[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

November 5, 2004

Room 800
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, D.C. 20201

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
(703) 352-0091

TABLE OF CONTENTS

P R O C E E D I N G S [10:09 a.m.]

Agenda Item: Call to Order – DR. LUMPKIN

DR. LUMPKIN: Good morning. We have a quorum. Seems that you
have had a busy day yesterday; I again apologize for not being able to be
there, but one of the things – lessons I learned early in state government
is to remember who pays your paycheck – [laughs]. And there are certain
times when you just kind of need to be there — to collect it [laughs].

[Laughter.]

DR. MAYS: Well, yesterday was payday?

DR. LUMPKIN: And yesterday was one of those days.

My name is John Lumpkin, and I am Senior Vice President, Robert Wood Johnson
Foundation, and Chair of the Committee. We’ll start off with introductions, and
then we’ll begin with our agenda, starting off with some of the updates on
what’s going on over at the NIH. But first, introductions, so why don’t we
start off with Jim.

[Introductions]

DR. LUMPKIN: Thank you. Before we get started, just looking at the agenda
and the action items that we have before us, I’m going to give my guesstimate
of 2 for this afternoon for completion time. And of course that depends upon
our discussion. If we do need to get into some deep discussion – the
Quality Workgroup has made a mighty effort so they completely revised the
letter, so those of you who are really concerned about – twice, yes.

MR. HUNGATE: It was two sentences that had to be changed.

DR. LUMPKIN: Well, we took the hint.

MR. HUNGATE: The good news is it’s now all on the front page.

DR. LUMPKIN: Figured if we gave you fewer sentences to argue about, there’d
be fewer recommendations.

MR. HOUSTON: We only argue about two!

DR. LUMPKIN: As a result, I think, depending upon the length of our
discussion, we could be able to complete 2 or earlier, and then we’ll see where
we are at the lunch break.

But we have a great opportunity – it’s been a while in the making, and
we’re really pleased to have Dr. Friedman here to talk a little bit about
what’s going on at the NIH and some of the clinical trial research agenda also,
and I’ll turn it over to you, Larry.

Agenda Item: The NIH Roadmap for Medical
Research – DR. FRIEDMAN

DR. FRIEDMAN: Thank you. And I may need help figuring out how this thing
gets back on here, but – I’ll let someone else work on that while I start.
I’ll – question I had for someone before was how much this group knows
about the NIH Roadmap, and I was told to start from the beginning, and so I
will do that. Well, you have the slides, actually, so – they’re not in
color but we can go through them. I may to occasionally turn around to see a
slide –

The NIH Roadmap actually started two and a half years ago. It started
because of perception that the diseases that this country is having are
trending more towards chronic diseases rather than acute diseases.

Obviously, we have an aging population with the increasing prevalence of
chronic degenerative diseases and many co-existing conditions. We all know
about health disparities in this country and in fact worldwide. And there are
emerging and re-emerging diseases, certainly in my area, heart disease; we
worry tremendously about obesity, diabetes is increasing, also connected with
heart disease, and obviously we, despite the fact that I said earlier we trend
going from acute to chronic diseases, we’ve seen some re-emergence of some
infectious diseases.

So as a result of that, and as there are other issues, we – Dr.
Zerhouni, the, at that time, new Director of NIH, decided it was important to
position NIH to address these evolving public health challenges. We needed to
accelerate the path of discoveries. We needed to develop more rapid translation
from the discoveries into patients and into public health.

The Roadmap was developed after extensive consultations with many people
– scientists, stakeholders, health care providers.

The discussions addressed several topics: What are today’s scientific
challenges? What are the roadblocks to progress? What do we need to overcome
the roadblocks? And importantly, what needs to be done by NIH as a whole rather
than individual institutes? Remember that NIH has 27 different entities which
sometimes talk to each other. But we needed to do something that incorporated
all of the efforts of NIH.

So the NIH came up with the Roadmap idea, which is really a framework of
priorities that NIH as a whole must address in order to optimize its research
activities. It’s a set of initiatives that are central to extending the quality
of healthy life. And it’s also a way of having more efficient and productive
research.

The problems that we’re trying to address are well known. There are barriers
to communication between bench scientists and scientists who do clinical
research. And then there are barriers to translating the clinical research into
public.

From these discussions, three general themes emerged. First, we needed new
pathways to discovery.

Second, research teams of the future. And third, re-engineering the clinical
research enterprise. And I’ll spend most of my time on the last one of these.
I’ll give a couple of examples of the first two, but as I say, concentrate
mostly on the last.

In the bench activities, there are several things that we’re trying to do.
We’re trying to enhance building blocks and pathways, develop molecular
libraries, improve bioinformatics and computational biology, structural
biology, and also nanomedicine.

And initiatives within this general theme address technologies and
approaches necessary to meet current research needs. So we’ll be trying to
understand better the complexity of biology, biological systems, accessing
biological data and technologies and scientific resources and make the
resources more available, and promote multi- and interdisciplinary research.

An example: We’re looking at molecular libraries and imaging probes
activities, trying to develop research tools to facilitate biology and
pathobiology, pathophysiology; advances in biological research, and discovering
– discovery of biological markers.

We’ll be establishing Centers for Biomedical Computing, trying to focus on
software rather than hardware, and have programs and preparation for
partnerships with a variety of groups.

Turning to research teams of the future, the problem again, as I said in the
beginning, is that there is lack of translation among, or between, bench and
bedside and between bedside and the public, and so we need to develop research
teams that address the problem, the silo problem that we’ve had.

So we’re going to encourage multi- and interdisciplinary teams. We’re going
to support larger, coordinated, resource sharing teams. We intend to preserve
the strength of NIH over the years, and that’s the investigator-initiated
activities; certainly, historically that’s been our major strength. But we will
promote investigators to take creative, unexplored avenues, and that’s been a
criticism of NIH over the years, that we tend to do the tried and true.

In an effort do that last item, we’ve developed so-called NIH Director’s
Pioneer Award, which is to give researchers money to pretty much go where they
would like to go, and so they will have five years of support, $500,000 a year
for each of the – for those five years, and they can – you know, once
they get the money, it’s theirs to do with as the – their creativity
directs them. We just awarded the first nine of those and we plan to keep
continue awarding these each year.

The last item, and the one I’ll spend more time on, is re-engineering
clinical research. Let me go on to the next ones.

The standard model, unfortunately, is there’s laboratory research and that
goes to early translation research, early clinical research, then maybe some
clinical trials and epidemiology research, population research, and then we
hope that it’ll lead to public health improvements.

The problem, of course, is that it’s more circular than that, that what we
learn from clinical trials, epidemiology studies, population studies, bedside,
in fact what to go back to laboratory or – it ought to be in all
directions, because we do learn things. The only way that’ll happen, though, is
if we increase the communication among the various research teams.

And so we want to re-engineer the clinical research enterprise, promote
better integration – and I’ll go into some of these in more detail –
but we want to improve the clinical research networks that we fund, we want to
enhance them, we want to support translational research, we want to encourage
the development of technologies to improve assessment. I’ll talk a bit about
harmonizing regulatory processes and enhanced training.

The clinical research networks – NIH historically has supported many
groups of investigators that do multiple clinical protocols, clinical trials
and other kinds of studies. The National Cancer Institute has been doing this
for many years. Their institutes have started more recently. There are AIDs
clinical research networks. We’ve been doing them for 10 to 15 years in other
institutes.

The problem is many of the networks don’t talk to each other very well, if
at all. They have different understandings of their missions, different goals.
That’s fine, but they also have different definitions. They have different
ideas of how to proceed. And it would enhance our efforts if we could get them
to share resources, share data, share materials, share technologies.

So ideally what we’d like is to link existing networks of studies so that
trials and other clinical studies can be conducted more effectively, more
quickly, to insure that the research we get gets out into the public more
quickly.

The typical research network has a central node with multiple clinical
centers, and what we’d like to do is this sort of thing where we share. And
what we’ve done is initiated a program. We funded 12 groups of clinical
networks to do some pilot work, to see if they can indeed share materials,
share resources, share technologies.

Obviously, there are many barriers, one of the barriers, clearly, the
patient privacy and how they’re going to deal with that. Other barriers are
different technologies and can they come up with technologies that can indeed
be shared. Other barriers, frankly, are simply culture. Investigators aren’t
used to sharing either their information, their technology, or other kinds of
things, and so we need to break that down.

We’re also trying to enhance translational research. People use
translational in two different senses. Here it’s being used as the translation
from bench to bedside. Obviously, it can also be used from translation from
clinical research into the public.

And the problem is that academic investigators too often lack the resources
and expertise to study diseases, and we want to try to give them more tools,
more techniques.

And so we want to stimulate research at the bench to bedside interface to
implement mechanisms to prepare novel products, to insure support for
regulatory oversight. We want to invest in a modest number of programs to
facilitate research in many institutions.

We’ve been talking about developing research cores to provide assistance to
many of the researchers who might not have the basic tools or the ability to
conduct studies. Not – part of this is simply study design. Many people
would like to do research studies but they don’t have the technology or access
to the technology. They need statisticians to work with, they need people who
can help them design studies, they need access to other materials. So it would
be great to be able to provide that, or to assist them in getting it. That’s
pretty much what I –

This is too –

DR. STEINWACHS: High technology!

DR. FRIEDMAN: Too technology – yes, I just want to go on to the next
one. There! That’s good –

One of the things we’re concerned about is quality of life. There are lots
of definitions of quality of life. People measure them in various ways and each
– and then what do you do with it when you get it, because different
groups have measured it, defined it differently, so what – one of the
programs we’ve done is to try to develop computer-based adaptive testing to
increase the sensitivity of patient-reported systems.

We have just funded a coordinating center and six collaborating research
sites to try to come up with not standard definitions – we’re under no
illusions that we’ll ever get standard definitions of things such as quality of
life or pain or other patient-reported systems – but we want the groups to
at least take a look at are there ways of coming up with standard ways of
measuring these kinds of things so we can indeed share what we’ve learned
across different disciplines.

Another area is clinical workforce training. There are lots of people who
would, I think, like to do clinical research, but, frankly, they’ve never been
trained how to do it. And so we are coming – starting a number of programs
to enhance the training of clinical research both in academic centers and, we
hope, more broadly in the communities.

One of the programs that was just initiated, we just funded seven so-called
K12 Career Development Programs where we will not just provide information to
people who want to be clinical researchers but we will help them, we will
provide some resources for them, we will provide some salary for them. So we
hope that we will be able to generate more interest.

The last item that I mentioned is the so-called harmonization, and the
problem is that clinical research has been impeded by multiple and variable
requirements to address the same oversight concerns. There are many federal
agencies that have different requirements, different definitions of what they
want, and researchers have to abide by the – if they’re funded by the NIH,
they have to abide by the NIH requirements. They have to abide by the FDA
requirements. They have to abide by OHRP requirements. And there are probably
some others that they have to do.

And these may not be in complete agreement. In fact, we know that they’re
often not in complete agreement, driving investigators somewhat – well,
they’re unhappy; let’s just put it that way. And so one of the things we want
to do is to try to make these requirements more in tune with each other.

Obviously, this covers things such as adverse event reporting, human
subjects protection, the whole issue of central versus local IRBs, auditing and
monitoring clinical trials, the privacy issues – HIPAA and other issues,
financial disclosure, standards for electronic data submission. All of these,
it would be nice if we had some common way of doing it, and so NIH has created
an office in our Office of Science Policy that has started talking and holding
meetings with other government agencies and other groups, and the aim is to
provide clear, effective and coordinated policies and regulations.

We’re under no illusion that this will happen quickly. This is something
that will undoubtedly take a while.

Priority issues – we’ve starting already working with FDA and other in
trying to come up with standard adverse event reporting requirements. We’ve
talked – started talks about data safety monitoring requirements, auditing
of clinical trials. The whole issue of privacy is under constant discussion and
clearly an important one. Central versus local IRB discussions are taking
place. So we’ve started, but, as I said, we’re under no illusions that this
will happen quickly. We – it will – it’ll take a while, but we think
it’s certainly worthwhile. In fact, if nothing else comes out of the Roadmap
for clinical research, that’s probably the most important thing we can do.

As I say, we’re working with other agencies to try to do this. We’re
consulting with lots of people, lots of groups, to develop the tools and
resources necessary, and at the end we hope to have clear, effective and
coordinated rules for clinical research.

Obviously, nothing that we do can impair the need for clear protection of
human subjects.

What does the Roadmap cost? This slide shows the funding for last year, this
year and the next few years. It’s a lot of money.

MR. BLAIR: Would you mind articulating the dollar figures for me?

DR. FRIEDMAN: Excuse me?

MR. BLAIR: Could you tell me what the dollar – I can’t see –

DR. FRIEDMAN: Oh, I’m sorry.

MR. BLAIR: — so could you just tell me what the dollar figures are?

DR. FRIEDMAN: The dollar figures are $130 million in fiscal year ’04, $237
million in fiscal year ’05, $332 million in ’06, 448 in ’07, 520 in ’08, 507 in
’09. The total in all those years is $2,172,000,000. It’s a lot of money, but
in fact it’s less than one percent of the NIH budget.

MR. BLAIR: Oh, wow. What is the total NIH budget?

DR. FRIEDMAN: The total NIH budget is about $30 billion.

MR. BLAIR: Thirty billion?

DR. FRIEDMAN: — $30 billion a year.

So we believe that this amount of money will allow us to do the kinds of
things I’ve mentioned. But I also mention that NIH is committed to
investigator-initiated programs, and that’s why it’s not more than this,
because we do believe that all research, clinical and basic research, is
primarily going to be driven by investigator-initiated activities.

And this next is a pie chart that just shows what

I said now, that in fact it’s — for fiscal year ’05, it’s .8 percent of the
NIH budget going to Roadmap activities.

The money for the NIH Roadmap is coming both centrally and through
contributions from each of the institutes. We hope that it will benefit the
individual institutes by speeding the removal of barriers, roadblocks, by
providing opportunities for the institutes to work together and therefore do
things more efficiently.

For example, in the clinical trial networks that I showed, there’s no reason
why more than one institute can’t take advantage of that works, instead of the
way it is now where they’re funded and used by single institutes.

We intend to continue communication both beyond and within NIH in
development of the Roadmap. There will be ongoing evaluation and changes as
needed. We will consult with, and participate with, patient groups, health care
providers, foundations, industry, academia, other federal partners, all
stakeholders.

This slide shows the website where you can go to get more information.

And finally, it’s a work in progress. We are constantly making changes as
needed and as the other things arise.

I’d be happy to address any questions you might have. I am primarily
familiar with the clinical research aspect of it; that’s the area I’ve been
mostly – most working on, but I can certainly try to address other
questions if you need more. Thank you.

DR. LUMPKIN: Don?

DR. STEINWACHS: I’m Don Steinwachs. I enjoyed your presentation very much.
Very excited about the initiative. There were just a couple things, just sort
of side comments.

