are going to continue to
develop new technologies over time and new levels of integration and the like.
We have got to get it right now, because if we don’t have an architecture, if
we don’t have fundamentally a good understanding of what needs to be in place
for a long period of time, we could develop an environment that seems to work
pretty well right now, but we can’t upgrade it or we are stuck with something
that doesn’t work well in the long term.

MR. BLAIR: With respect to the focus on the NCVHS Standards Subcommittee
during this next year, in part we are once again responding to industry calls
that we are probably the appropriate forum to be able to examine how well HIT
standards are being developed, selected, coordinated, implemented and used,
which is quite a large picture.

For it to have value, we need to get the results upward in the
Administration as quickly as we can. The way we have developed this, first I
will start with our statement of purpose. We broke it down to four basic
elemental questions. We want to know from each organization that either is part
of this development process or affected by this development process; what are
the things they do, how do they fit in the picture that I just articulated,
what are the things they feel are not working well. Notice that I am using the
word we, because I think we really have to look at this that we are part of the
health IT community, and the solutions might not necessarily be limited to an
organization, but it may be across organizations, and maybe public-private as

Then the last question is, what do we need to do to improve things. So that
is our direction. We didn’t come up with a real name for this, so for lack of a
better name we are calling it the NCVHS standards initiative. If a better name
for this evolves, then that is fine.

In our breakout session this afternoon, we want to investigate how we will
do this. So there are a number of documents that we produced to help in this
discussion. One is a calendar of what we will do during this year when we would
have hearings and when we would wind up developing the recommendations. We also
produced at least a proposed set of panels for the hearings that would happen
on different days. I think it was Justine that indicated that for us to be able
to do this, we can’t do this all with hearings. We really have to up front use
another technique. She had suggested we get written testimony.

So there is a draft letter inviting folks to provide written testimony to
those questions, where we would do that up front. From the responses we get to
the written testimony to a broad number of folks, much broader than we could
possibly have hearings, we would then select some folks that would testify that
are kind of mainstream in thinking and some that are divergent, so where we are
getting a little bit of diversity in what we hear.

MS. MC CALL: I think it is a great idea.

MR. BLAIR: I think I am going to keep it at that level. One reason is
because we are close to lunch. The other is, come to our breakout session this
afternoon. We will go into it in greater depth.

Judy, do you have anything to add?

DR. WARREN: No, I think you’re fine.

MR. REYNOLDS: Any comments or anything on that? In our last couple of
minutes before lunch, one thing I think is important is again to remind the
committee that everything we say is public record, everything we say is being
put out through the Internet. I would ask that each of us keep an eye out there
for things where we may be mentioned as NCVHS, quoted as NCVHS.

We have had a very rich discussion today, I want to use one of Carol’s
words, familiar. We may be using familiar topics that taken out of context it
may appear that we could be judgmental. It may appear that we are making value
statements. But in the context of the richness of the discussion, it was a free
flowing discussion about the kind of things we need to get done.

So we have had an incident recently where three or four of us were quoted.
Not a problem, we understand. We signed up for this. But I think it would be
important for all of us to keep an eye on that.

I think the thing that we owe, and I will be happy to take it as the Chair,
we would owe any entity that might take that inappropriately, we would owe them
the context. I will be doing that on the particular one that is in this

So we have got a lot going on. We are working on a lot of theories. We put
up person centered, we went a lot of different places today. It can show up in
many different venues for many different things. So just keep an eye out there.
If you see anybody’s name, if you see NCVHS, let me know so that we can do the
appropriate legwork to make sure that any context in which we are painted is
given to the appropriate people that it could offend and/or create issues with,
in the appropriate context for the appropriate reason.

That is fine. We are a public domain. That is good, no problem at all. We
expect that, but we also need to relish in the fact that if our message gets
out, that we get it to the right people in the right way. We will take that
responsibility to do so. So please alert us if anything comes up.

MS. MILAM: I certainly don’t want to comment on that. I just want to go
back. One thing that occurred to me after I said I had no comments is that one
of the things I am still not clear about is from a Standards Subcommittee
perspective, we have laid out some issues that we have had, that Jeff and I
have gotten queries from industry and stuff about where the status is and where
we are doing with that.

As I participate on the Quality Committee’s call, some of the work they are
doing that also involves standards and terminology and stuff is really a
focused piece that I am not sure we would uncover in the set of hearings that
we are proposing. We are looking more globally at where the standards are.

I think that is worthwhile as we start talking about how we interoperate
with each other, that we have that tension; are we looking at national trends
in our subcommittee or are we looking at it being purposed in a particular way.

MR. REYNOLDS: I think as we look at this subject, we may find as we
continue to go around here that people may be touching pieces that they
wouldn’t normally do. They may be touching it for a specific reason and under a
specific subject. Whereas, we have been very distinct in the past; only these
people talk about this on their subcommittee and these people do this.

We are talking about a subject now and not a committee. Sometimes it
doesn’t map quite as easily and nicely as it did before. On the other hand, we
have got talented people on each of the committees that ought to be able to
handle that in the context of that particular subject that they are having the
hearing on. We have got to trust each other and we have got to keep open, and
we have got to do what we have got to do.

With that, we break for lunch. See you at one o’clock. Thanks.

(The meeting recessed for lunch.)


Agenda Item: Clinical and Translational Science Awards
(CTSA) Briefing

MR. REYNOLDS: Starting this afternoon we are going to hear from Jody Sachs,
who is the Scientific Project Officer for NCRR, National Institutes of Health.
It is on the clinical and translational science awards.

So Jody, if you would, please.

DR. SACHS: This afternoon I hope to provide you a brief overview of the
clinical and translational science award program. That includes the structure
and goals of the program.

A great deal of NCRR’s resources are involved in re-engineering the
clinical research enterprise. It is a trans-NIH program, 27 ICs. NCRR is the
National Center for Research Resources. I serve as a project officer within the
Division of Clinical Research at NCRR within the NIH. It is an Institute within
the NIH.

The CTSA program is the clinical and translational award science program.
It was funded in 2006. It started in 2005. I am going to talk a little bit
about why it started and what developed, what was the reason for it.

Early on, we realized that in order to get discoveries out, there was a
long delay from working at the bench and making those scientific discoveries to
the bedside in clinical practice, to getting the results implemented in the
communities. So in order to decrease the delays, there was a lot of thought
that went into turning everything upside down and making everything cross
cutting by harmonization, in terms of finding a better way to navigate through
a cumbersome, difficult process in clinical research.

One of the challenges at the time was that the current system for academic
advancement favors independent researchers or independent investigators. The
independent investigator grants are found in discrete departments and
institutions, and they are often limited from collaborative research, even in
the same institution.

So we decided was to increase the needs for collaboration, that a better
way to bolster the research process was to develop an interdisciplinary team.
In order to do so, they developed the idea of the CTSA program.

It was developed to catalyze change, to break silos, to break barriers, to
break conventions. It was to advance new intellectual disciplines in clinical
and translational science, to integrate resources and translational and to
identify and remove impediments to clinical and translational science. The
philosophy of the CTSA is a team approach. It is to work on connectivity,
partnership, collaboration and break down the institutional barriers.

As I briefly mentioned, the program started in the concept in 2005. It
began its funding in 2006. It is a mechanism of coordinative agreements. It is
a U-54. It is between the awardee, academic institution and NIH. It is
multifaceted in the research program. It is complex in the mechanism, because
along with the U-54 there is also a T component which is training, and also a K
component. It is a five-year award.

This shows you a brief descriptive of the governance for this cooperative
agreement. It is quite vast. If you look at it, there is oversight within NIH.
There is also the IC directors. The NIH is over here. Our NCRR Director, Dr.
Alving, sits here. The National Advisory Group sits over here. This is a
council to advice NCRR. In the center is the Consortium. The Consortium is made
up of other awardees to the program. Inside that sits an executive committee.
Then there is the Strategic Goals Committee, we will talk about that later, and
the Key Function Committee. There is also integration of the Child Health
Oversight Committee.

This briefly shows you, in 2006 there were 12 awardees. In 2007 there were
12 awardees, 2008 there were 14 awardees.

This is a group of partners. This shows you on the map the blue dots, so
the 2006-7 awardees, and the 2008 are in the red triangles. The map shows you
across the United States how the pattern looks for the program itself.

There are a couple of examples I wanted to discuss with you. This one is a
CTSA site at Emory University. If you look at it as an example, it demonstrates
that the award is actually a group of partners. This shows you the complexity
of the partnership. It has collaboration from Children’s Hope in Atlanta,
Morehouse School of Medicine, Georgia Tech and with that, there are contacts
with Kaiser Permanente in Georgia, CDC, Yerkes Primate Research Center as well
as the research center at the University of Georgia-Atlanta, VA Medical Center,
Georgia Research Alliance and the Georgia Bio.

There is one more example that I wanted to show you, because no two are
exactly alike in their collaborations. This one is a UC-Davis CTSA. It has
collaborators at the School of Veterinary Medicine, UC-Davis Cancer Center, the
Shriners Hospital for Children, the Lawrence Livermore National Laboratory, the
VA of Northern California, the California National Primate Center, College of
Biological Sciences, the College of Engineering and the College of Agriculture
and Environmental Sciences. The goal is to extend the CTSA philosophy of
interdisciplinary interactions and connections to formulate more partners in
collaboration beyond the actual organization itself.

