[This transcript is unedited]

Department of Health and Human Services

National Committee on Vital and Health Statistics

September 21, 2011

Embassy Row Hotel
2015 Massachusetts Avenue, Northwest
Washington, DC

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 266-8402


P R O C E E D I N G S (9:00 a.m.)

Agenda Item: Call to Order, Review Agenda

DR. CARR: I would like to welcome everyone to the first day of a two-day
meeting of the National Committee on Vital and Health Statistics. I am Justine
Carr, Chair, and I’m with at Steward Health Care and no conflicts.

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

DR. FRANCIS: I’m Leslie Francis, Law and Philosophy at the University of
Utah. I chair the Privacy Sub-Committee and am a member of the full Committee
and I have no conflicts.

DR. TANG: I’m Paul Tang, Palo Alto Medical Foundation, no conflicts.

DR. CHANDERRAJ: I’m Raj Chanderraj, practicing cardiologist, no conflicts.

DR. MIDDLETON: Good morning, I’m Blackford Middleton, a member of the full
Committee, from Partners Health Care, where I’m the Director for Clinical
Informatics, Research and Development, and a co-chair of the Quality
Sub-Committee and serve on the Population Committee, and no conflicts.

DR. MAYS: I’m Vickie Mays, Professor of Psychology and Health Services at
the University of California, Los Angeles. I’m a member of the Full Committee,
and I am a member on Populations and Privacy. No conflicts.

DR. BURKE: Good morning, I’m Jack Burke, Vice President for Compliance
Programs at Harvard Pilgrim Health Care in Boston. I’m a member of the Full
Committee and have no conflicts.

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

MR. SOONTHORNSIMA: I’m Ob Soonthornsima, I’m Chief Information Officer at
Blue Cross Blue Shield Louisiana, I’m a member of the Full Committee and a
member of the Standards Committee and have no conflicts.

MS. DOO: Lorraine Doo, with the Office of the Health Standards and Services
at CMS, Lead Staff to the Standard Subcommittee and no conflicts. And Judy’s
smiling at me.

DR. COHEN: I’m Bruce Cohen, from Massachusetts Department of Public Health,
a member of the Full Committee, and a member of the Population Health
Subcommittee, no conflicts.

DR. NICHOLS: I’m Len Nichols, from George Mason University, I joined the
Full Committee this summer and I serve on the Population Subcommittee and
Quality Sub-Committee. No conflicts.

MS. KLOSS: Linda Kloss, Health Information Management Consultant. I’m a
member of the Full Committee and the Privacy and Quality Subcommittees, and no

DR. WALKER: Jim Walker, I’m Chief Health Information Officer at Geisinger
Health System, and on the verge of being a member of the Full Committee, no

DR. GREEN: Larry Green, member of the Committee, no conflicts, very happy to
see all these people that are on the Population Subcommittee.

MS. MILAM: Sallie Milam, West Virginia’s Chief Privacy Officer. I’m at the
West Virginia Health Care Authority, Member of the Committee, and no conflicts.

DR. SUAREZ: Good morning everyone, I’m Walter Suarez, with Kaiser
Permanente, I’m the Co-Chair of the Standards Subcommittee, a member of the
Full Committee, looking for some more members on our Standards Sub-Committee,
no conflicts.

DR. WARREN: I’m Judy Warren, I’m from the University of Kansas School of
Nursing, Walter’s Co-Chair on the Standards Committee, and yes, we’re
recruiting heavily today. And I smiled at Lorraine because she’s a great staff
person and we’ve been working very hard, as you will see, on the agenda, and no

MS. GREENBERG: Good morning. I’m Marjorie Greenberg from the National Center
for Health Statistics, CDC and Executive Secretary to the Committee.

DR. ALBRIGHT: Matthew Albright, I’m with the Office of E-Health Services and
Standards at CMS.

MS. KANAAN: Susan Kanaan, writer for the Committee.

MS. WILSON: Nicole Wilson, Veterans’ Affairs.

MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC,
Committee Staff.

MS. JONES: Katherine Jones, CDC, National Center for Health Statistics and
Staff to the Committee.

MR. KYLE: Frank Kyle, American Dental Association.

MR. BARBER: Robert Barber, American Medical Association.

MR. SLAUGHTER: David Slaughter, Thompson Publishing Group.

MR. QUINN: Matt Quinn, National Institute of Standards and Technology, Staff
to the Committee.

MR. BARLOW: Peter Barlow, Price Waterhouse Coopers.

MS. QUEEN: Susan Queen, HHS, Assistant Secretary for Planning and

MR. MILLMAN: Mike Millman, ASPE, HHS.

DR. SORACE: Jim Sorace, HHS, ASPE.

MR. BIZZARO: Tom Bizzaro, First DataBank.

MS. GILBERTSON: Lynne Gilbertson, National Council for Prescription Drug

MS. WEIKER: Margaret Weiker, HP.

MS. SQUIRES: Marietta Squires, Staff to the Committee.

Agenda Item: Updates from the Department

DR. CARR: Welcome everyone. With that, I’d like to turn it over to Jim
Scanlon for an update from the Department.

DR. SCANLON: Thank you, Justine. Good morning everyone. It’s a pleasure to
see a full complement of members; it’s been quite a while since we had all 18
members and we have you for a good duration as well.

So let me give you an update of activities at the Department. You will get
other updates from ONC and Standards and so on, but let me give you an update
on policy activities, some of our data strategy and data planning activities,
many of which I think we’ve talked a little bit about before. In the areas of
policy, I think I talked a little bit at our last meeting about the HHS
Strategic Plan. And this is, I think you have a one-page summary in front of
you in terms of five goals, and a number of objectives under the goals, and of
course, there are a number of action steps under each of those. So basically,
these goals reflect some of the overall across departmental activities at HHS,
and where HHS invests time and priorities.

We’re in the process of updating the strategic plan, and we may modify the
goals a tiny bit and update it in terms of things that have happened, and when
that occurs, I think I’ll bring in our strategic planning folks to give you an
update. It just helps you, I think, if you see where, at least the way we
publicly express strategic goals, planning and so on.

Now in addition to the overall strategic plan, we have a number of high
priority initiatives that are secretarial or other initiatives. Let me just
tell you a little bit of what they are. And I think you’re familiar with these,
but we can certainly brief you more on these. One of these is tobacco control.
There’s a big effort now to reduce cigarette smoking and so on, and initiation
to cigarette smoking, as a major risk factor for a lot of chronic conditions,
so we have a number of activities there. On the HIV prevention and services
front, we have a number of initiatives as well. We published, about four months
ago, an HHS action plan to reduce disparities in health and health care, that’s
up on our web site. In addition, we’re now in the process of implementing many
of the action steps there. You’ll see from the plan that we have a set of
metrics, so that we’ll know – these are really metrics that we would try
to improve if the plan is working.

And then we’ve published, about four months ago, the National Quality
Strategy and the National Prevention Strategy. Another initiative is in global
health; there are a lot of initiatives here – and early childhood health
and development.

As a general rule within HHS, we try to see that any major initiative
that’s started includes some data experts to sort of plan ways that we could
measure progress, and to get some indicators, so that we could, instead of just
announcing the initiative and then moving along, we could actually see to what
extent we’re actually achieving some of these measures.

Of course, the other big one we’ve had in connection with the White House
is Healthy Weight, and this is basically initiatives through life style,
through education, other means, to reduce obesity and to help people achieve
and maintain a healthy weight throughout their life cycle.

Now obviously, health reform is a major priority across HHS, and you have
seen a number of regulations and other activities. Many of you are actually
applying for various designations in association with the health reform
legislation. But I wanted to mention a couple of the data initiatives there as

One of the sections of the Affordable Care Act requires the Secretary to
adopt data collection standards for sex, race, ethnicity, language and
disability. This is self-identified. So we have been busy within HHS working on
this. We have a work group under our HHS data council, and we published a draft
set of data collection standards in July; I think most of you saw those. They
were published for about sixty days. We received over 400 comments from the
public on those data collection standards. In general, they seemed to hold up
pretty well. They were meant to be minimum data standards. We have to stress
this idea. The idea here is not to collect everything that anyone ever wanted
about disability or race, ethnicity or so on. This is the idea of a minimum
data collection standard.

Once the Secretary adopts these items, they would have to be part of any of
our at least HHS-sponsored population health surveys. So again, the strategy
here is again not to – for example, we basically proposed one question,
that’s basically becoming a federal standard now for disability. Six parts to
it. Obviously everyone wants more than that, but if you can at least put these
basic screeners into most of our population health surveys, you at least have a
start. You have a way of linking specialized surveys back to the major survey.

So we are now – we’re basically almost finished going through the
comments, and we’ll propose what those final standards would look like. Our
hope is that the Secretary will adopt them and publish them in the next few
months, and then the agencies would – again, these are population health
surveys, health interview survey, MEPS. The current beneficiary, things like
that. They would have to include these standards either at the next revision or
certainly any new survey would have to include them as well.

In addition, we were asked to look at the next stage; well, what other
variables would folks like to standardize, and the overwhelming recommendation
was to look at SES, or socioeconomic status. So we will be looking at measures
there. I don’t know – there are a lot of dimensions, as you know, to SES
measurement. I don’t think anyone’s looking for one index, so we’ll look at how
various folks are approaching the measurement of SES, and then we’ll –
again, we’re looking at measures that have actually worked in practice
previously, and again, we’re looking at a minimum standard, so we’ll be looking
at this as well.

Associated with that initiative, and with health reform generally, we are
looking at ten domains that it is believed health reform or health systems
change would have an impact on, and I’ll read those ten areas to you. But in
each of those areas, we have agreed on a set of about half a dozen or so
measures that we will be monitoring and before long, we’ll make this available

So in other words, let me tell you what the areas are. Access to care, cost
and affordability, obviously insurance coverage, quality, vulnerable
populations, workforce; again this is primary care, and other public health
workforce – innovation; in other words, to what extent would the
provisions of the Affordable Care Act have a positive or negative effect on
innovation, population health, which would be the traditional public health
measures, to what extent will we see population health improve or not improve
as a result of various measures. Preventive services activities, and finally
health information technology.

So for each of these domains, we are identifying five to ten measures, so
that we can monitor to see how – sort of like a dashboard, to see how the
effort is going. And then there are a number of other activities in terms of
implementing both the implementation and the impact of health reform.

A couple other things. The leadership at HHS asked us to take a look at
really, in a very short time, take a look at our portfolio data collection
systems, both the survey, research, public health and administrative side, and
to look at ways that we could improve them in terms of faster turnaround data,
quicker data collection, more facile and nimble analytic capacity, sharing the
data, making it available, this is in connection with our open government
initiative as well.

And particularly to look at are the research, development and technologies
for data collection that we could employ, and I’ll talk about that in a minute,
and we’ve actually come up with a number of ideas, and some of them we were
actually able to get seed money to start moving on.

The other major area was to see how can we assure that the surveys, the
public health data, the administrative data and the electronic health record
data are, as they progress and move forward, can be done in a way that they are
aligned and converge so that we can – other folks have used various terms
to describe this – but it’s the idea that when we plan any one of these,
we are looking at the relationship to the other, and we are thinking of –
so that we would be in a place where we would have already thought through what
kind of data we would want, how would electronic health records help public
health or research, how would administrative data, including all of the new
data systems under health reform, including the exchanges and all of the other
– the data that would have to be supported to run the system, how could
that be done in a way where it’s more than just transactional, and that it
actually supports a broader vision for data that could be made available,
analyzed and shared?

So we sort of look at that as the alignment, or the convergence, side of all
this, it’s a little longer term, but again, our thinking was this is not going
to happen automatically, and in fact, an electronic health record may be
analogous, for data purposes, to a paper record, unless you actually know the
structure of the data, you know what kind of reports you want, you know how it
would be used and how it would be made available.

So we have a number of projects that we’re starting. Now we’re – in
terms of budget, we’re sort of finishing the 11 fiscal year; we’re a little
uncertain about what 2012 will bring, obviously, or 2013. So far, knock on
wood, we have been able to protect the data investments, particularly the core
surveys and data systems, but you never know. All of these plans rely on
obviously having the foundation there. But we have had some very interesting

For example, we’ll be looking at application of web panels, web-based data
collection to our surveys, for example. As a stand-alone or as an augmentation
to the survey, we’re looking at – virtually all of our statistical programs
now, are working on early release programs from the health interview survey, I
think you already know this. We have quarterly releases now with a six-month
lag. We have vital statistics. I think we’re looking at how we can make that

On the administrative side, CMS has been looking at very innovative ways to
make even the administrative data available more frequently. In essence,
instead of waiting for the last state to report, there are ways to sort of make
available what we have, as long as you understand the limitations of that data.

So we’re trying to push all of this forward. And this was really a 90-day
kind of an effort. We had some funds this past year so that we could get some
of these started; the web panel. At AHRQ they’ll be looking at quick response
telephone survey and other means for the MEPS. We’re looking at, on the
dissemination side, how are our research data centers going? Are there –
as you know those are, besides our public use files, and publications, the
research data centers are the place where research and others can go when you
want more or less research confidential data that wouldn’t be released
publicly, so you work with the research data center and try to work something
out. There are very positive developments there that are still, I think, again,
folks don’t like to work on site, and we still don’t have the remote access
entirely worked out, but we’re looking at how we might do things there.

So at any rate, we have a number of activities that we’re working on. The
other thing is we’re looking at – we’re always looking at special
populations that we have trouble getting – these are hard-to-reach
populations, or populations that are relatively small numbers, so it’s
difficult to get at them in an actual survey. Even with oversampling, you just
– the survey is just not the right – you reach a stage where the
survey is not the best way.

So we have proposed a strategy for race and ethnicity data. It gets you
ultimately to targeted community research studies for some groups. And we’ve
been asked to look at, in terms of vulnerable populations, we’ve asked them to
look at people with disabilities, particularly, and the LGBT community as well.
And we’ve had a couple – we have a project underway with NCHS to move
along towards collecting data here, and we’ve had a couple of listening
sessions as well.

The other thing is, we’re looking at what data do we already link, and how
do you get access to it, and are there opportunities for linking, again,
surveys and research with administrative data, ultimately with EHR data, and we
actually have a couple of pilot projects, where we will be looking at to what
extent can reports from EHRs, more or less as they exist now, well-established
EHR systems, to what extent can they provide – in this case it’s provider
data – for our surveys?

So again, we’re trying to get to the stage where we actually pilot some
ideas beyond just the concept of the framework. The other thing is, we’ve
established a working group not only on the disability – well, on the ACA
data, but we also set up a work group, we were asked to do this by a couple of
agencies, to pull together the Census Bureau, HHS agencies, OMB and others to
look at and sort of plan collectively the data we need for health reform, so
we’ve added a number of questions to the health interview survey and other
surveys, so we’ll be able to monitor a bit better, and we’re talking to the
Census about items they might add, or analyses they might do as well. And we’re
also looking, as a second step, at the administrative data that will be
resulting from health reform as well. So let me stop there, and take your

DR. TANG: First of all, Jim, it’s an incredibly exciting report and I’m
wondering a few things. One is, is there a central – the kinds of
initiatives you read off, is there a central place to go look for this stuff,
and I almost wonder, is it a little bit analogous to the NQF quality data
model, where they’re trying to create a central place to store our data
definitions related to quality measures; is there a repository for data that
you want to standardize, so that we can use it throughout the entire supply
chain. And as an example, let’s say the REL – Race, Ethnicity –
meaningful use is going toward IOM granular data – is that already
something that you’re thinking about?

MR. SCANLON: Different stages, Paul, for different items. For the data
collection standards, I think we’ll – with any luck we’ll have those
standards adopted by the Secretary within a couple of months, so that will get
them onto our surveys, and then that data will be part of all of our surveys.
We hadn’t really – the way we were looking at disseminating the data, and
I think you raise a good question, are there other ways to do this, and a
better way? We don’t have one data archive or center at HHS. We sort of –
you have to go to ARCQ or NCHS or NIH, for that specific data. What we have
done is to pull the data together in terms of inventories, and it will take you
as far on the web through a gateway as the data allow, but if you really want
individual data, then you’re sort of at the – you have to deal with the
research data center.

But I’d actually be interested in the NCVHS ideas about this. Maybe we could
have – is there a way, because what we emphasized was improving the data,
getting it faster, standardizing the data, making it available in new ways, and
as you know, we’re working with Todd Park – the model there, basically, is
whatever data we have that we can release, we would put it into our
healthdata.gov website. So that’s the notion of a place where you would go for
all of our data.

We’re still – we probably have over 300 data sets and tools there now,
but there’s still a lot more. And the surveys, this is tricky – it’s
difficult; claims data, for example, surveys and research, it’s one thing to
put statistical information up, summarize data, but when we’re looking at
individual – even if they’re anonymized, we just run into privacy issues.
There are folks who say they could reverse engineer and find individuals, so
what we’ve had to do for claims data, for example, we’ve had to remove a lot of
the dates and other material from the claims, so we had to kind of strip them
down to make them available publicly.

But again, I think we, if the Committee would be willing to give us some
thought, we’d really appreciate that. But we don’t have one archive.

DR. TANG: Could I just clarify? I’m referring to one archive for the data
itself, but really the data definitions; and the reason is, if we talk about
– you talked about minimum standards; sometimes minimum, it gets you a
little bit, but if everybody’s still collecting something, if they’re choosing,
we can’t compare them. So the race/ethnicity is one of them, if we only collect
the original let’s say six, then we won’t have the rest. The other example is
HRT Standards Committee, we used to say, either SNOMED or ICD-10, and that
didn’t help because – too many standards. They’re moving towards one,
SNOMED, in case of problems.

So that’s the kind of thing, actually, it’ll be more prescriptive, and may
turn out to be helpful in terms of the kinds of things that HHS is trying to
do, but trying to combine the data.

MR. SCANLON: And I think on the race/ethnicity standards, what we proposed
for comment, we really increased almost five-fold in detail. Because we’ve
heard, over the years, a number of folks – as you all know, won’t get into too
much detail, there’s five categories that are the OMB standard, and the people
have been trying to collect those for years. But the idea was that they can
mask important differences among the subgroups. So what we did was look at how
have surveys approached this, and what could we do? So we really added both on
the race/group sides and on the ethnicity side, we added quite a bit, and we
provide for a lot more detail. So that, in HHS, will become the minimum now.

But I think you’re right, Paul, we will – I think the idea was get the
minimum standard there, get it in all the measured surveys, and ultimately get
it into EHRs and administrative data. I think the thinking, interestingly, was
for EHRs, you have a lot more flexibility, because there, it’s not just a
statistical issue for analysis or epidemiology, but there, it’s a health care
issue, so you would need to know specific languages, and you would need to know
what, maybe specific ethnicities. So we’ll be working with ONC on a more
detailed set.

Much of this comes from the IOM report you reference, Paul, it’s basically
equality, is the role of race, ethnicity and other standardizing items to
improve quality.

So this is the first step. I think the next step will be maybe to, instead
of a minimum, maybe a core of demographic data.

DR. CARR: Marjorie wanted to comment on that. We have quite a few questions,
and we also have our ONC colleagues joining us, so let me let Marjorie go, and
I think we’ll go around the room.

MS. GREENBERG: Just in relationship to Paul’s question, I think in the past,
but of course we have a number of new members, but Mike Fitzmaurice has
reported about the US knowledge basis, Health Information Knowledge Base, which
is based on, actually, a standard that is used in Australia, and it’s an ISO
standard as well, but I wondered – we have put all of the data elements
for various – all the HIPAA transactions, a lot of different things, in
there, and I’m thinking that that could be a repository for these standards as
well. Because this, of course, is also something that the vocabulary of the
task group or work group of the Standards Committee has looked at as sort of
one-stop shopping, so I think all of those are possibilities.

DR. CHANDERRAJ: (starts off-mic) – collection of data – these data
sources, especially for race and ethnicity, there are multiple races where this
data has been gathered; what we are finding difficulty, it has become a
meaningful use criteria, the front office is finding it difficult, and people
are very sensitive because, considering discrimination, other things, they’re
difficult to give our their race and ethnicity, especially when they’re
scheduling their appointments. I was wondering if one source where they’re
being recruited into the insurance or the HHS, that data is enough, and we need
ASF criteria as meaningful use, because we’re finding it very difficult.

