[This Transcript is Unedited]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
February 14, 2007
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, D.C. 20201
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030
TABLE OF CONTENTS
- Full Committee Meeting — Plenary Session – Call to Order – Simon P. Cohn, M.D.
- Data Linkage Issues – Donald M. Steinwachs, Ph.D.
- Committee Actions
- Subcommittee on Standards and Security — NPI Letter
- HIPAA 8th Report – Jeffrey S. Blair and Harry Reynolds
- Discuss Issues for 2005-2006 NCVHS Biennial Report
- Subcommittee and Workgroup — Additional Updates
P R O C E E D I N G S [10:15 a.m.]
DR. COHN: Well, good morning. Happy wintry wonderland outside and, of
course, Happy Valentine’s Day. I want to call this meeting to order. This is
the second day of meetings of National Committee on Vital and Health
Statistics. The committee as you all know, is the main public advisory
committee to the U.S. Department of Health and Human Services on national
health information policy.
I am Simon Cohn. I am associate executive director for Kaiser Permanente
and chair of the committee. I want to welcome committee members, HHS staff and
others here in person. I don’t believe we are quite on the Internet, but we
should be shortly. As you all discovered yesterday, especially our new members,
you need to speak clearly and into the microphone. These are unusually
difficult microphones in that respect.
With that, let’s 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 relating to any of the issues coming before us today,
would you so publicly note during your introductions.
I want to begin by observing that I have no conflicts of interest.
I will do introductions and then we will talk about the agenda for the
morning, knowing that as previously mentioned, we will be adjourning by 12:00
noon and that there will be a hearing of the Population Subcommittee planned
for this afternoon.
MS. GREENBERG: Good morning. I am Marjorie Greenberg from the National
Center for Health Statistics, CDC and executive secretary for the committee.
MR. ROTHSTEIN: I am Mark Rothstein, University of Louisville, School of
Medicine, member of the committee. No conflicts.
DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center, member of the
committee, no conflicts.
MR. REYNOLDS: Harry Reynolds, Blue Cross Blue Shield of North Carolina,
member of the committee and no conflicts.
DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of
the committee. No conflicts.
MR. LAND: Garland Land, NAPHSIS, member of the committee. No conflicts.
DR. VIGILANTE: Kevin Vigilante, Booz-Allen & Hamilton, member of the
committee, no conflicts.
DR. FRANCIS: Leslie Francis, University of Utah, member of the committee
and no conflicts.
DR. STEUERLE: I am Gene Steuerle, The Urban Institute, member of the
committee, no conflicts.
DR. SCANLON: Bill Scanlon, Health Policy R&D, member of the committee.
DR. GREEN: Larry Green, University of Colorado, member of the committee. No
DR. OVERHAGE: Marc Overhage, Indiana University and Indiana Health
Information Exchange, member of the committee and no conflicts.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention,
liaison to the full committee.
MR. BLAIR: Jeff Blair, Lovelace Clinic Foundation, member of the committee.
MR. SCANLON: Good morning. I am Jim Scanlon from the HHS Office of Planning
and Evaluation and I am the executive staff director for the full committee.
DR. COHN: Let’s talk about the agenda for this meeting. Actually, will
those on the phone please introduce themselves.
DR. STEINWACHS: Don Steinwachs, Johns Hopkins University, member of the
committee. No conflicts.
DR. COHN: Thank you for joining us.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and
Quality, liaison for the committee.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member
of the committee. No conflicts.
MS. MC CALL: Carol McCall, Humana, member of the committee. No conflicts.
DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the committee.
DR. COHN: I guess I should ask about John Paul exactly, whether he has made
it to Pittsburgh or whether he is calling in from Reagan Airport.
It has been a good morning and I think we are all recovering from a little
bit of snow in Washington, D.C.
Of course, I should comment that this has been somewhat exceptional meeting
in the sense that we have had to adjourn early yesterday because of the threat
of weather and then actually over the night there actually was some weather.
So, the new things are relatively slushy and obviously, we will appreciate
everybody’s ability to make it here, as well as those calling in on the phone.
I do think, in terms of the agenda, and we are going to change the agenda
around a little bit. I do want to make sure that we have an opportunity to talk
about issues and issue papers that are likely to be coming up over the next
couple of months.
I would suggest that includes a topic that we didn’t get to yesterday,
which is this discussion paper on data linkages that I would like Gene Steuerle
to talk about a little bit just because I think we should be expecting that to
be coming forward, at least certain aspects of it potentially is a letter for
full committee discussion either sometime between now and probably our June
I am also going to ask Harry Reynolds and Jeff Blair to at least briefly
discuss an early draft of a letter that was supposed to be discussed at the
Standards and Security Subcommittee, but, of course, as we know, that was
cancelled. So, this has not been vetted within a subcommittee yet, but once
again, it is likely to come up as an issue in the relatively near future.
Then we will reflect a little bit on the HIPAA annual report. Now, my own
view, and we will discuss this sort of as the morning goes on before we
adjourn, is there will likely be a need for (a) some conference calls by
subcommittees and workgroups, as remember, Populations, Privacy and Standards
and Security and the NHII workgroup, all had their subcommittee and workgroup
So, this will have to be taken care of by the phone. But I think there is
also going to be a need for a full committee conference call between now and
June to deal likely with a couple of the letters we are talking about, as well
as potentially the HIPAA report. So, I mean I would just suggest that. I mean,
the good news, well, actually, for better or for worse we obviously didn’t have
— haven’t had a full committee meeting and will obviously be trying to make up
for that by a conference call and I hope we have your concurrence on that
before we adjourn today.
So, we will talk about these three issues. I would still obviously like if
there is time permitting, to talk a little bit about the international
activities, but we will sort of see how that all goes.
I should also comment that between now and the next meeting of the full
committee face to face, there will be a meeting of the Executive Subcommittee.
We will be talking a lot about strategy issues and hopefully revisiting the
strategic retreat that occurred in June and we will be bringing to the
committee discussion in June sort of some additional thoughts and compilations,
I think, based on our experiences of the last nine months.
So, if we don’t make it to a full discussion of cross cutting issues today,
be aware that we will be bringing that forward in June.
So, with that, Gene, I actually would like to start out with you talking
some about your — the data linkages thought paper you had and maybe you can
brief the committee on it, as well as give us some ideas about where you think
that this is going and I presume there is likely to be a letter coming forward
at some point from the Population Subcommittee.
DR. STEUERLE: I would encourage other members of the subcommittee also to
chip in and I know Don is on the line here.
We held a Data Linkages meeting, which I think was quite productive. We not
only had representatives from many of the health communities, such as AHRQ or
ASPE or CMS or NCHS. So, we had representatives from many, many of the parts of
HHS, the health research community, but we also had representatives from Census
and IRS and Social Security and the Veterans Administration.
This is one of these areas where people sense — you could sense from the
dynamics of the meeting that people felt a tremendous potential if we could
figure out how to work together and combine and use these data sets. At the
same time, sort of a sense of frustration often with how do we really make it
happen. Then part of the purpose of the hearing was not only to try to identify
a number of opportunities, but actually to try to figure out how we can break
through some of the barriers.
I think anyone who has worked in a bureaucracy and has had their own set of
assignments and sees other things that aren’t being done knows this feeling,
especially if that other assignment is not really part and parcel of anyone’s
assignment within the agency itself.
Among the barriers that people talk about, Census is actually doing
probably I would say the most significant job in terms of actually trying to
create a data linkage center, but, of course, then they also don’t have access
to non-health data. HHS can do some data linkage within itself but often they
use it to really merge their data with other data such as social security data
or census data and then, of course, there are all the issues having to do with
whether these linkages do or do not improve your information.
For instance, there is a very large gap in the estimates of the Census
Bureau and Medicaid in terms of Medicaid participation. It would be nice to
know what those differences are in part because it is often with the Census
data that we are able to identify the characteristics of the people that are
getting Medicaid or they are not getting it. When you have these types of gaps,
it creates a real gap, not only in terms of our knowledge of what is going on,
but actually how to administer the programs.
So, where do we think we might head? Well, the recommendations that we are
thinking about putting forward, we listed seven. A couple of them are somewhat
innocuous, like commend the Center for Medicare and Medicaid Services for its
forward thinking. Of course, we are going to do that. But, in fact, I think
they are actually in particular within the center and also within Jim’s office
actually thinking very dynamically on this.
I should say, by the way, the draft of a summary of the workshop was
actually prepared by Jim’s staff and they really did a nice job of pulling it
A second recommendation would obviously be to encourage continued research
to improve technologies. Let me list these and I am going to come back to a
particular issue. A third one is to more formally inventory HHS program data to
more formally try to identify where administrative data systems could be
beneficially linked, either with survey data or with other administrative data.
A fourth one is to try to set department-wide standards for linking HHS
administrative data systems. The reason for this recommendation came in part
from the discussion at the hearing that every time someone wanted to go through
a particular data linkage, they often had to go through a different set of
protocols. There weren’t these standards, not only within HHS but sometimes
across agencies as opposed to just having a common form, a common way of trying
to get through not just the standards but then getting through the legal
questions of confidentiality.
A fifth one is to look for ways to reduce time to get the permission. This
is, again trying to simplify or streamline the enormous permission efforts that
go into trying to link data sets. It really can be mind boggling, so much so
that someone trying to undertake a project often drops out of doing it.
More formally, we were thinking about suggesting a program for conducting
research on the quality of linked data sets because linked data sets, while
they improve our information also have quality issues.
And then the final one is to explore ways of working with other agencies,
such as OMB, Census and Social Security, among the ones I have mentioned.
One of the issues here, as I say, is how to more formalize this issue
within the department itself so that it is not just a second or a third or a
fourth thing someone would like to do as part of their job, which tends to, I
think, deter a lot of the potential.
The difficulty for us is while we might have people who came to us and say,
gee, I would really like to do this particular data linkage to do this
particular research project, that is at a level of detail that probably this
committee can’t get into, but yet that is really the heart of the matter is
identifying these items and then trying to figure out some way to allow it to
I should say also — and I probably should have begun with this — is with
linkages there is an enormous potential, not only for improving information,
but for doing it very, very efficiently because when you are talking about
linking data sets, you are talking about linking information for which the cost
of retrieval and collection has already been paid. In the case of surveys, you
actually put a lot of money into the collection with its administrative data.
If you can link those and make use of them as opposed to survey data, you don’t
have to pay to go back out and collect information. People in some sense or
administrators have already filed a tremendous amount of information, but often
without thought as to how it is going to be used by the research community.
So, the potential for saving as well as efficiency is enormous. So, what
would we — what are we exploring doing as next steps? Again, this is outlined
in a draft that Jim’s staff prepared, but one is do we prepare a memorandum to
the Secretary and if so, how exactly do we make our summary and our
recommendations? It seems like outside of the commending of people, which is
nice, we need to figure out some way of perhaps formally trying to jump start
or push forward this agenda.
Another step would be examining accessing data for policy and research
purposes and whether we want to go further into the — there are various
federal requirements of protecting and accessing data systems. This actually
gets into privacy and confidentiality issues, by the way, as well. Mark and I
briefly talked about whether we need to have some discussion there.
Areas of research include are there ways to create synthetic data? There
are ways of taking data sets, combining them together, say, for instance,
merging three or four records together into a single record and determining
whether this type of synthetic data is useful for — and sometimes it is
useful, sometimes it is not. That, again, takes research.
An issue came up, Jim raised it yesterday, with research centers is can we
figure out a way to make better use of research centers as a way to get outside
access to data. We can talk the world about trying to combine data together,
but if users can’t really get access to it, you can spend moderate or a fair
amount of resources pulling together the data and then no one really is there
to be able to use it.
