[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

February 22, 2006

Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, SW
Washington, D.C.

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

List of Participants:

  • Simon P. Cohn, M.D.
  • James Scanlon
  • Marjorie S. Greenberg
  • Jeffrey S. Blair, MBA
  • Justine M. Carr, M.D.
  • John P. Houston, J.D.
  • Stanley M. Huff, M.D.
  • Robert W. Hungate
  • Carol J. McCall, F.S.A.
  • Mark A. Rothstein, J.D.
  • Donald M. Steinwachs, Ph.D.
  • A. Russell Localio, Esq., M.A.
  • Harry Reynolds
  • William J. Scanlon, Ph.D.
  • C. Eugene Steuerle, Ph.D.
  • Paul Tang, M.D.
  • Judith Warren, Ph.D.
  • Kevin C. Vigilante, M.D.
  • Irma Elo, Ph.D.
  • Karen Trudel
  • Steve Steindel

TABLE OF CONTENTS

P R O C E E D I N G S (9:10 a.m.)

Agenda Item: Call to Order

DR. COHN: Good morning. Please be seated. I am going to call this meeting
to order. This is the first day of two days of the meeting of the National
Committee on Vital and Health Statistics. The National Committee is the public
advisory committee of the U.S. Department of Health and Human Services.

Is this on?

Good morning, everyone. I guess this one is on. I guess we got a bad mike
here. Anyway, good morning, everyone. I guess everyone can hear everyone now.

I want to call this meeting to order. This is the first day of two days of
meetings of the National Committee on Vital and Health Statistics. The National
Committee is the public advisory committee to the U.S. Department of Health and
Human Services on national health information policy.

I am Simon Cohn. I am the Associate Executive Director for Health
Information Policy for Kaiser Permanente, and chair of the committee. I want to
welcome committee members, HHS staff and others here in person. I believe we
will be having Dr. Elo arriving tomorrow, so we will welcome her at that point.
We have a new liaison from the Board of Scientific Counselors, NCHS. Hopefully
when she arrives, we will be able to welcome her.

Do you want to announce that today we will not be on the Internet, but I
believe we will be on the Internet for the remainder of the week, which
includes tomorrow’s meetings as well as the Standards and Security post
meetings, which will occur after this.

I want to remind everybody to speak clearly and into the microphone, so we
can capture everybody’s thoughts.

With that, let’s have introductions around the table and then around the
room. For those on the National Committee, I would ask if you have any
conflicts of interest related to any of the issues coming before us today,
would you so please publicly indicate during your introduction. I do want to
begin by observing that I have no conflicts of interest today.

Marjorie?

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

DR. HOUSTON: Good morning. I am John Houston. I am a member of the
committee, as well as the Subcommittee on Privacy. I am from the University of
Pittsburgh Medical Center, and I have no conflicts.

DR. WARREN: I am Judy Warren from the University of Kansas School of
Nursing, a member of the committee and a member of the Standards and Security
Subcommittee, and I have no conflicts.

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

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

MR. HUNGATE: Bob Hungate, Principal, Physician Patient Partnerships for
Health, card-carrying member of Medicate, and only conflicted to that degree.

DR. STEINWACHS: So, Bob, do you have Part D coverage? I’m Don Steinwachs,
Johns Hopkins University, member of the committee and no conflicts that I know
of.

MR. LOCALIO: Russell Localio, University of Pennsylvania School of Medicine
and a member of the committee. If I have a conflict, I’ll announce it prior to
asking any question. I don’t know of one right yet.

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

MS. MC ANDREW: Sue McAndrew, Office for Civil Rights, privacy liaison to
the committee.

DR. SCANLON: Bill Scanlon, Health Policy R&D, member of the committee,
no conflicts.

MS. MC CALL: Carol McCall, Humana, member of the committee, no conflicts.

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

DR. STEUERLE: Gene Steuerle, member of the Subcommittee on Populations, no
conflict.

DR. HUFF: Stan Huff with Intermountain Health Care and the University of
Utah in Salt Lake City, no conflicts.

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

MR. BLAIR: Jeff Blair, Director of Medical Informatics at Loveless Clinic
Foundation. Yes, that is a change.

DR. ROTHSTEIN: Mark Rothstein, University of Louisville School of Medicine,
member of the committee, no conflicts.

MR. J. SCANLON: Good morning. I am Jim Scanlon. I am the Executive Staff
Director of the full committee, and I am with the Office of Planning and
Evaluation here in HHS.

(Introductions around the room.)

DR. COHN: Welcome, everyone. I want to thank you for joining us. When I saw
the snow coming down this morning early, I realized it might be a little trying
for many people to get in here this morning, so I want to thank you for
everyone being here in a prompt fashion.

Before we do agenda review, I do want to make a couple of comments. This is
our first meeting for 2006. I think we have much to look forward to in 2006,
but I want to take a minute to reflect back on 2005 and the events of 2005 in
relationship to the National Committee.

I think 2005 as we look back on it has proved to be an interesting and
exciting year for the committee. it is a year that has witnessed a major
acceleration of activities and multiple new initiatives related to national
health information policy and movements towards the National Health Information
Infrastructure.

I think we all realize that the Katrina disaster, which was one of the
headlines of 2005, had many outcomes. It was clearly a tragedy. It did open our
eyes to the importance of improved infrastructure, including the National
Health Information Infrastructure. We will talk about learning’s from that
tragedy tomorrow. I know Jim will be leading that conversation.

In addition in 2005, Secretary Levitt’s 500-day plan was unveiled, which
included as a centerpiece the next phase of the HHS health IT strategy. What we
are seeing and participating in is an acceleration of activities and efforts to
move health care into the information age, to transform the health care system
and improve the health of all Americans. This is a vision we foresaw when we
published our document, Information for Health in 2001.

This year’s events have also included the establishment of America’s health
information community and its breakthrough groups. I am pleased that we have
NCVHS members participating on the work groups and acting as liaisons from the
NCVHS. I particularly want to note Mark Rothstein, who has participated on the
surveillance work group, and John Paul Houston, who is on the EHR work group.
Thank you for participating and serving as liaisons for that activity.

This year has also seen the strengthening of the Office of the National
Coordinator, which now has a budget, key staff in place, and infrastructure
contracts underway. As you all know, David Brailer will be joining us later
today.

The executive subcommittee including Jim and Marjorie have been working
with me on how we can best support and assist the Secretary and the Department
going forward in this new environment. As we envisioned last year, our work is
complementary to the other initiatives, and of course very much in support of
the Secretary’s 500-day plan and the President’s ten-year HIT plan.

Additionally in 2005, the initial e-prescribing rule was released with
significant input from NCVHS, and pilots will soon be starting. As 2006 begins,
NCVHS will be providing ongoing advice and guidance to HHS related to
versioning and maintenance updates and modification to this suite of standards.
I know Karen Trudel will be providing us an update on e-prescribing during the
morning’s updates and presentations.

HIPAA regulations continue to be implemented and are moving, at least in my
view, from implementation to stabilization. As 2006 begins, the committee is
actively looking into issues related to optimization of the HIPAA regulations,
and we will be talking about that a little later on this morning.

I should also note that 2006 marks the tenth anniversary of the passage of
this landmark legislation. We think we will have some celebrations as the year
progresses.

Additionally in 2005, the personal health dimension and PHR has received
greater focus and attention. Our letter and report to the Secretary was
released in September and is now being turned into a formal report. CMS
additionally released an RFI on personal health records last fall, and the RFI
responses were recently published. Again, I think Karen will be updating on
that later on today.

Also in 2005, the Population Subcommittee released its report on
eliminating health disparities, a report which is now available on the web, but
which will soon be available in paper, hopefully in the next month or so. As we
begin 2006, the committee continues to distinguish itself in work-related
privacy and confidentiality of health care information, and is augmenting
activities in relationship to quality and the NHII.

All in all, there is a lot going on related to national health information
policy. Much progress has been made, with much more to do as we move into 2006.
As I commented, it is an exciting and fast-moving time. I want to again
acknowledge all of you for your hard work and dedication to the task.

I should also mention that because of the pace of events, the Executive
Subcommittee has been considering whether to hold a full committee strategic
planning retreat later on this year so we can all talk about future activities
and work plans. This will be something we will be talking about later on today,
and we want your input on this proposal.

Agenda Item: Review of Agenda

With that, let’s move into the agenda review. This morning begins with a
Department update. Jim Scanlon, our Executive Director, will lead off, followed
by Karen Trudel from CMS and Susan McAndrews from the Office for Civil Rights.
This will be followed by a discussion of HIPAA return on investment. A letter
is in your packet, but is being withdrawn as an action item for today’s and
tomorrow’s meeting. But our co-chairs will be briefing the committee on issues
involved in preparation for a letter coming forward in June.

After the morning break, David Brailer will be joining us for an update on
the many new initiatives and contracts now underway. As I mentioned, before
lunch we will be talking more about the strategic planning retreat and getting
input from the full committee as we make final decisions about whether to do
it, as well as how to structure it. This conversation can continue based on
interest. We have provided what I would best describe as a working lunch to get
additional feedback and input from all of you as you see fit.

After lunch, Mark Rothstein will discuss the status of work underway within
the Subcommittee on Privacy and Confidentiality. A new report will hopefully
come forward in June. This will be followed up by an IOM update on a report
titled Performance Measurement: Accelerating Improvement.

After the adjournment of the plenary session at about 3 p.m., we will have
meetings of the subcommittees and work groups. Different from previous
meetings, we are staggering the work groups and subcommittee meetings so all
committee members will have the opportunity, though are clearly not required,
at least to be able to attend the various work groups and subcommittee
meetings. Thus, after 3 o’clock, the Quality Workgroup will be meeting from
three to five, the NHII Workgroup will be meeting from five to probably 5:45,
and then tomorrow morning from eight a.m. to about ten a.m., the Population
Subcommittee will be meeting. We have had the Privacy Subcommittee meeting
previous to this meeting, and Standards and Security will be meeting as post
meetings after the meetings adjourn tomorrow.

There will be dinner tonight for committee members and staff. We will take
numbers after lunch in relation to the reservations.

With that, Dr. Elo has arrived, so we want to thank you for joining us. You
are the new liaison from the Board of Scientific Counselors from the National
Center for Health Statistics, and we want to welcome you. I understand you are
a professor of sociology?

DR. ELO: Demography and sociology.

DR. COHN: From the University of Pennsylvania. I hope there is no conflict
of interest.

DR. ELO: I hope not.

DR. COHN: Another representative from the University of Pennsylvania. But
we welcome you. Thank you for joining us. We look forward to an update from you
tomorrow about the work of the Board of Scientific Counselors. Thank you.

DR. ELO: Thank you.

DR. COHN: With that, Jim, why don’t we let you lead off the updates?

Agenda Item: Update from the Department

MR. J. SCANLON: Thank you, Simon, and good morning, everyone. As Simon
indicated as we begin calendar year 2006, a number of developments have
occurred since we met in November. I am going to update you briefly on some of
the areas related to health IT policy and population health statistics as well.

Let me start with the most recent development, which is the President’s
fiscal year 2007 budget. The budget, which was sent up just a few weeks ago
earlier this month, again continues the effort to promote and accelerate
electronic health records and health information technology in health care. It
includes a budget of $169 million for health information technology, an
increase of about $58 million over the current year, 2006.

Let me tell you a little bit more about the content. $116 million of the
dollar amount is for the Office of the National Coordinator, information
technology funding. It will support strategic planning, coordination, further
analysis of technical, economic and other issues relating to adoption of health
information technology.

The AHRQ continues its initiative with about $50 million. Here, part of the
funding, $50 million at the Agency for Health Care Research and Quality, will
support continued adoption, development and diffusion of information technology
in a range of health care settings. Remember, the initial focus was on hospital
care. The new emphasis will be on ambulatory care settings as well.

Then from my own office, the Assistant Secretary for Planning and
Evaluation, we are designated for four million dollars. We are asked to take on
our traditional role of evaluation and economic analysis of electronic health
record adoption and the economic factors that promote or hinder and influence
health IT adoption in the U.S.

So again, that is the fiscal year ’07 budget. The President sent that up
earlier this month. In ’06, the current fiscal year, we are continuing on some
of these activities that we began as well.

Just a quick word about the population health area. In the President’s
budget, most of our major HHS statistical systems, the Health and Human
Services statistical systems, are being funded at current levels, which is
actually a major accomplishment, to protect and promote these core statistical
systems, because most of the budgets were — other than preparedness and
pandemic flu, most of the other areas have not received large increases. So in
a relatively restrained budget environment, protecting these core statistical
systems is actually quite a priority and an accomplishment.

The AHIC briefly, David will talk more about this later today, but as you
know, the AHIC, the American Health Information Community, has been meeting and
is meeting later in March, March 7. They have established four working groups
in the area that will report back at the March meeting. The working groups are
looking at what possibilities there are for fairly quick breakthrough
applications in several areas, and David will tell you more about that today.

More recently, within HHS and within the federal government, we have
established an interdepartmental Council on Health Information Technology. This
includes HHS agencies as well as the Defense Department, the VA, OMB, the
Office of Personnel Management and so on. Again, this is the federal
coordinating point for what breakthrough ideas might arise from the AHIC, or it
will also serve as a policy coordination point among the federal agencies for
what we may want to do on health information technology, electronic health
record adoption and so on. Part of that group is an internal HHS group, so it
will help HHS get our own policy coordination in order as well.

Again, on the population statistics side just briefly, there are a couple
of areas. I will update you on where the Data Council is with some areas that
it has established previously, but there is also, as I will talk tomorrow, some
focus on the data and capabilities needed to support emergency preparedness,
pandemic planning, what did we learn from the Katrina response, the Rita
response and so on in these areas that we could do better in terms of health
information technology, and data and statistics as well to support decision
making and response.

A couple of updates from OMB. OMB has issued — again, this is on the
population statistics side — guidance for statistical surveys, which is an
update of previous guidance. It is also updating some of its statistical policy
standards. We will be having a database of this at our Data Council meeting in
February.

This is basically best practices for conducting federal surveys and
statistical activities, things to consider, how to contract, response rates to
look for, certain design features to look for, so it is basically a best
practices document.

For those on the public health side, OMB has also issued a draft bulletin
that sets out standards and best practices for risk assessments. A number of
risk assessments are done in the environmental area, in the public health area,
climate change and so on. This is a draft. Agencies are being asked to look at
this and comment on it.

OMB has also asked the National Academy of Sciences to conduct a review, to
establish a small panel and conduct a review of the draft, and HHS is among the
several agencies that will be funding that activity at the National Academy of
Sciences.

As I indicated at our last meeting, our Data Council has initiated a study
of statistical standards, standards in our major data collection systems and
statistical systems. I can brief the committee in more detail on this later,
but the focus is on the content and code set standards as well as statistical
standards. We are looking at first of all what is already available in terms of
standards, what is being used in our major statistical systems. This would
include not only the population-based surveys, the health interview surveys,
for example, but the provider-based surveys and facility-based surveys as well,
to what extent are we using standard classifications that have already been
adopted for other purposes, and then we are looking for opportunities for
integration or for what would be the payoff and what would be the pathway to
including these standards down the orad in the surveys.

We are also considering, and this is an area I know the committee has been
interested in and I think we just need final approval to begin this project,
both the National Center for Health Statistics and others have asked us to
begin looking at the potential of electronic health records for linkage and for
utility in some of our surveys.

We have always had a policy and a practice of being able to link health
care use data and other administrative data with our surveys when it was
justified and under the right conditions, analytic purposes, for example, links
with the Medicare data and Medicaid data, social security data and so on. This
is done for statistical purposes and for policy research and evaluation. These
are not administrative data sets.

But at any rate, we will be — several agencies have asked, could we begin
to look at probably through a workshop which the committee will be able to help
us with. Really, we have to look at this in a fairly tough-minded way, not what
might be available 20 years from now, but what is actually available now, how
realistic is such a strategy, and what would be the pathway again to get there.

I know the committee has started this. I know you have looked at secondary
uses of electronic health records, but we will be looking at it in a more
formal way, and we will be asking the committee to help in terms of an expert
workshop and panel and so on.

One more thing. In January we added at the request of the Secretary in our
Minority Health office, we developed and added a web portal on minority data,
race and ethnicity data, to our HHS website. This is part of the Data Council’s
statistics gateway. This is basically an entry to all of our agency statistics
on the web.

This was announced at a Minority Health summit back in January, but what we
did was just make it easier to access all of the race and ethnicity data that
HHS has on the various agencies’ websites. So it is a separate, Google-like,
not quite at the standard of Google, but simplified, so you can search for
specific groups, or you can use terminologies as well. We will be expanding
that. I would regard it now as a kind of a test, so any advice you have about
making it better, we would welcome.

The Data Council is looking at continuing efforts in four areas, and we
have added a fifth. This again is mostly on population-based data. We are
looking at what is the adequacy of the data in these areas and what are
improvements that we could make, again given the budget climate, which is
fairly restrained.

The first area is improving prescription drug use and expenditure data; I
told you about that previously, a couple of projects underway. Health insurance
data, this was a project that we started under our previous ASPE, Mike O’Grady.
We are looking at the adequacy of health insurance coverage data in our major
surveys, what accounts for the differences in the surveys, what accounts for
the variations in the estimates and so on, and can we understand those better,
and which data are more appropriate for various uses.

We are looking at state data on health policy, access to care utilization
and health insurance. That is probably the least far along, I would say. And we
are looking at the income and asset and related data that is collected in our
major federal surveys as they relate to Health and Human Services policy. We
don’t make separate income estimates here in HHS, but we do use it as a
variable to understand Health and Human Services issues.

Of course, there are efforts to improve race and ethnicity data. The portal
was one of those. Now we have added a look at what can we do to improve data
for public health emergency preparedness for measuring readiness, for measuring
emergency preparedness in health care facilities and so on. That is at a fairly
early stage, but we have had a couple of Data Council meetings where we looked
at what did we learn in the data area, and what are ways of moving forward.

I’ll stop there.

DR. COHN: We will hold questions for the moment. I want to welcome an
honored guest, Winston Wilkenson. I am going to ask Susan to do a formal
introduction for you, but I understand you are the new Director of Civil Rights
for the Department. We are very pleased to have you join us today.

MR. WILKINSON: Thank you.

DR. COHN: As you probably know, the National Committee is the principal
advisory committee to HHS on national health information policy, including
privacy and confidentiality of health care information. We have had a long and
very close relationship with the Office for Civil Rights around the
implementation of the privacy rule, HIPAA. So we look forward to an ongoing
close and collaborative relationship in that regard.

MR. WILKINSON: I look forward to working with you. Thank you.

DR. COHN: Susan, do you want to —

MS. MC ANDREW: I just wanted to give Winston an opportunity to come and
meet with you. In December, Rick Campenelli left OCR to go full time into his
job as counselor to the Secretary for Human Services. He had been dual tracking
as director of OCR and as counselor for most of ’05, and it was a tall order
which he handled very well, but eventually decided to go full time as
counselor.

At the same time, he made sure that OCR was well taken care of, and Winston
joined us. This is actually his second tour of duty with OCR. He was a deputy
director of the Office for Civil Rights back in 1988. He left Foggy Bottom here
to go out to the clean air and snow slopes of Utah. Not exactly sure what lured
him back, but we did have a little flurry of snow on the way in today, so maybe
it will make him feel at home. But I did want to introduce you all to Winston
and just have him say a few words to you, because I know that we will be
working with you as he assumes the leadership of OCR. This will be a very
important component of our work.

MR. WILKINSON: I am delighted to be here this morning. I have been on the
Board about a month, month and a half, so the information curve is huge. I am
learning a lot. I look forward to learning more about this group and working
with you in the future. I hope no questions.

DR. COHN: No questions. I don’t know if it is fair to have anybody ask any
questions this early in your tenure. We are delighted to have you take the
helm, and we look forward to a close and collaborative relationship. Hopefully
you will soon learn, we do have a Privacy and Confidentiality Subcommittee that
has been very active in terms of overseeing and providing advice and guidance
on all the HIPAA work, of course recognizing that HIPAA is just one step in
relationship to privacy and confidentiality of health care information.

I guess I would ask, do any members of the subcommittee have any questions
of the committee?

MR. WILKINSON: I am going to be in and out this morning. I have kind of a
busy schedule, so if you see me going in and out, forgive me.

MS. MC ANDREW: And Mark Rothstein is the chair of the Privacy and
Confidentiality Subcommittee. You spent some time with Mark yesterday.

DR. ROTHSTEIN: Yes, so we look forward to working with you. Welcome.

MR. WILKINSON: Thank you.

MS. MC ANDREW: Should I go ahead and do the rest?

DR. COHN: Did you have anything more?

MR. J. SCANLON: No.

DR. COHN: We will just do the questions all at the end. Russ, did you have
a question?

MR. LOCALIO: I’ll wait until the end.

DR. COHN: Well, if it is for Winston, you probably ought to ask it now. No,
you’ll wait, okay. Susan, why don’t you proceed?

MS. MC ANDREW: Just two brief items. One to update you on the status of the
complaint system for HIPAA. We have as of the end of January received 17,656
complaints. Our closure rate is up to 71 percent.

We have worked a bit to refine the types of entities against whom
complaints are filed. The top five continue to be private health care practices
and general hospitals as the top two. That has not changed. We have combined
several of the outpatient facility groups that were in our system into one
grouping, so now outpatient facilities are the third most frequently complained
against group.

We have also combined the various types of health plans from health
insurance issuers and group health plans into one category. So health plans are
the fourth most complained against entity. Pharmacies happily have fallen into
fifth place. I’m sure that their drugstores are very happy now.

We are continuing to work on getting more finite information out of our
data reporting system. There is a lot of data in there now, with 17,000
complaints. We want to make sure that we get the most information we can out of
that system.

The types of issues, that hasn’t changed. Impermissible uses and
disclosures get the most complaints. Inadequate safeguards is the second most
complained about group. Refusal or failure of the individual to access their
records, to be able to access their records, is in third place. The minimum
necessary standard and problems with defining that is the fourth area. Finally,
the need for authorizations or the failure to have them when required to do so
is the basis of the fifth area of complaint.

We have 285 referrals to the Department of Justice, and still no further
information from the Department of Justice on the second HIPAA prosecution that
was underway in Texas. They haven’t done much since filing the complaint.

On the regulatory front, last week we issued in the Federal Register the
final enforcement rule. This is a joint rule with CMS. It will cover
enforcement procedures from the initiation of the complaint through the notice
of determination for civil monetary penalty through the appeals process. So it
finalizes all of that complaint processing and determination of when there is a
CMP and what the appeal rights of entities are who have been issued a CMP. We
have not issued our first CMP, so we haven’t tested the waters yet.