MR. SCANLON: No, this is a classic problem. You need the data to sort of
measure potential disparities or discrimination, yet at the same time you don’t
want the very data to be used for selection or other things. So there are
various ways in education and in health care, to do that, but what we will be
doing, it would be self-identified, so the individual, and the focus here is on
basically, population surveys where the individual is there, or the household,
in a household or in some other setting, and they’re asked, which of these
– they can refuse, obviously, but you’re absolutely right.

And our administrative data too, claims data and enrollment data. This has
been a long-term issue. We have tried to incorporate the five basic
race/ethnicity categories, in Medicare data, Medicaid, S-CHIP and even in HIPAA
as well. It’s hard to get it mandated, but it’s one of these things – and
we’ve talked to the health plans and so on, where it’s still a sense of issue.
But on the other hand, you don’t – you can’t tell if there are disparities
without it. So it’s just a difficult issue.

We have collected it, though, for quite a while now in our surveys, and our
hospital discharge data, and it’s – still a lot of missing items, but
basically it’s usable –.

DR. CARR: I’m going to continue around the room, and I know we have Jodi
Daniel waiting. What I’d like to ask is if you have a question that is relevant
to the work of the Committee, let’s hear those now, and then at the break, Jim
will still be here at 10:15, and if there are more questions to understand in a
greater detail, we can do those off line. Blackford?

DR. MIDDLETON: Quick question I had, Jim, basically I agree with Paul
wholeheartedly. I think part of the challenge is to move way upstream in data
definitions, and to really bind them to standard terminologies wherever and
whenever possible, and to make that as coherent a single specification as you

USHIK is a metadata repository containing a lot of measure types, but
doesn’t go so far as the NQF in actually binding them to specific standard
terminologies, or recommended terminologies. So that really would be something
the NCVHS could be helpful with. I think we could make some strong statements
in that regard, et cetera. So look forward to talking about that further.

I think also, we may want to think about EMLS and other kind of standards
development organization tie-ins, because if this happens in isolation, it will
be at risk always of deviating from kind of the broader ONC and standards
development organizations’ efforts underway. My key question, though, and maybe
for later determination, is, you describe a whole bunch of agencies across
government, and we left out even the private sector. How do we actually achieve
an effective governance model that says here’s how we’re going to address these
decisions, make compromises around specifications and definitions? Is that
something Consolidated Health Informatics, or what is it now that will actually
do that? I’d love to hear more about that. And I’ll stop there.

DR CARR: You want to talk about that on the break?

MR. SCANLON: Yes, the initial focus was federal, obviously, but – in
fact, I think we would look towards industry standards as the starting place
for most of these as well.

DR. MAYS: I want to say, I think your report was equally as exciting, as
Paul said. I think the issue that I want to raise has to do with the role of
NCVHS in some of this, and so I’m going to start with a couple of places that
I’m hoping we might weigh in.

One is that, and this kind of gets to what Raj said, and that is, needing to
have some advice about the collection of data on race and ethnicity, so I think
while it’s great that we say this is what needs to be done, I’m wondering if,
at some point, we can try and address some best practices for the collection of
the data, because that’s where, in many places, it becomes quite difficult, and
I think we can help solve that.

The other is, if we think about Healthy People 20/20 and the four new areas
that have come up for Healthy People 20/20, we need to kind of look ahead and
say do we have the data that we’re going to need in order to be able to target?
So that would take, I think the new areas are social determinants, LGBT, access
of care and I know I’m missing one, I think it’s blood infections or something
like that.

So the question, again, for us, I think might be, particularly when we start
thinking about social determinants, that will get into addressing two of the
populations that you talk about, LGBT and SES, so again, I think the committee
should find a role to be able to do that. Marjorie, I think you sent out an
e-mail at one point; I want to know, for the Committee, when I had asked about
doing the race and ethnicity commentary, and we didn’t have enough time, you
said that there might be the opportunity coming up for the Committee to weigh
in on SES and LGBT, so it would be good if at some point we could discuss when
to do that, so that we don’t get – we have to rush or get caught behind
the eight-ball.

MS. GREENBERG: I think Jim – at the time when the other ones came out –

MR. SCANLON: We were just caught in –

MS. GREENBERG: You felt there might be, for –

MR. SCANLON: I think Vickie has a good point, though; maybe it’s the
Population Sub-Committee, but it would be most helpful, if you’re ahead of us,
and you have ideas to give us, that we could incorporate rather than –
it’s just hard for us to stop, because then it’s public before it’s meant to be
public, and then we sort of short-circuit the process, but I think on SES you
could – if the Committee wanted to have a workshop or a hearing, in terms
of contemporary measures, not the – the old stuff I don’t think anybody
uses – and how you approach, I know that the National Academy of Sciences
did some work in terms of SES.

I think on LGB, this is very tough, as you know, and transgender is very
tough. What we have, and we could certainly – we have NCHS testing
questions in the health interview survey, and they’re trying a couple of
different models, so there are more or less two or three pilot studies, each
one getting larger and perhaps we could have – it’s public, so they could
certainly get the view of the Committee or the Sub-Committee, at least, on some
of the best thinking there.

Transgender is very, very tough. We had a listening session; it’s just very
tough. But again, we’re trying to see where are the opportunities.

DR. MAYS: My final one has to do with health statistics; that is one of our
roles. Again, as we roll this out, the issue is, and I don’t know if there’s
funding to stimulate this, but we actually need to develop better statistics
for doing, like small population, weighting, estimates, so rather than us keep
worrying about these populations being so hard to reach, we actually need to
have some funding to stimulate the development of, I think, better approaches
for analyzing that data. So I don’t know if NIH can do this, or NSF, or if
there’s some way that we can also stimulate development of statistics.

MR. SCANLON: I neglected to mention – we’ve actually started –
we’re looking at the size of the sample data collection for special
populations. Are there ways to make indirect, model-based estimates and so on,
so we have a nice project – we’re starting with a health interview survey
to see to what extent we can make smaller – well that’s more local area,
state and local area, but we would definitely be interested there. And NIH
actually does have – a couple of the Institutes do have grant programs
that look at methods in these areas, measures and methods and so on.

DR. CARR: Okay, on the left hand side of the table raise your hand, and if
you have a question, Bruce.

DR. COHEN: Again, great report, and one area that I think the Committee can
focus on that I think is incredibly neglected both at the federal level and at
other levels, has to do with training around data collection. The data are only
as good as the training for those who collect it. Particularly for self-report
data, both on interviews and in the private sector, and the encounters with
providers and state and local government; there’s a huge gap in resources from
the Feds, from the private sector, and if we expect any of these data standards
to be adopted and used and generate meaningful data, we need to focus on
training the data collectors better.

There are some models in race and ethnicity, actually in Massachusetts we’ve
developed on-line training to expand our collection of detailed ethnicity data,
the encounter for collection of self-identified data is crucial if you want to
generate good data. I think the Committee could focus on it, and I’d like to
see the Department dedicate and allocate meaningful resources for developing
training for, in a variety of settings.

DR. CARR: Anybody else on the right hand side of the table – Walter and
then Judy?

DR. SUAREZ: Yes, Walter, as far as, again, very exciting and impressive,
just amazing report, with many initiatives. I wanted to touch very briefly on
the last aspect of what you mentioned, the assessment of data systems across
the organization, and what I wanted to just mention is sort of the new element
in the development of harmonized systems, and that is the health information
model, developing an enterprise like health information model, that’s just one
of the new areas that large systems organizations, including our own Kaiser and
others, either Mountain and other systems, are moving into, and I wanted just
to mention that in the federal government, there’s the Federal Health
Interpretability and Standards Modeling Initiative under the Federal Health

I think in order to achieve true interpretability of data systems and
ensure that the data, whenever it’s collected, in particular settings and a new
data initiative started, they always have to go back and reference a central
reference information model. And in addition to the federal effort on
developing a health information model, I think to the point made by Blackford,
there needs to be a larger interorganizational that involves federal, involves
private sector and involves, actually, international work being done on the
health information model, and so I just wanted to plant that seed, because I
think the message of health information modeling is going to keep coming back
to us and I think NCVHS could have an important role in that.

DR. WARREN: I guess I want to tag on with Paul and Blackford. I think when
you first start talking about the common data elements for race, ethnicity and
language and all of that, that needs to be done with looking at where it’s used
everywhere, and for me, that’s the EHR. And I’m still amazed how many different
peoples who are implementing their EHRs choose their own data elements, their
own data values for those elements, and place them in different parts of their
data model, and we’re never going to get anywhere until that happens, and so I
think one of the things we need to take on is how do we communicate to the
public that there are solutions for this, if we’re to go get that information,
because I’m not sure that many people know about USHIK.

They’re beginning to know about EMLS, because of the problem list, the
nursing problem list, that had been developed and posted there, so that’s
coming out as models that have terminology bound into them, that fit in a
certain slot in the EHR. And so I would like for us to do that, and while
Blackford mentioned EMLS, I think we need to take a look at the Library of
Medicine, and really look at the word “Library”. It could be the
place where we store the data definitions of all these elements and their
terminology bindings, so that now people can go to the library and they can
check out the whole package and go put it in their EHR. Don’t make each little
hospital have to become a terminology expert, HL7 expert and all of that.

MR. SCANLON: In fact, Judy, we designated, actually several years ago, at
least within HHS, rather than have every agency decide it was going to run its
own standards program, we designated the National Library of Medicine as the
core, as the center for not developing standards, but at least maintaining and
sort of the focal point for standards, and that would actually be a nice
service area for everyone. And there’s a network, by the way, as you know, of
libraries as well, for a lot of hospitals.

DR. TANG: A very short follow-up to what you said, this whole EHR thing, I
don’t think we’ll ever have a chance like we do now with the certification,
because it’s one thing to have a standard, it’s another thing to make sure
everyone uses, by definition, the certification.

SPEAKER: We have a process.

DR. CARR: Perfect segue to Jodi – Jodi is on the line from ONC for an
update. Are you there, Jodi?

MS. DANIEL: I am here, can you hear me? Is somebody from CMS going to be
giving updates on meaningful use, or would it be helpful for me to do that?

DR. CARR: I was trying to be sensitive to your timing, but actually Lorraine
was going to give the CMS update, so would you like to hear that first?

MS. DANIEL: No, that’s fine, I just won’t talk about it. I have the latest
on the meaningful use program, but if she’s going to do that, then I will just
talk about ONC-specific stuff.

Great. Well thank you, I’m sorry I couldn’t be there in person, and maybe
the next meeting, I will make sure I can move some things around to be there in

I just wanted to give some updates on some of our work from our Policy
Committee and Standards Committee on the impact on our rights and the timing
for that. I was going to talk a little bit about our consumer empowerment
program, our consumer eHealth program, which we just launched last week, and a
couple of other things, so I’ll just get started, because I’ve got a bunch of
things to cover.

So our Policy and Standards Committee has been very active in spring and
summer, working on providing recommendations to ONC and to CMS through ONC,
meaningful use and standards and certification criteria for certifying EHR

So we received, I know Paul Tang is there, he can give much more detail on
this than I could ever, but we received recommendations from the Policy
Committee on meaningful use for Stage 2, and so those have been received by the
Department, and we are now working on looking at those recommendations and
considering them as we work on our next stage of rule-making.

I think one of the most significant recommendations they made was for us to
extend Stage One of meaningful use. Farzad Mostashari, our National Coordinator
for Health IT, said that he understood the thinking behind that, and was
supportive of the recommendation and concept. Of course we have to go through
our rule-making process, and so we’re considering that very seriously, but
there are recommendation letters up on our website with all the details of the
different measures and for meaningful use and priorities that the Committee
thought HHS should be considering for Stage 2.

There is a meaningful use hearing looking toward stage 3 of meaningful use
that will take place October 5th and 6th here in DC, and
so it’s actually a pretty significant hearing, two days, and lots of great
folks coming to testify, and so the Committee is starting to already get a jump
on Stage 3, even though we’re in the process of just trying to think through
Stage 2 here in the Department, that’s great they’re looking forward.

And we have a work group that is going to be looking at data quality and
anti-fraud from the standpoint of are there things that ONC should be
considering in our thinking as we’re coming up with our program, like the
certification program in standards, that can have a positive impact on
preventing or reducing either erroneous billing or fraudulent activity? So
that’s just kind of a nutshell on the Policy Committee.

On the Standards Committee, we have a meeting next Wednesday, which I think
is actually going to be one of the most exciting meetings of the year for the
Standards Committee. They’re going to be reporting out from a lot of different
work groups, recommendations for standards and certification criteria for Stage
2 meaningful use. The way we have this staged is, we always have the Policy
Committee kind of reporting out first and setting the stage for recommendations
for meaningful use for the next stage, and then the Standards Committee takes
it from there and tries to identify the standards and certification criteria to
support those recommendations for Stage 2. So they’ve had a very active summer,
as the summer camp activities, and they’ve been working diligently to come up
with recommendations on standards and certification criteria for certified EHR

So ONC is going to be looking very carefully at the recommendations that
come out on next Wednesday, as we put together out standards and certification
criteria, rule-making proposed rule, that would align with Stage 2 of
meaningful use.

Also, we put out an advance notice of proposed rule-making this summer, on
metadata standards. This was in response to the PCAST report that came out last
December, I believe it was, that was suggesting some new thoughts and ways of
looking at some of the work that ONC is doing with respect to nationwide health
information network and health information exchange, and after a lot of input
and thinking, and hearing from our policy committee and then work on specific
recommendations regarding metadata standards from our Standards Committee. ONC
put out an advance notice of proposed rule-making on metadata standards that
went out for comment this summer. I think the comment period closes like any
day now, I can’t remember the exact date, but our expectation is that we would
take any comments and input from that advance notice of proposed rule-making
and roll it into our notice of proposed rule-making on standards more broadly.

So we wanted to get a little extra input on this, because it was sort of a
new approach, and some new thinking, and our expectation, though, was that we
would take any ideas that come out of this activity and roll it into our
regular standards rule-making activity.

So leading into that, so timing on our regulations. We intend to have
proposed rules for standards and certification criteria, as well as working
with CMS on their proposed rules for meaningful use, by the end of the calendar
year, end of December, early January. Basically, we’re working on the same
timing that we did for Stage 1, where the rules would come out at about the end
of the calendar year, we would have a comment period, process comments and then
have final rules out in the summertime. So that’s the same timing we did the
last go-round of this; we’re trying to keep that same approach.

Our CMS colleagues and the ONC folks are working diligently on trying to get
those regs put out and coordinated. We’re also working on governance
rule-making for a nationwide health information network. This has been
something that’s been a really challenging effort, I’d say, on our part. It’s
been – some really interesting new issues in thinking through how we would
structure a governance mechanism for a nationwide health information network,
and we are going to be putting out an advance notice of proposed rule-making
again, to get a little bit of extra input before doing a proposed rule on this,
and not sure exactly the timing, but we’re trying to at least time it with the
other rules, and hopefully even get it out sooner. So no promises here, but
we’ll see how things go.

We also just recently launched a new initiative that folks might be
interested in, called Query Help. This is under our S&I framework,
Standards and Interoperability Framework Activity. The goal of Query Health is
to establish standards and approaches for distributed population queries of
electronic health information. So the way that this is being run is kind of
similar to the direct project, where we’re getting both public and private
sector input, a very open and transparent collaborative approach to trying to
look at what it’s going to take, and what kind of standards and issues we need
to address in order to distribute population queries.

This is something that was one of the five goals in our strategic plan, is
to focus on a learning healthcare system and use electronic health information
as a way to support a learning health system, and so this is a significant
activity to step in that direction. We just kicked this off, so folks who are
interested in it, I don’t have the URL off the top of my head, but I know if
you just search for Query Health in an internet browser, you can find it pretty

Again, it is an open process; they are looking for folks to participate.
They have Wikis and things for folks to comment on different ideas that are
coming out of that program, so please look forward to engaging in that.

As I mentioned, our strategic plan, exciting that we just got it out. We had
put out a draft strategic plan in March. This was based on significant input
from our Health IT Policy Committee, significant input from other agencies in
HHS and our federal partners it is a federal Health IT Strategic Plan, and
there are five goals put forth in that plan. One is focused on adoption and
meaningful use, including exchange of information. One focused on outcomes
using health IT and health information exchange to focus on improved outcomes,
improved efficiency, et cetera, one focused on trust – privacy, security
and trust, a fourth was on consumer eHealth and consumer empowerment through
health IT and the fifth the advancing(?)the health care system.

We just put out a final strategic plan on Monday, last Monday, a week and a
half ago, which was pretty exciting. This was based on after we got comments,
about 240 comments received, and what I think is really interesting is that in
light of open and transparent government and multi-stakeholder input, we’re
trying to figure out, and we haven’t gotten this figured out yet, but we’re
committed to making this an iterative and living document, so it’s not the
strategic plan that sits on the shelf, but it’s the strategic plan that gets
modified as things change, gets modified based on input from others, as we are
working toward some of the strategies and tactics that are set forth in the
strategic plan. I’m not exactly sure what this is going to look like yet, but
we have the support of the folks in the White House to make this the first
iterative and living strategic plan.

So we’d really love, once we get that up and running, I can let folks know
about it, but we’d definitely love input and contributions from the brain trust
that’s sitting around the table at NCVHS.

Finally, I just wanted to mention, our other big event, our big event last
week during Health IT Week, and I’m sure everybody knows that the President’s
proclamation of last week as being Health IT Week, which is sort of exciting
for us over here. But we kicked off the week with the Consumer Empowerment
Consumer eHealth Summit on Monday. We had a cast of significant players here,
in the federal government that was participating, the Secretary of HHS, the
Surgeon General, Don Berwick from CMS, Aneesh Chopra, and Todd Park, and we
also had a significant presence from lots of other organizations that were
pledging to engage consumers and empower consumers through health IT.

The focus of our consumer empowerment and consumer eHealth program is
focusing on access, attitude and action. We are looking at, and I would say the
primary focus of our launch last week was on access, making it easier for
consumers to get access to their health information, in a timely fashion. While
we know that patients have a right to access their information, we also know
that many don’t. We know that there are barriers to folks getting access to
their information, we know that there are providers that are not inclined to
make that readily available, and a lot of the great work and recommendations
from our policy committee about patient and family engagement are trying to
encourage our meaningful use program, more ready electronic access to
information, and so we’re building on that, with our event from a week ago

So the way we’re looking at this, the way I look at this, is that we’re
trying to figure out how to align the public and private sector activities to
promote a patient’s access to information, not just their right of access, but
their actual access to their information, and then making it actionable, and
useful to consumers.

So the central piece of this that we announced last week was a pledge
program. We now have a consumer empowerment pledge that folks are signing on
to. We have a lot of different types of entities that participated in the
event, that were our first set of pledgers, but the list is growing, and we
have a pledge for data holders and for non-data holders. The data holders to
sort of make it easier for patients to get access to their information using
direct protocols, or Blue Button or other mechanisms, and for non-data holders
to provide education and support for consumers to get access to their
information. So that, there’s a lot of great ideas that were raised from the
initial pledgers, but there was also, I think, a lot of opportunity to really
affect the attitudes, and to encourage people who want access to their
information to get it; not just because they have a right to, it’s because it’s
useful, because it’s easy, because it’s meaningful and because they can use it
to improve their health.

We also, the Secretary announced proposed regulation to remove regulatory
barriers to patient access, specifically a proposed rule under CLIA and HIPAA
that would enable individuals to get access to their lab data, directly from
laboratories. Right now that isn’t a universal right that people have, and
there are some places, some states, where it is prohibited, so there’s a
proposed rule on that that is open for comment now.

And then addressing, once people have had access to their information, how
do we make sure that it’s protected? As I’m sure folks in this room know, some
PHRs are covered by HIPAA, some PHRs are not covered by HIPAA protection. There
are some folks who are concerned that the HIPAA protections aren’t really
designed with the PHR in mind, where it’s a consumer-controlled repository of
information. And so one of the other things we announced is a PHR model privacy
notice, that we’ve been working on for some time, with the expectation that we
were looking at the things that people cared most about with respect to data
sharing practices and security measures, and how to communicate it in a way
that was understandable to individuals.

So it doesn’t replace peoples’ privacy practices and privacy notices, it’s
sort of a layer on top of it that looks exactly the same no matter what PHR you
go to, so it enables better understanding of private history practices and
comparability across different practices. The goal here is transparency and
promoting patient choice, based on information, not setting rules on what PHR
vendors can do with the information, and what was really exciting was that the
three PHR vendors that were at our event on Monday, Microsoft HealthVault,
Dossia and NoMoreClipBoard all pledged to use it, and I think at least one or
many of them will have it up on their website this week.

