Fourth Panel - Data Quality, Accountability, and Integrity:
Review - What Did We Learn From the Testimonies?Review Plans for May 17-18 Hearings
Jeffrey S. Blair, M.B.A., Co-chair
Simon P. Cohn, M.D., M.P.H, FACP, Co-Chair
Kathleen A. Frawley, J.D., M.S., RRA
Kathleen Fyffe, M.H.A.
Clement Joseph McDonald, M.D.
Staff:
J. Michael Fitzmaurice, Ph.D., Co-Lead Staff
Mel Greberman, M.D., M.P.H.
Stanley Griffith, M.D.
Betsy L. Humphreys
Rob Kolodner, M.D.
Col. Lynn Ray
James Scanlon
William Yasnoff, M.D., Ph.D.
Guest Speakers:
Joseph Bormel, M.D., Cerner Corporation
Jeff Sutherland, Ph.D., IDX
For those on the Internet, and for those that might have come in for this day, I just want to very briefly put in perspective the purpose and context of the hearings of the CPR work group. The CPR work group's mission is to study uniform data standards for patient medical record information, and the electronic exchange of that information, and report to the secretary of the Department of Health and Human Services those recommendations by August 2000. So during this year the work group is having hearings almost every month on different topics and perspectives that relate to uniform data standards for patient medical record information.
The subject of today's meeting is data quality, accountability, and performance issues. We have two panelists here. I'm going to let them introduce themselves. Oh, I'm sorry, Simon has prompted me that we really ought to have the committee members introduce themselves first. So could we start to my left and kind of go around? Actually, not only the committee members, but other staff people and attendees.
[Introductions were made.]
MR. BLAIR: Okay, then Joseph, can you begin?
The Cerner Corporation is a leading supplier of clinical and management information and knowledge systems for health care organizations in the United States and abroad. We have more than 1,000 clients in the United States and around the world. These clients include: integrated health organizations; integrated delivery systems; community hospitals; ambulatory clinics; physician practices; management services organizations; blood banks; reference labs; and home health organizations.
Cerner and I very much appreciate the opportunity to testify, and to provide our industry-oriented perspective to the National Committee on Vital and Health Statistics hearings on data quality, accountability and integrity.
What I would like to do is to contextualize my comments today in terms of the comments that were made yesterday. There were four points that I thought were particularly salient that I wanted to underscore today. Harold Solbrig's comment that the question about PMRI is what is its purpose, and that really needs to be the foundational question;
Doug Pratt's comments that in the acute care facility, where more than half the health care dollars are spent, that the facilities which we used to call hospitals, have dramatically decreased revenues, and dramatically increased expenses, which is painting the landscape that we work in;
Jack Harrington's comments regarding the intended use of data as being foundational; and Wes Rishel's comments that we need to raise the bar, and we need to raise the bar slowly enough that it's appropriate.
Mike asked me to address what the PMRI value is; how it can be made more valuable; how can it be better for the health of the nation and for business? I would like to start out with a 30 second anecdote.
A good friend of mine, a lifetime friend for the last 20 years woke up four weeks ago on Saturday morning and had about 5 percent blindness in one eye. It was a Saturday morning. I called her for reasons unrelated to that Saturday night, and she asked me, did she need to do anything about it? I was wanting me to buy into her whole denial thing.
I said this was an emergency and she needed to get emergent health care. She went to an emergency department in Maryland, a fairly large one. She has commercial insurance. She is mid-thirties, a mother of two, a very intelligent lady. They did not check her blood pressure, and they did not weigh her. Several days later in an ophthalmologist's office she had a fundoscopy which revealed that she had a hypertensive emergency, and that that was the fundamental issue to understand in order to take apart why she presented at the health care system. So that's 1999, with good medical insurance in a contemporary setting.
With that as a contextualization, let me begin by giving you a conceptual diagram that brings together a lot of the points that were made, as well as helps clarify some points that I think got muddied together. When we look at the information that is captured during a clinical encounter, the patient medical record information, there are really four components to that.
It is a component of the patient's lifetime medical record, which becomes very, very important for a lot of population reasons, as we all know. One component is the descriptive documentation aspect. These are the comments that Rachael made yesterday that health care is document-centric.
It's true, but it's true from the perspective of the provider who needs some sort of a diary of what happened last to remember -- it's a memory jog for what they were doing for the patient, and to record what was happening from the standpoint of having good record keeping. This is the aspect that physicians focus on. This is the aspect that they evaluate when they are looking to use a medical record.
There is another aspect that is overlapping, but also has some clear areas that don't overlap, and that is the context of care management. That is the context that for somebody for example, presenting with a hypertensive emergency, there are certain things you should do, like record blood pressure. That should be recorded and captured in the clinical encounter.
There is a third aspect, which is clinical performance measures. Certainly everyone in the room is more than aware of many examples of this. I'm talking about discrete, codified, granular information of the type that you get with HEDIS statistics, ORX(?) initiatives, those sorts of issues. They tend to be at the level of something that you can count, and something that you can clearly identify. It is relatively context-free once you get beyond the population that you are dealing with and time frames.
The fourth aspect is process automation, and these are the aspects of everything related to process. In my testimony there are the eight steps of process that is in your handout, and we may read it into the record. This is the perspective of the CIO. It is also the perspective of the CFO. It's getting the bill out. It's getting the patient uniquely identified correctly. It's getting the billing codes and the whole coding system.
There is clearly overlap with the other three. The super bill is the aspect of that that is seen by the physician, and also the results reporting of lab results, et cetera is the aspect of that that is seen by the physician coming in from the left side of this picture. Taken by itself, it is clearly devoid of enough of the care management aspects that it makes it very, very difficult post hoc to analyze care, understand decision-making, and improve the system.
One of the big lies of health care automation is that we can do this without increasing the amount of time or work involved on anyone's part to increase the amount of information that is captured, increase the degree of codification. Our challenge really is to recognize those challenges and figure out ways to both minimize them, and give people enough back and properly incentivize them that we don't dramatically impact their productivity, and we improve productivity of the more global system, which is more of a systems thought.
There are also two axis here that I have alluded to, but let me just make them explicit. Often on this left-hand side is the three text aspect. It's the uncodified aspect that is clearly an important part of a medical record. Off to the right-hand side is the aspects that are only codified, they are only useful to populations when they are codified.
In the middle is something akin to what was described as the clinical templates within the RIM, which is fully contextualize, granular information at the third level. You basically need to understand for example, that the blood pressure was recorded in the context of somebody with new onset sudden visual loss. You need to understand a number of other aspects about it to know that other things were considered.
So the granular information in and of itself is not sufficient without it being contextualized to the frame of what was the reason for the visit. What was perceived by the caregiver as the thing that needs to be managed during this visit?
Then there is the information that is still in someone's head. We all understand that challenge. We certainly need systems that can prompt to collect that where appropriate. In the case of guidelines, getting that information out is absolutely critical to know how to run down a guideline.
In my written comments this is the points one and two after the listed (a) points, which is the encounter-independent aspects of information capture and information use, which includes expectation tracking and alert generating. For example, if I see someone, a woman, and I get a pregnancy test on her, and it turns out that it comes back positive, that may come back. That may come back independent of the encounter, and it needs to be addressed possibly independent of that encounter.
So then the challenge is to recognize there are different perspectives, to recognize that virtually no single human being sitting at a table can master more than two of these perspectives, and typically they are somewhat zealously bound to one, and have great difficulty seeing the other ones. That's part of our challenge, to create a system that can do the data capture as a by-process of the care process, that meets the overlapping requirements that are necessary for all the domains.
Standard definitions of the data elements, they are pretty obvious to this group. Then process flow is integration glue, so that you can dramatically reduce the time it takes to capture information by using precompleted templates for example, that capture the state so that documentation can be done by exception, and so that the tool can actually collect larger amounts of data without adversely affecting productivity.
I will freely grant that the state-of-the-art, as we all know, is that we are really not there yet today. We are not there yet because of three major problems. There are challenges in leadership which have been identified already. There are challenges with incentives, particularly between physicians and people doing care management, also beyond the scope of this testimony.
Then there is the issue of the tools; how ready they really are. One of the major issues with readiness in terms of physicians is the speed with which they can do screen flips. Which brings up the issue that did not come up explicitly yesterday, which is the dark side of middleware, which is that you need to optimize and test those issues as part of your design.
So to address Harold's initial comment, what business problem are we trying to solve, and to use the largest business problem from the medical management construct, I went to an ACPE course last week that was offered on advanced concepts in risk contracting and medical management. The point that they made was bed days per thousands is the single biggest short-term opportunity, the low hanging fruits, to improve the cost structure of health care delivery.
What you are seeing here is Medpar(?) data here for two hospitals that are part of one of the 20 largest hospital systems in this country. Both of these hospitals, X and Y, are owned by the same consolidated group of organizations. You are seeing a real diagnosis of pneumonia with complications.
The points that I wanted to bring out on this slide is first of all there is a huge difference in the average length of stay. At Hospital X the length of stay was 5.6; at Hospital Y the length of stay was 8.2. That's an average I appreciate everyone in this room understands that medians would be a better measure than that. But this is the state-of-the-art in terms of commercially available profiling data that you can get back.
The other major pieces from this I would like to point out is that the average cost for Hospital X was $5,800; the average cost for Hospital Y was $8,000. So you've got a $3,000 cost difference in the delivering of care, and the nosology of DRG 89 is possibly not granular enough to do anything useful and meaningful. This is part of the problem of taking the next step in management, and where the patient medical record information is absolutely critical in moving beyond this point.
To just extend this, now going to another one of the top 20 largest health care systems in the country, over $1 billion in revenues, this is another one, but it's the same diagnosis to make the point, the have an average charge of $11,000, so their average costs are probably in the same range. But the range of case costs for their 110 cases for this particular year was $700 to $56,000. So you've got a standard deviation of $8,000 on an $11,000 average charge for pneumonia.
If you were to extend this and say, well, pneumonia is a special case, Joe, and you made a very nice point, but it doesn't really apply more broadly, other major diagnoses like congestive heart failure, in this case risk adjusted with our DRGs so that the zero terminal digits are the mild cases, and the two is the most severe case show also very, very wide standard deviations, very wide ranges, and large enough numbers of cases for a multiple facility chain, that is a major chain in this country, that this is a substantive issue.
There is a lot amount of variation that, if it is from chance, or if it is from patient factors, if we are going to manage the system, we need to clearly understand that. You can also apply this to surgical diagnoses, and you come up with the same numbers. This is all in your handout.
So to go beyond the current limitations of patient medical record information, we need to both be able to produce a reasonably good estimate of what the expected cost is to manage that population, to know what the particular costs locally are, where our opportunities for management are, and to know about what the drivers are, and where we are underutilizing and overutilizing resources from a variety of perspectives, whether it is from a pathway perspective, whether it is a benchmark perspective, or whatever. The patient medical record information is absolutely critical to have information to do that.
Closing with the point around pneumonia, you need to be able to take that pneumonia group 89, DRG 89, be able to separate it out into those that are clinically low risk, and those that are clinically high risk. To make that explicit, the low risk patients have normal blood pressure, normal pulse rates, no mental status change, normal albumin and creatine all within the first two hours of being seen in the emergency department, so that we know what we are talking about. We know their risk is four times lower of death, et cetera.
Then be able to separate that group out from the standpoint of communicating to those stakeholders who we need to influence, which cases have significant variation and costs not explained by independent triggers, ages, co-morbidity. And to get to Clem's point yesterday, the importance of being able to set information together. The term for that is event sets, but it is basically not a unique concept.
To be able to say for pneumonia, the important set of information clinically that goes beyond what we are currently capturing is these are adequate reasons for higher costs. This is a commercial source of this, but anyone who is a clinician in the room will recognize that those things make sense.
These are inadequate reasons for increased costs, which is pleurisy, cough, and fever. These patients possibly could have been managed without admitting to the hospital, with 20 times lower costs. There is very good data in the recent literature, Infectious Disease Clinics of North America has got a publication in the last year. They done meta-analyses, they have done a very, very broad ranged look at community acquired pneumonia. This is known to be a public health problem across the country in terms of how we do decision-making around site of care, and identifying patients at the beginning of care.
So we need sets of granular data. We need it in that middle section of the four overlapping diagrams that appropriately contextualize the information. Hopefully, this example made that clear.
The other thing we need to do is we need to have measures of data so that we can see what the current variation is. We can bring in initiatives like Pathways, or one of a number of other medical management initiatives, actually be able to see that we have made an impact in overall value, defined as more quality and less cost, and be able to see the new level, the new variation, and know from an industrialization standpoint, what we have got there. Once again, that has explicit implications for PMRI.
So my current way of looking at the world, which is the last eight months, and will probably be different eight months from now is I'm using the term medical management to group together programs undertaken by administrative, clinical, and financial management to provider organizations to improve quality and lower costs, reduce inappropriate variation, and meet reporting requirements.
One of the most important things that I do is I help create awareness and then acceptance within organizations for what we are doing and why. Physicians are very skeptical. They typically don't get good information about the larger system changes.
So I use the care world as a metaphor to help explain to people all the things they have been hearing about, and how they all relate together. I want to share that with you, and it's in your handout. In the center of this picture is a sphere which says "Care" in it. It is a circle. There are two axes here. The vertical axis, as you go to the top, is higher acuity and higher cost care. As you go from left to right, it is the time axis.
When you extend the care world and you look at the setting of care, you see at the very top, acute, urgent, and emergent care, like my friend who had the emergent hypertension. You have got just below that chronic diseases. You've got in the leading edge of this care world, demand management and cost centers, those sorts of issues that are part of care, but they are part of before the patient properly hits the care system. Then you've got health, wellness, and then the very, very important aspect of self-care and the dramatically increasing role and importance of patient self-education, particularly when we are under risk.
The only other major object in the care world seen is the population that is requiring care. You can divide the population up into four major groups. This is how people do it in commercial managed care. These are actually real number for a commercial managed care contractor in the middle of the country.
The top bar, the highest cost is catastrophic care. It's about 23 percent of medical costs. If you are thinking from a risk standpoint, that's a quarter of your medical risk costs for a commercial population. The average patient costs $30,000 per member per year. It's about 1 percent of the population.
The major other categories are chronic care, which is disease management, episodic care, and wellness. In the interest of time, I'm going to move forward. But the issues of patient medical record information is different for each group. If you are doing managed Medicaid or managed Medicare, and you are possibly being forced into it, which many of our clients are, this drives what new clinical patient medical information you need to manage, to reduce variation around these cost numbers.
So then the game of medical management is to identify patients from the population, intervene as effectively as possible, and then inform the stakeholders with measures that are substantive and salient. That is the issue of patient medical record information. That's the functions that it serves. That's the value of comparability.
The big piece of that is the acceptability of the number to physicians. That's where precision accuracy and the consequences of inaccuracies drive real costs in terms that you are all very familiar with.
These are the names of a variety of initiatives that you have all heard of. The major of these every organization is required by regulation to do, for example, the ORAX(?) reporting. The major axis here, in the very first left-hand bar is prospective medical management, things that are done before a care encounter begins. Concurrent medical management is the middle section. Then the last section to the right is retrospective initiatives, which is primarily where payers get a crack at the data doing claims analysis, which is the primary way we do profiling today.
My point is that if you do this with systems that don't use some common definitions and some common understanding about definitions for elemental data, you end up with impedance mismatches that dramatically impede the ability to do things like do clinical profiling and cost profiling, recognize that amongst your variation you are trying to reduce is recording blood pressure.
You want to move that back to the case management or the pathway level to make sure the patient presenting with sudden onset blindness gets their blood pressure taken, and be able to record that and trend that in the way you saw in the earlier graphs. Unless you have consistency of terminology between your initiatives going all the way forward to risk assessment, people who are overweight and have hypertension you could have identified before the blindness occurred, you don't have an opportunity to improve the health of the population.
You have an opportunity, but the costs to do it are much, much higher. So in summary, billing data lets you evaluate patterns of resource consumption, the what, the when, the where, and the who, but not the why, and not the clinical context. Without common situation-specific granular codified PMRI the consequences will be lower cost effectiveness of medical management initiatives, and I think this was defined fairly well in the early slides.
At greatest opportunity is PMRI captures a by-product of routine care that is common and codified. This is the critical first step to quicken the pace of health care improvement.
I think in the interest of time I will not read my formal comments into record, but I have had them read by enough people that I know that they are clear.
Thanks for your attention.
MR. BLAIR: Thank you, Joseph. Jeff Sutherland, could you address the committee.
DR. BORMEL: While he's doing that, I could read my answer to the first two questions into testimony.
MR. BLAIR: Please.
DR. BORMEL: The first question, what are the definitions for patient medical record information? How would we define or describe it? We defined patient medical record information as data required to deliver appropriate, effective, and efficient care at the appropriate place and time to achieve optimal health outcome.
Bringing in prevention aspects of the care mandate, and implicitly the population focus, we believe it becomes necessary to make the distinction between patient medical record information and person health information; the former having an acute care and higher acuity, and probably a disease connotation, the latter being more concordant with the NCVHS's defined computer-based health record.
In our experience, maintaining and attempting to integrate the three types of CHR, personal, patient, and population has huge not-so-hidden costs, frequently leading inexorably to failures to operationalize basic business and clinical objectives. These objectives take the form of process automation and process-focused quality initiatives which were outlined in the Power Point slides.