This is a depiction of the CTSAweb.org website. This is a public website
that is accessible to anyone. It shows you the website address, CTSAweg.org. It
shows you the members as well as all the committee activity. It shows you what
national activities are ongoing, members, meeting schedules, summaries. So
anything you need to find out even in the news is on this website.

The CTSA is looking to create regional network opportunities. This depicts
another map representation showing you the West Coast over here regional area,
the Midwest regional area and the East Coast regional area. Those you can see,
they have had some regional meetings, and those are about four or five
different CTSA awardees who reach out to each other to see what they can do
collaboratively, and work together.

Another program I oversee is through NIH Roadmap 2004 to define how many
clinical research networks exist and to do a searchable inventory and a
database of those clinical research networks. It is found publicly. It is
Clinicalresearchnetworks.org. By that you can search and find out there are 271
clinical research networks out there; about 60 percent are government funded.

I wanted to mention a couple of the points that are on this slide. The
Community Engagement Steering Committee is a key function committee. It is one
of six key function committees. It is there to help successfully broaden the
community outreach at the CTSA sites. It is to work in unison and try and get
some agreements across all the awardees to form partners and collaboration.

One of the priorities on their agenda is to leverage partners for funding,
as well as a number of other issues that they are trying to do to impact other
CTSA programs, foster new research dissemination and implementation in clinical
and population-based research.

The reason why I mention this is because you can see leveraging
partnerships for funding is high on their priority. The other program I
mentioned through the clinical research networks. We have leveraged as an
example — this is just one example to show you — we have made it possible to
leverage the clinical research network program with the CTSA program. There is
an RFP that was out about a month ago, and it was due last week for proposals
between the CTSA investigators who want to work with the clinical research
networks that already exist.

This particular RFP is not setting up new clinical research networks. It is
working on existing clinical research networks, but it is forming new
collaborations and new partners with what already exists and what is already
funded within the networks we have through AHRQ, through CDC, through HRSA. It
is to take what we have already created and build new collaborations with the
existing networks.

There are three areas of focus. The three areas for this proposal were
translational science dissemination research, cost-benefit/cost effectiveness
research and community engagement research.

In 2007, the CTSA Steering Committee had a desire to develop a national
consortium strategic plan. So in 2008 in October, they met and they came
together with a number of implementation strategies which highlighted nine
priority areas. As a result of that meeting in October 6-7, 2008, the nine were
combined into four areas. These are the goals that are currently set up through
the consortium.

I will just read them off. Goal one is enhancing the national clinical and
translational research capacity, which would include clinical research
management, expand research information and include phenotyping, both human and
preclinical models.

Goal two is enhancing training and career development of the CTSA sciences.
Three is enhancing consortium-wide collaborations. By doing so, they would
include the national resource inventory, create a data sharing network and also
include social networking initiatives.

Goal four is to enhance the health of our communities and nations. That
would include a national model for community engagement, inform public health
policy through research.

I just highlighted a few basic ideas that are out there in the plan and the
governance. I am happy to address any questions you might have, because I am
sure you have many.

DR. STEINWACHS: In discussions we had at the last meeting, Mark was saying
that there were some efforts to begin to think through how in the engagement
with communities there might be — and different CTSAs might use the same basic
instruments to gather information. I was trying to get a sense, as you move
into the community, of what that means in terms of development of health or
health related data and information.

Part of it is leading into that question of whether or not what is learned
at the community level could be similar across multiple communities, and
therefore in a sense provide information that might have national relevance in
a health statistical sense, even though it is maybe directed at particular
clinical kinds of interactions.

DR. SACHS: It is a great question and it is a great concept. We right now
through the CTSA program concentrate on research, not on health care.

Each CTSA has their own set electronic system, whether it is EHR or another
electronic way to capture clinical information, if it relates to research. We
don’t have a way to — it is not interoperable right now, and there is no way
to connect the systems.

There is no plan to connect the systems currently, but there is opportunity
within both the bioinformatics working group and the community engagement
working group to work on projects.

If you look at some of the goals that they have here laid out, there are a
couple that I want to highlight. In goal three, this means that these are goals
for the whole consortium, and they need projects to work on to establish these
goals. So the data sharing network and the national resource inventory is
something maybe as a potential possibility to tap into, as you might promote a
project to this group to work on that area. Also, goal number four, a national
model for community engagement.

They are trying to reach out through the communities. I know the community
engagement coordinator is trying to look for potential projects to work on and
have the CTSAs participate. So they are happy to look at these issues and
address the issues. Unfortunately there is not a lot of extra funding that
would fund such projects, but it is something to consider.

DR. WARREN: My question is something that probably a lot of people want to
know. The understanding is, as new organizations join the CTSA Consortium, they
are being held accountable to some of the same strategic goals and membership
participation. Yet, starting with this last round of funding, there is about
half as much money available.

So as you start fleshing this out, because I know the goal was to fund
about 60 research consortiums, how is that being looked at by NIH, having
everybody have to participate to a certain level and yet not funding to the
level that those that are already there are at? You knew you would get a money

DR. SACHS: I didn’t expect it in this group, though. I expected it more
with the CTSA money group, because every time we meet it is all about money.

We are in a flat budget. The truth is, there isn’t enough money to go
around for everything you want to do. So in order to fund up to 60 in 2012 and
have a total top dollar amount anticipated of $500 million, there had to be
some broad reaching outlook on where our spending was currently and where our
spending is going to be in 2012.

We did do that look at the spending and the resources. If we continue to
spend the way we started out, we would not make 60, and we would reach far
beyond $500 million. So we identified cuts and we made those cuts to adjust the
budget so we could fund up to 60.

DR. WARREN: I understand the budget cuts. I guess my concern is the
expectation of each of these centers to produce the same amount and level of
work, with some getting a lot more money than others to do that same work. Or
are there going to be lesser expectations of those that are funded at a lower

DR. SACHS: I understand the question. It is a good question, but I think
when we started out, we had key functions as part of the RFA and we asked the
applicants to address these key function areas. As we continued to make budget
cuts, we didn’t stress — in the applicants that are applying now, they don’t
have to address all those key function areas.

So I think we made it flexible enough in the applications that if you were
to come in now and you had a plan to only address one or two key areas and you
had a reason why, it would be perfectly acceptable. There is no demand to make
an application across all five or six key elements.

DR. SUAREZ: I was looking at goal number four and particularly the first
bullet, the national model for community engagement. It seems to me we do have
actually a national model, at least one that could be seen as such,
particularly for minority health research. It is called community based
participatory research, CBPR.

I was wondering, are you incorporating the principles and the guidelines
and concepts along CBPR into the development of this national model for
community engagement in clinical research?

DR. SACHS: I know that the community engagement key function committee just
met in October. I know a person who was at the meeting who shared that
information. So I think they are going to work together and discuss that, and
how they can work on a model.

They want to do metrics, and they want to identify the best approach. I
know AHRQ is working with them also. So there are a number of different
agencies that are working with NIH on this community based approach. I think in
all, they have a very broad view. I think they want to take into consideration
the work that has already been accomplished.

DR. MIDDLETON: In some ways this is reminiscent of a lot of the NHIN
efforts, where islands of activity can help develop interoperability within
regions and whatnot. Certainly the interoperability within these different CTSA
sites is an overarching goal.

My question has to do specifically with what are the expectations of
individual sites for interoperability within themselves? Some of these sites
are very large. I happen to know the Harvard environment a little bit, and I
know that sometimes the left hand and the right hand aren’t aware of what data
standards might be in place. So are there expectations that sites can access or
adopt from CTSA planning, if you will? Any recommendations along those lines?

DR. SACHS: One of the key function committees is Bioinformatics. The
Bioinformatics Committee is working on trying to define what the sites look
like in terms of what kind of systems they have in place at the CTSAs.

All the applicants within the Consortium are asked to work together. The
problem with Bioinformatics, that one particular group, has responded to say
that if they work together they need more funds to work together, because they
can’t find a way to create an interoperable system unless they have more money
to do so.

So it is a double-edged sword. Everybody needs to work together. Everybody
needs to define what systems they have, and everybody needs to map out and
figure out how they can work toward an interoperable system.

I am hoping the goal committees that have just been established which deal
with data sharing and national resource inventory can come to grips with this
term. Your question is how are they going to develop this. I can’t answer that
right now because this happened just within the last 30 days, and they are
meeting today the first time on the first call, which is to discuss how they
are going to deal with the issue of trying to work together as a consortium.

DR. MIDDLETON: I understand your response well. Of course the more money
problem is a problem.

One of the things that might be considered by this committee is what
guidance might we wish to offer the CTSAs in this regard specifically, both
about the standard set that might apply to clinical and translational research
and perhaps even about the process. Perhaps in this regard we could model the
process that is going on in HITSP for the other clinical information systems,
HIT; does there need to be an analogous process for clinical research HIT
standards. We certainly have a mechanism in place that we could piggyback onto.