The other exciting thing is that FTC, the Federal Trade Commission, said
that the model notice was enforceable if somebody basically did something that
was inconsistent with what they stated in their notice, that it’s something
that FTC can and would be able to enforce, so if an entity said they are not
providing information or sharing information for marketing purposes and in fact
they do share information for marketing purposes, the Federal Trade Commission
has the ability to enforce that misrepresentation.

So it provides some transparency, some accountability and enforcement, as
well as empowering patients and consumers to make informed choices based on
privacy and security practices.

And then we also announced a challenge grant related to access to
information. So this is sort of a new launch. We’re really excited about this
program, and I’m sure there will be more to come on that.

So that’s what I have to report on. I’m happy to take a few questions.

DR. CARR: Thank you, Jodi. I think Joy is not going to be joining us today.
I wonder if you might just say a word, if you could, about the data
segmentation initiative?

MS. DANIEL: I don’t have a lot of details on it because I have not been
involved in the day-to-day. I know they just sent out a notice that this is
getting kicked off, with an opportunity for folks to participate; I’m trying to
see if I can put my hands on that quickly. If not, I can send it to you,
Marjorie; you could share it with – I’d really defer to Joy on that,
because I haven’t been involved in the development of it.

DR. CARR: Any questions for Jodi? That was great Jodi, appreciate it very
much, and we look forward to having you join us in November, if that works out
for your calendar.

MS. DOO: I will actually work backwards from where Jodi was talking, because
she left off with something about consumer engagement, and we are part of that
whole process of freeing the data. What Medicare has been working now, for
probably a year and half, is this thing called the Blue Button. Now other than
Paul, how many of you have heard about the Blue Button? Excellent!

So MyMedicare.gov has been working on this blue button; most of you are not
eligible, but if you were, you’d be able to go on and actually get your stuff,
and we have not promoted it at all; we’ve not done any outreach, we’ve not done
campaigning, it’s not been in the My Medicare handbook, but aside from that,
we’ve had over 300,000 downloads. People have actually come to the site, found
it and gotten their stuff.

And we have just launched now, where you can actually get your diagnosis and
procedure information. We’re going to be expanding it from 12 months to 36
months’ worth of data, and we’re going to be adding the Part D Pharmacy data.
So it’s really going to continue to become much more robust, and we actually
had a meeting with the Deputy Administrator yesterday, and she has agreed that
we can begin to really do more outreach, and to begin to promote it.

So tying in with consumer engagement, with giving people access to their
information, particularly for Medicare, for the FOIA requests that we get,
should really become a very, very rich tool. So we’re very excited about that,
so it was nice that Jodi ended on that and we could say that there is a
definite commitment to it from CMS and I think it’s going to get better and
better, and we’ll keep you updated on our statistics.

And on meaningful use, as she said, we are working very vigilantly with them
on that regulation. I actually have some data for you on the Medicare incentive
payments, both Medicare and Medicaid, and I can actually get these to you so
you can look at them, but Medicare incentive payments go out for actual
meaningful use, as you’ve heard before, and Medicaid is for the adoption,
implementation or upgrading, so there’s a slight nuance in what those payments
are actually based on, and of course there are 23 states that are now
participating for the Medicaid incentive payments, so that number is continuing
to go up.

So just to give you an idea – first of all, on terms of active
registration, so these are people who have filed to apply to be considered for
the meaningful use incentives, for Medicare year-to-date there have been 71
thousand eligible professionals that have registered, and on Medicaid it’s been
17 thousand. So a fair number of people, eligible professionals, have
registered, and 1900 hospitals. And again, these are registrations. So then in
terms of payments and people who have gone through and actually been qualified,
if you will, to receive them, so year-to-date under Medicare for the eligible
professionals is about 2100 eligible professionals and 37 million dollars.
Hospitals has been four, but to the tune of 5 million dollars. But the Medicare
and Medicaid hospital payments has actually been about 220 million. So there
are funds going out; that’s on the Medicare/Medicaid side.

On Medicaid incentive payments, year-to-date for eligible professionals is
about 4400, 93 million dollars, and for hospitals there were 15, for about 32
million. And again, I’ll send this to you, but it gives you an idea of the
number that are actively trying to participate, while they are on the Medicaid
side or the Medicare side, and there are numbers that are increasing that are
actually receiving these incentive payments.

There is an appeals program that is being implemented so that as
individuals, say, well I applied and something didn’t happen, or something
happened to my data and it didn’t actually meet the requirements, that there is
an appeals process that people will be able to go through and either be judged
to be able to receive it or explained why they’re not able to.

So the program is moving forward, and I think continues to evolve and grow.
So each month, we should be able to bring you more and more data on that.

On the other little side of the world that we work on, under the Affordable
Care Act, our small piece is under administrative simplification, which the
Standards Sub-Committee, obviously, has been very engaged on. The first
regulation went out in July, which is the adoption of operating rules for
eligibility and claims status. We received 48 comments, so nothing near Jim’s
four hundred, and we are working through those; there’s a number that are
substantive, none that are surprises – we expected those, so we’ve been
prepared, and we’ll determine whether we need to put out a final rule that
changes any of the regulatory language, or if it’s simply what we had goes into
effect. So we’ll be able to let you know that in the next couple of weeks.

And then we are – Matthew left the room for some reason, but we are
working on the next regulation, to adopt a standard for electronic funds
transfer, and that should go out by the end of the year. We feel pretty good
about it. And then, of course, what we’ll be talking about, I think tomorrow,
are the operating rules for electronic funds transfer and electronic remittance
advice. So a proposal has come forward, the Standards Sub-Committee has that,
we’ve evaluated that proposal, have some feedback and we’ll move forward from

One thing just to remind everyone; for the electronic funds transfer, in
2008, Medicare made a policy that all providers who accept payments from
Medicare would be required to take their payments by electronic funds transfer,
and any newly-enrolling Medicare provider must, when they newly enroll, must
agree to that. So Medicare has actually been ahead of the game. The percent of
hospitals taking electronic funds transfer is like 98 percent; the number of
professional providers is probably around 60 percent, and so that’s the number,
from a Medicare perspective, we really have a big opportunity, and I’m sure
those numbers are pretty consistent across industry, so the statute reiterates
that requirement for Medicare, specifically.

So we have already begun to do some communication reminding providers, from
a Medicare perspective, they must do it, and hopefully the regulation that we
publish will help educate about the value add that this can provide, and the
efficiencies and the cost savings.

The other regulation that people are probably waiting for is the adoption of
a health plan identifier. That will come out by the end of the year. It’s, as
you can imagine, extraordinarily complex. We have spent a long time really
dissecting and working through what the implications would be. Bottom line,
it’s how it’s used in a transaction, but we do not want to mess up what the
providers do or what the plans do without really understanding what those
implications are from system and business process changes. But that is
underway, and then the other one that will come out this year is on compliance
certification, so here we are, adopting new standards and operating rules; we
have to be able to verify that industry is compliant.

We only are required to require certification from health plans. So we have
some thoughts in mind for how we can also engage the providers in that process,
but that proposed rule will come out this year as well. So our office, anyway,
has been busy.

And I don’t know if there’s other items that you’d want to know about from
CMS, either I can respond or bring them back for the next time. And one last
thing – Rob Tagalicod is the new Director of the Office of E-Health
Standards and Services; he was planning to be here today but unfortunately he
is ill; he will try and get here tomorrow, but he is very, very excited about
joining the group and he will talk to you a bit about the strategy now on
– you’ll hear lots of acronyms using HIE, which are the Health Insurance
Exchanges, and then there’s Health Information Exchanges, the way Jodi talks
about it, and Health Information Exchange, the way we talk about it, and he’s
got some responsibility for some HIE stuff that’s going to be happening at CMS,
related to information exchange and consolidations. He’ll be able to share an
overarching strategy that’s coming forward from CMS on that.

DR. GREEN: Lorraine, thank you. I was really struck that 1900 hospitals had
applied to be certified and 4 had been approved – can you tell me why
those numbers are so different?

MS. DOO: It is possible that they’re still validating the data, so it may be
that they’ve submitted what the claims information is. I don’t know the
day-to-day operation of how that’s happening, but I would be happy to find out
exactly why there’s such a huge delta and send that back. It could be the
reporting period is not finished, it’s just not mentioned.

DR. TANG: I think it’s the number registered versus the number who are
testing, right? So these people have registered; they have not applied. So it’s
not a denial.

DR. FRANCIS: I have a question about the button and how it works from a
privacy perspective. What do you do with respect to identity proofing and
authentication? So for example, do you require in-person identity proofing, do
you do anything about authentication other than knowing a password once you’ve,
say, set up a personal health record? My concern is that if somebody knows
somebody’s Medicare number, or Social Security Number and date of birth, they
can just pop right in and blue button down.

MS. DOO: If anyone knows anything about CMS and Medicare, our security
requirements are pretty intensive. And I can only speak for the blue button
that exists on Medicare. The VA, to get your pharmacy data, you must do
in-person authentication at a local VA office, to get your basic claims
information and access that, EHR is not in person, but the VA is doing
in-person authentication for pharmacy.

For MyMedicare.gov, in order to get on, you’re right; I could get on for my
mom, you’re 100 percent right, because I know her Medicare number, I know her
date of birth and I would know what password she typically picks.

DR. FRANCIS: This frightens me.

MS. DOO: So there are a number of required fields that you have to enter
first in order to get into the system that are not necessarily known or
knowable, so before you can even get a password to get into MyMedicare.gov,
there are five test questions that you have to answer. Right now, the password
is actually mailed to the address on file with Medicare, so you don’t get a
password immediately. I think they are implementing one where you again, if you
have an e-mail on record, they will e-mail you a temporary password and then
you go back in, so there are – it’s not as easy. And I don’t mean to take
this lightly at all, but it is not as easy as simply knowing a Medicare number
and somebody’s date of birth and whether they’re A or B. So there is a secure
process for that.

DR. FRANCIS: I’d love to follow up with you and know more about how it

DR. CARR: Thank you for the update, Lorraine. It’s 10:25, why don’t we
reconvene at 10:40, okay, 15 minutes. Thank you.

(Brief recess)

Agenda Item: Briefing on Population/Privacy
Community Health Data Report

DR. CARR: Next up is a briefing on population and privacy, community health
data report, from the hearing workshops that were held in February and May of
this year. So, Larry and Leslie and Sallie.

DR. GREEN: This is going to be a quartet; we are not planning on speaking at
the very same time; we’re going to speak in sequence. We’re welcoming Susan
Kanaan to the quartet, and she’s going to be sitting down here at this end of
our table and she will work us through this slide show.

Before we begin, I want to thank Marjorie for Susan. You talked about a
difference maker; this was crucial, absolutely crucial.

So we want to anchor our presentation in the conversation we just had. You
might just recall that Jim reported to us these five goals – transform
care, advance knowledge and innovation, advance health safety and well-being of
the people, increase efficiency, transparency and accountability of HHS
programs and strengthen the national Health and Human Service infrastructure
and workforce.

And we heard about the National Quality Strategy, the National Prevention
Strategy, the Healthy Living Strategy, ONC’s five-part strategic plan that’s
just out, and what galvanizes all of these things is they are all about people.
And the way they are all about people is all about measurement, and
measurement, as all of you know, depends entirely on proper data.

So what that means is that this presentation we’re about to go through is
actually right at the center of Health and Human Services goals, it is right in
the center of the charge of NCVHS and it is a journey, if you will that
continues several decades of work of this Committee. So it’s sort of like a
stop on the trip, is one way we can think about this.

And one other framing statement is, while we didn’t know it when we began,
we know it now, that this is a shared space for the entire NCVH committee. All
of the sub-committees, the way we’re structured, are pertinent and relevant

So let’s go over the first slide here, Susan. These were our guiding
questions for what really hit its active phase last February, and as many of
you know, we’ve had a couple of workshops, and those workshops were really
focused on those two questions right there. This reminds me of – what
we’ve learned there about community needs and how the federal government can
help reminds me of one of Carl White’s famous adages – People have
problems, universities have departments, governments have agencies.

And another thing we’ve learned goes back to a famous public health report
in the 1960’s. We have learned that health is a community affair, and that was
actually the title, or the name, of the Folsom Report, published in 1966.

Let’s go to the next slide, Susan. So place matters, is another thing that
it’s quite clear. This can be anchored in work that’s over 20 years old. Bill
Fogey(?) and Mike McGinnis started this in the early nineties at CDC and Dr.
Mark Datus(?) continued to update and refine it. While it’s not precise, it’s
accurate to say that what determines dying before you should have and suffering
when you didn’t have to? About 40 percent of the explanation lies in behaviors.

Highly personal and highly determined locally. About 30 percent of it is
genetic so far, and for the foreseeable future, that’s not exactly going to be
one of the most changeable possibilities, but behavior can be altered. And then
about 15 percent of it is SES stuff, socioeconomic circumstances, social
determinants of health. Maybe ten percent of it or so is a 2.7 trillion dollar
health care delivery system, and then classic environmental health and
environmental determinants probably make up the rest.

And then around this last one, communities as learning systems, this is
really –, and it’s interesting, it was advertised in advance and followed up
at this last meeting with Chuck Friedman, when he was here last time. Remember
that interesting little equation he had about meaningful use plus delta equals
a learning health system? Where we’re headed here, and what we’ve been learning
in these workshops, really fits in with that sort of notion. So we have this
emerging vision, and we’re just reporting it to the whole committee, like the
way station in Washington, DC at the Embassy Row Hilton.

Getting usable data into the hands of communities with capacities to use
them is really the vision we see trying to develop and figure out. Susan, I
think you’re going to go next.

MS. KANAAN: So the line at the top is really the key message here, and
Larry’s already mentioned it. This project has really deep roots in the
Committee’s entire history, and of course its population health mission, and I
just listed some of the major linchpins in terms of significant vision
statements and other reports that the Committee has done. I didn’t mention
standards and quality, but I could put standards and quality reports and
projects up there as well.

This is a cross-cutting project, and you can’t help but feel that all roads
are converging, in some ways, in this project.

DR. FRANCIS: With all the kinds of increases in the functionality of health
information technology, there are forms of data that weren’t available in the
way they used to be for communities to use, to link in new ways. One of the
important opportunities here is the ability to link clinical data with data
about what’s going on in the community in all sorts of ways from where the
grocery stores are to where the pollutants seem to be, and at the same time
we’ve got federal investment in community health work too, so there are massive
possibilities for both far more powerful and far more interesting uses of data
in ways that can better health on the ground. There are some scary aspects of
that too, which is why privacy and confidentiality are also involved, and to
make sure, it needs to be done right, in ways that don’t, for example, risk
community mistrust or the equivalent of redlining. So power and responsibility.

MS. MILAM: So you’ve heard a bit about our vision; the two committees,
Population Health and Privacy, what we wanted to learn about, some of the
questions we had. And so now, some nuts and bolts about how we went about our

We had two workshops; one in February and then one in May. The workshop in
February was broader, where we learned – we focused more on population
health, but we heard more about a project at its highest level. Then in May, we
took a deeper dive into some of the same projects, but mostly different
projects, with more of a privacy, confidentiality and security focus. And so we
heard from – they were all community level organizations. Some came from
states, representing eleven different states in four different regions within
the US, so we really had a nice cross-section of different types of projects.
Part of the work in designing the agenda was to draw in communities with
different backgrounds, to bring different issues to us, and it was truly an
amazing experience to hear from these different communities. Next slide.

These are the report contents. As you can see at the top, you’ll be getting
a full report to review in November. This is really a preview today, to give
you more information about what we did at the workshops, for those of you who
weren’t there and to get a preview of what the report is going to look like. So
when you walk through these different – there are five parts. And really,
the first part is about the learnings, the best practices that we heard from
these communities.

Then there’s a big section on what they need, and there was a lot of
commonality in what they need, and where they currently seek help, where they
get their resources. We have a section on what the opportunities are in today’s
environment, and some opportunities are within our grasp and some are beyond
us. We have a section about gaps and ideas for future exploration, and then at
the very end we have case sketches; you can read, in a paragraph – really,
not even a paragraph or two, a single paragraph that talks about what we
learned, in very succinct format, about each of the communities, and as I read
through these sketches of the communities, it brought back to life what we
heard about eight months ago, and I could visualize the presenters and a lot of
the discussion, and as you read these sketches, I think it will do the same for

What’s amazing to me is the work that Susan Kanaan did, not only in
organizing the speakers for the first one and the work that Maya did in
organizing the speakers for the second, but Susan’s work in skimming across all
of them to pull out commonalities and to pull out all of these different areas,
that’s a huge amount of synthesis from a lot of workshop data, and I think the
report is well-organized in these sections.

DR. GREEN: Here is a ten-point outline about the messages. As you all know,
our memories depend on language. But for humans to learn, they have to have
stories. And the stories from these fourteen activated, empowered communities –
somebody forgot to send them the memo that we were in a lot of trouble, we were
out of money, et cetera, et cetera, you know; they don’t seem to know that.
They’re just beavering away with what they’ve got under the circumstances that
they’re living under, and when you listen to the stories, Susan and the
committees have distilled these key issues so far. These are sort of themes
that keep popping up, that are not unique to a particular place but are
cross-cutting. Mark Hornbrook was part of the folks that created the second
edition of this new community engagement primer that NIH has supported; it came
out through the CTSAs, was released a few weeks ago. It’s amazing how congruent
the distillation is from these workshops with what is a very elegant, extremely
evidence-based review that tracks over decades about this.

So what this really did for us was contemporize it, assure us that it’s
alive and well, there’s a local demand, people are interested in this, and we
may beat this to death over the next few months, but underlying these ten
things is a message; we are missing an infrastructure.

MS. KANAAN: So the rest of our presentation this morning, before we invite
commentary and discussion, is just a quick overview of the contents and
structure of the report. It has six big sections at this point. Of course we
begin with an introduction, where we give the key concepts and the background
and the purpose, and I think kind of a subtext that weaves through the entire
report; certainly through the introduction, is the interdependence of three
dimensions, and if I’d thought about it I would have made a slide about that.
But I want to mention them to you.

Of course this is a data-focused, information-focused report because of the
nature of the Committee, and with trust as a very big component of that, or
condition of that. But really, in this report we want to talk about three
dimensions that are interdependent – collaboration, which is people taking
action together, data capacity and knowledge, and the third is trust, involving
privacy and stewardship. So I think of those as kind of cross-cutting.

The nature and purpose of the report, as we’ve mentioned already, is to
describe what we believe is a nationwide phenomenon and our vision for it,
which Larry has mentioned. And also, particularly, to identify how the federal
government can help communities use local data to improve local health, which
they’re already doing, but they need better data and better analytic capacities
and other things that we identify.

And Larry’s already talked to you about the other two main contents of the
introduction, which you see there in your bullets.

DR. FRANCIS: So one of the hopes is always that if there’s a lot of
information out about what wonderful things are being done on a smaller scale,
people can share and there can be a kind of burble up, which is what the Local
Solutions National Scale header on this slide indicates. What the second
section of the report is going to do is give an account of how communities have
identified priorities, built partnerships, worked together, how they’ve evolved
a variety of citizen and community groups, how new partnerships have been
forged with the recognition of how data can be enormously important and used in
creative ways, so we will be giving illustrations of how data have been used,
not just for are we getting the right number of folks with this particular
treatment, did they all get antibiotics before they get surgery or something
like that, but with respect to the question of a much broader definition of
health and improving the health of the community, linking multiple sources of
data, how communities are doing this, how population health data and clinical
data, how communities are generating their own data, how communities are
displaying data – data doesn’t do you any good if it’s in a closet
somewhere and you don’t know what’s happening.

How communities are using data to inform action, and several of the more
interesting ones are actually town-gown partnerships, and so several of our
examples will be town-gown partnerships to improve local health.

So we’re looking at what models there might be to make sure not only that
communities trust, but that their trust is warranted, and there are lots of
questions here. There’s the – some do hold the idea that data ought never
to be used without individual informed consent, at least if it’s identifiable
data. And then there are concerns even about what sorts of data are
identifiable, so we’re seeing those kinds of issues show up in the advance
notice of proposed rulemaking with respect to research.

What we want to do in this section is look at what are some of the models to
build warranted trust that make it possible to really use data in ways that
help people while respecting people, and so some of them that we’re looking at
include education efforts, efforts that involve community members and priority
setting, data use decisions, community-engaged research. How do folks who are
working with health data work with organizations and agencies that are the
sources of their data, so that there’s ongoing – it’s really an iterative
process of trust building, about the sharing of data, purpose specification,
use limitation and so on; what sorts of governance models, fostering ownership
and control, are there.

