[This Transcript is Unedited]

National Committee on Vital and Health Statistics

January 29, 2004

Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, DC 20201
Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway, suite 160
Fairfax, Virginia 22030
(703) 352-0091

TABLE OF CONTENTS

P R O C E E D I N G S [9:10 a.m.]

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

DR. LUMPKIN: Good morning, we’re going to get started having a quorum. This
is a transition meeting and so I’m going to as we go around the room and make
the introductions I’m going to ask our new members to just tell us a little bit
more then just their name and where they’re currently working, just a brief
background if you would and also we’re welcoming Dr. Robbins, who is from the
Board of Scientific Counselors for the National Center for Health Statistics,
Centers for Disease Control, Department of Health and Human Services. And also
please if you could just spend a few minutes, a minute or so with a little bit
more detailed introduction of yourself and welcome.

So we’re going to start off with Marjorie. Oh, by the way, I’m John Lumpkin
and I’m senior vice president of Robert Wood Johnson Foundation, and chair of
the committee.

MS. GREENBERG: And I’m Marjorie Greenberg from the National Center for
Health Statistics, CDC, and executive secretary to the committee.

DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation and as of today no
longer member of the committee or the subcommittees.

DR. MAYS: Vickie Mays, University of California Los Angeles, member of the
committee.

MR. REYNOLDS: I’m Harry Reynolds, vice president of Blue Cross and Blue
Shield of North Carolina, one of the new members. I’ve been in the health
industry 30 years, worked at two large teaching hospitals, and have been with
Blue Cross for 26 years. Probably the only one on the committee that’s a
national HIPAA implementer and I lived, so I look forward to working with
everyone.

DR. ROBBINS: Good morning. My name is Aldonna(?) Robbins and I am as Dr.
Lumpkin said the new liaison from the brand new Board of Scientific Counselors
for the National Center for Health Statistics. My background is in economics, I
have done my tour of federal duty in the Labor Department and at the Treasury
Department. For the last 16 years or so my husband and I have had an economic
consulting firm where we look at the economic effects of federal, of fiscal
policy on the economy and my special areas are Social Security and Medicare.

DR. LENGERICH: Gene Lengerich, Penn State University, member of the
committee.

DR. STEUERLE: I’m Gene Steuerle, I’m a senior fellow at The Urban
Institute. I guess my claim to fame is a little over 20 years ago I worked with
Aldonna Robbins at the Treasury Department. My background is mainly in
economics and public finance, I’ve written a lot on health care but more or
less from the financing side, and have done other statistical work such as
chairing a Social Security Committee examining the methods and assumptions and
working with the IRS Statistics Division.

DR. VIGILANTE: Kevin Vigilante, Brown University, a physician. In my
clinical work and research dealt mostly with special populations including HIV
and incarcerated populations. The last several years been consulting to various
federal agencies with regards to IT infrastructures relevant to health care and
research and also with some applicability to bioterrorism.

DR. HUFF: Stan Huff with Intermountain Health Care and the University of
Utah in Salt Lake City, member of the committee.

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

MS. MCANDREW: Sue McAndrew, I’m with the Office for Civil Rights, I am the
senior privacy policy specialist for the Office.

MS. TRUDEL: Karen Trudel, acting director of the Office of HIPAA Standards,
Centers for Medicare and Medicaid Services.

MS. FRIEDMAN: Maria Friedman, CMS, lead staff to the Subcommittee on
Standards and Security but I’m here today to fill in for Judy Berek, who is the
CMS liaison to the full committee.

MR. BLAIR: Jeff Blair, Medical Records Institute, and member of the
committee.

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

DR. WARREN: Judy Warren, University of Kansas, School of Nursing, and I’m a
new member to the committee. My background is nursing informatics and I’ve done
a lot of work in developing terminologies, both nursing terminologies as well
as SNOMED, and have also done work at developing standards through HL7.

MR. HOUSTON: I’m John Houston with the University of Pittsburgh Medical
Center, I’m a member of the committee and on the Standards and Security and the
Privacy Subcommittees.

DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for
information technology to the director of the Agency for Healthcare Research
and Quality, liaison to the full committee and staff to the Subcommittee on
Standards and Security.

DR. CARR: Justine Carr, I’m a new member, I’m a hematologist at Beth Israel
Deaconess Medical Center in Boston. And I’ve been there most of my medical
career, actually all of it, and I work with our administrative datasets to
develop quality measures, I work with our medical records department on coding
issues. I was director of our blood bank and hematology labs, which became
automated, and I’m happy to be here.

DR. HARDING: Richard Harding, chair of the Department of Neuropsychiatry at
the University of South Carolina, member of the committee since 1997.

DR. COHN: I’m Simon Cohn, I’m the national director for health information
for Kaiser Permanente, a member of the committee and a member since 1996.

DR. LUMPKIN: And I can name that committee membership in six years, seven
years, eight years. Jim Scanlon had to run away for a short meeting, he will
return, he’s the staff —

MS. GREENBERG: Executive staff director.

DR. LUMPKIN: Executive staff director and about five positions in ASPE, at
least. Why don’t we go to the back?

MR. BUSSOWITZ(?): Roy Bussowitz, National Association of Chain Drug Stores.

MS. JONES: Katherine Jones, NCHS, staff to the committee.

MS. CANAAN: Susan Canaan, writer for the committee.

MS. JACKSON: Debbie Jackson, National Center for Health Statistics, staff.

DR. KILE: Frank Kile, American Dental Association.

MR. FANNING: I’m John Fanning, privacy advocate of the Department of Health
and Human Services.

MR. ALFONO(?): Bill Alfono, Blue Cross/Blue Shield Association.

MS. SKILLEN(?): I’m Elizabeth Skillen, I’m an HHS Emerging Leaders intern.

MS. WILLIAMSON: Michelle Williamson, NCHS, CDC.

MS. ZIGMAN-LUKE(?): Marilyn Zigman-Luke, AAHP/HIAA.

DR. FERRER: Jorge Ferrer, CMS.

DR. ORTIZ: Eduardo Ortiz, Agency for Healthcare Research and Quality.

MR. ROUDY(?): Dan Roudy, American Health Information Management
Association.

MS. WARK: Cynthia Wark, Consolidated Health Informatics Initiative and the
Centers for Medicare and Medicaid Services.

MS. WHITE: Gracie White, NCHS.

DR. LUMPKIN: Okay, we also have an open line on the speaker phone, is there
anyone on that? Okay. As in all previous meetings of the committee just note we
are broadcasting over the internet through the kind auspices of the Department
of Veterans Affairs, and so please make every effort to speak into the
microphone so people outside can hear you clearly.

The first order of business, just a note, for the new members of the
committee, new members and newly reappointed members of the committee who’s IDs
have expired, Jackie will be when they are ready pulling you away from the
meeting in ones or twos to get your ID picture, so if you see people getting up
and leaving it’s only because we didn’t want you to vote on a certain issue,
but you will all find it much easier to come into the building when you can
just flash your ID instead of having to stand there and wait for somebody to
come pick you up.

At this point any declarations of conflict with the subject matter of this
business meeting? Okay, I see none. Then we will proceed with updates from the
department and we’ll start off with Karen.

Agenda Item: Update from the Department – HIPAA – Data
Standards, Including Clinical Data Standards Adoption – Ms. Trudel

MS. TRUDEL: Thank you very much. I’m going to recap some updates that I
provided yesterday to the Subcommittee on Standards and Security, I apologize
to those individuals in advance for repeating myself but the status just didn’t
change from yesterday to today.

I’m going to talk a little bit about the Medicare implementation statistics
for the HIPAA transactions and code set standards, I’m going to talk a little
bit about the transaction complaints that we’ve received to date, and then talk
a little bit about the National Provider Identifier final rule, which was
published on January 23rd.

I’ll start out with the compliance statistics for Medicare, we do track
these weekly, and we are now up to, to be exact 61.35 percent of the electronic
claims that Medicare is receiving are being received in HIPAA compliant format,
which is quite an advance over even three months ago. Continuing to look at the
proportion of compliant claims week to week as we go along and looking to
identify a point in time where it appears appropriate to begin to make plans to
lift the Medicare contingency. We are not there at this time, I don’t have a
specific date or a percentage that will trigger that process. We’re very much
looking at it on a week by week basis and trying to assess where we are and
where we expect to be in a quarter or two.

Turning to the complaint, we have and I know Susan is going to laugh at me
when I say this, we’ve received a total of 46 complaints.

MS. MCANDREW: That’s less then we get in a week.

MS. TRUDEL: Yes, I know, I’m very sorry about that. Of those 35 actually
did turn out to be valid transaction and code set complaints, they were not
outside our scope of authority. Of those 35 27 did allege that a compliant
claim had been rejected by a health plan. There were several companion guide
issues, five code set issues, and almost half of the complaints indicated that
cash flow was an issue in their filing of the complaint which is to be
expected. And the vast majority of the complaints were from small providers
filing against health plans.

As we receive these complaints we go back to the covered entity that’s
complained against, we indicate what the complaint was, talk to them, try to
work through to a voluntary compliance, we’ve gotten very good results so far,
all of the complainees that we’ve contacted have been responsive and many of
them have already taken steps to resolve the problem. So I think that’s
actually working fairly well.

Let me move along to the National Provider Identifier, this was in the
works for many, many years. The final rule was published on January
23rd and this rule establishes a standard identifier, standard
unique identifier, that will be assigned to and used by all health care
providers in all HIPAA administrative transactions, so it’s not just a Medicare
or Medicaid identifier, this crosses the entire health care industry as does
the rest of HIPAA. The effective date of this regulation is not until May of
2005, that’s very unusual to set up an effective date that’s that far in the
future, but it will take CMS that long to be able to establish a process and a
system so that as of that date providers can actually begin to come to us and
apply for an identifier. That date then starts the normal two year HIPAA
implementation process. So we are not cutting into the normal two year process
for either providers or health plans, we’re basically giving them that entire
two years starting at the point in time when they can actually get an NPI.

There was a lot of discussion in the rule making process about what the NPI
and the system that goes along with it will and won’t do. The identifier itself
will replace the use of legacy provide identifiers in transactions and we hope
that it will simplify transactions including claims and COB and save money,
which was the intent of HIPAA. But it will not, the possession of an NPI will
not guarantee reimbursement to a provider by any health plan, it will not
enroll providers in a health plan, it won’t make a provider a covered entity,
and having one will not require a provider to abide by HIPAA and conduct
electronic transactions unless they’re a covered entity.

What does the identifier look like? It’s ten positions long, which is
different from our proposal. We proposed eight positions alphanumeric, we have
gone to ten positions all numeric based on the comments that we received from
the comment period.

MR. BLAIR: — numeric or alphanumeric?

MS. TRUDEL: Ten positions all numeric, one of which is a check digit. The
identifier does not convey information about the provider, if there’s a one in
the first position that doesn’t mean that you’re an internist, etc., and it is
compatible with health insurance card issuer standards worldwide. Any health
care provider can obtain an NPI whether they’re a covered entity or not, only
covered entities are required to obtain an NPI. They’re required to provide
updates of any information within 30 days of a change to the National Provider
System, and they must use those identifiers when they conduct HIPAA
transactions.

In addition to providers which are legal entities we allow for subparts of
a legal entity to obtain an NPI if they need to do so, for instance if there’s
a hospital system where the system itself is the legal entity, any subparts of
that system which are discreet providers and need an identifier can obtain one
as well.

Well, how will a provider obtain an NPI? There will be an application form
for them to complete, we are hoping to make as much of this entire process
electronic as possible. The application will be received by the system, it will
edit and validate data, determine whether there is already an identifier or
record on file for this profile, and send back a notification of what the
identifier is. We will be collecting the minimum amount of information
necessary for two purposes, one is unique identification, and two is
communication with the provider. That means that there is a certain amount of
data that we previously proposed to collect that didn’t make it through to the
final rule. Some of those items are race and ethnicity, certification
information, education or school information. We are not collecting information
about every single practice location that a physician might have, we only
collect one plus a mailing address. So those are the types of information that
people thought at one point would make the database richer for research
purposes but that we scaled back on consistent with the notion of minimum
information necessary for unique identification and communication.

The National Provider System that I referred to is being developed under a
contract with HHS, it will process the applications and assign the NPIs. It
will store information and it will also provide information to people who need
it. There will also be an enumerator, that will be an organization that
operates the system, receives applications, resolves errors, helps with
problems, handles data requests, and that is not yet contracted for, we’re
still working on that procurement.

There will be three levels of data to be disseminated, one obviously will
be the full dataset will be available to HHS and the enumerator. There will be
a second level of data to the public, which will be completely releasable under
the privacy act. There will be a middle range of data where we’re still
developing a strategy for how to handle that where we may need to obtain data
use agreements with organizations like health plans that need more data then
the minimum to be able to match their provider records to the new NPI records,
so more will be coming on that.

There is information about the regulation on the website, which is
www.cms.hhs.gov/hippa/hippa2,
and we’ll be developed additional frequently asked questions, outreach
materials to providers, but since we do have some time for that, the compliance
date for covered entities is not until May of 2007, we believe we have a little
bit of time to get that done.

Any questions before I turn it over to Sue?

DR. HARDING: Just a very good report, just one question, something that
comes up all the time. Is there any way linkage between NPI and Social Security
in any way, is it the Social Security plus a check digit or is there anything
that a certain group of people will be concerned about in that issue?

MS. TRUDEL: No, the NPI will be generated basically randomly, except for
the check digit. The reporting of the Social Security Number will be voluntary
and if a provider does give us their Social Security Number or Tax ID number we
will validate it but that’s not something that would be provided for instance
in public use files, no absolutely not.

DR. HARDING: Thank you.

MS. TRUDEL: You’re welcome.

DR. LUMPKIN: So are there provisions for vanity numbers like 007? I’d like
to get that one. Kepa?

DR. ZUBELDIA: Karen, could you give us an update on the reports changes or
guidance that is supposed to come in the spring concerning DDE and some of the
other things?

MS. TRUDEL: We’re working on a second modification rule, the proposed rule
I don’t believe it will be ready by spring but some of the items that we will
be addressing in there will be some clarifications to direct data entry, some
issues related to the treatment of supplies in retail pharmacy transactions,
and also some items that were raised by the Secretary’s Regulatory Reform
Committee that required some reg changes. At this point we’re still drafting
that regulation.

DR. ZUBELDIA: Do you have an estimated date?

MS. TRUDEL: Actually I believe it’s on the, it’s slated on the agenda for
late summer but it’s very difficult to assess when things are actually going to
turn up.

DR. LUMPKIN: So Kepa are we going back to the days when you used to always
be up at the microphone? Oh good, don’t be a stranger. Sue?

Agenda Item: Update from the Department – HIPAA –
Privacy Rule Compliance Update – Ms. McAndrew

MS. MCANDREW: Like Karen I’d like to start by reporting on how we’re doing
on compliance and enforcement efforts. As of the end of December, the end of
our calendar year 2003 we had received some 3745 complaints —

MR. HOUSTON: Could you repeat that?

MS. MCANDREW: 3,745. We have closed 40 percent of those and are continuing
to work on and investigate the remainder. The bulk of the closures were for
jurisdictional reasons, either the complaint alleged an occurrence that took
place before the April 2003 compliance date and we do not investigate
allegations that occurred before the rule went into effect for entities. Many
of the complaints were against entities that we do not cover, were not covered
entities, and we do not investigate those. Other of the complaints were closed
because the allegations did not make out a violation of the rule. In some of
those instances will we closed the complaint we were able to contact both the
complainant and the entity and provide technical assistance. A lot of the
complaints in this category concerned things like the hospital not talking to a
spouse, or not telling a spouse that the other spouse had been admitted to the
hospital, or a complaint about one provider not sharing files at the request of
the individual with their new provider. Since the rule permits but does not
require these kinds of disclosures by a covered entity they don’t technically
make out a violation of the rule but we were able to contact the providers and
give them assurances that these were permissible uses and disclosures of PHI
and could be done. And I think it brought a significant comfort level to the
covered entity. We’d also been hearing, seen a lot of stories in the press
about these kinds of difficulties in families and friends being able to get
information from covered entities and trying through various mechanisms to try
to dispel some of the myth that may arise from over compliance if you would.

In addition to the categories of cases that we closed because we could not
investigate them there were also those cases where there was a complaint made
out, we notified the covered entity and in follow-up contacts with the covered
entity we were able to resolve the matter, and so we were able to achieve
voluntary compliance like Karen. We are really encouraged by the reaction that
we’re getting when our investigators do call. The entities are very
cooperative, the privacy officers are anxious to find out about complaints and
to make sure that individuals do get access to their records and that if there
are weaknesses in there training, that employees get retrained and that their
security and safeguard provisions are adequate to protect this information. So
they really have been very cooperative and willing to take the necessary
corrective actions to resolve the complaints. We did not have to resort of
fiscal sanctions so we have not yet issues any civil money penalties for
violations.

In terms of the types of complaints that we get most often clearly
impermissible uses and disclosures of information makes up the bulk of the
complaints. Safeguards, complaints about the lack of safeguards of the
information, this can occur, people come into a doctor’s waiting room and see
files at the reception desk, or they’re in consulting with the physician and
claim that they can see PHI on the monitor, some complaints come in about
hospitals and people concerned about things that they have heard or things that
they have seen that they think the information is not being adequately
protected. So we do get a lot of safeguard complaints. I think access to
information is probably the third most frequent complaint that we get.

The types of entities against whom complaints are lodged, not unreasonably
turn out to be private practices, general hospitals, pharmacies, places where
people come and have interactions with the health system on a daily basis and
so this is where the individual is most likely to be concerned and we get a lot
of complaints against those three entities. Group health plans is also now
beginning to show up as an entity against whom complaints are made.

We continue to get complaints now at a rate of about 100 a week, so that
means that as of today, I didn’t check the numbers before I came because I was
running a little late but earlier this week we were up over 4,000 complaints
received. Needless to say that’s keeping us fairly busy but it is not the only
thing that we are devoting resources to, we are continuing to be as aggressive
as we can in continuing to provide technical assistance. We now have over 200
frequently asked questions up on our website and we continue to work on
questions, we are working in areas, some of which we’re looking forward to the
upcoming hearings. We are working on questions, frequently asked questions
around the FRPA, and I can never remember what that stands for but the
educational privacy, privacy of educational records and questions that have
come to us from schools and universities about are they covered entities and
what their obligations may be if they are, or even if they’re not there’s a
whole set of questions concerning the exchange of information between school
systems and providers that we are looking and hoping to get some guidance out
on. In addition law enforcement, which is another topic I think that will be
visited at the hearing, we have been pretty constantly since the fall been
dealing with matters, mostly from the media, about reports, interactions
between law enforcement and hospitals and others in obtaining information. And
so that’s an area that we will be concentrating on as we move forward.

Other then that we are busily trying to balance an aggressive enforcement
program as well as trying to dispel the myths and concerns of covered entities
with regard to things that they are permitted to do under the rule, the rule
was designed to allow information to flow as freely as possible within in order
to achieve the health care that’s needed and to facilitate the payment flow for
that health care and we want to make sure that the entities that we regulate
are comfortable in knowing what they can do and how they can communicate, and
that the rule is not designed to thwart their business, it was designed in a
way that hopefully facilitates their ability to do business and continue to
provide quality care and allow individuals to have free access to that care.

We don’t have any regulatory changes in the offing in the immediate future
other then continuing to work with CMS and the general counsel’s office with
regard to the final, proposing the other half of the enforcement rule. There
were procedural interim rules that were put out last year and we are now
working on to complete the entire rulemaking for the civil money penalties and
the administrative hearing.

DR. LUMPKIN: Thank you. Questions? Simon.

DR. COHN: I was sort of listening and then sort of heard what sounded like
the enforcement rule at the very end there. Can you tell us more about, I
understand there’s a single enforcement rule coming out, spanning the whole
HIPAA implementation, when do you expect to be providing more details on what
this next phase of the enforcement rule is going to look like?

MS. MCANDREW: I think what we had promised when we did the interim
procedural rule was that to complete the package there were elements of the
enforcement process that effected more substantive rights of the entities
against whom civil money penalties may be imposed, and this just works through
those issues and revisits the procedural rules to the extent that we got
comment on those interim final rules so it just brings it all together in a
package.

DR. COHN: Just to make sure I understand, is this the next phase of the
enforcement rule or is this the sort of putting everything together into a
final enforcement rule?

MS. MCANDREW: This would be putting everything together in a final
enforcement rule.

DR. COHN: In a final enforcement rule, okay.

DR. LUMPKIN: John.

MR. HOUSTON: A couple of things. First of all I’d be interested in knowing
what the breakdowns are on the closed complaints on a percentage basis, you’d
listed out four separate types of complaints that had been closed. I’d also be
interested in knowing by percentage what types of complaints, as well as types
of entities, you listed out the entities themselves that had been the subject
of complaints. I’d sort of like to understand exactly on a percentage basis
what those were, I know I’ve asked that question in the past and you may not
have it at your fingertips now but it would be interesting to sort of try to
get some type of report that lays that out.