Somehow or other we need to really cope with this issue of being able to
get researchers using access to data. By the way, it was a major topic raised
by almost all the participants at the panel is that we often think of really
good things to do but then we really can’t get the researchers to do it. Of
course, in many cases, we being a researcher here, a researcher there, haven’t
thought of what another researcher on the outside might think to do. I mean,
just think of trying to corral some of the dissertation writers in a variety of
medical and social science fields to be able to use these data. Right now, they
have a very, very tough time getting in to use it. If they do get in, it is
often months or years in the process.
So, can a research center deal with this issue? That is a very important
Then there are other issues, such as a little bit more of a flyer, but, you
know, can we make better use of Internet systems? You know, we claim that
confidentiality prevents us from doing a great deal of things, but the Defense
Department, which has to do a few things on time without waiting for months to
get approval, has a number of Internet systems for accessing highly secret
information and are there ways we can learn from that.
Finally, we need some rules for tabulating sensitive data, as opposed to
just saying we can’t do anything with the data. So, these are the things we are
exploring doing as the next step, possibly putting in a memorandum to the
Secretary. As you might guess, a great deal of this depends on discussions with
offices like Jim’s because in many ways what we are trying to do is really
empower the people within the Department themselves to be able to do much more
here, but by giving it a little higher profile, we are hoping we can move that
So, I don’t know whether Don on line or Bill or Kevin, who else — Garland
is joining but I think he missed the meeting, but who — anybody else from the
subcommittee want to jump in here?
DR. COHN: Don, do you have some comments?
DR. STEINWACHS: I think, particularly, I understand, even within Jim
Scanlon’s shop that just aren’t done because it takes too long or it is too
hard to put the data together to get the right kind of information for policy.
So, this is both an issue internal to the capacity of government to do its job
well, as well as the issue for the opportunity of the research community to
really give us insights that we don’t have now. So, access and timeliness are
really the two big issues and I think what Gene did sort of summarized all the
pieces that we looked at and I think it needs a way to pull that together into
DR. COHN: Kevin.
DR. VIGILANTE: The only thing I would add is that there are interesting
parallels, I think, between the hearing on linkages and the hearings we are
going to have on the data required for surge capacity because after all, you
know, there is data already being collected by a variety of agencies and
entities that has gaps, duplications, but that could benefit from linking —
and the hypothesis is that linkages in that environment would also bring
benefit in terms of getting more bang for the buck, so to speak.
So, I think we bring this, you know, I think it was very instructive and I
think bringing that perspective into this preparedness environment will also be
a useful perspective to maintain.
MR. SCANLON: Just a couple things. I think this is a good area to look at
and I think if we can find — the committee can find a way to make some good
recommendations, it would really be very helpful to us because we struggle —
as Gene said, we struggle with this all the time. My office has — we have
probably sponsored a fair amount of this. We have linked survey data, social
trivia data to Medicare data all in one and it really is a — there are so many
obstacles to overcome. You are worn out by the time you do it.
Then you spend so much time just on that part of it that the analytic part
of it, I think, just doesn’t get enough attention. But the other thing I was
going to say is the — in a way the statistical system and the research system
has kind of responded to what the capabilities were over the years. First, it
was, you know, the answer was published reports and tables and analyses. Then
there was an additional element of public use data tapes where you had
non-identifiable micro level data for researchers, as well.
Then we moved to this web-based and we had this on the Data Council web
site as well, well, on our statistics gateware, where you can request public
use data files, but you can also create your own tables or do your own analyses
if the agency has them on its web site.
Then the research data centers were sort of the next development, where
under protected circumstances, researchers and others could get access to data
that would otherwise have to be identifiable and the agencies couldn’t release
that. So, in other words, you specify what analyses or what tables you would
like to have, but you never as a researcher walk away with any identifiable
data. That is kind of where we are now.
I really think we need another step beyond that now. I think there is some
other — maybe that is the way of thinking ahead. I mean, the committee has
always been sort of in the position of leap-frogging in a way, like with HEALTH
NT(?) and other things, public health data. The research data centers, they fit
their freely fitted niche. They are sort of boutique kinds of operations. You
are probably not going to have many dissertation students doing this because it
takes a lot of effort–it just takes a lot of effort.
But if the committee could think of some ways to
— what would the next generation look like of an analytic center that could
protect data, but at the same time link data, at the same time just make it a
little easier. I think we are having — we had to cancel today at our HHS
Internal Data Council today, for example, we were going to be reviewing the HHS
agencies data center experience and CMS, AHRQ, NCHS and SAMHSA and we sort of
have pieces of these in other agencies as well. You know, they fit. They
clearly — they are popular and they fit certain needs, but they are fairly
intensive and in some cases you literally have to be on premises. Not many of
them have remote access. Again, this is a balance of privacy versus data
Any way the committee could help us there would be helpful. Then as a
corollary, in our office, we are looking at this interest, not just linked
data, but how can we improve — we always have challenges of making the best
use of the data we already have and we clearly don’t. I mean, clearly, you are
limited by resources and various other things.
Then there is the other stuff of what data does no one have and that is
always the place where we are looking for new investment or redirecting
investment and so on. Many of these are in the nature of improving access to
data we already have. So, we are looking at — we are interviewing members of
the policy community, if you will, folks who are not statisticians and
researchers, but who are kind of the just the policy researchers or the
decision-makers or the staff to those folks, who are usually the gatekeepers,
in terms of how do they use data. What do they look for?
We have a few of them right here, by the way. But how do they use data?
What do they find? How do they approach it? Which of our data do they find are
the most useful and most of all, what would they think would be ways of
improving that. So, I think this could all tie together really.
DR. SCANLON: I won’t repeat the themes, the real potential here and the
fact that we haven’t utilized it completely and there is a real interest in
doing that. But I just wanted to add this also turns out it is an area where
there is a strong sort of overlap between the Board of Scientific Counselors
and our interest and we have had conversations. Debbie Jackson went to attend
their meetings in New York in January. We had a couple of conference calls with
members of the board and John and I are going to be attending the meeting in
April. Their interest is in what we have worked on in the Data Linkages
Workshop, as well as being very particular in sort of the issue of how do we
get better access to the data.
The research centers and what niche they fill and sort of what — which
niche they don’t fill has been a focus that this is something that we will
pursue, as well as I think it is the start of a much stronger interaction
between NCVHS and the board in the sense that we have got a common interest
through the Population Subcommittee in data for the 21st Century. They are
going through review of each one NCHS sort of programs. They are going to be
sharing those with us and I think that is both sort of the issue of kind of
what is going on currently in NCHS, how does it relate to data needs for the
21st Century, as well as how does it relate to the data linkages issue in terms
of always maximizing the potential that we could of the NCHS sort of capacity.
DR. STEUERLE: If I could just add one footnote here, too.
There are structural issues here involved. One of them is, of course, the
legal issue, whether there are legal barriers and whether there are actually
policy recommendations that need to be made. For instance, you know, just
simply allowing, since this is a center you do it or whether HHS has one
allowing some of these linkages to take place across agencies, that is still
not very clear.
I don’t know how far we want to go into looking at that. The other
structural issue, I think, is it goes back to this accountability and
responsibility. In some sense nobody is really accountable or responsible for
making it happen. If I can think back to NHII discussion, you know, eventually
you wanted to have a national core data because you — not just simply because
you want somebody to coordinate things. You wanted somebody whose success or
failure would be measured by whether he could advance that ball.
This particular case where, for instance, if you send something to say
privacy lawyers, they may say, you know, all their incentives are to say no
because in some sense — don’t get me wrong — because if you say yes and
something wrong happens, you get blamed but if you say no, it is not possible
under the law, no one is really going to blame you. You are interpreting the
So, the question is — I am not saying there aren’t people — don’t get me
wrong. Their people there are legal experts I am sure within HHS, who very much
try to advance the ball because they care about it, but it is not clear who has
responsibility for saying, okay, do we move — is it — forward and the ability
to improve health outcomes with better information is extraordinary here.
I mean, we are not really just talking about some narrow researcher’s
agenda. There is just extraordinary potential here.
DR. COHN: Gene, I had no idea you had spent so much time with lawyers, but
DR. STEUERLE: It didn’t take much time. I was with Treasury and IRS for 15
DR. COHN: Leslie, you had a comment.
DR. FRANCIS: This isn’t a legal point at all. I just wanted to point out
that I don’t know whether you have thought about this and it is probably way
down the line but there are some state agencies in addition to research centers
that have some very good data sets that it might be interesting to think about
MR. REYNOLDS: Gene, for those of us who aren’t as close to this, what kind
of data are you guys talking about? What data are you trying to link together?
DR. STEUERLE: Well, almost everyone that we talked to had a different idea.
I mean, actually part of my own motivation was because I had been very
interested, say, in Medicare data linked with social security data, which would
allow me to measure lifetime earnings and who was getting what Medicare
benefits, which is a much better than annual income. That would be an example.
There are other actual health data, which is health outcomes or if you could
actually measure health outcomes, you could — I am probably remembering my own
anecdotes and there are 30 others from the committee.
The President recently produced a major change in the taxation of health
benefits of people and yet we need better linkages of the health insurance that
people are receiving with their actual status to be able to predict who wins or
who loses from those types of things.
DR. SCANLON: Some of the linkages have been surveys either done by NCHS or
done by CMS and between the survey respondents’ information and their Medicare
claims and this really enhances the power of that survey in terms of
understanding what is the experience of these people.
DR. STEUERLE: The health outcomes of Census data so you can really get a
very good socioeconomic view of who is getting what or not getting what.
DR. COHN: Larry.
DR. GREEN: Has the subcommittee heard anything or thought about how data
linkage connects to community-based participatory research?
DR. STEUERLE: I don’t think we had any witnesses on that. There is nobody
who actually touched on that, but clearly relevant.
DR. SCANLON: Actually, I guess, one of the things that was touched on is
the barrier that is created when one tries to look at communities or sort of
smaller geographic areas, that the issues of confidentiality and privacy become
even more profound when you start to subdivide the country. This is a problem
because there is the issue of community. There is the issue of markets. If you
are an economist, how do markets differ and how do those influence the
experience that people have are critical and, yet, when we talk about creating
a data set that may have wider availability, we end up stripping out all kinds
of this type of information in order to protect the confidentiality.
DR. GREEN: It seems to me, as a newcomer here, that community-based
participatory research is trying to emerge in the United States. It is a 50
year old concept. It is a proven concept. There is a great deal of evidence
that supports that it is a way to actually achieve public health improvements
at the community level. You know, you don’t save the world with it. You just
save your town.
That specificity is its great, great strength, plus the fact that it is
research that from the initiation of it is designed for action at a community
level. What I am hearing from the folks in Africa, Australia, Canada and the
U.S. that work this territory is that they see that they are, particularly in
the United States, awash in data from these large data sets that are unlinked.
We do run into the problems Bill just mentioned when you do move to a
particular market or a particular geopolitical unit.
But they know that you have data for their citizens, their people there. I
think one of the first ones Gene made was how expensive it is and how much we
spend on getting these data collected. From a public perspective, if the
government has these data and we need them to answer questions that at a
community level we would like to take action on, one of our greatest needs is
to measure baseline, do something, initiate a program and remeasure it.
What I am hearing is that it cannot afford that cost that they are
wondering if there aren’t some systemic solutions, very much like what I just
heard, that might allow at least at a state level and in some instances when
you look at Census, you could drive it all the way to block group level for
some of these areas.
I think they are looking for help. So, the point I am driving at, if this
hasn’t been connected into this subcommittee’s thinking, it is possible in our
mission to actually look for ways to promote public health and the public good.
But this is actually potentially very important and we might have use cases,
many, multiple use cases spring up from around the country that would move away
from just being the nerdy-headed researchers like me, that are prepared to go
to the trouble to arrange the RESDAC(?) visit and to do all that, but we just
got school teachers and principals and local businessmen that are really going
to come to the table and talk about what they need to do to make their town
healthier and they are prepared to measure it. They would like to work with
somebody on this, but they really can’t get there.
