[THIS TRANSCRIPT IS UNEDITED]

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

March 3, 1998
PUBLIC MEETING
MORNING SESSION

Hubert H. Humphrey Building
200 Independence Avenue
Washington, D.C.

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
703-352-0091

TABLE OF CONTENTS

Morning Session

Call to Order/Welcome/Introductions/Agenda Review - Dr. Detmer

Update from the Department -

Data Implications of Balanced Budget Act - Dan Waldo, Liz Richter

Report from the President's Commission on Consumer Protection and Quality in the Health Care Industry - Richard Sorian

Afternoon Session

Review of Reports from President's Commission on Consumer Protection and Quality in the Health Care Industry - Drs. Detmer, Iezzoni

Update on Guidelines for Documenting Evaluation and Management (E&M) Services - Drs. McCann, Segal


PARTICIPANTS

DON DETMER, MD Chair
JEFF BLAIR
BILL BRAITHWAITE, MD
SIMON COHN, MD
KATHRYN COLTIN
JOHN FANNING
J. MICHAEL FITZMAURICE, PhD
KATHLEEN FRAWLEY
DANIEL FRIEDMAN, PhD
KATHLEEN FYFFE
ROBERT GELLMAN, JD
MARJORIE GREENBERG
RICHARD HARDING, MD
LISA IEZZONI, MD
CLEMENT MC DONALD, MD
ROBERT MOORE
PAUL NEWACHECK
JAMES SCANLON
BARBARA STARFIELD, MD
GEORGE VAN AMBURG
ELIZABETH WARD


PROCEEDINGS (10:24 a.m.)

Agenda Item: Call to Order/Welcome and Introductions/Review of Agenda.

DR. DETMER: I would like to call us to order. I am Don Detmer. I chair the national committee. We typically start our meetings by introducing ourselves at the table and then going around the room and welcoming everyone here, so that they have a chance to introduce themselves as well.

After we have done that, I will be also going through, before we get into our actual business, reviewing our agenda.

We have some new members of the committee with us today. I particularly want to welcome them. I would like them, if they would like, to say a little bit more about themselves than simply their name and where they are from.

We just had an orientation downstairs and had a good time to get better acquainted, but not all of you have had a chance to talk with them. So, Jim?

MR. SCANLON: I am Jim Scanlon. I am with the U.S. Department of Health and Human Services, ASPE. I am also the executive director of the national committee.

MR. NEWACHECK: I am Paul Newacheck. I am a new member. I am with the University of California at San Francisco and the University of California at Berkeley. I do health services research and also teach in the health policy area. My background is in economics, public policy and public health, and I use a lot of survey from the National Center for Health Statistics.

DR. COHN: I am Simon Cohn. I am a practicing physician and the senior consultant for clinical data for the Kaiser Permanente Medical Care Program. Paul will be happy to know that I actually did my MPH at UC Berkeley.

MS. WARD: I am Elizabeth Ward. I am part of the west coast contingent here. I am from the Washington State Department of Health.

DR. HARDING: I am Richard Harding. I am a child psychiatrist from South Carolina.

MR. BLAIR: I am Jeff Blair and I am with the Medical Records Institute.

DR. FRAWLEY: I am Kathleen Frawley, vice president of legislative and public policy services for the American Health Information Management Association.

DR. FRIEDMAN: Dan Friedman, Massachusetts Department of Public Health. I am also a new member. At the Department of Public Health I am responsible for health statistics and basically non-communicable disease surveillance.

MR. GELLMAN: I am Bob Gellman. I am a privacy and information policy consultant here in Washington, and an old member.

MR. FANNING: I am John Fanning. I work in the Office of the Assistant Secretary for Planning and Evaluation of HHS.

MR. SCANLON: I am still Jim Scanlon. Dave is unable to be here today. I will give a report from Dave.

DR. BRAITHWAITE: I am Bill Braithwaite, from the Department of Health and Human Services, staff to the committee.

DR. IEZZONI: I am Lisa Iezzoni from the Beth Israel Deaconess Medical Center in Boston.

DR. MC DONALD: I am Clem McDonald from Indiana University and the Regenstrief Institute. I am an internist and an informatician.

DR. STARFIELD: I am Barbara Starfield from the Johns Hopkins University. I am trained as a pediatrician and I am a health services researcher.

MR. VAN AMBURG: I am George Van Amburg from the Michigan Public Health Institute. I am a statistician and health services researchers.

MS. FYFFE: I am Kathleen Fyffe. I am a new member to the committee. I am a federal regulatory director at the Health Insurance Association of America, which is a trade association that represents about 250 commercial health insurance companies. In that capacity, I also sit on the National Uniform Claim Committee and the National Uniform Billing Committee.

DR. FITZMAURICE: I am Michael Fitzmaurice. I represent information technology at the Agency for Health Care Policy and Research.

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

DR. DETMER: I introduced myself as Don Detmer. In the remaining time outside the committee, I also spend a little time at the University of Virginia. I am a vascular surgeon and a senior vice president there.

(Introductions made of those present in audience.)

DR. DETMER: And Bob Moore from HCFA. All right, thank you. It is nice to have all of you here.

We have, as always, a busy agenda. I want to start by seeing -- I am sure the board will support this -- the sentiment of the board to thank two people, actually.

I would like to draft a letter on your behalf to thank David Garrison for the work that he has done on the data council.

We report to the Secretary through the data council. He has been given a new assignment, and I would like to at least express for us our appreciation for the work that he did, chairing the data council.

I think that he really did help us get this new order of things off the ground, and I am very grateful to that.

Also, a letter to Harvey Schwartz. Harvey has been sitting at this table with us for five years as AHCPR's representative, and he has been reassigned.

Michael Fitzmaurice, who I think all of us know, is sitting where he used to normally sit, and we hope that will become a permanent fixture.

I would like also to see us, if there is no objection, thank both Harvey and David for their work. That seems like general assent. So, I will go ahead and do that, and the letters to them will be in our next minutes.

I do want to go through the agenda. We have actually quite a bit of work. We started off today already downstairs with an orientation meeting for new members.

I think that was, at least from my perspective, quite useful. In terms of the book, I want to go through. The way we have structured this meeting, we have the mornings sort of set up the next couple of days, to talk about quality data standards -- the first part of tomorrow afternoon, too.

The point is that the committee has had a long history of interest in quality, and it is also apparent that the President's Commission on Consumer Protection and Quality in the Health Care Industry is coming forward with some of its work.

The executive committee has been working also -- of this committee -- relating to this topic. In fact, I want you to flag J-14 and 15 in your agenda book. John Lumpkin is going to chair, actually, a little ad hoc work group to pull together a framework for action for us by the end of this year, that would look at how we would choose to look at quality and a national information policy.

That is just a heads up. I think that the quality discussions that we will be having at this meeting, both today and tomorrow, will be useful to that -- data quality standards, the panel tomorrow morning, and then hearing from the deputy director of the President's Commission today.

In the afternoons, you will recall the Kassenbaum-Kennedy HIPAA legislation mandates us to also look at computer based medical records, patient records.

We are going to get into that also a little more actively, and this meeting will start a serious run at that, with three items.

The first I flag for you is chapter 14 in tab D, which is in your book. It is essentially the chapter in the commission's report on information systems, that you may want to comment on.

They are going to be having, I think, their final meeting later this month, next week or something like that, or soon -- two weeks.

Again, if there is something that we want to weigh in on that, we can.

The second item is to hear about just an update on what is happening on the evaluation and management codes -- E&M codes -- that HCFA has been working on. AMA, I think, will also be talking with us on that, as an information item.

Then there is a panel tomorrow afternoon that Paul Tang and others will be presenting to us on standards for computer-based patient records. So, that is a second item.

We also have a variety of subcommittee meetings with their agendas. In addition to that, I want to reference tab G, and I want to thank the staff for working with me on this.

What we did is submit to Congress our first report on our activities for the past year. That went off to Vice President Gore, the President of the Senate, as well as other congressional leaders.

It just so happened that was dated on my birthday, which was sort of fascinating. But at any rate, I want to thank the staff for that, not for having it on my birthday.

Then I think the other comment, before we get underway, do we actually approve our November minutes?

MS. GREENBERG: I think you signed them.

DR. DETMER: I think the point is, in Tab I are our minutes, which I actually have reviewed and approved. If there are any corrections or concerns about those, also please let us know on that. Are there any?

Okay, that is essentially our agenda. Are there questions about the agenda?

The last point that Marjorie just flagged for me is, we will be discussing the report on consumer protection that has come out.

Dr. Iezzoni and Bob Gellman and I, looking at Lisa's draft, have got a draft before you for discussion, that we may well wish to put up on our web site as our own kind of reflections on that report.

Anything else? Okay. With that, we start with an update. David Garrison, as we heard, will actually be represented by Jim this morning. Then we will also be hearing from Bill and John on the department's view on privacy and data standards components. So, Jim?

Agenda Item: Update from the Department - HHS Implementation of PL 104-191 Health Insurance Portability and Accountability Act of 1996.

MR. SCANLON: Thank you, Don. Before I update you on some data policy developments and data-related policy developments within HHS and the data council, let me just describe a couple of personnel changes within HHS.

Dave Garrison, who has been the ASPE co-chair of the data council, has moved up to become the director of the Office for Civil Rights here in HHS. He took over as of yesterday.

He remains as a data council member, but the co-chair of the data council from ASPE will now be Margaret Hamburg, Dr. Margaret Hamburg.

She is the assistant secretary for planning and evaluation here in HHS. She is the former health commissioner in New York City.

Peggy has a long background in public health data issues and so on. We are very pleased within HHS to have her join Dr. John Eisenberg as the co-chair of the data council.

Peggy will take over at the March 11 meeting of the data council. Most likely Peggy or John will be giving these reports from the data council at future meetings.

The only other personnel announcement I will make is what I hope you have already heard, that Dr. David Satcher was appointed Surgeon General of the U.S. Public Health Service and Assistant Secretary for Health.

He is moving up from Atlanta and should be full time on the job by next week. So, obviously Dr. Satcher is interested in public health data issues as well.

DR. DETMER: I will just interject here. One of the things that goes with the role of chair is that I sit also on that advisory committee at CDC.

I have had a chance to, as probably a number of you get to know David, Dr. Satcher, I think he is terrific.

I am delighted, frankly, that we currently now have somebody of his both stature as well as his person in that role.

MR. SCANLON: Let me, with that, go into some developments within the HHS data council and within HHS.

You will recall that the data council is the senior policy level board within HHS that advises the Secretary on data policy issues and privacy issues.

It deals with the human services side as well as the health side. It also provides a forum within HHS for the discussion of data policy issues.

The council, as you know, has been serving as the departmental focal point for HIPAA, for all the requirements relating to the administrative simplification provisions of HIPAA. Obviously, that is one of the priorities.

John Fanning will be briefing you in a few minutes on where we are with privacy developments on the Hill as well. Bill Braithwaite will be briefing you on where we are with the standards, the first wave of the administrative simplifications requirements, and where we stand on those notices, and so on and what the next steps might be.

Let me mention a few things that have occurred within HHS in the data policy area. The Secretary, about two months, issued a policy to improve data on race and ethnicity within HHS.

The policy was recommended by the data council and it requires that virtually all data systems within HHS include race and ethnicity categories within the data collection or the data system.

There are certain exceptions relating to certain kinds of data, but in general the presumption is that data collection systems within HHS, from this day forward, will in fact include the standard race/ethnicity categories.

The background is that there were obviously many data systems within HHS that did include race and ethnicity in the standardized way.

There were some significant data systems that didn't, and there was no clear policy that existed. You will recall that the OMB policy gave you a standard when you asked the question or collected the data. It didn't require that anybody collect the data.

You could choose, as a sponsor of a data system, not to ask that, and that wasn't entirely satisfactory.

So, the Secretary, on the recommendation of the data council, has now issued a policy where the presumption is that this data will be collected.

You will recall that last November OMB revised its standard classification. I think you have all gotten a copy of that.

There were several changes, one addition to the actual categories. Under the new policy, individuals can designate more than one area. There could be multiple areas of reporting in terms of self-characterization of race and ethnicity.

The policy went into effect on November 1 here at HHS and the Secretary has instructed the heads of the agencies to implement the policy in accordance with their normal agency data planning clearance and data collection cycles.