MS. MCANDREW: We can approximate some of that, I was just trying to think.
On the closures, it’s only a little difficult because unfortunately as in any
computer system when you put in an other category, people are in a hurry, they
push that other button, they don’t think about it. So we have been trying to
sort through and reclassify the clutter that’s in the other so that the other
statistics firm up a little better, but putting the big clump of other aside I
think our no jurisdiction cases are probably, they’re over half of the
closures. I believe the no violation allegations we don’t classify those as
jurisdiction, and I think they’re probably the next most frequent category and
the corrective action technical assistance is the third.

MR. HOUSTON: And again, I’d like if at all possible at some point
understand by type of entity as well as type of complaint what the breakdowns
are.

MS. MCANDREW: It’s possible for the, I think we can probably work on the
institutions, the types of entities against whom complaints are made, again,
we’re bothered by this other, we have a big other health category, but I think
if you take those out you’ll still find the breakout is, there are private
practices and general hospitals.

MR. HOUSTON: By the way, the reason why I think this is important is we’re
taking testimony and trying to understand where the problems are with the rule,
it also would be helpful to understand from this side of the equation
complaints, whether there is any clear relationship between what we’re hearing
in terms of problems with the rule against where you’re getting complaints, and
just try to scope and get a magnitude of these problems.

MS. MCANDREW: I think we’re a little difficulty in sorting out, providing
percentages on the types of issues only because a single, it’s not one
complaint one issue, so it’s a little bit more difficult to correlate.

DR. LUMPKIN: But perhaps if we could request something in a little bit more
detail reporting of the complaints so that the committee as they’re doing their
deliberations can review those and guide their questioning and direction.

MR. HOUSTON: And I do have then a second question. You’d discussed over
compliance and you gave two examples and I guess a question and I guess a
comment at the same time is often where something is permissible under HIPAA
there may be a state law issue that precludes say a release of information
outside of a hospital, and I guess I’m wondering whether OCR when they provide
guidance whether they look at where the questioned complaint comes from and
whether there is some other state law issue that may be causing the hospital to
take the position that it is, and again by your example, a release of
information outside the hospital, I know in the state of Pennsylvania that
there are other laws that are implicated there. So I’m concerned, and I often
have, I know my own institution, have to go back and somebody says well HIPAA
says I can do and you need to come back and say yes, you’re technically correct
but there are state law issues. So I’m just wondering whether OCR has that
capability or does provide that other type of guidance, too.

MS. MCANDREW: Basically if we have, in those areas the most that we have
done is to place a call to the entity to talk them through to make sure that
they are not refusing to maintain a facility directory simply because they
think it will violate HIPAA. And we are, that is how we’re using the technical
assistance. Clearly if in the course of the conversation the entity says that
they have a conflicting obligation then clearly the more restrictive practice
by state law or other federal obligation that they have does control —

MR. HOUSTON: I was just a little concerned hearing what you’d indicated
before because again, oftentimes what happens is somebody gets advice and they
come back and say well HIPAA says I can do this, and then we’re forced to go
back and say well no, yes, you’re right but there are other state law issues
that are implicated that we need to be concerned with. And I just again, I
think unfortunately what happens is the consumer will often go to multiple
points and gets very frustrated when they get different answers before they, or
they, there’s I think a source of frustration when that occurs.

DR. LUMPKIN: Richard?

DR. HARDING: As a member of the subcommittee just want to recognize the
very positiveness that we heard from people about OCR’s availability when
complaints came in, the way they were handled, and also the frequently asked
questions were constantly referred to as being extraordinarily helpful, the 200
FAQs that are on the web. And those things kept coming out in the early
testimony in our first hearings and I wanted you to know that and hopefully be
complimented by those things, especially since April when the rule became
finale.

The one concern I was going to ask you if you had any knowledge of would be
that so far as you say it’s been kind of educational and there have been no
penalties and so forth. Of course implied in that is so far there have been
none of those things and there is concern that there could be the start-up of
things like audits of covered entities or other ways of dealing with things
other then waiting for a complaint to come in. Is there any activity going
forward for OCR to begin that kind of process of going out and looking at
covered entities and auditing kinds of activities?

MS. MCANDREW: We do of course have the ability to do compliance reviews,
right now there are no plans to use that authority other then as maybe
necessary to investigate an event that is brought to our attention, it may not
be a complaint, it’s likely not to be a complaint although it may be an
anonymous complaint or something that we can’t handle through the normal
complaint process. But it might be a media report or some other kind of report
of a particularly egregious event that we would want to look into, but there
are no plans right now from changing from a complaint or event driven
compliance effort to something that would be more of a overarching audit and
periodic review type approach.

DR. HARDING: You understand my concern with fraud and abuse in the past and
in TALA(?) and other things, the black helicopters start circling and all those
rumors start up, that there are people being trained at the present time to do
that, etc., etc., but there’s nothing like that at the present time.

MS. MCANDREW: No —

DR. LUMPKIN: Okay, we have time for one more question and then we’re kind
of running late. Harry.

MR. REYNOLDS: You didn’t mention employer groups, the original rule large
employer groups, many of them that are self funded were covered by the rule and
it’s understanding that —

DR. LUMPKIN: Can you speak into the microphone?

MR. REYNOLDS: Large employer groups that were self funded and of a certain
size had to be in effect by April of ’03, a lot of the other employer groups
April of ’04. Do you have any indication of how employer groups are dealing
with this? Because you mentioned complaints, have you had any about how
employers are handling this information or anything?

MS. MCANDREW: One of the, I mean group health plans, and I don’t think the
category necessarily would distinguish those that are self funded from those
that are fully insured, does garner a number of complaints. Clearly if it’s a
small group health plan we would not take those complaints because their
compliance requirements don’t kick in until this coming April, but we have been
getting them against large group, the larger group health plans. We have been
getting, I will say one of the probably larger components of the
non-jurisdictional cases that we have gotten are complaints by individuals
against their employer but it is that, it is against their employer not their
employer acting through their group health plan, it’s just mostly on the job
workplace gossip about medical conditions and it’s not a covered entity
situation so we treat those largely as non-jurisdictional cases unless there’s
some indication that the source of the information was from that part of the
employer that was dealing with the group health plan.

DR. LUMPKIN: I have just one last question. As part of the implementation
process I believe just about every state in the nation has done an exemption
analysis, preemption analysis. Has OCR looked at those and done any analysis of
where, what the impact of this rule has been on state law?

MS. MCANDREW: No, we haven’t asked for nor has anyone volunteered to share
with us their state law preemption analyses, it would be very interesting to
take a look at those. I would say that we have only had one request for an
exception determination from that preemption analysis.

DR. LUMPKIN: Really? Wow. Okay, thank you very much, we’re going to move on
to update on the NCHS Board of Scientific Counselors. Vickie?

Agenda Item: NCHS Board of Scientific Counselors – Dr.
Mays

DR. MAYS: It’s always nice to start off with exciting news and the fact
that the National Center for Health Statistics as its Board of Scientific
Counselors is something that is both rewarding and exciting for the committee.

They’ve had two meetings up until this point in time, the first one began
in October, I think it was October the 10th, and the second one was
just last week. The group that has been appointed to the board has a good
mixture, is very diverse, what’s really nice and my counterpart is one of those
individuals, is they have economists. And I think that some of the issues that
we have been concerned with in terms of particularly in the Subcommittee on
Populations about social economic position and increasing some of the data in
terms of measures of wealth and things like that, it’s nice to see the
complement of talent that will be present in terms of the discussions that we
will have in the future.

As the liaison I think the role that so far has evolved for us relative to
that committee is that of, very similar to what we do here when Jim Scanlon
does the departmental updates. We thought that at least at this point that that
would be a good starting point in terms of our relationship with that committee
is to do an update of the types of things that the committee has been involved
in to give the board a sense of the scope of our work, the mechanisms that we
use in terms of accomplishing our goals, and to also keep them updated in terms
of areas that overlap.

For the last two meetings the agendas have pretty much been that of a
presentation of NCHS, so they’ve gone through many of their surveys, what the
issues are, one of the things that I’ve heard Dr. Sondik talk about is the
board being involved in also some of the intramural agenda setting activities.
So it seems like the board will have a pretty full plate, but I think its
direction and the areas of focus at this point in time I can’t quite comment on
because it really has been more of an orientation. What I’m looking for from
them is kind of a better sense of how as the liaison we can work together and I
think that’s just a matter of it will evolve over time.

DR. LUMPKIN: Aldonna?

Agenda Item: NCHS Board of Scientific Counselors – Dr.
Robbins

DR. ROBBINS: Vickie has given you a good overview of what has happened so
far. I think there’s some materials that are being passed out that are simply
the composition of the Board of Scientific Counselors, or BSC as we call
ourselves, and a printout from the internet describing the purposes and just
general information on the board. As Vickie said we are definitely the new kid
on the block compared to this committee, which has seen around for over half a
century, and our purpose is to advise, make recommendations to the Secretary of
HHS, the director of the CDC and the director of the National Center for Health
Statistics about the scientific and technical program goals, objectives,
strategies, and priorities of NCHS. And as Dr. Sondik, who’s the head of the
center pointed out to us, in the past this committee has provided guidance to
NCHS but your agenda has definitely broadened to cover areas throughout HHS and
so what the National Center felt it needed was to get some guidance that was
specifically directed at research, that effects, because it views itself
essentially as a research agency, it is the principle, the country’s principle
health statistics group.

The board has 15 members and as Vickie said we are a diverse group. By my
reckoning the disciplines cover statistics, biostatistics, gerontology,
epidemiology, public health, and as Vickie pointed out economics. Our chair is
June O’Neil, who is a former director as many of you probably know of the
Congressional Budget Office, and an economist.

As Vickie said we so far have been concerned with getting some orientation
and the staff have been doing a great job in bringing us up to speed on NCHSs
many programs, which include the National Health Interview Survey, the National
Health Care Survey, the National Health and Nutrition Examination Survey, and
the National Vital Statistics System. We are still very much feeling our way
but so far there are several topics that have generated interest and will
likely receive more attention in the future. One that we seem to have
gravitated to is the dissemination of data. At our first meeting for example
the board recommended that the NCHS staff prepare a feature article in
connection with the release of Health, US, which is one of its major
publications, and the purpose of the article would be it would be directed and
circulated to media. This was done and the result was a number of articles that
appeared in major publications like the Washington Post, which highlighted
information from Health, US, on obesity, diabetes, teen smoking, teen
pregnancies, that were in addition to the life expectancy data that are often
just focused on.

And going forward the board is likely to examine who is using the data,
what data is being used, how it’s being accessed, and for what purpose. The
board will undoubtedly be looking at questions of sample designs, of how can we
extend, change, the data collection efforts at the National Center, to better
address needs that are coming up. And as Vickie pointed out I think a prime
area of interest is going to be economics, we’re hearing about budgetary
pressures, which often unfortunately fall heaviest upon data agencies and these
are likely to intensify as concerns over the deficit mount. And then there are
the requirements of the President’s management agenda to assess product quality
and program performance, and so being able to measure the costs and the
benefits of NCHS programs or just to have a way to decide how should we next
spend the next research dollar is going to go a long way toward dealing with
these realities.

And so I think the board’s direction will become clearer in the coming
months, and we are going to appreciate any guidance that this committee can
give us, and I look forward simply to watching you old pros at work today. So
thank you.

DR. LUMPKIN: Thank you, any questions? Marjorie?

MS. GREENBERG: It’s not really a question but I want to thank Vickie and
Aldonna, I wanted to mention that I had the opportunity to attend this last
meeting and shared with the Board of Scientific Counselors the interest
obviously of this committee in working collaboratively with the board, and in
particular we had discussed at the, I think it was the Executive Subcommittee
meeting, which you’ll probably be going into more later and Ed actually
discussed this previously but addressed it again at that meeting, having a
joint meeting at some point with the board probably in 2005 given that they’re
really getting organized now in 2004. And that was very well received, there
was a lot of receptivity to that. Actually one of the board members is a former
member of the national committee, Dr. Trevino, he sent his regards.

Also I just wanted to mention that Dr. Sondik, who as you know is the NCHS
liaison also to this committee, sent his regrets, he’s hosting a meeting on I
believe cancer surveillance out in Arizona today, and the deputy director had
hoped to come and has illness in the family. But in any event I assure him that
they’re well represented.

DR. LUMPKIN: But you’re here.

MS. GREENBERG: But I am here.

DR. LUMPKIN: Vickie?

DR. MAYS: One of the discussions that took place at the board meeting was
about vital statistics, and one of the members later reminded me, I shouldn’t
say reminded me, informed me because it was something that I didn’t know. But
at one point in time there was a liaison to our group from vital statistics,
and then I think then Dan came on, and Dan kind of served that role. So the
question was raised as to whether or not there can be a liaison from NAFSIS(?),
which would be the group that in the past I guess had represented vital
statistics.

DR. LUMPKIN: Marjorie?

MS. GREENBERG: We don’t actually have liaisons from organizations to the
committee and as we discussed yesterday in the orientation each member
represents areas of expertise as opposed to representing a particular
organization. We have in the past pretty regularly had a state, a director of a
state center for health statistics who usually also is the state registrar or
overseas the state registrar or works with the state registrar, George Van
Amberg(?) of course was a member for a number of years and prior to him
Marianne Friedman, and then Dan Friedman although, no relation by the way,
although he was not the registrar he was very much involved with the state,
director of the state center for health statistics. So that is a, it wasn’t
really a liaison but certainly if we don’t have someone from that constituency
we certainly need to make sure we reach out to them. And I believe that they
had, it might have been the person that brought it up, but the current
president of NAFSIS is a member of the board.

DR. LUMPKIN: And you forgot to mention it, I was a state registrar.

MS. GREENBERG: Were you? You were the state registrar?

DR. LUMPKIN: Yeah, for 12 and a half years.

MS. GREENBERG: No, you weren’t really, you were the state health director.
We didn’t consider you the state registrar.

DR. LUMPKIN: If you check the record of every kid who was born in there in
the state of Illinois, on their birth certificate, my name, was born in
Illinois over the last 12 years you would see my name and underneath it says
state registrar. But Jim.

MR. SCANLON: Let me change the subject. Again, I think the development of
the Board of Scientific Counselors is actually a very good development for the
center and my only concern and I think we’ll just have to work on this
relationship, NCHS is one part of the national health statistical system and
data system, and they’re one part, a big part, here in HHS as well, but the
health care sector is a little different from other sectors in terms of the
data and statistics so we actually rely on a whole panoply of research,
surveillance statistics, evaluation and so on, administrative data, and again,
my only urging here would be that we have a good liaison relationship with the
board that, my point here is to avoid sort of heading in different directions
in terms of recommendations to NCHS where it may not be in the best interest of
the whole system. So I think the way we solve that is to have a fair amount of
liaison interaction, it’s our responsibility to keep you informed what’s
happening, and it’s your responsibility to kind of work with us through Vickie
and others as well. I think it adds to the power and the decision making
apparatus, particularly on scientific and methodology issues, but again, this
is a highly related area and so we have to keep the liaison and the
relationships open.

DR. LUMPKIN: So welcome.

DR. ROBBINS: Thank you very much.

DR. LUMPKIN: Jim? Your update? Just a quick agenda check, since we’re
running a little bit late, my intention would be to go to Jim’s update, take
our break, and then do CHI until lunch.

Agenda Item: Update from the Department – Data Council
– Mr. Scanlon

MR. SCANLON: Let me give a quick report on a number of developments in data
policy since we met I think in November, and I’m actually happy to report that
progress is continuing on a number of issues in the data policy area and in the
NHII area, I think you’ve already heard from Susan, Karen, in a few minutes
about HIPAA standards and CHI, but there a couple of other things actually
going on. I think we’re actually going to have a budget for the fiscal year ’04
shortly and that helps the committee as well in addition to HHS, and actually
the outlook for ’05, though it’s not a big growth budget actually has some
positive, if the President, when the President sends the budget up next week
for ’05 I’ll talk a little bit about some potential areas there which the
President has already alluded to in some of his talks about what will be in the
budget.

But first of all I think we’ve probably already, John, welcomed the new
members, when I had to run downstairs. We have a number of changes on the
committee —

DR. LUMPKIN: But they won’t feel welcome until you do it.

MR. SCANLON: Some changes on the committee, four new members, hopefully
you’ve already introduced yourselves, and four retiring members, which we’ll
honor a little later today —

DR. LUMPKIN: Graduating.

MR. SCANLON: Graduating members, we never retire, you go into the active
reserves for the NCVHS, you’re always on call, the Surgeon General can always
activate you in retirement status.

I wanted to report also that the Secretary has renewed the charter for the
committee for another two year term so we’re legal until 2006, and we really
didn’t require any changes to the charter other then some technical ones
because I think the charter allows us to do virtually anything, cover virtually
anything of substance in this area as well.

In addition the department has done a solicitation for staff to support the
subcommittees of the full committee, and I’ve actually gotten a number of staff
nominated to be, for various subcommittees. I was hoping we could actually
finalize it for this meeting but it probably will be for the March meeting.
There were some nominations for staff to be on the Executive Subcommittee,
which obviously doesn’t work that way, and I have to do a little more sorting
out but my guess is there are probably a dozen new names suggested and I would
just have to clarify some of this. So we’ll work with the subcommittee chairs
and the executive committee on getting the staff sorted out but I think we’ll
clearly have a number of new staff joining the various subcommittees as well.

Let me just bring you up to date on some developments within the department
and then let me talk about the budget. As I have alluded to previously the
council, we have established within HHS a Council on the Applications of Health
Information Technology. We have other councils, interagency councils, within
HHS dealing with research coordination and with other applied information
technology within the agency, the Data Council and some other councils, but the
leadership thought that in recognition of the potential of information
technology applications that the department really needed a focal point to get
agency views together, kind of organize our own investments, and identify
opportunities within HHS for health information technology applications, and
have a place where we could work out sort of a coordinated voice and
relationships and dealing with external partners as well.

So the council was formed several months ago, it’s meeting more or less on
a monthly basis, Dr. Lumpkin as the chairman here is invited to participate in
those meeting, and we have a small steering group to kind of plan the agenda
and look at some of the areas where we need to move ahead. The focus so far has
been on looking at some of the proposals in the pipeline and trying to get them
on a more coordinated basis, but in the months ahead I think a more strategic
view of looking beyond what’s in the pipeline to how we could use these things
more systematically and plan better will be on the agenda for the council. So I
think that was a very positive development and Dr. Lumpkin brings us, virtually
at every meeting could bring us the benefit of the thinking of the NCVHS as
well.

Let me talk a little bit about the 2004 budget, the Congress passed I guess
a week ago and the President is expected to sign the fiscal year 2004 budget,
and I think we actually have some very positive developments in the information
policy area and the NHII area in that budget. I’ve mentioned them to you before
when we were only hoping that we would get them and now I think we’re actually
going to see these. First of all, in my own office, the Office of the Secretary
level, we have a $3 million dollar initiative that is included in the budget
and it’s for overall work related to leadership and convening and so on for the
National Health Information Infrastructure, and this would be kind of the glue
that brings the agencies together as well as our work with the private sector.
We would be continuing the activities begun at the conference last year, the
NHII conference last year, as well as a number of other activities. The whole
goal here is to use a variety of activities to promote and accelerate the
development and the use of electronic health records, NHII, interoperable
standards and so on to support health care, and to some extent human services
more broadly as well. So we’re very pleased, we’ve already begun putting
together a plan in our own office as to how we would distribute the funding,
but we had a number of ideas from the committee and from other places as well.
So we’re very happy.

Again, as a departmental initiative in the ’04 budget, our office ASPE
worked with AHRQ, Mike is here, and we have in there, and actually this is
probably, this is actually a considerable ramping up in terms of the support
here, $10 million dollars for standards related work. And this is included in
the AHRQ budget, Mike and I are working together and we’re looking at the
recommendations for standards work and promotion and support and gaps that have
been identified through various processes, the CHI work for example has
identified a number of areas where literally if we didn’t support the standard
on a more continuing basis it would be hard to actually implement it. So you’ll
remember some of the medication standards that came forward as the CHI, Rx-Norm
supported work, some of the mapping and so on, so I think we’re planning, we
put together kind of an initial funding plan with Mike and AHRQ and we’ll be
moving forward as soon as that funding is released to kind of get some of the
standards that either continuing the support for some standards, in some cases
providing initial stabilization and support for some of the standards work as
well. So we’re very happy about that as well. I think we’re setting aside a
bit, Mike, as well for kind of initiatives that may come up during the year but
I think we’re very pleased with that as well.

And the largest increase is actually a $50 million dollar increase in the
AHRQ budget for a program of demonstration grants and research relating to
health information technology in health care settings, started out as
hospitals, to improve patient safety and quality, and the request for
applications have already been released, I think two months ago, Mike, so
hopefully some very capable researchers and evaluation specialists and
clinicians and informatics folks are putting together proposals, submitting
them to AHRQ, and we’ll get that underway.