This use for these data might really put energy into this linkage. And you
may think that is totally crazy, too.
DR. COHN: Larry, I am glad that you are joining the Population
DR. GREEN: [Just for] advertising, I just realized that for people
listening, my name is Larry Green and Lawrence W. Green really has authored a
great deal of literature about community-based participatory research. I want
to give him due credit. Just because I have his name, I am not that guy. There
is another Larry Green that really is a driving force for community-based
participatory research and that is not me.
DR. HOUSTON: Did he publish the article two weeks ago in JAMA? Who was
that? Was that him?
DR. GREEN: That was not me. That was him.
MS. GREENBERG: I think he was also a member — he was a former member of
the committee, the other Larry —
PARTICIPANT: And the CDC.
MS. GREENBERG: I wanted to mention kind of picking up a thread from
yesterday that another major type of linkages that goes on is — I mean it is
the ultimate health outcome with death records and there is the National Death
Index is used extensively to link both by researchers who are trying to see
whether their subjects are still alive or not and also in longitudinal studies,
et cetera, and then the linked birth and death files, such kind of again
reinforces the importance of having the 12 months worth and full collection of
these data to — because of these various linkage purposes.
MS. MC CALL: I would also add — this is Carol McCall — I think that there
are a lot of consistent themes with what we have been talking about and what is
needed for the research community with what is happening in the business
community. Again, everybody is kind of — we have oceans of data and it is
raining, right? So, the issue is not going to get any easier. What I have been
doing here in my work at Humana, again, with all the research that we do on
data, have been tapping into some of the consultancies. Gardiner(?) is an
Looking at where the whole world of what in business is called business
intelligence and where that is going and there is a whole driving and emerging
force to kind of take those types of capabilities to the next level
strategically. What I find is that there are a lot of common themes and
Gardiner has a lot to say as do some other of these, you know, experts in this
area that around the data that everybody is dealing with the same issue about
how you cross lock data and they have some very good things to say about
essentially what the governorship, the stewardship that very important to start
with reference model, you know.
So, I don’t think that the desire is unique to business. It is not unique
to some of the research we are talking about here but some of the problems are
very much in common that I find and that there are also some new ways that are
emerging to begin to resolve some of the problems so that those can become much
more of a mesh. There are things about what it means to actually harmonize some
of that at a meta data level, new ways of dealing with ontologies and
taxonomies, which is really what makes us able to go from, you know, kind of
data island, from one to another.
So, as we go into this, I think it might be worth while to look at how some
of those problems are being solved in industry and some of the techniques to do
that and see how applicable they might be to this particular setting.
DR. COHN: Carol, thank you for your comments.
I think this has been a very useful briefing on all of this. I am sort of
trying to think of where — how to describe where this needs to go. I will
speak to my own background, which is that I think I recognize at least
intellectually the value of data linkages, though I think I would have to be
reminded of a document that is more than what I see here about the national
value, the public policy value, just because I think that is assumed in what I
am saying as opposed to a reminder to those of us who don’t spend all of their
time in research about where the opportunity really is.
I hear an intellectual view, an assumption of the value. I think it would
be useful I think for the country to be reminded of exactly what it is we are
talking about here and — the value to the country might be in terms of all of
Obviously, I am glad that you began conversations with Mark and privacy. I
think in any of these conversations, obviously, the issues of privacy needs to
be considered strongly and I see it referenced here, but, I think that this
should be something as it goes forward that needs some input either by someone
from the Privacy Subcommittee or reviewed by the Privacy Committee or whatever,
just to make sure that there is the sort of appropriate balancing.
Now, Gene, I actually as we were talking — I was a strong believer in
actionable recommendations and a recommendation at a high enough level that
says go off and be good or you should think about things or whatever is to me
not very actionable. But I am an emergency physician so I tend to be very
action oriented. I did hear in our conversation, you know, some very
interesting ideas you were bringing up that aren’t reflected here. No. 1 is
that there needs to be a HHS structure to help promote some of these things or
deal with some of these things or does it already exist?
You know, it is those sorts of things like how do we make actionable the
view of this being an important area to move forward. Now, as I say all that, I
don’t know what direction this Population Subcommittee is going to take on this
one and it is probably a conversation for you all to have because this can
either be focused on data linkages and do you need additional input given that
you have had one hearing on it? Do you need to have another opportunity to get
additional public input and I think Carol McCall just brought up other groups
that you probably have never even considered having come in.
I think Larry also brought up — this Larry Green — brought up some other
groups that might provide some interesting pieces. I don’t want to turn this
into a 50 page, four year effort, but the question is is there additional input
that might help round out the perspectives on this? Or is this the first
installment of, you know, health services research for the 21st Century?
I am looking at you raising questions just because I don’t know exactly
where you want to go with this. Judy, did you have a comment on all this?
DR. WARREN: Yes. As I was listening to you summarize, I just wanted to
know, yesterday, we heard from John Loonsk a tantalizing little piece that they
may be coming to us later on to help them look at secondary use of data. I am
wondering if that isn’t linked with this effort?
DR. COHN: It may be a later chapter. I don’t — everything is related to
everything. And it is a question of how you parse the effort so that you can
actually make progress and I don’t mean to —
DR. WARREN: No, that is why I asked — if it is a later piece, then I am
happy with that.
DR. COHN: No, we will be coming back and talking about secondary uses, but
I don’t think this is the chapter necessarily we would be starting with.
DR. SCANLON: I think there are a couple of short term actionable items that
we might recommend and they relate to two things that I think we heard at the
workshop. One is the issue of access. This, I think is maybe sort of in the
context of not only the next steps in the research centers, but sort of the
question of sort of how the research centers operate and is there any way to
improve access to them kind of under the current rules and with appropriate
So, that would be sort of one area and the second area was — and we need
to see if we have enough information for this, but there was the sense that
each data linkage involves a new reinvention of the wheel and there is not a
need for that, that it is not necessarily a structure within HHS, but
potentially a process that becomes specified, that there is some agreement that
these kinds of processes and appropriate approach to doing the data linkage,
providing the right kinds of safeguards, et cetera.
I think if we have enough information there, that might be something that
is also sort of short term. It does feed into a bigger agenda for the longer
term about data for the 21st Century, but I don’t think we want to wait and
have everything with a bow on it before we can start to move forward on some of
MR. SCANLON: There are a lot of items here actually. You don’t need a
master work to develop these. There are truly digestible pieces here that would
make sense. You don’t have to pull them altogether necessarily.
The other thing is I think — this is health statistics for the 21st
Century. I don’t think the previous work really dealt with this. I think it
was, you know, focused on structural sorts of things. I think the focus should
be on functionality, on this is what is needed and this is how you approach it.
I am more interested personally in how it functions and what the outcome
is. Focus on structures and, you know, state health boards and all of that
really is not particularly — it is probably not a 21st Century approach.
DR. STEUERLE: As I hear the mandate back to the subcommittee — and we were
starting with the very issues that have been raised here and the ones you did,
Simon, is first we need to put in there a little more of a story so it is
compelling. I mean, basically our story is with these data linkages we think we
can improve health outcomes for the population. That needs to be clear up
front. There is a cost to not doing these things to the public. That is a much
more compelling story than researchers like data.
The second thing I heard would be to identify some actionable items, even
if they are one or two or three. I mean, basically all of us were involved in
this community. We may better list hundreds of things we would like to see done
but it would be nice to say here are two or three steps, steps forward, because
there is always more that we can do.
The third one, which may be the toughest is — and I am not quite sure how
to — this last issue of structure, are there actually suggestions we can make
to the Secretary, does Jim need two more staff people, do we need somebody who
is in charge of this to make it happen. I am still worried about who has the
incentive to really make this happen because it is just not going to be a once
every six month meeting of our subcommittee that is going to be adequate. It
really needs something internal within the system to advance the ball and I am
not sure whether we will be able to iron that out or not. But that would be a
third item that we probably need to at least constantly keep in mind.
MS. MC CALL: Going back to — I have a suggestion going back to some of
Larry’s comments about kind of community-based things as a possible approach,
which would be to use the lens of a community — okay, the community has some
things that it wants to solve. What is the outcome? What do we want to try to
Then almost do kind of an inventory if that is what you — if that is what
we want to call, then we have layed that out. What do we actually have today
that we could begin using? Then how would we link that up? There are a whole
bunch of issues that would come peeling out of that. But then what it does is
it allows for essentially a gap analysis that says, all right, here is what we
have today and here is how — what we need to do, make recommendations for how
to use that.
Then create the gap analysis that will imply then maybe some broader or
longer term things to think about, all of them again pointing toward this 21st
Century vision but not waiting, you know, for everything to be in place to
actually fall for it. It is very local. It is very relevant. So, that is one
DR. VIGILANTE: I think that is part of the story, but I go back to Gene’s
comment, that there has to be a forcing function. There are too many barriers
and not intentionally constructed, but agency barriers, budgetary barriers,
risk barriers, that no one on their own really has either the incentive or the
authority to surmount.
I think there are real analogies to the failures of information sharing in
the intelligence environment that we have observed at the national level among
national intelligence agencies and at the local level between law enforcement
and intelligence agencies. While that is a different paradigm and there are
different urgencies involved with the sharing of data in that setting, time
urgencies, I do think the lessons are similar if you want to create forcing
functions for information to be shared in a usable way. Perhaps even examining
that paradigm would be useful.
But I do think that unless organizational structures are in place to align
the incentives properly and decrease the friction, it is just not going to
happen and we will just be saying it is nice to do. I think we have to actually
sort of contemplate what those structures might be.
DR. COHN: Well, Gene, I want to thank you for bringing this to our
attention. We will now try to answer the question here. I think it has been a
very useful conversation and I guess I am hoping that the subcommittee can
think about what they consider to be next steps. My view is, of course, is to
try to get something that doesn’t stretch on as you — I don’t think we need
the entire book and we don’t need everything absolutely handled and this can be
a first installment, but I would certainly look — I guess I would hope if,
indeed, we do a conference call, the full committee, that we might be able to
discuss a draft with something maybe even more final for the June full
committee meeting. That would be, obviously, my own hope. I mean, whether or
not you decide to have additional hearings to deal with particular issues, I
think is part of your overall project plans.
DR. STEUERLE: I don’t know that we need so many hearings on this particular
issue. I think in the Subcommittee on Populations, there are a lot of data
issues we might want to address but we would like to figure out some way to put
something — reflect this somehow in the way of having issues based some
actionable suggestions. We have been working closely with Jim’s staff, who have
been extremely helpful because, in fact, they deal with this issue all the
time. So, it is not new to them.
DR. COHN: Okay.
Well, Don, do you have any final comments before we move on to our sort of
next set of issues?
DR. STEINWACHS: Really no final comments, other than to share the same
feeling that Gene expressed and you did, as Bill and others, that we really
want to move towards some actionable, useful items. There are lots of avenues
here for longer term exploration and that is — the other question is what
priorities are to be for those, but the more immediate one is what can we do
that is actionable and valuable.
DR. COHN: Hopefully, we will discuss it a little later about potential —
if we need a conference call or not for between now and June, but I am not
expecting the final document coming forward to that one but it may be an
occasion for us to look at the next draft with the idea of a final document for
the June time frame.
So, anyway, that is item 1 for the discussion of the morning. Now, item 2
— and Harry and Jeff, I am going to turn to you to talk a little bit about a
letter that, as I said, is really — subcommittee deliberations, hasn’t been
agreed to by the subcommittee yet, but given that this once again will likely
— may come before us between now and June, I thought it was important that we
at least discuss the information in open session.