Walking through the common process of care will serve both to illustrate this point, as well as to explicitly answer question 1a and 1b. Patient medical record information is needed for the eight process components, and the underlying functions of all health care delivery encounters.
They are: (1) identify the person or persons uniquely involved in this encounter; (2) assess their needs; (3) plan for care based on that assessment; (4) order the components of that care
; (5) schedule those orders; (6) carry out the orders; (7) document what was done; and (8) account for the resources consumed, communicating that accounting to the stakeholders.
There are also two process components that transcend the bounds of typical health care encounters that involve monitoring a patient's health status, expectation tracking and alert generating. This model applies equally to traditional health care delivery and ambulatory and acute visit-based encounters, as it does to prospective and retrospective care management.
By that we mean that the steps and the functions served by health information underlying these steps is vital to effective demand management, cross continuum disease management, and population health management, as well as retrospective cost and quality profiling, and patient self-education.
Let's quickly define the scope of PMRI in terms of those process steps. Step one requires unambiguous person identification, both of the persons receiving care and the associated providers of that care.
Step two requires fully coded health status summary information. Traditionally this has included active problems, allergies, current medications, and other information summarizing the current care context.
Steps three and four require ways to make explicit references to guidelines and associated orderable components of that specified care. This scoping exercise could be extended to all ten enumerated process steps. This would add process measures, outcome measures, discrete test assays, coded health maintenance goals, et cetera.
Question (c) was how comparable does PMRI data need to be for these purposes? There is tremendous cost and quality penalties when these eight process steps are handled without commonality of standards that the health information infrastructure has the potential to create. Without comparable PMRI defects in identification, assessment, planning, and all other subsequent processes are inevitable.
The precision and accuracy or lack thereof has direct impact on clinical, financial, and satisfaction outcomes. Using ordering of drugs as an example, the consequence of inadequate information management contributes directly to adverse drug events, a national problem that kills 60,000-140,000 American each year, and costs the nation more than $76 billion annually.
Much of that expense is shouldered by the agencies of the federal government. The lack of national standards to concretely identify drugs makes complex DUR impossible to do. I refer you to the testimony done by Dr. Tim McNamara in the December 9th proceedings of this group.
Comparable and structured granular codified process information constituting the PMRI serves another vital function. It allows recording of encounter data one time to serve all subsequent purposes of that health information. As outlined in the tasks for information infrastructure, the NCVHS concept paper of October 14, 1998. These purposes include population data needs, transaction needs, integrated knowledge management, decision support, research collaboration, and the evolving consumer demands around health information.
This data must be encoded unambiguously and preferably by the provider himself or herself, rather than a post hoc encoder, which is frequently the state-of-the-art today. Substantial quality is lost when this is done, using a coder that is, due both to the introduction of another receiver in the party line, as well as intrinsic decay that occurs with measurement accuracy with time.
Another significant problem occurs when the person doing the coding is forced to use a coding scheme that is designed for another purpose. For example, using ICD-9 codes to capture clinical context. This commonly occurs when a physician is forced to use these billing codes in a clinical setting. This insures the loss of quality and accuracy, as well as decreases the physician's confidence in management initiatives derived from the garbage data. That is a logical consequence of trying to link together coding schemes post hoc that were intended for purposes other than that for which they are being used.
Summarizing these points, we conclude that having providers record appropriately codified information would improve quality. What is less generally understood, however, is that the process only becomes effective and in fact possible when the benefit exceeds the implementation burdens.
In other words, if the recording process slows down the physician, they would be disinclined to use it, and rightly so. That necessitates removing steps from the new process of automation. For example, when a physician using a computer-based health record identifies and assesses a patient for their most significant problem, for example, sudden onset of visual loss, the benefits could be created if the infrastructure is integrative.
The CHR can suggest a plan which would include capturing blood pressure in this case, recommend orders, scheduling, facilitate activating that plan, speeding up the speed with which it happens, so people don't have to wait for six hours in the emergency departments for things like, for antibiotics to be started in the case of the pneumonia example. It also would speed up the documentation and accounting process. These steps can each speed up the physician, offsetting the burden of entering codified information.
So in conclusion, further, it can assure data quality, accountability, and integrity of the composite encounter information sets insuring that blood pressure and other key observations are recorded. Please note that the process required the physician only to initiate two processes, identifying the patient, which actually could be done prior to the physician seeing the patient, and assessing their need before the automation facilitated the completion of the remaining six steps.
The resulting facilitated total care process would exceed the performance of today's health care delivery system in that there would be less variation introduced by oversight and other task interfering causes.
Thank you.
MR. BLAIR: Thank you. Jeff, are you ready?
I have just annotated some of the experience that is relevant to this. From 1975-83, I was grant funded by NIH for data collection as part of a national system. I have worked with Bill Braithwaite for many years there. Many of you know him.
In 1983, I left health care and went into the software industry, and for many years was in software tools, particularly object-oriented systems, component-based systems, Internet development, and I participated in the standards committee in the information processing arena, the accredited standards committee for object information management, SQL database design, particularly the new SQL standard that is emerging that is object-oriented.
Finally, in 1996, IDX asked me to come back into health care to help bring that technology base to what IDX was wanting to do. John also have many, many years of clinical experience, both with NIH and more recently with software vendors.
Last year there was a billboard on my way work put up by Apple Computer. It has the Dali Lama, and it said, "Change your mind!" It caused me to really think about how do we change our minds about the problems that we have in health care? I have been using this slide in a little different form to start all my presentations ever since by first quoting three things that are thoroughly documented in the leading journals.
First, a 26.4 percent increase in the number of people 65 years of age or older would result in a slight decline in net Medicare expenditures if the increase was caused primarily by health promoting activities. This sort of thing creates a dissonance in people's thinking.
Forty-five percent of deaths are due to bad habits. That was well known 20 years ago. I spent many years in epidemiology and biostatistics studying cancer epidemiology.
Case control studies show that health care automation can triple compliance, cut costs in half, and improve clinical outcomes by 50-100 percent. There are literally dozens of papers now, case controlled studies in the leading journals that document this in area after area after area.
Now here is the assertion that I'll --
MR. BLAIR: Jeff, could you just restate that. I wasn't sure I heard that correctly.
DR. SUTHERLAND: Case control studies show that health care automation can triple compliance, cut costs in half, and improve clinical outcomes by 50-100 percent. Now obviously these papers are directed toward specific areas, but there are many of them in the literature, and JAMA had an entire issue on it in October this past year.
The final statement I'll say, and relevant to today, the infrastructure is available with Web technologies to implement a universal, sharable medical record. The challenge is to agree on its content and structure, number one, and two, to commit to do it. That's what we are about here. If we did it, costs would actually be reduced, and health would be improved.
Here is some data that reflects off a comment that the previous speaker started. I pulled some of the data in the literature on adverse events. One in 25 hospital admissions result in an injured patient. Three percent of these adverse events cause permanently disabling injury; 1 in 7 leads to death.
So about 23,000 hospital patients die each year from injuries, in this case specifically linked to medication use. A large portion of that is caused by -- and this again is right out of the medical literature -- the studies show that 80 percent of the nurses will add wrong 10 percent of the time, and 40 percent of them will make mistakes 30 percent of the time. So without automation to control the process, you are in a system which is riddled with errors.
In Boston recently the editor of the Health Section of the Boston Globe was subjected to an adverse event. This fatal error was the cause for significant reform in Boston. Last week the front page of the Boston Globe for four days straight was on medical adverse events and what was being done in Boston and other parts of the nation to deal with it.
Interestingly enough, the cornerstone of improved operations for in this case it was [unintelligible] Cancer Center was to introduce physician order entry; to automate physician order entry. There were a number of other procedures that they put in place along with that, but the automation of that order processing was considered central to dealing with this problem and avoiding it in the future.
So the net of this is that we have about 180,000 unnecessary deaths, and 1.3 million injuries on the average year from medical treatment in the United States. It is well pointed out in the book, "Demanding Medical Excellence," that if this was occurring the airline industry, we would have major programs to end it immediately.
In fact, in the airline industry there was not a single death in the United States. There were some external to the United States, but last year there was not a single airline death in the United States because of the procedures that have been put in place to assure safety.
The interesting thing for this committee to address is again, the medical literature has shown that the majority of these adverse events, more than 50 percent, maybe more than 60 percent are preventable with online information processing. While at the same time, data presented at MIT last year and the previous year show that only 5 percent of U.S. physicians have any form of real automation that they have hands-on in the course of clinical practice.
So we have a situation in the United States where we have major problems -- and this is only area where we have major problems -- in adverse events. Automation can improve it, and a severely underautomated community. So that is something that many of us feel strongly something must be done about.
I talked with Bob Mays before this presentation, and he asked me to introduce some of the future thinking that has been in previous presentations that I have done where we have been together in conferences. His point was that very often we get so embroiled in dealing with our legacy systems and the message passing with them, between them, that we don't spend enough time thinking about where is information processing going, and what new potentialities are arising that we might take advantage of?
In information processing in general, the worldwide adoption of the Internet and its associated protocols is the number one driving issue. It has altered the nature of information processing in that inter-networking is now essential to business and between businesses, and the primary focus has actually shifted from building new applications to integrating suppliers, partners, and clients.
The core issues are connectivity, integration, scalability, robustness, and the capability to rapidly evolve these systems. As such, the comparability of data between network systems has become an overriding issue for business in all areas.
I have included a graph of Bellcore's realtime sampler of growth of the Internet, which is interesting, because in 1995-96 it was growing at a rate of about 100 percent a year. In 1997-98 it slowed to 50 percent. You can see at the beginning of 1999, it starts to pick up again. We may be moving to 100 percent growth rate.
The Internet as a system is already the largest human construction that has been built. To have such a large construct growing at 100 percent a year has incredible effects. Just to show you where health care is, you can see the growth pattern. It is estimated that in 1999 in pharmaceutical and medical there was $1 billion of business done on the Internet. It is going to quadruple in 2000 and go to $4 billion, the next year more than double, $9 billion; in 2002, $20 billion; 2003, $44 billion.
These are estimates from Forrester. I have to tell you that every estimate Forrester has made on the past on the Internet has underestimated the effect. So these are probably underestimates of what is going to happen.
The editorial in Forbes magazine this week said, quick, fire your marketing department. Hire an epidemiologist, because the effects they are seeing on the Internet are epidemics rather than normal business growth. Typically, you will have a small group of users beginning to do something, and then you will get this explosion, like an epidemic, where it spreads rapidly through the industry.
So from the point of view of certainly what we are doing with IDX, but we think this is general in the industry, that people are being driven to an Internet-based architecture. That architecture will front end -- and certainly this is true of all of our systems this year -- will front end all of the systems, both newer systems and the legacy systems.
It will also serve as a mechanism to drive work flows across these systems to do EDI kinds of processing, but also to apply rules to the data flowing across and between systems. On the diagram I have shown also that in the back end we have a decision support capability that ties all the systems together on the back end.
Here is the problem that we face. I can't say this is a typical client, because all IDNs are different, but they all have this problem. This particular client has five of our systems, and four systems from other vendors. It's a small IDN. All of those need interfaces and data being sent, hopefully standards-based data, HL7, through the system.
Just to bring this client up, we had to create more than 25 new point to point interfaces. The clients are not happy with that strategy. They really want to see us move to newer technologies, and particularly component technologies and the use of Web-based and XML technologies.
Here is an example of that. At every OMG meeting for the last three years the University of Michigan people who are there at CORBAmed have met with me and said, how do we implement a component to build an interface? Here is a simple example. It's one at the top of their queue of dozens of items.
How do you take charges from all of their systems, post it through in this case the IDX system, and have a single invoice? It's a simple thing that is very good for the client, for the customers, for the patients. To do it in the current way requires setting up a point to point interface from each of their systems. I don't know how many there are, but there are more than five, I can tell you that. And to post one charge from each of these systems requires 17 HL7 transactions.
They said we think we can use an OMG CORBA solution to drastically reduce the time to implement, the cost to maintain, and the complexity of the operation. In this case, we actually went to Java technologies, because we knew they will eventually integrate well into the CORBA environment. Their request was that we create for them a single JavaBean with three functions on it: (1) is this patient in the system; (2) if it is, here are the charges from all the systems; and (3) are they posted properly?
Instead of six months of implementation and hundreds of thousands of dollars to build what they would have to build, this took a few days to implement, a few weeks to test, and you see an order of magnitude reduction in cost and effectiveness on the order of five to ten.
So we have many clients wanting to drive to this kind of strategy with the data being passed in the calls to these components being represented in XML structures, which we have had a lot of discussion about yesterday.
I'm turning now to the role of components in comparable PMRI. What is going on about actually doing this sort of thing in the industry? HL7 and CORBAmed and HL7 and the ActiveX organization sponsored by Microsoft are talking about harmonization of their standards. There are, however, few interoperable products on the market.
As vendors, we need to support these standards, HL7, ANSI X12, but also the COM standards, the CORBA standards, and the emerging enterprise JavaBean standards. These component-based standards in the industry. Our clients need all of that, as well as all the health care standards.
What we have found is that standards that work well, tend to be small and pragmatic, and build from the bottom up. CCOW is a good example. It's very specific. It focused to managing patient context between applications on the client. It works well. It's easy to implement.
XML we believe is likely to be the level at which interoperability of syntax is achieved between systems. It works with any object interface. It is machine interpretable. The area that we need to focus our new research on is XML in the context of a component model. We are only beginning to understand those capabilities. For example, in addition to simply passing XML data across the network, you can actually evoke a remote procedure across the network in XML. So you can invoke behaviors, as well as data representation within XML as a technology.
There really have been three Web revolutions: HTML, Java, and XML. XML is viewed by the W3C as HTML next generation. So it is not just the latest fad. It is actually a replacement for the whole current HTML architecture for the Web. The standards are becoming embedded in the Internet trading protocol standards. The object model transport standards from the OMG. Microsoft and others are basing their entire global ecommerce strategies on XML.
What this means is that there will be not only tremendous market forces, but also a proliferation of tools to handle XML that could accelerate our capability to use it effectively in health care.
Basically, XML and its associated stands are designed to support distributed object technology the Web. They are designed to move up from common CORBA, which are viewed as low level component standards, up into the native Web environment, and be able to speak XML, and have all behaviors evoked on the Internet in the XML environment.
The other interesting thing about XML that is worth thinking about is that these structures can be specialized through subclassing. This might be of help to the standards process. You can have a general standard which can be specialized by subclassing for specific domains, which then can be specialized again, even for specific institutions without losing the global standards and the interoperability.
MR. BLAIR: Jeff, maybe you could help relate this back to data quality for us a little bit.
DR. SUTHERLAND: With the current situation I just described with HL7, simply to post a transaction, which is probably the simplest possible thing, the number of transactions you have to execute, and the number of interfaces you have to build causes people to unable to do it. Patients wind up not getting single invoices.
If you translate that into clinical data, it turns out to be worse than a patient not getting a single invoice, because the information and the quality of that information is not moving appropriately, and they are not getting the right treatment, and you are getting adverse clinical events.
DR. FITZMAURICE: Jeff, does this have implications for pulling together patient medical information and storing it in a logical way using XML?
DR. SUTHERLAND: Yes, I'm actually getting to that in a slide in a moment.
I won't discuss our view of the PMRI, because it really is similar to what was said yesterday, except to point out that there are some future requirements that could alter things substantially. There are interesting presentations being given by some leading clinicians in the United States right now, pointing out that in the future it may be possible to do a 3-D whole body scan as today's patient walks in the office, and have a holographic view of every organ in the body.
In addition, to have comprehensive genetic data, given the mapping of DNA that has predictive value for things that should be looked for. And that those two data sets may be more powerful than anything in the record today. What that implies is that those data sets are so huge, they are going to have to store the record as a distributed record, and really using distributed object technologies, and probably the Internet, be able to retrieve this sort of information from the past.
This leads into the next slide. Here is a way that you could visualize implementing a medical record which includes all information at any site that was ever gathered on any patient. I have tried to simply state it here. Let's say I walk into a clinic visit.
I was flying on the airplane, and a woman was looking at me as I was doing some of these slides. She said, "How come if I get stopped for speeding in California, the police officer gets my driver's record immediately on the computer in his console, but if I go into a clinic when I am traveling, they can't get any medical information that might be essential to me to get proper care?"
It is easy to conceive that if I had a URL, a Web address that was linked to the Web at Massachusetts General, where my primary record is, that Massachusetts General could set up a Website that would tap all the data that I ever had, but also previous history that might exist in Dallas could be linked into those URLs. You could get a Web-based view of that entire record. That is easy to see.
If you then bring XML into the picture, and the ability to handle objects, behaviors, components, and think of it as more just a linkage of URLs, you could build a comprehensive, distributed clinical medical system with this Web-based XML technology. I believe that this is the future of where the medical record is going to go.
One of the important that John and I have been discussing throughout this meeting is that one of the problems -- there is so much work to be done to get comparable data to improve treatment, that that's going to take a lot of time and resources.
An initial first pass that at very low cost could give us significant benefits would be to allow the patient and the physician to simply view the medical record information that is already there, and let the physician's mind interpret and provide the comparability insofar as is possible between that data. That could significantly leverage medical care.
Again, when you think about the problems of data quality, here is a data quality problem. At the University of Michigan, they tell me, when you walk into the emergency room, your medical record is your skin. That's the quality of the medical data for emergency treatment. That has significant clinical implications, and I would say that that's probably true in a lot of institutions around the country.