DR. FITZMAURICE: Can I add just a word, Jim? You can find the three
requests for grant applications on the AHRQ website, ARHQ.gov, under funding
opportunities. There are implementation grants, there are grants to show the
value of health information technology, and can you believe it, grants to write
grants. We give you planning grants to pull together partners, formulate the
idea, and then come back to us with a grant. We would like to have your letters
of intent in by February the 6th, and the grants are due in for all
three of those by April the 22nd of this year. And there’s quite a
large set aside for rural hospitals and rural areas, partnerships in that area.

MR. SCANLON: The Secretary can give a priority to small and rural hospitals
as well. And I think, Mike, it’s actually broader then just hospitals now,
isn’t it? I think we, so that’s actually a very positive development.

Let me say a few words about the NHII related activities. We’re planning
again, I think we already talked about this at the NHII Workgroup, we had an
inaugural, probably an annual conference on the National Health Information
Infrastructure we sponsored this last June, late June early July here in
Washington, and we’re planning again to have a second annual conference on the
National Health Information Infrastructure, hopefully we’ll have the Secretary
again as a keynote. At that meeting the Secretary actually launched a number,
well, made a couple of announcements for where we actually launched a number of
NHII related activities. I know we’re working, our own staff is working with
the NHII Workgroup and the full committee on planning the agenda for that
conference so that we can actually move forward. It’s kind of a convener role
as well for bringing all of the interest in the NHII together and moving
forward.

Let me mention two quick activities within the Data Council and then I want
to talk about the ’05 budget quickly. Our Data Council is our internal
department wide committee for coordinating data statistics and standards and
other related activities, and we are following up on a couple of issues, though
there was a broad interest existing in the department even before, on a couple
of issues raised in the Vision for Health Statistics Report that the committee
filed, I think it’s almost two years ago now. And one of the issues was for
geocoding and the general look here is to looking at our major data resources,
our data collection systems, our public health surveillance systems, our
administrative data and so on, to sort of evaluate what sorts of geographic
level detail we already may be using in those systems to look at ways of
standardizing that information, to look at how we tabulate the information, and
there are some issues there, and to make some recommendations for moving
forward. So we’ve just awarded a small contract under the Data Council, they’ve
just begun the project and I think we’ll report to the full committee here and
to the Populations Subcommittee as we move a little further along. So again,
we’ll get the full, we’ll get the participation and the input from the
Populations Subcommittee and the full committee generally.

The hope here, there is actually a government wide, it’s actually called
the Geospatial Geocoding Initiative, and all federal agencies are to look at
their data holdings, again, this is statistics and research, this is not
administrative data, for how the information could be better accessed and how
it could be more standardized and comparable so that if you’re interested in
HHS data there’s a certain way to go, if you’re interested in EPA data it’s
comparable, but at any rate I think the committee will be interested in helping
us with this as well.

Secondly we are continuing our efforts to improve user friendly access to
the extensive data resources in HHS. We as I reported previously have created
an HHS statistical website, that website includes links to all of the major
data collection systems and data and tabulations and analyses that our agencies
produce. They’re unified in one place, you can search by terms or if you’re an
aficionado and you know exactly what data source you’re looking at or you want
to find you can go directly there as well. There are short cuts to our major
data systems, the Health Interview Survey, the Medicare Term(?) Beneficiary
Survey and so on, MEPS. We actually take you to, one of our pages will actually
take you as far into the agency data in terms of tabulations as you may want.
Some of them actually allow you to do tabulations, not only looking at the
tabulations published or any of the research reports or statistical reports
published, but in some cases you can actually do tabulations. AHRQ has some
capability in this regard, NCHS does, and SAMSA does as well and actually CMS
does as well. So this is an attempt to if not unify at least bring together in
one place a gateway in essence, user friendly access to our major data systems
in HHS. This is anonymized data, I hope no one misunderstands this, this is
statistical data, published data, tabulations, there’s no individual data here.

In many cases in the three agencies I’ve mentioned there actually is a
facility whereby researchers and analysts can request access to data through
one of the research data centers, we have three of them now in HHS, so you
might be able to create tabulations and analyses, particularly small area and
small number analyses, that are not public but are done under confidentiality
protected provisions. It’s not done over the computer but it’s done upon
request to the agency and so on, we can brief the committee on those further.

But we’re expanding and extending the gateway, we’re organizing it in a
little better user friendly fashion. I think I’m going to ask the Populations
Subcommittee later to kind of give us some ideas about how if they wouldn’t
mind looking at it in terms of improving the friendliness, the user
friendliness of the data particularly. We’re not creating any new data, this is
just linking to the data we already have.

We also provide, if you’re really coming to the HHS website and you really
want to look at the scientific literature or research, we provide a link to the
NLM and PubMED(?) and MedLine and all of the facilities there. We also have a
link to our policy research database, which my office particularly has
sponsored over the years. This has most of the major evaluation policy research
that HHS has sponsored all the way back to the ‘70’s. Some of the major
evaluations and RAND health insurance experiments, the New Jersey Negative
Income Tax Experiment, those were supported by HHS and their, the documentation
is there on the website as well.

Quickly, the ’05 budget, John, if I can. It turns out that a number of
folks are getting interested in the National Health Information Infrastructure,
our Secretary got interested last year and is really a proponent now, and
actually the President is now beginning to mention the NHII in a number of
addresses in the health area. In his radio address on Saturday he talked about
five points to improve health care in the U.S., but one of the points was
actually by moving American medicine into the information age, and he said that
my budget for the coming year proposes doubling to $100 million, this is the
$50 million that we’ve counted for the demonstration projects, the money that
we spend on projects that use promising health information technology. This
would encourage the replacement of hand written charts and scattered medical
files with a more unified system of computerized records. By taking this action
we would improve health care, help prevent dangerous medical errors, saving
both lives and money.

So when the ’05 budget is sent up to Congress next week, February
2nd I think it will be, we expect to have this initiative included
and possibly some others as well. So it looks like what began as a
collaboration between this committee and the Data Council and our network
within HHS is now turning into a very broad and very high level initiative. So
let me stop there and see if there are any questions.

DR. LUMPKIN: Vickie?

DR. MAYS: Three questions, one in terms of the AHRQ National Health
Disparities Report. Can you at all tell us if there is any follow-up to that
report? I mean it’s been received by Congress and there’s been a lot of
discussion about it and I understand there’s possibilities for some activities
so I wonder if you could update us about that. Second, did we get a response
yet from the Data Council, the Secretary said I think it was in about 90 days
he would be responding to one of the, the first letter that we sent —

DR. LUMPKIN: Which one Vickie —

DR. MAYS: That was the one on targeted surveys. And then my other question,
in terms of the Geospatial Geocoding Initiative, will that contractor that you
have, will they be looking at all about what variables should be used as
opposed to what’s there but making any recommendations about —

MR. SCANLON: It will be, let me answer that one first, Vickie. Let me start
with the third. Yes, we’re looking at sort of, one feature is looking at what
we currently have, but I think in many cases it’s fairly limited and I’m not
sure how standardized, other then the usual sort of geographic and geopolitical
kinds of descriptors. So yeah, we’re looking at what the standards are, what
are reasonable categories for, and what’s missing, for example. There could be
metropolitan area designations that would be useful but may not be used. So
it’s meant to be both descriptive and normative in the sense of where should we
be. And again, the idea here is to not create some special categorization in
HHS, it’s to use broad categories that more or less are compatible with what
other agencies are using as well. And the idea here is to promote the best use
of that information.

Let me work backwards, and I’m going to ask Mike to answer the Disparities
Report, I know they’ve been sent up to Congress and I know work is beginning on
the second annual reports.

But let’s see, on the targeted surveys and on the improvements to
statistical systems, I think we probably are not going to respond until after
the President’s budget for ’05 goes up because I think there’s some very
positive, well, I hope, there were some positive directions being considered
and I think it would make more sense to wait until that budget is finalized
next week and then we can say what’s actually in the President’s budget, but it
actually looked quite promising.

And Mike, about the Disparities —

DR. FITZMAURICE: About the Disparities Report, it certainly has received
quite a bit of attention and discussion and AHRQ is pleased to present, pull
together the facts and present them. We plan to do it again, that is another
annual report, and we look forward to again, a lot of public attention to
what’s going on in our nation.

DR. LUMPKIN: Okay, seeing no other questions, nicely done Michael, we will
take a ten minute break.

[Brief break.]

DR. LUMPKIN: Let’s get started again. The main reason for us having a
special meeting today is actually this particular item, which is the discussion
of the Consolidated Health Informatics. We have before us or will have before
us a letter on CHI which we’ll do after the presentation, but we’re going to
have an update, Simon, do you want to lead in?

Agenda Item: Presentation: Consolidated Health Informatics
Initiative and Recommendations – Dr. Cohn, Ms. Trudel, and Ms. Wark

DR. COHN: We’re going to be sort of talking back and forth but I think the
process here for the next hour and 15 minutes, hour and a half, Karen will
start out I think with sort of a broad overview of CHI. I think many of the
current members are pretty familiar with pretty familiar with all of this but
for the new members I think it’s a useful update and certainly for those on the
internet I think this will be very useful.

Then we’ll sort of move into a conversation between Cynthia Wark and myself
as we move through the recommendations, and this is the time, yikes, where
there are lots of recommendations coming forward, this is sort of the end of
phase one of CHI, and I believe we have 14 recommendations coming forward. So
you know we sent out about a 40 page email to everyone, we of course know that
you all read it and memorized it, but just in case you didn’t we wanted to give
you a flavor of what we’re recommending, as well as an occasion for you to ask
any questions with the end result hopefully being that you’ll approve the
approach of the subcommittee and agree with the letter that we composed.

With that, Karen, would you like to start out?

MS. TRUDEL: Yes. Again, I’m Karen Trudel and I’m not wearing my other hat
which is that of the program manager for the Consolidated Health Informatics
Initiative, and I’m joined by Captain Cynthia Wark, who’s the deputy program
manager. I’m going to talk a little bit especially for some of the new members
about the CHI strategy, how we got here, what this means, why this is different
then HIPAA, and again, CHI is part of the President’s eGov portfolio, there
were 24 eGovernment initiatives, our particular goal was different then most.
Most of them were involved in building systems that crossed department and
agency lines, like e-grants. In our case when we started to look at potential
applications to consolidate we discovered that what we needed to do first was
to get ourselves all onto a platform where we were talking using the same
clinical vocabularies, and we felt that that was an absolute, it was a
necessary preliminary to doing any kind of consolidated actual applications.

So we’re adopting existing clinical vocabulary and messaging standards to
enable interoperability in the federal health care enterprise. That is where
this is different from HIPAA because these standards are only for use at this
point in the federal health care enterprise although we do understand that the
federal enterprise provides a significant tipping point where if we are all
adopting the same standards and using them there’s definitely a reason for
private industry to follow.

Rather then converting to these new standards all at once they are built
into individual IT architectures, in other words as agencies bring up large new
systems or large system rewrites, when they begin to do their planning and get
their approvals through the federal IT system they will need to demonstrate
that they are using these standards in those new systems.

We decided to be very careful about preserving individual partner agency
business rules, so that the standards that we adopt don’t change how agencies
do business, that’s somewhat similar to the way HIPAA operates. And we have
used the NCVHS very extensively to both get a reality check as to how the
standards that we’re proposing will work in the real world, and also to use
this as a forum to communicate what we are proposing to do with the industry as
a whole, and I’m especially grateful for the committee in setting up this
additional meeting because without this meeting we would not have been able to
come anywhere close to meeting our deadline of getting the first round of 24
standards done by the end of the fiscal year, we’ll come within a month of it,
which I think is pretty close considering what we’ve undertaken here.

This is just a slide about how this works, OMB has an eGov office, they
oversee all of the individual eGov initiatives. In this particular initiative
there is a CHI Council that is the governance body for this particular
initiative, the lead partners are HHS, VA, and DOD. A vast array of supporting
partners, and many of them have been active in this initiative.

Again, quickly, we’ve deployed teams of experts, we identified 24 domains
where we needed to look to adopt standards, each one of those domains has a
team of subject matter experts from across the CHI Initiative. They defined the
scope, they identified candidate terminologies, through the deliberation
process there’s been analysis and feedback by the CHI Council, from NCVHS, from
internal department organizations, and then finally there is a government wide
roll out of standards as they are formally adopted. If you see the arrow at the
bottom that says final reports to NCVHS, that is where we are today with the
last 14 of the domains.

The range of possible recommendations when we looked at a particular domain
was was there a standard that was already in place that was perfectly
acceptable and all we had to do was make sure that there was a way to keep it
up to date. In some cases we were able to make that kind of recommendations. In
other cases we could adopt a standard but we identified gaps at the same time,
the gaps did not preclude us from going ahead and implementing the standard but
we have now a list of action items that we will need to take back to standards
developing organizations to say this standard would be a lot better if you
could address this gap. In some cases the standards were just not ready for
prime time quite yet, there were conditions that precluded us from being able
to actually use the standard until the conditions are addressed. And there were
temporal issues where we thought the standard looked okay but we had to wait
for a ballot to take place. In some cases there was absolutely no solution at
all and in those cases we talked about what some of our next steps were, who we
could partner with, how we could go about moving toward something to adopt in
the future.

We started out with our 24 domains as our marching orders and we were very
lucky to avoid any scope creep, so we had 24 to start with and we still have
them. The first five were adopted last March, and I’m going to plagiarize a
little bit from Steve Steindel who talked about this yesterday, in some cases
we were looking for not only low hanging fruit, but fruit that somebody else
had already picked for us, and these first five standards actually are that.
They were ready to go, they were no brainers, and so that’s why they didn’t
take very long. LOINC for laboratory result names, HL7 messaging standards
including scheduling, medical record and image management, patient
administration, observation reporting, financial management and patient care,
the NCPDP scrip in the retail pharmacy industry, IEEE 1073 for connectivity,
and DICOM messaging for image information to workstations. Those were the fruit
that someone else picked for us.

Interestingly after that, and again getting back to Steve’s analogy, we
looked for the low hanging fruit and when we couldn’t reach any more low
hanging fruit we had to go and get a ladder, and in some cases the ladder
didn’t reach and we had to get an even bigger ladder, so that’s some of what
we’re bringing to you today. We have already brought six domain standards to
the committee for approval over the last three to four months, so those will
not be discussed today. Those are recommendations for medications, laboratory
test order names, laboratory result content, units, immunizations, and
demographic. And if there’s any interest in the reports on those I can be
reached and I can provide you with what the process that the group looked
through, the whole process.

The next slide shows the recommendations under consideration, these are the
ones that we’re going to talk to you about today, in some cases again we have
recommendations, and in some cases we found that there really was nothing
there, so I’ll turn it over now to Simon and Cynthia.

DR. COHN: And Cynthia, let me just make a couple of comments here.
Obviously I think what you’re seeing here is really the type of synergy that
we’d like to have with HHS and I think this is an excellent example of the
private and public sector working together to do something that needs to
happen. I mean Karen mentioned about prepackaged fruit, and I think that we
should observe that the people that did the packaging for that fruit was
actually the NCVHS. We’ve had a long history of leadership in both the
administrative and clinical data standards, I mean that’s been true through its
55 year history, 54 year history, Marjorie? I don’t know the years but under
HIPAA, as part of HIPAA we were actually rechartered and actually we’ve had a
major role and responsibility for administrative medical code set standards
under HIPAA as well as the standards themselves, and there was a part there
that talked about we should study clinical data standards and patient medical
record information standards and the electronic exchange of such standards,
which I know Jeff has memorized and I’m sure I’ve misquoted it slightly.

But we had a first report in 2000 that sort of set off sort of the
framework for moving forward, but without specific recommendations in terms of
the actual content. In ’92 and ’93 we actually came up with specific
recommendations but the real question got to be was how to implement, and I
think our recommendations were that the government needed to lead with the
implementation and really set the example, and that this was not going to be a
HIPAA style implementation where things were mandated throughout the industry,
but that we thought that it was actually important that the government both set
the example and that there were actually good business reasons for people to
migrate towards standards, and if you think about it for clinical care,
decision support, identification of best practices and outcomes research, as
well as financial reasons because increased standardization saves money on the
implementation of these sorts of systems, I think the government has been
taking the lead and obviously we’ve been very pleased to be able to provide
advice and guidance.

Now the NCVHS recommendations are sort of at the, have been at the 3,000
foot level, I’m not sure that I consider the CHI recommendations at the ladder
level but I think we’re moving down to maybe a high ladder, which is the sort
of the 300 foot level of these recommendations, and I’m expecting as we move
sort of forward we’ll get more and more concrete and move down to greater
levels of specificity and concreteness because at the end of the day what
everyone wants to know is exactly how to implement these terminologies in which
standards and how to use them so that we’re dealing with standards that are
sort of aligned to how you use an electrical plug. I mean nobody sits around
and goes well, geez, will that plug work in that outlet, let me guess here, and
really we want to get to the point where this is sort of how things work in
health care and how people can best leverage their IT investment.

So anyway, with that what we’re going to do is to really go through in
relatively rapid fashion a lot of the domains. This is sort of my idea of how
best to handle the letter and I will apologize, I think the toner cartridge on
the printer seems to need new ink, so it’s going to be a little hard on your
eyes. But really what we’re focusing in on is the bullets in the page and a
half letter, and basically each bullet is a domain under consideration. What
Cynthia will do is talk a little bit about what the domain is, what the
recommendation is, and then we’ll talk about what our recommendations are
around that. And as I say we’ll try to handle this relatively quickly, some of
them are really very non-controversial, others we will talk about a little bit
because they are controversial, but we will also cap the conversation because
we do want to allow people to have lunch and a lot of times where there is a
lot of controversy the recommendation was is that more work needed to be done
in that area.

Questions before we start off? The hope is that when we’re done with this
you will have reviewed the letter and be comfortable with voting.

Cynthia, would you like to start off?

MS. WARK: Okay. I will start off with a few slides on the anatomy and
physiology recommendations, I would like to say that each of these slides sets
that you will see are excerpted from the written reports. You have a copy of
the written reports attached to the letter and all of those are posted on the
NCVHS website.

The reports reflect an enormous amount of work on the part of well over 100
subject matter experts in the federal enterprise. We had team leads throughout
the federal government who stepped up to the plate and led these workgroups and
went through all of the steps that Karen talked about, and I have to give
public recognition to someone who repeatedly performed the task of team leader,
as we moved through the schedule in 2003 moving from one domain to the next, we
had one person who on three occasions raised their hand to be a team leader,
and believe me this was no easy job, convening subject matter experts from
around the government who have their day to day jobs that they are doing and to
try to meet with those people and even just to find the time to get everybody
together to work through the steps, and work through some very difficult
issues. Steve Steindel has led personally three of these teams so I do want to
—

[Applause.]

MS. WARK: The first of the domains is anatomy and physiology and Steve led
this team. Team members were Dan Pollack from CDC, Kathy Johnson from NASA, Lee
Wells from the VA, Ross Barner(?) from the Department of Defense and Sherry
Decoronado(?) from NIH.

The team started off with a description of the domain, anatomy being a
terminology used to describe anatomical locations for clinical, surgical
pathology specimen descriptions and research purposes, and physiology being a
terminology used to describe or infer both normal and abnormal human physiology
at least at the organ system’s cellular and biochemical levels. They scoped out
the domain to address anatomical location of a procedure and injury, anatomical
description of specimen, subcellular anatomy, measured or inferred physiology
or organ or organ system, measured or inferred physiology of cell and
morphology.

The alternatives that were considered were MESH, the NCI Anatomical
Terminology, SNOMED CT, Clinical LOINC, Foundational Model of Anatomy from the
University of Washington, the HL7 Site Table, and the Veteran’s Administration
NDF-RT Medication Physiologic Effect Access. This really required the group to
evaluate each of the alternatives they identified to gather information to
interact with subject matter experts from those organizations, because as we
said we were not developing the standards but evaluating standards that have
been developed by external standard development organizations to the
government, so this did require an enormous amount of work.

The recommendations for anatomy and physiology, under anatomy is SNOMED CT
will form the core anatomy terminology, the HL7 Site Table will provide a more
simple anatomical Site Table for general usage, and the NCI Thesaurus for
research purposes, it extends present anatomy terminologies into subcellular
structures, and that could be used in conjunction with or mapping to SNOMED CT.
In the area of physiology there was not a recommendation for a standard coming
from the workgroup.

DR. COHN: And of course the expectation here is that these will all be well
mapped by the National Library of Medicine when it goes into the metathesaurus.
Our recommendation was basically we agreed with what CHI had come forward with.
We thought that there were recommendations for anatomy and we agreed with them,
we also recognized that really did not appear to be an answer for physiology at
this point, I guess which is what you’re saying up there. But we also felt that
there was an issue related to the physiology definition of the domain that
really needed to be revisited because we just weren’t sure that that was
really, we questioned whether the focus of the investigation was the right
focus and it needed to be evaluated. Cynthia? Any comments? I’m sorry, I
thought you might have another comment on that domain. Are there any questions
about this one? Comments?