DR. HORNBROOK: The more we talk amongst ourselves, the CTSAs, the more we
learn that there are a lot of similar experiences going on between the
universities and their community collaborators.

Judy’s two examples are really good ones. Each one of the CTSAs has their
own set of external collaborators. Inside those collaborations is the ability
to reach out and assess the health of large important groups in the local
populations, whether they be federally qualified health centers, Medicaid
folks, Indian tribes, et cetera.

The key issue of course is that as we have rolled these out, the GCRC
culture hasn’t changed that much, the general clinical research centers which
the CTSAs are replacing. So the old funding pathways that went to provide the
hospital beds, the outpatient offices, the nutrition services, the blood
laboratory services, the genome wide assay services, all these things that were
provided at a reduced or free cost for biomedical research, still take up a
chunk of CTSA resources, leaving a lot less to go out in the community in
translational work.

So to me, it seems like it is an analogy to an electronic medical record
system. It is not the software that makes the difference, it is the human
culture. When we rolled out our medical record system in Permanente Northwest,
half the physicians retired within five years because they didn’t want to
women’s work, if you’ll pardon the expression. Of course, the modern day
physicians do keyboarding in their sleep. So the generational differences in
terms of attitudes toward electronic medical records made a big difference.

Here, if you are a basic scientist you should be talking to clinical
scientists and if you are a clinical scientist you will be talking to
population scientists. Those silos need to be broken down by the CTSAs, but
they aren’t strong enough yet to break through the old cultures.

Emory has a wonderful diagram. You saw a wonderful diagram. You should go
sit inside those boxes, see how communication is really going on right now. It
is kind of sad. Same way inside of our CTSA.

I think that the hope in the CTSA program — if we threw more money at it,
it is not going to change the culture. We have got to change the basic culture
of biomedical research in this country and have it merged with health services

So what I was hoping, by bringing the CTSA program and this committee
together, is that we could provide a symbolic leadership piece, to show the
accountability of NIH to the nation’s health by linking the CTSA program to our
national health statistics, so that somebody would say to the NIH someday, your
CTSA program has to show up in our health statistics sometime, somewhere. That
is what I was trying to do, is to get this discussion started.

Of course, there is a huge chasm between us and getting there, but somebody
has got to make the first step. Thank you.

MR. REYNOLDS: Any other questions?

DR. STEINWACHS: Just to add on, it seemed to me that when you were talking
before, Mark, you had given some estimate of the communities or geographic
areas. Just in terms of thinking about how you get enough of those that they
would give you representativeness.

So that would be one goal to have, is a sense of what that is beginning to
look like. Even at the national level, if you had the resources, going back to
those dollars and cents, you could do health interview surveys, health
examination surveys, a variety of things in those areas at high rates of
sampling, as compared to what we do nationally, and to bridge from the top
down. But the other part of this is from the investigators up, what would be
coming up that would make this a truly unique set of interactive resources.

DR. WARREN: I would just like to follow up both on what Mark and Don had
talked about.

As we have done thinking about CTSA in Kansas, I can tell you that one of
the things we are beginning to look at is exactly what Mark is describing. If
we really want to look at health outcomes and how to measure them, what better
way to do it than to start with the research and see what is being measured
there, especially as we start going from not only just bench research, but how
to actualize that in practice. You are going to have to use some of those
measures that were designed in research in order to collect the data for
outcomes, so putting that together.

I think this is an opportunity for us to bridge what the researchers are
doing and what the clinicians are doing for the betterment of the population.
How’s that for getting it all in one sentence? That is the goal. That is the

MR. REYNOLDS: Any other questions or comments?

DR. HORNBROOK: Maybe Kansas has a better chance than some of the other

DR. WARREN: I don’t know.

DR. HORNBROOK: We are hoping that Iowa and Kansas, because they have long
histories of community sharing of data and community health planning, that they
might be able to pull this off.

DR. WARREN: The advantage that Kansas has is, we don’t have very much
population, so it is easier to collect. Everybody knows everybody.

MR. REYNOLDS: Any other questions? Jody, I would like to thank you. You
obviously stimulated some thinking. I think we need to take some of the things
that have been stated as to what we could or couldn’t do, three or four of you
around the table that would visualize that. So you may want to put something
together for us to figure out how to do that based on what Blackford said, and
Don, Mark and Judy.

DR. HORNBROOK: I am part of that Northwest consortium that you saw on the
map. We are having a meeting next month. One of the things that I want to do is
to track those different CTSAs, how well they are able to get to their
community partners and start making it real, because that is where we are going
to have access to the existing data systems.

Agenda Item: ONC Update on AHIC

MR. REYNOLDS: Thank you. Our next item is Dr. Charles Friedman from ONC,
gave us an excellent update last time on the work that they are doing as it
relates to ONC and an update on AHIC 1.0.

DR. FRIEDMAN: Hello, everyone. While we are warming my presentation up —

MR. REYNOLDS: You might want to wait. Even though we can hear you, the
people on there can’t if you are not near a mike.

DR. FRIEDMAN: Thank you, Harry. It is a delight to be here again. I noticed
on the agenda, my talk was listed as an update on AHIC I. I took a little
license with that to broaden it to an update on ONC activities which include
AHIC I. I hope that is all right.

MR. REYNOLDS: Your reputation and what you have done for us so far allows
you that latitude.

DR. FRIEDMAN: Thank you very much. Otherwise it would be a somewhat shorter

The agenda of my update includes first of all circulation of a glossy hard
copy of the synopsis to the strategic plan which I described in some detail
last time. I have some additional copies that I can leave here. Everyone is
welcome to a copy.

I will then say a few words about the final meeting of the AHIC, which
occurred on November 12. I will make some comments, all of them in significant
ways related to the AHIC, relating first to interoperability in standards, then
to a recent report from the State Alliance for E-Health, and finally I will
describe in somewhat more detail because it has now actually happened the trial
implementation event of the NHIN on September 23. I will preview the next event
in the NIH development progression, which is scheduled for December 15 and 16.

First of all, with regard to the final AHIC meeting, I will just go over
the agenda and describe some of the things that happened. At the outset of the
meeting there was an announcement of the CMS PHR demo.

For those of you who have not heard about this, CMS has contracted with
four personal health record vendors. Actually they have not contracted directly
with them, they have contracted through their contractor, Meridian, to enable
the population of four PHR products with Medicare claims data for traditional
Medicare customers in Utah and Arizona. That project is going to be rolling
forward very soon. It was announced at the AHIC meeting.

The meeting then went on with two reports on the AHIC Successor. You will
be hearing much more about the AHIC Successor when I finish, so I won’t dwell
on that.

Then there was a panel on adoption, which included closing reports and some
recommendations which were accepted by the AHIC relating to electronic health
record, chronic care and consumer empowerment.

Work group activities. There were some preliminary results from the first
adoption survey related to EHRs and hospitals that is using our standardized
methodology. Then there was an update on the secure messaging pilot, which is
also rolling forward in two sites.

That was followed by closing reports from the remaining work groups and ad
hoc groups that had not reported up to that time, the quality work group, the
personalized health care work group and the clinical decision support ad hoc

The meeting closed with a really nice recognition by Secretary Leavitt of
the dedicated services of the AHIC members.

So that was the final AHIC meeting on November 11.

As circumstance would have it, the first meeting of the AHIC Successor
board occurred the next day, and I am sure you will be hearing from Laura more
detail about that.

Let me move to an update on the status of the standards and
interoperability activities as they are progressing. I think you have seen this
slide before, or something very similar to it. This shows the steps in the
annual cycles of standards development that begins with setting of priorities
by the AHIC, the development of use cases reflecting the interoperability needs
for those priorities, the harmonization of standards by HITSP resulting in
interoperability specifications that received Secretarial acceptance, and
following a one-year testing and implementation period those are recognized by
the Secretary, following which they are reflected in use in the NHIN in
certified EHRs and other health care information technology systems and through
Executive Order 13410 they are required for us in federal systems and systems
supported by federal health care contracts.

Where are we in this process? At the moment as I speak, the HITSP is
working on developing interoperability specifications for the six use cases
that reflect the priorities identified by the AHIC in 2008. The Secretary has
accepted 60 standards or interoperability specifications that derived from the
four 2007 use cases, and 52 interoperability specifications are currently
recognized coming out of the 2006 use cases. This is as we speak.

We expect things to change significantly in January as the calendar clicks
over. HITSP will have completed its work with the 2009 use cases, and will be
working on several activities and areas during 2009.

They will be working on a newborn screening use case that was prioritized
by the AHIC. They will be working on 12 areas of gaps and extensions in
previous use cases that were prioritized by the AHIC, in acknowledge of the
fact that attention needed to be paid to those aspects of the previous use
cases that had not received sufficient attention, and where gaps and the need
for extensions have been identified.

HITSP also will be working on quality measures resulting from further work
with the quality use case. A new priority area going forward, which could touch
in the future in interesting ways, or connect to it at least, work going on in
the CTSA program. They are priorities that will lead to some harmonized
standards for clinical research as part of this process.