I think that the government, if they understood what is possible, could facilitate the efforts of standards bodies to drive things towards this level of integration. Obviously, one of the most important things with respect to the single security model -- I have a slide on that later -- the HISB organizations need to standardize data descriptions, transformations, object component models. And as I said, I believe the infrastructure of the future will be totally based on W3C Internet protocols for sharing this kind of medical information.
I have some PMRI comparability requirements. Access to PMRI today is primarily text-oriented, and even that gives you a lot if you can get it. You don't need a lot of standardization and mapping if the physician can see the textual records. You do need to accurately identify the patient.
When you are actually doing processing of the PMRI by another system, it requires much more structure in coding. The coding standards become real important. And again, accurate identification of the patient.
Analysis of the PMRI for multiple systems in epidemiologic studies requires yet a different cut on the quality of data that you want to see. You often don't want to know who the patient is. You just want to know that you don't have duplicates, and you want to know that in a specific area things are coded well enough to make an epidemiologic inference.
Some comments on the role of object and component models, on the utility and availability of the information. HL7 created the RIM because message formats were not enough to support interoperability. It was discovered that object models can be very helpful for message creation and interpretation. The RIM needs some further work in areas like managed care. We have looked at it. It's not sufficient to handle managed care right now.
There is a lot of work, but it is limited in terms of output at CORBAmed. In the OMG, this area is still in its infancy. What we have discovered in object technologies is that it is very important that models be developed in small slices, that global models that have not been tested in a bottom-up way in a real environment tend to fail. The reason for that is that object models are refined and evolve with use. You almost virtually never will get the best model until you have actually implemented it in a number of different situations.
The other thing relevant to the model discussion yesterday, it was brought up that often vendors are proprietary. They want to protect their model, et cetera, but there is a bigger issue, a broader issue in that customers or health care provider organizations want specialized models. Health care is a regionalized industry. It is a cottage industry. There are regional trends, state law conflicts, idiosyncratic institutional policies.
In some cases in the leading institutions, for example at Mayo, there are models within a customer institution that are created for competitive advantage. So it's not just the vendor that is oriented this way.
The vendors want an efficient model that covers multiple customers in a well defined market. That is what they are optimizing for. They are usually proprietary for addressing that specific market need. They are tuned for a market space, and that market space changes over time. So the vendors proprietary model will be altering over time.
From the government's point of view what you want is a universal model across vendors to assure good sharing of quality data. There you need to focus on interoperability, facilitation of the emergence of XML vocabularies, and support some stability and also some evolution of the system. So there are really quite different views of what the model should, depending on who is looking at what ought to happen.
One of the interesting things John and I have discussed since we both have been heavily involved in clinical research in the past, when you are doing a clinical trial or well funded epidemiologic research, you develop very specialized data collection systems to assure quality and comparability of information.
This process is too expensive in routine care, but there are a lot of things that you discover in clinical trials in epidemiology about how you collect data. There has not been good technology transfer over into the health care environment. There are a lot of things that are known and could be done that are not transferred over very well.
The other important thing that is true in the health care environment is we believe that care providers have to be direct users of the computer record themselves in order to get quality data. All of the vendors are struggling with that.
Comments from the previous presenter on the challenge of getting physicians to do physician order entry, for example. Your response has to double over normal response time in order to get the physicians to use it. And the information processing that occurs in the context of order entry is significantly more information processing than occurs in a typical transaction for most other users.
So we think the data quality requires direct use of the CPR systems by care providers. It has certain requirements, which I have illustrated. The ability to get systems into those primary care providers, and have them used have not been achieved on a broad scale today. In fact, it's only in very isolate areas that you have intensive use of computing systems by physicians. And as a result, your data quality is compromised, and will continue to be compromised.
Is the current state of things -- this is going back to some of the questions that were raised -- impairing our ability to measure outcomes? Absolutely, because most patient data, especially ambulatory data is still paper-based. It's incomplete, and it is illegible, even when you can find it.
Enterprise data, the patchwork of electronic and paper, loading of this information in decision support systems is very labor intensive. Cross-enterprise we have no universal shared patient and provider identifiers, and lack of shared medical concepts and coding, which has been discussed at length.
More specifically, the electronic clinical data acquisition is not part of the clinical work flow. When you introduce human and paper intermediaries into the clinical work flow, that reduces the quality of the data. And the clinicians cannot benefit from computer support for coding and enforcement of standards. At the root you have the problem of lack of agreement on shared medical vocabularies, codes, and concepts.
So what is needed to address these problems? We need to embed the clinical data acquisition into the clinical work flow, and provide enough value that clinicians will be willing to use computers for this purpose. The question should be, should CDC, C pay clinicians more for using a CPR, and charge them a fee for sending in paper, because it costs you more to deal with it. I think if there is not some incentive in the system like that, you just never move this problem forward.
We need to agree to codification of medical vocabulary standards. We need to use a clinical computing environment to support quality data acquisition and coding. Is private industry making progress in this? Yes, we are working hard at this, and investing significant amounts of money in it.
Is there a role for the government? We don't think that in the context of the clinical use of computing directly, but that the government should support the development of standards and provide incentives for quality. I think this is generally consistent with most of the comments yesterday.
What are the criteria for quality was one of the questions. We are not aware of any national criteria in general. In isolated areas there are some standards, but in general there is no broad, comprehensive, quality metric for clinical data in the United States.
Whose responsibility should it to develop such a criteria? The data users have to participate extensively. They have the domain expertise to know what is feasible.
What is the role of the standards development organizations? To work with the major data users to help develop these standards.
Finally, this is a plea from the person who is responsible for focusing standards implementation in IDX. Her view is that the impact of 50 state laws and one federal law on the patient medical record is devastating. The complexity and confusion that will ensue will negatively impact the production of individual confidentiality.
The complexity will make it impossible to adequately code information if there are 50 state laws and one federal security law and confidentiality standard. So this is a strong plea for whatever this group can do to move us towards one federal standard for security and confidentiality of information.
Additional roles for the government -- I think those of us who have worked in the research arm of NIH recognize that there is a lot of understanding and things done there that could be translated into the health care community, but there is nothing really in the mission of NIH that causes that technology transfer, except in a few isolated areas. So if we can encourage closer collaboration between the NIH and the Library of Medicine as a laboratory for the patient medical record.
Encourage support for information system use in patient care and clinical research. There is some of that, but it is definitely not a priority. When things get cut, that's what tends to get whacked out of the research budget.
Allow costs of integrated data management for clinical research and patient care. NIH could do that. C could allow some compensation for the use of IS.
So in conclusion, we think the Internet presents huge new opportunities for reduced costs, integrating the data, and improving the clinical quality, and radically improving what the industry has known as customer service, translating a patient into a customer who gets really good service.
The Web standards will enable distributed message documents and components. This could have a dramatic impact on the quality and interoperability of data. Health care domain standards could enable the distributed record.
The government facilitated the Internet itself. That might be a useful model to go back and think about how did the government help create this phenomenon of the Internet? Is there something in that model that could be applied to the creation of an online patient medical record system within the United States that provides the kind of data quality that we would like to see, the kind of interoperability that we need, and even more important, the kind of care that could dramatically reduce these 180,000 people who are killed every year, and the 1.3 million who are injured unnecessarily in our health care institutions?
MR. BLAIR: Thank you both for extremely informative presentations. We very much appreciate that. Committee members, do you have questions? Simon, maybe you can help me identify the individuals.
DR. FITZMAURICE: A question for Jeff. You mentioned that there are problems with data quality, accountability, and integrity. One of the specific problems is lack of agreement on shared medical vocabulary, codes, and concepts.
Well, we are seeing a transformation. Doctors are coming out of medical school with some facility on computers. Will it take another generation to agree upon and embed a shared medical vocabulary, codes, and concepts at the medical school level, or can something be done in practice now? It sounds like it might be expensive. People say what's in it for me? They may want to just continue writing something and put it on a paper, and putting the paper record away.
DR. SUTHERLAND: I think there are two issues. One is the use of computers itself. The younger generation tends to take to them easily, and the older generation tends to resist them.
I think the common vocabularies, there are some significant issues here. If you take any disease entity and look at how it is categorized today, and try to standardize it, you have different research groups who will argue about how we should codify that disease. And over time, as you get new medical information, the way you codify the disease changes.
So whatever standards process we have for this encoding has to have mechanisms for bringing expert groups to agreement, and then allowing for evolving of that codification scheme over time.
DR. FITZMAURICE: So what you seem to be saying is that it's a job perhaps for the medical professionals and the specialty groups. Maybe there is a need for coordination and a push in that direction, but they are really the ones who have to agree on the vocabulary and adopt it?
DR. SUTHERLAND: Yes.
DR. COHN: Other questions?
MS. FYFFE: Thank you very much. Both presentations were very informative. Joe, would it be possible for you to give us full sized copies of your presentation?
DR. BORMEL: Yes, I've actually got the electronic version for you.
MS. FYFFE: This was a little difficult to read.
The other question I have for both of you is, and this is playing off of the example you talked about in terms of the state policeman being able to pull up a record of somebody's driving history from other states very quickly, and yet you can't do anything close to that when it comes to some basic medical record information.
If it was within your power to implement the lowest level, the most basic type of communication system of very, very basic medical record information so that a Medicare patient who lives in Wisconsin during the summer, and goes south during the winter can have their information transmitted back and forth between a couple of hospitals and physician offices, what would you do? I'm talking about just very, very basic information.
DR. BORMEL: Well, if we're talking about where we want to be in five years -- and this goes to the comments about some of the quality standards. I think that the work of the NCQA and HEDIS is just absolutely a perfect example of very, very good, clear thinking that is quality focused, that provides an opportunity to move forward. I like the reporting set. I also am very, very excited about the testing set. So let's use that as an example of how we would make information available for you when say you lived here and you were down in Florida, and to bring in the technology piece.
I think what we need is we need to have some way, perhaps sanctioned through something similar to what we have all been talking about, the importance of using the Web, using DTDs, and using the concept of clustering information. So that if you are being seen down there, and you have identified that it is okay for your records to come, that there is a summary frame that is in the appropriate DTD that perhaps was in some way sanctioned -- is allowed as credit in the overall quality points you get from an organization like a HEDIS, to be able to make that available.
Last week I had a chance to speak to Alice Dockfield(?) who is the head of the background committee for HEDIS. Part of their whole thrust is not to create a hurdle requirement, but to create increasing levels of quality. Getting back to Clem's point, if I wanted to talk about what kind of things needed to be in those DTD frames at the granular level, it would be sets of results that were relevant for a clinical purpose.
So for emergency care I would want the summary frame to be very, very good. If I was a patient who was on anticoagulants for example, I would want that frame of information to be similar to what you see up there, which is well thought out PMRI data that is grouped together at a granular level to solve a problem, and deployed through a low cost, readily available medium like the Web.
MS. FYFFE: Let's say you had a 71 year old male who has had one heart attack, and he lives in Wisconsin during the summer, and comes down to Florida in the winter, and presents to an ER with chest pains. There are some basic things you are going to want to know. That is the type of thing I'm talking about.
DR. BORMEL: You're going to want an EKG. That is the sort of thing that if it was part of the DTD, that we automatically created that. We had some smarts to do that on the sending side. Which kind of gets at the aspect that unless you incented through making this something that is part of for example the testing set of an SDO like an NCQA, that can use it for its marketing, its real business purposes and get some traction out of it, that is the kind of things that in my opinion have really moved the industry forward.
I'm very concerned, because I think there has been a lot of technology focus around exchange of information. And we have kind of lost -- the issue of the Internet is absolutely outstanding. I'm a huge fan of the way things are going. But I think that we do need more development of computer reminder standards, et cetera, and the infrastructure at a granular level to pull together information to get better quality of care delivered.
The Web itself is frequently a distraction, because we sort of define that as boy, if we could get the servers to all work together, we could do some very, very whizzy things. I think that whizzy things are really handy.
I think that getting back to your issue of being able to bring an EKG up using Web technology. Here is a Web technology. It is VRML. It is a great example of something that was done by consensus. SIG figured out how to do it well, put it in the public domain, because it was in their interest for that to be the standard, and not to have to write to some new standard.
It allows you to do things like bring up a lot of information, including things like EKGs, and be able to contextualize. It gives people the perspectives that you want them to see, that you know they need to see. Like they need to see the patient's cardiac information. Or they need to see that they had a chest x-ray, and here it was.
The needed to see that this was the area that had the infiltrates. So Web technology is great, but the focus on creating Web technology and creating vocabularies I'm a huge fan of. I think it's not the majority of the story. I do think there is a role for government and for consensus panels to come up with some traction to move forward the use of DTDs, the use the HL7 to actually look at some of the high volume clinical issues like the pneumonia example, like computer reminders, and do come up with a set of distributable DTDs that have an agreed upon linkage to the granular things that drive them.
DR. SUTHERLAND: Can I comment on that? I'm in agreement with what he is saying. This will really help the vendors. I mean we're working on all this stuff in our clinical system.
Putting on my patient hat for a moment though, I want to see my medical record. I want to know what my cholesterol was in every reading over the last 10 years. My bank statement is on the Internet. It would be a lot easier to get the cholesterol information than it is for the bank to get the financial information. So I don't need a 3-D whizzy wig to do an electrocardiogram.
DR. BORMEL: Thank you. That's exactly the point.
DR. SUTHERLAND: But I want to know the basic medical data. I want to read what the physician said about me the last time I was in there. There are a lot of people like me. I'm not alone.
DR. BORMEL: And I want my friend who had the high blood pressure four weeks ago to be able to go on the Net and find her blood pressure as it was recorded in the emergency department, and it be there.
MR. BLAIR: Joseph, you gave us a statistic, a dollar value with respect that if we had good data quality, and we had electronic health records of some kind to be able to communicate good data, that it would enable us just simply to avoid the adverse drug reactions. What was the dollar figure? It was $70-some billion.
DR. BORMEL: The numbers were $76.6 billion annual.
MR. BLAIR: Seventy-six billion dollars per year just with adverse drug reactions. And we pretty well know that with electronic health records --
DR. YASNOFF: This is Bill Yasnoff from CDC. I have to point out that that $76.6 billion figure is from a single paper which was a delphi study of estimates of experts who are all pharmacists. So this study has been very, very widely quoted, and certainly the dollar amount is in that range, but I don't want too much credence to be put on this in the record, because it is from a single source, and it's just estimates.
There is no question, however, that the dollar cost is very high, and it is a very serious problem. It's not just in hospitals. It's in the outpatient setting, where really virtually nothing is being done with respect to information management for physicians; to get them the information that they need before they prescribe, except in certain advanced clinical settings.
MR. BLAIR: I'm so glad that you pinned down exactly the source of it, and apparently what you are saying is that we don't know the accuracy of that, but people generally consider that to be in the ball park? Is that true, Bill?
DR. YASNOFF: That's right. There certainly has been documentation of tens of thousands of hospital deaths from adverse drug events.
DR. MC DONALD: We're kind of in this tension, because we're scientists, and we want to be honest. I think must of what we are saying is grossly exaggerated, even the ones about deaths. People get on 40 drugs, also have cancer and endstage heart disease and all the rest.
But on the other side of it, nobody does justification of those glorious marble foyers in the hospital, and they must cost as much as a computer system in some cases. No one does cost justification of the government regulations that hit us, that cost billions of dollars a year.
There is an obvious intent of hospitals and care institutions to automate everything, because it's just obvious. Sort of like the UPC didn't have a big study of that before they grocery stores went forward with that.
So I think on the one hand we kind of overset our standards we have to reach to say why we want to automate this. On the other hand, I think we've got to be careful. With the limited data we have, we weaken our argument. So I'm glad you brought that one up.
DR. YASNOFF: Let me state some other data, which I think is much better. There have been at least 39 different studies of hospitalizations that were caused by adverse drug reactions. There was a very nice meta-analysis done of these studies a few years ago, which came out with a rate of 5.1 percent. In other words, 5.1 percent of all hospitalizations are due to adverse drug events. These are outpatient adverse drug events.
Now, Clem's point is well taken. A lot of these events are people on chemotherapy. You are not going to not give them chemotherapy. Some adverse events are inevitable, so the issue of how many of these hospitalizations are preventable has often been studied. The general consensus in the literature is that about one-third of those are preventable if clinicians had the information they needed. There have been a couple of studies with rather dramatic results that have tried to do interventions, which I would be happy to discuss.
MR. BLAIR: Let me just take this point a little bit further if I can here. So you are saying about a third, which -- and we understand that this is imperfect information. On the other hand, we understand that it is not the total adverse drug reaction, or it's not the total problems we have with quality of health care. But if we were to just pick that, a third of it would be in excess of $20 billion per year. I don't remember seeing --
DR. YASNOFF: No, this is 5 percent of all hospitalizations are due to outpatient adverse drug reactions. A third of those are preventable, so you are looking at 1.5, 1.7 percent. The GAO did a study of this. They estimated the cost to be about $20 billion. I think a more conservative and easy to justify estimate is about $12 billion of hospitalizations are due to this problem in the outpatient arena alone.
Of course that doesn't account for any cost, any extra administrative cost, any cost for additional doctor visits, it doesn't take into account economic loss from work time lost and so on. So there is no question that this is a serious problem. It has large financial and quality of life implications.
