[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Full Committee Meeting

September 17, 2008

Hubert Humphrey Building
200 Independence Avenue SW, Room 505A
Washington, DC

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

Table of Contents

P R O C E E D I N G S (10:00 a.m.)

AGENDA ITEM: Call to Order, Welcome

MR. REYNOLDS: Are we on the internet, sir? Okay, good morning.

I’d like to call this meeting to order.

This is the second of two days of meetings of the National Committee on
Vital and Health Statistics. The National Committee is the main public advisory
committee to HHS on national health information policy.

I am Harry Reynolds, I work at Blue Cross and Blue Shield North Carolina,
and Chair of the Committee.

I want to welcome Committee members, HHS staff, and others here in person.
I’d also like to welcome those listening in on the internet.

I’d like to remind everyone as we start the meeting today to speak clearly
and into the microphone.

Let’s now have introductions around the table and then around the room.

For those on the National Committee I would ask if you have any conflicts of
interest related to any issues coming before us today, would you please so
publically indicate during your introduction. And I have no conflicts. Jim?

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

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

MR. BLAIR: Jeff Blair, Lovelace Clinic Foundation, member of the Full
Committee. No conflicts.

DR. STEINDEL: Steve Steindel, Center for Disease Control and Prevention,
Liaison to the Committee.

DR. FERRER: Jorge Ferrer.

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

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

MR. LAND: Garland Land, National Association for Public Health Statistics
and Information Systems, a member of the Committee, no conflicts.

DR. OVERHAGE: Marc Overhage, Regenstrief Institute, and Indiana Health
Information Exchange, a member of the Committee, and no conflicts.

DR. HORNBROOK: Mark Hornbrook, Kaiser Permanente Northwest, member of the
Committee, no conflicts.

DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of
the Committee, no conflicts.

DR. LEPKOWSKI: Jim Lepkowski, University of Michigan, Liaison to the NCHS
Board of Scientific Counselors.

DR. MIDDLETON: Blackford Middleton, Partners Healthcare, member of the
Committee, no conflicts.

MS. MILAM: Sallie Milam, West Virginia Health Information Network, no
conflicts.

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

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

MS. MCCALL: In his subconscious there are many. Carol McCall, Humana, member
of the Committee, no conflicts.

DR. WILLIAM SCANLON: Will Scanlon, Health Policy R and D, member of the
Committee, no conflicts.

DR. CARR: Justine Carr, Caritas Christi Healthcare System, member of the
Committee, and no conflicts.

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics,
CDC, and Executive Secretary to the Committee.

MR. SORACE: Jim Sorace.

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

MS. CHAPPER: Amy Chapper, CMS.

MS. JAMISON: Missy Jamison, National Center for Health Statistics, CDC.

MS. JOHNSON: Angela Johnson, American Osteopathic Association.

MR. BIRNBAUM: Adam Birnbaum, Blue Cross Blue Shield Association.

MS. DWYER: Sheila Dwyer, American Optometric Association.

MS. BICKFORD: Carol Bickford, American Nurses Association.

MS. CASH: Amanda Cash, Health Resources and Services Administration.

MR. KYLE: Frank Kyle, American Dental Association.

MS. VIOLA: Allison Viola, American Health Information Management
Association.

MR. REYNOLDS: Quickly going through the agenda for today.

First thing we’ll hear is a letter from Standards that we talked about
yesterday, and I know they did significant work on.

Next, we’re going to have readout from each of the subcommittees on the
preparation for our Executive Subcommittee Strategic Plannings, so they’ll
cover the things that we’ve done over the last couple breakouts.

Then we’ll have the update on the BSCS, Board of Scientific Commissioners,
by Dr. Scanlon.

Marjorie and Debbie will update us on how we’re doing with the
60th Anniversary.

Wrap-up and close, and then that will join the Plenary for today.

And then the Executive Subcommittee will have a brief meeting this
afternoon.

So with that, unless there are any changes, Judy? When Judy starts talking
look at the tension on her face, technology is not always your friend.

[General laughter.]

DR. WARREN: We had the best laid plans of mice and men.

MR. REYNOLDS: You need a microphone, Judy.

Agenda Item: Letter from Standards

DR. WARREN: We had the best laid plans of mice and men, and then the
internet went down last night. So we’ve been scrambling to reconstruct the
letter that we labored over yesterday.

Our committee met and took all of the –

How would you like me to do this, Harry, start at the beginning and just
look at the changes?

MR. REYNOLDS: Yes, we need to, we sure do.

DR. WARREN: So the first paragraph, the National Committee on Vital and
Health Statistics, NCVHS, is directed by the Medicare Prescription Drug
Improvement and Modernization Act of 2003, MMA, to develop recommendations for
uniform standards to enable electronic prescribing, e-prescribing, and
ambulatory care. This letter will constitute our comments relative to the
Department of Justice, DOJ, Notice of Proposed Rulemaking, NPRM, regarding Drug
Enforcement Administration’s, DEA, intent to revise its regulations to provide
practitioners with the option of writing prescriptions electronically for
controlled substances.

There are no changes from yesterday.

MR. REYNOLDS: Please continue.

DR. WARREN: Prescription writing is a critical factor in patient care and
patient safety. The National Association of Chain Drug Stores, NACDS, estimated
that in 2006, 3.4 billion prescriptions were written with another 2 billion
refills and renewals processed, amounting to $249 billion spent on prescription
drugs.

Of these, it is estimated that 11 percent, or 374 million prescriptions for
controlled substances, are written each year. There were no changes in that
paragraph.

MR. REYNOLDS: Please continue.

DR. WARREN: Time and again the healthcare industry has stated through both
NCVHS testimony and discussions in public forums that the inability to
electronically prescribe controlled substances is a major barrier to overall
e-prescribing adoption by providers.

On March 2005, the NCVHS made recommendations to you specifically addressing
the need to include controlled substances along with other drugs and
e-prescribing (see attached letter). The Subcommittee had a lot of discussion
on this in being cognizant of the comments that came out yesterday that there’s
a great deal of information in that letter. Rather than trying to summarize it
in this one, we would just attach the letter so that people could go and look
at each of the points.

So that was our solution to that problem.

Any comments about that?

MR. REYNOLDS: Any comments? Mark?

DR. HORNBROOK: This is a minor thing, but those of you who have electronic
medical records recognize the difference between physician orders and
medication dispensing. In fact, the gap can be quite substantial.

DR. WARREN: All of that is covered in the original letter; the entire cycle
of e-prescribing is covered.

DR. HORNBROOK: Okay, thank you, great.

DR. WARREN: That was one of the main reasons we decided to attach the
letter, because we couldn’t figure in a short one or two page cover letter how
to put all that in again.

MR. REYNOLDS: Please continue, Judy.

DR. WARREN: In that letter we acknowledged that controlled substances are
medications that have the potential to cause addiction, be abused by certain
individuals, and be acquired illegally, and the U.S. Department of Justice,
DOJ, Drug Enforcement Administration, DEA, has regulatory authority over the
prescribing and dispensing of controlled substances.

There was no change in that.

Here I’ve left in so you can see both in your letter and also on the screen
where our changes did come in. Most importantly in the testimony leading to our
March 2005 recommendations, e-prescribing networks, software developers,
providers, standard development organizations, and prescription transaction
standards developers, all expressed concern regarding potential DEA security
requirements and authentication, specifically the use of Public Key
Infrastructure, or PKI, a framework of policies, protocols, and digital
signature technology in e-prescribing.

Testifiers concluded that PKI would impose significant additional costs for
e-prescribing networks which are struggling to establish an adequate business
case for their services, and delay the adoption – excuse me, I left out
the word “and” – delay the adoption of the use of e-prescribing
as the result of the cost and burden to install and maintain PKI.

Notice that we deleted two of the bullets that had been there previously.

Any comments at this point?

MR. REYNOLDS: Please continue.

MS. MILAM: You need to take out the “and.”

DR. WARREN: The “and” and the bullets are misplaced, we’ll handle
that.

MR. REYNOLDS: Bill?

DR. WILLIAM SCANLON: I’m the incredible cold reader on this, not really
knowing the details of what’s been happening. So the question is potential DEA
security requirements and authentication. Were these things that DEA had in
some ways proposed?

DR. WARREN: Oh, yes. And that’s why we’re making –

DR. WILLIAM SCANLON: So this is not in the abstract. There are two ways to
read that. The testifiers are coming in and they’re giving you testimony about
things that might be considered.

DR. WARREN: No. What we’re summarizing is we took testimony. There was
concern at the time when we heard testimony that DEA would be requiring various
security measures. At that point in time no one knew what they were.

DR. WILLIAM SCANLON: So it is that there’s not a DEA proposal out there when
you were taking testimony?

DR. WARREN: Right.

DR. WILLIAM SCANLON: Okay, thank you.

MS. GREENBERG: I thought it was – did DEA themselves come? I thought
somebody came.

DR. WARREN: DEA came and gave testimony, but they did not propose specific
security requirements, that they were still looking.

MS. GREENBERG: They didn’t support PKI or try to make a case for it?

DR. WARREN: That was one of the technologies they were looking at.

Jeff and Steve, do you want to add any more to that?

MR. BLAIR: Your statement is accurate.

MR. REYNOLDS: Yes, it is correct.