So HITSP will be working in all of these areas beginning in January 2009.
Having pushed out the door, and you see this on the slide in the upper right
diagram, the interoperability specifications from the 2008 use cases.

We also expect, looking to the bottom right of the slide, that the
Secretary will recognize in January the interoperability specifications which
were accepted from the 2007 use cases, and convey to those recognized status,
so there will be a full set of recognized — or an expanded set of recognized
standards now spanning the 2006 and 2007 use cases.

You may ask why I didn’t list a number of those as 112, reflecting the sum
of 60 and 52. The answer is that there is some overlap between the 2006 and
2007 sets. After we evaluate the overlap, we will know what the final number
is, but 112 is the maximum because there is some overlap.

So that is the expected progress that we hope to see and expect to see in
the interoperability agenda.

This slide I am sure you have seen before. We call this the eye chart. I
can read it from here, I don’t know about you from back there, but it does
outline — and you have the hard copy which I hope you can read — the use
cases and their foci in 2006 where there were three of them, in 2007 where
there were four of them, in 2008 where there were six of them in those cycles,
and shows the areas where gaps and extensions have been prioritized for 2009,
along with the newborn screening use case.

A few words about the State Alliance for E-Health. I don’t know if there
has been a presentation to this group about this before. I thought it would be
— especially because they have just issued a report, copies of which I could
not secure for everybody, but I will show you the URL to find it. That report
has just been issued by the State Alliance.

The State Alliance was created in 2006 by the National Governors
Association Center for Best Practices. It does address the role of states, and
the states obviously have a very important role to play, in facilitating
adoption of interoperable health IT.

The members of the State Alliance are state officials, either elected or
appointed. The Alliance is co-chaired by two seated governors, the governor of
Tennessee and the governor of Vermont.

In addition to a central group, the State Alliance has spawned three task
forces that if you think about it align with three of the themes of our
strategic plan, one relating to health information protection, one relating to
health care practice, which aligns with the adoption team of the strategic
plan, and one relating to health information, communication and data exchange,
which aligns with the interoperability theme.

The State Alliance has just released this report, which contains a set of
recommendations for action at the state level and a set of strategies, some of
which I will illustrate in a moment, that lie underneath these recommendations.
The six recommendations address leadership and support, privacy and security,
the use of standards based interoperable technology, streamlining licensure
processes to enable cross-state e-health practice, the empowerment of consumers
to manage their own health, and very important, the development of workforce
capacity to support all of the above.

At the bottom is shown the URL from which you can download a copy of this

To put a little flesh on the bones here and just give you a little sharper
sense of some of the strategies that are delineated in this report, I have made
rather arbitrary selections of these strategies.

Under leadership and support, a strategy called out is the notion of
creating a signal coordination authority within a state for public and private
efforts relating to health IT and health information exchange.

Relating to privacy and security is a strategy, one of several, that would
promote the consolidation and updating of relevant laws within states.

Under promoting standards based interoperable technology, a strategy is to
require public program systems within states to use the recognized standards,
the number of which is about to increase as I showed you earlier.

Under licensure processes, there is a strategy to direct state licensure
boards to adopt common application procedures for licensure.

Under the engagement of consumers is one strategy among several that
Medicaid and state employees health plans implement PHRs for their customers,
and under workforce is a strategy relating to the importance of executive
leadership for state agencies who are trained in HIT and health information

These are not the only strategies falling under each representation, but
rather ones that I just culled out for purposes of example.

I would like to close this quick run through with a revisitation to the
Nationwide Health Information Network and the opportunity to update you on the
events which occurred in September or just before that the last time, and
describe what would happen. I think you might have heard my voice tremor
because of the utter fear inducing prospect of doing a live demo involving 20
separate organizations in the presence of the Secretary of Health and Human
Services and the general public. Other than that, there was nothing scary about
this at all.

I am happy to say — Jeff may want to comment, but I am happy to say that
with just enough glitches to show that it was real and not rigged, it worked
very well. I think if it had gone absolutely perfectly, people would have
thought we rigged it and just cross connected all the computers in the room,
instead of having the computers in the room just be the controllers of the
computers that were really doing the work at each of the locations across the
country that were actually exchanging the information.

So we did all that, and I will say a little bit more on that in a moment,
in September 23. Just completed and in anticipation of the next big event which
is going to occur in December, we completed basic interoperability testing
involving the NHIN participants for the seven system priority use cases that
will be demonstrated, again live, again before the public — I feel like a
ringmaster of a circus, I just need a hat and an elephant — but will be
demonstrated live and before the public at the NHIN public forum on December 15
and 16. This is a completely public event, and everybody is welcome. We already
have about 500 people registered to attend this event.

I want to just give you a flavor for what happened on September 23. First
of all, the entire demonstration on the 23rd was around realistic patient care
scenarios. In one case, and I will get to it in a minute, the scenario wasn’t
exactly a patient care scenario, but it was certainly related to important
health concerns for the nation.

The first set of demonstrations related to supporting the patient and
illustrated emergency care, transfer of care and the wounded warrior. I will
say a little bit more about the wounded warrior in a second.

In part two, we illustrated how using the existing core capabilities of the
NHIN, patients could turn off and on at their own direction the flow of
information about them. That is obviously an important component to have in the
NHIN to build and maintain trust in the system.

Finally, in part three we illustrated how the NHIN could be used to
dramatically reduce the time it takes for the Social Security Administration to
assemble the information it needs about each applicant for disability insurance
and evaluate that application in as I said far less time than the eight months
on average that it takes now.

Once again, the 21 participants in the NHIN cooperative, all but one of
which are listed here, participated on September 23. I will just give you a bit
more flavor of this bey describing the wounded warrior scenario that was
demonstrated on September 23. This involves six members of the consortium and
probably the most variegated group. Two of the participants, the Department of
Defense and the Department of Veterans Affairs, are of course governmental
agencies. Kaiser Permanente is an integrated delivery system, and CCHIT Med
Virginia and Care Squad which operates in Eastern Tennessee are RIOs,
regionally based health information exchange organizations.

This was all demonstrated around a fictional but realistic wounded warrior
named William Ozzie, who was injured while in deployment in Iraq. The
importance and the case that is made for nationwide health information exchange
through this scenario is really seen in this slide, which points out that of
all of the care that is provided to veterans in this nation, 40 percent of it
is provided outside the VA, making flow of information about these people
between the VA and all of these other care providing entities, wherever they
happen to be, very important.

Similarly, for service members, of all the care that is delivered, 60
percent of it is delivered outside the military health system, again making the
flow of health information about these people very, very important as it needs
to move between military health system sites and these other sites, wherever
they happen to be.

This busy slide shows you the basic scenario, beginning with the injury to
William Ozzie in Iraq. He is transferred to Bethesda, Maryland, from there to
Richmond, Virginia, to Kingsport, Tennessee, to Pinehurst, North Carolina, and
then to a veterans VA medical center in Richmond. Most people familiar with
these kinds of scenarios considered this one completely realistic and typical
of what health information exchange needs to support.

The information exchange that was demonstrated was that of a summary
record, where the ultimate destination in this scenario, the VA Medical Center
in Virginia, was able to in real time access the records about the care of
William Ozzie as that care occurred in Defense Department environments in
Virginia, in Tennessee and in North Carolina. The exchange of this information
and its assembly at the VA facility and the VA system was illustrated.

To bring this presentation to a close, I would reiterate that we have
demonstrated these core capabilities of the NHIN in September. We have now
tested the capability of demonstrating information exchange relating to the
2006 and 2007 AHIC use cases, including quality, bio surveillance, laboratory
information exchange and other areas, in preparation for the live demonstration
on December 15 and 16 at the NHIN forum, which will be at the Grand Hyatt in
Washington. If you go to that URL, you will be at a site where you can register
for this event.

That concludes my remarks. Thank you very much.

DR. SUAREZ: Hi, Charles. Thank you very much for the update, and
congratulations for all the work that has been done this year and in the last
few years. The office this year has been one of the most productive of all in
many respects, with all the things that have occurred, from NHIN to HITSP to

But I think change is coming, as they say, in many respects, nationally and
in many other ways. There is a lot of talk that has already started about what
kind of change might be coming to the approach that is being used by the ONC
for the work that is being done.

I just wanted to give you one thought. There have been discussions all over
from, let’s stay the course, to let’s revamp everything and eliminate
everything that has been created and start over. There has been a letter
recently published by a person out there that calls for something like that,
and everything in between.

But I think one specific item I wanted to offer, I think it is time to
consider some of the potential ways in which we can improve the process into
the future, is this process of use case development and use case driven

I think we have experienced already over 14 or so use cases and several
other gaps and extensions that are coming up. I think it has been an
interesting process for those of us and many people that have been involved in
the development of taking the use cases and developing the work that is needed
to come up with some harmonized standards, and then seeing it be attempted to
be applied in the real world through NHIN and other efforts.

The thing that is challenging and has been challenging from the beginning
of the use case approach has been the fact that each of these use cases is very
focused. Certainly there was the need to start with some concrete areas and try
to address those.