The enforcement rule will become effective on March 16, and it will replace
the interim final procedural enforcement process that is there. It also
updates, makes minor changes in the OCR complaints rules, which have been in
the privacy rule since 2000, and broadens those complaint processes so that
they cover both the privacy rule and all the other regulations that are part of
HIPAA that are enforced by CMS, the security rule and the transactions and code
sets as well as the identifiers.

So that is the end of a long process, and we are very happy to have that
suite of rules now totally in place. I think those are the major privacy
events. I will turn the floor back over to Simon.

DR. COHN: Thank you. Do you want to go, or should we take questions for a
couple of minutes? Do you have a preference on that?

MS. TRUDEL: Let me just add a little bit to what Sue just said about the
enforcement rule. We hadn’t either of us prepared a lengthy presentation on
what is in it. We will just open that to the group, if either the full
committee or any of the subcommittees would be interested in having a deeper
presentation on what the enforcement process now looks like, the different
levels of appeals, how we count violations, how we determine the amount of a
penalty, we can try to work that into the committee’s future schedule.

DR. COHN: I think everybody is nodding their head on that.

MS. TRUDEL: Okay, we’ll take care of that jointly. I just want to report on
a number of things. Actually, Simon, you added a few to my to-do list.

DR. COHN: My apologies.

MS. TRUDEL: No. Let me start talking about e-prescribing. I think everyone
is aware that the four pilots have been awarded, and they are moving forward.
The groups will be making presentations on how their individual programs are
going to work. Each of the grantees will be doing presentations for the
Subcommittee on Standards and Security at the Friday session.

We again acknowledge the significant assistance that we have gotten from
our colleagues at AHRQ, particularly Dr. John White. He has been absolutely
wonderful in getting these pilots up and running. In fact, AHRQ is providing
the substructure and processes around which the grantees can get together
periodically, talk about best practices, compare notes, make sure that everyone
is on the same page. That first discussion has already taken place, facilitated
by AHRQ.

The next thing I wanted to discuss was the personal health record, request
for information. As you mentioned, Simon, we did publish a compilation of the
responses we got from industry to the request for information.

Again, to refresh your memories, what we were asking the industry to tell
us is what they thought CMS’ role should be in encouraging, facilitating the
standing up and use of personal health records. One of the overarching themes
that I would say jumped out at us, which was not at all surprising to me, was
that they wanted us not to build a Medicare stovepipe. They didn’t want us to
build a PHR that only had Medicare beneficiaries’ data in it, that only had
Medicare data in it, that had different standards and different requirements
than would be available for the industry as a whole.

We have taken that to heart. Some of the particular comments that we
received were that CMS should facilitate and contribute data to PHRs, that we
should do that obviously at the patient’s authorization, and we should be
mindful of privacy and security concerns with respect to any vendors to which
we are providing data. They also suggested that we should not establish our own
certification criteria for PHR software or vendors, that we should not
establish our own standards for PHR content, vocabulary, messaging, et cetera.
Instead, they very strongly suggested that CMS bring its voice to the table in
the standard bodies and the certification processes that are already underway,
that are trying to get their arms around this.

It also suggested that CMS had a very strong role to play in terms of
education, and that we should use the communication mechanisms that we already
have with Medicare beneficiaries and with partners who communicate with
Medicare beneficiaries to make sure that we help to convey the benefits of
using and having a personal health record, and what that can do to the changes
in outcomes and quality of care for patients.

So essentially, that summary is available on our website. Our next step is
to develop an action plan that will help us to step forward and begin to
implement that vision. That is still under internal review, but we expect to
have that posted on our website probably within the next month or so.

So we are indeed moving forward, and are working very, very closely with
the consumer empowerment group of the AHIC to make sure that whatever we do is
in concert with the way both the Department and the industry are moving.

Let me turn to the national provider identifier. First, some enumeration
statistics. As of last week, I think we have enumerated almost 330,000
providers. About 280,000 of those are individuals, the rest, roughly 50,000,
are organizations. So we are continuing to make progress in that area.

The paper that describes how Medicare is going to enumerate subparts of
organizational providers, which is something that was of a great deal of
interest to the health care community, was posted on our website early this
month. Information on EFI, which is basically the bulk enumeration of
providers, the first round of information of that has already been published on
our website. We expect to have more specifics very shortly, and to start doing
this electronic file interchange bulk enumeration late in this spring.

The data dissemination Federal Register notice is the one thing that we
have not published at this point. It is targeted for publication of March or
April.

The claim attachment rule, update on that. The comment period closed on
January 23. We received 111 comments, which does not seem like much, but some
of them were quite voluminous and extremely technical. We are working as usual
with the standards developing organizations to help us with the technical
issues that specifically relate to the standards. That is somewhat complicated
by the fact that we had to tease out which ones go to HL-7 and which hones in
to X-12. We are nearing the completion of that process, so we should be able to
fan out the comments to the appropriate organizations. While we are waiting for
their feedback, we will then look at the comments that are related to more
policy issues, broader issues.

Let me talk a little bit about the actual Medicare implementation of
statistics, which I usually do a report on for the remittance advice, which is
the 835 transaction. We now have 96 percent of the receivers in production in
HIPAA compliant format. We are at the point now where we are beginning to think
about lifting the contingency, and as we did with the claim transaction, before
we get to that point we are doing some fact finding to figure out who are the
people who are not compliant, why are they still not in production, what can we
do about it, how would cutting off the contingency influence them, and what
should the timing be.

So that process of fact finding is underway. We will have to look at that
before we make a decision of at what point we do lift the contingency.

With respect to the coordination of benefits transaction, the 837 outbound,
we are moving receivers from our legacy systems onto the new coordination of
benefits contractor for Medicare. That contractor’s processes are HIPAA
compliant. We have 569 receivers that we still have not moved. We have moved
about 20 over in the last month, so that is a process that we are chipping away
at.

MR. BLAIR: Could you clarify receivers?

MS. TRUDEL: Receivers, these are insurance companies who are receiving
HIPAA compliant coordination of benefits transactions. They may be private
insurance companies, they may be state Medicaid plans.

The number of non-HIPAA compliant transaction claims that we are rejecting
is on average holding steady at between 1,000 and 2,000 a week. It has been as
high as 9,000, it has been as low as 300, but we aren’t seeing any disturbing
increases in that respect. The number that I think we are the most proud of is
that the number of eligibility queries and responses that we have been able to
respond to in real time last week topped a million. So from my perspective,
that is really significant, that that is what HIPAA is all about.

These are pieces of information that either providers didn’t have at all,
or that they had to have somebody calling on the phone and waiting to hear a
verbal response for. So I think this is an indication that people really do
understand what is going on here and what is available to them, and are making
use of it. We are very proud of that.

I think that is all I have to report. Thank you.

DR. COHN: Karen, thank you, great progress. We appreciate it. Time for
questions and discussions.

MR. BLAIR: Congratulations, Karen. With these achievements, this may be too
early, but as I am listening to the fact that so many of the HIPAA transactions
are now being implemented, are we getting close to a point where we can have
some measure of the return on our investment from the CMS standpoint and the
benefits we are getting from this evolution to health information technology?

MS. TRUDEL: I think that we can respond in terms of the numbers, how phone
inquiries are going down from providers with respect to eligibility queries.
There are a few very measurable pieces of data.

I think a lot of the return on investment that is a little bit less easy to
quantify is the effectiveness and efficiency, process efficiency measures that
are happening at the provider sites. I don’t have any insight into that right
now, but I think that is where we need to go to measure where the true return
on investment is.

MR. BLAIR: I would agree with you. However, if it is simply a matter of
maybe looking at the volume and the number of claims or eligibility inquiries
between this year when we have been automated versus previously, it is just a
matter of harvesting the cost of handling that volume. Maybe it is low-hanging
fruit, where we could show some real return on investment. Is there anything in
the works during the next three, six, nine months, even at a general level? I’m
just trying to measure that.

While I totally agree with you that we want to look at the larger ROI from
the private sector, if these numbers are not that hard to get within CMS, at
least we could show that we are getting ROI at the federal government level.

MS. TRUDEL: I think we would be happy to collect any data that you are
interested in. I’m not sure that it tells the whole story. I think we know
obviously how many transactions we are processing. I don’t think that it can be
said that every transaction that we process means one fewer phone call. I’m not
sure that every time a provider submitted a claim without having the
eligibility information, that there was a negative impact to that.

So I think there are some connections that aren’t quite clear in my mind,
but if there are additional discussions that are going to occur in the
subcommittee, I know Maria can help facilitate bringing that information back
to us, and we would be glad to gather any information that we can.

DR. TANG: I have a question for Susan. On the HIPAA complaints, you said
there were 17,000 and 71 percent have been closed. When they are closed, are
you finding that the complaint is generally justified, and it is a question of
those top four categories? Do the complaints pan out? When you say closed, then
the provider agrees for example to make some sort of change?

MS. MC ANDREW: There is still a variety of reasons for closure, including
some that are closed without investigation because they turned out to be
non-jurisdictional, or the complaint itself did not state an activity that
would if proven be a violation of the privacy rule. So we still have a fair
number of non-jurisdictional or administrative type closures.

The other closures however where there has been an investigation are closed
because the entity has taken some corrective action to make sure that if it is
a matter of access that the individual had access, if that showed a systemic
problem, that they have changed their policies and procedures to make sure that
everyone knows what the access rules are. So it can be either an individual
type corrective action or a systemic corrective action.

We are attempting to quantify this coming year the number of closures that
do result in some policy change or some more systemic change. So we will have a
better handle on how many of the complaints actually do result in broader
improvements.

DR. TANG: So how are we using these statistics? For example, are we looking
for a decrease in the complaints as a measure of success? Or if the rate of
complaints stays the same, do we contemplate increasing the education or
finding some way to improve upon the situation?

MS. MC ANDREW: I think that first of all, we are looking at the complaints
and the individual opportunities for education and corrective action and
technical assistance to the provider and the plan communities.

I don’t know that you can directly measure success off of the numbers. I
think we are interested in our closure rates largely to know that we have
gotten into that complaint and have seen what it is about, and have made sure
that the outcome is correct. So that is what we are looking for in terms of the
closure rates.

DR. TANG: So I guess in your announcement of the ten-year anniversary of
HIPAA, I wonder if there is some way that we need to think about, is the state
of information privacy better off ten years from now. If we can’t use these
quantitative measures, is there a survey we can use? I have a sense as a
practitioner, but it seems like we do want to know what the impact is, and if
it is either unchanged or worse, we want to be able to address that.

DR. COHN: I see you are looking at me as you say that. I would charge the
privacy and confidentiality work group to begin to think about that. I think
you are asking exactly the right question.

Mark, I think you have a question?

DR. ROTHSTEIN: I want to first answer Paul’s observation and then get to my
question.

DR. COHN: He was probably looking at you and not me.

DR. ROTHSTEIN: I think the answer is more complicated than just looking at
HIPAA data. I am often asked what has HIPAA accomplished. I think it is very
difficult to measure that, because I think many of the benefits of HIPAA are
outside of the enforcement or regulatory process.

I think the biggest benefit of HIPAA is, it has changed the ethic of both
providers and patients. They appreciate the importance of privacy more. It
would take a lot of research to find out whether there has been a decrease in
elevator talk, and there has been a decrease in waiting room consultations and
so on. But I do think that what was often just an abstract ethical principle
has now been brought to the fore, both for providers and for patients. So how
to measure that is kind of difficult.

My question for Sue picks up on Paul’s, and it is a two-part question. Many
of the complaints in the old days, two years ago, were found to be facially
defective because they alleged unlawful conduct by non-covered entities or
clearly demonstrated a misunderstanding of the parameters of the privacy rule.
So my question is, have you over time been able to track whether that figure of
facially invalid complaints has been declining, as one would expect, as people
become more familiar with the privacy rule?

Related to that is the second question, and that is, how are you using that
information as part of a feedback loop, not for necessarily individual
providers or covered entities, but in terms of general outreach and education?
So for the defective complaints, how does this indicate what we need to do in
terms of public education? And for the ones where after investigation there is
some merit, how does that influence the outreach and education that is directed
toward covered entities?

MS. MC ANDREW: Other than observing that the rate of closures for
jurisdictional cases, investigated cases, has increased, we haven’t — it would
be an interesting run that we can try to do off the data to see how that
correlates with new complaints. We can see the trend going in that direction.
Some of that however is finally investigating cases that we have had in our
inventory for the last year.

So it would be an interesting data run and something that we can look into,
to see how that breakout is going over time for new incoming cases.

On the other question, in terms of having found how we are using the data
to guide outreach and education activities, that is something that we have had
a couple of conversations with John, about the data. Right now, the types of
programmatic data that we can get out of our system isn’t that good for making
those kinds of decisions. So we are working with our data people to see if we
can do better programmatic type searches and compilations and aggregations to
get that kind of outreach guidance.

Right now, the system was built and operates very well in terms of managing
the claims process and looking at administrative back door kinds of functions
and comparing our regions and making sure all of that flow is there. But in
terms of generating good data for programmatic decisions, the system is a
little less successful about that. So we need some retooling.

DR. STEINWACHS: I was just wondering, you mentioned that there were
continuing complaints about lack of access to medical records. I was wondering
if you could characterize in any way what the kinds of problems are, whether it
is the fact that someone will not let you have your record, or the cost or
other factors make it difficult or prohibitive in some way.

MS. MC ANDREW: It s all aspects of our access requirements. Most of it I
would say is that the individual feels that they have made a request to see
their records or to get a copy of their records, and the entity has not
responded, or has denied them access for impermissible reasons. We still
occasionally get the complaint that a copy of the records was denied by the
provider because the individual hadn’t paid.

DR. STEINWACHS: Paid for the service or paid for the record?

MS. MC ANDREW: Paid for the service. We have —

DR. STEINWACHS: I’m trying to figure out how to populate my PHR, you see.

MS. MC ANDREW: We have had some complaints more recently that go to the
reasonableness of the fee that is being charged for the copy, and some
complaints that they can’t afford the $50 charge.

MS. MC CALL: The $50 charge for?

MS. MC ANDREW: The copy of the record.

MS. MC CALL: Wow.

DR. STEINWACHS: Carol is thinking of a new market here.

DR. COHN: I guess I should ask, Susan, is this for copying costs?

MS. MC ANDREW: Yes. There are still disputes in terms of whether — the
rule only allows the provider to charge copying costs. So there are a variety
of processes, including per page fees or other types of fee arrangements which
can result from the individual’s perspective in unreasonable charges. There is
also a continuing problem in terms of some friction between the privacy rule’s
copying only cost requirement and some state fee structures, which allow for
other types of basic charges, and then a separable copying fee, ten dollars in
research and retrieval, those kinds of issues.

DR. STEINWACHS: So just to understand, a basic charge might be to charge
something to retrieve the record or something like that, and then you on top of
that load copying charges for each of the pages.

MS. MC ANDREW: Right, and the privacy rule would say that that search and
retrieval and refiling charge is not allowed.

DR. STEINWACHS: Not allowed, okay.

MS. MC ANDREW: It is not allowed. It is only the copying. But that still
may be embedded in some carryover from pre-privacy rule state practices.

DR. CARR: I would like to go back to what Mark was saying in terms of
appreciating the impact on confidentiality for the patients. It occurs to me
that JCHO has very specific measures when they look at acute care facilities
about whether confidentiality is being provided in terms of areas to speak and
records and so on. I just wonder if there isn’t any trended data from early
when they introduced these measures to performance today which might give us
some sense of compliance within hospitals.

DR. COHN: Anything more?

DR. CARR: No, but I appreciate Mark’s point very much, that that is a huge
impact, and that is a cultural change, and it is palpably different in patient
care settings. We haven’t thought about it in a quantifiable way, but I do
think JCHO compliance might actually tell a story.

DR. HOUSTON: Not my main question, but I still wanted to ask a question
regarding the copying fees and the like. I think I heard you say HIPAA does not
allow providers to charge for somebody to be able to access their medical
record.

MS. MC ANDREW: For just the inspection of the record, no.

DR. HOUSTON: Right. If a covered entity decides it wants to — that the
most convenient way for it to provide access would be through copying the
record, that would still preclude them from charging the patient. Am I hearing
there are covered entities that are using the need to retrieve and copy as the
basis for providing access? Or am I misunderstanding this?

MS. MC ANDREW: No, I think it is just that it is not atypical for providers
to have been operating under a state fee structure, state law fee structure,
that included administrative activities, including retrieving the file,
selecting out the portions that needed to be accessed by the individual, and
refiling the material. They had in the past been allowed under state law to
charge for those retrieval services, as well as charging for copying. Under
some fee structures, those may actually be bundled charges, others break them
out separately.

DR. HOUSTON: So there could be a possibility that a patient could ask
simply to access the record for the purpose of the review under HIPAA and still
end up having a charge. Is that fair to infer from what you just said?

MS. MC ANDREW: Right, and should we get a complaint like that, we would
look at the provider’s fee structure and determine whether or not they are
operating under a fee structure that includes impermissible charges.

DR. HOUSTON: So you are saying OCR’s position is that they would not be
permitted to charge?

MS. MC ANDREW: They would not be permitted to charge for anything other
than costs related to copying.

DR. HOUSTON: Even if the copying was their mechanism for providing access?
I know a lot of providers are unwilling to provider the original record to the
patient, for fear that the patient could destroy, damage, mark up the original
record.

PARTICIPANT: I’m hearing that they can.

DR. HOUSTON: They what?

PARTICIPANT: That they can in fact charge if access ends up being defined
in their eyes as, I’ve got to make a copy. Then they would end up being able to
charge.

DR. HOUSTON: It is the provider’s convenience to make a copy versus
providing the original.

MS. MC ANDREW: The fee structure goes, if the individual has asked to
obtain a copy.

DR. HOUSTON: So if the provider simply provides a copy as its way of
providing access, they could not charge?

MS. MC ANDREW: No. If you have decided, either I can’t let this individual
have the original, or sit in a room with the original unsupervised, so I am
going to make a copy and let them sit in the room and doodle on the copy, then
that is not a copying charge.

DR. HOUSTON: I have another question.

DR. COHN: That was your warmup.

DR. HOUSTON: With the announcement of the final enforcement rule, as well
as the fact that it has been a number of years since the privacy rule has —
the compliance period has passed, is OCR going to change its enforcement tone
or the tone of the way it is enforcing the rule? Is there any plans to become
more aggressive about the way it is enforced? I know a lot of it is intended to
be a collaborative effort with the provider, and where there is an issue to
work with the provider in good faith, as trying to address any issues. It
becomes a closed issue as long as that collaboration seems to occur. Is there
any change, or any thoughts of OCR on changing the tone of the way it is going
to enforce?

MS. MC ANDREW: I think at the present, we do not intend to change our
enforcement priorities. We will continue to engage in voluntary compliance with
the provider. I think that has proven to be a very efficient way of getting
problems corrected. We are still getting good cooperation from plans and
providers about the individual complaints.

We are looking at the enforcement rule as having the apparatus there now
firmly in place. Should we need to use the civil monetary penalty authority as
a way of getting compliance, but I don’t think we intend to — now that that
rule is in place, to alter our priorities and decide, now we are going to be
bad cop. I think we are very serious and we give a lot of attention to our
complaints and take very seriously our enforcement activities. I think we just
feel that voluntary compliance is the most effective way of making sure that
the privacy rule gets embedded as a part of everyday practice, and that we
continue to move the cultural shift over. I think that voluntary compliance
does that a lot better than the fear factor.

MR. LOCALIO: Jim, you mentioned among other things that HHS is going to
look at the potential of linkage of surveys with electronic health record data,
and there is going to be a workshop as a tough-minded way of looking at the
problem. Is that — ?

MR. J. SCANLON: Yes.

MR. LOCALIO: So my question is first of all, are you going to look at the
issue of linkage or on the adequacy of the health record as a substitute or
supplement for survey information? Will the workshop have a formal or informal
participation with NCVHS? Is there going to be a report to NCVHS? Will this
involve registry data, Vista, Veterans Administration, Medicare Part D or
electronic prescribing?

MR. J. SCANLON: Et cetera, yes. I might take the Fifth Amendment on that.
No, actually this is a proposal of several of our agencies. This is anonymized
data for the most part. This is for policy research and evaluation. This is
four our statistical systems.

I think the concept is that — and there is a history to this. I remember
when HIPAA was passed all those ten years ago, everyone thought we wouldn’t
have to do surveys anymore, because this was such a wonderful — and everyone
knows it takes ten years to get claims data to the point where — not anymore,
but it took vital statistics probably 50 years to get to the point where you
could actually reach the quality and standardization that you could use it.
HIPAA, it didn’t take so long.

But at any rate, we want to have a group of folks to understand what the
needs are, who understand capabilities. We are looking at to what extent our
provider-based surveys could use this information. I think down the road we
would look at to what extent our population-based surveys, if there were
records to link to, this could serve as a resource as well.

In terms of the design of the workshop, it is just a concept at this stage.
I think what we would do, I have to get approval for funding, is really what I
am trying to say, which I should get shortly, and when I do, the plan is to
have the NCVHS help us plan who should be there and what the content would be.
Whether there is a report or not, I’m not sure, but I think we are trying to
get people to start thinking about this, and basically look at it in a
sophisticated way, based on real capabilities and real needs, not cheerleading
and not what people think they have, and not virtual capabilities; real
capabilities, and what is the time line, what can you realistically expect.

We need to do this, anyway. We have always had as a strategy in our surveys
and statistical activities, for example, that we would augment or link our
survey population-based data with records, administrative data and other
things, anonymized for analysis when it was necessary to do so. Otherwise, you
spend a lot of money and a lot of effort trying to do separate surveys, and
they don’t really work out well.

So we have long had that as a standard element of our data policy, our
statistical policy. This is the logical next step. We moved into claims data,
we moved into other administrative data, and now to the extent that electronic
health records will be at the point where they can provide on a large scale
high quality standardized accurate data to supplement what might be needed in
surveys, I think we would. It may be quite down the road, but at least our
agencies want to start taking a look at it.

DR. COHN: Jim, I think it is an important question, and I thank you for
bringing it up, to a point where it is not finalized for certain.

We have two other questions, and then we have to turn to the next topic. I
saw other hands up here, but there will be lots of conversation with Jim
Scanlon between now and tomorrow at adjournment. The next one is Gene, and then
Paul, you have the last question, and then we will move to the next topic.

DR. STEUERLE: I am going to speak a little bit without a license here,
because this is not my field at all, privacy. I get the feeling at the National
Committee on Vital and Health Statistics at times where we are fairly narrowly
focused on the privacy and confidentiality issues and how they might be
affecting the population if we went to vital and health statistics. So we focus
in narrowly. We have always picked a little on Susan and said, you’ve got a
little bit of HIPAA data, and John, Paul and I a few times have said, can you
give it to us this way or slice it this way.