MS. GREENBERG: So it was one of the ones they were looking at. So I think
potential is good.

MR. BLAIR: Where would potential be added?

MS. GREENBERG: It’s already there, regarding potential. It’s added in right
here.

MR. BLAIR: Oh, I see, okay.

MR. REYNOLDS: Judy, continue please.

DR. WARREN: At that time the NCVHS recommended that HHS and DEA work
together to reconcile different agency mission requirements in a manner that
will address DEA needs for adequate security of prescriptions for all
controlled substances without seriously impairing the growth of e-prescribing
in support of patient safety as mandated by MMA.

Finally, we stated the need for HHS to evaluate emerging technologies such
as biometrics, digital signatures, and PKI, for higher assurance
authentication, message integrity, and non-repudiation in a research agenda for
e-prescribing and all other aspects of health information technology.

So we took out the word “repeated” because people didn’t like
that, and I realize there’s two D’s there, we’ll take care of that.

MR. REYNOLDS: John?

MR. HOUSTON: I’m a little confused. I guess if you look at the top of the
paragraph, most importantly you talk about PKI and some of the –

DR. WARREN: Excuse me, John, there should be a new paragraph that starts at
that time. Remember I was merging an email and two versions of the letter to
get this copy.

MR. HOUSTON: My point and concern is we’re all over the map with regards to
PKI, because at the top of the page at least it sounds like we’re saying we’re
concerned about PKI, and then further down in the paragraph at that time you
talk about the need to evaluate technologies such as PKI.

I guess the question I have is why would the letter of NCVHS have
recommended PKI if we’re concerned about the use of PKI technology? I
understand this is a past letter you’re reciting, but it’s awkward.

MR. BLAIR: Could I suggest one thing? The idea of research and exploring
other things such as biometrics and PKI, I don’t think that’s necessary for the
objective of the letter. And I think we had at least discussed the idea of
dropping that sentence.

DR. WARREN: We had discussed it, and then we left it back in because that
was one of the recommendations that we made to the Secretary, and one of the
things that’s happening with DEA is there is no testing evaluation or research
on their approach currently to authentication. We had recommended that, so we
just wanted to restate it again. So, yes, that sentence was edited out.

MR. HOUSTON: Are we ultimately saying as part of this letter that we don’t
believe that PKI is an appropriate technology for e-prescribing? Is that really
what we’re – maybe I’m missing the purpose of the letter. What is it we
ask ultimately here, other than we’re providing input to the Secretary as to
NPRM?

DR. WARREN: We are providing input to the Secretary so that he can make his
comments to NPRM.

MR. HOUSTON: And what is that input?

DR. WARREN: Our letter says we’ve already looked at the stuff, we are
attaching our recommendations in the letter because the letter is two years
old, and there have been no changes in our recommendations since then. And it’s
just to update him, we’ve already looked at this, we had concerns about various
security and authentication, we had recommended that all those be evaluated.

MR. HOUSTON: Okay.

DR. WARREN: So in this new NPRM none of those have been evaluated.

MR. HOUSTON: Then can we shorten, why don’t we just simply say it in those
terms without getting involved in what I think becomes a very unclear set of
paragraphs on the second page. If you’re going to attach the letter, say here’s
the letter, we still believe this is true, you need to consider it.

But when we start getting into this restatement and stuff like that, to me
it confuses me because I don’t get a sense of what’s new. I understand it’s a
restatement, but it almost seems like it’s a reiteration, and it’s inconsistent
inside itself.

MR. REYNOLDS: We got Leslie, Marjorie, and Carol.

DR. FRANCIS: As I understand it, it’s actually when you read it this way it
sounds like our earlier letter said these are the technologies that should be
evaluated. Yesterday the way it was presented to us, the way what I thought
people were saying, was that our view had been that a technology which is
cumbersome and a real barrier to e-prescribing ought not to be imposed unless
there’s evidence that it improves security, etcetera.

So I take it that it was kind of a hypothetical, that if any of these are
going to be used it should only be after appropriate evaluation. And so this
sentence just completely confused me.

MR. REYNOLDS: Marjorie.

MS. GREENBERG: I think part of the problem for those of us, I’ll include
myself, who have not actually read this Notice of Proposed Rule Making, is we
have no idea what they did end up recommending in this Notice of Proposed Rule
Making. And I would imagine that Secretary Levitt doesn’t either, unless this
is an issue of particular interest to him. You know he’s got his hands full
with what HHS is doing, let alone with what DEA is recommending.

And given that, then we don’t know just how relevant our past
recommendations were or weren’t. Clearly they didn’t recommend PKI, so our
concerns about PKI at least aren’t being countermanded by their letter.

So is there some way, maybe the Notice of Proposed Rule Making is so complex
and involved that it’s impossible, but is there some way upfront of summarizing
other than its intent to revise its regulations to provide practitioners with
the option of writing prescriptions electronically for controlled substances?
Is it possible to summarize what they are recommending in this, or against
which we feel our recommendations are still relevant?

I think the context is missing here as to we’re talking about PKI and then
we say but actually they didn’t recommend that in this. So why are our
recommendations still relevant? I don’t get the context here, and I admit that
I haven’t read their NPRM, but I think that would mean a lot, I mean I’m in
good company.

MR. REYNOLDS: Carol?

MS. MCCALL: Actually, Leslie handled the question that I had. But an
additional comment, when you were explaining it to the good Dr. Houston here,
Judy, your explanation was wonderful, which is to say look we did a lot of deep
work a couple years ago, you are reconsidering a number of things. That work,
given what we learned and given what you’re doing, will be particularly
relevant, and so we’re highlighting it for your attention. And that’s the
headline, read it, and don’t reinvent any wheels, all of that.

Now, if there are particular things within that – kind of a “such
as” – I think those can be powerful. But that, the way you described it,
was perfect, and yet I think it’s getting lost in some of the details.

MR. REYNOLDS: Bill Scanlon.

DR. WILLIAM SCANLON: There was a potential message that Mike Fitzmaurice
raised yesterday which I would characterize as PKI is off the table now, but
who knows on the basis of comments that they get from everybody, could it come
back. So the message to deliver is we thought it was not appropriate before,
and we would suggest that you remind DEA that bringing it back would not be
something to do.

So there’s the question of I think the first part sets that up, Leslie’s
interpretation of the “finally” sentence I think deals with some of
the tension between the bullets and that. But then we haven’t reached the last
paragraph, and the last paragraph the question is how clear do we get in terms
of our request or our ask, which is to say, don’t bring this back.

And part of that could be a kind of politic way of doing it would be to say
DEA in their NPRM did something really positive, (it’s a little backhanded),
and did not include PKI, and keeping it off the table is where you should be
for the future. I think being more explicit about that message, to clarify.

MR. HOUSTON: Is that the only point we were making is PKI? The other way to
say it is we didn’t believe PKI was appropriate before, we still don’t believe
it’s appropriate to be included. That’s the other tack to take, don’t even
include the letter.

My concern is when I read the second page even if we’re saying we don’t
believe that PKI is appropriate, then why are we talking about reiterating our
desire to evaluate emerging technologies including PKI? It does send a mixed
message to me.

MR. REYNOLDS: Jim.

MR. JIM SCANLON: Let’s see, I think the sequence went like this. Their
original proposals, though not published in a proposed rule, they were really
focusing on PKI. And then we had a hearing, other folks heard about this,
they’ve had hearings on the hill, and they were pushed back from incorporating
PKI in the proposed rule.

The proposed rule now does not contain the PKI for authentication. It
contains some other procedures that I think, I’m not a security expert, from
what I’ve learned from others creates similar problems in terms of the
infrastructure required and security clients.

Maybe that’s what we should say, we should just say that we’re pleased that
the proposed rule does not contain the PKI requirement, but it does contain in
our view similar requirements for security authentication and in-person
proofing, whatever it was, that have equal or similar consequences.

MR. REYNOLDS: Steve, I’m going to go to you in a minute.

The reason we didn’t do that, my understanding is that we haven’t re-held
hearings. And so having not adjudicated those through a hearing, we were
reissuing a previous finding, not necessarily holding another, having not held
another hearing to kind of give open public review of whether or not this new
way is good or bad.

This was just to remind the Secretary of our letter, and to remind him of
the fact that if the other doesn’t work and they put PKI back in, that is not
where we go. So that’s all we really adjudicated was that.

Steve and then Leslie.

DR. STEINDEL: Harry, that was basically the comment I was going to make,
thank you.

DR. FRANCIS: But there is a way to reconcile the two points, which is to
simply say we raised these concerns about PKI. The DEA should not put a
different authentication system into place without considering whether these
same concerns would apply.

Because we’re already on record about the concerns, and we can certainly
call to the Secretary’s attention it’s important to make sure these concerns
don’t apply without actually saying, we haven’t had the hearing, sure, but it’s
up to us to say you better make sure about this.

MR. REYNOLDS: Yes. Look at the last sentence. I think the way we tried to
nuance it in the last sentence is to basically say if you put the wrong
security in and you really lock this thing down you’re going to impair the
implementation of e-prescribing. That’s what we heard throughout the hearings
that we had, that’s what we heard relative specifically to PKI, and that’s why
we tried – it was nuanced in here to say, remember if you lock it down.