Along with the standard itself, and the requirement to include the standard, the Secretary encouraged the agencies to expand the collection of data that would improve research on disparities in health status and services needs between minority groups and the general population.

In general, the policy applies to administrative data as well as research survey data, surveillance data, evaluation data and so on.

In addition, the policy encourages the collection of subpopulation data within the major groups as well, when that reporting would improve the usefulness of the data, and when statistical reliability would support that.

Finally, the Secretary encouraged agencies to collect data on variables other than race and ethnicity that might be useful in assessing and improving the health of minority populations and the provision of needed health and social services.

This might relate to cultural background, socioeconomic status, language use and so on.

So, agencies are now in the process of implementing this in accordance with their normal data revision processes and budget processes.

A final aspect within the policy was the idea of promoting more innovating analyses of data that has already been collected, consistent with confidentiality principles.

An agency might be able to pool years of data and so forth, or link data to be able to come up with some analyses.

Again, there is sort of a criteria of statistical reliability here. Obviously, no one is served if the data are not reliable.

Assuming that the agency has concluded that such analysis is reliable, the Secretary's policy promotes this.

In addition, there was a broader race initiative which you heard the President describe a week-and-a-half ago on Saturday.

This is a government-wide initiative, but HHS' contribution to this initiative is basically an initiative that sets a national goal of eliminating long-standing disparities in health that affect racial and ethnic minority groups.

There are six areas that have been chosen. This is by the year 2010. Obviously, some of these are very long-standing chronic diseases and other issues, so they would take a while.

The goal here, the long-term goal, is to eliminate disparities. There are six areas that will be the focus here.

One is infant mortality. Another is cancer screening and management. Another is cardiovascular disease. Another is diabetes. The fifth is HIV/AIDS rates, and the final is child and adult immunization levels.

The hope here would be to establish these goals, and to try to marshall the resources of HHS to try to eliminate these disparities by the year 2010.

This would be consistent with Healthy People 2010, the next iteration of the national health objectives.

Let me say a few words about the government performance and results act. You have heard two acronyms. One is BBA, the Balanced Budget Act, and the other is GPRA, which is not a cumulative grade point average.

It deals with a very significant initiative within the federal field to focus on performance measurement and accountability in program performance across all the federal agencies.

This law requires, first of all, that all the federal agencies prepare a five-year strategic plan and submit it to Congress. This was done last fall in connection with the budget process.

The strategic plans include general mission statements, as well as general goals and objectives that the agency covers in its major functions. Those plans are to be updated every three years.

GPRA also required that each agency develop an annual performance plan, where it would have to say what it hoped to accomplish relating to that strategic plan, every year.

This began with this current round of budget submissions for the fiscal year 1999 budget. So, all of our agencies have now developed annual performance plans, that include the objectives that are to be sought.

These are generally quantifiable performance goals that indicate the performance level to be achieved, and they describe the resources that will be used to achieve those.

Obviously, these raise very significant data problems and issues. A number of agencies have well developed data sets that they can use to measure performance. In other areas, this is much more difficult.

The plans were submitted, as I said, to Congress, along with the fiscal year 1999 budget. They will have some weight in budget formulation.

Beginning next year, agencies will be required to actually issue performance reports that indicate how well they have done.

So, for this year the agencies have indicated what they hope to accomplish in objective terms for fiscal year 1999, and then next year they will actually be reporting on that.

The data council is beginning to turn attention to how it might develop some unified approaches across HHS to help the agencies in doing this. But it is related now to budget, and I think a number of agencies are now taking this very seriously.

Let me turn a little bit now to the data council's agenda-setting process. At the February meeting of the data council, the council reviewed its past agenda and upcoming topics and actually engaged in a discussion of what new areas or what other directions would we like to look at in the months ahead. Remember that the data council meets monthly now.

There were several new items that were added and let me kind of take you through the general areas.

You will note that many of these parallel areas that the national committee is working in, that is actually desirable, but there are other areas as well.

There are areas that have been general themes for the data council for some time. I will just describe these briefly and then I will stop and we can answer questions.

Obviously, the first area is in the health data standards area. Agenda topics that will be coming up include standards for claim attachments, probably a little bit later, maybe in April, and obviously the longer term standards for electronic medical records that the committee will be thinking about.

Unique health identifier for individuals, I think Bill will update you on where we are for that process. Obviously that will be a continuing discussion within HHS.

There is an interest in classification systems and code sets. Probably at our March meeting, there will be a discussion of plans for the ICD-X, a clinical modification in the United States, and at subsequent meetings we will be dealing with procedures and other standards as well.

The council will also be discussing something we initially discussed here, how can we assure an open public process, and an accountable process for the maintenance and revision of the data standards, the classification code set standards that are mandated by HIPAA.

In health information privacy, John will tell you about where we are, but the council has a continuing interest, obviously, in providing technical assistance to any developments on the Hill and in thinking of what HHS might have to do, should the case eventuate where HHS should literally have to publish standards as a regulatory issue.

There are other issues as well, international issues associated with the European Union privacy directive, what does this mean for health data, and John will tell you a little bit more about this as well.

The data council has always had an interest in broader national health information infrastructure issues, but I think this year the council will actually put some effort into a conceptual framework and how we might pull together some of these areas.

The Vice President asked HHS in pre-HIPAA days, the Vice President asked HHS to take the lead in the federal area, in terms of coordinating health data standards and privacy, as well as telemedicine activities.

When HIPAA came along, of course, this gave the formal mandate, and I think HHS has drawn the other federal agencies together.

I think the whole area would benefit, obviously, from a broader look at how do you bring together the various pieces of a national health information infrastructure strategy.

Of course, data collection strategy has always been an interest of the data council, and within HHS this is always a challenging issue.

So, what the data council will be doing in the months ahead is, first of all, review the status of our HHS survey integration plan.

You will remember that this was a plan that tried to bring most of the population surveys in HHS into an overall coordinated framework.

We have actually linked some of the surveys so that in both data collection and analytically they can be linked.

The next steps in that process will include looking at provider surveys, looking at employer surveys. A project we have underway that has actually been quite difficult to get a handle on is, given these very significant changes in the health delivery system -- organization and financing and delivery -- what are the information needs people really believe are the most important, and how would we want to restructure our own survey and data activities, administrative data and regulatory data to address some of those needs in the years ahead.

You will recall that typically our surveys have grown up in a way that they focused on a setting by setting approach, an emergency room survey, a hospital discharge survey, an ambulatory care survey, nursing home survey and so on.

While these are a useful way of getting a cross section in those settings, I think the desire is to have a little more integrated look at this as well.

So, the department is talking to a number of people, a number of agencies, and planning some other activities, to try to get the best sense of what people believe -- how these should be refocused if, indeed, they should.

A couple of other things. Should there be a tobacco settlement -- and most likely there will be on the Hill -- most of the bills that are under consideration include some provisions for being able to monitor teen tobacco use and so on. Some of them even include brand-specific kinds of requirements.

So, we have a work group within HHS that is looking at legislative language and what sort of monitoring and surveillance tools would one have there.

There is always an interest in HHS looking at our grant policies to the states, and how we treat integrated information systems.

I think the view here would be to look at how, across agencies, HHS could create some more user friendly policies and grant policies, to develop integrated information systems at the state level.

There will be continuing work on strategy for race and ethnicity data. We have a working group that has been tasked with coming up with recommendations this fall on action steps for improving race/ethnicity data, as well as tabulation methods.

Now that individuals can check more than one category in the race/ethnicity standard, how does one actually tabulate this, and how does one count the populations now. We have a group looking at that as well.

Obviously we will be looking at the data strategy needed to support Healthy People 2010. There have been a number of improvements over the past decade in those data sources, but there is still a small, difficult group of objectives, where it has been very difficult to get data, and we will be looking at that in the years ahead.

Finally, the council will be looking at the other side of the Health and Human Services equation, the human services side.

With the March meeting we will have Pat Ruggles, our deputy assistant secretary for the welfare side, raising the issue of what are the data needs and issues to support welfare reform.

Obviously, with devolution, with the number of performance kinds of concepts in welfare reform and so on, where are we and where do we need to go. This includes both population-based data and administrative data.

Actually, one last point, the council wanted to look at what kinds of information systems did we need to support quality measurement and improvement within our own health programs, within the Indian Health Service, HCFA, the systems where we deliver care or finance care.

These would have to be HIPAA compliant, obviously, but how can HHS use data to improve its own quality improvement efforts in our own health care systems.

I think I will stop there and either take questions or move on.

DR. STARFIELD: Jim, thanks. That was very helpful. I wanted to ask you a question about the goals or the objectives of nation.

The 1990 ones, or maybe the updated ones from 1990, had over 100 specific objectives that had to do with racial and ethnic minorities. It had a couple of handful having to do with disparities across the socioeconomic groups.

Is there anything thinking specifically about doing something about that?

MR. SCANLON: Yes, Barbara. First of all, remember, this effort started in 1990 with the first set of health objectives for the nation.

These were then updated again in the year 2000 and now the view is on the year 2010.

I think there is -- the overall plan for how this framework will be structured will be presented in April, and we will schedule a full briefing for this committee.

Basically, one suggestion is to simplify. There were too many goals, probably, and to simplify it to some extent.

There is also some thought that one might want to focus on the overall population, in terms of targets, and it is not clear whether one would have specific targets that would be at a different level for minority groups.

There will also be objectives -- at least this is the thinking -- where there will be a large set of objectives where there is data, and those will be called objectives with baseline data.

There is another set of objectives that will be considered more developmental objectives, where we may not have the baseline data to start.

There will be desire to set up some sort of an objective anyway, with the understanding that one could proceed in that direction.

Previously, the lack of baseline data pretty much threw out an objective. Now I think there is this idea of creating developmental objectives that are a little harder to get at, maybe baseline data is not available. But they would be put into the hopper as well and there would be efforts made.

Again, the effort here would be, at least in the long term, to eliminate disparities, not to necessarily keep separate targets, but to literally think about having the elimination of disparities. This would be very difficult.

DR. STARFIELD: I was speaking specifically of socioeconomic disparities.

MR. SCANLON: And there will be a section -- again, assuming that the Secretary approves this -- that would focus on subgroups dealing with socioeconomic disparities rather than just race/ethnicity per se.

MR. VAN AMBURG: Jim, I was under the impression that the data council was going to take up the issue of a population standard for age adjustments at its February meeting. Did it?

MR. SCANLON: It did, actually. Should I take a minute or two, Don, to talk about it? At the March meeting, the data council discussed a proposal for NCHS to revise the national -- the standard reference population that is now used for calculating age adjusted mortality rates.

Most of our agencies in the United States use the 1940 population, which was actually a much younger population, and the population pyramids looked differently then.

So, after several workshops, NCHS has proposed that we move away from the 1940 population and, instead, use the projected year 2000 population distribution for age adjusted mortality rates.

Obviously, this would not affect age specific mortality rates, where you literally use empirical information. But the data council heard a briefing and is looking at the potential impact of what this might be.

In general, it was a pretty favorable reaction. Council members are still getting their comments in. There were some questions about how this would impact actuarial projections for benefit programs and entitlement programs.

In general, those kinds of actuarial analysis use the age specific rather than the age adjusted population. So, it looks pretty favorable.

We will take it up again, and the chances are it will be proposed to the Secretary for adoption in HHS.

MS. FYFFE: Jim, could you elaborate on the five-year plans that you mentioned, and whether they are at the department level or the agency level?

Yesterday, during some subcommittee meetings up in Baltimore, there was discussion of five-year plans with HCFA folks and with Veterans Administration folks.

I think there was some confusion about the five-year plans and the planning horizon.

MR. SCANLON: What the law requires is that the agency -- and they mean HHS, for example -- actually submit the strategic plan.

I think I may have actually distributed copies of the HHS strategic plan -- but I will get them for you -- at the last meeting.

It is at the HHS level that the submission actually went to Congress. That is a five-year plan and it has broad goals and objectives, and that is linked directly to GPRA.

Many of our agencies do have their own agency-strategic plans with mission statements and so on. They are not necessarily consistent with one another.

I mean, the departmental plan was an attempt to bring together the 10 -- literally 10 -- operating divisions with very diverse programs in HHS, together around common goals, often population-focused goals.