But I think it is time to consider an alternative approach, what I am going
to call a domain driven approach. I know AHIC 2.0 is talking about value cases
instead of use cases now. A domain driven approach in which we are focusing the
attention on specific domains, for example, the laboratory domain with several
types of messages, not just one message, or the pharmacy related or medication
related domain that deals with several types of messages, not just one, or the
radiology and lab, X-ray or many other types of domains, the public health one,
will help us begin to assemble the right teams around those domains and try to
avoid the spread of the thin expertise in some areas to try to capture
information about the multiplicity of use cases we are dealing with, from
electronic health records to lab to medication management to public health use
cases to bio to quality, the same type of expertise cutting across all those.

So my thought is perhaps it is time to consider looking at the possibility
of shifting to a domain driven approach rather than a use case or a value case
approach. I don’t know if that is something that is already in the mind of the
Office of the National Coordinator or has been discussed in any other venues
that perhaps could help us take this into the next level.

I think it will help us also re-energize the initiatives that are happening
behind the scenes through the use case approach into this new domain based

DR. FRIEDMAN: Thank you for those comments. I have a lot of reactions.

First of all, we are always open to new and good ideas. So if you would
like to at some future date share your thinking in greater detail and have more
interaction about it than is possible in this time frame, we will welcome that.

Second, there are obviously a lot of ways the use cases, that whole process
as it unfolded beginning in 2006, could have been done. I want to acknowledge
at the same time that a lot of progress has been made. Yet any process can be
improved. But what we have, we have, and the question before us is how to make
best use of our resources going forward.

A third point in response is to recognize that — and I am sure Laura will
talk about the value case approach when she gives her presentation — the winds
of change are blowing here, and this process in a graduated way is going to
move from the A 1.0 to the A 2.0. That provides an opportunity to think about
how to improve it.

So I think in that spirit, it will be very helpful to probably defer this
issue until Laura has a chance in the next time slot to talk about the value
case process, and see where you think the change needs to be, aligned with the
changes that are already being foreseen by the AHIC Successor and their
movement to the value case strategy.

MR. BLAIR: It is not very often that my comments deal with emotion. Chuck
was mentioning the atmosphere on September 23 when the 19 different HIE
networks around the country demonstrated that they could share information
using interoperable standards and using live patient scenarios.

There were about 400 folks in the room, and there was one article that was
written about it that I thought was able to capture the emotion, the feeling in
that room. The article wound up saying that the attendees were from all of
these networks and health care organizations. They were health care
professionals, they were information technology executives, they were
clinicians, and there were some politicians.

In that room, these people were too professional to do high fives. These
people were too professional to wind up getting giddy, but it was close. So
that was the atmosphere on September 23 within Health and Human Services.

So I want to offer my congratulations to Chuck, to Rob Kolodner and to ONC.
It was a glorious day, and the Secretary of Health and Human Services ended it
by saying that we will all look back on that as a historic day.

DR. FRIEDMAN: I did see a few high fives, Jeff.

MR. REYNOLDS: There was not a question in there, was there?

MR. BLAIR: No. I snuck it in.

MR. HOUSTON: Harry, there is an old saying that 90 percent of questions are
really statements.

DR. FRANCIS: This is a question, a genuine one. In the trial implementation
demonstration, what happened with respect to opt-in and opt-out of information
exchange? What did that mean? Did it mean for example that our young warrior
was asked whether he wanted his records transferred or not, or did it involve
our young warrior saying he didn’t want his psychiatric or drug treatment
history records transferred? What did it mean?

DR. FRIEDMAN: Great question, thank you. Just to be clear, we did not
demonstrate the opt-in/opt-out as part of the wounded warrior scenario. That
was a separate scenario that was part two of the demonstration.

What we demonstrated, if I can remember, and those of you in the room who
were there can correct me, was a scenario whereby an individual to whom the
implications of allowing his information to flow out over the NHIN initially
declined. So we demonstrated that — and I forget which participating health
information exchange actually executed it —

MS. MILAM: West Virginia.

DR. FRIEDMAN: West Virginia, thank you, we actually showed how in the West
Virginia system a parameter could be set that turned the flow of that patient’s
information off. It was an all or nothing, totally opt-in or total opt-out. I
think that is probably what you were asking.

DR. FRANCIS: That is exactly what I am asking.

DR. FRIEDMAN: That doesn’t mean that that is as granular as it is going to
get. Options for more granular opt in and opt out and finding the right level
of granularity for this is going to be a challenge for us all, is being

Then the scenario continued. There was something that happened that caused
this person to want to change his mind. I think he moved?

MS. MILAM: He moved to Delaware.

DR. FRIEDMAN: He moved to Delaware, and take it away.

MS. MILAM: This individual moved to Delaware and at that point decided that
he wanted to participate in the Nationwide Health Information Network. Earlier
he had decided not to. So we went to his physician’s office in Delaware, and
after talking with the folks there decided to participate and they retrieved
the data, and that was the end of the story.

But this was a real high level demonstration, showing about what opt-in
looks like, what opt-out looks like. There were two demonstrations. I think in
December we will be dealing with a lot more of very specific granular issues in
privacy, in terms of probably getting into — well, i know at least in West
Virginia, I don’t know how much we are going to demonstrate, but you do have
areas of especially protected information that requires separate patient
authorization, and we stayed out of that for the first demonstration.

DR. W. SCANLON: Thanks very much. My question goes to the chart of the
NHIN. I understand this is for the demonstration that you had. I would ask,
where are we in terms of being able to put CMS on that chart because I can
think of some uses where it might turn out to be very helpful.

DR. FRIEDMAN: A great question. One comment I would make to begin is that
through the federal health architecture program we are developing a software
solution called NHIN Connect, which will be a gateway to the NHIN, built
initially or use by all federal agencies.

The Connect has two components, one that is the universal coupling for the
NHIN, and then a separate component which customizes that application to the
needs of the particular agency that is connecting.

So while CMS is not shown here as one of the federal agencies participating
in this year’s events, there are discussions underway with CMS about
implementation of the Connect for specific applications. If all goes well, if
Connect works as we think it is going to work and we believe it is going to
work, because we think it is going to work, they will have the same level of
challenge, which is surmountable and doable, implementing the Connect for their
purposes that the other agencies have faced implementing for theirs.

So CMS is in the queue for specific things they are doing, and we believe
we have the skids greased through the Connect solution to make this possible.

MR. REYNOLDS: Mike and then Sally, and then I would like to move on to
Laura Miller. Chuck, are you going to be able to stay with us?

DR. FRIEDMAN: Yes, I am planning to stay through Laura’s presentation.

DR. FITZMAURICE: I want to join in with Jeff and all the rest of us around
here that think highly the way ONC has moved us forward in the past four years
or more. We have achieved more in health care data standards than we have
achieved probably in ten years as a result of this concentrated effort.

So I have a suggestion and then maybe a really quick question.

The suggestion is that HITSP selects the standards and the data elements
that fulfill the functions of the use case. i agree with Walter that
eventually, big business is going to force us to move toward domains, that they
won’t find the use cases fitting them exactly.

But the use cases we have, the interoperability specifications that come
out of HITSP tend to be cumbersome sometimes and stack up to six inches of
paper. Even if you have them in Word documents and Excel spreadsheets, it is
hard to navigate across them.

What I would suggest is, for the HITSP output for each interoperability
specification, could we have a table that shows the standards chosen, a second
table that shows all the data elements chosen, maybe for very large classes of
databases like laboratories, where it all comes from LOINC? Then all the other
paperwork, thirdly, that were documents in Excel spreadsheets could be stacked
up. But just getting those first two tables would let us explain to
Congressional staff, to our friends, here is what we have been working on in
HITSP to produce.

This would relieve a large burden of implementation, because each
implementer has to go through what each HITSP expert does to get down to the
data elements if we don’t have that table.

My question. The process is, the use case goes from AHIC to ONC to HITSP
back to AHIC to ONC to the Secretary, where it gets adopted and recognized.
AHIC no longer meets. So are we going to be sending the current
interoperability specifications from HITSP directly to ONC for the Secretary to
adopt and bypass what would have been AHIC? This is all right with me.

DR. FRIEDMAN: Say again how you describe the process about it going back to
AHIC again?

DR. FITZMAURICE: Before we had sent it back to AHIC, I believe, and AHIC
would recommend that the Secretary adopt them, and then the Secretary would
adopt them. So we may have to bypass that step in November-December. I just
wondered if I am accurate on that or not.

I don’t see that it has a strong implication, since ONC goes over those
interoperability specifications anyway.

DR. FRIEDMAN: No, I don’t think it does have a strong implication. I think
an important implication in what you are talking about, Mike, and then I think
Laura is going to address, is the graduated process for the assumption by the
AHIC Successor over time of some significant elements of this, with the
government remaining in a very important role.

We fully anticipate that at the end of the process that up to the lower
right corner of the screen will work somewhat differently, will be the common
element which will persist, that is, the recognition of the standards by the
Secretary, which will enable the same things to happen as a consequence of that
process going forward. Maybe that list of boxes on the bottom left of the
slide, which are consequences of standards recognition will enlarge over time
as well.