What does transparency mean? What forms of transparency are there? I’ve
never thought that publishing a notice in the Federal Register was exactly
likely to – it’s not something I read on the breakfast table, you know
– requires somebody else to go find it, typically, although there are
often people who call to my attention what has shown up in the Federal
Register; that’s one model of transparency, but there are many, many others,
and so we’re looking at that as well.

And the way we’re doing this is, we’ve got fabulous examples of different
strategies that communities have tried, and what’s worked, and also we’ve got
some examples of communities that have been very resilient; they’ve tried one
thing and it didn’t go as well, and so they’ve tried something else.

MS. MILAM: So the next section of the report, Section Three, speaks to the
needs and the gaps that we’ve heard, and we heard them both in the data, in
terms of the data, as well as in terms of the privacy trust and some governance

A lot of the discussion that we had earlier this morning with Jim’s report
and Vickie’s comments particularly, as well as comments of others, are very
similar to what we heard from a lot of the community participants and community
actors, and I’m thinking it might behoove us to review Jim’s report and
Vickie’s comments, particularly, against some of the workshop testimony.

As you can see, there’s a lot of discussion around community indicators and
issues with analysis of data, but I’m wondering if we ought to go back and look
at the data collection issue and see if we heard about some of that from the
communities as well.

A lot of what Jim reported on in terms of HHS’s focus really goes to a lot
of the issues that we heard. And there’s probably a lot of synergy that we have
the opportunity to explore, if we assure really tight alignment, I think,
between this part of the report and HHS areas of new focus.

Let’s go to the next slide. So as Larry said, what we heard, really, in an
overriding sort of way, is that we’re missing an infrastructure in all of these
different areas. Communities are doing well with what they have. Some of them
have the internal expertise, a lot of them find the expertise at local
universities or from government or from others. A lot of them are going about
it in some of the similar ways, through some non-profits that are supporting
them; for example, with the health indicators, and there are some really
leading examples of how communities have used health indicators, but they’re
not going about it in the same ways, and so perhaps there’s some opportunities
to standardize some of these indicators, to standardize some of the data

Some of the recommendations we heard from NAHDO came around standardization
of collection of data elements, even down to name, and that’s getting
difficult. You lose an opportunity for data linkage, as well as others, when
everybody is collecting data in different ways.

So you can see this list of all of the various examples of where we need to
build better, or better support, infrastructure.

DR. GREEN: The fourth section of the report is organized – they’re
addressing a federal role here. The verbs that have surfaced so far are seed
and harness. These communities that we heard from have no shortage of ideas,
and they’re absolutely expert in themselves. And that implies what is not a
needed federal rule. But the seeding and harnessing of capacity is really a
key, key message that we’re hearing?

The next slide, there’s a longer continuing list of possibilities. I’m just
going to call out the third and fourth bullet for your attention. I think,
without exception, these communities find that they are stuck doing projects
that have a beginning and an end, and that the project has to build
relationships, they have to establish trust, they have to find each other, they
have to find the right players, and then just about the time they’re ready to
do something, and they get started, the funding runs out and it stalls, and the
support for the organizational framework stalls. So longer funding periods,
sustaining funding, and organization that crosses projects and questions is a
pretty important issue.

And that fourth bullet about technical(?) assistance; communities seem to
lack analytic capacity. Right across the board. And it’s a very difficult thing
to – this is where the NIH translational research effort with community
engagement is plowing fields all across the country right now in 60 different
locations. Those are very important messages, and in the fourth section of the
report, we’re going to try to crystallize those.

MS. KANAAN: The fifth section could be a 200-page report in itself, and I
have to say, I think we’re still figuring out what to do with that content,
because this environment, as I’m sure you all know, is absolutely exploding;
there’s more history, we’re discovering more history as we go along, and Larry
mentioned the Folsom Report, some earlier NCVHS work, et cetera; but every day,
it seems, or at least once a week, I learn about a new initiative or study or
whatever that’s going on. I just learned from a colleague at CDC about a new, I
think interagency, project on community health needs assessment that the CDC
was asked to do by the IRS, having to do with community benefits, so the list
goes on, and I think we still need to figure out what it’s important for this
report to talk about – some of it involves an annotated bibliography, but
we don’t want the tail to wag the dog in this report, but we definitely need to
at least acknowledge some of the main drivers.

Larry mentioned translational, the work on translational research, community
engagement, work on community engagement, et cetera. The list goes on.

It’s a very exciting environment, and there are many drivers and
opportunities. That’s kind of the big message there.

DR. FRANCIS: Did you want me to comment specifically on privacy, security
and trust questions?

MS. KANAAN: It looks to me like my assignment was number five and your
assignment was number six. So you could comment all of them.

DR. FRANCIS: It is really hard to find models about engagement that –
well, that looks like genuine trust. There’s excitement – oh, look at the
cool new things we can do – but we have found some, but there are gaps
– one of the knowledge gaps here is whether there are other strategies.
The most promising one is the community engaged research one, that we’ve heard
a lot about. That’s absolutely clear. But we worry about things like community
subgroups, where, and this goes to the health disparities question, where there
may be something that has been longstanding alienation in the community. We’re
working to identify models where health departments have developed longstanding
relationships with various community organizations, and so on. Another gap has
to do with community resources and limitations on the data that are available
and how to try to deal with that, and then we’re identifying questions about
community health assessment and how to even understand that.

I must confess, I have some law students who are looking at the question of
what models people have been using to try to get communities involved in data
use questions, and it’s a hard slog. It’s like a literature vacuum. When you do
an environmental scan and you don’t find the environment; the hearing in May
was not easy to put together, for similar reasons, and so we may end up making
up some of it ourselves – or at least suggesting; actually, what I think
we’ll end up doing is suggesting what may need to be done.

MS. KANAAN: I would just add to what Leslie said that I think the final
section 6, in some ways, is what we would be writing about, researching about
and talking about if we had two years and a huge budget, and were preparing a
many-hundred page report, kind of like, I guess, the future research subject.
Some of the questions that we’ll identify require deliberation that could
happen right here within the Committee. Some of them are research questions,
finding out more about what’s happening communities. We’ve barely scratched the
surface, although we think we’ve identified some leading-edge communities, but
what else is happening out there is one of the big questions. And who knows how
far we can go in learning more at this point.

In terms of the attachments, you can see the list, who I’ll call to your
attention are the special tailored recommendations from NAHDO that Denise Love
brought to the May workshop, that folks thought might be helpful to attach to
the report, and then our very own determinants of health model, which was in
the 2002 report on the Vision for 21st Health Statistics, which
continues to be a very useful model, and you can see the other attachments

And that is the end of our presentation!

DR. CARR: Let me just start by saying what a fantastic job you’ve done.
Having been at the hearings and being awestruck by all of the information, I
think you’ve done an excellent job at categorizing the themes and beginning to
make them actionable, which leads me to my next question.

We’re putting together a report, but are there – are you also
envisioning a letter, and/or actions, steps, coming out of this report, next

MS. MILAM: Those are really good questions, that we will address this
afternoon, and we’ll get back to you, Justine, if that’s okay.

DR. GREEN: But our framing is that this report is a framing document, from
which the full Committee can decide about if there’s a space and a place where
we should move toward a letter or move toward a specific theme. So we think
we’re being sort of systematic about this – we’re trying to distill it,
trying to introduce the Committee, a full Committee, to all of it, and then
trust the Committee’s process to help us know if a letter or a further step is
needed, and if so, guide that.

DR. FRANCIS: Certainly with a report, there’s a letter of transmittal of a
report, but I would really welcome thoughts people have around the Committee
with respect to the question of where you see particular areas for ongoing,
more specific, committee recommendations and letters. As I was sitting here
earlier today, for example, and listening to what Jim was saying about minority
health and some of those initiatives, health disparities questions, I think one
of the things we are turning up is that the relevance of some of this to
addressing the disparities question and how better use of data might – and
quite fine-grained small community data might be helpful in that regard, so
that might be a place for a quite immediate next springboard.

DR. GREEN: Christine, I’d like to jump in – Leslie’s understanding that
I don’t mean to be presumptuous here, but Leslie could use a co-chair.

DR. FRANCIS: Yes – thank you.

DR. CARR: I just want to say one other thing – I did send around to all
the co-chairs, or solo chairs, as the case may be, a document, or a figure,
that we had put together last spring about the Learning Health system and all
of the considerations related to that, and I’ll try to get something together
at noon that we can distribute that will guide our discussions in the
sub-committees, so that we’re building on the work already done, and targeting
a meaningful impact.

MS. KANAAN: I just wanted, on the subject of actionability, to call your
attention to slides 14 and 15. We’ve already begun to develop a pretty good
list of possible recommendations for federal actions.

DR. CARR: Okay, now questions. I started on the left side of the room
before, I think I’m going to start on the right, going down.

DR. NICHOLS: Well first of all, fantastic overview of what’s coming. And
what really kind of hit me was the focus on community, on trust, on
stewardship, but then what I didn’t see anywhere, and maybe I just missed it,
is what I would call, what’s the proper role for local health system leaders?
How can the federal government help, how can the federal government, how can
everybody engage local health system leaders? In my idiosyncratic sojourns
around our nation, what I noticed is, people who run hospitals actually pay
attention to the population around them, and it’s a really good idea to get
them engaged.

So I would encourage the Committee, if you haven’t already done it, to think
about how to go back and extract some of that from the rich material I’m
looking forward to reading.

DR. COHEN: I’m very excited about this report, and the opportunity to work
with you guys. I want to second what Len said; partnerships are a key to local
success, and there are partnerships between community organizations, local
government and health care providers. So to the extent that we can encourage
systems that connect providers to local community groups, we have a much better
chance of success.

Following up that thought is a concern I have in this Committee, and in the
federal government and the private sector, we’ve really been focusing on
creating clinical data exchange systems. I don’t know any local community
coalition that really uses individual level clinical data. My concern is, in
our focus on doing all the things we do about clinical data exchange, which
really has to do, I think, with government and providers, the need for
population health data at the community level and at the aggregate level, gets
overlooked, so I really want us to – and I don’t think anybody has spent
much time thinking about the relationship between aggregate clinical data and
community health, so I think this is an opportunity for the Committee, as we
move forward with focusing on strengthening our ability to exchange clinical
information, how that plays into population health.

I could go on forever, but one other major point. Our focus is on data, and
that’s totally appropriate for what we do, but at the community level, data is
only one minor piece of how decisions get made, and how policy develops. In my
experience in working with community and community groups, it’s the ability to,
as the data experts, how can we make ourselves available and useful and engage
and build that trust around data, and have data work for communities to help
develop policy, rather than have data come in with the notion data is going to
dictate what you do? I think it’s a delicate balance, and this is a real
opportunity to show how data can help communities in their process, in their
political and policy development process. And again, that’s part of the trust;
I think that should be the frame and context for what we can do.

DR. CARR: I think Larry wanted to just make a –

DR. GREEN: Those are fantastic. Your point about expanded view of clinical
data exchange; we heard from Indiana, examples of where that’s been achieved,
and it’s powerful. And we heard from a Denver community in five neighborhoods
that’s enriched with Latinos and African-Americans, and there is a serious
local hypertension problem that is unaddressed. They’re into the restaurants
and getting sodium content of food down, they’re – but you know what they
really would like to have is they’d like to know blood pressures.

Well, the people living there only – there’s only about 85 thousand
blood pressures taken a year for the people living there, and they’re totally

DR. FRANCIS: So one of the questions, just to follow up, we heard,
particularly from NAHDO, some of the – and this would be, I think, maybe a
gap next step, what to think about – what are some of the barriers to
optimal linked involvement, because there are some. They range all the way from
proprietary interests to concerns about legal barriers, and thinking –
you’re absolutely right about the importance, and so thinking about why our
examples didn’t always highlight that, is a really important next step.

DR. CARR: Thank you. Okay, I’m moving now to the left side of the room and
starting with Ob.

MR. SOONTHORNSIMA: Very good reports and comment. I just have, listening and
looking at the PowerPoint, it appears to me that there are other converging
themes, or running themes. For example, I think you talked about it, Larry, but
there’s only one bullet point around sustainability, perhaps? A financial model
of how these committees actually operate. And I imagine what you said, Susan,
that you could do 200 pages of this. Obviously there’s so many different models
with different anchor stakeholders in those communities, who are really,
they’re funding this or sharing the cost. So those, beyond the data itself, it
seems like those might be broader, bigger issues, because at the end of the
day, without money you have no mission, so you can go so far as getting good
data, getting good standards, getting good inputs, but how do we sustain to
ensure that these committees – I wonder, in these 200 pages of reports, or
these examples of what you’ve seen, are there any emerging themes or models
that we could make this report more actionable, more useful, for other
communities across the country, because every community is different, to your

The second point, and this is really not a suggestion, but another thought
is that because we focus on data, not so much the government’s models and so
forth, so I wonder if there are some ways for us to look for examples of common
data architecture that could cross these different communities. If there are
any emerging data architecture, that could be done more efficiently and
effectively across the country.

DR. HORNBROOK: Just three points, which I think the whole Committee may need
to weigh on to help the Population Sub-Committee address some of the rewrites.

First, in terms of context, do we want to invoke the single payor systems in
Europe, for example, due to the fact that they do have clinical data, they’re
using clinical data to make resource allocation decisions, they get better
health than we get for less money. Or is that in some sense, waving the red
flag this Committee doesn’t want to wave in front of a population that is a
very charged issue.

Clearly, I’ve seen in the UK where they take the area data on utilization
and the areas that have the lowest amounts of use get the highest priority for
incremental resources, which happens, in most cases, to be Wales.

MS. MILAN: Susan has, as an example, some indicators from London on how
they’re centralized. So it’s most subtle, not as direct –

DR. GREEN: I think you can leave out the adjective there, Mark – report
geographic facts.

DR. HORNBROOK: Then another issue is the state of our state health care
departments. Our national statistics system is a federal/state/local
consortium. The states, of course, have been under tremendous budget pressures,
and they have been cutting, cutting and cutting, and of course just to be
micro, at CHR I’ve hired epidemiologists from the State Health Department
because they’ve lost their jobs. So I’ve watched Oregon just shrink the Health
Department, watched them shed off very experienced epidemiologists, in injury
prevention control, in cardiovascular disease, and so also, wouldn’t we talk to
Georgia Health Department about birth certificate statistics?

The programmer that deals with birth certificates is a part-time contract
programmer, not a State employee. That’s how much they have carved out of their
vital statistics system. So, when we ask to put this data together, the states
have been pulling out the resources, and it’s very strong. We could say
something about that, or we could say it’s obvious.

And then finally, a third kind of editorial point, which is does the
Committee want to engage in geographic communities only, or do you want to
engage in virtual communities? Because what we’re seeing in these examples is
actually a combination of both geographic and virtual communities, because
they’re using the virtual community to send their data out; they’re on the Web,
and people anywhere in the world can see their examples and get ideas and
emulate what they’re doing, so in some states yes, there’s is a tremendous
potential here for social networking of various kinds that Web 2.0 supports for
engaging voters, patients, family members, whatever, in health improvement.

DR. MAYS: Again this is one of these exciting times in terms of being on the
Committee, so I kind of love this initiative. I want to start, and I have three
points – I want to start with where Len and Bruce actually were, and that
is this whole notion around the kind of state/local health departments, et

The belief is that the role of the federal government, quite often, in
terms of data – it kind of rolls down, so at the federal level there are a
lot of rules and initiatives, and the State Department then has to deal with
those and the State Department passes it down. The focus of the report seems to
be a lot about the community, but yet, what we actually have a greater strength
of being able to do is to find the kind of best practices that can be put into
state, city and local government, because that’s where the difference is made,
as far as I’m concerned about the data, because that’s where, then, your
funding goes. You could tell the community a lot of things but you don’t
actually have a way to fund the continuation of those things. So it becomes a
report, it becomes a set of recommendations that while they can jump up and
down, they’re going to jump up and down and go back to the Department of Health
or back to the state, and the state is not, in any way, suggested, mandated, to
do it, then all this great energy and expertise, we’ve lost.

So I would suggest kind of tweaking the focus to come up with – what
the community gave you were the issues and the problems, but what this
Committee, which is a federal committee, can do is to tell its entities what is
best to do. So if we could have recommendations that really focused on that, I
think it would be great.

Second is, you don’t want to not include NIH, because very honestly, some of
what you heard are problems that already, I think, in the mix of being fixed.
One great example is the CTSA, or CTSI, depending on where you are. UCLA alone
got something like 21 million dollars. There are – Mark, are there what,
how many of them are there now? Exactly.

So the thing that the community is telling you is a problem; actually there
are some fixes that are on its way, so you want to make sure that you kind of
lift up NIH to ask them to continue to do this, and to kind of push through
with maybe accelerating it a bit. For example, Larry, when you said that the
community is complaining about they don’t have the analytic skill. Well let me
tell you, if we want to keep our CTSI money, it’s something that we’re doing.
So you want to encourage, I think, an entity like NIH, to build this into
research grants, that we have to give the data; I mean everybody knows if your
study is over 500 million you have to make your data public.

Well a good push would be, we usually make it public, but at the level of
other researchers. Can we then be asked, and I hate to say this as a
researcher, without getting more funds, is that is there also some place and
some way to make those things also more accessible to the community?

DR. CARR: We have a couple of other speakers, we have an important thing and
we’ve got to get everybody up to get fingerprinted – so be concise.

DR. MAYS: My third point has to do – I think for the importance of
this, maybe we need more time, but –

DR. CARR: You’ll have a chance this afternoon in that meeting, so to develop
ideas is fine, but to give us some headlines to think about now would be

DR. MAYS: The other one is the building of trust. I honestly think that
– that actually concerns me, I think, to make that a big part of this
report. It’s saying that the community is distrustful, but it’s almost saying
it as if there isn’t a reason. Again, this is a federal committee, and I think
if we talk about building protections, if we talk about procedures and policies
and then some kind of accountability, that’s more our job. Educating the
community doesn’t mean that there aren’t problems. Educating the community
doesn’t change – I mean, we can’t get into local politics, but I think at
a national level, we can provide an advisory of how one should behave, and ways
in which if people don’t behave, that’s there’s like consumer protection
orientation around data.

DR. MIDDLETON: I’ll endeavor to be brief; as challenging as that may be.

This is really terrific, and I’ll just underscore all the other comments;
that it’s exciting to see the grass roots level efforts coming to really bear
fruit. Medicine is very local, data is going to be local, but my suggestion
– well first a question. One of the things I think we need to do is to
frame how to establish criteria, or the principles by which we suggest we move
the field forward; in this case, the Community Health Data Initiative and the
Learning Health System.

A specific question would be, what determinants of premature mortality do we
actually have data for, and what of those that we have data for can we actually
do something about? So obviously, guiding data collection, guiding data
exchange, based upon the best evidence, so we’re doing things which are
valuable and useful, from the get-go, is kind of the suggestion.

And then the idea of principles and criteria, which might guide both policy
developers and then local implementation. I’m reminded, just very briefly, of
what Bruce Blum said years ago, in 1984. Data, when analyzed, results in
information. Information, when interpreted, results in knowledge. Knowledge,
when acted upon, results in wisdom. So the key part of this that – I don’t
think you – could be addressed better, is how to build in the
knowledge-sharing component for this Learning Health System. Lots of
interesting work going on in this regard, we have a big project about sharing
knowledge for clinical decision support. I suggest we have to build in from the
get-go, kind of knowledge-sharing architecture and considerations that will
allow us to actually capitalize upon the learning’s at the local level, at the
national level.

So the suggestion would be, on slide 16, two specific additional bullets;
what are the questions about knowledge sharing that we have to address, so we
can capitalize upon and achieve scale in the Learning Health Care System, and
what are the questions about knowledge implementation, effective use and
measurement, so we can feed back to the local level what is learned across the
aggregate system at scale? So two specific things that I hope you’ll consider
and I’d be happy to help address.

DR. CARR: I think I have Paul and then Judy and then we’ll conclude.

DR. TANG: In my lumping style, one, I thought the couple workshops were
truly inspirational, as you’ve described, and it just showed, I don’t think
we’re short of community resources, people who want and can make a difference.
I do think it happens locally, and the biggest thing I think, actually, is
trust; that’s what makes things happen.