MR. BLAIR: Okay, then let's take the last numbers that you wound up giving, which I think was around $12 billion, just for hospitalization just for adverse drug events, just for the preventable portion of that, is that correct?
DR. YASNOFF: Yes, that's just for the preventable portion.
MR. BLAIR: Now some other folks in the committee or in the audience may know the latest figures of the total expenditures on information systems within health care. The numbers that I think I saw last were in the vicinity of about $12-15 billion. Is that not correct? Does anybody have a better estimate?
DR. MC DONALD: Those probably don't include the personnel in hospitals at all.
DR. YASNOFF: I think the way I have understood this best is to look at percentages. In the health care industry we spend about 2 percent of the total revenue on information systems. In banking, and there has been a reference to banking, 10 percent of total revenues are spent on information systems. Basically, and no offense to any bankers who may be listening on the Internet, to keep track of one number, your balance, and transactions related to that number.
Obviously, in health care the information we have is just a tad bit more complex than that, and I think we have a very good case that the expenditures on information technology in health care are grossly below where they need to be in order to do an effective job of keeping track of information.
DR. COHN: I'm not sure where we got to on all of that, but that was a useful.
Chuck, we need to begin to wrap this session up here pretty quickly.
MR. MEYER: I wanted to address Kathleen's issue, and it goes directly to what Jeff was saying as well. There was a critical phrase that you used, and everybody glossed over it. It was, I live in Wisconsin and I winter in Florida, how can I move my medical record? Why do you need to move it at all? The issue comes down to access, not transport.
Therefore, with a Web-based medical record, as is being proposed, and many vendors are pursuing, it comes to a point of saying I can clearly identify myself as the person this information is about. I can give authorization to access that. And there is no doubt that there are issues of privacy involved, et cetera. The security of servers, all of those things come into play.
But in essence the ability to access that record by any physician regardless of where you are is the crux of the issue, not the ability to transport it hither and yon as you travel about the country. Otherwise, pack that paper under your arm and keep moving.
DR. COHN: We're I think nearing the end of the session. I personally want to thank both of our presenters. I thought it was a fascinating set of discussions. I think some of it was a reminder of what we talked about yesterday at perhaps a slightly more strategic level in some cases in relationship to quality. I found it very useful, and I think we'll be thinking about it.
I do want to capture, based on the last five minutes of conversation, and once again, I think this is a to do for our work group. I think there needs to be a briefing on the recent literature, and the costs and opportunities related to quality. That is something that I'm hearing as we were talking about, and Dr. Yasnoff was coming up with some figures on the back of the envelope and all of this.
There is a tremendous amount of literature that exists out there, and maybe one of the services we can do as we look at quality and standards and patient medical record information, to try to tie that in to where standardization may begin to help us reap some of those benefits.
Beyond that, I think we need to adjourn for about 15 minutes.
MR. BLAIR: After the 15 minutes we will be reviewing as a committee the things we have learned during the last few days.
[Brief recess.]
One is a discussion by the panel, and if others have other additional comments to make, we will be focusing on in a bulleted format, what we have learned, and as a corollary, what more do we need to know about certain things to once again try to synthesize and capture the workings from the last day and a half.
Then we are going to spend a little time talking about the next set of hearings, which is on medical terminologies and health care terminologies. We are going to be discussing both the questions that will be discussed, as well as potential testifiers.
Then we have a series of other issues that we wanted to bring up. Does anyone have anything for this last session? No.
Okay, with that, why don't we start talking about really what we consider to be sort of the bulleted items from this session?
MR. BLAIR: Simon, should we have the group focus first on what -- should we solicit what we learned from the message format piece first? Ask the group. I don't know whether we should divide it off or merge what we learned from both sessions.
DR. COHN: I think in the interest of time I think we should just merge them. I know some of the people are going to be leaving relatively soon, so I think I was actually going to start out with Kathleen, if she has any comments, because I know she is going to need to be leaving relatively soon.
MR. BLAIR: Especially the people who we know are going to be leaving relatively shortly. We would like to capture your thoughts.
MS. FRAWLEY: I thought this morning's panel on data quality was very, very useful. I think that one of the things that I would like to see us do is possibly expand that again. See if we can get some more people in to talk about that issue. I understand that we did have other invitees, and that they weren't able to come to join us. I think that's very important.
Then before the break, Simon, you had asked for really some more information in terms of the reports that have been published in terms of some of the useful empiric data that is out there. I think there is a lot that we can learn from some of the studies that have been out there.
Having worked as a hospital attorney, and knowing really patient incidents and what goes on in the health care delivery system, I think that certainly being able to look at how we can improve patient care by the use of computer-based systems is very helpful.
As far as yesterday --
MR. BLAIR: Before you go on with those two, I just wanted to make sure, Michael, did you have a chance to capture the first two points that Kathleen made.
DR. FITZMAURICE: Can you read those again?
MS. FRAWLEY: One would be to expand some of the discussion that we had this morning in an upcoming meeting on data quality. I know that you invited a number of colleagues from other organizations.
The other was the point that Simon had made. I think there are a lot of studies that have been published, that we really need to make sure that we have that information captured.
DR. FITZMAURICE: You want to obtain a briefing on the studies of adverse drug events?
MS. FRAWLEY: I think that Bill Yasnoff obviously is familiar with some of the literature. I think that all of us could pull some information.
DR. MC DONALD: Let me just clarify. This is not just in general. This is in relationship to how the computer record can help that?
MS. FRAWLEY: Absolutely, that's the construct. As far as yesterday, one of the things that I thought was interesting that we didn't talk about a lot yesterday again had to do the fact that there was an overarching theme that came across, the fact that again, we still seem to have some disconnects with the SDOs in terms of working together. That came out a few times. It certainly came out in some of the discussion on HISB. The fact that we still are struggling in terms of leadership issues. Really getting the SDOs to work together.
There were some concerns about XML, some of the work going on at HL7, some of the working going at ASTM, and how we can make sure that we all are at the table together. We have seen that play out. I think Chuck brought it out yesterday in terms of just the issue in terms of vocabulary and code sets.
I realize we didn't get a chance to really talk about that as a work group. I'm not sure that we have answers for it, but I think it's a dimension that we shouldn't forget. People did bring it up in their testimony yesterday. We heard it a couple of times.
MR. BLAIR: That's the third item. Did you capture that in terms of coordinate of --
DR. MC DONALD: I'd like to comment on that. As one who has tried mightily to coordinate standards, I think we should let the market do it. Honest to God, I think we should stop trying to coordinate standards. We haven't done any good with it. When we got six of them in the room together, three of them revolted, and I won't name names, and they said they didn't want to do it.
DR. COHN: Clem, without trying to argue or solve the problem, let's just note it as an issue.
DR. MC DONALD: The case in point. The person who brought it up may be more specific. It wasn't so much coordination, it was a fissure of an activity that was fairly unified.
MR. BLAIR: Fissure? Explain.
DR. MC DONALD: Well, the person who organized the new committee was the chairman of the old committee in HL7. I would call that a fissure.
MR. BLAIR: Actually, I think you went from Kathleen's point about coordination via ANSI HISB, and now you are going to the area of XML.
DR. MC DONALD: No, the specific issue that was brought up -- Chuck is the one who brought it up, and you maybe could speak to it more clearly.
MR. BLAIR: Okay.
DR. COHN: Chuck, I actually would prefer you not to speak to it for the moment, but just capture it and then we can discuss it.
MR. MEYER: I'll try not to be too lengthy at all. The point that I was addressing was specific to the apparent conflict evolving between the ASTM E3125 or whichever one it was, and HL7, SMGl/XML in the development of the clinical template/standard DTDs. Unbeknownst to me until this committee, I didn't know that Rachael was both of those committees. So I don't see why there is apparently a sense of divisiveness developing on here. I was reacting to a posting that Wes Rishel had made on the list server.
DR. COHN: Thank you. Now I want to go back and let Kathleen finish. I actually thought that Kathleen said two things. Kathleen, clarify this for us. I thought that you were making the general comment about coordination of SDOs, which a number of speakers did reference one way or another. I think Clem is also bringing up this issue of clinical templates.
MS. FRAWLEY: The coordination piece is important only because of the fact that a number of people made the reference yesterday, and even today it again came back out in testimony. If you are talking about what the role of the federal government should be, or what recommendations we need to make, I think it's an issue that we have been struggling with.
Having been a member of HISPP and then HISB, and seeing these organizations struggle for years with trying to establish some leadership, and trying to get the SDOs to collaborate, I think it's a real issue. We have heard a lot of testimony over the last day and a half about the lack of collaboration in certain areas.
So I'm just raising it, because at some point we are going to need to talk about it as a committee. The only point of raising the point now is we don't need to solve the problem. We have been sitting at these groups for years, and we can't fix it. But when we make our report, and present it to the full committee, it's something that we are going to have to address.
MR. BLAIR: Let's give Michael a chance to echo back to us what he has captured, to just make sure that he has captured each point correctly.
DR. FITZMAURICE: I've got on this one coordination of SDOs, collaboration is an issue; an issue for consideration for recommendations. In other words, it's a very strong issues, in other words. Do you want the previous ones, Jeff?
MR. BLAIR: Let's all make sure that we agree that you've got each item captured.
DR. MC DONALD: We agree that this is what Kathleen said that we agree that this is what we should do?
DR. COHN: No, we agreed that Kathleen said this and observed this.
DR. FITZMAURICE: The first one, Jeff, is there is a need to obtain briefings on studies of adverse drug events and how computer-based patient record information or patient medical record information can improve patient care generally.
Secondly, we need to expand the data quality presentations in future hearings.
Thirdly, standards, a comment was made about the market, do it, but coordinate.
Coordination of SDOs, and collaboration is an issue for consideration for recommendations.
DR. KOLODNER: I thought the recommendation was not to try to get into coordination.
MR. BLAIR: I don't think we're making any conclusions. I think we just want to try to capture at this point, what it was the different committee members learned. Then once we have captured that, we can then have future discussions to be able to either assimilate them. Some of them may overlap. Some of them we may decide on whether to act on them or not. So we just want to try to capture people's thoughts right now.
DR. KOLODNER: At least what I heard was Clem saying about the market do it, don't get in the middle of trying to coordinate.
DR. COHN: Well, when he has the chance to report out his thoughts, we will make sure to capture that as a bullet.
MS. FYFFE: Quickly, I want to echo what Kathleen Frawley just said. I'm sorry, Clem. I've been to so many meetings where time has been wasted because of the positioning and discussions among the different SDOs that it has become counterproductive. So I think there does need to be some formal coordination from somewhere else, because I don't think the market is working it out very well.
MR. BLAIR: Kathleen?
MS. FRAWLEY: I have no further comments.
MR. BLAIR: Who leaves the soonest? Is it Clem and Kathleen?
DR. COHN: Okay, Clem, you're next.
DR. MC DONALD: Well, there were just a lot of interesting things that went on the last day and a half. I don't think it's easy to boil it down. I think that number one, there is a lot of activity in the industry. That they are going really this way.
I also heard a very unified approach to standards. What I would like to kind of point out is that at meetings such as this we don't see the mass of the players properly. If you look at the mass of the players, I don't think we have a problem in standards right now. The whole industry is doing HL7 or X12. Some of these other standards they are doing, because they are very specific.
If you look at your automobile, you've got standards on your oil can. They don't interfere with the standards on the tires. They are just different standards. So there are some sort of different vertical markets.
I think that there the coordinating activity is more political than the actual standards activity. There is good collaboration between X12 and HL7. There is good collaboration in some domains between ASTM and X12 and HL7. So that I don't think we have a problem we can fix anyway, and I think it's just life. Humans are humans. It's moving very well from my perspective. I think if you look at the people in the industry, you have a lot more cohesion and coherence than there was three or four or five years ago.
DR. COHN: Do you have anything more that you felt you needed to know?
DR. MC DONALD: Not about the content of the last day and a half.
DR. COHN: I'm actually going to sit here. I have a list of about 10 things that I wanted to put down, and provide some comment and see what other people have. These are perhaps a little more specific than some of the general points that were brought out.
One of the things that I heard from a number of people yesterday is that there is a need for a solution that allows standards developers to reference and use proprietary vocabularies in a manner that is equitable to the public standards developers and the vocabulary developers. I think we heard that from a number of people.
DR. FITZMAURICE: Would you repeat that again?
DR. COHN: A need for a solution that allows standards developers to reference and use proprietary vocabularies in a manner that is equitable to the public standards developers and the vocabulary developers.
MS. FYFFE: What do you mean by that?
MR. BLAIR: I think he's saying what he heard so much.
MS. FYFFE: There are sort of like two parts to that statement. What was the second part, Simon? I don't understand what you are saying.
DR. COHN: The equitable?
MS. FYFFE: Yes.
DR. COHN: I don't know what equitable is. I thought we might ask some other people. I thought that might be a question we might ask the terminology developers actually. What I heard was that it needs to be equitable. I don't know what the nature of that equitability is, but clearly what I heard from the SDOs was gee, we need to be able to use vocabularies, and we see that there is an issue.
DR. YASNOFF: I want to say this a different way, and see if this is what you are saying. Is what you are saying, or is what we are hearing that the SDOs are saying that the cost of incorporating proprietary vocabularies is too high? Isn't that what they are really saying?
MR. BLAIR: Some vendors might feel that way; others might not.
MS. FYFFE: Is that what Simon is saying?
DR. YASNOFF: Is that what you're saying? Is that what they are saying? I heard it that way.
DR. COHN: Actually, I think I heard a variety of issues. Once again, I won't prejudge the issue at this point. I think that some of it had to do with a desire to use multiple different vocabularies for certain things, and having difficulty trying to figure out how to do that. Some of it may be uncertainties or being unclear about what prices are. So I think it's a variety of things.
DR. MC DONALD: I thought I heard from the vendors' voices, although they were HL7 presenters, they said that there are problems with the current proprietary codes because of the licensing fees and the complexity of managing it. That is, you really can't meter things very easily in some of these complex environments.
There was another statement that it would be nice if the codes themselves, not the added value, were done at a very low cost, so that people could get to a standard code, and then it could attach to added value.
MR. BLAIR: Michael, do you want to grab what Clem just said as well.
DR. FITZMAURICE: What I heard was that there is a need for either a common vocabulary or a set of vocabularies, maybe set by specialty. They didn't want to be held up in the price of their own product, paying a high price to the developers of code sets and vocabularies, but they thought it was necessary to get value out of the patient medical information that was developed.
But the other side of that is someone has to pay for the maintenance and the development of vocabularies and code sets. And people want it, but they don't want to pay a high price for it. But I hear that about automobiles and groceries, so it's something that the market is going to have to work out.
DR. COHN: We're not trying to reach consensus. We are trying to I think capture what it is we observed. I think that Clem was right, that probably one of the issues had to do with just licensing issues. So pricing, access, an issue of covering costs, and probably licensing. Just the whole issues around licensing, work with different vocabularies is sometimes perceived as an issue. Where it is an issue or not, I don't know.
DR. MC DONALD: If I could just further comment. There is a special case here that it would be nice for public good to have one code system for some dimension. That is, not have three, so that the people receiving the messages would know what it meant. But that implies either some sort of market extraordinary dominance, does happen in the U.S., or some sort of help from a governmental push.
Once you do that, then you have this funny economic situation where the market can't decide. So that is sort of the real tangle you are in. If you have just one, and if it is proprietary, then there is an arm lock on everyone else. If you have many, the market works it out. So I think we have a special challenge, because we would like to standardize on one thing at least for a given field, there would be one code, or for fields of the same types. How do you do that? That's the challenge I think.
DR. COHN: Okay, well, without trying to solve the problem, I'm just observing that there is an issue there, and maybe something we may want to ask the vocabulary developers for some of their opinions on.
MS. HUMPRHEYS: I'm sorry I wasn't here yesterday to hear this, but I do know that what has been expressed to me in the past is there is also this view that supposing HL7 is defined in such a way that there are 20 possible valid code sets for different parts of it. And you are receiving HL7 messages. All you want to do is correctly interpret an HL7 message. You don't actually create HL7 messages, you just interpret them.
Now how many licenses do you have to have? You are not creating the data. You just have to be able to read it. So in the standards arena you have these different sets of users, some of whom are creating messages, and some of them have to read them for certain points of view, and may even have to read them to say this is a message I don't even want. I'm just going to use the other ten messages.
So I think that that becomes another licensing issue. How big a license do you need in order to read an HL7? How much do you have to pay in order to accurately interpret HL7 messages, whether you are creating them or just interpreting them for some other purpose?
MR. BLAIR: I think that is an excellent point, and it goes beyond the vendor concerns. Michael, if you could capture that as an extension of this point, which is the user perspective for a licensing, licensing medical terminologies, as well as the vendor concern about licensing medical terminologies.
DR. COHN: Should I give number two? Number two was I put a question here, because I heard different views, but this whole issue of whether there was value or need for a single reference model that was somehow above the current reference information model, to link together various message format standards. I think I heard things both ways yesterday. I think it's something we need to investigate a little further to see if there really is a business case around that.
DR. MC DONALD: I'm not sure what you are saying.
DR. COHN: Well, I asked actually a number of different groups yesterday. I asked HL7 whether there was a need for something to put together the various models. They said, gee, they didn't need a single reference model above the reference information model, but they did need mapping between the various models that existed.
