[This transcript is unedited]

Department of Health and Human Services

National Committee on Vital and Health Statistics

November 16, 2005

Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, D.C. 20201

Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway, suite 180
Fairfax, Virginia 22030
(703) 352-0091


P R O C E E D I N G S [9:05 a.m.]

Agenda Item: Call to Order, Welcome and Introductions, Review of Agenda – Dr. Cohn

DR. COHN: Well good morning everyone, I want to call this meeting to order,
this is the first day of two days of meeting of the National Committee on Vital
and Health Statistics, the national committee is the public advisory committee
to the U.S. Department of Health and Human Services on national health
information policy. I’m Simon Cohn, I’m an associate executive director for
health information policy for Kaiser Permanente and chair of the committee. I
want to welcome fellow committee members, HHS staff, and others here in person
and of course also welcome those listening in on the internet. And as always I
want to remind everyone to speak clearly and into the microphone because we
know the acoustics in this room.

Let’s now have introductions around the table and then around the room. For
those on the national committee I would ask if you have any conflicts of
interest related to any issues coming before us today would you so publicly
indicate during your introduction. I want to begin by observing that I have no
conflicts of interest for any of the items today. Jim?

MR. SCANLON: Thank you, Simon, good morning everyone, I’m Jim Scanlon, I’m
with the HHS Office of Planning and Evaluation and I’m the executive staff
director for the full committee.

MR. ROTHSTEIN: Mark Rothstein from the University of Louisville School of
Medicine, member of the committee, and I have no conflicts.

MR. BLAIR: Jeff Blair, Medical Records Institute, and I’m not aware of any

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention,
liaison to the full committee.

DR. HUFF: Stan Huff with Intermountain Health Care and University of Utah
in Salt Lake City, member of the committee and not aware of any conflicts for
today’s discussion.

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

MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, member
of the committee.

DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center, member of the
committee, no conflicts.

MS. MCCALL: Carol McCall, Humana, member of the full committee, no

MS. MCANDREW: Sue McAndrew, Office for Civil Rights, liaison to the Privacy
and Confidentiality Subcommittee.

MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services,
liaison to the full committee.

MR. LOCALIO: Russell Localio, University of Pennsylvania School of
Medicine, I’m a member of the committee, I have no conflicts.

DR. VIGILANTE: Kevin Vigilante, Booz-Allen & Hamilton, no conflicts.

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

MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield North Carolina,
member of the committee, no conflicts.

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

DR. WARREN: Judith Warren, University of Kansas School of Nursing, member
of the committee, no conflicts.

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics,
CDC, and executive secretary to the committee.

MS. SQUIRE: Marietta Squire, NCHS, staff to the committee.

MS. SIDNEY(?): Cynthia Sidney, NCHS, staff to the committee.

DR. BICKFORD: Carol Bickford, American Nurses Association.

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

MR. ALFANO(?): Bill Alfano, Blue Cross and Blue Shield Association.

MS. BOYD: Lynn Boyd, College of America Pathologists.

MR. BRUCKLE(?): Mark Bruckle, Academy of Managed Care Pharmacy.

MS. GOVAN-JENKINS: Wanda Govan-Jenkins, NCHS, CDC.

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

MS. PICKETT: Donna Pickett, NCHS, CDC, and staff to the Standards and
Security Subcommittee.

MS. FRIEDMAN: Maria Friedman, CMS, lead staff to the Subcommittee on
Standards and Security.

MR. DICKMAN(?): Barry Dickman, Department of Veteran Affairs, HIPAA Program
Management Office.

DR. KILE: Frank Kile, American Dental Association.

MS. WILLIAMSON: Michelle Williamson, CDC, NCHS.

DR. COHN: Well welcome everyone and I guess we’re getting close to happy
holidays because we’re moving to mid-November though I’m obviously delighted at
least for this moment the weather in Washington seems to be very pleasant and
almost balmy, though I hear by the time we leave this afternoon we may notice a
slightly different weather pattern coming through. Now I guess I have to remind
everyone please put your cell phones on mute or stun or however that works best
for you.

Now before we do agenda review I do want to make a couple of comments and
sort of help set the stage for the discussions for today and tomorrow. I think
for all of us this continues to be an interesting and exciting time and
certainly the pace of events in our area, national health information policy,
continues to accelerate. Indeed I am describing this sort of publicly is what I
describe as living in an accelerated environment and all the things that we’ve
talked about over the last couple of years are suddenly really beginning to
come to pass. In a little over the two months since our last meeting of the
full committee I think much has happened and I’ll just sort of run through them
and probably talk about them for a second knowing some of them we will be
talking about more during the deliberations of the day.

First of course is Secretary Leavitt’s 500 day plan which includes as all of
you know as a centerpiece the next phase of the HHS/HIT strategy. This is
continuing to unfold, obviously what we’re talking about here is an
acceleration of activities and efforts to move health care into the information
age and transform the health care system. This is the vision we foresaw when we
wrote our document information for health in 2001 which we laid out a strategic
vision and having reviewed that recently it’s very interesting that while
things aren’t happening exactly as we suggested most of the elements are
actually coming into play so I think we can congratulate ourselves on some of
our vision as well as obviously congratulate the department on moving forward
in this very important area.

The executive subcommittee, Jim and Marjorie, has been working with me on
how we can best support and assist the secretary and the department going
forward in this accelerated environment. And as I’ve commented before obviously
because of our content expertise and experience we do have a lot to contribute
going forward. In addition of course we have a reputation for a strategic focus
and also being practical, which is something I think that is well appreciated
by the department. We have had ongoing discussions with HHS leadership on how
we can best make a contributions and these conversations continue. I did
however one to share with you a statement made by Secretary Leavitt at the
first meeting of America’s Health Information Community on October
7th, I know Jim shared this with some of the subcommittees but let
me just quote a couple of sentences from his introductory comments, and I quote
from Secretary Leavitt, we will use the depth, expertise, reach, and experience
of other people and organizations that are critical to our success. The
National Committee on Vital and Health Statistics has significant expertise and
more then 50 years experience as a public advisory body. I am pleased to say
the NCVHS chair has expressed to me NCVHS’s support and engagement, we will
invite NCVHS to be actively engaged in our work. So we obviously we appreciate
the comments from Secretary Leavitt and obviously we step forward to be
actively engaged in helping anyway we can.

I believe it is safe to say that we will be playing an important role in
helping to assure the success of the Secretary’s new HIT strategy and
initiatives. And certainly this will be a topic as we hear from Dr. Brailer
later on today about ONCHIT and all the new initiatives and contracts that
they’ve awarded over the last couple of months. So that’s item one out of a
number of items. Item two is e-prescribing and the final rule. Now I know Karen
Trudel is going to be discussing this but I obviously wanted to first of all
congratulate CMS on having completed the final rule and published it, so
congratulations. We also wanted to thank HHS and CMS for including so many of
the NCVHS recommendations in that final rule and being a prolific reader of
final rules these days, all 165 pages of that one, I did want to point out that
the NCVHS is being asked to provide ongoing advice and guidance to HHS related
to versioning and maintenance updates of this suite of standards and it sounds
like much the same sort of pattern as we’ve done with HIPAA. So I obviously
want to thank the government, the federal government, for their faith in us.

Item three is the claims attachment standard, we’ll be talking about that,
that’s a Notice of Proposed Rule but we get another thing that’s out now that
we have to deal with.

Finally is the Commission on Systemic Interoperability that released its
report and its recommendations three weeks ago. This federal commission was
charged with taking a fresh look about how to accelerated progress towards an
interoperable future. I was honored to have been a member of that though not
with my being the chair of NCVHS but a representative from a private entity. We
were pleased that CSI in their recommendations specifically named the NCVHS, in
particular those recommendations related to data standards and it did request
that NCVHS collaborate with AHIC to ensure acceptance and use of a set of
interoperable non-overlapping data standards.

While I will not be reviewing these recommendations in any detail with the
committee today, I think we’ve had a presentation with Scott Wallace
previously, I know Marjorie had sent around the website for this. I will
however knowing how busy we all are make sure that we package the executive
summary and the recommendations and we’ll send them out as an email so you can
all review. I think it’s important probably that subcommittees and workgroups
review these only because some of them may impact or provide you additional
thoughts for what your 2006 work plan potentially should involve, and so we’ll
sort of do that after the meeting for at least your review and thoughts.

All in all as I commented there’s a lot going on related to national health
information policy. This is an exciting and fast moving time and I want to
acknowledge all of you for your hard work and vision in helping make all of
this a reality so thank you.

Now let me shift gears. Obviously while this is going to be somewhat old
news because we’ve publicly announced this in September, sent this person a
letter, mentioned it on executive subcommittee calls, we haven’t seen him since
all of this happened. So since we’re actually seeing him today I wanted to take
a moment and congratulate Jim Scanlon, our director, for his well deserved
promotion at HHS. He was previously acting deputy assistant secretary for
science and data policy in ASPE and he’s now the deputy assistant, got rid of
the acting, deputy assistant secretary for science and data policy. We’re
obviously delighted about the promotion and Jim since we’re seeing you here in
person congratulations.


MR. SCANLON: I think I set a record for longevity in that acting position
and I hear that I’ve been nominated for thespian —

DR. COHN: Congratulations. I also want to thank the full committee for all
of your comments and suggestions at the end of our last full committee meeting
in terms of meeting planning. I think many of those suggestions were taken to
heart by myself and by the executive committee as we planned out the meeting
today. We will obviously continue to fine tune this and this will be sort of an
ongoing conversations likely at the end of each of our meetings about how we
can make the meetings more useful and helpful. But I’m hoping that all of you
will feel that we will at this meeting have considerably more time for
discussion and reaction about the topics and issues that are coming before us.

Now the other thing that sort of came out of that meeting was I think a
discussion about what I described as strategic planning. Based on your input we
are at least discussing the possibility of a full committee strategic planning
session attached to one of our full committee meetings in 2006. I’m not
formally announcing it at this point but I think it will be an ongoing part of
conversation about how we can do this in a way that is useful and successful.

Well with all of that background let’s talk about the agenda for a minute.
This morning we begin with an update from the department, we start with Jim
Scanlon, our executive director, followed by Karen Trudel, thank you for
joining us, and Susan McAndrew from the Office of Civil Rights. After the break
we’ll be talking about the health claims Notice of Proposed Rule Making, as
this is an open comment period we’ll be reviewing a draft letter that the
Subcommittee on Standards and Security is bringing forward in relationship to
that. Late this morning we are pleased to have David Brailer join us for an
update on the many new initiatives and contracts underway, sort of once again
an exciting time.

After lunch we’ll be beginning to discuss a couple of issues, we start off
with Mark Rothstein, we’ll be discussing the status of work underway by the
Subcommittee on Privacy and Confidentiality relating to privacy and the
National Health Information Network. This will be followed by once again a
presentation and discussion being led by Stan Huff relating to hearings being
undertaken by the Subcommittee on Standards and Security on secondary uses of
clinical data.

Now from there we will break up into subcommittees and workgroups for the
remainder of the afternoon and we’ll talk about that potentially in the
afternoon about where we’ll be going, what the various meetings are as well as
the starting time tomorrow which is actually at least to my knowledge unchanged
from your current schedule for a change of pace here.

Oh, I did want to before I finish here mention at 6:30 there’s a dinner for
the full committee and staff and I guess we’ll be identifying people, getting a
number after lunch.

Well with that, Jim about if I turn it over to you and thank you.

Agenda Item: Update from the Department – Mr.

MR. SCANLON: Thanks very much, Simon, and good morning everyone. As Simon
indicated a number of developments have taken place, progress continues to be
made on health information technology and policy here at HHS and I think it’s
fair to say that we’re now seeing the fruit of many of the collaborative
relationship between NCVHS and the department over a number of years, many of
the ideas that you now see manifested in contracts and in structures and in
directions you’ll remember had their nucleus in many cases in the discussions
here at NCVHS and I hope the collaboration will continue forward as well.

As Simon indicated the AHIC, the American Health Information Community, had
its inaugural meeting on October 7th, I think we’ll get a report
from David later today. The focus there was pretty much as an initial meeting
always is on kind of getting organized, but then they began to turn their
attention to what are possibilities for fairly quick progress use cases and
applications. And I think they have another meeting scheduled late in November,
the 29th I believe it is, and I think hopefully some progress will
be made in those areas where what is the committees, what the community’s
desire in terms of moving forward. There’s no meeting I think scheduled in
December and then I think there’s working on a meeting in mid-January.

Aside from that there are a number of activities that Karen and Susan and
David will describe later today. Again not only e-prescribing and some of the
HIPAA progress but also on the FDA side you’ll remember a number of initiatives
at FDA aimed at, and many of them again coming out of the committee’s
recommendations, aimed at bringing the benefits of interoperable health
information technology to that world as well. You remember seeing the bar
coding, the proposal for bar coding that would incorporate standards. There are
some other initiatives that will be coming forward again from FDA that will
support Rx-Norm and Daily Med and it’s kind of bringing all of these various
strands of health information technology potential together across a lot of
department’s programs. Mike?

DR. FITZMAURICE: Jim I wonder if I could add to what you reported, I’m going
to be leaving today about 11:00, 11:30, to go to a celebration at FDA, they
have just had the first structured product label come in from a manufacturer,
be approved by FDA, and then put up on NLMs Daily Med website.


DR. FITZMAURICE: This is the start of the pipeline for getting all of those
little package inserts up on a website where people can read them, it’s also a
place where knowledge vendors can go and form a common base with all the other
knowledge vendors and add their value to it and resell it to electronic health
record systems and others. This is quite a momentous achievement, could not
have been done without the expertise of NLM and FDA and many others, and the
financial support of AHRQ, that came from NCVHS, it came from recommendations
by the Institute of Medicine, and many policy committees within HHS and our
partners at VA and DOD. It’s truly as Jim said a collaborative effort
spearheaded around NCVHS’s recommendations that the department do something and
AHRQ working in collaboration with ASPE and Jim were able to make it happen. A
lot of kudos for NCVHS. Thank you for your support.

MR. SCANLON: Let’s see, let me turn to just for some contextual information
the budget world. As you know we’re, this is sort of what supports all of our
activities, we’re now in fiscal year ’06, HHS like many other federal agencies
is still operating on a continuing resolution, I think it’s taking us through
December and it more or less sets spending at the level of last year, a little
bit, so we hope to have a regular budget sometime later. HHS is quite
accustomed to this situation, we often have a later appropriation, but again
we’re hoping that some of the HIT initiatives, the standards efforts and others
that we, and some other population statistics efforts that we worked for and
got into the President’s budget will find their way in the actual appropriate
that’s enacted by Congress as well.

Let me say a little bit now about the population statistics area, within our
Data Council we have been working on data improvement and enhancement
initiatives in five areas and again these are for the most part budget neutral,
they are meant to try to find ways of improving and enhancing the data,
collection of data analysis and the data availability in several areas that are
of particular interest to the policy community, let me just briefly run through
those areas. The first is in prescription drug utilization and expenditure
data, this is both for program purposes and for policy utility as well. We have
a number of enhancements underway, now that we’ll have the Part D Medicare
Benefit beginning in January much of this will support that. All of you who are
eligible for Medicare I hope you’ve gone to the CMS website to look at your
options for Medicare Part D as of yesterday.

The second area is health insurance data, we’ve had a lot of interest,
actually it’s more health and insurance seems to be the interest. As you know
from our statistical systems we have estimates of the number of uninsured
population in the United States, this of course is the other side of the coin
of the population that does have insurance and what the nature of the coverage
is. And our surveys tend to produce somewhat differing estimates of the size of
the, and the relative size of the uninsured population so the Data Council and
ASPE working with several of our agencies is trying to shed some light on why
do they differ, what are the assumptions, are there artifacts that produce this
difference. Interestingly the two surveys within HHS are reasonably close but
the Census Bureau surveys, there are two of them, they’re quite different at
two extremes. So Census Bureau, the population, the current population survey,
tends to produce the highest estimate of the number of uninsured. At any rate
we’re trying to work on why is that so, what are the correlates, what is this
related to and so on.

A third area is really the state and to some extent the sub-state area and
there are some efforts here looking at state data on health care access,
utilization, health insurance coverage, so policy related data at the state and
the sub-state level.

A fourth area deals with improving income information and associated
information in our major statistical surveys. Again, the interest here is not
pure data but data for policy purposes and we have a couple of activities
there, in fact we’re looking at, we held a workshop, federal workshop, about a
month and a half ago where we pulled in all of the agencies that produce, that
collect this kind of information on their surveys and as well as some of the
policy community folks and tried to look at how we’re measuring this, why are
we differing. And we’ll probably be doing an evaluation in the year ahead that
looks at this more systematically and some ways of improving.

And finally but certainly not least we have again within the context of
budget neutrality we have a race and ethnicity data improvement initiative
underway under the Data Council’s auspices. The Council is looking at ways that
we can get better use out of our current resources, how we can draw more
attention to getting the data analyzed and organizing the data a bit better on
race ethnicity related to health and human services. And we’re looking at some
web based approaches, we’re also looking at possibly some workshops in the year
ahead where we can bring together the major HHS data producing agencies with
the analysts and see if there are ways we could increase their interest and
their ability to analyze the data. We can’t really do it all here as you know
in HHS.

We’ve also started a study that kind of combines the data standards area
with our statistical systems area. We’ve initiated a study of data standards,
again these are more content standards, not message format standards, code
sets, data item standards and so on in our major HHS statistical systems. And
we’ve identified sort of three phases I think the committee could help us here
as well, the first stage will be just to pull together in one place the various
code sets, standards, content oriented standards in the health area that are
existing. And this would be looking at CHI standards, HIPAA standards, there
are a number of statistical policy standards, for example the race ethnicity
standardized data item measurement is a statistical standard. There are
standards for classifying industries and occupations and so on, so we’re going
to be looking at what are the extent standards currently in some formal or
informal a set of adoption, what are people working on, that’s the first
compilation —

MR. BLAIR: Does that so include identifier standards like NPI?

MR. SCANLON: Well these are statistical systems so I’m not sure, we’ll
probably to look at to what extent they would be applicable but in the
statistical systems to be honest there’s virtually no interest in individual
identity other then for the initial data collection and then for matching —

MS. MCCALL: I’m sorry, I missed the question, can you repeat the question?

MR. BLAIR: My question was whether the evaluation included identifiers, for
example the National Provider Identifier.

MR. SCANLON: That’s probably not going to be in initially but I think we
would at least include those in the focus. I could see down the road where the
National Provider system for example, the data system itself, could be very
applicable to our surveys, particularly our provider based surveys. But the
initial focus will be on content code set standards, ICD, CPT, you know the
alphabet as well as I do, that will be the first look. But the second look —

MS. MCCALL: The question that I would have is in addition to code set
standards will there also be work on standard, I guess we’ll call it
classification of taxonomy systems, so how to group them so that you get the
same answer.

MR. SCANLON: Well yeah, the whole idea of statistical classification systems
is, and there’s a long history actually on the statistical side as you know to
help do this, on the economic side, and yes, those will be parts. We actually
have, they’re not all that well known but within the federal statistical
community there are a number of statistical policy standards, they are
classifications just like that and theoretically agencies are supposed to be
using them when they collect that kind of data, so those clearly will be there.
We’re also, we have a contractor to help us here and we’ve asked them not only
to look at the formally adopted standards but are there almost best practices,
conventions, that people say well yeah, if you’re going to do that then this is
the way you should do it.

MS. MCCALL: Will those be published as well?

MR. SCANLON: I think so, yeah, we’ll put together a compilation with all the
references and source documents, but secondly, that’s the first stage, the
second stage would be to look at maybe our major statistical workhorse kinds of
systems possibly up to two dozen, this would include the family of health care
provider surveys, emergency departments, doctor’s offices, hospital discharge
data. It will include the Health Interview Survey, the MEPS(?), the Medicare
current beneficiary survey, the mental health and substance abuse surveys, so
we’ll be looking at those in terms of what standards are they employing now, I
certainly hope they’re using the race ethnicity standards, that’s already been
adopted as policy, but to what extent are they employing some of the other
standards as well. And then based on that to look at some directions for future
work, this would be sort of benefits cost potential, what are the benefits,
what are the limitations, what’s the applicability, and there’s always cost as
you know associated with these things and to kind of give us some ideas for
moving along.

So I think we’d like to, I’ve asked the Data Council to kind of serve as our
internal brain trust on this issue and I would like to bring this to the NCVHS
when we move a little further along to get some feedback as well.

And then finally on the privacy side and again combining privacy and
statistics we’ve employed a consultant to begin to pull together kind of in a
monograph form the current authorities in policies and practices for
statistical confidentiality in our research and data systems. So this would
include the statutory authorities of the National Center for Health Statistics
for AHRQ, for SAMSA has some as well, and then other practices and policies
related to data sharing as well, so that we hope to begin. Much of this
information as you know is known but it’s not really been pulled together in
kind of one overall monograph as a reference and I think we’re asking, we’re
going to have that project as well.

So let me stop there and see if there are any questions.

DR. COHN: I think there’s probably a variety of questions. John Paul and

MR. HOUSTON: The last comment that Jim made, when you were talking about
confidentiality were you also looking at standards to ensure that as data is
aggregated that information couldn’t ultimately in the aggregate be such that
it can be —

MR. SCANLON: Disclosure avoidance standards.

MR. HOUSTON: I wasn’t sure whether that’s what you were referring to. And
that will be published as to what those standards are going to be in?

MR. SCANLON: Whatever the authority for it and the practice and the policy,
we will describe those, yeah. So we’ll go from, I mean in many cases NCHS and
AHRQ they actually have statutory protection of information, identifiable
information, comparable to the Census Bureau which is always sort of held up as
a gold standard. So taking that authority out of the agencies, employ that,
what are the policies and practices they use to kind of cover that through the
entire effort. And disclosure avoidance would be one of those areas.

MR. BLAIR: Thank you, Jim, I think that it sounds like the way you’ve
describe it that this is an inventory which certainly is needed. One of the
things that I tend to think of because of the work on NCVHS since we’ve been
working in this area for so long, or at least I tend to think of these not just
as line items with the number of folks that are using these for statistical
purposes, we tend to think of this, or at least I tend to think of it as
something that is dynamic, that is evolving to provide additional capabilities
where some of the clinically specific standards will be very enabling. And of
course the National Library of Medicine has been doing mapping among many of
those code sets. So my question is will this research paper, I don’t know what
to actually call it because I don’t think you refer to it as an inventory, will
it identify the code sets or terminologies which are mapped by NLM and will it
identify the purposes for which each of these code sets will be used?

MR. SCANLON: You’re referring to the data standards project, right?


MR. SCANLON: It’s not meant to be an inventory at all, it’s meant to be an
evaluation of the extent to which and the potential of to what extent the
existing sets of code sets and content standards and statistical policy
standards are being employed and if they’re not sort of what are the barriers
and what’s the utility. It may be that standards that are quite applicable for
clinical description or reimbursement make no sense in a research or
statistical program in the sense of you’re starting there with it, it depends,
I think you could argue for the standardization as well as for the, when you’re
trying, you’re usually trying to pick the best measure when you’re doing
research or statistical work.

So I think we’re keeping an open mind but it’s not meant to be an inventory,
it’s meant to be these are the standards that have already had some measure of
adoption or use and it will include the content standards that NLM is looking
at. And you’re familiar with them, it’s everything from ICD to, and ICD is used
in some, it’s used in our mortality classification system, it’s used in, I
think it used to be used in the Health Interview Survey, I’m not sure it is
now, I think in some of our provider surveys.

But it’s much more then inventory, it wouldn’t really be worth our time to
do just an inventory, we want to see to what extent they’re being used. Again
there may be reasons why they’re not being used, we’ll have to see what exactly
that is. There’s always the balance in a survey or in a research project that
has specific objectives, you have to find the measurement of the variables as
you all know as well as I that best suits the question and that’s always,
that’s sort of where you start, if a standard is the best way to do that and it
often is certainly for continuing statistical system then there’s almost no
reason why the standard implementation and cost shouldn’t be used. I think for
example in the hospital discharge data I think that already employs some of our
standards, ICD and so on.

But we’ll see, I think we’re just starting and I think we’ll have to see
where it takes us.

DR. COHN: I know Russ has a question and then I have a question and
clarification and then hopefully we’ll wrap this area up. Russ?

DR. LOCALIO: This is Russ Localio. Jim on your last comment about the
consultant, I’m not going to ask who but when will it be finished and how will
it be released and will there be a period of comment?

MR. SCANLON: We’re just starting on it, we just awarded the contract, I
won’t mention who it is but he is well known to you and no one would argue that
he’s not probably one of the best experts on this area. But I’m guessing it’s a
sixth month study and I would be happy to come back, there’s nothing
confidential about it, these are well known, these are public laws and so on so
I’d be happy to bring it back.

DR. COHN: Well I think Russ actually was asking some of the questions I was
which is I think we all think that this is a fascinating investigation and we’d
love to have some updates about it as you move forward, I don’t know if it’s a
presentation for February or a presentation for June but potentially we need to
sort of figure that one out. I think from my view, I mean given that, this is
an area where obviously standards are critical and there’s obviously a tension
here though because beyond standards there’s the issues of there’s sort of the
pros and cons of linkages because the standards actually do provide some
ability to be able to use the data for more then one would be able to use for
otherwise, also reduce redundancy of repeated data collection which I know is
something that I think is populations is thinking about as one of their issues
for next year but there’s also privacy issues, so I think there’s going to be
an interesting tension and a conversation we’ll need to have.

MR. ROTHSTEIN: Simon, maybe we can invite the contractor when he’s finished
to give a presentation to the full NCVHS on some of the findings.

DR. COHN: Well I was actually thinking that maybe even during the process we
might get an update in the middle and the answer may be both. But absolutely —

MR. SCANLON: But again, this information, these are public laws and regs and
so on, it’s just that they haven’t been pulled together, some of you are
familiar with these, those of you who do business with our research and
statistics agencies but again this would be a place of pulling it together and
when you’re pulling things together you do find comparisons and contrasts and

I guess one other thing, Simon, if I have the time, we were planning to have
the NCVHS brief the Data Council on the race ethnicity data recommendations, I
think they’re formally transmitted now and we have them within HHS and perhaps
at a, we’ll work something out but I think we’d like to have a briefing to the
Data Council and I think it fits in well with our internal initiative on race
ethnicity data.

DR. COHN: I think our chair of Populations would be more then pleased.

— [Laughter.] —

DR. COHN: Well Jim thank you for a very interesting update, and Michael,
congratulations. Actually before we move on I do want to suggest that
potentially given the work that’s happening I think an important event around
package labeling that maybe the committee would like to prepare a letter
congratulating the, I’m not sure what the term is, the department, I think
we’ll have to get some help from Mike about exactly who to send this to.

DR. FITZMAURICE: I would say it’s an NLM, FDA and AHRQ, and the department
for recognizing the importance of this.

DR. COHN: Is everyone okay with us preparing such a letter? Okay, great.