DR. LUMPKIN: Any concerns? Because what we’re going to do is after we’re
done walking, we’re essentially walking through this letter, we’re going to
take a vote, so if you have concerns about this particular time, the
recommendation that’s before you is that we concur with the recommendations
from CHI for anatomy and physiology and we concur with the need to revisit
physiology in 12 to 18 months. Okay.

DR. COHN: Okay, good.

MS. WARK: Okay, the next workgroup was billing and I led that workgroup
myself along with a host of representatives from the Centers for Medicare and
Medicaid Services, the Social Security Administration participated, and there
were several representatives from the Veteran’s Administration and the
Department of Defense.

We defined the billing domain as standards that are used to implement
electronic exchange of health related information needed to perform
administrative functions in the federal health care enterprise. This was in the
category of a validation effort. We approached this with the assumption that
the HIPAA transactions and code sets would serve as the basis for these
standards.

For the scope of the billing domain we included all of the areas that are
currently covered by HIPAA and we added two additional areas appeals, a
certificate of medical necessity that the workgroup thought it was worthwhile
to take a look at and see if there were any standards available that could be
adopted by the federal government.

The alternatives for billing included all of those that are already
identified as approved transactions and code sets under HIPAA, we also added
ICD-10-CM and ICD-10-PCS.

The recommendations from the billing workgroup are that we adopt the HIPAA
approved transactions and code sets, both those currently approved as well as
future updates so that any of the areas that are not currently implemented
under HIPAA but do have standards implemented in the future, that those would
automatically be adopted through CHI. We did not come up with recommendations
in the two additional areas that I mentioned.

And that’s it for the billing workgroup.

DR. COHN: Okay, and as you can imagine we concurred with these
recommendations with just I think a couple of minor wordsmithing changes to the
report. And those other two domains, other two possible standard transactions
are probably things that we need at some point to sort of review at the
subcommittee level to identify what may be possible in that area.

Comments, questions? Kepa?

DR. ZUBELDIA: Sorry, I missed the meeting a couple days ago in the morning,
but the question I have is in the health plan identifier and provider
identifier domains, since those are part of HIPAA and for one there’s already a
final rule that came out last week, what’s the reason for not including those
in the scope?

MS. TRUDEL: This is Karen. The reason is that at the time the reports were
written the plan ID obviously had not been published and we did not have a
clear date for the provider identifier. What we are doing is rather then
continuing to revise these reports on the fly we will go back periodically and
correct anything that has occurred to change recommendations, so that’s
something, because we said and future update, we will go back and have a way to
annotate reports to show subsequent actions that have effected the initial
recommendations.

DR. LUMPKIN: So this particular recommendation, which is to concur with the
CHI recommendations for the billing domain as modified, those modification
include wordsmithing such as on the second page adding in the word identifiers
in front of transactions and code sets, just to clarify since that’s what the
recommendation is. Any questions on this recommendation? Concerns? Next?

MS. WARK: Okay, the third area is nursing, this was led by Lieutenant
Commander Alicia Bradford from CMS along with representatives from the
Veteran’s Administration, the Department of Defense, and the Indian Health
Service.

The nursing domain was described as a standard that will be used to
identify, classify, and name the delivery of nursing care. The scope was
identified as assessment and observations, plan and goals, diagnosis,
interventions, and evaluation and outcomes.

There was a long list of alternatives considered including SNOMED CT, the
ABC Codes, NANDA for diagnoses, NIC for interventions, NOC for outcomes, the
Omaha System, the PCDS or Patient Care Data Set, the HHCC or home health, the
Perioperative Nursing Data Set, the International Classification for Nursing
Practice, and Clinical LOINC.

The recommendations for nursing are to adopt SNOMED CT and specifically the
nursing concepts that are contained within the findings and procedures
hierarchies. Also that collaboration between the source nursing terminologies
and the SNOMED CT convergent terminology group for nursing is essential. These
efforts should continue and the mappings should be maintained in the UMLS. And
essentially what the workgroup found is that the majority of the alternatives
considered are already incorporated into SNOMED CT or have plans to do so in
the future, so that was the basis for the recommendation of SNOMED CT.

DR. LUMPKIN: Are we going to come back to medical devices?

DR. COHN: I hope so. Just in terms of nursing and then we’ll talk about
medical, I don’t know where medical devices is in this presentation but we’ll
find out. Obviously as you can imagine our work was made easier by the fact
that there was already work underway to really integrate all of these nursing
terminologies into SNOMED so it made it easy for us to concur with these
recommendations. Judy, do you have a comment? Please.

DR. WARREN: Yeah, it’s a picky one but since I’ve worked hard to do it, I
don’t know if this is, I mean this goes into knowledge I have and I don’t know
what my waiver covers so I’ll make a comment and if I should keep my mouth shut
tell me. The example for a NOC outcome in the letter is in error, the NOC
outcome is not under the procedures hierarchy, it’s an observable, and so if we
want this to go out and be accurate I can get you an accurate example by
tomorrow.

MS. GREENBERG: And certainly information like that is welcome.

DR. WARREN: A lot of people would be very upset because we’ve spent a lot
of time really looking at outcomes and how they need to be modeled because
they’re a strange kind of, they’re difficult, they’re not as easy as findings
or procedures.

DR. COHN: Okay, so you’re basically supporting the recommendation but have
some wordsmithing additions or modifications to the report related to accuracy.

DR. WARREN: The other thing, it’s just nice to know that a lot of the hard
work that we’ve done within the nursing community is finally coming to fruition
and being recognized, so I mean this took a lot of effort to get these
recommendations to where CHI could look at them so it’s wonderful.

DR. COHN: Steve Steindel?

DR. STEINDEL: Simon, that will change the line to concurs with the CHI
recommendation for the nursing domain as modified, instead of as presented.

DR. LUMPKIN: And procedure, since what we’re adopting is the letter and not
the attachment we can, if it’s acceptable with the sign off of Simon and myself
we can accept the wordsmithing change to that example language if that’s
agreeable, so we’ll include that as part of the motion.

DR. WARREN: And if I can make telephones work I can probably get it for you
this afternoon.

DR. LUMPKIN: That’d be even better. Thanks.

DR. COHN: Questions?

DR. LUMPKIN: Anybody nursing any grudges about this section? Okay.

MS. WARK: Okay, here’s the recommendations from the supplies workgroup, and
originally the domain was titled medical supplies and resources, the resources
term was excluded, that was looked at as staff resources and so we re-termed
the workgroup medical supplies. And the team was led by Brock Hefflin and Larry
Kessler from the —

DR. LUMPKIN: I’m sorry, can I interrupt you just for a second because the
heading we have says medical devices and supplies domain, is that the same
domain?

MS. WARK: Yes it is, I’m sorry, there was mention of staff resources in
some earlier versions of the portfolio and I just wanted to explain that staff
resources was not included in the phase one work, so it is medical devices and
supplies.

DR. LUMPKIN: Great, thank you.

MS. WARK: Was led by FDA along with representatives from the Centers for
Disease Control and the Department of Defense and the Veteran’s Administration.

They defined the domain as any instrument, apparatus, appliance, material,
or other article intended to be used by human beings to diagnose, prevent,
monitor, treat, or alleviate a disease, injury, or handicap, or to replace,
modify the anatomy or a physiological process.

The scope of the supplies domain is all medical devices and supplies and
they noted that there are nearly 7,000 generic groups, and that the names are
used primarily to inventory the products and document their utilization by
health services establishments and to regulate their availability and
utilization in the community by public health agencies.

The alternatives considered were the FDA Medical Device Classification, the
Healthcare Common Procedure Coding System, HCPCS, ICD-9, UNSPC, the United
Nations System for Product Classification, SNOMED CT, the GMDN Global Medical
Device Nomenclature, and the UMDNS Universal Medical Device Nomenclature
System.

The analysis was that both the GMDN and UMDNS were similar in scope, the
UMDNS is available through the National Library of Medicine and supported by an
established business plan. The GMDN is an international standard and is
strongly supported by the FDA for global communication and as an eventual
replacement terminology. And the workgroup noted that efforts are underway to
start to merge the terminologies. Therefore the recommendation from the
supplies workgroup is that no one terminology is recommended, rather we should
wait for the Global Medical Device Nomenclature and the Universal Medical
Device Nomenclature System to merge and adopt the resulting terminology.

The terminology resulting from a merge of these two terminologies will
enable the U.S. federal system components to utilize one set of medical device
supply names, definitions, and codes, and to use these same product identifiers
to communicate with foreign establishments. So that was the recommendation from
the supplies workgroup.

DR. COHN: And this is actually consistent with actually independent
hearings the subcommittee held during the fall. I will say quite frankly most
of us were disappointed that we weren’t able to more clearly define the right
answer for implementation today, and indeed I think this is sort of a
frustrating issue nationally, and probably internationally for that matter,
that we can’t provide more guidance and direction on this. Because this is
obviously a critical area for patient safety and others to basically come to a
single standard for this terminology, but clearly there’s work underway and
we’re very hopeful that there will be increased collaboration, hopefully
merging of these two terminologies.

We did observe in our recommendation, and this just has to do with how
specific these nomenclatures get, that these are still a level above if you’re
really talking about patient safety issues identifying sort of that type of
device that you might do for patient safety investigations, so this is helpful,
it helps you categorize, identify related devices, but it still stays once
again a level above that specificity. And therefore we sort of recommended that
HHS further investigate device type, which actually is a level more specific
then these nomenclatures, as a component of device identification with the idea
that we can hopefully help drive this effort into greater specificity.

Anyway, that was our recommendation, good as far as it goes but more needs
to be done here. Questions, comments? Harry?

MR. REYNOLDS: Is there a time, in other words are you willing to wait a
year, two years, three years, or indefinitely, for these to merge?

DR. COHN: Should I ask the CHI that question? How long are you willing to
wait for them to merge? I’m an emergency physician so I sort of have a short
fuse —

MS. WARK: Well, the majority of the standards that we’re recommending for
adoption have been developed by organizations outside the government and it
didn’t make sense to us to go in any different direction or to take any action
when it was clear that there was a significant effort underway and the
government was involved in that. How long that will take is not known exactly
but I think they are estimating somewhere between a year and two years.

DR. COHN: Aside from this joking basis, actually I wasn’t even joking that
much, but I think we’ll be tracking this in the subcommittee and I think if
there’s things we can do to help encourage that effort I think we will take
action to do that.

DR. LUMPKIN: We don’t want this to be divisive.

DR. COHN: Thanks, John. Karen?

MS. TRUDEL: The CHI Council will be looking at these and tracking them
periodically also and in all cases where we made this kind of a recommendation
it was because we had seen good forward progress being made. And if at some
point in the future it appears that that progress is totally bogged down then
that would require a reassessment.

DR. LUMPKIN: Okay.

MS. WARK: Okay, the next area is history and physical and this team was
co-led by Dr. Viet Nguyen and Linda Nugent from the Veteran’s Administration,
and there were representatives from the Department of Defense, the Indian
Health Service, and the Centers for Medicare and Medicaid Services.

This group very quickly determined that a standard did not exist at the
present regarding the content and structure of a history and physical document
thus they recommended that the domain be addressed in the next phase of CHI
once standard development efforts in this area progressed and the foundation is
determined via the domain of text based reports. So that was what the workgroup
brought forward as the recommendation.

DR. LUMPKIN: Questions or comments?

DR. COHN: Obviously we concurred with this one and we’ll be talking more
about text based reports in a later recommendation.

DR. LUMPKIN: Okay, we’re on a roll.

MS. WARK: Okay, the next area was disability and the team was co-led by
Jennie Harvell and Samuel Shipley from ASPE with representatives from the
National Library of Medicine, Social Security Administration, the National
Center for Health Statistics, the Veteran’s Administration, the Centers for
Medicare and Medicaid Services, and other representatives from Department of
Defense and ASPE.

There was a lot of slides here that I’m going to go through fairly quickly
and sort of get to the bottom line. This workgroup did a huge amount of work
beginning with looking at the use of disability data in the federal health care
enterprise, and included in the paper is a description of that data use by CMS,
CDC, NCHS, SSA, VA, and DOD. They sampled disability terms from the instruments
that are used in those federal programs, including the Nursing Home Minimum
Dataset, the Home Health Outcome and Assessment Information Set, the Functional
Independence Measure for Rehabilitation, the Residual Functional Capacity Form,
and the National Health Interview Survey and National Health and Nutrition
Examination Survey.

The alternatives that they looked at were SNOMED CT, the International
Classification of Functioning, Disability and Health, and other sources in the
UMLS. They proceed to undertake a rather detailed analysis of the terms in
those instruments and they mapped them through a meta-map transfer program that
the National Library of Medicine uses. And there’s a lot of information in the
report, part of the reason that we had so much detailed information stemming
from the workgroup’s findings is that essentially it really wasn’t clear to
what extent the terms were available in the terminologies that they looked at
and this slide shows the study findings and the percentage coverage of the
terms from the various federal instruments in the terminologies, and the
workgroup analyzed where there were complete terms available, partial, or none,
and the total line at the bottom of the chart shows that SNOMED CT had complete
coverage of 56 percent, partial coverage of 39 percent, five percent were none.
And in the ICF complete coverage was 35 percent, partial 52 percent, and 13
percent none.

The timeframe for this study was rather limited, they did not have a
validation effort, so therefore they were working with an individual’s
evaluation of these terms. There was some other research that they looked at
that had been conducted by the Mayo Clinic that found for three selected
clinical domains captured by the MDS that SNOMED CT provided a complete match
for 46 percent of the MDS terms, the minimum dataset, and that ICF provided a
complete match for two percent of the MDS terms.

Ultimately they came forward with a recommendation that there isn’t
anything ready for adoption in the federal enterprise, and their thinking in
all of the deliberations and information gathering that they went through was
certainly laudable and will be very helpful in the next phase of any work that
is done in this area, but they did not come forward with a recommendations to
adopt any of the classification or terminology systems that they looked at.

DR. COHN: As you can imagine there was a lot of discussion in the
subcommittee about all of this. This is clearly an area where more work needs
to be done and actually there was some discussion about getting the
Subcommittee on Populations involved in this discussion also obviously as it
goes forward.

Our own view is that there was sort of a little confusion in the workgroup
around both what they were supposed to be doing in scope and possible
approaches because there was sort of an overlapping of two issues, one had to
do with this issue of questionnaires and scales and responses, and then there
was an issue of terminology, and the workgroup was having trouble sort of
parsing them apart, which is why we were trying to provide some advice in our
bullet here. And you sort of see the recommendation that we’re obviously
agreeing that more research is needed, which is really what that recommendation
is.

We recommended investigating, you think about it in question and answer
style because they really were having a lot of trouble with the scaling and
question and what is the response type thing and they’re actually, to expect a
clinical terminology to support all aspects of questionnaires is probably
somewhat of a tall order and yet there are some terminologies, and since Dr.
McDonald isn’t in the room we can actually talk about things like LOINC for
example, and that sort of style of question and answer, is actually a very good
model for that sort of questionnaire but even with that once you have that then
you still need a clinical terminology within the answers and things like there
may be a number of terminologies that were evaluated, which may find great
utility and it would be relatively comprehensive in those areas, but once again
it’s a question of creating expectations and asking the right questions here.

So this is sort of what we understand them to be doing in the next phase is
to sort of revisiting this. We were recommending that they think about it in
that way and obviously we also added a comment just because we didn’t think
that the evaluation was really inclusive enough of all the stakeholders, so our
final sentence is we further recommend the future activities consider the
unique needs and perspective of the different disability groups and other
domain stakeholders. So I think we should be expecting more work going on and I
would expect in the very near future in the disability domain with sort of a
reevaluation and re-approach. Questions, comments? Vickie, did you raise your
hand to volunteer to help on this one?

DR. MAYS: I was thinking deeply about what you need from us.

DR. COHN: Okay, well hopefully the structure isn’t the issue, it may be
more the issue of representation and making sure it reflects the needs.
Comments, questions? Okay.

MS. WARK: The next workgroup was genes and proteins, this was led by Dr.
James Sorace from the Center for Medicare and Medicaid Services, with
representatives from the National Institutes of Health, the FDA, Department of
Defense, Veteran’s Administration, and other representatives from NIH.

They described the domain as allowing the federal sector to exchange
information regarding the role of genes in biomedical research and health care.

The scope of genes and proteins was defined as inherited genetic variation,
for example genetic disease, pharmacogenomics, disease susceptibility traits.
The second are was acquired genetic changes, for example cancer. The third was
infectious disease where genes and proteins are involved in pathogenesis, drug
resistance, or identification. And protein nomenclature and gene nomenclature.

The alternatives that were considered were the Human Genome Nomenclature,
the Gene Ontology Nomenclature, and SNOMED CT.

The recommendations from the workgroup are that we adopt the Human Gene
Nomenclature sponsored by the Human Genome Organization which is jointly funded
by NIH and the UK.

DR. COHN: And we concurred with the recommendation for the genes and
proteins domain. Obviously the domain if you look in the documentation and all
that included a number of other areas, inherited genetic variation, infectious
disease, and protein and gene nomenclature, and those weren’t, I don’t think
that any recommendations were made in those areas, we just wanted to observe
that obviously something like one quarter of the work was really done
specifically, we are presuming that the other areas are being deferred for
future work.

MS. WARK: Correct.

DR. COHN: Questions, comments?

DR. STEINDEL: I have a question, Simon, is the HUGO Nomenclature available
at low or no cost?

MS. WARK: We worked with the National Institute of Health to get
clarification on the funding and availability of the nomenclature and it is
free, not only to federal entities but also for commercial use. It does require
a license but the license is free and the organization has since changed the
language on their website to clarify that.

DR. COHN: Okay, next.

MS. WARK: The next area was non-laboratory interventions and procedures and
this workgroup was led by Dr. Jorge Ferrer from the Centers for Medicare and
Medicaid Services, along with representatives from the National Center for
Health Statistics, the Veteran’s Administration, the Department of Defense, and
Indian Health Service.

It was defined as a standard that will be used to describe specific
non-laboratory interventions and procedures performed or delivered in the
provision of health care.

The scope of the domain was procedures by site, method, intent, focus,
device, and regimen or therapy.

The alternatives considered were SNOMED CT, MEDCIN, ICD-10-PCS and CPT-IV.

The recommendations are to adopt SNOMED CT and the specific location in the
SNOMED CT hierarchy that formed the basis of the recommendation is the
procedures access, so that would exclude the administrative and laboratory
procedure areas in SNOMED.

DR. COHN: We concurred with their recommendation. Questions, comments?
Okay.

MS. WARK: Okay, the next area is diagnosis and problem list. This workgroup
was co-led by Karla Porter and Beth Acker from the Veteran’s Administration
with representatives from the Indian Health Service, the National Center for
Health Statistics, the Department of Defense, and the Veteran’s Administration.

The domain was described as a series of brief statements that catalogue a
patient’s medical, nursing, dental, social, preventative, and psychiatric
events and issues that are relevant to that patient’s health care.

In scope was clinical diagnosis or problems, subjective symptoms or
observed findings, and synonyms. Out of scope was nursing diagnoses because
that was being considered in a separate workgroup, also out of scope was
modifiers and descriptors, dental, and alternative medicine.

The alternatives considered by the workgroup were SNOMED CT, ICD-9-CM,
ICD-10-CM, ICPC, MedDRA, MEDCIN, and DSM-IV.

The recommendation is to adopt SNOMED CT, the diagnosis and problem content
within the hierarchies of diseases and findings.

Gaps for the diagnosis and problem workgroup specifically were noted that
mappings are needed between the classification systems and the clinical
terminology.

DR. COHN: And we concurred with this recommendation. We actually also
suggested that we, I mean we recommended that we add to this list for mappings
the International Classification for Primary Care, ICPC, for the mapping
recognizing that it would likely find value and utility in primary care for
diagnoses and there’s certainly a fair amount of work going on outside of the
United States that shows some value to that.

Comments, questions? Judy?

DR. WARREN: I just want to clarify the reason that nursing was not in, out
of scope, was the fact that it was assigned to another work team, not the fact
that it’s not part of a problem list?

DR. COHN: Exactly, it’s just that it was already handled.

DR. WARK: Okay, the next workgroup was clinical encounters, and this
workgroup was led by Greg Seppala from the Veteran’s Administration, with
representatives from CDC, Indian Health Services, the Centers for Medicare and
Medicaid Services, the Veteran’s Administration, the Department of Defense, and
the Agency for Health Research and Quality.

The domain description, the workgroup sort of struggled a bit to define
what it was that we were calling a clinical encounter and they adopted the
definition for a clinical encounter from the ASTM E1384-02a standard guide for
content and structure of the electronic health record. The encounter services
as a focal point linking clinical, administrative, and financial information.
The encounters occur in many different settings, ambulatory care, inpatient
care, emergency care, home health care, field and virtual.