I heard from X12 that they actually thought that there was a need for a larger model, because for example they were sending eligibility data with X12, and having to send it through HL7 internally, and then having to send it out as an X12 message. They thought that the fact that there was not a larger hole caused them to have problems. If I'm misstating it, please --
DR. MC DONALD: Both of the parties are here, so I'm afraid to say anything. What I kind of heard was wouldn't it be nice if we had it, but that's not the highest priority, because the energy spent on doing that would be a distraction from doing the ones that we are all focused on. Rather at the areas where there was interactions, there should be close collaboration and sort of mappings.
DR. COHN: So should we change that and say it may take the form of mappings?
DR. MC DONALD: Well, it's a long, philosophic, metaphysical question about who has got the biggest one of all. I guess that comes up in a lot of contexts. I think what we have is a different world. You have different sort of physics. There are some big, dominant ones right now that are going to be the major ones. I think that there are ways to deal with the mappings. I don't know that we need another hearing on it, I guess is what I'd say.
DR. COHN: We're capturing ideas. We're not saying that all these things need to be mappings. If there are issues we can ask people to respond by a letter, or ask other people some of these questions, if we decide that they are pertinent questions. I'm just once again, trying to give you what I sort of heard and was pertinent in the last day. I thought this was an issue that we sort of went around on. Once again, it may be a place where the government can be of some help if there needs to be mappings done or elsewhere. Something like that.
I heard a whole lot of requests for acceleration or otherwise known as additional funding. They feel into the areas at least that I captured, having to do with funding for harmonization, for clinical templates, something known as the PRA, and also something having to do with creating incentives for wider participation by providers and others in the standards development process.
It seems like I've gone way past your ability to put all this together. I guess you're pretty much got it there.
DR. MC DONALD: I just want to extend it a little bit. What I heard was it was modest. They weren't saying give us a lot of money. It was for some highly narrow areas of focus to help with the things, the logistics of the process, the meeting space, the movement, the kind of thing like conference grants fund. So there ought to be some mechanisms in some of the federal areas for funding it, not for doing the whole effort.
You've got to keep the market forcing. If people aren't interested enough to comment, they shouldn't be involved. That sort of thing. So that's what I heard was some small leverage funding could help a whole lot.
DR. COHN: Now I also heard that there was a -- on another issue, Mike, are you ready to take another issue?
DR. FITZMAURICE: Yes.
DR. COHN: That there was a need for some conformance testing. And that that somehow needs to be handled. Clem is actually nodding his head in agreement, so that's a good sign.
DR. YASNOFF: Can we say standards conformance testing, so that we're clear.
MR. BLAIR: Conformance testing of standards, yes.
DR. COHN: Once again, another issue now had to do with I heard from a number of people that one of the end goals that we really have, and I just captured this as an end goal that we probably ought to be seeking in all of this is to reduce requirements for bilateral agreements. That will be one of the signs that we really have moved toward comparable patient medical record information, will be probably in some of the other environments.
If you can have information that is understandable without having to come to bilateral agreements, that will be one of the signs that we will have gotten it.
MR. BLAIR: If I can just expand? I think the bilateral agreements may have been in more than one area. One of the areas I heard bilateral agreements was the vendor of one system communicating with a system maybe by a different vendor, or even by the same vendor. So it was like system to system bilateral agreements. And the other one I thought was SDO to SDO. Is that not correct?
DR. COHN: Not the second.
DR. MC DONALD: The only thing I would be cautious on is there are two levels of bilateral agreements. One is what I agree to send you, and the other how I agree to send it to you. The what is -- there is still going to be some of that. But the how, it shouldn't necessitate an agreement for you to understand it. I'm saying the registration, that should be done the same, one way. If I'm not going to send you STD data, I may not want to send you that, because I don't trust you or the database or something.
DR. FITZMAURICE: So, Clem, you're saying that how it is sent is how it should be covered by standards?
DR. MC DONALD: There are going to be a lot of circumstances where that has to be discussed.
DR. COHN: Okay, now like Kathleen, I also heard this issue of encourage collaboration between SDOs. It was an earlier conversation. I think for this point there are two pieces having to do with syntax. What I heard was that relationships to syntax, I heard XML will become increasingly important, because of Internet access. I think everyone heard that.
I also heard from one of our speakers this morning that we really needed to be leveraging the syntaxes from efforts outside of health care to the maximum extent possible. And that that was really the future; not having health care develop its own syntaxes. We need to develop our own semantics.
DR. MC DONALD: That's the same thing though. XML is an external syntax.
DR. COHN: Exactly. They are closely combined. Now I'll stop. Kathleen, do you want to speak?
MS. FYFFE: I have nothing to add.
DR. COHN: Jeff?
MR. BLAIR: I think when we explore some of these cost/benefit and data quality issues, that that will get into a lot of other things. I don't think need to add points from that. I think that was a good list. Now you said you had ten items. Did we get all ten of them out?
DR. COHN: I have a couple of others. I got embarrassed continuing, so I'll bring them at a later time.
MR. BLAIR: No, go. Keep going.
DR. COHN: Okay, let me add the next couple here, which is that -- this is just something I was listening to from today which has to do with providing incentives on quality. This is something we need to at least think about. What I wrote, and this was just as a thought as I was listening to our speakers this morning, which is should there be some sort of an incentive related to payment policy?
If patients are paid for using systems that are guaranteed to help improve quality a la adverse drugs, software, CPRs, et cetera. I think there was a question around incentives and public policy that probably we need to consider at some point.
DR. FITZMAURICE: Simon, do you mean provide incentives for better quality data, or for data about quality of care?
DR. COHN: No, I think we are talking about providing incentives for people to implement and use systems in health care that improve quality.
DR. FITZMAURICE: To the data?
DR. COHN: No, quality of care.
MR. BLAIR: Okay, good clarification.
DR. COHN: It really has to do with the use within organizations of systems that can be somehow shown to improve patient quality.
I think I've got all of mine. Clem, do you have anything else that you wanted to add? Okay, Bill?
DR. YASNOFF: I wanted to add something that I thought was very important that I heard this morning, and that is that unless we have comparable data from different systems, we cannot have an effective quality improvement program in the health care arena. I think this is an important issue in the federal government that we should take note of. It's a strong justification for the types of standards that we are talking about.
DR. COHN: Rob, do you have a comment?
DR. KOLODNER: No.
DR. COHN: Bob, do you?
MR. GELLMAN: I don't have a substantive comment, I have a procedural one.
DR. COHN: Please.
MR. GELLMAN: I don't understand 10 percent of what we heard over the last two days. I wasn't here in the afternoon yesterday anyway. I never do at these meetings, but everybody else does. At least everyone else hits a higher percentage at least.
Where are we headed with all of this? There was a mention earlier of recommendations. Who are we making recommendations to? Who is the audience of what we are doing? Is it the industry? Is it the secretary? Is it the Congress? I'm not sure I know the answer to that.
DR. COHN: Jeff wanted to take a stab at that, and I'll chime in.
MR. BLAIR: Bob, we tried to stay as close as possible to the mission as we understood it as defined by the HIPAA law. We almost start to quote it like a mantra. Let me go back over it again, and you may have some useful insights in terms of whether or not we are faithfully going down the path, okay?
Right out of the law it winds up stating something to the effect that the NCVHS will study uniform data standards for patient medical record information, and the electronic exchange of that information, and that we will be making I think it says recommendations and proposals for legislation or legislative proposals --
DR. FITZMAURICE: Legislative proposals, you are right.
MR. BLAIR: -- thank you -- to the secretary of the Department of Human Services by August of next year. So given that time frame the work plan -- we developed a work plan which would lay out our ability to try to explore the issues that might relate to this mission. You should have a copy of that. We also had those hearings in December where we tried to validate whether or not we had the right focus areas to pursue.
Then based on that, we are scheduling hearings almost every month during this year to gather information. With the information that we gather, we hope that we will be in a position by the end of this year or the beginning of next year to start to sit together as a committee and formulate recommendations that would then be revised, reviewed, examined, and then finally submitted to the secretary of the Department of Health and Human Services by August of next year.
Does that answer your question?
MR. GELLMAN: Yes.
DR. COHN: Now, I was going to talk about some of the things that we heard. We obviously identified this morning an issue, something we need to know more about at a minimum, which is I think a briefing on the research literature around these issues, which I think we identified. Are there other things that we came away feeling that we needed to know more about?
I had mentioned this issue of the code sets and all that, talking to the developers, trying to find out what their views where on some of these.
COL. RAY: One quick comment. I think that according to the charter that Jeff has talked about, we are really focusing on standards, which as Rob and I talked about is that middle layer that we continue to talk about. I think the number one problem that we have is how are we going to get a hold of that data.
Where does the input start? I think we heard Wes yesterday and I think we heard Joe this morning talk about it has to start with the provider. Where do we get the incentives to capture that data at the beginning of the patient care? I think we need to hear more about that. I can tell you the market is very slim out there in terms of products that allows us to easily capture the data at the point of care.
If we: (a) don't show an incentive back to the provider that it's important that we capture this, or (b) we do not make it easy for him to do it as part of his daily work flow as he sees a patient, then we are never going to capture the data to standardize.
So I think we have to kind of back up every once in a while and say what is the marketplace out there if we are going to capture this data? Is it a small set of data that we need to capture instead of everything? So I would like to see us learn more about data capture at the provider level.
MR. BLAIR: Could I ask you if that is a separate issue from data quality, or is that related to data quality?
COL. RAY: I think we have heard all of them say if we are going to have data quality, it has to start with the provider. The provider will provide that quality if there is incentive for him to put it in.
MR. BLAIR: Michael, were you able to capture that?
DR. FITZMAURICE: Yes, Jeff.
DR. COHN: I think we have Joe.
DR. BORMEL: As somebody that talks to organizers of managed care systems on a daily basis, the hot new issue is what can legally be done in terms of gain sharing. One of the issue that -- yes?
DR. COHN: Gain sharing?
DR. BORMEL: Basically it's incentives for benefits in improving care delivery. The reality is that there is a huge opportunity for the government in this space, because the legislation around allowing what were hospitals and physicians to work together has been historically a problem. There are now several major consulting companies to facilitate these gain sharings.
This is directly related to quality. It is related to quality in the sense that when lawyers talk about this whole topic, they say the way to structure a gain sharing relationship that is reasonable, which means incentives to physicians to potentially use PMRs is to wrap yourself in quality. Show that by virtue of doing this, you are getting a higher level of quality.
So there is a huge opportunity of this committee to make recommendations that are along those lines of incentives, because that is very real to people today.
DR. COHN: Joe, would you do me a favor and make sure that -- and this is Joe Bormel speaking from Cerner -- that Mike has captured your comments appropriately. I don't think we have gotten it.
DR. BORMEL: I'm not sure if the words are right, but if you put it in quotes, "wrap yourself in quality" to protect yourself from the impression of there being a malalignment of incentives in terms of the ultimate care that is being delivered.
DR. KOLODNER: Are you talking about quality of care or quality of data?
DR. BORMEL: Quality of care.
DR. YASNOFF: I think you mentioned this, Simon, and I want to be sure we captured this need for additional information with respect to this issue of what the SDOs are saying about the proprietary vocabularies. That they have some problem with the proprietary vocabularies.
I don't think we have enough information about exactly what their problems are. I would like to be sure that we get that, so we don't try to solve the wrong problem, or a problem that doesn't exist. In other words, we have inferred there is some cost problem. We talked about how the users are paid and so on. If the problem relates to for example, how the vocabulary folks price their product, that may not be a problem that we want to deal with.
DR. COHN: Okay, thank you for capturing that issue of making sure that we actually do understand well from the SDOs. I think it's actually also the vendors, the issues they have.
DR. FITZMAURICE: Bill, is it accurate to say vocabulary problems dealing with pricing may be beyond our scope? Does that capture what you were saying?
DR. YASNOFF: No, what I'm saying is we need to ask the SDOs and also the vendors of the proprietary vocabularies about these problems that the SDOs say they have in incorporating the proprietary vocabularies. We need more detail about the reported problems of incorporating proprietary vocabularies into standards.
DR. COHN: Bill, I would also presume that you would also say, just sort of thinking ahead to the next set of hearings, that if we had a very clear understanding of at least what we thought the problem was -- not the problem, the issue, we could ask some of the people at the next hearing, since many of them will be representing terminology developers, to comment both on what their view of the issue really is, and if they have any thoughts about it.
DR. YASNOFF: Yes, and I think clearly the point has already been made that developing and maintaining vocabularies is very expensive. There needs to be a mechanism is recoup those expenses. If there is a way to align things differently that would make it easier for vocabularies to be maintained and used, that is something that we should know about.
DR. COHN: Okay. Now, Jeff, you had a comment?
MR. BLAIR: Actually, if there were no other comments?
DR. COHN: Actually, Mel was raising his hand, if you would rather defer to him.
DR. GREBERMAN: A few comments related to some of the points raised earlier. Going back to the conformance testing, I think it was very valuable to have some discussion from people who have done it in terms of some of the standards areas that we're exploring, to get some real examples, and have the perspective.
I think one of the things we're going to need to decide is besides how we will do it, but who will do it, if it ends up being agreed upon as something we want to push. I think it would be valuable to have the perspective of professional associations, providers, and industry from a variety of perspectives.
One of the thoughts that comes to mind, as I brought up briefly when we discussed this yesterday, DICOM has had some experience in this area, and I'm sure others have too. I think from that perspective I'll go to my next point.
I think we have heard a lot in terms of some of the issues related to vocabulary words, if you will, but I think we would like to see if there are special issues in terms of the patient medical record information that relate to some of the surrounding areas such as medical images, sounds, others that I think we increasingly think of as part of the record information. So I would hope we would have some discussion, or at least input from some of the other groups that might lend that perspective.
DR. COHN: Let me make sure I can capture that second thought, which is I think at another hearing on message formats you would like to make sure that it includes for example DICOM and people for example -- which other groups are you thinking about in terms of including under that umbrella?
DR. GREBERMAN: I'll have to think about that one. I know that DICOM does. Clearly, there are other kinds of messages that are at least parts of the record. I'm not sure who is dealing with sounds, for example.
MR. BLAIR: There was a special interest group in HL7 that attempted to deal with that. I think that for lack of attendance and support, they haven't been able to sustain it.
MS. HUMPHREYS: A person who might be a good person to talk about the use of standards and the need for them in these non-textual data would be Henry Lowe(?) from the University of Pittsburgh, because he has a multimedia patient record system that he has deployed there at the Pittsburgh Cancer Center. He has done a lot of work with attempting to use existing standards for the transmission of these. So he might be a good person to talk about that from a user's perspective.
DR. COHN: I suspect he would also have a slightly different view of what patient medical record information is on the basis of that also.
MS. HUMPHREYS: A very inclusive view.
DR. COHN: An inclusive view, exactly.
MS. HUMPHREYS: I'll say my bias -- that's the proper view.
DR. COHN: Other comments about what we learned before we move on to talking about the next set of hearings?
DR. KOLODNER: One thing, and I guess it was touched particular today. Since I wasn't here yesterday, I'm not sure whether it was, or how much it was yesterday. That is that as we put the patient at the center of all of the activities, what the impact is on standards and on other things if we start with the fundamental view that the patient is at the center, and that when we are talking about the impact on the vendors, and on the SDOs by going back and saying, okay, now with patients at the center with their health and wellness at the center, how does that change things?
How does that get us to work either together differently, or how does that change the emphasis that we might as a committee might want to recommend as far as activities for the government to do, or for others to do? It came up a little bit in Jeff's presentation where we talked -- there was one slide where he talked about the virtual object distributed medical record.
He talked about patient and provider seeing things together, but that it really came back to the person. I think that it would be important not to have an industry view drive things, but really what we are ultimately about, which is the people in population.
DR. COHN: Let me just ask once again whether what we captured up there, because I heard about patient-centered focus. This is that it changes the PMRI perspective, or does it change the issues around standards? I wasn't sure. How well is that capturing the issue that you are bringing up?
DR. KOLODNER: Since I'm seeing a number of terms used instead of or to complement PMRI -- I'm looking at the notes that I had -- PMRI in contrast to person health information. That in fact our perspective may need to be broader than just the PMRI if the patient health information or those three components of the health record, the patient, as well as the population views are to be accommodated by the kinds of standards we recommend, or the kinds of activities we recommend.
DR. COHN: Do we need to reference the National Health Information Infrastructure view of the world in this?
DR. KOLODNER: I think that that is one place where we have tried to capture that as a committee. It may be that with each of the groups that presents, that we ask them to look at how does it change when you are looking at either -- and again, I'm not sure how they relate to one another, person health information versus levels of the CHR.
DR. COHN: Okay, well, let's capture that, because I think that is a very useful piece for us to remember, because certainly if the work we do doesn't fit with the overall population views, or really what is individual data that is a more personal even than personal medical record information, we are going to be out of sync.
Other comments about this?
COL. RAY: I just want to make one other comment. I think we talked a lot yesterday about XML, but I think this morning we talked a little bit about how do we have access to that record if I'm moving from Wisconsin to Florida or how that works.
MS. FYFFE: Or just across town.
COL. RAY: Or just across town. I think that if we are looking at standards and looking at the future, if we wanted to bit off a chunk and said what would make a core set of information that I would want to view? Certainly, I don't need to see 10 years of cholesterols in order to take care of a patient at a specific visit. But what would this group recommend to be here are the core set of data that you would want? Is it a summary of care? Is a problem list, medications?