DR. FRIEDMAN: Yes –

DR. STEINWACHS: You made mention of the, you know, focus on chronic disease
and the growth and –

DR. FRIEDMAN: Yes.

DR. STEINWACHS: — but we’re still using the terminology of “bench to
bedside.” Bedside is not usually where chronic disease management is on.
It seemed to me it’d be nice if there was a way to come up with a different
terminology than “bench to bedside,” which sounds acute –

DR. FRIEDMAN: Yes.

DR. STEINWACHS: — and episodic and it’s its nature.

DR. FRIEDMAN: Yes, it’s this traditional way of doing – I guess most
people understand it, which is – but you’re absolutely right.

DR. STEINWACHS: Yes. You know, you talk about the translation, you know,
from bench to clinical and clinical to the public. I guess in the public you’re
sort of putting in practice, or in community practice, and, you know, being
interested also in sort of health services research that sort of – and NIH
funds a fair amount of that, but it makes it a little obscure, I think,
sometimes when you talk about translation from clinical to the public, even
though I recognize that this – some of the barriers are actually trying to
get things that are developed through research into a form that can actually be
used in practice and there are many treatments other than pills. But it seems
to me it’s very hard to implement, and it’s sort of interesting. Well, how does
NIH help that process of facilitating models of delivery that work instead of
great models but you can’t make them viable in the community?

DR. FRIEDMAN: Yes – well, again, traditionally, that has not – or
NIH has not seen that as its mission, but the fact is that we do put a fair
amount of money into it. We put, I think – I’ve been told anyway –
that we put more money into those activities than ARHQ does, which obviously
has it as its mission.

More and more institutes are seeing that as part of their mission. I can
speak primarily for mine. We’ve just formed a new branch directed exactly at
that, those kinds of activities. We see it as appropriate research ‘cause
it’s not just a matter of doing the translation, doing the transfer of
information, but it’s finding out the best ways of implementing that transfer.
And obviously that’s a research agenda that we can, and will, undertake.

And so, I know NCI has been doing that kind of thing for some time.

DR. STEINWACHS: Thank you.

DR. LUMPKIN: Jim?

MR. SCANLON: Thanks, Dr. Friedman, very much. Just a couple questions. In
terms of mechanics, did – has NIH actually established an office to
coordinate the budget here in the portfolio or is it still done through
individual institutes? I mean, in a way this was a clever, very clever, move on
the part of the Director of NIH to try to get a little bit more – even
though it’s one percent – control over the institutes and moving forward
on some common things.

[Laughter.]

DR. STEINWACHS: Jim, you sure you want that in the Minutes?

[Laughter.]

MR. SCANLON: Oh, it’s late, late. I’m not the first one to observe that.

DR. FRIEDMAN: All right – yes. No, all of the Roadmap activities are
directed or managed through one or another of the institutes. The money for the
– each activity comes through transfers from other institutes to this
– to the institute that happens to be running it. But they’re all done
under Roadmap imprimatur, if you will, with – under Roadmap I.D. So it’s
–

MR. SCANLON: And could I ask – the – now, you yourself said that
NIH still is committed by far in terms of majority of mechanisms to the
investigator-initiated, or the center investigator-initiated approach. So how
– what is the expectation that investigator-initiated research will yield
the kinds of proposals that are multidisclipinary or big science or other
– that would meet the criteria for the – for a Roadmap kind of
concept because other – if –- were they coming forward with such
proposals before and we just couldn’t fund them or does this really require
something new –

DR. FRIEDMAN: Right.

MR. SCANLON: — in terms of Roadmap type activity?

DR. FRIEDMAN: Yes, I don’t think it’ll change so much the actual kind of
funding in the sense that obviously the typical RO1 will continue to 250,
$300,000 a year. NIH has always funded multi-center clinical trials,
epidemiology studies, specialized centers of research, those kinds of things,
and we’ll continue to do that.

I think the major change is going to be twofold. One would be, we hope, a
mindset so that investigators, when they come in for their RO1s, will think
more broadly, not just, oh, I’m going to study this single topic, this –
you know, with one investigator, in the laboratory.

The second is that we hope that the Roadmap activities will provide an
infrastructure to assist many investigators in doing the kinds of things that
we’d like to see done.

DR. LUMPKIN: Vickie?

DR. MAYS: Very good presentation. Thank you for being here.

I have a question about – particularly in terms of some of the clinical
trial activities, because quite often what emerges as a difficult problem is
the IRB issues, and I saw that you had it up there. But I guess I’m wondering
– NIH sometimes does these consensus meetings, and my sense is that there
are some things that are agreed upon, agreed upon by researchers and agreed
upon by NIH, but then when you get into the IRBs, each one kind of goes off on
its own. And so I’m wondering whether or not you have in mind any particular
kind of processes where you might begin to develop a body of knowledge about
some of the specific clinical trials or research in general issues that then
might be put out there in the universe for the IRBs to use. I think it might
make it a little easier for us.

DR. FRIEDMAN: Yes, that’s – I guess that gets, to some extent, to that
harmonization activity. Certainly, we hope that we will be able to work
effectively with OHRP and with FDA on common understanding, if you will, of how
IRBs oper – well, not operate; they’re supposed to be independent –
but some of the general things they need to think about when they’re reviewing
clinical trials or any other clinical research, for that matter.

Obviously, there’s a lot of uncertainty, a lot of differences of procedures,
among IRBs. We have –

DR. MAYS: I’m actually talking content and not process –

DR. FRIEDMAN: Yes –

DR. MAYS: — in terms of things that –

DR. FRIEDMAN: Yes.

DR. MAYS: — within the research found –

DR. FRIEDMAN: Well –

DR. MAYS: — that would be agreed upon —

DR. FRIEDMAN: Yes.

DR. MAYS: — because those, then, I think the IRBs could just move quite
quickly on. The actual operating thing, it’s almost like the law prevents us
from micromanaging that. I don’t even think you at NIH could micromanage that.

DR. FRIEDMAN: No, I know we can’t.

DR. MAYS: Yes.

DR. FRIEDMAN: Well, it’s something – I – you know, I don’t have
any –

DR. MAYS: I wrote for a consensus meeting.

DR. FRIEDMAN: Okay.

DR. MAYS: I think that really in the field would –

DR. FRIEDMAN: Yes.

DR. MAYS: — change if we –

DR. FRIEDMAN: Now, obviously there are lots of meetings that IRBs have.
Whether they provide that kind of – the kind of thing you’re saying, I
don’t know, but a consensus – well, we’ll think about it.

DR. LUMPKIN: Richard?

DR. HARDING: Dr. Friedman, thank you for a very clear presentation. On Page
6 of your handout, under Priority Issues, you have No. 5 that says that one of
your priority issues is “Confusion regarding applicability of privacy
requirements and HIPAA” –

DR. FRIEDMAN: Yes.

DR. HARDING: — “to clinical research.” That, of course, is one of
the issue that this Committee has, is monitoring the HIPAA requirements and so
forth. And I

wondered what your process was for trying to decrease the confusion,
‘cause I know there is confusion. But what does NIH to kind of in a
process way to try to deal with that –

DR. FRIEDMAN: Yes.

DR. HARDING: — complexity?

DR. FRIEDMAN: First of all, the official response is NIH is not responsible
– it’s not, yes, for –

[Laughter.]

DR. FRIEDMAN: There – yes, is not in our – so we can’t do any
– make any official – you understand that.

DR. HARDING: Yes.

DR. FRIEDMAN: We can, however, provide information and education materials
and we have been doing that. We have them on our website for researchers as to
what the requirements are or are not for various kinds of studies. And as new
issues come up, we do update the – that information.

So that’s the kind of thing we can, and have been, doing.

DR. HARDING: So you do a “frequently asked question” kind of
–

DR. FRIEDMAN: Exactly.

DR. HARDING: — that you generate?

DR. FRIEDMAN: Well –

DR. HARDING: The answer to –

DR. FRIEDMAN: We – working with the other agencies that are responsible
for HIPAA, we provide, you know – we can’t come up with them
independently, obviously; we have to make sure that we’re consistent with
everything else. But once we do that, yes, we then put on the website the
Frequently Asked Questions as – updating them as appropriate.

DR. HARDING: Thank you.

DR. LUMPKIN: I have a question. You – in part of your presentation, you
showed the diagrams of the networks and trying to get the networks –

DR. FRIEDMAN: Yes.

DR. LUMPKIN: — to link to each other. And then you did mention a little bit
about standards. I’m wondering what work you’re doing to make sure that if
you’ve got this system of data collection that’s going on and the goal is to
have more –

DR. FRIEDMAN: Yes.

DR. LUMPKIN: — cooperative research and sharing, what kind of standards
work are you looking at, or adoption of standards, to be able to enable that?

DR. FRIEDMAN: Right now, we’re still in the preliminary phases. I mentioned
that we funded 12 groups to look at ways of sharing. We may come up with 12
best practices. After that, I don’t know. I’m – you know, once we see what
these 12 groups come up with – they’re funded for three years – we
will then have to proceed from there. Some of them may be better than others,
some of them may be more efficient than others; we don’t know. Some practices
may turn out to be better than others. Until then, there are no standards that
we want to implement.

What we’ve said, of course, is that all of these groups have to be
consistent with the departmental procedure, so –

Yes, the other thing we do I didn’t mention is we’ve also funded a group to
do an inventory of clinical trials networks, so that we can see what all of the
networks are currently doing, and can we come up with some – this phrase
“best practices,” but obviously there’s not going to be a single set
of best practices. A lot of it will depend on individual circumstance.

DR. LUMPKIN: Marjorie?

MS. GREENBERG: Probably comes from either from sitting next to you here or
from working with this Committee all these years ‘cause I was going to ask
something also related to the common data standards and informatics which of
course is a major focus of this Committee. But – and I also have – in
that broader issue, I have a specific question about the patient-reported
outcomes because quality of life and more specifically functional status is an
information gap, sort of a need –

DR. FRIEDMAN: Yes.

MS. GREENBERG: — addressed by a few subcommittees of this Committee, and I
have a specific question. Actually, this activity came up at a meeting I was at
earlier in the week, but whether NIH or in these particular projects whether
you’ve looked at any particular international standards or national or
international standards or framework for looking at these issues, and in
particular whether you’ve considered the international classification of
functioning disability and health, the ICF.

DR. FRIEDMAN: Yes. Well, first of all, all of these were just funded in the
end of September, so nothing’s been done yet, obviously. They’re just beginning
to work.

But yes, they’ve been – you know, they will all have to – we are
encouraging these groups to be as consistent as possible with national and
international standards because obviously if to come up with something
completely separate doesn’t make much sense. So, that’s part of the intent.

MS. GREENBERG: I think maybe the Quality Workgroup in the subcommittee might
welcome a presentation in the – on the –

DR. LUMPKIN: Yes.

MS. GREENBERG: — these projects.

DR. FRIEDMAN: Yes, we can certainly do that.

MS. GREENBERG: Maybe we can follow up with you on –

DR. FRIEDMAN: Yes, I think – I can put you in touch with the person
who’s specifically responsible for that project.

MS. GREENBERG: That’d be great, thank you.

DR. LUMPKIN: Jim?

MR. SCANLON: I was going to follow up as well. The – in the internal
discussions within HHS, the folks who are heading up the clinical trials
research infrastructure, data infrastructure, they’re participating very
directly in all of the others, CHI, data standards efforts. There are folks
from NLM and other parts of NIH.

And so the formulation here is that clinical trial information
infrastructure activities would be – are at least – they would part
of the overall national information infrastructure rather than a separate kind
of an infrastructure. So this – as this proceeds – but there’s
clearly an awareness of how the two will fit together. In the National Library
of Medicine, mothers are a very central part of the clinical trials research
network.

DR. LUMPKIN: Bob?

MR. HUNGATE: May I follow up just a little bit on Dr. Harding’s question
earlier about the Priority Number 5?

I live in Boston, and just two weeks ago, maybe even a week ago, there was a
letter by a health lawyer in Cambridge who was articulating discomfort with
electronic disclosure of private information. And it’s my sense that this very
much is related to the IRB’s role in privacy and so on and that there is a
public trust issue here that’s on the other side of that, and I don’t know
– it’s not clear in my mind where that responsibility resolve rests in
this system, and that’s, I guess, an open question.

DR. FRIEDMAN: Yes. No, it’s two things. One, many of the programs which
we’re funding, one – of major activity is to see can, you know, can it be
done, given the issue you’ve raised?

The second thing is an activity I did not mention, but we do have, as part
of the Roadmap, a public trust activity. There was – and there’s a group
that is meeting to see how we can in fact enhance or make things consistent
with – and so, we do recognize that that’s a major issue and we are –

MR. HUNGATE: I’m glad to hear that.

DR. LUMPKIN: Great. Are we going to talk about

the clinical trial research?

Agenda Item: Clinical Trial Research
Agenda – DR. FRIEDMAN

DR. FRIEDMAN: Yes. I need – probably need a little help here getting to
my next – let’s see. If I can – okay.

While I’m doing that, let me – I can – let’s see. Okay, good.

Those are titled, in the Agenda, is the Clinical Trial Research Agenda, but
since I’m from NHLBI; I hesitate to commit to anything other than that, so I
will talk about that, and then during questions we can see if I can expand or
broaden.

We’ve always viewed the biomedical research programs as – well, it’s
akin to the arrow I showed on the Roadmap activities where we start with basic
applied research, do clinical investigations, clinical trials, demonstration
projects and education projects, and we hope that ultimately the information
gets disseminated to the public for public health reasons.

The objectives of the NHLBI clinical research, obviously, are to develop new
treatments based on basically research about these mechanisms, that’s the
beginning of the arrow; evaluate therapies to treat or prevent conditions;
provide answers that instruct clinical practice – a clinical trial isn’t
much use if it doesn’t help the clinician; to identify patients most likely to
respond to specific treatments, develop new strategies to improve treatment
delivery and adherence – and this gets to the point we were talking about
earlier.

Let me give my definition of clinical trials, because people have different
definitions. Clinical trials I see as intervention studies. We are doing
something with or two people. We hope that it’s generally with –

[Laughter.]

DR. STEINWACHS: We also do!

DR. FRIEDMAN: They are prospective in the sense that we start now, we treat
them or intervene in some way, and then we follow and see what happens. They
are done in people. Clinical trials, by definition, are in human beings.

And there are various phases of clinical trials. Traditionally, the FDA has
had Phases 1, 2, 3, 4. That kind of gets blurred these days because there are
many trials that have a Phase 1-2, 2-3 et cetera, and they’re not terribly
applicable to non-pharmacologic studies and many clinical trials are not
pharmacologic.

Most clinical trials are sponsored by industry. I’ve heard different
figures, but it’s probably in the 70 percent range. It’s unnecessary and would
be inappropriate for NHLBI, or for that matter NIH, to sponsor trials that

would, and should, be done by industry. We don’t have the money and it’s
their responsibility under the guidance direction of the FDA to prove that
something is worthwhile before it’s allowed to get out there.