So, the agency strategic plans, most of the agencies have them. They don't correspond necessarily exactly with the strategic plan for HHS, but they are consistent with it.

Even there, I am not sure -- it is difficult for a federal agency to project out because literally every year they can get legislation that changes the nature of their programs, and budgets, of course, make a big difference.

To some extent, the Hill gets upset if an agency talks about changes that haven't been enacted into law. So, the agencies have to be fairly careful. They more or less focus on current operations, and then general goals that everyone would agree on.

The other agency representatives may want to say more about their own agency plans.

The HHS strategic plan, though, you will see it is an attempt to bring the various HHS activities around common goals, and I will get you copies if I haven't done that.

MR. NEWACHECK: Jim, you talked earlier about the HHS survey integration effort, and the population-based survey integration effort as well underway. Can you say a few more words, though, about the provider surveys and the plans there?

MR. SCANLON: The survey integration plan, remember, was an attempt to bring together all the major health surveys, national level health surveys within HHS, under a coordinated framework.

The centerpiece of this effort, really, was to take the national health interview survey, make some improvements to it, and increase the sample size, and to use that as a hub from which the samples of other population-based surveys would be drawn.

So, the Medical Expenditure Panel Survey that AHCPR conducts literally draws its sample, now, of families from the health interview survey.

So, you now have a very powerful link, both in terms of data collection terms and analytically.

Other population based surveys, like the NHANES, similarly will be related in terms of sampling to the health interview survey sample as well.

The other major feature is that we now have the medical expenditure panel survey in the field continually. So, in terms of getting estimates of insurance coverage and medical expenditures, we literally have estimates every year.

You remember, previously it was 10 years between surveys and that clearly was not acceptable for a sector this large.

We will also probably have the survey of family growth draw its sample from the national health interview survey.

Everyone understood that HHS also does surveys of employers. We do a number of surveys of providers, and other data collection -- regulatory data, for example, that involves providers.

So, the next step in that process was to create a group within HHS to take a step back. We are not changing any of the provider-based surveys at the moment, but to try to get the best thinking in terms of where we should go in the future.

It has actually been a very difficult task. It seems that the supply side, the delivery side, and the organizational side is, for some reason, less interesting than the health status and the outcomes side.

It has been difficult getting people to focus on, what is it about capacity, what is it about health delivery, what is it about shifts in care and capacity that you would want to know about.

How do you even know that changes are occurring? So, it has been a laborious effort. I think we are getting to the point now where we have been talking to federal agencies -- CBO, OMB -- and we have begun to talk to outside groups.

I think we are beginning to get a handle on this, but I think the data council would be very happy to have the committee maybe at least have a discussion of what this might be.

It is quite complicated. There are data sources in the industry. There are sort of industry analysts who can tell you what they believe is happening. It is hard to get an actual grip on this systematically.

DR. DETMER: Thank you very much. John Fanning.

Agenda Item: Update from the Department - Privacy Component.

MR. FANNING: I am here to give a brief report on what is going on in the area of health information confidentiality.

One significant thing that is going on, of course, is some consideration by the Congress of health record confidentiality legislation.

As we have heard before, the health information portability and accountability act required the Secretary to send to Congress recommendations for the protection of health information.

Those recommendations were sent up to Congress on September 11. The Senate Labor and Human Resources Committee has held three hearings on this topic; one to hear the Secretary, another on October 28 and another one last week.

That committee -- Senators Bennett and Jeffords -- are working on a draft of legislation. They circulated the draft last week and are still working on it.

Meanwhile, Senators Kennedy and Lahey have introduced their own bill as 1368.

We here in the department are working with the committee to give them any technical assistance or help they need about our recommendations and what we think is desirable from our standpoint.

If there is anyone who doesn't have copies of the recommendations we sent up on September 11, I have copies to give you. It also appears on the administrative simplification web site, which is easily reachable from the committee's web site.

Are there any questions about the legislative scene or our recommendations?

MS. WARD: Are those two bills at the point where they are worth seeing, or are they still being sort of --

MR. FANNING: Well, as 1368 is introduced, of course, there doesn't seem to be any immediate action coming. I think it will be better to say until Senators Bennett and Jeffords introduce theirs.

DR. DETMER: Any other questions or comments?

MR. FANNING: One other item, one of the things the data council will be looking into is the potential impact of the European Union data protection directive on activities in this country.

The European Union data protection directive requires, as of this coming October, that the member states have legal controls that regulate -- in effect, prevent -- the export of identifiable data to countries which do not have adequate privacy protections.

One of the issues, then, is does the United States have adequate privacy protections, and there has been a certain amount of negotiation going on between the Department of Commerce and the State Department and the EU.

We are examining the extent to which any such restrictions would affect health activities.

Our impression from within the department is that there is very little health information that goes with identifiers from EU countries to the United States, but we are still pursuing that. If anyone knows of any cases that we haven't found out, I would be appreciative to hear about them. That is all I have, Tom.

DR. DETMER: Thank you very much. Bill?

Agenda Item: Update from the Department - Data Standards Component.

DR. BRAITHWAITE: I know most of you have been involved in creating or discussing the proposed rules for the standards for health data interchange. So, I will go over this very briefly.

The department's interagency drafting teams have put together -- have done a marvelous job of doing this. They have put together six documents that are in the process of being cleared now for publication, one each for the four identifiers required by HIPAA and one on the transactions and one on security.

National provider identifier, the transaction to medical code sets and the employer identifier, those three proposed rules, notices of proposed rule making, or MPRMs, have been drafted.

They are in the final stages of clearance. Although it is very risky at this point to estimate when they will actually be published in The Federal Register, because things keep being delayed by unpredictable things that come out of the blue, we really hope that they will be out in the next couple of weeks.

The ones right after that, the one on the payer identifier, one on security, and a notice of intent for the individual identifier, I expect to follow as another battery of three, in a few weeks after the first ones.

People have asked a lot of questions lately. My phone is ringing constantly about what has happened to these rules. We have gone through the process of developing them and now they seem to have disappeared. What is going on.

So, I have posted on the administrative simplification web page an explanation of the clearance process that these are going through, so that people can read to get some feeling of where these are at.

In brief, it is that there are three levels of clearance that these things have to go through before the MPRMs get published in the Federal Register.

Then, after that point, there is a starting point for a 60-day comment period. After the public has had 60 days to comment, then we sit down and try to interpret those comments and write up a final rule.

Then final rule has to, again, go through that same clearance process. Then, finally, it gets published in the Federal Register.

Then Congress has, I think, it is 60 days after that publication date to essentially veto those rules, if they desire to, although I don't expect them to touch it after their publication.

As you know, the industry gets two years after that publication of the final rules in which to implement these standards, in general.

The Notice of Intent on the individual identifier is the department's expression of the fact that there is no industry consensus out there as to what should be done about the individual identifier.

Essentially what that means is a delay in the process of rule making. So, the notice of intent will come out, as I said, shortly after the first three rules come out, the first three proposed rules come out. Then we will expect public comment on that, and we expect that this committee will want to hold a hearing or two about individual identifier.

Then, if things go well and we seem to be coming toward a consensus -- which is what is required under the HIPAA law -- we will publish a notice of proposed rule making for that identifier sometime this fall, with the expectation that early next year will be a final rule on that identifier.

Claim attachments, of course, will also be on about the same time line, because the HIPAA law gave us an extra 12 months to come up with standards for claim attachments.

This committee has been already very helpful in that realm by holding a hearing on that.

That is a very brief overview. All the details of this are found on the administrative simplification web page. As John said, that is linkable directly from the committee's web page and easy to find.

There is one other thing that we have added to the administrative simplification web page because of this intense interest in what happened to the rules, and that is some instructions on how to sign up for an electronic mail notification system.

So, you can send in an electronic mail message, get registered and then, as soon as we get published, we will send out an e mail message to everybody who is registered. So, you will be the first to know if you follow that sign-up procedure. So, I would be happy to answer any questions.

DR. DETMER: I think it would be useful for you to let us know, you know, on our e mail.

DR. BRAITHWAITE: You will be certainly included on that list.

DR. DETMER: Questions and comments?

Okay, well, thank you very much. I appreciate that update on what is going on. Are Dan Waldo and Liz Richter here, please?

While they are changing chairs, I will make a couple of introductory comments. There are data implications of the Balanced Budget Act.

We have asked a couple of colleagues from HCFA to come talk to us on that issue, and I don't know which of the two of you -- Dan, you are going to kick this off; is that right?

MR. WALDO: Yes, because I know less than Liz. I just do the set up and she delivers the punch.

DR. DETMER: It is nice to have you here. We are looking forward to your comments.

Agenda Item: Data Implications of Balanced Budget Act.

MR. WALDO: Thank you. It is a pleasure to be here. I was happy to come down and avoid the rain up in Baltimore. Is it snow now? It was snow in Frederick. It was raining. Oh, well, I will have that to look forward to when I go back.

As you all know, the Balanced Budget Act of 1997, which was passed in August, posed a tremendous workload on the Health Care Financing Administration, both in terms of the regulatory activity that we do and the data that is needed to support the regulation.

Virtually every one of the 200-plus data systems that are maintained in the agency are protected by BBA provisions, many of which were effective, either on October 1 of 1997 or January 1 of this year.

Fortunately, we have got a little bit of a hiatus. We don't have another big thing happening until July of this year.

Needless to say, these new data requirements sort of put a sparkle in the eye and a spring in the step of most of our systems owners, who were worried that they would only have to deal with millennium between now and the end of the year.

There are three basic types of data requirements that have been imposed by the Balanced Budget Act. First, there is new data that we are going to get from existing entities.

For example, we need to get information from hospitals on the types of practice patterns that they are engaged in, so we can do a prospective payment system for hospital outpatient. Similarly, for SNIF and for home health.

We are also getting more data from existing providers and entities and, in some cases, new entities. Liz will tell you a little bit later about the encounter data that we are planning to collect in order to be able to do risk adjustments for managed care payments, which can only be described of a really ugly nose of a really big camel.

The third is new data that we are going to get from, in many cases, new entities. The principal example there is the information campaign that we are mandated to run for beneficiaries, beginning in October of this year.

I would like to run through very quickly the scheme of the information campaign because it is such a data intensive operation.

I have a transparency here that I am going to use. I apologize; our LAN didn't do colors today. Right now it is not really clear what we are going to be doing. Things come into focus as you go along.

The public education campaign is predicated on the existence of a knowledge base that will be used to feed any of the five different ways in which we plan to get information out to our beneficiaries.

We have the classic print media through things like the Medicare handbook and public information brochures.

There are media campaigns in which we are going to be engaging, the first of which will be to promote the prevention benefits that were passed as part of BBA.

We have a 1-800 number, a toll free number, that is intended to bring together all the existing telephone contacts with contractors and our regional offices into one consolidated operation, probably operating maybe over two or three different physical entities.

There will be face-to-face information transmitted to our beneficiaries, either through the regional offices, through district offices, the Social Security Administration and any of the beneficiary advocacy groups that operate under contract, or in cooperation with the agency.

Finally, there is an internet site, Medicare.gov, that will be going live later this month. That is designed to be specifically focused on beneficiary issues, and is designed for the kind of people who use it.

We reckon that about 15 percent of Medicare enrollees currently have access to the internet.

In order to get all this information out of the data base, we are working on developing a navigator system that will allow people, through any of these processes, to work either on a batch system or interactively with a knowledge data base.

The knowledge data base down here is the crux of the thing. It is something that we haven't built yet, but we are working on putting together.

As you can see, it is fed by all the various data sources that we have -- the Medicare plus choice plans that are required to provide us with information on their benefit structure, their co-payments and so on, Medigap and Medicare Select, the supplemental insurance programs, our data sets including the group health plan -- a data set that is being redesigned, consumer information, the enrollment data base -- which is something that we are going to have to tremendously expand as a result of Medicare plus choice, because there are so many different ways that people can feed into the system -- and also any one of the number of demos that are mandated by the act.

We have a number of prevention demos going on with the Veterans Administration, with the Department of Defense. Then we also have social HMO demos, the On-lock demo has been expanded nationwide, and so on.

There is going to be a need for this tremendous development of data set infrastructure in the agency, to be able to pull all this stuff together in a logical, if not physical, sense, so that we will be able to get timely information out to beneficiaries in a way that was intended by the act.