But rather than go into that part of the subject, it seems to me there is
this broader issue. I feel like I don’t — as an economist at least, I don’t
feel like I have a story on whether the privacy and confidentiality issues are
net a plus or a minus for society. We have HIPAA, it looks like maybe it has
created a better culture, that is a plus. But I’m sure I hear at least
anecdotal stories from providers that there is a real cost to what is going on.
I don’t even have a survey of providers that is telling me what are some of
these costs, what do they think it is.

Now, mind you, what I am thinking about in trying to put something
together, when you think about doing a cost-benefit analysis on an
environmental issue, there is really no way to get a full bottom line
quantitative measure, but it doesn’t mean you don’t still go out and try to
gather the information, even if qualitative, or other little debates that maybe
don’t even belong in this committee.

I understand there is still this debate on whether — when they give blood
tests, because of confidentiality they don’t do AIDS testing unless you ask for
it. There is at least some debate whether there are a few hundred or a few
thousand people who are dying because that information isn’t automatically
generated, like other disease information when you give blood tests. So there
is just a lot of confidentiality and privacy issues — again, I am speaking
without a license — that might be out there. I don’t have a sense that we are
gathering information on it, outside of looking narrowly at an administrative
process under a law written by Congress, primarily in response to some
complaints by the public, which is worth doing.

So I am raising the broad issue without knowing where to go with it, and
whether that is an issue for the National Committee on Vital and Health
Statistics.

DR. COHN: I think Mark wants to respond. You may actually end up joining
another subcommittee. You better be careful.

DR. ROTHSTEIN: Just very briefly, I agree with everything you said. The
NCVHS sent a letter to the Secretary at least two, maybe three years ago,
specifically asking that a research program be undertaken by the Department to
probe those sorts of questions and to try to get a sense of what effects if any
HIPAA was having, and that has not been implemented yet. But we all do support
that.

DR. STEUERLE: It is more than HIPAA.

DR. ROTHSTEIN: I understand, yes. But privacy in general.

DR. COHN: A good question, thoughtful. Paul, the last question, and then we
will move on to the next set of issues.

DR. TANG: Susan, I understand that HIPAA permits a patient to request their
information in electronic form if that is feasible and practical for the
organization. If a state law were to prohibit transmission of information
specifically in electronic form, do you think that that would be in conflict
with HIPAA’s rights for patients, or do you think HIPAA would supersede that
kind of law? So the state law is not mandating the electronic transmission, but
it prohibits providers from transmitting or providing access to certain
information by a patient if done in an electronic form?

MS. MC ANDREW: Off the top of my head, I would probably say no, as long as
the right of access is honored, as opposed to the form of the right of access.
Then I think HIPAA is served and is not in conflict with the state law. So if
you can get 90 percent of your records electronically because they are in
electronic form, you have to get the other portion of it on paper, because I
can’t give it to you electronically.

DR. TANG: So if the information is available and feasible to communicate to
a patient electronically, but a state law prohibits that transmission only in
electronic form, not in paper, would that be in conflict with HIPAA?

DR. HOUSTON: No, if it is related to a privacy issue, then the more
stringent state law — if the basis is privacy, I would think HIPAA says the
state law would be more stringent and would apply. So I think in that
particular case, state law would govern the manner of disclosure. Again, if it
is privacy related.

MS. MC ANDREW: I don’t think it necessarily would be a conflict with HIPAA,
as long as the individual could get access to that information.

DR. TANG: On paper.

MS. MC ANDREW: On paper or through some other form. I don’t think we would
necessarily say that that state law is in conflict simply because it governs
the form that that access has to take.

DR. COHN: Sorry, Paul. I think Paul was trying to construct a legal
argument.

We need to move on to the next agenda item, but I want to thank everyone
for what I think has been a very interesting update. Susan, thank you for
joining us. Thank you for introducing your new boss, and we look forward to
working closely with him. Karen, we are delighted and very excited about the
progress being made in both HIPAA and e-prescribing.

Jim, I think knowing that the details are still to be worked out, I think
the committee has for awhile now been talking about this issue of connecting
the NHII to population health. What you are describing is actually a focused
look at that, so we certainly applaud that activity. I think I speak for the
committee that we would be happy to help in any way we can as you move forward
with that proposal.

Now, with that I am going to turn it over to Harry to talk a little bit
about some issues relating to HIPAA ROI. As I said in the introductions, the
actual letter itself has been withdrawn for the moment, but Harry may comment
about that further. I think that may have been my fault, but I think the issue
is still very much alive and will likely come back to us in June. Harry?

Agenda Item: Subcommittee on Standards and Security
Letter – HIPAA ROI

DR. REYNOLDS: In the spirit of teaming, this is a full committee
recommendation. A couple of things. Thanks for the announcement that today it
has been ten years since HIPAA occurred, and now we can remember when we
actually started twitching. Having been involved with that for this long, I
couldn’t exactly get that date clear, but now I have it.

The letter in Tab 3 that we submitted to you we had prepared as a
committee, and we had then taken on the recommendations, of which there are
six, to the Executive Committee.

We have recently withdrawn the letter. There are a couple of things. One,
we had planned to come in today and add an introductory paragraph to each one
of these that would more or less explain what was going on, but we did have six
key areas that we wanted to focus on. So we worked on that some.

But as we got further into it, I think one of the things that the ten-year
announcement today reminds us all of is, we have been at this for ten years,
and what is the ROI and what does it really mean, and how do all the pieces fit
together, and what is really happening. So there is a lot of stuff that has
been implemented. So I think we all would congratulate everybody that has
presented to us, as far as what we have seen, the fact that there are things
that are implemented.

However, we have picked six key items that we feel still are
considerations, that need to be dealt with further. We also owe a yearly report
on HIPAA to Congress and others. So what we have decided to do in withdrawing
this letter is put together more of a holistic view of where it stands,
including HIPAA ROI.

We also — and this may be helpful maybe to other committees — one of the
things that we feel that we fell short of is, if you take the recommendations
one, two and three, the first word is encourage. That is not necessarily an
actionable position to take. So as we enter some of these, what could be
considered more controversial subjects and more controversial situations, we
feel that as a committee we need to do a little more diligence and seek counsel
from all the right players to make sure that we make actionable
recommendations, and that those recommendations truly do make a difference.

So in one way, shame on us for putting the Executive Committee through
this, but I hope that you will congratulate our effort and the fact that we
want to make a difference. I think that is what this whole committee sits
around the table to do rather than be able to check off another activity. We
really want to make sure that we take this subject and we do something that we
all as a committee can bring forward and recommend, and we hope that each of
you would walk out feeling that we made some recommendations that were
different.

I don’t believe what you will see later will eliminate some of these
issues. These issues are definitely prominent issues. I think Karen touched on
one perfectly today. There is more activity on these eligibilities, but is that
just somebody checking somebody’s eligibility, or is it really making a
difference in those provider sites in reducing costs and reducing phone calls
back and forth and so on.

So statistics are one thing. Results are what I think we are all after,
especially as you start looking at return on investment. So the number of
transactions is important, but the actual outcome to the health industry is the
other thing that I think is really key as we look at it.

So we plan to — probably around the June time frame when we all get
together again, you will see us coming back here with probably a fuller report
and a different-looking letter, and more actionable recommendations that we
feel can really help the Secretary take a look at some of the things that need
to occur, rather than just encouraging him to accept that this is an issue, or
accept that there are further things that need to occur. So that is the reason
that we are doing this.

Simon, unless you or Jeff want to add anything else, we can open it for any
questions from the floor. But that is about all I would need to say initially.

MR. BLAIR: Well said, Harry.

MS. MC CALL: I applaud the tack that you are taking right here. Thinking
about not only taking a more active than passive role in terms of the words and
the specific recommendations, I would also make a friendly suggestion of not
only talking about the ROI and what has been achieved, but also looking forward
and creating something that says this is a very important foundation. Not
everything that is needed out of this has been done. I think it is important to
be pithy and insightful about what has been achieved so far, but there is a sea
change, and this is an important foundational pillar. To call that out in very
specific ways I think is really valuable, especially on an anniversary.

DR. SCANLON: I do also concur in terms of the idea of being more aggressive
about the recommendations. I think they will be very positive.

I would like to focus on — there was a sentence about the inability of the
testifiers to demonstrate a positive rate of return to this point. I guess I
have concerns about how exactly we express that. There is a question of one,
how hard are you looking for positive returns, and two, even if you are looking
very hard, there is a question of, can you really identify them when there are
many things changing.

In the ten years that HIPAA has existed, certainly the practices of the
insurance industry have shifted a number of times, and the practices of
providers in response have also had to shift. So there is a question of, as
your activities are changing, are you able to isolate and say this is what the
impact has been, if it hadn’t been for this we would have done these things in
a different way, it would have had this kind of cost.

In the best of worlds, even if we were to take Gene seriously in trying to
measure this, it would be hard to do. The question is, has anyone come anywhere
close. I think it is a question of, yes, this is their testimony, but how do we
interpret it, what do we say about it.

DR. REYNOLDS: Bill, I think that is the reason I used the word story rather
than just a list of six recommendations. This has been a ten-year journey. It
has been a ten-year journey with many moving pieces. It is a ten-year journey
that if you stand here and look back ten years, you see one thing. If you stand
here and realize the change that may drive it, and you also take a look at, as
Carol put, going forward, I think we have got a lot of lessons learned
throughout this process. Some of those lessons learned are good, and some of
those lessons learned need some work. So I would concur with your comment.

DR. CARR: We talked about this in a conference call, the fact that in the
quality group we had heard from John Halamka about the return on investment in
Massachusetts. So we could go back and seek his experience, if only to identify
a best practice, opportunities for other states to follow.

DR. TANG: I also think the tack you are proposing is a good one, and we
should be more proactive in our recommendations.

One question is whether you consider it within the scope of this RIO
discussion to also do, even if it is qualitative assessment or rendering of
lessons learned about the method by which HIPAA had put forth, whether it is in
standard setting or — probably the privacy area is not within your scope, but
there is a way that HIPAA put these standards into place, and was that a useful
one, or what are the lessons learned from that.

MR. BLAIR: I’d like to expand slightly on the observation that was made
just a moment ago that return on investment may not be broad enough to be
appropriate to represent what we want to measure.

One of the things is that a lot of the health plans and providers and
clearinghouses that were covered entities did not enter this process of
implementing the HIPAA transaction standards with the idea that they had a
choice. It was a Congressional law and a regulation, and therefore there are
many folks that went through this process, well meaning, trying to do the best
they could, trying to comply with government regulations. That is the key word.
Their focus and their attitude was complying with federal regulations. They
felt it was a good thing. There should be some benefits, but it wasn’t as if
the chief financial officer of the entity had a choice of different projects or
initiatives to invest it, and they wound up doing baseline and benchmark
estimates of what they are investing in this area, and then they made a choice
from which they then would have the information to measure on return on
investment.

So many of the folks who testified to us — and I think even right now
today, they don’t have the benchmark data to give us a return on investment.
That was lacking. It isn’t saying that there wasn’t a positive return on
investment, but they didn’t enter the process with the idea of comparing this
project with other projects, so they didn’t gather the data to measure it.

So maybe as this opportunity to redo the letter, we look at it a little bit
more broadly and not limit it to a label of saying that we are just measuring
return on investment. Maybe it is that we are winding up seeing whether the
benefits justified the investment. If you move to the word benefits you get a
little bit broader, you give folks the opportunity to point out other related
benefits that may even be subjective, but that are still considered positive or
valued. So that is my suggestion.

DR. COHN: Well, Jeff, obviously the Subcommittee on Standards and Security
will have a chance to opine on this as they take it back. Karen has a comment.
I want to give everybody break here in just a second, so Karen, we will let
yours be the last comment and then we will wrap up and give everybody a
ten-minute break.

MS. TRUDEL: Just very quickly, I wanted to follow up on Carol’s point,
because I think it is very well taken, to think about the future and moving on.

One of the things that I think is really important is looking at how the
standards for the administrative transactions can coexist in a provider setting
through practice management software, which many small practices have now, and
electronic health record software, which many small practices do not yet have.
They need to be able to talk to each other while we are building more silos.

DR. COHN: Right, that is another part of secondary uses of data, you are
absolutely right.

I am going to give everybody a ten-minute break at this point. I do want to
recognize that as we talk about this ten-year anniversary of HIPAA, knowing
that this is going to be going back, knowing that one of our statutory
requirements every year is to do an annual report on HIPAA administration, we
are going to have to think a little bit about how we — do we do one report
this year, do we do multiple pieces that together form a report. I know there
is going to be a big story on privacy and confidentiality. We are going to have
to think about whether we wait for everything to come together, or whether we
subdivide them with different time frames and different pieces coming out.
There are a number of different ways we can go forward on this one, as a big
report either together or in separate pieces, we just have a letter in June
with a bigger report in September. These are things that we will need to think
about over the next couple of days. September was the last report last year, so
June would not be inappropriate. But on the other hand, privacy may not have a
chance to catch up on that one if we try to go for a June report. So I am just
trying to think if there are ways to try to make that happen.

Now, having said that, why don’t we take a ten-minute break. We will come
together right at 11 o’clock and then to our next session.

(Brief recess.)

DR. COHN: This is our second morning session. I want to welcome David
Brailer. David, thank you very much for joining us. We are delighted about the
progress that your department is making, as well as the exciting new
initiatives and activities underway. Thank you for joining us to help update
and brief the committee.

Agenda Item: Update on Office of the National Coordinator
for Health Information Technology, AHIC Developments, Contracts, Coordination,
NHIN Architecture

DR. BRAILER: Thank you. I appreciate the ongoing support and leadership of
NCVHS and all of you as individuals, and opinion leaders and people that can
influence the health care market.

Recently we have been communicating to the public and to the industry that
we have most of the pieces in place now that will represent the vehicle by
which our health information technology plans become manifest. I would like to
review those with you briefly. I would say most of this will be a review of
things you already know, but I will do it from the perspective of creating a
context so the pieces fit together, so you can see maybe the whole vehicle as
opposed to the parts.

We viewed our challenge being creating the conditions in a marketplace
where these technologies that we believe are so important would come to be made
available widely, without the requirement for mandates or conditions of
participation. At the same time, we recognized that there were many long term
pieces that needed to be developed, but we couldn’t wait for those long term
pieces to be put in place in a normal, orderly form before we would start
assessing the issues of when the doctors use these life-saving tools in their
practices.

Therefore, we developed a process that has both long term efforts that are
underway as well as short term efforts superimposed on them. The long term
efforts you know quite well. They are to set the foundations for the industry’s
capacity to have a set of standards. You have talked about that, we have talked
about that.

I am happy to report to you that our health information technology
standards panel, organized by ANSE, is now underway. It has had its third
meeting of its board, and the whole year’s efforts are planned, and it is
operating on schedule with respect to our contract with it, to begin assessing
and laying out a road map for standards in the U.S.

Again, I want to emphasize, in the end we want to see a single coherent set
of standards come from this. I want to recognize that this effort of
harmonizing what is otherwise a very unwieldy set of standards and standards
development mechanisms requires patience, it requires time, and it requires
some degree of collaboration in the industry to decide to change its practices.
There is no shortage of people that have other, more aggressive ideas about how
to create a unified set of standards in the U.S. This approach that is more
voluntary, that brings together the best of everyone’s efforts and allows them
to be linked as opposed to creating something more top down, is starting to
succeed and is worth a substantial effort before we take further steps.

Our certification process, again, setting a long term foundation for better
information in the marketplace, creating the tools for us to have more
objective reference points for policies, is underway. I think it is a landmark
organization.

We now have the ambulatory EHR certification criteria out. We will have the
first found of certification results in the ambulatory space by June. We have
now started the certification commission on inpatient EHR certification, and
within this calendar year they will start on network architecture
certification. So that is really moving along very well.

Our health information security and privacy collaboration, which is not
here to tinker around with privacy issues that are maybe left over from the
past, but to begin redefining the paradigm for privacy in the digital era of
medicine, is underway. The RFP that asks each state to participate in this, so
we create a new leadership group that brings together federal and state leaders
around privacy and security is nearly complete. We should be awarding the
contracts to each state for their own designees to participate within the next
60 days.

But this is an effort again that is long term. We will not have the results
of what it takes to develop the privacy and security policies to protect health
information as it becomes completely interoperable for a long period of time.
These long term efforts as supplemented by our new effort that you have heard
described here, to have an objective assessment of how well we are going with
adoption, from this new adoption review panel, are things that we started.
These were the first efforts that we developed in the office, because we knew
that if we didn’t develop ways of making the health information industry more
coherent, more organized, more able to work within the boundaries of rational
constraints, that we would not be able to begin moving the process forward. You
have heard about these a lot, I won’t dwell on these.

But superimposed on that, over the past 90 days we have unveiled these
so-called breakthroughs. These are being developed with the American Health
Information Community, who I would consider your first cousin, not your
sibling, in terms of helping us guide the process through the Department’s
policy machinery.

These breakthroughs are envisioned as things that could happen within a
relatively short period of time, a year, or perhaps two years or three years,
very finite, very specific. If you think about these breakthroughs, they
represent things that in the end we should be able to determine if they
occurred or not.

We laid out things that are quite visible, medication history for each
American, an online registration summary that allows you to have the ability to
share your demographic and insurance information with those that you want it to
be shared with, secure messaging between doctors and patients, the ability for
us to have a universal portable lab information, and then finally,
biosurveillance methods that allow us to collect data at the federal, state and
local level simultaneously with a very low lag time, i.e., 24 hours from the
event occurring.

These are things that came from many different breakthroughs. What they all
shared in common were the things that had relevance and value to a specific
stakeholder group. They gave us leverage points for going forward. They in
their own right are not the universe of health information. They in their own
right are good starting points. But the polarity that they create is conflict
with the long term infrastructure. There is no question that the priority that
we might have for standards in the U.S. might not include for example something
that is in the realm of secure messaging. I’m not saying that because I am
signalling you that that is a concern, I’m using that as a hypothetical.
Likewise with other breakthroughs.

Yet, for us to titrate those breakthroughs with the standards that we need,
we have to adjust the agenda of the standards panel to prioritize those
breakthroughs. Likewise the architecture and certification and adoption
evaluation, to make sure if we say that we are going to deliver a medication
history, we have to measure ourselves objectively to know whether that was an
empty promise or something we delivered on.

So the polarities of managing those short term breakthroughs against the
longer term infrastructures really become the device of progress. What I mean
by that is that we are both able to focus on things that give a short term
value, so we are held accountable, so we can’t make ten-year promises and then
tell people in ten years we will get to the real implementation details, that
it is apparent on a weekly or monthly basis whether or not progress is being
made. Yet, those breakthroughs fit within a broader context, so they are not
incoherent, one-up exercises that might lead to a narrow victory with nothing
that goes further.

In an ideal world, the U.S. might have had the long term infrastructure in
place a decade ago. I don’t say that to criticize anything that has been done
in the past. I just recognize that this would be a lot easier if we were here
talking only about how do we start focusing our health information machinery on
breakthroughs that the American public can benefit from. We don’t have that
luxury, and so we have to do both. This mechanism, this vehicle of being able
to manage the polarities between short term needs and long term coherence is
what the American Health Information Community is focused on, it is what my
office is focused on, and it is what a new group that we have created called
the Interagency Health IT Policy Council is focused on. This is a group of
federal leaders that could come from more than 25 agencies whose purpose is to
receive the agenda and to begin asking themselves what does it take in terms of
changes in federal policy to make these things come about, and to hold the
agencies accountable for the changes they commit to make.

So that machinery is new. It is about 30 days old, but it has been meeting
regularly and intensively in fact, in anticipation of the recommendations that
will be coming from the American Health Information Community within 60 days
about the particular policy changes needed for the breakthroughs to come into
being.

So this is largely putting our cards out. There aren’t a lot of other
things that we are planning in terms of our machinery to accomplish both short
term results and long term breakthroughs to be played. We are now in a period
of not discovery or not deployment, but implementation, of getting the
breakthrough work groups to own their topic, to begin having them transmit
their recommendations to the federal agencies, and we stay on top of those
changes, to be able to make sure that our goals for standards or for
certification or for architectures are being played out as we expect.

The implementation oversight task has become very much the predominant mode
of the Office of the National Coordinator, to insure that we are not living
only in the world of vision, but that we are able to make sure that our tasks
on a daily basis are linked to those visions. It has been a substantial change
in what we do on a daily basis in that office, a substantial change in how we
interact with agencies, how we interact with those in the private sector,
because we mean business and we are here to get this done. So far, I want to
tell you that we have had wonderful, wonderful cooperation from federal
agencies, from states, from private sector entities.

I expect that there will be some pretty tough tasks that come out of the
AHIC recommendations. My view is that health IT has so much support and such
unanimity around the belief that it has transformative value, that if the
things that need to be done were easy, it would have been done long ago. So the
things that are going to be called for to make for example a medication history
widely available or to make any of the other breakthroughs occur, or to make
some of the long term changes that the infrastructure calls for, are going to
be hard. They will require some difficult decisions. They will require changes
in what has been done or what might have been done in the past. But that is
where we are in terms of now being poised to determine what it takes to get the
job done, and how it is that we will make sure that the commitment and the
promise is followed through.

So I hope that NCVHS will continue to help us accomplish this goal. I see
you very much linked in to how the long term infrastructures are being played
out. They very much are manifesting the agenda that NCVHS has had for at least
a decade. But I hope you will be very closely linked to the Health Information
Technology Standards Panel, to create a vessel by which its recommendations
cannot just be made in a uniform way out to industry, but in a specific way
into government through your analysis.

I hope that you will be involved with our architecture projects, to begin
helping us discover what are the lessons learned — it is premature at this
point, but in months, the lessons learned and what the findings are that will
help us guide architecture deployment in the United States. I certainly hope
that you will stay primarily involved with our health information security and
privacy collaboration, because it will begin within months producing some very
hard-hitting and insightful recommendations about how do we begin anticipating
a digital era with these policies.

So there is a lot to do. I appreciate very much you all being very involved
with this. I am very proud to be implementing the agenda that most of you have
called for for a period of time.

With that, let me stop and thank you again. I’ll be happy to respond to any
comments or questions.

DR. COHN: Thank you very much.

DR. ROTHSTEIN: Thank you, David. I have a question relating to the
relationship between the NCVHS and the architecture group in particular. We
hope to have at our June meeting the final report of the Subcommittee on
Privacy and Confidentiality regarding the NHIN and privacy and confidentiality
issues.

Several of our recommendations will deal specifically with the kinds of
privacy and security measures that will need to be embedded in the architecture
of the NHIN. Hypothetically, let’s assume that we have this letter out in June,
and that you and the Secretary find merit in some of these recommendations. How
does that then get worked into the activities of the architecture groups?