But there are many important trials that would not be done by industry, and
I see that as the primary mission of certainly NHLBI when it comes to clinical
trials. For example, life style change trials wouldn’t be done by industry.
They might – drugs that are off-patent. Step care, or strategies. In many
of our hypertension trials, we start with one drug and we add another one if
need be or we add a third, or change. Or there might be a strategy. The
strategy is to reduce cardiac arrhythmias by whatever means, drugs and/or
device. Well, industry isn’t interested in those studies because at the end of
the day, they can’t go to the FDA and say, it was our drug or device that made
a difference because it was a package deal. So those kinds of studies are ones
that NIH do.

Classes of drugs or devices – you may not study a particular drug, but
you may study any of several drugs of the same class so that you end up with a
more broad outcome at the end.

Surgery studies. Uncommon conditions which don’t – aren’t likely to
lead to big sales at the end.

And some others. For example, it may be need to stimulate a field, or there
– a lot of the device companies are small — you know, they make them
themselves in the garage; they don’t have the money to run a clinical trial,
and so it may be appropriate for us to do some of those clinical trials.

Guidelines that we’ve used for setting priorities for our clinical trials
– obviously, public health is important; it’s going to improve public
health. It’s going to improve or enhance scientific understanding.

To the extent that we can get others, other agencies, other institutes or
industry, to share the funding, that’s great.

Translation of findings into practice. Sorry, I used the word
“translation” there but –

DR. STEINWACHS: That’s quite all right. I’ll support that!

DR. FRIEDMAN: — obviously, at the end of the study, is it something that
can be implemented in practice, or is it – you know, it may be wonderful
science but it’s just so complex and difficult and costly that at the end, it’s
interesting but not terribly useful. And, as I mentioned, should industry do
it?

Yet, we can’t get away from ethical issues when we’re talking about clinical
trials. It has to be an important question. If it’s not an important question,
we can’t justify putting people at risk, or even putting a new burden on them.

It has to be designed well. It has to answer the question we set out of
– again, it may be an important question, but if we can’t answer it, it’s
not designed well, it’s still not ethical.

We have to start out clinical equipoise. We can’t know which – we may
hope that one group is better than another but we can’t start out with the
presumption, with the knowledge, that one is better than the other.

All of our studies have to undergo scientific and ethical review and they
all have to have appropriate monitoring during the course of the study for
safety and for study integrity.

Some of the basics that we have at NIH, they’re mentioned in the previous
discussion. Most research is investigator-initiated RO1s. And obviously,
investigators come in to do clinical trials also. Single center or
multi-center.

There are also clinical trials that are initiated by the Institute. They may
be multi-center clinical trials that we would solicit investigators for using
request for proposals or request for applications. They may be multiple,
single-center trials. They may be small studies, that we want four or five or
half a dozen of them going on at the same time that we’ll solicit.

Through our specialized clinical centers of research, there may be clinical
trials going on. And then through the research network that we talked a little
bit about before, that we would solicit clinical trials, and I’ll get into the
networks in a little bit more detail.

For an investigator-initiated clinical trial, anybody, not just clinical
trials but any researcher that wants to come in with a project that costs over
$500,000, direct cost, in any one year needs permission to apply to NIH. Since
essentially all clinical trials will hit that, will be over $500,000, we pretty
much see all of them.

And the decisions – the factors that we use in deciding whether or not
to accept are: Is it relevant to our mission? Does it complement ongoing
activities? Does it provide valuable additional knowledge? What’s its public
health applicability? And, is there a plan by the researcher at the end to
disseminate the information? Is the cost reasonable? Does it comply with the
various NIH policies on inclusion of women, minorities, children? And does it
include a monitoring plan?

And if has those, then, yes, we say, sure you can come in, at which point it
undergoes peer review, and then, if it does well enough in peer review and goes
– does well enough in our advisory council discussions, it would be
funded.

DR. STEINWACHS: Dr. Friedman, you’re one slide behind right now.

DR. FRIEDMAN: Am I? Sorry.

DR. STEINWACHS: Need to go one more.

DR. FRIEDMAN: Oh.

Now, Institute-initiated. The ideas for these studies come from various
sources. They come from workshops we may hold, working groups, other meetings
which may take place. Often, results of prior studies will say, hey, there’s
another interesting question that we need to answer, so we need another
clinical trial. And obviously, individuals and groups of various sorts suggest
clinical trials.

All of the Institute-initiated clinical trials are, after they’ve gone
through a fair amount of development and iterations by institute staff,
presented to a Board of Extramural Advisors that we have that then reviews them
and decides which ones are meritorious. They then go to our Advisory Council
and then ultimately the Institute Director has to decide whether or not to fund
them.

What I have not put in here because it wasn’t – I didn’t think
completely applicable is we do many clinical trials in our intramural program
as well. Those are primarily small, early phase clinical trials that have their
own process of review and decision making. If anyone’s interested, I can talk
about that.

I mentioned that I’d talk a little bit more about networks because it’s
relevant to the Roadmap. By networks, we mean a flexible mechanism that
includes multiple clinical sites, a data coordinating center – other
laboratories as needed, and all of these groups agree to collaborate in the
development and conduct of multiple protocols over – here it says five
years, but obviously it could be extended as needed.

And why do we have clinical networks? Well, it’s mostly to fill a gap in the
research activity in a particular disciple.

The first one we started was a clinical research network in asthma because
in our – in my Institute, asthma was not receiving enough clinical
research — clinical trials were not being done adequately or in sufficient
quantity.

And so we developed a clinical trials network in asthma, and it’s ongoing
and has done many important clinical trials.

So as to address some important management questions in clinical topics and
to be able to rapidly implement clinical trials – a problem with many of
the single, investigator-initiated clinical trials or the clinical trials that
we start up for a single question is it takes a year or two, sometimes three,
to actually begin the protocol. The advantage of a network is you can do that
more rapidly, within months.

They’re efficient. They share resources among various groups. They allow
recruitment of adequate patient numbers. And they provide rapid discoveries and
lead to future protocols – that’s an important one. Yes, you get an answer
from one of them that you – but there’s still some questions; well, you
can then implement another protocol that will address the unanswered question
from the first one.

This next slide shows the range of studies that we’ve done, things in safety
and efficacy, for example. Hepatitis C trials. We’ve done regular versus as
needed use of beta-agonist in asthma. We’ve looked at optimal platelet dose to
prevent bleeding in thrombocytopenia; reduced intensity from non-myeloblative
transplantation.

We’ve looked at prevention of fungal infections in allogeneic transplants.
Remember this is Heart, Lung and Blood Institute. Pharmacogenetics of asthma
therapy. Comparison of cell source for hematopoletic transplant.

We’ve looked at therapies for children with asthma and ACE inhibitors after
atroventricular septal defect in children, steroid therapy in Kawasaki disease,
many others.

Next slide shows the duration of the networks that we’ve had. You can see we
started them 12 years ago, not nearly as long ago as NCI but we did start it.
But now we – one, two, three – we have a dozen right now and planning
on starting others in various fields ranging from asthma, adult and childhood,
to respiratory distress syndrome, thalassemia, pediatric heart diseases, blood
and marrow transplantation, transfusion medicine, chronic obstructive pulmonary
disease, resuscitation, pulmonary fibrosis, sickle cell, heart failure –
so, a variety of different areas.

Summary – when we fund or design clinical trials, we get input from a
broad constituency. The decisions are based on the importance of the question,
opportunity obviously, feasibility, and program balance in heart, lung and
blood.

Clinical trials require flexibility in approach in kind of trial. We’ve done
many small studies, we’ve done studies that have had 40,000 and more
participants. They’ve been based in hospitals, acute care settings, they’ve
been done in the community, among many community physicians.Obviously, the goal
is improve public health.

I’d be happy to answer any questions to the extent I can talk about other
institutes or NIH as a whole.

DR. LUMPKIN: Let me just ask a sort of a background question. How many
clinical trials would you say are ongoing at your Institute? And if you have an
idea of how many are going on, ongoing at NIH?

DR. FRIEDMAN: Yes – the reason I’m hesitating is part of it is
definitional. And do you mean late phase trials, early Phase 1 trials and Phase
2 trials? If you mean early Phase 1 and 2 trials, there are many hundreds going
on at NIH. The Cancer Institute probably does half of all the clinical trials
at NIH, in all phases.

If you mean just late phase, Phase 3, Phase 4 clinical trials, there are
several hundred at NIH overall, again about half of them at NCI.

My Institute probably has, I don’t know, 70, 80 going on at any one time of
the late phase trials, obviously.

DR. LUMPKIN: Okay.

DR. STEINWACHS: As you know well, we rely greatly on the evidence that comes
out of clinical trials to talk about what is quality of care and sort of how to
measure that quality, and certainly the Institute’s come forward with the
recommendations like those in asthma treatment, others. Seems to me that there
were two things that would help me if you could address. One is that I

think approximately half of Americans with a chronic disease have more than
one chronic disease, and I think the history of our clinical trials has
typically been individual disease instead of looking at some of these clusters
and saying, how do we assess quality, or how do we assess efficacy of treatment
when you have a dual condition, dual diagnosis?

And then I guess, a one-step extension of that is, you know, all of us have
also said, well, once you have the efficacy information, then you still are
faced, at least in clinical practice, with applying that to a population that
has many other characteristics and burdens and so it sometimes goes into that
effectiveness area, and I guess – so the question of how you see what NIH
is doing that helps us get to both, broader applicability of quality standards
and into better understanding of effect across the broad population.

DR. FRIEDMAN: Yes, well, in fact you’ve brought me back to the Roadmap
because –

DR. STEINWACHS: I thought that was my job.

[Laughter.]

DR. FRIEDMAN: — obviously to the extent that we can get clinical trial
networks to collaborate, work together, and to be more open – I didn’t get
into this, but one of the goals is not just to get two or more networks to

share resources and technology but to the extent that there are networks
doing studies in one area that might lend themselves to doing studies in
another area – absolutely. Easy ones are heart disease and diabetes, for
example, which go together, unfortunately. Or heart disease and obesity. Or
obesity and – so those kinds of things – or hypertension and many of
the other conditions.

So the hope is that we will stimulate more such trials, one, because it’s
more efficient to do it that way, but, two, because we do then perhaps answer
more real world questions since many people, particularly elderly people, do
have more than one condition.

And you’re absolutely right – clinical trials historically have been
very pure; we only want people who have exactly this. And then the
generalizability of the translation becomes some – questionable.

DR. LUMPKIN: Jeff?

MR. BLAIR: I’m going to pass – thank you.

DR. LUMPKIN: Jim?

MR. SCANLON: Looking further down the Roadmap in terms of maybe the next
generation of clinical trials and some of the other concepts in the Roadmap, do
you foresee a – again, understanding that the clinical trials are largely
hypothesis-based testing, is there the possibility that routine medical records
from hospitals and ambulatory care practices at some point will be utilized in
research or is it just too haphazard and it’s just a – it’s not a
protocol-based hypothesis testing framework?

DR. FRIEDMAN: Yes, I think they ought to be used. I think they can be used
in several ways.

First of all, simply – one of the biggest problems in clinical trials
is screening and enrollment. It takes a long time. It’s a lot of effort. To the
extent that availability of medical records with all of the privacy issues that
we can’t forget about are there, then that would help tremendously there. So I
think it would help in the actual conduct of the hypothesis testing part.

As far as the other, yes, I think – you know, we sometimes turn up our
noses at research that is, you know, either anecdotal or just, you know, cases
here, there and such, and probably rightly so in most circumstances because the
selection is problematic. But if we can truly get broader access to medical
records and if they are truly of sufficient quality – you guys know a lot
more about that than I do – then yes, I think they could be used to answer
important questions.

DR. LUMPKIN: Like to follow up?

MR. SCANLON: I think that there are folks who say that we’re getting to the
point where pure clinical trials as you describe them were getting so expensive
and

difficult to do and it involves multiple conditions at any rate that in a
way this has to be a direction, and not just medical records but insurance
data. There are systematized large-scale databases that are existing and
they’re largely the byproduct of medical care or insurance or plan operations
and I think even our Medicare program is starting to look at that as a
potential source of – if not (?) in clinical trial, at least some
evaluation of procedures and medications and things like that.

DR. FRIEDMAN: Yes. Now, I would agree. In fact, I didn’t say it but all too
often we see – you know, the people say, well, it’s the clinical trials
versus the observational studies versus the medical records versus – it’s
not. It’s clinical trials plus observational studies plus medical records plus
everything else.

We have – whenever we get the results – you know, if I got the
results from a clinical trial that was totally contradictory to everything else
I thought I knew, I’d question that result. And so it always has to be put in
the context of all of the information.

DR. LUMPKIN: Gene?

DR. LENGERICH: Just a comment, and then I wanted to follow up on that. And
one is, I think there’s also been literature that’s shown that in a lot of
cases, the observational – when observational trials studies and clinical
trials have been done on the same question, they’ve been very similar, the
results have been very similar. So that does call into question multiple –
the need for multiple, multiple, expensive trials of either type.

My question had to do – is actually building upon that. In the cancer
world, there’s probably two or three percent of cancer patients that actually
go on trial. Probably 10 or 15 percent of those that could actually do. So I’m
wondering if you have a sense of what sort of percentage actually enter into
your trials and how you see that changing over time? And I think that’s related
to Jim’s question –

DR. FRIEDMAN: Yes.

DR. LENGERICH: — as well. And what efforts are you doing to insure that,
and particularly if there’s populations that you’re particularly addressing?

DR. FRIEDMAN: You know, I feel – and I’ll also comment on your first
point – but the – well, I’ll do that first. Yes, you’re right. Most
of the time, the results from observational studies and other research agree.
But sometimes it doesn’t. And if we knew when it wasn’t and when we had to do a
clinical trial –

[Laughter.]

DR. FRIEDMAN: — that would be wonderful. I’m still waiting for the
technology that tells us when it won’t agree and when we need to do the
clinical trial. And I’ve had enough experiences of my own where they don’t
agree, and in retrospect the observational studies just got it wrong for all of
the biases we’re well aware of.

There – I don’t think we’re doing any better than cancer in terms of
percent of people coming into our studies. Yes, we just completed a
hypertension study that had over 40,000 people in it but there are in the
United States, you know, 40 million people with hypertension, and obviously not
all those 40 million would have been eligible for this particular study, but
the fact is, you know, recruitment took a long time. You’d think with 40
million hypertensives, you could have done it in a few days. It – you
know, it took a long time. So I agree with you, it’s a problem.

Do I have a solution? I’m afraid not.

DR. LENGERICH: Any particular efforts from NHLBI to increase that or look at
that?

DR. FRIEDMAN: Yes. Obviously, we do the same efforts that all of the other
Institutes do. We have widespread involvement of investigators, of public
groups, of educational approaches, campaigns. Do they work? They probably work
a little bit, they help a little bit – we like to think they help
‘cause we continue to do them.