MR. REYNOLDS: Jeff, do you want to make any brief comments or lengthy
comments you are welcome to? Then if not, I will go through — I will kind of
go through the body of what we were trying to do, but I would defer to you
MR. BLAIR: Thanks. First of all, thank Simon for selecting with our limited
time that we bring this to the full committee at this point for input. The full
committee might be aware of the fact that this is a little different than most
of our other letters, very different actually, because this is trying to ask
the health care community, the standards community to say how do we accelerate
the process of going through standards development, NCVHS improvement, Federal
Government regulation approval so that we could start to move faster to make
standards available for use.
So, this is really a process issue. So, if you think of it that way rather
than just a standards issue, then maybe the rest of you can contribute. So,
that is the only thing that I would say as a preface.
MR. REYNOLDS: Okay. You heard us yesterday discussing the NPI and how long
it takes the industry to get things done. So, today we are talking about
speeding up not only the industry, but the standards as they start to be
The current process and I will just use a couple of examples that we have
in the letter that we are going to be talking to you about later. An NPRM,
which is a notice of proposed rulemaking for claims attachment standards was
drafted in 1998 and published — and then you have a public comment period
MS. GREENBERG: It isn’t a rule yet, is it?
MR. REYNOLDS: You are correct, right. It was published that there was going
to be a rule.
MS. GREENBERG: There was a notice of proposed rulemaking but we don’t have
MR. BLAIR: More than seven years.
MR. REYNOLDS: Yes. And then you would have your two year implementation or
more after that. So, as these things are moving through standards organizations
of which there are many — and I thought that was an interesting difference
between a lot of the research — our standards organizations out there working
on a lot of these administrative transactions and other things putting together
these pieces of how data can be shared and transmitted, but it is taking too
long. The same thing occurred, an NPRM was expected to obtain public comments
and issues in the pharmacy industry for billing of supplies and professional
pharmacy services, first identified in 2001 and not yet published.
So, there are numbers of things that are out there through the standards
development. The other thing that we are finding as the implementation of HIPAA
went on, it was under a certain version of the claims record and the remittance
record and so on. You know, that has been going on for quite awhile and there
are changes that need to be made to that as everybody tries that looks at it
and uses it, but the process again to get those things done is a five plus year
So, we have been approached — and for those of you that looked at all at
the health IT bill last year, the streamlining of this process was listed in
that health IT bill with NCVHS listed as a possible part of that process. So,
we are kind of playing off of that same thing, too, since, you know, that bill
did not go forward and there is no understanding completely yet whether or not
it would come back in its similar form or a different form going forward. So,
the testimony that we heard was basically that the Sainer’s(?) Development
Organizations would like to be able to do their deliberations, make their
deliberations more public, more visible or more open for comment even than they
are now, which they are very open now, promote — more people becoming a part
of it so that more of the industry really got a look at it then. Then rather
than going through a lot of some of the other process, have NCVHS be the
primary public viewing, you know, through the FACA committee process, the
primary public viewing of the process for vetting and then it could go on to
the Secretary for consideration and approval.
Once these standards are out there, trying to move them along so that you
are not coming up with a standard and then five to seven to nine years later be
able to do something a little different with it or deal with it is what this is
really all about and what this process is really trying to do. So, we are in
concurrence with that. I will just give you some highlights of what kind of our
recommendation would be.
Well, let me say one other thing. In the January meeting, we heard from
health care providers, payers, vendors and clearinghouses representing entities
covered by HIPAA and those supporting these entities. There was no one that was
against, you know, this type of a process, as long as it continued to have this
public view. In other words, people could have their public environment to make
their comments, especially NCVHS because different level people work at the
standards organizations and they have come in and testified at NCVHS and I
think they were happy with that.
So, we are just basically recommending to the Secretary that it does take
too long. We recommend that the Secretary examine this proposal and evaluate
its ability, whether or not, you know, the Department is in agreement that
shortening this would be a good thing and then second have the proposal
examined by legal staff to determine how its features might be incorporated
into the process that is consistent with both the Administrative Procedures Act
and streamlining the process. So, you know, that Administrative Procedures Act,
we want to make sure that that is brought in, too.
So, that is kind of what we are trying to get to to look at, moving this
along faster so that the standards don’t become stale and basically lose
momentum, especially as business is changing. So, once you make business go to
these and then you don’t update them, you really start to lose the whole
benefit of getting them the first time.
That would be a quick summary, Simon, of what we are talking about, not
eloquently done necessarily, but it gives you a framework so we can have some
DR. SCANLON: I guess I am wondering have we really identified the root
cause of these delays and have we eliminated it sort of in this recommendation
because the disconnect for me is that CMS puts out sort of the payment rules
for Medicare providers every — I mean, I had the misfortune a few weeks ago of
looking at the hospital outpatient and the hospital inpatient sort of rules.
Each one is close to a thousand pages long. The NPRM probably came out maybe
April, May. The final rules were published in August. So, we are talking about
It is an issue that, yes, it can be done when it has to be done and when
someone has the will to do it. The question I guess I have is why were these
things hung up? I mean, I — and that is in some respects a rhetorical question
because I know that things get hung up. I couldn’t tell you exactly, but I am
sure that we can go and find an NPRM that has not yet reached the final rule
stage and that is a lot older than the five years and the seven years that you
What happens sometimes is that things die after they have become NPRMs and
it is a slow death, to say the least. In this process, we are still talking
about at some point, as I understand it, we are telling the Department, you
know, now the ball is in your court and it is your job to issue those things. I
guess and not to put the Department sort of on the spot, but are they going to
be speedy or were they not part of the problem sort of in terms of the five
years and the seven years?
That is why I guess what I have been struggling with is what is the real
root cause here in terms of these delays because I am not sure it is the
Administrative Procedures Act or the NPRM process.
DR. COHN: I think, Gene, you had a comment.
DR. STEUERLE: I think you ought to continue this line of discussion first.
DR. COHN: Okay. Actually, I should ask is Karen Trudel on the line by
chance? Because it would be very nice to have her as part of this conversation,
Marjorie, you had a comment?
MS. GREENBERG: Well, I won’t respond to that, except that I think the
proposal that has come out of the DSMOs that generally is supported — the
DSMOs are the designated standards maintenance organizations, who maintain
these standards. I guess if you could get a three month turnaround like that,
maybe we wouldn’t be making the proposals, but is that you actually remove one
— you don’t go through the NPRM process and then the final rule. You go
through all these other comment opportunities both at the standards
organizations and before NCVHS and then you have an interim final rule or
something as a — you know, just before you actually implement, I guess.
But you actually drop one part of the process. So, it is not that you would
still — the letter would not tell the Department to just do the same process,
but faster, but it would actually kind of change the process and appreciate in
some ways the process.
DR. SCANLON: Right and I guess the question is — I mean, going back to —
what I don’t know is the part we are dropping, is that responsible for the bulk
of the delays in the past or are we going to sort of have a similar kind of
experience, I mean, in terms of delays. That is my only issue. Have you built
in sort of the safeguards so that you will have a speedy process because it may
be important to have in this new process some very rigid deadlines or something
that drives it.
You know, the CMS rules come out quickly because if you don’t pay
providers, you would have a very big crisis on your hands. So, that is a
compelling reason why they are going to move forward. So, the question is how
do you create the same kind of compulsion here to expedite this process?
DR. COHN: Okay. Well, now we have Jim, Steve, Jeff and Mark. I don’t know
if they are all responding to you, but they raised their hands very quickly
after you brought this forward.
DR. SCANLON: And I am speaking out of ignorance here.
DR. COHN: No, I think you are a very capable observer of the scene.
MR. SCANLON: There are actually many reasons. Remember, with HIPAA, just
philosophically, HIPAA was a mandatory process. It wasn’t like — it wasn’t a
voluntary process. That was the process the industry used previously. Once you
are telling the whole weight of the Federal Government to start putting people
in jail or fining them, not that we have, by the way, but then a whole
different perspective emerges and you have to — you then have to deal with
issues that you don’t on a voluntary basis, but I think part of the problem was
the statute itself. It required, you know, the folks who drafted it, they
drafted it in a way where there was not a lot of flexibility given to the
No. 2, it was the industry, I think, and many of the standards were not
ready really. They were virtual standards and when the committee looked at
them, when the Department looked at them, they were in no position to be
implemented as they were. A lot of cleaning up needed to be done.
Implementation guides needed to be done. I hope we are past that now, but that
took a lot of time.
The other thing is there were very issues involved and the one person’s
delay is another person’s public protection process. So, that is why you have
an Administrative Procedures Act. It is to protect in a way the minority — you
know, the folks who will have to deal with it. So, I think that all of these
factors came into play and I think what is being proposed here is one of them.
It is eliminating some of the procedural statutory requirements and yet trying
to find a substitute. In other words, if the proposal here looks like what we
saw in the health IT bills, where basically you would retain much of the public
comment in the NPRM, but you would substitute, I think, some involvement of the
NCVHS for some of that public participation and review. Then it is addressed at
one of those problems. It is the one where there was some structural and
procedural requirements that almost — and it is literally a double, almost
triple jeopardy. You had to go through — first, you had to go through the
industry standards process in voting. Then you had to go through an NPRM. Then
you had to go through a final rule and other folks as well. Then you had to go
through implementation, which is very complicated.
You could argue that that is not a good model even anymore given the way
the industry is working now. But, again, you have to have the public protection
and if you want a mandate something, then you were sort of forced into this
general framework. You can certainly look at removing certain barriers and I
think the focus here is on one of them. It is on those sort of the public
protection, can we meld and can we streamline that process.
DR. COHN: Before I give it over to Steve, I do also want to clarify just to
make sure that everyone understands the proposals really have to do with
updating a previously approved HIPAA administrative and financial transaction
MS. GREENBERG: Not new standards.
DR. COHN: These are not being referenced in terms of new standards nor in
relationship to privacy and I would have to look back at the book to see if
security — I think security was — it is not part of it. So, it really is that
concept of the updating process that we are really — and I don’t think that
Harry quite made that clear. Of course, we didn’t ask him to —
DR. SCANLON: Also, what Jim said that was very helpful was that in some
respects the situation has changed. I mean, in terms of the question I was
raising and whether or not the proposal was sufficient, it is potentially
sufficient because it is a different world. It is not trying to do what you
were trying to do in 2000. It is what you try to do in 2007, which is very
different and you are sort of comment also sort of characterizes it, it is
different than what we tried before.
So, both of those things — I was trying to help you in terms of — I was
being strong enough here and you are saying that we may be because we are
taking on a different challenge.
DR. COHN: Maybe but I would have you continue to keep asking those
questions. Bill has actually a tremendous amount of congressional and federal
EPA experience. So, I listen very carefully when you ask these questions.
Steve Steindel, you are next.
DR. STEINDEL: I think Jim did a very nice job of summarizing a large
portion of what is needed to address your question. Just to add some
information about why the standards development organizations and DSMOs are
bringing this forward is because one of the observations is the procedure
really goes like this. It is first the SDOs meet. You know, they go into their
sausage factory, however long it takes, and they produce a standard to address
the needs of industry. Once they produce that standard and decide, okay, it is
time to upgrade the HIPAA transaction requirements, they go in and CMS releases
an NPRM. Well, first, there is a delay that we all know from the government
process of getting the NPRM through. So, that introduces one level of delay,
which can be, you know, anywhere from a few months to a year or two from the
point that this standard development organizations develop the standard.
Okay. Now, the NPRM goes out for comment. The great world now looks at this
and they are going to say, well, how does this affect my business and, as Jim
points out, one of the reasons we have the Administrative Procedures Act is to
give people who might not have been involved in the process a chance to
comment. Well, they come back and comment and they say, well, this is going to
affect my business. Well, in this particular case the business that is really
being affected is a standard that was developed by a standard development
So, now the standard development organization has approved that standard
like three years ago and now they are asking for changes in that standard. So,
it has to be reopened. It has to go through the standard development process,
which can take another year or two and then go back for the final rule or maybe
another NPRM. So, this is where the steps of delay comes in and what this
compression of the time frame tries to do is to decrease the amount of time
from when the standard development organizations develop these new modified
Now, as we said, these have already been introduced in one form. So, these
are modifications to the point where they actually can be implemented from now
the undefined time frame because of all these changes to something that might
have a better chance of being defined and planned for.