In order to be able to do this, the agency is developing -- is sort of re-thinking the IT vision, for the way in which we process our data.

This is referred to internally as the sunflower chart. It is sort of an organic, natural approach to data.

There are common elements, as you can see in the center. Conceptually, there are common data elements -- data processing, management and storage, retrieval -- that cut across the various types of data and the uses to which the data are put.

There is also a common data interface layer that basically allows people who are not familiar with a similar code, to be able to get in and get out of the data sets and use the information, and then any one of the plethora of different applications that have, in some cases, specialized, and in other cases special applications to the data set.

This is, as you might imagine, occupying about 40 percent of the time and attention of this chief information officer, the other 60 percent being occupied by millennium activities, and then the other 30 percent with contractor operations, which explains why Gary Christophe doesn't have much of a personal life.

As you can imagine, the kinds of data collection, storage and display work that we are talking about doesn't come cheap.

In the fiscal year 1998 budget, the agency was allocated some $95 million from fees which were assessed on managed care plans in order to provide an information campaign.

That covers roughly 60 percent of the budget for the information campaign, which is currently estimated to be about a hillion jillion dollars.

There is another about $80 million out of the administration budget that we are spending on balanced budget activity, and a substantial part of that is devoted to the data systems, to the collection or the maintenance and retrieval of those.

Big pieces, for example, the group health plan system needs to be completely redesigned. My colleague, Bob Moore, has graciously agreed to give the rest of his life in pursuit of that, which could be a very short-term proposition.

DR. DETMER: He is smiling.

MR. WALDO: Yes, but I remember from when I had infants, that smiles sometimes don't mean what you thought they meant.

The budget for fiscal year 1998 is about $.73 million for that activity, and it is likely that we could spend upward to $15 million a year over the next two years, just on redesigning that one system.

Other data systems that are being held in house, we are estimating are going to cost us about $6 million in fiscal year 1998, maybe another $1 million next year to get everything tuned up.

I will remind you this is independent of any of the other systems work that is being done in the agency, with the contractor transitions or the millennium compliance activity.

The biggest piece that we are going to be facing, I think, over the next three years is the collection of encounter data that, as I mentioned earlier, is needed for risk adjustment.

Right now, we are figuring that this could cost us about $6.5 million in fiscal year 1998, to set the system up and collect the data.

We have to figure out what we are going to collect. We have to figure out how we are going to collect it and we have to figure out where we are going to stick it once we get it collected, so that we can keep it separate and be able to understand how it looks compared to fee-for-service data.

The figure in fiscal year 1999 and 2000 will probably be upwards of $40 million, once we get fully engaged in collecting both inpatient and ambulatory data.

What I will do is, I will stop at this point and let Liz tell you a little bit about encounter data, and then we will attempt to dodge your questions.

MS. RICHTER: I am heading the group that is trying to decide what non-inpatient hospital data we are going to collect.

The inpatient encounter data is clearly mandated by BBA, whereas the rest of it is at the discretion of the Secretary, and that is why we split the work into those two piles.

Briefly, the reason we need it is we are doing person level risk adjustments to pay managed care plans, so that we can eliminate the incentives to not pick up sick people.

So, Dan will have a certain payment attached to him for a given calendar year, and it walks with him if he changes plans.

Because of that, we need 100 percent data on everybody. We are not sampling.

The next question is, what is our schedule. The first two years of risk adjustment, we are going to use a model that only requires inpatient data as a transition.

We don't like that, and neither do the plans, because if you don't hospitalize a patient, you don't get credit for them being sicker as usual. So, they are as eager as we are to move to a more comprehensive risk adjusted payment model.

They get a little less eager when they find out what kind of data we are going to require them to submit to us to be able to do that.

The more comprehensive risk adjustment models that we are looking at right now require the use of hospital outpatient department data and physician and limited license practitioner data, the professional services.

So, if they bill labs ancillary to a visit, we don't require the lab data, but we do require all the professional service data for that model.

We haven't finalized a schedule for collecting that data. We want to move quickly to get rid of the incentive for plans to hospitalize patients, but we want to be sure that we can collect the data effectively, that the plans can submit it reasonably correctly, that we can store it at HCFA, and that we know what we are going to do with it once we get it.

Instead of just collecting, just saying data is good, let's get lots of data, we want to actually tie it to what we need to do with it, and what we are going to be able to do with it, which are two different things sometimes.

So, we are working through right now scheduling. Physician and outpatient data will definitely be the next step.

We are beginning to talk with the industry about what their capabilities are. We are helped on this because they are already working with us on the inpatient data, which is required for discharges starting July 1, 1997, but which was not to be submitted until January of this year. It will actually be a little later than that.

So, we are working right now with them on how to format the data. A lot of them use UB92-like data now, and that is great, because that is what we are requiring.

Others of them are less familiar with it. There is a transitional data set, because the requirement was retroactive, which we don't expect any of our other requirements to be, looking forward.

A lot of these discharges, they had already closed out before they knew they were going to have to submit the data.

So, for the period that was retroactive, we have designed a more limited data set that will give us bare bones information to start estimating the impact of risk adjusted payments, but that is really not useful -- we wouldn't be comfortable using it to calculate actual payments, because it is much more skeletal in design.

They have already -- they are actually due on Friday to have their intermediary picked out, that they are going to submit the data to.

We are paying the first three months of the data line transition cost, just to get them transitioned into doing this.

We are fairly far along on the planning of that, and we hope to have the data starting to flow later this spring.

The due date for the year July 1, 1997 to June 30, 1998, is September 17 of this year. That is a requirement because we have to have all the data in in time.

In January we have to publish a notice about how we are going to pay. Then in March and April, we have to tell them. We have to give them an estimated payment rate, based upon the patients in the plan.

So, September 18 is really a drop dead date. We would prefer to have it sooner than that, but they have to work with their hospitals to get their data.

So, there has to be some lag, and we have sort of settled on that as the latest date we can do, to do what we need to do with the inpatient data.

We will be looking at how much of it comes in after the deadline, to see for payment years, whether that is actually a realistic time frame.

It is only two-and-a-half months after the close of the data year, and that is very tight. So, we want to -- that is one thing that we are going to be watching very carefully, is whether it is actually doable or not for them, and to what degree it is doable and how much their payments would change with different due dates. That might have some implications for what data year we actually pick.

The non-inpatient data, as I said, we are going through now starting to do some of the same things, looking at all of the edits we put on the fee-for-service data, to figure out what edits we should turn off.

For instance, all the medical review edits that say you should have no more than five E&M visits from a primary care physician in two months or we won't pay for it, really aren't appropriate to put on the encounter data, because if the plan paid for it, the plan paid for it. It is not our business whether we would have in fee-for-service or not.

So, we are trying to go through the edits to categorize them all and to go through them with industry, to sort of figure out what minimal edits we need to be comfortable that the data we are getting is correct and reasonable, but to minimize the amount of return data they get for incomplete or incorrect records which is, according to them, the most expensive part of all of this, once you accept that they are going to be submitting the data. That is probably going to be one of the more intensive processes of moving forward on this.

That is really where we are right now.

DR. DETMER: Well, I will open this up for discussion.

DR. STARFIELD: That was very clarifying. Given that there are two different kinds of prospective payment -- and it is not clear to people listening which one you are talking about -- but there is the episode based, facility based DRG type of prospective payments --

DR. DETMER: A little louder; I am missing a few words.

DR. STARFIELD: There are two kinds of prospective payment. One is the DRG-type, episode, facility based, and the other is the kind that managed care deals with, which is the capitation prospective patient for an individual.

That is really what you are dealing with, I think, is the latter.

MS. RICHTER: Yes.

DR. STARFIELD: That has tremendous implications for information. If you are into the former one, which is the DRG-type hospital based one, you really only have to think about the hospital based data.

If you are into the person-based one, you have to have data systems from different kinds of facilities that have to link with each other, that have to speak with each other, and you have to put it all together.

That has got a lot of implications for what we think of in terms of information needs. So, it is clearly of interest to this committee.

We would hope that you would sort of keep us in mind when you are doing this. We had some hearings yesterday that there were a lot of different facilities that have to be brought into this whole process.

DR. IEZZONI: I have one major question and then just a comment. The first question has to do with the data that you are going to use to risk adjust.

In the past, HCFA has let contracts for researchers to try to develop risk adjustment for capitating care.

I know that even as recently as the fall of 1996, one of the things you were really excited about was combining diagnostic information with self reported functional status information; for example, from the Medicare current beneficiary survey, given that functional status information is often more predictive or equally predictive of future costs, then the ICD-9-CM kind of information.

Even though you didn't say so explicitly, I gather that you will not be having functional status information on these encounter forms, that you will be relying on ICD-9-CM diagnostic codes to do your risk adjustment?

MS. RICHTER: That is right.

DR. IEZZONI: The second comment was that we did have a very informative and productive day yesterday at HCFA, for which we are very grateful, and we thank the HCFA people for speaking to us, about the prospective payment systems that you have to create for rehab facilities, for chronic disease hospitals, for SNIFs, and for home health care.

I don't know whether it is politic for me to go on the record and say this, but I will blunder, nonetheless, forward and say that the time lines that you have are impossible.

I really don't see how you are going to be able to do what is required for you to do with the time that you have available.

It might be easier where you don't need to collect new data, but there are some systems -- for example, the home health -- where you have a contract with APT Associates right now, that is just now gathering data upon which you are hoping ultimately to be able to base a home health prospective payment system.

I just don't know whether, at some point, the committee can help you kind of make clear that some of the things that are required of you just may not be possible or feasible.

I don't know how it works within the Federal Government when you are not able to meet a deadline that is congressionally mandated, but my heart goes out to you.

DR. RICHTER: We accept the sympathy.

MR. WALDO: We don't talk about possibilities or impossibilities. All things are opportunities. Some opportunities are insurmountable.

We are actively engaged in an intentional planning process, to figure out what we can do and what we can't do. Where we can't do things, we are going to have to start managing expectations on the Hill.

I think there is a fair amount of willingness on the part of the Hill to recognize what they have done to us, and to work out in advance some ways to slip things.

Absolutely, the more guns you can have in a fight, the better off you are. So, we will stay in close touch with you on things that we can and can't do, and may take you up on your offer.

DR. IEZZONI: That was a personal offer.

MS. FYFFE: I am a neophyte in this discussion. I appreciate very much your good presentation. I have just a couple of questions, I guess, for Liz.

You say you need 100 percent data. Is this 100 percent of the 30 million Medicare beneficiaries?

MS. RICHTER: No, just the beneficiaries enrolled in the Medicare-Plus-Choice. We already get data on the fee-for-service beneficiaries, because that is how the providers get paid. It is about 15 percent of beneficiaries.

DR. DETMER: Fifteen percent of 100 percent.

MS. RICHTER: Right, it is all of those beneficiaries.

MS. FYFFE: You also said that you wanted to prevent gaming in this system, so that the plans would not take only the healthy patients.

MS. RICHTER: That is what risk adjustment is really designed to do.

MS. FYFFE: I understand what risk adjustment is. I guess I am wondering, if you are going to have complete information, to be able to prevent that from happening.

MS. RICHTER: What it does is, it allows us to adjust the payments for the sickest patients, so that the plans aren't penalized for taking them compared to the payment they get for that person.

That is really what we are looking for, is that they can be neutral about whether they want to take somebody regardless of their health status, because they know that the payment will reflect the extra resources sicker people will require.

MR. MOORE: We already do that with the end-stage renal patients. They are not allowed to go into a plan if they don't need dialysis.

Once they are in a plan, then we do change the rate with the plan to account for the more intense care.

MR. WALDO: We want to make it more expensive, basically. We needed, on the one hand, as Liz said, to make it more financially acceptable for the plans to accept patients who are at higher risk of health care. We also want to make it less profitable for them to seek out the ones who are at lower risk of health care.

DR. COHN: First of all, you both have my sympathies, and I do understand the stresses and pressures you are under.

I would say that within my organization I have had the opportunity over the last couple of months -- and I represent a large HMO -- to work with them around trying to meet the requirements. It has been somewhat of an illuminating experience.