But it’s a struggle, it really is. I think part of the problem is a lot of
times the practitioners think they know the answer; they’re not willing to
necessarily put people into studies, and it’s difficult.

DR. LUMPKIN: Russ?

MR. LOCALIO: I’m Russell Localio. I sit on the Subcommittee on Populations.
We look into things like health disparities across different subclasses of
population.

Now, at an Institute such as yours, is there any concerted effort to looking
across trials and asking the question whether certain subgroups or certain
subclasses do better than others, not just within one RCT but across them, and
what are the challenges that face someone trying to ask the question whether
certain subgroups do better than others? Thank you.

DR. FRIEDMAN: Well, I’ll give you two contradictory answers because on one
I’ll have my clinical trialist hat on and the other my practitioner hat on.

My clinical trialist hat – well, I’ll quote Richard Pito: “Look,
but don’t believe.” In other words, you do subgroup analyses but there’s
always the danger — in fact, more often than not, we’ve seen that they have
not been borne out when you do other studies. If you see a trial that seems to
show that one subgroup in particular benefits, the likelihood is that when you
do the next trial, you won’t see the same sort of thing.

Or qualitative outcomes. Quantitative is a different issue, and that’s, I
guess, when I turn to my clinician hat. There’s no question that there are some
people who are at higher risk than others who might benefit perhaps a little
bit more, although that’s questionable. But it really comes down to core basic
risk level, and obviously all treatments have risks and therefore you want to
emphasize the treatment of those who are at higher risk of the condition and
more likely to benefit absolutely even though the relative benefit may be the
same across the risk.

So there, yes, of course you want to look at subgroups to see which are the
people at higher risk of having adverse consequences from the condition and
therefore might benefit more from the treatment that you were going to
implement.

There may be some times when the relative risk is also different. There, I
wouldn’t believe it until I saw repeatedly among different clinical trials, and
this gets to your other question: Yes, we’re always doing med analyses or their
equivalents. It’s common to do either among our studies or our studies –
‘cause we’re always in contact with the studies that are done by others as
well.

And yes, it is commonly done.

I’m trying to think those have actually led us to say a particular subgroup
is beneficial – benefits more than others, and offhand I – other than
the absolute risk I mentioned earlier, I’m hard put too think of them. There
may be – in other fields there may be some; we just don’t see them in
heart disease very often, if at all.

DR. LUMPKIN: Okay. Steve, did you have your hand up?

DR. STEINDEL: Yes.

DR. LUMPKIN: Steve.

DR. STEINDEL: Thank you. I’m with CDC, and thank you for your presentations.
Of course, we have a great deal of interest in what’s going on with the Roadmap
and the other clinical trial information gathering systems.

And one of our particular, I would say point of interest from my point of
view at this particular moment, is we are starting to work with an MLU with NCI
on their bioinformatics grid. As you mentioned earlier, you were talking about
standards and you’re following the standards et cetera.

One of the problems we have seen, and “we” being both at CDC and
within the profession as a whole, is not necessarily selecting the standards
but implementing them. And this is what we’re trying to work out with NCI, is
to share experiences on getting these things actually working and
implementable.

My question to you is: Do you have any plans working with the Cancer
Institute in picking up what they’re doing with caBIG, because obviously we
would like to come into a common environment and not necessarily have to work
out what works with most of your programs, not necessarily have to work out one
transfer protocol with one area of NIH, another with another, and a third with
the Roadmap.

DR. FRIEDMAN: Yes. The answer is yes, of course. NCI has been heavily
involved in all of these activities. Ken Buto in particular has – is part
of the oversight committee for the networks and the NECTAR and such, and when
it was developed, it was done with full knowledge of caBIG.

DR. STEINDEL: Thank you. That’s very encouraging.

DR. LUMPKIN: Don?

DR. STEINWACHS: Thank you. My time has come again; I appreciate it. Make it
brief – I can see already!

[Laughter.]

Just a – you had put on your – I’m probably standing in the way of
lunch and it’s probably very dangerous thing in this group.

PARTICIPANT: No!

DR. STEINWACHS: You listed on your clinical trials surgical trials, and I
know NHLBI has done some, but historically, relatively little has been done
– you know, do clinical trials in surgery ‘cause of all the problems
of what’s a control group, what’s a comparison. At the same time, we were
talking to someone about trying to move to this other sources of data, and I
wondered: Could you talk some about how the Roadmap or the Institutes are
trying to deal with the fact that the evidence base that we say we need to have
on drugs, we need to have on non-drug, non-surgical therapies, largely doesn’t
exist on surgical therapies? I may be wrong, but that’s it.

DR. FRIEDMAN: Well – no, I think you’re right. It doesn’t.

The Roadmap hasn’t specifically addressed that because it’s trying to be
pretty generic, so it has intentionally not taken the – a position of
looking at specific fields, disciplines, anything else. Certainly, it’s a major
issue of showing that certain surgical procedures are or are not beneficial.
It’s, as you well know, considerably more difficult than simply prescribing
medication because you have all of the problems of the surgical technique,
skill, training, the whole team. They’re – and then all of the
modifications that individual surgeons do as they – once they get in there
and they say, oh, yes, I want to – I better – so –

Nevertheless, I think we’ve been successful in some of the surgical studies
we have supported, and I see no reason why can’t continue. I’ve gotten away
from the Roadmap because, as I say, the Roadmap doesn’t specifically do that,
but you’ve started me thinking and now I will see if we can possibly bring it
in some way.

DR. STEINWACHS: That would be helpful.

DR. LUMPKIN: Kevin?

DR. VIGILANTE: Thank you. Kevin Vigilante. I seem to remember, and correct
me if I’m wrong, but one of the surgical studies, I believe, lung reduction
surgery for folks with severe emphysema, was funded in a fairly unique way,
that there was some partnership with CMS and I think perhaps industry, maybe
not.

DR. FRIEDMAN: No, it was just the CMS.

DR. VIGILANTE: CMS. Is there a future for that sort of collaborative funding
which sounds very encouraging to me actually in terms of best practices?

DR. FRIEDMAN: Yes, we certainly hope so, because it turned out to be very
worthwhile. That particular one, CMS came to us. They had a problem: Should
they or should they not fund that kind of surgery? And so, working together we
were able to develop a good clinical trial.

We’ve talked with CMS also about other specific studies. NIH would like to
have a more broad agreement – no, not agreement, but understanding so that
we can do more things without having to implement it each time. And we’ve had
some discussions with CMS along those lines. How it’ll turn out, I don’t know.

DR. LUMPKIN: Well, thank you. I’d like to thank you very much. It’s been a
very interesting discussion and enlightening and as we said, we’ll want to
follow up on a few issues, and I appreciate your coming.

DR. FRIEDMAN: Okay. You’re welcome.

Agenda Item: NCVHS 2003-2004 Annual Report
– Outline/Research Agenda Ideas – DR. LUMPKIN

DR. LUMPKIN: We’re going to move on to the Annual Report, which is the
outline which is under Tab 7.

If you look at the second page, there’s the time frame for completing this,
the goal to have this reviewed at our June meeting. Any comments or suggestions
on the outline of what – something that might be missing, additional
–

MS. GREENBERG: I might just point out that under “Scope” –
you know, “Introduction, Scope of Committee Activities” – these
are some suggested sort of themes, cross-cutting and themes, but we welcome
others, and others may actually come out of the information gathered through
– in the second part. But, you know, I don’t think – these aren’t in
stone.

DR. LUMPKIN: So Scope would be for – well, an important thing to
remember, too, it’s ’03 to ’04, so once we close out this year, we’re done with
the stuff that goes into the Report. But we aren’t done on reporting on that,
yes. Jim?

MR. SCANLON: Well, I see the – one of the headings is “Toward a
New HHS Research Agenda,” and it –

MS. GREENBERG: Well, I think that’s supposed to say –

MR. SCANLON: — seems awfully broad. You mean, information policy research
—

MS. GREENBERG: — what?

MR. SCANLON: Do you mean information policy research agenda or –

MS. GREENBERG: Yes, this thing –

MR. SCANLON: We don’t normally advise on research.

MS. GREENBERG: No. Yes – this was actually –

DR. STEINWACHS: But many of us are willing to, Jim, if you need some advice.

[Laughter.]

MR. SCANLON: And in –

MS. GREENBERG: This was sort of shorthand for —

DR. LUMPKIN: The next item we’re going to cover.

MS. GREENBERG: The next item, yes, which – and so I think this is kind
of a – is sort of a shorthand. It’s a — NCVHS recommendations for a
research agenda related to health information policy.

DR. LUMPKIN: Yes. It’s the HIPP research.

MR. SCANLON: HIPP research.

DR. LUMPKIN: Didn’t we just – that’s a different institute, different
institute. Different HIPP. That’s more of a joint study.

PARTICIPANTS: Boo, boo!

[Laughter.]

PARTICIPANT: He fractures me!

MS. GREENBERG: Disarming!

MR. SCANLON: It’s a good skeletal outline.

DR. LUMPKIN: Yes.

PARTICIPANT: It’s Friday, yeah.

DR. LUMPKIN: Okay – so we can improve the bare bones of this one and
move on?

[Laughter.]

PARTICIPANT: Hear, hear!

DR. LUMPKIN: Okay. The next tab is the “Research Agenda Ideas” for
which there are a lot of pages. And as I was reading through those, I was
struggling to come up with some structure to this, without avail.

But I think that that’s one of the thing that if I could suggest that a few
of us sort of take some thoughts over the next few times and then when we have
our conference call, which we need to have, for the Executive Committee,
perhaps we can try to put some structure about how we want to address it.

The other thing to note is that there’s not much there from Standards and
Security.

MS. GREENBERG: I think the –

DR. LUMPKIN: Or did I miss that?

MS. GREENBERG: No, I think the only – Debbie, where’s Debbie? Maybe you
want to –

We only received something in advance from – what we have here is what
we received in advance, which is from the Subcommittee on Populations, and we
appreciate that.

Now, my question was: Did each of the other subcommittees address this in
your breakout session?

DR. LUMPKIN: I know that Quality wanted to.

DR. VIGILANTE: There was an intent.

DR. LUMPKIN: There was intent.

MS. GREENBERG: Well, have – I think in some cases the lead staff may
have compiled the research recommendations in the recent reports but there
wasn’t time to discuss it during the breakout sessions and so if the lead staff
have not done that, then we need to get that

quite quickly.

DR. LUMPKIN: Jeff?

MR. BLAIR: When I took a look at this preliminary list, the question that
came to my mind was – I tend to think of research generating information
that would be helpful to make a decision or a recommendation.

MS. GREENBERG: Excuse me. Could you repeat that?

MR. BLAIR: Pardon?

DR. LUMPKIN: Could you repeat that? That’s what Marjorie would say if she
had spoken into the microphone, but she didn’t, so –

[Laughter.]

DR. LUMPKIN: She said, could you repeat what he just said.

MS. GREENBERG: It’s all right.

MR. BLAIR: When I looked at the preliminary list, I kept trying to match it
up to “Recommendations for Decisions” that we need to make or would
like to make but we need the results of that research to support our
recommendations. And I began to struggle with that connection.

I know that, you know, during this last year when we did make our
recommendations, some of our recommendations indicated research needed to be
done

because we weren’t able to make a decision on those things. So, I’m a little
bit lost. Maybe I’m missing a piece here, ‘cause I thought that we asked
for research to support our recommendations but here’s just a list of some
research ideas and I don’t know how to make the connection.

MS. GREENBERG: You’re talking about the submission from the Subcommittee on
Populations?

MR. BLAIR: There was another short list that I think was suggested in the
Executive Committee meeting which – maybe that was like a summary of
things that we had asked for research for in the past but without it being tied
somehow to recommendations or decisions? I kind of was left intellectually
groping, like I was yesterday.

[Laughter.]

DR. MAYS: When we had our retreat in August, I think it was, there were a
series of things that came up then that I think we talked about. So wherever
those Minutes are, I think Jeff is reminding me, wherever those Minutes are, we
did identify some things then.

And they weren’t recommendations – I mean, they weren’t things that
were drawn on recommendations but they were issues that arose in terms of our
retreat and discussion. So –

MS. GREENBERG: I think the excerpt from the Minutes is actually here; it’s
on this first page.

DR. MAYS: Okay. Well, there were some. do remember we had a discussion then
about some research ideas.

DR. LUMPKIN: Right. Now, part of – if you look at what was done by
populations, part of this list was created by going through prior
recommendations that included research as a recommendation.

There are other areas where we may want to suggest it in the list that came
from the Steering Committee – for instance, the effectiveness and impact
of HIPAA. It’s not something that – unless we have research, we don’t
really know what – how it’s going to impact. Or what’s going to be the
impact of the privacy regs on how people interrelate to their doctors? Are we
seeing changes in patterns of use of clinics? Are we seeing changes in referral
patterns?

There’s a whole host of areas that I think we probably wasn’t to get a
little bit more refinement.

MR. BLAIR: Yes!

DR. LUMPKIN: And it’s really the work of the subcommittees to, as we prepare
for our Annual Report, to hopefully, if they can find time on their agenda, to
give us a little bit of refinement. This is a new area for us. We haven’t
really tried to pull together conceptually as part of our Annual Report areas
that we would like to see

research in order to help us develop the policy recommendations that we
have. So this is an attempt for us to do that and it’s a little bit more
difficult to do in the full Committee than in – with the subcommittees.

I saw John.

MR. HOUSTON: I’m not sure I have a comment. I just –

MS. GREENBERG: If I could just –

DR. LUMPKIN: It was just a quizzical look upon your face.

MS. GREENBERG: — expand on that a little bit. I think the – this idea
originated when we were talking about the fact that specific recommendations
related to maybe adopting a particular standard or doing some particular thing.
Often we’d get some feedback as to whether those were taken on board by the
Department or were being under review or what have you, but that
recommendations that research needed to be done, generally we didn’t have a lot
of follow-up on that, and those kind of hung out there as, you know,
recommendations, but without much – we didn’t have a good idea as to
whether people then went forward and did some of this research or not, and
frequently felt that they didn’t.

So the idea was initially to pull out the places where specifically research
on – in an area was recommended

in one of our letters of recommendation. So in its most simple-minded form,
literally you had to find the word “research.” I mean, that was kind
of the — you know, the baseline.

So, for example, I mean, I commend the Subcommittee on Populations because
they really pulled out a lot of important stuff here. But only some of it was
actual recommendations for research.

Now, it may have been – you know, something that we need more work in
this area so maybe, you know, that’s kind of also you can assume there was an
– the research word was unmentioned. But in some cases it’s like we need
more subgroup data or we need surveys in languages – I mean, that wasn’t
specifically research, so – although it may need research in order to take
it forward.

So – and I’m not picking on Populations. It’s sort of like the common
saying that no good deed ever goes unpunished, because none of the rest of you
provided us anything so I can’t pick on you, but it’s –

[Laughter.]