In scope for this workgroup was clinical encounters, admission, discharge,
and transfer information, provider information, accident information, death and
autopsy information. Out of scope was areas that were being considered by other
workgroups such as demographics, allergy information, diagnosis and problem
list, financial or payment information, insurance information, interventions
and procedures, and also practitioner to practitioner interaction, practitioner
to records interaction, and ancillary service visit.

The alternatives considered for the clinical encounters domain were the
ASTM standards for the guide for content and structure of the electronic health
record, the standard specification for coded values used in the electronic
health record, the X12N 837 health care claim message, SNOMED CT, the CMS Form
HCFA-1450, the CDCP data elements for emergency department systems, and HL7
version 2.4 and above.

The recommendation is that we adopt Health Level 7 version 2.4 and higher
with identified gaps to be addressed in the future. The gaps are that,
essentially the workgroup noted gaps but also stated that the standard is
usable at present. There was quite a bit of discussion generated in our NCVHS
hearings and within the workgroup and with others about the fact that the
standard does not currently account for home health field and virtual
encounters and not that anyone would say that that didn’t need to be done but
that the standard just had not been developed to that level and the workgroup
noted that. Clinical services that do not meet the definition of clinical
encounter, such as a practitioner to practitioner interaction, again was not
something that the workgroup found in any of the standards that they evaluated.
The National Provider System Identifiers for practitioners and health care
organizations of course is not currently in the standard, standard location
identifiers and standard hospital service names. So those were the gaps noted
by the workgroup.

DR. COHN: The subcommittee had considerable discussion about this one and I
think part of the problem is the term encounter, just because most of us think
of an encounter as potentially having something to do with billing or a
billable service or something that somehow relates to that, and had some
trouble with the actual definition which defined the scope of the work because
it actually doesn’t include all billable encounters, doesn’t include encounters
in the lab, doesn’t include, I mean that sort of thing and so we’re sort of
scratching our head almost more of what was the business case of why you would
artificially restrict that scope as opposed to, and obviously I think the
fundamental discussion. We actually have no issue with the standard being
recommended, which was the HL7 ADT standard, but it was really more, we just
couldn’t quite figure out why they would artificially restrict the scope like
that.

Having said that at the end of the day we had to sort of figure that this
is government and the government needs to determine its own scope for these
things and not everything has broad applicability in the private sector, and so
we made comments and moved on. And so our recommendations are is that it
concurs with the recommendations as modified to really include the explicit
notation of the gaps that you see here which were basically not in the original
document, and also the notation of the fact that the personal health records
were also out of scope, which was another piece that was not included.

We understood, can I finish the sentence and finish the recommendation and
then you can ask?

DR. FITZMAURICE: It was about that sentence.

DR. COHN: Oh, I’m sorry, what did we say about that —

DR. FITZMAURICE: I might suggest that the inclusion, could we frame it as
exclusion because we are recommending exclusion of the personal health record,
because it is out of scope.

DR. COHN: We didn’t recommend that, we just noted that they excluded that.

DR. FITZMAURICE: If the inclusion is okay, fine, that sounds better as
exclusion I think.

DR. COHN: Oh, I see, okay. I will consider that to be a wordsmithing
modification to all of this. But basically we’re saying CHI understands the CHI
definition of an encounter refers broadly to all types of practitioners
interacting with the patient, however, some explicit clarification may be in
order because there was a little bit of ambiguity in that. We note that the CHI
Workgroup scope does not include many encounters observed in health care as
might be enumerated in an electronic health record, and then we also noted that
NCVHS notes that a similar concept of an encounter exists within the HIPAA
process and harmonization should occur between the two, or at least some sort
of mapping.

I think as I look at these gaps also I would sort of look forward to seeing
what the government does with standard location identifiers as well as standard
hospital service names, which has been certainly a historic issue in most
settings of care where you have more then one facility trying to come to some
common agreement about that. We presume that will be in some subsequent set of
recommendations or actions from CHI.

Comments or questions?

DR. LUMPKIN: I think that perhaps the best way to list that, to put that
would be, because exclusion/inclusion gets a little bit confusing, would that
the explicit notation of CHI included gaps and the listing of the personal
health record as out of scope.

DR. STEINDEL: That’s fine, Mike and I just talked about it, we said noting
the exclusion.

DR. LUMPKIN: Okay, yeah, comments on this recommendation. It’s a little bit
murky but clearer then what we had before. Okay.

MS. WARK: The next workgroup was text based reports, and this was co-led by
Dr. Viet Nguyen and Linda Nugent from the Veteran’s Administration, with
representatives from the Indian Health Services, the Centers for Medicare and
Medicaid Services, the Veteran’s Administration, Department of Defense, and the
Social Security Administration. They also brought in a representative from GSA
to address some of the e-authentication efforts.

The text based reports domain was described as standards and terminologies
used to define the messaging architecture and syntax of clinical text
documents. Clinical text documents were defined as generated by health
professionals, comprised of free text, and primarily unstructured data.

In scope was text document structure and syntax, electronic signature,
document section headings, and clinical document types or titles. Out of scope
was clinical signs and symptoms, vital signs, physical exam observations and
findings, laboratory findings, diagnosis, and problems and orders.

The alternatives considered for text based reports were the HL7 clinical
document architecture, the ASTM guide for content and structure of the
electronic health record, the Continuity of Care Record, SNOMED CT, Abstract
Syntax Notation One, the CEN, the Portable Document Architecture, Rich Text
Format, XML Extensible Mark-up Language, and HTML hypertext mark-up language.

The recommendation is that we adopt HL7 clinical document architecture, the
current version is 1.0 and we are also recommending that subsequent releases
that are approved be adopted. It is noted that HL7 released the ballot for CDA
release 2.0 on December 8th of 2003 and it is anticipated that this
new release will be ANSI approved before the end of 2004. The workgroup did not
make a recommendation specific to electronic signatures, they stated that they
considered the GSA OMB e-authentication policy and the NIST FIPS Pub 199 as the
defining documents for authentication control.

DR. COHN: We concurred with the recommendation of the text based report
domain as presented, we did note that the committee will be further studying
the HL7 CDA as well as the Continuity of Care Record as part of our ongoing
work later on this year. We further note the need for e-signature is an
important component that has been investigated by the committee in the past and
actually is going to be an important upcoming issue for e-prescribing.
Obviously HIPAA had this as an issue but now suddenly there’s a business case
on it, and we’re re-exploring these further, both the federal government
authentication policies and how all of this relates to e-signature as well as
other possible approaches to this as part of our e-prescribing work over the
next year.

DR. LUMPKIN: And this could be a Texas sized problem.

DR. COHN: Yes.

DR. ZUBELDIA: I have a question on the electronic signature part of this,
that second bullet talks about the authentication policies as defining
documents. Is this based on a presumption that the electronic signatures will
have to be digital signatures that are self authenticating? Or are there other
authentication requirements associated with this text based reports that are
implied?

MS. WARK: There isn’t any of what you said implied in this statement, the
workgroup determined that this was really outside of their scope and they’re
deferring to the e-authentication effort that is ongoing.

DR. COHN: Kepa, I received an email last night from Alicia, who had pointed
out where this is on the web and I’ll be happy to forward this to you, I mean
this is the first time I had heard about it. Apparently it’s a working document
or an advanced draft or something in relationship to that and I think we need
to evaluate it and sort of see where it is. It sounds like this was not fully
evaluated but was really more of a reference that there is another workgroup in
the eGov initiative that’s focusing on this area.

MS. WARK: Correct.

DR. LUMPKIN: Okay.

MS. WARK: The next workgroup was population health and the team was led by
Steve Steindel from the Centers for Disease Control, and there were
representatives from across the federal government. This workgroup convened in
I believe it was late spring and held off for a while because it was determined
that as the other clinical domains progressed and recommendations were made to
the council that the population health workgroup wanted to take those into
consideration, but you can see here that there was a large number of
representatives from across the government, Indian Health Service, the National
Center for Health Statistics, FDA, HRSA, Department of Defense, Agency for
Health Research and Quality, and other representatives from CDC.

As I mentioned the approach to the population health domain was that they
defined it as code sets used to report public health data and for the purpose
of population health statistics. They noted that population health data is a
combination of clinical data and additional data, therefore the population
health domain would be partly dependent upon standards used for other clinical
domains. And that was the reason that we put the group on sabbatical over the
summer and then reconvened in the fall.

The workgroup noted that there was a large number of solutions they
anticipated evaluating and they also noted that any adopted standard would need
to integrate historical data for trending purposes. They anticipated that it
would be difficult within the project timeframe to make a specific
recommendation on a standard and rather then trying to bite off more then they
could chew in that timeframe they decided to produce a report in phase one that
could serve as foundation for guiding future work and their goal was redefined
as preparing a list of population health data collected, including purpose at
all levels. They would note the terminologies and classification systems used
to collect population health data and relate aspects if any of a clinical event
that related to the population health data.

In scope was public health reporting, population health statistics, and
billing data or statistics. Institution health statistics were not in scope but
recommended to be similar to external uses.

The alternatives for population health, they started with SNOMED CT, LOINC,
the ICD series of classifications, HL7, CPT, HCPCS, MedDRA, and multiple
others, and they compiled a matrix of current terminologies that reflected the
workgroup members and agency’s input that participated in the workgroup.

Their findings were that the current terminologies were numerous and not
coordinated, that the list that they developed contained some recent public
health reporting systems used by health and human services that contain one or
more standardized terminologies, but that there were others that were not using
standard terminologies that, I’m sorry, that there were some on the list that
HHS uses that do not contain standardized terminologies.

The recommendations also noted that the diversity of terminology needs
found lead to the conclusion that a specific CHI recommendation is
inappropriate at this time and as noted in the report there are a number of
recommendations that the workgroup came forward with for future work to be
completed.

DR. STEINDEL: This is a minor clarification on what Cynthia gave in the
report, the matrix which probably forms the bulk of the handout that you have,
I think it’s about ten plus pages in that handout, those who are familiar with
the population health reports coming out of HHS, you will probably notice that
there are some major ones that are not there, one of which and I use as an
example deliberately, I picked on my own agency, CDC, the National Notifiable
Disease Surveillance System is not on that list. Because right now we do not
use standard codes, we are moving towards standard codes, and we do have
standard codes for some of them, but it is not totally moved into a standard
coding system and we wanted to point out that as an example.

DR. COHN: Effectively, I mean let me just say our recommendation and let me
just talk about it for a second, which is basically we’re agreeing with the
recommendations for CHI. Let me just bookmark this one because I think this one
is one we’re going to probably almost need to put on the full committee list
for the year because this is really the big enchilada as far as I’m concerned.
We’ve got clinical data, we’ve got clinical terminologies, now how exactly are
we going to make this work for population health? Exactly what are we going to
do, how are we going to ensure at the end of the day that all of this fits
together? I mean this is, I don’t think of this so much as a domain as a
strategy and I don’t know whether this is the 21st Century
Statistics phase two, the next phase of the NHII report, I mean it’s really I
think a very big issue.

I think Steve appropriate identified, he sort of felt that NCVHS, the Board
of Scientific Counselors of NCHS, National Library of Medicine, probably others
need to all be involved in this conversation. And it’s not, I mean I think we
can all make this happen, this is that issue of mapping, interlocking,
appropriate use of terminologies, appropriate aggregation of data, clarifying
to make sure that meaning is the same as data that is captured with
administrative code sets, it’s all of those pieces that at the end of the day
need to be in place and we need to have assurances in place to assure that we
have better quality data five years from now then we have now. Karen, do you
have a comment on that one? Am I appropriately referencing the topic? Okay.
John?

DR. LUMPKIN: Well, I have a question because I’m a little bit confused by
this recommendation. There is data that flows through the population health
system that is derived from clinical data. But in trying to look at this I
would expect let’s say diagnosis of disease would be out of scope even though
it flows through the population health system. Now there are other codes that
for instance if you have someone who has a case of diarrhea and as part of the
investigation you look at the water that they drink from a private water well.
And those private water wells have different kinds of construction types, they
could be buried, they could be buried slab, they could be board, they could be
drilled, they could be dug, all those have implications because they have
different rates of contamination that you can expect. So that’s just some sort
of coding that obviously would need to be there in that system which no one
that I know of has ever even thought of trying to code water well construction
types in some sort of consistent fashion.

But my question is, are we saying in this recommendation, do we actually
say that the clinical data that flows through the population health dimension
should be consistent with standards for clinical data?

DR. STEINDEL: Yes.

DR. LUMPKIN: Okay. Then this is a small on my face.

DR. STEINDEL: Yes, it explicitly states in the report and notes that in
many cases the population health and public health reporting systems use data
that is identical to clinical data and that the CHI domains in those areas have
already made recommendations for standards, and those standards should be used
for that reporting system. And it also explicitly states in the report that one
of the things that needs to be investigated is tabulating a more detailed list
of what’s being gathered in terms of population health statistics. And what you
point out is just one example and it notes that much of the data in that area
comes from the non-clinical domain and that that needs to be noted and areas
where standardization needs to occur needs to be noted.

MR. SCANLON: I think, I don’t disagree with the conclusion here or the
recommendation that where a lot more further study, and I think it’s almost
strategy rather then standards, those standards would be part of the strategy
and it’s certainly more then one domain. I think once we rename this the
population health rather then public health reporting I think it took on a
whole new range that is not, probably needs to be much more differentiated. But
again, there are standards issues, there are statistical standards that are not
health statistics standards that are already used, more or less best practice
standards, they’re age standards, race ethnicity standards, there are
statistical classification standards, that are coming more from the statistical
not clinical side, that are used or could be used in many of our data systems.
And there are of course clinical types of diagnoses standards and others that
we hope we will ultimately get to the point where we’re using when the
information comes from that source. But there’s a whole array of other
variables I guess I would call them, or measurement scales, that are largely
defined by the nature of the inquiry in that field, and I’m not sure those are
subject to the standardization that we’re talking about here. You think of what
is the concept you’re measuring, what’s the best measure, and it’s integral to
a whole field, other fields of science and I’m not sure that the CHI standard
is necessarily the model for where you go there. At any rate I don’t disagree
with the conclusion, I think it’s just a more complicated strategy that you
have to look at.

DR. LUMPKIN: Gene.

DR. STEUERLE: Thinking about this, this is strategy rather then anything
else, I’m just, and given that you’re not really making a recommendation at
this time, I’m just curious if someone is conducting a new survey, particularly
a government sponsored survey, whether there is some benefit of having that
group or whatever to go through some intermediary committee, not necessarily
for approval but to say how does what we’re doing map with respect to what we
know from what’s out there now. And is there an effort a presume at this time
to do mapping across matrices, just trying to figure out what’s out there so
people have some comparisons. So if I’m doing a new survey, I’m asking a
question that might have been asked somewhere else, someone can immediately
point to me how that question has been phrased before, the terminology that’s
been used, even if there’s no approval. I guess I’m sort of asking what’s, in
absence of a recommendation what’s the strategy for the next survey that’s
going out, is there some place they should be going for information?

DR. STEINDEL: I think Jim and I are probably thinking the same way. First
of all the report does recommend the creation of the type of list that you’re
talking about, so we do have enumeration of what reports are out there and
what’s being used for those reports. So that answers one part of the question.
I think the second part of the question at least within HHS is whenever a new
statistical survey is proposed it goes in front of the Data Council of HHS and
one of the questions that’s asked is what’s been used before or what’s been
done in this area before to try to harmonize.

MS. GREENBERG: Well, also of course there’s a whole process of OMB approval
that part of which is exactly what you’ve described —

MR. SCANLON: Yes, I’m painfully familiar with that process. As Gene
probably knows from his stay in the Treasury Department virtually any new data
collecting, not just the survey that any federal agency wants to undertake, has
to go through a fairly exacting process and approval by the Office of
Management and Budget and there’s a whole structure and a whole set of rules.
But one of the criteria clearly is are you using existing standards, again this
is not a CHI issues so much as there are other statistical standards for
economic data, age data, and so there’s always a comparison of are you
employing the standards in that data collecting, why are you using the measures
and the variables you are, is there another survey like that, or any data
collection for that matter that is duplicated. Now you can argue anything can
be improved obviously but there’s a fairly extensive process for doing that.

And in addition we have, on our Data Council website we have virtually all
the major data collection systems in HHS on the website, and you can actually
look at what they are, anyone else can before they’re starting a new survey. It
gets a bit tricky because literally some of this is amenable to
standardization, some of this is not. Some of this is new science, it’s new
data, it’s research, it’s administrative, so there’s always kind of the tension
between what’s innovative, what’s new measurement versus what’s more or less
routine statistical and you standardize.

And then I know the workgroup already raised the point and I think I’ll
stop here, of the, for the data collections where we have used certain
standardization categories there’s an issue always of the changing them and the
effect on time series and comparability, so there are a number of bridging
kinds of techniques where you can look at those things. But I view this as an
entirely different, this is not so much a CHI direction as a strategy for how
you standardize where you can, you coordinate where you can, all of the other
data collection that the federal government is involved in and it’s more of a
strategy.

MS. GREENBERG: Your answer about OMB was not why I had my hand raised.

DR. LUMPKIN: Oh, you’ve got to use finger code now. Go ahead.

MS. GREENBERG: Just going back to the exchange between John and Steve
related to clinical data and the alliance with CHI domains, and you mentioned
diagnosis in particular, now as you heard the recommendation for the diagnosis
domain was to use SNOMED CT, but in some cases SNOMED CT, data coded in SNOMED
CT is collected by some population health systems. But this level of
aggregation that’s required by the particular system, or the need to map from
the clinical data to the terminology that’s actually used in the population
health system is another area of complexity so that ICD is, for example
mortality data uses ICD-10, it does not use SNOMED even though that’s clinical
and diagnosis data. And at this point I don’t think we’re recommending that
that should change, but those are the things that have to be looked at and the
types of mapping, and do you want to go directly from the clinical data this is
being collected —

DR. STEINDEL: And that’s what the report calls for, is a study to say what
the impact of that is and how it should be done.

MS. GREENBERG: Exactly. So I think the report is clear on that, I just
didn’t think the exchange necessarily made that clear.

DR. LUMPKIN: So I think we’re comfortable in how we’re going to population
this section of our recommendation.

DR. COHN: yes.

DR. LUMPKIN: Shall we move on to the last one and hope it doesn’t compound
the discussion.

MS. GREENBERG: The only thing I can say is that since NCHS has recommended
to do something about this it might be something that you want to engage the
board on, the Board of Scientific Counselors, currently there aren’t resources
to do it, or plans I don’t think.

DR. STEINDEL: And the Data Council I guess —

MS. WARK: The last team here was chemicals and Steve’s true calling as a
chemist came to bear on this workgroup, he was the lead from the Centers for
Disease Control, and there were representatives from FDA, EPA, and CDC.

The domain description is chemicals of importance to health care outside of
medications, because medications had been dealt with by another workgroup,
health care purposes, chemicals will be those found in the work place or the
environment that might be related to health, and commonly the first and perhaps
only use of a chemical code would be during a first encounter and perhaps be
part of a history and physical.

Again, non-medicine chemicals were in scope and drugs or medicine chemicals
were out of scope.

The alternatives considered were SNOMED CT, the Registry of Toxic Effects
of Chemical Substances, the Chemical Abstract Service Numbers, and the
Environmental Protection Agency’s Substance Registry System.

The recommendation is to adopt the EPA’s Substance Registry System. The
analysis showed that as of November of ’03 the number of substances currently
in the SRS are in excess of 87,000, the number of submitting organizations
represented in the SRS are 37, and the number of information resources included
in the SRS are 965. The benefits are that is federally maintained, does not
require a license fee, it has been widely used for years by EPA programs, and
is available on the internet.

There were some critical conditions and gaps noted, the first being that
establishing interagency communication so that medical needs are addressed in a
timely and coordinated fashion would be needed, and the workgroup did not that
that communication has started between the EPA and the FDA. Also developing a
mechanism so that similar tables from other agencies can be matched against the
SRS table and missing elements added. There is a note that this will require
new unidentified resources. The workgroup also noted to investigate the
availability of a subset or view of information from the database in an
acceptable format for health care use as a no or low cost distribution item.
EPA is willing to provide this view as a periodically updated, perhaps every
six months, compressed file for internet download. And lastly there should be a
requirement for registering an object identifier if it is to be used in HL7
messaging.

Non-critical gaps were identified is a task EPA is undertaking is a review
of the commonly regulated chemicals and the selection from the many synonyms
available of an EPA preferred name. These kinds of problems highlight the need
for an agency wide system like SRS and the need for someone to review any
changes to chemical content in SRS. Also a non-critical gap is the introduction
of common chemical download format, such as the MDL MOLE(?) File or developing
a chemical XML format.

DR. COHN: And we concurred with these recommendations as presented, we
noted and support the specific need for resources at the EPA to obviously
accomplish the additional work required. I think we all think this is going to
be critical work, certainly John, the next time he has to deal with a well,
which may be a while from now, he may not be able to describe the construction
issues but at least he’ll be able hopefully to identify the chemical
contaminations with this.