And one of the things we discussed significantly with PKI is the way PKI
works, as we showed the whole process in there of the prescription process, it
wouldn’t let it happen as it does now in a lot of ways, and so it was really
going to shut it down.

So that’s the data that we heard. John.

MR. HOUSTON: Again, one question, maybe a comment. Are we still only talking
about PKI, or are there other things that are in the mix here in terms of
recommendations that we want to reiterate?

MR. REYNOLDS: We are talking about PKI, and we are talking about anything
else that could come up that would replace PKI, or anything else that could
impair the growth of e-prescribing. And we talk about the kinds of things that
would impair it in our other letter.

MR. HOUSTON: I really think that rather than doing a bad job of
re-summarizing the letter in this letter, I think the best thing to do is
simply reiterate our strong position, that the prior letter is still relevant,
and that it’s meaningful in the context of the NPRM.

MR. REYNOLDS: And attach it.

MR. HOUSTON: And attach it and say go for it. Because this really gets
confusing when you start to re-summarize, because the re-summarization doesn’t
add clarity, I think it just –

MR. JIM SCANLON: I think you either do that, and the Committee may not feel
comfortable, you apply the significance of that letter to what they are
proposing, which would mean that you really said PKI and the general point was
the security requirements at this onerous level will do more harm to
e-prescribing. They’re not proposing PKI, but they’re proposing in many
people’s view similarly onerous and burdensome requirements.

Arguing about PKI is just not going to help that much because people will
say we didn’t propose that, right. So is there any way the Committee feels
comfortable at least making the translation?

MR. BLAIR: I’d very much like to have the words you just articulated, I
think you’ve just hit the nail on the head, and I almost feel like that’s all
we really need to say in the letter, what you said, Jim.

MR. REYNOLDS: He was just reiterating that what Jim said should be the
letter with our original letter attached.

Is that what I heard, Jeff?

MR. BLAIR: Yes, that’s my feeling.

Judy, how do you feel?

DR. WARREN: Yes, I’m fine with that.

MR. REYNOLDS: Which means we’re talking about a very, very abbreviated first
page, which says attached is our – yes.

MR. JIM SCANLON: I think it’s appropriate, I mean it’s a say what you mean,
mean what you say.

MR. REYNOLDS: Again, I think this is good because as we talked a little bit
on some other stuff yesterday, I think because we have been ahead of the curve
on some things, and those things come up in their finality, we’re going to want
to consider each time whether or not we play. Sometimes play means if our
original letter we send doesn’t change anything and doesn’t make a difference,
then we don’t do it.

If it does remind the discussion and the Secretary especially of the fact
that we did that, and that is still important and that is an issue in this
newest round of what’s going on, that’s good.

So that’s how we’re going to kind of go through this process going forward,
and again each time we will say no or yes. We’ll decide whether it’s relevant,
and if it’s irrelevant then we won’t do it. John.

MR. HOUSTON: And to sort of maybe turn it around a little bit, I think the
letter could be viewed a little bit as whiney in one sense. If you’re simply
saying we want you to be made aware of the fact that we wrote this letter
before and it’s now meaningful in the context of this NPRM, and please take
that under advisement, for your information, I think that comes across simply
as a reminder, which I think is probably the best way to put this letter back
in front of him. Otherwise, it almost looks like, hey, you didn’t listen to us
once. You know what I’m saying?

MR. REYNOLDS: Does that seem like the will of the group? Don.

DR. STEINWACHS: Harry, are you ready for a motion subject to approval?

MR. REYNOLDS: I’d be more than happy to. That’s why I was asking the will of
the group.

DR. STEINWACHS: I move we accept this with review by the Executive
Subcommittee, I guess.

MR. HOUSTON: We know it’s not accepting the letter, it’s accepting the
letter as revised.

DR. STEINWACHS: John, why don’t you make the motion?

MR. HOUSTON: I make the motion that based upon the comments and discussions
here today that the Subcommittee, along with Harry, revise the letter
consistent with this and submit it, because I know there’s a timeliness factor
to this as well. So I don’t think there’s time to bring it before the
Committee.

MR. REYNOLDS: We will run it by the Executive Subcommittee, we will
definitely do that.

DR. WARREN: I was going to say I’m not willing to not run this by the
Executive Subcommittee.

MR. HOUSTON: We’ll leave it to the approval of the Executive Subcommittee.

MR. REYNOLDS: We will go through the appropriate process in the appropriate
time to make sure we meet.

There’s a motion on the table. Is there a second?

DR. HORNBROOK: Second.

MR. REYNOLDS: All those in favor?

[“Aye”]

MR. REYNOLDS: Opposed?

[No audible response.]

MR. REYNOLDS: Thank you very much.

[MOTION CARRIED]

MR. REYNOLDS: Next, who wants to have the opportunity of going forward
first?

Agenda Item: Subcommittee Work Plans

MR. REYNOLDS: In your readout of the subcommittees, the point of this whole
session here is a readout of what you did in your breakouts, but more
importantly giving the Full Committee a flavor as to what you’re going to be
bringing forward to the Executive Subcommittee for us to plan this next 18
months, including hearings, including subjects.

Justine presented a chart yesterday, I know there was discussion, I sat in
in the Quality and Populations Group on the Medical Home idea.

So each of you as Chairs, or whoever is going to do it, would you just
please put the whole Committee in context as to what you’re thinking, what are
your key focuses. And obviously we’re going to spend time on that this
afternoon, and then we’re going to spend significant time as the Executive
Committee next month.

We have to strike a plan, we have to strike a plan that’s pragmatic, and we
have to make a difference. So that’s the goal in the end here.

So who would like to go first? Don is looking like he’s ready. He made a
motion earlier so he’s hot, let’s go with him.

DR. STEINWACHS: I’ve now had enough coffee and I’m awake, so I can function.

Let me just take you through quickly where we are. We had an excellent
discussion yesterday afternoon on what to follow on the Patient Centered
Medical Home. These discussions generate all sorts of nuances as we’re
accustomed to here. So I’m trying to strike a balance, and it was actually Jim
Scanlon who came forward with an idea that seemed to fit, and that was that we
might look at the Patient Centered Medical Home as a use case in assessing
specific needs for data standards, terminology data infrastructure. Sort of do
it that and avoid what I think was some concerns around what extent are we
endorsing, buying into a specific model. In the hearings it very clearly came
forward that that model still is not well-defined. There’s a vision, a common
sharing of vision, but there are elements of that model that are not.

So I would think one of the first steps would be for us to state our
assumptions. In some of the areas of the discussion I heard would be to
strengthen our vision of the extent to which that is a health promotion and
prevention model. A lot of discussion does get generated by the word
“medical” in many ways, and health, and we’d like to think of
populations.

That is at I’ll say at a micro-level, thinking of delivery of healthcare,
the idea that the goal would be that everyone would have a medical home or a
home for their health, and therefore you have a population approach in the
ideal.

The other, which is certainly important to all of us, is that the health
statistic system that we have needs to be able to support healthcare reform in
terms of providing information needed in a policy environment. So what I did,
and some members of the Committee can take me a step back, I sort of expanded
that idea. Again, this was part of the discussion that Jim joined in on, that
we could think about doing under assessing the adequacy of health statistics or
identifying trends in health status, access to care, utilization costs, is
that’s a huge undertaking if you do. We might use this idea of a use case or
two, and so maybe have two or three, a couple use cases.

One could be the medical home, this kind of transformation at the
micro-level, is our ability within health statistics, look at transformation in
terms of: Is it occurring, who’s getting it, what are the impacts of that
transformation?

The second, this was more discussion between Jim and myself, so the other
members of the Committee may want to talk about this, is that certainly when
you think of health reform you think of insurance coverage, you think of
healthcare costs. So it seems to me we ought to look at a second use case that
focuses in on access insurance coverage costs. If you say do I know exactly
what that is, I don’t, but I think it would make this then very relevant. It
would be some of the macro-system changes and the micro, and we might be able
to undertake that.

We have not thought through how long, how complex. I think the next step is
on that.

Garland shared with us, and we had some discussion depending on how you want
to put it, there is sort of a crisis in the vital statistics system right now.
There are a lot of things that could solve it, more resources, being a little
more aggressively in the modification and changes in the way in which vital
statistics are captured, contingency planning is going on. The BSC, Board of
Scientific Advisors, is going to be talking about it this week.

Our proposal was that after they talk about that we ought to talk with them,
and Bill will be there as our liaison: Is there something here together that we
ought to do? We thought that providing input where input might be valuable, and
priorities and the consequences of potentially not capturing key parts of that
dataset for some period of time, or maybe forever, I don’t know, might be a way
if it was useful to communicate with the Secretary about potential costs of
loss information and opportunity, versus the issue of costs of actually getting
the systems in place in all the states in a timely way.

I think that really depends on that liaison working with the DSC. So I don’t
see this as us going in there.

Mark Hornbrook brought what to me was a fascinating idea, and I see this as
moving on a somewhat slower track maybe, but might start out with a
presentation if the Full Committee agreed to it. Mark talked about the CTSAs,
which are the Clinical and Translational Science Awards.

So NIH has done away with what you call the old awards, General Clinical
Research Centers, which is really a support, infrastructure support for
conducting clinical research in academic health centers. Essentially every
academic health center had one. That program phased out, and the target now is
to fund up to 60 CTSAs, which would be only to half of the academic health
centers, focus on clinical and translational science, it’s actually taking the
clinical science into the community.