MS. GREENBERG: — you know, but, I mean, but that makes it an easier ask to
– at least for starters and for this report to at least pull out those
things where specifically we recommended research.

Now, beyond that, though, there are recommendations that were made that
probably can’t be advanced unless there is some research, and there, many of
the areas, for example here, are in that category. It’s not something that can
just be implemented, you know; it’s going to need some demonstration projects
or – and of course, how do you define research is a whole other topic, but
–

And I think for those, if we want to include some of that in our – in
this year’s Report, there needs to be some prioritizing, obviously, some –
as John said – kind of pulling together some broad areas.

But I do think at a minimum we should be pulling out where we specifically
recommended research, and I think Standards and Security has in the last four
or five years used the “R” word in some recommendations –

[Laughter.]

MR. BLAIR: Could I refer to the “R” word? Actually, the year when
we I think had our greatest number of recommendations asking for research was
the year 2000 –

MS. GREENBERG: Yes.

MR. BLAIR: — in the PMRI report. And is it possible if we could include the
scope to go back to then, then I think that we could make a rich contribution.

MS. GREENBERG: Yes, I think we said the last three to five years or –
didn’t we say that, Debbie?

MR. BLAIR: I thought it was just this – maybe I misunderstood; I
thought it was – that it didn’t go back –

MS. GREENBERG: No, we said “over the past four to five years.”

MR. BLAIR: Yes, I think that the scope of the Report is ’03 to ’04, but this
particular section of the Report, on research, we’re really – we’ll want
to sort of –

DR. LUMPKIN: Okay.

MR. BLAIR: And then we’ll do this with our other annual reports on an
ongoing basis, talk about what we believe ought to be on the research agenda,
and as things occur or times change, we can move things off and move other
things on.

MS. GREENBERG: Yes, this actually said “full research related idea that
are already included in published NCVHS recommendations reports over the past
four to five years.”

MR. BLAIR: You’d have to be blind to have missed that.

[Laughter.]

MS. GREENBERG: Oh, dear!

PARTICIPANT: Boo!

DR. LUMPKIN: Thank you for that insight.

[Laughter.]

MS. GREENBERG: Well, if anyone had eyeballed it, they would have noticed it.

DR. LUMPKIN: Bob?

MR. HUNGATE: I’m not sure I want to enter this discussion. The –

PARTICIPANT: I think Jeff can see better than most of us, actually. Or me,
at least.

MR. HUNGATE: — uncertainty that I have here in terms of research per se is
understanding for me, and this relates to the process here of the Committee. I
can see the use of past recommendations for research as needing reiteration,
but I’m trying to put the process of where do hearings fit and where does
research fit the hearings; you know, what is the sequencing and then what’s the
follow-up, if you will, behind recommendations that we make?

You know, you don’t want more research on recommendations you’ve already
made, it seems to me, but yet we have listed here from our discussion last
summer ICD-10-CM as one of the research topics. Well, that doesn’t seem right,
because it seems to me what we want to know is what the reaction is to our
recommendation. You know, what am I missing?

DR. LUMPKIN: Well, actually, I would suggest that there may be times when we
do want to have research on a recommendation, that we’re pointing in a certain
direction, and particularly when those research – those recommendations
result in things being adopted by the Department. So, for instance, doing
research on HIPAA privacy and its impact would be actually doing research on a
recommendation.

So I think it really has to do with the agenda of the workgroups and the
subcommittees on whether or not — knowing that it’s important.

There are some things which we may make recommendations on and we’ve done
that and we’re going to move on and others where we may have established that
we’re going to come back.

I do want to point out that Anna did submit –

MS. GREENBERG: Yes.

DR. LUMPKIN: — some items and they’re on the back of Page – the second
page in – under Tab 8.

MS. GREENBERG: And (?) also suggested to me that – Anna’s is directly
out of the quality report and Mike’s was more forward thinking but that doesn’t
mean that it couldn’t be included, but I don’t know if I’ve been clear about
these two categories. One is where research specifically was recommended by the
Committee and we don’t have any knowledge that it – you know, that the
research has been done. And two, the other, was areas of research that might
be, you know, recommended, or implied by recommendations that have already been
made or even future research topics.

DR. LUMPKIN: Vickie?

DR. MAYS: There was also, I thought, another piece of the process, at least,
I think that the Subcommittee on Populations was thinking about, and that was
– I also thought that in terms of our list, pieces of that are to get
prioritized to give to the Data Council ‘cause I thought we were also
trying – the Data Council was going to look at budget, and in terms of
looking at budget, we had talked about if there were any topics and
prioritizing those to make sure that Data Council understood that they were
– that those were very important coming from here, so for Populations, I
mean, I think there’s a direct relationship of some of those items to Data
Council. I don’t know in terms of some of the other subcommittees or not.

DR. LUMPKIN: Mark?

MR. ROTHSTEIN: Well, I was just going to ask if you could clarify what we
hope to accomplish by putting this together because that will influence what we
put in our records. I remember the conversation and now it seems like we’re
going beyond that and trying to put more material in, so could you tell us
where you see this going?

DR. LUMPKIN: Jim?

MR. SCANLON: I guess I have the same concern that Mark has. It’s one thing
to complete an annual report by closing out the two years and indicating what
recommendations were previously made, but if I think it’s a research agenda
development activity, that’s a new recommendation, and I don’t think you want
to do it this way, sort of haphazardly. I think you have to actually initiate a
process of deliberation and about what are the priorities for information
policy-related research in the coming year. I wouldn’t mix ‘em together
– it’s just a little bit haphazard.

DR. LUMPKIN: So, let’s sort of follow up on that then. What we would do for
the Annual Report, just so we don’t get Scope – is to summarize those
recommendations. And since it’s the first time we’ve done that, this section
will go back to the time frame of the years in the past and that will just be a
summary of those recommendations we’ve made. And I think moving forward we’ll
look at as we go gear ourselves to think about, to the extent that we have time
available on the subcommittee and workgroups, that at one – at one point
we’re going to want to have an ongoing research agenda to, I think, give
guidance to the Department in areas where research can be done.

Jeff?

MR. BLAIR: If we do that, and I’m assuming that we’d do something like a
word search on our recommendation

letters to come up with the sentences or phrases where we made our
recommendations and be able to reference those, sometimes the sentence that
makes the recommendation for research will be very difficult to understand the
purpose of that unless the sentence or two previous to that which points out
the problem and that the research is addressing the problem in order to be able
to understand why that research is being recommended. So, you may have to do a
little bit more than just include the sentence with the recommendation.

DR. LUMPKIN: Well, actually I think you’re going to need to do more than
just do a word search because there are places where in our reports that we may
actually suggest that there be research done without making that a formal
recommendation, and I think that would be important to pull in and say, you
know, we couldn’t make a decision on this because we need to know more about X,
Y, Z. I think that would be important to add in there.

And second is that you’re absolutely right. There will need to be some
writing done on these recommendations so that they stand on their own when
they’re included into the report rather than just being a compilation or
cut-and-paste from various reports.

Vickie?

DR. MAYS: Could you just tell me if the process that we’re talking about
will also fit what Jim is doing, ‘cause I guess I thought what you needed
may be a little sooner and a little faster than the process that we seem to be
talking about? It sounds like we have a lot more time to have discussions and
pull together the recommendation; I’m not even sure when the report is due. But
in terms of the work on the budget, isn’t that sooner?

DR. LUMPKIN: We already have – the Department already has all of your
previous recommendations, and many of ‘em were presented to the Data
Council. So I think, in terms of the budget for ’06, I don’t –

DR. MAYS: Can we prioritize them, if we can – we have some of those we
actually would like to see, like the target surveys. So, I mean, if it will
help, you know, I’ll just be on record; should we prioritize them?

MR. SCANLON: Well, if you want to prioritize, that’s fine, but that’s a
whole new set of – I mean, is that a –

DR. MAYS: No, that’s –

MR. SCANLON: — the Committee has to agree to all that, doesn’t it?

MS. GREENBERG: Oh, I think – I mean, there’ve already been
recommendations made on that.

DR. MAYS: Exactly.

MS. GREENBERG: But you’re saying that –

MR. SCANLON: But if you want to say the top three, the top three are your
priorities, it seems to me that’s a deliberative – that’s another
recommendation.

MR. BLAIR: Yes.

MR. SCANLON: But in terms of the content, Vickie, I wouldn’t worry too much.
The recommendations that you’ve made across the Standards, Populations, in this
area already are quite familiar, and they are being factored into budget
issues, budget planning, to the extent any resources, you know, what actual
resources are available. So, I’m not –

And some of them clearly were higher priority than – I mean, on their
face they were higher priority than others, so I don’t think that’s quite so
much an issue in terms of time. But if the Committee certainly – I just
think you need more time and deliberation. If you actually want to systemize
this way of looking at, you know, research agenda or information agenda, to
support the Committee’s work, I just think you need more time and deliberation,
and you probably want to get other views as well.

MS. GREENBERG: I would suggest the following, that each subcommittee or
workgroup, by the Chair, working with the lead staff, develop a list of
specific research recommendations that have been made if you haven’t already
done that.

I do think this one from Populations needs to be reduced to those where
research – specifically research or something very similar to that was
recommended, ‘cause a lot of these can’t actually be even – I mean,
you could imagine research, but they – that’s not what the recommendation
is. But in any event, as I said, I don’t mean to pick on it because it’s a
really useful selection, but – and that we will plan – we would plan
to include those in this year – in this two-year report.

MR. BLAIR: So when do you need that list from us?

MS. GREENBERG: Well, the time frame here is – let me see; where was
that?

DR. LUMPKIN: Tab 7, second page.

MS. GREENBERG: Yes, okay.

DR. LUMPKIN: Tab 7, second page.

MS. GREENBERG: Tab 7, second page?

DR. LUMPKIN: Yes.

MS. GREENBERG: Excuse me, yes; I was on Tab 8.

All input due to Susan Canan(?) February 1st. So this is one of
the inputs.

MR. BLAIR: So what you’re saying is you need it by February 1st?

DR. LUMPKIN: Correct.

MS. GREENBERG: But what you want – I mean, if the Chair and the lead
staff are going to work on this together, then it would – you’d want to
probably, you know, share it with the other members and staff, and that we
could then say – we would explain in the report why we’re doing this and
what the plans are for the future, as Jim has suggested, to try to think more,
you know, and discuss more fully a – some priorities for a research agenda
in health –

DR. LUMPKIN: Debbie?

MS. JACKSON: I’ll help to continue coordinating the schedules. And one of
the first projects we’ve had like this – so I’ll just kind of keep
everyone informed through email traffic so that I can coordinate this and get
this on to Susan. So, we’ll – you’ll be hearing from me, and just like the
first request for it – I sent it out to the Chairs and the leads –
I’ll do the same thing to get this document going.

MS. GREENBERG: I mean, I think there are a few different reasons to be doing
this. One is, just by pulling these out, it does put them all on one plate, and
even if the Department doesn’t pursue some of these, there’s ideas that other
people might want to pick up or to pursue with different agencies as to doing
it. So I think they kind of give them some visibility, but also they could
contribute to this broader discussion of research priorities –

MR. BLAIR: Could I —

MS. GREENBERG: — related to health information policy.

MR. BLAIR: — ask – would it be unreasonable if the staff to the
Committee maybe due a first cut for the members by doing that word search and
the sentence search so we have at least the identification of those
recommendation letters and, you know, at least, like a first cut of these, and
then we could go ahead as members of each of the subcommittees examining those
and seeing if we need to have additional wording to make them more
understandable and to see if we might want to prioritize them, as Vickie says,
or, but in short, could we get a first cut by the staff?

MS. GREENBERG: Although what I think is Jim is saying, that if you then want
to set priorities among them, that probably isn’t going to happen in 2004, and
so it really doesn’t belong in 2004.

MR. SCANLON: No, that’s part of the new agenda.

MS. GREENBERG: 2003-2004 report. I would have to agree with him.

MR. SCANLON: And there might be entirely new ones, priorities for which
would not even be identified –

[Laughter.]

MR. BLAIR: Okay – I don’t know whether we – maybe we wouldn’t
prioritize them, but anyway, could we at least get the first cut from the
staff?

MS. GREENBERG: Sure. I think, however, you know, however we want to do it, I
agree. I mean, I think the most basic thing is to kind of do a word search on
research, but I do think that that might be a little too simplistic to pull out
things where research was clearly implied, if not specifically stated.

But, I mean, I don’t think we should go beyond that for this year’s –
for this two-year report.

But, you know, I mean, I think we could even try to devote, I mean, half a
day or something, of a future meeting talking about these, you know, future
research things. It’s not the type of thing that I think we can just, you know,
do in a very brief time, but –

DR. LUMPKIN: Right. But –

MR. SCANLON: And I think the other issue is that with the framework, things
are kind of changing fairly quickly now in terms of the overall framework and
how you would approach national health information networks, and I think it
would be – until you have the benefit of sort of seeing that and the
reactions to that, it would have a completely – you might have a
completely different set of suggestions. So we do need more time.

DR. LUMPKIN: But I think the discussion at the full Committee has to be
predicated upon discussions in each of the subcommittees and workgroups because
what we want to do at this – at the full Committee is really talk about
the interrelated priorities as opposed to trying to prioritize across the
entire work of the Committee.

So, again, that’s a process we’ll have to build up to because it’s not one
that we’re used to doing.

Vickie?

DR. MAYS: I would suggest that when we have a discussion at the full
Committee level that we make sure that we have our rep from NIH and that we
also try and get somebody from the Agency for Health Care Quality Research to
also serve as kind of the rep to make – no, I’m just saying to make sure
that they’re here for that and that they’re serving in the role as the rep so
that there’s some things that they can give us directions on in terms of the
feasibility and kind of where the agencies are going that would make these
things more easy to be picked up by the agencies.

DR. LUMPKIN: So if I get your drift, what we’d like to do is actually not
just to pick on those two agencies but for all the liaisons to try to get a
little bit of feedback or input from their agencies on how this agenda might
impact them or issues they may want to see.

DR. MAYS: I think yes. I mean, I was thinking of those two as primary
research – but yes, yes.

DR. LUMPKIN: Well, there’s research and then there’s research.

[Laughter.]

MR. SCANLON: I think you’re including everything from needed information to
– which is – you could call it research, but I – actual, formal
research.

DR. LUMPKIN: And you heard Dr. Friedman comment how they fund more health
services research than us.

[Laughter.]

MS. GREENBERG: Well, in health statistics, too.

DR. LUMPKIN: In health statistics. You know, it’s an 800-pound gorilla. And
there was nothing from CMS, ‘cause they’re very biased about – I’m
sure they don’t fund any research –

MS. BEREK: We were funding all (?) clinical trials.

DR. LUMPKIN: Yes. I’m –

[Laughter.]