So in terms of – part of what you asked was longer funding; I think the
only place that is worse asked than the federal government is the state
government, as we’ve heard. So I just don’t think asking for – what I
think, it’s not that they need money, I think they need this infrastructure
that Jim talked about this morning. So I’ll go back to your vision, and the
thing I was just going to add – so you said your emerging vision is
getting usable data into the hands of the communities with the capacity to use
them, and I’m just interpreting the width – that’s a very small subset if
you’re saying communities with the capabilities. If we change that to and — so
what we need to get in their hands are standardized data and the tools to use
them. I think what they are capable of doing, much more than the folks who
already, in a highly-inspiring way, have done, is to just give people who have
the yearning for the ability to improve their own communities, the ability to
do that.

That’s where I think NCVH can play a role, and it really feeds into what Jim
was talking about, maybe 2.0 version, you’re coming out with stuff and it seems
very appropriate for NCVHS, as one of your advisory groups, to help provide
that road map to the standardized data, because otherwise, the folks who are so
passionate about this have to reinvent everything every time, and that’s what I
feel very sad about.

The one other thing to speak about the community, I don’t know where this
quote came from in the report, but it was a lovely definition of community that
I just want to read because I think it gives us a bit of insight. It says in
your report, “A community is an interdependent group of people who share a
set of characteristics, joined over time by a sense that what happens to one
member affects them all.” And that goes beyond geography, and it talks to
– someone else brought up the – this is it. It’s interdependent
people – that’s what gives them passion.

That’s what gives them the resourcefulness, and what we need to do, I think,
as a national committee, is to get the data in a standardized format with the
tools to use them. And they will. So I don’t think it’s the money, because the
money isn’t there, it’s the things, the tools, the enablement, the empowerment,
that I think will bring the most bang for the buck. And I think Blackford and I
have agreed to certainly work on that data part in our quality of work

DR. CARR: Excellent, so this is the beginning of a discussion that will
continue throughout the afternoon and really, we’re welcoming all committee
members to attend. I think this is just fantastic.

With that we change gears to Standards.

(Administrative comments)

Agenda Item: Standards – HIPAA Report,

DR. CARR: Now Walter, on to you, and Judy.

DR. SUAREZ: Okay, we’re going to change gears a little bit. We’re going to
talk about the tenth HIPAA Report to Congress. Very quickly, first I wanted to
just thank everybody that has been involved in developing this report; the top
Committee members, the leadership of the Privacy and Security Subcommittee, and
certainly, Lorraine and Matthew and our lead consultant that has helped to
develop these, Margaret, who helped develop this report.

In your presentation, there’s a few slides. This is the first reading for
the full Committee of the report, and we’re not going to read it, of course, we
sent it to you beforehand; it’s on your tab 3 of the packet. The idea was to
introduce to you the concept, the content, the way we approach the report and
then the process we’re going to take between now and November to complete the
report and present it back to you for your approval before sending it to

So slide number two, just some background. We are, under the Federal law,
required to submit to Congress and make public a report regarding the
administrative simplifications provisions of HIPAA. This was encoded into the
Federal law itself, as part of our new task. Second of all, they talked about
the elements that are needed to be addressed in the Committee report, the
extent to which persons are required to comply with HIPAA administration
publications are cooperating in implementing the standards. The extent to which
entities are meeting the security standards, whether the Federal or state
government are receiving information of sufficient quality to meet their
responsibilities under the Act, any problems and the extent to which timetables
are being met. So there was some general content of expectations.

So this year, we’re taking this particular report as a special milestone,
the tenth report. It’s not the tenth year of reporting; of course, the tenth
year was in 2006, when we met ten years of the HIPAA law. But this is our tenth
report. We haven’t been doing these reports annually. So we decided to take
this opportunity, in this kind of a special milestone, to take a little bit of
a more comprehensive view of what has happened with HIPAA over the last 15 or
so years.

The report focuses first and foremost on HIPAA administration publications.
We don’t touch on all the other responsibilities, of course, of the Committee.
We try to link as much as we can, elements of the other activity that we do,
but our main task is to talk about administration simplification.

Second, we are organizing the report, as I’ll mention in a minute, into the
journeys that have been taken by the industry toward achieving administrative
simplification, where we are today and what is coming, and then thirdly, we
wanted to briefly highlight, in the report, some of the key roles that NCVHS
has played as the lead advisory board to the Secretary on Administrative
Publications, so those are some of the background elements. The process to
develop a report, it has been a journey in itself. We started earlier this
year. In January and February, the Standards Subcommittee developed a proposed
approach and a high level outline that we presented to the full Committee in
February, and with some comments and edits, received general approval to
continue that outline and approach. The Subcommittee then developed a more
detailed outline, a timeline and a task to be accomplished to achieve this
completion of the report. We did that in March of this year.

We engaged a lead consultant, Margaret, to conduct all the background
research and aggregation of the documentation, review the documentation and
then help us develop a draft of the report. And then we started working through
the report development itself. We started with the first section of the report
and had a sub-committee review between March and June, basically, and then did
a second section of development between May and July, and then the last section
of the report between June and August, basically. So it was progressively
adding content and review by the Sub-committee.

As I mentioned, the Privacy and Security Sub-committee co-chairs and Lisa
were involved in reviewing the privacy and security-related content of the
report, as well as any other aspects of the report.

Our first full review of the Committee is today and we expect a revised
draft, based on Committee input, to be prepared and finalized, again, with the
input from the Standards and the Privacy Subcommittees during the month of
October, and then in early November, we will present the report to the
executive sub-committee in our way to bring it back to the full Committee in
November for approval. That’s our sequence and schedule.

The outline of the report – I mentioned we wanted to take a broader
look at HIPAA, and after 15 years, really, of working on this, look at the
journey itself, and that’s what we organized as a first section.

We will certainly have an executive summary that will summarize the main
findings from the report and an introduction, and I’ll mention a few things
about those in a minute.

The first section, which is the journey, basically the background of what is
HIPAA, administrative simplification, and what has been, the regulations that
have been basically promulgated under this law, as well as another legislative
initiative, more recent legislative initiative, like the Affordable Care Act,
and the provisions in there that deal with administration simplification.

Section Two is where we are now, and what we tried to do was really look at
the effect of the various components of HIPAA, the effect that the transactions
the identified standards have had, the effect that the Privacy and Security
components have had, and the effect of the semantic interpretability aspects of
HIPAA, something that not a lot of people knew about back in the early days of
HIPAA, and know that it came from, really, HIPAA have had in terms of where we
are going with that, semantic interpretability.

And then this Section Three is the journey forward, so basically addressing
some of the issues and gaps in each of these areas; in the standards,
transactions and causes identified, the Privacy and Security, semantic
interpretability, and overall, as kind of a perspective of integration and
convergence of administrative clinical quality, all sorts of aspects of –
I’ll mention a few things in there as well in a minute,

And then the appendices, which we basically include the statutory reporting
requirement from HIPAA, description of the transactions and, just some
background about those elements.

So very briefly, the Executive Summary and introduction. In the report we
include descriptions of the fact that despite enactment of HIPAA in 1996, and
the adoption of the first set of rules in 2000, and the initial implementation
of those standards in 2003, HIPAA goals remain as current as ever today, and
particularly with the new national health IT initiative, there is now an
increased interest in the overall concept of the convergence of all these
standards and these reporting requirements, and submissions and administrative
and business processes, much more integrated with the clinical and quality IT
processes. So we kind of highlight that in the Executive Summary.

We provide a brief overview of the report content, the aspects that form the
report, and then provide a summary, a very brief summary, of the major
initiatives underway, including, of course, the transition into 5010, D.0, 3.0,
ICD-10, the HITECH meaningful use and the Affordable Care Act health reform and
other things.

And then we are going to be gathering a summary of findings, really, kind of
a highlight, bulleted messages of what are the main findings and main themes
out of the report itself. So that’s the executive summary.

The section one, the journey – as we go along, if you want to stop at
any point we can do that. At the end I’ll talk about the next step, and
certainly, what we want to do today is more listen to your perspectives in
terms of the overall structure and reconfirming, basically, that the approach
is the right one, and perhaps some ideas of enhancing some of the content, but
the detail work you can do off-line and send us, and I’ll mention at the end a
few steps about that.

So, a journey, section one – we provide a brief, of course, overview
and a description of what HIPAA administration simplification is, and
categorize it into its core elements, the financial administration transactions
and causes, the unique identifiers, privacy and security and the data standards
for patient medical record information; that was something that was actually in
HIPAA, which now we know as the semantic interpretability, that continues,
significantly, under HITECH meaningful use and ONC activities.

And then we start with each of the main sections about the journey, how each
of these components has been developed and identified some of the key issues
and challenges in this early part of the report, so in the financial
administrative transactions and causes, we summarize progress being made in
issuing all the regulations in support of HIPAA, the regulations being
developed under this new Affordable Care Act legislation, that relates to these
transactions and causes of operating rules, standards and the new standard for
EFT and claims attachments and other things. And then identify some issues and
challenges with the initial implementation aspects of the standards. And then
also highlight the role played by NCVHS in selecting and recommending the
standard that was probably a critical aspect of what we were doing, which I’m
continuing to certainly do with respect to transactions and causes, the

So that’s what we include in this first part of the report, we refer to
administrative transactions and causes. In terms of the unique identifiers, we
again summarized the identifiers being adopted through regulations so far
– employer ID, national provider ID, the upcoming national plan ID, which
I would think you know here that by the time we put this together, our
regulations will be likely out; we heard it’s probably going to be a little
later than the time frame we have for the report.

And then we discuss some of the limitations in the definition of unique
health identifier for individuals. We note the constraints that exist in
defining a national unique health identifier for patients.

So that’s basically the identifiers part. The Privacy and Security Act, that
we describe the process and timeline for adoption and implementation of HIPAA
privacy and security regulations, again summarizes some of the NCVHS collective
set of recommendations, that were otherwise addressed related to privacy and
security. For example, the collection of baseline data for analyzing the effect
of privacy rule, the elements of personal health records that were made of
recommendations from the Privacy and Security sub-committee harmonizing FERPA
and HIPAA, data stewardship, all these aspects. So we highlight some of those
as contributions, really, of NCVHS in the process.

And then we review regulatory steps recently taken by HHS to enhance and
strength the privacy and security components of not just administrative
simplification, but in general health information management. So the delegation
of authority of the security rule to OCR from CMS, brief notification of
regulations, then the regulation accounting of disclosure, those are recently
released rules and actions taken.

And then the last part of the semantic interpretability and other health
information technologies; we mentioned how originally HIPAA called for the
recommendation for a uniform data standard for an electronic exchange of
patient medical record information, PMRI, as we refer to it. NCVHS conducted
extensive analysis back in 2003 through 2006 and developed a series of guiding
principles for the adoption of these patient medical record information
standards. And of course now, all of that has been rolled into the work that is
being done by ONC and there’s HITECH through the Standards and Policy
Committee, the meaningful use program, those things, so really kind of serving,
in that respect, as a kernel, as providing some groundwork for this work that
is now being driven by ONC.

And then in 2006, NCVHS developed recommendations on the functionality of a
nationwide health information network, another component that we highlighted,
related to other health information technology aspects of what we do. So that’s
sort of a quick review of the journey. We include a table; it’s the one that’s
displayed on the screen right now, of all the various letters concerning
HIPAA-related matters that have been issued; a total of 73 letters, amazing
– and other documents related to recommendations that had to do, somehow,
with HIPAA.

All right. So Section Two is really a section that deals with where are we
now, and the approach we took with respect to that was really try to assess,
try to understand and provide some information about what has been the effect
of all these regulations, ultimately. And so we organized it in the same kind
of order, the effect that HIPAA transaction identifiers have had, so we mention
that while progress has been made, significant progress has been made toward
standardization of transactions and causes and business and administrative
processes, there are still some concerns, of course. Not everyone is doing
electronic transactions, in the first place. And it’s important to know that
HIPAA allowed providers to choose whether they were going to do or not
electronic transactions. It was not a requirement for health care providers to
do it.

Health plans were required, by virtue of being required to be able to
accept, or submit, electronic transactions, or be helped on how to do them, and
clearinghouses were also required to do them, but providers had the ability to
say yes, we’re going to do electronic transactions or not. So still today, not
everyone is doing electronic transactions.

Not all electronic transactions are being used. So there’s limited use of
certain transactions. We know that claims and claims payment is sort of the
bread and butter of administration simplification, but a lot of the other
transactions, and there’s a total of eight different transactions, and now
growing to additional transactions, are not all being used. Eligibility has
some limited use, it’s being used by some large organizations, but it has some
limited use in other smaller organizations, and there’s very minimal use of
other transactions, like the referral authorization transaction. So that’s an
important point that we wanted to mention there.

Providers are using other mechanisms allowed in the HIPAA regulations to
conduct some of these transactions; something called Direct Data Entry, or DDE
systems. So these are the on-line interactive tools that are being offered by
payors to allow providers to conduct some of these transactions.

So if I want to enter a claim, I can actually go on a website and enter it,
one by one, into the Web, or if I want to check eligibility, I can do it on
line on a one-by-one basis. I can also actually upload, via some of these web
tools, some of the batch files that have a whole host of inquiries, let’s say,
for eligibility, but for the most part, these direct data entry are used to
interactively conduct some of these transactions.

So that takes us into not everybody using the HIPAA standard type of
transaction. The current Version 4010 also was highly customizable, as we know
now, through things like payor companion guides. We used to refer to HIPAA as
it was good because it provided us with one standard, but there’s four thousand
different flavors of that standard. And indeed, there are thousands of these
companion guides that go along with this 4010, so the good message was that at
least we got to a one standard, and now what we needed to do was reduce the
variability of the usage of that standard.

Clearinghouses significantly are used today to convert the nonstandard
transaction that a provider or payor does to a standard format, and then back
to a nonstandard, so if I don’t really – my systems internally don’t
really do, or generate, an actual HIPAA transaction like an 837, a claim
submission message, then I can send the file in some electronic format –
it could be paper to some clearinghouses, and they will convert them into an
837 and then send it to the payor, or the payor clearinghouse, and the payor
clearinghouse will convert that A37 back into the internal system that the
payor uses. That is the role of the clearinghouses, and that is what they do.
So that created, of course, the sense that that natively, organizations never
needed to really have systems to do the electronic transactions, but they could
certainly rely upon clearinghouses. So those are some of the kind of concepts
that are somewhat different, actually, from what we see in the electronic
health record world.

Also a lack of usable electronic remittance advice has shown to prevent
providers from using electronic denial management tools and dramatically
improved payment recovery, so that lack of the use of that electronic
remittance advice has important implications for the limitation of
administrative simplification and an improvement in business processes.

There continues to be very limited use of the complaint process, said to
drive enforcement. That’s a critical aspect that we really want to emphasize,
because as much as there is a way to try to enforce this, the enforcement
depends on entities complaining of the fact that other entities are not
complying with these regulations, but it seems like nobody complains about
anybody here. So very limited amount of information about compliance in that
respect, and the ability to do enforcement.

And Medicare, as a payor, is using their authority to mandate, and many
other payors are actually doing the same thing, are using their business, or
position, to mandate the use of certain transactions electronically, so they
mandate the electronic submission of claims, as you heard from Lorraine,
they’re mandated the electronic submission of fund transfers, or conduction of
electronic fund transfers, so there are ways in which payors can take advantage
of really, their position, to move forward with the adoption of these

Readiness for Version 5010. We also mention in this section about
transactions and causes of readiness for 5010. We summarized evidence of the
state of readiness and talked about some of the things that are happening with
5010. Clearly, we kind of point to the fact that, as I mentioned, with 4010 we
had such a great variability. 5010 is the next version, that is truly helping
the industry come to a lot less variability in the use of the standard, a lot
less number of companion guides, or details –.

That’s basically a quick rundown of some of the things that we covered in
that section. On the HIPAA Privacy and Security rule, on the Privacy rule, we
note a few things. We mentioned, actually, how today HIPAA has been viewed
largely as a privacy and security thing. Not a lot of people relate to HIPAA as
all the other components of HIPAA, but they all remember and know HIPAA privacy
and security along with it.

There is a perception that privacy and security regulations lack strong
enforcement. Contrary to the perceptions, the number of privacy complaints
filed suggests that HIPAA has actually raised collective consciousness
concerning privacy, so some of the interesting statistics that we’ve been able
to gather – OCI has received almost 60 thousand, 58 or 59 thousand,
complaints, and issues around privacy, and have been able to resolve over 13
thousand through resolution agreements, and this is between 2003 and 2011.

Some of the other thousands of complaints, many of them were received, but
they were resolved without even having to go to a resolution agreement, but
they were complaints that were not necessarily truly something that were HIPAA

DR. CARR: Walter, I want to just make sure we have enough time for some
discussion, because you’ve covered in depth, and I’m hoping that everybody has
read this, so if there’s any –

DR. SUAREZ: All right, I’ll just highlight very briefly, then, a couple of
other things. The Privacy and Security rule, we mentioned a number of things,
highlighted some of the most common five complaint types on security.

DR. CARR: Actually, Walter, let’s just, because our time is precious and
we’re under that time frame –

DR. SUAREZ: Let me just say a final word. The next section of the journey
forward is really addressing some of the gaps. We organized that the same way,
gaps around the transaction process identified, Privacy and Security, and the
most important part, probably, is at the end, really, the fact that we see into
the future, increased converging, as I mentioned, standards and
interoperability world in quality transactions, and the administrative world,
and that’s sort of a critical paradigm shift that in the future we’ll see.

We do not provide, in this report, recommendations. This is not a report to
provide recommendations, it is a report to summarize where we are with things.
So the process, the next step, we can take you there, so we’re completing this
first review now. Members can e-mail to us any detailed comments or work
anything or changes.

DR. CARR: Okay. I really do want to get the comments and the feedback; I
think everybody is accountable for reading everything that’s in there. This is
what I want to say. The work that has been done on this is extraordinary,
probably doesn’t exist anywhere else to have this, all this collation of stuff.
I think what we need is an outside group to now take this and pull out an
executive summary that punches out the storyline that the Congressional members
can read and remember and understand, and my recommendation would be that we
begin with what is the ideal state? When this was envisioned, we pictured
something like you go, whatever, like your ATM and you go in and your money
comes out and a million things happen in the background and it takes about five

We should say, this is our future state; this is the ideal state. This is
where we are today. Here are the key players; providers, payors,
clearinghouses, banks or whatever, and here’s – the data that you have in
there, here are the percent of people using it, here are the percent of people
not. To put out there, here is the gap, here’s where we want to be, we’re more
than ten years into it, and this is what lags behind, this is what is in the
queue, that we think a year from now we’re going to get this much better, and
this is what remains.

I think we want Congress to take from this what they could do, how they
could think about this. I know we don’t want to make recommendations, but we
can set the table for here’s the gap between where we are today and where we
need to be, and we can use some data that’s in there of what is the value of
the gap, especially in this time of financial distress. We’re part way there,
but we’re not all the way there, and the price that we’re paying is enormous.

So I’d like to open up comments, then, around the room. Paul?

DR. TANG: I thought it was also a very nice summary and gave a story about
how far we’ve come.

One of the gaps that we haven’t acted on was in HIPAA, and you know what I’m
referring to. But times have changed a lot, we are interested in populations,
we are interested in tracking over time, and we are interested in satisfying
the needs of citizens. We have to know who they are. Even if we don’t know who
they are.

DR. WARREN: In our gap, we could say it came to our attention that –

DR. CARR: We have the legislation cited in there specific that says that
this work cannot be funded.

DR. TANG: But you might say, what is the newly understood invisible need,
and how has the world, how has our society changed in acceptance and
understanding, and that it can be voluntary? Because that wasn’t part of HIPAA,
it was mandatory. There are ways you could at least – because this is
going to Congress, and this is a thing that causes errors, harm and
interference with communities trying to help themselves. It just has to be

DR. WARREN: Maybe we break our mold and we do put a recommendation at the
end, and this is it. It’s an opportunity statement.

DR. TANG: We’re not recommending to go back to where HIPAA has had us go,
recognizing that we understand the benefits and have really attenuated the
risk, even through actions of Congress, like HITECH. We’ve done so many more
things, and society’s changed, and Congress probably just hasn’t been updated
on those issues.

DR. NICHOLS: Paul – I’m sorry, I’m not sure I understand exactly what
you’re talking about. The unique health identifier? Just say that, that’s what
I was going to say, just say it, okay?

DR. WARREN: It’s also been known as the third rail of health care.

DR. NICHOLS: I get the third rail part, I just want to clarify we’re
thinking exactly the same way.

DR. WARREN: Excellent points. I don’t have a list here. Linda.