So all the CTSAs are identifying a community population with which they are
going to be doing translation, collecting information and understanding.

A very interesting idea Mark brought forward, he could expand on it better
than I, would be if this really happens and plays out, and this is the mission
in IHCs, there could be a kind of partnership at these community levels, and it
would be 60 times however many populations are involved, that you could have a
combination of information coming forth that we from genomics up through
healthcare delivery through health status.

What Mark said is the current plan is to make all the data accessible in
some way, and I guess maybe certain items be standardized potentially at
cross-settings. So there could be a kind of synergy between the National Center
of Health Statistics and what they do with NHANES, NIH and HIS(?), and other
things. What NIH is doing it could be a true partnership that will really
strengthen our capacity to answer some of the questions that go from the person
through the community, and project onto the country.

Mark, do you want to add anything?

DR. HORNBROOK: Well, Judith is writing one right now.

DR. WARREN: Painful. I just wanted to support the whole notion of us working
with that, because as I’ve been reviewing the materials and stuff and writing
not the first submission but resubmission, one of the things that has become
painfully clear to me that in their RFA they don’t specify any of the data
standards and stuff that we’ve been working on here.

I think it would be really good to push our agenda into another HHS agency,
to really say the researchers need to follow some of the same standards that
clinical practice has.

So I’m all for this. I think this could be another one of those that is, I
don’t know another word other than cross-cutting, but one of those issues that
all of the subcommittees might be interested in participating.

DR. STEINWACHS: Harry, I think the suggestion we had was that if the Full
Committee was interested in this, that maybe for a Full Committee meeting
invite NIH appropriate representative to at least educate us. Mark is I know
very involved, and others here, and then there could be some general
consideration about the merits.

MR. REYNOLDS: One thing I think you saw yesterday, one of our goals is when
we have these Full Committee meetings is to spend a decent amount of time on
continuing to educate us all on what’s going on out there in different venues.
Otherwise, anybody brings a letter in or anybody brings a subject in, we’ve got
people sitting in here not having a clue what we’re talking about.

I think out of any of these things that come from the subcommittees, if
there is warm-up, I’ll call it warm-up on a subject, and we decide that’s a
subject we’re going to bring a letter in on, then let’s go ahead and warm
people up, and let’s let them understand from their own perspective, not just
the people on the committee that understand it. We can ask the questions based
on our own knowledge to the presenter, rather than trying to decipher that in a
letter one sentence at a time, and agreeing or disagreeing with something we
really don’t understand the context of. I’d like to see us do that on a
continuous basis.

I’m sorry, Mark, and then Larry.

DR. HORNBROOK: We have Mary Ellen, Mary Jo Deering on the Committee, and I
wanted you to remember there’s a Populations Sciences Work Group in the CA Big
environment, and I can’t see any drawback to having all the NCHS survey
instruments in G forge in the CA Big environment.

If you could do the CDEs, the Common Data Entries for all of your
instruments, it sets up the foundation for every other researcher to go and use
those instruments for standardization. So you have a way of leveraging your
work and survey research methodology into clinical trials and into population
research, because they’re inside this already well-established place that all
the scientists are supposed to go to, to make sure that their data are
standardized.

We’re trying to make population research as standardized as clinical
research and as biomedical research with molecular entities, and genomics and
metabolomics and proteomics.

MR. REYNOLDS: Larry.

DR. GREEN: I want to support this, and suggest we need some guiding
questions such as after NIH spends a few billion dollars on this enterprise how
will they know whether or not they made any progress on their problem.

Another type of question is that part four of these awards is usually
referred to as the community engagement component. If you look across the
awards that are made to date, it is very difficult for someone writing a new
proposal to find the common denominator that explains what community engagement
is, and how would you know it if you saw it.

There is a parallel here to our hearings at the patient center and medical
home. How would you know one if you saw it? How would you know a community
engagement, an effective community engagement strategy if you saw one? The
metrics of this are not worked out, and the potential of doing what Mark was
just saying is how can the population metrics related to improving health
through biomedical research, how can we take advantage of what we’ve already
got to get to those metrics. I’m pretty sure this work hasn’t been done, and
it’s midstride in its implementation.

So I want to argue also that not only do we need a question or two to guide
us, but we also need to recognize that this is timely.

MR. REYNOLDS: I’m going to cut this off, unless this is really, really
important, because –

DR. HORNBROOK: I just wanted to say one last thing here, is that the CTSA
world is trying to change biomedical science from individual RO-1 cottage
industry to big science, and this Committee needs to be part of that movement
and getting all of your social survey research assets into the mainstream of
clinical research. And population epidemiology research would be very important
for big science, not just let every individual scientist decide which surveys
they want to use.

DR. STEINWACHS: I need to wrap this up.

MR. REYNOLDS: That would be a good thing.

DR. STEINWACHS: So we still are online, and I failed to deliver, so Marjorie
reminded me, she read me the minutes that said that I was supposed to have done
something a month ago that I haven’t done, and that was to put together a plan
for revisiting the vision for health statistics in the 21st Century.

The discussions today both in the Quality Committee as well as in the
Populations Committee keeps coming back to the value of revisiting that in
terms of integrating NIHN, EHRs, PHRs. It also would integrate some more work
in data linkages, because in order to have the capacity you have to be able to
link and use data that cuts across socioeconomic status environment as well as
healthcare. So we will get that.

The last thing, which is currently a lower priority, is revisiting the data
linkages, which is what we had talked about before. I think given the
constraints on time, effort, and energy, that that sort of sits out there as
one of those things in the future that is valuable but not pressing.

MR. REYNOLDS: Okay, thank you. One thing that as we hear these readouts, one
question I promise you I’m going to have when we get together for our strategic
plan is this is a good list, we’re talking about what can we pragmatically make
a difference in in the next 18 months.

So as we go through our planning session this afternoon we’ll talk a little
bit about it, but when we get back together in October that’s going to be the
question. Because as soon as we say cross-cutting my next question will be who,
and what does it look like that you would like them to do to make sure that
what you’re cross-cutting is going to happen.

Second, it will be, so which of these do you want to have hearings, and what
do you want to come out of those hearings, and what do you want to deliver, and
how do you want to make a difference?

I’m just kind of setting that up as where we’re going, because a lot of
great ideas, but what does it look like, what does it create itself to be, and
how do we make a difference with it? So that’s going to be consistent, but it’s
the exact same questions after we finish each one of them, so that’s not
pointed at anybody in particular. I would ask the exact same questions of
anybody.

So that’s where we’re going.

DR. MIDDLETON: Harry, just a quick question. It’s for Garland and for the
Committee at large. I don’t know if this is usual NCVHS process and procedures,
but if we are at risk for having the appropriations for national data
collection for the information infrastructure upon which all of our public
health epidemiology and all the rest of it is based go away, do we need to
write an emergency letter of some kind to whomever that substantiates the
importance of population statistics in public health data gathering so that
that work continues? Is that something we can do?

MR. JIM SCANLON: Well, I don’t know, I think everybody’s well aware of this.
The problem is – ironically NCVHS is scheduled for a fairly sizable increase in
the budget – the problem is with the budget process, it’s not anything the
Secretary or even the President can do anything about.

And chances are NCVHS will receive that money, but it will be later in the
year, it won’t be at the start of the fiscal year.

So I don’t know, I mean you certainly can write in and the Secretary raising
the question and urging him, but he’s already tried to add money to the NCVHS
budget. I don’t know what we can do.

DR. MIDDLETON: Jim, it’s my ignorance being revealed. Is a letter to the
states, or the governor, or the NGA, or something?

MR. JIM SCANLON: No. Vital statistics is a different matter. That’s
specifically where I thought that the BSC was actually finishing an evaluation
of the vital statistics.

MR. REYNOLDS: Jim, you want to help us here?

DR. LEPKOWSKI: There was an evaluation done about a year and a half ago, two
years ago on the Vital and Health statistics Division within NCHS, and out of
that came a letter to the Secretary that went through CDC, noting these
problems, these budget problems. It was somewhat controversial because it’s the
Board of Scientific Counselors commenting on budget issues.

Nonetheless, the science was threatened from the point of view of the Board,
and that generated a letter that went to the Secretary.

At this point, though it is cuts in the current system, it is not a complete
elimination, but there are substantial cuts that are recommended right now by
NCHS and NAPHSIS is reacting to that, and the Board has yet to discuss it,
which we will be doing tomorrow and Friday.

MR. LAND: The other thing besides vital statistics, which of course we’re
deeply concerned about, as I understand it some of the other national surveys
are also being impacted. They’re talking about cutting by half the survey
sample for health interview survey. I heard that maybe two other surveys are
being eliminated, but I don’t know the details of those. It’s a general issue
of our national population based information that is being jeopardized right
now.

MR. REYNOLDS: What I’d like to do is obviously Bill Scanlon’s our liaison to
the Board of Scientific Counselors, Don’s got Populations, and I think between
the two of them if they feel that there would be some place for us to weigh-in,
whether it’s specifically on surveys that make a difference or something, that
might be a letter that we would at least entertain for the Full Committee to
discuss. So that’s the way I’d like to approach that, if you’re okay with that.