DR. LUMPKIN: That’s right, as long as we get the right reaction.

DR. COHN: We’ll send you down first to find out.

DR. LUMPKIN: Any comments on chemicals?

DR. COHN: The final note here on the letter is I think something that was
brought up during our conversations day before yesterday as we reviewed these
areas, and we do recognize CHI as looking for sort of additional comments on
future directions, next steps. We did observe that the personal health record,
and it isn’t so much the personal health record but it’s the person’s interface
to whatever it is, be it personal health record or whatever, the terminologies
for that have really not been explicitly discussed and obviously we encourage
future investigation by the CHI.

I guess I would, I mean we’ll be moving this now but I just wanted to take
an opportunity to really congratulate Karen, Cynthia, and others, Steve
Steindel, for what we think has just been incredible work, obviously we’re
delighted to see this sort of work occurring in the government, the government
taking leadership in this area, and hopefully providing a tipping point in the
industry. So an amazing amount of work, we look forward to the next phase.

MS. WARK: And I’d like to say thank you for recognizing the efforts that
have happened over the last year or so, not only in the government with the
team leads because the idea was that the representatives would come together
and hash things out in the workgroup, they dealt with some very, very tough
issues and they came up with some really solid recommendations and some reports
that will help future work. And I’d also like to thank the committee members of
the Standards and Security Subcommittee who were very forthcoming with
explanations, clarifications, information, all of the representatives from the
standards development organizations that helped us out, it was just an enormous
effort and I’m really in awe myself of all the work that happened over the past
few months and people like Steve who really took a leadership in this
initiative. So thank you all.

DR. LUMPKIN: It’s been moved by Simon that the letter with the following
changes under the section on nursing, that that would read as the nursing
domain as modified. Under the section on clinical encounters the word inclusion
would be changed to listing for the personal health record as being out of
scope. Is there a second to the motion?

MR. BLAIR: I would be happy to second the motion.

DR. LUMPKIN: Moved and seconded by Jeff. Is there a discussion on the
motion to adopt this letter? All those in favor signify by saying aye.

COMMITTEE: Aye.

DR. LUMPKIN: Opposed say nay. Any abstentions? Well, I think I would like
to add my congratulations in addition to Simon.

[Applause.]

Let me just in addition to Simon’s comments let me sort of add my
perspective on this. It was a number of years ago that the CHI came before, we
were aware of that as a committee, and it started off as sort of a kind of
small initiative, not a lot of support higher up in any of the agencies
involved. We as a committee saw immediately the importance of that and Simon
and the Committee on Standards and Security offered to be the advisory
committee to this initiative even though it was beyond the work of the
Secretary.

As we developed our recommendations on Patient Medical Record Information
we put forward in the process that was closely assisted by staff from the
department the concept that the Department of Health and Human Services should
take the lead and that the next round of clinical data standards, or clinical
standards, or health information standards, should be those standards where
leadership is shown by the government. And they used that as part of their
business processes rather then the mandating process under HIPAA.

And what we’ve seen now is the completion of that first phase and I would
say that this event and what we have helped accomplish today is nothing short
of historic. And as we look back upon the years of transformation of health and
health care through the use of information technology the CHI process, the
recent events over the last 12 to 18 months with our work in the NHII, this
period of time will be seen certainly as that tipping point where we have
really made a significant difference.

So my hat’s off, of course I don’t wear a hat. Congratulations to the CHI
and also to the committee for really having made this and passed this
milestone.

And with that we’re also going to pass another milestone and go to lunch.
Let’s reconvene at 1:15.

[Whereupon at 12:15 p.m. the meeting was recessed, to reconvene at 1:30
p.m., the same afternoon, January 29, 2004.]

A F T E R N O O N  S E S S I O N [1:30 p.m.]

DR. LUMPKIN: If we can have the consulting groups take their seats. Even
though we’re behind schedule we’re okay, and still on target for an on-time
adjournment if not a touch early.

The first item on our afternoon agenda is a Privacy Subcommittee update.
Richard.

Agenda Item: Privacy Subcommittee – Update – Dr. Harding

DR. HARDING: Thank you, Mr. Chairman, and I appreciate this opportunity to
give a brief update on the Committee for Privacy and Confidentiality. Most of
the new members here don’t know our chair, Mr. Mark Rothstein who is an
attorney, and also the director of the Center for Bioethics and Law at the
University of Louisville. He’s not here but he will be next time and he asked
that I sit in for him during this brief update. There are no action items to be
voted on after this.

Part of HIPAA is something called administrative simplification, which you
all know, and part of that is including asking that we look over and monitor
standards for privacy and individual health information or the privacy rule,
which came out in April 15 of this last year. We have as a group been helping
with the coming out of that rule but also since its come out have been assigned
the task of helping monitor how that rule is rolling out so to speak here in
the country, and so we have had hearings in November to look at both public
health and research and some of what covered entities are going through. And
then we have another hearing coming up in February, which will look at law
enforcement, school and minority issues, and how banking refers to the privacy
issue.

We have three members of the committee who are here by the way, John,
Simon, and Kepa, are all members of the committee, and at the end of my five or
ten minutes if they could say a word that would be great.

We will also having a report coming to the committee at the next full
committee meeting that will summarize the hearings and recommendations that we
would suggest be made to the Secretary through the full committee, and those
things come through the full committee, all recommendations.

Briefly, there are several areas of concern that were brought to us by
public health officials and researchers as well as other covered entities, and
I have tried to narrow them down to as simple and quick as possible, and they
would be the following. One is that there is less anxiety among those groups
then there was a year ago. When we were out doing some of the hearings a year
ago there were times when it was clearly a we and they with us being the they
and on the committee, and there was a time in Utah that we had some concern
that one of the testifiers was packing heat during the testimony although that
was, Marjorie I don’t think that was ever verified, but everybody was
concerned, there was that much affect going on at the time about that. So that
was in Utah though and Kepa will have to speak to that there in a little bit.
Now there’s less anxiety although it still clearly is there, there were a great
deal of complimentary statements made for the Office of Civil Rights for their
education and frequently asked questions page they have as I mentioned this
morning.

There was felt in the public health area to be lots of misunderstandings,
not that the law was wrong but there were issues, or the rule, but there were
issues where there was an adverse effect, I tried to write this down, adverse
effect on reporting of notifiable conditions to public health officials. That
is people had some concern about sending in information about individuals
because of fear that they did not have proper authorization to do that and
there was a debate that went on whether that was being just too conservative
about the authorization or if that was some way to avoid having to send that
information in and that was discussed. That conservative stance err on the side
of caution was one that was frequently brought up.

In research there was a great deal said and more will be coming to you
about this but one of the things was the divergence between the common rule and
the privacy rule and some of the difficulties that people had in interpreting
that. One of the amusing things to me was one of the concerns that one of the
researchers had about keeping DNA anonymous. If you think about that keeping
DNA anonymous is kind of an oxymoron or whatever. A great deal of information
and concern about the burden of accounting for disclosures, that came out from
multiple, multiple sources, that the accounting it was understandable but the
burden of that was overwhelming to many of the researchers as well as public
health officials.

There was concern about notice in non-traditional settings, such as health
fairs or shopping malls, when someone gets flu shots at the mall is that, do we
have to have notice and so forth in that kind of a situation. There were
concerns about business associate agreements, the proverbial Pakistani
transcriptionist who came out of the fourth line of subcontracts out of
University of San Francisco. The minimum necessary issue was one that was very
difficult for people to figure out what was minimally necessary. Disclosure
accounting again came out.

And then the February hearings as I said, we were going to begin, we will
begin the issues of law enforcement, school and minority issues, and banking
issues as they effect privacy. In addition beyond that other issues that we
will be monitoring will be fundraising, non-traditional settings, the payment
chain, and employer access to health care information.

With that I will stop. Mr. Chairman if any of the other members of the
committee would like to mention something that I didn’t I’d be glad to have
them say a few words.

MR. HOUSTON: Did you speak of the common rule at all?

DR. HARDING: I only said that there was concern about the divergence
between the common rule and privacy, go ahead.

MR. HOUSTON: I just wanted to, not necessarily expound upon but sort of
restate the importance of that. I think that there was a pretty clear consensus
from the individuals who spoke regarding the research that there was definitely
a problem with the difference between the common rule, federal policy regarding
HIPAA, especially as it related to preparatory research functions which is an
animal that the common rule doesn’t even recognize. And I think that that’s
something that has to be, it sounded pretty clear from the individuals at the
meeting that that’s something that had to be dealt with other then simply
getting guidance, which was I think what, I think three was the OHRP, NIH
document regarding research which something was there from OHRP but suffice it
to say I think that was an issue that was at everybody’s sort of fore.

MR. SCANLON: I think part of this is just a matter of working it through,
some of these things are not true but you’re right, I think that providers are
behaving in an understandably defensive position until things are clearer.

But there are a number of guidances that have been issues relating to
research and public health, one of the guidance documents that was published I
guess not to long ago in public health was meant to clarify the streamlined
burden of accounting issues that you could undertake for public health or for
research, so I think it’s a matter of kind of working it through.

And maybe we’ll even schedule a little briefing on what other guidance
documents are being considered in HHS for the subcommittee.

MR. HOUSTON: And in fact to dovetail on that there was just came out a
weeks ago a repository guidance document relating to research repositories
which I think actually answers one of the points that we made in the draft
letter, or at least I think it addresses it and I think we could probably pull
that out of the letter frankly based upon the guidance that came out from NIH,
so I think that was good.

DR. FITZMAURICE: If I could just read off the five that are available now,
they’ve been put together by NIH, AHRQ, FDA, and CDC. The first one is
Protecting Personal Health Information in Research, Understanding the HIPAA
Privacy Rule. Second, Health Services Research and the HIPAA Privacy Rule.
Third, Research Repositories, Databases, and the HIPAA Privacy Rule.
Institutional Review Boards and you know it. And finally Privacy Boards and the
HIPAA Privacy Rule. Those are the five that are available and we’re working on
one right now, Health Services Research and the Privacy Rule.

DR. HARDING: — there’s one more then and we’ll stop, or Vickie has —

DR. LUMPKIN: Okay, Vickie?

DR. MAYS: I just wanted to ask a question when you were saying that you
were going to deal with minority issues, we’ve actually been concerned with
some of the privacy and confidentiality issues relative to surveys,
particularly when it comes to small racial and ethnic minority groups that the
problem is that then it’s very difficult to do analyses. One of the members of
the subcommittee, Russell Localio, has been working on that so if there’s a way
in which we can have him maybe have some time on your agenda the next time your
subcommittee meets to share with you our concerns that would be great because
then we can kind of work with you on that.

DR. HARDING: Great.

DR. MAYS: Okay, thank you.

DR. HARDING: I will give that to Mark and Kathleen, Kathleen had an illness
in her family and so wasn’t here today, our main staff, but we’ll —

DR. LUMPKIN: Gene?

DR. STEUERLE: Did you call this the common rule?

DR. HARDING: Yes, for research.

DR. STEUERLE: I thought you said something else which is —

MR. HOUSTON: The federal policy which is —

DR. STEUERLE: Which is the difference between, well I was going to say I’m
actually on a different topic, I thought you said common good and privacy
issues, which is also to me a really interesting issue. Some privacy efforts
seem to me do raise cost and they’re not just administrative costs, they’re
cost for the public health, we don’t get information that we might want as a
public or in some cases individuals aren’t getting information that perhaps if
they had would lead them to behave better in ways that would effect people, I
think of as an example the fact that blood tests don’t give you AIDS
information, as an example. It could be very costly for some people in society
so I’m just curious, what does this group do to gather statistics on that side
of the issue, what are the costs for some of these privacy concerns. You’re
getting anecdotal information about the extent to which defensive medicine is
practices but do we gather statistical information on that? Do we try to gather
information on both sides to try to figure out how society can weight this
balance? Or are we mainly just trying to implement a set of rules that has sort
of come down? Does the question make sense?

DR. HARDING: Yes it does, I don’t think though that we have, to this point
we have not had the capacity or the will I guess to gather that type of
specific statistical information and have often looked to other agencies for
that.

DR. STEUERLE: I know some of it might even be qualitative, but even
qualitative sometimes —

DR. LUMPKIN: Marjorie?

MS. GREENBERG: Well, the committee did send a letter, I don’t know, last
year, to the department about the importance of doing a systematic evaluation
of the impact of the privacy rule on various areas, research, health, health
care, public health, etc., I don’t think it specified some of the more
quantitative aspects that you’re suggesting but that would certainly be a part
of it and I think it probably, the role of the Privacy Subcommittee to
follow-up with the department, to keep that on the agenda. I mean part of the
problem is the longer you go without initiating such a study the baseline slips
away from you also.

DR. LUMPKIN: Jim.

MR. SCANLON: The rule itself, the final rule, Jane made an attempt to
quantify the benefits and the costs, it’s kind of in a very general net way as
all regulations do, but since then it’s more anecdotal and you could argue that
because there wasn’t a baseline really, I’m not even sure what the statistics
would be to be honest in terms of a quantitative approach, but I think the
thinking is that this is still a fluid situation with providers still learning
and adapting to guidance and other things and that probably hasn’t stabilized
enough to do anything quantitative. But we are interested in quantitative, I
think it’s just an initial attempt, it just wasn’t clear what exactly the
design would be.

MR. HUNGATE: Just a short, in the upcoming recommendations from the Quality
Workgroup there is one that asks for further investigation of the
interpretations of the privacy rule that go beyond the rule, that have limited
disclosure in health care situations where the patient may be deleteriously
effected by the failure to disclosure, which is the same problem and is a cost
to the rule, so that’s part of the upcoming report.

DR. LUMPKIN: John.

MR. HOUSTON: Sort of a different thread but I think maybe related somewhat
is with everything that’s going on within NHII I know that one of the concerns
with coming out of the original conference, when was it this last summer I
guess, was issues related to how NHII would work with the privacy rule as well
as the fact that you still had state, sort of preemption, more stringent state
laws, and I guess maybe one of the questions that we need to maybe explore, or
start to try to explore in a structured fashion, is how do we deal with, or how
do we deal with NHII in the context of the privacy rule and frankly potential
issues related to how we can share information to support NHII. I don’t know
what the framework is to do that but I think it’s important to start thinking
about that.

DR. LUMPKIN: I think it’s a good point. Let me sort of toss something to
the committee as a follow-on to my questions earlier this morning and you
mentioned the preemption analysis, there have been, now that things have
settled down, I know in Illinois we did a fairly extensive preemption analysis,
my guess is the final document was close to 800 pages or some and I think
almost every other state in the nation has done that. There’s an incredible
volume of analysis there comparing state laws to the federal privacy rule, and
so I think one of the things that we would be concerned about as a committee is
that you have multi-state organizations, who just don’t know what the rules are
from state to state, and that could be an issues. So I think there may be some
value of either looking at that ourselves or perhaps as a recommendation at
least taking some testimony, enough to the point where you could craft a
recommendation to the department in relationship to that. I was particularly
surprised to hear that there was only one request for a waiver of preemption,
that was really quite amazing because I know in Illinois we probably looked at
over, at least 100 to 200 laws, somewhere in that neighborhood.

MR. SCANLON: And it’s hard, often states don’t even know all the laws that
may apply so even a state analysis is difficult.

DR. LUMPKIN: Well we spent, we had an outside contractor and we literally
spent hundreds of thousands of dollars on this preemption analysis just in one
state. John?

MR. HOUSTON: I don’t even think it matters whether you have multi-state
operations for a facility, again the whole concept of NHII is making
information available as necessary for the purpose of treatment, and if you’ve
got, if a patient is in the hospital in one state and the information is at a
facility in another state, frankly right then and there you have to deal with a
multi-state issue even though the organization itself is handling the
information but may only be operating in one state. I think it really is
germane.

DR. LUMPKIN: Well, the complication is is that with the full preemption
that’s provided by the privacy reg that we could have a discussion, make a
recommendation to the department, they could follow up on it in order to free
the flow in certain clinical situations, and state law would totally prohibit
it. And that could be —

MR. HOUSTON: That was my point and I think it came out this morning even
with the guidance that OCR gives, it doesn’t necessarily consider the state law
issues which I think in many, many cases if not most cases still take
precedence. I know that in Pennsylvania that is in fact the case and more
stringent, so even though you answer the HIPAA question it really doesn’t
completely answer the entire question, or there’s still preclusions.

DR. LUMPKIN: Okay, anything else on privacy?

DR. HARDING: The only other issue that I wouldn’t want to talk about much
but just the fact that civil litigation for breaching privacy is becoming a
HIPAA issues, and it’s a very anxiety producing thing for physicians, as well
as other professionals, because there’s already been one malpractice company in
Louisiana who said that they do not cover that type of problem, that if you’re
accused of having a breach of privacy in your office that is not included in
your professional liability insurance. So that’s another topic for the future
that we’ll, and that’s the kind of thing that really gets doctors worked up,
they have unlimited liability over something they don’t have complete control
over.

DR. LUMPKIN: That sounded like my practice all the time.

DR. STEUERLE: — you could do a survey of insurance companies and see
whether they’re actually adding to their charges because of privacy, it’s
something worth tracking.

DR. LUMPKIN: And I think what we would want to do is make that as a
recommendation since we don’t have the resources within the committee to do
that, but we do advise an agency that has one of the largest economies after
the United States.

Well, thank you. The next item on the agenda, the claims, oh wait, we have
one other item before we go to this item. Jim.

Agenda Item: Appreciation of Retiring Members – Mr.
Scanlon

MR. SCANLON: I know this morning the committee welcomed the four new
members and this afternoon the Secretary wanted to honor our retiring members,
it looks like the only, Kepa is here as the only remaining retiring member, but
the Secretary has always appreciated the work of the committee and we have here
for the four retiring members, and let me mention them again, Kepa Zubeldia,
whom I’ll talk with in a minute, Dr. Ted Shortliffe from Columbia University,
John Danaher, who filled out his term and then left, and then Dr. Clem McDonald
who was at some of our meetings yesterday, so that’s the four that are
graduating I guess you could say from the committee.

And really it is, I was joking that you never really sever ties with the
committee because really we call on you even after you’ve graduated for
testimony, for consultation and for other matters as well. But I’d like to read
to Kepa the letter of appreciation and the certificate of appreciate that the
Secretary has written and we have similar letters and certificates of
appreciation for the other graduating members as well.

Dear Dr. Zubeldia:

It gives me great pleasure to award to you this certificate of appreciation
for your four years of service to the Department of Health and Human Services
as a member of the NCVHS. The committee is one of the oldest and most
prestigious advisory groups serving the department. Its recommendations have
helped shape health statistics, health data standards, and epidemiology for our
nation and have had a profound effect on new legislation. Your knowledge,
expertise and experience have contributed greatly to the excellent work of the
committee.

We wish particularly to commend you for the time, effort, leadership, and
counsel you provided as a member of the Subcommittee on Standards and Security,
the Subcommittee on Privacy and Confidentiality, and the Workgroup on the
National Health Information Infrastructure.

Only the very best are asked to serve and we are proud to have had the
opportunity to associate with you in this endeavor. Should the occasion arise
we would like to feel free to call upon you for further assistance.

Sincerely, Tommy G. Thompson, Secretary of HHS

[Applause.]

DR. ZUBELDIA: It’s been an honor and a privilege to work here, and as you
new members will find out it’s a wonderful, wonderful place to work, and it’s a
great opportunity to have an impact on something positive for the entire
country. So thank you for the opportunity.

MR. SCANLON: Thank you, Kepa.

DR. LUMPKIN: For those of you who weren’t at dinner last night, not for
lack of trying, Clem did leave this with us so his parting remarks are —

Okay, so that’s what Clem had to say. And we weren’t sure if that pig was
saying oink or LOINC.

Okay, the next item, the claims attachment letter, we’re going to —

DR. COHN: We’re not bringing forward a letter today, we’ll be having
hearings on March 3rd to further delve into the claims attachment
issue and hopefully coming forward with a letter for the next meeting.

DR. LUMPKIN: Great. Okay, the sixth report to Congress, which was sent via
email I believe.

Agenda Item: HIPAA 6th Report to Congress –
2002-2003 – Dr. Cohn

DR. COHN: Well I guess I’ll start off since my name seems to be here, this
is one, I’m trying to think why I’m responsible for this one, I’ll have to
think about it.

Obviously we really want to thank both John Fanning and Kathleen Fyffe and
Jim Scanlon for their work helping put this together for us. This is a little
unusual in the sense that every year we are supposed to come up with a report.
We decided to put together two years into this report only because this last
year has been so involved with the initial implementation of a number of the
rules that we thought that it needed a little perspective upon which to advise
Congress about all of this.

I think you’ve all received a copy of what I consider to be, it’s clearly a
draft document, and we’ll sort of talk about how we move from here but this
document is not ready for approval today but really much more a, it’s something
we should take a look at, b, we would hope that any of you who have comments
about it would provide sort of a redlined document to us with the idea that we
will compile it all together and hopefully have a final version for the March
document. And obviously Mark Rothstein needs to provide input, etc., to make
sure that it represents not only standards and security but privacy and other
pieces.