MS. KLOSS: A couple of points. I think the time is right to say something to
Congress, Health IT Week, when HIMMS was up on the Hill last week, this was
clearly one of their key messages, to reopen that discussion.

I agree with everything that Justine said. I think one of the ways to create
a sense of urgency may be to look at the, to reflect on the lessons learned
from this journey, because I think that isn’t covered here. And there are so
many lessons that seem to pop out relating to this kind of large system change,
what worked and what didn’t work. And I thought if we – we might position
it that way because this is instructive for the kind of change we’re embarking
on in health reform.

So issues such as enforcement and optional, not having a thousand different
guides. So I think unfinished business and lessons learned from a changed
management, from a system changed management perspective, might kind of take it
out of the sting of getting ourselves too deeply into specific recommendations.

And then one other, just kind of thing that popped out at me was the –
going back to our discussion earlier this morning, the semantic
interoperability, and how that agenda hasn’t, over this tenure, gotten the same
level of attention as the administrative simplification, and I thought that we
could leave, punch this up by setting some specific goals. I think on
administrative simplification, it’s such an area where you could say, we need
to see ten percent improvement, look at it like gasoline consumption, ten
percent reduction by, some kind of goals that are really realistic for
everybody to shoot for.

DR. CARR: Okay. So I have Larry, Len, Bruce, and we’ll have Blackford and

DR. GREEN: I am going to be piling on here. But it’s line 55 in the
Executive Summary, to reflect upon the entire journey. I really think this is
our opportunity, and from my perspective, it’s okay for the members of this
committee to agree that we have some opinions about this. And that the basis of
this reflection can be an NCVHS committee reflection. It doesn’t have to have
citations in it. If Paul wants to call that out, why can’t we call that out?

So again, to pile on administrative simplification, tenth report. Boy, it’s
really a lot simpler to navigate health care information transfer in the United
States now. We have gone so far. I’m being totally facetious – I mean, one
of the reflections is that after all this time, all this work, a ton of work
and a lot of expenditures, it’s amazing how little we’ve actually gotten done.
And the people are waiting.

DR. NICHOLS: I just want to make sure what we’re doing here. Did I hear that
we are not supposed to make recommendations?

DR. CARR: That’s not been part of the format of this report.

DR. NICHOLS: Of this report? Now it is to me. So surely it’s time to break
the mold. I mean, I just feel like – piling on, I’m ready to pile on.
There’s no way you could be sensible about this proposition without using this
opportunity now, especially now, and if not now, when, to make this point? I
just think if we don’t do that, we’re embarrassing ourselves.

DR. SUAREZ: You have to be clear, you’re talking about making a
recommendation –

MR. NICHOLS: Then you figure out how to do a unique identifier, that’s
right, and you’ll have one year.

DR. SUAREZ: One health identifier for a patient.

DR. WARREN: Let me be clear. We are talking about rewriting the Executive
Summary, which has always been one page, and which we’ve drafted, and we’re
talking about adding recommendations and some things like that, and so what I’m
getting concerned about is it’s already taken us a year and a half to write a
letter that’s supposed to go out annually; we’re now talking about adding a
significant amount of time that maybe a strategy would be let’s have the report
in the format that we’ve been told to submit it, but maybe in the letter that
forwards it, we could add recommendations and stuff like that.

DR. CARR: What I am going to ask for, and think about it, we’ll ask later
today, is volunteers who will take this, who have been not involved in reading
it, and who will then lift out of it the important messages. I think that the
fundamentals are all there – it reads well, it’s everything you’d ever
want to know. But I think our opportunity is in the opening page or two; we
could have a two-page, break with tradition, Executive Summary, that really
lays out, this is what it was supposed to be, this is where we are today, this
is our opportunity statement, in language and in conciseness that is a call to
action to achieve these opportunities.

So think about who wants to be there and I’ll ask for it later.

DR. WARREN: I’m hearing two things. One is, beefing up, or whatever, the
Executive Summary in the way that you describe. But the other is the idea of
putting recommendations, actually developing or agreeing on recommendations, in
the report, and I was having the same thought that Judith was, that I think the
report provides kind of the fodder for some recommendations, but that they
might be included in a cover letter.

DR. CARR: That’s fine. But I think that we set the table for when someone
reads this, it’s so obvious what needs to be done that how we state it is less
important, about whether it’s recommendation, but more the kind of story
Executive Summary that’s taken out. Blackford?

DR. MIDDLETON: I support the idea of a more activist recommendation, whether
it’s in the report or in the letter, about a national health care identifier. I
think it’s high time. And it’s actually not that big a movement away, because
we’re really disinhibiting what HIPAA said originally 15 years ago. We’re
almost a generation into this. So that’s number one.

Number two, I guess the idea, thinking along the activist lines, you
mentioned the idea of a dashboard, Justine, the idea that we might actually
more actively monitor what is the impact of our work through, for example,
measuring the number of claims submitted one way or the other from the ASC X12
and 5010 or prior 4010 or other. I think that kind of information would be
extremely valuable for this group to understand its own efficacy and impact.
I’m not suggesting we do something really too fancy, just get maybe annual or
some kind of level of periodicity that makes sense, drawn from other sources,
and just then use it as a management template.

DR. CARR: Lorraine, you just raised your hand? Are you responding to

MS. DOO: Only to ask the Committee to also consider methods by which we
might obtain that, because we have done surveys, industry has done surveys,
WEDI has done surveys, AMA, AHA and we can’t get people to report? So not
saying it cannot be done, just it’s been attempted many times, so to get some
ideas from people about good ways to get quality data would be terrific.

DR. MIDDLETON: If we anointed someone, if this committee asked and anointed
someone to do it, it would happen.

DR. HORNBROOK: Just a question – since this is a tenth report, does
that mean that you always have to follow the same writing style? I mean, the
question I’m asking is, would it be important for us to make this accessible to
a lower level reading audience with less jargon and more plain language?

DR. CARR: We have a plan for that, right, HIPAA primer? We have a plan for
that. But I agree with your observation, remembering that the members of
Congress, so many of these acronyms are unfamiliar to them and what they do. I
see you have a picture in the back and it’s a start, but I really like this
picture of how information flows, or whatever. On to Paul and then Ob.

DR. TANG: I think that was a really nice suggestion, because it’s really an
opportunity for a lot of things, and to reconcile the stuff in a painting
forward way. I don’t recall, as I read it, whether you mentioned EHR
certification. I go back again to what’s changed and what are the new levers
they have, and that’s so powerful for certification, because not only must the
vendors, all the vendors in the country, do such and such in a standard form,
we actually have to use it to get paid. It’s an incredible opportunity that
just really does evaporate with time. A lot of these things –

DR. WARREN: No, we did not mention it. Remember, this is a HIPAA report, so
it doesn’t have all those others, so that one of the concerns we had in pulling
it together was how to scope report, or else we could start writing a Federal
Register kind of report, that people would not read because it would be too
lengthy, and we did look at companion legislation, because we wanted to get in
some of the things from HITECH at ACA that were impacting on this.

So at this point, maybe we should just scope this out as a HIPAA report, but
then follow up with some other work that starts linking it to everything else
that’s going on. Because I do think you’re right, and we talked about whether
or not to include –

DR. TANG: I guess the theme I’m hearing from everybody is, it’s an
opportunity, and if we take another year and a half it won’t be an opportunity,
actually, anymore. But I think it’s not that we’re reporting on HIPAA; HIPAA
actually had a goal, it was actually insurance portability, that some other
things got linked to it. That was, in a sense, an end. Now I think HIPAA, in
today, in ACA and HITECH, it’s an enabler. If we turn it into one. And we’re
the body that advises the Secretary on this, and how can we turn HIPAA into an
enabler of everything from reform, the top agenda, to collecting and using
data? It really is a convergence. Clearly administration wants to do that. I
also hear it’s a lot of work. But I think that’s what the lumping comments –

DR. CARR: I want to hear from Ob and then I’m going to take volunteers for
the committee that’s going to make a draft Executive Summary.

DR. FITZMAURICE: Can I get on your queue too?

DR. CARR: We’ll let OB speak and then we’ll invite your comments.

MR. SOONTORNSIMA: Going back to Blackford’s point in terms of looking at
statistics in terms of adoption, I think that the statistics right here, I
think we can call it out pretty quickly. For example, there’s a page here that
talks about 75 percent of the claims are submitted electronically? Reverse
that, 25 percent is not submitted electronically. That’s powerful enough

So I think we can definitely do that, so now journey forward, and it’s going
to be about not only the ID for the consumers, but also the adoption, more
along the line of compliance, across industry, and that is the call to action,
is for the industry to now fully embrace, because health plans and others have
done, clearinghouses have done enough in terms of spending the money, and
continue to do so, but we really have to realize the effect on — efficiency,
by forcing the adoption. So that could be called out.

DR. CARR: Mike?

DR. FITZMAURICE: I have two comments, one is on the unique health identifier
characteristics, it starts at 837. It says that appropriation bill 699 has
prohibited spending funds for development until specific legislation calls for
such expenditure. I remember initially it was prohibited from spending funds
for its final implementation, not the development. So I wonder if more recent
language has changed that to expending funds for its development.

I think it may be a non-sequitur to say that without funding to explore the
issues, NCVHS cannot advise; does that mean that we’re linking funding for the
development of a unique identifier with funding for NCVHS? I’m not sure I see
the tie-in.

And then I’m not sure I see the tie-in on the last sentence that begins,
“NCVHS observes that HHS has standards on metadata.” We haven’t
explained how that ties in with identifying individuals. It does tie in with
their expressing preferences.

MS. GREENBERG: Sorry to interrupt, but those who are going to NCHS now need
to go.

DR CARR: Before we go, who are the volunteers for the committee? I have
Linda and Leslie, Dr. Tang, did I see your hand go up? That’s Mark, Ob, am I
missing anyone?

Okay. It would be them giving feedback. We’re losing much of our committee,

MS. GREENBERG: I understand what you’re trying to do, but –

DR. CARR: I am asking them to be editors and advisors on the Executive
Summary, so I’m asking them to read what’s been written and cull out from that
what are –

MS. GREENBERG: From the whole report.

DR. CARR: – the bullet points. Did you know, Congressman, did you know
– boom, boom, boom. This is where we want to be, this is where we are,
this is our opportunity. So it will be structured feedback to you, specifically
with taking what’s in here and making it – and highlighting it in the
Executive Summary. That’s the charge.

MS. GREENBERG: I don’t think they should actually, as a committee or group,
try to write it. Just pull out –

DR. CARR: No, just cull out what are the key bullet points for the people
who read one, maybe two pages, what’s going to grab their attention.

With that we will retire for lunch or travel and then resume at 1:30. Thank
you everyone.

(Whereupon, a luncheon recess was taken.)


Agenda Item: Standards Letters for Action

DR. CARR: The question is, do we have a quorum? Is the action today
or tomorrow?

DR. WARREN: The action could be today, but it doesn’t have to be today, it
could be tomorrow.

DR. CARR: Okay, who’s leading us through this? Judy?

DR. WARREN: Our plan is, Walter’s leading it, I’m taking office notes.

DR. CARR: All right, excellent.

DR. WARREN: Because I can read my writing. We have a quorum, at any rate.

DR. SUAREZ: All right. So we’re going to do three letters, and you have
PowerPoints and you have the letters as well. We thought it would be most
productive, instead of reading letter by letter and statement by statement in
each letter, to just go very quickly through the information about what’s
included in the letter and then focus on the recommendations themselves. You
know what we want, certainly if you have any wordsmithing to do on any of the
letters, you can provide those to us, but we wanted to make sure that
conceptually the recommendations were okay.

We’re going to start with the acknowledgment letter, so there’s – the
tab number, acknowledgment is tab number six. And then there’s probably a
presentation about the acknowledgments.

DR. CARR: At your site we handed out the slides, so they were distributed

DR. SUAREZ: The first slide is the background, very quickly, of
acknowledgments, so if you can move this one slide. Electronic acknowledgments
are really a critical component of the way we conduct business, and it is
really an efficient and cost-effective way to execute all these administrative
transactions. There is a number of benefits, of course, of acknowledgment;
ensuring appropriate communication has been established, allowing the recipient
of the information to confirm the receipt of the message, informing the
submitter that the message has been received and informing the submitter that
the message has either been rejected and why.

And in the interest of time, because we have three and we only have what is
it, an hour? I’m going to just quickly jump into some of the core concepts.
Slide number two just talks about a couple of things. Basically, in the health
care industry, we are currently voluntarily using acknowledgments, and we’ve
been doing it for some time, but it’s not universally done. Standards are not
consistently followed. The business requirements and operating rules are not
the same across payors, and so that’s the reason why we needed to move forward.

This electronic acknowledgment is not part of HIPAA in the original
legislation that called for regulations on standards and a name and number of
standards, and it was named and referenced in the Affordable Care Act, and
that’s where we picked up the requirement, really, of saying we need to
recommend standards to the Secretary that provide for the timely
acknowledgment, response and status of transactions on the claims processing
side. So that’s the background of where this requirement for us to write this
letter came from.

Currently there are three – if we go to the next slide – there are
three types of acknowledgments we use in connection with a health care
transaction, and it gets a little technical. One is called a TA-1, which
provides for a simple – it’s like a certification that you receive in a
mail packet, simply like that. It doesn’t get inside the packet, it just says
yes, I did receive it. The 999 implementation acknowledgment, which is one step
more detailed than the TA-1, notifies the submitter of an electronic
transaction that a transaction has been accepted, it has been rejected or it
has been accepted with errors. So it gives the submitter of the transaction
some more detail.

There’s one specific acknowledgment that is used with a particular
transaction, the health care claims transaction; it’s called the 277 CA, the
Health Care Claim Acknowledgment transaction, which when I send a claim, if I
receive a 277 CA back, it confirms that the claim has been received, it has
been accepted for processing or it has been rejected and it tells me a little
bit about what the problem was with the transaction.

We held a hearing in April of 2011 to understand the current practices and
the recommendations from the industry, and you can see there, just in the
interest of time, again, briefly summarizing, there’s consistent and very
strong acceptance and support for adopting the transaction. There’s support for
ensuring that in the process of developing the rules, we find ways to
accelerate that to make the standard move very quickly and be adopted and
implemented very quickly. There was a need to ensure that the conditions for
applicability and submission of acknowledgment transactions were well-defined,
and there were some special conditions to consider, specifically; how to
handle, whether there was a need for acknowledgment in real-time transactions
versus the batch transactions, and some of the pharmacy transactions, how much
there was a need for those.

So the recommendations to HHS; the first recommendation is to adopt the
following three health care electronic transactions as standards, and define
the corresponding conditions under which each of those must be used. So we
define the ASC X12 TA-1 as the electronic acknowledgment transaction viewed by
the receiver of a standard transaction to report, and read the actual
definition that we’re recommending, and then the condition of use. For the
TA-1, it would be required only to be submitted back as an acknowledgment by a
receiver of a transaction when the submitter of that transaction has elected to
receive it, and this is important because in every single one of the X12
transactions, there is a little marker that says – sort of like when you
go to the post office and say yes I want a receipt back – you don’t do it;
– well if you don’t do it then the recipient of that is not going to send
you back anything, but if you check yes, I want to receive a TA-1 back, then
what we are saying in the rules is that if the submitter says yes, I want one,
then the receiver of that transaction must send back a TA-1 and must use the
X12 stamp. That’s what this means.

The second acknowledgment is the 999, Implementation Acknowledgment, so we
define it as the electronic acknowledgment used to report X12 syntactical
errors, and then the condition of use is required as a response to all adopted
administrative transactions. So it will be required all the time, a 999.

Then the 277-CA, we’re recommending the definition to be the electronic
transaction used to acknowledge the receipt of a health care claim, and
communicate the result of the preprocessing application level validation
errors, and then the condition of use is required in response to each submitted

So that’s the first, and most critical, recommendation, basically, is that
the Secretary adopt these standards and the definitions and conditions of use.

The second recommendation is about adopting the X12 standards and
corresponding implementation guides that are current at the time of adoption
for each of these transactions. So that’s same — the standard should be the
X12 standard.

And then the other recommendations are in the last slide, Adopt the Standard
Implementation Specifications using any available expedited proposed rulemaking
procedure. For example, shortening the comment period time, so instead of
giving 60 days comments, use a 30 day comment period. The reason is, the
industry, at least we heard in the hearing, they want to see this happen
quickly, and the Secretary does not have interim final rule authority to
expedite rules for acknowledgment.

An interim final rule authority was granted to the Secretary under the
Affordable Care Act for all these other transactions like health plan ID or the
EFT or the operating rules or these others, but acknowledgment wasn’t a
specific one, so the secretary will probably have to use a regular
proposal-making process. What this is saying is the Secretary should consider
ways to accelerate that regular proposal-making process.

Encourage the industry to use a transaction, in the meantime, as we wait
until the compliance date. Adopt the CAQH core operating rules related to the
use of acknowledgment for eligibility and claims status, which were excluded in
the interim final rule published July 8th. What does this mean?
Basically, that when the operating rules in the interim final rule were adopted
for eligibility and claims status, that interim final rule had a little
statement that said except for the operating rules that relate to
acknowledgment, because at that point the regulations and the standard had not
yet been adopted. So what we’re saying is that in these regulations, the
Secretary adopt those operating rules related to acknowledgment. So lists of
comments and suggestions about additional operating rules that will best
support the use of available acknowledgment standards, so this is the concept
that operating rules need to be applicable to all the other transactions with
respect to acknowledgment. Consider excluding real-time transactions from the
requirement of an acknowledgment standard. So when I do real-time transactions
like a real-time eligibility or a real-time pharmacy claim, in a real-time
exchange there’s no even time, there’s no reason, there’s no need for an
acknowledgment of me doing some real-time activity, so the recommendation is to
exclude real-time transactions.

And then seek input regarding the need for acknowledgment related to
non-real time pharmacy transactions. There was some debate during the hearing
about health plans would like to receive an acknowledgment back from the
pharmacy when the health plans send a payment to the pharmacy; they want to see
a pharmacy acknowledgment back to the health plan. So those were the
recommendations and I’m going to stop here and see if there are questions and

DR. CARR: Walter, thank you, that was very, very helpful, and Judy, helpful
to help us to frame, to understand what it is that we’re talking about. My one
question is, were there any, is there anything in here that promoted

DR. SUAREZ: The only controversy was how quickly can we set this up. I mean,
really, honestly, I think this hearing was very consistent in terms of its
support for the adoption of acknowledgments. This was recommended to the NCVHS
by the members of the Designated Standards Maintenance Organization group, back
in February of last year, and we just never really, with all the other
responsibilities, we never acted upon it, so this is something that is overdue.

MS. WEIKER: Hi, this is Margaret Weiker, I’m with HP. I’m also Chair of the
ASC X12 and Insurance Subcommittee, and I noticed on some of the
recommendations there were a few errors. You recommended that the 999, the ASC
X12 999, be used for all adopted administrative transactions. The X12
acknowledgment is not used in the pharmacy world. It is not used for the NCPDP
transactions, so in that recommendation, I think it should be changed to
acknowledge all ASC X12N adopted administrative transactions, because pharmacy
does not use that.

DR. SUAREZ: That is actually what the letter says.

MS. WEIKER: That’s what the letter says?

DR. SUAREZ: I apologize, but the slide didn’t reflect exactly what the
letter said, but the letter says, I read: “This type of acknowledgment is
applicable to all ASC X12 transactions.”

MS. WEIKER: Okay, that’s good. Also, you are recommending they’re not used
in real time at all, and I know you had something in there about excluding
pharmacy. But there are circumstances in which, in a real time environment, you
could potentially send back a 999 transaction. For example, if I receive a
real-time 270, an eligibility enquiry, and it is in such bad shape that I
cannot generate a 271, which would be the normal response, back to it because
it’s missing mandatory data elements that are not supported in a 271 to report
back, there are circumstances where you would send back an X12 999, reporting
those type of errors, which basically says there’s so much wrong with this I
cannot even generate a 271. So there are circumstances in which you would want
to send back, so to allow for that.

DR. SUAREZ: It’s a good point, and the recommendations, as considered,
excluding real-time transactions from the requirement to use the acknowledgment
standard, so maybe something around the fact that should not apply to every
real-time transaction; let the trading partner decide which ones, and then if
they choose to do an electronic acknowledgment on a real-time, that they must
use the adopted –

MS. WEIKER: The ones that are made. But if it’s a normal transaction, you
would get a 271, and you would never receive a TA-1 or a 999. But in the
instance of a major type of error, you would send back those acknowledgments.