DR. LUMPKIN: — just being sarcastic, of course. So we know that there are
other agencies that are – as they’re trying to develop their policy
agenda, are in fact conducting what we would consider to be research, although
it may not be the NIH RO1 stuff.

MS. GREENBERG: I would suggest we go back to probably 2000 – 2000,
2001, 2003, 2004.

DR. LUMPKIN: Okay.

MS. GREENBERG: Debbie will be following up with the Chairs and the lead
staff. And probably also Susan – well, she’s also be following up with you
for the other input to the report as well, working with Susan Canan.

DR. LUMPKIN: Reality check. It is now noon. We have one action item, report
from the subcommittees, and then future agendas. Do you want to press on?

MS. GREENBERG: Can we take a short break?

PARTICIPANT: Either that or come back at 12:30.

DR. LUMPKIN: Or come back at 12:30?

SEVERAL PARTICIPANTS: Yes.

MS. GREENBERG: Bring food – can you bring food in here?

MR. BLAIR: Okay. You know, it may give us some shots to get earlier flights
if we could finish in the next 45 minutes? I mean, it seems like all there is
left on the agenda.

DR. LUMPKIN: Do you want to do the letter from Quality and then see where
we’re at?

MR. HUNGATE: Why don’t we pass it out quickly so you can look at it to make
your judgment as to whether you –

PARTICIPANT: Take a five-minute bio break.

DR. LUMPKIN: Okay, we’re going to do a five-minute bio break. We’re going to
pass it out and we’re going to see where we are at.

(Break)

Agenda Item: Reports from Subcommittee and
Workgroups/Item I, Workgroup on Quality, ACTION ITEM – MR. HUNGATE

MR. HUNGATE: — not changed in content except in a better direction. I’ll
read it, stopping at the end of each paragraph.

“In May, 2004, the NCVHS issued a report entitled Measuring
Health Care Quality: Obstacles and Opportunities. The Quality
Workgroup, together with the Subcommittee on Standards and Security, conducted
hearings based on this” – “on the report. One opportunity for
data improvement was universally sought by the purchasers of care, endorsed by
the providers of care, and is poised for implementation by the designated
Standards Maintenance Organization. The NCVHS recommends that the next version
of the Uniform Bill for Hospitals (UB-04) and the ANSI ASC X12N 837I HIPAA
Implementation Guide be revised to facilitate reporting of a diagnosis
indicator to flag diagnoses that were present on admission in secondary
diagnosis fields for all inpatient claims transactions.”

Okay?

MR. ROTHSTEIN: Is that supposed to be 837I?

MR. HUNGATE: I.

MR. ROTHSTEIN: That could be an “I.”

DR. LUMPKIN: Okay.

MR. HUNGATE: I said “I,” but it doesn’t read “I.” It’s
compensatory capability of the brain.

“The secondary diagnosis indicator can help to distinguish between
pre-existing conditions and those that develop or were first recognized during
the hospitalization. The ability to make this distinction can enable both case
mix/severity of illness adjustment at admission and quality improvement
opportunities in care processes. There is experience –“ That dash
should not be there.

MS. GREENBERG: There’s “experience with,” it’s supposed to say.

MR. HUNGATE: There is –

MS. GREENBERG: “With collecting this information.”

MR. HUNGATE: “There is experience collecting the information in New
York and California hospital discharge systems where it has proven valuable for
both risk adjustment and outcomes assessment.”

With the striking of the dash.

DR. LUMPKIN: Dash.

MR. HUNGATE: — dash, okay?

DR. LUMPKIN: We’ve dashed the dash!

MR. HUNGATE: Dashed the dash, all right.

“While testimony received on this recommendation has made a business
case for including the diagnosis indicator on a claim, the Department should
work with interested stakeholders to more explicitly describe the elements for
effective implementation. Testimony observed that variation in definition among
users could reduce the benefit to be gained from the information collected. The
National Uniform Billing Committee and ASC X12N should work together to specify
the code set, reporting conditions and use cases for the indicator. The
evaluation” – “education and evaluation will be needed to assure
that the information is recorded consistently and accurately.”

MR. HUNGATE: I don’t see any reaction; must be okay.

“The Workgroup will continue to liaise with the organizations in the
public and private sector that are addressing the information needed for
quality measurement.”

DR. LUMPKIN: Okay. It’s been moved by Bob Hungate; there’s a second by Don
Steinwachs. Is there discussion?

DR. FITZMAURICE: Could I make a suggestion, that instead of
“flag,” we use the word “identify?”

DR. LUMPKIN: Can you –

DR. FITZMAURICE: In the first – oh, sorry. In the recommendation –
“The NCVHS recommends that the next version of the Uniform Bill for
Hospitals . . . be revised to facilitate reporting of a diagnosis indicator to
flag diagnoses that were present . . . .” I would substitute
“identify” instead of “flag” as a more common term.

MS. GREENBERG: This is, I think, the way this indicator – indicators
all have been described.

MR. HUNGATE: This is the language of the bodies that deal with it.

DR. FITZMAURICE: All right, okay.

MR. HUNGATE: So it’s their term.

DR. FITZMAURICE: All right. They can explain it to the Secretary. That’s
fine.

MR. HUNGATE: Jim?

MR. SCANLON: From the amendment, last sentence, “the Workgroup. . .
will continue its liaison with.”

MR. HUNGATE: “Continue its liaison with.”

MS. GREENBERG: I agree.

MR. SCANLON: “With the organizations.”

MS. GREENBERG: To liaise. “Liaise” is a word but it’s a weird one.

PARTICIPANT: Not sure it’s a word.

MR. SCANLON: “Continue our liaison with.” Liaison with –

DR. LUMPKIN: “Continue its liaison.”

MR. SCANLON: “Its liaison with the key organizations.”

MS. GREENBERG: He’s using “liaison” as a verb as opposed to
“continue its liaison.”

MR. SCANLON: Right.

MR. HUNGATE: Acceptable?

MR. SCANLON: Very good. Very nicely written.

DR. LUMPKIN: Seeing no further discussion, all those in favor, signify by
saying “aye.”

COMMITTEE: Aye.

DR. LUMPKIN: Opposed, say “nay.”

(No response.)

DR. LUMPKIN: Any abstentions?

(No response.)

[The letter to Secretary Thompson is approved
unanimously.]

DR. LUMPKIN: Okay. Send it off.

Agenda Item: Reports from Subcommittee and
Workgroups/Item II, Executive Subcommittee – DR. LUMPKIN

DR. LUMPKIN: The next item is a report from the Executive Subcommittee, and
I don’t think we met between this meeting and the last meeting.

MS. GREENBERG: No.

DR. LUMPKIN: So we have no report.

MS. GREENBERG: But you say you wanted to have a conference call and –
before the end of the year?

DR. LUMPKIN: I think we’re going to need to have one.

MS. GREENBERG: Okay.

DR. LUMPKIN: Questions? Okay?

Agenda Item: Reports from Subcommittee and
Workgroups/Item III, NHII Workgroup – DR. LUMPKIN

DR. LUMPKIN: The NHII Workgroup – I have a little report here, since I
wasn’t at the Workgroup.

The Workgroup discussed the upcoming hearing, which will be a week from
today, as well as the topics for the January 5th through
6th, our Workgroup hearing. We’re going to continue to hear from
vendors on the public health – on the PHR, the personal health record.
Those are

stand alone and specifics and to reflect on a number of varieties and
models, including their second –use of secondary data.

Looked at standards for whatever Mary Jo wrote here that I can’t read.

[Laughter.]

DR. LUMPKIN: Interoperability related to H.L. 7OMG, interoperability
effort, and the impact on EHR and – electronic health records and personal
health records.

The other issues that we thought would be important to discuss: The
governance issues for the RHIOs, the regional health information organizations,
and comments on the RFI, which is coming out in the National Health Information
Network.

Let’s see. We’re going to continue to follow activities of various
commissions and committees and organizations and how they relate to each other
and to the whole.

The Committee is kind of struggling a little bit on how we’re going to
prioritize. This will be held in a conference call to do that, perhaps. And
continue to work on issues of how we best interface with the office of the
National Health Information Technology coordinator since that is an ongoing
issue, as frequently items that we have identified as being important to work
on have also been identified by the office of the national coordinator for
Health Information Technology (CHIT). National Health Coordinator – that’s
why I didn’t want to get there.

[Laughter.]

DR. LUMPKIN: Anyway – to make sure that we can add value to their
process.

Anybody who was at the meeting want to comment?

Thank you, Mary Jo.

MS. GREENBERG: I’d say the only thing I would mention is – actually
Michelle, come up here, because they – we – if you don’t mind. We
tested out a way to do a web-based conferencing technique that we have not used
before, so we tested it out during the conference – during the actual
Workgroup meeting yesterday, and then are going to be using at the meeting next
Friday, at the hearing, and it is an opportunity probably, you know, for
something we – if it works well, we could, you know, try to implement more
throughout our activities. So if you could just briefly mention what that is?
This is Michelle Williamson from NCHS.

MS. WILLIAMSON: I think Mary Jo would agree that it went pretty well
yesterday. We were able to provide a few users with a URL so that they can
access any of the presentations from the speakers during the conference. So
hopefully during the hearing we will upload the presentations right on our
laptop and everything that we upload, the speakers will be able to go through
and the presenters will hear the audio as well as, you know, presentations.

MS. GREENBERG: And then also could participate as well, right?

MS. WILLIAMSON: There’s the opportunity. It depends upon how we want to open
up the venues that are available. There is the availability of having the
people type in questions; we can put them at a queue. We can look at the
questions in the queue, decide which ones we want to address, how we want to
address them.

We will also have the audio capability of allowing the people on the phone
to ask questions as well if want to open up – open it up to the audience,
so a lot of capabilities.

DR. LUMPKIN: Okay. Well, we’ll be able to play around with that. If you
could – maybe if we could send around the Committee the links for the
meeting on Friday, and I would ask those of you who aren’t going to be here on
Friday, if you have five or 10 minutes during the hearing to just sort of go to
the website and see what it looks like.

MS. WILLIAMSON: Okay.

DR. LUMPKIN: That may give you a better idea of the potentials for this
technology in upcoming hearings and meetings.

Jim?

MR. SCANLON: The – as we were talking about the NHI Workgroup and some
upcoming things, I’m thinking that a couple of things will be issued quite
possibly in the next

few weeks that the Committee may want to provide comments on, and we really
– we don’t have a full meeting until March.

One of those would be the request for information on the whole National
Health Information Network and the – David Brailer was speaking about the
other day. It really asks – sets forth a number of questions which advice
and comment is requested on this whole concept of a national – or National
Health Information Networks.

In terms of procedural issues, I think the Committee has to find a way if it
wishes to address that between now and then, probably a 60-day comment period,
so it would fall between or most likely fall between the meetings.

And secondly, it’s quite likely, or at least possible, that proposals for
initial e-prescribing standards would be issued as well in the weeks ahead, and
there are two I think, the Committee would want to be in a position, at least,
to provide comments. So, I know, procedurally I think we’ll have to –

MS. GREENBERG: Yes. I remember, it was several years ago probably at this
point now, but where between — our longest stretch of time is always between
the November meeting and the February or March meeting and typically now this
the very beginning of March and we’re now at the very beginning of February, so
that’s a fair stretch, but I think it was the privacy Notice of Proposed
Rule-Making or something where the privacy subcommittee took the lead in
developing comments and then had its own – had a open conference call,
open to the public, in which they discussed those comments, prepared a letter,
and then that letter was discussed in an open conference call by the Committee,
and those – the list got forwarded in lieu of their being an actual
meeting.

So, you know, we’ve done that in the past and we can do it if the timing
requires it.

DR. LUMPKIN: John?

MR. HOUSTON: Regarding the RFI, what specific action would NCVHS – what
are you thinking they would – what would we need to do with regards to the
RFI?

MR. SCANLON: The RFI requests views and ideas on a series of questions
related to how – I have to be careful here; I don’t want to issue the RFI
–

[Laughter.]

MR. HOUSTON: But would NCVHS be a respondent?

MR. SCANLON: How (?) interoperability and standards fits together.

DR. LUMPKIN: Would we assume –

MR. SCANLON: Well, I don’t know. You might want to weigh in on what the
Committee’s views are on some of these things.

DR. LUMPKIN: So there may not be a Committee viewing.

MR. HOUSTON: I wasn’t sure whether it really was within our purview to
respond to an RFI or whether to give input prior to the point where the RFI was
going out the door or –

DR. LUMPKIN: Mary Jo?

MR. SCANLON: Somewhat of a chicken and egg, and it’s the same thing with
regulations. It creates a problem with –

DR. DEERING: Just to clarify, (?) set that on the table as one of the things
you might cover in our January 5th or 6th hearing, so I
guess I’ll ask the question very specifically, because we didn’t know if it
would be welcome or not. I mean, we thought it seemed like it would be.

So do you think that including testimony on the RFI as one means of
preparing the NHII Workgroup to prepare some draft positions and then to
circulate that to the full Committee –

MR. SCANLON: No –

DR. DEERING: I’m asking a process question here.

MR. SCANLON: That’s a little different. I think we generally try as a
Committee not to have hearings while we have a proposed rule or other public
comment process open.

When we did this previously on standards and privacy, it really caused a lot
of confusion. Some of the stakeholders didn’t know whether they were supposed
to write in or testify to the Committee.

I don’t think we want to have a parallel process for public comment while we
have an opened proposed rule or RFI. But I think the Committee in its own
deliberations might want to look at the RFI and see if it does want to –
are there areas on the RFI that it wants to weigh in on or not. And then
subsequently we could see.

But I don’t think it would be a good idea for this Committee to have any
public hearing during the time that the RFI or proposed rule is open. It’s very
confusing and it – I mean, it does create some doubt about that whole
– the whole rule-making process.

DR. LUMPKIN: Well, just so I understand the process of – the RFI
requests information, sort of people’s vision on how this is going to roll out.

MR. SCANLON: Right.

DR. LUMPKIN: And it’s a specific time frame to get input.

MR. SCANLON: Right.

DR. LUMPKIN: And it closes.

Now, if we were to make a recommendation to the Secretary on that, I’m not
sure that we would necessarily, because of how we’re constituted, be held to
the same time frame.

MR. SCANLON: That’s right. You’re – you have a special – you’re
not just a member of the public, obviously.

DR. LUMPKIN: I’m assuming that any recommendation, whatever we make on this
sort of thing, will be considered by the Secretary, since that’s our charge.
Given that, let’s – you know, I think we can look at the RFI and then make
a determination whether or not – when we ought to comment on this process
and it’ll be most useful.

MR. SCANLON: Yes.

DR. LUMPKIN: And we may or may not need to do something before our next
meeting.

The issue of the MPRM that may or may not come out between now and our next
meeting I think would handle those as any others and look at it and if we feel
we need to make a comment, then we can do a special phone meeting of the full
Committee, followed – following a meeting of the subcommittee that’s most
appropriate for that, Standards.