PARTICIPANT: [Inaudible.]

DR. COHN: John, thank you for doing that. Do you want to talk about it?

MR. FANNING: No. There’s the text.

MR. SCANLON: Remember, this annual report covered two calendar years, 2002
and 2003, so it will take us up through December and remember this was a very
active year for implementation so it was always, the committee always had to
give some thought to when would be the best place to sort of stop the
reporting, or should we let that phase of implementation proceed. But I think
we are going to try to end it as of the end of December, John, as the reporting
period and we will have, and I think the focus at this point, the draft you
have was circulated and we asked everyone to provide at least the updated
factual information on where everything was, what had occurred, what had
literally been done process wise and where we were in the implementation stages
of both privacy and transactions and code sets and so on.

So I think we’ve, I hope we’ve succeeded in getting the factual information
in there. We have not done an executive summary, which would go at the
beginning of the report, probably a three page, four page, executive summary,
nor have we John I think put any recommendations. I think we identified areas
of where the committee has expressed some desire to monitor but it’s sort of an
unusual year compared to previous annual reports because we’ve actually
implemented, we’ve actually begun implementing, so that’s the kind of the
spirit and the tone of the report. But I think Simon you were going to suggest
a process for —

DR. COHN: Well, the process was obviously for comments to come in and then
we’ll consider it, hopefully approve it at the next meeting. I was going to
suggest, I mean this is obviously the awkwardness of finishing at a certain
period when life goes on and what to do about well geez, there’s a National
Provider Identifier rule that has been now released, for example, and things
like this. And what we may want to do is in the cover letter at least
acknowledge what’s happened since this report was produced, which would be sort
of the end of the year, just sort of acknowledge that there is continuing to be
work and all of that.

DR. LUMPKIN: Or we could try to be seers and we can say we’re predicting
that the National Provider ID final rule will come out in the very near future.

DR. COHN: The one other point I would make about this document and
obviously it’s an issue of sort of perspective, but I do think that whatever it
is that we do needs to have as much facts on the status of implementation as
possible, and so for example Karen Trudel earlier today was talking about
percentage of compliant claims and things like this, and I think that, if we’re
talking about really tracking and just to remind all of you, in the initial
HIPAA regs in 1996 one of our responsibilities actually in the legislation is
to report annually to Congress on the status of implementation. So this isn’t
just a good idea that we sort of try to do from time to time, but this is
actually part of the legislation. So we obviously need to be serious and make
sure that this is as helpful as possible.

DR. COHN: John.

MR. HOUSTON: A specific comment, I noticed in the last section, section
Roman Numeral four, important issues, second to last, sorry, there’s a
conclusion section, I don’t think there’s really any discussion, I know you
reference Mark needing to add some input but I think that an important issue
really as it relates to privacy and some of the testimony we did take prior to
December 31, though we haven’t formulated any recommendations yet, I do think
there needs to be a placeholder in there to indicate that we recognize that
there are a variety of issues related to privacy, maybe mention those subject
areas and that in mid 2004 there will be additional recommendations. It really
is missing in that section and so I think it would be helpful to have that in
there.

DR. LUMPKIN: Mike?

DR. FITZMAURICE: One other thing that I would suggest we add is that
Congress did tell us to do a report on ASCA and the compliance plans that came
in, Steve and I did one and the committee approved it and I believe it’s up on
the website, we should probably put in a paragraph or a couple of sentences
based on the ASCA report.

DR. LUMPKIN: I agree.

DR. FITZMAURICE: They just might look for that since they told us to do it.

DR. LUMPKIN: Just in my quick read through I don’t remember seeing it, that
was a comment I had. Jeff?

MR. BLAIR: Forgive me for not having actually read the document, Marjorie
wound up pointing out some of the PMRI items, the message format standards and
the PMRI terminology recommendations to be added, but the other thought, and
maybe it’s in there, I’m not sure, John our chair, John Lumpkin our chair, made
an observation that I think it would really be important to try to capture in
the document, I’m going to phrase it slightly differently but I think it gets
at the same point, and that is that when we started to deal with the standards
that was called PMRI from the HIPAA law, which many of us began to call
clinical data standards, and then became adopted as CHI standards. And when the
Secretary adopted them and announced them he announced them within the context
of the NHII, that transformation I think has a lot of positive connotations and
I think it would be really compelling to not only include that in the document
but probably want to include that in the executive summary.

MR. SCANLON: And Jeff if you have any suggested language, I think as the
past few annual reports we’ve begun making that sort of pointing towards the
NHII as the step we were heading in and we could continue that as well, maybe
in the transmittal memo and in the executive summary.

DR. LUMPKIN: Maria?

MS. FRIEDMAN: CMS has some additional tweaks and we’ll provide them
separately.

DR. LUMPKIN: Okay. Other comments?

MR. SCANLON: Could I ask for any members, send your comments to Kathleen
Fyffe, Kathleen will be pulling the documents together, I mean the edits
together and come up with a revision, not just edits to the text but new areas,
areas of concern, where we would be looking for in the next year to monitor,
and then we’ll pull it together into hopefully a final document.

DR. COHN: And I guess what we’re hoping for is is that if you do that
relatively soon with the idea being that I’m just going to suggest this, that
the next version be circulated to the executive committee, which is basically
all the chairs of the subcommittees and John to make sure that it does
represent the various aspects of the work that we’ve been doing and then we’ll
be distributing to the full committee obviously in advance of the meeting, the
meeting in March, with the idea that we can approve it and get it on to the
Secretary.

DR. LUMPKIN: Right around the corner, March.

DR. COHN: I know, it’s almost February.

MR. HOUSTON: Do we have the latest electronic version or can we get, if not
can somebody email all of us the electronic version?

DR. COHN: I think you’ve all received the electronic version from Debbie
Jackson, that is the latest version. Obviously if you have new content just
send in your thoughts and we’ll get them all included. I’ve already redlined
mine and I think Maria has it hopefully —

DR. LUMPKIN: And if anybody wants a hard copy of it Jackie has it at the
desk. Okay, thank you.

DR. LUMPKIN: Next item on the agenda is the Population’s letter on National
Child Health Longitudinal Study. Vickie, you’re up.

Agenda Item: Population’s letter on National Child
Health Longitudinal Study – Dr. Mays

DR. MAYS: Yes, thank you. Let me talk about the genesis of this letter
since we have several new people. At our November meeting we had a presentation
from Dr. Peter Scheidt, who is the study director for the National Child Study.

The National Child Study is a longitudinal study that is being done by
three agencies but mainly housed within NIH at NICHD. So it’s a combination of
CDC, EPA, and NIH that are working together to do this longitudinal study. The
longitudinal cohort will actually look at some of the effects of environmental
and other influences on the health and development of more then 100,000
children, and they get enrolled from pre-birth to age 21 in the U.S.

This was authorized, at least the planning stage of it some time ago, so
this is not something that just happened yesterday, but this actually began
matter of fact back in the Clinton Administration, Clinton and Donna Shalala
and it has taken resources to bring to bear to actually do the planning to see
how feasible this would be. The study itself is not funded at this point, they
will have to go and get new money is the thinking for this study but for the
past 12 years or so or longer they’ve been in the feasibility stage.

So at this point if you go onto the NICHD website what you’ll see is that
there is a structure that this study is function under in which there is a
coordinating committee, hypotheses are sent to the coordinating committee,
there are I think something like 16 work groups, those work groups include
sampling, recruitment and retention, social determinants, environmental justice
and health disparities, biologic factors, chemical factors, so there are a
number of workgroups that are generating hypotheses, some are engaging in
workshop, and again all of this is at the level of feasibility.

So since this is a study of such magnitude we asked Dr. Scheidt to come in
and talk to the entire committee so that we could get a sense of the study,
where it was, and the extent to which that study overlaps with many of the
areas that this committee is concerned about in terms of advising the
Secretary.

So based on the presentation and kind of some of the work of the
subcommittee in its hearings, in which it has been given advice on how to
approach some of these issues, we decided that probably the best tack would be
to follow-up the presentation with a letter. But the letter isn’t going to the
Secretary, the letter that we want to send is actually going to the director of
the institute who is in the position of coordinating all the input, because we
thought at this point in time that’s probably the most appropriate.

So should I just proceed now and read the letter?

DR. LUMPKIN: Yes.

DR. MAYS: No questions? Okay. Duane Alexander is the director of the
National Institute of Child Health and Human Development at NIH.

Dear Dr. Alexander:

The National Committee on Vital and Health Statistics, an advisory
committee to the Secretary, Department of Health and Human Services, is charged
with advising the Secretary on broad health statistics and data issues. The
Subcommittee on Populations of NCVHS concerns itself with HHS population-based
health data issues. The committee is particularly interested in assuring that
adequately, timely, and relevant data are collected and available for use by
health planners, researchers, policy makers and communities in order to monitor
and assess health status, health behaviors, care and access to treatment in
racial and ethnic minorities and other vulnerable populations.

Should I stop there, John, or do you want me to read —

DR. LUMPKIN: Why don’t we read through and if anyone wants us to stop —

DR. MAYS: Okay, sounds fine, if I don’t see the hands, let me know.

The purpose of this letter is to commend the National Institute of Child
Health and Human Development for spearheading efforts to plan and conduct the
National Children’s Study, and to offer some important insight, it should be
insights, sorry, we have learned from representatives from racial and ethnic
minority groups about ways in which to improve health data. Our examination of
the myriad ways that federal dollars are spent on the collection of health data
as well as conclusions reached in a report of the Institute of Medicine,
Unequal Treatment, and in a workshop report on Improving Racial and
Ethnic Data on Health of the National Research Council make clear that
improvements are needed in federal data collection efforts in order to provide
adequate data for the various racial and ethnic minority groups in the United
States. This is particularly true for many of the geographic, geographically,
sorry, distinct or smaller subpopulations of racial and ethnic minority groups.

Over the past two years the Subcommittee on Populations has held a number
of hearings around the country to learn more about the status of available
health data and the accompanying statistical and methodological issues involved
in the analyses and dissemination of health data for racial and ethnic minority
populations in the United States including the territories. The subcommittee
prepared letters containing several recommendations to the Secretary that would
improve data collections methods, analytic techniques, reporting and
dissemination for racial and ethnic minority groups. The testimony from the
hearings underscored a compelling need for innovative approaches to data
collection (e.g., targeted surveys) for small groups of racial and ethnic
minorities and those who live in sparsely populated areas. The need for more
population-specific data was stressed to address disproportionate gaps in
health care outcomes within and across racial and ethnic minority groups. These
letters and other information about the subcommittee’s work can be found on the
NCVHS website at http://ncvhs.hhs.gov.

The Subcommittee on Populations invited Dr. Peter Scheidt, NCH Study
Director, to present an overview of the NCS to the full committee of NCVHS on
November 6th, 2003. The NCVHS members found the presentation to be
enlightening and were appreciative that Dr. Scheidt shared with the committee
the overview of the study. This important longitudinal cohort study will
examine the effects of environmental and other influences on the health and
development of more than 100,000 children, from pre-birth to age 21 across the
United States. It is a landmark undertaking with much complexity.

The NCH has the potential to be a rich dataset for answering questions
related to children’s health and development. The NCS stands poised to offer
populations in the United States comprehensive child health guidance,
interventions and policy directions of a magnitude that could assist the
Secretary’s agenda to reduce and eliminate health disparities in racial and
ethnic populations.

The NCS study, as shared with us by Dr. Scheidt, has a number of
substantive and methodological areas that relate to the work of NCVHS in our
advisory capacity to Secretary Thompson. These include but are not limited to
protecting participant privacy and confidentiality, the standardization of data
collection and usage of terminology, the inclusion of diverse racial and ethnic
subpopulations in adequate numbers for meaningful statistical analyses, the use
of language translations to ensure broad participation and the inclusion of
social determinants, particularly measures of socioeconomic position and the
measurement of health disparities. Guided by our hearings as well as several of
the recent IOM reports we have identified a number of issues that if addressed
early in the planning stages can enhance the recruitment and participation of
racial and ethnic minorities as well as provide data that can be used by health
planners on behalf of these subpopulations.

NCVHS recognizes that despite attention of the last decade the research
initiatives on eliminating health disparities are in early stages of
development. It is because of this early stage of development, the Secretary’s
initiatives in the area of health disparities, and the compelling data needs
for racial and ethnic subpopulations that the Subcommittee is interested in
NICHD’s leadership efforts to establish a cohort study to longitudinally assess
the health of children and their families. We are also interested in the status
of preliminary planning work done through work groups and methods for
recruitment and retention of specific racial and ethnic minority subgroups.

Health disparities have been documented in several HHS reports. Its
elimination is a HHS priority initiative and has been highlighted by Congress
in a number of pieces of legislation. The NCS is an excellent vehicle through
which much can be learned that can contribute to the reduction and elimination
of health disparities. The following points highlight recommendations that we
obtained through hearings that may be of use to you as you continue planning
for the implementation of this landmark study.

– Use a population health approach to ensure the adequate distribution of
the sample of study participants across race, ethnicity, geographic context,
and socioeconomic characteristics.

– Use a population health approach to ensure that the sample size is
sufficient for analyses of casual relationships particularly for the core
hypotheses for all subpopulations of interest.

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

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

The NCVHS Would appreciate feedback on these issues and welcomes continuing
dialogue with its Subcommittee on Populations on how these issues might be
addressed. The NCVHS remains committed to the importance of a population health
approach to improving health across the United States. We will follow the NCS
with great interest and would appreciate receiving periodic updates on the
progress of the study.

Sincerely, John R. Lumpkin

DR. LUMPKIN: Okay, we have a letter before us, it’s been moved by Vickie,
is there a second?

DR. COHN: Second.

DR. LUMPKIN: Seconded by Simon. Is there any discussion on sending this
letter forward? All those in favor signify by saying aye.

SUBCOMMITTEE: Aye.

DR. LUMPKIN: Opposed say nay.

DR. MAYS: Thank you.

DR. LUMPKIN: Thank you.

DR. MAYS: Can I do any update or are we not doing that?

DR. LUMPKIN: I don’t think we’re going to do committee updates.

DR. MAYS: Okay. Can I do one, there’s one —

DR. LUMPKIN: Now that you mention it since you weren’t here through no
fault of your own, you can give a short update because our new members don’t
really know that much about your committee and you might want to do some
recruiting. Because the other subcommittee chairs actively engaged in —

Agenda Item: Update of Population Subcommittee – Dr.
Mays

DR. MAYS: Well, let’s see what we can do then. Okay, let me just do a short
brief update and in that welcome anyone who wants to join us in some of the
ventures that we’re going to do.

One of the reasons I did want to do the update is because we want to come
to the March meeting with our report, so I guess we always say those things
that we need to have on the agenda for the March meeting. So we should come
forth with our report, which is on one of our first hearings which looks at the
issue of race and ethnicity in a lot of the federal surveys.

Also we are engaged in trying to look at this issue of mental health
statistics, particularly trying to move mental health statistics from being a
persona non grata to really ensuring that it has a place in the federal
collection of data. I mean we’re kind of at a point now where health includes
not just physical health but it also includes mental health and emotional well
being, so we want to start taking a look at this issue with the inclusion of
mental health statistics, which I think kind of follows on our early work on
cultural status anyway, so it’s a continuation of that.

Also we were able to discuss briefly and I thank Simon, even though I was
not able to be at the executive committee retreat I did read with great
interest Simon’s comments and then we talked about it when the report was
discussed for the subcommittee on what had taken place. But Simon’s comments
about for example this issue of thinking more about the capture of race and
ethnicity and how best to capture it. We were moving to I think directions of
thinking about that and the decision was that one, I will talk with Simon’s
group a little further but that we will move ahead on thinking about that and
hold some hearings on it. So I think that that will also cross a couple of the
subcommittees so we look forward to further dialogues on that.

There’s also the issue of the collection of data on race and ethnicity, we
have only begun to talk a little bit about how the mixed race data is going to
be used, what some of the issues are in terms of collapsing mixed race data, so
that is rising on our agenda also to have some further discussions on.

We also discussed the notion of identifying some of the liaisons for people
that we want to have some continuing relationship and again, this comes up from
the discussion at the executive subcommittee, so we’re going to be reaching out
and identifying some people, particularly within Census. So we had a pretty
good discussion about what is it that we need and the difference between Census
itself and some of the Census committees like the RAEIT(?), I think that’s the
way they say it, that committee. So we’re going to talk further I guess maybe
at the executive committee level about those individuals.

Letters to the health plan, those are still there and we think that if
we’re also starting to engage the health plans in discussions about capturing
issues of race and ethnicity it might do very well to send out letters and then
to tell them about our plans to hold hearings on this, so I think we may still
be somewhat timely in that information.

So that’s an abbreviated version of our work plan, our work plan is a
little bit longer. We’re a fun group, what else, we’ve met in California a
couple times. And Colorado, Philadelphia, unfortunately the next APHA is here
in Washington, D.C. so we can’t tell you that that’s going to be anyplace
different.

Thanks.

DR. LUMPKIN: Questions?

DR. BICKFORD: Carol Bickford, American Nurses Association. When you take a
look at population and address ethnic minorities and vulnerable populations are
you addressing those that are in the corrections facilities?

DR. MAYS: We haven’t done that specifically, we’ve actually been, our work
has been flowing from the OMB guidance so it hasn’t in terms of specific place
based populations gone there, it’s just been in terms of race and ethnic group.

MS. GREENBERG: One of our new members actually worked with incarcerated
populations. I’m recruiting him for you.

DR. VIGILANTE: The National Children’s Study has also thought about
incarcerated populations in terms of parents and then ultimate outcome of the
child.

MR. BLAIR: Some people consider the National Committee on Vital and Health
Statistics to be an incarcerated population.

DR. LUMPKIN: But that’s the kind of incarcerated population that like
former Representatives and Senators go to, and Governors, not the one that, the
uniform population goes to. Country club.

MR. SCANLON: I was going to say, we’re going to check to see that the doors
are locked, Jeff.

I was going to say in terms of the scope of the Populations Subcommittee
one of the emphases currently is on race ethnicity but the scope includes all
populations, any vulnerable populations, institutional populations, any
subgroups, so the current emphasis on some of the issues related to race
ethnicity is certainly not meant to preclude the coverage and the scope, all of
those areas are within the scope of the Populations Subcommittee, including
economic perspectives on populations —

DR. MAYS: We actually welcome kind of bridging out, we have this as a
particular task but with your expertise it can be a great home for you.

DR. LUMPKIN: Okay, next item on the agenda is an update on the retreat by
the executive subcommittee and then we’re going to review our meeting agendas
and then we’re going to be out of here, my guess is with discipline by 3:00.

Agenda Item: Executive Subcommittee Retreat – Dr. Lumpkin

DR. LUMPKIN: Just wanted to go over a few items, the full minutes of the
subcommittee retreat, or summary, is under tab four. I’ve already discussed
with you the fact that I think that we’ve made a lot of significant progress
and noted that, we had some discussion on that.

We started off the discussion with talking about staff for the committee
and staff support, which is very crucial. A couple things I wanted to let the
full committee know is that again, as we discussed here, that the committee
could not do its work without the active participation of department staff, but
that letters of appreciation were sent to each of the staff members at the end
of last year, and in addition as part of the results of the retreat we’ve also
sent off letters to the heads of each of their operating units to note the
accomplishments. Because we’ve heard sort of second hand in social events and
other things the fact that some of the staff have a day job with the department
and then they work in our committee and their home agency may not appreciate
the work they do with the committee the same way that we value it so we wanted
to make sure that their heads of their operating units understood how much we
appreciate their work and how vital it is and how much it makes a difference in
the work of the department as a whole.

We had some discussion about a GSA report that was done on all advisory
committees. Debbie and Jackie were the ones who really did most of the work in
submitting the report. And what we found out is that in the last year the NCVHS
made 12 sets of recommendations totaling 77 recommendations, and 71 percent of
those were at least partially implemented by the department, which is
outstanding for any sort of committee. And we kind of looked at that and said
that well, we think we’re comfortable with that level, we don’t want to be at
100 percent because that means we’re not pushing the edge enough but certainly
71 percent says that we are being heard in the way that we want to be heard and
we continue to raise issues that sometimes the department can’t respond to but
we’ll certainly think about that.

We spent a fair amount of time talking about aligning the health
information strategies with the department’s health objectives. This was on our
agenda at the prior retreat and one of the things we noted is that we’re
actually in better alignment now then we have been in the past and that was a
very positive one. The department has a set of eight goals that came out of
their strategic planning process and we believe that the work of our committees
is actually aligned with each one of those eight goals, and I’ll just read them
to you very briefly, they’re in full text.