Okay, Karen you’re on next.

Agenda Item: Update from the Department – Ms.

MS. TRUDEL: Thank you, I’ll start with an update on some HIPAA issues and
then move on to some general health IT/e-prescribing things that are underway.

As I think everyone is aware CMS Medicare fee for service has ended its
contingency plan for inbound claims so we are receiving now only compliant 837s
and the statistics show that as of last week we only rejected 5,000 claims and
that’s a drop in the bucket for Medicare fee for service for being
non-compliant. The 835 remittance advice, we are up to 92 percent of the
receivers in production so we’re pushing forward towards that goal. And the 837
coordination of benefits transaction is somewhat behind that because we’ve been
phasing in a COB contractor, so the statistics for that are about 31 percent of
the submitters are in production at this point.

Very interesting to report though that in the summer we did phase in the
electronic 270/271 and all of the 270/271 data is being held at a central data
mart so that at this point people don’t need to query the particular contractor
that may be holding data. We started very slow and the volume has just
skyrocketed, for this quarter so far which is just October and half of November
we’ve received 2.8 million 270s and have been able to turn them around in just
a few seconds.

We have 20 submitters in production, they’re primarily clearinghouses and
providers with very, very heavy volumes, they’re having to do this over regular
phone lines. And there are about 50 more submitters who are somewhere in the
process of establishing connectivity, testing, and moving into production —

DR. STEINWACHS: Karen, for those of us less knowledgeable, 270s are —

MS. TRUDEL: I’m sorry, that’s an eligibility query and response, I mean to
say that right up front, eligibility query and response.

DR. STEINWACHS: Thank you, we were talking about a highway leaving town —

— [Multiple speakers and laughter.] —

MS. TRUDEL: I apologize for throwing around numbers and acronyms.

The internet version of this will be available in approximately the April
timeframe and that’s intended for smaller providers who don’t have the kinds of
volume that would necessitate their actually establishing connectivity, going
through AT&T or whatever. So I think we’re doing very well with that and
the fact that we’ve had 2.8 million queries coming in just tells you that
people really are taking up on these other transactions that are coming along
behind the claim as we always suspected that they would.

The attachments proposed rule I’ll talk about a little bit more later, the
comment period will end on November 22nd and I’ll talk a little bit
later about the fact that we’ve been receiving some industry push back on
extending that so that people can make a really careful analysis of the
technical documents that go along with the proposed rule.

The HIPAA transaction and code set and security complaints, I don’t really
have very much to report, we still are getting very small volumes as compared
to OCR and for the most part we’re having excellent good luck on achieving
voluntary compliance and we have about six corrective action plans that are in
process that are being monitored at this time.

The NPI, the National Provider Identifier, we continue to enumerate
providers to issue IDs through the web based system and two of the other
aspects to NPI implementation, the data dissemination process and policy and
the procedures for enumeration not on a one on one basis but in terms of large
files, which we call bulk enumeration, the procedures for that will not be
available until sometime in 2006 but we do continue to work for those.

Let me turn to e-prescribing a little bit, as Simon did mention the final
rule was published on November 7th, we were all very relieved about
that, and have gotten some questions but mostly a lot of good feedback and
relief that it happened. We now turn our attention to the pilot that was
required in the legislation and our friends at AHRQ have agreed to help us with
that process, they already have a process in place that’s excellent for
reviewing scientific type studies, and we’re taking advantage of their

We received 16 proposals and 14 of them met the basic criteria that were in
the RFA, so they moved forward into the study section process. The review panel
will met on December 1st and 2nd I believe and the panel
is composed of a number of distinguished experts in the area of e-prescribing
including Mr. Blair. So we’re looking forward to, the ones we’ve looked at so
far look really wonderful, there’s a good mix of collaborators and partners and
geographic areas and there’s some, there’s really some potential to find out
some really great information from those.

Let me talk now a little bit about what we’re doing inside CMS to try to
cope with the, all of the initiatives and spotlights that are focusing on
health IT these days. One is the office that I am in, the Office of eHealth
Standards and Services, is the group that is coordinating all of the e-health
activities within CMS. We have just established an eHealth Steering Committee,
had its first meeting last week, and it’s composed of the senior executives in
the agency who have interest in the e-health area and they will give us
guidance on strategic directions and priorities and things that we need to work
on, not just projects like public health, personal health records, but also
some underpinning types of initiatives like making sure that we have an
integrated data strategy in the area, in the agency, that will support not only
what we’re trying to do today with e-health, what we might need to do five
years down the road, and also to support some of the department’s initiatives
that have to do with drug data, etc., so that’s a very, very exciting area that
we’re embarking on.

Our second goal is to coordinate with HHS, especially the Office of the
National Coordinator, AHIC, etc., and so we have also initiated some
discussions and ongoing dialogues with the Office of the National Coordinator
to make sure that whatever initiatives CMS undertakes are consistent with a
direction that he and the Secretary are planning to go in. So I think that’s
probably a good thing.

On the personal health record front we did publish a request for information
in July asking people in the industry what they thought CMS’s role should be in
the area of personal health records. We received over 50 responses and they
were very robust, we are in the final stages of developing a summary of those
responses, it will not include any action plan or policy on the part of either
CMS or the department, it’s strictly going to be a report of what was given to
us so that’s our first deliverable in the PHR area. I’m estimating that that
will be published within the next month or so.

Our next step will be an action plan which we will be rolling out in the
early part of 2006 that will say okay this is what the industry told us and
we’ve digested it, we’ve thought about it in context of what the Office of the
National Coordinator is planning to do, the RFPs, the contracts that are in
place there, and this is how we think CMS should be positioned in the area of
personal health records.

Just a couple things to report from what we did here in the responses, most
of the respondents said that CMS should not be in the business of providing
personal health records to Medicare beneficiaries. They felt that that was the
wrong thing for us to do, that we should concentrate on educating on the
benefits of personal health records, that we should concentrate on facilitating
the exchange of data if the beneficiary authorizes it with the personal health
record vendor that they have selected. We also received comments that I thought
were rather interesting that we need to make sure that we are the ones, we CMS,
pursue especially vigorously personal health records that are directed towards
specific chronic disease management and similar areas where the market as a
whole may not be going and where Medicare beneficiaries may have a particular
need. So that was rather interesting.

I think that’s all I have to report on and I’ll take any questions.

DR. WARREN: Judy Warren. Go back and talk about, because I didn’t quite
understand, you said that one of the responses you got about the PHR was people
thought CMS should not be doing that and yet they also thought that in some
areas that PHRs may not show up in CMS may cover that void, is that right?

MS. TRUDEL: I think in some cases the comments didn’t exactly gel with each
other so that’s part of the analysis process. I think the sense that I got from
the comments taken as a whole were that we should not be in the process of
actually standing up PHR products but that we should be working with the
industry who develops PHR products and to try to partner with them or
collaborate in such a way that the products that they stand up will meet the
needs of our beneficiary population.

DR. WARREN: I guess I’m just concerned by some of the responses that you did
share that if we have PHRs for individual chronic conditions, etc., that what
we’re doing is kind of supporting fragmentation of personal health data, which
concerns me, that we would be making choices on partial data, I just want to be
sure I understood what you were saying, the responses.

MS. TRUDEL: I don’t think the suggestion was that there should be a personal
health record product that strictly addressed diabetic management or COPD
management but that the products that are available would be robust enough that
they might have a component that would have tools in it that could help someone
with that condition.

DR. COHN: Karen, before I open it up are you done?


DR. COHN: Okay, I wasn’t sure whether people had jumped on this one. Okay,
Harry I think you’re next and then Paul.

MR. REYNOLDS: Thanks, Karen. Two questions, you mentioned the 270 which is
the eligibility, I don’t think you mentioned the 276/277 which is the claims

MS. TRUDEL: No I didn’t and I didn’t for a reason, the 276/277 because it is
the claims status can only be handled by the specific carrier or intermediary
because they’re the ones that have the information about the claims status as
it is at the moment. And so all of the carriers and FIs have implemented
276/277 functionality and from what I’m hearing they’re not receiving very many
of them. I think that one of the reasons why the 270/271, the eligibility, has
become so popular is that we do have the data mart where all the queries go to
one place and the clearinghouses especially find that very, very convenient.

MR. REYNOLDS: Second question, out on the HHS website it was noted that
claims attachment rule is now schedule sometime around 2008. Is that a position
or is that —

MS. TRUDEL: The claims attachment final rule? It’s very difficult, the
regulation agendas that are published because they go so far out into the
future very often are developed on the basis of well it will take six months to
do this and 12 months to do that and three months to do that, so you really
need to look at those as a guide post as opposed to a cut and dried date.

MR. REYNOLDS: Since the committee is about to send a letter forward I just
wanted to make sure whether that was just kind of somebody putting a
boilerplate answer down versus a position.

MS. TRUDEL: Pretty much, yeah, I mean we try to beat the dates to the extent
that we can.

MR. REYNOLDS: That’s fine, thank you.

DR. TANG: I have a couple questions please. The first is do you consider
facilitation of online care including its reimbursement part of the health
steering committee’s jurisdiction or things to discuss?

MS. TRUDEL: I’m sorry, could you repeat that?

DR. TANG: So you said there’s an establishment of the eHealth Steering
Committee and you talk about some of the projects like PHRs, is one of the
topic areas to be considered facilitation of online care including its

MS. TRUDEL: Actually we’ve had to make some fairly tough decisions about
what is in the purview of this committee, which is e-health and health IT
oriented, and what is in the purview of our quality council which is another
executive level organization. And they tend to look, if you look at it it’s
kind of quality slices this way and health IT slices this way and the decision
is that the quality related items stay with the Quality Council, so they’re the
ones who are interested in tele-health and electronic health record adoption
issues, vista, things like that.

DR. TANG: And electronic visits, or electronic encounters would be in that,
the quality area?

MS. TRUDEL: I think if that’s something, if anybody in CMS is thinking about
it that would be the group that is.

DR. TANG: And the second is, relates to, and this may be premature to ask
this but you talked about some of the feedback saying that CMS should not be in
the business of offering a PHR, do you interpret that as saying that the kinds
of experiments you’re doing in Indiana with the beneficiary health data
accessibility over the web as not, do you interpret those comments to say that
that’s not something CMS should do?

MS. TRUDEL: No actual I don’t because the beneficiary portal was never
really intended to be a personal health record per se, it has some of the
qualities of a personal health record but it doesn’t have an awful lot of the
qualities that people seem to think that a personal health record should have.
So I think that what we’re doing there is a tool that has some personal health
record like functionalities to it and I didn’t get the sense from any of the
comments that we should step back from that.

DR. COHN: I’m just reminded by our letter that we passed in September about
the ambiguities around exactly what a personal health record is and isn’t and
is it a portal, is it a, I mean is it a what, and I think that may be some of
the reflection we’re seeing here. Thank you, Karen. Michael.

DR. FITZMAURICE: I think Paul probably asked one of my questions which was
the personal health record, I think what CMS is doing to make information
available from the claims data to the beneficiary, I think it’s outstanding and
would hope that those comments wouldn’t be construed to say gee we shouldn’t do
it, and I think your answer was no, you think it’s a good thing and you’ll keep
pursuing it.

So my only remaining question is at the very beginning you gave some numbers
and statistics about the claims, 31 percent of submitters are in production,
but there were some at the very beginning, I’m not sure if you mentioned the
837 or what others, you mentioned the 835 remittance advice, I wonder if you
could just briefly review those.

MS. TRUDEL: Right, for the incoming claim which is the 837 we’re rejecting
any transactions that aren’t compliant.

DR. FITZMAURICE: And what percentage or what number of those have been
rejected? In the past month or whatever you have.

MS. TRUDEL: I mean we’re taking 99.9 something of claims are compliant at
this point and they have been for some time. The number of rejects last week
were just a little over 5,000 Medicare wide.

DR. FITZMAURICE: And after that was the 837 —

MS. TRUDEL: The 835, the remittance advice going back out to the provider
and that’s at 92 percent of receivers in production.

DR. FITZMAURICE: Very good, CMS is to be congratulated on this.

MS. TRUDEL: Thank you.

MR. BLAIR: The eligibility of the 270, what percentage is that now?

MS. TRUDEL: You can’t do percentages on eligibility because you have to be
signed up in order to conduct the transaction, so essentially 100 percent of
the people who’ve qualified are conducting the transactions but we did 2.8
million transactions in the last month and a half. And that’s with only 20

MR. REYNOLDS: Which some of those in the past, Karen, probably would have
been phone calls.

MS. TRUDEL: Many of them would have been phone calls, yes.

DR. COHN: Probably millions.

MR. REYNOLDS: I was serving it up for you so you could get —

— [Laughter.] —

DR. COHN: I actually had a question for you and once again I think I was
referencing that one of my joys in life is to actually read final regulations
from CMS and certainly there’s enough there to keep everyone busy for probably
decades if not longer. But I was particularly fascinated in the e-prescribing
rule and I will apologize, you can certainly say no comment to the question
that I’m asking, but the committee has gone on record as have many others about
this concept of streamlining the processes relating to both HIPAA and other
regulations in this area and we’ve talked about that in relationship to claims
attachment, we obviously had talked about that in relationship to e-prescribing
and we’ve also talked about it in relationship to HIPAA.

Now I was very gratified to see that there was a discussion about potential
ways that things may be streamlined for e-prescribing and for those of you who
didn’t read it there’s a concept at least in the discussion part of the, it’s
150 page discussion, the five page law, but that describes how CMS is I think
considering strongly the approach of backward compatibility and if things seem
to work and the public and NCVHS and everyone else thinks that a new standard
or revision to a standard is really backward compatible and it’s of value to
the country there may be a way to allow that to occur without having to go
through full rulemaking process, or at least the Secretary might have some
discretion in relationship to this.

I’m actually wondering, first of all I want to congratulate you, it looks
like a very good move forward in terms of lessening administrative burdens and
regulatory burdens for each sort of minor change, but is this something that
would be at all applicable to the actual HIPAA regulations also? Or is it, do
we need to see how e-prescribing goes with this first?

MS. TRUDEL: As it happens we are also working on another HIPAA modification
rule which we hope will address some of the streamlining issues and we do, we
have already scheduled a discussion to take a look back at what we’ve thought
about HIPAA from the perspective of e-prescribing, so not sure how that’s going
to come out but we definitely are thinking along the same lines as you are.

DR. COHN: And I presume this will be an internal discussion about regs that
need to come forward. Great, well congratulations. Other questions before we
move on to, Jeff anything before we move on?

MR. BLAIR: It turned out that the final rule for e-prescribing was I think
November 7th and the pilot test announcement for the RFAs, the
requests for applications, was I believe late September, middle September, so
in an effort to try to do everything that was possible one of the things that
apparently was not possible was for them to be sequenced a little differently
and as a result during that pilot test piece it indicated that, I think, I’m
trying to remember whether it was the medication standard or medical history,
was indicated as a initial standard as opposed to a foundation standard, and
when I saw the final rule it wasn’t exactly in sync. This may not make any
practical difference because it’s going to have to be tested either way but I
was wondering if you had any clarification for us on that.

MS. TRUDEL: Actually when we published the RFA because we knew it was coming
early we didn’t distinguish between whether something was a foundation standard
or not and we simply said that all of the standards including whatever turns
out to be a foundation standard needs to be tested together, so that as far as
I can tell from my read we pretty much kept our options open in the RFA and
that whether the medication history and the formulary benefit management which
were pretty much the two standards that were a little bit kind of on the cusp,
whichever way that went we provided neutral language so I think we’re fine.

DR. COHN: Well Karen, thank you very much, and congratulations on the
various work going forward including e-prescribing and it sounds like your new
work on e-health. So thank you.

Susan McAndrew from Office of Civil Rights, thank you very much for joining

Agenda Item: Update from the Department – Ms.

MS. MCANDREW: Thank you. With regard to privacy rule compliance, as of the
end of October we had received over 16,000 privacy rule complaints and we have
closed 68 percent of those complaints. We are continuing to receive a fair
number of non-jurisdictional complaints but the percentage of closers are also
increasingly including complaints that are resolved through voluntary
compliance on the part of the entity.

There has not been much movement in terms of the types of issues that are
raised most frequently in those complaints, it continues to be headed by
impermissible uses and disclosures as the primary reason that people are
concerned. We also continue to get a lot of complaints raising the adequacy of
the safeguards with regard to that, that plays along usually if you have an
impermissible disclosure you have a safeguard that has broken down somewhere.

We continue to get a fair number of complaints that are concerned about
denial of access to their health records, we also have begun to get more
complaints concerning the amount of fees that are being charged with respect to
those access of records and whether those fees are reasonable.

Minimum necessary is also frequently raised in our complaints as well as
whether or not a disclosure required an authorization and none was provided in
the record.

The types of entities also has not changed much, the most frequent entity
type complaint against are private health care practices followed closely by
general hospitals. In addition a variety of outpatient facilities get a lot of
complaints as well as pharmacies and following somewhat behind would be a
variety of health plans led by group health plans as the type of entity that is
complained against. And we also continue to refer cases to the Department of
Justice and we have to date referred approximately 256 cases.

I will say with respect to these numbers that we were finally able in
conjunction with this meeting, Linda Sanchez and I were able to sit down with
John Houston to discuss the potential for our own type of data mining and we
had a very productive discussion about what the capabilities of our current
complaint database is and what the current reports look like and we will have a
continuing discussion with John and I believe tomorrow morning with the Privacy
Subcommittee as a whole to identify additional data areas that would be of
interest that are also feasible to extract from our database. So hopefully we
will be able to produce, I’m not, I’m hopeful that this may integrate into the
monthly statistics for the use of all but at least we may also, it may be that
for the time being it may just be periodically more robust reports if we can’t
generate some of this data on a monthly basis, but we are very happy to be
moving forward on that effort.

On some other fronts there was released just last week a new survey done by
the California Health Care Foundation using, I’m forgetting their consultant,
but they did, they had done a privacy survey largely focused on privacy and
electronic systems back in 1999 and the 1999 survey predated HIPAA, the
regulations, it was surveyed even before the NPRM was issued, so they wanted to
do an update of that survey based on experience with HIPAA implementation as
well as all of the new activity in electronic health records and other HIT
movement in the health industry. I think we had met with them following their
announcements of their privacy results, I think we’re still looking at some of
those results.

They had some very strong recommendations in terms of the additional need
for public education which I think echoes many of the concerns that the
committee has expressed and they also had made some comments about enforcement
and we did question then on that because as I was looking at the survey results
there really were no questions or data points collected in that survey that
would cause them to, that would support their recommendation on attitudes
toward the enforcement under HIPAA. So we were a little concerned about that
being a headline item based on the survey results.

In other fronts, on the regulatory front we are in conjunction with our
General Counsel’s office and CMS coming to closure on the final enforcement
rule and it’s hopeful that perhaps by the next NCVHS committee we’ll be able to
have a report on a final enforcement rule. This is setting up, trying to make
uniform the procedures across HIPAA in terms of how complaints are handled and
investigated and how CNPs will be imposed and what the hearing rights will be
with respect to any imposition of civil monetary penalties.

In addition we are participating with the other components of HHS in a new,
becoming sort of an annual event, a regulatory reform task force has been
formed up I believe, ASPE is in the lead on that together with OMB to take an
overarching look at department wide regulation that may be imposing undue
burdens on the health industry, and so they have launched a series, they have
asked for public comment on regulations, department regulations in the health
area that they impose undue cost. And in addition to those public comments they
are starting a series of four public hearings across the country, the first one
was held last month, earlier this month, I can’t remember, in Washington, D.C.
and there are four others that will be held between now and February in
Chicago, Oklahoma City and San Francisco.

The other initiative that we are beginning discussions with AHRQ on concerns
the recently enacted Public Safety and Quality Improvement Act which sets up
patient safety organizations and participating providers who will be working on
patient safety activities and producing patient safety work products which will
have confidentiality and privilege conditions attached and there is also a
scheme for, an enforcement scheme that relies on civil monetary penalties for
violations of the confidentiality protections and there’s also a private remedy
which attaches to reporters of information on quality and safety who may have
experienced an adverse employment action as a result of their reporting. And so
we are talking with AHRQ in terms of handling the enforcement aspects of the
patient safety civil monetary penalty.

And that’s it.

DR. COHN: Okay, Susan, thank you very much. Paul Tang and then Mark.

DR. TANG: Two questions, one you reported 256 cases were referred over to
the Department of Justice, what happens? Do we have any outcomes to report?

MS. MCANDREW: When we refer them to the Department of Justice the department
has, will make a decision as to whether or not they will initiate a criminal
investigation based on that referral. If they do not the case may come back to
us and we would pursue that case just as part of our normal caseload if there
are civil aspects to that complaint. Some contain only criminal allegations and
so those cases we would close with the referral to DOJ.

DR. TANG: So have there been any prosecutions?

MS. MCANDREW: Actually there have to date been no prosecutions based on any
of the referrals to my knowledge.

DR. TANG: What about the case in Seattle?

MS. MCANDREW: The Seattle case was not based on a complaint referral because
we did not receive a complaint from that individual about that incident, but we
did refer to the Department of Justice the press reports related to that
incident. There’s also a new indictment that has been brought in Texas for
which I have very little information at this point, and that also as far as I
know was not based on a complaint that we had referred. So they do, they have
their own investigatory means as well.

DR. TANG: And the second question relates to a high profile case that was
apparently brought to your office in terms of the JCAHO, is there something
that you can share with us on the details of that complaint?

MS. MCANDREW: That is not really, that’s not a complaint issue, we met last
week with the American Hospital Association and actually will be meeting this
afternoon with JCAHO and the American Hospital Association representatives to
talk through their issues. The American Hospital Association had asked us for
guidance on the scope of business associate activities under their contracts
with JCAHO and so we’re trying to, at this point we’re still in the process of
trying to identify what the issue is and whether or not there’s any meaningful
guidance that OCR can provide. I do understand there was some announcement
recently by JCAHO, I think they were having their own board meetings yesterday
and today perhaps and there was some article in the press this morning
concerning that one of the recommendations is that JCAHO would no longer do the
kind of data mining activity that results in the sale of information to Blue
Cross and Blue Shield.

DR. TANG: The reason for asking that is because later on today we’re going
to be talking about secondary uses of data so I just want to thank you for
sharing some of that.

DR. COHN: Mark Rothstein and then Carol McCall.

MR. ROTHSTEIN: Sue, we both know that John Houston has great plans for
mining your complaint data but I have a question that may be not exactly
flowing from John’s use and that is to what extent has OCR used the complaint
data to help guide its enforcement assistance activities? In other words it
seems to me that having a sort of a feedback loop from the complaints could
help decide in what areas you need more guidance, in what areas you want to
emphasize in our outreach programs because you have lots of complaints in a
certain area, people are obviously not getting it. Is there some system in
place or have you thought about a system for having the complaints in some sort
of aggregate form feed into your other activities?

MS. MCANDREW: We have from time to time used that, I think we haven’t gotten
to the point of doing that on a systematic basis and so it’s of interest to us
as well to in conjunction with John’s needs and the committee’s needs for this
data is to raise the profile within OCR in terms of getting some more
management substantive programmatic reports out of the system. Right now, it
was really designed largely as a management monitoring tool so most of the
reports that are imbedded in the system now go to workflow and monitoring
progress and various administrative steps. Which are very helpful in terms of
seeing how productively the regions are working, tells me very little about how
the program is working. So we are interested in making a more programmatic use
of that information and making that more systemic.

DR. COHN: Okay, Carol, I think we’ll let you ask the last question and then
we’ll wrap this up.

MS. MCCALL: It’s actually very related to Mark’s comments and it has to do
with some of the uses of the database, before the question just an observation
that in a microcosm what you’re experiencing is essentially, if you design the
ebb to help the workflow but don’t think about how you can use it to report,
that’s what we’re going to experience if we don’t understand how a lot of EMRs
and EHRs are going to be used to actually drive quality, so keep that in mind,
a taxonomy I’m sure is something that maybe Jim Scanlon’s team could put
together for you.

The specific question though, you mentioned volumes, that they come from
private practices and hospitals, and which is not to be unexpected I would
think because the volume of activity in those places, utilization tends to
follow that curve, it’s a lot more active in physician office visits then
perhaps admissions and things like that. Will you be doing things that try to
create a denominator for that so that you could say relative to the amount of
care being delivered in physician practices versus hospitals in terms of just
visits or admissions we get a relatively higher percent, so those types of
things as well as others as you go about the data mining would be valuable. But
do you have any insight into which has a relatively higher proportion?

MS. MCANDREW: I think other then just common sense and logic would say that
the private practices and the general hospitals not only have many more
interactions with the public and so therefore that’s where the rubber meets the
road for many individuals and I think also the individual, that kind of face to
face interaction tends to heighten the individual’s interest and expectations
in privacy and how that data is being handled.

One of the things we were talking to John about that may go somewhat to your
point is to try to correlate or get some profiles in terms of the size of the
entities within the private practices, large group practices versus small
groups, hospitals, number of beds, and that kind of thing. The database right
now does not capture size.

DR. COHN: You’ll notice that John Paul has not asked one question during
this particular session, this may be the first time. However, John Paul did ask
to make a final comment before the break.

MR. HOUSTON: Just a real quick comment, I mean the dialogue was really good
with Susan and Linda and I just wanted to sort of expand on Susan’s last point
which is that we looked at some strategies yesterday to try to, since they only
capture information by hospital, it’s not hospitals over various sizes, you
don’t really get a sense on where some of the problems that big hospitals, that
are small hospitals, that are rural hospitals, one of the things that we’re
thinking of trying to do, as we talked about is whether we can capture like bed
counts, something out of an AHA guide or zip code to try to get a sense of
where these hospitals are to try to get better statistics about where the
problems lie. So again, I think there’s a lot of opportunities here and trying
to be practical about how to mine this data and get this type of information.

DR. COHN: Well we’re looking for the Subcommittee on Privacy and
Confidentiality to assist us with this in an ongoing fashion. Now I do want to
break, I know we can continue on with the conversation but we do need to be
back at 10:45 for our last session of the morning, so we’re going to break for
about it looks like 13 minutes. Thank you all.

[Brief break.]

DR. COHN: Okay, we are going to get started for our next session. What we
are going to do for the next little bit, for our next session we’re going to
start out with a discussion about claims attachments, there’s a brief
presentation that Karen Trudel I think will be providing and then we’ll be
talking some about the letter that the Subcommittee on Standards and Security
has developed. I do want to sort of explain to everybody about the timing of
this next period. We obviously have time for the discussion about the
attachments, we’ll have I think hopefully to get at least some briefing about
the letter that’s been prepared. David Brailer needs to be leaving here exactly
at 12:00 and I think we’ll expect to see him at about exactly 11:30 knowing how
he runs. So just recognize that we will do is to wherever we are with this
letter we will put a hard stop to the letter at that point and then if we need
to we can sort of talk about it in the afternoon either before or after our
break to go to the subcommittees, but I think that will be the plan of action
on this one.