Okay, Subcommittee on Standards and Security –

Jeff?

Agenda Item: Reports from Subcommittee
and Workgroups/Item IV, Subcommittee on Standards and Security – MR.
BLAIR

MR. BLAIR: Yesterday, we received a presentation from Jonathan Teich of the
eHealth Initiative which focused on the topic of clinical decision support
requirements and standards for e-prescribing, and it was a very helpful
presentation. We didn’t get to the point where we were able to meet separately
after that to really drill down, so our subcommittee is, at this stage, trying
to digest that information that Dr. Teich shared with us so that we could
update and refine our agenda for our subcommittee meeting December
8th, 9th and 10th.

John Paul, did you want to add anything in terms of the discussion on
security?

MR. HOUSTON: On which?

MR. BLAIR: That we had yesterday in our breakout.

MR. HOUSTON: Oh, you’re talking about the meeting – the testimony in
two weeks. Is that what you were –

MR. BLAIR: Yes. Did you want to add anything?

MR. HOUSTON: That’s – actually, we discussed that in Privacy this
morning, too. Mark, did you

want to discuss this?

MR. ROTHSTEIN: No, go ahead.

MR. HOUSTON: In two weeks time, we’re going to have testimony with regards
to issues with the HIPAA security rule and medical equipment, and at this point
in time we’re hoping to have six testifiers and in two separate panels in the
morning of that Friday; I guess it would be in exactly two weeks’ time.

The only issues – it’s been very difficult in getting this one
together. I don’t know why we’ve had trouble trying to get testifiers together
but it’s been sort of an issue.

MR. SCANLON: It’s security or privacy?

MR. ROTHSTEIN: It’s security. We’ve sort of jointly – it sort of falls
in the middle.

We were asked to spread our jurisdictions.

MR. SCANLON: So it’s really – it’s related to the HIPAA security rule,
so we’ve been using the Privacy Committee in conjunction with the Security
Committee.

DR. LUMPKIN: We got nothing else to do!

Okay, that is any other member of the Committee or staff that wanted to add
anything on the Subcommittee on Standards and Security? Okay. Privacy and
Confidentiality.

Agenda Item: Reports from Subcommittee and
Workgroups/Item V, Subcommittee on Privacy & Confidentiality – MR.
ROTHSTEIN

MR. ROTHSTEIN: Thank you. The subcommittee met this morning to clarify the
steps that we’re going to be taking in the next several months. We’re getting
ready to undertake a very extensive period of hearings and work over the next
several months.

Let me just very briefly go through the first three main hearings that we’re
going to have.

As John just mentioned, in two weeks we’re going to have a day and a half
hearing; the second half-day will be on the security issues, as he described.
The first day will be on privacy issues in e-prescribing.

We have another hearing scheduled for January 11th and
12th, at which time we’re going to consider a variety of issues that
have been sort of on our agenda, but we’re going to sort of put them all
together for very diverse hearings. We’re going to have one day on radio
frequency ID chips, a half a day on decedent and archival health information,
and a half-day on the limits on disclosure of PHI to third parties via
compelled authorizations.

DR. LUMPKIN: Cool!

MR. ROTHSTEIN: So as you can see, it’s a wide-ranging discussion.

We’re also planning to hold a – our initial two days of hearings on
privacy and confidentiality issues in NHII, especially the concept of patient
control over the electronic health record which is a very important issue.

So that’s our schedule through February, at least.

In terms of our work products, we’re not sure when we’re going to have our
recommendations on e-prescribing, whether it’s – whether we’re going to be
able to have it for March or June. In two weeks, when we have our hearing,
it’ll be clearer whether we need additional hearings on e-prescribing or
whether we feel we have enough to go forward.

DR. LUMPKIN: So we can cover that on our executive subcommittee conference
call on looking at how those things are going to play out on our meeting
agenda.

MR. ROTHSTEIN: Right.

DR. LUMPKIN: Marjorie?

MS. GREENBERG: I may have missed this, but when did you say you were going
to have the hearing on NHII issues and in particular the patient –

DR. LUMPKIN: February.

MR. ROTHSTEIN: In February. We’re trying to work out dates now that gel with
everyone’s schedule.

DR. LUMPKIN: Sounds like a neat agenda. What’s the dates for the hearings,
the smorgasbord thing?

MR. ROTHSTEIN: Oh, that’s January 11th and 12th. So
the three items on there would be RFID, decedent and archival health
information, and compelled authorizations.

MR. BLAIR: Those January hearings back up to the SSS hearings so that I
think there’ll be quite a bit of cross-participation.

DR. LUMPKIN: Okay.

MR. BLAIR: It’s certainly fascinating.

DR. LUMPKIN: Thank you. Subcommittee on Populations?

Agenda Item: Reports from Subcommittee
and Workgroups/Item VI, Subcommittee on Populations – DR. MAYS

DR. MAYS: We’ll start with the report because since we discussed yesterday
kind of the outline of the report, the goal still is to get that, even with the
comments made yesterday or additions, that we will still work on the goal of
getting that to us for the March meeting.

But because it’ll be long, what we’ll try and do – we were just having
a discussion yesterday with (?) – what we’ll try and do is to get the
strategy section out. Where’s the – you know, Simon’s not here,
‘cause Simon says, let’s (?) the recommendations.

So we want to try and get that part out first, so

we’re going to kind of switch the order in which we’re doing things, work on
that, get that cleaned up and get that out, because I think that the
presentation kind of gave people enough background that now they can actually
just go directly to the overarching recommendations and the strategies that go
along with that.

So I think we’ll do that a little differently, based on yesterday’s
presentation. And thanks for the feedback. I thought that what people added
really will make it a usable kind of report.

The other issue we want to talk a little bit about and bring the full
Committee up to date is kind of our ad hoc group on mental health statistics.
We really are moving forth on that.

One of the things I wanted to share, and to see if the full Committee wants
to get a copy, is that typically NCHS sends the full Committee of Health U.S.
for comment. We’re told that there is Mental Health U.S. which I was – I
mean, I was really surprised, ‘cause for all the research and stuff that I
do, I had no idea.

But they’re currently working on Mental Health U.S. 2004 and it’s in draft
form, and so Ron is more than willing to send that to the entire – either
just us or to the entire group, so, you know – okay, so we’ll have him
send it to the entire group for comments. And I think that’s the kind of thing
that actually will help us to get back on track with the mental health
statistics.

So part of what is slowing us down is that we actually need some people from
some of the other agencies, and I think that (?) Kennedy did a great job of
sending out a couple of emails so that Ron is, you know, going to interact with
us in terms of revision of materials, etc.

I think that we pulled the old report; I think we’re on our way to having a
little charge for that group and that the goal – I mean, the product that
we’re looking at is to get some kind of determination of what are the mental
health statistics that we want to be collected on an ongoing basis, and also to
try and, within HHS, bring mental health together in some places. They’re
typically reported on separately and there’s not a benefit of each informing
the other, so I think that that’ll be the goal.

So, you know, we’ll have a more detailed plan, Don and I – Don, who’s
taking the lead on that, Don and I will talk and, you know, we’ll come back
with more of a plan a little bit later.

The quality – we have some overlap with the Quality Workgroup, and I
think Quality should probably bring that up, but I do want to talk about –
we did have a – as part of our meeting yesterday, we asked Mark to come in
‘cause we had a lot of concerns about some privacy and confidentially
issues.

Typically for Populations, one of the things that we hear almost in every
hearing is that for some of the small groups like API populations,
subpopulations of Latinos, is that the data is not accessible. Typically, the
data’s not accessible because of privacy and confidentiality and there’s just
not a lot of data centers, remote sites – remote methods for accessing the
data.

So part of what Populations thought would be a big asset is that if there’s
anything that we can do about understanding policies, procedures and
regulations to determine whether or not there’s any recommendations that we
might be able to make that would make this data more accessible, that we would
have made a pretty good contribution.

But it turns out is that they’re all over the map. It’s like NIH has kind of
its set of regulations and NCHS has its set of regulations.

And part of what we want to actually request from Jim’s office, or, you
know, here, is that let’s see if we could get a contract where we could get
someone to sit down and really pull together all of the policies, procedures
and regulations concerning the release and sharing of data, and then we would
be able to look at those and see what our next steps would be.

And then I think at that point Privacy has agreed that once we’ve had a
chance to pull that all together, make some sense of it, that we would consult
with them again. And Mark said that he would consult with us on what questions
to give to the contractor. So, if that’s possible, we’d actually like to make a
request to be able to do that.

MR. SCANLON: That sounds like a good thing.

DR. LUMPKIN: Are you also going to look in methodologies for cell size, that
sort of thing, or –

DR. MAYS: No, I don’t think we were going to do that. That’s – as he
says, we’re going to do it sometimes. I think what the contractor would do
–

DR. LUMPKIN: Okay.

DR. MAYS: — that the group – I mean, we would – but in the
specific contract what we really want to focus on first is just getting the
policies, procedures and regulation for all the different groups that typically
manage data that we would want to get access to.

Now, we can – the other thing came up, and, I mean, we don’t want to
get in a big discussion about it, but that is also not only thinking about this
for surveys but also thinking about this relative to kind of more
clinical/administrative data. So we’ll discuss that in more detail, I think,
with Jim as we think about formulating the contract.

MR. SCANLON: ‘Cause, actually, I mean, we – if I could, it’s a
very good idea. We actually talked about this in the Data Council last year and
we just didn’t – we had some other projects we had to do.

But several of our agencies have research data centers, as you know, and the
Census Bureau has them as well, and we actually – for example, and the
National Center for Health Statistics has one; ARHQ has one and CMS has one,
and then the Census Bureau has one. And they’re – to some extent, they’re
governed largely by the confidentiality policies and practices of that agency
and what you can actually get or not get.

But we actually looked at, previously in HHS, should we think about having
one, and we were going to do some policy analysis there, but the
confidentiality statutes probably wouldn’t make that work all that well. So I
think this would be a nice – you’re thinking of the Data Center kind of an
idea where you can come on line, you can get access to the data or you can
request a table or something like that. We’d be happy with that.

DR. LUMPKIN: I would just suggest that as you’re tasking the contractor to
think about the cell size issue.

That was a big one for us when I was in Illinois in trying to release data,
particularly in smaller counties where there were just a very small number of
minorities. The cell size limitation is what really prevented us from releasing
data more so than not wanting to release data that was of use to minorities.

MR. SCANLON: It’s tough in confidentiality. Many liability investments.

MR. ROTHSTEIN: Well it may be that the particular rules of each of the
agencies that they’re going to check are keyed to cell size in certain
respects, so we’ll need to get that information.

MR. SCANLON: Yes.

DR. MAYS: And I think the other thing we’ll also look at is some of the
methodologies where even when you have small cell sizes that – you know,
technology is great. There’s a lot of different things in that. We’re just
wondering whether or not that’s all catching up with, you know, these policies
and procedures that really allow you to display data and do some, you know
–

MR. SCANLON: There are all sorts of things you can do to expand the cell or
to top code.

DR. MAYS: Exactly.

MR. SCANLON: I think the real problem is just the small numbers –

DR. MAYS: Yes.

MR. SCANLON: — but I think that would be worth looking at.

DR. LUMPKIN: Marjorie?

MS. GREENBERG: Just because we won’t be meeting again till March, I think
the way we left it yesterday – as you said – I said, well, I think
this is something we could do but, you know, we need to talk with Jim Scanlon.
So now Jim seems to be supportive of the idea. And I wondered, if you wanted to
try to get this – if this needs more discussion in the subcommittees or if
this is something you wanted to get started before the March meeting and if
–

DR. MAYS: Oh, yes, I think –

MS. GREENBERG: Okay. If so, then is there a staff person who will work with
Jim’s office? We need a way to take this forward, to sort of scope it out and
probably we would use a task order contract.

MR. SCANLON: Task order. We even have a – depending on the scope of
– we have other mechanisms, too. We can sort of issue tasks on a quick
turn around basis to one of our contractors, depending on the size and scope,
obviously. And then we have other contractors or individual consultants.

DR. MAYS: I was just going to say, I think the thing to do is for a couple
of us to have a conference call.

MS. GREENBERG: Conference call with Jim?

DR. MAYS: Yes, exactly.

MR. SCANLON: Yes, you can – we’ll set one.

DR. MAYS: And I think it sounds like there was some beginnings in Data
Council, so let’s build on that and come up with something –

MR. SCANLON: And along these, all these around the – yes.

DR. MAYS: — that satisfies both of us, yes.

MR. SCANLON: They’re on the HHS statistical gateway on the Web and they sort
of – you can actually see where you can get publications, where you can
create your own tables, where you can – where you need to contact the Data
Center. So we have a good start, and might even use the same contractor.

DR. MAYS: Okay. I think that would work.

MS. GREENBERG: All right. So there’ll be a conference call for the full
subcommittee or for a subset of the subcommittee?

DR. MAYS: Subset.

MR. SCANLON: Subset.

MS. GREENBERG: And let’s make sure that we have a staff person identified to
work on this so we can take it forward.

DR. MAYS: We can all smile on that one.

Okay, we’ll make sure. We’ll be on the phone; we’ll make sure. We’ll work
with you.

The other thing, we had a meeting on October 26, and in that meeting we had
an update from NICHD on a National Children’s Study. The person that came was
Sarah Knox.

And so we wrote a letter which actually just is kind of a thank you to Duane
Alexander because we have – remember in your packet we have the response
from Duane Alexander, and in that we just talked about, you know, thanked him
for having Sarah talk about what Sarah covered and then the issues that we both
were concerned about.

One of the things that came up is their concern about some of the privacy
and confidentiality issues in terms of small sample size et cetera. They even
indicated that as we discussed issues of this nature as well as kind of some of
the population-based issues that we both have as areas of concern, they would
like to be invited to participate; if there’s a hearing on any of these issues,
you know, they’d like to know so that they can actually insert some questions.

So we have a letter – it’s one page. I don’t know quite how we can deal
with it, whether I can read it and see if we can get agreement on a thank you
letter, or what? I have copies.

MS. GREENBERG: It’s a letter from the subcommittee?

DR. MAYS: No, that was a question I had —

MR. SCANLON: That’s the question we had.

DR. MAYS: — and I think you maybe need to see it. But it’s like the
original letter that went to Duane Alexander who’s –

MR. SCANLON: Right.

DR. MAYS: It’s the – we’re not sending it to the Secretary; we’re
sending it to Duane Alexander, who is the Director for NICHD –

MS. GREENBERG: Yes.

MR. SCANLON: Yes.

DR. MAYS: — under which the National Children’s Study was –

MS. GREENBERG: That’s when the original letter was sent out.

DR. MAYS: Exactly.

MR. SCANLON: That’s right.

DR. MAYS: But John did sign the original letter, so –

MS. GREENBERG: And now this new letter is –

MR. SCANLON: It just says thank you for coming?

DR. MAYS: It says – you want me to read it?