I do understand the problems that you are having, and I do have to admit that it is sort of an antithesis of administrative simplification, some of the pieces of it; I mean, just trying to deal with financial intermediaries, trying to do things on a time line where things are not clear.

I would first of all comment -- and this is just a comment -- that even the current issues around the UB92 and the concept of managed care are not quite as clear as you would like to think they might be, and specific issues around cost.

MS. RICHTER: We are fully aware of that, and working with the industry and AHP to work through that.

DR. COHN: Right, so that is some of the issues. Now in terms of the outpatient data, I would certainly encourage you to elicit as much comment as you could from the industry, as well as give them as much lead time as possible.

The other point that I would make in relationship to outpatient data is that the managed care industry doesn't typically use the more standard billing forms as a general rule.

HCFA 1500s are not always the way that managed care works with this data. You should be very clear about what data you need to do the risk adjustment and focus on making sure that you get that data as opposed to trying to capture all the data.

I think that would be -- that is sort of the lessons, as I have looked at this, that I would urge you to consider as you move forward into outpatient data.

MS. RICHTER: I appreciate that, and we are very aware that we are dealing with a different kind of animal than a fee-for-service provider.

One of the things we are interested in finding out now is the extent to which, especially for physician data, plans can get their hands on it.

That has two aspects to it, people who capitate so that they don't get service-by-service data from it all, and whole chunks of benefits, like mental health benefits, for example, that they might subcontract to another organization to manage.

One of our big questions with that is whether, in fact, the organization they subcontracted to has the encounter data and they are just not shipping it upstream to the plan that we contract with, that they are keeping it at the level where they are the ones that are capitated for all the mental health services, but it is available.

We have asked for comment on that issue specifically. We think of the physician data as the most problematic of what we need next, because of the capitation arrangements. We are looking very carefully to make sure we just get what we need and not what we would like in the best of all possible cost-free worlds.

DR. COHN: Thank you. I am actually sorry that Kathy Coltin is not around to join in this conversation.

MR. GELLMAN: I would like to ask about this 100 percent individually based risk adjustment that you are talking about.

I am just sort of curious as to how this is going to be carried out. Is this going to be prospective? Is it going to be retrospective? Are you going to develop a number that attaches to someone, that they are 1.X times the average person? Can you describe it?

MS. RICHTER: I will describe it briefly with the disclaimer that I am not the risk adjustment expert. I am helping on implementing and collecting the data they need for risk adjustment.

What we do is you take the diagnosis codes for somebody for a data year, and we will get to the question of retrospective, et cetera, later, because it is really independent of the basic model.

For the hospital model, you go into one of, I think it is 12 groups based on your highest value diagnosis code, if you had more than one hospitalization in a year.

Then yes, we come up with a multiplier that depends on your diagnostic codes. Then, much like the current methodology, your age, your gender, and whether they do institutional status and a couple of other things is still up in the air.

So, the answer might be, I am one-and-a-half times the healthy person who doesn't have a hospitalization, Dan is two-and-a-quarter, and that would follow for the payment year.

So, if you switch plans, your payment goes with you. We don't think of an aggregate plan where we might say Pacific Care has people, they get 1.2 times the healthy person. So, it is person based.

When we switch to the more comprehensive data, the diagnosis codes are additive rather than unique, in the sense that a diabetic might have an additive value of .1 and somebody with cancer might have .3. Then a diabetic who had cancer would be .4, because they would get both of those. There are a lot of other categories and they add up.

It is the same basic thing where you get a number assigned to you and that is the multiplier of the base rate.

That is still going to depend on the county. It still follows the rate book. So, there are still locality differences and things like that.

As far as the data, the decision isn't final yet about what the data year would be compared to the payment year.

The model that people seem to be fondest of is we use data from year one to calculate payments in year two. You want the diagnostic information to be as close to the payment year as you can, so that it is still relevant for the person.

If you do a concurrent model, which is diagnostic codes in year one for payment in year one, the problem is you can't really tell the plans what you are going to pay them for a person until the end of the year, which makes it kind of hard to plan what their financial situation is going to be.

Using the year one, year two thing still has some issues with it, if you just use calendar year, so calendar year 1999 data for 2000 payment. Because of the lags in getting the data in house, we probably couldn't have final payment rates calculated for beneficiaries until April or May.

So, plans would have interim payments for the first part of the year and then adjustments and final payments for the rest of the year.

They are not very happy with that, especially when you are on the hospital model where payments can change quite a bit.

They have suggested to us that we consider using, for instance, data from September 1 to August 30, so we can have a final payment calculated January 1 or February 1, so that we wouldn't have to make those adjustments and they would know prospectively what their payments were going to be for each beneficiary for the whole year.

There is also a model which seems to have pretty much disappeared, which is you use data from two years ago to calculate payment for this year.

The problem with that is when you get diagnosis information that is that old, it doesn't track the resource utilization very well for the enrollees in the payment year.

MR. GELLMAN: Let me make two points that I think are perfectly apparent. One is that it seems to me that however you do this, there are plenty of opportunities for gaming in the system, in terms of moving people from one year to the next and from one plan to the next, and I am sure you are fully aware of that.

The second thing is, I think you need to think really hard about the implications of a government issued number about the health status of people, that you are 1.5 times less healthy than the average person.

MS. RICHTER: No, you are not 1.5 times less healthy. You are predicted to use 1.5 times the resources that the average person does.

MR. GELLMAN: This is going to be like the old 1A, 4F system. You know, employers and other people are going to say, if you are over 1.75, you need not apply here. This is a heck of a number with a lot of implications.

DR. MC DONALD: To clarify, you are basically just going to be collecting billing information. There are no new kinds of variables?

MS. RICHTER: No, it may be fewer variables, but it won't be more variables; you are right.

DR. MC DONALD: So, there won't be new questions asked.

DR. FITZMAURICE: To get a sense of the magnitude of this, I tried to work up some numbers based upon guesses, and let's see how close my guesses were.

I am trying to look at the number of claims you are currently processing and the number of claims that you are going to be processing that are managed care, instead of fee for service.

I used 15 percent, so I am guessing there are maybe five or six Medicare beneficiaries under managed care. I am guessing that under fee for service there may be a million hospital discharge claims. That may be a little high.

MS. RICHTER: I can give you our current estimates.

DR. FITZMAURICE: Go right ahead, before I make a fool of myself.

MS. RICHTER: We are going with a base of six million beneficiaries in choices, just for budgeting purpose. We are assuming that 20 percent of them will have a hospitalization in a given year, that they will have 12 physician visits a year and two hospital outpatient encounters, on average. So, 12 physician and I believe the number is two hospital outpatient.

Then we have them for the other data types, too, but since that is much farther down the road, we will have much more of an opportunity to actually compare the health status based on the physician, the outpatient and the inpatient data for the enrollees compared to fee for service.

They are broadly based on the fee for service experience. They are a little lower, but not a lot. Until we start getting data in for budgeting, and especially for physician work loads, we want to be fairly conservative about the estimates we make on how much more work they are going to have to do.

DR. FITZMAURICE: How many hospital discharge --

MS. RICHTER: I think it comes out to 1.2 million.

DR. FITZMAURICE: For managed care?

MS. RICHTER: For managed care. It is about 11 million for fee for service.

DR. FITZMAURICE: And how many outpatient visits?

MS. RICHTER: Twelve million.

DR. FITZMAURICE: For managed care?

MS. RICHTER: For managed care.

DR. COHN: As I was going to comment, your numbers are about right, at least as we have projected them. The organization I am affiliated with takes care of 14 percent of the populations you are describing.

As we have looked at it, you are about right on those numbers.

Now, I have a question about, where you have talked, I think, about three different groups of data collection efforts.

One is the hospital data, which is the UB92. You mentioned sort of in passing the hospital outpatient data, and then we are talking about the outpatient outpatient data, another collection. Am I correct on that?

MS. RICHTER: The hospital outpatient data is also collected on the UB92 in fee for service, and we will be looking for parallel collection for encounter data.

The physician data is collected on the HCFA 1500 or its electronic equivalent, which I am supposed to say all in one word, according to our systems people.

DR. COHN: I am not talking about the form you used. I was actually referencing the time frame and the type of --

MS. RICHTER: We can't do comprehensive risk adjustment until we have both the hospital outpatient data and the physician data. So, we are looking at those in one chunk as the next step.

DR. COHN: That, you said, was two years from 1998 -- from --

MS. RICHTER: No, I did not say that. I said we did not have a date for that. We want to move as quickly as we competently can, to getting the more comprehensive data.

DR. IEZZONI: Two questions. What you are doing is somewhat analogous to what was done when DRGs were implemented even though, as Barbara pointed out, the unit of observation is quite different.

My question is, will you be publishing the ICD-9-CM codes, and the specifications that go into saying that a person is 1.5 times more expensive than the average or whatever.

For example, the DRG book comes out and looks like this. It is this thick. You can look at it and you can tell exactly how someone would be assigned to a DRG based upon a very clear kind of flow diagram within it.

Bob, it makes it much harder to game if a system is so opaque and all you get is a big logistic regression or multivariant regression results and various coefficients for the terms within it. You know, it is a lot harder to figure out.

So, are you going to be using a specific software and will the specifications of that be clarified?

MS. RICHTER: The question of the software is too far down the road for me to give you an answer of whether it is one or whether we would have contractors given specs.

We will publish exactly what, for the hospitals -- for example, for the hospital models, here are the 12 groups and here is what the multipliers are. Everything will be open.

The same thing with the more comprehensive model. We will also publish all the information for that.

DR. IEZZONI: The second question that I had is that even though Medicare, this capitated Medicare product will be maybe five or six million Medicare beneficiaries, even more Medicare beneficiaries are now using home health, long-term care, chronic disease, rehabilitation.

It just seems that so much of the energy and focus is on getting right the prospective model for the capitated Medicare product, that the folks who are kind of working in the trenches in these other areas are less visible.

MS. RICHTER: I don't think that is true at all.

DR. IEZZONI: You don't think so?

MS. RICHTER: Since I work on both sides of that, no.

DR. IEZZONI: It is more just for our committee -- I guess I just feel like our committee needs to realize that what we are talking about right now, the risk model for the capitated stuff, really pales in comparison to the amount of dollars that are on the other side of these huge data collection mandates that are about to have to go forth, to be able to meet the prospective payment requirements that Congress is mandating.

MS. RICHTER: We are very well aware of the difference between 15 percent of the beneficiaries and 85 percent of the beneficiaries, and both of them are very important.

DR. STARFIELD: Every time I think I understand it you throw in something like hospital model. Given that you are moving toward a comprehensive model, to talk about hospital models, home care models, outpatient models, sort of doesn't make sense. Maybe I am not understanding.

MS. RICHTER: I am sorry. There are two models. One uses the diagnoses from inpatient claims only. That is the first step. It is an introductory model to move us toward risk adjustment.

There is a more comprehensive model that is the end result right now, which uses diagnoses from physician claims, hospital outpatient data and inpatient hospital data.

So, there are really only two models, and the hospital model using the inpatient claims is really just there as a transition, until we can get the more comprehensive model.

DR. STARFIELD: You can see that a managed care organization, any kind of health care organization, wouldn't substitute one for the other. It all has to be put together.

That leads to my other question. Did the legislation mandate that you go the diagnostic route? Most European countries that do risk adjustment and differentially pay by need, will use adjusters based upon things like the Droman index or the Townsend index, which has to do with sociodemographic characteristics, which are very closely associated with need.

Did the legislation mandate that you only use diagnoses, or did it give you the flexibility to add on other things.

MS. RICHTER: It did not mandate that we use only diagnoses. All of our research and all of our efforts in defining risk adjustment have been based on a diagnosis-based system.

We explicitly didn't want to use procedures, because you get into a nice little spiral there, where if you pay them to do more to patients, they do more to patients, whether they need it or not.

As I said, I am not the risk adjustment expert and I am not competent to give you an opinion on why they focused on diagnosis codes.

DR. FITZMAURICE: In going through the numbers before, the numbers are quite large and this a very significant effort.

In other parts of this meeting and the meeting tomorrow, we will be talking about the HIPAA standards and so, as you have discussed it in terms of UB92 and 1500, is the program prepared to make the adjustment, along with the rest of the payers, to move to the HIPAA standards, once the Secretary announces them and there is time for implementation?