Now I think Karen is in the process of getting the presentation so Karen I
will turn it over to you for at least the background discussion about the
claims attachment NPRM and then we can let Harry and Jeff discuss the letter.

Agenda Item: Briefing on Health Claims Attachments NPRM
– Ms. Trudel

MS. TRUDEL: Okay, thank you very much, I would beg your indulgence on this,
I’m pinch hitting for this at the last minute, it’s not my presentation and I
apologize in advance that it has some somewhat distracting animation in it.
Luckily people will not notice on the internet.

One thing I’m going to say before I start is that while I mentioned earlier
that the claims attachment NPRM comment period date closes on November
22nd we did receive a very large number of requests from various
industry representatives saying that because of all the technical documents,
the booklets and different things that go along with the rule people really
felt that they needed more time to review and provide comments and people asked
for extensions of anywhere from 30 to 60 days. We are very sympathetic to that,
we would rather have good complete comments before we go into the final rule
period so that we don’t have to deal with an issue like the HIPAA modifications
when we had to go to the 4010A.

So we are working on putting forward a proposal to extend the comment period
for an additional 60 days, it would be a Federal Register notice and it is not
completely approved but it is in the review process so I’ll just mention that.
However until that comes out the official date for comments still is November
22nd just so you understand that.

Again I’ll just start from scratch very quickly for members that weren’t
around back in the stone ages. The claims attachment standard is one that is
required by the original HIPAA legislation and it is a health care claims
attachment so it is an attachment for a health care claim, not for a referral
or remittance advice or for other uses, so we’re only talking about developing
a standard for this purpose. And it is the additional clinical or
administrative information needed from a provider to allow the health care plan
payer to adjudicate a claim, so this does not have to do with, again we’re
excluding requests for information that come post adjudication for purposes of
medical review cross periods of time, this is a request for a specific piece of
information required to adjudicate a particular claim.

And I would say that, venture to say that in the administrative part of the
health care industry the claims attachment process is the most manual, the most
time consuming, expensive, and inefficient. It is something that is just plain
not automated at all at this point in time.

So the proposed rule clearly affects all covered entities under HIPAA, we
all know that. The health plans will be required to be able to accept or send
the transactions, the providers as always have the option of using the
transaction or continuing to conduct their business on paper. And
clearinghouses if they are in the communication loop will be required to use
the standard transaction. We’re proposing six types of attachment standards,
only six, and again everything else that’s outside that scope is something that
is not being regulated at all so there are no constraints on what people can
continue to do outside the scope of these.

The standards that we’re proposing, and I will attempt to stay out of
acronym land now, there is a request for information, it is a HIPAA
transaction, an X-12 transaction called the 277, so that is the request that
comes from the health plan and goes to the provider. The response that comes
from the provider back to the plan would be the X-12-N 275. The codes that will
be used in that request and also in the response are LOINC codes which are a
CHI standard and they are the list of codes that identify the specific
information that is being requested, so it’s a codified way of saying this is
exactly what I want you to give me, totally, unequivocal.

The additional information specifications are the basically the content
format and what the LOINC codes are that associate with each type of attachment
transaction because their subject matter is different, the content is
different, the specific LOINC codes that associate with, for instance an
ambulance claim is different then for a therapy claim attachment. And the
clinical document architecture, the HL7 CDA, is the XML based document markup
standard that would include the clinical content, the payload if you will that
goes back to the health plan in response.

The proposed attachments are for ambulance, emergency department,
rehabilitation, and there are nine different categories of that including
cardiac, rehab, PT, OT, psych, substance abuse, laboratory results,
medications, including current and discharge meds, and clinical reports which
could be almost anything in text form, op reports, discharge notes, etc. And
again it’s important to note that these attachment types don’t actually
correlate to a specific claim type always, in other words an ambulance
attachment probably will correlate with an ambulance claim, however a
laboratory result request for an attachment may correlate back to an ESRD claim
where for some reason the service that was built for dialysis there’s a
requirement for laboratory results before the plan can determine whether or not
they’re going to adjudicate the claim. Same with medication, same with clinical

There are other attachments under development, we’re not recommending them
at this time, they’re not really relevant to the discussion, but there are HL7
groups working on home health care, DME, periodontal, and children’s preventive
health service attachments, and they may come up for adoption or consideration
at a future time.

When we begin to talk about claims attachment data, electronic data, and how
it affects business processes it became very clear that there really are two
different variations. One is what we call the human decision variant which
means that the information that is coming in maybe electronic but it can’t be
utilized but a computer so you may have a scanned image or a text or an image
of a health record, it can come in electronically but a computer can’t work
with it. The computer decision variant is one similar to what is being used for
the structured product label where the values allow for automatic processing on

We’re allowing for both in this environment, we think it’s asking a little
bit too much to expect that health care providers will immediately jump to a
computer variant process because it requires a significant reengineering of
their business processes, and the same with health plans. So we allow for both,
the attachment can be submitted on paper if the provider wants to, the
attachment information can be coded into data and sent electronically, it can
be sent electronically but the plan may convert it back into text, it really
doesn’t matter to us, that’s all okay. But both variants basically encourage
participation in some level of electronic attachments.

I will only take a moment on this because this is the flow of the attachment
request and response, it starts when the service is delivered, the provider
submits a claim. If the health plan decides there’s a need for more information
they request it using the 277, the provider sends it back, and I think we’ve
just looked at that enough.

We’ve already talked about the comment period extension, again judging rule
of thumb NPRM to final rule a year or more, and from the date of the final rule
to implementation is two years, so that gives you an idea of the actual time in
the future that we’re talking about to implement.

Of course the attachment standards can be used voluntarily prior to that
date, there’s no stopping anyone from using them even today. And we have
already conducted a CMS pilot to look at the proposed standards and came up
with a number of changes that we believe need to be made. We are encouraging
industry to investigate other opportunities for pilots and the more pilots we
do the more we find out the little hidden problems or potential improvements
with the transactions.

I think I survived.

DR. COHN: Karen, thank you very much. I actually want to say that I think
some of us have received this presentation via conference call and the
conference call does not do the presentation justice. I also I think would
further say that every year we sort of reflect on maybe the single presentation
that had the most interesting aspects to it. We may want to consider this one
to really be the presentation of the year as far as, and unfortunately for
those on the internet, I mean the number of, the amount of animation was really

Anyway, Karen, thank you. Any particular questions about the presentation
before we move into the letter? Paul.

DR. TANG: With the flexibility in the proposed rule meaning basically all
kinds of variance in the ways it can get to you is this rule viewed as sort of
an encouragement rule to get people to start getting closer to computers?
Because it doesn’t sound like it’s moving a great towards standards, at least
enforcing standards. Am I interpreting that incorrectly?

MS. TRUDEL: Well I think even the basic level of standards use is a
significant advantage because it does allow for the plan to ask for exactly
what it needs and it provides structure to the provider in that the provider
can know by looking at the LOINC code exactly what the plan needs. Very often
what happens now is that the plan asks for something, the provider is not
exactly sure what the plan wants, and they send the whole medical record, or
the whole record of the encounter, they could possibly send one lab value and
they send the information that relates to a full hospital stay. So I think
that’s a significant advantage.

You have the ability to send these things via EDI where even if it’s just a
scanned image it is being sent electronically so you’re not faxing. It’s a lot
easier for the plan to associate the information back with the claim which
they’ve suspended and is hanging out there in their system. And so I think
there really are a lot of advantages.

The other thing is that, and we don’t go into this in the presentation, but
we specify you ask for what you need once, you don’t keep coming back if you’re
a plan. So if you need information ask for it all one time and I think
providers will find that to be advantageous because you don’t get into this
tennis match kind of process where you provide data but it wasn’t the right
data so they ask you for it again and you provide it again. So I think that’s
going to be considered another advantage.

DR. TANG: So I can see that the value in moving along the path, is there a
roadmap to a completely standard of more streamlined way of sending information
and getting it adjudicated in an automated fashion on your end? I mean so I see
all the advantages of where you’re taking in your first step, are there future
steps to follow?

MS. TRUDEL: I would say that the steps that should be taken in the future
probably should not be taken in the HIPAA arena because keep in mind that HIPAA
is a requirement, there are penalties, there are enforcement aspects to HIPAA,
we’re stating what the standard looks like, we’re setting the stage, and now I
think we let the industries, health IT and EHR adoption processes to feed along
with that.

Another thing that’s not mentioned in the presentation that’s important to
remember is that this standard is the first one where the HIPAA administrative
transaction world meets up with the CHI clinical standard world and it’s the
first time we’re using X-12 standards which are administrative primarily, with
HL7 which are primarily clinical, with LOINC, and all of them together form the
bridge to get from administrative to electronic health records. And if you
don’t build that bridge and people aren’t thinking about it, if EHR vendors
aren’t thinking about how could I take my content in my EHR and turn it into
something that I can pass to a practice management system so that it can create
a claim you’re again going to have two silos.

DR. COHN: Steve and then Justine.

DR. STEINDEL: I’d just like to introduce some clarifying words in terms of
terminology because in the last few months the CHI standards have taken on a
broader perspective then when they were originally introduced and Karen you
used the words LOINC and you said it was a CHI standard, specifically the
laboratory names portion of LOINC is a CHI standard and not all of LOINC —

MS. TRUDEL: I stand corrected.

DR. STEINDEL: And the actual attachment standard points to three parts of
LOINC, the clinical LOINC, the laboratory part, and the attachment part of
LOINC. The attachment part of LOINC if this is approved will by default become
a CHI standard because it will be a HIPAA standard but the other parts would
have to be looked at.

DR. COHN: Okay, Justine?

DR. CARR: This is really helpful and clarifying, I appreciate it, and maybe
this is a naïve question. When you say the proposed attachments, there are
six types and four others proposed, is this the current state or is this
derived from current state of what would be able to be transmitted? Just some
clarification on how these, why these six —

MS. TRUDEL: That’s an excellent question. When we started looking at this it
was pretty clear that no one was exchanging any attachments electronically and
the group that was doing the groundwork for this essentially did some surveying
and found that there were literally hundreds of potential different kinds of
attachments, some extremely specialized. And so they tried to do some kind of
80/20 analysis to figure out if we only adopted a certain number of them where
would we get the biggest volume and the six that we’re proposing are the ones
that if those were automated those are the ones that the industry would be most
likely to adopt and the ones where the types of data that’s most often
requested in a claims attachment.

DR. COHN: Other questions? Bob Hungate.

MR. HUNGATE: As I looked at the flow chart the presumption is that the claim
when it originally goes in says nothing about claims attachments, that the
claims attachment process is triggered by someone asking questions. Now I can
visualize a data mining methodology where a hospital might mine its data and
find that this vendor always asks these questions about this kind of claim. Is
there provision in the claim information to say this claim will have these
attachments? Is there a way to link the information from the claim to the
required attachments based on a specific vendor?

MS. TRUDEL: That’s an excellent point and that’s something that is debated
in the proposed rule. What we found in some of our initial discussions was that
providers said oh for heaven’s sake, I know every time I send an ambulance
claim this plan is going to ask me for this piece of information, why can’t I
just send it all at one time and that’s more advantageous to my processing and
my cash flow. What the plans said was yes that’s true but if you send me
attachment information that I don’t expect I don’t know what to do with it and
it seriously affects my business process because then I’m sitting here with
this piece of data with no claim to associate with it and I don’t know what to
do with it, all I can do is store it and hope that the claim will come in.

We’ve tried to split this down the middle and our proposal was that for the
most part an attachment would be based on the plan asking for information from
the provider. However in situations where a plan is willing to tell its
providers in advance this is how I ask for information then the provider could
send it in at the time of the claim and we request comment on this because it’s
really a very tricky issue for business processes on both sides.

MR. HUNGATE: That’s good, glad to hear that.

DR. COHN: Carol McCall?

MS. MCCALL: You talked about bridges and I think that they’re going to be
absolutely critical. The question that I have here around the standards and the
taxonomies that are being used, do you know the extent to which these are being
integrated in some of the AHIC work and the RFPs and the certification
essentially of EHRs?

MS. TRUDEL: Steve is going to answer that for me.

DR. STEINDEL: Yeah, I can give a comment on that, Carol. In terms of the
clinical information that’s going to be transferred in the claims attachments
the RFPs call for the people who were awarded the RFPs and for AHIC to consider
the CHI standards in any discussions that they have about what standards to
recommend in an area, and that’s the standard government approach for this. So
I would imagine that we would be seeing a congruence between what’s coming out
in the claims attachment and what’s coming out in the electronic health record
world. And at this point in time certification has not pointed to particular
standards because that’s a private sector activity and we haven’t had any clear
direction on that but they’re planning to.

DR. FITZMAURICE: I would also add that the AHIC probably at the end of this
month will be deciding on the use cases to be used throughout the standards
activities and that will be the opportunity to see where the attachments and
the clinical information within fits in with the use cases.

DR. COHN: Any other questions? Okay, well now, let’s now turn to the letter.

Agenda Item: Subcommittee on Standards and Security –
Letter on Health Claims Attachments NPRM – Mr. Blair and Mr. Reynolds

DR. COHN: Let me tell you we obviously have a number of options with this
letter, I mean this is a letter being proposed by Standards and Security,
excuse me, Subcommittee on Standards and Security. Obviously we’ll go through
it sort of basically paragraph by paragraph, we may make it through it in the
next 15 minutes, I mean we have to at least go through it once today. If
everybody thinks it’s great we can obviously pass it, we can provide comment,
take it back to the subcommittee, bring it back tomorrow. We could even decide
that given that there’s more time we could even decide that we need an
additional letter. On the other hand if we do that we would have to convene a
conference call of the full committee probably over the holiday season to deal
with that —

MR. HOUSTON: Mr. Chair, are you threatening us?

DR. COHN: No, I’m just giving you your options. So I mean I think we can
keep that in mind or if indeed there’s a 60 day period we can do a follow-up
letter with a conversation. The point I’m making is is that even if there is a
60 day extension we do not have a face to face meeting occurring until middle
of February which is long after that window closes so if there are additional
comments that really do require an additional letter we need to come up with
another process to deal with that. So that’s just sort of setting expectations.

MR. BLAIR: One thing Simon also, NUCC, NUBC has also written a letter which
covers a number of topics which I think Steve or you might be able to point out
that a number of issues are covered in that letter and we chose to not be
redundant and cover them in ours. Did you want to make a comment about that?

DR. COHN: Well actually the comment I would make is that a wide swath of the
industry, including many health plans, providers, organizations both public and
private are obviously in the process of reviewing this and providing comments
and I think that it’s very appropriate, there are probably many people around
the table whose organizations are providing comments to the Secretary as well
as many of you are members of other organizations which are providing comments
also. Jeff that’s not quite the comment that you wanted me to make but I mean I
think we’re all aware of that and obviously these are meant to be NCVHS

Okay, everybody okay with this so far? Okay, well Harry do you want to start
off with this?

MR. REYNOLDS: Do you want me to actually read the letter or just go by
paragraph by paragraph talking about the highlights?

DR. COHN: I actually would like you to read the letter given that it, yes I
would like you to read the letter and then ask for comments or clarification
paragraph by paragraph.

MR. REYNOLDS: And it’s also great to follow Cecil B. DeMille(?) and read a
letter. And we’re going to actually put those highlights in the letter when we
send it.

Paragraph one. As part of its responsibilities under the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) the National Committee on
Vital and Health Statistics, NCVHS, is responsible for studying, selecting and
recommending standards for electronic health claims attachments. We are pleased
therefore to comment on the new claims attachment Notice of Proposed Rule
Making, NPRM, which was published on September 23, 2005.

Any comments?

Second paragraph. NCVHS’s interest in the topic of claims attachments spans
several years including numerous hearings. Our recommendations most recently
were provided in our letter on claims attachments dated March 5, 2004. We
further evaluated the need for streamlined updating of transactions and code
sets to keep pace with industry requirements and new use cases. This issue was
addressed in the context of our recommendations on HIPAA related topics and
included in the recommendation number two in our letter on electronic
prescribing dated September 2, 2004.


Paragraph three. We appreciate the efforts undertaken by the Centers for
Medicare and Medicaid Services, CMS, in developing this claims attachment NPRM.
We believe that the use of electronic claims attachments will help decrease the
administrative overhead associated with clarification and adjudication of
approximately a quarter of the health care claims submitted in the nation today
and help advance initiatives related to the development and adoption of
electronic health records.


MR. HOUSTON: This language, a quarter, I would say one quarter.

MR. REYNOLDS: Okay, next paragraph. NCVHS supports the proposed standards
for electronic transmission of attachment information for the six types of
services as set forth in the NPRM but having only a limited time to review the
standards offers no specific technical comments. We do recommend flexibility
for adopting new claims attachments transmission and messaging standards in
additional types of attachments. In particular the NCVHS recommends a
streamlined process for adding new standards and attachment types and for
modifying existing standards. The committee urges the department to investigate
other ways that adoption of new versions could be accomplished without the need
for the lengthy and cumbersome rule making process.

MR. BLAIR: Question on that? I notice that some of the recent bills in
Congress seem to be continuing the process of having Congress specify a new
version of, I think it was CPT codes and going from ICD, well, is that correct?

DR. COHN: Jeff, I think that’s ICD codes you’re referring to.

MR. BLAIR: And also there was an NCPDP code that they specified in the House
bill that I saw for a different version. And so my question is whether it is
sufficient for us to direct that recommendation to the Secretary or whether
it’s beyond the Secretary’s ability to be able to make that modification
without the support of Congress to modify the law, I don’t know. Is there any
guidance on that?

DR. COHN: Harry do you want to comment or should I try to comment?

MR. REYNOLDS: No, you go ahead. I have your wing.

DR. COHN: There are obviously a variety, in any year there are a variety of
pieces of legislation that come before Congress and obviously without them
passing one it’s hard to comment specifically on pending pieces of legislation
however obviously there is significant Congressional in both the issue about
moving forward with ICD code sets and I of course would remind the committee
that we have previously had hearings, had a RAND report that we sponsored in
relationship to the issue of moving from ICD-9 up to ICD-10 which is part of,
which we have gone, we are previously on record as supporting the move from
ICD-9 to 10 in a measured and careful fashion.

It also turns out that there is a, to move to that one needs to have new
ANSI X-12 standards just because the current standards cannot accommodate
ICD-10 and so I think there is Congressional interest and discussion around all
of this, the recognition that these two pieces are interrelated. And I think
the recognition probably that something as important as moving from ICD-9 to
ICD-10 really is of interest to a wide variety of people across the country may
fall into legislation as well as regulation.

MR. BLAIR: The ICD-9 to ICD-10 I know that definitely is but it was like
going from one version of NCPDP Script —

DR. COHN: It’s actually ANSI X-12 I believe unless I’m mistaken, and you may
be referencing another bill potentially. Was there something else? Karen, do
you have a comment

MS. TRUDEL: Yeah, I just have a general procedural comment and Marjorie may
want to correct me if I’m not quite right on this, but the NCVHS as an advisory
committee to the Secretary should feel free to make whatever recommendations it
feels are appropriate to the Secretary, the Secretary then makes the decision
or the assessment as to whether he has the authority under his current legal
authority to take that kind of action or if not then he may wish to pursue
legislative change.

DR. COHN: And we can continue this conversation, I suspect that this issue
you’re bringing up Jeff may be a little beyond the scope of this letter but it
is something that should be talked about by the Standards and Security
Subcommittee only because I think you’re bringing up obviously a much bigger
issue which may be the purpose or point of another letter. Mike Fitzmaurice?

DR. FITZMAURICE: On the last paragraph in the sentence next to the last it
reads in particular the NCVHS recommends a streamlined process for adding new
standards and attachment types and for modifying existing standards. Well then
my mind naturally asks what streamlined process are we recommending, so I would
suggest a change in the sentence to in particular the NCVHS recommends that a
streamlined process for adding new standards and attachment types and for
modifying existing standards be found, or be developed.

MR. REYNOLDS: Everybody in agreement? I’ve got a question, were you going to
respond to Jeff and Simon? Okay.

DR. TANG: Actually I’m piggybacking on Michael because I was talking about
the last sentence, and Karen’s response to the question I asked about is there
a roadmap you’re planning and her response was no, we’d prefer this to happen
outside of the HIPAA process. Would that satisfy what you’re requesting in the

DR. COHN: Are you recommending some changes here or —

DR. TANG: Well I’m trying to make sure I understand what the letter is
requesting, so when I asked Karen is, this is a rule, it is not a complete
standard, set of standards, it is a direction and she explained how the
incremental benefits would accrue. And she also added that in order, this is my
interpretation, to make sure this is done in a streamlined and expeditious way
their thought is that further development of the next steps and roadmap would
occur outside of the HIPAA process. Did I misunderstand that Karen?

MS. TRUDEL: No, I don’t think you misunderstood it but I need to clarify
what I said a little bit. My point was that there’s some leeway in terms of how
prescriptive we want to be inside a standard and we chose not to be
particularly prescriptive within this standard. If for some reason the industry
decides that there’s a need to go to another version of the claims attachment
that has to be done by regulation and that’s what the issue of the modification
process addresses. So the current version of the standard provides a fair
amount of flexibility but if at some point in the future there’s a decision
that we want to step further or we want to adopt new standards for new
attachment types we’re back in the HIPAA realm again and there is a specific
modification process that the committee is already on record as saying needs to
be more flexible.

MR. REYNOLDS: And I would say as a committee we tried to step, this is not,
we prefaced in paragraph two carefully that we mentioned in e-prescribing we
had the same issue, the same recommendation, that as the industry, as NCPDP or
anybody else starts rolling out version, if every version has to be dealt with
through a large legislative process how will people move forward, we used the
term backward compatible as one of our terminologies that we used so that you
could allow people to move forward but you’re not penalizing everybody behind.

On the other hand we didn’t want to be too prescriptive because how this
actually works with all the HIPAA regs and all the other things that are going
on as to how things get approved, we were not trying to be prescriptive in
stating exactly what should happen, instead we were recommending that as you
look at more and more versions coming out, for example the attachments came out
on, mentions 4050 which is not actually an approved version yet, also people
are already working on 5010 so you find yourself in a situation that you got
lots of things in place.

So we were just trying to make a point, a clear point that the whole process
needs to be considered because there’s a difference between adding a
significant thing like an 837 versus possibly just changing some data elements.

John had a question first.

MR. HOUSTON: Just real briefly in the first sentence, the last part of it,
but having only a limited time to review the standards offers no specific
technical comments, I’m not sure whether that’s meaningful, I mean because
you’re talking about having a streamlined process later in that paragraph so
when I read it it sort of seems like it’s sort of whining a little bit.

MR. REYNOLDS: Comment on that Marjorie.

MS. GREENBERG: My concern on that is that does this raise the expectation
that if the comment period is extended, which there’s a strong possibility,
then you’ll be coming back with specific technical comments, and do you have
any intention of doing so.

MR. REYNOLDS: No, I’m not sure the committee ever had the intention of
diving into this at a significant technical level and anybody else on the
committee can jump in —

MS. MCCALL: Then it’s not because of lack of time. I would recommend then
that we drop it because it does set the expectation that we would come back.

First some of this is relatively new to me and I guess the whole concept of
taking this out of the realm of legislative activity and out of HIPAA. Is that
going to be well embraced? Or is that something that we need to make sure not
to bury the lead if that’s one of the key themes here. We did it this way the
first time but by God let’s not ever do it this way again because it will never
be nimble enough to adapt. Is that going to be easy to accomplish or is it
going to be hard?

MR. REYNOLDS: I would say until, the whole reason we have stayed out of
prescriptive is the way this all works, and if you make, if you allow the
adoption of new versions then how do you get everybody to move towards it
because there’s one school of thought that says if it’s not mandated it’s not
going to happen, there’s another school of thought that says let free
enterprise move as long as things are approved. And so I think it is an issue,
in other words in a lot of other situations I know from our committee we have
been a little more prescriptive in what we may or may not have said, this one
opens a whole new process, a whole new situation and a whole new structure as
to how it all plays together and whether it’s Karen looking at it from CMS,
whether it’s Congress looking at it, whether it’s the department looking at it,
whether it’s the industry looking at it, it’s going to take some vetting and
it’s going to take some issues. But the point is continuing to have everything
have to go through a three, four year cycle is not where we want to be so
that’s kind of the initial message that we’re sending out.

Please, anybody on the committee agree or disagree.

DR. COHN: I’m just trying to think of how we’re referencing here it, I think
we’re referencing it by reference to other documents that we’ve sent about all
of this stuff and I don’t know that we really necessarily need to go
extensively into this document rehashing other pieces though I do think we may
need a sentence at the very end where we talk about, I mean we’re sort of
saying department go off and come up with something streamlined and maybe we
need to say something along the lines for our part we will continue to work
with you to help identify and refine that streamlined process, and that’s sort
of the thing. Obviously the government itself it sort of, I mean there’s pieces
called legislation, there’s pieces called regulation, but then there’s also
pieces called streamlining the regulatory approach, and I think what we were
talking about primarily and have referenced previously has been trying to
streamline the regulatory approach on this.

MR. REYNOLDS: Before we get too many subjects on the floor at once does
everybody recommend in that next to the last paragraph that we strike the
limited time and whether or not we would come back with —

DR. STEINDEL: I have a comment on that. Actually in the various drafts I was
the one suggesting adding that wording and the reason why I added that wording
is without it it says we support the proposed standards. There are numerous
aspects of the proposed standard that if we had, and other groups are asking
for more time to review and we would never have the time as Harry points out,
that I think we would find we wanted to comment on. So I did not want the word
that NCVHS supports the proposed standard to be interpreted that we were fully
behind all aspects of it because we haven’t had enough time to review all
aspects of it from a technical detail.

MR. BLAIR: What if we took the entire sentence out so it doesn’t have the
statement that we support, just the entire sentence goes?

DR. STEINDEL: Or we compliment CMS on introducing, something like that.

MR. BLAIR: I think his idea of compliments, Steve is saying we compliment
CMS because this is making progress, this is moving the ball forward, and we
don’t have to say anything more.

MR. REYNOLDS: What I’d recommend is that the committee take this and bring
it back, this sentence back tomorrow for consideration.

DR. COHN: Karen, did you have a comment on this?

MS. TRUDEL: I just have one suggestion for pursuing additional language and
rather then saying that there’s an agreement in every aspect, what are the
aspects that the committee does agree with, does the committee agree that the
first six are good, that it’s good to take a phased approach, that it’s good to
use established standards like X-12 and HL7, I mean I think there are some
things that the committee could weigh in on and say that they’re good without
giving the impression that we buy in down to the lowest possible level of
technical detail.

DR. TANG: In my mind there’s a critical question of scope of this particular
piece of, particular provision of HIPAA, because an attachment can be as
expensive as basically the EHR and clearly that’s not, that may be what we need
but that’s not what we’re expecting I think of CMS. And that bears on the whole
process of what’s included and what’s excluded from this regulatory process and
modification. So I don’t know what the answer to that scope question is because
I think that will bear on what we want to comment on with respect to the
process. Do you have a clear definition for what standards is within the scope
of this regulatory process on claims attachment?