MR. JIM SCANLON: I think that has to be based on what exactly the Center
itself is looking at as options, not on what other people think. I mean, we get
them here and let them say it.

MR. REYNOLDS: Don, thank you very much.

Next we’ll go to Standards, since they met yesterday too, and we won’t go
into this morning’s.

Jeff, you going to cover that, please?

MR. BLAIR: Yesterday in the meeting we went through the letter, and
apparently there’s some more work on it, and we also reviewed the charter for
the Subcommittee. We went onto the focus portfolio, worked on part of that, we
didn’t quite finish that. We didn’t have time to get to the other letter
addressing 5010. I’ll express my personal feeling, is at this time I think the
value of us pursuing that is very marginal.

And, Judy, do you have a thought on that?

DR. WARREN: One of the things that we were looking at as a Standards
Committee is that many times these NPRMs are coming up and they’re addressing
the areas that we’ve already held hearings and information on, and that there
is a time gap of no new information. So we were trying to pilot a way that we
can write cover letters and resubmit our comments into that.

You saw our first attempt with the DEA letter. We were looking at that also
with the 5010 and ICD 10 NPRM that has just come out, whose comment period ends
the end of October.

Jeff and I have been talking back and forth. We still feel that strategy is
probably an appropriate strategy, we’re just not sure that we’re ready to
engage in it at this point, and would like more opportunity to discuss that
strategy with the Full Committee and the Executive Committee.

MR. REYNOLDS: The rest of your portfolio, Jeff?

MR. BLAIR: Pardon?

MR. REYNOLDS: Were you going to cover anything else on the kinds of things
–

MS. GREENBERG: Can I just seek some clarification on that?

MR. REYNOLDS: Sure.

MS. GREENBERG: Because if there is going to be a letter on these current
NPRMs, obviously the comment period closes before the next NCVHS meeting. Are
you thinking of an open conference call at which such a letter would be
approved?

DR. WARREN: No. At this point I don’t think we’re going to follow up on it.

MS. GREENBERG: Okay.

DR. WARREN: But the strategy itself is one that we want to consider. The
strategy is, when we have a body of testimony if we have written a complete
letter to the Secretary and NPRM comes up, for which there is no new
information between the time of our letter and the NPRM to remind the
Secretary, much in the way that we’re doing with the DEA letter, if that
information is out there.

MS. GREENBERG: Okay.

DR. WARREN: The reasoning for that, that we’re considering it, is it does
give NCVHS another opportunity to show how we’re contributing to the overall
effort, and that we’re monitoring these things and trying to be current.

Then I have one other item after Jim gets through with his.

MR. REYNOLDS: Jeff, anything else?

MR. BLAIR: Go ahead, Judy.

DR. WARREN: One of the tasks that our subcommittee has is to work with the
designated Standards Maintenance Organization, and this is a requirement of
HIPAA, that they provide us with an annual report on the status of all of the
standards that have been mandated through HIPAA. They have filed that report
with us. However, there are no changes from last year, so no hearings have been
held about some of their requests.

What we are requesting is we just accept the report and have it appended to
the minutes of this meeting so that everybody knows what that is. We’ve never
done it this way before, so I’m asking if that’s appropriate, or does the
Subcommittee need to do something different to accept this report.

MR. REYNOLDS: As long as the Subcommittee accepts it and then sends it on to
the Full Committee. Probably at the next Full Committee meeting it would be
good to have some discussion on it, I would highly recommend.

Is that it from Standards?

MR. BLAIR: Yes.

MR. REYNOLDS: You’ve got a lot to do between now and October, because the
same questions that we asked Don are going to be your questions.

We want to go to Quality.

DR. TANG: Quality Committee met initially with the Populations Committee
yesterday, and talked about the medical home concept. We continued our
discussion today, where we reaffirmed the vision that was set forth in, I can’t
remember which report it is, the three circles with the diagram, the provider,
the population, and the person. Back then, whatever it is, over five years ago,
probably the person was just another P to fill out the three Ps, because there
wasn’t a really good way of getting data or information from the individual.

We think that it’s time now, especially moving into the electronic age, to
be able to bring information from the personal to the table.

One of the themes we talked about also is reuse of information. Again, five
years with the paucity of electronic systems, I mean it was a nice concept, but
people really had to enter data multiple times in a paper-based world. In the
electronic world we really do want to focus on the use and reuse of data by
different parties, because that’s more efficient and less burdensome.

Reuse by whom, go back to focusing in on the individual or the person, we
saw as one of our important charges for this next 18-24 months to really look
at the emerging data needs of a health system. Not just health care, but health
system where the person comes first as a fully-engaged participant.

That’s a statement, but I think it’s a vision that we can come close to in
this next – well, move substantively closer to in the next couple years.

So we want to focus on what are the gaps in data, and how an individual gets
access to that data to be a part of a participant in their health village, so
to speak.

Our next step we propose would be a hearing where we can try to start
uncovering the data needs to support his new model. How do we get it from the
person, how do we get that reliably, how do we get it conveniently, how does it
get entered in the system of health and care so it can be reused by providers
and in population management?

That’s our initial task. We see ourselves as needing to provide and create a
framework for constructing the work over the next couple years, and using our
hearing as a way of gathering initial data in that framework to drive the
change in the next few years.

We welcome, and we think it’s probably going to be in the winter, tying it
to the November, probably earlier than we can manage, and we welcome input and
participation by the other groups.

MR. REYNOLDS: Privacy, security, confidentiality, all them.

Leslie, do you want?

DR. FRANCIS: First of all, we went over the draft of our letters and getting
them out into the big wide world, and made some changes to have it be a little
more user-friendly. But that’s a go. You had it in your packet, I believe.
Pardon?

MR. HOUSTON: Tab 5.

DR. FRANCIS: Tab 5, yes.

Secondly, we talked about the Committee charge, and I have that I think in
an approved form. We’re going to resend it around to members of the
Subcommittee, but we’re there.

Third, we talked about next steps, and we have a number of ideas on the
table, and I might mention a couple, then John has a couple to mention. One is
basically the question of how to use de-identified data in a responsible way,
which is not in opposition to it but what are some of the issues raised by it.

The other one that we’ve done some preliminary work on is personal health
records, PHRs, and the issues about protecting privacy in PHRs. Walter
suggested having a look at when it’s issued, the privacy and security framework
that ONC is about to come out with.

John, maybe you want to chime in with a couple of other thoughts, and then
we’ll explain what we’re going to do.

MR. HOUSTON: The other things we discussed, were looking under the theme of
data stewardship, which I think the Committee’s sort of taking on broadly, as
it’s sort of what you want to call the theme for the year or the upcoming work.

One of the things that I’m very interested in is the whole idea of
accountability and how do we ensure that there’s appropriate accountability in
place for the NHIN with regards to data stewardship providing access to
information. Things of that sort. That’s a fairly broad topic.

What we are planning on doing is to hold a conference call over the next
couple weeks with Subcommittee members to talk about if there are any other
subjects of interest, because we sort of let that out to people. The
Subcommittee is are there other things you want to put up for discussion and
then come to some conclusions as to what’s our highest and best use based upon
the timeliness and strategic importance and the like.

Again, we’re hoping to have a conference call over the next week or two so
that we’re prepared when the executive retreat occurs to be able to sort of
enunciate where we think we need to go over the next 12 to 18 months.

DR. FRANCIS: We’ve asked members of the Subcommittee, but we could also if
anybody on the Full Committee has areas of privacy they’d like to at least
throw out for consideration on our plate, please do that. Maybe send it to us
within a week because our conference call will be coming up.

Harry suggested also following up on sensitive health categories; that’s
another.

MR. REYNOLDS: Mark?

DR. HORNBROOK: Leslie, how much have you talked about cultural specific
sensitivities, I mean, American Indians?

DR. FRANCIS: That would be a question.

DR. HORNBROOK: We should ask you a question to put into your list.

DR. FRANCIS: The role of culture in understanding sensitive categories and
sensitive health data. Is that what you’re?

DR. HORNBROOK: Yes, Native Hawaiians, American Indians, and other kinds of
cultures have very specific areas where they’re very sensitive.

MR. REYNOLDS: Larry, and then Justine.

DR. GREEN: I’d just like to try to link this to discussions we had in both
Quality Subcommittee and the Populations Subcommittee, and back to our May
hearings.

We have reported out now a very clear message that for a person in America
to actually access and use healthcare appropriately and also be held
accountable for their contributions to being healthy and remaining healthy,
that they must trust the people that they’re interacting with over and over
again. I recall one person who actually said if this patient centered medical
home idea is not trusted it is not working. I think that’s a fertile
intersection with what I just heard that would align very nicely with what Don
said.

MR. HOUSTON: And to respond to that, again, I think that we’re not going to
have public trust in my mind unless we have accountability. Again, I really
look forward to seeing what ONC ultimately puts out, but I think it seems to be
the area of greatest void right now.

Leslie brought up a very interesting comment. If you look at what Chuck
Friedman presented yesterday there’s an enormous void as to who’s looking at
privacy and security. So I think it is a very good point, public trust is
absolutely the cornerstone of all this.

MR. REYNOLDS: We have Justine, and then Carol, and then Paul.