DR. BRAILER: It is a good question, Mark. Let me tell you my initial
thoughts about the process, without commenting on the substance. I hope that we
can talk as a group about the process.

The goal of the first round of contracts for the NHIN is to raise
questions. We are funding prototypes and experiments, not with the goal of
being able to advance the implementation of health information exchange on its
own merits, but to be able to precipitate the questions about what are the
public interests and architecture as they become deployed on a private sector
basis.

So it is possible that the place for those recommendations that you will
precipitate to be fed into may not be into this one-year round of contractors
developing prototypes, but into the review of that. Our expectation is that we
will take the output of the one-year contracts as well as other things that we
have discovered, for example, from our own health IT privacy and security
collaboration, and to feed those into a new round of bigger prototypes, more
communities, more aggressive implementation.

So I hope we can find ways to put them into use right away, but again, in
the end what we are asking them to do is just turn over the designs,
architectural plans. Then we are going to have a very detailed process of
review. I hope therefore it is a two-way street, so that we can have in common
to present to you their plans, so you can, rather than just giving us your
recommendations in a vacuum and give us the so-what about, we heard them say
this and here is what we were thinking, and therefore here is how we would
either change what we said or change what they are seeing.

So we will receive those. I do expect them to be meritorious based on the
long history of accomplishment here. But I hope that you will be more
interactive with us in being able to dialogue this. My assumption here is that
none of us know how this should work. It is too complicated, it is too new. We
want to leave 2006 or early 2007 with a pretty good idea at a high level about
what it takes to make this work in the United States. That is where that will
get filtered in.

DR. ROTHSTEIN: So I hear you to be saying — and I am comforted by this,
and I think the subcommittee members will be as well — that we should not be
overly concerned that the subcommittee and the full NCVHS and these four
architecture groups, at least with respect to privacy issues, are seemingly
working on parallel tracks, but not interacting with each other, because there
will be an opportunity at the end, before the next stage, to integrate their
ideas, our ideas, your ideas and so forth.

DR. BRAILER: Absolutely. This is a one-year period of performance.

I’ll tell you why we have done this project this way. I’ll do that by
comparing it with electronic health records. We are able to have a very
reasoned, very fact-based discussion about security and privacy and electronic
health records or decision support or standards. Why? Because there is a very
large body of knowledge that is bounded by the reality of the products that
have been built, the research that has been done, the experts that have been
created by our very large industry around electronic health records.

We are not able to do that with architectures, because we have never done
it before. There is not a class of experts on the topic, there is not a group
of companies or doctors or hospitals that have real world experience with this.
We are trying to create that practical experience through these projects so
that we can have something meaningful.

I have noted on several occasions that when people talk about what an
electronic health record should do, they come down to very, very precise and
specific features and functions. When they talk about architectures, it is
quite unbounded and quite hypothetical. So we are trying to use this to anchor
it down to reality.

Therefore, by definition we are trying to set the stage for the real
dialogue that you are anticipating in the period after this first round of
contracts. No decisions are going to be made. Again, this is really a way of
creating the fodder for discussion that leads to decisions. So I think the
timing is quite good.

I should also note that our health information privacy and security
collaboration is essentially playing a role not unlike what you just described
that the committee does with respect to those architectures. The architecture
will be fed over to them to review it from the point of view of the normative
ideas they have brought forward from their own expiration about privacy and
security. So there would be a perfect opportunity for your recommendations to
be able to get filtered into that process as well. I think the timing is
frankly quite good.

DR. HOUSTON: You mentioned twice in your last comment to Mark about your
collaboration or initiatives related to privacy and security. I would be
interested in getting a sense of what they are and how it is structured today.

DR. BRAILER: Sure. Let me start with who it is. Our contractor for this is
RTI, but like all of the efforts that we have created, the contractor is really
there to orchestrate a public process on our behalf. We are not treating the
contractors like a typical federal contractor, where they go off and do the
work for the government and then they come back and deliver it to us and there
is no public review. We are trying to create institutional processes where they
haven’t existed in the past.

The participants of this, when the HISPC, the Health Information Security
and Privacy Collaboration, come to be, will be a representative, a designee
from up to 40 states in the United States. We made that assumption based on
both budget tradeoffs and number of states that we felt would participate.

There is an RFP that is out. Most states have either submitted their
proposals or are coming down to the final wire of doing that. The recipients of
that will be given a small subcontract to develop their own internal process,
and then to bring that to the national process.

So we will have 40 state leaders designed by their governor and by the
qualifications of their review process, joined with a number of federal or
national experts in the topic. We will then begin this process of saying what
does the world of security and privacy need to look like if we have digital
health information, what is the status of security and privacy rules today, and
what needs to change to close that gap, but also talk about the process, is
this a process where the federal government should act, is this a process where
we should continue this federal floor and state superseding rule, or is it a
process where states should begin harmonizing at the state level, not unlike we
have done with e-commerce sales taxes. So they are asking both content and
process questions.

DR. HOUSTON: I knew about the RFP. I wasn’t sure how it linked in that.
That is very helpful, thank you.

DR. BRAILER: In the end, we hope this group will have some legs that will
inform a steering committee, that it will not be a one-up process for this
specific contract, but that there will be a new vehicle to begin a federal
dialogue. I mean federal in the Federalist sense, state and federal, about
security and privacy that can carry us several years into the future.

Again, the reason we did this is, we explored all the different mechanisms
for bringing the right parties together to talk about this. We couldn’t find
the institution that we could say, go do this. So like certification and
others, we have had to create our own tools so we can go about building the
ship here.

DR. REYNOLDS: David, how are you doing?

DR. BRAILER: Good, how are you doing?

DR. REYNOLDS: Good. I am amazed at the energy that you guys have been able
to create around the country as I go to all these different meetings. I think
it is well done.

DR. BRAILER: I am amazed by it, too, so don’t give us too much credit.
People are listening.

DR. REYNOLDS: On certification, I think one of the things that I have seen
as a benefit, one of the things that we continue to have to deal with is
adoption. That is one of the big things that you have. You look at
e-prescribing or you look at any of these other things, then you spend time
back in our home state, and we talk to individual doctors who are about to try
to write checks and do certain things and say, am I picking the right one, is
this going to last, are they going to be there tomorrow morning, what is the
deal, and is it going to continue to be viable.

So as we look at the standards, one of the things — a question I have, and
we are working through a lot of HIPAA issues, as the certification goes on, I
haven’t necessarily seen enough of the detail to know, when you look at some of
these other HIPAA transactions, and we just had a discussion on this before you
came in, like the eligibility and claim status and those things, as the
industry and government build this framework, then the more of those that can
be moved into this certification process, not maybe to the detail level, but to
the base level, I think it starts delivering a package — especially if you
step back and look at the individual doctor, starts delivering a package where
they would know that they would be HIPAA compliant, they would know that they
would be architecture compliant, they would know that they would have some
privacy things built in, they would know that they would have all the base
things.

We just talked about the ten-year anniversary of HIPAA. So as this starts
to become mainstream, the more of this in my opinion — and I know the
certification process has to be careful not to get too Draconian or have way
too many things in it, but I think the more of these things that are already in
tool sets for a lot of people can be picked up and plugged in there, starting
to deliver to the individual doctor, and all of us are still interested in
driving this to the local bottom line in the rural areas and everywhere else,
would really be helpful.

So I would love any comments that you would have on that.

DR. BRAILER: We have viewed certification as an absolute necessary entry
point for government policy. It really is a rare three-hit wonder, meaning that
it accomplishes three separate and distinct goals, which is pretty unusual, if
you think about the world of creating institutions and process.

The first is, in a very selfish way, if I ask lawyers in this Department or
lawyers in Treasury or lawyers in Commerce or lawyers on the Hill for each
different committee to write something that helps foster IT adoption, the first
thing they would have to do is tell the world what they are talking about. They
would each figure out some way to describe an electronic health record or some
other technology, and we would have the first self-inflicted wound occur.
Everybody describes it differently, and that creates arbitrary policies, it
creates policies with no strategic synergy and worse, for the private sector
decision maker it creates a huge amount of risk.

So some Congressional bill in the future might say you can do this because
we define it this way, but some federal executive rule says you can’t. So from
the point of view of just having clean and scientifically derived
determinations about what are we talking about, rather than lawyerizing these
we felt that certification was necessary.

You saw that in our proposed Stark rule, where we said — and it was still
lawyerly and convoluted, we can never get away from that in government, but
largely speaking if it is a certified technology it has certain benefits. It
begins to allow this modularity and policy that makes it a lot easier to tell
people what we are talking about.

The second piece you have described is, it is a risk reducer to the private
sector buyer. We have a market that is highly asymmetric. Vendors know a lot
more about their technologies, their functions and features, the performance of
that vendor, their historical delivery rate, their viability, than the buyer
can ever know. So this asymmetry is bad for buyers, but I have also argued to
the technology industry, it is bad for sellers.

We have demanded the industry suppress by a negative business case, we
know, but on top of that, it is suppressed by risk aversion that is based in
reality of being afraid of what they get. So certification doesn’t change the
whole landscape, but it does help take away product risk. And that itself, buys
us demand basis points at no cost to taxpayers, at no cost to health plans, at
no cost to anybody.

The third piece it gave us is a reference point for private policies. If
you are talking about pay for performance and there is a health IT kicker in
it, you can talk about health IT using these objective reference points. If you
are talking about some kind of a loan or a demand or a grant or some kind of a
requirement that is part of a new network, again there is a reference point. So
it is a win for everybody. Capital markets benefit from it, vendors benefit
from it, doctors benefit from it, health plans and the government. That is the
reason we see something like certification in many other industries.

The way it works, as you know, it has three core features for the
ambulatory record: privacy and security features, decision support features and
data sharing features. Those are represented to be the three minimum set of
things that are required, the three aspects of consumer benefit that had to be
part of our policy: privacy and security to protect confidentiality, data
sharing to allow portability, and decision support that will deliver the
promise of health status improvement.

Our view was, simply put, if it didn’t have one of those sets of features,
it probably was a suboptimal solution, given where we are in our state of
development.

But your question says, what about all the other things? We have required
all of our contractors, including certification, to incorporate the use case
from the breakthrough into their future work. So we have identified a
medication history. They are now at work figuring out how an EHR participate in
a medication history. It is not clear, because that may not be a feature of an
electronic health record. It may be a feature of the network, because the data
doesn’t reside necessarily in the electronic health record. In fact, it is a
data needer as opposed to a data supplier.

A good example is secure messaging. More or less, the statement that will
be made through that certification process and that use case is, secure
messaging has got to be part of the minimal set, not in the current round, but
in the next year and the next year after that.

The same thing with the registration summary. We clearly have our eye on
eligibility and enrollment data, to simplify that process and bring the promise
that we have sought for 15 years, ten years, into that. That breakthrough will
get put through certification at some point over the course of the next year.

So these are how we are starting to guide a process of raising the minimum
bar by which over time electronic health records have to become increasingly
featured to be considered minimally valuable. That is a process that — we are
not telling the contractor how to do that work; we trust their effort to bring
in public dialogue. As a checkpoint, we are going to filter it through the
American Health Information Community anyway for its own public dialogue. But
that is how we are going about the process.

DR. STEUERLE: David, again, congratulations on your very fine work today.
Also, thank you for your very kind comments about the committee. I have a quick
statement on that, and then a question.

The statement is, I really hope as we go along that you will continue to
advise us on how we can best use our resources to complement what you are
doing. There must be areas where we have more overlap and areas where we have
less overlap, areas where we can fill in the breach more than perhaps we do. I
think that should be an ongoing discussion. Mark raised it with respect to a
few things, but I hope you will feel very free to criticize us in a positive
way, saying if you used your resources this way I think it might produce more
output, even as good as the things you are doing are.

The question I have for you is whether there is any effort on your part or
within your groups to raise some of the incentive issues that you and I have
talked about, even on a policy level. You don’t have to answer what those would
be, but I keep wondering if for instance there aren’t ways down the road, maybe
not too far down the road, to suggest something like a variation in Medicare
payments, depending upon vendors, providers, whatever, doing certain things
with the way they submit their requests, or whether they have an electronic
health record or whether they do e-prescribing or some variation on payment. It
doesn’t have to be higher or lower, I’m not quite sure how to play that out,
but I am wondering if you have some group thinking about some of these
potential policy ways of adding one more lever to the ones you have.

DR. BRAILER: Gene, it’s a great question. I will comment first on your
comment. I think simply put, the more your work groups and your committees
align themselves with the dimensions of our long term infrastructure, so you
can create receptor sites, where our standards efforts, our architecture
efforts, privacy and security, find their own independent way into government
thinking, other than through our contracting mechanisms, I think it is a win
for everyone.

We don’t want to build a process that is slavishly dependent on federal
executive authority, that just goes off and does what we want it to do. We want
it to have public legitimacy in its own right. That is why we have required
them to have a FACA-like public process for everything they do, and we are
reality checking it with the AHIC.

But I think here, there is a very long term, very expert driven process. I
mean expert in terms of understanding the nuances of health information, that
only this group can bring. So I hope you will regularly begin taking up the
cause of listening to our contractors and helping legitimize their findings
where you agree with them.

The only caveat I would add to that is, we didn’t require in our contract
for them to go beyond talking to the AHIC. So we will work with you and them to
find the right ways to make sure that they get before you the appropriate times
without stretching the budgets in a way that causes them undue duress.

I think that is a great win. We have talked about this with Simon and
others for quite awhile, and I don’t think this is in the day to day lineup and
focus of what the American Health Information Community thinks about. I think
they are thinking about the breakthroughs very much and about the
transformational aspects of the consumer and doctor experience. I think in
terms of the hows and whats which occur more here, I think it is a very natural
way to partner.

So I hope we can really talk more about how to make that something
functional.

In terms of the question on the center, it should not be a big surprise
that the guy put in charge of health IT being an economist doesn’t think about
this. I spend a lot of time thinking about it. There is a group in my office
who do think about this. They go beyond my office into Treasury, into various
federal agencies, CMS, et cetera.

I think it is fair to say that even despite the prohibition on thinking
about federal spending in this topic, it was in the executive order, there has
been a large number of discussions about this topic. But I think it is becoming
more and more clear that we have incredibly limited authority to take on this
new challenge based on the statutory guidance that various agencies do. I don’t
think it is believed to be in the purview of various agencies to look at tax
issues, or to look at payment differentials.

Health IT lives in a very precarious land. It is not regarded as a clinical
technology, such that a national coverage decision or some kind of a more
clinical patient beneficial technological process is done. But nor is it office
equipment that would be deemed as part of the practice overhead and part of the
costs that are fixed in the practice.

So I think in the absence of reclassifying health IT as a clinical
technology, which I think would come with its own perils, we have to begin
legitimizing the economic treatment of these publicly beneficial private
investments that are not necessarily patient operative.

So I think that the barrier is going to be what authorities we have to do
that, more than any other single thing. We have got lots of ideas about pay for
use, pay for performance differentials, things like the Stark exception, other
things. I don’t think it is a deficit of ideas. I think it is a deficit of
authority and will at this point. But I am very encouraged that more and more
interest that gets focused on this translates into more and more expectation of
how we are actually going to get the work done. I hope you will keep talking
about.

DR. COHN: David, do you have time for a last question?

DR. BRAILER: Yes.

DR. TANG: David, congratulations.

DR. BRAILER: Thanks, Paul.

DR. TANG: And also the helpful framework you have put around the activities
you have. You have addressed a lot of the long term infrastructure needs like
the way you elegantly had CCHIT address the definition and the product
qualification, addressing standards and privacy.

Is there a strategy for addressing the implementation effectiveness? The
recent articles call that to mind, like the pediatrics article about how people
and the expertise needed to implement these complex systems can interact and
sometimes interfere with the benefits that we want to achieve. Is there a way
that we can either assess the effectiveness of implementation or address the
workforce capabilities to implement these systems?

DR. BRAILER: Paul, I think characteristically you have put your finger on
the weak link of this whole exercise. Not only evaluating implementation
efficacy, but being able to find the human assets and knowledge base throughout
the United States to allow this clinical transformation to occur, is obviously
the biggest challenge. It is the rate-limiting step.

We have been able to take some of the human dependencies out of the future
plan. I’ll give you a big example. Interoperability has the benefit of patient
portability, but it also gives us the ability to reduce the complexity in the
human knowledge labor requirements of implementing an EHR. If they are
interoperable, you don’t need 300 hours of an expert and interfaces between
Metatech and Cerner or whatever it might be to get it up and running.

I think there are many companies that recognize that even though those
might be lines of business for them, they are hardly what I would call high
margin and fruitful forms of revenue to the company. They are more as a cost of
business that is just there.

Interoperability lets us scale the capacity of the industry dramatically in
the out years, where the human capacity to implement is a rate limiting step.
We don’t have the equivalent for how to shrink wrap the cultural exchange and
the clinical transformation that occurs. I think too often, doctors still are
in a belief that these software technologies are downloaded and implemented,
and they are up and running.

In fact, one of my worries about certification is that it makes it even
more apparently trustworthy to those who think it is a software implementation
in its own right. But I worry behind that about where does the know-how come
from. We have been looking more closely at bachelor and nurse level and
physician level informatics training, and they are not producing the output
fast enough for the level of uptake.

So this is by far the rate limiting step. It is the biggest risk factor in
terms of whether or not something beneficial comes out the other end. It
clearly is something that in the end matters to the ultimate value, because we
are not in this for IT implementation’s sake. We are in it to produce better
outcomes.

I don’t have an easy answer to it. This has been something that we said is
a long term challenge, and we will take this up when we get the basic tools
underway, which is about now. There is Congressional interest in this. Some
others like yourself, have looked at this in more detail, but clearly this is
going to require a significant challenge. I certainly hope that NCVHS will
participate in this and help shake what it takes to have the asset not just in
place in aggregate in the United States, but in the zip codes where two and one
person doctor practices are that need the help, and how can we think about
changing the dynamics of this kind of an implementation, so it is easier to do
and requires less help.

So I wish I had an answer, but it is something that is now ready for
significant attention.

MR. BLAIR: I think that all of us that are a part of the community that
believes in the value of health information technology to improve the quality
of care and medical errors and the efficacy of health care, we all feel this so
strongly, that it is almost intuitive to us. We all tend to wind up looking at
the impediments and trying to move things forward, and we support each other.
We are really a very strong, broad community trying to move things forward.
Thank goodness, it appears as if there is some bipartisan support now in moving
things forward.

The piece that hasn’t been clear to me, maybe you have addressed this, it
would be good if you have, and if you haven’t, I would like to suggest that you
consider it in some way. A lot of these initiatives have benefits we
intuitively know are there, but we are moving quickly. We have asked for
federal leadership and coordination, and we have it, and Congress has moved
things forward.

The industry in many of these cases, whether it is complying with
standards, complying with HIPAA privacy regs, being able to move to health
information exchange and looking at all of these initiatives, there is this
idea that they have to do this for various purposes. In many cases, they don’t
take the time to do the benchmarks, to wind up saying what is health care
costing today, in a manner where we can show quantitatively return on
investments for each of these steps.

Like for example, medication history, or for example the return on
investments for being able to automate health claims and eligibility and
enrollment pieces, and the pieces on the standards harmonization, and the
pieces on the National Health Information Network. Is it correct that that is
going to be nationwide, the National Health Information Network?

DR. BRAILER: That is the title, yes.

MR. BLAIR: Great. So I am offering this, and I am requesting this, because
I know that two or three years down the road, this is a large movement, there
is going to be faltering steps as we go forth. We are going to find new
impediments, we are going to find new difficulties. There are going to be
people who are going to complain as they go through this transition.

If we could have the data to show quantitatively how each of these
initiatives are showing some form of return on investment, or if we can’t get
down to that specific, some other measurable benefit to carry us through the
difficult times that may appear two years, three years, four years down the
pike, to show that these initiatives are paying off, that would be so helpful.

So have you already begun to address that, or is that something that you
are considering?

DR. BRAILER: I wrote a policy finding for the White House before I actually
took this job about health IT and the federal government’s interest. I will at
least tell you some of my background thinking, because I consider it part of
the endemic landscape of this problem.

We have a classic network externality problem here that influences the
sense of the business case, or the return. People have focused often on the
misalignment of benefits, i.e., doctors invest and health plans get the
benefit.

I view it differently as an economist. The issue isn’t who invests and who
benefits. All the money spent in health care comes from consumers and all the
value accrues back to them. The question is, whose hands does it go through,
and which is more efficient and able to deliver consumer value back.

So I don’t quibble with that aggregate finding, because I recognize that
when people do accounting analysis, they don’t think like economists, and thank
God, because most companies would be bankrupt if they thought that way.

But what I do recognize is that the other issue is one that you are asking
about predominates, which is, there is no benefit to someone who is doing
health information exchange if everyone else is not doing it as well. That is
the network trough that we are in, where the stable thing to do is to not do
it. The person who bought the first fax machine, let’s ask ourselves, had to be
crazy. Who did they think they were going to communicate with? But the
brilliant person who bought the last one for $69 was interoperable with
everybody else because they already did it. Being able to drive that network
trough to a point where it becomes — I’ll use Malcolm’s term, a tipping point,
but economically where the market is catalyzing itself and reinforcing that
behavior, is really what we are trying to get to.

I think there is a legitimate role of government action where there is a
social benefit at the end of a network externality. We are in the trough right
now.

Now let me superimpose the other part of your question on it. How do we get
out of the trough? Well, we didn’t buy our way out of it. We are not spending
tons of money to buy our way out of it. We are not regulating our way out of
it. That is a common way, when there is something that is a benefit, but people
are not doing it because no one is willing to be the first mover.

We are psyching ourselves out of it. I think unlike previous health IT
psych ops, we have a lot of resonance with the public. It is the reason
governors are interested in and members of Congress are reinforcing it. People
begin now to get it and see that there is something real here that affects
their lives.

But that inevitably sows the seeds of the flip side of the hype cycle,
which is, people will say it didn’t live up to its promise. It was overhyped.
One of the things that I have been cautious to do is not be the chief
orchestrator of hype, such that it gets to the point where it is at a fervent
boil and it disappoints. In fact, I have cautioned Congress and cautioned
state, RIOs and other parties to not become, if I can quote Alan Greenspan,
irrationally exuberant about this topic. It is inevitably going to happen.

Our work is focused, Jeff, on how is it that whenever the peak goes up and
the flip side goes down, that that piece of incremental achievement, where
there is work going on that gets masked out of the psych pieces, that really
making real progress comes through.