DR. COHN: There are a number of standards referenced, things like HL7,
LOINC, there’s obviously X-12, this is a CDA document and I think they’re
asking for comments about that. I think there’s I mean a whole set of issues
about all of this stuff but I think as Karen has comment this is meant to be
something that sort of links the clinical and the administrative side. Now I
don’t know whether you’re asking about the issues about whether or not, how
much information you could ask for which of course is governed by minimum
necessary, but are you talking about the —

DR. TANG: It’s more they could get into data content standards for example
and is that the intent and so if that were true would that be, have to follow
the regulatory process and notification process, so that’s my real question is
how expansive is standards regarding claims attachment because that can be key.

DR. STEINDEL: Paul is getting into some of the nitty gritty things. May I
recommend that we defer it until the subcommittee discussion? Because you’re
bringing up some of the technical issues.

MR. REYNOLDS: Are we continuing then?

DR. COHN: I think we should continue, I’m sort of looking around —

MR. REYNOLDS: No, when David walks in I’ll stop. We were interested to see
that the development of the NPRM, this is the last paragraph, we were
interested to see that the development of the NPRM was informed by a small
scale pilot project with Empire Medicare Services which focused on the human
decision variant for sending text or converting data to text. We believe a
pilot, we believe pilot testing is critical for both the human decision variant
and the computer decision variant in which data can be used in an automated
fashion and read and understood by the computer. Because clearinghouses and
vendors may not have the experience with LOINC code sets we believe that pilots
should include testing of the full range of LOINC codes required by the
clinical and laboratory attachments along with any other untested claim
attachment types.

NCVHS therefore recommends that pilot studies should be funded and conducted
using both the computer and human variants for the full suite of claims
attachments and attachment types that are proposed for adoption in this NPRM as
well as the other attachments that are under developing including home health
care, durable medical equipment, periodontal, and children’s preventive health
services. The committee expects that the department will be able to leverage
partnership opportunities with the private sector that should be stimulated by
rulemaking in the areas of claims attachments.


MR. HOUSTON: I have two comments, one is a real nitpicking thing which is as
you talk about a pilot project in one place and a pilot study in another, make
it consistent. The other one is I don’t understand what that last sentence
means and I guess I’m not sure what it is, what it adds to the paragraph, or
whether it just needs to be clarified.

MR. REYNOLDS: I guess our comment is that obviously the private sector is
very interested in this and focusing on it and it’s not like you’re having to
possibly look real hard to find people that would be willing to pilot some of
these things. I think that’s where we were heading.

MR. HOUSTON: I think we should probably just clarify it, say it more

MR. REYNOLDS: Simon, I’ll turn it back to the chair.

DR. COHN: Harry, thank you for your good work on this one, we’ll finish off
the remainder of this probably some point in the afternoon.

Well with that I’m pleased to welcome Dr. David Brailer, David thank you and
whenever we see you we usually congratulate on your good work and I think never
more so then now, so please.

Agenda Item: Update on Office of the National
Coordinator for Health Information Technology, AHIC Developments – Dr.

DR. BRAILER: Thank you, that’s a very kind way to start the meeting, I
appreciate you all taking time to hear the update about what we’re doing in the
Office of the National Coordinator. That is our new acronym, ONC, we have
stopped the acronym ONCHIT for fear of constant abuse of the name.

— [Laughter.] —

DR. BRAILER: I’d like to just give you all a quick update on two things that
we have underway, first is a very quick briefing on the contracts that we’ve
signed since I last met with you which constitute a very large share of the
infrastructure that we will be laying out and playing from over the course of
the next year, and then also on the activities of the American Health
Information Community which is one of your peer advisory committees and we’ll
be working very closely with you to advance the health information technology
agenda. And I’ll be very brief and I’m passing out a copy of both the major
initiatives that are going on through the contracts as well as the
breakthroughs that are detailed for the American Health Information Community.
So I’m going to just very briefly comment on six contracts, one policy change,
and then I’ll turn to the community, and it’s largely following this major
initiative sheet.

So I think you all know that we awarded a contract to ANSI, the American
National Standards Institute, a couple of months ago to create a new group
which is the Health Information Technology Standards Panel, and that panel will
be our harmonizing agent for standards in the United States. The purpose of
this group is to not change or intervene directly into the affairs of the SDOs,
to let the SDOs continue their entrepreneurial spirit and to be part of
whatever global alliances they may be part of, but to create a coherent single
set of standards for the U.S.

And our challenges are three fold, first to make sure that the standards are
non-duplicative, non-overlapping, non-ambiguous. Two, to make sure that they
are complete, I’ll come back to that. And thirdly, to make sure they are
specific in detail. And I think standards in the U.S. generally speaking fail
on one or more of those nearly every time. They’re often duplicating or
ambiguous standards, standards exist but they are not complete enough to be
used to solve certain problems, and they often because of the consensus process
stop at the level of detail needed for two different software engineers or
coding teams to implement them in a way that allow them to be interchangeable.

And standards harmonization will focus its efforts on those three challenges
and we’ve asked them to be not data driven but business driven and what we mean
by that is don’t say what can we do to standardize lab data but say what can we
do to solve the problem of lab data arriving in an emergency room, so to work
from business cases, to help focus this and ultimately link the pain of
standardization, and let’s be honest, standardization of data is painful, it’s
costly, requires changes of systems, of business process, the only way we think
this will diffuse the U.S. is if we link that pain to a benefit and the benefit
comes from solving someone’s problem.

So we do want the standards community to directly integrate itself into the
problems that doctors, patients, and hospitals live with every day and to see
themselves as an ingredient of their success, and if they don’t see if that I
think we will not achieve the level of standardization that you’ve called for
since I was a child, which wasn’t that long ago.

Secondly, compliance certification, I think you’ve heard a lot about this,
we had the privilege of contracting with a group that has already distinguished
itself for the quality and detail of its work and the very, very well developed
public process and that’s the Certification Commission for Health IT. It’s
really a remarkable group of people who came together with a passion, its what
the private sector has done best I think in health IT recently, and we have now
contracted with them to develop first criteria for what constitutes ambulatory
electronic health record.

And to make it as simple as possible what they will do by developing those
criteria is change our language about health IT. We will no longer get into
debates about what’s the difference between an electronic health record and
electronic medical record, a computerized patient record and other things, we
will talk about functions and whether or not functions constitute those tools
and I think we need to get that level of specificity.

They have a very short deadline for delivering to us ambulatory PHR
certification criteria in a draft state, i.e., next month, and to finalize
those by no later then mid-2006. And expect to see prototype certification
results done by July of 2006 such that a system could ask to be certified such
that it gets a Good Housekeeping Seal of Approval as certified or not. We think
this is a benefit to physicians and hospitals that are trying to sort out their
options and are feeling confused and overwhelmed with all the different choices
they have and they want to kind of know what’s going on with products, it will
be the investment community put their capital against tools that help the
American public become more healthy, and it will help policy makers have
specific policies that can be enforced and operationalized in a way, and I’ll
come to the primary example of that that’s underway now which is the physician
self referral and anti-kickback safe harbor that we’ve proposed.

We will then follow compliance certification into inpatient electronic
health records, and then into national network architectures. But the
Certification Commission is required to lay out a roadmap for a variety of
different technologies that it can look at over the next three years.

Third is privacy and security solutions and we have contracted with RTI to
launch a new organization called the Health Information Security and Privacy
Collaboration. And this organization is novel in that it will be an
organization of states and state leaders to come together to begin
understanding what we need to do to move the paradigm for privacy and security
from the paper age to the digital age. It’s our sense that a lot of debates
occur about what’s right or wrong with current policies but the issue in the
middle of these is the irreconcilable challenges that paper introduces. We have
a debate about enforcement, that enforcement means cost and it means
significant barriers in a paper world. That debate changes dramatically in
electronic world, it is also is the same with disclosure accounting.

So if you look at many of the issues we’re facing we believe that they’re
imposed in part by our dependence on paper and so what this group is going to
start doing is looking at what should the policies and procedures and practices
look like at the state, federal, and business levels in a world that is
digital, what are the policies we should begin expecting and who is it that
should do things about these, what are federally driven, what are state driven,
and what are business policy driven. Because we want to make sure that our
paradigm for privacy and security keeps up with the technical innovation that’s
occurring today.

Now I need not say that to you as a group who is already well along in this
work but we have to be able to get this to live and breath at the level where
these laws are largely made which is at the state level. And so we want to be
able to get focused quickly on each state that wants to engage on this having
their own health information security and privacy collaboration that rolls up
into a federal effort to begin creating a living breathing effort. In many ways
I view this as the first cousin of compliance certification in that it is an
organization process we’re trying to create that gives us a platform to begin
addressing this problem over the course of time.

We announced last week four awards for prototypes of the Nationwide Health
Information Network. This was a very tough choice because we had more then 80
excellent proposals from well developed teams and consortia of providers with
very good health markets. But given the current status of our range of ’06
appropriations we awarded four contracts, those were to Accensure(?) and
colleagues, CSC and Colleagues, IBM and colleagues, and Northrop Grumman and
colleagues all working with three distinct health market areas. And these
market areas will work with these consortia to develop architectural
requirements for nationwide connectivity, they will submit those for review
across all four of them, and they will prototype those in the actual markets.

The output of this group will become inputs into the Certification
Commission in its dialogue about how do we certify architectures and our
thinking is that this is not unlike the electronic health record except we
don’t have a large share of providers offering the service today. In the end
the best analogy I can give you is that our vision for the Nationwide Health
Information Network is not unlike cellular telephony where the electronic
health record is like the handheld device, you have many choices, some that
have a lot of features, some that don’t, but all of them can connect to a
cellular network and you can have complete interoperability of sharing calls
back and forth and passing them off to any network.

So there will be a set of competing network operators who compete on the
price, the quality, and the data completeness of their service to doctors such
that they can connect to electronic health records and delivery them, the labs,
the pharmacy data, the other doctor’s notes, the other components that are now
done in one up specialized and highly cumbersome and costly direct integration
and interfaces. This project will take some time to play out, it’s an 18 month
project to start, and we expect to see this evolve significantly over the
course in time.

We just finished the report on an effort on health information technology
and health care fraud asking questions about what do we believe the impact of
health IT will be on the rate, incidence and prosecution of fraud, what do we
expect it to do with respect to fraud losses, and on the flip side what is it
that the both private enforcement and federal, state law enforcement
authorities should do to begin preparing for the world of cyber fraud. This
looked at legal regulatory issues, it looked at business practice questions and
it looked at economic models.

And the findings of the economic models would not be surprising to you that
with partial interoperability, with information silos, the exposure to fraud,
could go up, but more important the cost of policing fraud could go up
dramatically. But in an interoperable world where we’re able to get more
complete data and move information tools towards the point of care that can
help providers know while they’re seeing a patient and coding them whether or
not fraud could be being perpetrated, we can begin to move into a world not of
prosecuting fraud but of prosecuting fraud as preventing it at the source of
care which is much cheaper for everyone. And so there’s great potential, we’ll
be following this on with a much more specific demonstration project to begin
understanding what that means sometime in 2006.

We also awarded a contract to George Washington University, to Sarah
Rosenbaum and to David Blumenthal at Massachusetts General Hospital to pull
together an annual report on health IT adoption. Now there are many, many
surveys that exist about the level of health IT adoption and some of you know
that I wrote a paper on the level of health IT adoption, in fact I think Paul
Tang asked me to do that for his Patient Safety Data Standards Committee, and
what I ended up doing was writing a paper on how bad all of the statistics
were. And then of course like any good scientist I drew conclusions from it

But our sense was that we clearly have an obligation to report to the
President and to the American people about whether our policies are working and
what’s happening with adoption, in particular not just to focus on broad levels
of adoption but specific drill downs on adoption gap issues in urban versus
rural, large versus small, safety net versus general care environments, etc.
And the way to do that was to not just fund another survey that supplements the
ones in CDC and CMS and the private sector, but was to put together an expert
panel whose job it was to create a meta analysis framework for all of the
standards, or all of the surveys, and to be able to compile them into an
aggregate view of what’s happening.

The best analogy I can give you is the Council of Economic Advisors who
pulls together many, many data points, forecasts, models, leading indicators of
economic function and tells America what’s happening with the economy in an
objective quasi scientific way. And I say quasi because it is a meta derivative
product. And so this group will do this but hopefully over the course of that
not just tell us what the statistics say but through their meta standards allow
all of the data collectors to begin adopting common questions and common survey
techniques in working together. And we have given them authority to do specific
surveys if they need to drill down on a specific area or if they can’t resolve
a finding based on the data that happens to be made available. So this group is
going to be underway with a report due in mid-2006 on the first pass level of
adoption as an official report.

Those are the contracts that are underway, pending the ’06 appropriation
I’ll have other announcements to make but again what we’re doing here is using
the procurement mechanism to procure process, we’re creating entities,
organizations and process whose purpose is to create platforms and leverage
points so we can begin driving private sector adoption. This is a very
different way then publishing a regulation or a very different way then the
government procuring a network that it would use itself, it’s a hybrid of the
two. But in the end we think this will give us much more ability to manage an
evolving and organic world, it will give us much better ability to bring many
players along on a voluntary basis rather then a mandatory basis, and it will
let us begin dealing with the real so what’s of health IT which are the impacts
on efficiency, quality, on access to care and other things as opposed to
dealing with the technology itself.

So this is where we’re heading, we’re well underway now, my office has now
shifted directly into a focus of implementation. We have a new management team
in place and I think some of you have met them but the team that’s come in,
some people who are here, Robert Wase(?), the acting deputy, Robert could you
stand up, from DOD, we have Jody Daniel who is from OGC who is now the acting
director of policy and research. Dana Haasa(?) is the acting director of
programs and coordination and handles the American Health Information
Community. And John Luntz(?) who is the acting director of interoperability and
standards and most of the contracts that I just announced are under John’s
portfolio so he’s going to be a busy guy. And then Karen Belle who came over to
us from CMS who is the acting director of health IT adoption. This is a first
class team who are here and they are very implementation focused and locked in
on these goals.

We had one other announcement that was made recently where we announced the
proposed self referral and anti-kickback safe harbor that would allow hospitals
to donate software and services to doctors for health information technology
use. That rule change contemplated a world before we had certification criteria
where there’d be a very limited donation allowed, in a world after
certification where there could be an expansion of that limit or that cap or
easing of further restrictions for certified technology. So we’re putting our
policy interest directly in line where we are because certification gives us a
tool to do things and the basic argument here is any time we open up an
exception to a safe harbor, an exception or a safe harbor to these abuse rules
we expose the public to a risk of abuse.

So they need to get something back that is better for them then what they
theoretically could have lost and in this case what they get back with a
certified system is better protection of their health information, access to
state of the art clinical rules and prompts that their doctor could use about
how to make sure they follow current evidence, and interoperability to allow
their data to be portable and to move as they move through care. And our sense
is that that is a much better result for the American public and so that
proposal is out asking for comment.

Finally we have the American Health Information Community underway, it is
having its second meeting on November 29th starting at 8:30, and
this meeting will be a detailed discussion about five potential breakthroughs.
A breakthrough is defined by the American Health Information Community as a
health information technology innovation that could be seen by the public to
have tangible values in two to three years. And the five that we’re focusing on
are some area of consumer empowerment, a personal health record on the north
end, a record locator service on the bottom end, in the middle my registration
data, my drug data type things. And we’re going to have the American Health
Information Community target one of those areas and charge a workgroup to go
off and come back and tell us what federal policy, what business practice, what
financial, what legal, what cultural barriers need to be knocked down for that
to happen on a widespread basis.

Secondly is quality measurement, this is around how does health IT help deal
with this. Many of us know that quality measurement is largely rate limited by
lack of agreement on quality metrics which comes from lack of agreement on
practice standards. So we’re not sure that health IT can play the critical
catalyst role here but we’re going to look at it. Chronic disease monitoring
which is remote patient monitoring, disease management, and remote forms of
management of the patient, this is an area that’s quite fruitful,
e-prescribing, and then bio surveillance, both for bioterrorism and for
pandemic events that is largely built around being able to know that events
have occurred an to triage resources around those as they occur and probably
most importantly to allow the public health apparatus to manage those
situations as they occur given that they occur over time.

So the American Health Information Community expects to have its workgroups
operational by the end of the year, at least two or three areas, with others
being cued up as opportunities exist. So I ask you to follow that and we do
expect to have the NCVHS work closely with the American Health Information
Community to achieve the goals that we’ve all sought for a long time.

With that I’ll stop and be happy to take your questions or comments and
again thanks for having me come.

DR. COHN: And David again, congratulations, I also want to welcome your new
staff and directors and obviously congratulations on your new roles.

David as I commented and I think once again, I mean the work since you’ve
last updated us, I mean it’s always been sort of planning and future vision and
suddenly you have the processes in place, you have the contracts awarded, it
really sounds like we’re into implementation so congratulations.

Questions from the committee? And I know you only have a couple of minutes
so just let us know when we need to stop. Jeff?

MR. BLAIR: Thank you. Dr. Brailer, very impressed with all of the
initiatives you have in place now, it’s very exciting to see all of this.

One of the areas that I was wondering about was whether the folks that have
been awarded contracts for the architecture, whether they will be exploring how
we could wind up either integrating or facilitating complimentary
interoperation of some type between tele-health networks, e-prescribing
networks and health information exchange networks. Do you have any information
you can share with us about that focus?

DR. BRAILER: Well, Jeff, first thanks for the recognition of the work that
many people have done and I would say that while I’m the pretty face for what
it is on all this I’ve just summarized the work of probably 300 people in the
federal government who have worked tirelessly to get where we are so I think we
should just acknowledge that a lot of this stuff has been underway for a long
time before I got here and in the end the work just to for example award the
NHIN contracts involved dozens of federal staff reviewing lots of proposals. So

We are filled in health care with one up point to point information networks
and our current operational model is to continue that. And it’s not just in the
list of examples you gave, if you look at bio surveillance and things in public
health, if you look at what we’re doing with collecting quality data, if you
look at what we’re doing to collect data for adverse events, for creating web
portals, for being able to wire things around, doctors around patients, the
mode of practice in the U.S. is proprietary enterprise systems with a lot of
custom integration for point to point purposes.

The question that the NHIN contracts are asking is what is the high water
mark, how far can we go towards a generalized general purpose network that acts
like the internet for tying together the parties with multi functional
information sharing attributes such that if we want to collect data between,
share data between two doctors for a patient we can do that in the same
environment where a lab can make their data available to those doctors, in the
same environment where if it has data that is of statutory interest to the FDA
it can get that data, etc., etc. We spend in the government, federal government
alone, more then $5 billion dollars a year on health IT and most of it supports
these custom one up networks and data collections and we don’t know the cost we
impose on the private sector by having many agencies engage in what I consider
to be quasi regulation by asking them to submit data to agencies to comply with
certain interface standards and I think that’s going to continue.

It could be that we’ll find that there are legitimate business, financial,
jurisdictional, legal reasons why we need all these fragmented networks, not
just in the government but in the private sector. I hope we don’t, I would be
grossly disappointed. I hope we find that we can largely build out a lot of the
general context for what we consider to be silos, e-prescribing, health
information exchange, ongoing community, into a generalized environment where
we can the ability to share the cost across many players and across many
business functions, and we can get much tighter integratedness and capacity.

In the end my view, and I know this is being overly simplistic, is if we can
pop a personal health record on top of that network and make it useful for a
patient we have passed a goal where we start to become patient centered in our
networks. I don’t know if we’ll ever do that but that is at least is a simple
metric that we might think about.

We’re really asking ourselves here first how far can we go and we’re going
to be pushing these contractors and those of you that read the RFPs know that
the bias was showing in this to go as far as they could even if we had to scale
back as we began looking at how to make this practicable in real life in health

MR. BLAIR: Thank you.

DR. COHN: David before we go to more questions what time do you need to be
out of here?

DR. BRAILER: I’m okay, I’ve got a few more minutes.

DR. COHN: Okay, good. Judy Warren?

DR. WARREN: One, I think the briefing paper on AHIC is a wonderful document.
I do have one concern though, when you talk through all this, and you may
already know where I’m coming from, this is a briefing document that talks
about the impact that AHIC is looking at for physicians. Are you also going to
be looking at the impact that other clinicians have?

DR. BRAILER: It’s a good question and I guess I would first by commenting on
the premise, I think most of the benefit the American Health Information
Community is looking at is aimed consumers. When we —

DR. WARREN: But the concern that I have is when you look at this briefing
paper, and if other people look at it, all they’re going to see is that this is
about physicians doing things with and for patients, it’s not accounting for
any of the other clinicians that impact health care. So I would just say take a
look at it and maybe the word clinician is a better word then physician in that
it becomes more inclusive.

DR. BRAILER: For example in the first line of my personal health record
allowing an authorized clinician, yeah, I think unless we’ve made a mistake we
meticulously referred to physicians where it is something that physicians do —

DR. WARREN: But nurse practitioners also do that, they also do
e-prescribing, so do other —

DR. BRAILER: Point well taken but I think I come back to rather then dealing
with the issues that I think most of the public consider to be inter-nesting
between doctors and nurses, what the consumers want to know is what’s in it for
them, can they get their information, can they get the tools to make decisions,
and that’s where we’re putting most of our focus is to bring the consumers into
this and make health care much more transparent, much more accessible and much
more controlled by them.

DR. WARREN: And that’s what I applaud for the paper is it does put that out.
I’m just worried about the messages that were given in written documents that
people will take a look at and how it narrows their interpretation.

DR. BRAILER: I can assure you that Lilly Delanis(?) is not letting us get
away with anything from a doctor bias on the AHIC.

DR. WARREN: I know Lilly, I’ll keep up.

MR. VIGILANTE: Not to choose any more doctor bias but, as usual David great
presentation, thank you so much. I was interested in the anti-kickback rules
that generally apply to doctors and is this something from the point of view of
regulatory hierarchy that is going to be hard to do, does it require
legislative action, what are the barriers to this actually happening and what
might the timeframe be?

DR. BRAILER: Well we have, Kevin, we have put out the proposed rule but it’s
in an abstracted form, there’s a lot of details that in the final release of
what we thought could be an answer we just scaled back because we want to have
real dialogue about this. But we did this within the bounds of what we believed
we could do statutorily with no change and no authorization from Congress.
Congress is able to do things obviously that make those rules much cleaner and
there’s legal hurdles that we have to be able to cross that sometimes result in
ambiguity, it’s just how the regulations work.

But the instructions that the staff followed was to make it as clean as
possible and as specific as possible and that’s why you see for example both
self referral and anti-kickback open from CMS and OIG at the same time in that
proposal, that’s why you see it linked to something specific like certification
as opposed to something general like EHRs or health IT. That’s why you see it
being set up in a way that there will be contemplated specifically enumerated
caps. So from a legal and regulatory point of view we are on solid footing, the
question is going to be what are the unintended consequences that could result
from that which will surface during the comment period, what are the
implications that haven’t been contemplated that could be adverse, where is it
that our estimation that consumers dramatically benefit from this more, much
more then they could be harmed, where that calculus is not correct, those are
the things that are being probed and those I think turn into become either a
feasibility judgment of the overall initiative or they turn into specifically
modulated language that put restrictions or illumination or specificity around
any part of it.

And so the comment period Jody is ending, is it mid-February —

MS. DANIEL: I think it was just extended, I don’t know the date, it’s still
open but it was just extended I think by a month. I think it should be closing

DR. BRAILER: And then the process after that depends on the weightiness and
the degree of texture of the comments that we get.

DR. TANG: David, I want to join the congratulations to you, your team and
the many federal employees that have been working on this, I think your
accomplishments have been nothing short of phenomenal, I think you’ve set out a
very cogent and feasible strategy getting us very far.

One comment is you’ve put into place this certification process and a lot
rides on that, clearly if either the extremes of zero or 100 percent get
certified we wouldn’t be moving along your plan. In your mind what do you think
the sweet spot would be for getting through for certifying, what level would be
a sweet spot in your mind to certify companies as having functional EHRs?

DR. BRAILER: Well as an eternal optimist I’m a Lake Woebegone thinker, I
think America’s Health IT Community is well above average and I would expect to
see a lot of people, a lot of products be certified. But there’s a reality
beneath that which is the question as we contemplated certification was what is
the interpretation of certification because that translates into the percentage
that crossed the line if you would. And our sense was that if we engaged in
stating what is the best product we would not serve the needs of doctors or the
public or the investment community, the regulatory community, because we would
be largely picking winners and we don’t want to pick winners, or losers. If we
engaged in kind of a middle tier to say who’s a C or better and who’s a C or
less, that could help us probably have better specificity from a regulatory
point of view but it would be quite harmful to the doctor and hospital that
wants to be able to understand what they get for what they buy because a C
minus and a C plus could be quite similar systems and therefore but could be
charged at different prices.

We chose in the end to view certification as a minimal requirement, in other
words if a product meets all of those certification criteria it is minimally
configured to do the work that we would believe is necessary based on
interoperability, privacy protections, and clinical decision support to support
doctors and their practices in an ambulatory setting. Or said another way, and
this is the important point, if it fails to meet it it should have such a level
of concern to the vendor of that product or to the investment community or to
the doctor that it should be something that they would agree should be trued up
in their product.

Now the complaint against minimal certification is that it doesn’t stimulate
innovation, it doesn’t help us pick the best, and my view that’s what markets
are supposed to do, that’s not what government is supposed to do, we’re not
supposed to pick. And so the market will hopefully based on certification begin
asking the next question which is why do two certified products cost different
amounts of money, and it could be you get a lot more for twice the price but
we’ve never had a basis for asking that question and now we will. The market
will sort out essentially price performance, and I think the market will also
stimulate innovation, in fact I believe minimal certification starts to
stimulate modularity and starts to stimulate minimally configured products that
are aimed at very low price points which is an area we’ve identified many times
as a concern for very small offices, and so in the end we chose this.

Based on that I would certainly hope that a large share of existing products
can cross the line and to those who have, the very few who have chosen to
criticize that as simply just endorsing a whole swath of the sector I believer
there will be those that don’t make it, probably those who know they won’t make
it will never seek certification, there’s no reason to have it pointed out in
public. And I think the important thing is that certification criteria evolve
and become more stringent over time and raise everyone’s profile and over time
you might expect to see stratifications of that or much more detailed cuts of
who is certified for what.

DR. COHN: We’ve got Russ and then we’ve got Carol and then we will take a
break. Russ?

MR. LOCALIO: I just want to see if I can put 16 pages of Federal Register in
one sentence, I think it’s your goal that you want to have a physician, nurse
practitioner, podiatrist, nurse be able to be given a palm pilot by a hospital,
to be able to do prescribing without going to prison, I think that’s the gist
of it.

DR. BRAILER: Or getting a civil penalty.