What is the relevant set of data of what I would share so that if we wanted to create a DTD and transfer that across the Web to XML, we just define that out of this group and say this is a core set. If you want to expand or review back into it you could, but could this group come up with this is a core set, and then let the industry go develop the DTDs?
DR. COHN: Well, let me rephrase that a little bit, because I'm going to try to stay away from technology and having to have XML to do anything. I think if we can try to take syntax away from the semantics. I think what I'm hearing from you is that we should try to provide some leadership in what we think is the place that we should be focusing as a start around patient medical record information, and that we can make some near-terms gains in value that have high value to the patient, and potentially to the country.
And that recognizing that we have continually talked a 4-10 year strategy, that taking it away from the syntax issues for a moment, that maybe that's a leadership that we can provide. Is that right?
DR. FITZMAURICE: Starting points of high value for the patient, for the provider?
DR. COHN: For the nation in terms of both the short-term and longer-term focuses around this issue of patient medical record information.
Kathleen, if I could just ask you a question. We talked in previous sessions about concerns about whether we knew what patient medical record information is, and I think concerns that we were going to have a hard time delivering a report if we weren't moving in the direction of having some clarity.
Whereas I would say that we don't have clarity at this point, do you feel a little more comfortable hearing a variety of inputs on patient medical record information, and views of what it is and what it isn't?
MS. FYFFE: I think there is a little more clarity. Let me answer your question with a question. Are there any other subcommittees of this committee that we could talk to about that, that are developing a definition of what patient medical record information is?
DR. COHN: Well, we could talk to the subcommittee on standards and security, but I don't think other work going on on that right this moment, at least to my knowledge. But is your question in another vein? Do you feel that it would be useful to get -- to me the question is I think we need to keep asking the question as we go on in the hearings, but do you want to have a special session on that particular question?
MS. FYFFE: My perception, and again, I keep bringing up this analogy of the person in Wisconsin going to Florida, or even someone just going across town or whatever, is that there needs to be some basic information that is accessible by specialists, by primary care doctors, by other hospitals on patients.
I'm not a clinical person. I cannot determine what that medical information is. It should be determined by a clinical group such as yourself for example if you see ER patients or whatever. My concern is to be able to access or transmit that information in order to take care of people. I think we have made some progress in this one and a half days of hearings toward moving in that direction.
DR. COHN: Is there a next step that you would recommend in terms of investigating those issues? Certainly, there are a lot of different -- I hate to use the term "data sets," because I don't think that's really what we are talking about. I think we are talking about key elements that may need to be transported for special conditions or otherwise. There have been specialties that have done work on that as well as others.
MS. FYFFE: Actually, what I would suggest, and I think we have done a little bit of this already is to come up with a bare bones outline of what the report to Congress is going to look like that we have to deliver approximately a year from now. I do recall seeing some kind of outline on that, so that we don't waiver from our goal of our deliverable product from the National Committee on Vital and Health Statistics. I think we need to do that fairly soon. You can always change an outline, but I think it will help us get to our goal.
DR. COHN: Jeff, are you going to make a comment?
MR. BLAIR: No -- you saw my body language here. One of the things that we tried to do enable and facilitate that, because to be honest with you, I didn't even remember that you had brought up the question of what is the definition of patient medical record information. But you probably noticed that one of the first questions in the questionnaire to all of our testifiers is for them to give us that definition.
So I think we are in a position to begin to gather, just from these two days alone, and we will have more, to wind up seeing what the views are from all of the testifiers as to what they feel the definition of PMRI is. So that may help us.
DR. COHN: Yes. I guess what I'm suggesting is I think we are going to find that the edges of PMRI are very gray. We certainly have heard around the fringes, a lot of different descriptions. There is financial data. How much financial data and all of this. I think as we begin to look at this, my hope is that by approaching this issue of now that we know what the domain is, let's figure out what is important. As a first step, that might be helpful.
MR. BLAIR: Maybe we ought to specifically say that. Maybe that should be one of the items that Michael is noting, is for us to pull together a compilation of the definitions that testifiers have given us on PMRI, and start to see if there is any convergence.
MR. BLAIR: First cut.
DR. COHN: A first cut. I think what we're looking for from work group members and others is I think just some initial comments. I think recognizing that we have lost a number of the members of the work group, we are probably going to want to have further discussions to first refine the questions even after this meeting.
The other piece is that we would look towards advice relating to who we want to have testify at that session. I would ask that question both to the people at the table, as well as in the audience at this point.
MR. BLAIR: Could I add a thought on that? We wanted to try to get this to you as quickly as we could. This is the first draft. So that you could look at it here in hard copy. If you have some comments that you see right off the bat, great, then we could capture them now. If you want more time to look at them, if you want to feed back information to us via e-mail; especially Simon and Michael and I would be pulling a lot of this stuff together.
We will come up with an additional iteration. We may have two or three before Michael is able to get it out to the testifiers. So please don't feel like today is your only chance to give input to what the right questions should be, or who the candidates should be.
DR. YASNOFF: I have three comments. One is that as per the discussion today, we need to capture in here some type of appropriate questioning about pricing.
MR. BLAIR: Pricing and licensing.
DR. YASNOFF: And licensing. I'm not sure how to ask the question, but we would like the terminology developers to talk about at least -- we don't want a price list from them necessarily, but we would like to know at what points they charge for the product, and what issues they see in that area. Also, from the users, there is a question already what difficulties do you have using existing medical terminologies, but I think we should specifically say do you have problems with the cost or the licensing issues?
The second comment, I have some suggestions for folks in the various categories at the end of this document. Folks who could educate the committee. Betsy could certainly educate us about vocabulary. Also, Mark Tuttle, and I think it might be useful if he would be willing to come to ask Otto Barnett(?) to come. He has decades of experience with these problems that might be very useful.
Then under vendors that include terminologies in their systems, I'm wondering if Lexico(?) Technology, which is Mark Tuttle's company, would be an appropriate addition to that. Betsy may have some comments on that.
Then my third point is I would like to, in the scheduling of the hearings, however we do the scheduling, I think it would be very helpful to communicate clearly to the testifiers exactly how much time they have, and make it clear that we want them to stick to their time, and arrange the schedule so that we have sufficient time for discussion. I think it's really the majority of the benefit of our meetings comes from discussion. If we say that to them in advance, I'm sure they will cooperate.
MR. BLAIR: Could I suggest that as you glance through these, please observe, if you haven't already that there are two different questionnaires. There was one to the medical terminology developers, and then there is another to users, the users being vendors and others that would use the system.
MS. HUMPHREYS: I have a few comments.
DR. COHN: Are you volunteering to testify?
MS. HUMPHREYS: I would be very happy to testify. In fact, I would love to be here, but there this is scheduled exactly at the time that I'm giving the NLM update at the Medical Library Association annual meeting. It's an obligation which I cannot get out of. So unfortunately, this directly overlaps with their annual meeting in Chicago.
Under the role of your medical terminology place -- this is the draft questionnaire for the terminology developers -- I actually think it would be a good idea to in essence ask a first question, which I would slightly amend to be what is the intended purpose of your medical terminology. And then ask the developers, what is it currently used for?
Because you are going to have users, but you will not necessarily have users of every terminology, or users who understand the range of uses maybe as well as the terminology developers do. Really, it's kind of like who uses your terminology now, and what do they do with it?
DR. COHN: Good distinction.
MS. HUMPHREYS: I think this sort of captured under (b), so you say what is the clinical domain, scope, or health care setting addressed by your medical terminology. We also have terminologies that are addressed to specific kinds of providers, and we probably have some that are addressed to specific types of patients. This doesn't matter. It's sort of like what is the scope of your terminology. It could be a scope along any of those dimensions.
Now this next one, "Do you consider your medical terminology to be a classification system of medical nomenclature, reference terminology, or medical thesaurus?" Boy, I would give this question away. Forget it. After you have asked them what it's for, this tends to -- you can have people discussing how many angels dance on the head of a pin, and is mine a thesaurus and yours a whatever, a terminology, and I'm not sure you really want to get into that, especially if we're keeping them to time, as Bill has said.
And Bill brought up the pricing issue. I might have some suggestions which I can submit about wording of that question, because I get a lot of questions like that, about well, Betsy, there is this terminology in the UMLS and they have a category three restriction, and what about X, Y, and Z? I say, well, you'll have to ask them. But I at least have heard a lot of the concerns that people express.
MS. FYFFE: Because Claudia Tessier was not able to make this hearing from the American Association for Medical Transcription, will she be invited?
DR. COHN: Actually, I was thinking of her at the June session, only because this is medical terminology. I was thinking that she would come at the next time we talked about message format standards, if that's okay.
MS. FYFFE: Okay.
DR. COHN: Assuming she is available and all of that. We don't want to forget her.
MS. FYFFE: I don't want her to be overlooked.
DR. COHN: Okay. Bob Gellman?
MR. GELLMAN: I just have a process question. There are an awful lot of questions here, and everyone has a limited time. What you need to do is either set priorities. You need to ask for some questions, if they are really important, to be answered in writing rather than at the hearing. Or you need to focus the questions more on the issues that the committee is going to make decisions about, and maybe ditch a lot of the questions that aren't relevant to that.
DR. COHN: Michael, I hope you caught all those three points.
MS. HUMPHREYS: Bob's comment reminded me of my last note here, which I overlooked mentioning, which is down when we get to this Number 7, "What characteristics make your medical terminology clinically specific?" I just really don't know whether we want people discussing this in oral testimony, or just passing it if people feel they need to know this.
DR. COHN: Thank you. I think these will be a relatively long set of hearings, so maybe we can compress the questions.
MR. BLAIR: Please feel free, if we run out of time today, during the next several days if you have additional thoughts, then please e-mail us with your additional suggestions.
DR. YASNOFF: Just to follow-up on Betsy's point, which I agree with completely, it seems like it would be relatively easy with these medical terminologies, to ask them to submit a copy of a written description of their terminology that could be circulated to the members sufficiently in advance that for those who need to review it, it could be reviewed before the hearing. That would deal with a lot of these issues, so that we don't have to sit here and listen to them describe their vocabularies, which I don't think will liven up the hearings very much.
MR. BLAIR: Actually, I think that's a good point. One of the things we did actually it was almost a year ago is we have 6-10 page descriptions via format profiles of over 30 of these. So in a sense we already have them. The major weakness ironically enough is that question on the characteristics, how clinically specific it is.
But it is the one that winds up indicating the general description, the readiness of the code set, the questions related to market, questions related to relationships to other code sets, questions related to relationships to message format standards. So we do have that. That was distributed. Do you feel like we need to distribute it again? Everybody has that.
MS. HUMPHREYS: That's a good point. It would seem to me that it might actually be a reasonable thing to distribute the write-ups that relate to the vocabularies where people will actually be here to testify, and just say do you want to update this information? Then we'll send that out to the members of the committee, because as we all know, a year is actually a long time for some of these vocabularies in terms of who is using them now, or what enhancements or changes or expansions might have taken place.
DR. COHN: A very good point. Mel?
DR. GREBERMAN: I was just going to suggest what Betsy just did.
DR. COHN: Okay, so we are talking about basically an updating related to them that will be testified.
MR. SOLBRIG: One other thing you might look into is I know Health Level 7 has also last fall done a similar survey. You might be able to leverage some of the work. I think it was Sue Henry that spearheaded that one.
DR. COHN: Other comments or thoughts? This has been very useful, this bit of discussion. I think what we will do is as you have a chance to reflect on this, any e-mail comments are appreciated. Certainly we would ask for members of the audience or via the Internet if you have people that you think should be testifying, we would like to hear.
DR. GREBERMAN: I noticed on the list of WHO was noted, but I think there is an issue though especially for terminology, the international activities that are taking place, and how we want to relate to those.
MR. BLAIR: Could you elaborate a little bit? What are you suggesting? Are you suggesting we invite more?
DR. GREBERMAN: I need to do some checking, because I know several of my colleagues at the FDA are working on a number of harmonization agreements, and it's more than just our interest. The international agreement on terminology in a variety of areas, and I think it's something we have to pay attention to. I'll check for a little bit more detail on that.
MR. BLAIR: Could you e-mail us with recommendations as to how we do that?
DR. GREBERMAN: Sure.
DR. COHN: Betsy was going to make one other comment.
MS. HUMPHREYS: On the draft questionnaire for terminology users, I wonder if it would be any use to have people identify what, from their prospective, would be the highest priority data elements or pieces of patient medical record information for vocabulary standardization, or will everybody just say the same thing?
MR. BLAIR: I don't know.
MS. HUMPHREYS: It might be interesting to ask if they could wave a wand, and we could move to vocabulary standardization for N number of data elements, maybe should make it a small number, what would be their highest priority.
MR. BLAIR: You were saying this with respect to the medical terminology developers?
MS. HUMPHREYS: No, the users.
MR. BLAIR: Okay.
DR. COHN: That may be another way to indirectly get at that issue of the next four years or the next six years in terms of things that ought to be done pretty quickly.
Are we done with this particular phase? We'll follow-up with everyone and have further discussions on this. I know Jeff has a couple of issues. I just wanted to go through a couple of other items that I had bulleted as just things I wanted to hear comment and input on; I think Jeff and I would probably both like to hear comment.
I think Kathleen Frawley commented about the need for a harder look at the whole issue of data quality and quality data. They are sort of both together. I think that with some discussion, that we probably ought to approach the work group on quality of the NCVHS to see if perhaps later in the year we could go back and revisit some of that area in conjunction with them.
Is that a good idea as far as the work group is concerned? I see Jeff and Kathleen Frawley both agreeing. Other thoughts about that? No? Okay.
Another question is later on in the year we now have dates identified. But what is the view of the work group in terms of a need for at least one hearing outside of Washington, D.C.? Let me just bring that issue up. I guess I would speak from my own interest. I am actually not suggesting California necessarily, but I actually thinking more of Chicago probably, or something on that level.
But obviously I thought in previous times when we have gone out of Washington, we got a different view, and really I think understand a little better the tenor of what's going on in the country as a whole, rather than sort of the Washington view inside the Beltway. I'm curious about other views on that. I see one member nodding yes.
MS. FYFFE: Maybe we should spice things up like last July's hearing in Chicago when we all got interviewed by CNN afterward. That was the privacy and confidentiality.
MS. HUMPHREYS: In general, this topic is not as --
MS. FYFFE: I know.
MR. BLAIR: Is the lack of comments a lack of support for being at another city, or the fact that it doesn't much matter? If we could to go another city, it's okay?
DR. FITZMAURICE: Well, I guess I was thinking when you were making that comment, Jeff, would the people that we had testify here have said anything differently if they were in Chicago or Santa Fe? I am trying to think what would be gained out of another place? If we got some different people, people who could then travel, who wouldn't be able to travel now, there might be a great advantage in it.
If we got public opinion from different parts of the country, that would be a great advantage. But if we are pretty much picking the people we want to testify because of their expert knowledge, I wonder if they would say anything differently if they in a different surrounding.
MR. BLAIR: I don't know if it was a matter of saying anything differently. Maybe my thought -- I think I'm echoing Simon's; just tell me if I'm wrong -- is there may be in particular vendors, or members of terminology developers and standards developers, these folks have expressed to us that sometimes they have difficulty getting funds to travel.
You know what we might do? How about this as a thought? In May we are going to wind up having the hearings on medical terminology. Some of the medical terminology developers are small. Maybe if we wind up seeing that there are a number of them from the West Coast that are unable to make it, that may be a clear trigger to us to have a follow-up hearings on the West Coast to pick up those that had difficulty traveling to the East Coast. Is this getting close to the issue?
DR. COHN: No, actually I guess we don't have to decide now on this issue. One of the issues we heard today obviously had to do with the cost of travel for standards developers and others. I actually hadn't thought that that was necessarily the reason that we would travel to hear that. I guess in my own mind I was actually thinking more about users that were small and medium-sized users of standards, and otherwise to hear some of their thoughts and concerns.
People that sort of by definition would likely maybe not even involve themselves in standards development organizations. They would be people that would be unlikely for us to find and bring them out necessarily to Washington. That was really more the rationale that I was using. Once again, we don't have to decide right now.
MS. FYFFE: Des Moines, Iowa. You will have rural users then.
DR. COHN: Let's move on from this. This is not worthy of the time we're spending.
DR. GREBERMAN: But I think you raise some points that are worth exploring. I think if the intent is to get some of these people, and there may be other ways of doing it, for example we might talk to Dana Puskin(?) in the Office of Rural Health Policy, I mean rather the Office for the Advancement of Telehealth now, and see if they can combine some ways of getting some of their fundees in for discussions such as this.
So I know it would be very much harder for any of the feds around the table to travel to the locations, but there may be other ways of getting appropriate people in.
DR. COHN: Okay, well, I think we will rediscuss this. There is nothing we were going to do with this one that would be before the fall anyway. So I think it's an ongoing discussion. I think we're hearing mixed feeling. Des Moines was identified as one potential site of hearings, and we will continue on from there.
MS. HUMPHREYS: Actually, I want you to have the May 17-18 meeting in Chicago, so I can attend both.
MR. BLAIR: Can we go on? Because I don't want to lose time for my proposal.
DR. COHN: Yes, actually there were one or two other issues. This is just a comment that I'm going to make, and I will come back probably with a more defined proposal. Within all of our work theretofore related to administrative simplification, the NCVHS and HHS has used a set of principles for standard selection to guide. What I am actually going to suggest is either at the next meeting or by e-mail or somehow that we visit those criterion principles, and take a look and see their applicability to this work.