DR. CARR: I’d just like to add that there is a workshop being held on
September 26 by the Center for Democracy and Technology on de-identified data.
I was asked to summarize some of the observations from the ad hoc work group on
uses of data. I would welcome, I don’t know if any of you guys want to
participate as well, but they have put together a very substantial panel of
speakers, and I think it will be very informative.

It is in Washington, yes, I’ll send you the information. They are limiting
participants, but they would welcome further representation from NCVHS I’m
sure. So I’ll send that to you right now.

MR. REYNOLDS: Carol.

MS. MCCALL: One thing for your Committee to consider for privacy goes back
to a suggestion earlier about putting some of the NCHS instruments into some of
these more open architectures so that they could become more widely adopted.

I think there’s another question in there that may relate to privacy, and it
depends on ultimately how things are pursued. But the privacy link is if you’re
able to take these instruments abroad and get many, many people to take them,
will I be identified as the person who took that survey. Ultimately, data is
useful when it can get fused with other information, enough so that I don’t put
tab A into the wrong slot B, you can do it by saying it was Carol who took the
survey, there may be other ways to do it.

But there’s some privacy concerns related to what it actually means to data
in these environments, what our desire and constraints are when the instruments
are used more broadly that will relate to privacy. So I would put that on your
list, at least for consideration.

MR. REYNOLDS: Okay. Paul.

DR. TANG: Another group that’s developing criteria, and certification
criteria actually for privacy related to PHRs, is CCHIT. They got a chart from
AHIC to not certify PHR functionality, but to certify policies and practices of
PHR operators, privacy, security, and the function needed to implement the
above. In fact, I think at the end of this month they’re putting out their
initial criteria for public comment.

MR. REYNOLDS: We’ve heard from everybody. Again, as I say, for the October
meeting I realize some work needs to be done to get a little more pragmatic. I
think great ideas, good lists, but we got to move from there. Marjorie?

MS. GREENBERG: I just had a question. I know that the staff to the Privacy
and Security Subcommittee has sort of put together a huge literature review; I
mean it was quite an effort on their part, which I thank them. I don’t know
whether anybody else has done anything. I think if somebody else had done this
already there wouldn’t have been so much work on their part.

So I’m just wondering if that could be a resource. And I realize you may not
actually take that topic. But what are you thinking of doing with that?

DR. FRANCIS: Well, we’re thinking of using it to identify where there are
questions or problems in that very topic, and we just basically got it about a
week and a half ago.

MS. GREENBERG: Yes, I know.

DR. FRANCIS: So we haven’t – but that’s one of the things going to be
on the table with the conference call.

And part of what we had actually was the stuff from CCHIT and other things,
I mean it’s huge, absolutely it’s a notebook like this, I mean it’s herculean.

MR. REYNOLDS: But I think the question is, are there other uses of this that
NCVHS could be a resource, because of having done that.

DR. FRANCIS: Yes, there may be.

MR. REYNOLDS: To make that available to more of the industry.

DR. FRANCIS: Yes, right.

MR. REYNOLDS: So I’d like the Subcommittee to take that under.

DR. FRANCIS: Sure, absolutely.

MR. REYNOLDS: With that, those are the readouts.

Bill Scanlon is going to update us on NCHS and BSC.

Agenda Item: NCHS/BSC Update

DR. WILLIAM SCANLON: Let me ask Jim to join whenever I stray.

The first topic I was going to talk about has actually come up, and that’s
the whole issue of the NCHS budget, which is something that the BSC sort of has
been looking at. I think this is in part sort of a longer run concern, even
though we do have the current issue with respect to the Appropriations Bill,
which may be resolved at some point.

Over time there’s been some deterioration of the budget, sort of relative to
the activities that were underway. With vital statistics I can recall being in
meetings where there were discussions about how last year’s statistics were
paid for with this year’s money, and it was there was always borrowing going
on. It reached the point, where Jim indicated, the Board has included the
scientific integrity value of these efforts as being compromised or sort of
eroded.

I would say that the Board deserves a lot of credit for both raising the
issue and how they’re raising the issue, because it’s not just an idea of
saying the status quo has to be maintained. There’s discussions that I’ve heard
have been focused on what is the role of this information, what do we need,
what can we do in terms of changing the way we do things, what deserves
priority, who are serving in this process, which are all the kinds of questions
that should be asked in terms of devoting public resources to something.

Hopefully what comes out of that is a sense of what the value is of the
information, and therefore what the appropriate decisions are in terms of
funding it.

This is in a bigger context than we’ve talked about health reform here a
couple of times. In the bigger context people are talking about the whole
question of health reform and the fact that we already spend over $2 Trillion.
If you take realistic projections out into the future at some point you’re at
40, 50 percent of GDP. And that’s on the assumption that there’s going to be so
much screaming at that stage that we’re going to find a way to cut back.

Realistically, if you take the trends and you project them forward we’re
going to be beyond 100 percent of GDP, which we know can’t happen. But the
reality is that healthcare costs continue to consume this huge share of the
economy, and a growing share over time.

And people are recognizing that in order to try and find a rational way, an
acceptable way for the American people to control these costs, we have to know
a lot more. We have to know a lot more in the aggregate, we have to know a lot
more at the individual level, and we need to know in a timely fashion. The
question of where research, where statistics and statistical systems can play a
role in terms of contributing to that knowledge is something that is on
people’s minds.

In that context, there’s a real case to be made within the Department, as
well as within the government, because it’s not just the Department alone, I
think we need to know and think about in terms of who needs to hear the
message. There’s OMB, and the White House is involved in the budget as well as
Congress, so this is a very broad audience that needs to be reached in terms of
understanding exactly what is the situation with respect to the budget.

Beyond that, Jim, do you want to add anything about budget at this stage?
Okay.

The other thing I was going to say, and Jim please add to this, that BSC
continues their review of individual programs at NCHS, that the reviews of
mortality and natality statistics are done. You think you’re going to complete
the NHIS review tomorrow; you’re starting into the area of long term care
statistics. All of this is going on in the backdrop of what resources are going
to be available to be doing these surveys.

Caroline was right that the NHIS sample is to be reduced by 50 percent in
2009. I think the healthcare surveys, either ambulatory or hospital, are going
to be – I’m not sure which ones are –

DR. LEPKOWSKI: There are potential cuts of some survey systems. So in order
to be able to pay for the more prominent ongoing data collection systems there
are considerations going on right now about cutting some of the surveys,
whether it might be nursing homes or long term care, or ambulatory care. It’s
not that there’s a particular one that’s been identified, but the Board has
actually recommended that NCHS look seriously at eliminating some systems in
order to be able to pay for adequate sample sizes with existing service.

DR. WILLIAM SCANLON: We’re at in some ways a critical time in doing this
because there is a planned redesign of the National Health Interview Survey for
2013, as well as the NHANES, and I don’t quite understand all of the
implications of this, but the NHANES contract is up in 2013. So there’s going
to be a need to think about the current design of NHANES and the potential for
revising it for the future. It’s a very rich source of information, but it’s
also a very expensive source of information.

So I think I’ll stop with that.

And, Jim, do you want to add anything?

DR. LEPKOWSKI: One item to note, one of the discussions is about merging the
NHIS and the NHANES.

Right now they are two different data systems. One of them is a private
contractor, that’s the NHANES, and the other is the Bureau of Census. So this
has major implications for how these systems are implemented in the field in
order to address some of the cost issues, and address them efficiently.

In addition, we will have in attendance, I think Steve Steindel will be
there tomorrow, people from CDC. They have a substantial concern about
biomarkers and other genetic information that is now collected at NHANES, and
possibly it’s been suggested for NHIS, and their issues concerning privacy and
confidentiality.

There is a call for a change in the current confidentiality statement that
is being used by the surveys that confidentiality was developed under the SIPSI
Act, which applies to many of the NCHS surveys. And there’s some question about
whether or not there should be an alternative to allow broader access to some
of the genetic information that’s been collected.

So there are a number of issues that may tie-in with privacy and
confidentiality here that I’m sure Bill and I will bring to NCVHS as we learn
more about it, and examine it in the context of these reviews.

MR. REYNOLDS: Larry.

DR. GREEN: Could you clarify the timing, the 2009 reduction in the NHI and
sample size, is that a done deal? If it’s not already too late, when is it too
late to do anything about that?

DR. LEPKOWSKI: I’ve just read through the report of the Panel concerning the
NHIS, that just was sent to the Committee, the Counselors. I’m not sure even
from that report when that cut may occur, whether it’s during the year or at
the beginning of the year.

So, I’m sorry, Larry, I can’t answer your question, I don’t know.

DR. GREEN: You answered at least half of it. You believe that it is not a de
facto unrecoverable error yet. But it’s close.

DR. LEPKOWSKI: Yes, the issue that came up is that the cost for the data
collection as billed by the Bureau of the Census is going up 8 percent per
year. And the budget has been flat-lined, the actual money that NCHS has to pay
for the survey is about two-thirds the actual cost. The other funds are coming
from various agencies to contribute to the data collection through their
supplements.

And the two as of 2009 are no longer – well, the Bureau of the Census
costs are going to substantially exceed what money is available and what NCHS
thinks that they can obtain.

Also on the table are issues about external funding and whether or not a
survey can exist on the current NCHS funding alone, and that’s where the
substantial budget cut would come, if that’s the direction that they’re forced
to move.