MS. RICHTER: Yes. A large fraction of all of the written materials that we have developed about doing this so far is how this interacts with HIPAA and what the different implications are for doing things before HIPAA and after HIPAA.

We are working very closely with the people at HCFA who are working on the EDI standards to make sure that what we are doing is consistent with them.

We don't think that, given that the government is the one that is determining the standards that is saying, oh, we don't have to do it is a reasonable standard, assuming that everything before HIPAA will be consistent with fee for service and after HIPAA will be consistent with HIPAA.

DR. DETMER: I can't help but think that the government is going to have to put more incentives to move folks to computerization on these things.

The hospital side is about 85 percent computer based, apparently, on its billing. The outpatient side is down around, I don't know --

MS. RICHTER: Our contract is with plans and we are going to be requiring electronic submission of all of this data. There is not a choice.

That means if they still allow their providers to use paper claims, that is fine, but they are the ones responsible for making it electronic before it comes to us.

MR. MOORE: Under HIPAA, all plans are required to develop the capability to take it electronically.

DR. DETMER: The capability but not sort of mandated to do it.

MR. MOORE: I am sure there will be strong incentives when the plans start to implement this, to use that electronic format.

DR. DETMER: I would think so. Two last comments. Simon and then Paul.

DR. COHN: Just following on what Don was saying, I was actually just looking back at the dollars, Dan, that you had commented on for the development of information systems to support the effort.

They look pretty low in terms of what needs to happen. I would certainly encourage the government -- I don't know if we need to send something noting that there needs to be more funding for this, to make for a smooth transition on the information systems side.

MR. WALDO: We welcome your support on that.

MS. RICHTER: Yes.

MR. NEWACHECK: Just a point of clarification. On the inpatient risk adjustment you are using diagnosis codes. Is there any adjustment for severity within diagnostic code?

MS. RICHTER: No, it is just diagnostic code.

MR. NEWACHECK: There is a group called National Association of Children's Hospitals and related institutions, that has developed a similar kind of coding scheme for children to base prospective payment.

It has gotten a lot of criticism because of the inability to adequately account for severity by just using ICD-9 codes. But that is the way it is, it sounds like.

MS. RICHTER: It is, and remember, it is called the PIP DCG model, the inpatient one. It is only 12 groups. If you think about how many ICD-9 codes there are and we are collapsing them into 12 groups --

MR. NEWACHECK: Have you seen the NACHRI system that I talked about?

MS. RICHTER: I am sure people have at HCFA. I am probably not the right person. Pat Brooks has probably seen it. She is the inpatient coding.

MR. NEWACHECK: It sounds a little bit more sophisticated, but it is still problematic.

MR. WALDO: I might suggest that, given there are, what, 18 people at the table, which means 26 people who have expressed an interest in risk adjustment so far, that I know of, that it might be useful to schedule a meeting of this group with the staff from the Office of Strategic Planning, who are specifically working on the risk adjuster part of that.

If you are interested in doing that, I can provide you with names and even telephone numbers.

DR. IEZZONI: Can I just clarify? Did you say you were going to be using the DCGs?

MS. RICHTER: No, it is called the PIP DCG model.

DR. IEZZONI: I know, the inpatient DCG model, because the DCG is something that actually I know quite a bit about.

I have been kind of working with them since 1984. If anybody has any specific questions about this, you can ask me at lunch.

DR. DETMER: Just one second, Jeff. Perhaps, Barbara and Lisa, your subcommittees might think which of you might want to take this on.

I think it would be worthwhile for us to at least get back to you on that. Jeff?

MR. BLAIR: Help me understand this a little bit better, because a number of people have expressed concern that if you come up with some kind of a risk assessment or adjustment statistic or number, based on diagnosis, that that would be of concern to individuals, or that those folks that would be doing gaming, cost shifting, would be able to take advantage of that.

I had the feeling that that was going on today, without anybody providing any additional risk assessment numbers.

The other piece is that, you know, if you do this, it enables you to at least make a reimbursement adjustment to provide a disincentive for the cherry picking to go on.

I am having difficulty understanding that you are adding to the risk, or exposure, either to an individual or to the system, if you go forward with your risk assessment number. Could folks help me understand if I am off base, or if there is a piece of this that I don't understand?

MS. RICHTER: No, I think we would agree with you. I think the concern raised was if we went around publishing or making commonly available what everyone's profile was; that that would be problematic.

I am not sure that we would ship the plans back a list of people with their numbers. I think we would do the payment.

On the other hand, the system will be public. So, you can take various diagnostic code profiles and figure out what the payment would be for them.

DR. DETMER: Bob Moore, do you want to make any last comments on this? We appreciate this. Do you have any other thoughts before we thank these good people?

MR. MOORE: No.

DR. DETMER: Well, thank you very much. I think as you can tell, the committee has a lot of interest in this. I think we are interested in being helpful and useful to you. Thank you.

We have one more item before we go to lunch and that is Richard Sorian, I think has joined us. He is deputy director, as I understand, of the President's Commission on consumer protection and quality in the health care industry.

We had a couple of things we want to hear, actually, from you. One is about the first part of this, the consumer protection piece, but then also where you are on the quality side of this as well.

Both of these topics are of great interest to the committee, as you are aware, and we are interested in getting an update and then have a dialogue with you.

Agenda Item: Report from the President's Commission on Consumer Protection and Quality in the Health Care Industry.

MR. SORIAN: Certainly, and thank you for having me. It is a pleasure to be here. It is certainly a pleasure to be on the other side of the table for once, after the last year.

I can say to the previous panel that there are at least 34 other people who are interested in risk adjustment. The members of our commission are very interested, and I will mention that a little later.

I know you heard earlier from Janet Corrigan, our executive director, earlier this year, and I know that she was very pleased to meet with you. I will try to keep my remarks brief so I can answer questions and engage in dialogue, so I am not trying to guess what is of greatest interest to you.

The President created the Advisory Commission on Consumer Protection and Quality in the Health Care Industry about a year ago, March 26. In fact, next week will be our final meeting and we will be delivering our final report to the President at the end of next week.

So, as you can imagine, it has been a rather chaotic and rapid year for us. The commission has 34 members, two of whom are the co-chairs, Secretary Shalala from the Department of Health and Human Services, and Secretary Herman from the Department of Labor.

The remaining 32 members are from the private sector and represent virtually every point of view or constituency that there is in the health care industry.

That was quite deliberate. The President wanted this commission to develop a consensus opinion on the key issues of consumer protection and quality improvement in the health care industry.

He felt very strongly that by putting people with very differing views but with the same goals -- to improve the system -- at the table, the commission's recommendations would be more valuable to those who have to consider them in the policy arena.

So, it is a large commission, as you can imagine. Thirty-four members are a difficult group to try to work with.

We quickly broke them down into four subcommittees who worked on four different subjects. One was consumer protection, the second was quality measurement, the third was creating a quality improvement environment, and the fourth we called the roles and responsibilities of public and private purchasers and quality oversight organizations.

We came up with a subcommittee that had an even longer name than the commission.

The four subcommittees and the commission met monthly here in Washington, in Chicago and in Vermont. We had open public meetings. We have a web page and various other mechanisms for the public's interest and input.

We have had testimony from more than 150 different individuals and organizations, as well as a great deal of imagine, and you would imagine quite a bit of faxes as well.

In November of 1997, the commission delivered its interim report to the President which was entitled, the Consumer Bill of Rights and Responsibilities.

The first report was focused on the area of consumer protection, part of our dual mandate. It was delivered to the President in November. He accepted it on November 20 and quickly embraced it, and he has taken several actions since then. I won't talk necessarily about that.

Basically, the commission sketched out eight separate areas in that report, and I will very briefly go over them, but will be glad to answer any questions if you want to go back to some of those. I will also talk about our final report as it is shaping up for next week.

The bill of rights makes a couple of important statements at the front end before we get to the individual rights.

One is that the commission believes firmly that every American, no matter what kind of health insurance they have, and frankly, to as great an extent as possible, even those who do not have health insurance, should have the rights that are laid out in this program.

So, it doesn't matter if you are covered by a public program like Medicare or Medicaid or a private purchased health plan by your employer or even a privately purchased health plan, these rights should be provided to all Americans.

That said, the commission did not then specify how policy makers should do that. They didn't say that all of this should be embodied in federal legislation and state legislation or regulation or even in accreditation or voluntary efforts.

They said that all of those are feasible but that the bottom line must be that they be provided to everyone.

The President has talked about seeking legislation. He has also issued an executive order for government programs like Medicare and Medicaid, Federal Employees Health Benefits, the Veterans Administration and the Department of Defense.

He has also called for legislations and for voluntary efforts. Many large corporations and large health plans have actually announced either their intent or actual action to put these rights into place for many privately insured individuals.

So, we have seen a lot of progress since November, but there is still quite a bit to go.

The basic rights that were expressed in the consumer bill of rights and responsibilities are the following:

One is that consumers have a right to information. I am sure this committee firmly agrees with that, and the work that you do is very key to the ability of the system to actually accomplish this in the future.

It is a rather extensive chapter and it expressed in detail the kind of information that consumers need and should have the right to receive.

It also has a lot of reality checks in it, in that it indicates that there are certain pieces of information that are now currently available, should be available to consumers in a readily understandable manner that isn't always being provided to consumers.

This is basic information about what is in a health plan, what is in a policy, what benefits are excluded, what the processes are for people to actually obtain those benefits, to appeal a decision they don't agree with, et cetera.

Then we talk about the need in the future, and we talk about a three to five-year window into the future, for real comparative information about the quality of services, the quality of facilities, et cetera, that are offered under a health plan or in other places, including information from the facilities themselves.

If somebody is going into a hospital or a nursing home, they should get information from that source as well.

We fully recognized that the health care system and the health care industry is not currently capable of providing all of this information.

Parts of it certainly are and have been leading the way in developing information systems. We recognize that it is going to take a three to five-year period for the information system growth that is going on right now to reach its full ability to do this.

We say it has to be done in that five-year window. We are looking really toward about 2003 as an end point for the phase in of that particular important chapter.

The second area is a very specific area, access to emergency services. What we say is that people who are in emergencies or those who believe, based on prudent lay person standards, that they are in an emergency, should be able to go to any emergency facility to get the care that they need, and to have that care paid for if they have a health insurance plan.

That is actually a policy that has been adopted in more than half the states by the Medicare and Medicaid programs, and we believe that it should be adopted across the board.

The third area is another important area, is choice, choice of health plans, choice of health care providers.

In the area of choice of health plans, the commission really more of a hortatory approach, and urged employers and others, including public purchasers, to offer consumers as great a choice of health plans as possible.

We specifically chose not to mandate a choice of any kinds of plans or even types of plans, like a point of service plan, as some have proposed in the Congress and in the states.

We were concerned about the unexpected consequences that could have on some employers actually dropping coverage altogether, if they were required to offer a choice of plan. We felt that one plan is better than no plan, but that we did want to urge the system to increase consumer choice of plans.

We felt that would both address consumer content with the system, but also enable plans to compete for consumers based on their quality and other choices.

In the area of choice of health care providers, we made several proposals. First, we say that plans that use networks of providers, mostly HMOs, have an adequate network of providers to provide the services that they contract to provide to a consumer.

In cases where a plan does not have an adequate network, then a consumer should be able to go out of plan to any provider that they choose at no greater cost to them, and the plan should pay that provider at least at the rate that they pay the providers in their network.

This is a standard that the National Association of Insurance Commissioners recommended in 1996. We based our proposal on the NAIC model, but we really feel that is important so that people, particularly with chronic or long-term conditions, who go into a plan and are assured that they will get the services that they need, get them, and there is kind of a safety net there. But the consumer could go outside the plan to get the care that has been promised to them.

We then make a few very specific proposals in the area of choice of plan. We say that women should be able to go to an obstetrician, gynecologist or other health care provider to receive routine and preventive health services.

We do not recommend that plans be required to designate ob/gyns as primary care providers. They can do that if they choose, but women should be able to go to a ob/gyn to get routine and preventive services, either without a referral or with a standing referral or set of referrals for the course of the year.

We tied that to the U.S. Preventive Health Services task force recommendations for the kind of services that women need each year.

Third, we said that consumers or patients with chronic or severe conditions that require the regular services of a specialist should be able to go directly to that specialist, again, either without a referral or with a standing set of referrals.