MR. BLAIR: It is so nice when Jim and Steve can wind up saying everything I
was going to say. I don’t have to add anything else.
DR. COHN: Okay. Good.
DR. FITZMAURICE: This is Mike. Can I jump in?
DR. COHN: I was going to let Marc Overhage go and then you can go on next.
DR. FITZMAURICE: Sounds good.
DR. OVERHAGE: I think this is a good and important thing. I guess I
mentioned this to Simon walking in this morning. I continue to really worry a
lot about the other end of the process, which was great. We have got a standard
out there and it speaks a little bit to what Steve was describing. By the time
something gets to the implementers and then they say we can’t do it and it goes
back, I am not convinced we are making very much on the ground progress.
Frankly, I think we could spend a whole lot of time trying to — I mean, I
think there is a good and proper thing, but I guess — and this may not be the
right group to consider it and, Simon — but I am really more worried that the
things that are out there that are usable, maybe not perfect, aren’t being
used, by and large.
The example I gave Simon this morning was just day to day, I talk to a
payor every week that I say, so, how do I access your eligibility inquiry
process. That is the answer, even the large ones. So, I don’t really care if we
get the standards improved a lot if we aren’t getting them implemented. I think
they are both important processes. So, I wonder is this the question?
DR. COHN: Mike, do you want to comment or can I let Harry respond to that
because I am sure that Harry has a good response. Harry, why don’t I let you go
and then I will let Mike go.
MR. REYNOLDS: I have no response as a payor. I am not responding that way.
The way I am responding and I think — I am playing off of Marc’s comment and
we discussed it at the last hearing and that is the standards development
organizations are tending to have very technical people working on them and we
have to somehow figure if we speed — whether we speed this up or not, we have
to somehow get the business people involved in these standards so that they
understand how they are going to use the standard and get ready to use the
standard, not to have it be people that just get sent to meetings. Everybody
cheers that they have got a standard, but nobody in all the businesses that are
going to make a difference with it, especially as we talk about anything going
We have got to make sure that that middle step is in there, that everybody
understands from a business standpoint why it will make a difference. That
maybe, Bill, somewhat of the reasons that have happened in the past. If you
send a disparate standard in and it doesn’t have a package around it, like this
is going to move the world forward in the following six ways, it is kind of
hard to get anybody to root for it, other than maybe the people that put the
standard together. So, I think you are both absolutely right on and I think
that is the thing that we also discussed with the SDOs in the meeting is that
they also have to start looking at maybe trying to get other than just
technical people that are working on the standards, more business people
involved in that process earlier to get some buy in —
MS. MC CALL: I agree with you, Harry, and the reason is this. In addition
to what you said, the fact is the data that is being produced, whether it is
being produced by a health plan or a hospital or physician practice, is being
produced by a business and so since these are the generators, the creators of
the data and if the people that use it want something different, they have to
engage the people that create it, their suppliers, to actually talk about what
it means to create something new for them.
So, I think it is an absolutely vital step. Without that dialogue, things
will continue to remain slow. They are not going to necessarily speed up and
become much more nimble.
I guess I would add something else. There were some comments earlier to the
effect that I don’t really care if we get new standards. I just want us to use
what we have. I guess I would submit that by starting to use what we have and
finding out what works and what doesn’t work out of that whole process, I think
we will be able to make recommendations for how to change processes going
forward. So, it remains more than kind of a theoretical debate, but it is
grounded in something that people are actually trying to do.
DR. COHN: Okay. Now, I am going to let Mike talk in just a minute, but I do
want to just remind everybody as we talk about this one because we are — and I
realize that there are a number of M.D.s in the group and a lot of people who
deal with the claims transaction that has to do with professional or
institutional services, but I do want to remind everyone also that pharmacy is
covered under this one. Pharmacy is 95 percent implemented electronically and
they are under the same — that is what ACDDP(?) tells me. All I am saying is
is that I just have to remind you that this is not just a conversation around
professional and institutional claims and in transmissions.
I just wanted to make sure that we are aware of that in terms of the
Now, Mike, you are on next.
DR. FITZMAURICE: Thank you, Simon.
As I listened to what everybody said, I don’t disagree with anything that I
have heard, but I see that NCVHS is successful because we can get the players
to the table, if not as numbers around the table and there is a lot of power in
the numbers, we can bring people in to testify and to advise us. Now, this
isn’t generally true in all of the other standards — not all the players are
at the table at the same time in these other venues. Probably the reason for
that is that the gains for each player are so small it can’t overcome the
inertia and the benefits and costs of the workarounds that they develop
So, if we are going to have something to be gained by all of this, it takes
common action so that all may gain, even though some may gain more than others.
You have to listen, Steve, as to some of the benefits are greater than or equal
to the sum of the costs, both public and private for the health care systems so
that someone has to take the lead in developing standards, implementing them,
testing them and then monitoring them for public good. It is something that the
private sector has a large stake in, but the gains are split so far among many,
that the private sector finds a large cost in coming together to create small
gains in standards.
So, I applaud what ONC is doing. I applaud what NCVHS and other agencies
are doing. We can’t lose sight of the fact that the gains to be made can be
great, but we also listen to the industry to find out where the greatest gains
are and work from them. NCVHS can pull the people together. We can pull other
agencies together and have them report to us on what is going on. But because
the — are so small, we have to — what are the coordinating factors in this.
DR. COHN: Now we have the following people who want to comment and that is
Larry Green, Bill Scanlon, Jeff and Gene Steuerle and then I want to wrap this
piece up. Gene, you don’t want to comment? Okay. So, three and then I want to
wrap this up. We aren’t voting on this one today and we need to go to another
issue or two and then sort of try to put everything together.
So, Larry, you are next.
DR. GREEN: I actually have a question that builds on Bill Scanlon’s
question about root causes and also on Marc’s question about implementation.
The conversation I have just heard is my orienting conversation. So, I beg for
forgiveness for ignorance here or whatever. But I am surprised that the
conversation did not talk about commercial interests more either as an
impediment, a fear of loss of revenue or fear of exposure to added liabilities.
It seems implied, but it is not been made explicit. So, I want to take
advantage of being a newbie again to just ask the question of the subcommittee.
What is the effect of commercial interest and either delaying the establishment
of the standard or in implementing an agreed to standard. Is it irrelevant? Is
it a small thing, medium size thing, big thing? What is the committee’s view?
MR. REYNOLDS: I will take it and I will start it. I would say the hardest
part in driving this industry is exactly your point. Everybody looks at it
their own way. It is required but in some cases it is not required for
everyone. In some cases it — the large players can spend the money to do it.
Smaller players continually may feel dragged along, that they have got a sort
of small doctor’s office and maybe called upon six times to make changes
related to some standard and in the end did they really have a business case?
Somebody said they did but do they really?
What does adoption mean? What is the difference between having a standard
and then what does adoption really mean? If it is not incorporated in the work
flow, the smaller practices, if it is not — if it doesn’t make a difference in
their day-to-day life when they spend the money and in many cases, if they
don’t see additional reimbursement or they don’t see other things for it, it
So, the hardest part, Larry, is — and that is why we were just talking
about getting more people involved in the standards and so on. The standards up
until now have been a set of data, not necessarily all the business practices
and work flows and everything that went around it. So, the lack of getting all
the way — we did a HIPAA lessons learned situation and I will play off Marc’s
earlier comment. Some of the things are there. They are not implemented and
some of the things that aren’t implemented, whether it be on the payer side or
the provider side and other, are actually the ones that would probably have the
most business return in the end and so people had to put in the claims and
remittance, but some of these other things, like the eligibility and claim
status and other things that would eliminate phone calls and reduce bad debt
and do other things, the vendors and everybody from the industry to get those
So, it is really how do we — in the NPI discussion we had yesterday is a
perfect example. How do we get this whole industry to buy in? So, every time we
do one of these, you can talk to enough people that is the right thing. What
does buy in look like, feel like at all levels, you know, from the individual
provider to the large carrier, to the large hospital to a large other. So, part
of our entire effort is to continue to make sure the right people come to the
table to talk about the whole subject so that you are not implementing a
standard. You are making the health care industry better. I don’t think that
has been the discussion up until now. It has been implementing this standard.
So, go do this and just like you were talking about research and other things,
there is no big picture that says here is where we are going. So, this piece
helps this way and this piece helps this way. It has been a very focused due to
Nobody can give you the name and number, the 835 and 837. Come on. You are
talking to a CEO of a company or you are talking to a doctor and 837 and 835
are just some numbers somewhere. What did you just do for me or not? That is
the challenge that I hope we all take around this table is how do we take these
things and make something happen, not just congratulate ourselves or everybody
else that we implemented a numbered standard and hallelujah, who did it or who
didn’t. So, that would be my feeling. That is the struggle that we are
continuing to have as we try to drive through this is not to just make it a
numbered standard, but make a difference.
Does that help? I don’t know if it answered your question, but —
MS. MC CALL: Amen, brother.
DR. COHN: Now, Marc Overhage, I think you want to comment on this. Then we
will go to Jeff Blair and then Gene and then we are going to try to wrap this
particular piece up.
DR. OVERHAGE: No, go ahead. I think it has been said.
DR. COHN: Okay. Jeff.
MR. BLAIR: Five to ten years ago, I think our perception, when we talked
about standards in a large part was message format standards, the traditional
HL7, ASC, X12N and then it expanded to include the clinically specific
terminologies and in the last number of years it has expanded along the
directions that you have just raised and it has had various terms. It has
either been called getting the business community involved or calling it
business processes, work flows or codification of process. There is a document
that has just been released with a new name and I think this may be very
helpful because while we thought of ourselves as the standards subcommittee,
maybe we should begin to think of ourselves more broadly and consistent with
what — the document that has been released and its interoperability.
Interoperability includes technical standards. It includes semantics and it
includes business processes. If we start to look at it more broadly — by the
way, I think that document that has just been released is called “Coming
to Terms,” in this last week from HL7 and they have studied this for like
nine months or more. I think that maybe — and, Marc, I don’t know —
DR. OVERHAGE: I have to get to nine months or more first.
MR. BLAIR: Is it the more —
DR. OVERHAGE: Or speedy process.
MR. BLAIR: Well, the thing about it is that I think that maybe we could
find a way to accelerate the development of standards if we begin to look at it
more broadly than just in terms of technical standards and look at it more in
line with this document called “Coming to Terms,” where it is
interoperability as a whole.
DR. COHN: Gene, I will give you the last comment and then I want to wrap
this particular conversation up and then we need to talk about the HIPAA report
and then we will try to begin to put things together.
DR. STEUERLE: Mine is very narrow. As you redraft this letter, I think you
could beef up the recommendation, make it a little stronger and say you
recommend for this particular type of procedure and there have been many
discussions that have gone far beyond what this letter is about — this
particular type of procedure that the Secretary adopt the streamlined standard
along the lines that have been recommended after review.
I think it is too much you should review and think about and I just think
you should adopt a streamlined standard and give them the flexibility of how to
get there, if that is where you come out.
DR. COHN: This has been a very interesting conversation. I want to actually
— it is always wonderful when we get beyond Standards and Security
Subcommittee for a broader conversation really around the issues around this. I
think we are certainly each in our own way reflecting on the issues relating to
actually the administrative simplification that was envisioned by HIPAA versus
the tools which are the standards and that is sort of pieces — I mean, I think
you begin to see why in the annual report some people think I see a rosy view
of the world, but this issue of — and we see this in almost every IT
implementation that I have ever dealt with and I have been dealing with IT
implementations now — it is embarrassing. I think I wrote my first system back
in 1984. So, I have had 24 years —
PARTICIPANT: Was that Fortran?