DR. FITZMAURICE: And I suppose it is possible that a new process or new
Secretary might want to have a federal advisory committee make a recommendation
to him or her about these standards. Just a speculation.

MS. MILAM: Going back to your logic model, I think it is slide 12, the
Nationwide Health Information Network diagram.

DR. FRIEDMAN: Thank you for calling that a logic model.

MS. MILAM: It is exciting to hear that hopefully we will see Medicare as
one of the nodes on the network, particularly from a sustainability standpoint
as we are doing business planning at the exchange level. We are pleased to hear
that Medicare also realizes the benefits that will be accruing to new

Looking at your RX node for pharmacies, I am wondering, are you all
exploring or have you considered exploring a connection to SureScripts on
behalf of everybody participating to aggregate demand or to facilitate

DR. FRIEDMAN: I don’t have a detailed answer to that, Sally. I know the
idea is obviously an appealing idea. We have had internal discussions about it.
I am honestly not sure at this moment to what extent there have been formal
discussions that would have extended outside the government about that.

MR. REYNOLDS: Sally, did you mean all of SureScripts, which includes Rx sub
two, or just SureScripts?

MS. MILAM: All of SureScripts.

DR. DEERING: Very quickly, I think this would be of interest to people who
have been on NCVHS who have knowledge of its history as well as looking forward
about NHIN.

For those who recall the debates that went on for some time about bringing
the research dimension into the NHII as we used to call it, I think what is
exciting in December is that this is the beginning of bringing research into
the NHIN.

Because this is so new, it is not even showing up on ONC slides, but the
National Cancer Institute is bringing a big network into the NHIN. We will
demonstrate linking research and care in December. So I think that is the
beginning of moving in the direction that NCVHS was looking at a long time ago.

DR. FRIEDMAN: Thank you, Mary Jo. I had neglected to mention that. Very

MR. REYNOLDS: Marc Overhage, I understand you are on the phone and have a
question. Could you introduce yourself and then ask the question?

DR. OVERHAGE: The question we were talking just a moment ago, about CMS
participation in the NHIN, which will be a wonderful thing. I am curious if the
folks from ONC could comment on where discussions are about CMS’ belief that
they are able to share that information? As recently as a week ago the Data Use
Board from CMS suggested that they didn’t see an authority under which they
could make data available, for example, for patient care. I am sure that there
have been ongoing discussions about that would be interesting to get updated

DR. FRIEDMAN: Thanks, Marc, for that question. I wish I had a detailed
update to give you. I responded to the question about CMS more from a technical
than a policy perspective, and used the question as an opportunity to extol the
virtues of the Connect solution, and also to signal that we were talking with
CMS about their implementation of Connect, which creates a potential for
exchange. That is a very different discussion than the discussion related to
policies and procedures that would enable the information to flow.

I understand the problems and the issues. I don’t think we are at a point
where I can say anything specific about that, more than what we have already

DR. FITZMAURICE: Chuck, you are so darn honest.

Agenda Item: AHIC2 Successor Organization –

MR. REYNOLDS: Let’s move on to Laura Miller, who is going to give us an
update on the AHIC2 successor organization. Laura, we truly appreciate your
coming today.

MS. MILLER: Good afternoon. It is a pleasure to be here, especially with an
organization that if I understand it has a 60-year history, which in Washington
for an advisory committee is a record.

My name again is Laura Miller. I am the interim Executive Director. My
background is not health information, but health care operations for 28 years
in the VA, where I ran hospitals and ended my career as Deputy Under Secretary
of Health for VA. So I have seen health information in action, and know what in
the VA it contributed to the quality of operations. So I was very excited when
the opportunity arose for me to assist the AHIC Successor in its implementation
and in its startup. I would say that by the way, AHIC Successor will not be the
permanent name of the organization.

I really don’t need to talk about the American Health Information
Community, our predecessor obviously. Just one comment I would make. The
importance of this group to Secretary Leavitt I think is displayed by the fact
that it was the only FACA for which he himself served as chair of the 200 and
some-odd federal advisory committees in HHS. Obviously there were a number of
organizations that were spun off.

There was the creativity of the American Health Information Community to
identify ways forward organizationally and to serve as the facilitator for
those new organizations. So AHIC Successor is one of a series of, I guess I
would call them spinoffs from the American Health Information Community.

You just heard Chuck Friedman talk about some of the accomplishments this
last year and over time. I don’t think I could in any way add to that. ONC has
done an incredible job of taking a variety of issues and weaving them into an
infrastructure and a series of activities that have resulted in real movement
forward in many ways for the first time.

But I would note at the very end of this list that it was always the intent
that the AHIC would sunset, and that there would be a follow-on organization
that would be a public-private partnership. So that was the intent of
activities that started in 2007, and were designed for the AHIC Successor to
become the focal point for harmonization activities to build on AHIC itself,
and also to engage a broad range of health IT stakeholders to become
sustainable for itself over time by collaborating with other organizations and
individuals in all sectors of the health community, with a goal to continue to
facilitate health IT adoption, with the bottom line goal though of improving
and maintaining the health and well-being of individuals and communities.

So in late 2007 and early 2008, there were some very specific goals that
were developed for AHIC Successor. These are in our cooperative agreement,
these four goals, to accelerate the adoption of an interoperable health IT by
insuring availability of harmonized standards; to prioritize requirements for
health IT interoperability with stakeholders; to advance policies and technical
approaches to promote the vision and purpose of the organization, and finally,
to oversee and facilitate the Nationwide Health Information Network.

During 2008 there was a grant provided to LMI, who collaborated with
Brookings to facilitate the planning of this organization. A variety of
stakeholders were engaged. There were several planning groups that were
developed to identify the governance, the membership, the sustainability and
the transition from ONC’s AHIC to AHIC Successor.

I am just going to flip through these slides fairly quickly. It gives you
an idea of the level and quality of individuals who were involved across the
health care industry in this planning process. Each planning group was
co-chaired, in this case John Tooker and Laurie Evans co-chaired the governance
planning group. For the membership planning group, Jon Perlin from HCA and
Janet Marchibroda from E-Health Initiative co-chaired. For the sustainability
planning group, John Glasser from PartnersHealth and Rachel Block from the New
York E-Health Collaborative co-chaired. You can see a variety of people from
across health care.

The transition planning group was co-chaired by Lillee Smith Gelinas from
VHA and Peter Elkin from Mayo Clinic.

These groups had multiple meetings, devoted their time to come up with a
series of recommendations. Those recommendations were vetted in a series of
public meetings and calls, and were accepted by ONC.

In the governance process, the recommendations resulted in the composition
of a board of directors that is 15 directors that are a blend of at large
members, and there are two specific seats for consumer representatives. This
board is not meant to be representative of any specific sector in health care
other than the consumer sector.

In addition, it was designed to have strong federal participation. There
are three federal liaisons, and they are called liaisons because a federal
employee may not carry the fiduciary responsibility of a board along with their
federal responsibilities. However, other than having fiduciary responsibility
they are fully involved with the board.

Those two liaisons and one ad hoc liaisons are Secretary Leavitt himself,
who attended our first board meeting on the 13th, and Secretary Peake, who has
delegated that responsibility to Linda Fischetti, their chief health
information officer in VHA. In addition, Dr. Kolodner is an ex officio member.

So as you can see, the powers of the board include fiduciary
responsibilities as trustees of the organization, defining, monitoring and
re-evaluating strategies for the organization, selecting, overseeing and
evaluating a president.

Here, let me pause and say we are in the process of recruiting a
president/CEO. We are still very actively engaged in that process. So if there
is interest of anyone that you know, please encourage them to get their name
forward to me or to a member of our board.

As you can see, as you would expect, reviewing and approving operational
matters and overseeing the execution of the organization’s strategic plan.

This is a visual of the board of directors for year one. In addition to the
15 members that I named and the three liaisons, the three incorporators who are
John Glasser, John Perlin and John Tooker, who served as co-chairs of three of
the four planning groups, were the incorporators for the organization and are
serving for one year to insure appropriate transition as we go forward. The
balance of the board members will serve in one year, two year and three year
terms in order to insure appropriate transition.

Just to share with you quickly those involved, the board members is a very
impressive group of individuals, and they are displayed for you here. Paul
Tang, one of your members, is of course a member of our board. When we get to
the discussion portion of the meeting, I’m sure Paul will have equally as much
to say as I.

DR. FRANCIS: Could you just tell us who are the consumer representatives?

MS. MILLER: Yes, I’m happy to do that. Michael Lardiere at the top right,
who is with the Association of Community Health Centers, and Steve Findlay, who
is with Consumers Union.

DR. SUAREZ: Can I just interrupt with one quick question, too? There are
three open seats right now on the board? If you go back to the picture, 14, 15,
16 and 17, are they —

MS. MILLER: All of those seats are filled. What open means is that they are
at large, basically. I appreciate that comment. We probably should change the
nomenclature there.

In addition, the board was structured to have four board level committees,
nominating, finance and membership and communications, and an executive
committee. Those are obviously your more business oriented committees, but we
are in the process of finalizing a structure for the mission related and ad hoc
committees which would deal more directly with the goals of the organization.