MR. LOCALIO: Correct. Now is it also your hope that the physician, nurse
practitioner, podiatrist could use the same palm pilot with the same software
in all of the hospitals at which he or she works, is that the goal?

DR. BRAILER: Not per se, that is certainly the hope. Let me just step back
and remind everyone that the Medicare Modernization Act required that a safe
harbor be published and an exception to self referral for e-prescribing. And
like all slices of technology reality that get ensconced into the permanent
statement of statute that was a time when e-prescribing applications were
almost all handheld PDAs which is no longer the case and so there are things
that have carved out e-prescribing as a unique part and we serve that and met
the statute requirement by publishing the statutory exception. It is clearly
the expectation in e-prescribing that those tools will be physician centric,
they will not be to the peril of the e-prescribing community and those that
want to benefit from it There’s no requirement in the law that it be done that
way but the interoperability standards that are already underway with a
regulatory push for prescription data and the prescription drug plan sponsor
process that can aggregate themselves around that I think will find a business

Now in the electronic health record side that was done outside of statute
and again that is aimed at things that do include e-prescribing but go across
the whole gambit and there it’s certainly our belief that any product that’s
used will be used in the physician’s office and will tie to any other data that
they need. And that’s why we have modularly separated the electronic health
record from the network aspects to share information so we don’t deal with this
issue that literally the physician has five EHRs depending on who the patient
came in from. So I think there the law of practicality will be much more
stringent then the law of statute in terms of requiring that to happen.

DR. COHN: Carol, last question.

MS. MCCALL: I guess one more congratulations, this is relatively new for me
and just to see the progress, things come from concept to actual readiness to
go implement is just incredibly exciting. I want to kind of think about what
happens not only in that execution but even beyond that and in particular the
comment that you made about these breakthrough initiatives, there was one
comment in particular that I found very interesting and it was related to
quality and the fact that, and to your point that today there’s a lot of
information that we don’t have, benchmarks and standards and metrics that
haven’t been developed and so you’re not quite exactly what will happen in that

So with that as a backdrop I have two questions, the first question is have
you or will you kind of charge these major efforts and these contractors to
anticipate and try to link with those efforts? And the reason I ask that is
because there’s so much of the development of those metrics and best practice
that will come from this data, so that’s question number one.

And question number two is what other activities do you see AHIC taking on
in order to push that particular agenda forward? And how can we help?

DR. BRAILER: The particular agenda being quality measurement?


DR. BRAILER: The contractors are required to work both the general
deliverables, for example certification of electronic health records or develop
of a generalized network and also to incorporate three specific breakthroughs
into their use case planning. And our goal immediately with the AHIC is to
identify those use cases, those breakthroughs, so they can be passed to the
contractors, therefore certification as my one example but it’s true for
privacy, it’s true for standards, all of them, even there are adoption survey
group to certification for example would say okay we have bio surveillance as
one of the breakthroughs, what do we have to do to add to the minimally
configured electronic health record for ’07, for example, that would allow it
to be compatible with generalized transmission of the data that’s needed, and
etc., it will work through all that.

So the simplest answer is if the AHIC ranks quality measurement as one of
its priorities it would work through this process that way, and the contractors
would touch it, and I expect a large share of the time to be touched on working
breakthroughs, these won’t happen just by bully pulpit, they’ll happen because
we build the infrastructure and deal with the regulatory barriers and start
looking at cultural and financial economic issues in the industry.

If it doesn’t prioritize it and I signaled that I thought it may not only
because the community itself has come to us and said be careful there’s a lot
more here that’s outside the scope of IT then is in. I don’t know how it would
regard that, we haven’t visited that, I think the meeting on the
29th is going to determine it. It clearly made the list of things
that are top importance and I wouldn’t think that anything on that list will go
away and I know the Secretary is quite interested in that but I don’t know the
mechanism for that going forward and therefore I don’t know how the contractors
would touch it per se.

It’s fair to say that if the key constituents were trying to drive
consolidated standardized and unified quality metrics agreed and it was
telegraphed in such a way that we would certainly work with the IT community to
ensure that those became minimal features, or to work with other communities to
build SDKs, that’s a software kit, or some kind of a plug in that could extract
the data and send it forward. But right now there are so many different ways
that even the same thing like the did you give aspirin to a beta blocker or an
aspirin to a heart attack patient, that’s measured completely different ways
and so there’s still a lot of noise to be able to turn it into something that
software engineers could do really easily and cheaply for all of us.

DR. COHN: David, thank you very much for a major accomplishment and
congratulations from all. Thanks.


DR. COHN: Now we’re running a little late as you all know, what we will do
is to take a break now for lunch and reconvene at 1:15.

[Whereupon at 12:23 p.m. the meeting was recessed, to reconvene at 1:23 p.m.
the same afternoon, November 16, 2005.]

O N [1:23 p.m.]

DR. COHN: Okay, first a housekeeping item and then we’ll talk about sort of
what we’ll do for the next session and talk about later on this afternoon. Now
the first housekeeping item has to do for the committee members and staff about
the dinner tonight at McCormick and Schmitt’s, we actually need I think a show
of hands for those who are going to be coming so that we can make sure to
reserve a large enough table. Okay, thank you.

Now given that we have not, we’ve sort of almost made it through the letter
on claims attachments I think we need to finish off our discussion of the
letter prior to going into the sort of general discussions.

I also want to comment what we will do is, obviously the subcommittees have
plans for meetings obviously after our full committee meeting, we’ll of course
respect the amount of time that is being allotted for those meetings and what
we’re going to do is likely to squeeze down the length of time for the NHII
Workgroup so we’ll set that up before we adjourn today but I just want to tell
you all that we will obviously assure that Populations as well as Standards and
Security has adequate time on their calendars.

So with that Harry would you like to go back and we’ll sort of —

Agenda Item: Subcommittee on Standards and Security –
Letter on Health Claims Attachments NPRM Continued – Mr. Blair and Mr.

MR. REYNOLDS: Yeah, beginning with the paragraph that I’m sure you all would
applaud called finally, it’s always a good place to start —

DR. COHN: Well Harry did you get full comments on that paragraph beforehand?

MR. REYNOLDS: I thought I did but if anybody else has anything else.

Under finally the NCVHS recommends that the department extend the comment
period on this NPRM for up to 90 days to allow the industry to take the
necessary time to, and I’ve already gotten one recommended change comment on
the business and technical implementation issues associated with the standards
proposed in this NPRM. If you remember Karen mentioned up to 60 days in her
presentation so I don’t think we’re too far out of line with that request.

Any comments on that? And playing off an earlier discussion it was
recommended that before the final NCVHS wishes to thank you it was recommended
that we put something in there we will work to help define this process or
somebody brought up something that they thought we should add right before the

MR. BLAIR: Simon did.

DR. COHN: Well actually I had a comment but I think it was really more along
the lines of in the fourth paragraph in terms of this, I mean are we referring
to the rulemaking process piece or are we talking about something else? That if
we’re going to make a comment it’s probably there relating to something about
for its part the NCVHS intends to work, offers to work with you in the
department —

MR. REYNOLDS: And you say the fourth paragraph starting NCVHS supports —

MR. COHN: Yeah, I think so, I mean we can wordsmith that at the subcommittee
meeting, you may convince me that it really is at the very end but we can sort
of take a look at that.

So the subcommittee will take that under submission and come back with a
revised letter for your review tomorrow, I think this will likely be the lone
action item of the subcommittee though, I think we’ve already passed a letter
congratulating HHS on their structured product labeling in the beginning of
that so we’ll make sure that we come out with a letter congratulating on that

MR. REYNOLDS: Thank you.

DR. COHN: Okay, Harry, thank you very much. Now what we’ll do is spend about
an hour and 15 minutes and this will be led by Mark Rothstein talking about,
what we’re going to do is spend about an hour and 15 minutes talking about the
work being done, being obviously led by Mark Rothstein for the Subcommittee on
Privacy and Confidentiality on investigations into privacy in the National
Health Information Network, and then we’ll switch gears and spend about an
equivalent amount of time being briefed and talking about what the Subcommittee
on Standards and Security has been identifying around this issue of data reuse
and secondary uses of data. Mark.

Agenda Item: Subcommittee on Privacy and
Confidentiality – Status of NHIN Report and Recommendations – Mr.

MR. ROTHSTEIN: Thank you, Chairman —

— [Laughter.] —

MR. ROTHSTEIN: Today’s topic for discussion is a privacy and confidentiality
and the NHIN and the Subcommittee on Privacy and Confidentiality has spent
virtually the entire year working on this issue. We’ve held four one to two day
hearings, two of them in Washington, one each in Chicago and San Francisco.
We’ve heard from numerous witnesses including, and I’ll probably be leaving
some groups out, privacy experts, patient advocates, various health care
provider associations, health care plans, organizations and systems, and health
policy experts, and we even heard about NHIN developments in the UK, Canada,
Australia, and Denmark. We’ve also held our share of conference calls and
subcommittee meetings and now we’re actually making serious progress on putting
together a draft document.

I’m not sure when it will be ready for the full committee’s consideration
but the issues are so complicated and contentious that we thought it was a good
idea to brief you beforehand about where we’re going so that you can be
following along with us.

Our meetings on this topic have been lively to say the least but the
subcommittee members have agreed that we will present only consensus views to
the full committee and that we’re going to remain united in support of our
recommendations so that we don’t have members criticizing our own report once
we issue it.

Today John, Paul, Harry and I will each present a different area that we’re
planning to cover in the report even though we don’t have a draft for you to
consider so we’ll each have maybe 15 minutes or so to cover this area. And only
the first five minutes will be our telling you what the issues are and we want
time for each area for you to ask questions and then if there is time after the
clarifying questions if time permits to have discussion on the issues.

After today I think you will see how important and baffling these issues are
and we would invite you to send us questions or comments and certainly to
attend our meetings if you want. Tomorrow morning from 8:00 to 9:50 we’ll be
meeting in Room 443E and I know some of you have a meeting that begins at 8:30
but if you want to come at 8:00 to 8:30, when there are people from the full
committee there as opposed to purely subcommittee members we will sort of set
aside our agenda just to answer your questions if you have any.

One other thing I should say before we get to the individual section
presentations, I know this is a very astute group and you may see quite early
on that some of our recommendations may appear to be inconsistent. That’s
because they are. But there’s a reason for it and that is if you think about
it, if we control or limit the collection or use of disclosure at Point A we
don’t have to worry about it when it gets to Point B, but if we don’t limit it
at Point A then we have to have some rule in effect when it gets to Point B and
as well as Point C. So we may be putting in suggestions about doing things
downstream that would be mooted if we adopted a system of controlling it early

And because he has to leave early for another responsibility we’ve asked
Harry to begin first to talk about establishing and maintaining public trust in
the NHIN. John, did you have —

MR. HOUSTON: Do you want to describe generally the five categories that we
are going to discuss?

MR. ROTHSTEIN: Okay, well I can tell you the five areas that we’re going to
talk about today, establishing and maintaining public trust that Harry will
address, then John will address disclosures and regulatory issues, Paul will
address secondary uses, and I will discuss the fun issue of patient control of
information in the NHIN. Harry?

MR. REYNOLDS: Okay ready? Kind of the body, the ideas in the body of our
draft letter as it relates to establishing and maintaining trust in the NHIN.
We heard clearly that EHRs and NHIN creates significant and qualitative change
in information contained in the health records of Americans so it’s really
quite a big of a paradigm change. The general public is clearly concerned about
privacy, confidentiality, and security of all their records, the papers, the
issues coming up in the paper now about banks losing things and other things
have not helped that and we heard that testimony, but health information for
sure so they further differentiate there.

The public really doesn’t understand the benefits therefore they’re not
going to easily give their trust to the NHIN. We’d even talked about things
like a lot of things that have happened in the past, seatbelts you had crash
dummies, fires you had Smoky the Bear, but how do we get something that tells
people there’s something good about these electronic health records and where
they’re getting to because the public tends to rally around those kinds of

HHS and other involved entities need to begin efforts to establish the
public trust, there’s got to be something out there to start getting people
more education because you can’t just hand it to them, we heard that clearly,
you can’t just hand it to them and say congratulations, you’re in,
congratulations you like it, we’ve got to make sure some things get in place,
some key and obvious activities to do that.

So the three areas of focus for building trust are really to try to prove
that there’s better health care for each individual based on that and
measurable improvements so that if you really got good honorable key stories to
say on how it actually improved it, not that somebody said it, not that it was
in an article, but that it really did it.

The second is meaningful participation by the public or representatives of
that in the design, functioning of oversight of NHIN, rather then just
committees of selected individuals, make sure that there is a public
representation there in those early stages and throughout the process so that
the average type person has some kind of representative on the committees that
are doing things.

And then third an ongoing program of measuring and assessing the
effectiveness of privacy protections of NHIN and public understanding of those
protections. So not just announcing that they’re there, but basically make sure
that there is a continuing program to discuss how people’s records are being

So if you summarize it from a public standpoint we want ways to improve
their health and treatment, let them help, and continue to diligently protect
their data, so those are kind of the themes, those are the discussions, and any
of our recommendations would be based on those as a criteria we heard from the
many hours of testimony from the people that we heard throughout the country
because we did go across the country in these hearings.

So that would be kind of a summary, Mark, of that section and you want to
open it for discussions?


MR. BLAIR: I was muttering over here yeah, hurray, I enthusiastically
support this particular topic that you’re addressing and I wouldn’t have said
anything except yeah, yeah, yeah, may I suggest that since the topic is public
trust that just the sequence that you outlined, put the issue of improvement in
privacy and confidentiality and security protection not as the last item but as
the number one. That’s it. Applause, great, I’m very excited.

DR. STEINWACHS: I too think that this is a crucially important area. Now you
were looking for sort of a poster child for this and it seemed to me out of all
the things I’ve heard over the past few years is that the thing, patient safety
has much more traction with people then almost anything else, quality doesn’t
quite, the word doesn’t emote quite the way safety does. And you made me start
thinking of these commercials, this was something different then the American
Express equivalent that said my luggage didn’t arrive, I’m on a Caribbean
Island, but I have my American Express card. But you could think of something a
little different that is sort of like the grateful patient, I wouldn’t be here
today if it weren’t for the fact that the emergency room doctor had access to
my record and knew that, and actually there are probably lots of good live real
examples that could be drawn on and just make them confidential in a sense that
you’re reenacting something or replaying something without identifying.

But it strikes me that without something like that I’d be reluctant to say
you can have my records and use them for whatever. And then I would probably
still be very cautious and say well I only want you to have those parts that
you can really convince me fit the criteria, otherwise I need to control that
and it comes back to —

MR. REYNOLDS: That’s Mark’s subject.

MR. HOUSTON: Do we want to respond at all? I mean we want to obviously get

MR. ROTHSTEIN: Do you want to respond to it? Sure.

MR. HOUSTON: Yeah, I think it’s important to recognize, I mean I think we
all had a lot of discussion in our deliberations over this letter about really
what’s the core reason why we’re developing an NHIN and it is to improve
quality of care, reduce error rates, improve efficiencies and all of those
things and I think it’s in a way I guess assumed a lot of what we’ll be talking
about today is that there’s a reason why the NHIN is being developed and we’re
trying to focus on the privacy aspects, we’re trying to focus on privacy
because we recognize that it is that if we don’t do it correctly it is going to
be great inhibitor. I think the message obviously absolutely has to get out
that there’s a lot of reasons why we do NHIN but we’re really trying to focus
on the concept of privacy and how do we remove that, or how do we try to
address that if there’s a potential inhibitor to individuals wanting to
participate. So I mean that’s really at the basis for why we’re here.

DR. STEINWACHS: Part of what it made me think of is that the AHIC is trying
to develop use cases and it seemed to me that in a part for the privacy you
have to do both because one is how are you protecting the privacy in order to
make that information available in a way that could maybe save my life or make
a real difference to me personally, that maybe part of a model.

MR. ROTHSTEIN: I think that’s a very good point, Don, we have to make the
case, or someone has to make the case, to the public as to what they are
personally going to get out of it, quality and outcomes research are just too
nebulous to the average person but this could save your life they might be able
to —

DR. VIGILANTE: Didn’t MARKIT(?) present to us their, didn’t they do survey
research or consumer research on messaging, it was about a year ago, so along
those lines, what is the message that affects consumer —

DR. CARR: Do we have information on what percent of the population that were
affected by Katrina had electronic health records?

MR. SCANLON: You happen to have the data guru here. No, no, that’s the
answer, no. There are actually some interesting things done in databases and
David didn’t talk but there was actually a prescription website capability set
up for folks who were displaced, in fact that was a very good site. The
industry was able to put together a website based on medication histories of
folks displaces and then they were able to check those when the folks arrives
in Houston or other places. But no, there’s no, there’s not even good
information on how many hospitals overall have these sorts of capabilities,
it’s getting to be better now but certainly not on that fine a grain.

DR. CARR: But perhaps even doing just some modeling, I mean we know among
the practices or the hospitals there that did or didn’t have electronic health
records to say how many lives affected or would have been favorably affected
had it been available. And then secondly in the intervention how electronic
health record really did help organize in a mass, or whatever the prescribing
things. But I mean just to your point about how do you make a public case this
is a very public issue and it would be a profoundly different story I think for
folks if they had their electronic health record.

MR. ROTHSTEIN: Okay, I’ve got Steve, I had Russ, Bill, Paul. Did I miss

DR. TANG: Can I answer Justine’s question? There is one example and that’s
the VA which was able to come up the next day —

DR. CARR: Right, I think that would be a compelling juxtaposition of two
systems without getting into the detail of the others.

DR. STEINDEL: Mark, I really wasn’t paying much attention to just basic
terminology, are you going to refer to this as the NHIN or the NHII? And I ask
that very specifically because as we heard a few minutes ago from Dr. Brailer
there’s going to be very specific architecture that defines what the NHIN is,
at least in a test case point of view and certain parameters. And some of those
parameters may have implications on what we want to say in terms of privacy,
your downstream concepts, where if you’re talking about something a little bit
more abstract you might be able to talk at a different level. And my main
contention here has to do with whether we’re talking about instantaneous
ability to exchange information anywhere around the country or connected
electronic health records that are able to exchange information, not
necessarily instantaneously.

MR. ROTHSTEIN: Well that’s a good question. We were asked to address the
NHIN and I think the value of some of our recommendations that you’re going to
see, that we’re going to discuss later in the next few minutes, deal with how
you work privacy into the architecture of the NHIN. And so I mean I could be
persuaded that we should change the terminology but I think it’s very important
for us in our recommendations to the department to make it clear that privacy
is not something that sort of is tacked on at the end, that it’s part of the
development process and if we don’t do it now we’re going to be going down the
wrong path and that’s why it was linked to NHIN.

DR. STEINDEL: My question really had to do as a reaction to what Don was
saying about marketing messages and marketing messages might be different in
those types, in different scenarios.

MR. ROTHSTEIN: Well for starters we’re not going to get to anything
approaching that level of detail, that’s not going to be our job to come up
with strategies other then to say that we think it’s very important that it be
done promptly, enthusiastically, comprehensively with proper funding and so

DR. STEINWACHS: I thought you were just going to delegate this function to
the CDC Center for Public Health Marketing. Marjorie, is that the right name?

MR. LOCALIO: Well I will just bring up where I left off in September and
that is that sometime you have to bring up the problems of legislation because
those of us who have been following this for the last ten year know that there
are deficiencies in the current legislation which is why we have HIPAA. I just
want to make sure that somebody, as you go through your process you consider
this, I also want to point out some other issues that have occurred to me and
that is one of the most flagrant abuses or transgressions of privacy was that
horror story of the California transcription going to the service in Texas that
then subcontracted to somebody who subcontracted to somebody else in Pakistan
who said I’m going to put it on the web unless you pay us. So we have to
consider that when you have something on a network that means there could be
global exposure as well as national exposure and what can be done about that.
This is a serious issue, look at when we have, how many people have had viruses
attack their computer in the last year and how many of those viruses have
originated from outside the jurisdiction of the United States, I mean this is
an issue. So I just wanted to make sure that that’s covered sometime. Thank

MR. ROTHSTEIN: Yes, without going into the answer because it may come up in
later discussions we have specifically addressed those issues. Bill?

DR. SCANLON: I think your three steps are good sort of process steps in
terms of trying to instill sort of public confidence and trust, three is an
issue though of the substance and I think that in terms of involving the
public, I mean I think they’ve got to come away from this process feeling
pretty confident about things. And actually this is keying off something that
David Brailer and Paul were talking about in terms of certification, I think
it’s a sound strategy of saying we’re not going to go to an extreme in terms of
certification and pick a winner but we’re going to set some minimum standards
and then we’ll let the market work to a degree.

The minimums need to be high enough that people have confidence, I think
that’s a key because markets are wonderful but they don’t always work and in
health care we’ve probably got great examples of when they don’t work, or that
takes them a long time to work. And you don’t want to sort of having involved
the public in the process to have them come away feeling skeptical about this.
So I think maybe it’s not part of this message but this is something we should
be continuously sort of focusing on in terms of advising the department that if
this is going to be successful the public has to be confident because there’s
enough of a safeguard here that they don’t have to worry.

MR. ROTHSTEIN: That’s a good point, I mean you can’t sell something that
doesn’t have any substance and we certainly agree with you.

We’re going to take one more comment from Jeff and then move to the next
topic area.

MR. BLAIR: I kind of come back to my applause for the way Harry set forth
the issue, in short HIPAA privacy regs have among the physician community and
health care institution community been a set of rules that they have had to
implement and many of them are not very happy. I don’t know if we’re going to
be able to do very much to change that. The unfortunate thing which I think
this addresses is that the privacy regs do a lot to improve privacy,
confidentiality and security for the patient and the consumer. Unfortunately
that message has not gotten out as profoundly and clearly and pervasively as it
should, this is something which is an achievement, this is something which is
positive and yet we sort of are enduring the discomfort of those who are
implementing it without receiving the appreciation and trust of the consumers
and patients that it was meant to protect.

So the bottom line is I think this is a public relations issue, I think it
is a marketing issue, whatever word, or an educational issue, whatever word you
want to say and I do think that it needs to, a great deal of resources and
funding need to be put behind this because the consequences of us failing to
get this message across could be tremendous for the entire movement of
transforming health care into the information age. So much is at risk that it
could be lost not by a covert act but by an act of failing to get the message
out, the education, the public relations. So you can tell I feel very strongly
about this particular issue and it is true that Harry did pay me, it was 15
cents, so anyway, that’s my very, very strong support for this particular

MR. ROTHSTEIN: Thank you, Jeff. And now we’re going to go to John to talk
about disclosures and regulatory issues.

MR. HOUSTON: Thanks, Mark. I guess we’re going to break them up by section
so I’m going to talk about disclosures first and get some comments back. Really
I think when we discussed this matter we really looked at disclosures really of
being of two separate types and we thought they really needed to be addressed
separately. The first type as sort of I would characterize it as being a
primary use and that would be uses that are related to treatment, payment, or
health care operations which are defined and provided for under HIPAA today.
And then the second type of use is one which we’ve sort of characterized as
secondary uses or something that is provided pursuant to I think what Mark has
as being a compelled authorization.

So to the first part, primary uses, we recognize that not all individuals
necessarily need to have access to all PHI for a patient in order to deliver
care. We could look at the extreme example where you might say the physician
needs to look at the entire medical record in order to deliver care because
they don’t necessarily know what’s relevant, they need to have access, but that
doesn’t necessarily mean that somebody who’s processing claims or a dietician
or somebody else, a phlebotomist in a hospital, necessarily needs to see the
totality of that patient’s record that’s available through the NHIN.

So we thought that there needed to be some type of role based access
criteria scheme implemented in an NHIN in order to try to limit the access to
information that was relevant based upon the caregiver who was actually looking
at the record for purposes of delivering care or payment or whatever. And we
believe that this is a principle that needs to be inherent not just within the
infrastructure or the structure of the NHIN but also with regards to EHRs, and
an EHR being the internal systems that a hospital might use to deliver care
rather then NHIN which is the vehicle to deliver information from third parties
back to an EHR or to a provider in order to deliver care.

So that’s the concept of a primary use.

Now to secondary uses, the issue of compelled authorizations, again I think
that there’s a lot of cases where a patient or an individual is asked to
disclose PHI unrelated to TPO and those by example are such things as
employment, getting insurance, seeking a loan, things of that sort. And while
we recognize that those are typically provided, the information is provided
pursuant to some type of authorization, those authorizations are often again
what Mark I think has said as being sort of compelled, if you want the
insurance, you want the job, you’re going to provide the authorization.

And in a lot of contexts they’re entirely reasonable to expect that in order
yes to get those types of things you need to provide information. But what we
recognize though is that often these authorizations are overly broad and so
really the key here is that there needs to be some concept of limiting
authorizations to what is reasonably required in order to address the need and
we thought in terms of what we think the NHIN needs to have is this concept of
a contextual access criteria. So based upon who the individual or the
organization is that’s requesting the information, is there a way to limit the
disclosure to the types of information that are reasonably related to the
purpose that’s being requested so you don’t have to see the entire medical
record related to employment if there’s actually a very small segment of the
record that’s relevant to the job that this individual is going to fulfill.

So again we think that, I think it’s entirely reasonable to expect that
authorizations are going to occur but we need to have some mechanism to try to
limit what information is actually disclosed.

MR. ROTHSTEIN: John do you want to take comments on this before you get to
regulatory issues or do you want to do it separate?

MR. HOUSTON: Yeah, I think we do, I want to stop here. There was only one
other point I think we talked about, we thought it was important because we
really didn’t see a lot of activity to date with regards to both role based and
context based criteria, that we thought that it’d be good that HHS in some ways
should support research into how you would develop these types of schemes or
whether they were workable. So again, that was the only other comment I wanted
to make.

MR. ROTHSTEIN: Thank you. And now the floor is open for questions or
comments from committee members.

MR. SCANLON: Mine were in the nature of a friendly amendment, it sounds like
these are, the way you’re heading is you’re trying to identify some principles
that should govern the thought and the direction for privacy issues in the NHII
or NHIN which is quite good, and then presumably there could be recommendations
that follow depending on the form follows function kind of an idea of what
exactly it’s applied to. But you are thinking about principles I guess, what
you’re now describing almost reflects implicit principles and how you do that.

PARTICIPANT: Louder please.

MR. SCANLON: I was asking the framework that they’re using basically will
result in some principles for privacy in whatever the application may be which
I think would be a good way to think of this.

DR. TANG: Would you suggest that we stop our work after we’ve come to
consensus principles or would you also suggest that we provide recommendations
for actions that follow those principles? Where do you think would be a —

MR. SCANLON: Well let me introduce this strategy idea, you’ve given me kind
of, you’ve opened the door. I think the, and you’ll be sorry, I don’t want the
committee to get in the position of almost filing preemptive reports and
recommendations while we’re in this transition strategy relating to the AHIC
and what the NHII or the NHIN might looked like. And I think as the Secretary
indicated the committee will be asked to provide some advice on the privacy
thinking here and I think that should factor into the committee’s thinking in
timing here. I think if you, I don’t think you want, and principles generally
are a good way to proceed because if you need to get agreement on principles or
at least hash out where you disagree, and then whatever, again this is to some
extent a form, you have principles and then depending on whether the
application is a network or an electronic health record generally or
transactions, then the principles will make some sense. I’m afraid that if you
lock in specific recommendations assuming a certain application you would not
only be heading in the wrong direction but it will look almost preemptive like
you’ve answered the question before it was asked.