So that is what we are focused on. I hope that we have got the catalytic
energy here to get out of the trough. If we get the market to a 35 percent or
maybe 40 percent adoption rate, I think we have got a fighting chance to really
begin flipping the dynamics of the market where if you are a primary care
doctor, you just simply want your specialist or your hospital to be online,
too. We focus on the hardest part of the problem, primary care doctors, because
I believe they are the flipping point that starts shifting the behavior of
everybody else, but they are probably the hardest piece to access in terms of
their dynamics and their economics.

So we are underway at it. If we had more tools in our armamentarium, would
it be easier? Yes, but a lot of these tools come with a cost. Regulation has a
cost. It might get us out of the trough, but look what it does whenever we try
to get to the other side, which is ride the downhill curve of voluntary
adoption. It forces peoples’ hands. It is something that I think has a lot of
attendant costs in terms of how we lock in what we are doing and don’t let it
progress and innovate. Buying our way through it comes with other kinds of
costs.

So there is not a right answer, but I think here we are creating the seeds
of our own problems in the future. I am going to leave it to groups like you to
help manage that. Let’s be very honest. National coordinators will come and go.
I hope we will have one over the course of decades. But it is groups like yours
who represent public legitimacy, who can find a reasoned way to say what should
be done and what should not be done, what is right and what is wrong, what is
hype and what is real, is what really matters here.

So in the end, I hope you all don’t give up constantly being in the
leadership and the role of the educator and the truth teller that help us
understand what it takes to get the job done.

With that, I am getting the high sign that I am now late for a speech that
there are a thousand people waiting for me to give. So let me go hype them and
leave you guys. Thanks a lot.

DR. COHN: David, thank you very much. Do you need to talk before the break
or do you want to go after?

MS. GREENBERG: Yes, I think we should. Going from the lofty topic to the
more mundane of dinner.

(Discussion off the record regarding dinner arrangements.)

DR. COHN: Let me tell you what is going to happen now for the next couple
of minutes. It is 12 noon. Let me suggest that we break for half an hour. My
understanding is that those who ordered box lunches, it is down in 434-E. It is
right next to Jim Scanlon’s office. What I am going to have you do is get your
lunches. Why don’t we reconvene at about 12:30, and we will talk some about the
strategic planning piece that we are talking about and get some input, and then
we can move back into our regular agenda at 1 o’clock. Does that work for
everybody? Okay.

(The meeting recessed for lunch at 12:03 p.m., to reconvene at 12:39 p.m.)

A F T E R N
O O N S E S S I
O N (12:39 p.m.)

Agenda Item: Committee Strategic Planning

DR. COHN: I want to give everybody a chance to sit and relax a little bit
as well as have something to eat. It makes you all happier and a little more
verbal.

We wanted to take this occasion at least for the next couple of minutes and
talk about a plan for a full committee strategic retreat. This is thanking John
Paul Houston for being the original one who suggested this late last year. He
probably doesn’t even remember making the comment.

DR. HOUSTON: Of course I do.

DR. COHN: But I think we all thought it was a good idea, but we wanted to
talk a little more about it, get your input as well as agreement that it all
makes sense.

I think you all are aware that typically every summer the Executive
Subcommittee has a strategic planning retreat. Our view was that given the pace
of events that it really made sense to include the higher committee in those
sorts of discussions this year. At this point, I don’t know whether it is going
to suit to replace the Executive Subcommittee retreat or not; that will be
determined later on. But rather than being in an environment where the
Executive Committee spends a day talking about strategic issues, then comes
back in September and we all try to share in 15 or 20 minutes, it seemed to
make sense to leverage everybody’s good ideas, experience, expertise in terms
of trying to figure out future plans and work that needs to be done.

The next full committee meeting is in June. Just to remind you of what we
are talking about here, the full committee is meeting on June 21 and at least
part of the day on the 22nd. I think our intent was, once again assuming people
agree, think it is a good idea and all of this, would be starting in the
afternoon of the 22nd and the morning of the 23rd, us adjourning to someplace
probably not very distant from here, only not in the HHS building, to have
informal conversations about plans, strategies, priorities for the full
committee going forth for the next 12 months after that. The idea would be that
things would adjourn by midday on Friday the 23rd to allow everybody to get
back home for the weekend.

Now, at least as I am thinking about it, and this is probably my good idea
and the Executive Subcommittee has talked about it a little bit, but maybe my
thoughts are taking this a step further, I am actually thinking that we would
not try to structure speakers at this retreat, but that instead we would have
whatever speakers we felt we need on the first day and a half, with the idea
that it would be a committee member and staff retreat, where we would be
talking to issues without the formality of external speakers.

So anyway, that is as far as we have gotten. I am curious about thoughts,
ideas. Carol has been very good in helping us think through some of these
things, though you may want to make some additional comments.

MS. MC CALL: Actually I would love to hear what peoples’ thoughts are in
general, and then I will be happy to throw in as we go.

MR. LOCALIO: I just have a procedural question. Is the retreat an open
meeting or will it be transcribed? Is it a public meeting?

MS. GREENBERG: It would not be a closed meeting.

MR. LOCALIO: So it is a public meeting with just a different topic?

DR. COHN: I don’t know. Is it going to be transcribed?

MS. GREENBERG: I don’t think it would need to be transcribed. I would say
if we didn’t have any presentations, I’m not sure it would need to be
transcribed, but we would be obligated to do minutes, which we would want to
do, anyway.

MR. LOCALIO: Thank you.

DR. VIGILANTE: Is it the kind of thing — sometimes it helps with retreats
to have somebody else facilitate them, in terms of keeping us on track, keeping
us honest brokers. The whole process is often more productive, not always. It
is often more productive but not always if there is some expert facilitation
involved.

DR. COHN: I think you bring up a very good point.

MS. GREENBERG: We have done that in at least one Executive Subcommittee
retreat.

DR. VIGILANTE: And we have access to professional facilities.

DR. STEINWACHS: After Kevin, I don’t know what to say. It struck me one of
the nice things a retreat can do sometimes is help you think through priorities
and collaborative strategies. It strikes me that this committee has never been
so busy in the time that I have been here as it is now, and the busyness factor
is likely to rise because of what is happening with HIT and other areas.

So if you said to me what were the two things that struck me as most
important, one is a sense of what are our overall priorities, our large
priorities, and then how do we handle and manage what are both wonderful
opportunities, but also many times much tougher pressures for us to produce in
areas of security and areas of infrastructure and so on.

I know sometimes this comes up in a very parochial way when you talk about
the Population Subcommittee. It says we are looking more at the traditional
long term agenda many times of health statistics on populations, and the
interface with electronic health records that Jim is going to clarify for us,
so that will take care of that part. But it creates one of those dynamic
tensions.

I would not in any way want us to pull away from the electronic health
record. At the same time it seems to me — and we will be hearing later from
Irma about the link to NCHS, but sometimes maybe we aren’t paying as much
attention to some of the issues in the health statistics area that
traditionally the whole committee has been more engaged.

So it seems to me trying to look at the long term agenda and how do we
accommodate and how do we respond to what are very important opportunities to
make major contributions is one of the nice things a retreat allows you to do,
take a step back and then think about them.

DR. ELO: I think there are a number of issues that overlap with the
interests of this committee and the Board of Directors of NCHS scientific
advisors, particularly as they pertain to issues of confidentiality, data
linkage, records linkage across various data sources are issues that we have
discussed and will continue to discuss.

So I think tomorrow in the Population Subcommittee, we can discuss these
further, and tomorrow we will tell a little bit more to the full committee, but
I think you are absolutely right that there would be a number of overlapping
issues that would be worth doing.

DR. COHN: Bob, do you have a comment?

MR. HUNGATE: The real benefit I see in the retreat is the ability to
discuss at more length the longer term issues that do confront us. Getting the
structural synergy between our various pieces of activity so that we can make
the most progress, and finding some way of quantifying our own progress and
contribution. I believe in measurement, I believe in self measurement, and if
we can have as a thought some kind of goal setting tied to that, I think it
would help us.

DR. TANG: I agree with Don that there is a lot of activity going on in
things that touch our charge. It seems to me that we should consider the
importance of our capabilities on the committee, but also the receptor sites
for the vehicle for change.

We heard quite an open invitation from David Brailer in terms of
interacting with their contractors and the breakthrough communities. It seems
like we don’t want to let that opportunity slip by. It is a moment in time. If
I heard the whole strategy, there is a short term and a long term, and we fit
right in the middle. That is not something we get every time, so we need to
weigh that carefully.

DR. HOUSTON: Since I was the one that thought about this grand plan, I
would just simply like to agree with what has been stated previously, and I
think that is enough.

MR. BLAIR: Dr. Brailer indicated that he was planning on having us have a
little bit more of a role in a number of initiatives that he is doing. One of
them that he mentioned was that we would be in a review role, maybe for the
results of the prototypes of the National Health Information Infrastructure.

My thought was that if we could — let me step back a second. I kind of
thought that there was going to be an opportunity for us to be a little bit
more involved six months ago and then now. It seems as if there isn’t a
specific objective to try to do that, everybody agrees that their synergy is
that they don’t really get nailed down.

So maybe just prior to the retreat, we are having our full committee
meeting, so if it is possible to have Dr. Brailer there and identify those
areas which he needs help with, where during that retreat we could focus on
three or four or five of the areas to see what role we could begin to play,
then I think we could kill two birds with one stone. We would not only think
about the types of activities we can do and what the synergies are, but we also
begin to actually make the tie, so that our work is directly a part of the
federal initiative that is going on now.

DR. COHN: I think what your comment is we should certainly make sure that
we invite Dr. Brailer to present at the next full committee meeting.

MR. BLAIR: Yes, but in specific, if we tell him that when he comes, if he
can identify those areas where there are gaps or limitations or where he could
use some help from NCVHS, then we could use the retreat to organize ourselves
to grapple with those issues.

DR. HUFF: I think it is a good idea.

DR. COHN: That’s good. I was going to ask everybody at the end to review
this.

DR. HUFF: I don’t have anything else to add.

DR. STEUERLE: I’m not sure I have much to add, other than, I have been on a
number of retreats for a lot of groups and committees, and some work and some
don’t. I would just say, and this is not to be judgmental at all, but I think
it would be really important that the Executive Subcommittee at some point sit
down and say there are certain things we really want to achieve as an objective
out of this meeting, and this meeting will help us facilitate that happening.
If you can’t pinpoint that down, the things we sort of want to do but haven’t
pinpointed, then I would say don’t do it. If you have some things you want to
get out of it, you think that that particular format is going to work, then go
for it. That is easy to say, but harder to do.

DR. CARR: I think there is a balancing act. Certainly with all of the
electronic health records, HIT, we have been a part of that, and understanding
what role we might add value in going forward is important. But I think also,
stepping back to our roots of the total landscape, and what are the things that
are not being addressed as resources are going toward the electronic health
record, just so we play a vigilance role of things we want to continue to move
forward. So I think that is one thing.

Then within the workings of the committee, there is so much overlap now.
Almost the definitions of the subcommittees are at times arbitrary in terms of
which group deals with them. So I think having an opportunity to define what we
want to move forward and then how we are going to work together would be very
useful.

MS. MC CALL: Some of this is repeat. I am agreeing with a lot of what has
been said. I think specifically it is going to be important for us to clarify
the work that we believe that we need to do, so what are the most important
areas that we believe we are going to focus on. Part of that means clarifying
our role in general and re-establishing that, also vis-a-vis AHIC as well.

I do think we need to understand specifically how and where we intersect
with AHIC, but also where we don’t. In the Venn diagram, what I have heard
Simon say is that there is an overlap, but this is not an assumption
architecture that we are pursuing.

So I think that we need to understand where we overlap and where we don’t,
and where we don’t what our specific focus areas are going to be. Part of that,
to Jeff’s point is understanding specifically where they would like some
interaction.

I think the third thing is how we go about doing our work. So I would agree
that there is a lot of overlap, and that the way we organize going about this,
we may want to look at that as well. There are a lot of companies — in
industry for example there are functions, you guys live this all the time, so
there are functions, and then when companies get mature enough and they pursue
an initiative, they create cross-functional teams.

Is that appropriate, given what it is we are going to focus on in the
future? I don’t know. I think it is a worthy question to ask.

Last but not least, I agree with you, Gene, in that these types of
activities, retreats, they are wonderful to have, they are hard to do. It is
vital that we begin with the end in mind, with a very clear goal. There may be
homework, there may be things in the subcommittees that we want to charge
ourselves to bring forward. A day really isn’t a very long time, so we need to
be fairly pithy in what we do and how we prepare.

DR. SCANLON: I think it would be a good idea. This is based on the
observation of five of these meetings. I think that there is an incredible
amount of rigidity built into them. It is almost as if we pick the agenda off
of a menu, and we have a presenter, we have an update, we react to a
subcommittee product, and then we move on, and we don’t really spend much time
on introspection and a lot of cross fertilization among the different groups.
It is not set up to have that. I think having some time set aside — it has to
have goals, but it also has to have enough flexibility that the discussion will
allow for the brainstorming and introspection to sort through some of the
issues, would be a very good thing.

When you put together the agenda, if you were to try to do this in the
context of a regular meeting, what would be your candidates to leave out, you
would probably find, wait a minute, I can’t do that. I can’t really start off
and say we are not going to do this, we are not going to do that, and create
the time within the context of a regular meeting. So having an extension is
probably the only way we are ever going to have this happen, and I think it
would be a good idea.

DR. HOUSTON: I have got to leave, so let me just make one comment to
Justine’s comment. I think we do need to be critical over organizational
structure. Maybe critical is the wrong word, but maybe evaluate it and see if
it is the right structure to have in place for the type of work that we are
going to be doing.

Again, I don’t think we should foreclose the possibility of maybe
restructuring slightly to meet our needs. I know this committee since I have
been here has been the same, and it has worked fairly well. There are a couple
of areas where some things fall through because of the committee structure. But
I would just offer that we think about that.

DR. COHN: There is an old saying that form should follow function, which I
think is what you are probably referencing. I think Marjorie would like to make
a comment.

MS. GREENBERG: I’d like to hear from members, if there are any other
members, and then I have just a few thoughts.

DR. VIGILANTE: Are we going to go around again?

DR. COHN: Sure, we can go around.

DR. VIGILANTE: The two themes that just came up I think are very important.
On the one hand, to have a sense going in of what it is we are going to talk
about in terms of some sets of priorities, which I think means building in over
the next several months the next meeting and then the following, to understand
what is it that we want to tackle and brainstorm about. Then also make sure we
have enough room for real brainstorming, so that we are not excessively
strained.

So it is a balance of these two things, but I do think we need to go in —
I think we need to use the next few months in a preparatory way so that we are
not all sitting there saying what do we do next.

DR. COHN: I do want to reassure everybody that if we do this, we are going
to plan it well. Carol I know has been through a lot of these. We have all been
through these things, and we all know that this is an occasion for us to get
focused and clarify objectives and all that. So Kevin, I absolutely agree with
you, and I think we are hearing that very strongly.

So I just want to redouble that one. I think we do get it.

DR. STEUERLE: Three things I have struggled with since I have been on this
committee. One is in the discussion with David Brailer, just what is our future
role in NHII now that his office is established. I think we haven’t really
solved all these overlapping issues and where we can best use the resources. I
think everybody is well aware of that and deals with it. So that is one issue I
would put on the table.

The second one, which I care a lot about, I’m not quite sure entirely what
our role is in statistics. The Subcommittee on Populations has been struggling
with that issue, but I consider it really a much broader issue than even
population statistics. We are the National Committee on Vital and Health
Statistics, and it might not hurt to go back and have a little bit of an
initial session on the history of this committee and what it was meant to do
and how it has evolved.

The third one is NHII statistics, and then there is the broader issue of
the committee as a whole, how does it fit in the whole scheme of things. To
retreat back to statistics, there are other statistics shops, and we have got
our overlapping issues, too, that we have to struggle with. So the third one is
just the committee as a whole. I have a little bit of tension on the definition
of just what is the National Committee on Vital and Health Statistics. If
somebody asks me on the outside, I mention things we do, but I would have
trouble giving a complete definition.

So I would say, if we can deal with those in ways that are very concrete,
we should do it. I think to do that we have to have interactions with these
groups, the first two areas where we think there is overlap, to struggle with
it in a very tight and directed way.

DR. STEINWACHS: I was going to agree with Gene. I think it is very
important to have clear objectives. Maybe to amplify part of what he was
saying, it seems to me you don’t want the retreat overly structured. One of the
things that is nice sometimes is having more informal communication, having
ways to bond the group together in terms of the common mission, the common
vision, and understanding what each of us brings to the table maybe better than
we would otherwise.

So as my flippant remark on that, I was going to tell you that you should
have happy hour, one of those focused events. So if nothing else works for
convivial conversation, maybe that will.

Just another little piece, in a sense I have gotten to know a little bit
about all the people around the table, and those maybe I knew before. But if
you said, do I really know what kind of expertise people bring, and interests,
I’m not sure I do that well.

So it might even be worth some way to in the context of our mission to have
each of us talk a little bit about where we see ourselves fitting into that. So
if we do get into talking about mission goals and directions as to what we
think we bring to the table on that, that might create another little set of
synergisms about ways in which we could work together.

MS. MC CALL: I think the question that Eugene has put on the table is in
fact the right place to start. I think it wouldn’t have been asked probably but
for some truly transforming events within the last year or so on the horizon,
the whole momentum around EHRs and what is happening in health and health care,
and the perfect storm of cost and the lack of infrastructure and some other
events, and AHIC.

So as David said today, we are siblings. We are not even cousins, we are
siblings. So as I look at the work that we have done, is part of it out of
historical necessity, because there wasn’t an AHIC and now there is, so it is
an opportunity to recast, given the term vital and health statistics. I don’t
know, but I think it is that type of mission that we need to either clarify or
tweak or reframe, and I think the rest flows much more straightforwardly, not
necessarily easily, but more straightforwardly.

MR. LOCALIO: As a preliminary question, I asked whether the retreat was
going to be off the record, and I want to elaborate on that.

The two most important phrases that I picked up this morning were one from
Jim’s comment about his workshop being tough minded, and the other one was
David Brailer’s comment about avoiding irrational exuberance. Maybe the purpose
that I would get out of a retreat would be to be both tough minded and avoiding
irrational exuberance, because I think a lot of the things we discuss are
sometimes a little bit divorced from reality.

I would love to hear other peoples’ comments about how some of the issues
that we talk about apply in their own settings. I certainly could share that,
although this is not the proper forum to share it, but it might be more
appropriate in a retreat to see, this is what I hear when I am here at NCVHS,
and then when I go back to my regular job this is how things appear to me. I
would really like to have other people share that in a much less formal
setting. I think if a retreat could do that, it would be beneficial to us all.

Thank you.

DR. COHN: Let’s see, avoiding irrational exuberance.

DR. TANG: I would like to pick up where Carol left off, which is, the world
is transforming. This group put out the report, I think it was called
Information for Health, which put out the railroad schedule, the goal, the
destination and somewhat of a time line. It would be silly if the railroad
train is taking off for us not to be still ahead of it and planning out the
road map.

As a straw man, I would like to say, the goal of the retreat is to put
together a road map, and how our parts fit with our report, Information for
Health, the three circles, and dovetails or meshes with activities going on
with AHIC, the contractors, the other components of David’s plan. It is all
encompassing. It is not just in EHR. It really does talk about data that
supports population health. We put together the train schedule. Let’s go with
it.

MS. MC CALL: I have got to say something. I’m sorry, Jeffrey, I’m cutting
in line. Thank you, Paul. I am going to use this as an opportunity to please
ask each of you to come to the breakout session of the quality work group,
where we have begun to ask in a very preliminary way that very question. So
there is an opportunity, if you have read what is in the book, if you have read
the soft cover that has come out, please come. In a way, it is a precursor to
begin to plow some of the ground on some of the thinking, so it is a great way
for you guys to start to stretch on that question for the retreat.

Okay, done selling.

MR. BLAIR: One of the feelings that I have, we talked about the fact that
the world has changed. There is now an AHIC, there is now a framework to move
forward. Yes, a lot of it is built on the vision set forth by NCVHS, and we
graciously receive credit for that.

On the other hand, when I think of the last nine months and the initiatives
that have been put in place, I really feel as if a role for NCVHS as we go
forward has not been identified. So I want to take the comments that I made
before, but I want to extend them. I think we are proud of a lot of the
insights we have had as we look into the future and the initiatives we put
forward, and the issues we have identified. I don’t think I have to list them,
because we all know what they are.

But the problem is, because the world has changed, if we start pursuing
those, as good as they are and as worthy as they are, if they are perceived to
be independent or not matching with AHIC’s direction, then we may not receive
the same reception for implementation that we have received up until now.

So because of that, even if there are things we do independently of AHIC,
here is the kind of thing that I think could begin to at least have us moving
in parallel, if not in sync.

First of all, I think before that retreat occurs, we should do our
homework. We should identify all of the areas that we think we should be
pursuing during the next two to three years. Some of them will support the AHIC
initiatives and others won’t. We should share that with David Brailer before he
comes to us, and we should ask David Brailer first of all, when he does speak
to us, not only to pick from the list and say which ones he thinks we should
flesh out some more for direction, but also for him to add some that he knows
of that we don’t have on our list. We do our retreat, we flesh them out, we
figure out how we are going to do it, and then David Brailer comes back at the
end of the retreat, and we report back to him on how we would pursue the things
of interest to him. There may be other things we do independently, but that
way, we could get David to buy into, yes, we really are working on things that
will either fill in gaps or be synergistic and support some of his initiatives,
and we might have some things that are independent.

I think that way, we won’t just have a retreat and say we think we are
working together with David, but he winds up not agreeing.

DR. COHN: Marjorie, do you want to start off, and I’ll jump in?

MS. GREENBERG: I think everyone was really with you, Jeff, until we got to
the idea of inviting David or anyone else back. I think there is a feeling that
we can do this kind of work with interacting with David and with others before
the actual retreat, during the meeting, and then the retreat should be for the
committee and staff. That was the body language that I picked up, and I thought
to share that with you.

MR. BLAIR: Thank you.

MS. GREENBERG: But I like your idea of a list, maybe not just a shopping
list, but a structured list, that we not only might offer to David, but also to
Ed Sondik as the director of the population health statistics group, and to the
Board of Scientific Counselors, to our liaisons, maybe a few other people, and
have that input before we retreat. I think that is a good idea.

I saw a list that the NHII work group circulated last evening, and wow, it
was so many exciting topics on there, that it would take the committee the rest
of the century to address them all. But I think I am trying to give a little
preview here, so people will come to your NHII meeting from five to six.

Anyway, I want to also support what Carol said and what Bob would have
said. I know Simon is the chair, and he would have told you you are not on the
quality work group, you don’t have to come, we really encourage you all to be
there, because it is an opportunity, because nothing else is meeting at the
same time. So I want to share that.