MR. SCANLON: Why don’t you read it?

DR. LUMPKIN: Do you want to see it?

DR. MAYS: Yes, pass it around. There’s probably enough – just pass it
down. Thank you. And I’ll read it and then you can determine –

MR. SCANLON: Okay – yes.

DR. MAYS: “Dear Dr. Alexander” – it needs to be proofed but
– “the Subcommittee on Populations of the National Committee on Vital
and Health Statistics would like to thank you for your response to our letter
of February 29th, 2004.

“Since it is the charge of the National Committee on Vital and Health
Statistics to advise the Secretary on health statistics and data issues”
– should be a comma there – well, we won’t – I mean, we can
clean up these later –

MR. SCANLON: Right.

DR. MAYS: “. . . the scope and magnitude of the proposed longitudinal
study would be a significant resource on health statistics and hence our
ongoing interest in this study. The Subcommittee was aware that since the
initial presentation of Dr. Scheidt, a number of workshops, meeting and white
papers were commissioned on several of the areas of interest expressed in our
initial letter.

“In response to a desire for greatest specificity on the progress made
since our letter and your response of September 3rd, we worked
through our NCVHS-NIH liaison to arrange a presentation about NCS. Dr. Virginia
Cain, who serves in this role, was able to schedule Dr. Sarah Knox to update
the Committee on the status of the National Children’s Study. Dr. Knox was
available to meet with the Subcommittee on Populations at our October 26
meeting. She gave an impressive presentation, covering with ease of expertise
updates on the topics of genetics, measurement, methodology, privacy and
confidentiality, accessibility of data, ethics and a collection of data on race
and ethnicity. What the Subcommittee most appreciated was Dr.

Knox’s openness and willingness to entertain strategies that might enhance
or improve these topics to enhance population health, particularly for racial
and ethnic minority populations” – little bit too many
“populations,” but anyway –

“We have offered our assistance in providing input for the Committee
and where feasible, through our hearing process.

“We left Dr. Knox with a number of areas that in our role in advising
the Secretary for a study of this magnitude we would hope would be addressed.
These include:

“1. The importance of place in the form of geocoding should be a part
of the study.

“Sensitivity and creative solutions to the culture” – should
be “cultural” – “to the cultural and religious belief
systems of racial and ethnic minorities regarding the collection and storage of
biologic samples.

“3. Insure the data be made broadly available, easily accessible, and
cost effective for use by national as well to local community entities.”

And “4. insure that local communities where the research is conducted
will be fully integrated collaborative partners.

“The Subcommittee was pleased to see that the National Child Study is
as committed as the Subcommittee to insuring that careful thought is given to
the adoption of empirically based best practices that can insure quality data.

“It is our concern that an endeavor of this magnitude insures that
there is adequate participation of large enough numbers of racial and ethnic
minority for multi-varied level analysis on health issues that have been
identified as high priority in the NIH plan for the reduction of health
disparities.

“Equally as important for the Subcommittee is that a plan is being
developed to insure accessibility of the data on both the local and national
levels. Dr. Knox assured us that NCS is currently working on these issues. We
look forward to continual updates from NCS and assisting where feasible.”

So it needs some little cleaning up in terms of structure but that’s the
content. So we didn’t know what level that needs to be –

DR. LUMPKIN: Okay, so Vickie moves that we send this letter with editorial
license to be approved by the Chair.

PARTICIPANT: Second.

DR. LUMPKIN: So moved, and seconded. Is there discussion? Marjorie?

MS. GREENBERG: I’m sorry I wasn’t able to – I guess maybe I had left
before this was discussed, came upstairs. But some of these are – are some
of these new recommendations?

DR. MAYS: Are you saying new recommendations?

MS. GREENBERG: I mean, different than recommendations – some of them
sounded quite familiar to the recommendations that were made in the original
letter and seem to be sort of reemphasizing –

DR. MAYS: These were things that were discussed with Sarah as to – I
mean, they – well, I mean, I can tell you what the recommendations were in
the old letter, but what these are things that we discussed with her that she
would continue to update us on and that she is looking into and that we’re
concerned about.

So it’s – do you want me to give you – let’s see if I have the
letter for the –

MS. GREENBERG: It’s just that typically actual recommendations do not come
from a subcommittee. I mean – and this is a little –

MR. SCANLON: Can I make a suggestion? This is sort of confirming
conversation from a meeting –

MS. GREENBERG: But see, that’s what I said. It seems that it’s just sort of
confirming some of the earlier recommendations and some updates on them. It’s
just that they’re sort of – like I’m not sure about this one on geocoding
–

MR. BLAIR: Marjorie, does it make a difference that it is not addressed to
the Secretary?

MS. GREENBERG: No.

MR. SCANLON: No – no.

MS. GREENBERG: It doesn’t make a difference to whom it’s addressed to.

DR. MAYS: Okay, here’s the old recommendations that we had.

MS. GREENBERG: Yes, it’s under Tab 11.

DR. MAYS: “Use a population health approach to insure the adequate
distribution of the sample study participants across race, ethnicity,
geographic context and socio-economic characteristics.

“Use a population health approach to insure that the sample size is
sufficient for analysis of causal relationships particularly for the four
hypotheses for all subpopulations of interest.

“Identify and examine causal relationships that include behavioral,
social and economic factors as they interact with biology and the environment.

“Develop a plan for public data use that is timely and allows for broad
access.”

So the only thing that I think may be different is the very specific comment
about the biologic samples that were discussed, ‘cause we know that
particularly for American Indians, that’s an issue as to what happens with
samples residing after death.

But the others – and, you know, we can pull that out – are –
they’re part and parcel of the original recommendations.

DR. LUMPKIN: Now, the way I understood your motion was that this would then
goes from the full committee and we would just need to do a little editing to
sort of clarify that a couple places where it’s appropriate to have
“subcommittee” in there and other places where we would say
“full Committee.”

DR. MAYS: Okay, yes. That was my – that was the intent of my motion.

MR. SCANLON: Yes, I think it’s substantive enough so that it has to be a
full Committee.

DR. MAYS: Oh, okay. That’s where we –

MR. SCANLON: As long as the full Committee – that’s why you’re looking
at it –

DR. LUMPKIN: Right. Other comments? Okay, we have a motion that we would
send this letter, that there would be editing which would be reviewed by the
Chair to assume that it’s not content as we’ve done before, and that based upon
that, it would then be sent to Dr. Alexander. It’s been moved and seconded. Is
there further discussion?

All those in favor, say “aye.”

COMMITTEE: Aye.

DR. LUMPKIN: Opposed, say “nay.”

(No response.)

DR. LUMPKIN: Okay.

DR. MAYS: Thank you.

DR. LUMPKIN: Thank you. Bob?

Agenda Item: Reports from Subcommittee
and Workgroups/Item VII, Workgroup on Quality – MR. HUNGATE
(continued)

MR. HUNGATE: You’ve already dealt with the letter, which was the first thing
we addressed this morning. The second was the discussion with Vickie joining
us, which is a follow-on for the discussion that took place yesterday with
Populations around the use of administrative data by plans and in collections
of race and ethnicity data.

We concluded that we needed a little more specificity in addressing the
questions we wanted to answer, more structure to what we were doing, and
Justine has done some initial work, sort of grid work, for that, which will be
amplified by further work by Anna in a staff way to put this all in context,
and then that will be a document that we’ll share back and forth and go
forward.

That basically consumed our time, so we did not get to the discussion of
functional status as the next area for us to address. That will occur later.

The other element that’s kind of hanging business was that at the end of our
last hearing, we talked about the wish to hear back probably from the Data
Council of the reaction to the Committee’s recommendation on adoption of
ICD-10-CM. But I think it’s almost a year since we made that recommendation,
and I don’t think we’ve got any indications back.

This came up as a question in testimony, saying people are uncertain whether
we’re going to go there or not and it’s holding up development, and so there is
a sense of urgency toward knowing what the direction of the Department is. It
seemed to me we ought to reflect that here.

MR. SCANLON: Yes, it’s clearly under discussion. I might – Bob, on the
first issue you raised about health plan –

MR. HUNGATE: Yes.

MR. SCANLON: — as part of the National Academy of Sciences study that HHS
sponsored at the – looking at the adequacy of data for health and human
services, a workshop was conducted that brought in plans and others and looked
at some of the barriers and perceptions and so I can make that workshop report
available.

MR. HUNGATE: That would be helpful.

MR. SCANLON: But in addition you may want to

have some of the folks who did commission papers; they were from health
plans as well, so they could actually share that information with you.

MR. HUNGATE: The other thing I –

MR. SCANLON: Very realistic view, you know. It pointed out some real
concerns about liability issues and other things. It’s a very realistic kind of
view of how the plans see it.

MR. HUNGATE: In the context of our discussion of that subject, also we
allowed as how there’s a lot of things going on that we need to tap into and
watch for, and so it was our feeling that we were probably looking toward a
hearing maybe a year from now around this subject so that we’ve got time to add
that information into the database as we go.

But there was a wish to ask for a report back at, say, the March meeting, on
the status of the ICD-10-CM recommendation. I don’t know whether that’s recent
or not –

MR. SCANLON: Oh, we’ll try to arrange something, yes. I think –

DR. LUMPKIN: Okay.

MR. SCANLON: — it’s certainly been deliberated over.

[Laughter.]

MR. SCANLON: The other – you know, I might as well – you know, the
– there are a lot of proposals from various places to issue standards and
requirements and all sorts of things on the health industry and the research
and public health community and one reason the Commission on Systemic
Interoperability was created in law was to kind of look at all of these things
and sort them out. Harry, you’re a health plan; you have to actually do all
these things.

And I think – so there will be other groups that will be looking at:
Well, how do these things all fit together? Once things become HIPAA standards
that are required. CHI standards in – you know, are required at least in
our federal programs. So I think there’s an issue of how does this all fit
together, how does it move us all forward in a systematic way towards one
framework, and what is the timing on it?

And it’s probably a good development that we will see some sort of
scheduling time wise.

MR. HUNGATE: That’s pretty – thank you.

DR. LUMPKIN: Thank you. Future meetings?

Agenda Item: Future Agendas for NCVHS
Meetings – DR. LUMPKIN

DR. LUMPKIN: The schedule for next year is listed in the agenda. We probably
don’t know enough about

what items – I think we get some hint of the action items, but
obviously we’ll need to have a executive subcommittee I’m guessing January.

MS. GREENBERG: What, a call?

DR. LUMPKIN: A call.

MS. GREENBERG: Not by the end of the year, but January?

DR. LUMPKIN: Well, January is like right after the end of the year.

MS. GREENBERG: Yes, correct!

[Laughter.]

PARTICIPANT: No, it’s like the beginning of the year.

MS. GREENBERG: Well, I – do you want to know what I have here so far?

DR. LUMPKIN: Sure.

MS. GREENBERG: Okay. This is for the – first of all, I want to thank
everyone who worked on putting together this meeting and in particular Debbie
Jackson because we actually have had several things on our plate here that we
did end up – you know, we did get presentations that we had carried over
from September in some cases, others, and we did have a number of nice
presentations, and thank you to Debbie and Jim for facilitating those.

Okay. For March, the Board of Scientific Counselors will have met in January
so we will have another report as we did yesterday from Algona and liaison.
Yes?

DR. MAYS: Is there anything we can do to deal with the scheduling?

MS. GREENBERG: What scheduling?

DR. MAYS: Well, we’re going to have a joint meeting with them and, I mean,
none of that stuff is scheduled, and –

MS. GREENBERG: Well, that’s something we – I put down for the executive
subcommittee conference call. One of –

DR. MAYS: Okay.

MS. GREENBERG: — the things we need to talk about is how to proceed on that
joint –

DR. MAYS: Okay.

MS. GREENBERG: We talked about having a joint meeting in 2005 of the two
executive committees, and the Board is now organizing in some groups so
probably some kind of a natural group is evolving that would be – they
don’t actually have an executive committee at the moment, I don’t think, but
– so that’s something I thought we could discuss at our conference call.

And Algona is a representative to the – liaison to the executive
subcommittee.

The Annual Report – we will not actually have a draft in March. That
will be – we’ll be reviewing drafts in between the March and June meeting,
but we will have pulled together all these research ideas that – or
recommendations, and probably we’ll include that at least in the book; we might
have some little discussion on it.

We are expecting potentially some significant e-prescribing recommendations
– is that true, Jim?

MR. SCANLON: Yes.

MS. GREENBERG: In March – at the March meeting which –

MR. SCANLON: There’s a second round, and how significant they are, I guess
–

MS. GREENBERG: Yes.

MR. SCANLON: — we’ll see.

[Laughter.]

MS. GREENBERG: Well – we don’t – may or may not have ones related
to privacy, you said, and I think we’ll probably need to leave – if we do
have – I mean, if I recall, a lot of the harder issues we said we’d make
recommendations in March. I mean, the ones where there was not as much
consensus and –

MR. SCANLON: Yes.

MS. GREENBERG: — information, so we probably would have to leave a fair
amount of time on the agenda to

discuss those, depending –

MR. SCANLON: Depending –

DR. LUMPKIN: Yes, that’s right.

MR. SCANLON: I mean, if we have those and privacy recommendations, we may
not have as much time for presentations.

MS. GREENBERG: Right. That’s what I was thinking.

But we also are expecting the Populations Report.

So I would say – and did we just agree that we would ask for an update
on the status of the Committee’s recommendations on ICD-10-CM and –

MR. SCANLON: Yes, we’ll –

MS. GREENBERG: Okay. There are some – a few – well, in March, Dr.
Sondik is scheduled to give his annual update on NCHS, which would go well with
the BSC report.

We have – we’re still carrying over some recommendations related to
geocoding and possibly issues related to functional status et cetera.

But it seems to me what we’re talking about here is major recommendations
coming forward. I don’t think we need to worry right now about outside
presentations unless there’s something – and it’s really a bit far to plan
those, in any event. Maybe by the time of the January meeting or a conference
call we’ll have a better idea.

Well, if anyone wants to put anything on the table, although I realize that
stands between you and making your earlier flight –[laughs] – this is
the time to do so. Okay.

DR. LUMPKIN: Okay? Anything else on the meeting?

Agenda Item: Appreciation to Jackie
Adler

I have one other agenda item. As much as it – as it pains me to raise
this issue, as you know, this is Jackie’s last meeting with us as a full
Committee, and it pains her even more than me because she obviously would have
preferred that I didn’t say anything, but I could not have said anything
anyway.

We’re going to miss you.

[Applause.]

MS. GREENBERG: We did agree yesterday that the Committee approved a letter
from you –

DR. LUMPKIN: Yes.

MS. GREENBERG: — commending Jackie for her many years of service to the
Committee. And you think you’re going to miss her – think how much we are
going to miss her back at NCHS!

DR. LUMPKIN: The agenda having been completed, I think we stand adjourned.

[Whereupon, the Committee meeting adjourned at 1:07 p.m.]