So it’s more of, I don’t think I have the answer but I think if you would
factor in your deliberations the concept of leaving open whatever requests
might come from the Secretary and the department relating to privacy advice,
factor into the planning and the report, and sometimes, it depends on what the
nature and the level of recommendations might be. On the other hand you can’t
go wrong with principles live privacy by design, balance and other things like
that, so just kind of an overall strategy, not dealing with any specific

MR. ROTHSTEIN: Thank you, that’s very helpful. I’ve got Simon, Marjorie, and
then Steve. Simon?

DR. COHN: First of all I really like that, the title, Privacy by Design,
actually I found myself sort of liking much of what was being said though I do
find myself sort of going that this appears to be principles with the need for
further research and/or demonstration projects or whatever which is I mean
useful to help flesh things out because a lot of things sound good, the
question is is are they workable, when you really get to the implementation are
they doable.

I think with this idea of, was it internal, the access scheme and the,
actually for the internal one, the role based or whatever, I know it has been
worked on for a long time, one of the questions is is how well does it really
work and even though it’s very easy to say well geez a diabetic nutrition
educator only needs to see X but then you go well what exactly don’t they need
to see when you’re trying to educate them on nutrition and all of that and so
you get into sort of the good idea versus the reality of the situation.

Similarly and I guess it’s really just sort of a question and I will
apologize because I haven’t been part of all the subcommittee’s deliberations,
as good as the idea of under the compelled authorization area this idea of as
you described it I think these were contextual access criteria, I guess I’m
sort of, on one hand yes that’s a really good idea and then I’m going well
geez, any insurance that you get, is there things that they wouldn’t be able to
see and I’m going well jobs, well what wouldn’t they be able to see and it’s
sort of goes down into the reality area, I’m not saying that it isn’t a good
idea but it’s a sort of demonstration —

MR. ROTHSTEIN: No, Simon, let me clarify, when we say insurance we’re not
talking about health insurance, we’re talking about life insurance, disability

DR. COHN: No, that’s exactly what I was talking about. I’m just sort of
thinking, I mean once again I could be way off, I’m just trying in my own mind
thinking about exactly you, there probably is an answer, I just don’t know —

MR. HOUSTON: A couple points that I think are relevant here, the first being
I think that the NHIN to succeed they’re going to have to start to think about
context anyways because if 20 providers all hold information about a patient to
go out and search and get all that information to begin with I think could be,
could overload that type of an environment. So I think we need, I think there
is already an architectural need to start to think about how you gather data
and gather only the relevant data related to the particular request. And I
think towards that end I think if you layer on top of it something like well
there’s access, you can say okay, it does sort of fit in with some of the
architectural design criteria they’re going to arrive upon so I think there is
some opportunities to try to couple it together to solve this issue, for
solving some other issues.

DR. COHN: And let me just sort of say, I mean nothing I’m commenting should
be said to really in any way negate the idea, it was just sort of an
observation that in this one like anything else it’s sort of like at a high
level it sounds good and I think it really speaks of I think evaluation,
demonstration, etc., that’s really where I was trying to go.

MR. ROTHSTEIN: Well also keep in mind that we’re giving you the one inch
depth analysis of each of these problems, we could spend an hour talking about
how it might be done, where it’s done, what would be working and so forth.

MS. GREENBERG: I actually didn’t have anything.

DR. STEINDEL: Simon actually picked up a lot on what I was going to say. The
thing I thought it was very good about talking about context within the, what
words you were using, the forced disclosure, compelled authorization, I think
it’s very good to talk about context there. But I also think there’s a
contextual component of the first criteria as well, not just role based, and
this goes to what Simon was saying. When a health care practitioner is asking
for information for treatment purposes it’s done both in a role and a context
and that can help limit the amount of information that could be disclosed to
just what really is pertinent.

And one reason this is becoming the big issue is we’re starting to focus in
in the area of certification which was brought up before, especially in the
area of things like audit trail which in itself is so broad that no one can
really do it. But then if you say you need an audit trail to track the legal
requirements of an electronic health record then you can describe what
components need to go into the audit trail, so it has a contextual basis as
well. And that’s the only reason I’m bringing it up that you should not forget
that component in the first part.

MR. ROTHSTEIN: Thank you. Carol and then Don and then we’ll go to John’s
second issue.

MS. MCCALL: First a very specific question, John, you used an acronym, I
think it was TPO, what does that —

MR. HOUSTON: Treatment, payment, or health care operations, or operations,
each of those are defined within the HIPAA privacy rules.

MS. MCCALL: Just a new TLA right? The actual real question, you had referred
to this I think when you opened up that there would be some recommendations
that might seem on the surface to be contradictory because it had to do with
authorizations, I think, and where you actually, what you do upstream then
essentially makes moot what you might have to do downstream. Given now the
context of contextual access criteria, compelled authorizations, those types of
things, can you just for a couple minutes talk about contextual access criteria
and some of those either upstream or downstream, can you just give some
visibility on how those things relate or don’t?

MR. ROTHSTEIN: How that might work in real life?

MS. MCCALL: Yeah, what you guys talked about, what you wrestled with as you
tried to —

MR. ROTHSTEIN: Okay, very quickly, not to belabor this, in my personal view,
now I’m not speaking for the subcommittee, we hear a lot of talk about breaches
of security and invasions of privacy and so forth as if it all were caused by
computer hackers and snoops and so forth. I think the greatest threat to health
care privacy is through lawful compelled authorizations that people have to
sign as a condition of applying for life insurance or a job or to get social
security disability, you go on and on. I estimated that at least 30 million who
have to sign per year where you have to sign an authorization releasing your
medical records, and the idea is sort of akin to minimum necessary, if we could
somehow release only the information that these providers, these entities
legitimately need to decide whether I can do whatever the job requires and to
evaluate what my mortality risk is or whatever, and not send them all the other
sort of irrelevant sensitive stuff we’d be doing an immense job of protecting
privacy. Unfortunately in a paper based system you can’t do that because it’s a
mess and so what people tend to do is they send everything regardless of the
scope of the authorization, so even a more narrow authorization where they ask
for less they get the whole package anyhow.

And if you want my personal use case here is how an electronic health record
system could protect privacy, everybody is worried about electronic health
records compromising privacy, here’s how it could further privacy where let’s
just take life insurance as an example, life insurance companies really don’t
want or have the time or want to spend the money to review everybody’s file,
there are only ten things that they want to look at. And if you could find a
way to push a button and extract those ten things, oncology, heart disease and
so forth and skip all the rest of the stuff they would have all they need and
just think of all the private stuff that would be retained and the confidence
that people would have in the system.

But to do that, nobody has the capacity to do that, we need to do a lot of
research to see if that could be done, and there’s no research being funded in
this area. And if we could research it and integrate it into the architecture
of the NHIN then wow, wouldn’t that be terrific for everyone. Don?

DR. STEINWACHS: We’re developing classifications, I could tell by role and
context, and you’ve touched on it also, Mark, I think there’s the question of
the age of the information that you’re abstracting and so to me one of the
scarier things is to think of the search that goes from age birth to age 60 or
70 and you look at the physical records that are on some people, and the other
is the age old problem of mistakes and inaccuracies in records and I assume
somewhere in this it comes up in terms of what patients can do to try and
correct that. But it’s also a very tough thing if you’re talking about these
disclosures to an insurance company, well you pull up something and then is it
attached to it a patient disclaimer or how does the patient know and so on.

The last piece of this longevity issue it seems to me is I could see a
private industry starting where people are convinced that they ought to have
their old records automated and made available and so I think there may be in
this area also a great lack of research. But this idea of what is the useful
life of medical information I think needs attention in this country before we
automate everything or have a Google machine that searches that to come up with
all the related pieces. And I see an industry here I’m afraid of.

MR. ROTHSTEIN: That’s a great suggestion and I think it will work into the
discussion of the other sections.

John, can you move on to the second issue?

MR. HOUSTON: Yeah, regulatory issues, and really that’s broken down into in
my mind three separate distinct areas, one is jurisdiction, the second is
procedures, and the third is enforcement, and I’ll go in order.

And as an overview to all of this I think it’s important for people to
understand that there might be recommendations in the report that are
inconsistent with some of the provisions of the HIPAA privacy rule, it might be
in addition to, it might be inconsistent with, but it suffices to say that we
looked a the HIPAA privacy rule to help us sort of guide us to rationale behind
certain of our recommendations and things, we recognize that there may be cases
where we simply think there is some incompatibility in terms of our

But with regards to jurisdiction I think that what we decided upon was is
that really there’s a lot of conflicts between the various sources of health
privacy regulation, whether it be state/federal or state to state and that
those issues are going to be more pronounced with NHIN. And we also believe
that a national single standard would facilitate compliance. And since we’re
aware that the Secretary has awarded a contract to the governor’s association
to study the variations in state laws and with HIPAA the committee obviously is
going to defer the two to see what the recommendations or the outcomes of that
study is.

Now having said that one of the things that we also recognized and as
Justine had brought up is that events like Hurricane Katrina have also
demonstrated the importance of having a comprehensive medical, electronic
medical records environment, and one that may have to traverse state lines to
be effective. So those are sort of some of the principles under jurisdiction.

The other issue that we saw under jurisdiction was one whereby once
information is passed outside of a covered entity to an entity that is not
covered, and there’s a lot of those, the information loses protection. So there
is a great possibility that organizations that would participate in the
National Health Information Network may not be covered by HIPAA and we think as
a general rule we believe that coverage needs to be extended to all such
entities rather then those that are currently covered by HIPAA, so again
jurisdictionally we think that’s a very important concept.

Under procedures I’ve got a couple of themes, we do believe, I think it was
brought up earlier, that there really does not need to be participation for
cross section of the population. And while AHIC is a really powerful step in
that direction we believe that there needs to be meaningful participation to
ensure that there’s adequate representation and that people of vulnerable and
minority populations are, their interests are reasonably and adequately
represented. So again thematically that’s one of the concerns that we had and
one of the things that we think is a cornerstone.

Secondly we also think that it’s very important that the NHIN and individual
participants in the NHIN make sure that, make their information practices
available, and there have to be fair information practices, so that individuals
would know that they have the right to see an accounting of disclosures and the
right to correct errors and the right to understand what procedures might be
available to them to redress some type of harm. So again overall we thought
that all of that information needed to be reasonably available to individuals
in order for them to understand their rights and obligations.

And also we thought that patient notification in the event of a breach was
also an important concept. But while that was an important concept we’re not
really going to discuss it in this letter because we really think it warrants a
separate letter to the Secretary discussing security more broadly.

The third area we looked at under this topic was enforcement. We believe
that strong enforcement and meaningful penalties are absolutely essential to
the NHIN and we also believe that while there are enforcement provisions within
HIPAA we believe that they’re either inadequate right now or they’re simply not
demonstrating to the public that enforcement is occurring, there have been no
civil monetary penalties and things of that sort so there’s a concern that they
don’t appear to the public as being adequate. They may very well be very
involved and meaningful but to the public I think there’s a perception
potentially that really just enforcement is inadequate.

So we believe that there really should be more civil and criminal sanctions
imposed on individuals and entities for violations of the confidentiality and
security provisions of the NHIN. There should be some type of progressive and
severe penalties for egregious violations or violations that continue to occur.
There should be a variety of different types of enforcement mechanisms that
don’t necessarily have to be through the government, potentially it could be
through licensing boards, accreditation boards, or other types of contractual
arrangements. And that frankly I think one of the strongest measures that we
can take is that continued participation in NHIN can be conditioned upon
compliance with privacy and security rules and that if you don’t comply then
participation in NHIN could be curtailed for some period of time because of

And I think the final key concept here is that we also believe that
individuals need to have some type of remedy, direct remedy. Now we don’t
believe in necessarily a private right of action but that does not preclude
individuals for being compensated for actual harm. And again there’s a fine
line between private rights of action, not having a private action but also
having some type of mechanism in order to evaluate whether an individual has
actually had some type of actual harm that’s compensable such as in the case of
an identity theft and are there mechanisms to where an individual actually has
true out of pocket expenses associated with something and making sure that
they’re made whole.

So those are the enforcement principles and I think that’s about all.

MR. ROTHSTEIN: Thank you. Questions or comments from committee members?

DR. STEINWACHS: I couldn’t leave it without one comment, for some reason in
this discussion and maybe it’s because you’re a lawyer and it springs on me,
you made me think about the Witness Protection Program and people going
undercover and what kinds of protections there are for people who play special
roles or have special roles in our society, and I’ve never heard discussion of
that in this kind of context of if you were in the Witness Protection Program
how do you deal with the NHII, if you went under cover how would you do with
the NHII without leaving the person without, so that’s what you caused John and
I have some friends that really want to know the answers.

MR. HOUSTON: We’re going to give everybody your name.

MR. ROTHSTEIN: That is something that to be honest we have not considered.
Russ, did you want to —

MR. HOUSTON: We asked some people from the Witness Protection Program to
come in but they wouldn’t.

MR. LOCALIO: Well one suggestion that just came to my mind is that you may
want to have the enforcement apply to the information, in other words the
reason that the Miranda rule works is that confessions that are given without a
Miranda warning cannot be used. Well you could have some instances in which
information is disclosed improperly cannot be used.

MR. ROTHSTEIN: We will talk about that. Other comments? Okay, now we’re
going to go to Paul.

DR. TANG: The final topic here is secondary uses of data and for purposes of
this discussion we define it similar to the way Stan did which is confidential
health information that is used for purposes other then direct patient care. We
all recognize there’s lots of good reasons to use it, research, public health,
but indiscriminate use of that information poses very serious privacy risks.

And the origin of this concern is this basically that the entities that are
not covered by HIPAA, so you can imagine a third party who gets it through
legitimate reasons, or reasons that aren’t legitimate, but HIPAA does not
extend protection, doesn’t extend restrictions on the use of that data once
you’ve done something with it. And that’s where the concern lies. And because
as Harry said our primary objective is to ensure that citizens, consumers,
patients, trust this NHIN, that we need to ensure or try to assure them that
their data won’t be used for purposes other then which they had consented.

So this leads to the conclusion that’s similar to what John mentioned which
is we need uniform comprehensive, comprehensive means it covers all those
entities, everybody who has access to or stores that data, privacy policies,
that applies to any entity with access to confidential health information
anywhere and regardless of how they got that information. So it basically is
the protection follows the data and everybody is accountable.

Now the point that Russ brought up in terms of outsourcing to foreign
territories is a problem, some states actually have tackled that by saying you
can’t do that with health information and that’s an approach. But anyway, so
that’s an unresolved issue but we recognize that in our discussing it as part
of the process. So the primary principle we’re throwing out there for
discussion is really very uniform comprehensive protection of data no matter
where it goes.

MR. ROTHSTEIN: Questions or comments for Paul. Okay, I think some of those
came up earlier so that would explain why everyone is assenting to everything.

DR. COHN: I guess I would just sort of, as I was listening to this I was
just sort of observing obviously, I think Mark described it all this is not
necessarily internally consistent and I was just sort of thinking of uniform
national privacy policies and also reflecting on John Paul’s comments about how
we were going to wait and see what happens with the federal and state work that
relates to all this stuff. I mean I will just observe that those are not
necessarily completely consistent patterns and I guess they could be.

DR. TANG: They’re principles, so they create law, these are principles
because it addresses an issue that raises serious concerns.

MR. ROTHSTEIN: We’re cutting it two different ways. In one respect I think
we’re saying independent of the federalism issue that the scope of the HIPAA
privacy rule is not sufficient, that it’s too limited, that we want to cover
all of these entities who are not covered by HIPAA who get protected health
information. There’s a separate issue about the federalism whether it should be
the preemptive and so forth. So I don’t think they’re in this area necessarily
inconsistent but I’ve got several others that clearly qualify.

Okay, let me go to the last area and I was hoping that we’d be out of time
before we got to this but it seems that we haven’t. And that’s the issue of
patient control of their records in the NHIN and Don alluded to it earlier with
old records. And this has caused us the most difficulty. One way of looking at
is we want to promote privacy and autonomy and individual choice and that
suggests flexibility and people should be able to do lots of things. On the
other the more flexibility that you have, the more complicated the system
becomes, the more expensive it is, the more it’s going to be hard for
individuals to understand what their rights are, it’s going to be hard for
providers and other entities to comply with it. And you lose the health
benefits of the comprehensiveness of the NHIN, both on an individual and on a
system or societal level.

So there are two things I want to discuss relative to this, two questions.
The first one is to what extent if any should individuals have the right or
ability to elect not to have their health records disclosed through the NHIN?
Should they have a right to be out of the NHIN? And it would be easier and more
valuable if everyone were in the NHIN but mandatory exclusion with no ability
to be excluded from the NHIN, if we just said you’re in it and you can’t get
out and we’re going to start using your stuff, I think it would raise very
serious legal, ethical, and political concerns and would likely undermine
public support for the NHIN. And the Privacy and Confidentiality Subcommittee
is unanimous in the view that inclusion in the NHIN should not be mandatory
without some sort of option to be outside of the system.

Now that only frames the issue and it doesn’t resolve it because the
subcommittee is not in agreement on whether we should have an opt in or an opt
out option. Opt out, the advantages of opt out are it’s easier because you put
the burden on the patient, if they don’t do it they’re in. It’s simpler, it’s
cheaper, and it’s more likely to result in a higher percentage of individuals
within the NHIN which we consider a good thing.

On the other hand opt in advances the important interest in autonomy, in
choice, in respect for persons, and may lead to greater public support for the
NHIN. Under either approach public education is very important so that’s the
first issue.

The second more difficult issue is to what extent if any should individuals
have the right or ability to exclude certain information from transmission via
the NHIN? Or to block certain information to providers or other recipients?
Subcommittee members are not in agreement here, it’s good thing there are only
four members because there are only four different views. Arguments in favor of
not permitting this, in other words not permitting people to cut out certain
things, the sort of the all or nothing approach, is that it’s easier, it’s less
costly, it eliminates liability concerns of providers, you’re going to sue me
if I make a mistake because I didn’t have enough information, and it better
promotes individual and population health.

Arguments in favor of allowing exclusion or blocking are that a patient’s
ability to exclude certain information is essential to protect the privacy of
sensitive health information, it is needed to encourage people to get mental
health, substance abuse, STD treatment, and all these other kinds of services
that they might be reluctant to undergo if you couldn’t exclude or block that
information. Without exclusion or blocking people will opt out of the NHIN all
together and this is one of these sort of upstream/downstream issues. And
blocking, that technology where you can block certain information has been
successfully used in other countries, in fact all the other countries that we
talked to, and they generally told us that it’s rarely used but people love it
as an option.

Now that only gets us half way because if there is some exclusion or
blocking then the next question or series of questions is suppose we adopt that
in principle what issues can be blocked, how do you block it, will decision
support such as drug interactions include the blocked items where in some ways
you can have the decision support run under the blocking, can an extension of
this blocking block certain providers from getting access to this, I don’t want
my ex-wife seeing my medical records, can you have that kind of block. Will
clinicians be notified that certain types of information has been blocked, are
you going to flag something and say STD information not supplied at the request
of the patient or whatever, that might not be that helpful, will there be a
break the glass feature to allow emergency access, yes or no, and also even if
you include a blocking feature it’s not an airtight protection for privacy, and
this was a point that Harry made yesterday, because let’s pose you are seeing a
mental health provider and you want that excluded. If you’ve had a prescription
filled for an SSRI it’s going to be at the pharmacy, at the PBM, at the payer,
and they’re going to be able to infer that you’ve got, so even if you block it
it’s not going to be perfect and people need to know that.

Now the subcommittee members are not in agreement on this issue as well.
Both parts, whether you should be able to block anything and if you do have the
ability to block something how would you go about doing it.

Okay, Don, Simon.

DR. STEINWACHS: Just one thought that sometimes it sort of feels like it’s
all or none and it seemed to me that people have been trying to figure out what
is the in between ground about what would be the shared part and so family
physicians have their continuity of care record sort of proposal and so it
seemed to be interesting in a set of principles is to think about are there
options so that my whole, I’d sign up for NHIN but my whole record in detail
would never be retrievable, only this relevant sort of summary of things that
were somehow derived like this continuity of care record, so it’d be recent
stuff, diagnoses maybe. So if we had some options it’d seem to me that might
open it up a little bit because the other ones always sound Draconian sometimes
when you don’t have —

MR. ROTHSTEIN: Well I actually support that view but the members of the
committee will recall that in Chicago we had that hearing specifically in
Chicago to hear from all the medical associations and stuff. And we asked sort
of everybody what do you think of that and they didn’t like that at all because
no matter what specialty representative you talked to they were able to come up
with some scenario in which if somebody had chicken pox at age five that’s
going to explain their heart disease at age 85.

DR. STEINWACHS: Let me try another twist on you because, and then I’ll
quite. At least working around hospitals and never being a clinician I’ve had a
sense of how those huge records that patients have, you have a visit no one
actually looks at that whole record and oh, Justine does, thank goodness,
Justine does. But if you think about the compilation of many people’s records,
even when it’s electronic, if the assumption is any provider you go to has
access to that under the full NHIN then isn’t that provider accountable for
interpreting and understanding in your current context, whatever that context
is, all of that history? It seems to me this opens up a huge area of liability
that the medical societies haven’t thought a lot about that says maybe you have
to go back and find that case 45 years ago when the person was a child.

MR. ROTHSTEIN: I have Simon, Carol and Kevin, am I missing somebody? Okay,

DR. COHN: I don’t know whether to react to what Don was just saying or what
you were bringing up. I guess I will like Justine sort of say that even though
my specialty has been emergency medicine I’m typically one of the ones who
looks through the multiple volumes of the records because it isn’t what
information you have it’s what result you get and I think we’re all, I mean all
physicians all know of are really interested in the best result as opposed to
well because I didn’t know that it doesn’t matter but we’re sorry, which is I
think the outcome of what you’re describing as a potential outcome.

As I’m listening to all of this, and I’m actually glad I was not part of
this conversation, I guess I come back sort of going it seems like it’s almost
like we need to go back and look at problem definitions here because there
seems to be a number of undercurrents that I’m not even sure I can describe at
this point but that sort of are underneath all of these conversations. I’m
hearing for example that sort of blocking things but I’m sort of hearing
something that, I’m just not sure what we’re blocking from whom. It sounds like
maybe a patient A doesn’t want, wants to let this doctor see this but not this
other doctor see that and so there’s a dynamic going on here around what
providers think of patients.

I’m just saying I don’t know what the issue is, I’m hearing that but I’m
going well or is it geez, you want to block things going to an insurance
company and geez could you even do that if you’re creating a disclosure but
geez, I heard even in places where they block there are uses of it for public
health or population health, uses for, I mean we heard of a case in Denmark
where stuff gets blocked but it’s all used for, I believe it was used for
population health uses as well as for drug/drug interactions and so gosh is
that really blocked or not.

I guess this is one where I’m sort of going I think there’s some fuzziness
of thinking here that is potentially resulting in the outcome where we have
fuzziness of outcome.

MR. HOUSTON: Simon, I think those are all conversations that we had and
concerns and issues, I think it is the issue of patients not necessarily
wanting to have all their providers see all their information. And we did
raise, we had discussions about the issue of if information is blocked with the
way the architecture of the NHIN seems to be shaping up we’re not going to be
able to do effective drug to drug interaction because you simply won’t have the
information provided from the source system with the drug information in it in
order for the destination system to do the drug to drug interaction. So there
are a lot of issues here with regards to blocking of information and limiting
information, there’s a lot of, when we had this discussion I remember we
brought up, I remember Mark bringing up and I’ll say it but he said hey, this
is what we have today and I think the response that I know I had was well
that’s we’re trying to get away from is what we have today.

And I think this is really a sticky issue though because you still have
patients who still believe very strongly that they don’t want one specialist to
see the opinion of another specialist because they’re looking for a second
opinion, or there’s the minor has the abortion that doesn’t have to be
consented to by the adult and they would prefer that that information not be
known. Now obviously if the patient presents within a day and they’re in
hemorrhage that there might be some relationship but that for some period of
time, I mean that’s actually happened in one of our facilities and it was
because of the abortion. But the issue here is that at some point the
information can become stale and people have this privacy expectation that has
been voiced as a concern.

MR. ROTHSTEIN: I’m going to close the list, I’ve got Carol, Kevin, Justine
and Jeff.

MS. MCCALL: This just must have been some great discussions, I can only
imagine. No, seriously, a lot of fun.

A lot of the things that you’ve walked through, part of the back and forth
that I see is between execution and what’s really possible, and forget what’s
possible, what do you want, what’s true north, if I could actually have it this
is what I’d love to be able to do and I think that that’s important to be able
to actually have an opinion on the principles around it and then turn to the
community and say okay within this how far can we get and then we’ll see.

One thing I thought about in terms of let’s say that the principle were I
want people to have the capability to block, all right, and so let’s see how
far we can get. One thing could be is that there are consequences to that, I
mean it’s almost like a DNR, that first of all if I want to elect to block I
need to specifically do that and it needs to be perhaps hard and I need to be
told all the consequences of that, that maybe certain things won’t work.
Drug/drug interactions may not work. Certain things aren’t known and therefore
my liability as a physician would be reduced. You can’t come back at me if
there are things that I may need to know, just the scope of what I can do will
be less. They need to know that and there may be some boundaries.

The other thing is, this is a very specific thought, if something is blocked
can a doctor ever come up to the door and kind of go [knocking] can I have

MR. HOUSTON: Break the glass.

MS. MCCALL: Well not even break the glass, maybe it’s not, that’s kind of
very emergent situations, what if it’s not that but look there’s something
that’s blocked here can I see it or not. So it’s a less emergent situation. So
that was a very specific idea.

MR. ROTHSTEIN: Thank you. Kevin.

DR. VIGILANTE: This is really difficult, I’m wrestling sort of this and
probably expressing my confusion in real time. On the one hand it’s just so
hard to provide optimal care for folks and part of providing optimal care is
having complete information and those who practice in the emergency department
really know how big a difference it makes when you can get a chart with good
information in it and it really, it does make a huge difference in what you can
do for that patient. And when you block information in a systematic way in some
ways you kind of recreate the fragmentation of information that we’re trying to
overcome with this whole solution.

On the other hand I mean I can understand the sensitivity of folks thinking
about certain very personal and private things that are just going to be out
there in cyber space and while they may actually be more secure then they are
today in a paper record there’s still a lot of anxiety with it being out there.