Now, I had a few things here that I wrote down. I think we should make —
obviously the Executive Subcommittee will discuss this, and this has been
really useful feedback and I appreciate it. I think now we should retreat for
four days. But in any event, I think we should think in terms of some real
subject matter planning as you talked about, whether it be the road map — I
liked what everybody said, but I liked what Paul suggested, which is really
subject matter.

I also think we should think in terms of, this is an opportunity for self
criticism. Obviously when I hear one of our members who is a new member, but
was on the committee before, talking about rigidity, it is something I would
like to have less of even than in these formal meetings; admittedly they lend
themselves to it more.

So I certainly as the Executive Secretary would be very open to self
criticism and to that kind of feedback that we can think about how can we work
more effectively. I think we should think in terms of — it is a good time of
the year to be thinking in terms of, if there is one research project or
consultant, that type of consultancy that might support the entire committee,
whether it be the road map work or some other type of work. We do have some
funding from ASPE that we can use for something like that, not a lot.

Then I also think we should think about communication strategies, and how
can we — it would seem that we are not communicating adequately to some
constituencies. That is always the case, but how can we think of coming up with
not only our very thoughtful reports, but then some crisper ways of
communicating them to different groups, whether it be the community or whoever
our broad stakeholders are.

So those are just some thoughts that I had. So it is process and substance.

Then I haven’t even had a chance to mention this to Simon, but I was
thinking that possibly if people could still get home that night, or if they
didn’t mind going home on Saturday, if the full retreat ended around noon or
one, and the Executive Subcommittee, since we may not be able to have a
separate retreat for budgetary and other reasons, might have like two or three
hours to digest a lot of what was discussed, because it would be really fresh
then and it would have you there. So it would be a good opportunity. Maybe you
can still get late flights home, certainly people on the East Coast, but
everybody maybe still can get out of here that evening.

So that is just a thought to maximize the time that we have together.

DR. WARREN: I just want to follow up on Marjorie. When I was listening to
Jeff, I was probably one of those that had the non-verbal behavior when he was
talking about David Brailer. I kept thinking of the committee as more than just
working with David and the AHIC. Then Marjorie started commenting about that.
That is something I would like to see us look at in the strategic planning,
what relationships do we have, and what ones do we need to establish that we
don’t have. So looking at what is not there that should be on our horizon.

In my short experience on the committee, we have had such a tremendous
impact on what is going on and influencing people. I would like to see what
other parts within health care and the government that we could work with and
create some of the same win-win scenarios that we have in the past couple of
years.

So that would just be my piece. Let’s look beyond this initial flux of
health care IT and see where else that might go into, because we may find out
that there is a lot of synergy within all of these that we can influence.

MR. J. SCANLON: Again, I think in planning the retreat, just a couple of
things. I don’t like to argue against disclosure and openness, but we may want
to actually have a session that is closed, because there are forces and there
is history and there are ways that committees operate, and other forces are at
work that are probably best discussed in a confidential manner.

It is interpretive. It is an interpretive history and interpretive forecast
that probably doesn’t lend itself to being on the record. Again, that doesn’t
argue against the whole thing.

The other thing is, I think the committee has — at its best, it has been
at two extremes. One is, it was ahead and it was very thoughtful and very
capable thinking, where it was ahead of the curve. It could see where things
were going as a result of the committee process. Those things turned out to be
prophetic, and they turned out to be very useful. At another extreme, it is
where the committee was asked to do something specifically for the Department,
for an agency, for HIPAA, for whatever, and it very capably pulled together the
best thinking, the consensus, and was able to do that. But this was all in the
course of a very fluid and a very flexible situation, why the committee is
named what it is, what the statute says, what your charter says. You are part
of a moving river, and it is best understood — what it can do and can’t do is
best understood in that kind of a process.

So all these I think are quite fair game for a retreat. It is a
forward-looking and an interpretive look back as well. But I do think some of
this — and I’m not arguing for a closed meeting altogether — some of this is
probably discussed — since it is not leading to formal recommendations, I
assume, would best be discussed in at least a partially closed session, even if
it were a half an hour or off the record or whatever.

DR. COHN: That is a calming thought. I want to close this part of the
session. React to that, and then we will close the session.

MS. GREENBERG: It is true, there would be no actions taken during this.
This is strategic planning and all of that. If in fact people feel that it
really would be helpful to have an hour of the meeting closed or the entire
retreat closed, that is something — we have never done that, but there is a
process for it. But it takes awhile. You have to go to the Freedom of
Information officer, you have to make a case for it and you have to close up
the chain and all of that, to close a FACA meeting.

We don’t have to decide anything now. There is a process, because otherwise
if there weren’t a process it wouldn’t have teeth and legs. So if people
thought it would be helpful, then I think that decision needs to be made. The
worst-case scenario is, they say no. I have mixed feelings as to whether it is
even necessary, but I don’t see it as being necessarily problematic. I just
think maybe the Executive Committee can maybe be thinking about this. But it is
not something we would decide a few weeks before.

DR. COHN: Let me try to close the session. I don’t even know what comment
to make.

MS. GREENBERG: I think they want to have a retreat.

DR. COHN: Yes. Let me summarize. I think I am hearing a near unanimous
support about us having a full committee retreat. I guess I am reminded myself,
as I listened to various hopes, that without question we need to come up with a
clear set of objectives for the session. I think everyone has said that, and I
think we all agree.

I am reminded of conversations we have all had before, that one of the
strengths of the committee is that we have tended to have a balanced portfolio.
So not everything is ten years out, and not everything is due tomorrow, but
that we take a range of looks.

I would also comment that — and maybe this is in relationship to what Paul
was saying about the NHII report in 2001; I think many of us think that that
was a prophetic report. It is one of many of what have been prophetic reports.
One of the values we have is that we look around the next bend. That is how we
produce reports, with that sort of thought. So one of the key questions we are
going to have to be asking is priorities coming up, and what is next that
relates to our skills that we can add value to, that we can help show the world
what is beyond that next bend. I think that is some of how we are structured,
to get everyone’s best thinking on this.

The good news is, as we talk about all of this, I am reminded that at least
the Executive Subcommittee has done strategic planning sessions on an ongoing
basis. So rather than trying to reinvent the entire structure, I think we will
begin to look at those structures and look at those questions, and then move
from there, as opposed to having to go back to ground zero. I think many of the
questions I am hearing is the type of questions that we all try to ask every
year.

Now, I do hear something that would be very valuable with the Executive
Subcommittee that I can receive from all of you. I have heard interest, I have
heard you all have some very good ideas. E-mails to me that begin to talk to me
about what you see as objectives, either reasonable or unreasonable, as well as
this issue about not just the topics that we should be working on over the next
two to three years, but the objective of working on that topic, what we might
get, would I think be very valuable, because I think that is part of the
priority setting.

So as pre-work for the entire committee, I know how much you are all going
to love this, but I think the reality is that if you can put some thought into
sending something bulleted to us, it begins to provide some of those pieces
that we can begin to put together into something that gives us a little
advanced view of the structure, the discussion topics, the relative priorities
that we need to consider, because we clearly can’t do everything that we think
are good ideas. It at least allows us something to talk about, something to
begin to get input from Ed Sondik, from Dr. Brailer, from other thought leaders
within HHS and beyond. So that would be something that would be very helpful.

Now, beyond that I am going to ask Carol McCall, who is co-chair of the
quality work group and is a new member of the Executive Subcommittee, to assist
me in beginning to sift through some of this stuff and begin to propose a
structure to the Executive Subcommittee. We will be working on it, we will be
communicating with all of you.

I don’t think we are going to be spending long times having conversations
about closed sessions. I don’t think that is really the focus of the
conversation. but hopefully we will begin to develop, working with the
Executive Subcommittee, a structure in other things that then we will be
sending e-mails out to you, asking for your input, and thoughts about how we
can even improve on some of that.

Now, I will defer to an Executive Subcommittee meeting conference call,
probably in the next month or two, whether the Executive Subcommittee meets
after that day’s session, though I will admit embarrassingly that I actually
thought about the same thing. The question gets to be whether that really can
be done or not. We are going to have to think about that and see what the
Executive Subcommittee thinks.

But anyway, I really want to thank everybody for what I think has been very
good input. I have written down a lot of notes. The problem is, it is like my
medical record, and I can’t read it anymore, but hopefully I will be able to
remember at least some of the chicken scratching here.

MS. GREENBERG: We do have a transcript for this, at least.

DR. COHN: Yes, that’s good. Hopefully we will get a copy of that relatively
soon for at least this session. I want to thank everybody. It has been a
brilliant and very helpful conversation, so thank you.

We are running about 20, 25 minutes late for our next session, which Mark
Rothstein was going to take the lead on, talking about the work related to
privacy and confidentiality and the report. So Mark, I’ll hand it over to you.

Agenda Item: Subcommittee on Privacy and Confidentiality
– Update on NHIN Report and Recommendations

DR. ROTHSTEIN: Thank you, Simon. As you know, we are working in the Privacy
and Confidentiality Subcommittee on our report on the privacy and
confidentiality issues in the NHIN.

We met yesterday. We are making very good progress. I want to bring you up
to date on where we are, both procedurally and substantively.

I think there is widespread agreement among the committee members on the
substance of the draft report, in principle, as well as on our currently 28
draft recommendations, in principle. We have to do some rewriting to get the
language right, but that is I think easy to do, or certainly less difficult
than the substantive tasks that we have completed already so far.

We hope to have a new draft distributed to the complete NCVHS — this is
somewhat unusual — and ask for comments from the entire committee, which we
will then take into account your suggestions by e-mail and through conference
calls make those amendments or modifications. Then we will have a final draft
submitted to the Executive Committee, and it will be on the June agenda for
approval, we hope, by the full committee.

What is being distributed to you are a dozen, 12 of the 28 recommendations
that we are considering. These I have editorially called highlights. Other
words may describe them, but they are the 12 things I want to just touch on and
get a conversation going so you can see how we are thinking in terms of our
ultimate recommendations. I would ask you to please hold your questions until
the end so I can get through them, because we could spend all our time on the
very first one.

The numbers that I have used for this are the same as in the original
document, so the members of the subcommittee can recognize where they come
from.

Let me begin. Number two says that individuals should have the right to
decide whether they want to have their health records accessible via the NHIN.
There is unanimous agreement in the committee that it would be a bad idea
politically, ethically, legally, practically and otherwise to impose this
system on unwilling participants. We want to provide them with all the
information to make an intelligent choice, but they should have a right not to
be in it if they don’t want.

But that raises the question, as in number three, how do you not be a part
of it. There are two main ways you can do it: Have an opt-in or an opt-out
approach, and we recommend that the Secretary decide which one of these
approaches is most desirable and most practical.

Under either approach, in number four, it is important that it be a
knowing, voluntary, informed decision. In our construction of this, in our
discussion of it, we were informed by the problems associated with the HIPAA
notice and acknowledgement situation. We don’t want this to be a pro forma
ritual. We wanted to explore how this can be meaningful.

So that is the initial cut as to whether individuals want to be in or out.
What that means is to have their health information accessible via the NHIN. We
are going to take the questions at the end, remember? Thank you.

Number six represents the next decision point that the Secretary is going
to have to reach. That is deciding whether individuals should have the right to
control the contents of their information. So if you agree to have your
information accessible by the NHIN, does that mean you are in for everything,
or do you retain certain choices as to the kind of information that you want to
make accessible via the NHIN, and keeping other things non-accessible, for
example, psychiatric records. That is a decision point that must be reached in
number six.

If the decision is made to give individuals some ability to restrict the
scope of the disclosed records that should be limited, we think that if the
position is that individuals have a right to restrict certain disclosures and
the types of information, it should not be across the board. We discussed that
individuals might remove or block information that was of great clinical
significance and that would compromise care, and there have to be some sort of
rules set forth that would limit the scope of what people can choose not to
disclose.

We gave some examples. You might have an option of not including stuff that
was more than a certain number of years old, or within a certain condition or
treatment category, substance abuse, STDs, whatever, or the type of provider,
my psychiatric visits, for example. That is a very difficult thing to get a
handle on, as to what choices to give to people. It is a tradeoff obviously
between autonomy, the right of the individual to choose, and the need of the
health care providers and a system for adequate information.

Our thinking was that if we gave individuals unlimited discretion in this
area, we would basically be turning EHRs into PHRs. If you have PHRs that are
totally patient controlled, then the providers wouldn’t put much faith in what
they had. They would have to get new histories from the patients in order to
defeat the entire purpose. So this is an attempt to get some sort of tradeoff
if we go that route.

Now, when we go to number eight, it is another topic area. Indeed, this is
a different section of our report. We are tentatively recommending that HHS
should require that role-based access criteria, whereby health care providers
only have access to the information they need for treatment, payment or health
care operations be required for both EHRs and the NHIN.

We note that many systems already have this feature as part of it. So in
other words, the billing clerks don’t get access to the entire medical record.
The diet people don’t get access to the entire medical record. So your role and
what you are doing will indicate what you have an opportunity to see for
purposes of treatment, payment or health care operations. We believe that there
should be a standard for both EHRs and for information that is disclosed via
the NHIN.

An analogous concept, but in a different application, is number nine, in
which we are recommending or tentatively recommending that HHS should require
that EHRs and the NHIN adopt the use of contextual access criteria, whereby
health information disclosed beyond the health care setting on the basis of an
authorization is limited to the information reasonably necessary to achieve the
purpose of the disclosure.

The first one, role based access criteria applied within health care
settings, contextual access criteria would apply to information disclosed to
employers, insurers, mortgage companies, others who can in essence make a
condition of employment insurance — and when I say insurance, I don’t mean
health insurance, I mean life insurance, disability insurance — that
individuals sign authorizations releasing their records.

Even if they made a more limited request, which in certain settings legally
they are not required to do at the moment, even if they made a limited request,
I want Joe Smith’s records relevant to X, we don’t have the capacity to do that
now. We think that protecting the privacy of individuals really mandates this
kind of research and development into a new kind of architecture that would
allow only for this limited disclosure that would be relevant to its intended
non-medical purpose.

Number 13. We are thinking about recommending that HHS should harmonize the
rules governing the NHIN with existing privacy rules, including HIPAA’s privacy
and security rules and other federal regulations, which is those regulating
substance abuse treatment records.

We also think that we need to be thinking beyond the scope of HIPAA and its
three covered entities to think more broadly in terms of the NHIN. Historically
as we all know the purpose of HIPAA was to deal with health care transactions.
The NHIN is much more comprehensive. We on the subcommittee think we need to be
thinking more comprehensively in terms of regulating privacy and
confidentiality, and therefore in number 14 we say that HHS should insure the
privacy and confidentiality rules applicable to the NHIN should apply to all
individuals and entities that create, compile, store, transmit or use personal
health information in any form and in any setting, including employers,
insurers, financial institutions and schools.

Number 17, we say that HHS should develop a set of strong enforcement
measures that produce a high level of compliance on the part of custodians of
individually identifiable health information, but at the same time doesn’t
impose a level of complexity or cost that discourages investment.

In number 21, we say that HHS should impose severe penalties for egregious
privacy and confidentiality and security violations committed by any individual
or entity. As we know, under HIPAA there is the problem we have now, as to
whether it can be imposed on entities as well as individuals, and we suggest
that it should be applied to both in number 21.

Finally, of the 12 of the 28 that I have selected, HHS should establish and
support ongoing research to assess the effectiveness and public confidence in
the privacy, confidentiality and security of the EHRS and NHIN. This is
something we even talked about this morning, and we have repeatedly talked
about. This does not call for an annual doubling of the ASPE budget, but we
could make that an amendment as needed.

So what I hoped to give you in ten or 15 minutes is just a sense of the
things we are thinking. As I know you know, these are very complicated, complex
issues, and they often have many paths that you go down. If you do anything,
you have to think about B, C and D, but if you do B, you need to think about X,
Y and Z. We have been giving this a great deal of thought. I am very
appreciative of my fellow subcommittee members. I think we have all learned a
lot from each other. We hope to have something to you for a vote in June that
will be of value to the Secretary and others in both government and the private
sector who are wrestling with these issues.

So with that, we are going to open the floor. My subcommittee colleagues
have agreed to allow me to be the point person on this to present. They are not
going to present. They will help answer the questions.

DR. COHN: I was going to ask a question or two myself, since I missed the
last time.

DR. ROTHSTEIN: You must have been out when we all agreed we weren’t going
to ask any questions.

DR. COHN: You’re right. That is one of the things about being out of the
room when these decisions are being made. I am not so much going to argue, but
I am going to ask more for clarification.

Actually I had two specific questions. One had to do with number 13, one of
my favorite numbers, about — I’m sorry, it was nine. It has to do with the
contextual access by other implementation. Just to clarify that for me, the
first of two questions, I am presuming that that really solves only half the
problem, because you can have all sorts of contextual access in the EHR, and as
long as outside entities are allowed to request the entire record, it doesn’t
make any difference. Am I confused?

DR. ROTHSTEIN: No, that is correct. That is very astute, Simon.

DR. COHN: That is the first time anybody has said that today.

DR. ROTHSTEIN: The other half of it is that we need laws that limit what
people can ask for. So for example, let me describe the current framework for
getting information in the employment setting. After a conditional offer of
employment, where the employer says, you look great on paper, your resume is
terrific, you have got what we want, we are prepared to hire you to start March
15, but it is conditioned on your getting a medical examination. As part of
that, they can require lawfully that you sign an authorization releasing your
medical records to the employer.

Now, there are two states that don’t permit that. They are California and
Minnesota. In California and Minnesota, the custodian of the medical
information — well, the employer can only ask for information that is job
related. So if your job is to climb telephone poles, the employer can ask for
more information than if you are an office worker who is going to be sitting at
a desk all day.

But most if not all custodians of the information, notwithstanding the law,
they don’t have the wherewithal to limit the records, so they just send
everything anyhow, no matter what the law is. So what we are trying to
encourage is that the Secretary put some money into research and development of
this technology.

That is a long answer, and I apologize. The complexity of the technology
will depend to a great extent on its use. So for example, the easiest case
scenario is life insurance, because the end point is a singular end point. What
life insurers are concerned about is mortality risk, period. In fact, many life
insurers have gone to what is euphemistically or colloquially called
tele-underwriting, where they don’t get the medical records because it is too
costly to go through them. What they do is, they have a vendor who reads a
script of ten set questions and only those people who come up with a positive
answer, there is further analysis.

So what it shows is that it is possible to develop some sort of mechanism
for focusing on the relevance. If you get to employment, where there are tens
of thousands of job titles, it gets much more difficult, and I recognize that.

DR. COHN: Before moving on to question two, I was just going to suggest
that the subcommittee might want to consider having a recommendation which
deals with the other half of the question.

DR. ROTHSTEIN: We do.

DR. COHN: I apologize. That was question number one. The question number
two is maybe just a misunderstanding about 14. Maybe you can clarify, because
this is maybe a mis-writing issue. But as I am reading this, given that earlier
on in the document you have at least offered the possibility that people who
are involved — who opted in to the NHIN might have the ability to block
information.

As I read 14, I am trying to figure out is what you are proposing that any
blocking of information that occurs on the NHIN also applied to all individuals
and entities that create, compile, store, transmit or use personal health
information, including for example physicians’ offices or other things like
that?

DR. ROTHSTEIN: Yes.

DR. COHN: So this would also allow blocking of the provider’s record
vis-a-vis the provider?

DR. ROTHSTEIN: Yes.

DR. COHN: Really? In a local environment?

DR. ROTHSTEIN: Yes.

DR. COHN: I just wanted to make sure.

DR. ROTHSTEIN: Let me see if I can explain. Keep in mind, this is not — I
want to clarify, this is not a recommendation of the committee. This says when
we go back — if you are asking about recommendation number six, because that
is the one that is delete block, I want this to be clear that it is not the
recommendation of the subcommittee that individuals should absolutely have this
right. It is that HHS should decide whether individuals should have this right.
If they do, that right should be applicable across the board.

If we had contextual access criteria in effect, and this rule only applied
to third parties, we wouldn’t need it. The purpose of this rule is to apply to
providers. There is information that some individuals believe has no clinical
relevance today, and they don’t want their providers to see, and to the extent
that it does not compromise patient care, we think — well, there is an
argument that can be made, I don’t want to say we think because the committee
is not supporting this, an argument could be made that they should have the
right to not include such information.

So let me give you some examples of the kinds of things that were on our
mind. If you want, I can give you some examples.

DR. COHN: No, Mark, what I was trying to do was to clarify, because I
thought — once again, I missed part of the meeting yesterday. I heard about
this issue of blocking when you are transmitting something between providers.
This appeared to reflect on a provider’s own record, effectively their being
blocked from their access, which I thought was something I hadn’t seen before.

DR. ROTHSTEIN: It is number five of our draft recommendations, Simon, which
is not on here, but it is on the list that we discussed yesterday. So now that
you have raised it, I will tell everybody what number five is.

Number five again does not take a position in terms of recommendations.
Number five says HHS should decide whether the same rules regarding privacy and
confidentiality of health information applicable to disclosure by the NHIN
should also apply to information in EHRs. So that deals with the — you are
raising the question of, should it be just applied to what is transmitted, or
should it be information at rest, and we are saying that is a good question,
and that needs to be decided.

DR. COHN: Well, I guess I am confused, because I thought number 14 was
affirmatively saying that. This appears not the HHS should decide, this is an
affirmative recommendation that that is how it should be treated. I am just
asking for clarification.

DR. ROTHSTEIN: I don’t believe that rule 14 goes to that. What
recommendation, tentative, 14 is is to basically say that these rules
applicable to the NHIN should not be constrained by the three covered entity
classes of HIPAA, and it should be much broader.

DR. COHN: No, I’m not arguing with that. I was literally reading this and I
wasn’t sure what —

DR. ROTHSTEIN: We are recommending lots of things that are going to have to
be —

DR. REYNOLDS: That is consistent with what the committee recommended
previously in terms of pre-HIPAA.

DR. ROTHSTEIN: Right, this is just a jurisdictional issue.

MR. BLAIR: Can I ask a question? You probably noticed that Steve and I took
a bio break. When we came back, and I was listening to your listing off the
items, I really felt chagrined, because you have a great group of
recommendations there. I was really enthusiastic about the list.

As you began to read on more and more, I began to observe that many of
these are really requiring or recommending legislation rather than having HHS
decide. So I was wondering whether conversations in your group as to whether to
break certain of these out as legislation, others to say we are recommending
this to the Secretary, and thirdly, we are winding up saying we are sending
this issue to the Secretary to decide.