The first one, reduce the major threats to health and well-being of
Americans, obviously we’re doing that, through Populations and NHII. Enhance
the ability of the nation’s health care system to effectively respond to
bioterrorism and other public health challenges. In a number of our work from
the subcommittees are addressing that. Increase the percentage of the nation’s
children and adults who have access to health care services and expand consumer
choices. Again, NHII, Populations, Standards and Security all address those.
Enhance the capacity and productivity of the nation’s health science research
enterprise. Work of the NHII, Standards and Security, and Privacy are
addressing that goal.

Goal number five is to improve the quality of health care services, the
Quality Workgroup is most directly effecting that. Six, to improve the economic
and social well being of individuals, families, and communities, especially
those most in need. Populations and the committees integrating perspective, the
21st Century Health Statistics recommendations, all spoke to that
one.

Goal seven, improve the stability and healthy development of our nation’s
children and youth. Work by the Populations and NHII and Privacy addressed
that. And finally goal eight, achieve excellence in management practices, and
particularly recommendation 8.5, which is concerning information technology
use, and the work that we just did on CHI is a good example of trying to
improve the efficiency of the department.

We reviewed plans, we discussed the budget, which you had an update on, and
also some follow-up on the Health Statistics for the 21st Century
Report that we had. We’re making plans for a presentation by Barbara Starfield
and Dan Friedman, both former members of the committee, plus someone from the
private sector as sort of a follow-up of that very important report. And we
favor continuing to monitor progress of the health statistics vision as a task
of the full committee rather then of a particular workgroup.

Finally, the last area that we spent a significant amount of time on was
talking about optimizing the committee’s effectiveness, well actually next to
last. One was that we agreed to have a panel at the June meeting on the current
status of the standards process and how to have an impact on that, sort of a
catch up. We’ve had some significant impact and it’s time to sort of catch our
breath as we’re rushing forward. Of course we said that before the Medicare
bill was passed and now it’s not like we have any option of looking at the
standards agenda, there are some really significant requirements have been
placed upon us by the Medicare bill and the e-prescribing.

We wanted to invite Barbara Paul to brief the committee on CMS initiative
on using data to measure quality and have a discussion about patient safety and
a briefing on the patient safety task force and the Institute of Medicine
report as some of our future activities in the coming year.

We wanted to look at some of the issues related to privacy gaps, and that
would be some of the work that we would raise as cross cutting issues. And we
also looked at some issues related to Census Bureau and Vickie touched on that
because Census Bureau obviously has an important role, for those of us who’ve
trained and gotten their training in public health, I always learned that the
definition of epidemiology is a search for a denominator, and the Census Bureau
is very important in achieving those denominators.

Finally the executive subcommittee agreed to designate Dr. Cohn as the
regulator Data Council representative since now we have the Data Council and
the CAHIT, the Counsel on Application of Health Information Technology, it was
a little bit much for me to try to be at two monthly meetings in D.C. because I
do have a day job, as the rest of us, so that designation was made.

The last area was coordination with the NCHS Board of Scientific Counselors
and as Marjorie has let the cat out of the bag we want to look at a joint
meeting with the Board of Scientific Counselors in early 2005, and one of the
issues we tossed around as maybe a potential was one that a former chair of
this committee, Judith Miller Jones raised, about e-coding and the declining
number of autopsies, and what is the impact upon the vital records systems if
they aren’t having autopsies how do we know what people died from and therefore
we’re basing a lot of our projections about how we’re going to deal with death,
significant diseases leading to death in this country.

So that’s a brief summary of our retreat and if there are other members of
the executive subcommittee who’d like to add —

MR. HUNGATE: I would like to add we did talk at some length about the
Quality Workgroup and somehow that got dropped in the summary. So I’d like, at
least in what I see here —

MS. GREENBERG: It is here on the last section, implications of the quality
agenda for NCVHS.

DR. LUMPKIN: And I skipped over that.

MR. SCANLON: — new generation quality —

DR. LUMPKIN: Well, we spent some time talking, yeah, I think actually it’s
the last whole section. And we talked about looking at risk adjusted outcomes
—

MR. HUNGATE: My document is incomplete.

DR. LUMPKIN: If I can digress, one of my most interesting moments as a
state health official was when we discovered that in translating the State
Emergency Medical Services Act in 1980 from the legislature to the then the
company that printed up the laws, they lost the last page, and included in that
last page was language that sunsetted the State Emergency Medical Services Act.
When that was discovered it was the first time that I’ve ever been responsible
for the legislature going into a special recalled session in order to enact the
State Emergency Medical Services Act, so I’m very sensitive to the fact that
sometimes very significant portions get left off in translation. My name was
mud there for a while. Jim?

MR. SCANLON: Perhaps for the new members and certainly for any of the
current members, John was referring to objectives from the HHS strategic plan
when he talked about aligning committee activities with HHS strategic
objectives so maybe we should actually share for the new members particularly a
copy of the HHS strategic plan, or I can give you the website. I’ll send
everyone the website address.

DR. LUMPKIN: Great. Okay, any other questions or additions? One other item
I just wanted to give you a brief update from the NHII Workgroup, because there
has been a somewhat significant change in our work plan and I just wanted to
make sure the committee is comfortable with that.

As you know when we issued our report in December of 2001 we had a lot of
concern about using the term NHII, in fact we titled the document Information
For Health. Since that time the NHII has gotten a lot of traction and the
workgroup has been basically monitoring the adoption of that. One of our
difficulties in developing the tasks for the workgroup is every time we decide
to work on something somebody else was already plunging ahead and so we
realized that we weren’t really setting our vision far enough into the future
as we had done with the first report. So the work group will be working towards
developing a seven to ten year perspective on the vision, what the NHII should
look like in seven to ten years, and then working on those kinds of tasks, but
to fill in some of the gaps. Some of the gaps that we’ll be looking to fill in
are the interactions between the three current dimensions, the population
health dimensions, the personal health dimension, and the provider health
dimension.

We also revisited the fact that the initial work of the committee, we had a
lot of trouble coming up with the term dimension and one of the terms that we
used were views, basically the dimensions aren’t entities, they’re actually if
the NHII is going to work it has to work for this group of individuals and they
have to have the right ability, this aspect of the National Health Information
Infrastructure.

So in addition to developing a long range perspective, a long term road
map, the committee, the workgroup will also be working to explore adding three
additional dimensions. One is a purchaser/payer dimension, the second is a
health policy dimension, and the third is the research dimension. We’re going
to be looking at developing various models, now in order to accomplish this
we’re looking towards with your approval partnering with the NHII Task Center
led by Bill Yasnoff in ASPE, Assistant Secretary for Planning and Evaluation.

And they had a conference on the NHII last year, which the Secretary spoke
at, and they’re planning another conference coming up roughly the same time,
late June, probably more like July, with the thought is is that the workgroup
will work closely with Bill Yasnoff and the NHII staff in developing the
conference to help us as part of our work plan of developing models. We also
want to look at some of the fiscal and financial models and incentives related
to implementation of the NHII, issues related to architecture and those sort of
models.

So we have had a significant change in our work plan and wanted to raise
that. Since the time we had that full day meeting there have been some other
developments which have been of interest. The Connecting for Health has evolved
and it’s going into its second phase, and they after hearing the results of our
planning session have chosen to focus in on a very short one to three year
timeframe for developing a road map. But in the interest of trying to make sure
that all of this fits together they would be very interested in sending their
work product to us for our review and comment to forward it on to the
Secretary, so that will fit somewhere into our work plan.

So that’s just really kind of a brief run down, I think it’s also important
to note that because there’s so much going on as Jim mentioned, this issue is
now raised from the department into a White House level issue, which will also
help provide some consolidated approach as other agencies that have some
commitment to this as the partners in CHI, the White House will be assuring
that there is consistent direction and approach.

So that’s sort of a brief run down and sort of the directions and lest we
hear any objections to that approach then the workgroup will be moving forward.

Agenda Item: Upcoming Meetings – Dr. Lumpkin

Okay, the next item on our agenda our upcoming meetings. Our next meeting
is March 4th and 5th, you’ve all received the agenda. We
have a couple of action items that have been postponed, or put to this meeting,
so we’ll just need to fit those in.

MS. GREENBERG: Actually we have a very full day on the 4th,
which I mean a lot, and as you said a few action items from this meeting that
have gone to the March meeting as well as Dr. Mays said that you’re trying to
bring forward the Population’s report. The main impact of that on the first day
because we tried for the benefit of the new members, anything that’s going to
be an action item, and of course this was only a one day meeting today but we
try to bring it forward on the first day so that it can get hopefully if it’s
more then a letter you will have received it in advance, any kind of report,
but we discuss it on the first day of the meeting so that members and staff can
comment and make suggestions and then the appropriate subcommittee or workgroup
can in their session deal with those comments if it’s possible and bring it
back for approval the next day.

So bringing all those, putting all those things on the first day as well as
our presentation on Health Statistics for the 21st Century and our
normal updates, will probably reduce to some degree, which in a way is kind of
a catch 22, the time for the workgroups. Actually what I think we may need to
do is reschedule this, not have the NHII workgroup that afternoon, we’ll talk
about it —

DR. LUMPKIN: I don’t think we necessarily need to —

MS. GREENBERG: We don’t have to worry about that now —

DR. COHN: The Standards and Security Committee can give up its time.

MS. GREENBERG: Oh, you are now meeting the day before, so you would give up
your time entirely? Maybe not.

DR. COHN: Give us an hour.

MS. GREENBERG: That’s right, because we had spoken about needing a few
hours. Okay, so that might work and the Subcommittee on Populations will need
some time basically to react to comments. The Workgroup on Quality if there
need to be changes in the report will still need some time as well, and of
course there’s overlap in those two so we’ll do our best.

On the second day, and we can actually extend maybe the morning of the
second day for subcommittees and workgroups, we already have a meeting of
Privacy and Confidentiality, but at this point we have not finalized our agenda
for the second day in addition to meetings of the workgroups and subcommittees
and then report back, etc.

We have talked about, and some of these have come up, having a report on
the Patient Safety Report and it’s certainly and timely in relation to the
Quality report —

DR. COHN: I guess I would especially speak to the IOM Patient Safety
Reports since I think that they actually may have some work that they have done
that may be of use actually even to our e-prescribing activities.

MS. GREENBERG: Okay, so let’s pursue that.

MR. HUNGATE: A comment from the quality point of view, I would like, there
is some coherence between the Patient Safety Report and the work of the Quality
Workgroup and putting those together would help the discussion, in fact putting
the Patient Safety presentation prior to the discussion of the report —

MS. GREENBERG: We can’t actually do that. I mean we can’t move the Patient
Safety to the first day, but before the approval of the report we would have
the Patient Safety —

MR. HUNGATE: Because one of the, in our meeting in working on the report
it’s less clear what the real next steps should be and there’s some time here
for setting our agenda, and I think it would be very helpful to have some of
that discussion at the full committee level in the context to things like the
Patient Safety Report, the ARHQ Health Quality Report, the rest of the arena.
Maybe that’s not appropriate for the full committee but it seems to me we cut
across the other committees and that therefore it would be helpful. So that’s
why I raise it as an agenda issue.

DR. COHN: Can I ask a question? And I apologize, if indeed there is an
agenda for the March meeting it’s on my email and I’ve never actually seen a
copy of it on paper.

DR. LUMPKIN: You’ve got to be in your home office more.

DR. COHN: That’s what my boss says. And I guess, and I apologize, I’m a
little confused, is the Quality report the Population Report that’s coming
forward?

MS. GREENBERG: No, no, two separate reports.

DR. COHN: This is another report. I guess I would ask then, and once again
having no idea how much time is on the agenda, that has historically been a
pretty controversial report, at least the last couple times we saw it, and is
there going to be adequate time for us to either review it prior to the meeting
or to discuss it at the meeting?

DR. LUMPKIN: Both. It will go to the executive subcommittee before it gets
released to the full members so you will have an opportunity, Simon, to see it
and to clue us in to whether or not this is toned down enough to be less
controversial.

DR. COHN: Okay.

MR. HUNGATE: But that leads to the discussion of next steps and that’s part
of what I’m trying to position. That there needs to be enough time for
articulation and thought about what the next actions are beyond what we’ve
recommended.

MS. GREENBERG: And they certainly will be, between time on the first day
where we’d already scheduled an hour, I mean we’re going to have to work with
this agenda, but then there will also be time on the second day.

MR. HUNGATE: The other comment relates to the report itself wherein we have
organized the recommendations that cross reference other interests within the
committee with the intent of asking especially if you see your subcommittee
listed by a recommendation we especially want your feedback on that in
particular. Because it will speed, I’d rather do some of that by phone even
before the meeting if we have issues that really require discussion.

DR. LUMPKIN: So that will be going out, I forget what’s —

MS. GREENBERG: — but to the executive subcommittee I believe it’s like the
17th, the 13th —

MR. HUNGATE: Now don’t have it so far in front of the meeting that you
leave it until the last minute please.

DR. LUMPKIN: So it will be going out about two weeks ahead of the meeting
or so.

MS. GREENBERG: I think with all of this and the patient safety, that will
round out the agenda.

We’ve invited members, other members of the Board of Scientific Counselors
if they’re interested to come to that first day, the morning session, on Health
Statistics for the 21st Century, so we will have some additional
attendants.

DR. LUMPKIN: Do we have anything else to talk about at future meetings?

DR. VIGILANTE: Could I just ask one question about the schedule? This
morning at the NHII Subcommittee meeting there was mention of the
18th, a meeting on the 18th, is that fit into this grand
plan or —

DR. LUMPKIN: Yes, there is a workgroup meeting on the 18th of
February —

DR. VIGILANTE: For NHII.

DR. LUMPKIN: NHII Workgroup, and that will be in D.C.

MS. GREENBERG: I think I’ve pretty much confirmed that both that meeting
and the privacy meeting will be in this meeting, I know it’s a challenge
because people are, some people are going to need to cover both. Well,
unfortunately the privacy is the 18th and 19th, and the
NHII meeting is the 18th.

DR. LUMPKIN: Which is the only day we could get in because of the
timeframes of trying to get involved in the planning of the conference. And the
new members of the full committee, our brand new members, will not have
received the notification about the date of that meeting because it only went
to the workgroup.

MS. GREENBERG: And it’s not actually on this agenda because —

I think we did send it to everybody. You may recall that we had invited Dr.
Gerberding, the director of CDC, to the March meeting. She’s not able to come
to the March meeting, we’re looking into whether she can come to the June
meeting.

DR. MAYS: She can’t send a rep to the March meeting?

MS. GREENBERG: I think our first choice —

DR. MAYS: We’re talking about our future initiatives so if we’re in the
past by the time she’s already decided the future —

MS. GREENBERG: I should mention that both John and I are going down next
week to the meeting of her advisory committee, the CDC Advisory Committee, or
the CDC Director’s Advisory Committee, in which there is going to be a
discussion of the future initiatives and I guess we’ll see after that whether
there’s something we need to bring forward to people. And that’s where that
situation is.

I was just thinking, I’ll just throw this out and it could be, doesn’t have
to be discussed but it could be discussed by the executive subcommittee and
certainly we welcome anyone’s thought on this, as we were talking we realized
that this committee, this illustrious long standing committee, the national
committee, was established in 1949, so actually 2004 is our 55th
anniversary. We had a rather ambitious actually symposium, 45th
anniversary symposium for the 45th anniversary and we also had
really an excellent symposium at the National Academy of Sciences for the
50th anniversary and the report was, actually the NHII vision and
the 21st Century Vision for Health Statistics were rolled out at
that meeting, the initial reports, then of course the history also and you have
copies of all of those.

I don’t think that given everything that’s on our plate I would recommend
anything quite that ambitious for 55 but I think we should think of doing
something to mark the 55th and one thought that I had was just
during this meeting, either for June or September, might be to have a panel
with former chairs of the committee, some of whom are still very involved in
the issues that this committee deals with, such as Dr. Detmer, I think he’ll be
back in the states by then, as well as Dr. Blankenbaker(?) and even Dr. White,
Carr White, I don’t know whether he’d be able to come up or not. But we could
have a panel at as I said either the June or September meeting and then a
dinner again such as at Magiano’s(?), which everyone seemed to enjoy very much.

So we can discuss that but that’s something I just wanted to put on the
table. Are there other items?

MR. HUNGATE: One other scheduling item, when the Workgroup on Quality
talked about meeting the afternoon before on March 3rd, and the
scheduling as proposed overlaps the Workgroup on Quality with the NHII
Workgroup —

MS. GREENBERG: We have to work this out.

MR. HUNGATE: — it causes a problem and —

MS. GREENBERG: Everything overlaps with everything at this point, but we
will try, I know there’s staff and members are impacted by that. I think we’re
going to move one of these to the next morning.

MR. HUNGATE: Well it might make sense to move the Workgroup on Quality to
the following morning because I think it has less conflict with Privacy and
Confidentiality then with NHII.

MS. GREENBERG: This is true, but if you’re going to have to work on the
report you may want an opportunity to meet.

MR. HUNGATE: I don’t think we’re going to need to do much work on the
report.

DR. LUMPKIN: I don’t think we need the full committee to negotiate this
agenda.

MS. GREENBERG: We will send a new agenda to the executive subcommittee and
I don’t think we need a conference call of the executive subcommittee before
the March meeting because it looks like we’ve got the agenda pretty well set
but we certainly will need either a conference call or even an in person
meeting before the June meeting I think.

DR. MAYS: — you just want to do it by email? Okay.

MS. GREENBERG: I think we’ll do it by email —

DR. LUMPKIN: Because we won’t be adopting, we’re just going to identify
where there may be some problems.

MS. GREENBERG: Unless there’s a need, I mean we’ll set something up, I
should mention that the agenda includes the dates for the September, for the
June meeting, June 16th and 17th, 2004, I believe we’re
still solid on that. The dates for the September and November meetings we know
we have to change but we were waiting until the new members came because there
was no point agreeing among ourselves and then several people were going off
and new people were coming on. So we will poll people, we’ll check with Dr.
Lumpkin’s schedule and then we will poll people for new dates, there will be
meetings in September and November and it might not be too early to start
thinking about 2005 dates. I think the board is, the Board of Scientific
Counselors is already thinking about 2005.

DR. LUMPKIN: Okay, John made a request that because we get sort of bits and
pieces of having some sort of consolidated calendar that’s sent out on a
regular basis might be useful. The agendas when they’re completed show up on
the website but if we had a calendar that listed the dates —

MS. GREENBERG: We actually internally maintain something like that so we
can certainly —

MR. HOUSTON: That would be real helpful, and especially when we go to these
types of meetings, like today there was an 8:00 NHII I almost missed it, that
was partially my fault but it would be nice where we do have a full committee
and we sort of know where some of the subcommittees are going to be meeting, to
put that out there just, even if there’s not a lot of detail, just so we can
make sure we’re not missing something would be real helpful.

DR. LUMPKIN: Sure. Kepa?

DR. ZUBELDIA: Bold the changes. Draft agendas, there’s just the topics that
will be discussed and the different panels, it would be very useful for those
of us who have to make a decision whether to come or not.

MS. GREENBERG: We have a new policy, it’s really an old policy but we’re
trying more then ever to enforce it, which is that agendas for all the meetings
will be posted definitely at least a month before the meeting, even if we only
have topics. We’ve tried to do that and then often staff just want to get that
last speaker confirmed before we post it, but it’s as you said, it’s very
difficult particularly for people who are not members and it’s somewhat
optional for them whether they’re going to attend or not, so we have committed
to get those agendas up, just with topics even, at least a month before even if
we don’t have the speakers. And of course you have to recognize that things
change because of speaker availability and new topics that arise and all of
that but we will definitely, we’ve already committed internally to do that.

DR. LUMPKIN: Okay. Simon.

DR. COHN: I was going to say, just hopefully not to create further
confusion but just so when you see the emails you’ll understand what they’re
all about. Obviously we’ve got meetings being rescheduled for the full
committee in September and October, whenever, last half of the year. We’re also
going to poll for additional meetings for the Subcommittee on Standards and
Security for members of the subcommittee. Obviously we have not scheduled
anything for the last half of the year, we’ll be looking at the e-prescribing
work plan to make sure that we have enough meetings scheduled. So those who are
on the subcommittee, or those who are thinking about whether they want to be on
the subcommittee, and I may or may not know who you are, please let me know so
we send them out to the right people and get these things scheduled.

And I just want to let you know, this obviously will be a separate set of
emails, this is not the same meetings that Marjorie is going to be trying to
schedule. So just so people are aware.

MS. GREENBERG: And the Subcommittee on Standards and Security has
definitely agreed to meet on March 3rd? Or is that for polling?

DR. COHN: No, this is definitely, we’re definitely meeting, I think in
terms reluctantly but yes we are meeting.

MR. HUNGATE: The Quality Workgroup was saying they would meet —

MS. GREENBERG: Also planning to meet on the afternoon of March
3rd.

MR. HUNGATE: That was the plan.

DR. LUMPKIN: Okay. Do we have any other business before us? It is now
minute before 3:00, I promised we’d get done at 3:00, so please sit quietly in
your seats until the clock strikes 3:00.

[Whereupon at 3:00 p.m. the meeting was adjourned.]