DR. CARR: Very helpful, thank you. Any other comments? Hearing none, Walter?
It’s you again.

DR. SUAREZ: Okay. So we will make those changes and bring them back tomorrow
for approval.

The second one is, I’m going to go to the letter on the ICD-10 and 5010. So
that’s tab number five. Actually this executive summary really is an executive
summary, it really summarizes the entire presentation. So we, as NCVHS, we
periodically, almost annually, not every year but almost annually, or some time
around that, review the state of the industry’s progress towards compliance
with the implementation of HIPAA in general, particularly the transactions and
code sets.

We held a hearing in June of this year and heard extensively from providers,
the entities subject to this, and we created a letter that describes a series
of observations and recommendations. Here are the summarized observations; I’m
not going to read them here, I’m just going to highlight in the next few slides
some of the areas and then talk about the recommendations in each of them so
that we can expedite that.

We divided the letter into five sections. One is a cross-cutting section,
where observations or recommendations apply to everything related to 5010 and
ICD-10. So here, several things. The overall industry is concerned about the
ability to comply with the deadlines, but there was consensus that the
deadlines should be maintained. The biggest concerns were the ability by small
providers outside the large clinic-hospital systems, like long-term care, some
dental, the state Medicaid agencies was another major area of concern. The
majority of testifiers support strong reinforcement of the current data, so the
recommendation is to have HHS use all communication vehicles to recreate and
emphasize the compliance dates for both 5010 and D.0 and 3.0, and for ICD-10.

There were concerns about multiple concurrent priorities; you know, having
to deal with all this meaningful use and HIE and health reform along with
having to apply with 5010 and ICD-10, were some of the big concerns around
that. Education, communication and outreach was another major area. It seems
like there is never enough when it comes to education and outreach. In this
last part of the year, before January 1, 2012, which is the deadline for
starting to comply with 5010, there needs to be sort of a special final push in
terms of industry outreach and education. So the recommendations were
basically, HHS should create and deploy clear, more direct outreach activities
to promote testing, and we’ll talk about testing in a minute, leverage outreach
technologies and tools used to promote meaningful use to expand the awareness
around HIPAA 5010, particularly the first one. Consider creating a National
HIPAA Awareness Month. We had a HIPAA Awareness Day; we even talk about HIPAA
Awareness Weeks; every week or every other week or some sort of – we even
talked about a little button that says Have You Been Tested For HIPAA? –
CDC might have something to say.

And dedicate more resources and establish a more formal process to receive,
and this is an important aspect, really, having a more formal process to
receive and respond to industry inquiries, questions, requests for guidance and
FAQ, so that’s something we recommended.

The next slide talks about testing; clearly over the next few remaining
months of the year, testing is really the order of the day. It has proven to be
critical to identify and address implementation issues, as they were reported
during the hearings; some entities saying well, we tested and we found we have
to do this, we have to modify this. Very few organizations have established a
formal testing platform, and this is going to be particularly critical for
ICD-10. So many organizations test on the fly, or test on environments that are
not truly a formal testing platform, and that’s an important concept to promote

So the recommendation is HHS should immediately make wide-scale
announcements to encourage and foster testing; CMS should make test scenarios
and files available to trading partners for them to look and evaluate some of
the testing that they do. CMS and industries should also share results of their
own testing, the issues they have found and how they were addressed. HHS should
consider comprehensive multi-parties(?) for the HIPAA campaign process that we
talked about. Those were some of the recommendations around testing.

State Medicaid program readiness; certainly that was one important topic
that came time and again. There were lots of concerns about the readiness of
state Medicaid agencies to use 5010 coming up, let alone ICD-10. At least four
states were identified as not going to be ready by January 1st to do
5010, and there’s bigger concerns about ICD-10. We heard reports that 41 states
are at medium to high risk of not being able to meet the deadline for ICD-10.

So we had a couple of recommendations of HHS to establish a deadline for
submission of state Medicaid contingency plans to CMS, and HHS to fund CMS to
provide additional technical services and assistance to state Medicaid
agencies. I think that’s going to be really necessary to help push Medicaid
agencies into compliance in the coming months.

The next slide talks about recommendations specific to 5010, D.0 and 3.0. So
with respect to 5010, concerns about software vendors not ready, or not
providing sufficient communication and direction, and some concerns about the
limited use of certain transactions like the referral authorization
transaction, were some of the highlights – and the recommendation to CMS
to release data findings from the June 15 testing event, I think that has been
done already. HHS to encourage industry to take advantage of certification
programs to validate the transaction – this is something that I think Paul
mentioned as one of the areas, and then mentioned in the report, the HIPAA
report; it’s really this concept that certification could be a vehicle to
enhance the ability to comply with this transaction; I mean, certainly it’s
working in the meaningful use program.

HHS to encourage standards organizations to identify, define, accumulate and
address transaction issues as they are being found from testing and
implementation. This is really a critical aspect, to identify and address any
of these transactions issues as testing happens.

And then with respect to D.0 and 3.0, we heard concerns expressed about the
limited, or lack of, testing partners for pharmacy transactions, and the
dependency on successful completion of D.0 to be able to functionally execute
3.0 as well. And 3.0, for those that might not be familiar, is a Medicaid
subrogation transaction that is connected to pharmacy claims.

Recommendations: HHS to work with the pharmacy industry to do more
aggressive outreach and testing, and to increase the amount of education and
outreach content in CMS’ website, specific to D.0 and 3.0. We tend to always
say 5010 and ICD-10, and we forget the other two transactions, D.0 and 3.0, and
those are very important, and a lot more messages have to be put out; I know
the pharmacy industry is very, very well organized in terms of outreach and
education but we did hear some concerns about pharmacy testing and outreach.

Next slide is ICD-10 observations and recommendations. So one area was
crosswalks and general equivalency maps, and granted we’re 2, 2 and a half
years away from compliance – we’re only 2 and a half years away from
compliance with probably one of the largest transformational events in health
care, which is moving from ICD-9 to ICD-10, so there’s an ongoing need to, and
more importantly, escalating in 2012, educate people about crosswalks and
general equivalency maps. Many testifiers said that they will not be using,
actually, crosswalks, but they will do a full conversion in their systems to
use natively the ICD-10.

So there was some kind of concern, we need to have some education on GEMS
and crosswalks, but the other organizations were not going to be able to use
crosswalks. But at the end I think there’s going to be significant usage of
this, and I think it’s going to be important to continue educating people about

Concerns about the explosion of proprietary and vendor-provided code
conversion and crosswalks. A need to consider how to evaluate these vendor
tools, the quality of the intelligence of those tools in doing the
crosswalking, and the internal rules built inside the tool, because there is a
lack of really good understanding of why, when I put this code of an ICD-9, it
goes to this code in ICD-10, or vice versa. Understanding the intelligence and
the internal rules built into these tools is going to be critical.

Recommendations: HHS to work with associations to highlight educational
resource information available already, and we are getting more and more
information available on ICD-10. And then associations to solicit feedback from
constituents on the content and the quality of these available resources and
tools, and make those available.

Resources for ICD-10 – there’s some level of uncertainty about –
actually some level, there’s quite a level of uncertainty about the
availability of adequate number of trained resources for coders, under
geographic distribution, to deal with ICD-10. So the recommendation is for HHS
to work with organizations like AHIMA to assess the current level of coders in
the industry, the number of coders needed by 2013, what are the potential gaps
and then look at investing and expanding educational opportunities to increase
this workforce.

Then the last set of observations were just general other observations. We
had the opportunity to hear, during the hearing, from Workers’ Compensation and
from Property and Casualty. These are two areas that are not covered under
HIPAA today, but we wanted to start listening to what their perspectives were
with respect to 5010 and ICD-10. In the Workers’ Compensation world there is
the same type of claim that we send to a payor has to be sent to Workers’ Comp.
They use different formats in many states, so the question was how much can we
move toward using the same standard?

They basically said, we face very similar challenges, in other areas of the
industry, but we do have some unique circumstances that are associated with our
own business, whether it’s Workers’ Comp or Property and Casualty, that affect
how we use and comply with 5010 and ICD-10. So we’re going to be doing
significantly more analysis. We’ll talk about, later tomorrow, the coming
hearing in November on Section 10109 from the Affordable Care Act, which
actually calls for looking at ways to incorporate Workers’ Comp and Property
and Casualty into the use of these standards. So this was our first attempt,
actually, and a lot of very interesting information came out of that.

So in the meantime, we’re recommending that HHS encourage Workers’ Comp and
Property and Casualty to move to implement these same standards and separate
transaction codes and identifiers, while we complete our process of learning
from the industry and making more specific recommendations on how to bring
Workers’ Comp and Property and Casualty under the HIPAA standard.

But that was kind of a quick rundown of 5010 and ICD-10 here.

DR. WARREN: I did want to bring up one concern. Bill Scanlon was not able to
be here today, but e-mailed Walter and I. We used the word “enforce”
the deadline in two of the recommendations. Bill is fairly sensitive to how the
community will react to the word “enforce”, so I’d like for you to
think about that. The only other word that I can come up with that indicates
the same level of concern we have would be to adhere to the deadline, instead
of using the word enforce. So if you could think about that, if you think
that’s a good substitution, we could go with that.

DR. CARR: I have one question – you’re reminding me of the number of
groups that say they’re not ready for 5010, and we’ve made recommendations
about accelerating activities to get ready, but my question is, if say Medicaid
is not ready or some groups are not ready, what happens? What is the
consequence, and is there a contingency plan for what we do, given the
downstream effects of this?

DR. SUAREZ: Yes – this was discussed during the hearing. We tried to
stay away from the word “contingency” plan because it gets confused
with the 2003 contingency plan that gave the industry another year to comply
with. We talk about business continuity planning, meaning, basically, what’s
going to happen on January 2 when someone sends me a 4010 transaction and it’s
supposed to be a 5010?

I think everybody in the industry, providers and payors, are going to have
to deal with that. Everybody is going to be receiving 4010 transactions on
January 15, on March 1 – it’s going to take several months before 5010
catches up, particularly knowing that the level of testing today is so low. It
was reported, in some cases, only 4 percent of their trading partners have
tested by now, and we’re talking about June, so it’s six months ahead.

So what’s going to happen? Two things we mentioned, and we didn’t highlight
in this presentation, but we mentioned in the letter. Number one was, the
recommendation that the industry should not be absolutely strict with every
single rule in the transaction; that there is going to be situations where
minor errors could happen with 5010, and that they should not be rejecting
outbound any transaction that had minor errors, that they should work as part
of their business continuation plan to process those transactions and then work
with the submitters to try to fix those minor errors.

So that’s one aspect. But there is going to be 4010 messages and certainly,
there’s two possibilities – one, the health plan that receives a claim on
4010 processes the claim and not complain; that’s one possibility that will
probably happen. The other one is the claim gets rejected and the provider will
have to work with someone that can take that 4010 and convert it into 5010, and
that’s a clearinghouse, and then send the 5010 back to the health plan.

So the idea was to ensure that the compliance with 5010 would not, in any
way at all, affect access to care, affect the delivery of care services, and
affect the quality of care, but that the industry needed to be flexible to
doing this, initial months of the transition, to accommodate for some minor

But there’s no definition of what that contingency plan means; again, we
don’t call it that way, the business continuation plan, but every organization
will need to develop a business continuation plan that deals with if I get a
5010 clean, fine; if I get a 5010 with some errors what am I going to do; if I
get a 5010 with some fatal errors what am I going to do, and if I get a 4010,
what am I going to do?

DR. CARR: But what if you submit a 5010 and your partner can’t accept it?
Because that’s – let’s say, for providers, if they –

DR. SUAREZ: We asked that question to the representatives from the Medicaid
agencies. Basically, they have a step up, step down kind of concept, where if
they are going to receive a 5010, then someone, a vendor, will have to step it
down to 4010 to give it to the health plan that cannot receive 5010, but 4010.
So they will need to do that translation service, basically, as part of their
services. But the provider is complying by sending a 5010 and the clearinghouse
can take the 5010 and move it down to a 4010 and send it to the payor.

DR. CARR: But the protection for the, let’s say small, providers that can’t
get paid, I don’t see any requirements to do that, that you process – in
other words, if somebody submits a 5010 and they can’t accept it, we’re saying
that they ought to do something about it –

MS. REED: Hi, I’m Elizabeth Reed, and I work for CMS, Division of State
Systems, and I’m responsible for the oversight for the 5010, D.0 and 3.0, and
ICD-10 implementation. There are a handful of states who are having trouble
being compliant by the deadline, and we are working on the risk mitigation
plans. As Walter mentioned, there is a step up-step down approach that we are
recommending. We have several meetings coming up with those states, where we’re
trying to come up with a practical solution for that. Bottom line is that they
have to be compliant from the payor perspective.

But I also want to mention that there is a huge concern for the states who
are ready, about provider readiness, and there are discussions about accepting
both versions of transactions, so that the payments to providers won’t be
interrupted, and they’re looking at thresholds – they’re saying it’s
greater than 10 percent of their providers who are not ready. Then there’s a
possibility of them accepting both transactions until they are. So there’s a
lot of discussion going on right now.

DR. WARREN: I would like to add just one comment. All of the testifiers told
us to adhere to the deadlines. And if you go back and look in our history,
those deadlines were set at a hearing that NCVHS held, and we asked the
community, what is the timeline? Because one of the problems we had in
implementing HIPAA in the first place was that the timelines were always pushed
back. So people wouldn’t start working on them until the timeline was there, so
we would push them back, and CMS would push them back again, and so people quit
worrying about the timelines, and they said this time, you must set reasonable
timelines and you must adhere to them. If everybody knows that you’re going to
push them back, then nobody’s going to do anything, testing or otherwise. I
think that’s why you’re seeing a lot of late testers; they were waiting for CMS
to say oh, okay, we’ll push the timeline back. What we’re trying to say is
don’t do that; it ruins the credibility for any other legislation that’s coming

DR. CARR: In no way did I intend to imply that we should change that, but
just to say that given the testimony that we heard, there is a very steep hill
to get everybody compliant, and should there be one or two programs, perhaps,
that don’t make it, do they go under because they couldn’t submit their claims,
or whatever.

I think we’ve answered it sufficiently. We turn to Linda.

MS. KLOSS: Thank you for this excellent distillation of an important
hearing. I wondered what the subcommittee’s plans were for the next event of
tracking this, and if you were planning another hearing, or planning any data
collection, with what the discussion has been around, that and if there is a
next, kind of, milestone, might that be addressed in the close to this letter?

DR. SUAREZ: Yes. We do have plans, and we will be discussing them tomorrow
during the subcommittee meeting. We do have plans to continue to monitor
progression on at least an annual basis. We don’t have a date set for the next
hearing on 5010 and ICD-10, could be June of next year as well, or it could be
sooner, but the next one will be next year, and will be about how we are doing
with implementation of 5010, and then how we are preparing to deal with ICD-10,
or continue to do, as well as how we’re doing with beginning to implement
health plan ID, beginning to implement the operating rules that are coming up.
So it’s going to be a lot more interesting and dynamic.

DR. WARREN: As to your recommendation to put it in the letter, I’m very
reluctant to do that, mainly because the subcommittee has done that in the past
and then had to back away from it. We’ve had to completely redo our plans
because events have overtaken us, and so what I’d rather do is just see that in
a work plan, that we keep going, instead of actually putting it in a letter to
the Secretary.

MS. KLOSS: Thank you. I just thought perhaps that underscored the need for
everyone to keep their eye on the ball, but I understand why you might not want
to lay it out.

DR. HORNBROOK: I think that for us, as the committee, the incentive here,
think about it, is the payors who will switch immediately and enforce it
rigorously, because they can deny a lot of claims and get quite a bit of float;
even though interest rates are low, at least they get a cash flow advantage
from this, and course the physicians will delay until it’s absolutely mandated
that they do it, because they’re not getting any money on it. So that suggests
that we should be looking at this transition period for evidence of huge
amounts of denied claims and for evidence of any changes in practice, because
physicians can’t keep seeing patients, so there’s access problems because they
aren’t getting any money.

DR. SUAREZ: Great point; we do emphasize that a critical aspect of the
transition, is to ensure, and this is a message to the industry as well as to
HHS, to communicate that message to industry, to ensure that nothing in the
transition will affect, basically, the delivery of care, and monitor data,
particularly the first month. There is fear, of course, among providers and
among payors of thousands of claims being received on 4010 and having to be
rejected, or people even reverting back to the dreaded paper world, because
they say well, if you don’t take 4010 I’ll send you paper, how’s that? And then
right now we, in the health plan world, basically transition out from the
thousands of processors on paper to electronic transactions. That’s a very
important – I think the first two or three months of the year are going to
be – I mean the first few days, of course, but the first three months of
the year are going to be very critical, monitoring data. It’s an important

MR. SOONTHORNSIMA: To Mark’s point, I wonder if we should include any sort
of a window with which we would monitor the progress of adoption, because it
can be very expensive to the system overall, not only from an access
standpoint, where the provider stops seeing patients because they can’t afford
to, and health plans can’t continue to have dual systems, per se, to accept
– it’s very, very costly. So I wonder if there’s some way for us to
measure the gaps. Include it in the letter.

DR. SUAREZ: We can bring this up tomorrow morning at the subcommittee to see
if there is something we can say about more specific –

DR. HORNBROOK: Just a quick followup. Is it possible for us to think
strategically, Walter, about the things that the staff support could do for
this committee during this process? Just to put it in your head, to think about
what we could ask from Marjorie for intelligence-gathering from the Department
for us.

MS. DOO: One of the benefits of being on this committee is that I actually
get to know what we’re going to put in the letters and can provide guidance to
CMS, so we, as you can imagine, have not been sitting on our hands about this
issue for any amount of time. So there has been quite a lot of discussion
before the hearings and after the hearings about what our strategy would be in
terms of communication, education, and there has been a lot of communication
with industry to find out are you going to be compliant, if there are going to
be issues, how are the plans reaching out to providers, how are providers
reaching out to their software vendors, how are the software vendors reaching
out to their providers, and making sure that communication is just going on.

We were just in three different meetings last week, talking about this
issue, making sure people understood that the date was not changing, asking
what peoples’ risk mitigation strategies were going to be, making sure they
were thinking through them, so there has been a tremendous amount of work
already, not publicly on the website yet, that’s underway in terms of that,
it’s obviously not the only way, but this direct communication with our
colleagues, some of whom are here but many who may be listening, on this very
issue of we can’t afford to let this slip, we can’t afford to let patient care
slip, and certainly not provider payments slip.

So please do be somewhat assured that to the extent we’re capable, we can’t
go in and fix everybody’s system, but Elizabeth Reed is here; she’s spoken,
she’s working really closely with the states, and we are working really closely
with all of our commercial colleagues. So just at least be assured that we’re
hearing and we are making efforts to do that outreach and to really look at
what’s happening from a testing standpoint.

DR. FOLDY: Particularly for the higher risk providers, has there been any
thought given to trying to use the new infrastructure made available through
the regional extension centers for HIT? They are ONC’s, of course, but they are
specifically targeted at critical access hospitals, smaller practices and lower
income practices.

DR. CARR: You’re saying as a resource for 5010, ICD-10?


DR. SUAREZ: I think that’s a great idea; I think we should consider
including that as a recommendation to HHS, to the Secretary, to consider using
the recently set up regional extension centers to provide education,
particularly for small —

DR. FOLDY: I’ll just add an aside – my understanding is that these
organizations, I’m not sure I understand the details, are expected to become
more and more self-supporting, or at least are not expected to be supported to
the same level by meaningful use dollars over time. So there may be some

DR. SUAREZ: Moving right along – the last letter is a letter related to
the standards and operating rules development and maintenance process, under
HIPAA. So just a very quick – this should take a few minutes only –
just a quick set of background points.

There are certainly a number, a variety of issues with the current process
for developing and maintaining and implementing standards and implementation
specifications. And the Affordable Care Act, that requires operating rules, so
adds to that complexity of the process. So some of the main issues, and this
particular slide is a good summary of all of the largest issues – the time
it takes to develop, modify standards, so from the standard development
process, then time it takes to review and adopt standard from the regulatory
process, the process for considering and adopting changes, not chances but
changes, while standards are in place, lack of predictability in the process,
limited pilot testing of some of the transactions prior to their modification
process and the implementation of the new standard, lack of coordination in the
sequential and concurrent adoption and implementation of standards and
operating rules, limited participation from selected stakeholders, limited
cross-coordination between SDO’s and authoring entities of operating rules,
misconceptions or lack of understanding of the process, difficulty of
navigating requirements for submission of change request – there’s a
variety of issues that have been mentioned and identified in the current
process, and the next slide just highlights the fact that we wanted to get into
that process and see what can be improved and that needs to be changed.