DR. ROTHSTEIN: I want to see if I can understand this correctly. Your
suggestion is — or question is whether it would be a good idea to separate the
recommendations into pure recommendations, if you will, deferrals to the
Secretary raising this issue, we would like you to decide it, and here are some
things where you are going to have to go back to Congress for.

MR. BLAIR: Yes, three different things. I support the items you have. One
of the things that I didn’t want to happen is that, if we don’t separate them,
I’m afraid that a lot of those things will get lost or delayed because they
weren’t addressed to the right entity.

DR. ROTHSTEIN: Do any of our subcommittee members want to comment on Jeff’s
suggestion?

DR. REYNOLDS: I think it is a good suggestion. I think like we said this
morning in our letter, once we finalized all this, we need to decide what is
the actionable level. I just think we need to put the exact same filter we
talked about earlier, so when we officially bring them through, we may adjust a
few words here and there, and then we can use Jeff’s comments as another filter
to make sure that we understand exactly how much chance these things have to
happen, and exactly how big or how small they would be.

MS. GREENBERG: All the recommendations obviously have to be made to HHS,
but indicate a recognition that these would require legislative action. That
certainly can be done.

MS. MC CALL: I like the addition, Jeff, that you made. I also think it is
important that if there are different paths for making something come to
fruition, some may be legislative, some may be through other vehicles, to cull
that out, were there choices, and to talk about the pros and cons of the
choice.

I think what I would like for us to do is to send things, both this and
what we talked about earlier today, to the Secretary that are decision ready,
that our next action is very, very clear. So I think we can begin to try to
frame everything up that way. It brings out a question I had about number
three. We go on to say HHS should decide something, but do we have a point of
view on opt-in versus opt-out? Do we have if not a point of view, at least some
information that says, in this scenario this is the information that we
received, the pros and cons of this, the pros and cons of that, recommendations
for where it should go for decision, other than just to say, you know what, you
are going to have to decide this one?

DR. ROTHSTEIN: Carol, let me explain how we handled this situation. I just
want to tell Harry and Paul and Simon — you can’t get anything past this
group, they are too sharp, they catch it right off the bat.

The recommendations or the ones on the list that are cast as HHS should
decide whether to do A or B are written that way because there is disagreement
in the subcommittee about whether to recommend A or B. We couldn’t decide
whether, so we just said this is a decision point.

In the report itself, typically the language is, there are two benefits of
doing it this way and there are three benefits of doing it this way, and the
Secretary needs to decide which. It means that we are divided somehow on which
way to go. These are very difficult policy and political judgments, and they
are going to revisit them anyhow.

So you are exactly right, and we really struggled with all this.

MS. MC CALL: I’m not to say that we need to make a recommendation at every
point. It really is not our place. But where we cannot, to provide all insight
possible, all possible recommended paths for gathering more information, just
what their next action should be, just to make it as actionable for them as we
possibly can.

DR. ROTHSTEIN: Well taken. We tried to do that. When you get the draft, if
it is deficient in some way or another or we failed to make an argument, or it
seems to be slanted one way or another on something where we don’t take a
position, please — and that is for everybody.

MS. MC CALL: I would also like to — one more comment — really applaud the
process that you are going through in general. You have done a tremendous
amount of work. In order to actually get the value of the minds at the table,
are going to send it out to the full committee prior to the Executive
Subcommittee, I think that it is going to be a richer output. I know that you
may get a coefficient, a drag, added to it. We will try not to do that to you.

I also think it is an interesting mechanism for hooking people into the
thinking and the thought process, so that people can take it back into their
own work. So thank you.

DR. ROTHSTEIN: Well, it should be interesting how it works. Thank you.

MR. BLAIR: Is she suggesting that some of us are coefficients?

DR. STEUERLE: I realize that you have disagreement from the committee on
your last comments on this opt-in/opt-out issue, but I would just like to make
a couple of comments there.

I think the wording of HHS should decide may need to be refined a little
bit, even if you don’t fully agree with where I am going to go. I am an advisor
to a group that is dealing heavily with the opt-in/opt-out issue with respect
to defined contribution pension plans, 401K plans, 403B plans, this type of
thing.

By the way, this has a long history, 30 years of history of opt-in on 401K
plans, and whether people are participating and whether they are going to get
adequate pension coverage. It turns out two-thirds of the population are not
very well covered at all under retirement plans, and there is a whole variety
of reasons, and they are opt-in.

There has been a lot of very recent research which shows that you get huge
differences in participation between opt-in and opt-out, because the overriding
winner in either system is essentially inertia. Inertia dominates. So the
decision to do opt-in or opt-out has very striking implications for very large
portions of the population. For instance, in the retirement area, the people
who opt in the least are the people who need it the most. This even includes
retirement plans where there is an employer match, which means there is free
money on the table. You can opt in and borrow what you need on the side, and
you have got all this extra employment — and they don’t do it.

You can probably look in the federal thrift plan, which is a fairly
educated population. You can look across any population of employees. Low
income people for instance come out very differently than high income people
when you do opt-in. I think maybe you clarified that in your thing, but it also
has implications for what data set you have. If you only get ten percent of the
population who opt in and you have 80 percent with opt-out, it may make a big
difference between whether you develop an adequate data set that even protects
the people that opt in.

Given that there is inertia, there needs to be some incentive in any opt-in
system for people to really want to do it. The incentive is, sign up for this
thing and you are going to be helping other people. Some of us may decide we
will go ahead and do it, but it is not clear to me, the normal person looking
at something, even though you said you would have this very clarified set of
things to read, which I’m sure is going to end up — no offense meant, Mark,
but once they get done with it is going to look like the I Accept on the
computer when you download something. It’s 40 pages and you say, I think I
accept. It is going to be the way it is going to be written up, no matter how
clarified it is. It just seems to me to have a lot of implications.

So this gets me to my final comment. I realize that you probably have had
some of these discussions. It is not clear to me you want to say HHS should
decide, because maybe HHS shouldn’t decide. Maybe you want to leave this to the
private sector to decide itself on a provider by provider or state by state or
city by city, as to whether to go opt-in or opt-out. If HHS is going to decide
we can’t require opt-out, we are scared to go that direction, it is not clear
to me you want to require opt-in, because that could really restrict the
options.

My last comment on this is — which is also with respect to this analogy
with the pension world — if you go opt-out, and there is a lot of movements to
do this both in the private sector and Congress, a lot of the providers, in
this case employer providers or pension plans, are going to say, we think it is
legal to do opt-out but we are scared we get sued, in this case under labor
laws, we get sued under tax laws, we get sued under age discrimination laws.
Give us a safe harbor, that if we do opt-out, you are in unless you opt out. We
can’t be sued.

So I think in this whole discussion, you also need to talk about ways that
if people do opt out, even if you don’t require it, that there be some limited
liability somehow or another created for providers to decide to go this route.
Otherwise, I think they will be scared to death to do opt-out, for fear they
are going to be sued.

DR. ROTHSTEIN: It is the patient who is opting in, not the provider.

DR. STEUERLE: Right, but opt-out means the provider is going to put you in
this record unless you opt out. Then the provider is scared of being sued, so
why would the provider ever do it if it is just pure loss to them of being
sued. So what providers need, providers in the pension area, they need some —
if I do it this particular way, I do it a particular way under certain safe
harbor set of rules, I can’t be sued for using an opt-out system. That is
different from requiring opt-out. It is saying, if somebody does opt out, here
is the legal protection we will give you against being sued, if you do it
according to standards A, B, C, D and E.

DR. ROTHSTEIN: I have a question, and I think this will be very helpful to
the committee. If we didn’t use that language that you questioned, in other
words, the Secretary should decide, where should we go? We could say a decision
has to bed made on this issue, or another point of contention is. Does that
leave it out there?

We don’t have agreement in the committee, even in the subcommittee and I
doubt the full committee, to decide opt-in/opt-out. So if we get to the next
level of granularity as to what that means for liability purposes, I just think
we can’t go in that direction.

DR. STEUERLE: But what I can’t tell from what you are telling me is whether
your subcommittee dealt with this intermediate grounds, which is that you are
not requiring opt-in. You are leaving it optional. Are there people who don’t
want opt-out, but nonetheless would be comfortable with an optional opt-out? If
there are, which may be the intermediate ground, then you need to provide some
liability protection. You need it if you require it, but you also need —

DR. ROTHSTEIN: Well, there is going to be a default. What happens if they
do nothing?

MS. MC CALL: There are some nuances on this one, and I don’t think they are
going to be decided here.

DR. REYNOLDS: I’d like to comment. Gene, I thought those were good points.
One of the things that we are struggling with as we look at these things,
different than a pension and different than a 401, there is something in
existence that you can put it against. So you kind of understand the rules of
401K, you kind of can explain it to somebody, and they kind of exist. You say
there is an employer match and so on.

# One of the reasons that as Mark had said earlier some of these decisions
aren’t as crisp, you don’t know what it is, and NHIN is still a thought, is not
actually there yet. You secondly don’t know how extensive it is, and what are
the rules. You don’t know if somebody wants to be able to block a piece of
their record, what are the opportunities and so on.

So one thing I thought that David said earlier today and I thought a few
other people mentioned is, and you may have been the one that mentioned, in
some of these where it has a curve, in some of these we are far enough ahead of
the curve that we want to make sure that the subject is clearly defined. On
others where we think there is enough in place as far as our understanding is
concerned, so maybe even playing off of Jeff’s earlier comment, not only how
does it get resolved, until the reality is clear, the exact selection of the
answer may not be quite as clear.

So that may be another way that we parse it as far as at least our thinking
and filters before we bring it back to all of you. So that is one of the things
that we also are doing.

DR. REYNOLDS: Those people on your group who favor opt-in, by that do they
mean they want to prevent Kaiser Permanente in California, which is a leader in
this area in terms of electronic health records, at least from people — not
from Simon, but I heard this from Alan Entoven —

DR. COHN: The answer is yes.

DR. REYNOLDS: Okay. If they decide they really wanted to go with an opt-out
policy, you would deny them the ability to do that. Is that what you mean by
opt-in when you say you are requiring opt-in? Or do you just mean you don’t
want to require opt-out across the whole system?

DR. ROTHSTEIN: That is a good question that we will take up. I can tell
you, we didn’t want to distribute the report now because it is not ready for
prime time, but I will quote to you from the way this passage reads.

There are two basic approaches for giving individuals the choice of whether
to have their health records available by the NHIN, opt-out and opt-in. Under
the opt-out approach, personal health information is presumed to be available
to authorized persons by the NHIN, but any patient may elect not to
participate. The advantages of this approach 7 are that it is easier and less
costly and likely to result in greater participation in NHIN.

The other approach, opt-in, requires that health care providers obtain the
explicit permission of patients before allowing their information to be
available by the NHIN. Without this permission, personal health information
would not be accessible by the NHIN. The opt-in approach increases patient
autonomy, but it is more administratively burdensome and may result in fewer
patients participating in the NHIN.

You have added another dimension, about whether we have to have a uniform
nationwide approach, or whether it can vary by provider, by RIO, whatever,
which is something that we definitely need to consider.

MR. BLAIR: Yes, but I also think you get something else which is very
helpful to the discussion. Clearly this is going to ultimately be a political
issue, and when it becomes a political issue it is going to be about an issue
of how much freedom does the patient or consumer have. In a case like that, it
always tends to go in terms of not providing a restriction or literature.

So he redefined the choices. It isn’t just opt-in or opt-out. It is opt-in
or, if you opt out, then you release the provider from your former freedom to
hold them responsible for quality and safety. It redefines the choices.

I think that that winds up enabling and facilitating a decision, because up
until now people just saw liabilities on both sides, but now you wind up seeing
a balance. You can have this freedom, but if you have this freedom you assume
certain responsibilities as well. I think that helps.

DR. ROTHSTEIN: Jeff, I respectfully disagree with you. I don’t think that
is the on-off switch. To be heretical for just a minute as per usual, I am now
given a choice as to whether I want to opt in or opt out. I want to opt out. I
see no benefit to me to being in the system unless they drag me in after a car
accident, because if I want my records shared electronically by the NHIN, I
will sign a piece of paper and direct any particular provider to do that.

So by doing that, by opting out, by not being part of the system, I am not
releasing anybody to do anything. Why should my failure to say I want to be
permanently in the NHIN mean I am making any judgment with respect to
liability? I am making a judgment as to the risks and benefits personally.

DR. STEUERLE: Can I just clarify language, because I know this is
confusing? When I say opt-out, I mean you are in unless you opt out. Just so
you know that we may have a language confusion.

DR. ROTHSTEIN: Okay.

DR. COHN: We need to begin to wrap this up. I know we could spend all
afternoon on this, and maybe the three days in June.

DR. HUFF: My question maybe is a simple one. When we talk about opt-in and
opt-out, is it specifically restricted to the national network, or can I opt
out of having any electronic record?

DR. ROTHSTEIN: That is a good question. Actually it is recommendation
number one on our list, which says, the method by which personal health
information is stored by health care providers should be left to the health
care providers. We discuss in there that you do not have a right to require
that your records be maintained on paper or on tree bark or any other form.

DR. COHN: Would you like to make a last comment?

MR. LOCALIO: This is very much procedural. Can you give us a timetable?
Because between now, the end of February, and June, an issue this broad there
is not a lot of time.

The second question I have is, if we decide to vote on this in June, since
I have been here I have never seen anything other than a unanimous vote on a
report or recommendation. Is that always the case? What are the procedures for
minority views?

DR. COHN: Russ, let me try to address that, and I will also look to our
Executive Secretary and Executive Director now.

From this conversation I am reminded that we have a ways to go on this
document. Curiously, when I am out of the room, things seem to be much easier
than when I am in the room on this one. So maybe I’ll show up in June again for
these conversations.

I do believe that number one, there are going to be conference calls to
further refine all of this stuff.

DR. ROTHSTEIN: Yes.

DR. COHN: I am hoping that things where there is no recommendation, my hope
would be if it is appropriate that there are suggestions for things the
Secretary can do, he will get enough information that will allow him to make a
recommendation, studies, pilots, on and on and on. There will be ways some of
this stuff gets further fleshed out.

But certainly for those of you who are engaged in this one, I certainly
encourage you all to participate in at least some of the conference calls so we
can begin to have some of the conversation before June, because otherwise we
may have to extend the meeting for a couple more days just to handle this
issue.

Now, in terms of committee consensus and all that, we strive for committee
consensus. I think it strengthens the recommendation. It is something that I
think is a very desirable attribute. In the history of the committee, consensus
has not always been reached and indeed, there have been occasions where there
have been reports with dissenting comments. So certainly if at the end of the
day this thing comes out as two people dissenting or even three people
dissenting or whatever, and people want to submit any comments, of course that
is a very appropriate thing to do, and we would welcome that.

Now, I will see however that if this thing winds up going to a seven to
eight vote or something like that, I think at that point, it has to go back to
the subcommittee to develop a slightly greater majority than just a bare
majority. But that would be something we could all discuss, and hopefully that
would not be the case.

Mark.

DR. ROTHSTEIN: We did discuss this yesterday in the subcommittee. It is
certainly a fair topic for discussion in the wider full committee. I think our
feeling, and my colleagues will correct me if I misstate this, our feeling was
that it would not be as powerful a letter if we said the committee by a ten to
seven vote says this and by a 13 to four vote says that.

Plus, the issues are so important and so contentious, people who were in
the minority on one point or another then might feel compelled to write a
dissent. So now we have got a report with one or two or five different
dissents. I think that overall would not be good.

No one is going to find this report that we have written or any report 100
percent to your liking. What we have tried to do is come up with language where
if it doesn’t go your way, at least you can live with it. That is why in
several key areas basically, we just deferred to punted or ducked the question,
because we couldn’t reach agreement. But it is the committee’s call, whether
you want opt-in, we don’t want opt-in, whatever. But I think then there is a
cost to doing it that way.

Is that fair, Harry?

DR. REYNOLDS: Yes, and I would add one thing to that. We have held hearings
on this in Washington, Chicago, San Francisco, so since this is such a
widespread issue, we have gone out to the environments, too. We have heard a
whole lot of testimony, so a lot of what is written here is also based on — it
is not the findings just of the committee. It is a significant number of
testifiers.

So that is another thing we hope everyone can keep in consideration,
because sometimes we have had to park our own personal feelings sometimes,
based on what we have heard from everyone that is out there, and it is the
desire of them also.

DR. TANG: I have a process question that perhaps the committee could advise
the subcommittee on. That is, we heard Harry this morning retract the ROI
letter, appropriately, and got commendation for that. What is the committee’s
feeling about whether it is useful to provide recommendations that say someone
else should decide, versus perhaps coming to a vote in the subcommittee?

I think that is a legitimate process question, and maybe the committee
sentiment would be useful to the subcommittee in its deliberations.

DR. ROTHSTEIN: What are you saying? Paul, I don’t understand.

DR. TANG: The ROI letter was retracted because they didn’t feel that the
verb encourage was strong enough to come out of the committee. There are some
draft recommendations that say the Secretary should decide, which seems similar
to the encourage comment.

So the question is whether the committee feels that we would take the tack
that the standards committee said, which is, let’s put a real action verb
versus, let’s hedge or suggest that somebody else decide. Is that a legitimate
question to ask the committee to comment on?

DR. COHN: I don’t think we are going to have a vote on the level of the
action verb that passes the committee. But I think what we tried to do, and I
will almost reproduce what Carol McCall was saying, which is something I think
we have held to as a general view, we to the extent possible like to have
things decision ready. That isn’t just throwing decisions over to the Secretary
because that doesn’t help a whole lot.

There are some times that at least the way you phrase the question, you
can’t answer the question, or there isn’t enough information. So we certainly
encourage on any issue that we are trying to advise on, if there is indeed an
issue there, maybe we can’t say yes or no, but we can say if you do X, Y and Z
you would have more information upon which to base a decision. So that becomes
not, you decide, but we recommend you do because it is not clear what decision
you should make yet. You ought to do research, you ought to do pilots, you
ought to do demonstrations. There is a variety of things that are not yes or
no. So it is just sometimes a different way of framing the question.

But it is a full committee decision when it comes to a vote about whether
— it isn’t typically a one out of 23 recommendations. It becomes the main
issue. It is how they all play together.

DR. ROTHSTEIN: I think the difference between the other letter and our
letter is that there was committee agreement, but there was a problem as to
what was going to happen after it left here.

Our problem is, there is no agreement. We can agree on whatever verb you
want, but not on the substance that goes after the verb.

DR. COHN: I’m glad to see the committee is going to be meeting between now
and June. Don, final comment, and then we need to wrap up, and we will have our
next presenter.

DR. STEINWACHS: I was just curious. The opt-in/opt-out got me thinking
about the question of what I would call almost a patient safety record. It is
not your whole medical record, but has information about allergic reactions and
maybe a few critical kinds of conditions, something that if you came to the
emergency room you would sure as all heck like them to know.

In the testimony you got, did people talk about some sort of minimal amount
of information that you might opt in for, but not opt in for the whole record?

DR. ROTHSTEIN: Yes, we did hear that testimony in Chicago in particular,
the continuity of care record, where there would be eight or ten specific
fields. Without saying that, that is implicit in the idea that we are going to
limit what patients can exclude, block, et cetera, so that what would be left
would be at least this core.

But we can’t say too much, because the more we say the less chance we have
— this is not disparaging my colleagues; the more we say about these kinds of
things, the less chance we are going to have everybody on board. That is just
in the subcommittee.

DR. STEINWACHS: I agree about the idea. You need to have a set of
principles in a sense laid out, but you can’t get too specific. But thank you,
that was helpful.

DR. COHN: More to come on this one. I would ask the subcommittee to give to
the full committee the schedule for conference calls on the topic, so those
interested can participate.

With that, Mark, thank you very much. I know any conversation on this that
includes the chair is always a difficult conversation, based on yesterday. But
thank you for putting up with me and the others.

I want to invite Dr. John Ring to join us. I want to thank you for being
willing to brief the committee on the new report on performance measurement and
accelerating improvement. I don’t think you were intimately involved in the
project management of this activity, though maybe you can clarify that for us.
We want to thank you for being willing to come, anyway.

Agenda Item: IOM Report Briefing – Performance
Measurement, Accelerating Improvement

DR. RING: Dr. Cohn, that has to qualify as one of the understatements of
the year.

My name is John Ring. I am recently appointed as the Director of the Board
on Health Care Services at the Institute of Medicine I take particular care not
to say that I have taken the place of my predecessor, Janet Corrigan, because I
think it is probably impossible for anyone to do that job. I do want to
recognize though the important contributions that Dr. Corrigan made, first as
an overarching study director not only to the performance measures report, but
also to the two that follow in what we are now calling the Pathways series.

I would also like to recognize Rosemary Chalk, who is the Director of
another board at the Institute of Medicine and who was willing to step in and
take Janet’s place from a functional perspective as study director. She has
made great contributions, too.

I am substituting as a presenter today for Karen Adams, who is the staff
member who was the principal author for the performance measures report. Karen
cannot be with us because as of February 17 she has taken a position with
Commonwealth Fund. While we are all delighted at her good fortune, we are sorry
to lose her, particularly at this juncture. I had to take great pains not to
take it personally that she chose my birthday as her last day of work at the
Institute of Medicine.

I have brought one of the other staff members with me, Samantha Chow, who
was involved directly with the work that has gone into this report. It is my
firm intent to defer any difficult questions, particularly logic questions, to
her. That is the reason that I brought her up to the front of the room, so that
she could not make an easy escape.

Very simply put, this is why I think all of us are engaged in this process.
We recognize that there is a shared mandate for change, that the quality of
health care provided in the United States is both suboptimal and uneven, that
its cost nonetheless is considerable, and that health care value which we
define very loosely as quality for cost, should be improved.

There is as one comes to anticipate in the IOM process a relatively
extensive background that goes into forming this mandate for change. Work by
McGlynn indicated that less than 50 percent of the indicated health care
services are actually received in the United States. Work by Hussey and
Reinhart demonstrated unequivocally that other countries have better
performance and oftentimes realize performance at substantially lower cost, so
that the value of the health care they provide is different and better than
what we do in this most of First World countries.

Baker and Chandra Fisher have indicated that just as there is variability
from country to country, there is also considerable variability, one might term
that a disparity, in value within the United States, and that areas that spend
considerably more on their health care do not reap an improved quality.

For us at the Institute of Medicine, we come back however to two seminal
works, largely the production of Dr. Corrigan and her colleagues over the
course of the last ten years. The first report in the Quality Chasm series, To
Err Is Human, outlined the scope of the problem, and that scope is
breathtaking. The second report, Crossing the Quality Chasm, laid out what we
see as a vision for radical change within the health care system. That
articulates the six aims, that health care should be safe, it should be
effective, it should be patient centered, it should be timely in its
administration and efficient, and that it should be equitable. We have made
some but certainly not sufficient progress toward these goals.