As I have looked at what it is that we are doing, and our references and our work plan and otherwise, I am left a little concerned that we need I think to go back to those principles, to make sure that we are appropriately aligned as we move forward to the presentation of the final report, and just to make sure that our activities are really moving us along consistent with those principles. So that will probably be something that maybe we can do during the time in June or otherwise. That's just sort of a comment.
DR. FITZMAURICE: Simon, could I ask are those the guiding principles for the HIPAA administrative standards selection or are these a different set of principles that we find somewhere else?
DR. COHN: No, these are the same principles that somehow have really not been discussed in the context of this work.
DR. FITZMAURICE: Do they exist somewhere, or are you proposing we develop them?
MS. HUMPHREYS: No, they are the ones that you helped write, that are in the front of the NPRM.
DR. FITZMAURICE: So they are the guiding principles?
MS. HUMPHREYS: Right.
DR. COHN: This is the observation. I was reviewing those documents in preparation for this meeting, and I thought this could be of value at a meeting in June if we have a work group where otherwise we can sort of discuss and make that they fit, or if they need to be modified a little bit for this particular work. But we somehow need to incorporate and align ourselves with those principles.
MS. HUMPHREYS: That seems like a very good idea. And it is an interesting question as to whether principles for the selection of administrative standards are carried over one for one for clinical standards or not.
DR. COHN: I think that is the question, if they do need to be modified. It was just an observation, as I said, as I was looking through everything. It seems like they are at about the 80 percent level probably apply, but we need to articulate them as standards upon which we are doing our work. I don't think June will be either too early or too late to begin that activity.
Jeff, I think you had a couple of things, and I have one just sort of to bring in. This had to do with our June meeting. Jeff, did you want to bring up a couple of issues?
MR. BLAIR: Thank you. I have a proposal to make for a name change to the work group. Let me give you some background as to why I am making this proposal. I saw what had happened -- I wasn't there, but I saw the publicity that came out of the June hearings that we had. I felt as if -- this is my personal feeling -- that many of the issues of privacy and confidentiality I strongly, strongly share.
My concern was that sometimes there are folks in the media that will pick up a phrase, or pick up some piece of information from what the committee is doing. If they don't have the time to fully describe it, then the intent or the direction of what we are trying to do could be misrepresented, and people could get emotionally upset.
I feel like we are at risk with the name of our committee for that to happen to us. I have received some e-mails, I have members of the media that have contacted me. And in particular one of the things that they key off of is the name of the committee where it says that we are the CPR work group, and based on the other things that we have done, many folks are concerned that our mission might be to in one way or another, make recommendations that would mandate the use of computer-based patient record systems.
Now fortunately so far I have had the time to explain that our mission is uniform data standards for patient medical record information, and the electronic exchange of that information. And it takes a little bit of time sometimes to explain what that means, all right? So you can wind up seeing that through -- we may not always have the luxury of being able to explain what our mission is.
We could suffer unfortunate representations where the public at large could become very concerned, or certain physician groups, in particular small group and solo practices that are very concerned about this issue, and rightfully so, from their vantage point. I think that we could avoid a problem in this area with very simple effort.
Here is the proposal that I make. I propose that we alter the name of our work group to fit more closely with our mission. The name that I'm suggesting right now, it could be others, but I'm just going to suggest it to get this off the ground and getting a sense of the committee, whether you feel the same way, Patient Medical Record Information. It could be abbreviated PMRI, but the name that I propose is that we rename to the Patient Medical Record Information Standards Work Group.
I would like to put that out. I would like to get some discussion, and then a quick vote to see if the majority of you agree with the name change, or disagree. If you disagree, then we'll just put it on the shelf and not worry about it. Could I hear some feelings or reactions to this proposal?
DR. FITZMAURICE: I think the name that you have proposed connotes exactly the right focus for the working group. The name doesn't matter as much as getting the report done, and getting accurate information in it. But if you perceive that it is causing a problem with external publicity, the name change you propose will address that.
MR. BLAIR: Anyone else.
MS. FYFFE: I think that it's a good change. I support it.
DR. COHN: I'll speak. I actually do not feel strongly one way or another on this one and I continue to abstain, only because I'm not sure that I consider it to be a particular issue. I think one should just be aware as a procedural issue, of course we all need to understand that we will not make a decision today on this, even if we were to support it.
This would be something that would be recommended to the executive committee, and from there, if thought appropriate, to the committee. So it's really more of a sense of the work group type piece. I am actually sorry for this discussion that we don't have two members of the work group here to chime in on this.
MS. FYFFE: What would be the time frame of presenting this to the executive committee?
DR. COHN: Well, I think it could be discussed at the April meeting. It would obviously have to go to the NCVHS in June. So there isn't going to be any quick changes for all of this.
DR. YASNOFF: I think that name more accurately represents what we are doing. I think it does make it less likely that you have to explain in detail what the mission is. And having had to do that on a number of occasions at CDC, I think this would facilitate communicating what is going on here. So it seems reasonable to me.
MR. BLAIR: Any other comments, positive or negative?
DR. BORMEL: I was just wondering whether you want to consider health record information standards work group to connote the broader scope of application of this work?
MR. BLAIR: I understand that not all the members of the committee are here. I would like to at least, and maybe Simon you could help me with this, could we just get a raising of hands of those folks that might support, might opposed, or might abstain?
DR. COHN: Jeff, I think we have already heard from actually the three members of the work group that are here, and I have heard Kathleen Fyffe thinks it's a good idea. I understand you think it's a good idea. I am abstaining. Did you want to have a vote of the staff to see whether they support it?
MR. BLAIR: Can we get a feeling from them, what their thoughts were? Michael you expressed your thought. Anyone else on the staff have a thought on this?
DR. KOLODNER: I think especially if we do the health record, it will be a bit broader, as long as it fits within the mission that we are charged with, that I'm comfortable with that.
DR. GREBERMAN: I agree with that. I think it makes a lot of this confusing to the outside world to really understand what we are doing I think.
MR. BLAIR: I would go on record that I happen to have proposed patient medical record information because that was in the law, patient medical record information standards work group. If it becomes health record standards, as long as that word "standards" is in there, I would feel fine with that also. So maybe Simon, you could carry that to the executive committee.
MS. HUMPHREYS: I was just going to comment that you may need to look in the fact that the name that Jeff proposed directly reflects this part of the charge to the committee. Whereas, I think health in some sense is a better word, it doesn't directly reflect. So the committee, for example, has not been asked to talk about public health data or other types of health data that might be encompassed in the word "health" information standards. So I just bring that up. I am sort on the take it or leave it side of this change.
DR. FITZMAURICE: Just a thought to follow on what Jeff said. He is kind of neutral as long as there is standards in the title of the working group. You might want to think what is the purpose of the working group. Is the purpose to complete a report and die, or are there other issues that you might want to have a health record standards work group work on? We probably don't know that at this point. So I don't know one way or the other. It does leave it open though.
DR. COHN: That's actually an argument for leaving it the same also.
DR. GREBERMAN: I do have a question though for clarification in terms of the mission. Is the focus to be on electronic and computer-based systems, in which case one of those words might be part of that. Or if it doesn't matter, then the broader issues of health or medical records without computer electronic would probably suffice.
DR. FITZMAURICE: I guess given the sense not to wrap ourselves in technology, the information is what is important. How it is communicated accurately is of secondary importance.
DR. COHN: Jeff, do you feel a strong view? Would you like me to have people raise their hands at this point, or you've had enough input at this point?
MR. BLAIR: I think I have had enough input. I guess the only thing -- I guess I would appreciate if we had a show of hands. Then we would wind up having a definitive idea of how people felt about it. Should I just go ahead and ask?
DR. COHN: Do you want to have them vote on all the possibilities?
DR. FITZMAURICE: And whom do you want to vote?
DR. COHN: Let me just ask first, would it be acceptable if we changed the name to the patient medical record information standards work group, and after that we'll wind up asking if it is acceptable to have the health record standards work group. You can vote yes to both. Then we'll also wind up checking if you oppose.
So the first one, is it acceptable to change the name to the patient medical record information standards work group?
DR. COHN: Okay, no? Abstained?
DR. KOLODNER: Everyone else was in the affirmative, except Simon abstained.
MR. BLAIR: Let's try health standards record work group.
DR. COHN: Against? Abstained? More abstentions on that one. Kathleen Fyffe and myself abstained.
MR. BLAIR: To make it complete, all those that feel like we should not change the name of the work group?
DR. COHN: Against? Abstained? Okay, any other issues related to that. Hopefully, we won't spend more time of the work group on that discussion.
Let me move to one other issue, and Jeff, I don't know if you have anything else as we wrap up. I suspect by the time we meet in May that there will be at least a draft agenda for the June NCVHS meeting. It really brings up the issue I think at the minimum the work group needs probably a couple of hours if possible for a meeting. We'll have a full day of hearings before, so it's really more of just a business meeting to figure out and identify next steps, as well as probably talk about that principles issue.
Is there a need for any particular hearings, education, or otherwise for the NCVHS as a whole?
DR. YASNOFF: Is there going to be an interim report submitted by us to NCVHS at that meeting?
DR. COHN: I doubt it. We will know better after the May hearings, but I don't think there is the intent at this point. I think if there is something that comes out that is tremendously pertinent that needs to be communicated to the secretary in the interim, I think what we will do is to produce a letter that then will be vetted by the committee at the June meeting. But in terms of a whole report, I don't expect such a thing.
Were there comments about that? Going back to the question, is there a need for any education to the work group in relationship to this? Or at this point is it perhaps premature? I'm not seeing a lot of enthusiasm for anything beyond just meeting.
MS. HUMPHREYS: You have potentially a large list of people for May 17-18?
DR. COHN: Yes.
MS. HUMPHREYS: So I suppose it is conceivable that you could move some of the people you wanted to provide additional information or education to another meeting, rather than straight testifiers, to see how many people were developers or whatever.
DR. COHN: Remember, we have a day before the June NCVHS meeting that is already scheduled for hearings. So what you are saying is we could do some of that, move them into that day. I guess we could also potentially, if we thought it a particularly good panel, a panel of particular pertinence to the entire committee, we could put it during the two days of meetings.
What we were trying to elicit was whether there was anything in particular that we though needed to be educating the overall committee on as we move forward in all of this stuff. I'm not hearing at this moment anything.
DR. FITZMAURICE: Do we want to take some time to lay out who might be the testifiers at the May 17-18 meeting? That might give us a head start on getting people here, because April 17 comes around awfully fast. As you soon as you get your tax return in the mail, there it is, and you have only a month to go.
DR. COHN: Before we jump into that, is there anything else that we want to talk about, or that needs to be handled? Okay, we'll do that. Then just do a wrap-up and then we'll be done.
DR. FITZMAURICE: The starting point I guess is the list that Jeff has prepared on page 4 of the handout, where we have experts, vendors, and users.
MR. BLAIR: Let me get the feeling of the committee on here. The reason that we listed a section called "experts" was we thought, just like we did yesterday morning, if we had some educational presentations to start off with respect to issues, constructs, terminology about medical terminology, what is nomenclature, and what are the issues related to hierarchy and clinical specificity, so that's why those names are there.
DR. FITZMAURICE: The experts that I see on here are Jim Samino(?), Keith Campbell, Kanta Specman(?), Chris Shoot, Alan Rector, Angelo Rosi Mory(?), who I think is based in Italy.
DR. COHN: And Alan is in England.
DR. FITZMAURICE: Are there other experts that you suggest to educate the committee?
DR. COHN: Well, Bill Yasnoff had already mentioned Betsy Humphreys and Mark Tuttle. You already have that captured.
DR. FITZMAURICE: Is there a particular set in the educational component, or the educational panel we'll call it, of a hierarchy or a priority ranking of things that we want to know? That is, do we want to know definitions first? And then do we want to know something about a system that uses these, and have someone run us through the scenario of how important vocabulary and terminology is in doing a particular function a la patient care, a la quality assurance, a la comparing health plans?
I guess the answer is yes, plus more.
DR. COHN: The answer was what?
MS. HUMPHREYS: I do think it would be very interesting to figure out what you want the experts to tell you that you will not hear from the vendors, the users, and the code set developers. Jim and Chris have both previously briefly the entire NCVHS on important issues related to this, and certainly Jim has done good work on and published work on the desirable characteristics of clinical vocabularies, and could review that.
I guess I don't remember what the overlap is between the people that will be on the committee, and those who have already heard that or read that. A lot of these folks have testified before.
DR. COHN: I can't speak for all of them. Actually, I had thought that Dr. Shoot would be likely to present the recommendations, as well as a review of the Second National Terminology Conference, and any input from that. So that one made sense to me.
I'm not sure that I, at this point, have conceptualized what the other experts are going to want to talk about, or if we will have them as experts or just testifiers in relationship to the other categories.
MR. BLAIR: If I could just add, I'm not sure it has to be this way. It was just some of the thinking that was behind some of the names that were there. I have seen Jim Samino present the desiderata which is the characteristics of what you would look for in terms of a clinically specific medical terminology. He has been presenting that at the tutorials at HL7, and it is understandable that there are many of the committee members that, if they are not familiar with the details of medical terminology, that he speaks at a level that makes that understandable.
MS. HUMPHREYS: I agree with you. I think that's a very good presentation. I was just trying to remember, and maybe it doesn't really matter because the time the committee would have heard it would have been long enough ago that it would be useful to run through it before all these other presentations. Because I think he actually has presented to the NCVHS, that work.
MR. BLAIR: The other person -- I have read Alan Rector's paper where he quoted Angelo Rosi Mory's hierarchy. Actually he has called it different generations. I didn't know whether that might be useful. I haven't seen Angelo present or Alan Rector present. Maybe some folks have feelings as whether or not they would be good educators on these basic concepts of the different generation hierarchies. Simon or Betsy, do you have a thought on that?
MS. HUMPHREYS: I guess I think that Angelo speaks a lot more clearly to people who are really into vocabulary issues and classification issues than he does to people who are not already very familiar with these issues. I'm a great admirer of his work. I think it's very interesting, but I'm not so sure that he would eliminate these issues for people who are not sort of up their eyebrows in them already. Simon, would you agree with that?
DR. COHN: Yes, I'm not sure that I think of Angelo as somebody who discusses basic concepts of health care terminology. I think him as a worldclass expert. There is a particular skill that has to do with taking complex views and trying to make them simple. I think that's really what we are seeking at this point.
MS. FYFFE: Are these experts disinterested parties? In other words, are they objective?
MR. BLAIR: I don't know if there are any disinterested parties.
DR. FITZMAURICE: You mean do they have a conflict of interest? Their own coding system for example?
MS. FYFFE: Yes, or do they work for a vendor?
DR. COHN: I think that there are various levels of interest and disinterest. I'm actually having a little trouble, because I'm feeling a little uncomfortable with this discussion. I think the question is that we need to have a mixture throughout the hearings. I think as you commented, we need to have some disinterested experts to be able to give us a broad overview.
Then with that, talk to more experts who have specific interests. And maybe there are some of the experts that we have that may actually have a specific interest. As long as we're aware, and they disclose them in advance, it's not a problem.
MS. FYFFE: Ideally, you would like experts to disinterested, but if you can't achieve that, then you need to hear from all sides.
DR. COHN: And we'll do both. Maybe there is some further progress we can make on the expert category.
DR. FITZMAURICE: I would suggest maybe Mark Tuttle, but he is a developer. He might have a good perspective over the uses of vocabulary that could cut across a lot of different uses as an educational purpose for us. He also works for a company that does that.
DR. COHN: Yes, well, certainly it actually owns a company that actually deals with some of that. He also may have a view of how terminologies fit together, or don't under certain circumstances.
DR. FITZMAURICE: Is there agreement on Mark? Is there still a concern with having Mark be invited to the expert panel? I've got so far that we would like Jim Samino, Chris Shoot, Mark Tuttle. We would like to have Betsy.
DR. COHN: It sounds like Betsy isn't available unfortunately.
MS. HUMPHREYS: We could provide somebody else.
DR. COHN: Mark Tuttle I think also represent a lot of the knowledge, or Betsy, am I mistaken about that?
MS. HUMPHREYS: He certainly can represent some of it. I don't think that he -- and as I say, if you want to have various government agencies represent their views, you can do that at a different time.
MR. BLAIR: Here is a thought. Jeff is groping again. Betsy, if there is any way that you could be there either for the first day or the second day, I think it would be really helpful. If you really can't, would you consider doing one of those educational presentations on a video tape, where at least we could present it?
DR. COHN: Actually, perhaps I can amend that. Betsy, if you are unable to come, if you would provide some written testimony to the committee, I think we would appreciate it. Is that okay?
MR. BLAIR: Video tape you feel is an inappropriate medium for us to listen to that day?
MS. FYFFE: I think it's an imposition.
MR. BLAIR: I'm sorry.
DR. COHN: I think for someone who isn't going to be there physically to interact, we can also get information through written testimony, rather than taking the time of the committee to watch a video tape. But we would obviously encourage you, if at all possible, to be at one of the two days.
DR. FITZMAURICE: It might also be worthwhile that afterwards, maybe for the hearings after May, that a good use of Betsy might be to kind of here is what I read, or here is what I heard through the Internet, and here are some of my views, to get a more personal expression of how she views vocabularies and terminology, and how they fit together, rather than to fit it into the structure of the hearings. That would give her free will to tell us what she thinks we ought to know.