People who have chronic conditions who know, and the system knows, need to go back to a specialist on a regular basis, don't have to go back through the system each time to get a referral that everyone knows they need in the first place.

Then finally, in the area of choice, we say that people who are undergoing active care and have one of two things happen to them -- either their employer changes plans in the middle of their care -- this includes not only people with short-term conditions but pregnant women who are first the first trimester -- if the plan is changed by the employer -- that could also include the federal or state program -- if they are forced to change plans in the middle of their care, they should have at least up to 90 days to transition from the provider they are seeing to the new provider under the new plan, if the provider they are seeing is not under the new plan.

This was a somewhat contentious issue, and some in the medical community wanted us to allow that continuity to continue all the way to completion of treatment. Others wanted it much shorter.

We chose 90 days because we felt that was an adequate time both for the consumer to adjust to this rather dramatic change, but also for the one provider to talk to the new provider and kind of coordinate the transition of the care.

The second area that we make the same recommendation is the situation where somebody is in active care, including prenatal and post-partum care, and who is seeing a doctor who, for other than cause, is dropped by the plan in the middle of that person's care.

We obviously don't want somebody to continue seeing a doctor who is stripped of their license or who, for other reasons, for cause, is dropped from the plan.

If the plan makes a decision to just drop one or a series of providers, the patient should have, again, 90 days to transition from their old provider to their new provider.

We think these are important changes, but they do not disrupt the real basic network approach that managed care has successfully introduced into our system, but it tries to take some of the rough edges off that system.

The fourth area we addressed is consumer participation in treatment decisions. We recommended very strongly that consumers be given the information they need to make decisions about their care and that once they make a decision, those decisions are adhered to both by the health care system and by the consumer.

We specifically say that there should not be any so-called gag rules in contracts between plans and physicians.

If there are specific financial incentives for providers to provide less care, those incentives should be disclosed to the patient up front.

If the provider has some kind of financial interest in a facility to which they might refer either the patient or send some of their lab tests or things like that, that should be disclosed to the patient up front.

If a provider has some kind of other factors -- and we talk about things like some people don't provide certain services, won't provide certain services -- for example, abortion services -- they should tell their patients up front; these are patients that I won't provide. So, if you need them, you are going to have to get them somewhere else.

That should happen up front, rather than at the time when the patient is seeking services and there is a conflict.

The fifth area we addressed was the area of respect and non-discrimination. We make a clear statement that the patient should be treated with respect and the system should operate in a system of mutual respect.

So, patients should respect their providers and those who work for them, but also, clearly, the providers should respect the patients.

We lay out specific statements in the area of non-discrimination of three areas. One is in the direct provision of services, two is in the marketing of health care plans, and three is in the enrollment practices of health plans.

We have fairly long usual lists of the types of discrimination that have been outlawed, in many cases, by federal laws, in some cases by state laws, everything from race, sex, income status, to genetic make-up, sexual orientation and some other areas that are more emerging at the state level at this moment.

The next area that we address is one that you are well familiar with. It is confidentiality of health care records. We say very clearly that health records should be used for health reasons only.

Our recommendations, frankly, are very similar to Secretary Shalala's and I know you are very familiar with those. So, I won't go into detail there, but we are on the same track there.

Then the seventh area of rights was complaints and appeals. We really felt this was a very important area. We felt that in many cases consumers are frustrated with the system because they feel powerless, and that decisions made about their care are made by people without a lot to do with the actual provision of their care.

So, we say two things. One is that every health plan in this country should have a rigorous system of internal appeals, a timely system that allows a patient to say, I don't agree with the system made about my care, the denial of coverage for a service, the shortening of a stay in a hospital or nursing home or something of that sort, and to be able to appeal that decision internally and have a decision made in a fairly quick turnaround, including a 72-hour turnaround for issues that deal with urgent or emergency care.

There should be a maximum of 72 hours. We certainly don't think the plans should wait that long, but that is the maximum.

Frankly, most health plans -- I would say the vast majority of health plans in this country -- have fairly good internal appeals systems.

We want to try to make them a little more even in their strength, but our second recommendation in that area is even more important.

We recommend that an independent external appeals process be instituted for anyone in a health plan, so that if they don't agree with the final decision by the plan in that appeals process, they can take it to an outside group -- predominantly of health care professionals -- who have the training in the area in which the case is based, but are not, and never had anything to do with the initial decision made by their health plan. That decision by that external group would be binding on the plan.

We talk about two major areas of cases that should go to external appeals panels. One is decisions that the plan makes that something is either experimental or investigational.

Two is areas where the plan rejects coverage based on their decision that it is not medically necessary. That is a vast number of the kinds of appeals that are made.

We based our process primarily on the Medicare system, although the Medicare appeals process, external appeals process, does go a bit further, including basic disagreements over whether a service is covered or not.

We didn't want to get into contractual differences, because there are other mechanisms than that, but we did specify those two issues.

Finally, the commission felt very strongly that if you establish and enforce a set of consumer rights, that consumers should have more responsibilities within the system; obviously not the kinds of things that you could bind through law or even contract, but that we felt it was important to speak to the kinds of things that consumers should do in a system that protects their rights.

We did say early on that a system that does not have consumer protection cannot demand consumer responsibility. So, there is kind of a quid pro quo here.

It is a long list, but some of the things that are in there are taking responsibility for maximizing health habits, becoming involved in health care decisions, working with physicians and others to carry out agreed-upon treatment plans, making a good faith effort to meet financial obligations, and reporting wrongdoing and fraud to the appropriate authorities.

It is very basic, common sense, frankly, responsibilities but important to state in this kind of report, particularly one that goes to the President of the United States. So, we felt that that was a very important statement.

Those are the basic elements of the first report. I am trying to go faster, but I wanted to very quickly sketch out some of the things that we are going to address in our final report, unless you wanted to --

DR. DETMER: No, I think it would be good; we would like to hear. Do you want to question on this first report?

DR. STARFIELD: On the bill of rights?

DR. DETMER: Yes.

DR. STARFIELD: Yes, I want to congratulate you. I think this is a really incredible work. We didn't get the whole of it.

DR. DETMER: No, you have the whole --

MS. GREENBERG: The bill of rights.

DR. STARFIELD: No, I want to go beyond that. So, we got some of this.

DR. DETMER: I compliment you on the consumer bill of rights piece, as far as that goes. It is a very clearly written document.

We, in fact, plan after lunch to put together a document, essentially, since it has come out, essentially the board's take on that one. I think we are interested in getting into your next --

MR. SORIAN: The final report.

DR. STARFIELD: That is why I wanted to focus on the next one because we will do something systematic on the bill of rights.

There are four areas that I think, you know, were in various places mentioned tangentially or by inference in the report, but not, I think, sufficiently highlighted, and let me just mention those four.

One of them is the reduction of systematic disparities in quality of care across population groups. It is mentioned in several pages of the report, but it is not highlighted as one of the aims, for example, on page two of chapter three.

It is not one of the areas that you pulled out, and yet it would seem to me that might have been something, given the fact that you did refer to it later on several places, that you might want to think about the reduction of systematic disparities.

The other one has to do with evidence-based medicine, and you talked about that a lot. I think the report did not adequately recognize the fact that there are systematic gaps in evidence.

I think this is something, actually, we are going to highlight in our formal comments on the bill of rights, but I want to take it a little bit further.

If you -- there are -- most of the literature on evidence-based medicine really only relates to the less disadvantaged segments of the population.

If you want proof of that, take the editorial in the JAMA in November. There was an editorial in the special issue of quality of JAMA and it picked out eight exemplary studies.

All of the eight dealt with the elderly and seven of the eight dealt predominantly with white males. So, there are systematic gaps.

If you are going to take a stand, again, you know, you have to recognize that we need to get evidence on the more disadvantaged segments of the population.

The third one I want to mention -- and I can actually give you the pages -- errors in medicine. Almost all the evidence on errors in medicine is in inpatient settings.

So, we need to think about errors in outpatient settings and how we can get at that.

The fourth area is the role of perverse incentives resulting from payment mechanisms. This is something that is occupying this committee a lot.

I mean, there are -- if you are getting evidence on diagnoses on problems, we know that there are systematic gaps in that because of the way providers are paid.

They don't report things that they don't get paid for. There may be very big problems of quality of care in those areas. How are we going to get at the perverse incentives that come from our way of paying.

I have others, but those are the main ones.

MR. SORIAN: That is very helpful and I appreciate those. I think that we do address those in chapters that have been added since Janet spoke to you, I guess several months ago at this point.

Why don't I very, very quickly kind of run you through what we have got in the report. There are going to be, I believe, 14 chapters in the report next week, including a specific chapter on vulnerable populations that addresses the specific point that you raised, and we are in full agreement.

Also, we have a chapter on error reduction that addresses some of the issues. So, the final report, which does dovetail with the bill of rights, but is really focused primarily on the commission's second charge, which is to recommend ways to improve and continue to improve the quality of care provided in the United States, will be delivered to the President some day next week.

We have our final meeting on March 11 at the NIH campus in Bethesda. It is an open meeting for anyone in the public who wants to attend; obviously, members of this commission, certainly, if you have the time.

I wanted to run through the draft executive summary, which sort of gives you a feel for what we are recommending. Obviously the commission could make some changes on the 11th, but we are not anticipating any major changes in those areas.

First and foremost, the commission indicates in its report that there is a problem with the quality of care in the United States.

While the vast majority of Americans receive very high quality care, and probably the best care available in any country in this world right now, too many Americans receive poor quality care, and it is not possible to predict where poor quality care is going to be delivered.

It is not that some institutions always provide high quality care and others always provide low quality care. It would certainly be easier if we could just find the outliers, identify them and get rid of them.

The quality problems really permeate the system throughout. There have been very strong efforts by the private sector and the public sector to identify these problems and to address them in systematic ways.

Those approaches have started to show some problems, particularly in identifying the problems in quality of health care in the United States.

There clearly needs to be a more national systematic approach, and by that I don't mean a government approach to improving the quality of health care. We specifically do not believe that the government should suddenly become the quality czars over the system.

That wouldn't work and we feel it would be resisted strongly by the health care profession and by consumers alike.

What we say is that the problems in health care fall into four basic categories, and these have been well documented, and this chapter of the report probably has more references than any other, because we want to make it clear that this is an evidence based approach that we have taken.

The first area is avoidable errors. Frankly, most of the research, if not virtually all of the research, has focused on the inpatient side, although there is beginning to be some research on the outpatient side.

There was actually an interesting report in the Lancet, I believe this current issue of The Lancet, about medication errors outside the hospital system. But frankly, most of the research has been done in the hospital side.

We site a number of research findings, including the famous Lucien Lee(?) paper -- almost infamous Lucien Lee paper -- that indicated that approximately 180,000 people in the United States die as a result of avoidable errors in care in hospitals.

In his testimony before the commission he compared that to the airline industry, which has a much lower rate of error and death in their system.

The number of people that die in hospitals as a result of avoidable errors is equivalent to two or three large airplane crashes every two or three days.

The kinds of statistics that Lucien Lee has compiled in this area are very impressive, and we do rely heavily on them. We also rely on the work of many other people in this area. So, errors is number one.

The second is the over-use of services. There has certainly been a great deal of research about over-utilization.

One of the examples that we cited is that 80,000 American women undergo unnecessary hysterectomies each year, at the cost of $320 million to the health care system.

The third are is under-utilization of services, and particularly in the area of prevention, but not only in the area of preventions.

There are many Americans who don't get the services they need and, as a result, suffer health care consequences.

For example, a recent study showed that an estimated 18,000 Americans die every year because they didn't get beta blockers after they have a heart attack, even though the scientific evidence has shown that treatment with beta blockers is an effective and useful treatment.

I am not a medical professional. So, I am citing to you from research, but that is just one example.

Finally, the vast variation in services that has been documented by John Wenberg and others across the country, in regions, and even in small areas, where the provision of health care services differs so dramatically.

That is a clear indication that evidence based medicine hasn't taken hold in the system, to the degree that many feel that it should.

We do not embrace the evidence-based approach to health care entirely. We make very clear in a couple of our chapters that there are some parts of the health care system where people are providing service without a strong evidence, and that they should continue to do so, but that researchers should try to provide them with greater evidence.