DR. COHN: It was close to Fortran.
But in every software implementation that one ever sees, you do
implementation and then you have to go in later and you do optimization. That
is why I make that comment in the cover letter to HIPAA and I think there have
been very few implementations, I think. I guess we all hope that everything
will happen at once. We will do business process. We design. We all come to a
vision of common business processes and, et cetera, et cetera. I looked at
Kevin only because I know he has been consulting on some of these issues over
the years. It never quite happens that way.
You usually are busy trying to get things in and then you as a next stage
try to optimize. I think we are just maybe beginning to get into that process
on HIPAA. At least that is what I am beginning to think I am seeing.
But I just want to remind everybody that this is sort of how it works out
in the world and we just sort of need to keep that in mind in terms of this
letter, in terms of our HIPAA annual report and all of that. You all need to
sort of think about that.
Now, I want Maya to come back and talk to us a little more about the annual
report at this point. At the end of that, there is a couple of questions, sort
of globally I have for us. I mean, which is what of all of this might we feel
comfortable if it came to a conference call between now and June? Does some of
this stuff need to go back to subcommittee for further review, coming back to
us for a face-to-face meeting? I mean, as we begin to think about exactly what
we are going to be doing between now and June and that is why we are spending
this time talking about all of these things.
So, I just wanted everybody to reflect on that. Some of these things, you
know, there are many ways we could triage the various issues we have just been
Now, with that, Maya, do you want to — I guess I should start out with the
HIPAA letter. I actually reviewed it this morning and I think Maya vastly
undersold how good the whole thing was. I would myself sort of — yes, it needs
wordsmithing. It needs — I mean, there may be something else needed there, but
it is about 85 percent of I think what we were all sort of talking about
yesterday in terms of it being something that was broader than just HIPAA and
reframe the other HIPAA — other NCVHS activities, though it wasn’t the main
focus of the document.
I think Maya would like it to be more incisive and controversial perhaps.
MS. BERNSTEIN: The committee, unless you take a new vote, is not at liberty
of delivering anything new. On the other hand if you don’t see anything new
reported — so, that is okay. I mean, the report is supposed to be a report on
what happened last year. So, that is fine. The Congress hasn’t seen it yet,
even if the Secretary has. Normally, you write your letters to the Secretary.
The work that you do is directed to the Department.
So, reporting to the Congress is a bit different in that sense. Anything
new that you want to say, obviously, the committee has to go through its
process. So, I don’t want to overstate.
DR. COHN: I don’t know if any of you have had a — I mean, it is asking a
lot — some people were — last night. Others were trying to work through snow.
So, it may be a lot to ask people to have actually taken a look at it.
MS. GREENBERG: I was looking at it later last night. I should have waited
to the morning. I definitely wanted to thank Maya for taking this on at the
sort of midnight hour. I think most of the content, I agree with you, it is
very redundant. It is less redundant now that we have — you know, you have
streamlined the executive summary. So, I think that is good. It is actually is
more of an executive summary. The executive summary may need some need some
kind of concluding paragraph or something to give it a little punch, but I
think it is now not — it is not nearly as repetitive as the old versions were
with the long executive summaries, but there is still the report itself is very
— the style, which you were just following from the previous seven ones, I
It is very redundant. So, I think either we could — I mean, I don’t know
if you have the time to spend on it or we could bring in an editor or
something, but I think we could —
MS. BERNSTEIN: I can certainly do it. I just couldn’t do it by today.
MS. GREENBERG: Oh, sure. Understandably so. That is my sense.
MS. BERNSTEIN: I think what Simon is asking is about the process, what the
process is that the committee feels comfortable and how long you are willing to
delay before transmitting this report. You could hand it off to the Executive
Subcommittee and have me work on it some more and have the Executive
Subcommittee look it over and then present it back to the committee either in a
conference call to be scheduled so that could vote on it in a public conference
call or you could wait until the June meeting, which I understand is less
desirable. I don’t know if there are other possible ways to handle this that
Jim, Marjorie, somebody else could suggest.
DR. COHN: Before we get into the process, I am just curious have any of you
had a chance to look at it at all and do you have any comments just to sort of
give Maya some input.
Harry, then Judy, Larry and Marc.
MR. REYNOLDS: I have been through the body a number of times and Maya and I
have conversed. So, I have made all my changes to the body. I am comfortable
that I think that is where I am.
The payoff of our earlier discussions and maybe a comment that was made
yesterday, I think that the executive summary, let’s take the second one, for
example. It starts out “The NPPEF armed congress…” there was a rule
there that every provider has got to — we are trying to streamline the
provider numbering process in the United States to make it easier for them
rather than them having to deal with all the different entities they deal with.
And, oh, by the way, the Federal Government did a good thing by putting
together a national database that will enumerate those numbers and everybody
that would need to deal with that that would have access could go get it.
If it said that, if it said it that way —
MS. BERNSTEIN: Plain English, is that what you are asking for?
MR. REYNOLDS: Yes. That is where I am going. I like what is in the summary
as far as the subjects, but I don’t think it talks — in other words, back to
this idea, what difference does it make that there is an NPPEF, not the fact
that we have one. So, that would be my own — I have been through the body a
lot. I don’t have any comments there, but I would say if we could snap those up
as to what difference they made, then I think that would be perfect.
DR. COHN: Judy.
DR. WARREN: Mine was kind of style. On page 2, under activities —
MS. BERNSTEIN: Page 2 of what document?
DR. WARREN: Executive —
MS. BERNSTEIN: Executive summary. Okay.
DR. WARREN: The first paragraph under “Activities of NCVHS,” if
you go towards the bottom, it suddenly starts talking about a subcommittee, but
it doesn’t tell me which one and I guess I sort of thought that when we put
activities out, it was from the whole committee not from subcommittees. So, I
really kind of thought that should be eliminated from the —
DR. COHN: Remember, this is not the final version. We are not voting on it
DR. WARREN: Well, the point that I want to make is — and maybe I am not
making it well, but it is when we put out reports like this, should it come
from the entire committee or should the work of the subcommittees be presented.
MS. BERNSTEIN: No, I think you are completely right about that and I will
change it. I think the reason that got in there is because we were describing
the hearing and I didn’t want to say that the committee held the hearing
because, in fact, the full committee did not have a hearing. It was the
subcommittee. That is where the confusion came in, but maybe if the
subcommittee — we can say that the committee held a hearing. It happened to be
in front of other people.
MS. GREENBERG: I think we can refer to the work of the subcommittee but any
kind of conclusions, recommendations, whatever, come from the full committee.
DR. WARREN: Then my only request would be is if we do refer to a
subcommittee that its title be put in there, so we don’t start getting
concerned about who said what. You know, I was just reading this last night
thinking about, okay, I am a congressman or I am Nancy Pelosi and what does
this mean to me —
DR. COHN: Larry.
DR. GREEN: I am unencumbered by all the work that went into this.
DR. COHN: And remember, it is not time for wordsmithing.
DR. GREEN: This is not wordsmithing. I read it through two or three times
and I would like to raise one meta issue and then I have two very specific
questions about what something means.
The meta issue is I don’t think HIPAA has helped me a damn bit to speak of
in practice. It is two years into it. This talks about all the progress and
everything and it is called administrative simplification. I don’t think there
is any simplification of this too complex, overwhelming, dysfunctional health
care system. I want to get that out on the table.
So, the tone and the meta message, the meta message from this thing, I
don’t think I personally agree with, that my life as a citizen of the United
States, as a physician and most importantly as a patient and even more
important as the son of parents, who are trying to navigate the system, I don’t
think we are making very much progress on the intent of the original HIPAA
From that perspective — now, I will come here and I will look at all the
work, all the effort. I listened to the conversation this morning. I mean, this
letter seems unattached to some extent at a meta level to the conversation we
just had about our rate of progress and why we have all these delays in
So, remember, I started saying I am unencumbered by any real inside
knowledge about how we got to this letter. Now, having said that, I don’t
understand for sure what happened with this unique identifier for individuals
being postponed indefinitely that is mentioned on page 2.
MS. BERNSTEIN: Of the executive summary?
DR. GREEN: It is on page 2 of the 8th annual report, the larger thing.
MS. GREENBERG: It is by Congress.
MS. BERNSTEIN: Well, yes, there is a —
DR. GREEN: My point is that that is a very big deal.
MS. BERNSTEIN: Yes, there is more detail about that later in the report,
where it basically explains that the Congress has passed a law forbidding
appropriations to be spent on the matter. The Department cannot work on it.
DR. GREEN: So, many of the executives in the legislation are compromised by
that decision in my view. The privacy issues may be protected, but there are
other public health issues that are sorely compromised and data linkage is
sorely compromised. So, I just want to call attention to that and then in the
conclusions it seems to me that we are describing this high level of adoption
for the health care claims transaction process and, yet, we still have
misgivings about it that are really substantial.
So, it just seems to me that the letter is too darn positive from what we
have talked about here and what is going on. But, again, this is probably the
last time I can play this card. I will have to behave myself from now on, but I
am new here.
DR. OVERHAGE: It is good to have Larry here because I may seem more mild
that way. I am going to stand right in front of him because I agree completely.
But I did have maybe a concrete thought along those lines and I said a little
bit about this yesterday because I share that concern that this sounds like,
oh, we are getting it all done. Progress is being made and it is, but is
progress being made at the hundred thousand foot level and not necessarily on
I wonder if part of it — and I was reflecting a little bit on it
yesterday. I asked the question what is it we would like Congress to hear about
this and, frankly, I don’t think they give a darn about at some level did this
or that regulation get passed by the date that Congress said it should. I mean,
they do care about that, but not — I mean, they can find that out easily
enough and it is not really — I almost think what I would like to see if I
were a congress person in this report is sort of the how far are we along the
pathway. You know, and there are different trunks to that pathway. There is
getting those regulations promulgated. There is getting standards. I mean,
there are different trunks along it, but partly helping them understand that
those trunks are the foundation that has got to be there and we are well along
the way on the foundation at some — you know, from some perspectives. But we
haven’t got much of a house yet.
There is a lot of different parties and Simon was helping educate me
yesterday a little bit about some of the other organizations that might be
driving some of these pieces and so on. But if I were a congress person and I
saw, well, gee, we have this foundation but the house isn’t really quite — you
know, there is not even a frame yet. Well, maybe there is a frame, you know,
but we haven’t got any walls yet. Where do I look? Who am I expecting to drive
that forward? I mean, is that broader framework that I think might be helpful
to them to know, yes, HHS and the Secretary is doing these things and that is
good. There are some other parties that have to do things. Industry has to do
certain things. Providers have to do certain things.
We can’t lay all those out. We might be able to give them a framework for
thinking about that.
DR. COHN: Just to make sure I am capturing your views, which I actually
sort of resonate with, which is at least in some of these things referencing
other WEDI, CAQH, which I know Harry can’t comment about, other activities that
actually are moving things forward.
Jeff, why don’t you go.
MR. BLAIR: Actually, I was really glad that — is it Bill? I am sorry,
because I can’t — Larry and then Marc who made these comments. These are
comments that I have been hearing for quite some time from many, many sources.
I felt as if I wasn’t able to adequately communicate it here. So, I was really
glad that it was set forth. In order to put this document in a positive way,
because I think HIPAA, the positive thing about HIPAA was it was the first
major step that was taken by the Federal Government to help the health care
delivery system make the transition into the information age.
Now, it happened to have done it in a certain way. It happened to have been
imperfect, just like a lot of first steps are. But I think that this letter
would be much better received if it is represented as the first major step to
help the health care delivery system make its transformation into the
information age and that it was followed by other important steps, things like
the e-prescribing activities, things like the NHII activities, things like
other things being done in industry in cooperation with us in terms of things
that Harry is doing. So, my thinking is that if we put it in context with the
transformation that is going on and that the Federal Government is doing a lot
of good things that are part of, rather than celebrate it as an anniversary in
itself, I think it is much more likely to be received as a positive first step.