DR. WILLIAM SCANLON: It is true, Larry, in that there are possibilities if
you think about the logistics of this, about how you cut the sample by a half,
that you can delay some and concentrate the cuts in the second part of the
year, since this is a survey that is administered monthly throughout the year.

But actually in the conversations where this has come up and it’s decided
we’re going to cut the sample by 50 percent in 2009, those kinds of
contingencies have not been spelled out. It looks like there’s more
definiteness here than one might hope.

MR. REYNOLDS: Anything else? Bill and Jim, thank you, I really appreciate
what you’re doing.

Marjorie.

MS. GREENBERG: My favorite topic.

MR. REYNOLDS: That would be correct. Until we have a celebration it will
continue to be.

Agenda Item: NCVHS 60th Anniversary
Celebration Update

MS. GREENBERG: Okay. I think Harry has been talking about this kind of in a
sense short term timeframe of the next 18 months. Not coincidentally, that gets
us to about June 2010, which is when we’re planning to have hopefully the big
celebration or observation of the 60th Anniversary of the National
Committee.

Let’s put that in context. I think all the different proposals that have
come out for the subcommittees as to what you’re going to be addressing, I am
asking that you think in terms of products that you might have for rolling out
or introducing around that time. With the model of course having been a
colleague at ASPE, who I actually hired at NCHS, who was here at one of the
meetings yesterday, and she said, I can’t believe it’s the 60th, I
remember when we were working on the 50th. Well, many of us do.
Actually, I remember the 45th as well, and as I’ve said before, I
almost remember the birth of this Committee. I was born, but that was a little
young to be an Executive Secretary.

But in any event, I would thank Harry, he has given the staff quite a lot of
leeway saying that we’ve been with this Committee longer than he has, and I
really appreciate that. On the other hand, this is your Committee right now,
and we want you all engaged in this.

So some of the ideas we have – and we really have to pretty much bring these
to some closure so that we can make sure that we can deliver. As I was saying,
the 50th was when we rolled the very important visions on the
National Health Information Infrastructure, and those three concentric circles
that continue to come up in our discussions, and obviously really did I think
have an influence on the next ten years from the point of view of the health IT
agenda of the Department, and the country even, and for various reasons. But we
certainly I think contribute to that.

Then also the vision for health statistics, and I think that influences on
health vision also, and SCEMA(?) also keeps coming back in discussions after
you’ve heard over the last two days.

So whether we can top that, is a question. Those are pretty broad and they
can be an umbrella for a lot of things, or whether we want to build on those,
want to supplement them, those are all things to be thinking about. But that’s
kind of what we have as our backdrop.

One of the things that we did, so there’s documents that we’re talking
about, and those are what we did for the very important document –
actually we did a history for the 45th, a history of the Committee,
that was really the first history, but it was made possible by the fact that
there were these annual reports essentially going back to 1949. And then we
updated that with the 50th history, and I hope there’s nobody who’s
a member of this Committee who hasn’t read the 50th history
document, I know we sent it out to you. I think it’s a really useful and
important document.

So with that what we did is we updated the 45th to the
50th. What we have concluded, and the Executive Subcommittee
supported this, was that 50th history document is a really solid
document, 50 years is a milestone. So instead of touching that and trying to
like update it for making it 60 years, let’s keep that, we may reprint it or
whatever, but keep that as a major resource, and then do a 10 years out, the
last 10 years. Of course, a lot of that will focus on the health IT and just
everything that’s been going on in the last 10 years that the Committee has
contributed to and you’ve been hearing about.

We have the monograph and the important privacy recommendations, we have the
e-prescribing, we have a lot of final HIPAA stuff. We’ve got uses of data, the
two ad hoc reports, the NHIN functional specifications, and the secondary uses
or enhanced uses, and the data stewardship. So there’s more than enough to just
document and put in the context of the Committee’s history and its future.

I think that will be quite a rich document, and we’ve engaged Susan Kanaan,
who did the history, the other histories, to work on that. So we’ve agreed on
that, essentially getting started on that. In that context it’s summarized here
in the Executive Subcommittee conference call from I believe it was July when
we discussed this, and this was endorsed by the Executive Subcommittee.

We will then not do annual reports for 2007 and 2008. We’ve been doing
biannual recently, but 2005/2006, so we’re not going to be doing a 2007/2008
stand alone because we’re doing this 10 year thing, and as a result we really
shouldn’t do a 2009/2010 either. We’ve got to conserve resources but we don’t
want to be duplicative.

We will do sort of an accomplishments document that we can post on our
website, like a bulleted thing or something. So that’s all described here on
the last page in tab 7. If you have any concerns about that, let me know.
That’s what our plan is. Those will be important, and they’ll get wide
distribution, and you will all get an opportunity to review them, etcetera.

Then if you recall last time I sort of got into this idea, and I think
others joined me, on this idea of a series of events. We actually established
in ’49, so the 60th birthday, as it were, is really 2009. We’re
almost at 2009. We have a new administration for sure coming in, all of that, a
lot of new members. So we felt like we should defer this actual celebration to
2010 just as we had the 50th in 2000.

But we could be doing kind of a series of different types of things. One of
the things that I have suggested is Susan Kanaan interviewed or had sort of
oral histories or whatever with the Chairs, some of the Chairs around the
history, the 50 year history. I would really like the idea, and this was sort
of inspired by a visit to Dr. Carr White in Charlottesville, it is also
described here that we went in May to see Carr who’s just a giant of course in
our field and was a Committee Chair in the 70s, is to have some kind of event
convening the Chairs.

There are a number of living Chairs still out there, they’re all exceptional
people, and they’ve all retained an interest in the Committee.

DR. STEINWACHS: So, Marjorie, is there any evidence about whether or not
serving as Chair increases your longevity, or decreases it, or it makes no
difference?

[Laughter]

MS. GREENBERG: It doesn’t seem to lower your longevity, that’s for sure.

MR. REYNOLDS: Simon’s still hanging in.

MS. GREENBERG: Yes.

DR. STEINWACHS: Yes.

MS. GREENBERG: We haven’t lost him yet.

MR. REYNOLDS: I’m watching Simon.

MS. GREENBERG: There is this concern, we were talking about it last night, a
lot of people are concerned if they retire from their jobs they will drop dead.
There’s some evidence that it happens to people, but it doesn’t seem to happen
with Committee Chairs.

DR. STEINWACHS: I thought we could always put together a little evidence in
the 60 year report about the longevity of our Chairs, and maybe members.

MS. GREENBERG: How about Executive Secretaries? I don’t know.

DR. STEINWACHS: We can do a population health study on them.

MS. GREENBERG: So I have this idea of maybe an event in Charlottesville,
which isn’t that far away and where Carr White is living, and he is in his 90s
and I must say incredibly vigorous but doesn’t do much traveling anymore, and
that would be something we could videotape. We could also get some kind of
document out of that. I think it would be really great. So that’s one idea.

Don and I, we just haven’t let go of that 21st Century vision.
The latest thing we were talking about just this morning is at least doing
something to address, okay, we gave this vision, we had all these influences on
health, 10 years later are we collecting more data in these areas, what is the
data we have, where are the gaps, and that relates to what Paul was talking
about. We don’t want to really revisit the recommendations that had to do with
the enterprise and all that, they were sort of dead on arrival in a sense. And
we’ve moved on from that.

But there’s content in there, there’s things that conceptualize the system.
We just heard about the degrading of population health data, so it doesn’t look
like we’ve actually got more, it looks like we’re getting less. I think we’re
still playing with that, but it’s something that we would like to do.

Then there are some other things. I am, as you all know, the head of the WHO
Collaborating Center for the Family of International Classifications for North
America, it’s quite a mouthful, but it’s for the U.S. and Canada. We have our
annual meeting with other collaborating centers later in October. The theme of
this meeting is Public Health Informatics, and it’s actually going to be
followed by a conference – both these meetings are outside of New Delhi, India
– followed by a conference on Public Health Informatics in the Asia
Pacific Region.

This will be I think the third in a series of conferences being held on
Public Health Informatics. There was one in Seattle last year, which I believe
Walter went to. One of the recommendations, this Committee was initially
established because the World Health Organization recommended that countries
should have national advisory committees to oversee partly the international
classification of diseases. Frankly, this is going back to ’49 or ’48. WHO just
observed their 60th anniversary, so we’re one year later.

A lot of countries that are struggling with vital statistics systems, a lot
of countries do not have, I mean, we thought we had a functional vital
statistics system, but we’re starting to wonder whether we can really be a
model for the rest of the world in light of some of these problems we’re
having. Nonetheless, this is still a major problem in the world, having
functioning vital statistics systems for birth and death.

Again, you come back to the suggestion that these countries maybe should
consider a national advisory committee made up of stakeholders that can provide
advice and bring in on the whole area of population health data.

I’m going to do a little poster for this upcoming set of meetings on the
National Committee on Vital and Health Statistics 60 Years of Making a
Difference, that’s my theme. If I could have a few people who would be happy to
look at – I have to do this in the next few weeks. I think it relates to
Public Health Informatics, it relates to the Committee’s history and what role
a committee like this can have, so that it’s not just documenting it but
suggesting to other countries, maybe bringing out of the woodwork and finding
out about other advisory committees in other countries. We know that other
countries, certainly developed countries, do have similar types of advisory
mechanisms. I just thought it would be kind of nice thing to kickoff the
anniversary celebration with this poster.