But at the very least I think if you do block something you have to, I think
it’s in the patient’s interests to allow clinicians to know that something has
been blocked. Because at least if the patient is conscious you can ask the
patient, you can say okay this is blocked, in a conscious patient you can still
extract a history. In an unconscious patient or somebody who’s intibated(?) or
other circumstances in which they can’t communicate and that blocked
information is vital that’s a special case that I think would deserve special
treatment. So obviously not an answer to the question but I think it goes along
the lines of what you were saying Carol.

MR. ROTHSTEIN: Thank you. Justine?

DR. CARR: I’d like to echo what Kevin was saying, I think so much of this
whole initiative is to repair fragmented care and to then ask physicians to
create this new paradigm where sometimes you have your hands tied behind your
back or sometimes you have a blindfold, but at the end of the day the patients
come to you for care. I just find it to be just not feasible, I think if a
patient wants to have a paper record that they bring this page to this doctor
that’s fine but even thinking about the number of caretakers let’s say on an
inpatient episode of care how on Earth do you keep track of this one knows this
but that one doesn’t know that and all the handoffs, handoffs is a huge safety
thing today so now we’re going to even compound handoffs by hiding information
and hoping that everybody knows that. I very strongly disagree with that
blocking option, I can understand where it’s coming from but I think it’s
eroding the role of the physician and sort of imposing a block without an
opportunity to say do I want to deliver care in a fractured system. So I would
vote for no blocking, either you’re in or you’re out and try to work, at least
you have a clean dataset, you understand what your context is.

MR. ROTHSTEIN: Jeff, if you could be brief and then we’ll let have Bob have
a word because he hasn’t spoken yet.

MR. BLAIR: We have a lot of intellectual horsepower around this table and if
anybody, if any group is able to wind up to come to consensus on issues given
enough time this group could do so, but I don’t think we can and the reason
that I don’t think we can is we’re trying to come to agreement on patient
perceptions. Patient perceptions of what they trust, what they don’t trust,
patient perceptions of where they feel they have rights, where they don’t have
rights. And then given those first two you lay over it okay if they don’t trust
something what’s their perception about whether role based access, class based
access, location based access, would mitigate their fears or not. What about
their perception of whether or not they had control of authorization for a
particular health care provider to access that information if it was in the
system, or not? So there is a landscape of issues of trusts and rights and the
ability to mitigate it and the ability of feeling vulnerable that we don’t have
until a comprehensive survey of public attitudes is conducted to base our
opinions on. And I figure that this debate and argument will go on forever
until we understand public perceptions and fears.

MR. ROTHSTEIN: Simon wants us to wrap this up —

MR. HUNGATE: My comment is really quick, the ultimate block is a patient who
doesn’t tell you the things that you might like to know because they don’t
trust you. So it seems to me that data validity is a real issue and if you want
disclosure then you’ve got allow for some reasonable blockage, if you want full
disclosure there’s got to be some provision for that, and we disagree there.

MR. ROTHSTEIN: I can assure you you will have ample time to weigh in on this
later because we’re going to be wrestling this for a while. John —

MR. HOUSTON: Just one real quick thing in closing, recognize that I don’t
think we’ll ever have complete agreement on this, whether we do surveys, the
reason why the committee can’t come to agreement on some of these issues is
because there’s a good faith difference of opinion that is not unreasonable out
of any of the people that are discussing it and have different opinions. I
think this committee is going to have the same problem when this letter comes
forward and what we’re trying to do is put together reasonable recommendations
that while we may disagree with or have some slight disagreement with but
they’re reasonable and they try to move forward the concept of NHIN and that we
try to put privacy protections in place to forward that. And we are going to
have disagreements and when we bring this letter forward I think we just have
to recognize that and try to minimize those and try to come to as much
consensus as possible.

MS. GREENBERG: Also I think, just following up on what Jeff said too, I mean
I think, I’ve had the privilege of sitting in on a number of these hearings and
been part of these discussions and I really respect all of you who’ve been
struggling with these issues and will continue to, but you have the option too
of just not making recommendations in areas where there’s just clearly no
universal agreement around the table, even if there’s a majority. I think we
should remember what Jim said also about the importance of principles and also
laying out just what all the issues are and the different perspectives and what
the committee has heard and what the downside is and the upside of the
different approaches because ultimately any of these decisions are going to be
made in kind of a political environment I guess with a small p I mean, I’m not,
I was a poly sci major, I don’t think that’s a dirty word, political, and so I
think what you can do is even in these very difficult areas is really kind of
parse out the issues and —

MS. MCCALL: I think just to amplify that very quickly, Marjorie I think
you’re right on, I think that the goal should be to lay out what the big
questions are that need to be answered, any insight to Jeff’s point about what
people think and some of that can come forward from the hearings, and I would
say the third place to look and this may get to Justine’s point, she doesn’t
want to practice medicine in a world where it’s as fractured after all this
work as it was before.

And yet there are countries that have gone before and so what I heard you
say Mark was that you know what there are other countries, you spoke of people
from Australia and the UK and some other countries, where they have the
capability, it is rarely used, but has done something perhaps to fundamentally
increase the level of trust.

And then I don’t know what the consequences are form a political or a
regulatory or a legal realm for somebody kind of pulls that switch, those are
all learnings that can come so that we can get out of the hyperbole situations
and understand how it really works and what the consequences really were.

MR. ROTHSTEIN: Simon, sorry to go over.

DR. COHN: Well no, and Mark, thank you, I think this has been a fascinating
conversation. Should we clap and thank the Privacy and Confidentiality


MR. ROTHSTEIN: Please save it for after the letter is approved.

DR. COHN: And I want to redouble I think one of the things that Marjorie was
saying, as a committee we have a variety of options, I mean we can agree on
recommendations completely, there are occasions though not in my tenure has
this happened where things pass a majority vote and then there’s a minority
report and that is an option. Another thing which I think Marjorie once again I
want to redouble is the fact that there are, if indeed we are having this much
trouble with the issue sometimes just a clear understanding of the issue and
its multiple dimensions really does serve an important public policy purpose.
And so I mean once again, and we’ve seen this in Standards and Security also as
we’ve gone through, at times you discover sort of where there’s consensus and
as you move back you discover where there’s sort of principles and ideas that
need to be worked on and that need more work for a variety of reasons. So I
just want to remind everybody that we have lots of tools.

Now Maya wants to make a quick comment, I want to give everybody about a
five minute break before we move into the next section because I think people
need it, and then we will transition.

MS. BERNSTEIN: I just want to point out since no one mentioned the reason
that we had this discussion today based on the last meeting where everybody in
the committee said that they really wanted to have the opportunity to talk with
one another was the reason we started bringing this up today even though the
subcommittee doesn’t have a draft that it’s ready to show you, that it wouldn’t
be the first time that you saw these issues and what we’re dealing with in
February. So the idea is to prime the pump, to get you thinking about this, and
also to solicit your input over the next couple of months, if you’re thinking
about it and you have something that you want to share with us, if you’ve seen
some paper, starting tomorrow morning at 8:00, please come and talk to us about
it because the committee will be addressing these as a full committee at least
starting in February and I’m not sure the issues are going to get any easier.

DR. COHN: Okay, well shall we take about a five minute break and allow
everybody to stretch and all that, we’ll start at a couple minutes before 3:00.

[Brief break.]

DR. COHN: Okay, this is our second session of the afternoon, we’re going to
be talking about secondary uses of clinical data and Stan Huff will be leading
sort of the presentation and I guess conversation on this one. I want to thank
you for being willing to step forward on this.

Agenda Item: Secondary Uses of Clinical Data – Dr.

DR. HUFF: Thank you. Yeah, we’ll just move ahead without further adieu. When
we get to the conversation I’d be glad to hand the chair back to you, however
you want to do that.

One of the things that was in the NHII roadmap was this statement, the
comprehensive set of patient medical record information standards can move the
nation closer to a health care environment where clinically specific data can
be captured once at the point of care with derivatives of this data available
for meeting the needs of payers, health care administrators, clinical research
and public health. This environment could significantly reduce the
administrative and data capture burden on clinicians, dramatically shorten the
time for clinical data to be available for public health, emergencies and for
traditional public health purposes, profoundly reduce the cost for
communicating, duplicating, and processing health care information. And last
but not least greatly improve the quality of care and safety for all patients.

So this really is a good introduction to the topic because the topic is
basically we have this vision and I would have to say this has been a vision in
medical informatics for a long time, it’s a shared vision I think kind of
universally, and the question is are we making any progress towards this vision
with all of these things that we’re doing. And we probably are and the real
question is is do we truly share this vision, are there in fact things that we
should do that would move us closer to recognizing some or all or part of this

So just to start the discussion, primary use of data we’ve arbitrarily in
some ways defined as collection, processing, display of data, which is specific
to an individual person for the purpose of providing care and services to that
person, and that includes data exchange with other sites for the care of the
individual. Secondary use of data is processing and aggregation of data for
uses other then direct patient care or a slight extension to that is use of the
data for any purpose other then the purpose for which it was initially
collected. So both of those things I think you could consider secondary use and
the more you pick at this the more you could find out there’s some overlap in
that. But nevertheless I think at the end of the spectrum you’re okay.

So we began discussing this issue in the Standards and Security Subcommittee
as early as April of 2005, its just been this year, my date is wrong, but we
first had some discussion, we had the first group of testifiers in July and
then the second group of testifiers in September and a little later I’ll share
summaries, brief summaries, of what we heard from the testifiers already.

Just looking at this from a data flow perspective what typically happens now
in institutions, that you have a number of systems that go through some sort of
interface engine and you end up with a clinical data repository and you’re
using standard interfaces in that. And that could be more or less then this in
a given institution, it might be in some institutions that it’s just laboratory
data that’s flowing, other institutions it would be pharmacy and lab, other
institutions it would be text reports, other things. But to some extent there
is electronic data flowing now and it’s happening in standard interfaces,
they’re not as standard as we’d like them to be but you have things going. And
then clinicians can access and use that data to of that clinical data

Now I know at least in our own institution there’s quite a different sort of
flow when we talk for instance about cancer data registries. All of those same
sources of information but they flow to a person who’s looking at things in
paper charts and they might not always look as worrisome as this individual but
there’s a lot of work and a lot of going through manual things, manual
processes that then cause creation of electronic records that in the best
situations are standard interfaces and those get promoted on up to regional,
state, and national registries.

So part of the vision of this is could we have a future where those
electronic data flows that are happening go through some kind of automated
process, and I think in most cases we’re thinking of a semi-automated process
where somebody is watching and observing but the data gets filtered and in a
much more automated way the electronic data that exists ends up being placed
into a hospital registry and then moved on to regional or national registries.
And again hopefully we’re using standard interfaces and standard terminologies
wherever we can in that process.

Now jump to this, this is the actual sort of diagram at Intermountain Health
Care right now. Down the left hand side of the screen there are a number of
ancillary systems all of which are exchanging data with an interface engine
that’s sort of the hub of our system and we send admitting discharge kind of
information out to those ancillary system, those systems produce results,
pharmacy orders, clinical data, laboratory data, text reports, all those things
come back, go through the interface engine, and they’re converted there into
standard structured coded data. They’re already structured and coded in most
cases when they come from the ancillary systems but we convert them into
standard codes that are a common coding system and then we add those things
into the clinical data repository.

The different between these two databases, the clinical data repository is
the database that we use for real time patient care and then over in the right
lower corner you have the data warehouse and the data warehouse is the name
we’ve given to the database where we do longitudinal cross patient research.
And there’s a big arrow there that’s showing basically a real time or semi real
time exchange of data from this coded structured database that’s used for the
real time patient care into the data warehouse which is where we do the
population, cross population analysis and research.

So at least in our institution then that leads to the opportunity to do some
of this secondary use of data. To give you an idea of the scope of things our
data dictionary contains 875,000 concepts that we use to represent that data.
We have over five million relationships represented in the data dictionary
between those concepts and those relationships are things like anatomic
relationships between body parts so that you know a certain body part is a part
of another part, or the fact that a particular ingredient is a part of a
composite drug, those are the kind of relationships that are there. And then
there are lots of different names for those same things so they have roughly
five different names for each thing that we’ve got in there that’s represented
as an abbreviation or as a code or some other representation.

We’ve got ten people working full time that maintain that terminology for
our corporation and to go back to that, we care for, we have active clinical
records on about two million people in our system. We have 26 people who are
maintaining the interfaces and that number includes both the clinical
interfaces as well as the HIPAA financial and administrative interfaces and
it’s roughly half and half. But that gives you some idea of the number of folks
and kind of the investment that Intermountain Health Care makes in this kind of

So we’ve done some secondary uses of data at Intermountain Health Care and
let me just recount a few of those. One is the adverse drug event monitoring
and we manually tried to track adverse drug events for a number of years and we
suspected that we were tremendously under estimating the number of adverse
events that happened. And so Scott Evans and other people at Intermountain
Health Care said well what we’ll do is rather then ask people to report them
we’ll start looking electronically in the system to try and understand if we
can see from the system when these events happen.

And so they started looking for instance at the times when their stat orders
for Benadryl or stat orders for steroids that would be common treatments for
adverse events and just looking at laboratory data when there was a wildly high
drug level of some kind, etc. And what we found basically that electronically
we could detect nearly ten times as many adverse reactions as were reported
through a manual process and they’ve continued to improve that kind of
reporting and improve the sophistication of the system in detecting those kind
of errors.

Nosocomial infection monitoring, again for infection control purposes it’s
important to try and figure out if there are in fact nosocomial infections
going on and what the source of those is. And so electronically we have a
program that goes through and it basically simply looks to see if a patient was
admitted with no fever and a normal white count and then sometime during the
admission they get a high white count and a fever, or they get an infiltrate on
their chest x-ray, we say that’s a high likelihood that that person has a
nosocomial infection and then a nurse is sent out to investigate and find out
whether that truly is or not. But again detection of that kind of nosocomial
infection is now done in large part electronically as opposed to just directly
by some manual process.

We’ve done rule based billing in labor and delivery, this has worked, it’s
been done by Sid Thornton, and in this case basically we’ve worked closely with
the clinicians and with the billing staff at Intermountain Health Care and said
look, if these things are in the chart is it legal for us to bill for those
things and basically set up a rule base that says when this occurs it’s legal
and proper for us to bill this to the insurer and that happens, again, there
are people that review that but the bulk of the work is done automatically now
whereas before they were dependent upon people to submit pieces of paper or to
take a second step in addition to the clinical care to make sure that the
billing happened and so we have much more accurate and appropriate billing.

Reportable diseases, I mean this one is great and also shameful in a way.
Again we have known reportable diseases that we need to report to public health
facilities and we know whether those particular diseases occur because of
laboratory tests that either an organism grows or there’s an antigen or
antibody that’s found or in these days the DNA testing that tells you that the
DNA of the organism is available. So there are a number of things in the
laboratory that tell us those things. We look at the computer data, if we see
those things then that shows up on a reportable disease report, person confirms
it, and then this is the shameful part, it’s all electronic to that point and
then we fill out the form and send it over to the state health department in a
manual paper form. We really, I’m looking for graduate students and others who
would pick this up and we could make a proper interface there.

Another one of the things that we’re doing is what we call how am I doing
reports and an example of one of those is the hemoglobin A1C and physicians
that are practicing at Intermountain Health Care basically at any time can pull
up a report that tells them for their diabetic patients what the average
hemoglobin A1C is for their patient and it shows them match populations that,
not match populations, that’s not correct, what it shows them are averages for
the corporation for hemoglobin A1Cs for other physicians so they can see the
average for the corporation and they can see their average. And then if things
look out of line they can go from that report and actually see their own
patients and see the actual hemoglobin A1C for their own patients.

But what it allows and what we’ve seen is a remarkable change in physician
behavior if the current average for the corporation is 7.5 and a given
physician sees that this hemoglobin A1Cs are 9 something, it’s a remarkable
motivator for physicians to say why am I different, I mean they go look at
their things and say oh this guy is not my patient, I’m not really seeing, they
look at the individual patients and then they take action to try and in fact
provide better care so that that hemoglobin A1C value comes down as an average
for their patients.

The other thing, a couple of things we’ve done in terms of clinical research
and these are justifications where the solution to the problem ends up being
other kinds of policies and procedures but the justification for making a
change in clinical care comes from analyzing the data in the database. A couple
of those, one was transurethral resection of the prostate and basically from
the electronic record what we noticed is that there was almost a bimodal
distribution in the length of time that it took people to be discharged after
surgery. Some people were discharged at three days and other people were
discharged at five days and it was almost always three days or five days, it
wasn’t just a smooth distribution.

And investigation into that came down that it was either one way or the
other in a given hospital and with further investigation it came down to
basically how the staff in that particular hospital had been trained and
whether they pulled the Foley catheter on the second day or whether they waited
another day to pull the Foley catheter and that corresponded exactly to how
long their hospital stay was and there were no demonstrable differences in
outcomes between those groups. And so again they just educated the house staff,
house staff and the other physicians, and lo and behold the hospital stay for
that surgery reduced by about two days in the other hospitals.

Another interesting one was induction of labor prior to 39 weeks. It’s well
known clinically that if you induce labor in women before the 39th
week that you have a much higher probability of a premature birth and the
likelihood that the baby would go to an intensive care unit or that there would
be a longer extended stay for the baby in the hospital. And people said well
maybe we ought to put in a rule for that and the clinicians said oh no, it’s
nationally it’s all those other bad doctors that are doing this, we don’t do
this at our institution.

So somebody then basically went to the computer records and pulled them out
and did the study and lo and behold we were right on national average in
inducing before 39 weeks and we had all of the expected outcomes from that in
terms of ICU days and other things. And so then the clinicians said oh, maybe
we aren’t doing as well at this as we thought we were, and in fact they
instituted a rule and it’s a step wise function, once they instituted the rule
and really started looking at that closely the exact predicted change happened
in the length of stay and in the percentage of babies that went to the ICUs,
etc.. So it provides again a very strong motivation to clinicians because again
there’s a tendency always to think well I never do that, I mean there were
interesting things that came out of this.

It turned out that these things corresponded to things like how long the
mother had been visiting, waiting for the baby to be born, it correlated to,
people say well my mom is going to have to go home and if the baby is not born
before she goes home. It also correlated to days when there were Jazz games —


DR. HUFF: Yeah, Utah Jazz, correlated to when physicians were going to go on
vacation, I mean there were a number of things that come into this. But all of
those things basically once they’re recognized can be corrected.

Anyway I think that’s at least just a summary of some of the things that
we’ve done at Intermountain Health Care.

So to sort of categorize those the possible secondary uses of data could be
for billing, it could be for morbidity and mortality reporting, it could be for
quality, quality reporting as well as quality improvement, it could be for
patient safety reporting, it could be for clinical trials and post marketing
information on drugs, it could be in support of other kinds of clinical
research, it could be trying to understand the health population statistics.
One of the things I didn’t say, I mean because our electronic record is
standardized, I don’t know why you’d want to do it but if we had any interest
in it we could probably report daily a running average of how overweight the
population of IHC is because we collect that and it would be an easy thing, you
could almost have a running average to try and understand if a particular
intervention was having any impact at a population level on obesity. And then
obvious things in public health for bio surveillance, reportable disease
reporting, disease and cancer registries, all of those kinds of things are
possible and this isn’t a comprehensive list.

So why should we think about studying this? It would be to know what’s
already done, is there a feasible approach, are there things that should be
done, are there standards that are needed, are there new policies that are
needed, are there demonstrations or pilot projects that should be done that
might in fact improve the quality of care by the secondary use of data.

Just another principle, let me go back here a second, so this is just a
little bit about data collection and understanding how data collection relates
to this secondary use of data. At some level you start out with things that
are, things that you can perceive or things that you can observe like colors of
things and visual intensity, sizes, shapes, pain, heat, other kinds of things,
and most of these things are done at a subliminal level. I mean in physical
exam you’re not consciously thinking about these things but you are in fact
quickly integrating those things to say oh, this combination of this visual
intensity and this color looks like an abnormal color for somebody’s throat,
looks like a pharyngitis or they’ve got some cervical lymphadenopathy, they’ve
reported to me that they have pain, they’ve got a temperature of 38.9, they’ve
got a white count, etc..

And from that data you can apply another process and say oh with the
combination of those things I can really say that I’ve got an increased white
count, the patient has a fever, they’ve got a sore throat, they’ve got a
positive strep culture, I know that they’ve got an inflammatory process going
on. And knowing those things you can apply yet another set of rules or a
process and assert basically that the patient has acute streptococcal
pharyngitis and this goes on with yet another information knowing that they had
a splenectomy or other things you can assert that they’re an immunocompromised

Well the purpose in going through this basically is to say that if I end up
with in the medical record and the immunocompromised patient is the thing that
finally gets reported as an ICD-9 code or as part of a DRG grouping process I
can imply some things or maybe infer some of the things down below but my
ability to infer the fact that the patient had a positive strep culture or
other things is actually quite limited. And so in this sort of data collection
chain if you had your rathers what you would like is the most primitive data
because that then allows you to apply precise logic to the things that were
observed and see whether in fact the things that, whether the things that were
inferred were in fact true based on the observations.

So you could take a particular finding like the fact that they had acute
streptococcal pharyngitis and say what was the evidence for that and if there
were people who in fact had fever for other reasons of origin and there was no
evidence of a positive culture and there was no rapid strep test or other
things you’d say well that’s really suspect. The point being that the closer
you get to the actual observations that are used the more quality assurance you
can do on this kind of data.

Now the down side of that is that typically the closer you get to
observations the higher cost and the greater burden it is to try and collect
the data that allows you to do that. It’s a lot easier to just enter into the
patient’s problem list immunocompromised patient then it is to collect all of
this other information as specific coded detailed information. But there’s that
interesting tradeoff in sort of fidelity to the observations versus reporting
of these things at a higher more abstract level.

Related issues are that in that diagram for instance if the purpose was a
billing purpose, if you can where each of these little circles represents an
inference process that’s going on in somebody’s brain or it could be a computer
process that’s making that kind of inference, if you could establish those
rules as computable rules then you would have a much surer way of asserting
that you know this was true, that the patient had acute streptococcal
pharyngitis. And what you could in fact do is instead of a person going through
doing chart review and trying to find this information in a paper chart and
make that inference you could make that inference electronically. And that’s
what Chris Schute(?) has always talked about as “aggregation logics”
is a formalization of the logic that allows you to do that kind of inference on
the data.

A second sort of interesting rule is that because the cost of obtaining good
data is high in fact you may have to find secondary uses of data or you may
want to make secondary uses of data to justify the cost of getting the data
because often a single use of the data may not justify the cost and the
overhead of getting that good clinical data.

Now I want to be clear that there’s no expectation that reuse of clinical
data would in fact answer all of the data needs, you’re still going to need
surveys, you’re still going to need data collection instruments, you’re still
going to need other kinds of public health reporting because everything that
you want to know isn’t found in clinical data, you’re going to have to ask
other questions especially in research situations that wouldn’t be routinely
collected as part of clinical care. And so that might be questions about diet,
about hobbies or about exercise or who knows what, that you might want to ask
and so there’s no assumption in this that reusing clinical data for public
health purposes or for population statistics would be a substitute for any of
the, certainly not for all of the things that you need to collect and

The final thing I want to say as an introduction in this is just to give a
brief summary of the testimony that we have received already. This is a list of
folks that testified, we had Valerie Wattslaff(?) from AHIMA and Mary
Stanfill(?) from AHIMA, Clem McDonald, James Campbell, James Cimino(?) and Kent
Spackman have already came and talked to the Standards and Security
Subcommittee. So very brief summary of each of these folks.

The AHIMA testimony basically talked about the fact that there’s quite a bit
of work going on right now in computer assisted coding. There are two big
categories of what they talked about, one is computer assisted coding itself
which there are two branches of, one branch of that is where the person as
they’re providing clinical care sees associated billing codes and directly
enters the billing codes as they’re providing, basically what they’re doing is
seeing the billing codes that are implied by the clinical charting that they’re
doing and so they’re sort of approving the billing codes as they’re going
through providing clinical care.

A second way of doing that is natural language processing where you have the
patient record created and after the fact you apply natural language processing
and try and infer the billing codes that would be justified by what’s in the
record. Both of those things, software that exists today and people are doing
studies and doing, actually doing clinical trials.

The other kind of encoding is the semiautomatic coding from EHR data and so
that again depends on, the assumption there is that people are encoding data in
an electronic health record using SNOMED CT and that they’re applying some set
of rules and then asserting ICD-9-CM codes or in the future ICD-10 or
ICD-10-PCS codes that would correspond to that clinical data. That is in an
early phase and to my knowledge, they didn’t testify about people who were
actually doing that yet. Jim Campbell who is working in that area also, at the
time that he testified said that there were plans to do demonstrations or
prototypes but they hadn’t been reported on yet.

The AHIMA folks, their recommendations were to encourage widespread adoption
of EHRs, simplify and standardize the reimbursement framework, and to quickly
adopt ICD-10-CM and ICD-10-PCS because those terminologies would allow a much
more accurate representation of the information.

Clem McDonald talked about two different approaches and he spent quite a bit
of his talk talking about the use of coded data within the Indianapolis Network
for Patient Care. But sort of the way he broke it down is he was doing data
reuse in a different way then sort of we defined it at the start, he as reusing
it to say it’s not the people who collected the data that’s reusing it for
patient care it’s a different set of clinicians out of a different institution
that are reusing the data for patient care.

So in their network when a person comes to an emergency room you can see the
record from other hospitals and so it’s secondary, in the way that Clem was
thinking about it’s a secondary use because it was collected at Regenstrief to
care for the patient at Regenstrief, now they’re coming to an emergency room
and it’s somebody else in another institution, it’s still patient care but it’s
a whole different set of people who didn’t collect the data that are using it.

He talked through their use of data and the fact that they have a
centralized patient database, they’ve done a number of research studies, one
that he mentioned was they were able to detect an association between
erythromycin use and pyloric stenosis. And they’re also setting up, they’re
doing what we wish we were doing in terms of setting up an automated electronic
reporting from Indianapolis to the public health department.

So the other thing basically is that again the other idea is to capture
clinical data in a coded form from the start and then use it in other areas and
one of the things that he pointed out is that we don’t know what’s important
capture and that we need more formal studies to try and understand which things
are important to capture. So from the testimony that he gave for instance he
was saying we need things like Braden scores and Apgar scores and Cage surveys
and other things that have been tested and are known to be valid for a
particular, for understanding a particular situation or prognostically
important for that condition.

There are lots of things, in fact thousands of things where we don’t know
what’s important to measure or to understand. He talked about the Ottawa ankle
rules where people studied over 100 variables understanding when people came in
with a sore ankle to try and understand and predict whether an x-ray was needed
and whether the ankle was really fractured. And what they found is after
looking at hundreds of variables that you could predict whether they actually
had an ankle fracture and whether you needed to do an x-ray using five or six
variables. And that we need to do much, much more of that to determine what the
true signal is in all of the noise that we have flowing in clinical records and
what people collect in data.

So his recommendations were use the data we’re already collecting and do
research to find out what other things are worth recording.