That is my suggestion.
DR. COHN: Jeff, thank you.
Then we have Mark, Harry, Leslie and then we need to sort of figure out
where we are.
MR. ROTHSTEIN: Thank you, Simon.
I have sort of a substantive and a procedural comment. On the substantive
side, I agree with virtually everything that has been said. My criticisms of
HIPAA in general, the privacy rule in particular have resonated through this
room for seven years. But that brings me to my procedural comment and that is I
don’t know that this is the right time or the right method for addressing some
of our larger concerns about HIPAA. If we wanted to take a sort of a ten year
look or now maybe an eleven year look or a twelve year look at HIPAA, what we
really would need to do is perhaps appoint a HIPAA assessment working group.
This is not something that can be done by the committee as a whole. It is not
something that can be done at the time that the letter is in an early draft.
I mean, the issues that are raised are very important, very fundamental,
but I just don’t — and I appreciate the fact that this might be viewed as our
annual shot with directly going to Congress. But at this late stage, I think
that the best that we can do and the best that we reasonably ought to strive
for is to have a cleaner, tighter, more explicit letter that is understandable
by the members and their staffs and not try to sort of break new ground in
terms of our assessments on whether the Act has worked well.
We have nibbled around the edges of it in many different subcommittees and
many hearings. I know we have done that in privacy. We had a hearing not too
long ago like how would — and the issue was a research question. How would you
measure whether the laws had any effect? It became very complicated. So, my
plea would be just to try to keep us within the general format and not to try
to bite off too much now.
MR. REYNOLDS: I can go with that and the other thing maybe, Larry, for you
and Marc and some of the other newer members, the very last statement in the
executive summary, very last paragraph, mentions lessons learned. We are on
record with the Secretary, especially from Standards and Security, we built in
it. It came through the full committee. We are on record as to what have been
the significant implementation and return on investment and other issues
related to HIPAA. So, this is not a — this may appear to be a softball to
Congress, but we put a letter forward to the Secretary that was — and it is
actually — it is going to be attached, but we actually —
MS. BERNSTEIN: Are these the summary ones that are in on pages 10 to 13 of
the actual report? They are actually just listed there. That is the same ones,
MR. REYNOLDS: So, I agree and I think — trying to figure out what we do or
don’t want to say to Congress and I like the idea that this is a journey and I
actually would — ten years of HIPAA is kind of funny because it took a whole
lot of warm up and maybe we are in the second year because, you know, until —
you know, I mean really I am not sure — I mean, yes, we have been talking
about it for ten years, but we haven’t really implemented anything. You know,
the contingencies just went off last year on claims and — so, I think, you
know, first step of a journey I think is a great idea, but I did want to point
out that we have taken a hard look at that, Larry, and the comments you made
are not unrealistic to us. They are not unknown to us and we heard them and
some of us have actually made the other comments numerous times prior to you
making it as we have tried to implement it in our own jobs.
But I just think that is in there and we did try to take a shot at that. I
am not defending it. I am just making a statement that we are on record that
the next time this happens, other things need to be done differently.
Otherwise, nobody is going to get anything.
MS. BERNSTEIN: Can I ask a clarifying question? I want to ask Mark to
clarify, were you making a proposal that we should confine the report to the
HIPAA and leave off — I mean, to the activities of the last year and leave out
the larger lessons learned? I am asking Mark whether —
MR. ROTHSTEIN: No. What I was suggesting was that we shouldn’t try to make
sort of sweeping judgments about the successes and failures of the legislation
and our concerns about that. We had certain lessons learned. So long as we can
tie them directly to letters that we have already sent — what I am concerned
about is that we start adding new ideas and new concerns, new frustrations that
haven’t already been previously expressed. I think it would be very difficult
and awkward to do that now.
MS. BERNSTEIN: I was going to ask Larry and Mark if what they were saying
is the tone of the letter is still even if it is confined to — is still from
his point of view too positive.
DR. COHN: Now, Leslie is not here. Judy, did you have a comment?
DR. WARREN: Mine was stimulated — and Mark said a lot of it already, but
Larry had mentioned about the unique patient identifier and we did spend a lot
of time in reviewing the status of that and hearing of that. When I go through
the report, part of that is — I mean, none of that is reflected because it is
embedded in the report that we did on the National Health Information Network.
So, I am just wondering if maybe some of that needs to be pulled out and placed
in the discussion of the national identifier, especially since that is coming
out loud and clear from the AHEC as part of the — technologies. But we do have
this patient matching or however we want to phrase that.
Or if we just leave it the way it is because we don’t have a unique patient
identifier but kind of highlights some of that work that we talk about being
MS. GREENBERG: Matching patients with their records.
MR. SCANLON: I wouldn’t even include it in there, in the executive summary.
I mean I think you —
DR. WARREN: No, not in the executive summary. In the report.
MR. SCANLON: But, you know, again, you have to be careful. Congress has to
write that there will be unique patient identifiers. The fact that we are
looking at patient matching and identification, that is a little different.
That is not pitching for a unique identifier necessarily, but you just be
careful what you say back to Congress about actions they have taken prohibiting
DR. COHN: Well, maybe the answer here is — I actually agree with you,
Judy. I mean, I think that there is a section in the body where we talked about
the fact that unique identifier for individuals cannot be worked on and I think
maybe beyond that while that has been worked on, the committee has done work
looking at matching patients to their records in the past year —
MS. GREENBERG: And included recommendations in the NHIN report.
DR. COHN: I think it would be fine to have a sentence or two about it.
MR. BLAIR: Can I make another suggestion that I think is another way of
positively characterizing this? If we indicate that HIPAA was the beginning of
a journey and one of the things in that is that it expanded the NCVHS and
because it expanded the NCVHS, the NCVHS has taken on a lot of other things
that have built upon the initial first step that Congress has made with HIPAA
because NCVHS took the one or two liner in HIPAA on PMRI and expanded it into
the consolidated health informatics initiative standards.
PARTICIPANT: What is PMRI?
MR. BLAIR: Patient medical record information. There was like a one or two
liner in the HIPAA law saying that we should start to look at that. Well, we
took that and we expanded it tremendously and we — right. So, in part one of
the big successes of HIPAA was that it expanded it and made NCVHS capable of
driving forward clinically specific terminologies. It allowed us to do the
National Health Information Infrastructure. It put us in a position where we
could respond to Congress when they asked us for e-prescribing. It started a
lot of good things and I think that — so we have an opportunity to say a lot
of good things about HIPAA without emphasizing some of the areas that people
are frustrated with.
DR. COHN: Jeff, I think that actually the letter — I know you haven’t had
a chance to review the report. I think the report is actually excellent in that
it expands beyond HIPAA but it also has to include HIPAA and I am certainly not
going to be an apologist for the HIPAA implementation. I would actually rather
than describing it personally as a first step, I think it is a foundational
element. I think these are all sort of wordsmithing issues.
Now, let’s stop the conversation here about all of this stuff. We have got
like a couple of different things going on here. We have talked about a letter
from Populations. We have talked about a letter from Standards and Security on
potential sort of modifications or streamlining of the HIPAA process and you
have got this letter. Now, the questions I need to bring up to the committee
are are these things that we — do we feel comfortable during a conference call
between now and June addressing these issues or at least trying to make some
further progress on them and should we arrange a public open conference call of
the full committee for some time between now and — I mean probably sometime
like two months from now or something like this to really — to go through
these things? Do we feel that we can make progress or come to conclusion on one
or any of them? So, that is one set of options.
Alternatively, if there is a decision made that, gee, X could be sent off
to the Executive Subcommittee. Other things really need full face-to-face full
committee deliberation in June. That is another approach. So, I just have to
ask you all to sort of think about the three things that we have going here and
then we will talk about the biennial report, but I don’t think that is going to
be a vote between now and June.
MS. GREENBERG: It is not really a letter. It is a whole report.
DR. COHN: It is a whole report, but we haven’t started on it.
MS. GREENBERG: No, the HIPAA report.
DR. COHN: So, what is the preference of the committee on this one? Should
we schedule a committee meeting, a conference call to deal with these three
MS. GREENBERG: Two of them have not really been through their subcommittees
yet. Isn’t that correct? I mean, the Standards and Security hasn’t had a chance
to go over this first draft of their letter and talk about it and the data
linkages thing hasn’t really — because both subcommittees didn’t meet
DR. SCANLON: I don’t know if Donna is on the phone, but Gene and I would
believe it is not necessarily the issue of face to face that is critical in
June. It is June is further away than May.
DR. COHN: So, your view on that issue is that you need until June to come
forward to us for an action item. Okay. Well, that solves one issue.
MR. REYNOLDS: Our subcommittee, we heard the testimony. We have agreed that
we agree with moving something forward. I think we could edit it through some
kind of a conference call on Standards and Security in advance of whatever you
set up for the full committee. I think we could definitely do that.
One other thing I would like to ask that if we agree to these processes of
these letters, that the members of the full committee that aren’t on the
subcommittee, if you have a fundamental disagreement with any portion of the
letter it would be good to contact somebody on the subcommittee so the
subcommittees could try to work it out before it comes to the full committee
rather than waiting to a full committee call and then all the sudden somebody
is against the process.
I have no problem with wordsmithing or another, but if we are going to do
these things on conference calls trying to — at least the subcommittee could
work it through. Anybody can say anything they want to on the open call, but it
makes it a little more difficult —
MS. BERNSTEIN: We can certainly circulate drafts in the interim period. We
did that with the Privacy letter from June and actually thought it was pretty
helpful that the committee was very engaged when it got to the discussion and
also we collected comments in the interim.
MR. REYNOLDS: Yes, but making sure that the people comment. I guess that is
what I am saying. If there are comments —
DR. COHN: Maybe I am asking slightly more cerebral questions. We have
talked about that and then we will go to the HIPAA report. The question is your
confidence — a call is not the same as a face-to-face meeting in terms of
coming to conclusion on things. I need sort of your general sense of whether
these things can be dealt with. I mean, I certainly feel that the HIPAA letter
or report could either be dealt with during a conference call or potentially
even referred over to the Executive Subcommittee.
The question is is that — we certainly have a couple of options on this
one. So, I guess I am looking for at least in terms of the letter and the
issues that you heard discussed is there something that you feel that you can
come to a conclusion and feel comfortable voting on during a conference call if
we decide to move forward on that?
DR. STEUERLE: I would like to suggest that the actual report — maybe just
following a little bit of
DR. COHN: And this is Harry’s letter now we are talking about?
DR. STEUERLE: I am talking about the report to Congress. It seems to me
that we could put that back to the Executive Committee and let them put it out.
It is a report and it is not another set of recommendations. At some point I
think you can delegate a little wordsmithing. There were some contradictory
views on what should be done here, but I don’t know that it is the type of
thing that is worth coming back to the committee for another long discussion.
It seems to me I would delegate the authority to finish that up and send it out
to the Executive Committee myself.
MS. BERNSTEIN: — if I understood what conclusion was reached on the tone
of this letter so that I could actually draft it that way. I want to reflect
properly what the committee’s intentions are in that letter. If somebody thinks
they can summarize —
MS. GREENBERG: We have enough — we have a quorum here if the committee
wanted to pass the HIPAA report with the agreement that it will, you know,
basically include the content that includes the — maybe be tightened up a bit
and some of — but nothing new that needed to be voted on separately and then
referred to the Executive Subcommittee to finalize and — or that would be one
approach or have the Executive Subcommittee finalize and then have a conference
call, an open conference call in which it is approved.
DR. STEUERLE: My motion is for the first.
MS. GREENBERG: For the first. Okay. That is a motion on the floor.