So does anyone have a problem with me doing that?

MR. REYNOLDS: No.

MS. GREENBERG: Okay. A few people, I know Justine who’s really our in-house
historian now on the Committee, will be happy to look at what I prepare. It’s
not going to be – there’s a template and it’s not huge. I want to capture
pieces from the three diagrams, the influences on health, the population stuff,
standards stuff, privacy and confidentiality, all of that, very succinctly.

So if there’s anyone else who would be willing to review this? I know,
Harry, you’re willing to. It might just be the Executive Subcommittee. Okay,
great, the Executive Subcommittee. If there’s anyone who’s not on the Executive
Subcommittee and is interested in this and thinks they want to get their oar
in, let me know.

Mark, thank you.

Also, our North American Collaborating Center has an annual conference, or
has in the past for the last 14 years, on the International Classification of
Functioning Disability and Health, ICF. This Committee has made really
important recommendations related to ICF, which have now been endorsed
essentially by Consolidated Health Informatics Initiative and the Institute of
Medicine. That doesn’t mean that we have resources to really implement ICF in
systems, but it certainly still has legs, as Larry would say.

So I’m thinking that our 2010 conference, this year again we’ve had 14
annual conferences on the ICF, U.S. and Canada learning about applications of
ICF, ways to improve the ICF, etcetera. We are not able to have the
15th in 2009 because of the budget constraints. So it even impacts
on that little activity.

We’re just going to have some kind of educational event or something on ICF
if we want to. But in 2010 I want to have the 15th annual, or almost
annual, and that would be perfect to kind of align it with the National
Committee given your recommendations.

If you are interested in partnering on us with that in some way we would
welcome that, and it could fit in very nicely with some of the work that
Quality Committee is talking about doing in person centered stuff. Because I
think one of the things people care about the most is their functioning and
their social participation, and those are captured in ICF.

DR. WARREN: Plus it’s a code set.

MS. GREENBERG: What?

DR. WARREN: It’s a code set of standards.

MS. GREENBERG: And standards also. So it has a lot of things. So if that is
attractive to you, we got to start working on that now, too.

That kind of leads to asking each one of you to think in your own
organizations is there something you’re planning to do in the next 18 months
that relates to the work the National Committee does that you could highlight
the 60th Anniversary of the National Committee. See I’m losing sleep
thinking about all these things, but I don’t want them to just be my pet
projects.

Is there anything Blue Cross Blue Shield is doing that might fit in with
this?

Is there anything your universities are doing?

Is there anything your think tanks are doing that you’re going to be doing
anyway?

I’m not offering resources other than moral support and maybe some people
being there and some joint planning, because obviously resources is not what I
have a lot of, just a lot of ideas.

You can cut me off whenever you want to.

Is this something that people would be receptive to? I would like to make a
splash over the next 18 months to 2 years. I think the Committee has a lot of
visibility now and it is valued, and there are a lot of synergies. So that’s
something to think about, and then we’ll see how we could partner with you or
otherwise.

DR. WARREN: I think that is like exemplars, or something that would be more
along the notion of tabular data.

MS. GREENBERG: I’m actually thinking events in a sense, either publications
or events, meetings that you know are coming up in 2009 or 2010, or activities
that you’re involved with, that have synergies with the National Committee and
particularly the recommendations we’ve made over the last 10 years, whatever.
That you could have a session or a segment or something that highlights the
relationship of this to work of the National Committee. It is actually this is
a series of events things.

Because we know that our 60th celebration we’ll invite people
broadly, but there will be a limited number of people other than the Chairs, we
can’t travel people to it, the former Chairs I mean we’ll do that. So this is
an opportunity to get it out into the field, into the community where people
are working and living. Maybe we could think of two, maybe we could have ten,
who knows. But that’s what I’m really thinking of, like the Public Health Data
Standards Consortium, which Walter and I are very involved in, there’s a lot of
synergy.

I think we, being creative, we could think of something to also kind of
highlight the 60th Anniversary. I’m just thinking there are
opportunities here and putting that out as a possibility.

MR. REYNOLDS: Mark?

DR. HORNBROOK: What’s the politics of partnering with the Commonwealth Fund
or Kaiser Family Foundation for sponsorship for some events?

MS. GREENBERG: The fact is that all of those I think, it was Kellogg in
particular, I think, when we did the 45th Judy Miller Jones was the
Chair of the Committee, and she of course on the National Health Policy Forum
and those are her main funders, the ones you just mentioned, and I added
Kellogg and we actually got some support for them. She put a huge amount of
time into doing that.

We’re hoping that at least our basics, all the stuff I’ve described, is
going to require having a budget for NCVHS obviously.

Jim, I think you were out of the room, but it’s not too early, and I think
they’re going into a renovation, but to be talking with the National Academy of
Sciences about a date in June 2010 to have the culminating event, or the near
culminating.

The other thing is that the –

MR. REYNOLDS: It will be at the new building.

MS. GREENBERG: Yes. NCHS has a data users conference every other year. The
last two conferences, this year and two years ago, frankly one of our most
popular speakers was Harry Reynolds. Would you have thought that Harry would be
it was like a hand in a glove at an NCHS data users conference?

MR. REYNOLDS: Scare everyone.

MS. GREENBERG: Because he really got into uses of data and data policy and
all that, they loved it. The next data usage conference will be in the summer
of 2010, unless we can’t even do that, but hopefully we will. So we’d certainly
want to have an NCVHS session there.

That’s the kind of thinking I’m doing, having sessions here, sessions there,
raising the flag. Not just to make us feel good, but to get input in these
places where people don’t normally see us, or get a chance to talk with us.

DR. MIDDLETON: Marjorie, I first of all really love the idea, and I think
it’s important to acknowledge this Committee and all its work, and oftentimes
it is behind the scenes, people aren’t aware.

My question is, what can we do in terms of a marketing communications
campaign, can we leverage any HHS resources, can we ask of AMIA and HIMA(?) and
all the relevant societies and make them aware early on, so programmatically
they can fit us into a slot on whatever programs they have? Because they’ll
need to know well in advance.

MS. GREENBERG: I agree. That’s why I’m putting it on the table now, and I
know many of you are leaders in these organizations. But I think maybe we can
talk a little more about this this afternoon, and particularly in October.

I wanted to plant the seed here because you’re right, it is 18 months, or
I’d say it’s 2009/2010.

MR. REYNOLDS: Larry.

DR. GREEN: I would like to hearken back to the quick exchange with Don a
while ago about you sharing this notion about a 21st Century vision
of health statistics that we’ve got to do something about, at the end of Don’s
readout, that’s still on our Subcommittee sort of stuff.

At the risk at just stating the totally obvious, when I run back through my
head the readouts we just heard from our subcommittees in September of 2008, I
would be very surprised if the NCVHS was not at a point in the middle of 2010
to be able to outline any merging vision of what that’s actually going to look
like when the NHIN is worrying about this country and privacy issues, and
wrestled into submission in some way.

These sorts of historical events, in my view, are brought to life primarily
by a notion about what they’re doing right now that matters to the people in
the room. I want to just slightly agitate that we think about building our
subcommittees, the work we’ve been talking about the last 36 hours.

It seems to me that we should in some way assimilate in real time what we’re
learning and see that 2010 event as something of a target whereby we try to
hold ourselves accountable to each other to assimilate across our subcommittee
work something that is envisioning the way the NHIN was envisioned around the
50th celebration. And that’s the one that’s trying to happen, in my
view.

I vote we go with the flow, use what we’re doing, as opposed to setting that
aside as sort of another thing that we need to do something for. I’d like to
infuse into that event a distillation and synthesis of where we are in terms of
this envisioning of what Carr White taught me to put the two words together for
the first time for me: statistical compassion.

In a 21st Century vision of what statistical compassion looks
like is: fill in the blank.

Agenda Item: Wrap-up, Closing Comments

MR. REYNOLDS: Good input from everybody. I appreciate everybody’s energy.

The Executive Subcommittee will be getting together this afternoon, and
we’ve got to come out with something better than just the discussions we had
today. I think we made a good list of things, but I think this vision is key.
I’d like to be sitting here 18 months from now having added to some of the
value of the things we already heard, and/or coming up with some of our own
back based on what Larry just said. We have to figure out how to make a
difference and continue to make a difference, not just for 18 months, and I
think that’s going to be really key.

Last point of business. I’d like a round of applause for Steve Steindel.

[Applause]

MR. REYNOLDS: Major contribution to a lot of us on the Committee, and a lot
of us personally.

Steve, thank you again. Mary Beth isn’t here or I would –

MS. GREENBERG: But she was at our meeting this morning, and we told her that
we had recognized her.

MR. REYNOLDS: You did the same thing? Well, that’s a good thing, okay. And
we will be sending out letters too on both, but I didn’t want to do that.

Is there any other business?

MS. MIRAM: Could I request an hour for lunch?

MR. REYNOLDS: Yes, because I believe even if we come back at 1:00 we will be
done probably by 2:30, in preparations.

Lunch it says on the agenda 12:00 to 12:45, we’re going to do it 12:00 to
1:00, and I said even with that I believe we will be out of here before the
prescribed time.

Thank you, everybody.

Meeting adjourned.

(Whereupon, the Full Committee adjourned)