When the planning groups developed the framework for AHIC Successor, they
identified that the board should include representation some sense of a broad
range of consumers and stakeholders. Even though it is not a representational
board per se, we wanted a balanced board, so we looked at all of these member

I include this because these are also the segments that we will look to as
we begin a membership campaign starting sometime in January. We want to be sure
and include all of the stakeholder segments in our membership.

What will members be able to do? Members are going to be very involved in
setting priorities and identifying and quantifying opportunities for standards
adoption, and we will talk more about that when I talk about the value case
process; participating in the development and governance of the NHIN. Obviously
we need the expertise for developing policies relating to interoperable
standards based electronic health care systems. We need help in understanding
how to accelerate the implementation not only of using standards but of EHR in

In using and supporting their technical expertise and participating in value
case development.

You may wonder how we are being funded. We are concerned with that issue
ourselves. Right now we are fortunate to have a grant from the federal
government for the balance of 2008 and into 2009, and hopefully perhaps to 2010
or portion thereof. However, beyond that the membership dues structure and the
other opportunities for funding, including value case funding, are expected to
sustain the organization. So the federal government other than its
participation through membership or value cases will not be providing direct

One of the four groups that developed planning for AHIC Successor
identified the need to look at what still remained from the American Health
Information Community that should be identified as opportunities for
consideration for AHIC Successor. So the transition work group looked at some
very high level priorities of work that was still in process and/or had been
identified as needing to be done. ONC has taken that output from the transition
work group and synthesized it into priorities that could find one of several
homes, some of which might be appropriate for AHIC Successor, some of which may
belong more appropriately to the federal government in terms of some policies
having to do with security, privacy and confidentiality, some that may belong
to a federal advisory committee or to other organizations.

At our meeting on November 13, we received from Dr. Kolodner the output of
that process, which provided us a short list quote-unquote, of 17 key
opportunities that will need to be considered by AHIC Successor in its work as
we move forward, and a longer list of some 50 initiatives that ONC had

When Chuck Friedman was talking about the standards harmonization process,
he referred to the ONC use case process and identified that the contract with
HITSP will run for currently identified use cases through 2009. During 2009,
AHIC Successor needs to begin to ramp up the value case process to be prepared
to provide value cases to HITSP for 2010.

What is a value case? I would say first of all that the AHIC has been very
successful in identifying important use cases, many of which have been driven
in some ways by top down. This process is meant to be a more bottom up process.

It is envisioned that it will be a process whereby consortia of health care
industry or government stakeholders identify a need and submit a value case to
the AHIC Successor that describes an opportunity for information exchange that
they see as a necessary next step in their domain, if I could borrow that term.

It will illustrate a specific scenario for interoperability similar to a
use case, but also it will demonstrate a case for action based on the technical
business and societal value not only to the organization, but to the users.

So it presents the costs, the value and the risks for implementing a
specific scenario and describes potential measures of actual impact on
improving care. Once it is recognized, it would commit the submitting
organization to fund and execute the actions necessary to implement the case.
That is another key difference.

In order to start this process, AHIC Successor needs to set an annual
strategic direction by developing a framework. I will show you a sample of what
it might look like. Then once that strategic direction has been identified, the
stakeholder community will — there will be a call to stakeholders, and the
stakeholder community will submit value cases for consideration as national
priorities. There will be a process whereby a committee will use criteria to
conduct due diligence on each value case and recommend certain of those to go

Recognized value cases will then initiate the action that will end in
interoperability specifications. Over this process there will be a committee
that will manage the initiative to insure timely completion.

The purpose of using a value case is to underscore the fact that AHIC
Successor exists for individual and consumer benefit. We need to establish and
maintain trust with our stakeholders, but we recognize that some entities may
not have the capability to either develop a value case themselves, they may not
have the expertise, or they may not have the financial resources to fund the
process. So there is also going to need to be a mechanism to support value
cases for underserved populations or for certain population health initiatives.
It may include a scholarship fund if you will derived by application fees for
all proposals or some other initiatives that AHIC Successor undertakes.

Value cases will be evaluated. It is important that there be due diligence.
There will be subcommittees specific to a domain to assure appropriateness and
due diligence over the value case. Those will be populated with experts in
appropriate business and health informatics.

So there will need to be published criteria to determine value factors such
as the value of the case relative to how it supports expansion of the
interoperability roadmap, which you will see in the next slide, the value of
the case relative to key stakeholders segments, the level of risk, the impact
on industry and the likelihood of adoption, which are important. We don’t need
to be doing all this work and using the resources of scarce groups of
individuals if we are not going to see an outcome. Then the financial viability
of the funding entity.

This is a sample of what an interoperability implementation framework looks
like. This is just for understanding the approach. The actual interoperability
implementation framework has yet to be finally developed. In our next board
meeting of AHIC Successor on December 9, we are hoping to get a final review
and signoff of this approach, and then we will be seeking contract resources to
help us develop the framework.

What might a value case look like? These are two examples. One example
would be the clinical research arena. NIH and key members of the pharmaceutical
industry or academic medical centers and/or clinical research organizations
could present and fund a value case for interoperability scenarios linking
clinical trials to electronic health records.

In fact, there is an initiative underway by a group now to try and address
this and move forward. They had their first work group meeting at the recent
AMIA meeting last week.

Another example might occur in radiology, where a group of individuals
could form a work group and agree on their needs and move forward in a
particular way to address how to move images across the systems.

It is our expectation that the value case approach will facilitate adoption
because there is broader stakeholder input, a collaborative process with
stakeholders, and a funding and impact that will accelerate and support the

This is just a brief overview of how the process might work in terms of the
steps that are involved. I am not going to dwell on it because I think our time
is running short and I want to leave time for discussion.

Let me mention that this and a full document regarding the value case
process is currently on our website, and we are looking for comments and more
feedback until November 24. So our website is www.ahicsuccessor.org. Again, we
invite your review and your comments.

As I have said, we have had our first board meeting. Over the next three
months we have a lot of work to do. We have had a preliminary review of bylaws
with the board, still a couple of issues to finalize, and we hope at the next
board meeting to accept bylaws and to move forward with the next segments of
our strategic plan.

We want to complete our board and management setup activities. We have
started populating some committees; we need to move that process forward. We
would like to finalize the value case approach, get the framework developed
into an initial call for value cases early in the calendar year. And we need to
take into consideration the list of 17 opportunities identified by ONC and
determine how to move forward in each of those instances.

Finally, we need to launch a membership program because we need all hands
on board to continue the momentum that has been developed by ONC and the
American Health Information Community, and that we do not want to lose during
what Secretary Leavitt called the fragile period.

Again, there is our website. We are hoping for much involvement from a
broad range of stakeholders. Our December 9 meeting, if you will watch our
website, our December 9 board meeting will be open, and we hope to see
participation both on the phone and in person at our meeting.

So I am very pleased to have had the opportunity to present the
information, and be happy to take any questions if you have time.

MR. REYNOLDS: Yes, we do, thank you. I am going to ask the first couple,
because I haven’t asked any up until now.

I am still struggling with the relationship between ONC and the AHIC
Successor. ONC right now puts out RFPs and recommends work and people win the
bids, and then something happens. So now you have got AHIC Successor. Will AHIC
Successor — then I saw that ONC puts input into the AHIC Successor.

So will ONC still be doing use cases, doing other things like that, using
the federal funds that you have, and at the same time we might be getting
different or possibly even related value cases from the AHIC Successor? I can’t
quite figure out how it all cascades. Who has got the ball, is what I guess I
am struggling with.

MS. MILLER: The ONC and AHIC developed a set of use cases that they approve
for 2009. They did that in 2008, and those have been delivered to HITSP.

MR. REYNOLDS: Yes, because they were tightly coupled then. ONC and AHIC
were tightly coupled. So now the coupling is changing.

MS. MILLER: Yes, it is. ONC has only funded HITSP and CCHIT for that
process through 2009. From that point forward, from 2010 forward, ONC as I
understand it, and Chuck can jump in afterward, will not be developing use
cases. AHIC Successor will be developing the value case process, which would
then be conveyed for — we will be doing that during 2009 for HITSP then to
carry forward into harmonization activities in 2010. So there is a handoff.

Chuck, I don’t know if you want to add anything.

DR. FRIEDMAN: Sure, thanks, Laura. When I presented our strategic plan the
last time I was here, I tried to stress the importance of building one
infrastructure that serves many purposes. So I think it is very important to
emphasize what we are putting in place here is a different but still singular
way of moving this agenda forward.

There will be a gradual transition. As things move to the AHIC Successor,
that part of it which moves, the government will remain a participant in this
process. That is seen in the government liaison roles on the board and also in
the possibility which has been a part of discussions that the government itself
might sponsor value cases that meet needs perceived by government agencies to
move the health IT agenda forward for the nation.

So the spirit here is very much a single complementary process which some
of the activities that had been undertaken inside the government moving to the
AHIC Successor, with the government very much an active and complementary
participant in this process.

MR. REYNOLDS: So under AHIC, pretty much ONC was the player. Now under AHIC
Successor it is one of the players.