James Campbell who’s at Nebraska started off his talk and basically reminded
the committee of the strategy that we have for standard coded terminologies,
that we have this model of terminologies where we have a core reference
terminology, surrounding that are important other clinical terminologies and
surrounding that are important classifications that can be made from that. And
he talked through some of the barriers and successes that he perceived as we’ve
been progressing, he talked about issues in trying to correlate SNOMED to LOINC
including ICPC, the International Classification of Primary Care, into SNOMED,
the nursing classification systems, NANDA, NIC, NOC, Omaha, Home Health Care,
PNDS, and he went through some of the issues, barriers and successes related to
those terminologies and trying to create the core terminology.

He then focused specifically on the fact that there’s a map from SNOMED CT
to ICD-9-CM which is created specifically as a reimbursement map, in other
words it is intended specifically to try and automate the process of basically
applying a map to clinical data in an EHR that’s encoded in SNOMED CT and be
able to assert the billing codes that would be justified based on that clinical
charting data. And again there’s a fair degree of sophistication in the
mapping, it takes into consideration concepts that are basically a one to one
where if you see hypertension in SNOMED you can pretty much assert hypertension
in ICD-9. It takes into account other things where for instance you have
distinctions that are based on sex or on gender or coexistence of other things
and so they have a fairly sophisticated way of representing that logic.

Ultimately his recommendations were to continue and accelerate the
terminology deployment plan and work to achieve accurate mappings that would
support this kind of aggregations and use especially in the reimbursement map.

Jim Cimino reiterated potential uses of the data for automated decision
suppose information retrieval for use in info buttons which is one that we
hadn’t thought of until he testified. The idea that by coding data I can much
more accurately answer questions on online resources that will help the
clinician care for the patient, and then other things that epidemiologic
studies, syndromic surveillance, that sort of thing.

The major barrier that he saw basically was lack of standard coded data and
he did some analysis to say which areas would be the areas where we could
probably get the most benefit from having standard coded structured data and
that was a combination of what’s already close to being coded in that way,
where there’s standards available that people could use, the importance of the
data, that sort of thing. And the areas that he came up with were lab results,
problem lists, medications and allergies as the top four areas where we could
probably make some good headway.

And his recommendations were to support terminology development, provide
incentives for mapping to the standard codes, provide education and do research
on the areas where we could find, to try and find the areas that would in fact
be the most beneficial to people to pursue.

The final testifier was Kent Spackman, Kent talked about a success story
which was the Clinical Outcomes Research Initiative National Endoscopic
Database, and this is an initiative from the American Society for
Gastroenterology and this is an active database, there are 20,000 reports from
750 physicians each month that go into this database, they support it as a
not-for-profit organization. There have been over 50 research studies and
initiatives that went against this database.

The downside is that it’s a silo, it has, that data is not using standard
SNOMED codes or other things, it’s not integrated with the patient care record
so that happens, it’s an independent thing but it demonstrates what could
happen with structured coded data. He pointed out then the need for that thing
not to be a silo what you need is a reference terminology and a mapping from
those representations to a reference terminology.

There are some barriers to reuse and he emphasized that there are changes in
meanings over time and he went through some examples of lymphoma classification
systems, leukemia classification systems, and noted that there have been 25
schemes in the last 75 years for those diseases. Now he chose that because
that’s one of the outliers, I mean lymphomas and leukemias have been difficult
to classify for the last 75 years because our medication and our knowledge has
been changing about those.

Some of the issues that he raised basically were the value of secondary data
accrues mainly to parties other then those who collect it, and so that creates
an interesting question then about how we create incentives for the collection
of the data if the main benefit accrues to someone else other then those who
are sort of paying the cost and burden of doing it. The value of the data
depends on its accuracy and he brought up some very interesting issues about
who should have the responsibility for defining standards for data collection,
is it the professional societies that should do that, is it regulatory people
that should do that, who should decide it. And how would we know, it’s similar
to what Clem was talking about, there seems to be a need to do research to even
know what the most valuable kinds of data we should be collecting are in order
to move forward and so he encouraged doing some research to understand what
clinical data is essential to collect in order to support the kinds of uses
that we want from that.

So with that, that’s my summary, and then I would turn it back to Simon to
lead the discussion of what should we do now. Sort of the main question is is
this of interest, if it is how should we move forward, since real work gets
done in the subcommittees how would we want to sort of divide up the work and
talk about it.

DR. COHN: Okay, well Stan thank you. I do want to remind both old and new
NCVHS members that this has been one of the fundamental tenets at least from my
knowledge the last ten to 15 years and almost every report, be it Clinical Data
Standards Report, be it NHII Information for Health Report or whatever, we sort
of reference this idea of reuse and indeed if you think about it given our
responsibilities around health statistics, health information policy, I mean
it’s really an area that needs to be important on an ongoing basis to all of

Now I mean this area, and I guess the other piece I would say is that a lot
of the work that we’ve already done which is clinical terminologies,
recommendations around mapping, all of this, are work that all relates to issue
of reuse.

Now the question I tend to think of and it’s sort of beyond potentially a
research oriented question is sort of this issue of well what are, where are we
now, what are remaining barriers, how do we bust through those barriers. And
maybe I’m being sort of practical on this but I tend to think almost that
that’s sort of the way I tend to frame this sort of thinking though Stan I
think you’ve done something to sort of remind me of the larger conceptual
issues in all of this.

Now I had to give a talk yesterday to a group I will not name where I
actually was reflecting, I had to do some research and discovered that at least
according to a paper published last week that had been sponsored by the
California Health Care Foundation that somewhere around 22 percent of health
care costs continue to be around business and insurance related functions
primarily response around the claims activities and eligibility and all of this
stuff. And so when Standards and Security Subcommittee sort of took this on one
of my questions was of course well are there ways for us to, well yeah we’re
going to have clinical terminologies, we’re going to have, we still have all
this administrative billing that goes on, is there some way for us to actually
reduce costs, I mean is there a way to achieve administrative simplification.

I guess Stan I should ask you the open end question, is that something that
Standards and Security Subcommittee is going to work on you think?

DR. HUFF: Well I’m not the boss, we’ve got to ask Jeff and Harry but I would
think, that as I thought about it I thought that was the one area that clearly
fell within the scope and purview of Standards and Security would be focusing
on that issue of could we do the billing classification directly from clinical
data in some way and what things could we do to promote that.

DR. COHN: And I didn’t pay Stan anything to say that so thank you.

But I guess the question, the larger question since I know Quality was
interested in this topic and Populations has an interest —

MR. HUFF: Privacy and Confidentiality seem like they’re interested too.

DR. COHN: But maybe from the side of protecting privacy and confidentiality
and all of this as we move forward. I mean the question is is from a more
general view, A, we thought everybody needed to be updated, the question is is
what other aspects, other thoughts, is it a full committee issue or are these
things that need to be divided up in the subcommittee, so Stan I think that’s
sort of where you were going.

Paul I see your hand up and then Justine.

DR. TANG: Two questions, one thanks very much, Stan, that was very helpful.
One clarifying question on the work that you said Jim Campbell was doing, you
said he’s doing a prototype for the SNOMED ICD mapping?

DR. HUFF: The mapping is relatively complete, what they were doing to
prototype is to try and implement that in somebody’s institution and see if it
really worked.

DR. TANG: Isn’t this a mapping that’s done within UMLS?

DR. HUFF: Yes.

DR. TANG: And that’s what they’re using.

DR. HUFF: That’s the same one.

DR. TANG: Because I think there, I mean because they distribute this with
the SNOMED distribution, presumably some people may already be using it. But
that’s answers the question about —

DR. COHN: Paul I’m sorry, I think my understanding is that no one thinks
that that mapping is out of the box good enough for highly accurate —

DR. HUFF: I think there may be more then one activity going on because
there’s a mapping that has been, existed for a long time that is a part of the
UMLS meta thesaurus. This new work is actually being done and I don’t think
it’s covered by the contract of SNOMED with the National Library, somebody here
might know better then I do but I think this is a mapping that is along the
lines, they put a lot of new work into this to try, with the goal in mind of
using it for reimbursement whereas the other map was sort of done more
abstractly and —

DR. TANG: So who’s the new they you’re referring to?

DR. COHN: National Library of Medicine, AHIMA?

DR. WARREN: The new they is on the editorial board there is a liaison to
NCHS and he is responsible for ICD-9 work and so he’s been working with the
SNOMED Editorial Board to facilitate a mapping because there is some concern
that the one UMLS may not be good enough for billing and so this is a test to
be looking at that.

DR. TANG: Okay, so there’s some formal credible effort going on to do
mapping that would help the clinical to financial mapping —

DR. WARREN: And then Jim is taking it into their clinical site —

DR. TANG: The new one.

DR. WARREN: Yeah, the new one, to see whether or not clinicians can pick
from SNOMED terms, use the map to generate the ICD and then go on to —

MS. MCCALL: And one kind of extension of that, because it really does, it
has to be good enough for adjudication, is to link up with somebody that not
only wants to run it for adjudication but there are payers out there that are
looking at and have successfully done real time adjudication, so we have some
and I know others are doing it as well so that you could literally go end to
end so that’s another extension of that same thing.

DR. TANG: The second question I had has to do with this reuse and clearly
reuse, one of the good things about reuse is do once and get value many times,
another important one is to reinforce the quality of the first acquisition from
the physician. So the way you pay back the initial user is to give them part of
the benefits of the reuse and we go through lots of ways of making that
information useful to them and their efficient. But primarily what happens is
reuse goes to the secondary users which are often payers or quality measuring
folks, so the concept of how to give incentives back to the people entering the
data at level one which is where it’s best done, it’s most efficient —

MS. MCCALL: I find that, that’s a very interesting paradigm because what I
would say is these are great examples, Stan, this is just wonderful, I mean I
think the broad question is what would we need to do to kind of scale this
everywhere, what would that take and how would it change. But when you give
examples of the clinical research and inducing labor prior to 39 weeks and all
of that do clinicians see that as returning value to them?

DR. TANG: Depends on whether Jazz is having a good season.

DR. HUFF: I think most of them do, I mean I think the physicians are glad to
know where their hemoglobin A1C is falling relative to others and IHC has
provided incentives around those things as well, they’ve basically said that,
they’ve made bonuses and other things available to clinicians whose quality
indicators are better. I mean that’s an artificial incentive but —

MS. MCCALL: No, it’s really part of the mindset on the part of caregivers
that it is, part of their job is to know where things work and where they

DR. HUFF: I think that’s in general that’s true, I think in general
physicians are motivated to try and provide better care and if you can give
them information that helps them provide better care then they like that.

DR. COHN: Paul you finish and then I want to let Justine have her question

DR. TANG: So at any rate in answer to one of your questions about what can
NCVHS do I think we may have to relate to the policy of what something that Bob
Esterhay(?) said a long time ago fee for data, if you recall Dr. Brailer also
emphasized that making sure that there’s a business case and a business model
for some of the work they’re doing, I think we have to create the business case
for this as well and that’s the only way it will flow. There can be many ways,
pay for performance can be one of the indirect ways that it comes back to a
physician but there’s also probably a good case to be made for doing the work
and then the secondary reaping of the data.

DR. COHN: Justine?

DR. CARR: Thank you, Simon. Well, it’s always exciting to see what’s going
on at your place and I would like to make two observations. Number one is that
in addition to all of the traditional sort of burden of things you have to do
sort of the business world of medicine I think it’s very important to pay
attention to the fact that we’ve just had an overlay of a huge burden of
collecting the performance indicators that require actually chart review in all
institutions about how did you manage your acute MI, inpatient as well as
outpatient. And that’s sort of independent of all the coding and all of that.
And it’s very, very costly for the number of people that you have to hire, the
charts and paper that you have to review, the data you have to submit. So that
I think makes the case even more compelling to get electronic and get

I think the challenge that we’ve been thinking about in the Quality
Committee is just what then do you say for the electronic health record, what
you have is spectacular, you have every data element and it’s like Lego’s, you
could build a city with everything that you have. But you also have 26 people
maintaining it and you have very, very sophisticated analysts in decision
support but most institutions don’t have that, most are just struggling to get
order entry for prescriptions or medication. So I think as we think about it we
have the, your kind of building blocks which would be fantastic if we could do

And then as Simon, we were discussing at lunch, we have the other which are
these G codes that have just come about from CMS where you simply attach the
code that says yes I gave aspirin on admission, yes they went home on a beta
blocker, so that’s simple, that could answer our questions today and kind of
get the information out. But I think that one of the things that we want to do
with input from all the committees is to inform the architecture so that there
is a way for this information to be captured and transmitted, it may not be
building blocks, it may be true/false, yes/no, I did it or I didn’t do it, but
I think we’ve got to make these two processes intersect, the performance
metrics and the building of the electronic health record.

DR. COHN: Jeff and then Bill Scanlon.

MR. BLAIR: It seems to me that, and I’m not sure about this, I’m really
listening and struggling with this quite a bit, but I’m trying to make sure I
get the horse before the cart and it seems to me that the horse is collecting
clinically specific data from patient care and if the incentives are in place
to do that then the derivatives become just an additional cost saving
efficiency saving quality saving measure.

If the thesis that I’m making that the horse is clinically specific data for
patient care use then the first set of incentives for public policy would need
to be incentives for better patient safety, incentives for improving workflow,
in other words the clinically specific outcomes data so that you can wind up
improving clinical processes and workflow, whether that’s nosocomial infections
or any of the examples that you gave, until we reach a tipping point.

I don’t know where the tipping point is but at some point if there’s a
certain amount of data captured with SNOMED CT and LOINC and RxNorm they’ll be
a tipping point at which point it will be not only good for quality and patient
safety but it will be cost effective to maintain information with the
clinically specific codes and I think at that point it’s almost like you’d be
going downhill because then you wind up mapping, taking advantage of NLM’s
mapping from SNOMED to ICD-9 and CPT codes and the secondary uses I think
probably would flow probably with fewer incentives. I think the hard part is
getting to the tipping point with the incentives for the use of the clinically
specific data for patient care.

Do you think this is true or are there other issues and problems in the way
then just incentives? I guess I’m asking Stan but anyone who, there’s many of
you that know more then I do on this topic so anyone who has a thought on that.

DR. HUFF: Well I think that’s, I think there’s a lot of merit in the idea, I
mean I think there is sort of the merit in the idea of fee for data that Paul
was mentioning. I guess tied into that is somehow in the back of my mind is
that unless you’re in a situation where you can realize the benefit from
collecting the data then it’s not worth offering the incentive, so it’s kind of
a cart and the horse, chicken and the egg kind of a thing.

DR. COHN: And let me just make a comment also because I think that to my
view, Jeff, and really without trying to answer the question and be aware we’re
going to cut off this conversation in about ten minutes so I want to let
everybody know that this is not going to be an open ended conversation for the
next hour unless we all want to move dinner down to 7:30 and keep going.

But I think the concern that I have as I look at current billing processes,
current quality performance development metrics, G codes and otherwise, that
because we obviously are still living in primarily a paper based world there
are actually potentially disincentives for us to make a transition to wherever
we’re going.

I mean I do know that as wonderful as mappings being supported and developed
with the help of SNOMED, with NCHS, with NLM and all of that for mapping I have
a sense and I think we could all point out many good examples where that is not
going to be sufficient to really do what we’re talking about, we’re sort of
partially or maybe slightly automate or help things but won’t quite get us to
the end point, which is obviously what I think we all, I mean as I say that
it’s a sense that I have and I think we can all point out various examples but
I think we need to be looking at these and begin to sort of identify them and
see if there’s way for us to sort of fix all of that stuff or suggest those
areas where there really are roadblocks. I think it’s both a building issue,
it’s probably a quality issue, whatever.

And so I sort of say that, I sort of agree with what you’re saying but I’m
also think that our responsibility is to be ahead and sort of clear away the

MR. BLAIR: Maybe what we need, maybe we should try to study this from the
standpoint of a portfolio of incentives that would get us to the tipping point
and it may also be, when I say incentives it also may be certain barriers and
if we could identify that portfolio and have public policy and health plans try
to provide the incentives in an orchestrated way over a period of years to get
us to that tipping point then maybe that would make the big difference.

DR. COHN: Bill Scanlon you’re up next.

MR. SCANLON: I think this was an incredibly exciting presentation because it
showed that in some respects the new world is really possible and the question
is how do we get there. But I strongly sort of emphasize that I think that new
world is an incredible transformation of what we have now, there’s going to be
a tremendous shift in terms of the balance of power and people that are in
different positions are going to recognize that and be strongly resistant to

You gave some good examples in terms of looking at clinical practices and
changing sort of experience such as the prostate case in reducing length of
stay, well for some people that’s going to mean loss of revenue and they’re not
going to want those kinds of cases studied in that same detail, they’re not
going to want, in another world, not your system but in another world there’s
great independence between the payers and the providers and there’s conflict,
and the information is going to be able to used sort of by one against the
other and that’s going to be a source of great tension.

So I worry about what we’re going to have to do to reach the tipping point
because of the fact that we are going to change things so radically and that we
don’t sort of reach too low in terms of what we’re trying to accomplish because
really changing decisions at the point of care is something that also should be
coming sort of out of this in part sort of because we create better medical
knowledge so that people will do things differently sort of when they’re facing
a decision but also I think that within these systems there’s the ability to
create alarm bells that go off and say wait a minute, why are you doing that,
and not just on drug interactions but on a whole range of things.

I mean I said this maybe in this group but I’ve said it a lot of times over
the last few years, I’m getting tired of Wenberg(?) being able to reproduce his
work year after year after year and that we don’t make progress in reducing
those variation. And so the possibility of doing that is going to only come if
we are able to intervene sort of more at the point of decision making,
informing sort of not just the providers but the patients as well and the
payers so that all of them kind of have a much better sort of basis for saying
yes, we think we should go forward with this, no wait a minute, let’s think
about alternatives.

Let me just say the last thing and this is kind of a true confession from my
perspective on the Quality Workgroup. The struggle is this is such an
incredible broad sort of brave new world that we’re facing, what piece do we
decide to chew on for the moment because there just are so many sort of
opportunities there, what’s our comparative advantage relative to the rest of
the world.

DR. COHN: That’s well said. Now we have Russ, we have Bob, Carol has the
last comment and then we’ll wrap this one up.

MR. LOCALIO: Stan, all I have to say is that you’re doing something that
nobody else seems to be able to do. I just want to say from my perspective of
the ultimate secondary user the problem that I see is not the quantity of the
data but the quality of the data and given the choice between two million
observations generated quickly and inexpensively from a computer that are
filled with missing data and misclassified data and a sample of a thousand that
has complete data and perfectly classified I’d take the sample of a thousand
because I can easily estimate the variance but I can’t handle the bias in the
big population of two million. So I would like to separate the problem of
quality and the use of the computer to collect data because you ought to be
able to collect certain basic pieces of information and put them on a piece of
paper. You say for example that you’re collecting weight on people like every
encounter, but I met with one of my colleagues on Monday who’s working with a
data set from a computerized information system and he can’t get weight on a
lot of people from any time. And this is good organizations.

I’ll just close with one other example, I was discussing with my colleague
here, just last week I reviewed a manuscript from a large very good
organization, I won’t mention it but the zip code is 94612, very good
organization, they had missing data on a key variable 25 percent of the time.
You can’t do that, you can’t produce good work with missing data at that
frequency and so we have to do much more about quality of data getting into
these systems. My fear is that the ease of the computer is going to mean that
anybody just to fill the computer field is going to put junk in there and we’re
going to just have a huge system of inexpensive bad data.

DR. COHN: Thank you, Russ.

DR. HUFF: Just one response, everybody should know I’m not personally
responsible for any of this stuff, it’s a bunch of other folks at IHC that are
responsible for this stuff.

DR. COHN: Bob, would you like to continue on here please?

MR. BLAIR: Stan, how much problem do you have with bad data in your system?

MR. HUNGATE: Let me go back to your earlier question, Jeff, about
incentives. Quick story, my daughter was born in Sequoia Hospital around 1960,
I was here in Washington working on health policy in the mid-‘80s and the
Wall Street Journal came out with a little report of the administrative and
quality assurance staffing changes at Sequoia Hospital between 1960 and say
1987. It was about a 15 percent increase in the total expenses on a per
admission basis all of which was NQA and administration, not in clinical care.

The point is that the incentive, if this information collecting is going to
work it has to be of benefit to the clinicians, it has to be worth their time
to say the data has got to be right so there isn’t 25 percent missing, so
they’ve got to have the same trust in the information system that we’re talking
about patients having in the privacy and confidentiality. So that’s going to
take more time at the clinician level. The savings has got to come from
administrative expense, whether it’s within the institutions or whether it’s
outside, and that’s payment system changes.

And I don’t know whether that fits within the scope of this committee or not
but it seems to me that payment systems change gets to be a big piece of it. If
it were episode of illness where there were a total price if it weren’t built
up from a cost basis, it if were a prospective price you’d have a very
different dynamic at the data collection level. So it’s a complicated subject,
I’m not sure it belongs here but it’s critical.

The other was a question, Kent Spackman’s silo, did this database result in
any sort of prospective information for patients about the procedures that are
involved? Or was the information only for the clinicians?

DR. HUFF: To my knowledge it was consumed by the physicians, I mean there
was nothing to prevent the physician from using that information for instance
to give a patient, if they learned more about the fact from this database that
lesions of a certain kind were precancerous or cancerous in a certain percent,
they could have learned that from the database, whether they shared it with the
patient I don’t know.

MR. HUNGATE: My point kind of is if we’re going to talk about a health
system and a patient centric system we’re going to have t make sure that the
things get into the databases that relate to patients that let them have
prospective information. And it’s a gap that exists that doesn’t necessarily
get filled, it’s another piece of this total equation.

DR. COHN: Carol you have the last comment and then we will wrap up.

MS. MCCALL: The first thing that I’d say, I have some observations on your
presentation which again I think is just wonderful. What I’d love to do is have
you close with kind of an answer to the question that’s on the last slide which
is what should we do now. Because here’s my initial reaction is that if I go
back to, I guess it’s slides nine and ten, the first slide here, it says
statistical profile and then you had all these examples of secondary uses and
they really do span the gambit. And so it’s like the uber intersection, it’s
the master of all intersections of all things that we want to do and we’ve been
talking about for years and so it is where it all comes together. And so the
question that I would have is what is it that we need to do in order to create
that capability, not within one delightful organization where there’s an
alignment of things that may not naturally align, what does it mean to scale
it? And to ask that in some very profound ways, there’s cultural barriers,
there’s technological barriers, we talk about data, but data has many facets,
taxonomies and standards and quality, there’s economic issues, some people may
feel that it’s a zero sum game. And so it is so vast that I would love to see
it become at least for a while become a full committee topic and then it may
break down into work streams that go to subcommittees or workgroups or whatever
is an appropriate place to say what does it create.

Let me give you two examples and then I’ll toss it back. You have these ten
people that maintain, that do nothing but maintain the dictionary, there’s 26
people that do nothing but maintain the interface. And then there’s people that
do research and then report that research, all of those things those are day
jobs, but they’re also processes that you say we have to have somewhere. Is
AHIC thinking about them? Are those going to be institutionalized somehow
across the nation? How do you actually do the research, how will that get done?
How many people will that take? What are the organizations across the United
States that will do that?

And then how in fact will it be communicated back, I don’t know how you do
that today within IHC, I would love to know but I’ll bet you that it won’t be
replicable across the nation and so there need to be some mechanisms to bring
it back, to create it, to interpret it, and then transform it back. So all of
these things I think are part of creating this.

DR. COHN: Well Carol I think I actually, we’re finishing off the
conversation, Steve, I think what I was going to just do, actually Steve do you
have a quick comment?

DR. STEINDEL: I have a comment and I would like to ask Carol if she would
accept this type of modification to your statement, what should we do that’s
different then what’s being done with the NHIN?

MS. MCCALL: Okay, yeah.

DR. COHN: Okay, and that’s probably a good way of framing that. You know
Carol I want to thank you for handing it back over to me along with the
question here, though I think you’ve helped I think answer it in some way. I
mean really what we’ve been talking about over the last hour and ten minutes
has been part and parcel of almost everything else that we’re concerned about
and this is just, in some way it’s a piece of it, it’s a different cut, it’s a
different way of looking at all of this.

Clearly I think we have tasked and asked the Standards and Security
Subcommittee to take another look at this area because it has been looked at
before but to see if there really are barriers and once again I may be very
pragmatic and focused for the moment but recognizing that our responsibility,
part of our responsibility is to make sure at the end of the day the
administrative and clinical areas all come together and try to make sure that
there aren’t barriers that are there that actually retard this vision as well
as the vision of electronic health records and this is an important piece of
that. So I think that that’s an important thing for us to be looking at.

Now you started out by talking about how wide this area was and where
exactly it fits, my other view and once again we can talk about this tomorrow
when we talk about as we review the work of the committee and what we want on
the agenda this year but I think my sense is that the other piece of it for the
moment is that maybe there are reports on this and particular topical items
that maybe need to be generated as a regular committee set of presentations or
whatever, not just out of Standards and Security but maybe bringing in other
people for example to look at some of the quality issues and all of that and
that we sort of have some of the conversations as we go through the year about
this from all its various perspectives.

I would suggest also that knowing that you may be looking at pay for
performance and maybe even some of those G codes that you were talking about
earlier maybe one of the questions that you need to be thinking about in the
back of your mind is geez, are these things that actually can be done out of
clinical processes or are they by definition set up in a way before we are the
way we are dealing with things that well yeah you can do about 30 percent of
them or 60 percent of them in a computerized fashion but the way they’re
written, developed, whatever, there we’re back to manual processes again. Once
again not to say no we shouldn’t do it but more that we need to be instilling
that longer term vision into all of this work.

So you can think about that one tonight and see if you agree with me
tomorrow when we talk about sort of what we’re going, our sort of ongoing
activities but I think that would be how I would frame it.

Now having said that we are running significantly late and I do want to
apologize to everyone though I guess given the way the afternoon started we all
knew we’d be in this situation.

Now we do want to have people break up into subcommittees, my understanding
is that the Standards and Security Subcommittee is up here, Subcommittee on
Populations is in 425.

Now after that we actually need to have a meeting at least briefly of the
NHII Workgroup. Now my question for both subcommittee is would an hour for each
of you to break be sufficient? Okay, well I was going to say when would you
like the NHII Workgroup to start, let’s start that at 5:20, 5:25, we will not
go beyond 6:00, it will just be a very abbreviated meeting. The NHII group is
not, I don’t know if you realize it, even though we have able staff we are
missing our lead staff and I was expecting we’d have a conference call anyway
but we do need to have a face to face meeting.

So why don’t we adjourn now, remember 8:00 a.m. tomorrow morning for Privacy
and Confidentiality, 8:30 in the morning for Populations and Quality Workgroup
joint meeting, 10:00 full meeting again. Thank you.

[Whereupon, at 4:11 p.m. the meeting was adjourned.]