As far as performance measurement is concerned, those goals have a
particular focus. We intend through the development of a performance
measurement system to advance the quality agenda by enhancing the quality of
the clinical services that are provided, by reducing both waste and
inefficiency within the system, by promoting patient safety. Through decreasing
waste and efficiency and improving quality of service, we hope to not only
insure but to increase value. Finally but not least, to foster equity in the
delivery of health care.

Congress has heard the same thing that we have. We received a mandate from
them for study. That was actualized through the Medicare Prescription Drug
Improvement and Modernization Act of 2003, and it falls into two parts. Section
328 mandated that the Institute of Medicine develop a report that speaks to
performance measurement, not only the measurement system itself, but its use in
a particular fashion to promote quality of care, that is, the so-called pay for
performance program. Section 109 of the statute mandated a separate look at one
response to the quality consideration, that is, Medicare’s quality improvement
organization program.

Our response at the Institute of Medicine was several fold. First, as is
our wont, we convened a consensus committee to study these questions. We are
fortunate to have in the room today Dr. Steinwachs, who served very ably as the
coordinator for the performance measure report. I do not mean to put you on the
spot, but I do want to acknowledge that such value as this report may have is
due in large part to the review process which Dr. Steinwachs served so ably
here.

The consensus panel quickly decided that rather than producing two reports,
it should produce three, at no increased cost to the sponsor. The first charge,
that related to Section 328, morphed into the performance measurement report,
about which you will hear more in a moment, and in the greatly anticipated pay
for performance report which is scheduled for release in July of 2006. Again,
Dr. Karen Adams was the lead author for the performance measures report, and
has served up to her departure from the institution as the guiding force behind
the pay for performance report.

The Section 109 mandate is addressed through the quality improvement
organization’s report, which is scheduled for release either at the end of
February or during the first week in March. The principal study officer for
that report at the Institute of Medicine is Diane Wollman.

The next two slides indicate the members of the committee. So if you have
particular concerns, particularly those that you want to express forcefully to
someone, I direct you to Dr. Schraeder and his colleagues. The sponsor for our
report is the Department of Health and Human Services, in particular the
Centers for Medicare and Medicaid Services. The project officers with whom we
have worked and who as well have contributed to the quality of the process are
listed there.

The focus on measurement and performance comes about as follows. We
perceived that the current American health care system is performance impaired.
We recognize that much needs still to be done to realize that bold vision of
quality care that is laid out in the Quality Chasm series of reports, and that
performance measurement in particular is the key to effect any specific change.
That refers to public reporting, clinical quality improvement, provider
accreditation and again, that feature which is receiving so much attention of
late, pay for performance programs.

Development quality measures clearly has to precede implementation of
programs, else we have very little to do other than bandy about good theory.
Dr. Feinberg I think said it best, as he is so often able to do. Quoting from
the forward of the performance measure report, he stated, “The only way to
know whether the quality of care we provide is improving is to measure its
performance.”

What are the limitations of our current performance measurement system? We
use the term system loosely, because that is one of the problems identified by
the committee, the lack of a comprehensive and integrated system. Performance
evaluation currently relies on a voluntary consensus based effort. That effort,
though noble in its intent and oftentimes very productive, lacks statutory
authority to move forward to enact the entire vision, and I believe it lacks
overarching leadership as well, something that can be provided sensibly and
probably only at the national level.

There are particular critical domains of performance that lack owners and
in consequence they will remain unaddressed. Conflicts of interest, both
perceived and real, will limit the engagement and acceptance of performance
improvement measures by stakeholders. Finally, duplications can inconsistently
lead to waste. The public is confused; what measures should they attend to,
what measures are important for their personal health. Providers are burdened
by data gathering and reporting requirements, requirements they have to accept
because it speaks directly to their economic livelihood, which in turn defines
at least in part their ability to carry forth their missions. Finally, the
exchange of knowledge is limited, because each of us is looking at a somewhat
different thing. It is akin to the fable of the elephant and the blind man. The
programs look a little bit different, depending on what your perspective is.

The key recommendation of the performance measure report is that our
current non-system of performance assessment is an unsurmountable barrier to
improvement in health care quality, reductions of cost and consequent increase
in value. A well-coordinated national system of performance measurement and
reporting then is essential in order to achieve these goals. Again, we feel
that the federal government is the logical and necessary entity to take this
role, because it represents the 800-pound gorilla, the King Kong of performance
measurement.

What alternatives to the current system were explored by the committee? I
want to emphasize first and foremost that there is nothing in the performance
measures report, at least there is no intent that the performance measures
report should replace ongoing activities in the public or the private sector.
Rather, the intent is to supplement and strengthen these activities. This
clearly could be the role of the federal government, but which program? It
might logically be lodged within a particular office, for example CMS, AHRQ or
perhaps CDC. Clearly private stakeholders have contributed in important ways to
this process and could continue to do so, building upon the good work that they
have done before.

But it was the committee’s consensus, and a consensus relatively easily
achieved, that what we require is a new and independent board. Before I go
farther, I want to make all of you in this room aware that in the context of
the IOM review process, any committee recommendation that involves creation of
a new entity or a substantial increase in cost is particularly closely
scrutinized by the reviewers. There is a different standard of evidence, a more
convincing line of argument if you will that has to be advanced before that
report is improved for institutional release.

This presentation has one confusing and complex diagram for those of you in
the room to use at least in part as an eye chart in order to test your visual
acuity. But what this represents is the committee’s vision of the way in which
a performance measurement system could actually be schematized.

The purpose at the top is the reason for being for the performance
measurement system. The new independent board type entity to which I alluded a
moment ago has oversight, coordination and direct action functions throughout
this system.

I am going to complete my remarks by exposing those of you who haven’t read
the report to the full force of the institutional language.

Recommendation one reads as follows. Congress should establish a national
quality coordination board which has seven key functions. It will specify the
purpose and aims for the American health care system. That is a simple enough
task, isn’t it? At the very least, it allows us to come up with some relatively
high faluting language which is partial compensation for the work involved in
producing this report.

I question as an individual provider, as an American citizen, whether there
is sufficient societal consensus as to what our purpose and health care aims
are, but that may be a discussion for another day, and certainly a discussion
to which a performance measurement system can speak with evidence.

The second function is to establish short and long term national goals for
improving the health care system. This constitutes the road map. The final five
key functions on this and the following slide are operational in nature. This
entity could designate or if necessary design and develop standardized
performance measures. It could insure the creation of data collection,
validation and aggregation processes. Very important, it could establish public
reporting methods that are responsive to the needs of all stakeholders.

Again, from my perspective, that communication function is not a one size
fits all process. This key piece of translation has to be communicational in
nature. It has to speak directly to the stakeholder constituencies that are
involved. That probably will require a variety of methods in which the
information is disseminated.

It will be key not only for performance measures but for particular
programs such as pay for performance to identify and fund a research agenda for
the development of new measures, measures which in particular address gaps in
performance that is part of the reason for being for a new national
coordinating entity.

Finally, we need some type of a feedback loop, both positive and negative
in nature, that will allow us to evaluate performance measurement in as close
to a real time fashion as we can.

There are five more recommendations.

The second recommendation is that the membership of the board be structured
in a fashion that insures structural independence, substantive expertise,
contract authority, standard setting authority, financial strength and external
accountability. I can recall my Senate mentor, Michael Enzy, nodding his head
as he heard each of these presented, particularly the last, external
accountability.

The third recommendation is that while we want to include pertinent
stakeholders, public and private purchasers, accreditation and certification
entities, federal, state and local government authorities, we need to make
certain that whatever system is implemented makes ample provision for local
innovation. In that regard, the states serving as a laboratory for democracy, a
laboratory for health care innovation represent one option for the pilot
project nature that some of these initiatives are likely to assume.

The fourth recommendation is that the new entity should promulgate measure
sets that build on the work of public and private sector organizations. Again,
I want to emphasize the committee’s firm consensus that the wheel should not be
reinvented, that much good work has been done, but that at the very least a
more substantial coordination function is indicated, which function cannot take
place with any other than the federal level.

One of the points in this slide, to insure that technical and financial
assistance is available to all providers who need help in establishing
performance measurement and improvement capabilities, speaks very directly to
the function of the quality improvement organizations in the Medicare program,
which organizations will be the subject of the next report in the Pathways
series to be released.

One of the things that the committee chose to do, chose as a reflection of
the eagerness to get going with this measurement and improvement process, is to
identify what are called starter sets of measures that might reasonably be
implemented now, not necessarily as a final answer for any particular domain of
care which they address, but rather as a good place to start in something that
necessarily needs to be coupled with followup.

As you flip through your handout, as we amble through these four slides
here, what you can see is that we address different domains of care, ambulatory
care and inpatient care, specific disease processes, for example, end stage
renal disease, payor and accreditation organizations, and one area of
particular interest, longitudinal measures of outcome and efficient which are
particularly important for a process which is in evolution, and a process which
increasingly at least in the Medicare population will address issues of chronic
disease.

The fifth recommendation is that the new national entity should formulate
and promptly pursue a research agenda that supports this process. This very
simply recognizing that there is a lot we have to learn, a lot of data that
needs to be gathered and evaluated in order to test the good theories to which
all currently are attending.

The last recommendation is that Congress, the federal government, should
provide sufficient financial resources in order to carry out this challenging
task. This again links the federal government in another important fashion to
this national performance improvement measure, recognizing one of the few
fundamental truisms that the man who pays the piper calls the tune.

Having said that, having made a particular point in favor of federal
government funding, this should in no way be construed as a point against
public-private collaborations. Hopefully this will in fact foster this type of
collaborative effort.

Finally, to again diffuse the responsibility from myself and Sam, I would
like to indicate the subcommittee members who worked on this particular
performance measurement report. You will note that it includes members not only
of the full committee, but also those who were recruited for their particular
expertise to work on this particular report.

Finally, I would like to recognize Dr. Tang, who is a member of the Board
on Health Care Services, and in a very real sense one of my bosses. So I hope
that that is a friendly face out there in the audience.

If there are questions, it is certainly possible that I will not be able to
answer them. It is within the realm of possibility that Sam will not be able to
provide you an answer today, but we are dedicated to an open exchange of
opinion in this regard. Again, we see this as a process which is in evolution
with the report in a very real sense being a springboard to further activity.

That is my contact information. Please feel free to use it. Those are some
of the pertinent sites through which you can get further information about this
particular process, and in general about the entire Institute of Medicine
quality agenda, which is beginning with this series of reports its second
decade of activity.

DR. COHN: Well, John, thank you very much. I guess we are now free to ask
you any questions. I will just ask a very basic one, and I see Bob Hungate and
Justine also have questions.

The expected release schedule for these other reports is?

DR. RING: We anticipate that the QIO report, which lacks a particular name
at this point in time, will be released to the sponsor at the end of February.
There will be a brief series of Congressional briefings, particularly for the
Senate Committee on Finance, that will follow that sponsor briefing by a matter
of hours. Then the subsequent public release will be within a week. So you can
anticipate the release of this report, the QIO report, in the first week of
March.

That is not the one you are asking about, though. The pay for performance
report is the last of the reports to be addressed in this multi-year process.
That reflects not a lack of value to the committee or interest to the general
public, but rather the necessity to have something said about performance
measures first, else how do we go about paying for performance, which is
predicated on robust performance measurement. We anticipate the release of that
report the last week in June or the first week in July.

DR. COHN: Great. Bob Hungate and then Justine.

MR. HUNGATE: I have two questions. First, a commendation for the
constitution of the two committees. I will admit to being a corrupted but
frustrated patient. I served on the board of AHQA, which is the trade
association for the QIOs, for eight or nine years, and have worked with that a
lot. I was on the board at the Washington Business Group on Health when the
previous measures were developed. I have worked with this field for 20-odd
years.

The recommendations here remind me a lot of the content of the
recommendations behind the creation of AHRQ and the projects which were
supposed to come out and do great things on the same agenda that is listed
here. I was 50-some-odd then, I am 70-plus now, and have seen little
substantive change. So that is my frustration.

Where you come down on these things depends a little bit on where you sit.
I sit in the patient side. I look through and I like a lot of what I see
analytically. I like the statement by Dr. Feinberg. The only way to know
whether quality of care is improving is to measure performance. I agree. I
expect that from my personal physician. I expect that of the surgeon when I go
for surgery, and I know it isn’t there, and that troubles me.

This is asking for a national leadership in something where I think the
change is more local. I have come to believe in the strength of the democratic
model of the consent of the government. I see the IOM as at the apex of the
practice of medicine, and physicians at a very high position of respect in
society.

So when I look at the alternatives to the current system, I want to put
another one down at the bottom which isn’t here. That really leads to my first
question. What happens to the committees that are formulated, now that their
formal assignment has been done? I am hoping that they will stay in place and
continue to work.

I come from an experience in industry where we work through as a company
changing from a very slow information system to a real time information system,
changing from quality assessment to quality improvement. I think that is what
we are trying collectively to get to happen in health care, but we are falling
back on hierarchical methods. These recommendations are all hierarchical, and I
don’t believe that measurements at the national level are going to help me with
my physician. That is based on a long experience of dealing with the content.

So I would like to suggest that there would be another option. That is to
say that the practice of medicine needs to adopt the statement articulated by
Feinberg, and that the locus of implementation, rather than a national board,
needs to be the medical specialty and subspecialty societies themselves, that
the gathering of data and the assurance of validity of that data in self
measurement is the critical piece of the change component.

I articulate that because I think it is essential, and I think IOM is the
place to lead it. So the recommendations feel to me like they are asking
somebody else to tell us what to do, when in fact the answer ought to be pretty
clear.

So I would say that one recommendation instead, an alternative set, might
have been that we need to move the locus of attention from place to procedure,
so that the data that is collected can be fed back to patients to create valid
expectations. Right now they get expectations from clinical trials and some
research. The time cycle of diffusion is very slow, it needs to move through
real time.

I am trying to articulate a frustration which says that I am not going to
live to see if the result of these recommendations give me any benefit.

DR. RING: I am a little bit younger than you are, though I don’t think I
look it, and I certainly don’t feel it, and I am not certain that I will live
to see the full results of this, either.

Let me offer you, because I am so very new to my position, some individual
rather than institutional responses.

MR. HUNGATE: Mine is individual as well.

DR. RING: The first is that as a boots on the ground provider for the last
30 years, I have found universal receptivity to the concept of clinical quality
improvement. I find I have found very few of my colleagues who resent the best
of patient centered care, and this is coming from a pediatrician where that
patient centeredness is transmuted through the parents or other caretakers.

I agree completely that a logical and likely to be effective focus for
implementation is through the professional societies. Within the last three
days, we have seen an announcement by the American Medical Association that
they are going to work with CMS to do quality. Within the last three months the
Heart Rhythm Society has moved far along the path to what could be a similar
type of program as far as medical devices are concerned. Even as we speak, the
National Cancer Forum, another entity of the Institute of Medicine, is
presenting in part a performance measurement program initiated in a very
informal, very effective provider based fashion by Joseph Simone, addressing
precisely these issues of not only low quality, but low value cancer care.

So I think the physician provider community is very interested in
participating in this process. When I read through this list of
recommendations, I see it as somewhat less top down than perhaps it appears at
first glance. I think that with its emphasis on collaboration and local
initiative, there is the opportunity for physician professional associations,
for example, to participate. At the very least, the door is not closed to that,
and those societies will have the opportunity to put — I was going to say
their money where their mouth is, I guess that’s right, to put their money
where their mouth is, as far as actually participating in these processes.

My understanding of the work of this committee, certainly my direct
experience with that work in the second two reports, is that it is very patient
focused. So there is the intent in each instance to move from the abstract to
the operational, recognizing that the more operational you become, the less
flexible you may be, a bad thing, and undefined.

MR. HUNGATE: The thing I am trying to push for is that I would like my
physicians to be participating in data pools that enable them to do that. So to
me, the recommendation might have said, you can’t practice medicine without
participating in data pools that enable you to do better. That is a different
kind of recommendation which to me has the promise of faster action than to
create a board which is going to make it happen. But that is just an emotional
response to having dealt in this field for a long time.

DR. RING: It seems quite logical. Again, one of the collaborators
identified are accreditation organizations, and accreditation organizations,
particularly for example if they were to link to licensure, might be able to
advance that agenda. Clearly the committee chose not to become that
operational, but again, I believe they leave the door wide open to that type of
collaboration.

MR. HUNGATE: That is a very encouraging and helpful answer. Thank you.

DR. COHN: Justine and then Jeff, and then we will try to wrap up and break
before we move to the next group.

DR. CARR: Thank you. I comment this work for taking a very chaotic and
rapidly growing domain and trying to impose some structure on it. I hear what
Bob is saying, too. There is a lot to be done, but this is an interesting
organizational first step.

I just have a question. In recommendation number one, item number four,
insure the creation of data collection validation and aggregational processes,
I am curious whether there was further discussion or detail about that. I think
there are things in place, the organizations, the NQF, AHRQ. There are many
bodies trying to put forward measures and so on.

Something that we have dealt with in the quality work group and heard about
in some of our hearings is the enormous burden on the individual physicians or
institutions trying to generate this data. We spent the morning talking about
the electronic health record and so on. But was there any discussion or thought
about what does it mean when it says insure the creation of data collection
validation and aggregation processes? One of the challenges to expanding all of
these metrics is what is the evidence, and then what is the available data, and
then how do you get it. I interpret that to say there is a lot out there that
is already there. Do you have specific recommendations underneath here that
says how to harmonize, reconcile and exploit whatever existing infrastructure
to build your vision?

DR. CHOW: Our specifics pretty much are, we would like to exploit all
resources possible. It is just the idea that we are trying to coordinate all
the efforts going out. We recognize that NQF and NCQA have done a lot of work
in this already, and a lot of other organizations, a lot of private specialty
groups, already have. So what we want to try and do is get them — our vision
would be to see the NACB, this board, try and get them all in the same room
more or less and say — the burden is on the providers right now, because they
have to collect for so many different groups, and all the measures are slightly
different, based upon the different specialties. So what we would like to do is
collaborate those and collapse them into one set of measures that the provider
has to collect, and to minimize that burden.

DR. CARR: We were using a term earlier in the day that you may not have
been here to hear discussed. We talked about things being decision ready. So
you have a set of recommendations, so the question I would say is, they may not
be here in this PowerPoint, but are they in a form and to a level of detail,
that somebody could take them if they took the time to read them and go, we can
do that, I know exactly what to do next? Or is there more work to be done to
actually design what it means to insure the creation of data collection?

DR. CHOW: There is more work to be done, because we do not want to get to
that level of prescription.

DR. CARR: Thank you.

DR. COHN: Jeff, last question.

MR. BLAIR: First of all, I don’t want to miss my opportunity to indicate
how much I respect and admire the reports that the Institute of Medicine has
given us during these last ten years. They have been tremendously helpful and
influential.

I am really glad that you are digging in more on the area of performance
measurement. There were two concepts that I was listening for and I didn’t
hear. Maybe these are concepts that are subsumed under some of the topics that
you have. Maybe they were out of scope, or maybe there was a reason why these
two concepts were not included, and that is the gist of my question.

One concept gets to the relationship between performance management and
clinical decision support. I didn’t hear any phrase about clinical decision
support or decision support, which gets to deal with real time management of
quality using performance measurement, feeding it back.

The other one is the relationship between performance measurement where it
moves into an ongoing basis, where you get to continuous quality improvement,
which other sectors of our economy have moved into.

So John or Samantha, could you please help me understand? Were there
reasons why these concepts were not included? Were they subsumed or out of
scope?

DR. CHOW: In terms of CQI, we definitely recognize that there has been a
lot of work going on within the health care industry as well as outside. It was
outside the scope of this particular report, but it is definitely not outside
the scope of the series.

In terms of decision support, again, I will also say it was outside the
scope of this particular report.

MR. BLAIR: It was?

DR. COHN: I would assume that this isn’t a quality improvement report.

DR. CHOW: No. There is another report that covers quality improvement in a
broader scale.

MR. BLAIR: Thank you.

DR. RING: One parting shot. That is, I think you in somewhat different
words pointed out the importance of eliminating unfunded mandates as far as
performance measurement and improvement are concerned. Again, speaking as an
individual provider as well as a member of many hospital organizations, I
couldn’t agree more.

Currently, this task is routinely delegated to the relief shift nursing
supervisor at the end of his or her list of activities. You simply cannot based
on that type of investment move forward in this regard. I believe the report in
emphasizing the importance of the funding piece of it is saying something much
more than money is important. I think they are emphasizing the necessity to do
away with unfunded mandates.

DR. TANG: Simon, can I —

DR. COHN: It better be a very short question.

DR. TANG: It’s not a question. I am responding.

DR. COHN: You are his boss. Okay, you can ask him —

DR. TANG: No, it is not a question of John. it is a little bit of response
to what Bob and Jeff raised.

I would look at this report as much like our Information for Health. In
other words, our goal was to improve the health and health care of the country.
We chose a tool that seemed like a sine qua non. You could not do without
electronic health record systems and an infrastructure to move data around.

In a sense, the Achilles heel of quality is not having appropriate
measures, despite the thousands that are out there, that can leverage the tool
that we already recommended, the EHRs, and take it to the next level in a cost
effective way.

So I look at this as the solution to your frustration. Nobody could act on
what was demanded on providers. What they are proposing is, they are boldly
saying you can’t get from here to there, just like we did with the paper-based
system, and saying we need some very — in this case it is top down —
coordinated effort of defining a set of relevant quality measures, now that you
have clinical systems, and then how do we enable doctors to have measurements.

Perhaps I stirred up a question, but that is how I took their —

DR. COHN: Bob, I am not going to allow you a response.

MR. HUNGATE: We will start the quality committee meeting wherever we start
it on most of this subject.

DR. COHN: That’s fine. There will be continuing conversation. John and
Samantha, I want to thank you both very much for coming and joining us. It has
been a very useful conversation. We look forward to the upcoming reports in
this area. I think it is going to be very critical and very timely. John,
especially given you didn’t have a role in all of this stuff, I think you did a
wonderful job.

DR. RING: Thank you very much. Now we are going to beat feet back to work.

DR. COHN: That is well said. The plenary is now adjourned. We will take a
ten-minute break and start up with the quality work group, which will meet
until about 5 o’clock, and then the NHII work group will meet from five to
about 5:45. Dinner tonight is about 6:45. I think you have the information.

Remember, 8 a.m. tomorrow morning for Population Subcommittee in this room,
and then at 10 o’clock the full committee meets. Questions, comments? The
meeting is adjourned.

MS. GREENBERG: And everyone is invited to the Population Subcommittee.

(Whereupon, the meeting was adjourned at 3:15 p.m.)