We are not saying that, if there is no evidence, stop doing what you are doing. We are saying, if there is no evidence, stop doing what you are doing.

We are saying that if there is evidence that you shouldn't be doing what you are doing, stop doing it. If there is evidence that you should be doing something else, you should start doing it.

We want to make clear that we are not saying that every medical or health care interaction between a patient and a health care provider should have an evidence base or not occur. That would obviously be a rather foolish statement, and we want to make that very clear.

So, what do we recommend -- we also have a chapter that really tries to lay out the fact that the health care system is changing dramatically and continues to change very rapidly.

We talk about the fact that you have to be careful about what you do in a system that is changing so quickly. You might have the kind of unintended consequences that you would rather avoid.

So, we make a series of recommendations, the first of which is that the health care system needs to have an overall statement of purpose, and the commission has written the following statement of purpose for the health care system.

It is: That the purpose of the health care system must be to continuously reduce the impact and burden of injury, illness and disability, and to improve the health and functional status of the people of the United States.

I think it is a statement that nobody would argue with, but it is one that should guide the purposes, and certainly not by the government, but should guide all the participants in the system.

Then what we say is that there needs to be a national approach that really empowers and involves all the stakeholders, public and private and others, and needs to carry this forward in a more systematic fashion than we have so far.

We can no longer just rely on the leaders of industry and the leaders of the health care system to push the system for greater quality. We need to have a more coordinated approach.

The commission has recommended the creation of two entities. I know that no one is surprised when a commission recommends that something be created.

They felt very strongly that the process that they engaged in the last year is useful. They certainly didn't want to keep doing it for the next few years, and we were grateful for that, but that somebody needs to.

They recommend the creation of two entities, one public and one private. I think that was an important statement that they wanted to make clear, that there are public responsibilities but there are also private responsibilities, and that in both entities public and private participants need to be involved.

The first is the creation of what we are calling the advisory council for health care quality. It is a public entity that would have several purposes.

One would be to identify national aims for improvement, specific objectives within each aim for improvement, and to track the nation's progress in meeting those aims and objectives.

They would be publicly financed, but they would be made up of private sector and public sector experts, people from HCFA and other public purchasers, but also employers and health care providers, consumers, experts in the area of quality improvement and public health and others; the usual kind of roster, but a really comprehensive group of people.

They would report annually, both to the President and to the Congress, on the nation's progress in meeting the objectives of quality improvement.

The second group, which is a private sector entity, is called -- we are calling it the forum for health care quality, measurement and reporting.

This entity, obviously by being a private sector body, is voluntary. It can be created by consensus among the major stakeholders in the private sector and the public sector, but there would be no legislative mandate for this.

The public sector would have to commit to involving itself and participating in this process. We think that would be an important statement, because there is a great concern on the part of the private sector, that if they agree on a way to promote this and the public sector -- primarily Medicare and Medicaid -- are going off in a different direction, then all their efforts usually are frustratingly for naught, and they wind up having to change direction.

So, we wanted to have both people at the table, both sets of people at the table. What they would do is focus on quality measurement.

The area of quality measurement has certainly grown in the last decade quite well, but it continues to need -- in some ways it has grown too much and in other ways it hasn't grown enough.

So, it needs to grow more, and particularly into areas where it has paid very little attention because of the scarcity of resources, but particularly into vulnerable populations and others.

It also has produced such a large number of measures that many health care systems are overwhelmed by the demand for measuring this and measuring that and who wants this measure and who wants that measure.

The forum would try to sit down at the table with major employers, major consumers, as well as the health plans and providers, et cetera, and try to identify a core set of quality measures that all participants in the forum would then either require or provide.

So, if you are the employers and the public purchasers, you would say, we want this core set at least to be provided, and we would know that we would have consistent information across the system in those areas.

It would not be a stagnant set of objectives. They would obviously grow as the years go by and the council and the forum would compare notes and try to keep moving forward in the same direction.

An important element of all of this will be the establishment of national aims for improvement. Here we borrowed very heavily from the Healthy People 2000 approach that has worked so well in the public health area.

We are recommending that the advisory council create a set of national aims for improvement and the commission, in its work, has devised at least the first set for the council, since it will take some time for this to get up and running.

There are six of them. They felt it was important to keep that list fairly short, and six was the number that they came up with. They are as follows:

  1. Reducing the underlying causes of illness, injury and disability;
  2. Expanding research on new treatments and evidence of effectiveness;
  3. Assuring the appropriate use of health care services;
  4. Reducing health care errors;
  5. Increasing patient participation in their care; and
  6. Addressing over-supply and under-supply of health care resources.

Again, these are broad and probably hard to argue with, but the point is that they need to be broad so there can be specific objectives under each area.

These coordinate with the kind of research I talked about earlier, about the problems in the system. So, that is the first batch. It is the commission's recommendation.

The council really would be responsible for continuing to refine that and to set out the objectives underneath each broad aim.

Finally, the commission is recommending that a series of steps be taken in other parts of the system. I can sketch them very quickly. I know I am talking a little longer than I should have.

We look in the area of the market. We do believe that the market system that we have now has some strengths to it, and we also believe very clearly that you are not going to suddenly do away with a market based system of health care system in this country. So, we want to build on it and strengthen it.

The role of group purchasers is particularly important, since they make the decisions for consumers in so many cases today. About 95 percent of people with private health insurance get it through their employers.

We specifically single out group purchasers, both public and private group purchasers, as having a role to be more active and more coordinated in demanding high quality services.

Too often people are buying it based on price, not on quality. Some of that is based on the fact that they don't have a lot of quality information to make decisions based on quality and some of it, frankly, is because price is easier to make a decision on and quality sometimes costs more.

There needs to be a greater effort there, and that also involves the issue of choice that we discussed in the bill of rights.

We do make some recommendations to try to help small employers in particular to band together into purchasing coalitions, voluntary purchasing coalitions, so that they can get a better price, but also can compare quality and have the coalition give them the kind of data they need on quality that so many of these small and large employer coalitions are doing today.

In the area of consumers, we specifically lay out a series of things that can empower consumers, give them greater choice, give them greater information in the health care system so that they, through their employers but also individually, can demand quality based health care delivery and health plans.

We have a very important chapter on vulnerable populations. We did try to define the kinds of populations that we were discussing.

Frankly, somebody at one point said, who is left in this country. When we need health care, almost all of us are vulnerable.

We did single out those who were poor, the frail elderly, those living with physical and mental disabilities, children -- especially special needs children -- and the aged in general, but particularly the frail elderly.

In this area we do recommend, and we try to push the Health Care Financing Administration along as much as we can, to develop a risk adjustment system in the public arena, feeling very strongly that that would then be adopted in the private sector.

We do not recommend that there be separate systems adopted. We push for the public payers to do it. The Balanced Budget Amendment, which was enacted in the middle or our process obviously creates an important incentive for HCFA to do that soon.

We then say that accountability is very important, that all participants in the system have to be accountable for improving quality.

There is an important role for the existing and future quality oversight organizations -- the NCQA, JCAHO, HCFA and its quality oversight roles -- and that some of that needs to be better coordinated, but they will play a key role in the accountability of this system, both in this area but also consumer protections, we believe.

No matter who does what -- whether it is legislation, regulation or accreditation -- eventually it is going to come to groups like NCQA and JCAHO who are going to have to make sure that the system is being properly changed to meet those standards.

We do call for greater investment in research, both in the basic and clinical medical research that frankly gets the lion's share of the research money that the Federal Government provides and the private sector.

We also call for a significant investment in health service investment, and especially into AHCPR and its quality research activities.

Actually, the President's fiscal year 1999 budget, I believe, doubles the AHCPR quality research budget from 15 to 30. That is a start.

The commission really believes that there needs to be a continuous growth in that investment, and obviously that feeds into all the other things we have said about the lack of some research in some areas; that we certainly need some change.

We do talk to the role of health care workers, the development of information systems, and the adapting of individual health care organizations.

A lot of this is much more private sector oriented than the first report that really talks about the standards that are clearly kind of public duties to establish.

The government has the role of trying to coordinate this and provide continuous leadership. We feel -- the commission feels -- that the President, by creating this commission, took an important step of putting quality high on the national agenda.

What we are trying to assure is that once the commission goes away, that the agenda doesn't change back and that quality drops off the list and that consumer protection remains on and this kind of goes away and people study it for a while longer.

So, the creation of the council and the forum are key parts of this, but the other recommendations will help to guide that process.

Finally, this report, as anyone who looks at this system would, indicates the strong concern on the part of the commission about the rising number of uninsured people in this country.

It says that you can make the system as high quality as possible and provide as many protections to consumers, but as long as 41.7 million people don't have health insurance, you can't do a lot to improve the quality of their care when, frankly, they only access the system when absolutely necessary.

So, the President did not ask this commission to resolve that problem, and we were grateful for that, but we felt we would be remiss if we didn't point out that that problem needs to be addressed.

We did praise the action of the Congress and the President last year to provide funding to the states to cover more children who are uninsured, and we want to make sure that is not the last step that is taken in that area for a while.

In a nutshell, those are our two reports. I apologize for going on a little longer. I know everyone is going to lunch.

DR. DETMER: Thank you. I think what we plan to do is engage this issue after lunch. I think we are going to, as I say, put probably something on our web site relative to our reaction to the consumer report.

We may, in fact, wish to feed back to you folks, while you are still heading to your last meeting on some of these issues that you have raised.

Maybe what would be useful before we break is take a couple more minutes, if you have specific questions that would help clarify our conversation after lunch.

I think obviously it is an important piece of work and clearly we are very interested in it. Questions or comments?

DR. FRIEDMAN: In chapter eight where you talk about patient responsibilities, at the end there is a comment about increasing incentives for plans for communication and acceptance of treatment regimes.

Are those incentives for plan members or at the plan level itself? That is sort of a throwaway line, but it is also the last line in the report and it sort of leaves one dangling.

MR. SORIAN: I am trying to search my memory banks for what we intended on that in November. I think it was primarily aimed at plans.

I think that it, again, tries to point out that consumers have to play a role there as well. If the plans do what we say they should do, it doesn't work well if the consumer doesn't engage in that process in both directions.

So, we try to emphasize that and tried to tie that to some of our recommendations earlier

MR. SCANLON: Richard, the committee has a copy of several of the chapters that I think the commission looked at last week, the version that they looked at.

Chapter 14 deals with investing in information systems. To your recollection, did that largely stay intact as the commission reviewed it, or are there new features that came up?

MR. SORIAN: It stayed pretty much intact. Last week's meeting was actually an ultimate meeting and we thought we would have a lot of changes in chapters, but almost all the chapters stayed pretty much intact. We were grateful for that as well.

The commission has had an interactive process in which they have looked at these chapters, in most cases, three times, sometimes four, others two. Very rarely did they only look at something once.

So, they had an opportunity to weigh in at both the subcommittee and full committee levels, in many opportunities. So, that did help to shape the consensus behind that.

We do expect the consensus -- we don't even call them votes -- consensus opinion on this report by the 34 members.

The first report, one member did object to the report and made a statement very clearly that she didn't believe there should be a consumer bill of rights, no matter how it was written.

So, she didn't abstain. She objected. So, our consensus process worked, in that 33 out of 34 members were fully supportive of it.

There has been some debate about what consensus means and we don't take votes and sort of say, okay, there are 33 for and one against and that is consensus.

We continue to try to address concerns that people raise so that they can continue to change. But that chapter remains pretty consistent with the draft.

DR. DETMER: Other questions or comments? I will say that a number of us actually had the pleasure of testifying to the commission.

I think there is some sentiment in our group, in this committee, that obviously it has had a history of looking at quality -- this committee -- for 40-some years, and see us, the current members of the committee, playing essentially that boundary role between the private sector and the public sector, and see ourselves actually clearly interested in tracking many of these items that these new groups would also be created to look at.

I think I do feel that we at least had our opportunity to put views on the table as the process went along.

Any other questions or comments before we break? If not, I thank you very much. I think this has been very useful, and we appreciate it.

Why don't we break until -- I have like 12:50. Why don't we try to be back at 1:30 or very shortly thereafter.

(Whereupon, at 12:50 p.m., the meeting was recessed, to reconvene at 1:30 p.m., that same day.)


Afternoon Session