DR. COHN: Well, I think Maya is obviously asking what the tone of the
letter is and I guess this is an issue that I have to look at Larry and I don’t
know if he has had — I guess you actually have reviewed the whole letter a
couple of times now. I will tell you that I have — I don’t think that I share
necessarily your perspective on the HIPAA implementation, but then, of course,
I also had different expectations of the implementation because I considered it
to be foundational to next steps and not necessarily solving all aspects and I
think we both have parents involved with health care and I don’t think — I
would agree with you. I don’t think that the HIPAA administrative
simplification has certainly solved that.
The question is is, of course, how others feel in terms of the tone and how
they want to frame it. Larry, I don’t know if you want to comment.
DR. VIGILANTE: My own view is close to Mark’s, which is that, you know, if
we really want to evaluate what HIPAA has achieved, we need to actually go
through a process that evaluates what was achieved through a formal data
gathering process and write something that is based on evidence that we have
heard from the field.
I think that a letter that talks about what has happened in a descriptive
way but does not necessarily place a value on what has happened is probably at
this point the appropriate measured response. I think that there are — is
there room for lessons learned to allude to the fact that a great deal of
progress — that a great deal remains to be done and that we haven’t achieved
the vision yet. So, I think there are ways of sort of caveating this
diplomatically that can perhaps achieve some middle road and I would be
comfortable with the Executive Committee sort of hammering that out.
DR. CARR: I would like to — I liked the way Jeff put it. I think the
letter needs a point of view and that the idea of saying this was the first
step, moving into the electronic already implies that no one is claiming
victory, but saying as a first step how important it was and where we are sort
of on the journey.
So, I think the letter needs a point of view and I don’t quite get that
from that. I think the elements are there, but telling the story as Jeff began
I thought was very helpful.
DR. COHN: we have a motion to approve with work to be done to further
modify and by the Executive Committee is I think what I am hearing. Obviously,
the Executive Committee would at its discretion if the topics moved far off
what we have now to include this include this in a conference call of the full
committee, but recognizing that we will probably be as we have just been
describing. I think that is what you are suggesting now.
Is there a second on this one? Mark?
MR. ROTHSTEIN: I second the motion.
DR. COHN: Okay. Further discussion?
All in favor, aye?
[There was a chorus of “ayes.”]
[There was one “nay.”]
Okay. Jeff, did you oppose?
MR. BLAIR: Yes.
DR. COHN: Okay.
MS. BERNSTEIN: The motion carries.
DR. COHN: Anyone on the phone wish to vote? And, Jeff, you are opposed to
referring this to the Executive Committee?
MR. BLAIR: It is okay. My feeling is that I don’t feel like — and part of
it is me. You know, obviously, I haven’t read the letter. So, I am, you know,
at a — it is not really appropriate for me to make a stand. My feeling is that
I am not sure we have reached consensus on what we really want the letter to
say, what the message is and, therefore, how we would craft it. However, there
just was a vote and the vote was to put it to the Executive Committee and I
will support that and maybe the Executive Committee will be able to try to pull
it closer to consensus and, you know, so let’s just go down that path.
MR. ROTHSTEIN: May I just comment briefly? This may be helpful to Maya. I
think what the letter can say especially in the lessons learned is to have a
sort of focused evaluation of discrete things that we have studied and what we
have learned about what has worked and what hasn’t worked. In my judgment and I
think I hear some support for this view, what we ought to avoid is sort of
sweeping statements about whether HIPAA has been a success or a failure and the
reason for that notwithstanding the sort of the practical arguments that I made
earlier, is that we would have to go back and actually study the legislative
history of HIPAA and particularly the administrative simplification provision
to know what the goals were to see whether they were achieved.
I think there have been many goals that have been ascribed to
administrative simplification that in my judgment were never contemplated by
Congress and that it was a sort of a narrow goal and even narrower view of what
privacy needed to accompany the administrative simplification and if we view
this as sort of this field that is supposed to — or law that is supposed to
restructure the health care system and make it work and have privacy for
everybody at the same time, of course, that is not the result. So, in other
words not to avoid drawing conclusions in the letter, but to draw narrow
conclusions based on the kinds of issues that we have studied and that have
been parts of the recommendations that we have made to the Secretary over the
last several years.
DR. COHN: Certainly, the Executive Committee does reserve the right to
bring this back to the full committee for review if there are sort of any
issues that surface. But it will obviously be turned over to the Executive
Committee for work. You will I am sure all receive copies of versions as we
work on it. I think we just want to make sure that everybody is providing
appropriate input and feels that they are part of the process.
MS. BERNSTEIN: Notwithstanding, I did promise yesterday to circulate
electronically the letter to everyone on the committee and the staff. So,
before I start rewriting and get it to the Executive Subcommittee, if anyone
does to weigh in specifically on their part, please feel free to do so.
MR. BLAIR: And actually I would feel happier if the position that I took
would be represented as abstaining rather than opposing.
DR. COHN: So noted.
DR. STEUERLE: I didn’t mean that going to the Executive Committee that it
would not send a copy to you
DR. COHN: Jeff is on the Executive Subcommittee.
The good news is that I saw on the calendar we actually had to 12:30 to
adjourn. So, I am not as late as I thought.
Now, I am going to basically defer to termination on this final issue,
which is that letter from Standards and Security for them to do further
deliberation on it, as well as obviously Executive Subcommittee to do the HIPAA
for the work on the HIPAA letter and see if it is appropriate or necessary for
us to have an open conference call between now and June. So, we will not decide
that at this moment.
Now, there is an issue that has to do with the 2005-2006 NCVHS Biennial
Marjorie, did you want to talk about that briefly?
MS. GREENBERG: Very briefly. I know I am between you and your flights and
lunch and everything else.
Just to say that the — for new members, we did for many, many years do an
annual report. We now do a biennial report. This is a report on the entire
committee. Again, it doesn’t typically break new ground, but it is archival and
also should be interesting, hopefully, if you are interested in the committee.
The last report was the 2003-2004. So, now we are wanting to really get
started on the 2005-2006. Susan Kanan, who is a committee writer, will take the
lead on it. I think that it refers to the HIPAA report, but, of course, it
includes all the subcommittees, et cetera. What I would ask is that everyone
and particularly the new members look at the last one, the 2003-2004 report
because in this case now we are starting. So, we are not quite mid-stream the
way we were or close to the end with the HIPAA report. Send me and Simon any
suggestions on how — you know, if you think the whole thing should be
restructured or you think the current structure will work, et cetera.
So that our current plan would be to do a 2005-2006 report that would
basically follow the general format of the 2003-2004 report, but the Executive
Subcommittee is meeting and will have done some more strategic planning in
2005-2006 than we had done in the previous years. So, we may want to — you
know, there may be some areas that we want to emphasize. We will have a forward
by the chair, which can always — generally be more expansive or more
philosophical or doesn’t have to — I mean, it can’t say in it and there should
be a unique identifier, but, you know, it is an opportunity for reflection on
the chair that isn’t quite as limiting as some of our other work is.
Let us know. I would like — Susan, I think is — we need to get her
started on it and so I would like to have your approval to just — that she can
contact the individual chairs of the subcommittees and the chair of the full
committee to start, you know, putting it together and at least the foundation
of it and the nuts and bolts of it. But this is an opportunity to also give us
input if you think it should take — it needs to basically summarize what we
have done but if you think it needs something else or should take a different
We have tried I think in the last few years to make it more cross cutting
and less just subcommittee, subcommittee, subcommittee, workgroup. I think that
has been good. So, I just put that on the table and I would welcome any of your
comments. I guess our goal would be to have a draft reviewed at the June
meeting probably but maybe not approved until the September meeting. Does that
DR. COHN: Sounds good.
Now into subcommittee and workgroup reviews. Obviously, we had a number of
them cancelled this time. So, you know the NHII workgroup will have a
conference call to further discuss next steps.
Executive Subcommittee is having a meeting in May to talk about further
activities. I am also charging a small workgroup, really a planning group,
which will be composed of Jeff Blair, Mark Rothstein, Justine Carr and Harry
Reynolds to work with me around issues related to secondary uses of data, which
may come forward as another ad hoc workgroup activity. But we will be talking
more about that as we know a little more and sort of work on that issue.
Since Justine is actually the only group, one that actually had a meeting,
which was a conference call, if you want to just briefly discuss any
conclusions from that, I would certainly offer you that opportunity.
DR. CARR: Thanks, Simon. I want to thank the great turnout at 8 o’clock
this morning on the phone. We had Mark Overhage, Garland, Carol, Bill Scanlon,
Larry Green, Kevin Vigilante, Marjorie, Debbie, Michael Latt(?), Marybeth
Farquhar, John Waits(?) and Michael Fitzmaurice. So, quite an impressive group.
Just very rich, based on that. So, our goal was to discuss our plans for a
hearing as were outlined in our meeting earlier in January with Callan(?)
Clancy. Just briefly our national agenda as we know is to implement a full
electronic health record by 2014 and it is assumed that the electronic health
record will improve the breadth and efficiency of quality reporting. However,
current quality reporting initiatives rely on administrative data and data
extraction from the medical record or both.
Between 2007 and 2014, quality measures will rely on a blend of
administrative data and electronic medical record data. The Quality Workgroup
is planning to hold hearings to identify how this blend of administrative and
electronic data is currently being used for quality assessment and will seek
testimony on current state successes and challenges and how it should be
developed and improved over time.
At the end of the testimony, we should have some indication as to what it
takes to use administrative data and we will be asking each testifier to
present their use cases, what did it take to do it, how did it have an impact
on quality, what did it lead you to do, what are you planning to do next.
So, we actually got some great ideas and some suggestions of some I think
wonderful folks to testify. So, next step will be to complete that list of
people who could testify. We probably might even invite written testimony even
if we don’t have people come to speak. So, we will be looking into their
logistics of date and time.
DR. COHN: Justine, thank you.
Mark, do you want to make any comments about plans for Privacy?
MR. ROTHSTEIN: Yes, very briefly. We are going to send out an e-mail to all
the members of the subcommittee and try to get some dates for first an April
hearing on a topic to be named and also a series of conference calls to talk
about our two letters that are in the pipeline, the FIRPA letter and the
covered entities letter. So, we are going to have to do it remotely until our
next face-to-face meeting, which probably will be at the hearing in April.
DR. COHN: Harry and Jeff.
MR. REYNOLDS: I will just make a quick update. Thanks for agreeing to our
letter yesterday. We have got the one letter to work on that you saw. We
obviously have to keep an eye on NPI the rest of the year. We have hearings
scheduled in May and October. You heard Karen bring up the security discussion
yesterday, which we will need to include. We have put down a complete list of
the things we feel we should focus on the rest of this year and forward. So, we
will be finalizing what is going to be in our May hearing but that is kind of
where we are right now.
Then this ad hoc effort, kind of like NHIN, whether or not — what portion
of our committee it does or doesn’t pull into that effort to look at.
DR. COHN: Jeff, did you have any comments?
MR. BLAIR: No additional comments.
DR. COHN: I try to make sure that the planes run on time and we are
actually just at 12:30. I do however always at the end of meetings I like to
ask members — I mean I thought this has been a very interesting meeting. I
really want to thank the new members for providing I think some fresh insights.
I think that is always, as Marjorie commented, why we have members rotate off
and new members come on.
At the end of the session I always sort of like to ask people just for
brief views of what worked at this meeting, what didn’t. We obviously will try
to avoid having snow storms at future meetings, but, obviously, that is — heat
in the room, okay. We will work on heat in the room.
DR. FRANCIS: They finally managed to make a machine work. I gather you said
it wasn’t working.
MS. BERNSTEIN: I had to get fingerprinted twice on Friday and then I was
told that the machine was going in for maintenance essentially and they would
call me when it was done. So, I am surprised that they called you for
DR. COHN: Any comments from any of the members about how we can make these
meetings better or more interesting, more compelling?
Okay. Well, in that case the meeting is adjourned and thank you all for
[Whereupon, at 12:35 p.m., the meeting was concluded.]