MS. HUMPHREYS: Have you ever found a point where I wouldn't have done that? I am looking at your group of experts here, and I was thinking that get around your view, that rather than referring to these people as "experts" where you might want to say, well, we're putting them in opposition to vendors or users or whatever, maybe what you want to refer to these to say, who do we have? Can we put up some people who have experience using and analyzing lots of different terminologies?
That would certainly bring in Chris, it would certainly bring in Jim Samino, who I think have a broad view. It brings in Mark Tuttle. They have analyzed these things up and down. That is not to say whether they may have preferences among them. But they have really worked with many. Then we might think of some other people that would fit into that category.
I think that they are in a position to discuss characteristics or issues and problems that surround various types of structure or semantics in vocabularies as a result of having had to deal with lots of them.
DR. FITZMAURICE: Let me ask too on the structure of the first panel, are you included more to have a 20 minute presentation than a 10 minute presentation? I know that for this one, for these sets of hearings we tended to give them more time to lay out what it is that we should know. It seemed to work well the first day; certainly the first half of the first day. We gave them time to give us definitions, and then to work with those definitions.
DR. COHN: Let me make a proposal on this, because I'm looking at the people and maybe the topics. Now once again, we haven't even got to what we learned from these last two days in terms of process, but I certainly thought our plans to have a relaxed morning session yesterday morning didn't quite work out as planned. I think it to do potentially with the fact that we had four presenters, one right after another, and then tried to have all the discussion afterwards.
I think what I might think about is that we have a panel to start out with that potentially includes maybe Dr. Samino, Dr. Shoot, and then discussion with them around sort of these sort of high level -- what they can tell us. Maybe there is a second panel that might include Mark Tuttle, potentially Keith Campbell, to talk about the specific areas, and then potentially someone else.
Once again, rather than try to make the panels bigger and longer periods of time, keep the panels smaller with more discussion within a fixed amount of time. That may be the way we try to do it, having two or three per panel, at least for those initial panels in the morning.
MS. HUMPHREYS: If you're dealing with potentially Chris and Jim talking about characteristics of clinical terminologies and desiderata for them, and in some sense content issues, then you might consider having a panel that might include Mark, but others. People who basically are involved in this notion of terminology middleware. That is, developing terminology services for other systems.
Then we are going to get down to the real system developers later, and the real users. Because that is in essence what Lexico Technology, and there are a couple of other folks that do it, do, is provide the sort of terminology middleware. Therefore, they have to deal with a lot of different terminologies.
DR. KOLODNER: One of the things is whether we start with this broad view, or whether having their view or reactions to what has been presented, if they are able to at least listen or even attend, having their perspective of it might be a way to tap into their expertise, rather than opening it up and then having to drill down into the more specific things later.
DR. COHN: Lot's of interesting options. It puts a little additional strain on them, having to critique.
DR. KOLODNER: Well, what I'm thinking, and it doesn't mean that they have to, but for example today where Jeff and Joe were able to refer to other comments that had been made the day before. If may turn out that they are not available, that their time is so tight that they can say, well, I can give you half a day and fly in and fly out. But if it turns out that they are available, then having them be able to comment or pick up on themes and weave them in, or reflect that back to us. As opposed to us never being able to benefit from that observation.
DR. COHN: An interesting option also, just perhaps blending things a little bit, because I think the work group benefits from having potentially an overall conceptualization to begin to think about things and relationships. You weren't here yesterday, but we actually asked the panelists to stick around and participate in some of the discussion as we continued on through the day.
That may actually be another option. A question for the people here is whether that worked or not. It theoretically should work. Whether it did work or not is a whole other story. Kathleen, I guess I'll ask you. Was that a useful construct for how we did things yesterday?
MS. FYFFE: Yes, more of a dialogue.
DR. COHN: That is a blended view of what are describing.
Now let me move to ask some other questions here, because I want to cram through this a little bit. I think we have done some work at the beginning, the first morning. This may not be bad to at least mull over. Without listing names of vendors that you have identified, Jeff, or postulated, do we have vendors that we want to recommend, that we think are users, or types of vendors that need to be included.
MS. HUMPHREYS: Epic.
COL. RAY: I think I would like to see Purkinje. Since we are looking at Oceania, probably the other one to look at is Purkinje.
MS. HUMPHREYS: How do you have spell that?
COL. RAY: P-U-R-K-I-N-J-E.
MS. HUMPHREYS: I have seen it, now that you spell it for me, Lynn.
DR. COHN: Kathleen, let me ask you. You have at times mentioned vendors that aren't putting terminology in. Is there a value to -- or don't have much of a sense of this -- is there a value to have software vendors that are, rather than the ones that have tried to put it in, the ones that have chosen not to stick it in, or don't think that there is value to this area? You are looking at me funny. I may be mischaracterizing your comments. I think it's potentially small to medium-sized developers that may not be equal players in this area yet.
MS. HUMPHREYS: I'm sorry, I'm not familiar with all of these names. Do we have people here who do individual or small practice software?
DR. COHN: That's I think what I'm trying to get to.
MS. FYFFE: Yes, exactly. There are practice management system vendors who have installations in hundreds of medium to small size practices. I don't know off the top of my head the names of those vendors. The audience might be able to help.
MS. HUMPHREYS: There also are the people who are doing this business about letting people -- setting up systems so people can record their own personal medical information for themselves on Web-bases systems. Keep your own personal health records, immunizations for your children, your own material --
MS. FYFFE: That's very interesting. Who gets to access it? Can a doctor access that?
MS. HUMPHREYS: I guess in the case of these systems, they really are marketed directly to patients. I assume it's up to the consumer who the information is shown to. But it would seem to me that we might want to represent that group as well.
MS. FYFFE: Please.
DR. COHN: The personal medical record information systems. I think that's how we would describe that.
MS. FYFFE: My 71 year old typical patient from Wisconsin who goes to Florida could simply say here is the Internet address, and I'll give you the PIN number, and you can see what is going on. That's very interesting.
MR. BEATTY: For the small vendor you might want to contact somebody from like the MGMA --
MS. FYFFE: Medical Management Association.
MR. BEATTY: Right, that represents the vendors for some of the smaller systems and so forth, that are put into the provider setting. That might be one good place to look. The other thing, when you look at the software, and this kind of touches on one of the discussions Chuck and I had on the side was when you are looking at vendors, look at all of their various categories of vendors that will deal with this type of thing, from the patient's access to the medical record information, to the practice management vendors, to the people that will be providing software, doing data collection for data analysis purposes for research and education purposes.
So there is a broad spectrum of different types of software vendors that may have an interest in the patient medical record information.
DR. COHN: Great. Thank you for your thoughts. Other views on this? I should apologize to the vendors who may listening in about any misrepresentations I may have made.
MR. BLAIR: Betsy, did you want to go first?
MS. HUMPHREYS: I was just going to say, following up on his remarks under the user as part of this, you may want to have someone who is managing and collecting patient data for a clinical trials. And I don't think, although I could be wrong, I don't know if we have a big segment of the software developer groups that are targeted towards clinical trials. If we don't, no doubt we will tomorrow. But I do know that there are users, that is, people who are managing and collecting data specifically for clinical trials, and often they do rely on controlled vocabulary to do it.
MR. BLAIR: When we wound up talking about the definition of patient medical record information, I know that in the back of my mind I was thinking of it being predominantly clinical information, and just enough administrative information or demographic information to identify the patient.
But in my mind, I was excluding for the most part, the information that related to the reimbursement process, or legal information. Now actually, when we heard definitions during these last two days, a lot of folks that testified included financial, administrative, and clinical. They took a broader view.
When we get to medical terminology, the bias -- why don't we call it Jeff's bias, okay, because I think that's reasonable -- it's my focus anyway. So I would rather have my biases out on the table. And by the way, the end of my remarks is going to be that we include a broad definition, not a narrow one.
But because I am winding up saying we include a broad definition, which means that we do include practice management vendors. Vendors that have not pressed forward into clinical specific terminologies. Let's hear from them, because maybe they will tell us why. Maybe they will tell us that they didn't feel that these terminologies were ready, or too expensive, or there were licensing or pricing issues, or that they were too complex, or whatever it is, I think we should hear from them.
MS. FYFFE: Or their customers simply didn't ask for it.
MR. BLAIR: Right. Whatever it is. My thought is that I'm trying to see, and I don't know if we are going to answer this right now, I think we need to structure the panels and the hearings so that we don't get confused. I think that there is going to be a certain set of issues we need to hear from, from let's say practice management vendors that really haven't adopted clinically specific medical terminology yet.
I think we need to hear clearly from those folks that have been trying to adopt clinically specific terminologies, to hear what their difficulties are. So I probably would suggest that when we have the panels, that we separate those out so we don't start to get confused from the marketplace that they are representing. That would probably be my only suggestion.
DR. COHN: Based on what you are just telling, I share your same view of wanting to get all that, but I'm not at all clear that we need to separate the views of vendors, as opposed to having them sort of bounce off of each other, and see what the interaction that results. I don't know that I feel strongly one way or another. Do others have a view?
MS. FYFFE: I think if we look back to some of the comments I have made, and some of the discussions we have had about the business case, you know to get this vision implemented in the physician practices and offices around the country, I think many of your physician offices typically would have four or five doctors in the medium to small size, or maybe larger than that.
Who are their vendors? What do their vendors think about the possible recommendations we might be making out of this whole exercise? What are their views on whether or not it is feasible. Is it going to happen? In general, would it be cost prohibitive? I'm looking forward to the implementation of our vision here. I really think you need to hear from those vendors.
I know of one office in particular. They have been using the same vendor for probably 15 years. They are quite happy with their system. Everything is working well, and they would not really be interested in changing vendors. How do we get them on board on this whole thing? To me, that's really the practical implementation question that we need to be asking.
MS. HUMPHREYS: You know, Kathleen, as you were talking, it seems to me that the work group might very well want to hear from this broader spectrum of vendors on a whole lot of issues, not just terminology.
MS. FYFFE: Yes, oh, yes.
MS. HUMPHREYS: So I guess that may be a planning sort of positioning issue, who gets invited to the terminology one, where their views would also be interesting. But whether there has to be some other hearing where these people would be invited to comment on a broader range of issues, I don't know.
MS. FYFFE: I think back to some of the survey work that the Work Group for Electronic Data Interchange did four or five years ago. What I remember is that at that time there were about 200 major hospital information systems vendors. There are fewer than that now, because there has been consolidation in the industry.
There were about 2,000 practice management system vendors. This was four or five years ago. Let's say half of them have disappeared, or have been buying each other out. That means there are a 1,000 of them. If we don't do anything else, I think we ought to hear from a few of them. That's my point.
DR. FITZMAURICE: Now by practice management, do you mean the administrative side, or the clinical side as well? Because if I call somebody and they say, well, we don't have a clinical record system here. We've got a lot of bill paying systems.
MS. FYFFE: You have to hear from a representative sample of what exists out there. If they don't have clinical systems, we cannot ignore them. We've got to talk to the guys that have got to talk to the guys that have got purely the administrative practice management systems. Guess what? If that's all that is out there, then that information itself is useful to us.
MR. BLAIR: Generally when we wound up looking at vendors that identified themselves as practice management vendors, their applications typically include claims processing, accounts receivable, scheduling appointments. And tracking of the paper folders of a medical record. Now this is not a sharp, definitive definition. It is a general one. Maybe in the future it will evolve some more.
Now in the marketplace, as I have had the opportunity to view it, the folks that start to try to pull together whether they call it an electronic medical record or a computer-based patient record, very often they look upon that as either a separate application, and in many cases they are entirely separate vendors.
You might even see in many cases like Medic is an example of a very large practice management vendor who has made a strategic decision that the electronic health record area in an ambulatory care is a whole new business. It's a whole new marketplace. They are interfacing to Epics and Medical Logics and others that do electronic health records.
So the only point that I'm making here is to clarify a little bit, a generality on the definition of practice management. You probably would have to, if we are winding up inviting practice management vendors, unless they specifically say that they have developed an application which is an electronic health record, then it probably does not include that.
DR. COHN: Can I chime in on this one? Because I actually agree completely with your fact base, I just come to a different conclusion. I guess I have gone on record before as stating that the differences between administrative and clinical data are not anywhere as obvious as one would like to think. There is a big gray area there.
I think that it's useful to hear from this group. I think that the questions that can be asked, if you have a scheduling system, how does that all play in? Are you just putting the patient's name in, or maybe are you putting a problem in that they are being seen for? Is there an issue around that. It goes all over the map.
I think that, Jeff, I'm not sure, you may be agreeing with me in terms of saying, yes, we need to query them. So I think maybe we can stop the discussion at this point to say, yes, we need to recognize that it is getting close to one o'clock. Let me make a couple of other comments, because I think we have gone pretty far.
I'm actually suggesting similarly, as we talk about users, that we may want to get people that are users of clinical terminologies, and can speak to their experiences so far. But maybe we also want to hear from important other constituencies of users, that for whatever reason, have not adopted clinical terminologies, and find out what their --
MS. HUMPHREYS: Well, there is no dearth of users who built their own.
DR. COHN: Well, that's a whole other deal. Maybe we ought to talk to them. Now I will say that we are not going to get all of these groups together in one two-day session. There is a reason why we have a third, and we may even wind up with a fourth day around terminology, based on the complexity of that issue. But I think it begins to provide at least a conceptual frame to begin to approach it. I agree with you. I think we probably ought to either potentially hear from people that have, for whatever reason, built their own systems, and find out what their views are.
Now it's getting close to one o'clock and we identified that one was going to be our finishing time. Are there any other comments or pertinent statements that we should take into account as we planned this session in May?
MR. BLAIR: I think the only thing is for folks to send us e-mails on any other additional ideas they have for the May session, especially the comments on the document. We will attempt to get a revised version of that out to them before we get it sent out. That's about it.
MR. BEBE: A very simple question. I'm just wondering if you have any idea when the questions will get out to the invitees?
MR. BLAIR: Michael?
DR. FITZMAURICE: As soon as they are finalized they go right out to the invitees. I do not delay them an instant.
DR. COHN: So probably within the next two weeks we would hope.
DR. FITZMAURICE: But we need to know who the invitees are. To that end, I don't have enough names at this point to be able to tell you who would be on the next four panels.
MS. FYFFE: Is anybody in this room a member of the MGMA?
DR. FITZMAURICE: I have no trouble with calling their main office.
MS. FYFFE: Yes, call the Medical Group Management Association.
DR. FITZMAURICE: Do you want to have a full panel of them?
MS. FYFFE: No.
DR. FITZMAURICE: I'm trying to get your senses of whom do you want to get advice from for producing information for the report.
MS. FYFFE: The reason I think we are talking about calling the Medical Group Management Association is to get the names of practice management system vendors. Surely, as with many things in this world, if we ask them to name the top five or the most popular ten practice management system vendors, they could tell you that. So with that information, then we would go to Websites to get the location of these guys and call them in. That's the type of thing.
DR. FITZMAURICE: My sense is that you would not like to have a full panel of these guys, but you might have two of them; at least one, maybe two of them.
MS. FYFFE: Right. Now is that for the May meeting?
DR. COHN: I think that that would be potentially included in the May meeting.
MR. BLAIR: We do have one name. I think Medic is certainly within the top three or four. That's one name.
MS. FYFFE: I might be able to get you the name of one, Michael. I've got to check back in my office among my notes.
DR. FITZMAURICE: Thank you, Kathleen.
DR. COHN: I expect that we will be able to work on further issues, as well as revision offline and get that together.
DR. FITZMAURICE: Now do I take it that the people on the list, that you are comfortable if I begin calling them -- you're not comfortable? You want to give me additional names at some later date?
DR. COHN: I think with the use of the overheads I think you have identified I think two panels that I think we all feel pretty comfortable potentially going forward with. I think we have identified some pools of names that we now need to revise a little bit, and begin asking people to be -- trying to fit together panels and views. I think it's probably going to take another week as we look at the questions. Identify what we can do in the first two days, versus in additional hearings is sort of my sense.
Do you have a different view?
MR. BLAIR: Actually, I do, but it doesn't much matter. We can talk this through. It's a minor thing in terms of how do we wind up educating people as well as we can? What's the right form?
What I was going to suggest that while we are here together, we heard from the committee once before that sometimes it is agonizing to have these big conference calls. On the other hand, to balance it off we also don't want to have conference calls between Mike and Simon and myself that are excluding other folks that do want to participate.
This is an opportunity before we disappear if maybe we could agree on a time or a day and time or hour conference call while everybody else is here. We could get an e-mail message out to folks, and they could participate if they wish, and they don't have to if they don't want to. Could I just ask Michael and Simon if maybe sometime early next week might be a time when we can do a conference call to wrestle through the agenda and stuff? Is that all right?
DR. FITZMAURICE: I think that would be great. Tuesday, Wednesday, Thursday, Friday look pretty good, except Thursday mornings I chair a meeting.
MR. BLAIR: I'm busy on Thursday, but I've got Monday, Tuesday, Wednesday.
MS. FYFFE: Send me and e-mail. I don't have my calendar.
DR. COHN: I think we can handle this offline basically.
Thank you everyone, and we will continue working on this. I think as those on the Internet are probably aware of at this point, we'll have another set of hearings in May 17-18, which will also be broadcast on the Internet.
Thank you very much for your attention.
[Whereupon, the meeting was recessed at 1:13 p.m.]