So we held a hearing in April to gain some industry input and stakeholder
insight on the review and update process, and we really heard a lot of this
concept of the issues and some ideas of how we can try to improve the process.

One of the core elements of the process was created back in regulation. In
August 2000 the Secretary named three standard development organizations, SDOs,
and three data content committees to be the so-called designated standard
maintenance organizations, DSMOs, and formed a DMSO group to begin to review
and process any changes, and then report annually to NCVHS on the maintenance

The next slide just shows the regulation that established the creation of

The next slide basically highlights the issues that I just mentioned of the
current process, and so the next slide talks about the observations that we
made. Now just another background – we started this process in April. We
are providing this first letter of observations, but we are really looking at
trying to do the changes and trying to identify concrete changes, so we’re
going to hold another hearing later in November with the industry to define
exactly what are the kinds of changes and improvements in the process that we
can put in place?

You know, some of the general observations that you see here in the slide, I
mentioned before, we have a complex process of standard development
organizations, of data content committees, now operating rule authoring
organizations. All of us have to be members of all of them. It takes time to
develop any of these standards and then test them and then make sure that they
work, and then the regulatory process becomes also another long step. So that’s
why we implemented 4010 seven or eight years after the 4010 was actually
adopted, and we are implementing 5010 even though 5010 had been already –
for three or four years.

There needs to be some clear stated difference between the standards, the
implementation specifications and the operating rules, and the regulations that
we have just published in July help define that, and I think we are going to
find ways to even further clarify the differences and distinguish clearly what
is the standard, what is an implementation specification, what are operating

A few more observations – this is probably to me the most important
one, the first one, that we need to establish – we use all these terms
– dependable, orderly, coordinated, predictable, time-defined process for
adopting new standards, new implementation specs and operating rules. This was
one of the biggest concerns expressed during the testimony, the fact that we
don’t know when the next standard is going to come. We are talking about 5010
starts in January of next year; when is the next standard going to be expected?
It shouldn’t be a guess, or it shouldn’t be that someone sent a memo to someone
that said we should recommend this – and then start the process. It should
be something that should be scheduled, and it should be organized, and the
transitions well-defined.

And the coordination between the various transactions that are going to be
adopting this new standard, and the operating rules associated with those
transactions, need to be also well-coordinated.

Standards, implementation, investigation, and operating rules need to be
tested before adoption. This is another important aspect. We’re already talking
about the next version of 5010, 6020; whether we’re going to recommend that or
hear from the DMSO they recommend that as the next version after 5010, or
whether it will be 6050, who knows? But in any event, those have to be tested
and evaluated and made sure that they do work.

A lot of testing is done with specific elements during the development of
the standard itself, but they become Draft Standards for Trial Use, the DSTUs,
and they need to be tested before they get adopted, that’s the point, I guess.

So funding for this effort needs to be available. We need to formalize the
emergency errata process, so yes, we have 5010 started January first. What if,
in a few months after that, we find some significant errors, or in six months
or a year, there are some changes in the health care reform that’s going to do
changes in how we do business; what if we need to change the standard, do we
need to go through a new standard process, or how to handle emergency
situations, and so we need to define that, technical flaws that need to be
fixed. We have very limited avenue for that.

Next slide talks about the observations specific to the standard maintenance
process, so the current structure of DSMOs and members, plus the authoring
entities – we need to look at that and see whether we need to create a
different structure, what kind of structure we need, what kind of process
improvement we need to make in order to coordinate the maintenance activities
across the standard development organizations and authoring entities of
operating rules.

So we have a number of observations that need to ensure that the work of one
organization receives active input from the other organizations, and needs to
ensure that the changes that have been requested by one organization are
reviewed by all of the other organizations. Some of those are already being

It was interesting that we heard, every year we hear a report from the DSMO,
and they initially reported a lot of; I mean, there were thousands of change
requests over the years. Over the years they have started to kind of
significantly slow down, or be reduced, and a lot of the change requests are
coming directly now to the standards and development organizations rather than
to the DSMO, which is okay. It’s another way to do it. But all those need to
be, then, addressed to whatever new process for maintenance we work and define.

Overall, there needs to be established a transparent and understandable
coordinated process, eliminating duplicative efforts, identifying and resolving
conflicts between the standards and the operating rules, et cetera. So the next
steps – we are going to be working, and will continue to work, with the
DSMO group members, the operating rule authoring entities and industry
stakeholders to: Number one, establish this predicable time-defined process for
adopting new versions of the standard. Number two, develop modification changes
to the current process for processing and resolving change requests to the
existing standards.

Identify opportunities to improve coordination between SDOs and authoring
entities of the operating rules. Help clearly define and delineate the
difference between standards and operating rules, and identify strategies to
improve representation and participation from certain stakeholders across the

So we will be holding a hearing, coming up November 18th, with
SDOs, operating rule entities and other stakeholders, to advance this process
and to come back with recommendations on how to improve them.

This time, this was a letter primarily of observations from that hearing.
Again, in November we’ll have the second hearing, and after that we expect to
have formal recommendations.

DR. CARR: Are there any questions from the committee?

MS. KLOSS: As I read that, I assumed that this discussion applied to code
sets and vocabularies as well as other kinds of standards, is that correct?

DR. SUAREZ: I think it does. Absolutely, yes, it does.

DR. CARR: Additional comments?

MS. LOHSE: Hi, Gwen Lohse from CAQH CORE. One quick comment – as we
think about, and I know we’re far from finalizing this, but as we think about
the cycle with the operating rules and the standards, I just want to figure
out, as we’re moving forward, how to recognize right now, with 4010 and 5010,
for example, in 2006, the operating rules were able to take advantage of some
of the things that weren’t mandated in the standards, like in and out of
network variances, co-pays, year-to-date deductibles. Back to your comment
about how do we get the cost out of the system, get the providers what they

So as we’re thinking of these cycles, it doesn’t mean that the rules and the
standards need to necessarily be concurrent; but they can be at different
cycles that are expected cycles, but potentially not at the same time, so they
roll out at different times to take advantage of the different pieces that are
bringing value to administrative simplification.

I just want us to be thoughtful of that, as to what is the end goal, and do
we need to continue to roll out at the same time, or is there a value to roll
out at different times, so we’re looking at what has the biggest impact, and
then tracking it and then updating, so we’re very much supportive of
contributing to this going on, but I want to just make that quick comment.
Thank you.

DR. CARR: Larry, did you have a comment?

DR. GREEN: I’m not sure it’s a very helpful one, but I wanted to ask a
question – when I read this report, and I hear Blackford and Paul’s
comments about measurement development, it seems to me that there’s a lot of
parallel issues here, about how you establish a standard or a measure, the
process of development, how you get it implemented – am I not paying
attention here, or are we not basically trying to manage change here?
Blackford, help me out here. Tell me to quit thinking about this.

DR. MIDDLETON: No, keep thinking please. I guess – I apologize, I had
to slip out of the room for a moment – but obviously, following along the
administrative simplification and HIPAA sort of provisions and extending and
enhancing standards used for transactions obviously – critical, the
measurement issue, I think, applies across the board, whether it’s in a
transaction framework or a quality assessment framework, there certainly will
be common themes across both. But Larry, I’m missing, sort of, maybe the core
of your question. Is there quality assessment to be done in transactions?

DR. WARREN: Some of your work, Larry, there’s some work going on right now
within the ANA, to begin to look at the issue of where do evidence-based
protocols march up with quality indicators, and how do we generate the quality
indicator data out of data that has been documented in the patient care. So
quality indicator should be a byproduct of care delivery.

What we’re beginning to look at is where that fits in the standards. So
right now, we have an initiative going on, in fact Walter’s part of that at HL7
of creating clinical domain models that will then be referenced back to the REM
at HL7, also binding terminology to each of the data elements in that domain
model, et cetera, so when we’re done, you should have a package that is HL7
compliant, is also compliant with the quality model, because we’re also being
sure that we meet with that.

So one of the things we’re hoping to learn is, what are all the steps that
need to happen from at the patient bedside to the end, before you get that
quality indicator coming out? So it pushes up against some of the stuff in that
some of the claims data is also going to be coming out of patient care
interactions, whether it’s the admissions, so looking at admissions, transfers
and discharge data sets, things like that, and I think that’s where Paul was
looking at and why I got excited about him is, let’s start looking at this for
much more than health surveys; let’s look at it throughout the whole workflow
of health care delivery. So I think that’s where the match is.

DR. CARR: I heard something. I was thinking along those same lines, but a
little bit differently, going back to what Linda was saying, when we talked
about wholesale changes that we’ve done and things that we’ve learned, we look
at ICD-10 coming up as a wholesale change, that we ought to have a way, at a
high level, of understanding change, change management and processes around
that measurement and assessment of, are we getting what we thought we were
going to get, and are we creating any unintended consequences with that? Linda,
then Walter.

MS. KLOSS: Just a follow-up comment to my earlier question about code sets
and vocabularies – several years ago, AHIMA and AMIA had a joint task
force to look at the issue of maintenance of code sets and vocabularies, given
the experience of what it’s taken to get us to ICD-10 and the opportunity,
going forward, of using web and other kinds of tools to expedite the update of
these kinds of very complex, living standards, like vocabularies and

So I would think that when this hearing in November – we might carve
out a piece to talk about that issue, because I think it is slightly different
than the dismal, where a new version of a standard is promulgated, but the kind
of maintenance rigor over time is perhaps a little different.

The other thing – a couple of years ago I had the opportunity to be
part of a hearing, and it was health policy-related, but it was speaking about
best practices in the regulatory, modernization of the regulatory process, and
I think that there are certainly some names of researchers that have done some
good work there, and it might be useful to bring that perspective into the
hearing, so that we aren’t continuing to roll forward and find a way to tweak
things that perhaps are so badly broken that we need to look at a restart.

DR. CHANDERRAJ: I think there’s so many things being imposed on the
practicing physician and the providers, especially generating this data,
old-time physicians are not in the habit of attending to these details. They’re
practicing medicine in the best interests that they know, that they’ve been
trained. Some of these things, I think should be a core curriculum in the
teaching programs of medical students, to become aware of these facts, that the
data that’s been collected should be generating quality data as well. I think
once they become tuned into that, then it will be practical, but I think to
impose all this on these existing physicians is a mindset alteration for them
and they don’t know how to deal with them, and they’re dropping Medicare
patients and not dealing with this kind of quality issues.

DR. SUAREZ: Just a comment, I guess, thinking of 50 years of HIPAA, I’m now
beginning to reflect a lot more about this. I think it will come in time where
this concept of a claim will be quite different, and these administrative
processes, and these transactions, because at the end, if we’re going to be
paying for quality on a population base, or paying for not an encounter fee for
service kind of approach, we’re going to have to deal with a lot more clinical
content data than the simple administrative numbers that go on a bill. So I
think that is where, in the future, I see the convergence between the clinical
world that we’re dealing with under meaningful use and maybe that’s where Larry
was trying to go to, is really that convergence of saying we have to send a
referral abstract of the patient record for a referral, we have to send a
claim, which is a completely different system. The two sometimes don’t talk
inside the organization, and if they talk then I have to translate from SNOMED
into ICD and back and forth. It’s going to come the time where I think we’re
going to see a convergence of the two large systems, administrative and
clinical, and we’re going to be able to say, it is now integrated to do
clinical care, to do quality measurement and patient safety, to do
administrative functions and to fulfill all these requirements. That’s my hope
at some point, Version 7010.

DR. CARR: Mark, do you have a comment, and Larry?

DR. HORNBROOK: One of the things that I was thinking about was that we have
this tripartite data flow, hospital claims, professional claims and drug
claims, and they don’t intermingle very well. One of the things we should be
thinking about, perhaps, is can this committee talk about prescribing by
indication, so that every drug claim has a diagnosis on it that a physician
puts to that drug as to why they are ordering that drug. Can we talk about how
that changes the data flows, how it opens opportunities for better quality and
for better clinical management, and also for integration of drugs inside the
health care system, because people are using multiple pharmacies and not
keeping their drugs all in the same place. It seems to me like that’s what the
committee ought to be focusing on more and as much as we need to do this
detail, it seems like it’s slowing us down.

DR. GREEN: Aren’t we seeing, again, that we’re missing something? Whether
it’s for a plan identifier or it’s for a 5010 transaction, we simply don’t have
a system in place in the country to execute this type of maneuver. We don’t
know the state of the – we don’t know if people are going to be able to
execute this thing on January first; we don’t know whether it’s going to lead
to denials of claims and making money off the flow, we don’t know, we don’t
have a clue, really, about where the system is about this, and the system
that’s trying to get this done could use a little help. It’s one thing to
adhere to the deadline and make the recommendations, but – so anyway, what
I want to do is I want to connect dots that perhaps should not be connected,
but once again, what standards is working on here reveals, again, I believe, a
need for a new type of infrastructure, for what quality is working on, and what
populations is working on, for sure.

There’s just something missing here. There’s an empty space that’s not
occupied to help us accomplish our goals.

DR. WARREN: I’d like to respond to that, because it’s been a concern that
I’ve had. One, with the passage of AHQA, our subcommittee has been given a
charge by Congress with incredibly fast time lines that we have to meet, and we
have been running at full pace. With that, we have not been able to sit back
and do the kind of reflection and thinking that you’re talking about, about
what is the state of standards, operating rules, infrastructure to manage all
those that we need to have, and I agree, I think there needs to be a place
where we can kind of elevate ourselves and talk about that.

Right now it’s not going to be in the standards subcommittee. We are going
to be – we have our marching orders straight out because of – we’ve
been given to work on our timelines, but I do think it’s really important,
Larry, and I don’t want us to forget about it, because I think that’s where
NCVHS can make a difference.

DR. CARR: I think we’re all on the same page, which prompted me to continue
to resurrect our overarching view, so I handed out yet another version of our
work plan that we began last year; was it this time last year, when we had the
first part of our retreat, yes, September 2010, and we were going to identify
focus and themes for the next 18 to 24 months to align with our charter, the
national priorities, emerging issues in health and health care, resources and
time frames of committee members and meeting –. And invite feedback from
partner agencies.

If you look through the slides, there’s a slide – I wanted to hand this
out, to look at this today. So maybe the next slide, just our charter, that
talks about our scope of activities and our focus, and I think it gets a bit to
what Mark was saying too; sometimes we have to be in the weeds with our
standards things, but we also need to be remembering that we’re advising on
strategy on health data, statistics, privacy, et cetera. If you go to the next
two slides, again, reminding ourselves how important this shaping a health
statistics vision for the 21st Century is, tying in tremendously
with the work that you’ve been doing on the community data initiative, and
actually tying in with some of the things that Jim mentioned today, again
– next slide is again, the provider, the personal and the population
health dimension, keeping all three of them in mind.

And then the next slide, which it’s been a while since I put this out, and
it’s not quite right, but I think, borrowing that methodology, I think we put
this together a year ago June, when we began talking about a learning health
system, information on health and health care, and all that feeds into that,
and our data stewardship, health data stewardship role, that has gone
throughout, where we talk about data integrity, data standards, data analysis,
workforce and competency, research, as well as privacy, security, ethical use
and education. I just keep coming back to this, because these threads traverse
all of our discussions, and I think it’s a good – it’s important for us to
stay at the 15 thousand foot level, which leverages the expertise of this
committee. Each of us has some particular unique expertise, but there’s one of
us, maybe two of us, whereas as a whole, we have the collective overview of a
universe of things.

The next slide is one that I took with permission from Chuck Friedman. Again
same idea, learning health system for the US and focusing on the outcomes of
that IOM committee. We’re talking about governance, patient engagement, trust,
aggregation, analysis and dissemination, and these themes – Chuck asked us
on multiple occasions to think about how we integrate with the themes that came
out of that, and I’ve heard all of these, actually, mentioned today at some

Then, next slide, when you wonder why we’re in the weeds and you think about
all of the mandates that have been given to us from Congress, what choice do we
have? It’s detailed content, and I think that Walter and Judy have done a
fantastic job in educating everyone on the committee so that we’re aware of it,
and I think it’s impressive when you see how much output there’s been from
standards and we’ll continue to have that role.

Then I put together, for purposes of the subcommittee meetings, the detail
on the HHS goals. I’ll observe that they changed from our last version of
goals, but that’s okay – and they in fact had changed from the previous
version, but that’s all right. We have our goals now, and the details. So when
we look at the detail, some of these are tied to what we’re doing, some maybe
not so much. But we ought to be looking at those and lining up – we are
doing this and it ties to our Secretary’s goals.

And so this is just a little worksheet for you to choose which are these
things that we’re working on, and what are the actions. I know that there is so
much out there that we could be working on, but I think we do our best work
when we have a thematic harmonization, very much, again – I think the two
things that have predominated here are the community data initiative and
standards, and I think that the input on privacy and now what quality is
talking about as well.

And then these are the domains Jim provided us this morning – the
domains to monitor health reform; these are the domains where they’re coming up
with measures, and actually, Blackford, I have some detail on that as well, if
Quality wants to look at that. But access to care, cost and affordability
coverage, quality, vulnerable populations, workforce innovation and population
health prevention and HIT.

So I leave you with these just to ensure that as we map out the work that we
are doing and where we’re headed, that we keep this in mind, keep this charter,
this view and altitude in mind, and then tomorrow, we’ll meet back and give our
report out. Let’s think about how these tie out together. Walter.

DR. SUAREZ: Thank you for this – just a comment. I’ve been hearing all
day today how population health and privacy, working on this community health
information initiative, or project, and the standards, working on the world
that we work, which is very down into the nitty-gritty of things, and trying to
balance – I was trying to do a transition between listening to this
incredible report on CHIP, the project, and talking about HIPAA’s 10th
anniversary, and it’s hard.

But the reality is, number one, we’re not the only show in town. I know you
all know. Really, there is a health IT standards committee that is – we
are a subcommittee of standards of the National Committee. There’s a separate
thing called the HIT Standards Committee, and they work on the standards. There
is the HIT Policy Committee that defines the overall policy on information
technology, pretty much, in this country, and ONC just published the Strategic
Plan on Health Information Technology – all this larger amount of work
that is being done, and so clearly, we have some space that we filled because
of mandates, that we’re responsible for, and we do have to deal with those, but
we haven’t had a chance to step back, necessarily, as a full committee, and now
that we have full membership on the committee, maybe it’s an opportunity to
step back and look at this space that we are in and try to revisit exactly

So we do know that we have a mandate to do this HIPAA stuff and yes, we’ll
be able to do it, but really, put the context around all the things that are
happening, all the actors that are playing and where we fit. I think it’s going
to be challenging to try to adjust the HIPAA Report to Congress to meet some of
the overarching goals of the other committees, when they’re into different

DR. CARR: I’m not sure I agree because I think we’ve heard repeatedly the
importance of standards, and the data integrity, the utility of the data, all
of that depends upon data standards. So you’re talking about administrative

DR. SUAREZ: Yes, but data standards dealing with electronic health record is
not our space.

DR. CARR: But we’re about a lot more than electronic health records, and I
think that’s one of the important things, when we think about learning health
systems and all that goes into it, all of the contributions that are emerging
from the digital world, whether from devices or from surveys or liberating the
data, and I think that’s a good point, that we need to recognize that ONC has
their very clear mandates with regard to electronic health records, but our
traditional NCVHS role has been about population health and a much bigger
picture. I’m trying to keep us at that level, because we don’t want to
duplicate work that’s already being done.

So going back to this slide, when I did this, I was doing it on quality;
when I was the Quality Co-Chair, and trying to say what are the data sources,
where does it come from, who are the workgroups, and so on. I think that that’s
an important activity to understand who else is working in this space. But I
think that we have an important role. So we heard today also that governance of
NHIN is something ONC is doing, but what about there’s more beyond NHIN in
governance and thinking about those issues.

I agree with what all have said, but we need to be able to participate in
broader conversations, like what Mark was saying too, about in addition to the
detail, what about the big picture?

So this is just a starting point; it’s just something we can continue to
work on, and help us get to the right focus, where we do our best work.

I think with that, we will adjourn the Full Committee, welcome back our
travelers from Hyattsville, maybe take a five minute break and move into the
Populations and Privacy Committee.

(Whereupon, the Full Committee adjourned.)