MS. MILLER: That would be correct.

MR. REYNOLDS: My next comment. As you look at all the different things that
are going to happen, the one thing that I know for example we are struggling
with in our state — I am in North Carolina — but as we move from ONC to AHIC
Successor and so on and we talk about value cases, I never see anything up
there about what do the organizations look like that are going to be
sustainable in the states for HIEs and everything else.

I know for example Lovelace Clinic is driving it in New Mexico, and Marc
Overage is driving it in Indiana. In North Carolina NCHIA is not an
organization that has any worth and has done most of it through vendors and

So as we are more and more asked as players to play, trying to understand
what a good organization looks like that you would want the private sector
and/or the government to line up to and for the players in the state to sign up
for, I think is going to be a key driver to the success it is. You have seen
one HIE, you have seen one.

So any help that ONC and AHIC too can do along those lines to help define
that a little better, so that you could grab onto what does a good organization
look like, or you could help drive by the private sector, that would be great.
That would be a great thing to have, but I never seen it on the charts. When we
talk about interoperability I never see what does the organization look like
that might make it work.

MS. MILLER: I don’t believe that I have the answer for the business models
for all HIEs to share. But I do want to say that I think that the governance
structure for the NHIN, as we work with the ideas surrounding that, will be an
important piece that has to feed into those HIEs and RIOS, and is perhaps an
opportunity for them to think about different ways of structuring themselves.

I think there has much been written about the business case. Again, I am
not sure I have the answer at this point.

DR. FRIEDMAN: If I could just add one comment. ONC will continue to be
active in this space, of course. We will continue to undertake activities that
address needs that we see as existing and important to address.

So to that point, and it is a little too early to report to this group on
this effort, but since you brought up that specific example, Harry, we are
embarking on a HIE economic sustainability project, because there is such a
need out there. I hope in future meetings of this group, that someone will be
able to report on that to you.

MR. REYNOLDS: That would be very helpful.

MR. HOUSTON: It seems like with this idea of these different value cases
that — is there any structure around how you decide not necessarily how you
pick them, but how you make sure what you end up with is a lot of value cases,
and you still have gaps in terms of coverage of the different value cases.

You can have a bunch of value cases in one particular area and have nothing
in another. How do you make sure that you have adequate coverage, and is there
a way that you are going to plan to do that?

MS. MILLER: Yes. Looking at the framework once it is developed, I think not
only do we have a responsibility to put out a call, but we have a
responsibility to look at just exactly what you are saying, and to see if we
need to try to convene groups who might have a natural interest in those gap
areas to see if we can facilitate the interest and support for moving forward a
particular value case.

MR. HOUSTON: It also seems like — I know from the first AHIC, a lot of the
use cases and things that were put together, there wasn’t a lot of precision as
to how we decided to do things. I was on one of the work groups; I hate to say
this, but it was almost more like feeling what you decided what you were going
to focus on. I think we need to make sure we get more coverage, better
scientific approach towards making sure we don’t have gaps.

MS. MILLER: I believe that is why this framework is a very important piece,
and that it is divided up into different domains or areas. We need to take
adequate time and thought into putting together the framework to understand
exactly where the primary needs are.

DR. SUAREZ: I have two quick questions. One is going back to my comment
earlier to Charles about the domain approach, whether that is the value case

I think one of the challenges that we had with AHIC in 1.0 was the
competing relationship or competing condition of various use cases to try to
reach to the top so that they would then be presented to HITSP for
harmonization. Some of us in the public health sector were hoping that public
health will have its groups cheering for them to try to reach that level. But
some of us also working in the privacy and security standardization were hoping
that we would get a use cases back then, now it will probably be a value case,
on privacy and security specifically, to try to address the issues of
harmonization of technical standards for privacy and security.

But I am concerned that we will — and I totally understand the business
model that AHIC 2.0 was trying to reach, which is the only way to fund a
nonprofit public-private partnership is to bring whoever needs a use case to
put money and time into it.

It seems to me that by creating domains you would avoid competing interests
in terms of having one use case or value case be brought in front of AHIC 2.0
board and have four others, and then AHIC having to make a priority
determination to which ones get to move forward into the next stage.

Rather, if you have domains, the domains themselves are all going to be
participating, and that domain process gets perpetuated into HITSP, then there
is a flow of cases within domains that go down without having to compete with
each other.

So I would still encourage you to see that that kind of approach would
avoid competition between use cases and then have a problem of prioritization.

MS. MILLER: Hopefully the competition is not really a competition, but just
an education against criteria and not an evaluation of one against another, as
long as they meet the needs that have been identified as gaps within the

I think one other point. I believe that some of the prioritization of one
use case against another was as the result of the bandwidth that HITSP had and
still has. I think one of our issues is to obtain the resources in terms of the
people who bring forth a value case to expand that bandwidth.

But again, I would appreciate any input into the comments segment of the
website on the value case.

DR. SUAREZ: A second very quick —

MR. REYNOLDS: No, there can’t be very quick ones. Judy.

DR. WARREN: My question has to do with the goals that you mentioned with
the AHIC Successor. The very last one was, oversee and facilitate and NHIN.

That one confuses me, because ONC funds those projects and has provided
oversight. So is the oversight switching to AHIC Successor? Or are you sharing
oversight, or what?

MS. MILLER: Yes, it is going to switch. In reality there needs to be — and
this has been found in the discussion among the groups who have been developing
their data use agreements, that there needs to be a governance structure for
the NHIN as it moves forward, to approve applications, to join in the NHIN to
assure that people are meeting the requirements, et cetera, and over time that
doesn’t become a responsibility of the federal government.

DR. WARREN: Is there a time line for that transitioning?

DR. FRIEDMAN: Yes, but not a precise one. The plan, and I didn’t mention
this in my talk, is for the NHIN to go into limited production sometime in the
next calendar year.

It is not the plan that governance of the NHIN will have passed to the AHIC
Successor when we go into limited production, but as the NHIN matures, the plan
is to move, for all the reasons Laura just described, the governance of the
NHIN under the A2.

DR. FRANCIS: Clearly one of the central issues in all of this is the shift
from purely public to public-private. With that in mind, I am interested in
your slide about, AHIC coordinates and is informed by several related

Judy mentioned the NHIN projects, but CCHIT, HITSP, HISPC, what is
happening there? Are they gone? Are they Successor? Are they changed? Are they
the same? What is the story on that? There is a general governance question
that is behind that.

MS. MILLER: CCHIT at this point is an incorporated entity.

DR. FRANCIS: Okay, no changes.

MS. MILLER: And I’m not sure if it is this year, next year, at what point,
but their business model is going to lead them into self sustainability.

HITSP will continue. The intent is that the funding for HITSP will come
beginning in 2010 from AHIC Successor for value cases.

DR. FRIEDMAN: And HISPC — you’ve got to love these acronyms — HISPC goes
back to my comment before that not everything moves to AHIC Successor. There is
a project that will remain with the ONC. This is the security and privacy

DR. FITZMAURICE: Thank you for coming here and putting up the AHIC
Successor to us. There seem to be a lot of unanswered questions.

I have a couple of suggestions. One is to insert well specified on your
goal slide, and make well specified modified standards, so the standards you
come up with will be well specified.

Also on the goals slide, I would suggest a goal of reducing or keeping low
the costs and other burdens of implementing standards and data elements chosen
for the value cases. So some sense of keeping the burden low, so it encourages

I would urge greater specification of the data elements in value cases than
we have had so far in our interoperability specifications. But I think it is
the best shot that we have to move forward.

I noticed that there was no mention of HITSP nor the process for selecting
the value case interoperability standards and the data elements. For example,
there is no mention of the ANSE standards process for how the interoperability
specifications will be developed. That might be something you would want to put
into a future slide.

MS. MILLER: Thank you. I appreciate the feedback.

MR. REYNOLDS: Thank you, really appreciate both of you. For the committee,
a little bit of housekeeping. We will break until 3:30. What we are going to do
at 3:30 is, between 3:30 and 4:15 we will be here and we will have a 45-minute
discussion led by the Quality Subcommittee based on the fact we wanted some
more discussion on that. So I will turn it over to Justine and Paul at that
point, and it will be pretty much like a Quality Subcommittee, to have
everybody in the room.

Then from 4:15 to 5:30, Populations and Standards will go do their meetings
for an hour and 15 minutes. Tomorrow morning 8 o’clock is Privacy, and then
8:45 Quality again, and if anybody else needs to join that at that time to
continue the discussion and piggyback on what they are doing, then that is how
we are going to do it.

DR. WARREN: So Standards doesn’t have a full two hours?

MR. REYNOLDS: That is correct.

MR. BLAIR: When is the time for Standards?

MR. REYNOLDS: The Standards is 4:15 to 5:30, an hour and 15 minutes. Again,
what we agreed to earlier was, any of the subcommittees can continue their work
on conference calls.

PARTICIPANT: It wasn’t that way in the agenda.

MR. REYNOLDS: No, it wasn’t. Remember, we all changed what we wanted to
talk about and think about doing this morning, so we changed it.

(Whereupon, the meeting was adjourned.)